India is under the second wave of covid-19 facing a major public health crisis. There is a rush among people from all walks of life to get vaccinated as the Government has opened the vaccination for 18-44 years (until now, vaccination was only being provided to 45 and older). This immediately brought into focus India's readiness to vaccinate a large percentage of the population, stock available, and the price of vaccine.

In few days of commencing the programme, it became apparent that there were not enough stock, and many States have already stopped inoculating those below 45 years, primarily to make available vaccines for those that have already taken the first dose almost 4 weeks earlier and are in need of the second shot. With more than 3000 pharmaceutical companies in India, it is perplexing that only two companies - Serum Institute, manufacturer of Covishield (under licence from AstraZeneca) and Bharat Biotech, manufacturer of Covaxin have license and know-how for producing the Covid vaccine.

Vaccinating 1.3 billion

The challenge of vaccinating a sizeable population, assuming 70% of the 1.3 billion Indian population is required to be vaccinated to build herd immunity, is a daunting task. This would mean Indian requirement is 1.89 billion doses and the current supply is 540 million in a year, which may be scaled to 600-650 million in the next few months. With the current capacity, it is estimated to take 3.5 years to vaccinate 70% of India's population.

Tackling Supply-demand gap

Several options have been mooted in the backdrop of supply constraints, including procuring vaccines from foreign manufacturers. Earlier, the government was not so keen but in the face of mounting pressure, the policy has been relaxed, allowing bridging trials of the foreign vaccines simultaneously with its market deployment as opposed to the earlier requirement of conducting bridging trials prior to market deployment. The new policy covers vaccines that are approved by the USA, UK, EU, and WHO

Compulsory Licence for Covid Vaccines

One of the options that is being debated at the policy level, Courts, and Government is to invoke the compulsory license to shore up the manufacturing of vaccines by including more and more companies, for combating the situation. Supreme Court in Public Interest Litigation (PIL) has already asked Government if invoking the licensing provisions under Indian Patent Act will help with the availability of vaccines. The Indian Patent Act has provisions under section 84, 92 and 100 dealing different circumstances in respect of seeking license of a patent. At the same time, India and South Africa have mooted a resolution at the WTO for one-time waiver of the Patent rights over Covid related patents. However, the idea is being objected to by various developed economies and pharmaceutical companies. The argument being any Patent waiver disincentivise investment in R&D and stifle innovation. Further the reports suggest that there is no Patent protection for Covid vaccines in developing and low-income countries. Thus, there are no Patents to be licensed. Overall, there is a realism in the argument that the most significant issue around augmenting covid vaccine supplies is the lack of production capacity and raw materials.

Under section 92 of the Indian Patent Act in case of national emergency or in circumstances of extreme urgency or in case of public non-commercial use, the Government can grant license for a patent to the other parties. Thus, in the present situation, the Government can issue a notification for the extreme emergency and the interested companies can apply to seek the Patent license. However, merely approving a license to use a patent will not enable companies to manufacture the vaccine. A license will allow use of a Patent and the information that is publicly disclosed in a patent. However, it may not be enough to roll out safe, effective, and quality vaccine/drug efficiently unless the patentee shares the technical know-how, which does not form part of the patent document/ specification. The scarcity of raw materials for which India is dependent on USA and other countries is also a concern and needs to be addressed. Thus, it is not only the patent rights that are stopping the bulk production of the vaccine but also factors beyond Patents such as infrastructure/production capability, supply of raw materials, quality set-up, technical know-how and trade secrets.

Scaling up COVAXIN

It is becoming a pertinent question why the Indian Government cannot use its power to grant licenses for Covaxin, developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) a government body. Recently in a PIL before the Supreme Court, the court sought to know from the Government:

1. whether any fund or grant was provided for research, development, and manufacture of the vaccines to Bharat Biotech and Serum Institute.
2. plan to augment vaccine production

In response, the  Government submitted an affidavit, in the Supreme court, disclosing that the sale of Covaxin will yield 5% royalty payments for ICMR since the intellectual property governing the use of the vaccine was shared by them. Further mentioned that ICMR did not fund either Bharat Biotech or Serum Institute of India (SII), it only spent 350 million and 110 million respectively, on clinical trials.

The government also disclosed that it had allocated an amount of INR 2 billion for supporting augmentation of capacities for manufacturing COVAXIN and expect production of nearly 100 million doses/ month in the next 8-10 months. The vaccine manufacturers recommended for support are Bharat Biotech, Hyderabad; Indian Immunologicals, Hyderabad; Haffkine Biopharmaceuticals, Mumbai; Bharat immunological and Biologicals, Bulandshar.

To Sum Up:

The whole vaccine debate has patents, political and diplomatic issues intertwined. While on the one hand, there is an urgent need to have the Indian citizens vaccinated on a war footing. The shortage of vaccines and limited production capacity is a reality that India faces. The Government is in a tight spot as it navigates this phase, balancing the country's interest and adhering to its international obligation. The statement of the Government, by way of affidavit, in the PIL before the Supreme Court sums it up “Any exercise of statutory powers either under the patents act 1970 read with Trips agreement and Doha declaration or in any other way can only prove to be counter-productive at this stage, the central Government is very actively engaging itself with global organisations at a diplomatic level to find out a solution in the best possible interest of India. It is earnestly urged that any discussion or a mention of exercise of statutory powers either for essential drugs or vaccines having patent issues would have serious, severe and unintended adverse consequences in the countries efforts being made on global platform using all its resources, good-will and good-offices through diplomatic and other channels”.