TEMPORARY WAIVER OF MEDICAL PATENTS — A NECESSARY EVIL IN THE FIGHT AGAINST COVID-19?
The modern laws on Intellectual Property (IP) have their underpinnings in several legal theories and philosophies. The very idea of patenting a product — granting the sole legal right to the inventor of a product to exclude others from making, using or selling the product — is engrained in the need to spur innovation by providing an incentive for creativity.
This is particularly grounded in the intellectual property theory of utilitarianism which views IP rights from the point of view of society rather than the individual inventor and justifies the rights as an incentive for social and technological progress.[1] American law especially favours this theory as a basis for its protection of intellectual property rights. For example, Article I, section 8, clause 8 of the United States Constitution empowers Congress “to promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries.”
It appeals to common logic that inventors are encouraged by the guarantee that their efforts will be rewarded. In short, utilitarianism justifies intellectual rights because of the profit they bring for the whole society.[2] In a way, it kills two birds with a single stone. The inventor’s work is rewarded and the reward or anticipated reward is sufficient incentive for further inventions.
However, what happens when the greater good requires an urgency that production by patent holders cannot match?
The Coronavirus was acknowledged as a worldwide pandemic on 11th March 2020.[3] In just over a year and three months, globally, as of 1:28 pm CEST, 7 June 2021, there have been 172,956,039 confirmed cases of COVID-19, including 3,726,466 deaths, reported to the World Health Organization (WHO). As of 5 June 2021, a total of 1,900,955,505 vaccine doses have been administered.[4] The number of vaccine doses is literally a drop in the ocean when one considers that the world population is at least 7.5 billion.[5]
A prevailing suggestion and the subject of protests[6] has been to waive patents on covid-19 vaccines. On 8 October 2020, Moderna, a patent holder for a Covid-19 vaccine, released a statement that it was not going to enforce its IP rights during the pandemic.[7] In the same month, India and South Africa brought an initiative to the World Trade Organization (WTO) calling for a temporary waiver for patents on all products that could be useful in curbing the pandemic.[8] They have been joined by as many as 63 developing countries as well as United States, China, Ukraine and New Zealand in their call. A waiver if agreed upon will affect not just the vaccines but tests, medical equipment and possible treatments.
It must be noted that the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement)[9] in Article 31 allows member countries to issue compulsory licenses for the production of patented products without the patent holder’s authorisation. So there is clearly a framework for waiving patents that Member countries of the WTO may freely exploit. Countries like Israel, Chile and Ecuador have issued compulsory licenses in this regard.[10]
However, the TRIPS Agreement also provides several conditions for such use. The person or company applying for a licence has to have tried, within a reasonable period of time, to negotiate a voluntary licence with the patent holder on reasonable commercial terms. Only if that fails can a compulsory licence be issued. However, in cases of “national emergencies”, “other circumstances of extreme urgency,” “public non-commercial use” (or “government use”) or in the context of anti-competitive practices, a voluntary license need not be first sought. Even when a compulsory licence has been issued, the patent owner has to receive payment. The TRIPS Agreement says “the right holder shall be paid adequate remuneration in the circumstances of each case, taking into account the economic value of the authorization”, but it does not define “adequate remuneration” or “economic value”.
Also, the scope and duration of the licence must be limited to the purpose for which it was granted, and the grant must be non-exclusive. In addition, the legal validity of any grant of the compulsory license, including decisions relating to the remuneration of the patent holder, is to be subject to judicial review or other independent review by a distinct higher authority in the Member State.
The conditions are clearly quite restrictive which is not unexpected. Thus, any waiver under these provisions will not be so suited to purpose in a case of a pandemic. Moreso, because of the global nature of the Covid-19 pandemic, global action is much more fitting. Also, a factor that cannot be ignored is the fate of low-income countries. The provisions of the TRIPS still require that the patent holder be remunerated which might not be affordable for developing countries.
While many who opposed the patent waiver — notably the United States[11] and the Gates Foundation[12] — have made u-turns, many arguments have been made against a waiver chiefly that a patent waiver will not increase production and that it would disincentivise innovation.
This, it must be said, is ignoring the clear backdrop — that we are still in a pandemic and lives are still being avoidably lost daily. Laws are made for man and not man for laws. Where a law, no matter how honoured the principle it is based on, does not serve the people whose interests it should protect, then inroads must be made around it. The competing interests are apparent — the need for the inventors or patent holders to be financially remunerated and the need for lives to be saved. The scale certainly weighs in favour of the latter.
