tag:theconversation.com,2011:/ca/topics/generics-6215/articlesGenerics – The Conversation2018-09-13T14:32:54Ztag: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>
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<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>
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<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>
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<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>
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<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>
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<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>
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<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>
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<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>
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<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>
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<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>
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<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>
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<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/840072017-11-20T15:54:42Z2017-11-20T15:54:42ZHow a Native American tribe came to own one of the world’s most valuable patents<figure><img src="https://images.theconversation.com/files/195449/original/file-20171120-18533-xdziwm.jpg?ixlib=rb-1.1.0&rect=125%2C278%2C5865%2C2955&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/download/confirm/263977949?src=UK9X2IIMyX0j7kM0oB3Gxw-1-4&size=huge_jpg">Tashatuvango/Shutterstock</a></span></figcaption></figure><p><a href="https://www.allergan.com/home">Allergan</a>, the drugmaker behind Botox, is using an unprecedented tactic to protect its valuable patents – angering lawyers and politicians, and keeping the price of its medicines high.</p>
<p>There has long been a debate about patents and traditional knowledge in developing countries. Pharmaceutical companies in the West, like Allergan, are often accused of “bio-prospecting”. They collect raw samples of traditional medicines and plants, whose healing properties have been known to locals for centuries, and patent modified extracts of the active ingredients. (Under patent law, existing natural materials such as plants and trees cannot be patented as they are not “novel”.)</p>
<p>Under international treaties, such as the <a href="https://www.cbd.int/convention/">Convention on Biodiversity</a>, companies need to ask permission before bio-prospecting. However, under patent law, pharmaceutical companies don’t have to share revenues from drugs developed in part from the exploitation of indigenous traditional knowledge. To add insult to injury, the patented medicines are often too costly for people in developing countries to afford.</p>
<h2>Bizarre twist</h2>
<p>The debate over patents and the rights of indigenous peoples has taken a bizarre new twist in recent months. Allergan transferred the ownership of the patents on one of its most valuable medicines – Restasis, a treatment for chronic dry eyes that had US$1.5 billion in <a href="http://www.newsweek.com/how-racism-fueling-pharma-scandal-over-billion-dollar-patent-680596">sales in 2016 alone</a> – to the Saint Regis Mohawk Tribe of New York State. It now plans to lease back the rights to the drug.</p>
<p>This may seem like a case of the pharmaceutical industry seeking to right historical wrongs by giving something back to an indigenous group that has long suffered from discrimination and dispossession – but it is not. The deal is purely a self-interested one on the part of Allergan. But there is no doubt that, in an inversion of the classic debate about using patents to exploit the knowledge of indigenous peoples, the Saint Regis Mohawk Tribe will also benefit from the deal.</p>
<p>So how did this come about? US law grants Native American tribes “sovereign immunity” in relation to their reservations, shielding them from some US federal laws. Since 2012 there has also been a system of challenging patents at the US Patents and Trademarks Office (USPTO) known as “<a href="https://www.uspto.gov/patents-application-process/appealing-patent-decisions/trials/inter-partes-review">Inter-partes Review</a>”. This allows competitors to argue at USPTO panels that a granted patent ought to be invalidated. It is quicker and more cost-effective than challenging a patent in court.</p>
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<img alt="" src="https://images.theconversation.com/files/195452/original/file-20171120-18574-zipt2k.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/195452/original/file-20171120-18574-zipt2k.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/195452/original/file-20171120-18574-zipt2k.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/195452/original/file-20171120-18574-zipt2k.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/195452/original/file-20171120-18574-zipt2k.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/195452/original/file-20171120-18574-zipt2k.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/195452/original/file-20171120-18574-zipt2k.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">
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<span class="caption">US law grants Native American tribes sovereign immunity on reservations.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/download/confirm/116030641?src=hfFbyWvwgFQJgv3VD7Z-Pg-1-93&size=huge_jpg">Digital Media Pro/Shutterstock</a></span>
