tag:theconversation.com,2011:/africa/topics/vaccine-patents-104188/articlesVaccine patents – The Conversation2022-11-21T19:03:46Ztag:theconversation.com,2011:article/1949182022-11-21T19:03:46Z2022-11-21T19:03:46ZIntellectual property waiver for COVID vaccines should be expanded to include treatments and tests<p>Global inequities in access to COVID vaccines have turned out to be a “catastrophic moral failure”, just as the World Health Organization warned they would in <a href="https://www.who.int/director-general/speeches/detail/who-director-general-s-opening-remarks-at-148th-session-of-the-executive-board">January 2021</a>. Yet it took 20 months of negotiations for members of the World Trade Organization (WTO) to agree to a limited relaxation of patent rules for COVID vaccines – a move <a href="https://www.msf.org/lack-real-ip-waiver-covid-19-tools-disappointing-failure-people">decried by civil society organisations</a> as too little, too late.</p>
<p>Treatments and diagnostic tests are also very important in managing the pandemic, and like vaccines, are very unequally distributed globally. Unfortunately, negotiations to expand the WTO decision on COVID vaccine patents to include treatments and tests are in a sorry state. There is little chance of a decision by the December deadline WTO members set for themselves. </p>
<p>In the meantime, deaths and hospitalisation from COVID continue to place pressure on health-care systems.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/what-should-rich-countries-do-with-spare-masks-and-gloves-its-the-opposite-of-what-the-who-recommends-191265">What should rich countries do with spare masks and gloves? It's the opposite of what the WHO recommends</a>
</strong>
</em>
</p>
<hr>
<h2>Inequities in access</h2>
<p>By the end of 2021, more than a year after the first COVID vaccines went into arms, more than 76% of people in high- and upper-middle-income countries had received a dose, compared with <a href="https://globalizationandhealth.biomedcentral.com/articles/10.1186/s12992-022-00801-z">8.5% in low-income countries</a>. Even now, with almost 13 billion doses administered around the world, less than <a href="https://ourworldindata.org/covid-vaccinations">25% of people in low-income countries</a> have received a dose.</p>
<p>By September 2022, more than 330 COVID tests per 100,000 people were being performed daily in high-income countries, in comparison to <a href="https://www.who.int/publications/m/item/external-evaluation-of-the-access-to-covid-19-tools-accelerator-(act-a)">5.4 per 100,000 in low-income nations</a>. And of the three billion tests used globally by March 2022, only <a href="https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(22)00378-4/fulltext">0.4% were administered in low-income countries</a>.</p>
<p>Treatments are even more inequitably distributed. Most low-income countries are unable to access the new oral antivirals such as Paxlovid (made by Pfizer) and Lagevrio (Merck Sharpe & Dohme). These companies charge around <a href="https://www.reuters.com/business/healthcare-pharmaceuticals/price-covid-treatments-pfizer-merck-gsk-align-with-patient-benefits-report-2022-02-03/">US$530 and US$700</a> (A$800 and A$1,050) respectively for a five-day course of treatment in high-income markets such as the United States. </p>
<p>Pfizer has agreed to deals with UNICEF and the Global Fund to provide <a href="https://www.pfizer.com/news/press-release/press-release-detail/pfizer-supply-global-fund-6-million-paxlovidtm-treatment">10 million courses of Paxlovid</a> to lower-income countries at lower prices. But this represents a very small proportion of the treatments Pfizer is making.</p>
<p>Both Pfizer and Merck Sharpe & Dohme have established licensing agreements with the <a href="https://medicinespatentpool.org/progress-achievements/licences">Medicines Patent Pool</a>, enabling generic manufacturers to make their antiviral treatments for poorer countries in future. But they have restricted the number of countries that will be able to purchase the generic drugs to mainly low- and lower-income countries (<a href="https://news.bloomberglaw.com/health-law-and-business/pfizer-merck-pills-renew-concerns-on-covid-treatment-equity">106 and 95 respectively</a>). </p>
<p>This leaves many upper-middle income countries (such as Thailand, China and Mexico) in a difficult situation. They are unable to pay the high prices for the originator drugs but are excluded from accessing the lower-priced generics.</p>
<p>It’s clear more needs to be done to ensure all countries can access the tools they need to manage the pandemic.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/we-were-on-a-global-panel-looking-at-the-staggering-costs-of-covid-17-7m-deaths-and-counting-here-are-11-ways-to-stop-history-repeating-itself-190658">We were on a global panel looking at the staggering costs of COVID – 17.7m deaths and counting. Here are 11 ways to stop history repeating itself</a>
</strong>
</em>
</p>
<hr>
<h2>Negotiations at the WTO</h2>
<p>India and South Africa first put a proposal to the WTO in <a href="https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/IP/C/W669.pdf&Open=True">October 2020</a> to temporarily relax certain intellectual property rules in the Agreement on Trade Related Aspects of Intellectual Property Rights for COVID medical products during the pandemic.</p>
<p>The proposed waiver would have enabled companies around the world to freely produce COVID health products and technologies – vaccines, treatments, tests, and personal protective equipment (such as face masks) – without fear of litigation over possible infringements of intellectual property rights. </p>
