Introduction
The World Trade Organization was supposed to meet a few weeks back, but the meeting was called off due to the travel restrictions imposed due to the overlying threat of the Omicron variant. The main agenda of the meeting was to deal with the proposal to temporarily waive intellectual property rights on pandemic-related pharmaceuticals during the pandemic to allow underdeveloped and developing countries to come at par with the vaccination drive of developed countries.
The proposal proposed by South Africa and India to waive the IP rights on Covid-19 related medical products last year was revised so that the deal could be struck soon.[1] Today, even after one year of long negotiations, no consensus has been reached amongst the members as few countries like the EU, UK and Switzerland are against passing this waiver.
In this article, we would be discussing both sides of the issue regarding the IPR waiver. Is there any way which could bypass these patent protections on vaccines and other related products so that in time of the pandemic, and if yes then how practical it is?
Arguments For The Waiver
Vaccines generally can take even up to ten years to develop because it is a very complex process to develop them and one of the major problems faced in the process is that the virus can mutate very fast and that might render the vaccine ineffective. Hence, it is very important to work on it in the quickest way possible. In the case of Covid-19, the world developed vaccines in a matter of just 12 months. This feat can be only achieved by countries that have the best of talent and resources at their disposal. Consequently, few pharma companies were able to do it which favored developed countries as only they could afford the vaccines. This eventually created a great vaccine inequity which is now more highlighted as the Omicron variant is here knocking at our doors.
To override IP during emergencies, the provision of ‘compulsory licensing’ is already available to the countries under WTO rules. Countries like Bolivia are using this route to manufacture Johnson & Johnson’s Covid vaccine. But understanding it at a deeper level, research shows that compulsory licenses are extremely complex and time-consuming for the countries to apply for.[2]
In these times of emergency, countries supporting IP waiver are only asking that they should be at least allowed to manufacture vaccines without worrying about legal suits by big pharma giants.
Arguments Against The Waiver
Companies and nations who are against the IP rights waiver have a say that considering the waiver as the panacea would be an illusion of a solution. A temporary waiver if approved cannot overnight produce more vaccines unless the transfer of technology is done.[3] This also has high reservations as no data proves there are sufficient facilities around the world to make handle the needs of the day. It is important to realize that the world needs to focus on expanding manufacturing capacity and not just a simple waiver.
Any attempt to compromise with the standards would cost someone’s life. Also, cases of spurious copy vaccines have come into the news lately and these might even increase when IP rights are waived which shall serious consequences.
Trade barriers, bottlenecks in supply chains, scarcity of raw materials and ingredients in the supply chain, and the unwillingness of rich countries to share doses amongst poorer nations are some of the “real challenges” pointed out by the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) ” in scaling up production and distribution of Covid-19 vaccines.[4]
Rather than waiting for months and negotiations over IP rights, an effort to work towards expansion of manufacturing plants, ensuring an increased supply of vaccines around the world, and campaigning vigorously and safeguarding supply chains is needed.
Psychological Aspect Of IPR System
To make companies trust each other to gain maximum output, it is very important to have a strong IP protection system. IP protection gives companies legal protection that turns them into collaborators rather than seeing each other as competition. There is a risk of damaging existing manufacturing partnerships if any kind of tampering is done with the IP system which would prove to be detrimental and reduce the chances of players teaming up for future collaborations. Values like honesty and fairness are the foundation of the IP system due to which trust can be established in those partnerships. This would harm our ability to combat the pandemic.
It’s high time that we address this vaccine inequity, but the debate lies in which way we should proceed.
The Case Of Brazil And Article 73
While WTO is unable to decide something, a public health bill that was proposed in the senate of Brazil would be a silver lining in this mess or say a possible way out. In April 2020, a public health bill was proposed which would allow the country to bypass the barriers erected by the TRIPS[5]. It’s very interesting to discuss the legal backing behind this legislation.
Art.73 of the TRIPS agreement[6] comes to our rescue here. Trade law scholar Frederick Abbott explains that, within the meaning of Article 73(b) (iii), pandemic can be seen as emergency in international relations and this can allow governments to take suitable measures to protect their security interests.[7]
Doha Declaration on the TRIPS agreement and public health the TRIPS agreement should be implemented in a manner that promotes access to medicines for all and supports WTO members’ right to protect public health. Further, Articles 7 and 8 of the TRIPS Agreement states that member states can promote public health and take measures to prevent abuse of intellectual rights.[8]
If there is such a simple solution present out there then why are so many countries waiting and negotiating tirelessly with the WTO to pass out the waiver? The answer lies in cases that act as dark precedents. For example, during the HIV/AIDS crisis, when countries like South Africa, Brazil, and India tried to override these IP rights by following the due procedure by law, the US and the EU erected several legal barriers.
Here, in the case of Brazil, the bill was made into law in September 2020, when President Jair Bolsonaro, not only signed it but also made some changes using his veto powers which turned out to kill the bill. For this act, the senate of Brazil recommended charging him with “crimes against humanity”. But the strange part is that the charges did not contain his mangling of the IP bill, which is strange as this could lead to devastating consequences. Even when the law again came back to the senate to override the veto decisions of Bolsonaro, they were careless enough to miss the deadline and on top of that failed to set another which kept the bill hanging.