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<p>This new system has <a href="https://www.bloomberg.com/news/articles/2017-09-20/apple-likes-the-patent-death-squad-allergan-pays-to-avoid-it">invalidated many pharmaceutical patents</a>. By transferring their patents to the Saint Regis Mohawk Tribe and leasing them back from the tribe for an annual fee of up to US$15m, Allergan is effectively paying the tribe to take advantage of its sovereign immunity, which also shields the patents from challenge. If this unprecedented legal strategy succeeds, it could prolong Allergan’s monopoly and stifle generic competition.</p>
<p>Meanwhile, the tribe, as quoted in the <a href="https://www.allergan.com/news/news/thomson-reuters/allergan-and-saint-regis-mohawk-tribe-announce-agr">Allergan press release</a>, said it viewed the deal as a way to benefit from the patent system, and that it would use the money for good causes in the community.</p>
<p>Unsurprisingly, there has been a great deal of opposition to this tactic. Shortly after the deal was announced in September 2017, several US senators asked the senate judiciary committee <a href="https://uk.reuters.com/article/us-allergan-patents/senators-want-probe-of-allergan-transfer-deal-with-tribe-letter-idUKKCN1C22VY?feedType=RSS&feedName=healthNews">to investigate</a> Allergan’s alleged “anti-competitive attempt to shield its patents from review and keep drug prices high”.</p>
<p>There is also an <a href="http://uk.businessinsider.com/allergan-restasis-patents-invalid-in-texas-district-court-2017-10?r=US&IR=T">ongoing court challenge</a> that may yet lead to a ruling that this strategy is an abuse of the sovereign immunity process. Yet if the Allergan-Saint Regis agreement survives legal challenge it will encourage further deals between US Native American tribes and pharmaceutical companies. </p>
<h2>Ingenious tactic</h2>
<p>There’s no doubt that the legal tactic is an ingenious one. Yet, even if we consider it a good thing that the tribe has found a new source of revenue, the deal should give us all pause for thought. </p>
<p>In addition to the competition concerns, this tactic subverts the protection given to Native American tribes under US law, in part to account for their historical dispossession. In other words, it uses the tribe’s status to boost corporate power and control of patented medicines. </p>
<p>It also, of course, does nothing to help other indigenous groups around the world, particularly those in developing countries. Although it turns the classic debate over patents and indigenous peoples on its head, the deal may end up doing more harm than good.</p><img src="https://counter.theconversation.com/content/84007/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Luke McDonagh 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>The Saint Regis Mohawk tribe has struck a multimillion-dollar deal with Allergan. But the deal may do more harm than good.Luke McDonagh, Senior Lecturer in Law, City, University of LondonLicensed 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/504112015-11-13T04:07:08Z2015-11-13T04:07:08ZAfricans need to make their mark in the pharmaceutical industry boom<figure><img src="https://images.theconversation.com/files/101702/original/image-20151112-9400-1apnz3f.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">In most African countries, there is no oversight body for the pharmaceutical marketplace. </span> <span class="attribution"><span class="source">Reuters/Thomas Mukoya</span></span></figcaption></figure><p>Africa’s <a href="http://www.mckinsey.com/insights/health_systems_and_services/africa_a_continent_of_opportunity_for_pharma_and_patients">pharmaceutical industry</a> is one of the world’s fastest growing. In just ten years it has exploded – growing from US$4.7 billion in 2003 to US$20.8 billion in 2013. And based on projections for the next five years, the need for prescription medicines, generics, over-the-counter medicines and medical devices on the continent is estimated to grow by between 6% and 11%.</p>
<p>Despite the boom, the continent’s pharmaceutical industry faces several challenges that will stifle its growth. Africa has a <a href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4396384/">dire shortage</a> of specialists to conduct clinical research and develop novel medicines to tackle diseases on the continent. In addition, the regulation of the industry and new medicines is also not standardised.</p>
<p>But comprehensively <a href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4396384/">training</a> people in medicines development, regulatory sciences and clinical research remains a major challenge for universities, industry and regulatory agencies in Africa. </p>
<h2>More interest locally</h2>
<p>A range of infectious and non-communicable diseases plague the continent. Non-communicable diseases such as cardiovascular disease and diabetes are growing. In <a href="http://www.aho.afro.who.int/profiles_information/index.php/AFRO:Non-communicable_diseases_and_conditions">1990</a> they accounted for 28% of illnesses and 35% of deaths. This is projected to rise to 60% and 65% by 2020.</p>
<p>As a result of the disease burden, pharmaceutical companies have been expanding their activities in Africa. Local companies have been integral in this process. More than 300 pharmaceutical companies have manufacturing sites in <a href="http://www.mckinsey.com/%7E/media/mckinsey/dotcom/insights/health%20care/africa%20-%20a%20continent%20of%20opportunity%20for%20pharma%20and%20patients/pmp%20africa%20a%20continent%20of%20opportunity%20for%20pharma.ashx">Africa</a> and are active in drug production and clinical trials. </p>
<p>In South Africa alone, 270 new clinical trials start every year and 550 trials are active at any point. The continent’s largest generics company, South African-based <a href="http://www.aspenpharma.com/product-portfolio/overview/">Aspen Pharmacare</a>, is among the top ten generic companies globally. </p>
