tag:theconversation.com,2011:/uk/topics/generic-drugs-19121/articlesGeneric drugs – The Conversation2024-03-08T13:38:33Ztag:theconversation.com,2011:article/2228582024-03-08T13:38:33Z2024-03-08T13:38:33ZAsthma meds have become shockingly unaffordable − but relief may be on the way<figure><img src="https://images.theconversation.com/files/579691/original/file-20240304-18-r33cu5.jpg?ixlib=rb-1.1.0&rect=25%2C51%2C8538%2C5469&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Its price will take your breath away.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/man-using-blue-asthma-inhaler-medication-royalty-free-image/1179346207?">Brian Jackson/Getty Images</a></span></figcaption></figure><p>The <a href="https://www.businessinsider.com/cost-asthma-medication-doubled-unjust-2023-7">price of asthma medication has soared</a> in the U.S. over the past decade and a half. </p>
<p>The jump – in some cases from around <a href="https://doi.org/10.1001/jamainternmed.2015.1665">a little over US$10</a> <a href="https://www.singlecare.com/blog/albuterol-sulfate-hfa-proventil-hfa-without-insurance/">to almost $100</a> for an inhaler – has meant that patients in need of asthma-related products <a href="https://www.businessinsider.com/cost-asthma-medication-doubled-unjust-2023-7">often struggle</a> to buy them. Others simply <a href="https://asthma.net/living/cannot-afford-inhalers">can’t afford</a> them. </p>
<p>To make matters worse, asthma <a href="https://www.fda.gov/drugs/buying-using-medicine-safely/generic-drugs">disproportionately affects</a> lower-income patients. Black, Hispanic and Indigenous communities have the <a href="https://aafa.org/asthma-allergy-research/our-research/asthma-disparities-burden-on-minorities/">highest asthma rates</a>. They also shoulder <a href="https://aafa.org/asthma-allergy-research/our-research/asthma-disparities-burden-on-minorities/">the heaviest burden</a> of asthma-related deaths and hospitalizations. Climate change will likely <a href="https://www.hsph.harvard.edu/c-change/subtopics/climate-change-and-asthma/">worsen asthma rates</a> and, consequently, these disparities.</p>
<p>I’m a health law professor at <a href="https://www1.villanova.edu/university/law/faculty-scholarship/faculty-directory/profiles/AnaSantosRutschman.html">Villanova University</a>, <a href="https://papers.ssrn.com/sol3/cf_dev/AbsByAuth.cfm?per_id=2667484">where I study</a> whether patients can get the medicines they need. And I’ve been watching this affordability crisis closely.</p>
<p>In many ways, it shows what happens when law and policy decisions aren’t aligned with public health needs. The good news, however, is that there finally seems to be some political will to rein in the price of asthma meds.</p>
<h2>Why inhaler prices are skyrocketing</h2>
<p>In 2008, the U.S. Food and Drug Administration <a href="https://www.fda.gov/drugs/frequently-asked-questions-popular-topics/transition-cfc-propelled-albuterol-inhalers-hfa-propelled-albuterol-inhalers-questions-and-answers">banned inhalers</a> that use chlorofluorocarbons, or CFCs – which were once widely used as propellants – because they can damage the ozone layer. The FDA was following a timeline set by an environmental treaty, the <a href="https://www.unep.org/ozonaction/who-we-are/about-montreal-protocol">Montreal Protocol</a>, which the U.S. ratified in the late 1980s. </p>
<p>From 2009 onward, CFC inhalers were phased out and replaced with hydrofluoroalkane, or HFA, ones, which are more environmentally friendly. They’re also a lot pricier. For patients with insurance, the average out-of-pocket cost of an inhaler rose from $13.60 per prescription in 2004 to $25 immediately after the 2008 ban, <a href="https://doi.org/10.1001/jamainternmed.2015.1665">a 2015 study found</a>.</p>
<p>Today, the <a href="https://www.singlecare.com/blog/albuterol-sulfate-hfa-proventil-hfa-without-insurance/">average retail price</a> of an albuterol inhaler is $98. Unlike CFC inhalers, which have <a href="https://www.fda.gov/drugs/buying-using-medicine-safely/generic-drugs">generic versions</a>, HFA inhalers are <a href="https://www.scientificamerican.com/article/unlikely-victims-of-banning-cfcs/">covered by patents</a>. While <a href="http://doi.org/10.1089/jamp.2016.1297">the drug itself</a> hasn’t changed, the switch to a different device allowed companies to increase their prices.</p>
<p>In 2020, the FDA finally approved the <a href="https://www.fda.gov/news-events/press-announcements/fda-approves-first-generic-commonly-used-albuterol-inhaler-treat-and-prevent-bronchospasm">first generic version</a> of an albuterol inhaler. But generic competition still isn’t robust enough to lower prices meaningfully.</p>
<p>Patients with good insurance <a href="https://allergyasthmanetwork.org/advocacy-updates/united-healthcare-albuterol-epinephrine-cost/">may pay very little</a> or even nothing. But uninsured patients face steep market prices, and as of 2023, there were <a href="https://aspe.hhs.gov/sites/default/files/documents/e06a66dfc6f62afc8bb809038dfaebe4/Uninsured-Record-Low-Q12023.pdf">over 25 million</a> uninsured Americans. <a href="https://www.cdc.gov/asthma/asthma_stats/insurance_coverage.htm">Even insured patients may have trouble</a> affording their asthma meds, the CDC has found. </p>
<p>The same asthma medication for which U.S. patients pay top dollar is available elsewhere at much cheaper prices. Consider the following case for inhalers. The pharmaceutical company Teva sells <a href="https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ccd3aaec-4892-40d0-ad60-3e570178fbe1">QVAR RediHaler</a>, a corticosteroid inhaler, <a href="https://doi.org/10.1016/S2213-2600(24)00012-2">for $286</a> in the U.S.</p>
<p>In Germany, Teva sells that same inhaler for $9.</p>
<h2>Seeking meds from Mexico and Canada</h2>
<p>Some U.S. patients have traveled abroad to obtain cheaper asthma medication. After the 2008 ban on CFCs, it became common for patients to <a href="https://doi.org/10.1177/8755122515595052">visit border towns in Mexico</a> to purchase albuterol inhalers. They were sold for <a href="https://doi.org/10.1177/8755122515595052">as little as $3 to $5</a>. </p>
<p>A study of inhalers available to U.S. patients in Nogales, Mexico – about an hour south of Tucson, Arizona – found that Mexican products were <a href="http://doi.org/10.1177/8755122515595052">generally comparable to U.S. inhalers</a>. But researchers found some differences in performance, suggesting that American patients who use them could be getting a slightly different dose than their usual.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/580250/original/file-20240306-24-xrc96u.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Asthma medication is seen on the shelves of a Mexican pharmacy." src="https://images.theconversation.com/files/580250/original/file-20240306-24-xrc96u.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/580250/original/file-20240306-24-xrc96u.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/580250/original/file-20240306-24-xrc96u.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/580250/original/file-20240306-24-xrc96u.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/580250/original/file-20240306-24-xrc96u.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/580250/original/file-20240306-24-xrc96u.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/580250/original/file-20240306-24-xrc96u.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Asthma meds are considerably more affordable south of the border.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/the-interior-of-farmacia-san-pablo-news-photo/1041982048">Jeffrey Greenberg/Universal Images Group via Getty Images</a></span>
</figcaption>
</figure>
<p>There have also been reports of Americans turning to Canadian pharmacies to purchase asthma inhalers at much cheaper prices. In one case, a U.S. pharmacy would have charged $857 for a three-month supply. A patient obtained it for <a href="https://www.seattletimes.com/life/wellness/canadian-pharmacy-provided-inhaler-at-a-fraction-of-us-cost/">$134 from a pharmacy in Canada</a>.</p>
<h2>One potential fix: Importing cheaper meds</h2>
<p>U.S. law has long <a href="https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/frequently-asked-questions-about-drugs">prohibited</a> personal importation of pharmaceutical drugs. However, a recent development could <a href="https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-allow-florida-import-cheaper-drugs-canada-2024-01-05">pave the way for states</a> to import cheaper asthma drugs.</p>
<p>In January 2024, the <a href="https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-allow-florida-import-cheaper-drugs-canada-2024-01-05/">FDA authorized</a> the importation of certain prescription drugs from Canada for the first time. <a href="https://www.kff.org/policy-watch/what-to-know-about-the-fdas-recent-decision-to-allow-florida-to-import-prescription-drugs-from-canada/">For now</a>, this authorization is limited to Florida, and it covers only drugs for HIV/AIDS, prostate cancer and certain mental health conditions.</p>
<p>Should it prove successful, the program could serve as a blueprint for other states.</p>
<h2>Another possible solution: Price-capping</h2>
<p>Policymakers could also try borrowing a page from the insulin playbook. Insulin prices <a href="https://doi.org/10.1001/jamanetworkopen.2023.18074">climbed for almost two decades</a> before Congress acted, capping the cost of insulin for Medicare patients. The 2022 <a href="https://www.congress.gov/bill/117th-congress/house-bill/5376/text">Inflation Reduction Act</a> established an out-of-pocket ceiling of $35 per month for prescription-covered insulin products. </p>
<p>If this cap had been in effect two years earlier, it would have saved 1.5 million Medicare patients about $500 annually, <a href="https://www.hhs.gov/about/news/2023/08/16/first-anniversary-inflation-reduction-act-millions-medicare-enrollees-savings-health-care-costs.html">a recent study estimated</a>. It also would have saved Medicare <a href="https://www.hhs.gov/about/news/2023/08/16/first-anniversary-inflation-reduction-act-millions-medicare-enrollees-savings-health-care-costs.html">$761 million</a>.</p>
<p>A similar approach could be taken for asthma meds.</p>
<p>Congress could create an asthma-specific rule similar to the insulin case. Or it could place provisions for asthma-med prices into a larger piece of legislation.</p>
<p>While this approach depends on the political environment, there are signs the government is becoming more willing to act. In January 2024, the U.S. Department of Health and Human Services <a href="https://www.hhs.gov/about/news/2024/01/29/readout-hhs-officials-meeting-private-sector-patient-advocacy-leaders-improve-national-access-important-asthma-medications.html">hosted a meeting</a> to discuss the problem with manufacturers and other stakeholders.</p>
<p>It’s a start. And – together with other measures – it brings some hope that asthma meds might soon become more affordable to those in need.</p><img src="https://counter.theconversation.com/content/222858/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Ana Santos Rutschman does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>An inhaler that costs nearly $300 in the US goes for just $9 in Germany. What gives?Ana Santos Rutschman, Professor of Law, Villanova School of LawLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/2068482023-07-20T12:29:04Z2023-07-20T12:29:04ZBlame capitalism? Why hundreds of decades-old yet vital drugs are nearly impossible to find<figure><img src="https://images.theconversation.com/files/537557/original/file-20230714-29-wo8n77.jpg?ixlib=rb-1.1.0&rect=0%2C17%2C6000%2C3970&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">There is presently no end in sight to the drug supply shortage. </span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/young-pharmacist-checking-the-shelves-with-a-royalty-free-image/1344251576?phrase=generic+drugs&adppopup=true">FG Trade/E+ via Getty Images</a></span></figcaption></figure><p><a href="https://www.npr.org/sections/health-shots/2019/12/31/792617538/a-decade-marked-by-outrage-over-drug-prices">Past public ire</a> over high drug prices has recently taken a back seat to a more insidious problem – <a href="https://pharmanewsintel.com/features/drug-shortages-a-growing-concern-for-the-healthcare-industry-worldwide">no drugs</a> <a href="https://www.nytimes.com/2023/05/17/health/drug-shortages-cancer.html">at any price</a>.</p>
<p>Patients and their providers increasingly face <a href="https://www.nytimes.com/2023/06/26/health/cancer-drugs-shortage.html">limited or nonexistent supplies of drugs</a>, many of which treat essential conditions such as cancer, heart disease and bacterial infections. The American Society of Health System Pharmacists now <a href="https://www.ashp.org/products-and-services/database-licensing-and-integration/ashp-drug-shortages">lists over 300 active shortages</a>, primarily of decades-old generic drugs no longer protected by patents.</p>
<p>While this is not a new problem, the number of drugs in short supply has increased in recent years, and the average shortage is lasting longer, with more than 15 critical drug products <a href="https://www.hsgac.senate.gov/wp-content/uploads/2023-03-20-HSGAC-Majority-Draft-Drug-Shortages-Report.pdf">in short supply for over a decade</a>. Current shortages <a href="https://www.ashp.org/drug-shortages/current-shortages/drug-shortages-list?">include widely known drugs</a> such as the antibiotic amoxicillin; the heart medicine digoxin; the anesthetic lidocaine; and the medicine albuterol, which is critical for treating asthma and other diseases affecting the lungs and airways.</p>
<p>What’s going on?</p>
<p>I’m a <a href="https://scholar.google.com/citations?user=3jf-nyIAAAAJ&hl=en&oi=ao">health economist</a> who has studied the pharmaceutical industry for the past 15 years. I believe the drug shortage problem illustrates a major shortcoming of capitalism. While costly brand-name drugs often yield high profits to manufacturers, there’s relatively little money to be made in supplying the market with low-cost generics, no matter how vital they may be to patients’ health. </p>
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<iframe width="440" height="260" src="https://www.youtube.com/embed/aXbYGfz2ATE?wmode=transparent&start=17" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">The shortage includes chemotherapy drugs, antibiotics, medications to treat ADHD and other critical drugs. Some patients are able to get their drugs, while others are not, and in some cases patients are getting ‘rationed care.’</span></figcaption>
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<h2>A generic problem</h2>
<p>The problem boils down to the nature of the pharmaceutical industry and how differently the markets for brand and generic drugs operate. Perhaps the clearest indication of this is the fact that <a href="https://www.rand.org/pubs/research_reports/RR2956.html">prices of brand drugs in the U.S. are among the highest</a> in the developed world, while generic drug prices are among the lowest. </p>
<p>When a drugmaker develops a new pill, cream or solution, the government grants the company an exclusive patent for up to 20 years, although most patents are filed before clinical testing, and thus the effective patent life is closer to eight to 12 years. Nonetheless, patents allow the drugmakers to cover the cost of research and development and earn a profit without the threat of competition from a rival making an identical product.</p>
<p>But once the patent expires, the drug becomes generic and any company is allowed to manufacture it. Since generic manufacturers are essentially producing the same product, profits are determined by their ability to manufacture the drug at the lowest marginal cost. This often results in low profit margins and can lead to cost-cutting measures that can compromise quality and threaten supply. </p>
<h2>Outsourced production creates more supply risks</h2>
<p>One of the consequences of generics’ meager margins is that drug companies outsource production to lower-cost countries.</p>
<p>As of mid-2019, 72% of the manufacturing facilities making active ingredients for drugs sold in the U.S. <a href="https://www.fda.gov/news-events/congressional-testimony/safeguarding-pharmaceutical-supply-chains-global-economy-10302019">were located overseas</a>, with India and China alone making up nearly half of that. </p>
<p>While overseas manufacturers often <a href="https://openknowledge.worldbank.org/server/api/core/bitstreams/3842481d-7bc7-532b-8cd2-ab30f57c6519/content">enjoy significant cost advantages</a> over U.S. facilities, such as easy access to raw materials and lower labor costs, outsourcing production at such a scale raises a slew of issues that can hurt the supply. <a href="https://www.nytimes.com/2011/08/13/science/13drug.html?pagewanted=al">Foreign factories are more difficult</a> for the <a href="https://theconversation.com/the-fdas-lax-oversight-of-research-in-developing-countries-can-do-harm-to-vulnerable-participants-170515">Food and Drug Administration to inspect</a>, tend to have more production problems and are far more likely than domestic factories to be shut down once a problem is discovered. </p>
<p><a href="https://www.fda.gov/news-events/congressional-testimony/safeguarding-pharmaceutical-supply-chains-global-economy-10302019">In testimony to a House subcommittee</a>, Janet Woodcock, the FDA’s principal deputy commissioner, acknowledged that the agency has little information on which Chinese facilities are producing raw ingredients, how much they are producing, or where the ingredients they are producing are being distributed worldwide. </p>
<p>The COVID-19 pandemic underscored the country’s reliance on foreign suppliers – and the risks this poses to U.S. consumers.</p>
<p>India is the world’s largest producer of generic drugs but imports 70% of its raw materials from China. About <a href="https://www.cidrap.umn.edu/sites/default/files/downloads/cidrap-covid19-viewpoint-part6.pdf">one-third of factories</a> in China shut down during the pandemic. To ensure domestic supplies, the Indian government restricted the export of medications, <a href="https://www.nytimes.com/2020/03/03/business/coronavirus-india-drugs.html">disrupting the global supply chain</a>. This led to shortages of drugs to treat COVID-19, such as for respiratory failure and sedation, as well as for a wide range of other conditions, <a href="https://www.uspharmacist.com/article/drug-shortages-amid-the-covid19-pandemic">like drugs to treat chemotherapy</a>, heart disease and bacterial infections. </p>
<h2>Low profits hurt quality</h2>
<p>Manufacturing drugs to consistently high quality standards requires constant testing and evaluation. </p>
<p>A company that sells a new, expensive, branded drug has a strong profit motive to keep quality and production high. That’s often not the case for generic drug manufacturers, and <a href="https://www.statnews.com/2020/06/02/bring-manufacturing-generic-drugs-back-to-u-s/">this can result in shortages</a>. </p>
<p>In 2008, an adulterated version of the blood-thinning drug Heparin <a href="https://www.pharmaceutical-technology.com/features/generic-drug-safety-us-regulators-struggle-global-market">was recalled worldwide</a> after being linked to 350 adverse events and 150 deaths in the U.S. alone.</p>
<p>In 2013, the Department of Justice <a href="https://oig.hhs.gov/fraud/enforcement/generic-drug-manufacturer-ranbaxy-pleads-guilty-and-agrees-to-pay-500-million-to-resolve-false-claims-allegations-cgmp-violations-and-false-statements-to-the-fda/#">fined the U.S. subsidiary of Ranbaxy Laboratories</a>, India’s largest generic drug manufacturer, US$500 million after it pleaded guilty to civil and criminal charges related to drug safety and falsifying safety data. In response, the FDA banned products made at four of the company’s manufacturing facilities in India from entering the U.S., <a href="https://www.nytimes.com/2013/05/14/business/global/ranbaxy-in-500-million-settlement-of-generic-drug-case.html">including generic versions of gabapentin</a>, which treats epilepsy and nerve pain, and the antibiotic ciprofloxacin.</p>
<p>And while there may be multiple companies selling the same generic drug in the U.S., there may be only a single manufacturer supplying the basic ingredients. Thus, any hiccup in production or shutdown due to quality issues can affect the entire market.</p>
<p>A recent analysis found that approximately 40% of generic drugs sold in the U.S. <a href="https://ssrn.com/abstract=3011139">have just one manufacturer</a>, and the share of markets supplied by just one or two manufacturers has increased over time. </p>
<figure class="align-center ">
<img alt="A man in a suit points in front of a lectern that says $30 insulin, with fridges of insulin in the background." src="https://images.theconversation.com/files/537321/original/file-20230713-19-4vturh.jpeg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/537321/original/file-20230713-19-4vturh.jpeg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/537321/original/file-20230713-19-4vturh.jpeg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/537321/original/file-20230713-19-4vturh.jpeg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/537321/original/file-20230713-19-4vturh.jpeg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/537321/original/file-20230713-19-4vturh.jpeg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/537321/original/file-20230713-19-4vturh.jpeg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">California Gov. Gavin Newsom partnered with Civica Rx to manufacture insulin for the state.</span>
<span class="attribution"><a class="source" href="https://newsroom.ap.org/detail/CaliforniaGovernor/fb9c46b454aa451b87d3120061aa4fd2/photo?Query=insulin%20california&mediaType=photo&sortBy=arrivaldatetime:desc&dateRange=Anytime&totalCount=27&currentItemNo=6">AP Photo/Damian Dovarganes</a></span>
</figcaption>
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<h2>Repatriating the drug supply</h2>
<p>It is hard to quantify the impact of drug shortages on population health. However, a recent survey of U.S. hospitals, pharmacists and other health care providers found that drug shortages <a href="https://www.usp.org/sites/default/files/usp/document/supply-chain/pediatric-oncology-drugs-and-supply-chain.pdf">led to increased medication errors</a>, delayed administration of lifesaving therapies, inferior outcomes and patient deaths. </p>
<p>What can be done?</p>
<p>One option is to simply find ways to produce more generic drugs in the U.S.</p>
<p>California <a href="https://nashp.org/california-enacts-law-to-produce-generic-prescription-drugs/#">passed a law</a> in 2020 to do just that by allowing the state to contract with domestic manufactures to produce its own generic prescription drugs. In March 2023, California <a href="https://californiahealthline.org/news/article/california-generic-insulin-contract-civica-rx-newsom/">selected a Utah company</a> to begin producing low-cost insulin for California patients.</p>
<p>Whether this approach is feasible on a broader scale is uncertain, but, in my view, it’s a good first attempt to repatriate America’s drug supply.</p><img src="https://counter.theconversation.com/content/206848/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Geoffrey Joyce does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>The shortages, which have been going on for years, have typically affected only low-cost generics rather than profitable brand-name drugs.Geoffrey Joyce, Director of Health Policy, USC Schaeffer Center, and Associate Professor, University of Southern CaliforniaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1898682022-12-05T13:27:20Z2022-12-05T13:27:20ZPharma’s expensive gaming of the drug patent system is successfully countered by the Medicines Patent Pool, which increases global access and rewards innovation<figure><img src="https://images.theconversation.com/files/498366/original/file-20221130-8007-d247y0.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C2121%2C1412&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Drug patents don't necessarily spur companies to innovate so much as restrict access to their IP.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/medicines-and-money-the-cost-of-treatment-and-royalty-free-image/1129305852">Andrii Zastrozhnov/iStock via Getty Images Plus</a></span></figcaption></figure><p>Biomedical innovation reached a new era during the COVID-19 pandemic as drug development went into overdrive. But the ways that brand companies license their patented drugs grant them market monopoly, preventing other entities from making generics so they can exclusively profit. This significantly limits the reach of lifesaving drugs, especially to low- and middle-income countries, or LMICs. </p>
<p>I am an <a href="https://www.lucyxiaoluwang.com/">economist</a> who studies <a href="https://scholar.google.com/citations?user=M0QlVjcAAAAJ&hl=en">innovation and digitization</a> in health care markets. Growing up in a developing region in China with limited access to medications inspired my interest in institutional innovations that can facilitate drug access. One such innovation is a patent pool, or a “one-stop shop” where entities can pay one low price for permission to make and distribute all the treatments covered by the pool. My recent research found that a <a href="https://doi.org/10.1016/j.jhealeco.2022.102671">patent pool geared toward public health</a> can spur not only generic drug access in LMICs but also innovation for pharmaceutical companies.</p>
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<figcaption><span class="caption">Patent pools can help increase access to expensive drugs.</span></figcaption>
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<h2>Drug patents in the global landscape</h2>
<p>Patents are designed to provide incentives for innovation by granting monopoly power to patent holders for a period of time, <a href="https://www.wipo.int/patents/en/faq_patents.html">typically 20 years</a> from the application filing date. </p>
<p>However, this intention is complicated by strategic patenting. For example, companies can delay the creation of generic versions of a drug by obtaining additional patents based on slight changes to its formulation or method of use, among other tactics. This “<a href="https://doi.org/10.1016/j.jhealeco.2012.01.004">evergreens</a>” the company’s patent portfolio without requiring substantial new investments in research and development. </p>
<p>Furthermore, because patents are <a href="https://www.wipo.int/patents/en/faq_patents.html">jurisdiction-specific</a>, patent rights granted in the U.S. do not automatically apply to other countries. Firms often obtain multiple patents covering the same drug in different countries, adapting claims based on what is patentable in each jurisdiction.</p>
<p>To incentivize technology transfer to low- and middle-income countries, member nations of the World Trade Organization signed the 1995 <a href="https://www.wto.org/english/docs_e/legal_e/27-trips_01_e.htm">Agreement on Trade-Related Aspects of Intellectual Property Rights</a>, or TRIPS, which set the minimum standards for intellectual property regulation. Under TRIPS, governments and generic drug manufacturers in low- and middle-income countries may infringe on or invalidate patents to bring down patented drug prices under certain conditions. Patents in LMICs were also strengthened to incentivize firms from high-income countries to invest and trade with LMICs.</p>
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<figcaption><span class="caption">Determining what is patentable can be complicated.</span></figcaption>
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<p>The 2001 <a href="https://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.htm">Doha Declaration</a> clarified the scope of TRIPS, emphasizing that patent regulations should not prevent drug access during public health crises. It also allowed compulsory licensing, or the production of patented products or processes without the consent of the patent owner.</p>
<p>One notable example of national patent law in practice after TRIPS is Novartis’ anticancer drug imatinib (Glivec or Gleevec). In 2013, India’s Supreme Court <a href="https://doi.org/10.1186/1744-8603-10-3">denied Novartis’s patent application</a> for Glivec for <a href="https://www.upcounsel.com/patent-obviousness">obviousness</a>, meaning both experts or the general public could arrive at the invention themselves without requiring much skill or thought. The issue centered on whether new forms of known substances, in this case a crystalline form of imatinib, were too obvious to be patentable. At the time, Glivec had already been <a href="https://doi.org/10.1136/bmj.f2099">patented in 40 other countries</a>. As a result of India’s landmark ruling, the price of Glivec <a href="https://www.ip-watch.org/2018/05/20/five-years-indian-supreme-courts-novartis-verdict/">dropped from 150,000 INR (about US$2,200) to 6,000 INR ($88)</a> for one month of treatment.</p>
<h2>Patent challenges and pools</h2>
<p>Although TRIPS seeks to balance incentives for innovation with access to patented technologies, issues with patents still remain. Drug cocktails, for example, can contain <a href="https://doi.org/10.1038/s41587-021-01137-6">multiple patented compounds</a>, each of which can be owned by different companies. Overlapping patent rights can create a “<a href="https://doi.org/10.1086/ipe.1.25056143">patent thicket</a>” that blocks commercialization. Treatments for chronic conditions that require a stable and inexpensive supply of generics also pose a challenge, as the cost burden of long-term use of patented drugs is often unaffordable for patients in low- and middle-income countries.</p>