The Way Forward…
When we see the case of Brazil, it can be safe to say that other countries would follow. The question that lies in front of giant pharma corporations and the developed states is that how much they can sacrifice their credibility for those who want to continue pressing on their IP rights in the middle of this vaccine crisis.
On one hand, there is the impending danger of Covid-19 and on the other hand, are the monopolistic interests of pharmaceutical companies, and now the world at large has a very thin line to walk on. A slight misbalance would be causing devastating effects. This ‘right balance’ has been also called upon by the Vice President of the Niskanen Center, Brink Lindsey, in a report published by the think tank, Brookings. Talking about the long-term solution, he argues that, “policymakers are caught in an ideological fog that conflates “intellectual property” with actual property rights over physical objects, causing patent law to have unintended consequences”[9].
For innovation and greater trust amongst members, there is a need for the world to value exclusive rights. But at the same time, we need to keep in mind that this practice does not deviate IP holders from their agenda towards pursuing their own selfish needs and imposing restrictions such that the downstream innovation that majorly relies on the access of IP protected technology does not get hindered.
Further, article 66.2 of TRIPS states that “developed country Members shall provide incentives to enterprises and institutions in their territories to promote and encourage technology transfer to least-developed country Members to enable them to create a sound and viable technological base”.[10]
Talking about WHO, which established an mRNA technology transfer hub so that the technology holders can share the information related to vaccine manufacturing, shows efforts on its part, but it’s sad to know that data indicates none of the technology holders have interacted with the hub[11]. Here, a lack of effort is visible on the part of these monopolies as the bystanders’ effect comes into play. To fix this scenario the concerned authorities have to start by pointing out a starting point so that others can follow up or else no one would take the initiative to go first.
Altogether it calls for collective action and the hope still lies that the eyes open up soon before it’s too late!
YASH CHOUDHARY
1ST YEAR STUDENT
ILS LAW COLLEGE, PUNE
[1] Nayanima Basu, Vaccine Inequity Can Lead To More Covid Variants, Waive IP Rights Immediately, India Warns WTO, THE PRINT (30 November, 2021 02:42 pm IST), https://theprint.in/diplomacy/vaccine-inequity-can-lead-to-more-covid-variants-waive-ip-rights-immediately-india-warns-wto/774154/.
[2] Nature 593, 478 (2021), https://www.nature.com/articles/d41586-021-01242-1.
[3] Salil Tripathi, An Intellectual Property Waiver Isn’t A Vaccine Priority Now, THE LIVEMINT ( 13 May 2021, 06:32 AM IST), https://www.livemint.com/opinion/online-views/an-intellectual-property-waiver-isn-t-a-vaccine-priority-right-now-11620834668250.html.
[4] Aanchal Magazine and Prabha Raghavan, Explained: Intellectual property waiver for Covid-19 vaccines, THE INDIAN EXPRESS (May 11, 2021 8:43:46 am), https://indianexpress.com/article/explained/explained-ip-waiver-for-covid-vaccines-7304992/.
[5] Joseph E. Stiglitz, Achal Prabhala, Felipe Carvalho, Brazil’s Pioneering Solution to Vaccine Shortages, PROJECT SYNDICATE (Dec 2, 2021), https://www.project-syndicate.org/commentary/brazilian-solution-vaccine-ip-waiver-stuck-at-wto-by-joseph-e-stiglitz-et-al-2021-12?barrier=accesspaylog.
[6] WORLD TRADE ORGANISATION, https://www.wto.org/english/docs_e/legal_e/27-trips_09_e.htm (last visited December 28, 2021).
[7] Frederick Abbott, The TRIPS Agreement Article 73 Security Exceptions And The Covid-19 Pandemic, 116 SOUTH CENTRE 1, 7 (2020), https://www.southcentre.int/wp-content/uploads/2020/08/RP-116.pdf.
[8] Brook Baker, South Africa And India’s Proposal To Waive Recognition And Enforcement Of Intellectual Property Rights For Covid-19 Medical Technology Deserves Universal Support, But Countries Also Have To Take Domestic Measure, HEALTH GAP (October 10, 2020), https://healthgap.org/south-africa-and-indias-proposal-to-waive-recognition-and-enforcement-of-intellectual-property-rights-for-covid-19-medical-technologies-deserves-universal-support-but-countries-also-have-to/.
[9] Brink Lindsey, Why Intellectual Property And Pandemics Don’t Mix, BROOKINGS (June 3, 2021), https://www.brookings.edu/blog/up-front/2021/06/03/why-intellectual-property-and-pandemics-dont-mix/.
[10] Mark Eccleston-Turner and Michelle Rourke, The TRIPS Waiver Is Necessary, But It Alone Is Not Enough To Solve Equitable Access To Covid-19 Vaccine, AMERICAN SOCIETY OF INTERNATIONAL LAW (May 27, 2021), https://www.asil.org/insights/volume/25/issue/9.
[11] Vidushi Sagar, Lifting ‘Intellectual Fog’ From Pandemic: TRIPS Waiver & More Now Imperative Amid Omicron Threat, NEWS 18 (November 30, 2021, 6:28 pm IST), https://www.news18.com/news/india/lifting-intellectual-fog-from-the-pandemic-a-trips-waiver-more-is-now-imperative-amid-omicron-threat-4502978.html.