<p>These intellectual property rights included not only patents, but copyright, trademarks and trade secrets or know-how. Specifically, know-how is often essential for manufacturing vaccines and some treatments. However, under existing rules, there are limited pathways to <a href="https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3872796">compulsorily licence know-how</a> and other confidential information.</p>
<p>The proposal eventually gained the support of more than 100 of the WTO’s 164 member countries and was sponsored by more than 60. But it faced strong opposition from wealthy countries that house multinational pharmaceutical companies, particularly the <a href="https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/msf-urges-rich-nations-to-accept-trips-waiver/articleshow/89757281.cms">European Union, United Kingdom and Switzerland</a>.</p>
<p>On June 17 2022, WTO members belatedly agreed on a <a href="https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/WT/MIN22/30.pdf&Open=True">narrow, limited waiver</a>, applying only to patents, and only to COVID vaccines in the first instance. In the end it waives only a single rule, making it easier for vaccines made using its provisions to be exported from the country of manufacture to a <a href="https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4150090">second developing country</a>. </p>
<p>While the decision applied only to vaccines, it included a clause committing the parties to decide whether to expand the waiver to include COVID treatments and tests within six months.</p>
<p>That six-month period ends on December 17. Unfortunately, the same dynamics that slowed and watered down the initial proposal threaten to prevent a timely decision this time too. The <a href="https://www.euractiv.com/section/health-consumers/news/discussions-for-waiver-on-covid-19-diagnostics-and-therapeutics-at-standstill/">EU, Switzerland, Japan and the UK</a> are particularly reluctant to allow negotiations to move forward.</p>
<p>As with the original waiver debate, many countries lack the know-how to commence domestic vaccine manufacturing, particularly for <a href="https://doi.org/10.1377/hlthaff.2020.02097">novel vaccine platforms</a>. Lack of know-how was an even greater barrier to widespread COVID vaccine manufacturing than patents. </p>
<p>Many more countries have the capacity to produce treatments, but therapeutic patents are <a href="https://www.wipo.int/publications/en/details.jsp?id=4589">more prevalent</a> than COVID vaccine patents. So, expanding the waiver to include COVID therapeutics could help countries quickly scale up domestic manufacturing of essential treatments.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/wealthy-nations-starved-the-developing-world-of-vaccines-omicron-shows-the-cost-of-this-greed-172763">Wealthy nations starved the developing world of vaccines. Omicron shows the cost of this greed</a>
</strong>
</em>
</p>
<hr>
<h2>Help where it’s needed</h2>
<p>Low and middle-income countries have been impacted disproportionately by the pandemic so far, suffering <a href="https://www.who.int/news/item/05-05-2022-14.9-million-excess-deaths-were-associated-with-the-covid-19-pandemic-in-2020-and-2021">85%</a> of the estimated 14.9 million excess deaths in 2020 and 2021. </p>
<p>Globally, progress in reducing extreme poverty was set back three to four years during 2020–21. But low-income countries lost <a href="https://documents.worldbank.org/en/publication/documents-reports/documentdetail/936001635880885713/poverty-median-incomes-and-inequality-in-2021-a-diverging-recovery">eight to nine years of progress</a>.</p>
<p>Expanding the WTO decision on COVID vaccines to include treatments and tests could be vital to reduce the health burden on poorer countries from COVID and enable them to recover from the pandemic. The Australian government should get behind this initiative and encourage other countries to do the same.</p><img src="https://counter.theconversation.com/content/194918/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Deborah Gleeson has received funding in the past from the Australian Research Council. She has received funding from various national and international non-government organisations to attend speaking engagements related to trade agreements and health. She has represented the Public Health Association of Australia on matters related to trade agreements and public health</span></em></p><p class="fine-print"><em><span>Dianne Nicol has received funding from the Australian Research Council, the Medical Research Futures Fund, the National Health and Medical Research Council (NHMRC) and the Federal Department of Health. She is chair of the NHMRC Embryo Research Licensing Committee and co-lead of the Regulatory and Ethics Work Stream of the Global Alliance for Genomics and Health</span></em></p><p class="fine-print"><em><span>James Scheibner has received funding from Health Translation SA, as well as the Swiss National Science Foundation through the Personalized Health and Related Technologies project.