Recently, the proposal to waive patents on Covid-19 vaccines has been approved by the World Trade Organisation (WTO) in its 12th Ministerial in Geneva. The proposal had been initiated by India and South Africa almost before two years. This decision has, no doubt, added an impetus to the move towards achieving the principle of vaccine equity.
But the question still remains: Will the move of patent waiver make any meaningful impact at the current stage of the pandemic? According to experts, the World Trade Organisation’s (WTO’s) decision might be a politically-significant deal, which will have little immediate impact as regards getting new technologies for manufacturing or boosting vaccine production.
However, according to India’s Commerce and Industries Minister Piyush Goyal, “It will enable ease of authorisation for production of patented vaccines and India can produce for domestic requirements and exports.”
The decision on the Trade-Related Aspects of Intellectual Property Rights (Trips) will be a positive advancement towards vaccine accessibility, equity and affordability. Now, we can authorise production of vaccines patented elsewhere and no consent is required. Besides, there would be no limit on exports.
However, a similar liberal approach also needs to be taken on the diagnostics and therapeutics part so that faster pandemic response will be in place. In this context, the Minister said, “A decision on diagnostics and therapeutics would be taken in six months. There would be faster pandemic response in future and there would be fewer trade barriers in pandemics.” On the other hand, according to the world’s largest vaccine manufacturer in terms ofvolume, the Serum Institute of India (SII),“While patent waivers for Covid vaccines are ‘encouraging’, their demand is declining.”
According to the spokesperson of the Serum Institute, “During the Covid pandemic, innovators and vaccine developers partnered to develop a lifesaving vaccine at the earliest. It led to licensing deals like that of SII-Novovax, SII-AstraZeneca, J&J, and Aspen, among others. Today, the demand for vaccines is declining. The patent waivers for Covid vaccines are an encouraging and a progressive step towards safeguarding the accessibility and mass production of essential drugs and medicines in the face of future pandemics.”
If reports are to be believed, the current decision of the WTO is considered as a kind of ‘partial’ waiver. Anyway, maybe for now, we have to wait to see what the partial waiver is all about. Whatever it may be, the decision is too little, too late. Even then, the step is welcome and encouraging as information flow is a must for proceeding towards developing second-generation preventives and therapeutics. And easing intellectual property restrictions should be seen as the first step in this endeavour. From the legal perspective, a patent waiver is only the beginning of vaccine launch whereas various other obstacles like testing and regulatory approvals will need to be dealt with. However, the fact remains that IP rights globally are no longer considered to be a significant bottleneck towards increasing the access for Covid vaccines; instead, there are more bigger obstacles like having infrastructure to make the vaccine and having skilled manpower, etc.
Waiver of IP rights will not be of any significant aid to the Third World pharma companies which do not have the knowhow to produce medicines and vaccines. Therefore, until and unless the innovator company jumps into handhold, the manufacturer, the process of vaccine making might get complicated and tedious and the waiving of IP restrictions will be of no good use.
It is important for the manufacturers to know the patentee’s knowhow for developing a marketable product. Besides, there will be concerns about the need for the regulatory approvals for manufacturing and marketing the vaccines which will be same as before, which means even if the waiver applies to India, the immediate impact of it will not be a reality.
What we have achieved today as an IPR waiver is a result of global consensus, which was reached at the very early stage ofthe pandemic as it was considered that knowledge sharing would be essential and critical in the fight against the pandemic. There is no doubt about the WTO decision being a belated step, but there is no denying either that it is a part of the necessary course-correction.
(The writer is an Additional Central Government Standing Counsel, Central Administrative Tribunal, Cuttack and a Distinguished Adjunct Professor of Law and Media Studies, KIIT University. Views are personal)