News and developments
Crisis of covid vaccines and role of Patents
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 WHOCompulsory 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:- whether any fund or grant was provided for research, development, and manufacture of the vaccines to Bharat Biotech and Serum Institute.
- plan to augment vaccine production