</span></em></p>Time is running out to expand an agreement to relax patent rules on COVID vaccines. Members of the World Trade Organization should broaden its scope to treatments and tests.Deborah Gleeson, Associate Professor in Public Health, La Trobe UniversityDianne Nicol, Emeritus Professor of Law, University of TasmaniaJames Scheibner, Lecturer in Law, Flinders UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1796422022-03-21T02:02:10Z2022-03-21T02:02:10ZWhy a leaked WTO ‘solution’ for a COVID patent waiver is unworkable and won’t make enough difference for developing countries<figure><img src="https://images.theconversation.com/files/453165/original/file-20220320-36080-1bqusvq.jpg?ixlib=rb-1.1.0&rect=34%2C103%2C5742%2C3629&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><span class="source">Aaron Chown/PA Images via Getty Images</span></span></figcaption></figure><p>There was a brief moment of euphoria last week, when it seemed that COVID-19 vaccines, medicines and supplies might be <a href="https://www.reuters.com/business/healthcare-pharmaceuticals/drugmakers-condemn-plan-covid-vaccine-patent-waiver-2022-03-16/">liberated</a> from the World Trade Organization’s intellectual property rights straitjacket and a patent waiver would make them available and affordable to the unvaccinated in the global south.</p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"1504051488363999235"}"></div></p>
<p>But on closer scrutiny, Big Pharma and their parent states have won again. </p>
<p>The leaked “<a href="http://freepdfhosting.com/4d79fc6c70.pdf">solution</a>” agreed by the informal “quad” (US, EU, India and South Africa) is insufficient, problematic and unworkable. There are too many limitations to make any significant difference and it is a far cry from the original proposal from India and South Africa that would have effectively addressed the barriers. </p>
<p>While the WTO makes decisions by consensus, it is unclear how far this deeply flawed text can, or will, be reopened when members debate it next week. Given its fraught history, it is unlikely they will agree to remedy its defects.</p>
<p>Let us recall some stark and distressing facts. Into the third year of this pandemic, <a href="https://ourworldindata.org/covid-vaccinations">only 14%</a> of people in low-income countries have been vaccinated even once. Wealthy countries like New Zealand are 90% vaccinated and on our third shots. Indeed, by the <a href="https://www.ft.com/content/5144cd19-2c67-46d0-a37d-a869006bfbdb">end of last year</a>, more boosters had been given in high-income countries than total doses in low-income ones.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/the-big-barriers-to-global-vaccination-patent-rights-national-self-interest-and-the-wealth-gap-153443">The big barriers to global vaccination: patent rights, national self-interest and the wealth gap</a>
</strong>
</em>
</p>
<hr>
<p>A second stark and disturbing fact: in November last year the <a href="https://www.oxfam.org.nz/news-media/pfizer-biontech-and-moderna-making-us1000-profit-every-second/">People’s Vaccine Alliance</a> reported that Pfizer, BioNTech and Moderna, the companies behind two of the most successful COVID-19 vaccines, were together making US$65,000 (NZ$92,000) every minute. </p>
<p>They had received more than US$8 billion in public funding to develop the lucrative COVID-19 vaccines. Pfizer and BioNTech had delivered less than 1% of their total vaccine supplies to low-income countries, while Moderna has delivered just 0.2%.</p>
<h2>Pharma’s profits and property rights before right to life</h2>
<p>An important guarantor of pharmaceutical companies’ profits is a little-known trade agreement, the Agreement on Trade-related Intellectual Property Rights (<a href="https://www.wto.org/english/docs_e/legal_e/31bis_trips_01_e.htm">TRIPS</a>). </p>
<p>During negotiations to form the WTO during the early 1990s, the US had demanded strong protections for its corporations’ intellectual property rights as the price for agreeing to discuss genuine trade issues such as subsidised agriculture. The WTO’s members, aside from the least developed countries, have to implement these rules in their domestic laws.</p>
<p>The significance of the TRIPS was exposed in the late 1990s when pharmaceutical giants <a href="https://oxfamilibrary.openrepository.com/bitstream/handle/10546/620381/bn-access-to-medicines-south-africa-010201-en.pdf?sequence=1&isAllowed=y">threatened legal action</a> against South Africa and Brazil for producing generic versions of patented HIV-AIDS anti-retroviral medicines. </p>
<p>A global name-and-shame campaign led them to back down and saw a <a href="https://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.htm">Declaration on TRIPS and Public Health</a> adopted at the WTO ministerial conference in 2001. That <a href="https://unu.edu/publications/articles/south-south-cooperation-intellectual-property-and-aids-medicines.html#info">compromise</a> was a forerunner of the COVID-19 scenario. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/wealthy-nations-starved-the-developing-world-of-vaccines-omicron-shows-the-cost-of-this-greed-172763">Wealthy nations starved the developing world of vaccines. Omicron shows the cost of this greed</a>
</strong>
</em>
</p>
<hr>
<p>To date, only <a href="https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3778945">one country</a>, Rwanda (which belongs to the group of least developed countries), has been able to jump the <a href="https://www1.undp.org/content/dam/aplaws/publication/en/publications/hiv-aids/the-trips-agreement-and-access-to-arvs/5.pdf">hurdles</a> and import pharmaceuticals under the amendment to TRIPS.</p>
<h2>Tentative deal limited to vaccines only</h2>
<p>Two decades later, in October 2020, South Africa and India led moves for a TRIPS waiver for COVID-19 vaccines, medicines, test kits and other supplies. Despite another global campaign, which included <a href="https://thespinoff.co.nz/society/29-01-2021/open-letter-ardern-vaccine">New Zealand</a> public health advocates, unions, churches and development agencies, the European Union, Switzerland and UK blocked the waiver every step of the way. </p>
