IDMA adds voice to call for voluntary licences on vaccines

The Indian Drug Manufacturers’ Association (IDMA) has added its voice to those calling for voluntary licences on Covid-19 vaccines, to increase supplies in the country.

IDMA agrees that a simple waiver of patents on vaccines was not enough to increase supplies in the country. “What is more important is grant of “Voluntary Licences (VL)” by the patent holders to Indian companies with sufficient expertise in this field,” IDMA said in a position paper on patent waivers, issued on Wednesday. (IDMA represents small and medium-size drugmakers)

The example of AstraZeneca and Serum Institute is a successful working model, it said, adding that “other vaccine developers need to come forward and similarly transfer technology to Indian companies against reasonable royalties.”

IDMA’s statement comes against the backdrop of local and international developments involving Intellectual Property (IP). The call for voluntary and compulsory licences (CL) have increased in the country after the expanded vaccine roll-out slowed down considerably due to the shortage of vaccines. A VL is negotiated between an innovator company and a licensee and foreign companies are more inclined to such deals. In a CL, a third party is allowed by a country to make an innovative drug, on reduced prices and on a payment of royalty to the originator company. And this is a pathway allowed under WTO rules, but in the face of a public health emergency.

Internationally, India and South Africa are calling for IP waivers at the World Trade Organization on Covid--linked products. Recently the proposal received support from the US administration, but only for vaccines. Nevertheless, the support has triggered a slew of statements from various industry bodies.

The WTO has provided a provision of CL for tackling such an eventuality, IDMA said, urging Government to not shy away from invoking this provision.

The association also called for IP waivers on pharmaceutical products (including Active Pharmaceutical Ingredients), used directly or indirectly in the treatment of Covid-19. This would boost production and ensure there are no shortages anywhere in the world, IDMA said.

Responding to the timing of the statement, when a case on the vaccine policy is in the Supreme Court, IDMA’s Daara Patel told BusinessLine , the two vaccine makers (Serum and Bharat Biotech) had projected they had enough supplies and were ramping up capacities further to cover the local population. Pointing to the massive vaccine shortages in the country, he said, it could get worse in the coming months. There are qualified vaccine makers in the country with the required facilities.

More companies can be roped in to make the vaccines and a technology transfer can be done with full regulatory oversight, he said, countering apprehensions that such moves could give rise to counterfeits in the market.

The recent shortage of Remdesivir in India is a wake-up call, IDMA said, urging that capacities of all medicines connected with the pandemic be ramped up to ensure availability at reasonable prices.