<p>One solution to these drug access issues is <a href="https://doi.org/10.1257/0002828041464641">patent pools</a>. In contrast to the currently decentralized licensing market, where each technology owner negotiates separately with each potential licensee, a patent pool provides a “one-stop shop” where licensees can get the rights for multiple patents at the same time. This can reduce transaction costs, royalty stacking and hold-up problems in drug commercialization. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/488226/original/file-20221005-23-ac6y6n.png?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Diagram of licensing markets with and without a patent pool" src="https://images.theconversation.com/files/488226/original/file-20221005-23-ac6y6n.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/488226/original/file-20221005-23-ac6y6n.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=264&fit=crop&dpr=1 600w, https://images.theconversation.com/files/488226/original/file-20221005-23-ac6y6n.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=264&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/488226/original/file-20221005-23-ac6y6n.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=264&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/488226/original/file-20221005-23-ac6y6n.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=332&fit=crop&dpr=1 754w, https://images.theconversation.com/files/488226/original/file-20221005-23-ac6y6n.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=332&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/488226/original/file-20221005-23-ac6y6n.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=332&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Patent pools create a one-stop shop for multiple patients, allowing multiple licensees to enter the market.</span>
<span class="attribution"><a class="source" href="https://doi.org/10.1016/j.jhealeco.2022.102671">Lucy Xiaolu Wang</a>, <a class="license" href="http://creativecommons.org/licenses/by-nc-nd/4.0/">CC BY-NC-ND</a></span>
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<p>Patent pools were first used <a href="https://www.jstor.org/stable/43186442">in 1856 for sewing machines</a> and were once <a href="https://doi.org/10.1257/0002828041464641">ubiquitous across multiple industries</a>. Patent pools gradually disappeared after a <a href="https://supreme.justia.com/cases/federal/us/323/386/">1945 U.S. Supreme Court decision</a> that increased regulatory scrutiny, hindering the formation of new pools. Patent pools were later <a href="https://firstmonday.org/ojs/index.php/fm/article/view/1912/1794">revived in the 1990s</a> in response to licensing challenges in the information and communication technology sector.</p>
<h2>The Medicines Patent Pool</h2>
<p>Despite many challenges, the first patent pool created for the purpose of promoting public health formed in 2010 with support from the United Nations and Unitaid. The <a href="https://medicinespatentpool.org/">Medicines Patent Pool, or MPP</a>, aims to spur generic licensing for patented drugs that treat diseases disproportionately affecting low- and middle-income countries. Initially covering only HIV drugs, the MPP later expanded to include hepatitis C and tuberculosis drugs, many medications on the World Health Organization’s essential medicines list and, most recently, COVID-19 treatments and technologies.</p>
<p>But how much has the MPP improved drug access?</p>
<p>I sought to <a href="https://doi.org/10.1016/j.jhealeco.2022.102671">answer</a> <a href="https://dx.doi.org/10.2139/ssrn.4016897">this question</a> by examining how the Medicines Patent Pool has affected generic drug distribution in low- and middle-income countries and biomedical research and development in the U.S. To analyze the MPP’s influence on expanding access to generic drugs, I collected data on drug licensing contracts, procurement, public and private patents and other economic variables from over 100 low- and middle-income countries. To analyze the MPP’s influence on pharmaceutical innovation, I examined data on new clinical trials and new drug approvals over this period. This data spanned from 2000 to 2017.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/488228/original/file-20221005-13-vnh0dm.png?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Diagram of the Medicines Patent Pool licensing structure" src="https://images.theconversation.com/files/488228/original/file-20221005-13-vnh0dm.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/488228/original/file-20221005-13-vnh0dm.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=255&fit=crop&dpr=1 600w, https://images.theconversation.com/files/488228/original/file-20221005-13-vnh0dm.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=255&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/488228/original/file-20221005-13-vnh0dm.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=255&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/488228/original/file-20221005-13-vnh0dm.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=320&fit=crop&dpr=1 754w, https://images.theconversation.com/files/488228/original/file-20221005-13-vnh0dm.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=320&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/488228/original/file-20221005-13-vnh0dm.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=320&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">The Medicines Patent Pool works as an intermediary between branded drug companies and generic licensees, increasing access to drugs.</span>
<span class="attribution"><a class="source" href="https://doi.org/10.1016/j.jhealeco.2022.102671">Lucy Xiaolu Wang</a>, <a class="license" href="http://creativecommons.org/licenses/by-nc-nd/4.0/">CC BY-NC-ND</a></span>
</figcaption>
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<p>I found that the MPP led to a 7% increase in the share of generic drugs supplied to LMICs. Increases were greater in countries where drugs are patented and in countries outside of sub-Saharan Africa, where baseline generic shares are lower and can benefit more from market-based licensing.</p>
<p>I also found that the MPP generated positive spillover effects for innovation. Firms outside the pool increased the number of trials they conducted on drug cocktails that included MPP compounds, while branded drug firms participating in the pool shifted their focus to developing new compounds. This suggests that the MPP allowed firms outside the pool to explore new and better ways to use MPP drugs, such as in new study populations or different treatment combinations, while brand name firms participating in the pool could spend more resources to develop new drugs.</p>
<p>The MPP was also able to lessen the burden of post-market surveillance for branded firms, allowing them to push new drugs through clinical trials while generic and other independent firms could monitor the safety and efficacy of approved drugs more cheaply.</p>
<p>Overall, my analysis shows the MPP effectively expanded generic access to HIV drugs in developing countries without diminishing innovation incentives. In fact, it even spurred companies to make better use of existing drugs.</p>
<h2>Technology licensing for COVID-19 and beyond</h2>
<p>Since May 2020, the Medicines Patent Pool has become a key partner of the <a href="https://www.who.int/initiatives/covid-19-technology-access-pool">World Health Organization COVID-19 Technology Access Pool</a>, which works to spur equitable and affordable access to COVID-19 health products globally. The MPP has not only made licensing for COVID-19 health products more accessible to low- and middle-income countries, but also helped establish an <a href="https://medicinespatentpool.org/covid-19/mrna-technology-transfer-hub-programme">mRNA vaccine technology transfer hub</a> in South Africa to provide the technological training needed to develop and sell products treating COVID-19 and beyond.</p>
<p>Licensing COVID-19-related technologies can be complicated by the <a href="https://pubmed.ncbi.nlm.nih.gov/34194207">large amount of trade secrets</a> involved in producing drugs derived from biological sources. These often require additional technology transfer beyond patents, such as <a href="https://heinonline.org/HOL/LandingPage?handle=hein.journals/ilr101&div=32&id=&page=">manufacturing details</a>. The MPP has also worked to communicate with brand firms, generic manufacturers and public health agencies in low- and middle-income countries to <a href="https://medicinespatentpool.org/partners/how-to-get-or-give-a-licence">close the licensing knowledge gap</a>. </p>
<p>Questions remain on how to best use licensing institutions like the MPP to increase generic drug access without hampering the incentive to innovate. But the MPP is proving that it is possible to align the interests of Big Pharma and generic manufacturers to save more lives in developing countries. In October 2022, the MPP signed a licensing agreement with Novartis for the leukemia drug <a href="https://medicinespatentpool.org/news-publications-post/mpp-signs-licence-agreement-to-increase-access-to-nilotinib-for-the-treatment-of-chronic-myeloid-leukaemia">nilotinib</a> – the first time a cancer drug has come under a public health-oriented licensing agreement.</p><img src="https://counter.theconversation.com/content/189868/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Lucy Xiaolu Wang receives research funding from Cornell University and the Institute for Humane Studies.</span></em></p>The Medicines Patent Pool was created to promote public health, facilitating generic licensing for patented drugs that treat diseases predominantly affecting low- and middle-income countries.Lucy Xiaolu Wang, Assistant Professor of Resource Economics, UMass AmherstLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1822042022-05-09T12:05:35Z2022-05-09T12:05:35ZNonprofit drugmaker Civica Rx is taking aim at the high insulin prices harming people with diabetes<figure><img src="https://images.theconversation.com/files/461576/original/file-20220505-11-rf28d7.jpg?ixlib=rb-1.1.0&rect=552%2C0%2C2505%2C1949&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">High insulin prices are leaving some people who need the drug without access.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/advocates-with-t1internationals-new-york-new-jersey-and-news-photo/1166231700?adppopup=true">Erik McGregor/LightRocket via Getty Images</a></span></figcaption></figure><p>Doctors have been treating <a href="https://www.diabetes.org.uk/research/research-impact/insulin">diabetes with insulin</a> since <a href="https://www.cmaj.ca/content/167/12/1396">1922</a>. A century later, about <a href="https://www.cdc.gov/diabetes/data/statistics-report/index.html">1 in 5 of the 37 million Americans</a> living with diabetes take this medication – a hormone that helps cells absorb sugar from the blood.</p>
<p>This medication helps avert a host of medical problems including heart disease, kidney disease and stroke. Some <a href="https://familydoctor.org/insulin-therapy/">1.6 million Americans living with Type 1</a> diabetes, a condition in which people don’t produce any insulin, depend on it for their survival. So do millions more people with <a href="https://my.clevelandclinic.org/health/diseases/21501-type-2-diabetes">Type 2 diabetes</a> – a condition in which the body doesn’t make enough insulin.</p>
<p>But an estimated 1 in 4 of the Americans who need it have so much trouble affording this <a href="https://doi.org/10.1001/jamainternmed.2018.5008">lifesaving medication</a> that they skimp on doses because insulin prices have been skyrocketing for years. For example, the full cost – not counting insurance coverage – of about one month’s worth of a <a href="https://www.mayoclinic.org/drugs-supplements/insulin-glargine-recombinant-subcutaneous-route/description/drg-20067770">commonly used kind of insulin called glargine</a> has nearly tripled from US$99 in 2010 to <a href="https://www.businessinsider.com/insulin-price-increased-last-decade-chart-2019-9?r=US&IR=T">$284 in 2022</a>. </p>
<p>The exact amount Americans pay for insulin varies quite widely, <a href="https://www.commonwealthfund.org/publications/issue-briefs/2020/sep/not-so-sweet-insulin-affordability-over-time">depending on their insurance coverage</a> and which version of the <a href="https://www.kff.org/medicaid/issue-brief/pricing-and-payment-for-medicaid-prescription-drugs/">medication they’re prescribed</a>.</p>
<p><a href="https://civicarx.org/civica-to-manufacture-and-distribute-affordable-insulin/">Civica Rx</a>, a nonprofit that <a href="https://catalyst.nejm.org/doi/full/10.1056/CAT.21.0189">manufactures generic drugs</a>, is trying to help solve this problem. It’s planning to produce <a href="https://www.healthline.com/diabetesmine/why-is-there-no-generic-insulin">generic insulin</a> for no more than $30 for a month’s worth of the drug at a factory being built in Petersburg, Virginia. Eventually the drugmaker intends to sell all three of the most popular kinds of insulin, starting in 2024 with glargine.</p>
<p>Based on my <a href="https://scholar.google.com/citations?user=rTIsA4UAAAAJ&hl=en&oi=ao">research regarding the pharmaceutical industry</a> and my work as a doctor who treats patients with diabetes, I believe this effort, announced in March 2022, may greatly increase access to insulin for hundreds of thousands of people who need but can’t currently afford it.</p>
<p><iframe id="UW6jg" class="tc-infographic-datawrapper" src="https://datawrapper.dwcdn.net/UW6jg/1/" height="400px" width="100%" style="border: none" frameborder="0"></iframe></p>
<h2>Generic insulin competition is limited</h2>
<p>Americans rely on robust <a href="https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/generic-competition-and-drug-prices">competition from low-cost generic drugs</a> to make pharmaceutical products more affordable. This system has historically been more successful with blockbuster drugs like atorvastatin – a cholesterol-controlling drug better known by the <a href="https://www.axios.com/lipitor-pfizer-drug-patent-sales-2019-6937cdfb-47f1-46bc-8cf0-39e6b88e235e.html">brand name Lipitor</a> – and azithromycin – an antibiotic sold under the <a href="https://www.vox.com/2016/2/16/11008134/generic-drugs-safe-effective-cheaper">brand name Zithromax</a>.</p>
<p>Unfortunately, this system has failed to restrain increases in insulin prices, which are <a href="https://pharmanewsintel.com/news/insulin-prices-8x-higher-in-the-us-compared-to-similar-nations">far higher in the United States than other countries</a>.</p>
<p>One reason this has been the case has to do with the fact that insulin is a <a href="https://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/what-are-biologics-questions-and-answers">biologic drug</a>, meaning that it’s produced using DNA technology by living organisms. Biologic drugs are harder to manufacture and are regulated by the Food and Drug Administration in a different manner than more conventional drugs.</p>
<h2>Seeing reasons for optimism</h2>
<p>I’m excited about this initiative because it promises to increase access to all people who require insulin in the U.S., regardless of insurance status or where they buy medications.</p>
<p>One reason is that Civica Rx is a nonprofit that will be more able than private-sector drugmakers to put the interests of those who pay for insulin – patients and health insurers – ahead of investors’.</p>
<p>Another is its pricing strategy. Civica Rx plans to charge only about 20% of the list prices for brand-name insulin products. <a href="https://corporate.walmart.com/newsroom/2021/06/29/walmart-revolutionizes-insulin-access-affordability-for-patients-with-diabetes-with-the-launch-of-the-first-and-only-private-brand-analog-insulin">Walmart and some other big-box retailers</a> already sell insulin at a discount, but their prices are still higher than what the nonprofit plans to charge. </p>
<p>And findings from <a href="https://doi.org/10.1016/S2213-8587(15)00364-2">my own research suggest</a> that intellectual property protections will not likely be a substantial barrier to Civica’s efforts. </p>
<p>I’m also optimistic because of support from large insurers like <a href="https://civicarx.org/civica-to-manufacture-and-distribute-affordable-insulin/">Anthem and Blue Cross Blue Shield Association</a> for this effort. It’s reassuring that Civica Rx’s leadership includes many people with decades of experience in the <a href="https://civicarx.org/board-of-directors/">pharmaceutical industry and in health policy</a>.</p>
<p>But I see some reasons to be less optimistic. </p>
<p>First, there have been prior attempts to manufacture generic insulin in the U.S. <a href="https://www.biopharma-reporter.com/Article/2013/06/17/Insulin-CMO-Sued-by-US-City-Over-Failed-Manufacturing-Plant">None have succeeded</a>.</p>
<p>Another possibility is that brand-name insulin manufacturers may try to push doctors to prescribe <a href="https://www.news-medical.net/health/Drug-Patents-and-Generics.aspx">newer patent-protected versions</a> of insulin, which would be harder for Civica Rx to market as a generic – at least initially.</p>
<p>Success is far from guaranteed, given that the established players all have a strong financial interest in seeing Civica’s efforts fail.</p>
<h2>Lawmakers are taking action</h2>
<p>Several state legislatures have also tried to deal with this problem. Some have enacted laws <a href="https://www.nashp.org/drug-price-transparency-laws-position-states-to-impact-drug-prices/">mandating drug price transparency</a> and provided funds to guarantee <a href="https://www.minnpost.com/state-government/2020/04/a-great-day-minnesota-legislature-finally-passes-emergency-insulin-bill/">emergency access to insulin</a>.</p>
<figure class="align-left zoomable">
<a href="https://images.theconversation.com/files/461578/original/file-20220505-17-yssztk.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Two women and two men in suits next to an 'affordable insulin' sign in front of the U.S. Capitol building." src="https://images.theconversation.com/files/461578/original/file-20220505-17-yssztk.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/461578/original/file-20220505-17-yssztk.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/461578/original/file-20220505-17-yssztk.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/461578/original/file-20220505-17-yssztk.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/461578/original/file-20220505-17-yssztk.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/461578/original/file-20220505-17-yssztk.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/461578/original/file-20220505-17-yssztk.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Members of Congress – from left, Rep. Dan Kildee, D-Mich.; House Majority Whip James Clyburn, D-S.C.; Rep. Angie Craig, D-Minn.; and Rep. Lucy McBath, Ga. – express support for capping insulin prices at $35 a month or less in March 2022.</span>
<span class="attribution"><a class="source" href="https://newsroom.ap.org/detail/InsulinCosts/37695cd7b2174975adfe0bc92170e895/photo?Query=insulin&mediaType=photo&sortBy=arrivaldatetime:desc&dateRange=Anytime&totalCount=364&currentItemNo=8">AP Photo/J. Scott Applewhite</a></span>
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</figure>
<p>But to date these assorted responses have <a href="https://www.goodrx.com/healthcare-access/research/how-much-does-insulin-cost-compare-brands">failed to lower prices for brand-name insulin products</a>, although I think it’s possible that prices would have risen faster without them.</p>
<p>Congress is also responding.</p>
<p>Four weeks after Civica Rx announced its plans to produce insulin at well below current prices, the U.S. House of Representatives <a href="https://www.npr.org/2022/03/31/1090085513/house-passes-bill-to-cap-insulin-prices">passed a bill that would limit insulin copays to $35</a> for insured patients. This measure was also in <a href="https://www.wusa9.com/article/news/verify/insulin-costs-about-10-to-make-but-retails-for-nearly-300-pharmaceutical-companies-eli-lilly-novo-nordisk-sanofi-pbms-insuli/65-73a3cafd-3340-45cd-8324-a5e3e1c78fa5">President Joe Biden’s</a> stalled <a href="https://www.youtube.com/watch?v=GJT_04kyv5I">Build Back Better</a> spending plan.</p>
<p>The House bill would leave out many patients – most <a href="https://khn.org/news/article/insulin-copay-cap-passes-house-hurdle-but-senate-looks-for-a-broader-bill/">notably the uninsured</a>. But this measure would also <a href="https://khn.org/news/article/insulin-copay-cap-passes-house-hurdle-but-senate-looks-for-a-broader-bill/">mark a positive step</a> should <a href="https://khn.org/news/article/insulin-copay-cap-passes-house-hurdle-but-senate-looks-for-a-broader-bill/">the Senate</a> <a href="https://rollcall.com/2022/04/06/with-senate-readying-vote-on-insulin-bill-advocates-seek-changes/">follow suit</a>.</p>
<p>People living with insulin-dependent diabetes have been waiting a long time for someone to do something to make it more affordable. It looks like that time may finally be arriving.</p><img src="https://counter.theconversation.com/content/182204/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Through his University, Jing Luo receives funding from The Leona M. and Harry B. Helmsley Charitable Trust and has previously received funding from Arnold Ventures. Both of these organizations have made contributions to Civica.</span></em></p>About 1 in 4 Americans with diabetes who need insulin struggle to pay for this lifesaving drug.Jing Luo, Assistant Professor of Medicine, University of PittsburghLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1748742022-04-06T12:24:13Z2022-04-06T12:24:13ZRepurposing generic drugs can reduce time and cost to develop new treatments – but low profitability remains a barrier<figure><img src="https://images.theconversation.com/files/455834/original/file-20220401-30230-ka75fr.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C1998%2C1488&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">From thalidomide to Viagra, drug repurposing salvaged failed treatments by giving them new targets.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/illustration/pills-jars-royalty-free-illustration/676746260">smartboy10/DigitalVision Vectors via Getty Images</a></span></figcaption></figure><p>Discovering new ways to use existing drugs can come about intentionally or by chance. </p>
<p>Sometimes physicians or patients notice an unanticipated beneficial effect from a drug. One example is <a href="https://dx.doi.org/10.1038%2Fnrd2030">sildenafil</a>, a drug originally developed to treat severe chest pain from coronary artery disease. While sildenafil failed clinical trials, researchers noticed that one of its side effects was induced erections. This led to its successful rebranding as the erectile dysfunction drug Viagra.</p>
<p>Most of the time when drugs are repurposed for diseases or conditions they were not originally intended for, it’s done deliberately. As scientists raced to develop treatments for COVID-19, drug repurposing came into the spotlight for reasons <a href="https://www.scientificamerican.com/article/common-antidepressant-slashes-risk-of-covid-death/">good</a> and <a href="https://www.nytimes.com/2022/03/30/health/covid-ivermectin-hospitalization.html">bad</a>. </p>
<p>As a <a href="https://scholar.google.com/citations?user=O4qsjycAAAAJ&hl=en">researcher focused on drug discovery and development</a>, I have seen the potential of repurposing and the challenges it faces. While finding new uses for drugs that have already been tested for safety and approved by the FDA can substantially <a href="https://doi.org/10.1038/534314a">reduce the time and cost</a> of development, financial and logistical barriers can make it difficult to get to market.</p>
<h2>The success of thalidomide</h2>
<p>When repurposing is successful, a drug that is ineffective or harmful for one condition can be lifesaving for others. </p>
<p>One such drug is <a href="https://dx.doi.org/10.1177%2F2040620711413165">thalidomide</a>, first approved as a morning sickness treatment. It gained notoriety in the late 1950s when it caused birth defects in an estimated 10,000 infants worldwide, resulting in <a href="https://www.medicalnewstoday.com/articles/how-the-thalidomide-scandal-led-to-safer-drugs">changes in drug regulation and development</a> that included increased developmental toxicity testing. Thalidomide was globally banned by the end of the 1960s.</p>
<p>In the 1990s, however, researchers discovered that thalidomide <a href="https://dx.doi.org/10.1073%2Fpnas.91.9.4082">inhibits angiogenesis</a>, or the growth of new blood vessels that deliver nutrients and oxygen to tumors. Its new use as a treatment for a blood cancer called <a href="https://dx.doi.org/10.1177%2F2040620711413165">multiple myeloma</a> ultimately saw clinical and commercial success. This led to the development of <a href="https://dx.doi.org/10.1177%2F2040620711413165">improved versions</a> of the drug that treat cancer with reduced side effects.</p>
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<iframe width="440" height="260" src="https://www.youtube.com/embed/5olSLe4faiw?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">Repurposing generic drugs could offer a cheaper and faster way to develop new treatments.</span></figcaption>
</figure>
<p>Scientists have continued to find other therapeutic uses for thalidomide. </p>
<p>When researchers discovered that thalidomide <a href="https://dx.doi.org/10.1016%2Fj.chembiol.2015.05.009">targets a molecule in the body</a> that marks other proteins for destruction, they leveraged this function into an emerging technology called <a href="https://doi.org/10.1038/s41392-019-0101-6">PROTACs</a>. Many drugs work in the body by inhibiting a particular target that produces an unwanted effect, typically in a way that is reversible and temporary. PROTACs, on the other hand, are a type of drug that can destroy the target altogether. This potentially increases the effectiveness of the drug and reduces the chance of drug resistance.</p>
<p>An example is <a href="https://clinicaltrials.gov/ct2/show/NCT03888612">bavdegalutamide</a>, a PROTAC that combines thalidomide with an inhibitor typically used to treat prostate cancer. This inhibitor works by blocking a target that supplies the tumor with hormones that help it grow. An ongoing phase 2 clinical trial on bavdegalutamide hinges on the idea that destroying the target would cut off hormone supply to tumors and stop their growth more effectively than conventional inhibitors.</p>
<p>Researchers are currently churning out PROTACS often by repurposing existing drugs. With ongoing promising results, 2021 saw the launch of a <a href="https://doi.org/10.1038/d41573-021-00052-4">flurry of clinical trials</a> testing PROTACs as a treatment for a number of different cancers.</p>
<h2>Repurposing for COVID-19</h2>
<p>Reearchers have used a myriad of drug repurposing approaches <a href="https://doi.org/10.1016/j.patter.2020.100090">during the COVID-19 pandemic</a>, ranging from educated guesses to large-scale drug screening and data mining from millions of electronic health records. Irrespective of how researchers decide which drugs to repurpose, all candidates must demonstrate strong clinical benefit in people before they can be authorized or approved for a new proposed use by the FDA.</p>
<p>My research team and I tested 1,425 FDA-approved drugs in human cells infected with COVID-19 and found <a href="https://doi.org/10.1073/pnas.2105815118">17 repurposing candidates</a> for further examination. Several of the leads we identified have since entered preliminary clinical trials, including drugs originally intended to treat <a href="https://clinicaltrials.gov/ct2/show/NCT04465695">leprosy</a> and <a href="https://doi.org/10.1101/2021.06.22.21259318">prostate cancer</a>, as well as a <a href="https://doi.org/10.3390/medicina57080842">supplement derived from milk</a>.</p>
<figure class="align-right zoomable">
<a href="https://images.theconversation.com/files/455845/original/file-20220401-23422-jsu15t.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Illustration of pill capsules falling into pill bottle." src="https://images.theconversation.com/files/455845/original/file-20220401-23422-jsu15t.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/455845/original/file-20220401-23422-jsu15t.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=826&fit=crop&dpr=1 600w, https://images.theconversation.com/files/455845/original/file-20220401-23422-jsu15t.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=826&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/455845/original/file-20220401-23422-jsu15t.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=826&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/455845/original/file-20220401-23422-jsu15t.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=1038&fit=crop&dpr=1 754w, https://images.theconversation.com/files/455845/original/file-20220401-23422-jsu15t.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=1038&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/455845/original/file-20220401-23422-jsu15t.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=1038&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Drug repurposing could help expand treatment options for various diseases, including COVID-19.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/illustration/pills-and-capsule-jar-royalty-free-illustration/676742914">smartboy10/DigitalVision Vectors via Getty Images</a></span>
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</figure>
<p>Researchers initiated <a href="https://dx.doi.org/10.3389%2Ffphar.2021.704205">hundreds of clinical studies</a> early in the pandemic to test drug repurposing candidates for COVID-19. There have been a few notable successes including the generic antidepressant <a href="https://dx.doi.org/10.1016%2FS2214-109X(21)00448-4">fluvoxamine</a>, which reduced the risk of hospitalization by 32% in one clinical study. One <a href="https://doi.org/10.1080/07853890.2022.2034936">meta-analysis</a> on fluvoxamine and two other <a href="https://theconversation.com/could-oral-antiviral-pills-be-a-game-changer-for-covid-19-an-infectious-disease-physician-explains-why-these-options-are-badly-needed-169919">antiviral COVID-19 drugs</a>, molnupiravir and Paxlovid, found that they all offered protective benefits against COVID-19 with comparable safety profiles.</p>