<p>The <a href="https://ustr.gov/about-us/policy-offices/press-office/press-releases/2021/may/statement-ambassador-katherine-tai-covid-19-trips-waiver">Biden administration</a> shifted its position in May 2021 to support negotiations for a waiver, but limited it to vaccines. That announcement brought a fence-sitting <a href="https://www.beehive.govt.nz/release/nz-backs-moves-improve-global-access-covid-vaccines">New Zealand on board</a>.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/us-support-for-waiving-covid-19-vaccine-patent-rights-puts-pressure-on-drugmakers-but-what-would-a-waiver-actually-look-like-160582">US support for waiving COVID-19 vaccine patent rights puts pressure on drugmakers – but what would a waiver actually look like?</a>
</strong>
</em>
</p>
<hr>
<p>The proposal remained stuck for 18 months. Some richer countries demanded completely unrelated trade-offs to advance their commercial objectives, while the hard core refused to budge. Last December, the talks moved to a new phase where the “quad” of key WTO members tried to broker a deal.</p>
<p>When that tentative deal was announced last week and the <a href="http://freepdfhosting.com/4d79fc6c70.pdf">text was leaked</a>, the euphoria quickly subsided. </p>
<p>The text applies only to patents on vaccines, and only for COVID-19, which means a similarly fraught process would be required for future pandemics. WTO members will decide in six months whether to extend it to medicines, diagnostics and therapeutics, as South Africa and India had proposed. Realistically, that won’t happen.</p>
<h2>Odds continue to be stacked against poorer countries</h2>
<p>Beyond these limitations, there is no guarantee that governments can access the “recipe” for all currently patented vaccines, let alone second-generation vaccines still applying for patents, or the technology needed to produce them.</p>
<p>There are many legal uncertainties. A WTO member state can authorise “use of patented subject matter” that is otherwise protected under TRIPS Article 28.1 “to the extent necessary to address the COVID-19 pandemic”. </p>
<p>When does COVID-19 cease being a pandemic, who decides, and what happens when COVID-19 is just endemic? Which uses of patented subject matter will be considered “necessary” (a restrictive concept in trade law) and which go too far? The text still allows those matters to be taken to a dispute.</p>
<p>The odds are stacked further against poorer countries. Eligibility is limited to WTO developing countries that exported less than 10% of the world’s vaccines in 2021. That means China and non-WTO countries are excluded, as are countries like Brazil that recently surrendered their developing country status. </p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"1504885847924961281"}"></div></p>
<p>Coverage of least developed countries is unclear. And the complex and burdensome notification and compliance requirements are likely to be as unworkable as the previous TRIPS waiver.</p>
<p>Four things remain to be seen. First, will the deal actually be gavelled through without debate and amendment in another travesty of the WTO’s consensus process?</p>
<p>Second, what trade-offs will richer countries demand in return for their support?</p>
<p>Third, will this be the end of moves to set aside TRIPS rules, even temporarily, to secure genuine access to life-saving COVID medicines, vaccines and medical supplies for the majority of the world’s people in the developing world once the immediate COVID-19 crisis has subsided?</p>
<p>And will the New Zealand and Australian governments be complicit in this happening?</p><img src="https://counter.theconversation.com/content/179642/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Jane Kelsey 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>Only 14% of people in poorer countries have received one vaccine dose, but a leaked WTO ‘solution’ to waive patents fails to ensure developing countries can access life-saving vaccines and medicines.Jane Kelsey, Professor of Law, University of Auckland, Waipapa Taumata RauLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1732982022-02-14T18:13:29Z2022-02-14T18:13:29ZHow the intellectual property monopoly has impeded an effective response to Covid-19<p>In an interconnected world, a pandemic can be overcome only when it is overcome everywhere – no one is safe until everyone is safe. Vaccination delays and supply shortages in protective equipment and treatments increase the possibility of the virus mutating. This undermines our ability to control the pandemic, even in highly vaccinated countries. And yet two years into the pandemic, vaccine doses are highly concentrated in rich countries.</p>
<p>As of <a href="https://webassets.oxfamamerica.org/media/documents/A_Dose_of_Reality-Briefing_Note_kOW1yUs.pdf">October 2021</a>, only 0.7% of all manufactured vaccine doses had gone to low-income countries. Manufacturers had delivered 47 times as many doses to high-income countries as they had to low-income countries.</p>
<p>Since its inception, <a href="https://www.who.int/initiatives/act-accelerator/covax">COVAX</a>, the UN-backed initiative dedicated to promoting access to Covid vaccines, has struggled to obtain doses. It recently passed the <a href="https://www.reuters.com/world/global-vaccine-sharing-programme-reaches-milestone-1-billion-doses-2022-01-15/">1 billion doses delivered</a> – half way to its goal of delivering 2 billion doses by the end of 2021. Indeed, AstraZeneca, Pfizer/BioNTech, Moderna, and Johnson & Johnson <a href="https://webassets.oxfamamerica.org/media/documents/A_Dose_of_Reality-Briefing_Note_kOW1yUs.pdf">have delivered</a> between 0% and 39% of their already inadequate commitments to COVAX in 2021.</p>
