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This article has been written by Sankar Ghosh, pursuing a Certificate Course in Intellectual Property Law and Prosecution from LawSikho.

Introduction

Since 1970, we have been celebrating April 26 as the World Intellectual Property Day. However, this year, it cannot be a day for celebration, but one for introspection, devotion and to show global solidarity.

 In the wake of this international IP day, we find ourselves racing for what many argue will be the most coveted resource of our time: the COVID-19 vaccine. Hence, let us invariably take the opportunity to reflect upon the role of intellectual property (IP) in the ongoing global health crisis and vaccination thereby dedicating IP to finding a solution. 

As we have crossed a year mark of the COVID-19 global pandemic, the second wave has struck many nations as a bolt from the blue. Oxygen is getting delivered through green corridors, a shortage of Remdisivir drug reported across the country.

New strains/variants of the virus have emerged playing with mankind. The stealthy path of such a virus remains difficult to be tracked. We fear that the existing vaccines might not work against them. The international trade rules have become contentious issues.

One year into the pandemic we are wondering whether COVID-19 is a surreptitiously developed  biological weapon capable of mass destruction of mankind and for that whether China should adequately compensate the international community and member-states, particularly India,  for serious physical, psychological, economic and social harm caused. [1]

COVID-19 vaccine is not just about the safety of people but getting a nation’s economy moving again and geopolitics is shaping the decisions around who will get the vaccine first.

During this pandemic, we have seen what we can achieve when we put resources in science. Vaccines were developed in record time.

But so far on average 1 in 4 people in rich countries have received the vaccine compared with just 1- 500 in developing countries.

The virus has affected the rich and the poor, democratically but its vaccine may not be so.

Governments along with international community and vaccine developers must step up the game and address the vaccine inequity.

Proposals for waiver of IP on COVID-19 vaccines

A universal advocacy campaign is currently seeking to exempt COVID-19 vaccines from IP protections, contending that this action would mobilize additional manufacturers and help address vaccine access disparities. There is Mohammad Yunus, a nobel peace prize winner joining the campaign to take the COVID-19 vaccine free of any IP. [2]

India followed by South Africa floated the idea in December 2020 of a waiver that would override IP rules, allowing generic or other manufacturers to make vaccines and drugs. [3]

Such waiver must last until the world has herd immunity and the pandemic is declared over by WHO.

The proposed TRIPS Waiver would support the international collaboration with respect to development, production and supply of COVID-19 vaccine. And many underdeveloped and developing countries have come out in favour of this.

The waiver proposal of IP aims to allow nations to choose not to enforce, apply or implement patents and other exclusivities that impede the production and supply of COVID-19 vaccine, until universal herd immunity is reached.

If the proposal is considered, the waiver would send a pivotal signal to potential manufacturers that they can start producing needed COVID-19 vaccines and related medicines without fear of being blocked by patents or other monopolies.  

Opposition to proposal of IP waiver

The proposal of IP waiver was opposed by the United States, UK, EU as they have a strong pharma lobby.  They argue that the TRIPS Agreement already has mechanisms within it to enable countries to compulsorily license patented products. [4]

 This is true but the process is both cumbersome and there’s some ambiguity when it comes to sell lines needed for vaccines. 

They are suggestive of the voluntary mechanism, such as donations to WHO’s COVAX facility as an alternative. 

Although these countries all over the world have taken extraordinary measures to contain COVID-19, they hesitate even recognising the evidence that IP is a barrier.

These are all good arguments but the central issue is the need to get the vaccine to people everywhere quickly.

The WTO has delayed discussion of the IP waiver proposal and it appears to be at an impasse. 

Argument for patenting of life-saving vaccine

One of the justification for the protection of intellectual property dominates the debate on the patenting of life-saving drugs centres on fairness or compensatory justice. There is no doubt that, the development of new technologies, particularly in the field of biomedical and pharmaceutical medicines, requires huge investment in research and development that is fraught with significant risks and uncertainties.

The pharmaceutical industry strongly depends on the patent system to recoup its past costs on research and development, to generate profits, and to fund further research and development for future products.

Not allowing companies to profit from their invention would blunt the incentive to invest. For instance, the CEO of Pfizer claimed that IPs were what brought a solution to the pandemic in the first place. And we may well need the ingenuity of these companies even in this pandemic if new vaccines are needed to control the variants.

 It’s also worth noting that some companies proposed to sell the vaccine at cost while the pandemic lasts and at cost to poor countries even after that.

Why the debate

There’s nothing new of course about the decades-long debate over intellectual property rights and life-saving medicines.

‘Once upon a time drug companies promoted drugs to treat disease. Now, it is often the opposite. They promote disease to fit their drugs.’ [5]

Nearly everyone experiences heartburn from time to time. The remedy used to be a glass of Milk or an over-the-counter antacid to relieve the symptoms but now heartburn is called “Acid Reflux disease” or “Gastroesophageal   Reflux disease” and marketed along with the drugs to treat it as a harbinger of serious esophageal disease which it usually is not. Such is the case of exploitation of people and in this they will stoop to any level. [5]

While there is no doubt that the patent system is the best way to encourage inventions, India recognised as early as in 1970 that it was equally necessary to provide safeguards against possible abuses of the system. Thus, in 2005, while adopting patent reforms to respond to the obligations under TRIPS  India was conscious of the need to continue the balance between Public Interest needs and providing a sound system of intellectual property protection in accordance with the International norms and Standards. [6]

Heads of several Nations and UNESCO have already referred to future COVID-19 vaccines as ‘global public goods’, or the ‘people’s vaccine’.[7]

The Doha Declaration, when read with the TRIPS agreement, provides flexibility in the space of   Public Health; it was not designed to address a global health crisis due to pandemic.