<p>Unlike these new COVID-19 antivirals, however, fluvoxamine has a <a href="https://doi.org/10.1176/appi.books.9781615371624.as13">40-year track record</a> of safely treating depression and obsessive-compulsive disorder. Despite this, fluvoxamine has not been authorized for emergency use by the FDA, and the National Institutes of Health states that there is <a href="https://www.covid19treatmentguidelines.nih.gov/therapies/immunomodulators/fluvoxamine/">insufficient evidence</a> for its use against COVID-19.</p>
<h2>Drug discovery challenges</h2>
<p>Successful drug repurposing highlights the difficulty of predicting off-target effects of new treatments. </p>
<p>Eflornithine, for example, is a drug found to be ineffective against cancer – but it does turn out to inhibit <a href="https://doi.org/10.1111/j.1365-4632.2006.03079.x">facial hair growth</a> in women and cure a parasitic infection called <a href="https://doi.org/10.1016/s0140-6736(87)91131-7">trypanosomiasis</a>, or sleeping sickness. It’s often not immediately obvious why one drug would effectively treat two seemingly different health issues like these.</p>
<p>There are approximately 2,500 FDA-approved drugs, and an average of 46 new drugs are <a href="https://doi.org/10.1038/d41573-021-00002-0">approved each year</a>. However, <a href="https://doi.org/10.1038/nrd.2016.136">over 90%</a> of drugs that enter clinical trials fail. This increases to <a href="http://dx.doi.org/10.1126/scitranslmed.aaw8412">97% for cancer drugs</a>. While many shots on goal are required to produce a viable drug, each failed drug is a candidate for repurposing. Researchers like me have been collecting these “failed” compounds for further testing, trawling through research papers, patents and clinical trial databases to find repurposing candidates. Some labs have used <a href="https://doi.org/10.1016/S2589-7500(20)30192-8">artificial intelligence</a> to automate this process. </p>
<p>But it can be difficult to ascertain what drugs are available to repurpose. While one drug development database proposes that there are <a href="https://www.gostardb.com/about">47,000 previously tested compounds</a> ready for repurposing, there is <a href="https://doi.org/10.1093/bib/bbaa003">no central repository</a> for this information.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/455846/original/file-20220401-23379-gm7g5b.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Illustration of various pills falling into an open hand" src="https://images.theconversation.com/files/455846/original/file-20220401-23379-gm7g5b.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/455846/original/file-20220401-23379-gm7g5b.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=793&fit=crop&dpr=1 600w, https://images.theconversation.com/files/455846/original/file-20220401-23379-gm7g5b.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=793&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/455846/original/file-20220401-23379-gm7g5b.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=793&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/455846/original/file-20220401-23379-gm7g5b.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=997&fit=crop&dpr=1 754w, https://images.theconversation.com/files/455846/original/file-20220401-23379-gm7g5b.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=997&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/455846/original/file-20220401-23379-gm7g5b.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=997&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Parsing through the thousands of drugs for repurposing candidates can be difficult without knowing all the available options.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/illustration/catching-pills-royalty-free-illustration/676747518">smartboy10/DigitalVision Vectors via Getty Images</a></span>
</figcaption>
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<h2>Commercialization landscape</h2>
<p>Drug repurposing faces an <a href="https://doi.org/10.1126/scitranslmed.3009120">intellectual property barrier</a>. Repurposing is most accessible with <a href="https://doi.org/10.1186/s40545-020-00282-8">generic drugs</a> that don’t have patents restricting their use for other conditions. But there is <a href="https://doi.org/10.1186/s40545-020-00282-8">less opportunity for profit</a> with generics than with new drugs.</p>
<p>Patents allow drug suppliers to have a monopoly over sales for a span of time. Repurposed drugs are typically granted “<a href="https://doi.org/10.1126/scitranslmed.3009120">use patents</a>” that protect the use of an existing drug for a new particular disease. But companies consider this type of protection less valuable than a “composition of matter” patent that restricts drug sales just to patent owners. An <a href="https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/generic-competition-and-drug-prices">FDA analysis</a> found a drug with two drug suppliers resulted in an average 39% price reduction, and six or more suppliers resulted in a 95% reduction. With less patent protection on a drug, more competitors can enter the market and manufacturers make less money.</p>
<p>Because of this perceived lack of commercial potential, drug repurposing is typically left to academic institutions that don’t have the resources to get either new or retooled drugs through the <a href="https://doi.org/10.1001/jama.2020.1166">costly approval process</a>.</p>
<p>It’s possible that if fluvoxamine were a new drug in development with patent protection within a Big Pharma company, it might have already gained FDA approval to treat COVID-19. But as it stands, fluvoxamine is a widely available generic that any doctor can prescribe “<a href="https://theconversation.com/off-label-use-is-common-in-medicine-a-bioethicist-and-legal-philosopher-explain-why-the-covid-19-vaccines-are-different-171007">off-label</a>” to treat conditions that have not been approved by the FDA, like COVID-19. </p>
<p>[<em>Over 150,000 readers rely on The Conversation’s newsletters to understand the world.</em> <a href="https://memberservices.theconversation.com/newsletters/?source=inline-150ksignup">Sign up today</a>.]</p>
<p>This leads to a <a href="https://globalforum.diaglobal.org/issue/june-2020/repurposing-challenges-conceptualization-of-a-research-agenda/">tragedy of the commons</a> whereby no company will invest in the clinical trials needed to bring a repurposed drug to the marketplace because the resulting benefits would be immediately shared with all competitors.</p>
<p>Bringing a new drug to market is a <a href="https://doi.org/10.1038/d41573-021-00190-9">lengthy</a> and <a href="https://doi.org/10.1001/jama.2020.1166">costly</a> process with a <a href="https://doi.org/10.1038/nrd.2016.136">high failure rate</a>. When the pharmaceutical industry can’t justify developing a new drug because of a low return on investment, drug repurposing can fill the gap. <a href="https://covid19.nih.gov/news-and-stories/repurposing-drugs-to-save-time-and-lives">Federal support</a> could make repurposing more appealing from a business standpoint, giving companies the incentive to enter the marketplace and boost this cost-effective way to address unmet medical needs.</p><img src="https://counter.theconversation.com/content/174874/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Jonathan Sexton receives funding from the National Institutes of Health. </span></em></p>Drug repurposing can redeem failed treatments and squeeze out new uses from others. But many pharmaceutical companies are hesitant to retool existing drugs without a high return on investment.Jonathan Sexton, Assistant Professor of Internal Medicine and Medicinal Chemistry, University of MichiganLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1803152022-03-31T03:34:52Z2022-03-31T03:34:52ZWhat is the PBS safety net and is it really the best way to cut the cost of medicines?<figure><img src="https://images.theconversation.com/files/455154/original/file-20220330-13-1xo1vg7.jpg?ixlib=rb-1.1.0&rect=1%2C0%2C997%2C627&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/pharmacist-holding-medicine-box-capsule-pack-704036482">Shutterstock</a></span></figcaption></figure><p>Earlier access to free or cheaper medicines is on the cards, after a <a href="https://www.health.gov.au/resources/publications/budget-2022-23-pharmaceutical-benefits-scheme-safety-net">federal budget announcement</a> made earlier this week.</p>
<p>Improved access to subsided prescription drugs through the <a href="https://www.pbs.gov.au/pbs/home">Pharmaceutical Benefits Scheme</a> or PBS will benefit Australians who need multiple medicines throughout the year. This is particularly so for people with chronic conditions or who have multiple members in the family who need scripts.</p>
<p>From July 1, access to free or cheaper medicines will kick in sooner, under the so-called <a href="https://www.servicesaustralia.gov.au/pbs-safety-net-thresholds?context=22016">PBS safety net</a>, as the threshold for access has been lowered.</p>
<p>However, this isn’t the only way to reduce the costs of medicines.</p>
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Read more:
<a href="https://theconversation.com/health-budget-2022-spends-a-little-on-favoured-interest-groups-but-misses-a-chance-for-real-reform-179835">Health budget 2022 spends a little on favoured interest groups but misses a chance for real reform</a>
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<h2>What’s changed?</h2>
<p>If you only fill a script now and again, concession card holders pay A$6.80 and general patients pay up to $42.50 for a PBS-subsidised medicine.</p>
<p>However, if you need multiple scripts throughout the year, once you reach a certain threshold, the PBS safety net can kick in. Then, medicines are free for concession card holders and cost $6.80 for general patients.</p>
<p>The PBS safety net is <a href="https://www.servicesaustralia.gov.au/pbs-safety-net-thresholds?context=22016">calculated by calendar year</a> and is reset on January 1 each year.</p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"1474168994223386631"}"></div></p>
<p>As of July 1, the <a href="https://www.health.gov.au/resources/publications/budget-2022-23-pharmaceutical-benefits-scheme-safety-net">PBS safety net threshold will be reduced</a> to $244.80 (down from $326.40) for concession card holders and $1,457.10 (down from $1,542.10) for general patients.</p>
<p>You can reach the PBS safety net sooner each year if you <a href="https://www.servicesaustralia.gov.au/how-to-reach-threshold-sooner-family?context=22016">combine your family’s PBS accounts</a>. In other words, if you or your partner or children require multiple medicines, your family may have quicker access to free or cheaper medicines for the rest of the year.</p>
<p>The PBS safety net is not to be confused with the <a href="https://www.servicesaustralia.gov.au/what-are-medicare-safety-nets-thresholds?context=22001">Medicare safety net</a>. This relates to doctors’ fees charged for out-of-hospital services.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/explainer-what-is-medicare-and-how-does-it-work-22523">Explainer: what is Medicare and how does it work?</a>
</strong>
</em>
</p>
<hr>
<h2>Who will benefit?</h2>
<p>An average patient pays about <a href="https://www.aihw.gov.au/reports/australias-health/medicines-in-the-health-system">$121 out-of-pocket costs</a> per year on medicines, way below the PBS safety net thresholds. </p>
<p>So the PBS safety net only affects those who continuously use many prescription drugs. <a href="https://www.health.gov.au/resources/publications/budget-2022-23-pharmaceutical-benefits-scheme-safety-net">Under changes announced in the budget</a>, concession card holders who fill more than 36 prescriptions a year (three per month) or general patients who fill about 34 scripts a year will benefit from the reduced thresholds.</p>
<p>A large proportion of these are <a href="https://www.aihw.gov.au/reports/australias-health/medicines-in-the-health-system">older than 65, with chronic conditions</a>, who require medicines continually.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/455389/original/file-20220331-39548-1tyyit3.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Elderly woman's hand resting on walking frame" src="https://images.theconversation.com/files/455389/original/file-20220331-39548-1tyyit3.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/455389/original/file-20220331-39548-1tyyit3.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/455389/original/file-20220331-39548-1tyyit3.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/455389/original/file-20220331-39548-1tyyit3.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/455389/original/file-20220331-39548-1tyyit3.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/455389/original/file-20220331-39548-1tyyit3.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/455389/original/file-20220331-39548-1tyyit3.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Elderly people on multiple medications are among those expected to benefit from the latest changes.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/aging-time-1111826444">Shutterstock</a></span>
</figcaption>
</figure>
<p>For elderly patients, some medications are essential to control their symptoms and prevent them from being admitted to hospital. These medications include those to treat heart or mental health conditions.</p>
<p>So the money spent on improving access to these essential medicines could be offset by <a href="https://www.nejm.org/doi/full/10.1056/nejmsa0807998">lower hospital costs</a>.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/last-year-half-a-million-australians-couldnt-afford-to-fill-a-script-heres-how-to-rein-in-rising-health-costs-178301">Last year, half a million Australians couldn't afford to fill a script. Here's how to rein in rising health costs</a>
</strong>
</em>
</p>
<hr>
<h2>Other ways to cut costs</h2>
<p>Australia uses a range of mechanisms to manage the costs of prescription drugs, in addition to the PBS safety net. In general, these relate to how the government assesses drugs and sets prices.</p>
<p>After a new drug enters the market, the <a href="https://www.pbs.gov.au/pbs/industry/listing/participants/pbac">Pharmaceutical Benefits Advisory Committee</a> reviews its clinical effectiveness, safety and cost-effectiveness (or “value for money”) compared with other treatments before recommending it for listing on the PBS.</p>
<p>For clinically-equivalent drugs with different brands, the PBS only subsidises up to the price of the <a href="https://www.pbs.gov.au/browse/brand-premium">lowest priced brand</a>. If a patient needs the more expensive medicine, they pay a brand premium.</p>
<p>However, this brand premium <a href="https://www.nps.org.au/consumers/keeping-your-medicines-costs-down#what-is-the-pbs-safety-net?">cannot count towards</a> the PBS safety net threshold. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/cant-pronounce-the-name-of-your-medicine-heres-why-15416">Can't pronounce the name of your medicine? Here's why</a>
</strong>
</em>
</p>
<hr>
<h2>How about cheaper generic drugs?</h2>
<p>Assessing drugs for “value for money” and only subsidising clinically equivalent drugs to the price of the lowest priced brand are among measures allowing Australians access to cheaper <em>brand-name</em> drugs than countries without price controls.</p>
<p>However, Australians pay a higher price for <em>generic</em> prescription drugs – drugs no longer under patent protection – than many other countries. </p>
<p>Generic drugs are often not subsidised because they are cheaper than the PBS general co-payment of $42.50. So patients pay the full cost.</p>
<p>In fact, <a href="https://www.aihw.gov.au/reports/australias-health/medicines-in-the-health-system">about 30%</a> of all PBS-listed medicines cost less than $42.50, many of them generic drugs. </p>
<p>The cost of these PBS-listed, cheaper, non-subsidised generics counts towards your PBS safety net threshold.</p>
<p>To control prices for generic drugs, the government requires manufacturers to disclose how much they charge pharmacies. The government then reduces the amount it pays to pharmacies for each generic drug. </p>
<p>This <a href="https://www.pbs.gov.au/info/industry/pricing/price-disclosure-spd">price disclosure policy</a> has been effective to lower the prices of generic drugs. But this price disclosure policy does not guarantee Australians get the best prices for generic drugs some other countries enjoy.</p>
<p>Instead, the government could set a price for each generic drug, by using the best price obtained by other comparable countries. This <a href="https://grattan.edu.au/wp-content/uploads/2017/03/886-Cutting-a-better-drug-deal.pdf">international benchmarking</a> pricing strategy is used by other countries such as Canada, New Zealand, Japan and many member states of the European Union.</p>
<p>If the Australia government can get cheaper generic drugs as these countries, it would mean substantial savings for many Australians.</p><img src="https://counter.theconversation.com/content/180315/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Yuting Zhang receives funding from Australian Research Council, Department of Veterans' Affairs, and National Health and Medical Research Council.</span></em></p>Changes in the latest federal budget will mostly affect people who need multiple medicines throughout the year, perhaps for chronic disease. But there are other ways to reduce drug costs.Yuting Zhang, Professor of Health Economics, The University of MelbourneLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1740872021-12-22T16:58:22Z2021-12-22T16:58:22ZGeneric drug names provide information for doctors, so why is Health Canada promoting the use of pharma brand names?<figure><img src="https://images.theconversation.com/files/438724/original/file-20211221-49721-1iiafqu.jpg?ixlib=rb-1.1.0&rect=143%2C53%2C5838%2C3260&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Generic drug names are assigned at the global level by the World Health Organization in conjunction with national naming authorities.</span> <span class="attribution"><span class="source">(Shutterstock)</span></span></figcaption></figure><iframe style="width: 100%; height: 175px; border: none; position: relative; z-index: 1;" allowtransparency="" src="https://narrations.ad-auris.com/widget/the-conversation-canada/generic-drug-names-provide-information-for-doctors--so-why-is-health-canada-promoting-the-use-of-pharma-brand-names" width="100%" height="400"></iframe>
<p>Brand names are widely used when we want to refer to a specific product — an Apple computer, a Tesla car. Sometimes brand names are so widely used that they take over — we ask for a Kleenex instead of a tissue.</p>
<p>Drugs have two names. The brand name is the one that’s chosen by the company making it and that company is the only one allowed to use the name. (The name that the company proposes is <a href="https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/frequently-asked-questions-guidance-document-industry-review-drug-brand-names.html">reviewed by Health Canada</a>.) Brand names are almost always short and catchy so that doctors will remember them. </p>
<p>Generic names are assigned at the global level by the <a href="https://www.ismp.org/resources/are-national-efforts-reduce-drug-name-confusion-paying">World Health Organization in conjunction with national naming authorities</a>. These names are often long, but part of the reason for the length is that they tell doctors about the pharmacologic property and/or chemical structure of the medication.</p>
<p>The generic name for the new <a href="https://www.npr.org/sections/health-shots/2019/05/24/725404168/at-2-125-million-new-gene-therapy-is-the-most-expensive-drug-ever">US$2-million-per-patient drug for spinal muscular atrophy</a> is onasemnogene abeparvovec. The brand name is Zolgensma. Which one are doctors (and patients) going to remember and use? The answer is obvious. </p>
<p>One of the <a href="https://dx.doi.org/10.1503%2Fcmaj.112160">associate editors at the Canadian Medical Association Journal</a> makes the point that “some brand names are created to be reassuring or promising — so-called ‘benefit-led’ names such as Paxil, Celebrex and Gluconorm — when they actually need to be prescribed with great care and consideration of the drug’s potential effects on the individual patient.”</p>
<figure class="align-center ">
<img alt="Prescription bottles and white tablets on a white background" src="https://images.theconversation.com/files/438725/original/file-20211221-50268-1dtvkss.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/438725/original/file-20211221-50268-1dtvkss.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/438725/original/file-20211221-50268-1dtvkss.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/438725/original/file-20211221-50268-1dtvkss.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/438725/original/file-20211221-50268-1dtvkss.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/438725/original/file-20211221-50268-1dtvkss.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/438725/original/file-20211221-50268-1dtvkss.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Some pharmaceutical brand names are meant to sound reassuring or promising.</span>
<span class="attribution"><span class="source">(Shutterstock)</span></span>
</figcaption>
</figure>
<p>Is the use of brand names the right way to talk about prescription drugs? Apparently, Health Canada thinks so. Want information about safety problems with a medicine? On Canada’s recall site, you’ll see the <a href="https://recalls-rappels.canada.ca/en/search/site?search_api_fulltext=Daclizumab">brand name in CAPITALS</a> and the generic name in lower case and in brackets. </p>
<p>Want to see if there is a shortage of the drug that your doctor just wrote you a prescription for? Go to <a href="https://www.drugshortagescanada.ca/">Drug Shortages Canada</a> and you’ll find the brand names of the drugs, again in capitals. </p>
<p>If you’re interested in why Health Canada approved a particular drug, the <a href="https://hpr-rps.hres.ca/reg-content/summary-basis-decision-result.php?lang=en&term=">Summary Basis of Approval document</a> will help you understand. But once more the brand name is the most prominent one, and again it’s in capitals.</p>
<h2>What’s in a name?</h2>
<p>In medical school, students are taught to use generic names. <a href="http://www.icmje.org/recommendations/browse/manuscript-preparation/preparing-for-submission.html">Medical journals</a> tell authors to use generic names in the articles that they write. Does it matter which name doctors use? The answer is yes.</p>
<p>When <a href="https://doi.org/10.1177/0310057x0903700401">Australian anaesthetists and doctors training to be anaesthetists in two teaching hospitals</a> were given the brand names of drugs, they could only correctly identify the therapeutic group that the drug came from in just over half the cases. Without knowing what therapeutic group the drug came from, doctors could accidentally have used another drug from the same group or they could have used the drug incorrectly.</p>
<figure class="align-right ">
<img alt="Illustration of a pharma rep shaking hands with a doctor" src="https://images.theconversation.com/files/438732/original/file-20211221-167342-k9z3mu.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/438732/original/file-20211221-167342-k9z3mu.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=600&fit=crop&dpr=1 600w, https://images.theconversation.com/files/438732/original/file-20211221-167342-k9z3mu.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=600&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/438732/original/file-20211221-167342-k9z3mu.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=600&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/438732/original/file-20211221-167342-k9z3mu.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=754&fit=crop&dpr=1 754w, https://images.theconversation.com/files/438732/original/file-20211221-167342-k9z3mu.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=754&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/438732/original/file-20211221-167342-k9z3mu.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=754&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Seeing drug company sales representatives more frequently is associated with more brand name prescribing, which translates into more expensive prescribing. Sales reps also usually leave out important safety information.</span>
<span class="attribution"><span class="source">(Shutterstock)</span></span>
</figcaption>
</figure>
<p>The <a href="https://dx.doi.org/10.1002%2Fpds.4224">more money that doctors receive from drug companies</a> in the form of meals, travel arrangements and ownership royalties, the less likely they were to prescribe by generic name. Seeing <a href="https://www.cmu.edu/news/stories/archives/2017/may/marketing-and-prescribing-behavior.html">drug company sales representatives more frequently</a> is associated with more brand name prescribing, which translates into more expensive prescribing. Sales reps also usually <a href="https://doi.org/10.1007/s11606-013-2411-7">leave out important safety information</a> about drugs they are promoting, so besides prescriptions costing more, they might also be more likely to harm patients.</p>
<p>Brand names, drug regulation (the domain of Health Canada) and pharmaceutical promotion have come together in a particularly egregious way in the case of buprenorphine-naloxone, brand name Suboxone — an opioid medication used to treat opioid addiction. </p>
<p>Even though generic formulations of the drug have been available in Canada since 2013 (and even earlier in the United States), the drug is widely referred to by its brand name, including <a href="https://www.theglobeandmail.com/canada/article-the-timmins-tag-team-when-opioids-and-official-inaction-were-killing/">in the media</a>, <a href="https://news.ontario.ca/en/backgrounder/47406/taking-action-to-prevent-opioid-addiction-and-overdose">by policy makers</a> and by doctors. </p>
<h2>Branded education</h2>
<p>One way this happened was through the promotion of an “educational” program developed and delivered by Indivior, the company that holds the rights to Suboxone. In some provinces, completing this branded program is <a href="https://crism.ca/wp-content/uploads/2018/03/CRISM_NationalGuideline_OUD-ENG.pdf">a pre-requisite to being able to prescribe buprenorphine-naloxone</a>. The same strategy has been executed for a related injectable form of buprenorphine, also owned by Indivior. </p>
<p>This use of the branded program is the case even though there are perfectly <a href="https://www.camh.ca/en/education/continuing-education-programs-and-courses/continuing-education-directory/opioid-use-disorder-treatment-course">good, accredited, non-industry educational programs</a> already available to teach appropriate opioid addiction care and prescribing to doctors, nurses and pharmacists. </p>
<p>The inclusion of the brand name in the title of this program flies in the face of <a href="https://policybase.cma.ca/documents/PolicyPDF/PD21-20.pdf">recommended practices</a> and <a href="https://www.cfpc.ca/CFPC/media/PDF/Understanding-Mainpro-Certification-English-April15-2021.pdf">accreditation standards</a> for Canadian medical education programs.</p>
<p>Yet, the branded program is fully sanctioned by Health Canada through that body’s review and approval of the <a href="https://pdf.hres.ca/dpd_pm/00063411.PDF">Suboxone product monograph</a>. This document, which describes the nature of the drug and its approved uses in Canada, includes a description of the requirement for participation in the branded “training program.” </p>
<p><a href="http://doi.org/10.1056/NEJMp1906680">As has been documented in the U.S.</a>, Indivior and its parent company Reckitt Benckiser have engaged in a variety of unscrupulous practices to promote their multibillion-dollar buprenorphine product line — ultimately paying <a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/press-releases/indivior-solutions-sentenced-part-2-billion-resolution-false-safety-claims-concerning-suboxone">some of the largest fines in U.S. pharmaceutical history</a>. In this light, a branded “educational” program seems to be one more vehicle for brand name promotion, and one in which Health Canada is directly complicit.</p>
<p>When doctors use brand names they may be less knowledgeable about the drugs they are prescribing, their prescriptions cost more and patients may be more likely to suffer side-effects. When Health Canada prioritizes brand names over generic names it is actively contributing to all these problems.</p>
<p>Health Canada should know better and must do better.</p><img src="https://counter.theconversation.com/content/174087/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>In 2018-2021, Joel Lexchin received payments for writing a brief in an action for side effects of a drug for Michael F. Smith, Lawyer and a second brief on the role of promotion in generating prescriptions for Goodmans LLP and from the Canadian Institutes of Health Research for presenting at a workshop on conflict-of-interest in clinical practice guidelines. He is currently a member of research groups that are receiving money from the Canadian Institutes of Health Research and the Australian National Health and Medical Research Council. He is a member of the Foundation Board of Health Action International and the Board of Canadian Doctors for Medicare. He receives royalties from University of Toronto Press and James Lorimer & Co. Ltd. for books he has written. </span></em></p><p class="fine-print"><em><span>Abhimanyu Sud has received funding from or consulted with the Canadian Institutes of Health Research, Health Canada, Association of Faculties of Medicine of Canada, University of Toronto, Centre for Effective Practice, and Mississauga-Halton Local Health Integration Network for research and medical education relating to opioid use and drug policy.</span></em></p>Generic drug names are often long, but they can tell doctors what type of medicine it is and how it works. But it’s brand names that appear first and most prominently in Health Canada materials.Joel Lexchin, Professor Emeritus of Health Policy and Management, York University, Emergency Physician at University Health Network, Associate Professor of Family and Community Medicine, University of TorontoAbhimanyu Sud, Assistant Professor, Department of Family and Community Medicine, University of TorontoLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1608022021-05-12T14:56:17Z2021-05-12T14:56:17ZPush for COVID-19 vaccine patent waiver isn’t a panacea: but it could nudge companies to share<figure><img src="https://images.theconversation.com/files/400295/original/file-20210512-19-32xcql.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><span class="source">Shutterstock</span></span></figcaption></figure><p>A new proposal, this time from the US, on how to open up access to vaccines against COVID-19 by relaxing patent rights, has added to an already complex and fraught debate between the World Trade Organisation’s 164 members. </p>
