US Backs IP Waiver Call: Much more to it than Just the Knowhow, say Vaccine-Makers

Vaccine-makers are treading with caution on the opportunity that will open up for them if a proposal to waive the intellectual property (IP) on Covid-19 vaccines comes good at the World Trade Organization.

The initial proposal from India and South Africa at the WTO sought a temporary IP waiver on Covid-19 medicines, diagnostics and vaccines for the pandemic period. And, late on Wednesday, the US administration said it would support an IP waiver on vaccines. The proposal still needs a go-ahead from all WTO members, after which negotiations will start to frame the context for the IP waiver, especially in terms of how long it would be allowed.

India’s vaccine-makers are at an advantage to make not just for India but also emerging markets, said A Vaidheesh, former head of GlaxoSmithKline (GSK) Pharmaceuticals (India). There will, however, be a need for greater collaboration between these companies and innovators, he is quick to add, as biological products require expertise.

Complex process

It’s not simple ‘reverse-engineering’ of a chemical compound, he said, adding that vaccines are complex and much attention is required in the manufacturing process and quality-control as also sourcing of ingredients.

Nevertheless, the recognition of the need to end the pandemic by the US (a major proponent of the IP regime) and its support for a waiver, is a momentous one, he said.

The domestic market has Covishield, the AstraZeneca-Oxford University vaccine, made by Serum Institute of India and marketed at home and abroad.

And there’s Covaxin, from Bharat Biotech and the Indian Council of Medical Research. Waiting in the wings are Russia’s Sputnik V from Gamaleya Institute, the Johnson and Johnson vaccine, and Pfizer, which has shown renewed interest in bringing its antidote to India. Pfizer and Moderna have new generation mRNA vaccines that could interest vaccine-makers. Pune-based Emcure is the only local company working on an mRNA vaccine.

Other biotech companies that can benefit include Panacea Biotec, and Wockhardt, to name just a couple. Interestingly, the waiver also opens up India’s Covaxin to being produced by other companies.

Letting the IP be open-source and free for all is one thing, but a company looking to make an innovator’s vaccine will need to have the technology, equipment and will require hand-holding, said a vaccine-maker. About 200 components sourced from different regions go into a vaccine, he said, pointing to the raw materials complexity.

Pharma companies usually do not make vaccines because they are public health tools, sold mainly to governments and multi-lateral agencies, “so there aren’t huge margins there,” observes an industry-hand. Waiving IP could scare companies from venturing into making innovative products, an expert said, although the inequities in vaccine distribution make collaborations inevitable.

Bodes well

R Uday Bhaskar, Director-General, Pharmaceutical Export Promotion Council, said the patent waiver “augurs well’ for public health and can address existing imbalances in vaccine production, globally. “For example, Africa and Latin American countries do not produce a single Covid vaccine and it may take years for them to develop one. Patent waiver can be of great help in such instances,” Bhaksar said.

M Narayan Reddy, Chairman, Virchow Laboratories, pointed out that “In a way, (a) patent-waiver is already operational in different forms, and drugs like Remdesivir are being produced by more than one player.” As Covid vaccines have been given emergency use authorisation, a patent waiver would also depend on the actual grant of patents to the products, he pointed out.

‘Wrong answer’

Disappointed with the development, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) said, “a waiver is the simple but the wrong answer to what is a complex problem.”

Waiving patents on vaccines will not increase production nor provide practical solutions needed to battle this global health crisis.

Elimination of trade barriers, addressing bottlenecks in supply chains and scarcity of raw materials, and a willingness of rich countries to share doses with poor nations are the real issues, the IFPMA said.