<p>But clinical research in sub-Saharan Africa is mostly performed by international companies with local subsidiaries. Since the 1980s, pharmaceuticals have set up medical departments and contracted research organisations to help their medicine development. Increasingly clinicians are also leading research in the form of <a href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3530977/">investigator-initiated</a> trials. </p>
<p>These clinical trials need to be managed and performed by local appropriately qualified specialists. </p>
<h2>Regulation trouble</h2>
<p>Aside from the research and development of medicines, the continent faces two other pharmaceutical challenges. The first is regulating the pharmaceutical marketplace. The second is approving new medicines. </p>
<p>In South Africa, pharmaceutical professionals must comply with the <a href="http://www.marketingcode.co.za/images/SACodeMarketingPractice.pdf">Marketing Code Authority</a>. Set up in 2014, it oversees the promotion and marketing of medicines and provides ethical guidelines.</p>
<p>But staff are often not adequately trained and up to date with the ever-changing local and international marketing regulations. And in many other African countries, oversight bodies do not exist.</p>
<p>When it comes to authorising new medicines, the <a href="http://www.mccza.com/">South African Medicines Control Council</a> is the most established regulatory body. </p>
<p>But its review timelines are too long and unpredictable. This is because the council relies mainly on external reviewers from universities and research institutions to review products. There are also delays in approving clinical trials.</p>
<p>In November, the South African parliament <a href="http://www.timeslive.co.za/politics/2015/11/10/Parliament-passes-health-bill">passed</a> a bill to phase out the Medicines Control Council and create the South African Health Products Regulatory Agency.</p>
<p>The agency should be set up by 2016 and promises to streamline the process. It will fall outside the mandate of the South African National Department of Health and in-house staff will do much of the work. A mass of trained internal and external reviewers will, however, still be needed to carry out its mandate. </p>
<p>Specific recommendations to train local regulatory experts exist. The health department has set up the Institute for Regulatory Science to train staff, clinical trial specialists and industry employees. But it will still be a long time before the institute is functional.</p>
<h2>Creating a syllabus</h2>
<p>Internationally, standardised training programs exist. Pharmaceutical medicine has been recognised as a medical speciality in the UK since 2002. This means drug safety regulations and the marketing of pharmaceuticals can be adequately managed by qualified medical experts.</p>
<p>The UK pharmaceutical medicine diploma exam was offered in South Africa in 2011 but the initiative was later abandoned due to the lack of medically qualified candidates prepared to take the exam. </p>
<p>Globally, Europe’s <a href="http://www.pharmatrain.eu">PharmaTrain Federation</a> has established standardised educational programs. It is now developing an accredited certificate for medical and non-medical specialists worldwide. The federation and its international <a href="http://ifapp.org/About-ifapp">counterpart</a> have a working group to discuss medicines development education and regulation in low and middle income countries. </p>
<p>The group will provide the standards for tailor-made programs in these countries. Pilot projects will be planned in Zimbabwe, Ghana and Ethiopia.</p>
<p>Until recently, the continent has not had an academic program in medicines development which covers the range of drug discovery to marketing. Since 2010 this diploma <a href="http://sun025.sun.ac.za/portal/page/portal/Health_Sciences/English/Departments/Medicine/Pharmacology/Pharma%20Postgraduate%20diploma">program</a> has been offered by Stellenbosch University.</p>
<h2>Growing the industry</h2>
<p>Universities, other educational institutions, industry, clinical research organisations and regulatory agencies need to work together to grow the local expertise in medicines development and regulation. </p>
<p>More trained specialists will advance the science and the practice of developing novel medicines. Ultimately getting these medicines on the African market will benefit the public and the patients who need it most. But Africans need to make a bigger contribution to this process.</p><img src="https://counter.theconversation.com/content/50411/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Bernd Rosenkranz is affiliated with PharmaTrain Federation and the UK Faculty of Pharmaceutical Medicine. He is President of Fundisa African Academy of Medicines Development. </span></em></p>Africa’s pharmaceutical industry has mushroomed in the last ten years. But its ability to keep pace with demand is being held back by a number of factors, including a shortage of specialists.Bernd Rosenkranz, Professor and Head, Division of Clinical Pharmacology, Faculty of Medicine and Health Sciences, Stellenbosch UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/424722015-06-07T23:23:23Z2015-06-07T23:23:23ZHealth Check: how do generic medicines compare with the big brands?<figure><img src="https://images.theconversation.com/files/83763/original/image-20150603-3452-1npwrfb.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Generic medicines may have a different colour, shape, size and taste than the original brand.</span> <span class="attribution"><a class="source" href="http://www.shutterstock.com/pic-268624877/stock-photo-senior-caucasian-woman-about-ninety-years-old-sits-near-the-mirror-takes-out-pills-and-reads.html?src=U3eprotUUrC1_kWSUhwgHg-1-121">Konstantin Gushcha/Shutterstock</a></span></figcaption></figure><p>The word “generic” is derived from the Latin “genus” which means “kind” or “class”. For medicines, it was originally used to describe the active chemical ingredient of a drug, in lieu of the scientific name, which is often difficult to remember and pronounce. </p>