<p>In early May, the US took the world by surprise when it <a href="https://ustr.gov/about-us/policy-offices/press-office/press-releases/2021/may/statement-ambassador-katherine-tai-covid-19-trips-waiver">announced</a> that Washington supported an exemption from the World Trade Organisation intellectual property (IP) rules protecting vaccines. The waiver would allow each state to authorise the production of patented vaccines without the consent of the pharmaceutical companies holding the patent.</p>
<p>South Africa and India originally proposed an <a href="https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)32581-2/fulltext">exemption</a> in October 2020. It was opposed by the US (initially), the EU, Switzerland, the UK and Japan. Such a waiver would be optional (countries could opt out) and suspend specific IP rights protected by the WTO <a href="https://www.wto.org/english/tratop_e/trips_e/intel2_e.htm">TRIPS Agreement</a>. </p>
<p>This exemption plan is supported by more than 100 countries. It would allow states to bypass the monopoly of IP holders by authorising the production of cheaper generic drugs and other anti-COVID technologies. The waiver would be temporary, until the majority of the world’s population developed immunity.</p>
<p>The US-supported exemption is slightly different. It covers vaccines only, maintaining IP protection on other products such as diagnostics, treatments, ventilators, respirators, syringes and refrigerators maintaining low temperatures during storage and transport of doses.</p>
<p>But would the WTO waiver be enough? </p>
<p>We believe there are arguments against the waiver. These include the fact that other factors would still stand in the way of easy and quick access to COVID-19 medicines for all countries. But we also argue that the campaign to have a waiver agreed at the WTO could have beneficial outcomes, such as pushing pharmaceutical companies which hold important IP to share it voluntarily.</p>
<h2>The cons</h2>
<p>One <a href="https://www.cato.org/free-trade-bulletin/unnecessary-proposal-wto-waiver-intellectual-property-rights-covid-19-vaccines#does-novel-virus-present-novel-issues">argument</a> against the waiver is that it is unnecessary. </p>
<p>The TRIPS already allows flexibilities. Countries seeking access to medicines can grant compulsory licences (that is, without the IP holder’s consent) under certain conditions. Some have done so during the pandemic. </p>
<p>In March 2020 Israel <a href="https://www.keionline.org/32503">issued</a> one, speeding up the production and sale of Kaletra as an anti-COVID treatment. The US-based pharmaceutical company AbbVie holds the patent.</p>
<p>And the Indian generic manufacturer Natco recently <a href="https://spicyip.com/2021/05/natco-files-compulsory-licence-application-for-covid-drug-baricitinib.html">applied</a> for a licence to produce Baricitinib. This is a rheumatoid arthritis drug that can also treat coronavirus. The IP is held by the US pharmacuetical company Eli Lilly.</p>
<p>States that lack production capacity can, meeting additional conditions, license production abroad with a view to importing the drugs. On 10 May, Bolivia <a href="https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=s:/IP/N/9BOL1.pdf&Open=True">notified</a> a <a href="https://healthpolicy-watch.news/company-pushes-canada-to-grant-compulsory-license-for-johnson-johnson-covid-19-vaccine/">licence</a> to the WTO, for 15 million doses of Johnson & Johnson vaccine produced by the Canadian company Biolyse.</p>
<p>However, compulsory licences must meet a host of requirements. These include the payment of <a href="https://www.mondaq.com/india/patent/616430/fair-remuneration-for-compulsory-licensing">fair compensation</a> to the patent holder. </p>
<p>The waiver proposed by South Africa and India would instead allow countries to circumvent these requirements, insulating generic manufacturers of anti-COVID drugs and technologies from lawsuits.</p>
<p>Another <a href="https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3789820">argument</a> undermining the waiver is that it cannot benefit generic producers (and patients), because it would not address the lack of production capacity and poor healthcare systems of many countries. Moreover, it could not alleviate the shortage in raw materials and the steep learning curve of manufacturing processes.</p>
<p>Take the Pfizer <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/mrna.html">mRNA</a> vaccines. This technology was developed recently and with revolutionary know-how: no pharmaceutical company can replicate it quickly. The bottleneck is not just IP protection, but the underlying processes around the protected technology. </p>
<p>If a TRIPS waiver passes, Pfizer could lawfully engage in being obstructive by, for example, refusing to disclose its know-how. It would be difficult, if not impossible, to require pharmaceutical companies to reveal that secret, also <a href="https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3843327">because</a> even if such companies were dragged into courts judges would not know which information should be disclosed.</p>
<p>Patents can be suspended by law, but confidential information kept by pharmaceutical companies is not easily retrievable. This has become clear in Bolivia’s plan to import Canadian-made generics. The Canadian manufacturer admitted that “<a href="https://www.reuters.com/world/americas/bolivia-signs-jj-vaccine-deal-with-twist-someone-else-would-make-it-2021-05-11/">if Johnson & Johnson agree to hand over the formula</a>” production could start in less than half the time. </p>
<h2>The pros</h2>
<p>Waiving or relaxing IP rights over anti-COVID technologies cannot fix the global pandemic alone. Nevertheless it could remove some roadblocks. </p>
<p>Arguably, the waiver could push pharma companies holding patents to increase the supply of their drugs. For example, the recent Natco application for a compulsory licence over Baricitinib has prompted Eli Lilly, the patent holder, to grant royalty-free and non-exclusive <a href="https://www.business-standard.com/article/companies/eli-lilly-signs-licensing-pact-with-cipla-sun-lupin-for-covid-19-drug-121051100039_1.html">voluntary licences</a> to Indian generic manufacturers Sun, Cipla and Lupin. Eli Lilly is also negotiating licences with other Indian producers.</p>
<p>So, flexing the muscles via granting compulsory licences sometimes seems to pay off in terms of encouraging patent owners to share their technology. This happened at the beginning of the pandemic. After Israel issued the compulsory licence over the Kaletra drug early last year, the patentee AbbVie voluntarily <a href="https://www.statnews.com/pharmalot/2020/03/20/abbvie-israel-hiv-kaletra-coronavirus-covid19/">dropped</a> its patent rights.</p>
<p>Waiver talks might produce a similar effect: convincing companies to focus on technology transfer and training, perhaps at a profit, and letting go of the plan to maximise patent-based revenues.</p>
<p>It could also be argued that a waiver would be a fair move to make given that over US$12 billion of <a href="https://www.reuters.com/world/americas/bolivia-signs-jj-vaccine-deal-with-twist-someone-else-would-make-it-2021-05-11/">public funding</a> has gone into the research and development of vaccines.</p>
<h2>A compromise in sight?</h2>
<p>It is still not clear what kind of a waiver WTO members can agree – if any. Negotiations might produce a softer solution than proposed by South Africa and India: perhaps a very short exemption with limited coverage, for example only vaccines, as proposed by the US.</p>
<p>Such compromise could neutralise the <a href="https://www.ft.com/content/f54bf71b-87be-4290-9c95-4d110eec7a90">refrain</a> of big pharmaceutical companies against any unwelcome relaxation of IP rights. A limited and short suspension of proprietary rights over COVID vaccines would have a lesser impact on innovation incentives.</p>
<p>A game changer in the fight against COVID could be last week’s WHO <a href="https://www.ft.com/content/7220cbdd-4b8c-49f1-9cf7-5146a691adb6">approval</a> of the vaccine produced by the China-owned company Sinopharm and the Beijing Institute of Biological Products. This is the first vaccine developed by a non-Western country to obtain the WHO green light.</p>
<p>This vaccine can be stored in a standard refrigerator, and “easy storage requirements” – the WHO <a href="https://www.who.int/news/item/07-05-2021-who-lists-additional-covid-19-vaccine-for-emergency-use-and-issues-interim-policy-recommendations">pointed out</a> – make it particularly suitable for developing and least-developed countries. </p>
<p>In addition, there’s a strong likelihood that China could produce enough vaccines to meet its own needs, and still have surplus that it can export. One <a href="https://www.nytimes.com/2021/05/07/business/economy/china-sinopharm-vaccine-who.html">estimate</a> is that the Sinopharm vaccine could be supplied to more than 80 countries. </p>
<p>This would benefit people in states which have not been able to access sufficient vaccines and that have recently been hit hard by COVID. These include India, Brazil, Indonesia and the Philippines.</p>
<p>Strengthening the global supply of vaccines would provide a major boost to efforts to contain COVID-19. Running in parallel with efforts to ease IP rules could see the balance shifted towards containment.</p><img src="https://counter.theconversation.com/content/160802/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>The authors do not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and have disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Waiver talks might convince companies to focus on technology transfer and training, and let go of the plan to maximise patent-based revenues.Enrico Bonadio, Reader in Intellectual Property Law, City, University of LondonFilippo Fontanelli, Senior Lecturer in International Economic Law, The University of EdinburghLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1519342021-03-25T11:38:38Z2021-03-25T11:38:38ZWhy India is banking on health diplomacy to grow African footprint<figure><img src="https://images.theconversation.com/files/391375/original/file-20210324-15-1gbiqtr.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Workers at India's biggest syringe manufacturer ramp up production in September 2020 in race to meet COVID-19 vaccine-driven demand.
</span> <span class="attribution"><span class="source">Photo by SAJJAD HUSSAIN/AFP via Getty Images</span></span></figcaption></figure><p>India has stepped up its global ambitions and foreign policy re-engagement with African countries in recent years. Its bilateral trade <a href="https://www.mea.gov.in/Speeches-Statements.htm?dtl/30924/">increased</a> from $7.2 billion in 2001 to $63 billion in 2017/18. India is now the third largest export destination and the fifth largest investor on the continent. </p>
<p>While it plays catch-up with China’s commanding presence in Africa, India has signed numerous new bilateral agreements. It has also strengthened its diplomatic presence and is actively furthering trade, infrastructure and private sector investments. </p>
<p>In our <a href="https://www.sum.uio.no/english/research/projects/indaf/">research under a multi-year project</a>, we found that New Delhi promotes an alternative model of development. It showcases the successes of its Green Revolution and advances in information, communication and technology. But it also highlights its ability to develop “Triple A” technology – affordable, appropriate, adaptable. </p>
<p>India’s expertise in <a href="https://www.cambridge.org/core/journals/biosocieties/article/abs/first-world-health-care-at-third-world-prices-globalization-bioethics-and-medical-tourism/1DD37C055DF0FFE983C5018776426C69">affordable healthcare</a> has assumed increased significance during the ongoing pandemic. New Delhi is already reaping the benefits of an <a href="https://www.thehindubusinessline.com/news/national/indias-vaccine-maitri-initiative-earns-praise-at-wto/article33979754.ece">ambitious diplomatic initiative</a> to deliver Made-in-India vaccines to developing countries. </p>
<p>India is one the <a href="https://www.bbc.com/news/world-asia-india-55571793">largest producers</a> of drugs globally. It manufactures 60% of the world’s vaccines. Many African countries have purchased or <a href="https://www.ndtv.com/india-news/sent-229-lakh-covid-vaccine-doses-to-other-countries-foreign-ministry-2369480">received these as gifts</a>.</p>
<p>New Delhi’s capacity and willingness to produce and share COVID-19 vaccines have further boosted the country’s diplomatic heft and recognition as a <a href="https://www.project-syndicate.org/commentary/india-covid19-vaccine-diplomacy-by-shashi-tharoor-2021-03">global power</a>.</p>
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Read more:
<a href="https://theconversation.com/interested-in-vaccine-rollouts-across-africa-heres-a-map-to-guide-you-156802">Interested in vaccine rollouts across Africa? Here's a map to guide you</a>
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<h2>India’s Africa policy</h2>
<p>India’s historical footprint in Africa differs from that of other powers. New Delhi offered support for African countries in their struggle against colonial rule. Indo-African partnership followed in the post-colonial period. This was cemented by <a href="http://ris.org.in/others/NAM-RIS-Web/NAM-Articles/Harshe-India%20Non-Alignment-EPW-1990-min.pdf">solidarity with and support for the Non-Aligned Movement</a> and the fight against racism. </p>
<p>India also offered support for <a href="https://www.mea.gov.in/Portal/ForeignRelation/India-SouthAfrica_Relations.pdf">South Africa</a> in its struggle against apartheid. In addition, New Delhi points to the presence of a <a href="https://mea.gov.in/images/attach/NRIs-and-PIOs_1.pdf">sizeable Indian diaspora</a> and their <a href="https://www.vifindia.org/sites/default/files/final-an-overview-of-indian-diaspora-in-africa.pdf">economic and philanthropic contributions</a> on the continent. </p>
<p>Since the early 1990s, India has moved from idealism to pragmatism and the explicit pursuit of commercial interests. The change was driven by robust economic growth at home and the need to access raw materials and new markets. </p>
<p>India’s <a href="https://www.springer.com/gp/book/9788132226185">push</a> for South-South cooperation relies on three broad elements. The first is a shared identity as part of the “Third World”. Second is expertise in cost-effective development technologies. Third is a recurrent articulation of the principles of mutual respect and solidarity. </p>
<p>Its long history of being <a href="https://www.journalofdemocracy.org/articles/poverty-inequality-and-democracy-growth-and-hunger-in-india/">democratic and its successes in reducing poverty and preventing famines</a> have also bolstered the legitimacy of its developmental approach in the Global South. </p>
<p>Since 2018, the India-Africa partnership has been based on a set of <a href="https://pib.gov.in/PressReleasePage.aspx?PRID=1540025">principles</a>. These have emphasised “local priorities”. They call for joint efforts to reform global institutions, combat climate change and fight global terrorism. They also highlight capacity building for agriculture, education, digital technology and cooperation on peacekeeping and maritime issues. </p>
<p>How and to what extent might Africa benefit from India’s growing interest? We identify three broad sets of health-related opportunities and benefits that may shape the future of India-Africa relations.</p>
<h2>Three major areas of collaboration</h2>
<p>The first relates to India’s formidable reputation as the <a href="https://www.business-standard.com/article/current-affairs/india-pharmacy-of-the-world-during-covid-19-crisis-says-sco-secy-general-120062100435_1.html">“pharmacy of the world”</a>. It has actively contributed to meeting <a href="https://in-pursuit-of-development.simplecast.com/episodes/rory-horner">global demand for vaccines, over the counter medicines and low-cost generic drugs</a>. The relatively low manufacturing costs make Indian products affordable throughout the world. </p>
<p>Almost 20% of India’s pharmaceutical exports, valued at US$ 17 billion, are to Africa. Southern and western regions of Africa are the largest importers of Indian medicines. These include antiretroviral (ARV) drugs that cost only a <a href="https://pharmaboardroom.com/articles/africa-the-global-launchpad-for-indian-pharma/">fraction</a> of those produced by Western companies. </p>
<p>The second relates to capacity building and collaboration in the health sector. Leading Indian <a href="https://www.eximbankindia.in/blog/blog-content.aspx?BlogID=7&BlogTitle=Healthcare%20in%20Africa,%20built%20by%20India">healthcare providers are collaborating with African partners</a>. Some have opened or plan to open speciality hospitals across Africa. </p>
<p>Since 2009, the <a href="https://au.int/en/flagships/pan-african-e-network">Pan-African E-Network</a> supported by India has offered tele-medicine services. This also connects Indian hospitals and educational centres with their counterparts in Africa. With its state-of-the-art medical facilities, which offer services at competitive costs, India has also emerged as an attractive destination for “medical tourism”. </p>
<p>The third relates to India’s active “medical diplomacy”. Africa’s reliance on a <a href="https://theconversation.com/the-world-needs-pharmaceuticals-from-china-and-india-to-beat-coronavirus-138388">cheap supply of essential medicines in addition to an affordable COVID-19 vaccine</a> is only likely to increase in the near future. </p>
<p>But Africa’s success in containing pandemics such as Ebola offers lessons to India, too. An illustrative example is Senegal, which has adapted its experiences <a href="https://www.worldometers.info/coronavirus/country/senegal/">from the 2014 Ebola outbreak to fight COVID-19</a>. Numerous additional lessons on disease control from African countries can also be scaled up to improve India’s health sector.</p>
<h2>Future collaboration on health</h2>
<p>India appears well-poised to share its digital capabilities for improved and affordable access to universal healthcare. New Delhi has revamped its tele-medicine and online video consultation infrastructure on the continent. This offers a cost effective and safe option for treating contagious diseases.</p>
<p>In the near future, India’s partners may benefit from its <a href="https://health.economictimes.indiatimes.com/news/health-it/india-to-become-the-world-leader-in-digital-health/55154100">online and mobile applications</a> to improve accessibility and affordability of healthcare. Online platforms can be used to <a href="https://main.mohfw.gov.in/Organisation/departments-health-and-family-welfare/e-Health-Telemedicine">access information</a> on blood banks, public hospitals, and organ donation. Mobile applications can help track the vaccine status of children and disease awareness. </p>
<p>But there are also some challenges that must be resolved. Combating the menace of counterfeit medicines on the African continent is one. In addition to existing measures to curb criminal activity, mobile apps can verify medicines to tackle the problem. </p>
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Read more:
<a href="https://theconversation.com/dummys-guide-to-how-trade-rules-affect-access-to-covid-19-vaccines-152897">Dummy's guide to how trade rules affect access to COVID-19 vaccines</a>
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<p>A major challenge is improving access to generic medicines through negotiated intellectual property rights waivers. At the World Trade Organisation, India and South Africa have taken a moral stance against <a href="https://www.bmj.com/content/372/bmj.n292">“vaccine nationalism”</a>. Their <a href="https://www.pharmaceutical-technology.com/features/wto-ip-waiver-proposal-covid19-vaccine/">joint proposal</a> in October 2020 for a temporary waiver on drugs and COVID-19 vaccines was nevertheless rejected by the organisation. </p>
<p>Since then, however, <a href="https://foreignpolicy.com/2021/03/10/wto-intellectual-propert-waiver-india-south-africa/">mainly African countries</a> have shown growing support for the proposal.</p><img src="https://counter.theconversation.com/content/151934/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Dan Banik receives funding from the Research Council of Norway. </span></em></p><p class="fine-print"><em><span>Renu MODI receives funding from the Research Council of Norway, Oslo</span></em></p>There are three broad sets of health-related opportunities and benefits that may shape the future of India-Africa relations.Dan Banik, Professor of political science, Director of the Oslo SDG Initiative, Host of "In Pursuit of Development" podcast, University of OsloRenu Modi, Professor in African Studies, University of Mumbai Licensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1438032020-09-11T12:19:05Z2020-09-11T12:19:05ZWhat’s in your medicine may surprise you – a call for greater transparency about inactive ingredients<figure><img src="https://images.theconversation.com/files/355618/original/file-20200831-20-1ik5bx8.jpg?ixlib=rb-1.1.0&rect=337%2C271%2C4844%2C2809&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">GettyImages</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/close-up-of-prescription-drugs-royalty-free-image/506115031?adppopup=true">Peter Dazeley/Getty Images</a></span></figcaption></figure><p>There are many more ingredients in every pill you take than what is listed on the bottle label. These other ingredients, which are combined with the therapeutic one, are often sourced from around the world before landing in your medicine cabinet and are not always benign.</p>
<p>Earlier this year, the U.S. Congress passed the <a href="https://www.congress.gov/bill/116th-congress/senate-bill/3548/text?q=product+actualizaci%C3%B3n">Coronavirus Aid, Relief and Economic Security Act</a>, which requires manufacturers to <a href="https://www.fda.gov/media/136486/download">report real or potential drug shortages to the FDA</a>. Manufacturers are now required to report disruptions in the manufacturing of an active pharmaceutical ingredient – the part of the medicine that produces the intended therapeutic benefit.</p>
<p>But the CARES Act doesn’t include excipients - the “inactive” ingredients that make up the bulk of a final medicine. It also doesn’t include the materials needed to package and distribute medical products, such as vials and other containers, packaging, and labels. While the CARES Act improves the flow of information and may signal potential drug shortages, it is intended to support regulators (like the FDA) in their public health responsibilities. It does not increase transparency to consumers of medicines.</p>
<p>As a trained pharmacist and researcher interested in uncovering risks to medicine quality, I believe patients and clinicians would benefit from having more information about all the ingredients in medicine. But for this to happen additional measures are needed to <a href="https://www.usp.org/sites/default/files/usp/document/about/public-policy/supply-chain-transparency.pdf">increase transparency</a> for all components of a medicine, including excipients. </p>
<h2>Product labeling for ‘inactive’ ingredients</h2>
<p>As the so-called “inactive” ingredients in medicines, excipients are often mistaken as being free from potential harm. But the evidence suggests otherwise. Between 2015 to 2019, health-care professionals, patients, and manufacturers filed nearly <a href="https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/fda-adverse-event-reporting-system-faers-public-dashboard">2,500 reports to the FDA</a> about an adverse reaction to an excipient. </p>
<p>While excipients are listed on packaging or package insert for over-the-counter and prescription drugs, this information can be difficult to find. Furthermore, patients often switch from brand name to generic versions, or the pharmacist substitutes one manufacturer for another. While the active pharmaceutical ingredient remains the same, excipients may be different, and even seemingly slight differences can significantly impact patient safety. For example, a patient may be allergic to an excipient in the newly refilled medicine with a different manufacturer.</p>
<p>Excipients are critical materials and serve a broad variety of functions. They serve as fillers, help the body to absorb the medicine, and add flavor or color to drugs. In fact, some are often found in food products, such as lactose, peanut oil, and starch. In the United States, excipients are approved by the FDA as part of the review process for the finished medicine; they are considered by the regulatory agency as generally recognized as safe or “GRAS.” However, a complete picture of their clinical effect remains unclear.</p>
<p>Research from MIT and Brigham and Women’s Hospital has found that <a href="https://doi.org/10.1126/scitranslmed.aau6753">92.8% of oral medicines </a>contain at least one potential allergen, a concern for individuals with known sensitivities and intolerances. My recent <a href="https://doi.org/10.1371/journal.pone.0235076">research</a>, investigating the safety of excipients in biologics, which are large complex molecules that are mostly administered through an injection, found case reports of injection site reaction, severe allergic reaction, spike in blood sugar level, and acute kidney failure associated with these “inactive” ingredients.</p>
<p>Despite some evidence that excipients are responsible for drug reactions, the amount of each excipient added to each drug is not reported for nearly half of biological medicines. In fact, our study found that <a href="https://doi.org/10.1371/journal.pone.0235076">44.4% of the biologics’ labels do not list the concentration</a> of the most commonly occurring excipients. This is true for all prescription medicines, not only biologics. </p>
<p>This lack of information has important implications for patients with diseases prompting dietary restrictions – such as gluten or lactose intolerance, food allergies, or diabetes – because the amount of wheat starch, lactose, peanut oil, and glucose in their medicine can be potentially harmful.</p>
<h2>Extending transparency to sources of medicines and their ingredients</h2>
<p>Food package labels are required to contain the manufacturer’s name, address, and telephone number alongside the ingredients list. This information allows consumers to contact manufacturers directly to inquire about the source of product ingredients and notify the company of any known or probable reactions to the ingredients. In the event of a recall, information about the source of foods also provides critical information to public health officials, allowing them to alert the public about potentially contaminated food items with specificity. </p>
<p>That is not the case for medical products even though the source of drug ingredients is just as, if not more, important as for food.</p>
<p>[<em>Deep knowledge, daily.</em> <a href="https://theconversation.com/us/newsletters/the-daily-3?utm_source=TCUS&utm_medium=inline-link&utm_campaign=newsletter-text&utm_content=deepknowledge">Sign up for The Conversation’s newsletter</a>.]</p>
<p>The <a href="https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/food-and-drug-administration-safety-and-innovation-act-fdasia">FDA Safety and Innovation Act</a> of 2012 mandated that drug manufacturers submit information about suppliers of excipients including names, addresses, and contact information. However, because this information is considered “proprietary” to the manufacturer, it is not disclosed publicly. While FDASIA was a step toward supply chain transparency, it still leaves the patients and health-care professionals without information that could be critical.</p>
<h2>Potential transparency policies to improve patient safety</h2>
<p>In a research paper studying the risks associated with excipients, <a href="https://doi.org/10.1371/journal.pone.0235076">my co-author and I</a> make three main recommendations to improve patient safety. </p>
<p>First, reporting requirements similar to those for food and active pharmaceutical ingredients should extend to excipients. Second, clinicians and patients should have easy access to that information, including amounts and potential adverse effects. The public should also be given information about how to completely and accurately report adverse events related to excipients. Third, regulatory agencies should provide guidance for excipient reporting, facilitating greater transparency about excipient use and supply source.</p><img src="https://counter.theconversation.com/content/143803/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Yelena Ionova receives funding from U.S. Pharmacopeial Convention (USP) Quality Institute. </span></em></p>There are ingredients in your pills other than the one designed to treat your ailments. Those unnamed ingredients can alter how you respond to a medicine or even make you sick.Yelena Ionova, Postdoctoral Fellow in Quality of Medical Products, University of California, San FranciscoLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1336882020-03-25T12:29:55Z2020-03-25T12:29:55ZMedical supply chains are fragile in the best of times and COVID-19 will test their strength<figure><img src="https://images.theconversation.com/files/322736/original/file-20200324-155666-1vd69rc.jpg?ixlib=rb-1.1.0&rect=630%2C0%2C4685%2C3186&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">The pipeline of pharmaceuticals is easily disrupted.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/pharmacy-medicine-capsule-pill-in-production-line-royalty-free-image/1138523291">Gumpanat/iStock via Getty Images Plus</a></span></figcaption></figure><p>The COVID-19 pandemic has brought medical supply chains into the spotlight. There has been a national <a href="https://www.foxnews.com/health/fears-grow-possible-shortage-coronavirus-testing-materials">shortage of testing kits</a>, and at least <a href="https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-supply-chain-update">one drug is already unavailable</a> because of the outbreak, though it hasn’t been publicly named.</p>
