WTO's vaccine patent waiver may have little impact on ground now: Industry

Serum Institute says while patent waivers for Covid-19 vaccines are 'encouraging', demand for vaccines today is declining

The World Trade Organization’s (WTO’s) green light for a politically-significant deal of a patent waiver for manufacturing Covid vaccines may have little impact in boosting vaccine production immediately or getting new technologies for manufacture, according to experts.

Commerce and Industries Minister Piyush Goyal said the Trade-Related Aspects of Intellectual Property Rights (Trips) decision will boost vaccine equity, accessibility and affordability. “It will enable ease of authorisation for production of patented vaccines and India can produce for domestic requirements and exports,” he said.

The minister said a country can authorise production of vaccines patented elsewhere and no consent is required. Also, there would be no limit on exports.

“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,” Goyal said.

The world’s largest vaccine manufacturer by volume Serum Institute of India (SII) said while patent waivers for Covid vaccines are ‘encouraging’, their demand is declining.

A Serum Institute spokesperson said, “During the Covid pandemic, innovators and vaccine developers partnered to develop a life-saving 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 progressive step towards safeguarding the accessibility and mass production of essential drugs and medicines, in the face of future pandemics.”

Legal experts point out that it needs to be seen what exactly a ‘partial’ waiver is.
 

Aparna Gaur, leader, IP practice, Nishith Desai Associates, told Business Standard that, “News reports mention a partial waiver. Maybe, we need to wait and see what’s partial about the waiver.” Either way, it may be too little, too late.”

Gaur said vaccine demand is not at the same level where it was when the talks started. “And, a patent waiver is only an initial step towards a potential vaccine launch. Several other hurdles like regulatory approvals and testing will need to be cleared.” 

Actually, IP rights are no longer considered an obstacle to increasing access for Covid vaccines globally. India and South Africa have been pushing for lifting IP rights for Covid vaccine production for some time now.

In March, Mahima Datla, MD, Biological E, the makers of Corbevax, said that Baylor College of Medicine in Texas (with which the company collaborated to develop the vaccine) has already waived IP restrictions. This is because it wanted to make sure that Corbevax — a protein subunit vaccine for Covid — is accessible.

Datla had said while IP is not the only obstacle, the more serious obstacle is having infrastructure to make the vaccine and having trained manpower, among others.

Moreover, vaccine makers feel that unless the innovator company comes forward to handhold another manufacturer, the process of making a vaccine will not be so simple. This is even if the IP restrictions were to be waived.

“Even if the technology is available immediately, it would take nine months to a year to develop the processes and commercialise them. Vaccines are biological products using viruses, and manufacturing involves an extremely complex process. Any change in that process can result in failure to get the right vaccine candidate,” said a senior executive of a vaccine firm.

Manufacturers may need the patentee’s know-how to develop a marketable product. Regulatory approvals for manufacturing and marketing such vaccines will still be required. So, even if the waiver applies to India, it may not have an immediate impact, said an industry insider.

The Concerns

• Need to understand 'partial' waiver

• Without tech transfer from innovator, difficult to make a marketable vaccine product

• Even after tech transfer, it will take 9 months to a year to make vaccine 

• No shortage of vaccines globally now

• Obstacle for equitable distribution infrastructure and trained manpower