TRIPS waiver on Covid-19 vaccines need of the hour

The Covid pandemic will be spoken of in the future in the same breath as the two World Wars, the Great Depression and 9/11. In short, it is a watershed event. An event of this magnitude should have been dealt with a common strategy by the international community. With the advent of vaccines, everybody was hoping that there would be a swift end to the pandemic. On the contrary, the situation has worsened with many nations witnessing a second or third wave. We are failing to slay the virus because of a lack of common action.

Nations have been, from the very outset, facing shortage of diagnostic kits, medical equipment, therapeutic drugs, and now of vaccines. The big businesses are following a business-as-usual approach, holding on to their Intellectual Property, giving only limited manufacturing licences, which are not sufficient to meet the current needs. Initiatives by the World Health Organisation, like the Covid-Technology Access Pool (C-TAP) and the Covax vaccine alliance are no doubt commendable. But the C-TAP has been a non-starter as the big businesses that can make vital contributions have stayed out, and Covax’s target of procuring two billion doses by the end of 2021 to cover at least 20% of the population of each participating country is not enough to take us out of the woods.

The India-South Africa proposal for waiver of the WTO Agreement on Trade-Related Intellectual Property Rights (TRIPS) is a request for waiver from obligations arising out of Sections 1,4,5 & 7 (dealing with copyrights, industrial designs, patents and undisclosed information, respectively) of part II of the TRIPS agreement, for prevention, containment and treatment of Covid-19. It is only a temporary measure, to be availed of until the majority of the world population has developed immunity through a wider vaccination programme.

The waiver proposal goes beyond patents in view of the fact that Covid-related products are covered by other forms of IP protection as well. The proposal has received tremendous support, not just from developing countries but also from lawmakers of developed countries, civil society groups and eminent individuals. Another welcome development is the US support for it, announced by President Joe Biden.

But a handful of developed countries are opposing it. They are of the opinion that the inbuilt flexibilities of the TRIPS agreement like compulsory licensing (CL) would be enough to tide over the issue. The sponsors of the waiver aver that the inbuilt flexibilities will not be of much help in an unprecedented situation like this as they were not designed for it. The flexibilities involve a ‘case by case’ and ‘product by product’ approach that is complex and time-consuming. A single Covid-related product contains several components, each of which may be covered by a patent. Producing that product through the CL route will take time as licences have to be issued for each component. If the parts are to be manufactured in different countries, then each nation will have to issue a CL. Synchronising the manufacturing process will then become very difficult.

Also, CLs have territorial restrictions, which means that through this process, products can be produced only for domestic markets. Countries that do not have the required manufacturing capacity to produce can issue a compulsory licence to a third party under Article 31 bis, but they come with a lot of stipulations.

Compulsory Licences have very rarely been issued for copyrights or industrial designs and could throw up new challenges. All this will make much-needed international collaboration difficult, leading to loss of precious time. The waiver, on the other hand, would be an all-encompassing measure and would enable scaling up of manufacture of all Covid-related products without having to think about IP infringement, thereby ensuring equitable and faster access to Covid-related products and a swift end to the pandemic.

The explosive situation in India has certainly set off alarms. International aid can help in bringing the situation under control, but it cannot end the pandemic.

That can happen only through simultaneous vaccination drives in all parts of the world. As long as the virus has a free run, newer variants will continue to appear, threatening the gains in other parts of the world.

Intellectual Property Rights are no doubt legitimate rights and incentivise innovation, but these are unprecedented times that require unprecedented measures.

The opponents of the proposal need to look at the economic losses across several sectors due to the pandemic than just the loss of profits for ‘big pharma’. Loss of lives and livelihoods in any part of the world will have an impact on the global economy. Therefore, the waiver proposal assumes importance and urgency. The waiver is not a panacea or a substitute for prudent policies and their efficient implementation by governments, but it will make the task less onerous for them.

(The writer is an independent researcher)