New Delhi: India, South Africa and many other developing countries will have to wait long before they can start manufacturing “copycat” versions of some of the world’s leading Covid-19 vaccines, even if the World Trade Organization (WTO) agrees to waive, temporarily, the intellectual property and patent rights on them.
While over 120 nations have supported the proposal, all 164 member countries of the WTO are yet to begin text-based negotiations on the matter in Geneva.
The US, after much dilly-dallying, Wednesday said it will “support” the move proposed by India and South Africa in October 2020, but commencing the negotiations will not be easy, sources told ThePrint.
The joint proposal by India and South Africa seeks to temporarily waive all intellectual property and patent rights provisions that come under the TRIPS Agreement of the WTO on Covid vaccines, medicines, diagnostic kits, protective gears and other products required to fight the pandemic.
The Agreement on Trade-Related Aspects of Intellectual Property Rights, also known as the TRIPS Agreement, came into effect in January 1995. It is a multilateral agreement on intellectual property.
On Thursday, while presiding over the General Council meeting in Geneva, WTO Director-General Ngozi Okonjo-Iweala lauded the US’ support and urged all member countries to commence the negotiations at the earliest.
“As I told the General Council yesterday, we need to respond urgently to COVID-19 because the world is watching and people are dying. I am pleased that the proponents are preparing a revision to their proposal and I urge them to put this on the table as soon as possible so that text-based negotiations can commence,” Okonjo-Iweala said.
She added: “It is only by sitting down together that we will find a pragmatic way forward — acceptable to all members — which enhances developing countries’ access to vaccines while protecting and sustaining the research and innovation so vital to the production of these life-saving vaccines.”
The General Council is the highest decision-making body of the WTO. The GC met on 5-6 May and TRIPS waiver proposal was one of the agenda items at the meeting.
Since the proposal was floated by India and South Africa, over 120 countries have supported it, and there have been several rounds of formal and informal meetings on this so far. The sources said while it will be “an onerous task” to get all members on board and discuss it, the US’ backing to the proposal has certainly made the task to begin negotiations much easier.
A huge opposition has now come from Germany, which believes suspending IPR for Covid vaccines will have “serious implications” on its production.
“The protection of the intellectual property is a source of innovation and it must remain so in the future,” German Chancellor Angela Merkel said Thursday.
Meanwhile, the US statement has impacted the country’s pharma stocks with the shares of Moderna, Novavax and Pfizer plummeting. Pharma groups in the US and EU have also criticised President Joe Biden’s administration for the decision.
Pfizer has said it’s “not at all” in favour of the waiver.
Hence, the sources said, even if the talks begin next week, it can take “a month to a year” to have a broad-based consensus.
TRIPS waiver will be just beginning of a long process
According to many experts in the field, while the waiver solves the issue of obtaining the legal right to manufacture the vaccines of other companies, that of sharing the know-how of manufacturing the vaccine still remains unsolved.
They claim waiving patents and giving access to the recipe are two different things.
“We are just halfway done. For instance, it completely depends on Pfizer, if they want to share how they manufacture the vaccine. But yes, they cannot sue you for infringing on their product. Let’s see which companies come forward in sharing the latter. Otherwise, globally we need to create pressure again on the big pharma to share technology,” said senior advocate Anand Grover, who specialises in drug patents.
Many believe it will be an incredible opportunity for India to harness its manufacturing capacities to fulfil its own demand, followed by that of several countries across the world.
Despite exporting millions of Covid-19 vaccines, India’s manufacturing capacity has remained under-utilised, said Achal Prabhala, a vaccine supply expert who is a fellow at the Shuttleworth Foundation.
“India’s manufacturing capacity is severely underused. We already have 24 registered vaccine manufacturers out of which only three are being used to make Covid vaccines, presently. This includes Bharat Biotech, Serum Institute of India, and Biological E. Panacea might soon make Covaxin as well – but what about the other 20?”
Apart from this, Prabhala said, there are several drug makers and biologics manufacturers who can jump in and make more vaccines.
“Several drug makers including Dr. Reddy’s and Hetero will be manufacturing Sputnik V. We have several hundred pharmaceutical companies in India who can potentially produce vaccines for us and for the world around,” he said.
“For instance: mRNA vaccines can be potentially produced by any pharma company that manufactures injectable drugs whereas other traditional biological vaccines can be produced by any pharmaceutical company that currently makes biologic drugs.”
Leena Menghaney, global IP advisor, MSF Access Campaign, highlighted that “as a start in India, the Drug Controller General of India needs to ensure that there is no patent linkage in the regulatory process so that emergency approvals are available to generic producers of patented medicines”.
She added: “The move will help countries such Bangladesh, Canada and others apart from India to unlock their capacities.”
What happens if TRIPS waiver comes into effect
If all countries agree to the temporary TRIPS waiver on Covid products, several countries including India can start manufacturing the bouquet of Covid-19 vaccines instead of waiting for the pharma giants to allow domestic production.
For instance, India can begin manufacturing the vaccines including the one-shot Johnson & Johnson vaccine apart from the long-awaited vaccine from the US drugmaker, Pfizer.
The other countries will also become eligible to start production of made-in-India Covaxin, manufactured by Bharat Biotech and AstraZeneca’s Covishield.
The move puts India again in the spotlight for aggressively increasing the production of the bouquet of vaccines at the cheapest possible price and export across the globe.
Known as a powerhouse of vaccine manufacturing, India produces 60 per cent of the world’s vaccines and accounts for 60-80 per cent of the United Nations’ annual vaccine procurement. India has exported 66 million doses of Covid-19 vaccines across the world until May 6, mainly through the Pune-based Serum Institute of India (SII), which is the world’s largest vaccine maker.
Apart from SII, other exports were made by Hyderabad-based vaccine maker Bharat Biotech.
Move incomplete without tech transfer
According to health experts, the manufacturer that produces the vaccine holds great amount of technical know-how and working experience that are enormously important for any company manufacturing vaccine.
This is the reason tech transfers are done under strict agreements when pharma giants make manufacturing deals with other companies. For example, UK’s AstraZeneca wanted SII to be treated as priority customer in return of accessing its technology behind the vaccine development from the Oxford University.
“The IP suspension is a step in the right direction but will probably be not enough in the absence of further support through tech transfer and guidance to set up the relevant infrastructure for quality vaccine manufacturing,” said Dr Anant Bhan, researcher in the fields of global health, health policy and bioethics.
“Trade tricks are very important, such as working experience of over the years apart from the appropriate technology, necessary infrastructure, facilities, quality norms and safeguards.”
However, experts also believe the issue of export bans and supply chain constraints is harmful for intellectual property rights.
Amesh Adalja, senior scholar at the US-based Johns Hopkins Center for Health Security, said, “I would say that Moderna has not been worried about its patent throughout the pandemic, and no one else is making it.”
Last October, Moderna had announced that it will not enforce Covid-related patents against those making vaccines intended to combat the pandemic.
“I don’t think the suspension of intellectual property rights can be beneficial in the long run to any country because what it will do is destroy the engine of innovation that made these vaccines in the first place. The issue that needs to be corrected is export bans and supply chain constraints,” Adalja said.
(Edited by Sanghamitra Mazumdar)