<p>As <a href="https://emilyltucker.wixsite.com/eltuck">operations</a> <a href="https://scholar.google.com/citations?user=AovKv2oAAAAJ&hl=en&oi=ao">engineers</a> who focus on how these supply chains work, we know that even in the best of times, the U.S. drug supply chain is relatively fragile. Shortages regularly occur, and the COVID-19 pandemic has the potential to further disrupt a system that patients depend on, sometimes for life or death.</p>
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<h2>A snapshot of how drugs are made</h2>
<p>Drugs can be divided into two broad categories: brand name and generic. </p>
<p>Brand name drugs are those that are still patent-protected, like Chantix and Truvada. They’re typically very profitable for manufacturers. This generally leads to a reliable supply of such drugs, often with some degree of redundancy – companies may maintain extra capacity or contract with multiple suppliers to prevent disruptions from causing shortages.</p>
<p>Patents, on the other hand, no longer protect generic drugs like ibuprofen and azithromycin. The profit margins for generic pharmaceuticals are low, and the supply chains for generics with low demand are often fragile. <a href="https://www.fiercepharma.com/manufacturing/concern-for-drug-shortages-grows-as-covid-19-outbreak-drags">Almost 90% of the U.S. drug supply is generic</a>.</p>
<p>A typical pharmaceutical supply chain begins with a manufacturer of the active pharmaceutical ingredients, or API. API plants are often overseas. <a href="https://www.fiercepharma.com/manufacturing/concern-for-drug-shortages-grows-as-covid-19-outbreak-drags">China and India are major API producers</a>, particularly for generic drugs. The APIs are then shipped to plants where they are formulated into drugs for shipment to wholesalers, distributors, hospitals, pharmacies and patients.</p>
<p>Supply chains for generic drugs are often lean. Typically each stage <a href="https://www.gao.gov/assets/670/660785.pdf">holds little inventory</a>, ranging from a few weeks to a few months. The active pharmaceutical ingredient may be made by a single manufacturer, and the finished form of the drug is nearly always made at a <a href="https://doi.org/10.1038/clpt.2012.220">single manufacturing plant</a>.</p>
<p>Federal <a href="https://www.gao.gov/assets/680/678281.pdf">regulatory protections</a> require the API manufacturer, the plant and the line on which the drug is manufactured all to be reviewed by the Food and Drug Administration. This is often a lengthy process.</p>
<p>This leanness means that a problem at any stage can disrupt the entire supply chain for months. The <a href="https://www.gao.gov/assets/680/678281.pdf">average drug shortage lasts 14 months</a>, and some have lasted for over three years. Unfortunately these are not rare events and don’t only happen when there are worldwide pandemics. Within the U.S., <a href="https://www.ashp.org/Drug-Shortages/Shortage-Resources/Drug-Shortages-Statistics">hundreds of drugs have been short since 2015</a> – including cancer treatments, antibiotics and central nervous system agents. </p>
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<p>Disruptions can take many forms, and this leads back to the COVID-19 situation. To curtail the spread of the virus, many <a href="https://www.fiercepharma.com/manufacturing/concern-for-drug-shortages-grows-as-covid-19-outbreak-drags">manufacturing plants in China were closed for weeks</a>. In late February, the FDA announced the <a href="https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-supply-chain-update">first COVID-19-related drug shortage</a>. Other such shortages may well occur. </p>
<h2>Making sure the supply chain won’t snap</h2>
<p>The effects of COVID-19 extend beyond manufacturing. The pandemic may lead to spikes in demand, which may in turn cause shortages. This is what occurred for the test kits: Demand rapidly increased once people needed to be tested. If demand surges for medications as well – such as hydroxychloroquine and chloroquine, which are being eyed as <a href="https://www.cdc.gov/coronavirus/2019-ncov/hcp/therapeutic-options.html">treatments for COVID-19</a> – there may be shortages even if the supply is unaffected by plant shutdowns.</p>
<p>During the COVID-19 outbreaks, the public can reduce shortages by taking action to manage downstream effects. “Flattening the curve” is about reducing demand spikes to help health systems manage the crisis without becoming overloaded. By washing your hands, physically distancing and not hoarding, Americans can help to limit the spread of the virus and take some of the stress off of hospitals.</p>
<p>Other strategies include <a href="https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-supply-chain-update">extending the available supply</a>. For example, the federal government or pharmaceutical companies could extend drug expiration dates if appropriate, or scientists could develop methods to test multiple people using the same kit.</p>
<p>At a broader scale, the U.S. should put resources into rapidly ramping up production where possible and keeping the supply chains as “connected” as they safely can be – for example, continuing to allow cargo to be shipped between continents even if passengers are not. </p>
<p>In the long term, there are <a href="https://doi.org/10.1080/24725854.2019.1646441">strategic steps manufacturers can take</a> to <a href="https://www.fda.gov/drugs/drug-shortages/report-drug-shortages-root-causes-and-potential-solutions">reduce drug shortages</a>. Decentralizing supply chains could help counter upstream disruptions. Rather than producing a drug in a single plant, companies could distribute production across multiple plants, ideally in different areas of the world. This could prevent a single problem from affecting the entire supply.</p>
<p>To increase supply and adaptability, the federal government could allocate additional resources to help shorten the time it takes for agencies to review whether manufacturing plants and suppliers are up to safety codes. Contracts to purchase drugs could also incorporate incentives for companies to maintain reliable supply chains. Many shortages are also caused by manufacturing quality issues; investing in higher quality manufacturing processes could reduce the frequency of disruptions. </p>
<p>Unfortunately, if supplies are not adequate, <a href="https://doi.org/10.1016/j.mayocp.2013.11.014">drugs may be rationed</a> or patients may not receive care. This, in effect, is at least part of what’s happening with COVID-19 testing kits, where <a href="https://www.usatoday.com/story/news/2020/03/11/coronavirus-covid-19-response-hurt-by-shortage-testing-components/5013586002/">demand is much higher than supply</a>. </p>
<p>There are strategies that pharmaceutical companies and the government can and should pursue to lessen the effects of the current crisis. However, until they invest in longer-term solutions, there will continue to be medical shortages. These are not easy choices in a time of high drug prices, but the COVID-19 pandemic should be a wake-up call to the vulnerabilities of medical supply chains.</p>
<p>[<em>You need to understand the coronavirus pandemic, and we can help.</em> <a href="https://theconversation.com/us/newsletters?utm_source=TCUS&utm_medium=inline-link&utm_campaign=newsletter-text&utm_content=upper-coronavirus-help">Read our newsletter</a>.]</p><img src="https://counter.theconversation.com/content/133688/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Emily Tucker receives funding from the National Science Foundation Graduate Research Fellowship Program under Grant DGE 1256260. Any opinions, findings, and conclusions or recommendations expressed in this material are those of the authors and do not necessarily reflect the views of the National Science Foundation.</span></em></p><p class="fine-print"><em><span>Mark Daskin has received funding from the National Science Foundation and also from General Motors (in the past) and Ford Motor Company (presently). He has also received internal funding from the University of Michigan. The latter is the only funding that is directly related to this article.</span></em></p>Drug shortages occur regularly in the US, even in the best of times. The pharmaceutical supply chain embodies ‘just in time’ shipping and has little built-in redundancy.Emily Tucker, Ph.D. Candidate in Industrial and Operations Engineering, University of MichiganMark Daskin, Professor of Industrial and Operations Engineering, University of MichiganLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1255292019-12-04T13:31:39Z2019-12-04T13:31:39ZWhy your generic drugs may not be safe and the FDA may be too lax<figure><img src="https://images.theconversation.com/files/304745/original/file-20191202-67023-k3jy0m.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Generic drugs can be a great way to save money, but a recent study shows there are risks involved.</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/hand-hospital-medical-expert-shows-pill-559764592">HQuality/Shutterstock.com</a></span></figcaption></figure><p>Generic prescription drugs have saved the U.S. about <a href="https://accessiblemeds.org/resources/blog/2017-generic-drug-access-and-savings-us-report">US$1.7 trillion</a> over the past decade. The Food and Drug Administration approved a <a href="https://www.fda.gov/drugs/abbreviated-new-drug-application-anda/activities-report-generic-drugs-program-fy-2018-monthly-performance">record 781 new generics</a> in 2018 alone, including generic versions of Cialis, Levitra and Lyrica. They join generic versions of blockbusters from yesteryear, like Lipitor, Nexium, Prozac and Xanax. </p>
<p>Seniors are the biggest purchasers of generics, because <a href="https://www.mdmag.com/conference-coverage/aafp_2010/how-many-pills-do-your-elderly-patients-take-each-day">they take the most medications</a> and are on fixed incomes, but virtually everyone has taken a generic antibiotic or pain pill at one time.</p>
<p>This leads to a vital question: Are generics safe? If drug manufacturers followed the FDA’s strict regulations, the answer would be a resounding yes. Unfortunately for those who turn to generics to save money, the <a href="https://fortune.com/2013/05/15/dirty-medicine/">FDA relies heavily on the honor system</a> with foreign manufacturers, and U.S. consumers get burned. <a href="https://dianerehm.org/shows/2014-02-20/safety-prescription-drugs-made-outside-us">Eighty percent of the active ingredients</a> and 40% of the finished generic drugs used in the U.S. are manufactured overseas. </p>
<p>As a pharmacist, I know that the safety of prescription medications is vital. My research, <a href="https://doi.org/10.1177/1060028019881692">recently published</a> in the “Annals of Pharmacotherapy,” raises alarming concerns about our vulnerabilities. </p>
<h2>Where are your drugs being made?</h2>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/304774/original/file-20191202-66986-cx7lhn.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/304774/original/file-20191202-66986-cx7lhn.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/304774/original/file-20191202-66986-cx7lhn.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/304774/original/file-20191202-66986-cx7lhn.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/304774/original/file-20191202-66986-cx7lhn.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/304774/original/file-20191202-66986-cx7lhn.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/304774/original/file-20191202-66986-cx7lhn.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">A pharmacist at a drug plant outside Mumbai in 2012, shortly after a change in patent law allowed production of a generic cancer drug.</span>
<span class="attribution"><a class="source" href="http://www.apimages.com/metadata/Index/India-Generic-Drugs/9d0fb82a0ea441ea9eecbcc8cea2d032/44/0">Rafiq Mugbool/AP Photo</a></span>
</figcaption>
</figure>
<p>Generic drug manufacturers either <a href="https://www.fda.gov/consumers/consumer-updates/generic-drugs-undergo-rigorous-fda-scrutiny">make bulk powders</a> with the active ingredient in them or buy those active ingredients from other companies and turn them into pills, ointments or injectable products. </p>
<p>In 2010, 64% of foreign manufacturing plants, predominantly in India and China, <a href="https://www.gao.gov/assets/690/681689.pdf">had never been inspected by the FDA</a>. By 2015, 33% remained uninspected. </p>
<p>In addition, <a href="https://www.fda.gov/ICECI/Inspections/ForeignInspections/ucm113565.htm#31">companies in other countries are informed</a> before an inspection, giving them time to clean up a mess. Domestic inspections are unannounced. </p>
<h2>Faking results</h2>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/304772/original/file-20191202-66994-pcueld.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/304772/original/file-20191202-66994-pcueld.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/304772/original/file-20191202-66994-pcueld.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/304772/original/file-20191202-66994-pcueld.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/304772/original/file-20191202-66994-pcueld.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/304772/original/file-20191202-66994-pcueld.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/304772/original/file-20191202-66994-pcueld.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">The FDA informs manufacturing plants in other countries when it plans to inspect their plants.</span>
<span class="attribution"><a class="source" href="http://www.apimages.com/metadata/Index/FDA-Generic-Asthma-Inhaler/51460da760a5483e9e8db780ee64a26b/60/0">Andrew Harnik/AP Photo</a></span>
</figcaption>
</figure>
<p>As I detail in my paper, when announced foreign FDA inspections began to occur in earnest between 2010 and 2015, numerous manufacturing plants were subsequently barred from shipping drugs to the U.S. after the inspections uncovered shady activities or serious quality defects. </p>
<p>Unscrupulous foreign producers <a href="https://doi.org/10.1177/1060028019881692">shredded documents</a> shortly before FDA visits, hid documents offsite, altered or manipulated safety or quality data or utilized unsanitary manufacturing conditions. <a href="https://www.bbc.com/news/world-asia-india-22520953">Ranbaxy</a> Corporation pleaded guilty in 2013 to shipping substandard drugs to the U.S. and making intentionally false statements. The company had to withdraw 73 million pills from circulation, and the company paid a <a href="https://corpwatch.org/article/ranbaxy-pays-500-million-fine-selling-bad-batches-generic-medicines">$500 million fine</a>.</p>
<p>These quality and safety issues can be deadly. In 2008, 100 patients in the U.S. died after receiving <a href="https://www.scientificamerican.com/article/heparin-scare-deaths/">generic heparin products</a> from foreign manufacturers. Heparin is an anticoagulant used to prevent or treat blood clots in about <a href="https://www.hepoligo.com/heparin-drugs/heparin">10 million hospitalized patients</a> a year and is extracted from pig intestines. </p>
<p>Some of the heparin was fraudulently replaced with chondroitin, a dietary supplement for joint aches, that had sulphur groups added to the molecule to make it look like heparin.</p>
<p>One of the heparin manufacturers inspected by the FDA received a warning letter after it was found to have used <a href="https://www.yourlawyer.com/pdf/Warning_Letter-04-21-08.pdf">raw material from uncertified farms</a>, used storage equipment with unidentified material adhering to it and had insufficient testing for impurities. </p>
<p>These issues continue to this day. Dozens of blood-pressure and anti-ulcer drugs were recalled in 2018 and 2019 due to contamination with the potentially carcinogenic compounds <a href="https://www.bloomberg.com/news/features/2019-01-30/chinese-heart-drug-valsartan-recall-shows-fda-inspection-limits">N-nitrosodimethylamine</a> or N-nitrosodiethylamine. </p>
<p>One of the major producers of these active ingredient powders used by multiple generic manufacturers was inspected in 2017. The FDA found that the company <a href="https://www.bloomberg.com/news/features/2019-01-30/chinese-heart-drug-valsartan-recall-shows-fda-inspection-limits">fraudulently omitted failing test results</a> and replaced them with passing scores. </p>
<p>This raises a critical question: How many more violations would occur with inspections occurring as frequently as they do in the U.S., and more importantly, if they were unannounced? Relatively speaking, the number of drugs proved to be tainted or substandard has been small, and the FDA has made some progress since 2010. But the potential for harm is still great.</p>
<h2>What’s next?</h2>
<p>How safe should U.S. residents feel when 80% of the active ingredients in our drugs are made overseas? Evidence shows that the FDA can’t trust the documents that foreign manufacturers produce to ensure that their products meet quality standards. The widespread willingness of foreign manufacturers to falsify, manipulate or shred documents in order to sell lower-quality or unsafe drugs to U.S. citizens shows that only frequent unannounced FDA inspections or FDA testing of batches of medications when they reach the U.S. will compel them to follow the rules. </p>
<p>Patients taking prescription drugs are sick and vulnerable; they should not be subjected to poor-quality medications that can make them worse. Similarly, domestic generic drug manufacturers employing U.S. citizens should not have to face strict regulatory compliance that effectively is not required of foreign competitors. </p>
<p>It is expensive, logistically challenging and politically unpalatable for the FDA to show up for unannounced inspections of foreign plants. If the agency is not given that right or the funding to ramp up testing of their products here in the U.S., it should not be subjecting U.S. citizens to the drugs produced in foreign plants. Unless we tackle this issue soon, I am afraid there will be a major incident where patients are killed and the golden goose – those immense savings associated with generic drugs – will also be sacrificed. </p>
<p>[ <em>Like what you’ve read? Want more?</em> <a href="https://theconversation.com/us/newsletters?utm_source=TCUS&utm_medium=inline-link&utm_campaign=newsletter-text&utm_content=likethis">Sign up for The Conversation’s daily newsletter</a>. ]</p><img src="https://counter.theconversation.com/content/125529/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>C. Michael White does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>As drug prices soar, consumers look for cheaper generics. A recent study showed safety issues in some generics made abroad, however, suggesting that the FDA’s honor system may not be enough to ensure safety.C. Michael White, Professor and Head of the Department of Pharmacy Practice, University of ConnecticutLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1175732019-06-04T12:43:04Z2019-06-04T12:43:04ZCheaper versions of the most expensive drugs may be coming, but monopolies will likely remain<figure><img src="https://images.theconversation.com/files/277686/original/file-20190603-69059-tgvmza.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Some biologics can cost up to a million dollars for a year's worth.</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/medical-business-prices-concept-making-money-621316742?src=wFltT8tHxqaqy6Q7WNm52A-1-0">Tero Vesalainen</a></span></figcaption></figure><p>In May, the Food and Drug Administration issued much-anticipated <a href="https://www.fda.gov/media/124907/download">guidance</a> that could revolutionize the pricing of some of the most expensive drugs on the market in the U.S. and, possibly, globally. </p>
<p>In this document, the FDA explains to drug manufacturers how to develop their own copycat versions of a special class of drugs called <a href="https://theconversation.com/biologics-the-pricey-drugs-transforming-medicine-80258">biologics</a>. Unlike most drugs, biologics are not chemically synthesized but are made, for the most part, inside living organisms. This makes them complicated to manufacture and tricky to imitate. </p>
<p>The FDA’s new guidance will allow drug manufacturers to create their own cheaper versions of biologics that could be automatically substituted for one another, including by pharmacists. Just as happened with “generic” drugs, bringing competition into biologics markets will, hopefully, lower the prices of these medicines. But, it is unclear by how much or whether the guidance will do so for all biologics. </p>
<p>As a legal researcher specializing in the regulation of novel biotechnologies, I have been following efforts over the last 10 to 12 years to bring competition into biologics markets in the United States. So, I am excited to see how the FDA’s new guidance affects competition in biologics and whether it ultimately increases patient access to these drugs. </p>
<h2>Why are biologics so expensive?</h2>
<p>Following the maturation of recombinant DNA technology in the 1970s, biologics have been emerging as a prominent class of pharmaceuticals. To illustrate, <a href="https://www.genengnews.com/a-lists/top-15-best-selling-drugs-of-2018/">seven out of the 10 best-selling pharmaceuticals in 2018</a> were biologics, including Humira, Opdivo, Keytruda, Enbrel, Herceptin, Avastin and Rituxan. The world’s best selling pharmaceutical, Humira, which is prescribed for a variety of autoimmune diseases, including <a href="https://www.niams.nih.gov/health-topics/arthritis-rheumatic-diseases">rheumatoid arthritis</a>, <a href="https://www.niddk.nih.gov/health-information/digestive-diseases/crohns-disease">Crohn’s disease</a>, <a href="https://www.niddk.nih.gov/health-information/digestive-diseases/ulcerative-colitis">ulcerative colitis</a>, <a href="https://www.niams.nih.gov/health-topics/psoriasis">psoriasis</a> and juvenile idiopathic arthritis, brought in nearly <a href="https://www.genengnews.com/a-lists/top-15-best-selling-drugs-of-2018/">US$20 billion</a> in worldwide sales last year. </p>
<p>The <a href="https://www.forbes.com/sites/theapothecary/2019/03/08/biologic-medicines-the-biggest-driver-of-rising-drug-prices/#548079af18b0">growing importance of biologics</a> is due, in large part, to their remarkable therapeutic qualities. Biologics provide treatment and sometimes even a cure for some of the most devastating and often previously untreatable illnesses, including numerous types of cancer, autoimmune diseases such as <a href="https://www.niams.nih.gov/health-topics/arthritis-and-rheumatic-diseases">arthritis</a>, <a href="https://www.niddk.nih.gov/health-information/digestive-diseases/crohns-disease">Crohn’s disease</a> and psoriasis, some forms of blindness and more. </p>
<p>But biologics are also very expensive, typically costing in the range of <a href="https://www.nytimes.com/2018/01/06/business/humira-drug-prices.html">many tens of thousands</a> to <a href="https://www.reuters.com/article/us-usa-healthcare-cancer-costs/the-cost-of-cancer-new-drugs-show-success-at-a-steep-price-idUSKBN1750FU">hundreds of thousands</a> of dollars a year. In a few cases of biologics indicated for the treatment of rare diseases such as <a href="http://pharmatimes.com/news/brineura_hit_with_nice_rejection_1279019">neuronal ceroid lipofuscinosis type II</a> or Batten disease and <a href="https://icer-review.org/announcements/icer-issues-final-report-on-sma/">spinal muscular atrophy</a> the price comes closer to a million dollars per treatment year. As a result, although biologics account for only about <a href="https://www.forbes.com/sites/theapothecary/2019/03/08/biologic-medicines-the-biggest-driver-of-rising-drug-prices/#314eccda18b0">1 to 2% of prescriptions written in the United States</a>, they are <a href="http://doi.org/10.1056/NEJMp1902240">responsible for more than 30%</a> of the spending on pharmaceuticals overall and their “share” in pharmaceutical spending only continues to grow.</p>
<p>The high price of biologics is partly due to the costly manufacturing facilities and the large investment in research and development necessary in order to take biologics through clinical trials and FDA approval processes. In 2009, the R&D cost for a copycat biologic was estimated at between <a href="https://www.ftc.gov/sites/default/files/documents/reports/emerging-health-care-issues-follow-biologic-drug-competition-federal-trade-commission-report/p083901biologicsreport.pdf">$100–200 million</a>. Conducting the research and clinical trials necessary to develop a <em>new</em> biologic is estimated to cost in the range of hundreds of millions dollars for a typical biological product. </p>
<p>But the <a href="https://www.healthaffairs.org/do/10.1377/hblog20190405.396631/full/">primary reason biologics prices are so steep</a> is that the manufacturers of these drugs enjoy a monopoly and are able to keep their prices very high for a very long time.</p>
<p>The reason most pharmaceutical companies have monopolies on biologics is that these products are structurally and chemically complex. It is very difficult and sometimes even impossible – at least using current technologies – to know their exact structure and composition. This, in turn, makes it difficult to produce identical or near-identical replicas of biologics, which is what generics drugs are. This is why there are no generic biologics on the market. But that might soon change.</p>
<h2>FDA guidance could make biologics cheaper</h2>
<p>Congress has long recognized that the best way to lower the prices of expensive pharmaceutical products is through competition. That was the rationale behind the enactment of the <a href="https://www.govinfo.gov/content/pkg/STATUTE-98/pdf/STATUTE-98-Pg1585.pdf">Hatch-Waxman Act</a> in 1984, which created a legal pathway for approval of imitation or “generic” versions of pharmaceuticals. </p>
<p>The Hatch-Waxman Act revolutionized competition in pharmaceutical markets that led to significant price drops – often by as much as 80-90% – in thousands of pharmaceutical products. This has saved American consumers <a href="https://accessiblemeds.org/sites/default/files/2018_aam_generic_drug_access_and_savings_report.pdf">hundreds of billions of dollars each year</a>. </p>
<p>Following Europe’s lead, in 2010, as part of the Affordable Care Act, or Obamacare, Congress passed the <a href="https://www.fda.gov/media/78946/download">Biologics Price Competition and Innovation (BPCI) Act</a>. This was meant to do for biologics markets what the Hatch-Waxman Act did in 1984 for non-biologic pharmaceuticals. </p>
<p>But the BPCI Act only created the legal pathway for approval of imitation biologics. It did not address the technical challenge of comparing the original, expensive biologic with its cheaper imitation. That is something that the FDA must still figure out. Not an easy task. </p>
<p>Now, more than nine years after the enactment of the BPCI Act, the FDA issued its guidelines which explain, for the first time, to potential follow-on biologics manufacturers what the FDA requires in order to approve a copycat biologic. In the guidance, the FDA provides instructions how to prove that two products – the original biologic and the copycat – are similar enough to be deemed substitutable.</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/277703/original/file-20190603-69087-1b77y8m.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/277703/original/file-20190603-69087-1b77y8m.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/277703/original/file-20190603-69087-1b77y8m.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/277703/original/file-20190603-69087-1b77y8m.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/277703/original/file-20190603-69087-1b77y8m.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/277703/original/file-20190603-69087-1b77y8m.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/277703/original/file-20190603-69087-1b77y8m.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Manufacturing facilities for biologics are wildly expensive making it difficult for competitors to enter the market.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/pharmaceutical-factory-woman-worker-protective-clothing-1042879324">TRAIMAK/Shutterstock.com</a></span>
</figcaption>
</figure>
<h2>Monopolies may persist</h2>
<p>Once FDA approves interchangeable versions of biologics, this should drive competition in biologics and, ultimately, cause their prices to drop. As many regulatory agencies in countries around the world follow the FDA’s lead, agencies in other countries will likely do the same, leading to larger cost savings globally. </p>
<p>But concerns remain that the FDA’s guidance might not be enough to drive prices down significantly. Development of similar biologics is estimated to cost about <a href="https://www.ftc.gov/sites/default/files/documents/reports/emerging-health-care-issues-follow-biologic-drug-competition-federal-trade-commission-report/p083901biologicsreport.pdf">$100-200 million</a>. This is much higher than the development of generic drugs, which is estimated to cost, typically, between $1-5 million. There are not very many companies with the kind of facilities, expertise, and money necessary to develop interchangeable versions of biologics and chaperon them through the FDA’s approval process. As a result, it is quite possible that there will not be a lot of companies able to compete. </p>