While it has been noted in the past in relation to the lack of availability to HIV/AIDS medicine in South Africa that lack of financing and not the patent system is the problem,[13] such remarks ignore the reality of the increased cost of drugs and treatment that is a direct effect of the largely unfettered powers in the hands of patent holders.[14] Especially in such a relatively novel situation as a worldwide pandemic, it is maintained that a lack of financing cannot be divorced from the patent system. For instance, the European Union has agreed to pay 15.50 euros ($18.90) per dose for the Covid-19 vaccine developed by Pfizer and BioNTech.[15] The countries that can afford this are indisputably high-income countries. This accounts for why of the 225 million vaccine doses that had been administered as of 7 March 2021, the vast majority was in a handful of rich and vaccine producing countries, while most low- and middle-income countries remain largely unvaccinated.[16]
As important as patents are, their disadvantage in limiting production and key access to lifesaving medical supplies in the past, means that another look should be given to them especially in a global pandemic. Be it waivers, deferred remuneration of patent holders, technology transfers, or the current compulsory licensing system under the TRIPS, something has to give. Patents ought not to be inalienable rights if people’s lives are to remain a priority. A consensus desperately needs to be made at the WTO level where talks are ongoing about a possible waiver. In the words of Dr. Tedros Adhanom Ghebreyesus, Director-General of the World Health Organization (WHO), “We need equal access to life-saving tools everywhere, if we are to end the #COVID19 pandemic. If a temporary waiver to patents cannot be issued now, during these unprecedented times, when will be the right time? Solidarity is the only way out. #VaccinEquity”[17]
[1] ‘Utilitarianism’, Black’s Law Dictionary (9th edn Thomson Reuters 2009)
[2] Law Right, Intellectual property theories: are they fairly justified?, < https://www.law-right.com/intellectual-property-theories-are-they-fairly-justified/> Accessed 8 June 2021
[3] World Health Organization, WHO Director-General’s opening remarks at the media briefing on COVID-19–11 March 2020, 11 March 2020. <https://www.who.int/dg/speeches/detail/who-director-general-s-opening-remarks-at-the-media-briefing-on-covid-19---11-march-2020> accessed 7 June, 2021
[4] WHO Coronavirus (COVID-19) Dashboard, https://covid19.who.int/ accessed on 7 June 2021
[5] The World Bank, A changing world population, 8 October 2018, <https://datatopics.worldbank.org/world-development-indicators/stories/a-changing-world-population.html#:~:text=The%20world%20population%20has%20increased,1960%20to%207.5%20billion%20today> accessed 8 June 2021
[6] Denise Balibouse, ‘Waive COVID vaccine patents to benefit poor nations, activists say,’ Reuters (Geneva, 4 March 2021) <https://www.google.com/amp/s/mobile.reuters.com/article/amp/idUSKBN2AW1VO> accessed on 7 June 2021
[7] Morderna, Statement by Moderna on Intellectual Property Matters during the COVID-19 Pandemic, 8 October 2020. <https://investors.modernatx.com/news-releases/news-release-details/statement-moderna-intellectual-property-matters-during-covid-19>
[8] Jamil Chade, “WHO aims to boost global vaccine production, but no agreement on patents,’ Swiss Info (Geneva, 7 June 2021) <https://www.swissinfo.ch/eng/who-aims-to-boost-global-vaccine-production--but-no-agreement-on-patents/46677640> accessed on 7 June 2021
[9] All 164 Member countries of the World Trade Organisation are signatories to it — <https://www.wto.org/english/thewto_e/whatis_e/tif_e/org6_e.htm> accessed on 7 June 2021
[10] Andrew Green, ‘COVID-19: Countries race to strengthen compulsory licensing legislation,’ Devex (Berlin, 30 June 2020) <https://www.devex.com/news/covid-19-countries-race-to-strengthen-compulsory-licensing-legislation-97595> accessed 7 June 2021
[11] ‘US U-turn on COVID-19 patent waivers heaps pressure on European Union ahead of India meeting,’ Times Now Digital (7 May 2021) <https://www.timesnownews.com/international/article/us-u-turn-on-covid-19-patent-waivers-heaps-pressure-on-european-union-ahead-of-india-meeting/754014> accessed 8 June 2021
[12] Catherine Cheney, ‘Gates Foundation reverses course on COVID-19 vaccine patents,’ Devex (7 May 2021)
<https://www.devex.com/news/gates-foundation-reverses-course-on-covid-19-vaccine-patents-99810> accessed 8 June 2021
[13] International Intellectual Property Institute, Patent Protection And Access To HIV/AIDS Pharmaceuticals In Sub-Saharan Africa, 2000, <https://www.wipo.int/export/sites/www/about-ip/en/studies/pdf/iipi_hiv.pdf> accessed on 7 June 2021
[14] ‘t Hoen, E.F.M., Kujinga, T. & Boulet, P. ‘Patent challenges in the procurement and supply of generic new essential medicines and lessons from HIV in the southern African development community (SADC) region’ J of Pharm Policy and Pract 11, 31 (2018). <https://doi.org/10.1186/s40545-018-0157-7> accessed 7 June 2021
[15] Nasos Koukakis, ‘Countries worldwide look to acquire the intellectual property rights of Covid-19 vaccine makers,’ CNBC (22 Jan 2021) <https://www.cnbc.com/2021/01/22/countries-look-to-acquire-the-ip-of-vaccine-makers-to-fight-pandemic.html> accessed 7 June 2021.
[16] Dr. Tedros Adhanom Ghebreyesus, ‘Waive Covid vaccine patents to put world on war footing,’ World Health Organization (7 March 2021) <https://www.who.int/news-room/commentaries/detail/waive-covid-vaccine-patents-to-put-world-on-war-footing> accessed 7 June 2021
[17] https://twitter.com/DrTedros/status/1367428637314670606?s=19 Accessed 7 June 2021
