Patents, Patients & a Pandemic: Breaking down the jargon around the 'TRIPS waiver' & COVID

The war against COVID is fast turning into a battle for resources -- from vaccines to medication. While India has been able to achieve a degree of self-sufficiency in the past with testing kits and made-in-India vaccines, the need of the hour is to mass produce as much medication and as many vaccines as possible to meet the growing needs of the country and the world at large. 

If mass production of vaccines can solve the crisis, what is stopping this production?

The biggest hurdle that has emerged in the process of mass vaccine production has been Intellectual Property. Just like authors, artists and designers are likely to have exclusive copyrights to sell, create, publish and profit from their work, pharmaceutical companies are effectively the creators of the drugs. As creators of the drugs, they have exclusive rights on their sale, distribution and creation. 

The control over who manufactures life-saving drugs and vaccines comes by holding a patent on the drug formula and other Intellectual property linked to them. Meaning, manufacturers and organisations world over, who possibly have the raw material and ability to produce COVID medication and vaccines en-masse cannot do so only because of legal limitations. 

So, does it mean patents & other Intellectual Property are always bad?

At the outset, the simple answer is no, not always. Patents and other forms of Intellectual Property may seem like the evil holding the world back when countries are facing the scourge of COVID but these very Intellectual Property rights provide the incentive to companies to innovate, design and create new drugs and technologies. Research and development (R&D) increases when intellectual property rights are guaranteed as an end result, because inventors & innovators can reap the full benefits of their work

Intellectual Property not only serves as means to encourage and reward companies for their creations - technical, medical or otherwise but also to ensure that others do not rip-off and take monetary advantage of their inventions and creations that have come after significant financial investment, years of research and use of other resources. 

If Intellectual Property is not the villain, why is there a sudden uproar against it now?

Intellectual Property over medication and vaccines gives a monopoly and control to select players and prevents equal global access to all. In times of a grave crisis, making Intellectual Property a priority puts an artificial barrier in ensuring medication and vaccination reaches all parts of the world with alacrity. It creates a disparity that puts profit-making interests over humanitarian ones.  

An article published in the leading peer-reviewed general medical journal, The Lancet, rightly points out, “COVID has proven that the IP system doesn't work. It is not designed to deal with pandemics.” For example, in March, certain Stanford scientists reverse-engineered certain Moderna vaccines and posted the entire mRNA sequence on GitHub. The science behind creating the Moderna vaccine is for all to see.  

Despite the sequence being out in the open, those with resources to replicate the sequence cannot push generic versions into the market given that there is no suspension of Intellectual Property rights on COVID-19 vaccines yet. Non-suspension of Intellectual Property rights, forces a hands-tied approach in the middle of a pandemic. 

Okay, but what does the WTO have to do with it?

As part of the agreement establishing the World Trade Organization (WTO), an agreement on how Intellectual Property is shared and governed by member countries was laid down. The agreement was called The Agreement on Trade-Related Aspects of Intellectual Property Rights and is more commonly known as ‘TRIPS’. 

This TRIPS agreement provides the basic minimum standards on how 7 different forms of Intellectual Property: copyrights, trademarks, geographical indications, industrial designs, patents, layout designs for integrated circuits, and undisclosed information (trade secrets) are governed. 

This agreement also includes certain permissible limitations and exceptions that can be invoked in cases where the benefit of Intellectual Property and innovation is overshadowed by larger concerns of welfare and development. In short, the WTO has the ability to invoke a waiver of certain Intellectual Property rights, thereby ensuring greater accessibility to key drugs and vaccines across the globe.  

What kind of waiver exactly are we talking about here?

India and South Africa on October 2 asked the WTO to allow all countries to choose to neither grant nor enforce patents and other Intellectual Property related to COVID-19 drugs, vaccines, diagnostics and other technologies for the duration of the pandemic, until global herd immunity is achieved. 

India and South Africa's joint proposal clearly reads: “Internationally, there is an urgent call for global solidarity, and the unhindered global sharing of technology and know-how in order that rapid responses for the handling of COVID-19 can be put in place on a real time basis. In these exceptional circumstances, we request that the Council for TRIPS recommends, as early as possible, to the General Council a waiver from the implementation, application and enforcement of Sections 1, 4, 5, and 7 of Part II of the TRIPS Agreement in relation to prevention, containment or treatment of COVID-19. The waiver should continue until widespread vaccination is in place globally, and the majority of the world's population has developed immunity.”

This waiver is not an all-out shutting down of the agreement on TRIPS but a waiver on select parts of it, for a limited time period to enable consistent and free supply of medicines and vaccines. 

Where do other countries stand?

Beyond India and South Africa, over 60 countries have co-sponsored the proposal before the WTO and now, more than 100 support the proposal. While initially, the United States, the UK, Australia and the European Union among others vacillated over the TRIPS waiver proposal, the growing call from citizenry to put humanity first combined with the diplomatic pressure is shifting the tide. 

The United States has since changed its position and declared support for the waiver of Intellectual Property protections on COVID-19 vaccines. 

In fact, even the European Commission President Ursula von der Leyen has now said, “The European Union is also ready to discuss any proposals that address the crisis in an effective and pragmatic manner. And that’s why we are ready to discuss how the US proposal for a waiver on Intellectual Property protection for COVID-19 vaccines could help achieve that objective.”

Who is opposing the TRIPS waiver?

Unsurprisingly, pharmaceutical giants have come out in strong opposition to the waiving of Intellectual Property rights by the WTO and member nations. The European Federation of Pharmaceutical Industries and Associations on May 6, issued a statement against an IP waiver for COVID-19 vaccines. 

EFPIA Director General Nathalie Moll argued,  “A waiver risks diverting raw materials and supplies away from well-established, effective supply chains to less efficient manufacturing sites where productivity and quality may be an issue. It opens the door to counterfeit vaccines entering the supply chain around the world.”

This argument by pharmaceutical companies and lobbyists fails to hit home when nations are grappling to access vaccines and the current producers have put their hands up citing production limitations to meet the increasing demand. With 3,245,762 deaths and counting, non-removal of Intellectual Property restrictions, decidedly, does more harm than good. 

Has it been done before?

The pandemic being witnessed today may have been unprecedented, but easing the restrictions placed by the agreement on TRIPS is not. In 2001, WTO Members adopted a special Ministerial Declaration at the WTO Ministerial Conference in Doha to address the growing worry that patent rules might restrict access to affordable medicines in developing countries including HIV, tuberculosis and malaria. 

The Doha Declaration affirmed that "the TRIPS Agreement does not and should not prevent Members from taking measures to protect public health".  This declaration went on to assert, “that the Agreement can and should be interpreted and implemented in a manner supportive of WTO Members' right to protect public health and, in particular, to promote access to medicines for all.”

The TRIPS waiver being called for now only enables the cause of “medicines for all” that was recognised exactly two decades ago. 

Is the TRIPS waiver a full and final solution?

A waiver, if granted by the WTO, will not be the be-all and end-all of the collective fight against COVID, but it will certainly be a massive step forward in the right direction. A waiver will remove the artificial hurdles currently placed on manufacturing, scaling up, and supplying critical medicines and vaccines.  

Intellectual Property has its place in ensuring innovation, competition and augmenting R&D, but the unique circumstances that confront the world today have proven this is neither the time nor the place to put Intellectual property interests over the lives of millions. 

Intellectual Property is at the core about providing financial encouragement to innovators, but the intrinsic motivator of altruism, should and must, trump private selfish goals of profiteering. If TRIPS is not waived, there will be a human cost to pay.