<p>Over time, this definition has broadened to include additional brands of existing medicines.</p>
<p>Researching, developing and bringing a medicine to market is a costly process and now <a href="http://www.scientificamerican.com/article/cost-to-develop-new-pharmaceutical-drug-now-exceeds-2-5b/">exceeds US$2.6 billion</a>. Pharmaceutical companies are given a patent period of 20 years, including time for clinical trials, where they have exclusive marketing rights to recoup their investment. </p>
<p>After the patent period, another company can produce the same medicine under a different brand name. These usually (but not always) less expensive brands have become known as the “generics”.</p>
<h2>Ingredients</h2>
<p>Generic medicine contains the same active ingredient in the same dose as the original brand. </p>
<p>As well as the name on the bottle or the box, the inactive ingredients – so-called excipients – may differ. These are needed in the manufacturing process for a variety of reasons: </p>
<ul>
<li>as a filler, if the quantity of active ingredient is very small</li>
<li>as a binder to hold all the ingredients together</li>
<li>to stabilise the active ingredient so it stays effective for longer</li>
<li>to improve the absorption in the body of the active ingredient</li>
<li>to sweeten or flavour the medicine</li>
<li>to coat the tablets or capsules to make them easier to swallow.</li>
</ul>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/83764/original/image-20150603-3459-uw0wga.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/83764/original/image-20150603-3459-uw0wga.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/83764/original/image-20150603-3459-uw0wga.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/83764/original/image-20150603-3459-uw0wga.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/83764/original/image-20150603-3459-uw0wga.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/83764/original/image-20150603-3459-uw0wga.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/83764/original/image-20150603-3459-uw0wga.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">You can check the medicine’s ingredients on the consumer medicine information leaflet.</span>
<span class="attribution"><a class="source" href="http://www.shutterstock.com/pic-267678902/stock-photo-medicine-pills.html?src=pp-same_artist-267678878-Pgksr2NnwnxynyLnG6ghMA-3&ws=1">Kwangmoozaa/Shutterstock</a></span>
</figcaption>
</figure>
<p>Most companies use the same or similar excipients, such as starch, lactose, gluten, sugar, preservatives and food dyes. So the likelihood of having an adverse reaction to an excipient in one brand of a medicine more so than another is very slim.</p>
<p>But if you have a particular allergy or intolerance or wish to avoid certain substances for cultural or medical reasons, ask your pharmacist, or look at the ingredients listed on the consumer medicines information (CMI) leaflet that comes each prescription. CMIs are also available on the <a href="http://www.nps.org.au/medicines">NPS Medicine Wise website</a>. </p>
<p>Generic medicines may have a different colour, shape, size and taste than the original brand but, importantly, they must meet the same standards of quality, safety and effectiveness as the original brand. </p>
<h2>Price</h2>
<p>Generics are usually less expensive than the original brand simply because their manufacturers don’t have the initial costs associated with the research and development. How much less expensive will vary from product to product, and from time to time. </p>
<p>The government <a href="http://www.pbs.gov.au/info/industry/pricing/pbs-items/fact-sheet-setting-an-approved-ex-manufacturer-price">subsidises</a> Pharmaceutical Benefits Schedule (PBS) medicines to the lowest (benchmark) price. In some cases, originator brand manufacturers have brought their prices down to that competitive benchmark level. More commonly, there is a premium on the innovator/originator brand of an average of A$2 to A$3.</p>
<p>For antibiotics, for instance, there is a difference of A$3.05 between a course of Amoxil (the original) brand of amoxicillin antibiotic and that of the lowest priced generic. The difference between the antibiotic Keflex and generic cephalexin is A$6.30. </p>
<p>For gastro-oesophageal reflux, patients pay A$2.50 above the benchmark price for the premium brand, Losec.</p>
<p>For the oral contraceptive pill, a four-month supply of Microgynon 30 is A$11.40 more than its equivalent benchmark generic product. </p>
<p>But there is currently no difference in cost between originator brands and generics for the widely prescribed cholesterol-lowering medicines atorvastatin (Lipitor) or rosuvastatin (Crestor), or the blood pressure medication irbesartan (Avapro).</p>
<p>To compete with the generics-only manufacturers, some of the research-based innovator-brand pharmaceutical companies make their own “generics” under a different brand name to be marketed at the benchmark price.</p>
<h2>Pricing changes</h2>
<p>The proportion of PBS prescriptions dispensed as generic medicines is now <a href="http://ajp.com.au/news/app2015-live-blog/">around</a> 42% by volume, but just 19% in dollar value. The government wants to increase this volume to reduce the cost of the PBS. </p>