<p><a href="https://www.fda.gov/about-fda/center-drug-evaluation-and-research/generic-competition-and-drug-prices">Previous research shows</a> that significant price drops in pharmaceuticals occur only after several competitors enter the market. So, it is quite possible that many biologics will have too few competing interchangeable versions to drive prices down significantly. </p>
<p>Also, original biologics makers have been taking a variety of measures to avoid losing their monopolies. Some have been amassing large patent portfolios. Others have been known to file lawsuits and abuse regulatory processes to delay the entry of competing products into the market. It is likely that they will continue to do so in order to prevent interchangeable versions of their biologics from entering the market. </p>
<p>Finally, the FDA guidance itself only applies to protein products, which are only one kind of biologics. So, there still is no clear regulatory path for FDA to approve interchangeable versions of some of the most expensive biologics – like <a href="https://ghr.nlm.nih.gov/primer/therapy/genetherapy">gene therapies</a>. </p>
<p>The FDA guidance may prove to be an important step toward lowering the prices of biologics. It comes at a good time, given the drug pricing crisis in the United States. But the guidance alone may not be enough.</p><img src="https://counter.theconversation.com/content/117573/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Yaniv Heled has served as consultant on biosimilar litigation. </span></em></p>Biologics, therapies made inside or of living cells, are a growing share of pharmaceutical sales. But the cost of these miracle treatments makes them unaffordable for many. New FDA guidance may help.Yaniv Heled, Associate Professor of Law, Georgia State UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1088782019-01-03T11:20:46Z2019-01-03T11:20:46ZHealth insurers want you to try cheaper drugs first, but that can hurt you<figure><img src="https://images.theconversation.com/files/251796/original/file-20181220-103657-13cc8x0.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Physicians often have reasons for prescribing a specific drug. </span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/black-female-physician-prescribing-pills-older-342696572?src=oyytOrGRNrDicvSJ_k-E-w-1-3">Burlingham/Shutterstock.com</a></span></figcaption></figure><p>Few people are familiar with the term “step therapy,” but most Americans have health insurance policies that adopt it. <a href="https://www.goodrx.com/blog/what-is-step-therapy-how-to-get-insurance-to-pay-for-your-non-preferred-drug/">Step therapy programs</a>, also known as “fail first policies,” require patients to try less expensive treatments before insurers agree to pay for more costly alternatives. Thus, insurers can deny coverage for a drug your doctor prescribed because you haven’t found other, cheaper medications to be ineffective first. As many as <a href="https://www.aad.org/advocacy/state-policy/step-therapy-legislation">75 percent of large employers</a> have insurance plans with step therapy, and <a href="https://q1medicare.com/q1group/MedicareAdvantagePartDQA/FAQ.php?faq=What-is-Step-Therapy-in-Medicare-Part-D-&faq_id=200&category_id=1">Medicare</a> is <a href="https://www.cms.gov/newsroom/fact-sheets/medicare-advantage-prior-authorization-and-step-therapy-part-b-drugs">increasingly</a> embracing this approach as well. </p>
<p>My husband and I encountered step therapy when he was prescribed a new medication for his Parkinson’s disease. As a professor of law and bioethics, I have since researched and <a href="https://scholarlycommons.law.case.edu/cgi/viewcontent.cgi?article=3009&context=faculty_publications">written</a> about this phenomenon. I have found that step therapy can be sensible in some instances, but it also raises important concerns and should be carefully regulated.</p>
<h2>Benefits and risks of step therapy</h2>
<p>Health insurers have good reason to be worried about health care costs and to try to limit them. Medical costs have famously ballooned in recent years. According to a <a href="https://www.hsgac.senate.gov/media/minority-media/breaking-brand-name-drugs-increasing-at-10x-cost-of-inflation-mccaskill-report-finds">congressional report</a>, “the prices of many of the most popular brand-name drugs increased at nearly ten times the cost of inflation from 2012 to 2017.” Thus, it often makes sense to require patients to try cheaper but equally effective choices, such as generic rather than brand-name drugs.</p>
<p>However, in some cases, step therapy can <a href="http://www.steptherapy.com/blog/the-true-cost-of-step-therapy-legislation/">increase costs</a> in the long term, even if it lowers them in the short term. It can also significantly <a href="https://patientengagementhit.com/news/how-does-step-therapy-impact-patient-care-access-costs">hurt patients</a>. This is because doctors may have very good reasons for prescribing particular drugs for specific patients. In such cases, individuals forced to take different medications can suffer severe side effects, complications and health deterioration. </p>
<p>For example, <a href="https://www.bostonglobe.com/opinion/2016/07/23/medical-therapy-that-therapy-all/wttF75QVPmvEXWJknhW6MO/story.html">Eitan Kling-Levine</a>, an ulcerative colitis patient, was required to take several drugs that were ineffective for him during a six-month period before getting his physician’s chosen therapy approved. During this time, his disease progressed to such an extent that his colon had to be surgically removed. </p>
<p><a href="https://www.statnews.com/2016/08/22/step-therapy-patients-insurance-treatments/">Kathleen Arntsen</a>, a glaucoma patient, believes that she lost her vision in one eye because of step therapy. She had to try two different drugs over seven weeks before being allowed to switch to the more expensive Travatan Z eye drops that her physician initially prescribed. Others suffer unrelieved pain, depression and other symptoms because of step therapy constraints.</p>
<h2>Imprecise medicine?</h2>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/251797/original/file-20181220-103643-1597lyz.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/251797/original/file-20181220-103643-1597lyz.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=390&fit=crop&dpr=1 600w, https://images.theconversation.com/files/251797/original/file-20181220-103643-1597lyz.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=390&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/251797/original/file-20181220-103643-1597lyz.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=390&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/251797/original/file-20181220-103643-1597lyz.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=490&fit=crop&dpr=1 754w, https://images.theconversation.com/files/251797/original/file-20181220-103643-1597lyz.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=490&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/251797/original/file-20181220-103643-1597lyz.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=490&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">A big push in medicine is the focus on precision diagnostics and care. Step therapy goes in the opposite direction.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/closeup-female-scientist-filling-test-tubes-146154983?src=mcfpyx06LcQU-4EPAekYdA-1-26">sirtravelalot/Shutterstock.com</a></span>
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<p>Step therapy is a one-size-fits-all approach to treatment. This is contrary to contemporary <a href="https://allofus.nih.gov/about/about-all-us-research-program">precision medicine</a> research initiatives. Precision medicine refers to tailoring treatments to individuals with particular characteristics. It aims to enable doctors to select the right treatment for patients based on their symptoms, genetic makeup or other attributes. Step therapy policies that dictate which drugs all patients must take first could be a major hindrance to implementing precision medicine findings.</p>
<p>In addition, step therapy requirements can come as an unpleasant surprise to doctors and patients. Health insurers do not publicize their step therapy policies, and they can be difficult to locate on health insurers’ websites. Unexpected coverage rejections can cause treatment delays, exacerbating patients’ health problems.</p>
<h2>Step therapy regulation</h2>
<p>Some states have addressed step therapy through legislation. Eighteen states have <a href="https://www.aad.org/advocacy/state-policy/step-therapy-legislation">enacted laws</a> that regulate the practice, and several others have pending proposed bills.</p>
<p>None of these statutes completely bars step therapy. Instead, they limit it in a variety of ways. </p>
<p>For example, doctors may request that step therapy be waived for particular patients for medical reasons, and many laws require insurers to approve or deny such requests within <a href="https://healthpayerintelligence.com/news/mn-law-allows-some-patients-to-override-payers-on-step-therapy">72 hours</a>. The laws also instruct that waiver requests must be approved for patients who are already <a href="https://healthpayerintelligence.com/news/mn-law-allows-some-patients-to-override-payers-on-step-therapy">doing well</a> on their doctors’ drug of choice. Exemptions must also be given for those who have <a href="https://www.aad.org/advocacy/state-policy/step-therapy-legislation">previously tried</a> the insurer’s preferred drug and found it to be ineffective or intolerable. Such provisions can be particularly beneficial for individuals whose employers switched to a new insurance plan that suddenly places new step therapy demands on them. </p>
<p>Still other laws strictly limit the duration of step therapy protocols to <a href="https://law.justia.com/codes/mississippi/2016/title-83/chapter-9/accident-and-health-insurance/section-83-9-36/">30</a> or <a href="https://www.lawserver.com/law/state/connecticut/ct-laws/connecticut_statutes_38a-544">60</a> days. If the trial period ends and the insurer’s mandated treatment has failed, the doctor’s drug of choice must be approved.</p>
<p>Step therapy statutes protect many patients. However, only a minority of states have them. Moreover, a federal law called <a href="https://www.dol.gov/general/topic/health-plans/erisa">ERISA</a> makes state statutes that regulate insurance <a href="https://web.garretsongroup.com/dev-blog/handle-erisa-self-insured-plans-stop-loss-coverage-low-attachment-points">inapplicable</a> to self-funded insurance plans. If your employer pays for medical claims out of its own pocket, it has a self-funded plan, though it may contract with an insurer to administer the plan. <a href="https://www.kff.org/report-section/2018-employer-health-benefits-survey-section-10-plan-funding/">Experts estimate</a> that over 60 percent of workers are enrolled in self-funded plans. Therefore, step therapy statutes do not protect the majority of workers even in states that have them.</p>
<p><a href="https://www.law.cornell.edu/cfr/text/42/423.578">Medicare regulations</a> offer seniors many of the <a href="https://www.law.cornell.edu/cfr/text/42/423.568">safeguards</a> that are available under state step therapy statutes. However, non-Medicare patients may be left at the mercy of health insurers. Federal law provides Americans with a <a href="https://www.healthcare.gov/appeal-insurance-company-decision/appeals/">right to appeal</a> insurance decisions. However, the appeals process may be lengthy and cumbersome.</p>
<h2>Potential solutions</h2>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/251798/original/file-20181220-103638-1mzbt6b.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/251798/original/file-20181220-103638-1mzbt6b.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=402&fit=crop&dpr=1 600w, https://images.theconversation.com/files/251798/original/file-20181220-103638-1mzbt6b.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=402&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/251798/original/file-20181220-103638-1mzbt6b.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=402&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/251798/original/file-20181220-103638-1mzbt6b.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=505&fit=crop&dpr=1 754w, https://images.theconversation.com/files/251798/original/file-20181220-103638-1mzbt6b.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=505&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/251798/original/file-20181220-103638-1mzbt6b.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=505&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">If you are denied coverage for a prescription from your doctor, you can consider filing an appeal.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/insurance-claim-form-143702539?src=TZ9olK4tHnXCsJ_qeayPMQ-1-40">Emilie Zhang/Shutterstock.com</a></span>
</figcaption>
</figure>
<p>So what should be done to protect patients subject to step therapy? As a first measure, I believe, based on my research and experience, that all states should pass step therapy statutes. In addition, federal laws that govern health insurance should include provisions that specifically address step therapy. </p>
<p>Third, insurers should improve transparency and provide easily accessible information to patients and clinicians about their step therapy programs. Finally, insurers should monitor and incorporate up-to-date scientific and financial evidence into their step therapy programs. Step therapy requirements should be updated to reflect precision medicine research findings.</p>
<p>They should also be adjusted if it becomes clear that particular requirements can harm patients and increase long-term costs.</p>
<p>Most importantly, if you disagree with an insurer’s decision to decline coverage for a treatment your doctor recommends, don’t hesitate to appeal. You have an absolute right to do so even if you are not covered by a state step therapy statute or Medicare regulations. You may have to call your physician repeatedly to make sure the insurer is contacted and the paperwork is completed. Doctors are very busy, and they don’t enjoy or get reimbursed for arguing with insurers. But persistence is worthwhile. Your health may depend on it.</p><img src="https://counter.theconversation.com/content/108878/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Sharona Hoffman received funding from Case Western Reserve University to write her article, "Step Therapy: Legal and Ethical Implications of a Cost-Cutting Measure," Food and Drug Law Journal, vol. 73, pp. 38-65 (2018). </span></em></p>Insurance companies sometimes try to cut costs by substituting less expensive drugs for a specific drug prescription. That’s raising problems in many cases, and actually causing harm.Sharona Hoffman, Professor of Health Law and Bioethics, Case Western Reserve UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1089772018-12-21T16:49:43Z2018-12-21T16:49:43ZCelebrating solutions that chip away at big problems: 3 essential reads<figure><img src="https://images.theconversation.com/files/251644/original/file-20181219-45394-rklicz.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">No longer tangled and pointing in the right direction</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/thinking-about-structuring-business-process-solutions-1028847439">turgaygundogdu/Shutterstock.com</a></span></figcaption></figure><p><em>Editor’s note: As we come to the end of the year, Conversation editors take a look back at the stories that – for them – exemplified 2018.</em></p>
<p>Slowing the pace of climate change, increasing access to health care and comprehensively covering the news are very different but worthy goals with some things in common. </p>
<p>One is gridlock. The <a href="https://www.cnn.com/2018/12/10/world/climate-change-us-coal-cop24/index.html">nation’s leaders</a> are <a href="https://www.cbpp.org/sabotage-watch-tracking-efforts-to-undermine-the-aca">doing little</a> to <a href="http://www.governing.com/topics/politics/gov-trump-cuts-public-radio-broadcasting-rural-lc.html">solve these problems</a>.</p>
<p>Another is sticker shock: Holding the line at <a href="https://www.nationalgeographic.com/environment/2018/10/ipcc-report-climate-change-impacts-forests-emissions/">2 degrees Celsius</a> of global warming – <a href="https://www.sciencenews.org/article/global-warming-limit-degrees-ipcc-climate-change">or less</a> – would cost trillions of dollars and require <a href="https://www.wri.org/publication/transforming-agriculture-climate-resilience-framework-systemic-change">systemic change</a>. The same goes for securing adequate <a href="https://www.politifact.com/truth-o-meter/article/2017/jul/21/how-expensive-would-single-payer-system-be/">medical treatment</a> for <a href="https://www.thebalance.com/how-does-health-insurance-work-3306069">all Americans</a>. <a href="https://www.knightfoundation.org/public-media-white-paper-2017-levin">Reporting the news</a> costs billions, but nobody knows how to <a href="https://doi.org/10.1080/21670811.2016.1246373">pay that tab</a> either.</p>
<p>To see how disheartening this is, search the internet for the terms “<a href="https://350.org/overcoming-despair/">climate change</a>,” “<a href="https://www.boswellbooks.com/book/9781595985941">health care</a>” or “<a href="https://www.cjr.org/analysis/crisis-of-trust-inside-newsrooms.php">newsrooms</a>” and “despair.” You’ll generate hundreds of thousands of hits or more.</p>
<p>That’s why I like to pause, especially at the year’s end, to celebrate innovations and encouraging trends that chip away at huge challenges.</p>
<h2>1. Bypassing drug shortages</h2>
<p>For example, the emergence of <a href="https://theconversation.com/nonprofit-drugmaker-civica-rx-aims-to-cure-a-health-care-system-ailment-104744">Civica Rx</a> is encouraging. The nonprofit generic drugmaker, which launched in 2018, will soon begin producing 14 hospital-administered generics. Most of them are too scarce to meet demand. </p>
<p>The venture has not disclosed its business model. But “should it choose to do so, Civica Rx could theoretically set the price at or near the cost of production,” writes <a href="https://scholar.google.com/citations?user=ckOu9WsAAAAJ&hl=en">Stacie B. Dusetzina</a>, a Vanderbilt University health policy and cancer scholar. That would make a big difference in a country where pharmaceuticals can sell for <a href="https://www.vox.com/science-and-health/2016/11/30/12945756/prescription-drug-prices-explained">triple what they cost elsewhere</a>.</p>
<p><iframe id="CMBR7" class="tc-infographic-datawrapper" src="https://datawrapper.dwcdn.net/CMBR7/1/" height="400px" width="100%" style="border: none" frameborder="0"></iframe></p>
<p>If Civica Rx succeeds at making treatment in hospitals cheaper and better, there will be fewer excuses for not fixing the rest of the health care system’s broken pieces. </p>
<h2>2. Scrapping emissions</h2>
<p>Just as Civica Rx makes it possible to feel more optimistic about the future of U.S. health care, the industrial-scale repurposing of steel and aluminum holds promise regarding climate change.</p>
<p><a href="https://www.isri.org/recycling-commodities/recycling-industry-yearbook">Scrap metal gets recycled</a> the way cans and boxes from <a href="https://www.citylab.com/city-makers-connections/recycling/">your household</a> do, only on a bigger scale. <a href="https://theconversation.com/how-recycling-more-steel-and-aluminum-could-slash-imports-without-a-trade-war-97766">Repurposing metal</a> from demolished buildings and nonroadworthy cars saves money, tempers landfill problems and uses much less energy than starting from scratch.</p>
<p>Because the process requires less power, it “has a much-smaller carbon footprint,” explains <a href="https://scholar.google.com/citations?user=4XQeuikAAAAJ&hl=en&oi=ao">Daniel Cooper</a>, a University of Michigan mechanical engineer. “The greenhouse gas emissions for recycling steel are around one-quarter of what they are for making new steel, and recycling aluminum cuts emissions by more than 80 percent.”</p>
<p><iframe id="fX2LY" class="tc-infographic-datawrapper" src="https://datawrapper.dwcdn.net/fX2LY/10/" height="400px" width="100%" style="border: none" frameborder="0"></iframe></p>
<p>Granted, <a href="https://www.nbcwashington.com/news/business/US-Struggles-With-What-to-Do-With-Tons-of-Recycled-Material-489971551.html">China’s unwillingness to import</a> as much American junk as it used to due to <a href="https://waste-management-world.com/a/tariffs-creating-more-problems-than-they-solve-for-metal-recyclers">trade tensions</a> is disrupting global scrap markets.</p>
<p>But the U.S. could potentially use all of steel and aluminum it throws out right here, Cooper contends. That would cut down on emissions even more by bypassing the <a href="https://theconversation.com/cargo-ships-are-emitting-boatloads-of-carbon-and-nobody-wants-to-take-the-blame-108731">carbon released into the atmosphere from hauling cargo</a> across oceans.</p>
<h2>3. Teaming up between newsrooms</h2>
<p>The traditional way to cover the news is inefficient. Many journalists often report on the same events and scandals, working in isolation and duplicating efforts. </p>
<p>That’s starting to change, observes <a href="https://scholar.google.com/citations?user=n_3ICpcAAAAJ&hl=en&oi=sra">Magda Konieczna</a>, an assistant professor of journalism at Temple University. </p>
<p>A growing number of news organizations “are sharing their high-quality journalism with other outlets,” she explains. “By teaming up, they can inform bigger audiences about the problems like corruption, environmental dangers and abusive business practices.”</p>
<p>Most of the time, the <a href="https://theconversation.com/nonprofit-newsrooms-are-reaching-bigger-audiences-by-teaming-up-with-other-outlets-102293">sharing involves news nonprofits</a> without big audiences, Konieczna finds. This collaborative approach helps “elevate the quality of the media where people are already going for news: newspapers and newscasts, whether directly or through Facebook and Twitter.”</p><img src="https://counter.theconversation.com/content/108977/count.gif" alt="The Conversation" width="1" height="1" />
Fixes for small pieces of massive problems show that overarching crises may be less hopeless than they appear.Emily Schwartz Greco, Philanthropy + Nonprofits Editor, The ConversationLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/998222018-09-13T14:32:54Z2018-09-13T14:32:54ZAfter a century, insulin is still expensive – could DIYers change that?<figure><img src="https://images.theconversation.com/files/236096/original/file-20180912-133877-hflsgu.jpg?ixlib=rb-1.1.0&rect=89%2C0%2C1204%2C877&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Miniature biomanufacturing kits like this prototype could revolutionize the pharmaceutical industry.</span> <span class="attribution"><a class="source" href="http://amino.bio">Amino Labs</a>, <a class="license" href="http://creativecommons.org/licenses/by-nd/4.0/">CC BY-ND</a></span></figcaption></figure><p>Soon after Federick Banting <a href="https://doi.org/10.1056/NEJMms1411398">discovered that insulin could be used to treat diabetes</a> in 1921, he sold the patent to the University of Toronto for about a dollar. Banting received the Nobel prize because his discovery meant a life-saving drug could become widely available. Nearly a century later, an American with diabetes can pay as much as US$400 per month for insulin, driving some uninsured patients to desperate and dangerous measures. Clearly, something went wrong. </p>
<p><a href="https://www.peccoud.org">Our lab</a> studies biosecurity, so when we heard that a group of do-it-yourself biologists was working to solve the insulin affordability problem by figuring out how to manufacture insulin patent-free, we got to know them. After digging into the insulin affordability issue, <a href="https://doi.org/10.1016/j.tibtech.2018.07.009">we argue</a> that what’s keeping insulin expensive is not patents – it’s regulations. By operating in a regulatory blind spot, DIYers could upset the status quo for drug production. </p>
<h2>Patents don’t make insulin expensive</h2>
<p><a href="https://www.scientificamerican.com/article/cost-to-develop-new-pharmaceutical-drug-now-exceeds-2-5b/">Discovering and developing drugs is expensive</a>. Patents help drug companies recoup the costs from their investments by granting them a monopoly for a limited time. Once the patent expires, competing companies can begin producing generics: off-brand versions of a patented drug. This healthy competition drives <a href="https://www.fda.gov/downloads/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/GenericDrugs/UCM609808.pdf">prices down</a>.</p>
<p>So why, with the original patent long-expired, is there still no affordable generic insulin?</p>
<p>The insulin for purchase today is not the same insulin used to treat diabetic patients nearly 100 years ago. That insulin came primarily from animals. Today, insulin is brewed up by microbes that have been <a href="https://www.fda.gov/downloads/AboutFDA/WhatWeDo/History/ProductRegulation/UCM593496.pdf">genetically engineered</a> with the gene for human insulin.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/236110/original/file-20180912-133880-1tsl0x5.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/236110/original/file-20180912-133880-1tsl0x5.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/236110/original/file-20180912-133880-1tsl0x5.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=380&fit=crop&dpr=1 600w, https://images.theconversation.com/files/236110/original/file-20180912-133880-1tsl0x5.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=380&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/236110/original/file-20180912-133880-1tsl0x5.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=380&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/236110/original/file-20180912-133880-1tsl0x5.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=478&fit=crop&dpr=1 754w, https://images.theconversation.com/files/236110/original/file-20180912-133880-1tsl0x5.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=478&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/236110/original/file-20180912-133880-1tsl0x5.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=478&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Insulin pumps are one of the newer ways to administer the drug to diabetic patients.</span>
<span class="attribution"><a class="source" href="http://www.apimages.com/metadata/Index/Insulin-Legislation/75bd28fc8ed840c3802727306873cce0/1/0">AP Photo/Mark Zaleski</a></span>
</figcaption>
</figure>
<p>And insulin is seldom injected with an old-fashioned syringe and needle anymore. Now there are insulin pens, pumps, test strips and other devices that improve the quality of life for diabetic patients. Pharmaceutical companies have also modified the chemical formula to produce faster-acting or longer-lasting insulins.</p>
<p>With each of these inventions came a new patent.</p>
<p>But the benefits of these “improved” insulins <a href="https://doi.org/10.2337/dc13-2915">are debatable</a>, and there’s nothing preventing competing companies from selling older, long off-patent versions of insulin. So <a href="https://doi.org/10.1016/j.tibtech.2018.07.009">what’s the holdup</a>? </p>
<h2>Regulations keep insulin expensive</h2>
<p>Insulin is a <a href="https://theconversation.com/biologics-the-pricey-drugs-transforming-medicine-80258">biologic drug</a>, which means it’s produced by a living organism, not a chemical reaction. This process, called biomanufacturing, is <a href="https://doi.org/10.1177/1932296813516958">more inconsistent</a> than chemical synthesis of non-biologic drugs like aspirin.</p>
<p>Making reliable biologic drugs is a little like winemaking. Even though the winemaker carefully follows a well-established process, minute differences will affect the final product. It’s always wine, but some vintages are better than others and tasting the wine is the only way to evaluate the final product. </p>
<p>So if a new company wants to make insulin, that insulin has to be tested on patients in expensive clinical trials. Bringing a biologic drug to market can cost as much as <a href="https://doi.org/10.4161/mabs.3.2.15005">$250 million</a>. No company can afford that lump if it can’t file for a patent to recoup the investments. </p>
<p>That’s why there’s only <a href="https://www.businessinsider.com/insulin-cheaper-generic-2016-12">one “generic” insulin</a> available so far. It’s <a href="https://www.basaglar.com/en/">made by a company</a> that was already a major player in the insulin market, and it’s only 15 percent cheaper than the patented version. By comparison, most non-biologic generic drugs cost <a href="https://doi.org/10.1056/NEJMms1411398">80 percent less</a> than the original.</p>
<p>Obviously, regulations are important for keeping insulin safe, but at what cost? <a href="https://doi.org/10.2337/dc12-0257">Ten percent of people</a> living with diabetes in the U.S. are uninsured, and there are nearly 10,000 crowdfunding campaigns related to insulin on the site GoFundMe alone. Stories about diabetic patients ending up hospitalized or worse because they <a href="https://www.cbsnews.com/news/the-rising-cost-of-insulin-horror-stories-every-day/">tried to ration their insulin</a> are all-too common.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/235627/original/file-20180910-123107-l09yxh.jpg?ixlib=rb-1.1.0&rect=0%2C4%2C962%2C637&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/235627/original/file-20180910-123107-l09yxh.jpg?ixlib=rb-1.1.0&rect=0%2C4%2C962%2C637&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/235627/original/file-20180910-123107-l09yxh.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/235627/original/file-20180910-123107-l09yxh.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/235627/original/file-20180910-123107-l09yxh.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/235627/original/file-20180910-123107-l09yxh.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/235627/original/file-20180910-123107-l09yxh.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/235627/original/file-20180910-123107-l09yxh.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Could big pharma eventually be cut out of the process by home brewers cooking up their own medications?</span>