<p>The <a href="https://globalcommissionforpostpandemicpolicy.org/home/vaccine-countdown/">Global Commission for Post-Pandemic Policy</a>, meanwhile, estimates that while Asia and Europe will be able to fully vaccinate 80% of their populations by March 2022 and North America by May 2022, Africa will not reach 80% at current rates until April 2025.</p>
<h2>Intellectual monopoly capitalism</h2>
<p>The unequal distribution of vaccines is partly due to insufficient production. This <a href="https://www.project-syndicate.org/onpoint/big-pharma-blocking-wto-waiver-to-produce-more-covid-vaccines-by-joseph-e-stiglitz-and-lori-wallach-2021-05">scarcity of supply</a> is due to intellectual property rights, which give pharmaceutical companies a monopoly on production and exclusive rights to license their technology to other companies.</p>
<p>India and South Africa, co-sponsored by more than 100 other countries, initiated a campaign in the World Trade Organization to <a href="https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/IP/C/W669.pdf&Open=True">waive intellectual property rights</a> to ensure the necessary production of vaccines, PPE, diagnostics, ventilators and medication. A waiver would ensure necessary production by allowing companies to produce Covid-related products.</p>
<p>Six months later, the United States surprisingly <a href="https://www.nature.com/articles/d41586-021-01224-3">supported the waiver for vaccines</a>, but not for other medical materials as advanced by the patent waiver initiative. Yet to date, Washington has not employed its political clout to apply the waiver globally, and Europe has refused the initiative.</p>
<p>Curiously, Brussels <a href="https://trade.ec.europa.eu/doclib/docs/2021/june/tradoc_159606.pdf">proposes</a> to use the very flexibilities of Trade-Related Aspects of Intellectual Property Rights agreement (<a href="https://en.wikipedia.org/wiki/TRIPS_Agreement">TRIPS</a>), that it resisted and even undermined through its trade agreements. As Nobel Prize–winning economist Joseph Stiglitz <a href="https://www.project-syndicate.org/onpoint/big-pharma-blocking-wto-waiver-to-produce-more-covid-vaccines-by-joseph-e-stiglitz-and-lori-wallach-2021-05">argues</a> these flexibilities are not helpful.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/441560/original/file-20220119-27-100zcjl.png?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Map showing the share of people who received at least one dose of Covid-19 vaccine, Jan 18, 2022" src="https://images.theconversation.com/files/441560/original/file-20220119-27-100zcjl.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/441560/original/file-20220119-27-100zcjl.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=424&fit=crop&dpr=1 600w, https://images.theconversation.com/files/441560/original/file-20220119-27-100zcjl.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=424&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/441560/original/file-20220119-27-100zcjl.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=424&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/441560/original/file-20220119-27-100zcjl.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=532&fit=crop&dpr=1 754w, https://images.theconversation.com/files/441560/original/file-20220119-27-100zcjl.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=532&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/441560/original/file-20220119-27-100zcjl.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=532&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"><a class="source" href="https://ourworldindata.org/covid-vaccinations">Our World in Data</a>, <a class="license" href="http://creativecommons.org/licenses/by/4.0/">CC BY</a></span>
</figcaption>
</figure>
<p>Intellectual property rights are political creature as they profit specific social interests and were <a href="https://books.google.fr/books?id=B81qmONSs9cC&lpg=PR10">lobbied</a> for by them, especially the pharmaceutical, agrochemical, entertainment and media industries.</p>
<p>The signature of what is known as the TRIPS agreement at the World Trade Organization in 1994 was a <a href="https://www.tandfonline.com/doi/abs/10.1080/14649880120067293">historic turning point</a> for intellectual property rights, and is today exacerbated by more stringent <a href="https://ageconsearch.umn.edu/record/15577?ln=en">US</a> and <a href="https://link.springer.com/chapter/10.1007/978-3-642-39097-5_13">EU</a> bilateral trade agreements.</p>
<p>These were key steps in the enforcement of <a href="https://academic.oup.com/cje/article-abstract/38/6/1409/2875367?redirectedFrom=fulltext">“intellectual monopoly capitalism”</a> which has transformed a world mainly based on open science into a world of closed science, and led to the concentration of knowledge into a few hands to an unprecedented degree.</p>
<p>The legal monopoly over knowledge, which extends well beyond national boundaries, enables owners of intellectual property rights (IPR) to exclude others from using new inventions, reduce competitive supply and increase prices. The control of IPRs is a central element in <a href="https://www.tandfonline.com/doi/abs/10.1080/00213624.2017.1320916">transnational corporation strategies</a> of accumulating intangible assets to extract absolute rents.</p>