<p>Government subsidy of PBS medicines is based on what is known as <a href="http://www.pbs.gov.au/info/industry/pricing/eapd">price disclosure</a> and <a href="http://www.pbs.gov.au/info/industry/useful-resources/manual/4_Drugs">weighted average pricing</a>. This takes into account the actual cost price of the various brands (originator and generic) and the market share of each brand. </p>
<p>From October 2016, originator brands will be excluded from the weighted average pricing calculations. Together with the proposed regular 5% reduction in prices paid to manufacturers of medicines still under patent, net savings of US$3.7 billion are expected over five years. </p>
<p>The good news for consumers is that prices of many common generics, including cholesterol-lowering medicines atorvastatin and rosuvastatin, are expected to drop by 25-40% from October 2016.</p><img src="https://counter.theconversation.com/content/42472/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>John Bell co-owns John Bell Pharmacist Advice Pharmacy in Sydney. He is a consultant to the Pharmaceutical Society of Australia. He has consulted for various pharmaceutical companies. </span></em></p>Generic medicine contains the same active ingredient in the same dose as the original brand.John Bell, Practitioner Teacher, University of Technology SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/356032015-01-21T11:00:00Z2015-01-21T11:00:00ZWhy are some generic drugs getting so expensive?<figure><img src="https://images.theconversation.com/files/68728/original/image-20150112-23792-x9z5rx.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Generics aren't always so cheap. </span> <span class="attribution"><a class="source" href="http://www.shutterstock.com/pic-121020331/stock-photo-closeup-of-bottles-of-pills.html?src=M9wDFoYeuUMoug15W8sF6g-2-71">Pill bottles via bikeriderlondon/Shutterstock</a></span></figcaption></figure><p>More than <a href="http://www.nytimes.com/2013/03/19/business/use-of-generics-produces-an-unusual-drop-in-drug-spending.html?pagewanted=all&_r=0">eight out of every 10</a> prescriptions dispensed in the US is generic. This growth is due to a large number of top-selling drugs going off patent over the past decade, as well as innovations in the retail sector, such as Walmart’s <a href="http://www.marketplace.org/topics/health-care/store-clinics-4-checkups-wal-mart-workers">US$4 generic program</a>. Over this period, generic drug prices declined or held steady, saving American consumers tens of billions of dollars annually. </p>
<p>But recently prices of some long-time generic drugs like digoxin (a heart medication), albuterol (for asthma) and doxycycline (an antibiotic) increased more than <a href="http://www.sanders.senate.gov/download/face-sheet-on-generic-drug-price-increases?inline=file">ten-fold</a> over a very short period of time. This has prompted the Senate subcommittee on health and aging to investigate why prices for some generic drugs have risen so high, so fast.</p>
<p>While price increases are good news for some generic manufacturers, almost everyone else is adversely affected. Consumers face higher prices, physicians have to prescribe alternative therapies or deal with angry patients. And the local pharmacist can actually lose money if drugs were purchased at new higher prices but is reimbursed at a predetermined lower rate. </p>
<h2>Why are prices going up?</h2>
<p>The majority of cases come down to two broad factors: reduced competition due to consolidation in the industry, and market and regulatory forces that altered incentives for firms producing generic drugs. </p>
<p>In a nutshell, it’s the bad side of capitalism where intense competition and lower profit margins lead to cost-cutting measures. Lean inventories, outsourcing production and manufacturer consolidation can allow the remaining firms to regain some market power and raise prices, sometimes precipitously. We’ve seen this pattern happen before in the airline and cable industries where highly competitive, deregulated markets led to consolidation and higher prices over time.</p>
<p>A manufacturer of generic drugs does not have to do significant research or clinical testing the way a drug company developing a new or novel drug might. They just have to present evidence to the FDA that the proposed generic drug has the same active ingredient as the branded product and that they have the manufacturing capability to safely produce it on a large scale. </p>
<p>Firms usually file applications to produce a generic drug before the patent expires. This means that the generic firm can begin selling its product the first day the patent of the branded agent expires. A small number of firms typically enter the market in the first year after a patent expires, which means they can earn significant profits. </p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/68733/original/image-20150112-23795-1prp0j0.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/68733/original/image-20150112-23795-1prp0j0.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/68733/original/image-20150112-23795-1prp0j0.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/68733/original/image-20150112-23795-1prp0j0.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/68733/original/image-20150112-23795-1prp0j0.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/68733/original/image-20150112-23795-1prp0j0.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/68733/original/image-20150112-23795-1prp0j0.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">Priced out.</span>
<span class="attribution"><a class="source" href="http://www.shutterstock.com/pic-200155724/stock-photo-substance-abuse-this-is-a-shot-of-prescription-pain-pills-spilled-out-on-money-to-portray.html?src=2LpnRbTlF_44QKJbJbfUAA-3-76">Pills and money via RONORMANJR/Shutterstock</a></span>
</figcaption>
</figure>
<h2>Higher profits induce more competition and lower margins</h2>