<span class="attribution"><a class="source" href="https://www.flickr.com/photos/sanofi-pasteur/5283263633">Sanofi Pasteur</a>, <a class="license" href="http://creativecommons.org/licenses/by-nc-nd/4.0/">CC BY-NC-ND</a></span>
</figcaption>
</figure>
<h2>Democratizing insulin production</h2>
<p>Some people are taking matters <a href="https://doi.org/10.1016/j.tibtech.2018.07.009">into their own hands</a>, tinkering to meet their medical needs. In 2015, patients and hobby scientists launched an initiative known as the <a href="http://openinsulin.org/about-the-project/">Open Insulin Project</a>. </p>
<p>As in winemaking, the specific know-how required for insulin production is a guarded secret. The goal of the Open Insulin Project is to figure out a patent-free method and release the information, so that competing companies can manufacture “generic” insulin. </p>
<p>Given the cost of regulatory approval, it is more likely that the project could enable patients to “home brew” their own diabetic treatments. There is currently no structure for regulating drugs that are not produced commercially. One report estimates that as many as <a href="https://www.bloomberg.com/news/features/2018-08-08/the-250-biohack-that-s-revolutionizing-life-with-diabetes">2,000 patients have already reverse engineered</a> their own insulin pumps and electronic monitoring systems. The insulin itself could be next. </p>
<p>Is it possible to make biologic drugs like insulin more affordable without compromising safety? One suggestion that has been gaining steam is to <a href="https://doi.org/10.1038/nbt.3888">scale down biomanufacturing</a>. Right now, biologic medicines like insulin are cooked up in giant batches. Ensuring that those batches are consistent and free of contamination is a major challenge.</p>
<p>Think about the meat department in your grocery store. Many big-box stores stock hamburger that was ground in a central processing plant and then distributed. If an <em>E. coli</em> outbreak occurs in the plant, it’s going to spread to all of the stores downstream, potentially infecting hundreds or thousands of people. </p>
<p>The meat is also exposed to more potential contamination events through storage and transport. And, if contaminated meat is identified in one store, it won’t be immediately clear whether or not all the others are safe.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/236112/original/file-20180912-133892-1h8px3t.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/236112/original/file-20180912-133892-1h8px3t.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/236112/original/file-20180912-133892-1h8px3t.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/236112/original/file-20180912-133892-1h8px3t.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/236112/original/file-20180912-133892-1h8px3t.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/236112/original/file-20180912-133892-1h8px3t.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/236112/original/file-20180912-133892-1h8px3t.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/236112/original/file-20180912-133892-1h8px3t.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Industrial-scale production – whether of hamburger or drugs – makes it harder to zero in on the source of problems when they occur.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/meat-grinder-industry-775823329">David Tadevosian/Shutterstock.com</a></span>
</figcaption>
</figure>
<p>Now, consider a small local butcher who grinds meat in-house. Any safety risk is going to be isolated to the customers of that one store and the source will be obvious.</p>
<p>Similarly, producing medications in smaller batches reduces the potential impact of any one safety event. Pharmacy compounding provides <a href="https://doi.org/10.1038/nbt.3888">an example</a>. In compounding, drugs are specially mixed or produced for a very small number of patients. Compounded medications are not subject to clinical trials.</p>
<p>If insulin were made in smaller batches, manufacturers might be able to forego clinical trials and use simpler and <a href="https://doi.org/10.1208/s12248-016-9908-z">less expensive tests</a> to confirm that each batch of insulin produced is safe and comparable to previously approved insulins. It would be like using chemical tests to identify important flavor compounds in two vintages of wine instead of organizing taste tests. <a href="https://doi.org/10.1016/j.tibtech.2018.07.009">This model</a> could also apply to other expensive biologic drugs such as those that treat cancer, HIV and rheumatoid arthritis.</p>
<p>The technology necessary for small-batch insulin production <a href="http://news.mit.edu/2016/portable-device-produces-biopharmaceuticals-on-demand-0729">already exists</a>. <a href="http://peccoud.org/insulin/">Future research</a> could help automate and streamline small batch medicine production in order to minimize safety risks.</p>
<figure>
<iframe width="440" height="260" src="https://www.youtube.com/embed/vs4XxGwsBnA?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">The authors describe how biohacking insulin and other biologic drugs have important implications for the future of pharmaceutical drug regulation.</span></figcaption>
</figure>
<h2>The future of medicine</h2>
<p>The pharmaceutical industry is <a href="https://doi.org/10.1016/j.tibtech.2018.07.009">ripe for disruption</a>. In the coming decades, drugs might be produced in very different settings. Hospitals have already begun <a href="http://www.latimes.com/business/la-fi-generic-drugs-hospitals-20180906-story.html">plans to make their own medicines</a>. DIY biologists could provide patients with the knowledge needed to produce for themselves the drugs their lives depend on.</p>
<p>As the industry and regulatory agencies gain more experience with biologic drugs, it is also possible regulations will ease up, lowering the cost of approval. This would enable the emergence of small-scale drug manufacturers that could provide off-brand drugs at a lower cost. </p>
<p>One thing is certain, the future of medicine will not be “business as usual.” Biomanufacturing technologies will continue to evolve. These changes could enable <a href="https://doi.org/10.1016/j.tibtech.2018.07.009">decentralized production of life-saving drugs</a>. How the regulatory system and pharmaceutical industry will adjust to that future is yet to be determined.</p><img src="https://counter.theconversation.com/content/99822/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Jean Peccoud receives funding from the National Institutes of Health and the National Science Foundation. </span></em></p><p class="fine-print"><em><span>Jenna E. Gallegos does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Small-batch brewers are starting to tinker with biologic drugs to meet their own medical needs. A side effect of their success would be a disruption to how big pharma makes and distributes drugs.Jenna E. Gallegos, Postdoctoral Researcher in Chemical and Biological Engineering, Colorado State UniversityJean Peccoud, Professor, Abell Chair in Synthetic Biology, Colorado State UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/770932017-05-09T14:16:03Z2017-05-09T14:16:03ZPrescribing generic drugs will reduce patient confusion and medication errors<figure><img src="https://images.theconversation.com/files/168498/original/file-20170509-20757-1w3h710.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">If doctors prescribe generic drugs rather than their brand name equivalents, most times patients benefit.</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/download/confirm/559764574?src=cvIlBVQ8z139t7FZlLOmNg-1-81&size=medium_jpg">from www.shutterstock.com</a></span></figcaption></figure><p><em>In last night’s federal budget, Treasurer Scott Morrison announced an <a href="http://www.abc.net.au/news/2017-05-01/budget-to-push-generic-medicines-to-save-dollars/8486736">anticipated</a> range of measures to encourage doctors to prescribe generic medicines rather than their more expensive brand name equivalents. So unless specified by the doctor, patients will receive a prescription with the generic medication name on it.</em></p>
<p><em>This is part of A$1.8 billion in measures announced to reduce the drugs bill over five years. But beyond saving costs, the push towards generics may also reduce confusion among patients and medication errors.</em> </p>
<hr>
<p>“Are you taking aspirin at the moment?” I ask Iris, a pensioner in her 80s.</p>
<p>“No dear, I haven’t taken that for years,” she says, as she empties a large brown paper bag filled with medication boxes, new, old and empty.</p>
<p>I see a new bottle of aspirin emerge from the bag and ask if she is taking them.</p>
<p>“Oh yes, I always take my <em>Astrix</em> tablets.”</p>
<p>It’s not just elderly people who can be confused about which medication they’re taking. <a href="https://theconversation.com/cant-pronounce-the-name-of-your-medicine-heres-why-15416">Drug names are long, complex</a> and there are usually multiple brands for the same product.</p>
<p>For any medication, there are likely to be <a href="https://www.mja.com.au/journal/2011/195/11/what-s-name-brand-name-confusion-and-generic-medicines">up to 15 different</a> brands available. People are likely to use these brand names to describe the drug, like Iris did with her Astrix tablets.</p>
<p>In Australia in 2010 only <a href="http://www.publish.csiro.au/AH/AH12009">19.5% of scripts</a> issued by GPs used the generic term for a drug, compared with 83% in the United Kingdom.</p>
<p>Encouraging doctors to prescribe generics goes beyond economic value. It has the potential to lead to a simplification of the language around medications, less influence on our purchasing decision by pharmaceutical marketing, and fewer medication errors by both doctors and consumers.</p>
<p>When we visit the GP, unless a specific reason exists, we should receive a script written with the generic term.</p>
<h2>What is a generic term for a medication?</h2>
<p>The generic term for a medication is the name of the <a href="https://www.tga.gov.au/book/prominence-active-ingredients-medicine-labels">active ingredient</a> it contains. This is the ingredient that actually does the work of controlling your asthma or reducing your risk of heart disease.</p>
<p>There is only one generic name for each medication. But several different brands may be available. The brand name is usually the largest writing on the packet. Nurofen, for instance, is the brand name for the generic medication ibuprofen.</p>
<p>Generic medications are available for older drugs, and are commonly offered by your pharmacist as a cheaper alternative to the original branded medication. These drugs are tested to contain exactly the same active ingredients, <a href="https://www.tga.gov.au/publication/australian-regulatory-guidelines-prescription-medicines-argpm">so they produce the same effects</a>. </p>
<p>However, there are a few rare exceptions, such as in <a href="http://www.sciencedirect.com/science/article/pii/S1059131106000033">some epilepsy medications</a>, where drug levels may differ slightly between brands. So in such cases, doctors can choose to prescribe the branded version for its specific clinical benefits.</p>
<hr>
<p><em><a href="https://theconversation.com/explainer-how-do-generic-medicines-compare-with-brand-leaders-1386">Explainer: how to generic medicines compare with brand leaders?</a></em></p>
<hr>
<p>Which medicine name your doctor writes on you prescription - brand name or generic - can <a href="https://www.mja.com.au/journal/2011/195/11/what-s-name-brand-name-confusion-and-generic-medicines">often be a lottery</a>. </p>
<p>If your doctor writes a prescription for a brand name, your pharmacist may offer to substitute this for an equivalent generic drug. So, people often leave the pharmacy with a medication name or package that bears no resemblance to the prescription.</p>
<h2>Potentially confusing for patients</h2>
<p>The main problem with all these multiple names is the potential for confusion, especially for those most likely to use multiple medications - <a href="http://journals.lww.com/americantherapeutics/Abstract/publishahead/Error_in_Drugs_Consumption_Among_Older_Patients_.98899.aspx">the elderly</a>.</p>
<p>As a result, patients are at risk of not understanding which medications they are taking or why they are taking them. This often leads to doubling-up of a certain drug (taking two brands of the same medication), or forgetting to take them because the name on the package doesn’t match the script.</p>
<p>This problem of some patients’ poor medication literacy significantly affects doctors, nurses and pharmacists, who need to know which medications people are using. While our own GP may have your list of medications, often we visit multiple doctors who won’t have access to these list (different GPs while on holidays, emergency departments or specialists). If patients doesn’t know their medications, neither will doctors.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/168541/original/file-20170509-11023-o7zd95.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/168541/original/file-20170509-11023-o7zd95.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/168541/original/file-20170509-11023-o7zd95.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/168541/original/file-20170509-11023-o7zd95.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/168541/original/file-20170509-11023-o7zd95.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/168541/original/file-20170509-11023-o7zd95.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/168541/original/file-20170509-11023-o7zd95.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/168541/original/file-20170509-11023-o7zd95.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Many elderly patients are confused about the names of their medications.</span>
<span class="attribution"><span class="source">from shutterstock.com</span></span>
</figcaption>
</figure>
<p>An advisory group for Australian pharmaceuticals, well aware of the dangers this confusion can cause, and as far back as 2005, <a href="https://www.health.gov.au/internet/main/publishing.nsf/Content/5B47B202BBFAFE02CA257BF0001C6AAC/$File/guiding.pdf">promoted the use</a> of prescribing and labelling with generic terms. The US Institute for Safe Medication Practices estimates that <a href="https://www.ismp.org/newsletters/acutecare/articles/20070809.asp">25% of medication errors</a> result from name confusion.</p>
<h2>Why do doctors use brand names when prescribing?</h2>
<p>In a busy clinic running half an hour behind, the generic name of a medication is often the last thing on the doctor’s mind. There are thousands of medications and even the most diligent doctor can’t remember them all. </p>
<p>Pharmaceutical companies have marketed brand name medication to both doctors and (in some countries) consumers, so they are far more memorable and palatable – for instance Viagra, rather than the generic term sildenafil.</p>
<p>But when doctors rely on using brand names in conversation and prescribing, this can cause confusion. Doctors using branded prescribing can lead to <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3307571/">serious medication errors</a>. This may be due not knowing the active ingredients in those medications, or mixing up brand names, which are becoming increasingly difficult to recognise when written in doctor’s handwriting.</p>
<p>So, to avoid confusion, medication errors and allowing for patient control over purchasing decisions, we <a href="http://onlinelibrary.wiley.com/doi/10.1111/imj.12805/full">recommend</a> doctors use generic terms when prescribing unless a specific reason exists.</p>
<h2>How does this affect me?</h2>
<p>Everyone uses medications. The key issue here is autonomy. A script that contains the generic term for a medication allows that person to decide exactly what type of medication they wish to purchase, rather than that be influenced by what brand the doctor writes on the script.</p>
<p>When language excludes (for instance, by being complex or relying on jargon) or confuses, it restricts our autonomy. At present, the language of medications may have two, three or ten words for each drug, and the words we use are often influenced by pharmaceutical marketing and what a doctor prescribes. </p>
<p>The greatest effect of this budget announcement may be the chance to simplify this language to a singular generic drug term, to reduce confusion and allow us to be more involved with our medication decisions.</p><img src="https://counter.theconversation.com/content/77093/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Matthew Grant does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>A push towards prescribing generic medications rather than their branded equivalents, as flagged in the budget, may have benefits beyond simple cost savings.Matthew Grant, Research Fellow, Palliative Medicine Physician, Monash UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/678122016-10-31T02:10:03Z2016-10-31T02:10:03ZDrug prices: Where do we go after the Election?<p>Martin Shkreli. Valeant Pharmaceuticals. Mylan. These names have become big news, but just a year ago, most Americans devoted little time and attention to the question of pharmaceutical pricing. Now, a Kaiser Health Tracking Poll released Oct. 27 suggests many people care more about the increasing prices of drugs than they do about any other aspect of health care reform. </p>
<p>Nearly three in four, or <a href="http://kff.org/health-reform/poll-finding/kaiser-health-tracking-poll-october-2016/?utm_campaign=KFF-2016-October-Tracking-Poll&utm_source=hs_email&utm_medium=email&utm_content=36540781&_hsenc=p2ANqtz-9y4XyWbnH2EByO5oZUOm602gYAR4P8H5SXRNCJHtMH3Hd3MKgfHUoxkcci1a9XhGmJREOPFVA8z14CwZiuoa-pi1Ya9Q&_hsmi=36540781">74 percent</a> of respondents, said that making sure that high-cost drugs for chronic conditions are affordable for patients should be a top priority for the next president and Congress. And 63 percent similarly said that government action to lower prescription drug prices should be a top priority. </p>
<p>This poll comes on the heels of highly publicized scandals involving individuals and companies who hike the prices of products like the EpiPen, a life-saving anaphylaxis treatment whose price roughly <a href="http://www.forbes.com/sites/matthewherper/2016/08/30/the-consumer-rip-off-at-the-heart-of-the-epipen-scandal/#59f9776d2a87">quintupled</a> in five years, to more than US$600, or Daraprim, a drug used to treat parasitic infections whose price increased by <a href="http://www.chicagotribune.com/business/ct-turing-doubles-down-1205-biz-20151204-story.html">5,000 percent</a> overnight.</p>
<p>Many drug makers and their CEOs have raised the prices of their products with impunity. As prices have risen, so has the level of outrage among consumers. Policymakers are taking note. </p>
<p>Importantly, to the extent that high drug prices are a problem, it is not an easy one to solve. As academics <a href="https://coderedblog.com/2015/09/23/all-low-priced-drugs-are-alike-all-high-priced-drugs-are-high-priced-in-their-own-way/">have</a> <a href="http://ldi.upenn.edu/healthpolicysense/what%E2%80%99s-story-drug-prices">argued</a>, there are many different reasons why a drug may have a high price. </p>
<p>We simultaneously want to reward companies who come up with new, innovative cures for chronic conditions while preventing companies from raising the price of older generic drugs without good reason. Coming up with policy interventions that would target only the latter activity while at the same time providing certainty of profit potential to innovators up front can be challenging.</p>
<p>At the same time, policymaking around drug prices is politically difficult. Strong pharmaceutical interest groups oppose seemingly any action in this space, <a href="http://www.reuters.com/article/us-pfizer-ceo-clinton-idUSKCN11E2N7?feedType=RSS&feedName=healthNews">arguing</a> that even actions targeted at generic drugs would decrease innovator companies’ incentives to invest in new cures. Although I and others have <a href="http://annals.org/aim/article/2566330/innovation-innovation-tradeoffs-drug-pricing">argued</a> that this concern is oversimplified, it nonetheless has had a significant impact on the debate. </p>
<p>Despite this opposition, the growing appetite among the <a href="https://cdn1.sph.harvard.edu/wp-content/uploads/sites/94/2015/11/STAT-Harvard-Poll-Nov-2015-Controversy-Over-Rising-Drug-Prices.pdf">public</a> for doing something, anything, about high drug prices has led to a proliferation of policy proposals on the subject. These proposals would affect different drugs and would act on different institutions within the drug pricing ecosystem. As we approach Election Day, it is worth thinking about which of these actions would be implemented at different levels of government. Given the different proposals and the concerns that people have expressed over high drug prices, it’s worth looking at possible solutions.</p>
<h2>Reforms at the federal level</h2>
<p>Many of the most commonly discussed reforms would take place at the federal level. Although there are greater political challenges to enacting change at the federal level, the potential effects are also much broader than for reforms enacted at the state level.</p>
<p><em>Allowing Medicare to negotiate drug prices.</em> The most commonly proposed drug pricing reform would give Medicare the authority to negotiate drug prices. The thinking is that because Medicare has such purchasing power, it will be able to demand discounts for the tens of millions of Americans covered by its plans. This solution is so popular that it has been praised by both Secretary Clinton and Donald Trump. And yet, it <a href="http://www.nytimes.com/2016/02/02/upshot/the-real-reason-medicare-is-a-lousy-drug-negotiator-it-cant-say-no.html?_r=0">wouldn’t work</a> on its own. </p>
<p>Here’s the problem: Not only is Medicare itself legally prohibited from negotiating drug prices, but it is also legally required to cover certain prescription drugs. Medicare can’t get up and walk away from the bargaining table if it doesn’t like the price the pharmaceutical company is offering, which significantly limits its ability to demand discounts from companies.</p>
<p>If Medicare were given the authority to decline to cover a drug if its manufacturer did not provide a discount, that would improve its bargaining power – but that would also prevent Medicare beneficiaries from accessing the drug in question, which is highly unpopular. Although some scholars have proposed <a href="http://content.healthaffairs.org/content/27/1/33.full">creative ways</a> around this problem, none has yet made it into the political discussion.</p>
<p><em>Constrain price increases.</em> Much of the public outrage accompanying high drug prices has come in response to companies that raise the prices of old drugs, seemingly only to increase their profits. As such, a number of proposals would constrain the ability of drug companies to increase their prices over time. In fact, one of these even became law in the wake of Martin Shkreli’s activities around Daraprim, enabling Medicaid to recoup additional rebates on a generic drug if its price rose faster than inflation. </p>
<p>Recently, Secretary Clinton has put forth a <a href="https://www.hillaryclinton.com/briefing/factsheets/2016/09/02/hillarys-plan-to-respond-to-unjustified-price-hikes-for-long-available-drugs/">plan</a> that would prevent such price hikes more broadly, outside of just the Medicaid program. At the same time, Secretary Clinton’s proposal would account for the reasons behind the price increase, allowing increases where they’re needed to address situations like manufacturing problems. Because this proposal is limited to older drugs, it may face less political opposition, although its passage will surely not be easy. </p>
<h2>Reforms at the state level</h2>
<p>The federal government is not the only entity interested in curbing high drug prices. Many states are currently considering other measures that would take effect only within their borders, although some might have follow-on effects more broadly.</p>
<p><em>State drug price cap laws.</em> <a href="http://voterguide.sos.ca.gov/en/propositions/61/arguments-rebuttals.htm">California</a> and <a href="http://www.dispatch.com/content/stories/local/2016/09/30/drug-price-relief-act-headed-to-ohios-2017-ballot.html">Ohio</a> are currently considering ballot initiatives to cap what drug manufacturers can charge to public payers in the state (such as Medicaid) at the price the VA pays for them.</p>
<p>Because these initiatives don’t distinguish between different kinds of drugs, affecting both new, highly effective products as well as older or more marginal ones, we should carefully consider their real-world impact, and there are persuasive <a href="http://www.politico.com/story/2016/04/drug-makers-california-referendum-222334">arguments</a> on either side. <a href="http://blogs.harvard.edu/billofhealth/2016/04/27/state-drug-price-cap-laws-how-do-they-work/">My bigger concern</a>, however, is that these initiatives would not actually work to accomplish their stated purpose. </p>
<p>Not only are the prices the VA pays often <a href="http://kvpr.org/post/proposition-61-gives-california-mandate-lower-drug-prices-not-tools">confidential</a>, but as with Medicare, state Medicaid agencies must cover most FDA-approved drugs and do not generally have the ability to demand price concessions in favor of coverage. Removing these two legal obstacles would have additional policy consequences not contemplated within the current policy discussion of these initiatives. </p>
<p><em>Transparency laws.</em> <a href="https://www.pwc.com/us/en/health-industries/health-research-institute/assets/pdf/pwc-hri-high-drug-pricing.pdf">Several states</a> are considering bills which would require pharmaceutical companies to report information on their research and development costs, marketing and advertising costs, and prices charged to a number of different purchasers. <a href="https://www.statnews.com/pharmalot/2016/06/06/vermont-drug-prices-transparency/">Vermont</a> is the first state to have officially enacted such a law. Different states have crafted their bills in different ways, to apply to different classes of drugs at different times and to require the disclosure of different pieces of information.</p>
<p>These bills themselves do not directly constrain drug prices. However, they may serve to enable states to gather information that they can use to make such policy going forward. Alternatively, states like Vermont, which require justification for price increases, may use the laws to serve a “naming and shaming” function which has been <a href="http://www.nytimes.com/2016/01/19/upshot/even-talking-about-reducing-drug-prices-can-reduce-drug-prices.html?mtrref=blogs.harvard.edu&gwh=30541BF0F1F465860065B52A4CAA1FCF&gwt=pay">demonstrated</a> to hold down prices at least to some degree. </p>
<p>These are just a few of the many proposals that have been discussed with the potential to curb high drug prices. Others would tackle the issue indirectly, by attempting to speed FDA approval of competitor products or by limiting consumers’ out-of-pocket expenditures.</p>
<p>In addition, the private sector is taking action on its own to encourage different types of value-based pricing for pharmaceuticals, with groups like the <a href="https://icer-review.org/">Institute for Clinical and Economic Review</a> analyzing and providing critical public information on the value of many new products. But in the near term, these four proposals have the greatest possibility of becoming law and deserve our attention going forward.</p><img src="https://counter.theconversation.com/content/67812/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Rachel Sachs has previously received funding from the Brookings Institution for work on related topics. No funding was received for the preparation of this story.</span></em></p>The rising cost of drugs is more worrisome to most Americans than problems with Obamacare. Could proposals in California and Ohio help?Rachel Sachs, Associate Professor of Law, Washington University in St. LouisLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/507992015-11-24T06:14:01Z2015-11-24T06:14:01ZWorld’s poorest countries allowed to keep copying patent-protected drugs<figure><img src="https://images.theconversation.com/files/102187/original/image-20151117-7088-1co69d9.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Patent? What patent? (Pharmacy in Asmara, Eritrea)</span> <span class="attribution"><a class="source" href="https://www.flickr.com/photos/barduran/272484039/in/photolist-gdnnNP-9fkrMv-gdeFRb-o9sVPa-q5y1F-787Lv9-7885ty-ddVKqv-7MTwpz-8v2ymq-783N4T-9YBNnH-gddn3j-gdmFf6-gdgjoe-ggBCSd-ggBEN6-gdmCF8-gdgyvq-gdgoRH-gdd8PK-gdfgpc-ggB6A5-ggBtPH-gdo77i-gdodbw-gdp6wj-gdnyJh-gdd1Wi-gdhmpr-gdgzzX-gdgewF-gddXE7-ggAAxz-gdnSJB-ggyM3X-gdcJBp-gdczHb-gde5yp-gdeLjE-57dYY-787D4h-783DBR-hg5xeH-783zZT-6fsPEe-cHqvBm-7g5qW6-gdeTJ6-gdoUT3">Barbara Durand/flickr</a>, <a class="license" href="http://creativecommons.org/licenses/by-nc/4.0/">CC BY-NC</a></span></figcaption></figure><p>The World Trade Organisation has agreed to <a href="https://www.wto.org/english/news_e/news15_e/trip_06nov15_e.htm">extend a waiver</a> that allows poor countries to copy patented medicines. The waiver, which was due to expire in January 2016, has now been extended to 2033. </p>
<p>The countries that will benefit from the waiver are the 48 poorest nations, classified by the United Nations as “Least Developed Countries” or LDCs, and include many African and some Asian countries. About half of the 900m population across these countries live on less than <a href="http://unohrlls.org/about-ldcs/facts-and-figures-2/">US$1.25 a day</a>.</p>
<p>All other countries, including developing countries such as India and China, are still bound by the WTO’s agreement on trade-related intellectual property rights (or TRIPS) with respect to drug patents. </p>
<h2>Higher disease burden</h2>
