Patents on Covid vaccines can be canceled without harming companies like Bharat Biotech. here’s how

Workers unload boxes of Covaxin from Bharat Biotech in Lucknow, the capital of Uttar Pradesh, Sunday | Photo: ANI

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WWith the second wave of the Covid-19 pandemic wreaking havoc in the lives of people across the world, but even more so in India, it is increasingly urgent to vaccinate the entire population at the earliest. The flow The challenge lies in the mismatch of supply and demand, mainly due to the limited production capacity of vaccines. For India to achieve universal immunization, 1,878 million doses are needed – two doses each for 939 million adults. As there are only two manufacturers – Bharat Biotech and Serum Institute of India – with their current production capacity of 80 to 90 million doses per month, which could increase to 160 million doses by July 2021, there is a gap between supply and demand. to be bridged on a war footing.

To fill this gap, there is a growing clamor to invoke the provision of “ compulsory licenses ” under the Patent Act, 1970 as was done ten years ago for the treatment of cancer.

Also read: Sputnik V arrived on May 1 to boost vaccine collection in India, but is still ‘stuck’ in the lab for testing

Special case of license

In the case of a patented product, the compulsory license This provision allows the Indian government to grant manufacturing rights to other producers without the consent of the owner, especially in a national emergency. India’s first compulsory license was granted by the Indian Patent Office under the amended Hyderabad based drug maker act 2005 Natco in 2017. This enabled the company to manufacture and sell a similar version of Bayer Nexavar’s drug for the treatment of kidney cancer. The compulsory license was granted on the grounds that the vital drug was not available at an affordable price and that Bayer had not manufactured the drug to a reasonable extent in India.

In October 2020, India and South Africa had submitted a proposal to the World Trade Organization (WTO) for relax provisions in international agreements that govern intellectual property rights (IPR) for drugs and vaccines necessary for the treatment and prevention of Covid-19. Fortunately, some developed countries like United States and Russia have announced their support for the exemption from intellectual property provisions when the European Union opposes it and the United Kingdom, Canada, Japan and Australia have not yet made their decision. More than 120 countries have supported the proposal, while the 164 member countries of the WTO have yet to start negotiations. Under the prevailing circumstances, with the pandemic devastating both lives and livelihoods in large parts of the global economy, it may not be difficult to get WTO approval through a vote. majority.

As far as India is concerned, the medical experts are suggesting that through the open licensing method, vaccine technology could be transferred from Bharat Biotech to other manufacturers, as the vaccine was invented with the support of the Indian Council for Medical Research (ICMR). However, it is important to understand that ICMR support can be compared to banks providing financial support to startups. So, this does not mean that one can remove the DPI from the vaccine manufacturer because Bharat Biotech is a separate entity, not part of the government. Even among different PSUs or government departments, legal disputes often arise as they are all individual entities.

However, in the current state of the pandemic, a humanitarian approach is needed and there may be no complaints or opposition if traditional norms are violated, either at the WTO level. or at the national level. On the other hand, would it not be better for a balanced approach to be adopted taking into account not only the immediate vaccine supply, but also future needs?

Also read: Even if WTO waives patent rights, no country can start manufacturing a Covid vaccine immediately

Fight against opposition to waiver

To begin with, the exceptions adopted today to guarantee universal vaccination are only a purely temporary measure to cushion people as much as possible. ten months. According to medical experts, one or two more doses of an improved version of the vaccine will then be needed to be followed by a lifelong vaccine. In addition, a vaccine for children under 18 has yet to be developed. The point is that today the whole world is looking to scientists for their help and efforts. So is it fair to discourage scientific talent, whether at the WTO level or at the national level? After all, medical inventions involve the talent, time and energy of scientists besides the money of promoters.

Equally important is to understand and not deny that the issue of intellectual property rights has been built into the trade agenda. In the pre-WTO era, developing countries, including India, allowed the manufacture of the patented product by other manufacturers by changing the manufacturing process. Subsequently, these companies also started to export cheap drugs, thus making a profit. The TRIPS Agreement has thus become essential for resolving trade disputes relating to intellectual property rights at the international level. Therefore, countries like those in the European Union, which have reservations for the relaxation of IPRs, can be convinced with assurances at the WTO that drugs to cure and prevent the coronavirus would only be used for one. domestic use and not for export. In addition, there should be a provision for appropriate recognition for the original patent owner.

So, when it comes to relaxing the IPR provisions for Covid-19 vaccines, or for that matter all essential drugs, it is high time that nations act with a humanitarian angle at the WTO, but it is equally important not to discourage research and development efforts. . In addition, patent companies should be encouraged to explore technology transfer to facilitate the manufacture of vaccines and drugs in a shorter period of time and with the payment of some kind of royalty.

Domestically, attempts should be made to transfer technology from companies like Bharat Biotech to manufacturers with the requisite potential and know-how. However, the brand value should be with Bharat Biotech with some sort of franchise arrangement. The company’s R&D expenses must be offset by an appropriate pricing policy.

Dr Jagdish Shettigar is Professor of Economics at the Birla Institute of Management Technology, Greater Noida, and a former member of the Prime Minister’s Economic Advisory Council.

Dr Pooja Misra is Associate Professor, Economics, Birla Institute of Management Technology, Greater Noida. Opinions are personal.

(Edited by Prashant Dixit)

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