<p>But those high profits encourage more manufacturers to start producing the generic drug. More manufacturers means more competition and this in turn makes profits decline. Tighter profit margins lead firms to cut costs, consolidate or perhaps even exit the market. Over time, only a few larger firms remain. How readily firms enter and exit the market and how quickly prices adjust varies considerably from drug to drug and across industries. </p>
<p>Recent consolidations in the generic drug market have reduced competition in some drug classes like antibiotics or medicine for asthma and diabetes, at a time when demand for low-cost medications is at an all-time high. This provides the leverage firms need to raise prices substantially. While there are many generic manufacturers operating in the US, three firms – Teva, Mylan, and Sandoz – have over <a href="http://www.statista.com/statistics/205057/percent-of-generic-prescriptions-dispensed-by-corporation/">40% of the market</a>.</p>
<p>And large research-oriented manufacturers like Pfizer and <a href="http://www.novartis.com/products/sandoz.shtml">Novartis</a> are <a href="http://dealbook.nytimes.com/2012/05/02/novartis-to-buy-fougera-pharmaceuticals-for-1-5-billion/">buying</a> smaller generic companies or directly producing generic versions of their own patented drugs, so-called <a href="http://www.reuters.com/article/2014/01/14/us-pfizer-valeant-idUSBREA0D0CZ20140114">branded generics</a>. This creates a potential conflict of interest. For instance, if the firm has sufficient market power, it has an incentive to decrease generic production to shift demand to the more profitable branded product.</p>
<p>Tight profit margins lead firms to cut costs. Holding on to inventory is expensive and firms have to weigh the costs of storing additional supply against the loss of profit from a potential disruption in supply. As profit margins shrink, inventories tend to decline. In this environment interruptions in the supply chain, for whatever reason, have more immediate impact on retail prices at the pharmacy. </p>
<h2>Market forces create cost pressure</h2>
<p>The second major driver of sudden price increases is the combination of market and regulatory forces. Walmart’s US$4 generic program was a windfall for consumers, and so successful that it was copied by competitors. The downside of this competition is that it’s hard to make a lot of money when the product sells for so little. </p>
<p>This trend forced generic manufacturers to lower their costs or get out of the market. Many other industries including electronics and clothing have felt the same cost pressures in an increasingly global marketplace and a common response is to outsource some or all production to lower cost countries. </p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/69444/original/image-20150119-14484-1h0r6d6.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/69444/original/image-20150119-14484-1h0r6d6.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=346&fit=crop&dpr=1 600w, https://images.theconversation.com/files/69444/original/image-20150119-14484-1h0r6d6.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=346&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/69444/original/image-20150119-14484-1h0r6d6.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=346&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/69444/original/image-20150119-14484-1h0r6d6.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=435&fit=crop&dpr=1 754w, https://images.theconversation.com/files/69444/original/image-20150119-14484-1h0r6d6.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=435&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/69444/original/image-20150119-14484-1h0r6d6.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=435&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Moving production overseas cuts costs.</span>
<span class="attribution"><a class="source" href="http://www.shutterstock.com/pic-143779399/stock-photo-tablets-coming-out-of-the-machine.html?src=y4XfJtMXX8mt-cC0gL367Q-1-1">Tablets via akank/Shutterstock</a></span>
</figcaption>
</figure>
<p>Outsourcing production raises a slew of issues that can have adverse affects on the reliability of generic drug supplies. Foreign factories are more <a href="http://www.nytimes.com/2011/08/13/science/13drug.html?pagewanted=all">difficult</a> for the FDA to inspect, tend to have more production problems and far are more likely to be shutdown than domestic factories. </p>
<p>In 2013 the US Department of Justice fined the US subsidiary of Ranbaxy Laboratories, India’s largest generic drug manufacturer, <a href="http://www.reuters.com/article/2013/05/13/us-ranbaxy-settlement-idUSBRE94C0PT20130513">US$500 million</a> after they plead guilty to civil and criminal charges related to drug safety and falsifying safety data. The FDA has also <a href="http://www.reuters.com/article/2014/01/24/us-ranbaxy-ban-idUSBREA0N06Z20140124">banned</a> products made at four of the company’s manufacturing facilities in India. In 2008, after branded versions of the blood thinner heparin, which were manufactured in China, <a href="http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm112597.htm">were recalled</a>, the FDA found that the active ingredient <a href="http://www.consumerreports.org/cro/2012/08/are-generic-drugs-safe/index.htm">had been contaminated</a>. According to FDA <a href="http://www.fda.gov/AboutFDA/GlobalInitiative/">estimates</a>, 40% of finished drugs are made abroad and 80% of manufacturers making active ingredients were located outside the US.</p>
<h2>Can we bring prices down?</h2>
<p>How can patients be protected from these sudden price increases? There are many options, but none of them are ideal. One possibility is to impose price floors – that is, a minimum price – in selected drug classes to ensure generic manufacturers can make a profit. This is commonly done in agriculture, where a bumper crop can lead to excess supply of corn or wheat, depressing prices below the cost of production. </p>