<p>In an increasingly <a href="https://www.sciencedirect.com/science/article/abs/pii/S0277953620303154">financialised health sector</a>, where the priority is to increase profits for creditors and shareholders, the accumulation of a portfolio of intellectual property rights <a href="https://onlinelibrary.wiley.com/doi/full/10.1111/1758-5899.12911">allows</a> for the extraction of monopoly profits.</p>
<p>In 2019, investment management corporations such as BlackRock, Vanguard, and State Street were the <a href="https://www.sciencedirect.com/science/article/abs/pii/S0277953620303154">majority shareholders</a> in firms involved in vaccine development including Pfizer (75.1%) and Johnson & Johnson (68.1%). This is problematic, as research shows that a key determinant of innovation in the health sector could become <a href="https://academic.oup.com/spp/article-abstract/43/3/375/2363402">generating returns on investment</a>, not protecting health.</p>
<p>Therefore, some economist argues that the global economic system is <a href="https://www.tandfonline.com/doi/full/10.1080/09692290.2019.1659842">“structurally pathogenic”</a>, with negative rather than positive impacts on human health.</p>
<h2>The public pays twice</h2>
<p>A <a href="https://webassets.oxfamamerica.org/media/documents/The_Great_Vaccine_Robbery_Policy_Brief.pdf">July 2021 analysis</a> by the <a href="https://peoplesvaccine.org/">People’s Vaccine Alliance</a> shows that
Pfizer/BioNTech and Moderna are charging governments as much as 41 billion US dollars above the estimated cost of production for vaccines. The EU, meanwhile, may have paid 31 billion euros more than the estimated cost for its mRNA doses.</p>
<p>The same analysis shows that countries are generally paying between 4 and 24 times more than they could be for Covid-19 vaccines. But a recent <a href="https://www.citizen.org/article/how-to-make-enough-vaccine-for-the-world-in-one-year/">report</a> by the consumer advocacy group Public Citizen suggests that setting up regional hubs to manufacture 8 billion doses in one year would cost about $23 billion for the Moderna vaccine, and $9.4 billion for the Pfizer/BioNTech vaccine.</p>
<p>Put simply, without intellectual property monopolies, the money already spent by COVAX would have been enough to fully vaccinate the entire population of low-income and middle-income countries.</p>
<p>Moreover, citizens are paying the pharmaceutical industry twice: first because they are paying monopoly profit, and second because vaccines were developed with <a href="https://www.theindiaforum.in/article/political-economy-covid-19-vaccines">public funding</a> through large subsidies for research and development, and through public pre-orders of vaccines.</p>
<h2>Adverse effects of IPR on innovation</h2>
<p>The proponents of tight intellectual property rights argue that in their absence, inventions would be accessible to third parties without ensuring enough compensation for inventors, thus discouraging investment in innovation. But Joseph Stiglitz argues that there is <a href="https://oxford.universitypressscholarship.com/view/10.1093/acprof:oso/9780199660759.001.0001/acprof-9780199660759-chapter-1">no evidence supporting this mainstream view</a>.</p>
<p>Indeed, intellectual property rights establish distorted incentives to create market power. Monopolists use their power to block innovators who endanger their dominant position, and try to maintain their position by getting only a little bit ahead of their rivals – which has an adverse effect on innovation.</p>
<p>This became clear during the Covid-19 pandemic. <em>The New York Times</em> <a href="https://www.nytimes.com/2020/03/29/business/coronavirus-us-ventilator-shortage.html">reported</a> suspicions that one company, Covidien, had acquired another, Newport, to “prevent it from building cheaper products that would undermine Covidien’s profits from its existing ventilator business”, despite the fact that the Newport ventilator was developed with <a href="https://www.ineteconomics.org/uploads/papers/WP_127-Lazonick-and-Hopkins.pdf">public funding</a>.</p>
<p>As knowledge has been subdivided into separate property claims, we have seen the rise of <a href="https://www.nber.org/system/files/chapters/c10778/c10778.pdf">patent thickets</a> – dense webs of overlapping intellectual property rights claims that a company must use to actually commercialise a new invention. In this context, greater intellectual property rights lead to <a href="https://www.science.org/doi/10.1126/science.280.5364.698">fewer useful health products</a>.</p>
<p>A <a href="https://www.nature.com/articles/s41587-021-00912-9">recent article</a> showed that while key technological advancements for mRNA vaccines were invented in several academic labs or small biotech companies and then licensed to larger companies, the intellectual property rights owned by or assigned to those larger companies may impede future development of the technology.</p>
<h2>Intellectual property capitalism, growth and social polarisation</h2>
<p>Tight intellectual property rights are also counterproductive from a broader economic perspective. Several economists argue that intellectual monopoly capitalism <a href="https://academic.oup.com/cje/article-abstract/38/6/1409/2875367?redirectedFrom=fulltext">produces economic crisis</a> and stagnation. American scholar <a href="https://www.tandfonline.com/doi/abs/10.1080/09692290.2021.1918745?journalCode=rrip20">H Mark Schwartz</a> has demonstrated that firms based on intellectual property rights have a lower marginal propensity to invest.</p>
