Covid vaccine: TRIPs waiver patently needed

Last week, the announcement by Pfizer and its collaboration partner BioNT about their potential Covid-19 vaccine candidate showing an improved efficacy of more than 90 per cent in its Phase III, late-stage, study hit the headlines globally. Following this, Pfizer CEO Albert Bourla said they are close to a much-needed breakthrough to the world.

But many of the developing and least developed countries are now concerned on how a fair distribution of the vaccine can be ensured. This was read in connection with Pfizer already signing contracts with Operation Warp Speed, a US government programme for bringing a Covid-19 vaccine to the market, as well as signing supply agreements with the EU, the UK, Canada and Japan.

The concern on the fair distribution of the vaccine is now focussed on the decisions to be made by the WTO. In early October, India and South Africa had jointly submitted a proposal for a temporary waiver to the TRIPs agreement that protects patents and international trade, vis-a-vis the globally existing ‘exceptional circumstances’.

Their argument is that the TRIPS agreement is going to delay an affordable access of medical products, R&D related to that and manufacturing and supply of the medical products.

Call for global solidarity

The joint proposal said, “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”.

If granted, the waiver could substantially affect four sections of Part II of the TRIPs Agreement relating to copyright and related rights, industrial designs, patents, and the protection of undisclosed information for Covid-19 related intellectual properties (IP).

The two countries argued that a waiver of the TRIPS treaty for a specific period of time can improve the collaboration among WTO member-states and even allow manufacturing of generic versions of the potential vaccine without violating any of the international trade rules.

The proponents and their supporters are hoping that similar to the TRIPs flexibility that was sanctioned by WTO Doha Declaration on the TRIPs Agreement and Public Health in 2001 during the HIV/AIDS epidemic, this waiver could impact economic and legal aspects of import and export of pharmaceutical products. The joint request was taken for a discussion by around 40 member-states during a meeting in mid-October. However, the decision was kept on hold until the next meeting.

In view of the extremely low temperature requirements (approximately -70 degree C) for the storage and transport of the candidate vaccine proposed by Pfizer and BioNT, the required infrastructure and transport mechanisms would be a bottleneck for many developing and least developed countries.

A second potential vaccine candidate is by Moderna, which said it will release the first results of a late-stage clinical trial and thereafter apply to the USFDA for an emergency use of administratio, by November end. Its vaccine candidate also requires a storage and transport temperature of -2C. Moreover, several other potential vaccine candidates are reported to be on their final stage of clinical trials. The currently observed stringent temperature requirements as well as the TRIPs agreement pose challenges to fair distribution of a vaccine to the global community in a short period of time.

Alternative options

On the other hand, many developed countries and a few developing countries are of the opinion that a solution can be found within the TRIPs agreement itself and the TRIPs flexibility is unnecessary. They argue that alternative ways such as compulsory licensing or even government use of a patent without the authorisation of the proprietor can be resorted to. There are also several fasttrack programmes undertaken by national and regional IP offices to speed up the granting of Covid-related IP to facilitate a dynamic trade landscape.

For example, the US Patent and Trademark Office (USPTO) recently initiated a Covid-19 Prioritized Examination Pilot Programme. A group of entities has also entered time-limited pledges such as ‘Open Covid Pledge’ to offer free licences to others, refraining from enforcement of their Covid-19 intellectual property rights. In short, the opposers of the TRIPs waiver argue that IP cannot be considered as a stopper but as a catalyst for invention.

In any case, the decision taken by the WTO on the joint proposal submitted for the TRIPs waiver will have an impact on the speed with which the common global population is being immunised against Covid-19. Currently, the decision also seems to be dependent on the outcome of the upcoming election and appointment of WTO’s new director-general.

Whom the US President-elect Joe Biden supports will have a bearing on how fast the vaccine reaches the common people.

Thus, it has now become a prevailing question on how the WTO will open its negotiations during a pandemic period also considering the wide developmental disparities between its member states.

The writer is is an IP consultant practising at The Hague, The Netherlands

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