<p>The FDA could also require that generic manufacturers justify short-term price increases of greater than 50%, for example, to discourage price gouging. A variant of this tactic is currently done in Medicare Part D, a program that helps people over age 65 pay for prescription drugs, to prevent insurers from increasing drug prices after beneficiaries have enrolled and committed to a plan for a year.</p><img src="https://counter.theconversation.com/content/35603/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>More than eight out of every 10 prescriptions dispensed in the US is generic. This growth is due to a large number of top-selling drugs going off patent over the past decade, as well as innovations in…Geoffrey Joyce, Associate Professor, Clinical Pharmacy and Pharmaceutical Economics & Policy, University of Southern CaliforniaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/154162013-06-27T20:28:05Z2013-06-27T20:28:05ZCan’t pronounce the name of your medicine? Here’s why<figure><img src="https://images.theconversation.com/files/26320/original/33g9tw7g-1372312820.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Drug companies invent hundreds of new molecules that they hope to turn into saleable medicines.</span> <span class="attribution"><span class="source">Keith Ramsey</span></span></figcaption></figure><p>Gone are the good old days when medicines had simple, easy to pronounce names such as aspirin, paracetamol and morphine. </p>
<p>Nowadays pharmaceutical companies almost seem to revel in giving drugs names that are near impossible to pronounce, such as <a href="http://www.thefreedictionary.com/Phenoxymethylpenicillin">phenoxymethylpenicillin</a> (pronounced phen-oxi-methal-pen-a-sil-an) or <a href="http://www.thefreedictionary.com/hydrochlorothiazide">hydrochlorothiazide</a> (hydro-clor-o-thia-zide) or <a href="http://www.thefreedictionary.com/sulfamethoxazole">sulfamethoxazole</a> (sol-fa-me-thox-a-zol). </p>
<p>To make things even more confusing, some medicines have multiple names depending on whether they have been approved for sale to the public and if companies have created their own brand name. </p>
<p>But despite the seemingly random selection of drug names, there’s a defined structure to how they are decided. And recently, the <a href="http://www.ema.europa.eu/ema/">European Medicines Agency</a> (the largest government agency for the approval of drugs in the world and similar to Australia’s <a href="http://www.tga.gov.au/">Therapeutic Goods Administration</a>) released draft guidelines on the selection and approval of names for new medicines.</p>
<h2>Inventors, chemical and code names</h2>
<p>There was a time when there were no rules for how a drug was named. Usually, it was up to the inventor to decide and, more often than not, that person named the compound after (usually) himself. <a href="http://en.wikipedia.org/wiki/Potassium_permanganate">Condy’s crystals</a>, for instance, is the purple bath salt used as a disinfectant named after a chemist called Henry Condy. </p>
<p>Arthur Whitfield was a dermatologist who developed <a href="http://en.wikipedia.org/wiki/Whitfield%E2%80%99s_ointment">Whitfield’s Ointment</a> to treat fungal infections. And then there’s Lassar’s Paste, which is used to treat nappy rash and is named for <a href="http://en.wikipedia.org/wiki/Oskar_Lassar">Oskar Lassar</a>, a German scientist.</p>
<p>Things are different now.</p>
<p>Chances are that any new drug will have come from a pharmaceutical company. These companies invent hundreds or thousands of new molecules each year that they hope to turn into saleable medicines. </p>
<p>With this sort of volume being produced, pharmaceutical companies don’t have the time, or the need really, to name all of them. At this stage, drug molecules have two names – their chemical name and a code name. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/26317/original/fztx4zgj-1372312598.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/26317/original/fztx4zgj-1372312598.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/26317/original/fztx4zgj-1372312598.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=419&fit=crop&dpr=1 600w, https://images.theconversation.com/files/26317/original/fztx4zgj-1372312598.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=419&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/26317/original/fztx4zgj-1372312598.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=419&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/26317/original/fztx4zgj-1372312598.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=526&fit=crop&dpr=1 754w, https://images.theconversation.com/files/26317/original/fztx4zgj-1372312598.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=526&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/26317/original/fztx4zgj-1372312598.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=526&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption"></span>
<span class="attribution"><span class="source">Boston Public Library</span></span>
</figcaption>
</figure>
<p>The chemical name follows very strict chemistry rules and any chemist can determine the structure of a molecule from it. The chemical name of aspirin is 2-acetoxybenzoic acid and paracetamol is N-(4-hydroxyphenyl)ethanamide (in case you were curious).</p>
<p>In contrast, code names are simply an amalgamation and abbreviation of the drug company’s name and a sequential number. A drug code named GSK10093, for instance, would be the 10,093th molecule made by the company <a href="http://www.gsk.com.au/default.aspx">GlaxoSmithKline</a>. </p>