<p>The monopolisation of socially produced knowledge by intellectual property rights produces hierarchical relations among firms and between capital and labour, <a href="https://journals.sagepub.com/doi/abs/10.1177/1024529420968221">exacerbating</a> inequality and creating a situation where a handful of firms capture the lion’s share of global profits.</p>
<p>It should be noted that IPRs have exacerbated structural global polarisation. While production takes place in the South in exchange for poor wages and accompanied by environmental degradation, transnational corporations whose headquarters are mostly in the North (or in tax havens) <a href="https://www.tandfonline.com/doi/abs/10.1080/00213624.2017.1320916">extract monopoly rent</a> through IPRs out of value-added that is created in the South. What is <a href="https://unctad.org/system/files/official-document/tdr2018ch3_en.pdf">new</a> this time is that some historically technologically-advanced Western European countries have been locked out of the “fourth industrial revolution” – advancing information and communication technologies – partially due to IPRs.</p>
<p>Finally, there exists <a href="https://oxford.universitypressscholarship.com/view/10.1093/acprof:oso/9780199698547.001.0001/acprof-9780199698547-chapter-10">other mechanisms, including prizes and government supported research</a>, that reward invention and disseminate knowledge while avoiding the creation of monopoly power.</p><img src="https://counter.theconversation.com/content/173298/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Salam Alshareef ne travaille pas, ne conseille pas, ne possède pas de parts, ne reçoit pas de fonds d'une organisation qui pourrait tirer profit de cet article, et n'a déclaré aucune autre affiliation que son organisme de recherche.</span></em></p>From vaccines to treatments and even medical equipment, intellectual property rights have hampered the world’s efforts to fight the pandemic.Salam Alshareef, Enseignant-chercheur postdoctoral - Chaire Paix Economique, Grenoble École de Management (GEM)Licensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1605022021-05-07T16:37:07Z2021-05-07T16:37:07ZTRIPS waiver: there’s more to the story than vaccine patents<p>The US has <a href="https://ustr.gov/about-us/policy-offices/press-office/press-releases/2021/may/statement-ambassador-katherine-tai-covid-19-trips-waiver">announced its limited support</a> for the “Trips waiver”, a proposal to suspend intellectual property protections for products and technologies needed for the fight against COVID-19, including vaccines, for the duration of the pandemic.</p>
<p>This would involve a temporary suspension of certain rules set out in the Trips agreement, the intellectual property treaty of the World Trade Organization (WTO). </p>
<p>The waiver was first proposed by India and South Africa – two countries with robust generic pharmaceutical manufacturing capacity – in <a href="https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/IP/C/W669.pdf&Open=True">October 2020</a> as one important tool to address availability of COVID-19 vaccines, diagnostic tools and therapeutic treatments. </p>
<p>For seven months, the proposal has made little progress due to <a href="https://datawrapper.dwcdn.net/0izqI/3/">opposition</a> from the US, the EU, Switzerland, the UK, Japan and others. </p>
<p>The surprise announcement garnered a positive response in many quarters, and was soon echoed worldwide, with the <a href="https://www.reuters.com/world/europe/eu-willing-discuss-covid-19-vaccine-patent-waiver-eus-von-der-leyen-2021-05-06/">EU</a>, <a href="https://www.stuff.co.nz/national/health/coronavirus/125048729/new-zealand-to-support-effort-to-waive-covid19-vaccine-patents-after-united-states-backs-wto-bid">New Zealand</a> and <a href="https://www.devdiscourse.com/article/politics/1562740-macron-backs-waiving-ip-rights-for-covid-19-vaccines">France</a> expressing more willingness to negotiate.</p>
<p>Yet the US is the centre of attention because its statement is such a big departure from its previous antagonism towards other countries’ public health measures that affect intellectual property rights. For example in 1996, it threatened <a href="https://www.nytimes.com/2001/06/26/world/us-drops-case-over-aids-drugs-in-brazil.html">to impose sanctions</a> on Brazil for reforming patent laws to improve access to AIDS medication. </p>
<p>Given this history, and intense <a href="https://theintercept.com/2021/04/23/covid-vaccine-ip-waiver-lobbying/">lobbying from the pharmaceutical sector</a>, the US support for the Trips waiver was for many a <a href="https://www.nature.com/articles/d41586-021-01224-3">welcome surprise</a>.</p>
<h2>Narrow scope</h2>
<p>Support for the waiver, and the <a href="https://ustr.gov/sites/default/files/files/reports/2021/2021%20Special%20301%20Report%20(final).pdf">latest US Trade Representative report</a> indicating that the US will respect the right to grant compulsory licenses consistent with the the Trips agreement, may give all trading partners, not just developing countries, the confidence to boldly use those powers to improve the supply of COVID-19 vaccines without fear of trade retaliation.</p>
<p>But aspects of the US announcement are more narrow in scope than the original proposal. </p>
<p>The initial proposal would cover all technologies for the detection, prevention, treatment and response to COVID-19, while the US statement limits its support for waiving intellectual property rights in <a href="https://medicineslawandpolicy.org/2021/05/us-supports-the-covid-19-trips-waiver-for-vaccines-now-technology-sharing-must-become-a-reality/">vaccines only</a>. While vaccines are the centre of attention right now, the broader proposal would address the limited supply of therapeutics, <a href="https://msfaccess.org/sites/default/files/2020-11/COVID_Brief_WTO_WaiverProposal_ENG_v2_18Nov2020.pdf">like Baricitinib or Redemsivir</a>, or diagnostics, <a href="https://www.spotlightnsp.co.za/2020/05/05/covid-19-behind-sas-shortages-of-test-materials/">like reagents for COVID test kits</a>. </p>
