IP waiver proposal may open door to counterfeits: OPPI

As a global proposal from India and South Africa to waive intellectual property (IP) on Covid-19-linked health technologies garners support, the Organisation of Pharmaceutical Producers of India (OPPI) has countered that such a move “will neither lead to increased production of vaccines nor increased deployment”. Instead, they caution, it could open the door for counterfeit vaccines.

OPPI’s response comes days after the US put its might behind the IP waiver for vaccines during the pandemic period, a move that is expected to swing the support of other countries that may have earlier opposed the proposal at the WTO.

“IP is not the barrier to adequate availability of vaccines in India. Waiving of intellectual property rights could impact patient safety by opening doors for counterfeit vaccines to enter the supply chain. There is also a risk of diverting precsious raw materials and ingredients necessary to produce the vaccines from high-quality manufacturers to inexperienced ones, further disrupting the existing manufacturing capacity,” it said, adding that the move may also stifle further investment in research that was instrumental in delivering new vaccines and treatments against new virus variants. OPPI largely represents multinational drug companies.

“We are cognizant that with the rising Covid-19 cases in India and in other developing nations there is an urgency to rapidly produce greater quantities of vaccines. Vaccine manufacturing is a complex process and scaling up capacities involves the transfer of critical know-how. We believe this can only be optimally achieved when vaccine manufacturers are able to scale up capacities at their production sites and/or through licensing agreements with other manufacturers, along with supply agreements with governments to make required quantities deployed rapidly and reliably,” they said.

“With indigenously developed and manufactured vaccines already available for distribution, and additional global vaccines on the way, it is pertinent to determine and resolve actual barriers to increased availability in order to ensure that a larger number of Indian citizens are immunised against Covid-19 at the earliest,” the note said.

“Innovation is the bedrock on which the research-based pharmaceutical industry is founded,” the note said, adding that the global pharmaceutical industry and has helped develop not one but several vaccines within months of the onset of the pandemic.

The OPPI note further outlined a slew of tech-transfer collaborations, including, AstraZeneca and Serum Institute of India, Johnson and Johnson and Biological E, Gilead’s voluntary licenses to a clutch of generic companies on remdesivir, besides pointing out that Pfizer was the first to approach the Indian regulator on its vaccine, for an emergency approval, among others.

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