<p>These code names are usually dropped when the molecule enters human trials. But, occasionally, a code name comes into common use, such as the morning after pill <a href="http://www.tga.gov.au/newsroom/btn-tga-statement-mifepristone-gymiso-120830.htm">RU486</a>. </p>
<p>This drug was initially developed by the company Roussel Uclaf and was called RU-38486. But this was deemed too long to say, so it was shortened to RU486.</p>
<h2>Brand names and generics</h2>
<p>When a drug has approval from the government, it will usually have a generic name and one or more brand names. </p>
<p>Generic names can be used by any pharmaceutical or marketing company. Brand names are trademarked by companies and are used for drugs they hold patents for. </p>
<p>The famous erectile dysfunction drug <a href="http://www.viagra.com">Viagra</a> is actually a brand name owned by <a href="http://www.pfizer.com">Pfizer</a>. The same drug is also sold by the same company to treat hypertension (high blood pressure) under the brand name <a href="http://www.revatio.com/">Revatio</a>. </p>
<p>The <a href="http://www.news-medical.net/health/Generic-Drugs-What-are-Generic-Drugs.aspx">generic</a> name of the drug, which can be used by any pharmaceutical company now that Pzifer’s patent has expired, is sildenafil (pronounced sil-den-a-fil).</p>
<p>Generic names of most drugs are invented and assigned based on the disease they treat. If two drugs have similar sounding names, they most likely treat the same disease. </p>
<p>Take, for instance, <a href="http://en.wikipedia.org/wiki/Platinum">platinum</a> drugs, which are used to treat cancer. They have names ending with –platin: cisplatin, carboplatin and oxaliplatin. </p>
<p>Many antibiotics have names ending with –cillin (amoxicillin, piperacillin and penicillin) or –mycin (paromomycin, spectinmycin and herimycin). </p>
<p>Cholesterol-lowering drugs typically end with –statin (atorvastatin, fluvastatin and lovastatin) and drugs derived from monoclonal antibodies have names that end with –mab (abciximab, belimumab and ofatumumab).</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/26314/original/p4pfdnwt-1372311994.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/26314/original/p4pfdnwt-1372311994.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=450&fit=crop&dpr=1 600w, https://images.theconversation.com/files/26314/original/p4pfdnwt-1372311994.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=450&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/26314/original/p4pfdnwt-1372311994.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=450&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/26314/original/p4pfdnwt-1372311994.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=566&fit=crop&dpr=1 754w, https://images.theconversation.com/files/26314/original/p4pfdnwt-1372311994.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=566&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/26314/original/p4pfdnwt-1372311994.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">
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<span class="caption"></span>
<span class="attribution"><span class="source">Kevin/Flickr</span></span>
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<h2>A message for you</h2>
<p>The European Medicines Agencies’ <a href="http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2013/06/WC500144087.pdf">new draft guidelines</a> for naming drugs gives brief directions on how names should be developed. </p>
<p>Each drug name should not:</p>
<ol>
<li><p>mislead about what diseases the drug is capable of treating,</p></li>
<li><p>mislead about what the drug and medicine is made of,</p></li>
<li><p>be used for any promotional message,</p></li>
<li><p>be offensive in any language or have bad connotations,</p></li>
<li><p>be too similar to the names of other drugs (so they don’t get mixed up by health workers or patients), and finally</p></li>
<li><p>should give consideration to phonetics and the potential difficulties of pronunciation.</p></li>
</ol>
<p>So why do companies give drugs such difficult-to-pronounce names when simpler ones would be easier for everyone? Interestingly, it’s usually only the generic drug names that are difficult to pronounce; brand names tend to be simple. </p>
<p>Take, for instance, the <a href="http://au.finance.yahoo.com/news/5-best-selling-prescription-meds-210257318.html">highest-selling drug in the world</a>, the cholesterol-lowering agent <a href="http://www.lipitor.com/">Lipitor</a>. This is the drug’s brand name; its generic name is atorvastatin (a-tor-va-sta-tin), which is much harder to say. </p>
<p>While there are many factors that contribute to why a drug is given a particular name, the most important is that ultimately companies want patients to buy expensive, patented drugs rather than cheaper generics. It’s the branded drugs that make their money. </p>
<p>A simple brand name is easier for people to remember and pronounce, and more likely to be asked for at the pharmacy. If you can’t pronounce the generic name of your medicine, you’re unlikely to ask the pharmacist for it.</p>
<p>So remember, don’t just buy the brand name medicine just because it’s easy to say. Buying a generic, when it’s available, is cheaper and just as effective. Clearly, there’s a lot of profit in the right name.</p><img src="https://counter.theconversation.com/content/15416/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Nial Wheate 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>Gone are the good old days when medicines had simple, easy to pronounce names such as aspirin, paracetamol and morphine. Nowadays pharmaceutical companies almost seem to revel in giving drugs names that…Nial Wheate, Senior Lecturer in Pharmaceutical Chemistry, University of SydneyLicensed as Creative Commons – attribution, no derivatives.