<p>The waiver is critical for the least developed countries. Compared with richer countries, they have a much higher disease burden, especially infectious diseases such as HIV and malaria. In 2011, about <a href="http://www.unaids.org/sites/default/files/media_asset/JC2474_TRIPS-transition-period-extensions_en_0.pdf">9.7m people</a> in these countries were living with HIV. </p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/102183/original/image-20151117-9062-129l2ol.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/102183/original/image-20151117-9062-129l2ol.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=450&fit=crop&dpr=1 600w, https://images.theconversation.com/files/102183/original/image-20151117-9062-129l2ol.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=450&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/102183/original/image-20151117-9062-129l2ol.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=450&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/102183/original/image-20151117-9062-129l2ol.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=566&fit=crop&dpr=1 754w, https://images.theconversation.com/files/102183/original/image-20151117-9062-129l2ol.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=566&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/102183/original/image-20151117-9062-129l2ol.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=566&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Keeping antiretrovirals affordable.</span>
<span class="attribution"><a class="source" href="https://www.flickr.com/photos/london/75148497/in/photolist-7Da2K-dqrpWk-nASY65-6QqDih-q1rWe1-4RDAE5-79TYnV-7Ljyai-7LjxKn-7LoxbQ-7Loxsu-4RDzEj-6SnyF2-6SrCzG-6SrDh1-fLVoZ-7pFDc7-7LowhG-79xH8U-6NZfBP-7LovPC-7LjxEv-7Low2q-7LjxXF-7LovQJ-7LowUS-7LjxSg-7LovVw-7LovTb-7LowPf-7Ljxyg-7LovN5-7Lox6f-7Lowcf-7LjxhD-7LjxGV-7LowpN-7Ljynx-7LjxQ8-7Lowx3-7Ljy4Z-7LjxcR-ryePYE-6Sny9H-6Snyp6-b9r8ik-7Chtmm-7CdFAH-6TsF44-79xHoN">jonrawlinson/flickr</a></span>
</figcaption>
</figure>
<p>Many of the drugs that treat these diseases are still <a href="https://theconversation.com/explainer-the-problem-drug-patents-pose-for-developing-countries-45667">under patent protection</a>. Drug patents last for 20 years and allow drugs companies time to recoup their investment into research and development and turn a profit. Once the patent protection period ends, other drugs companies can then copy the drug and sell it as a generic medicine. These generics are much cheaper than branded drugs.</p>
<h2>Developing a local pharma industry</h2>
<p>Countries such as Uganda, Cambodia and Rwanda have already taken advantage of the WTO’s temporary waiver and begun to <a href="http://allafrica.com/stories/201511091872.html">develop their own pharmaceutical industry</a>. This has been helped by investments from drug companies in the developing world. For example, Uganda-based Cipla Quality Chemicals was originally a joint-venture between Cipla, a large Indian generics manufacturer, and the Ugandan government. It is the only company in Africa that makes triple-combination antiretroviral drugs. </p>
<p>Developing and strengthening manufacturing capacities in LDCs is important as these countries are often unable to import cheap copies of patent protected drugs from countries like India. India has many large generics firms within its borders and, although it ratified TRIPS in 1995, it only brought its patent laws in line with the treaty <a href="http://forbesindia.com/printcontent/29302">in 2005</a>. It too now has to respect international drug patents. </p>
<p>So the extension of the waiver is important, but it is only temporary, which doesn’t please everybody. Least developed countries and some NGOs would have preferred an <a href="http://www.ip-watch.org/2015/02/25/wto-least-developed-countries-request-waiver-of-ip-rights-on-pharma-products">indefinite extension</a> or at least an extension until a country is no longer classified as a least developed country, rather than the set date of 2033. This position is <a href="http://europa.eu/rapid/press-release_IP-15-5620_en.htm">supported by the European Union</a>, but not by the US.</p>
<h2>Patents don’t work for poor countries</h2>
<p>It costs pharmaceuticals companies about <a href="http://www.scientificamerican.com/article/cost-to-develop-new-pharmaceutical-drug-now-exceeds-2-5b/">US$2.6 billioin</a> to develop a new drug. If these companies were not allowed to protect their investment with patents, it is doubtful that any new drugs would be developed. So patents are an important incentive.</p>
<p>But patent protection doesn’t work for poor countries. Intellectual property (IP) rights, like patents, aren’t an effective incentive in countries which have not reached an adequate level of economic development because they have no intellectual property to protect. IP rights might be effective over the long term, but only after a local and relatively strong pharmaceutical industry is developed. The exemption could be dropped once countries that have benefited from it have developed enough, and the industry reaches a self-sustaining size. </p>
<p>Although building a home grown pharmaceuticals industry is not a requirement of the WTO waiver, a strong local industry would give poor countries direct access to much needed cheap medicines.</p>
<p>The WTO’s transitional waiver makes sense. By temporarily allowing LDCs to ignore patents on drugs, it gives them time to develop their own pharmaceuticals industries. And we are already seeing evidence of this happening. According to the UN agencies, UNDP and UNAids, the proportion of people with HIV who are not receiving antiretrovirals reduced from <a href="http://allafrica.com/stories/201511091872.html">90% in 2006 to 63% in 2013</a> thanks to the availability of drugs made by LDCs.</p>
<p>Despite some criticisms, the WTO’s decision to extend the waiver should be praised. It seems fair and reasonable, and it doesn’t excessively jeopardise companies that make branded (non-generic) drugs. They don’t seem to lose much from missed royalties. Overall, the poorest countries account for less than 2% of the world’s gross domestic product and about 1% of global trade in goods. Not a big business opportunity for big pharma.</p><img src="https://counter.theconversation.com/content/50799/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Enrico Bonadio does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>There is a window of opportunity for the least developed countries to develop their own pharmaceuticals industry.Enrico Bonadio, Senior Lecturer in Law, City, University of LondonLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/482242015-10-16T09:57:38Z2015-10-16T09:57:38ZClinton’s anti-drugmaker rhetoric may win votes, but does it threaten our long-term health?<p>At Tuesday’s Democratic debate, the candidates were asked to name the <a href="http://www.newsday.com/news/nation/hillary-clinton-bernie-sanders-among-five-democrats-set-to-debate-in-las-vegas-1.10954603">enemies they’re most proud of making</a>. </p>
<p>Front-runner Hillary Clinton’s answer? Drug companies (along with the National Rifle Association, “the Iranians” and Republicans). </p>
<p>What did the makers of medicine do to earn a place on Clinton’s hit list beside gun promoters, Iran’s hardliners and her GOP rivals? Most recently it was Turing Pharmaceutical’s <a href="http://www.forbes.com/sites/luketimmerman/2015/09/23/a-timeline-of-the-turing-pharma-controversy/">decision</a> to increase the price of AIDS medication, resulting in widespread condemnation and <a href="http://www.dailymail.co.uk/news/article-3271309/Pharmaceutical-company-hiked-price-medication-used-AIDS-cancer-patients-5-000-investigated-New-York-Attorney-General.html">subsequent investigation</a> by the New York attorney general’s office. More broadly, however, anti-drugmaker rhetoric like Clinton’s responds to a moral distaste for free markets when it comes to not-so-free medicines.</p>
<p></p><blockquote><p>Price gouging like this in the specialty drug market is outrageous. Tomorrow I’ll lay out a plan to take it on. -H <a href="https://t.co/9Z0Aw7aI6h">https://t.co/9Z0Aw7aI6h</a></p>— Hillary Clinton (@HillaryClinton) <a href="https://twitter.com/HillaryClinton/status/645974772275408896">September 21, 2015</a></blockquote> <p></p>
<p>Yet we are dependent upon these markets – and investors willing to take risks and expect returns – because without investment, the pipeline of drugs being developed will dry up. The rapid appearance of a policy from Clinton to tackle the way drugs reach Americans appears focused on making the buying public happy, for long enough to win an election, at least. But this apparently knee-jerk policy approach may not be good for long-term health. </p>
<p>Specifically <a href="http://www.usatoday.com/story/news/politics/elections/2015/09/22/hillary-clinton-prescription-drug-plan/72598898/">she said</a> she would intervene in the way pharmaceutical companies reinvest their profits in research, reduce the amount of drug exclusivity before generics are allowed on the market, allow foreign drug imports, let Medicare negotiate prices, and cap how much insurers can charge certain customers. In summary, she is using every lever she can pull to drive down prices, profitability and future prospects for biotech investors.</p>
<p>But how would such populist-inspired policies affect the flow of new medicines, particularly those we can only imagine right now? </p>
<p>Price caps and competition might appear good for the health of the nation today, with drugs already on the market, but how does the future look for these undiscovered medicines if Clinton and others have their way? </p>
<p>As <a href="http://www.lancaster.ac.uk/lums/people/chris-ford#publications">my own research</a> into the early stages of drug discovery highlights, breakthrough medicines begin as embryonic ideas in the mind of a scientist somewhere, and first must endure one of the longest and most financially high-risk product development processes known to man before eventually saving a patient’s life. </p>
<h2>Surviving the ‘Valley of Death’</h2>
<p>In the pharma industry, the “<a href="http://www.nature.com/news/2008/080611/full/453840a.html">Valley of Death</a>” is a well-known phenomenon: a brutal metaphor describing an equally brutal phase in the lifecycle of a growing biotech. </p>
<p>To shift from being a small, high-risk, big-idea start-up to a successful biotech business that contributes to health and the wider economy, these companies must overcome many hurdles. There are plenty of ambitious new ideas emerging from universities and elsewhere. There are successful giants with truly global operations. But in the middle lies the valley of death, and precious few biotechs make it through.</p>
<p>Why do we care about these small upstarts when we have world-class scientists in huge, established corporations? If most drugs were still discovered inside big pharma, perhaps we wouldn’t care. But those days are past, and the new order of this industry is one of collaboration, acquisition and what UC Berkeley’s Henry Chesbrough terms “<a href="http://openinnovation.net/about-2/open-innovation-definition/">open innovation</a>.” </p>
<p>It is not uncommon for <a href="http://www2.deloitte.com/content/dam/Deloitte/us/Documents/life-sciences-health-care/us-lshc-open-innovation.pdf">half the drug discovery pipeline</a> in a major pharma corporation to originate from outside its own laboratories, coming from smaller biotech firms, university spin-outs or partnerships. If too many of these start-ups fail, the acquisition pipeline for our drugmakers becomes increasingly fragile. </p>
<p>Thus, it’s important to understand what factors will help the best science get from idea to medicine, which levers government should pull – and which it shouldn’t – to fairly increase the health of the nation.</p>
<h2>Biotech incubation</h2>
<p>A pivotal role in moving great science from idea to medicine is played by incubators. As the name implies, these hubs provide a haven where conditions are right to promote early-stage growth. </p>
<p>If the goal of policymakers is to get more drugs to more people more quickly and more cheaply, finding ways to boost the scale and success of incubation makes a lot of sense. <a href="http://www.nature.com/nbt/journal/v33/n2/full/nbt.3137.html">This is what</a> governments in the US and around the world have done, in different ways. One example is the <a href="http://www.stevenagecatalyst.com">Stevenage Bioscience Catalyst</a> (SBC), the latest incarnation of biotech incubation. </p>
<p>Founded in 2010, this incubator offers insights into the forces shaping the biotech sector and has been the primary site of my extended research into the performance management of such innovation ecosystems. Helping biotech start-ups navigate the valley of death is the essential goal of this upstart, which is funded by the UK government, big pharma and a major charity.</p>
<p>The business model of the incubator is shaped by long-term aspirations for sustained growth across the entire biotech sector. There are two interconnected attributes that are particularly important: </p>
<ol>
<li>The business model is centered on science, rather than financial success of the incubator itself as a landlord, or its founders as investors, or its tenants as the current custodians of new scientific ideas. The primary concern of SBC is to identify great science, then help those who own it to advance it as efficiently and effectively as possible by providing a package of scientific and business services.<br></li>
<li>It understands and manages the complex mix of accountabilities that necessarily exist within its ecosystem. This form of drug discovery is no single company affair; it’s a giant relay race in which a precious scientific idea is the baton, moving from university lab to biotech start-up to big pharma company and finally to health care providers as medicines.<br></li>
</ol>
<p>Incubators such as SBC not only support the science, they support the intellectual athletes who carry it forward, and (indirectly) the providers of resources and capabilities to the baton holders. Each player has a role, each player expects some reward and, if these accounts go unsatisfied and the risks of engagement do not match the potential returns, the advancement of science may falter.</p>
<p>For policymakers, these two factors need to be considered in tandem before they regulate against drug companies: what will policies created in the wake of a public opinion backlash do to the long-term flow of ideas into incubators or biotech start-ups? And what will it do to the investment or risk appetite of every one of the myriad companies that are needed to support a drug discovery ecosystem? </p>
<h2>Demons or angels?</h2>
<p>Attacking the returns on investment in pharma seems to be a safe bet for politicians. They are perfect corporate targets for vote-winning appeals to aging Americans (who, incidentally, are a <a href="http://www.electproject.org/home/voter-turnout/demographics">high-turnout demographic</a> in elections). But such attacks are not well-grounded, for both financial and ethical reasons.</p>
<p>Firstly, the idea of systemic, excessive profitability in the pharma industry is an accounting illusion. My colleague, professor Igor Goncharov, <a href="http://www.research.lancs.ac.uk/portal/en/publications/rd-investments-profitability-and-regulation-of-the-pharmaceutical-industry(f5970be9-db8f-43ee-a856-2f9a10eae7e4).html">shows</a> that accounting rules in the US and Europe limiting R&D capitalization have a significant effect on the balance sheets of pharma organizations. </p>
<p>That is, prudent accounting significantly undervalues the knowledge-based intangible assets they hold because expenditure can be capitalized only once a drug receives approval, which is after most R&D expenditure takes place. Based on a highly cited <a href="http://www.sciencedirect.com/science/article/pii/S0167629602001261">2003 study</a>, the average cost to develop a drug in today’s dollars is in excess of US$2 billion. </p>
<p>But balance sheets cannot show the enormous investments (including the unsuccessful ones) required to generate each drug, and from them, each dollar of income. This leads to inflated return-on-investment figures and, in turn, to greater regulation.</p>
<p>As Goncharov explains: </p>
<blockquote>
<p>…the perception of high profitability of US pharmaceutical firms triggers excessive regulatory scrutiny and increases regulation of the pharmaceutical industry. Regulators seem to fixate on reported profitability and do not adjust for accounting distortions caused by R&D accounting.</p>
</blockquote>
<p>Secondly, as a society we do not mind, and even admire, the rapid growth and huge profits associated with high technology firms. Yet their efforts are seldom focused on preexisting social need. Rather they “create” a need through a new kind of product, then reap the rewards. </p>
<p>If we want investors to direct their funds toward drug discovery – meeting real, existing needs in society rather than constructed desires – surely we must accept these market rules and make sure the health of Americans remains an attractive investment?</p>
<h2>A holistic health policy</h2>
<p><a href="https://www.hillaryclinton.com/p/briefing/factsheets/2015/09/21/hillary-clinton-plan-for-lowering-prescription-drug-costs/">Clinton intends</a> to “hold the pharmaceutical industry accountable and rein in drug costs for American families” and “demand a stop to excessive profiteering.”</p>
<p>One element of her plan would require pharmaceutical companies that benefit from federal support to invest a sufficient (though unspecified) amount of their revenue in R&D or pay rebates that support basic research. </p>
<p>This sounds very attractive, but behind the rhetoric are some very difficult choices to be made about how much value could, or should, be distributed right down the pharma supply chain. </p>
<p>It’s a chain that is far from static, as projects succeed or fail, merge together or split apart. Trying to “follow the money” invested by government in early stage research could be problematic, but also unrealistic, as so much risk is still being taken on by pharma firms long after early-stage funding has been spent. </p>
<p>And if they bear this risk alone, these companies will, quite understandably, fight to retain control over how they spend their profits.</p>
<p>In reality, if the US government caps the upside risk on every successful drug by reducing how much of the costs can be passed on to patients while also limiting the time drugmakers have to generate pre-generics returns from 12 to seven years, it needs to reduce the financial risks of drug development too. Clinton’s proposals say little about this, but she needs to address the realities of the market as it is, rather than the socially righteous market as we would all wish it to be. </p>
<p>The US has created a health care market, for better or worse, and it is a highly complex system that touches the lives of every American. If Clinton wants to make medicines accessible, she needs to accept that she is just as accountable to pharma for holding down prices, as pharma is to the consumers.</p>
<p>If she fails to take on those accountabilities, the scientific marathon runners may never venture out of their homes and labs with their great ideas, the support structures for their ordeal will dry up, and the short-term grab of medicines for short-term health (and vote) benefits could yield a long-term health crisis for the US, and an investment crisis for the biotech industry.</p><img src="https://counter.theconversation.com/content/48224/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Chris Ford receives funding and research support from the European Social Research Council, the International Centre for Research in Accounting Trust, NEMODE (new economic models in the digital economy), and the Institute of Chartered Accountants in England and Wales. He has no organzational or industry affiliations related to research in any aspect of the health economy.</span></em></p>Clinton, who named drug companies among her enemies in this week’s debate, is pushing populist-inspired policies that could hamper the flow of new medicines.Chris Ford, Lecturer in Accounting & Management, Lancaster UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/456672015-08-06T04:34:04Z2015-08-06T04:34:04ZExplainer: the problem drug patents pose for developing countries<figure><img src="https://images.theconversation.com/files/90750/original/image-20150804-12023-znzety.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Generic medicine is essential to regions like the Southern African Development Community where HIV is endemic and cheap drugs are needed. </span> <span class="attribution"><span class="source">shutterstock</span></span></figcaption></figure><p>Patents and restrictions on intellectual property have become more problematic for developing nations in the <a href="http://www.ncbi.nlm.nih.gov/pubmed/18974405">last decade</a>. At the centre of the storm is the development and influx of inexpensive generic medicines that developing countries need to treat HIV, TB and other communicable diseases.</p>
<p>The generic industry is essential for provision of low cost medicines. In southern Africa, where there is a <a href="http://www.avert.org/hiv-aids-sub-saharan-africa.htm">high burden</a> of HIV and a lack of access to resources for health care and <a href="http://www.sadc.int/themes/health/pharmaceuticals/">medicines</a>, the industry is particularly important.</p>
<p>The growth of the generic drug industry has resulted in <a href="http://www.reuters.com/article/2014/01/17/us-safrica-pharma-idUSBREA0G0N720140117">tensions</a> with big multinational pharmaceutical firms. These firms rely on patents to protect the intellectual property of their products. Patenting laws like the World Trade Organisation’s agreement on Trade-Related Aspects of <a href="https://www.wto.org/english/tratop_e/trips_e/factsheet_pharm02_e.htm">Intellectual Property (TRIPS)</a> stipulates that patents last for 20 years from the date of registration. This gives manufacturers an opportunity to provide drugs exclusively for that period so that they can recoup money spent on research and drug development.</p>
<p>But it also places the power of managing drug prices in the hands of manufacturers. This drives up prices, making many medications inaccessible to the poor, particularly in developing countries. </p>
<h2>The big challenges</h2>
<p>This is particularly problematic for patients who have developed immunity to certain drugs.</p>
<p>Certain patients are reliant on new medication because of drug resistance. In Africa there are more than <a href="http://www.who.int/tb/publications/global_report/en/">32 000</a> people suffering from multiple drug resistant TB (MDR-TB). In 2010, according to the World Health Organisation, one in 20 HIV-positive patients worldwide were infected by a <a href="http://www.who.int/hiv/pub/drugresistance/report2012/en/">drug-resistant</a> strain of tuberculosis. </p>
<p>Accessing affordable drugs for these patients is problematic because new treatments still under patent are exorbitantly expensive.</p>
<p>The same problem applies to a range of other potential treatments. For example some third-line anti-retroviral therapies are still <a href="http://www.fixthepatentlaws.org/?p=144">under patent</a>, making them expensive. Third-line and second-line treatments are necessary for patients who are not responding to first-line ARVs. There are 2.5 million people in South Africa on ARVs. Around 9% are <a href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3392418/">failing</a> first-line anti-retroviral therapy year-on-year and need to be put on second-line and eventually third-line ARVs. </p>
<h2>The Indian generic drug market</h2>
<p>India is one of the key <a href="http://archive.biomedcentral.com/1758-2652/13/35/">providers</a> of generics to developing states. It supplies 20% of the global market for generic medicines and accounts for more than 80% of the world’s anti-retroviral purchases annually. It has provided a large proportion of key medicines to global aid and <a href="http://www.cssr.uct.ac.za/sites/cssr.uct.ac.za/files/pubs/WP236.pdf">non-profit organisations</a> such as <a href="http://www.doctorswithoutborders.org/news-stories/field-news/why-indias-generic-medicines-industry-so-important">Medecins sans Frontieres</a>, <a href="http://www.pepfar.gov/about/index.htm">PEPFAR</a>, <a href="http://www.unicef.org/aids/">UNICEF</a> and <a href="http://www.theglobalfund.org/en/about/diseases/">the Global Fund</a>.</p>
<p>Indian generic drug manufacturing capabilities, which have brought down the price of certain medicines, benefited from a lack of <a href="http://www.msf.org/article/lifeline-affordable-medicines-poor-countries-be-cut">patent barriers</a>.</p>
<p>But global patent laws imposed in the last decade, including one in India in <a href="http://ipindia.nic.in/ipr/patent/patent_2005.pdf">2005</a>, mean that certain drugs cannot be manufactured by the generic industry. </p>
<p>As a result India has granted certain <a href="http://timesofindia.indiatimes.com/home/sunday-times/all-that-matters/Changes-to-Indias-patent-law-will-impact-prices-of-life-saving-drugs/articleshow/32519848.cms">patents</a>
for TB, HIV and hepatitis C medicines manufactured by US firms, which stopped its manufacturers from reproducing those drugs. At the same time, India has not been limited by the patent laws. Its patent authority has rejected applications for patents from big pharmaceuticals such as <a href="http://in.reuters.com/article/2013/04/01/india-drugs-patent-novartis-glivec-idINDEE93000920130401">Novartis and Gilead</a> which manufacture cancer and hepatitis C drugs respectively. This means Indian manufacturers are allowed to produce the cheaper generics of the same products.</p>
<p>In addition to the patent challenge, India’s ability to produce generics could also be hampered if it finalises a <a href="http://www.livemint.com/Politics/551vX07cPJSdaLgmZfakSJ/India-EU-to-resume-talks-on-FTA-on-28-August.html">free trade agreement</a> with the European Union, which it has been negotiating for eight years. Talks are set to resume <a href="http://www.newindianexpress.com/business/news/EU-India-to-Take-Stock-of-FTA-Negotiations/2015/08/05/article2957820.ece">next month</a>. </p>
<p>Among the negotiations is a <a href="http://www.taylorwessing.com/synapse/regulatory_dataexclusivity.html">data exclusivity</a> clause, which will allow the pharmaceutical producers of European Union member countries to retain the clinical test data which shows the safety and efficacy of a new drug before it can be commercialised for up to five years. It would mean that the generic companies would need to generate their own data before they market those off-patented drugs.</p>
<p>If the clause is approved, it could constrain India’s generic industry and be detrimental to southern Africa’s pharmaceutical industries as generics of these drugs would not be imported to the region. </p>
<h2>Other barriers to drug provision</h2>
<p>Medicine provision in the region faces several challenges which patenting could exacerbate. These include:</p>
<ul>
<li><p>Regional <a href="http://www.thetradebeat.com/regional-institutions/regional-business-barriers-unlocking-economic-potential-in-southern-africa">business barriers</a> such as small markets, weak and differing medicine registration policies and restricted access to medicines because of intellectual property rights on drugs.</p></li>
<li><p>Multiple regulatory authorities, which mean there are conflicting laws for the different countries in the region. </p></li>
<li><p>National irregularities in supply chain management which result in stock outs. The supply chains of products are disrupted, causing delayed distribution of medication.</p></li>
</ul>
<p>Drug provision is also hindered by regulatory problems, such as drug regulators not having the capacity to evaluate medicines and approve new ones.</p>
<h2>The future of generics</h2>
<p>Patent laws and drug exclusivity agreements are a major challenge for the global HIV and AIDS movement. South Africa and the <a href="http://www.tac.org.za/news/over-130-organisations-and-experts-demand-patent-law-reform-south-africa">Treatment Action Campaign</a> fought a long but successful battle to gain access to more affordable medicines. It used <a href="http://www.section27.org.za/wp-content/uploads/2010/04/journal-HR-practice-heywood.pdf">constitutional litigation</a> to gain access to cheaper generic anti-retrovirals.</p>
<p>Other southern African countries like Malawi and Zambia also rely heavily on inexpensive treatment and generics because of high HIV rates and drug <a href="http://stopstockouts.org/">stock outs</a>.</p>
<p>Given the fact that the future of generic drug production hangs in the balance, developing countries need to consider <a href="http://www.thetradebeat.com/regional-institutions/regional-business-barriers-unlocking-economic-potential-in-southern-africa">alternatives</a> for southern Africa.</p>
<p>Pharmaceutical companies have traditionally offered <a href="http://www.hst.org.za/news/have-pharmaceutical-companies-come-party-africa">“cut price deals”</a> on anti-retrovirals to developing countries to prevent loss of income to the generic companies. These deals target specific products offered on a country by country basis. There is a lack of transparency around which prices are offered to which country. </p>
<p>There is an increased need for extensive research and development of new medicines and vaccines. This would allow additional companies to enter the market and ensure competitive prices.</p><img src="https://counter.theconversation.com/content/45667/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Erica Penfold receives funding from the Economic and Science Research Council. She is affiliated with the South African Institute of International Affairs.</span></em></p>The generic drug industry has become essential to developing countries that need access to cheaper drugs to treat their heavy burdens of communicable diseases.Erica Penfold, Research Fellow , South African Institute of International AffairsLicensed as Creative Commons – attribution, no derivatives.