Not Just TRIPS Waiver, But Transfer of Know-How Also Required

Big pharma industries are not in favour of sharing the rights and know-how needed to produce vaccines, citing intellectual property pilferage concerns.

By Dr. Amar Patnaik, 

Quick vaccination against COVID 19 is the only hope in ending the global pandemic which has claimed more than 3.4 million lives so far. A hindrance to mass production of vaccines is the intellectual property rights enjoyed by their manufacturers under the WTO’s Trade-related Intellectual Property Rights (TRIPS) regime. Big pharma industries are not in favour of sharing the rights and know-how needed to produce vaccines, citing intellectual property pilferage concerns. South Africa and India have proposed last year in the October 2020 meeting of the World Trade Organization that a waiver of these patent rights would permit pharmaceutical manufacturers across the globe to manufacture vaccines using the same patented formula without fear of being legally prosecuted for intellectual property infringement. This will help meet the imminent global demand for vaccines, treatments, and other equipment.

Waiver to enhance production and supply of vaccines

Globally, the annual vaccine production has fluctuated between 3.5 – 5.5 billion doses. The onslaught of the Covid-19 induced pandemic has brought to fore a formidable challenge for the vaccine producers. It is estimated that by the end of 2021, the global vaccine demand would be at 14 billion requiring the many fold expansion of the present capacity.

In India, we would need about 168 crore (to vaccinate 60% only) doses against which the current production capacity is 7.6 crore doses which is planned to be augmented to 13 crore doses. But even with this increased capacity, it will take 13 months to cover the entire population – a timeframe we do not have the luxury of enjoying.

Given the already escalating current vaccine shortage in India which has to vaccinate its 1.40 billion population not with just one dose, but two doses in most vaccine types and not just once this year, but may be every year thereafter and besides, most of Africa has to be vaccinated as well, hence, timely and affordable vaccine would continue to be a global concern until everyone has been vaccinated. In order to meet such humongous global demand, there is utmost necessity to quickly ramp up the manufacture and supply lines. Failure to do so may result in continuing and sometime more virulent forms/strains of the virus due to potential to mutate multiple times.

There are some ill-conceived criticisms that relaxation of TRIPS regulations might affect vaccine quality. Relaxation of intellectual property rights of the vaccines is unrelated with its quality. The World Health Organization (WHO) runs a Covid-19 pre-qualification program to ascertain the quality of vaccines, where producers are required to submit their products for thorough assessment. This is like a filtration process where vaccines that do not pre-qualify for the WHO program are kept out of programs like Covax which aspire for vaccine equity especially in economically weaker nations. Besides, new on-site quality assurance mechanisms can also be introduced. The United States of America has heeded to global call and supported a temporary relaxation of fiduciary obligations of Covid-19 vaccines.

Waiver is not enough

The acceleration of vaccine production is not solely centred around the issue of intellectual property rights. Waiver of TRIPS is an important step, but it has to be supported by transfer of technology, sharing of the know-how and also increased access to raw materials that are required for vaccine production. The WHO backed Covid-19 Technology Access Pool (C-TAP) was meant to facilitate such transfers. However, so far vaccine producing companies have refused to engage with the pool as it is a voluntary mechanism.

Also, time is the essence. Hence, even if the TRIPS relaxation were to come through, it would take time to build consensus which the world does not have and countries like India & China most certainly do not. Hence, these manufactures must tie up with local manufactures, build their capacities through on-site technology and know-how transfer through actual handholding and training and start manufacturing in that country itself without having to be concerned about breach of their intellectual property rights. This would make storage, transportation, and other logistics arrangements in the supply chain cheaper and easier to handle, thus keeping the cost of vaccines low.

Conclusion

The current vaccine production and sharing schematics suggest a wide inequity between the rich and the poor nations. Whereas the richer countries would immunize a fair share of their population by mid-2022, the poorer nations would have to wait till 2024. It should be noted that if the current vaccine inequity persisted it would lead to 2.5 million additional deaths. These deaths are avoidable, but it would call for a cohesive global effort. The rich nations would have to choose the path of cooperation over competition. They would have to support other nations in appending their institutional capacity and at the same time display leadership to circumvent regulatory hurdles. While TRIPS waiver could be an important step, alternatives have also to be explored very fast as no one is safe unless everyone is safe.

The columnist is a Member of Parliament, Rajya Sabha from Odisha. Views expressed are the author’s own.