 The process enumerated under Article 31 of TRIPS requires wide consultation and negotiation with the patent owner before any compulsory licensing and manufacturing of a drug can take place.

As it is a time-consuming process, it is not a feasible option to the exigencies of this pandemic.

Pharmaceutical companies that have the most to gain from a COVID-19 vaccine need to agree to either an open-source or licensing process.

If the virus continues to circulate because vaccines don’t achieve adequate global penetration, it is more likely to mutate, potentially initiating a new pandemic.

Hurdles

 At this crucial time, the pharmaceutical giants are being allowed to retain and pursue intellectual property rights to the COVID-19 vaccines under development. Thus, as long as the intellectual property rights of COVID-19 vaccines belong to MNCs, they are more proprietary vaccines rather than ‘the people’s vaccine’.

Finding a Solution

A Common Creative Licence on COVID-19 vaccine IP to disseminate knowledge is an open-source approach being advocated by researchers and academicians.

Leaders around the world have signed the pledge agreement that whoever creates a vaccine shows the recipe and the know-how with the rest of the world so that production can happen anywhere.

Whether it’s a TRIPS waiver or some other emergency mechanism that protects the profits and property of the vaccine developers, such as governments collectively purchasing patents and licensing them to producers, the need to expand and globally diversify vaccine production could be more urgent.

Accessibility issues arise only when countries try to monopolize the vaccine for every single one of their citizens fast.

One of the solutions to overcome the crisis is to create a global pool of COVID-19 related innovations, or innovations related to rare pandemics, in respect of vaccines and medicines. The purpose of creating and recognising patent rights is for the common public good, i.e., innovation needs to be made public in exchange for a limited monopoly. Wherein patents need to be disclosed to the public in order to enable further research.

Scaling up of Public-private partnerships (PPP) is necessary. Creating a pandemic patent pool at a global level, to pool all innovations, might be  the way forward. 

The above procedure is in line with the Doha Declaration on Public Health which is a part of the TRIPS agreement. Such a declaration recognises the need for taking measures to ‘protect public health’ and ‘promote access to medicines’.

The member states have the freedom to legislate guided by the principles and objectives set out in Article 7 and 8 of TRIPS agreement which read that the Doha declaration provides sufficient flexibility to member states to frame the patent law of countries to suit its special needs particularly in the area of patents for drugs and Pharmaceuticals.

It is explicitly recognized by the Doha declaration that TRIPS doesn’t and shouldn’t prevent members from taking measures to protect public health. TRIPS has to be interpreted and implemented in a manner supportive of WTO members’ right to protect public health and promote access to medicines for all.

The Medicines Patent Pool was established by UNITAID   as the first public health patent pool. Later, the patent pool’s mandate was expanded to treat tuberculosis and hepatitis C. Covid 19 Vaccines need to be included.

The purpose of creating and recognising patent rights is for the common public good, i.e., innovation should be made public in exchange for a limited monopoly.

In order to enable further research, patents need to be disclosed to the patent Pool.

Public-private partnerships (PPP) need to be scaled up. Creation of a pandemic patent pool at a global level, to pool all innovations, is the way forward. Let us not wait any longer.

Pooling of patent resources is in adherence with the Doha Declaration on Public Health which is a part of the TRIPS agreement. This declaration identified the necessity for taking measures to ‘protect public health’ and ‘promote access to medicines. [8]

Actually, what is to be done is protecting those in greatest need and highest vulnerability everywhere first because that’s the fastest and most effective way to end the pandemic. This means getting the vaccine to the elderly health care and essential workers and to those who are most vulnerable first around the world to help end the pandemic.

Intellectual property, technologies, know-how and data must be shared, so that when a COVID-19 vaccine manufacturer proves successful, the world is given the best chance to rapidly scale-up manufacturing and distribution.

The underdeveloped and the developing countries must be saved from the conquest through patent strategies by multinational pharmaceutical companies. We need to be allergic to the avoidable infiltration of giant corporates who care more for market occupation and maximize profit under IPR belony rather than common people’s health and social survival.

This pandemic will not be over until it is over for each and every one on this planet.

References

  1. https://www.businesstoday.in/current/economy-politics/icj-aiba-move-unhrc-against-china-over-coronavirus-outbreak/story/400139.html
  2. https://economictimes.indiatimes.com/news/international/world-news/covid-19-vaccine-should-be-made-peoples-vaccine-nobel-laureate-prof-muhammad-yunus/articleshow/79665036.cms?from=mdr
  3. https://www.pharmaceutical-technology.com/features/wto-ip-waiver-proposal-covid19-vaccine/
  4. https://www.pharmaceutical-technology.com/features/wto-ip-waiver-proposal-covid19-vaccine/
  5. The Truth About the Drug Companies HOW THEY DECEIVE US AND WHAT TO DO ABOUT IT’ by MARCIA ANGELL, M.D
  6. http://ipindia.gov.in/writereaddata/Portal/IPOGuidelinesManuals/1_58_1_14-krishna-iyer-ernakulam-kochi.pdf.
  7. https://en.unesco.org/news/unesco-calls-covid-19-vaccines-be-considered-global-public-good#:~:text=Press%20release-,UNESCO%20calls%20for%20COVID%2D19%20vaccines%20to,considered%20a%20global%20public%20good&text=As%20things%20stand%20today%2C%20the,vaccines%20until%20well%20into%202022.
  8. https://www.thehindu.com/opinion/lead/needed-a-pandemic-patent-pool/article31475628.ece

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