<p>Nevertheless, the US support could help bring the Trips waiver to the next stage of “text-based negotiations”. There is now hope that <a href="https://www.msf.org/countries-obstructing-covid-19-patent-waiver-must-allow-negotiations">formal negotiations</a> can start addressing outstanding issues, such as how long the waiver would last, and whether anything more than vaccines may be covered.</p>
<h2>Beyond patents</h2>
<p>As the Trips waiver gained public attention, many have referred to the measure as a “patent waiver”.</p>
<p>This has obscured other intellectual property rights which are included in the original proposed Trips waiver: copyright, trade secrets, and designs – not just patents.</p>
<p>Patents certainly deserve a lot of attention: the manufacturing and supply of one product, especially complex biologics like COVID-19 vaccines, is often governed by <a href="https://www.nature.com/articles/d41573-020-00119-8">multiple patents, which may be owned by different entities</a>. </p>
<p>But trade secrets, which protect different kinds of exclusive information, including data gathered during the regulatory approval process, and tacit know-how are also essential for manufacturing and producing vaccines.</p>
<p>Providing incentives to share or reveal trade secrets, information covered by non-disclosure agreements, as well as regulatory submissions, such as clinical trial data, would not only spur competition. It would also provide the basis for further innovation. </p>
<p>This was seen in the case of <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3110116/">Shantha Biotechnic’s development of a hepatitis B vaccine</a> for Indian domestic supply, which used yeast instead of the traditional bacterial system, allowing production of a low-cost Indian vaccine which went on to become the mainstay of a global vaccination drive led by Unicef.</p>
<p>Some of the COVID-19 vaccines on offer – those developed by BioNTech and Moderna – use mRNA, a relatively novel technology that has only recently been <a href="https://www.politico.com/news/agenda/2021/03/02/us-coronavirus-variants-471981">produced in large numbers</a>. Many countries may not yet have the means or know-how to produce them domestically. The WHO has set up a <a href="https://www.who.int/news-room/articles-detail/establishment-of-a-covid-19-mrna-vaccine-technology-transfer-hub-to-scale-up-global-manufacturing">mRNA technology transfer hub</a> to provide a mechanism to share the technology globally, but none of the current vaccine manufacturers have yet offered their help or expertise to this initiative.</p>
<h2>Sharing knowledge</h2>
<p>By covering multiple types of intellectual property in a global measure, the Trips waiver as originally proposed would provide more freedom to operate for manufacturers and suppliers and to do so in a speedy manner. </p>
<p>Companies in many different countries could use the shared knowledge without the need to negotiate country-by-country and product-by-product licence agreements. This would diversify locations of production. It is hoped and expected that the prospect of a waiver will spur efforts to persuade pharmaceutical companies to enter into more voluntary arrangements and non-exclusive licensing to enable the transfer of technology in a controlled and transparent way.</p>
<p>To end the pandemic, we need a number of different strategies to share around the benefits of existing COVID vaccines, treatments and tests, as well as enable further innovation from multiple sites. </p>
<p>Wealthy countries need to reverse their <a href="https://www.theguardian.com/commentisfree/2021/mar/17/rich-countries-hoarding-vaccines-us-eu-africa">over-ordering of doses</a>, export restrictions should be lifted to increase production, and data from regulatory approval processes should be made accessible. Governments should oblige companies, paying them where necessary, to enter into voluntary transfers of their know-how, share trade secrets and other undisclosed information.</p>
<p>The Trips waiver is a masthead for all of these things to happen simultaneously and urgently now.</p><img src="https://counter.theconversation.com/content/160502/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Jocelyn Bosse has previously received funding from the Australian Research Council (ARC) as a member of the ARC Laureate Project, 'Harnessing Intellectual Property to Build Food Security.'</span></em></p><p class="fine-print"><em><span>Dr Hyo Yoon Kang receives funding from the European Research Council project 'Patents as Scientific Information'. </span></em></p><p class="fine-print"><em><span>Siva Thambisetty has received funding from the EPSRC, EU Horizon 2020 and holds an LSE Knowledge Exchange and Impact grant. </span></em></p>The US has backed a proposal to waive intellectual property relating to COVID measures – but global efforts need to go beyond vaccine patents.Jocelyn Bosse, Lecturer in Intellectual Property Law, University of ReadingHyo Yoon Kang, Reader in Intellectual Property Law, University of KentSiva Thambisetty, Associate Professor of Intellectual Property Law, London School of Economics and Political ScienceLicensed as Creative Commons – attribution, no derivatives.