Home » Patent Wavier: The Real Answer to Vaccine Shortage?

Patent Wavier: The Real Answer to Vaccine Shortage?

Second waves of the COVID 19 pandemic have been encountered by many countries around the world. The number of cases and the death toll are unexpectedly staggering, especially in developing countries like India. The first wave of the pandemic in 2020 had resulted in huge damages to livelihood, but the actual intensity of the disease and how bad it could get only became evident during the second wave. Various techniques like lockdowns and restrictions have been used to fight the pandemic, but all of these had consequences, mostly economic. Each nation had different carrying capacity for such measures and the poorer ones could not sustain them for too long. Hence, the only effective method to fight this pandemic seemed to be immunization and vaccination to all.

This has led to a vaccine shortage across the world. Therefore, talks began in international forums to waive the Patent rights of the manufacturers. This discussion dates back to October 2nd, 2020 when India and South Africa suggested that the World Trade Organisation (WTO) approve exemptions of IPR for various items used in battling the pandemic such as vaccines, ventilators, drugs etc. This discussion gained steam in May 2021 after the U.S. government came in support of wavier of patent rights of the vaccine manufacturers. Some countries supporting this decision are Russia, New Zealand and France. Others, like Germany, have spoken out against the move.

It is indeed commendable of the USA to support such wavier, but practical aspects of this decision must also be taken into account. The biggest problem after the wavier (in case one is finally passed) will be of technology transfer. This means though other companies may step-in for production of vaccines, they will have no access to the equipment, laboratories, technical knowledge, high level quality control and infrastructure needed for efficient production. The reverse engineering methodology used in case of making of generic medicines is also insufficient in case of vaccines, especially for the ones made using the new mRNA technology.

The availability of raw material is another issue as significant portion of the available raw material is already being used for vaccine production. Such a wavier would in turn disrupt the supply chain of the raw material and its optimal utilization. In addition, rounds of clinical testing of the newly produced vaccines will take time and effort and according to experts, it will take at least a year for new waves of vaccines to enter the market. This means that a wavier alone would not provide immediate relief.

That is not to say that a waiver would have no effects at all on the situation, only that in the present form such effects may take longer to see fruit than we’d like in a global pandemic. For efficient and effective vaccine manufacturing and distribution, innovative information and the technical know-how should also be made publicly available along with the Patent. Existing methods that can play a key role in accomplishing the motive of this wavier are compulsory licensing or voluntary licensing. I.e., either the Patent holders provide license their product to other companies by themselves for vaccine production or are compelled by the respective governments under any law to do so. In any case the technology transfer has to take place in the crucial time of pandemic to give a boost to the production of vaccine along with the patent wavier.

Looking at the situation, the temporary waiving of patent rights is the first barrier to cross. Without this impetus, the lack of patent rights will stop what could be a number of crucial soldier-companies in the fight against Covid-19. We must remember, however, that there are many more barriers to cross. In addition to the problems mentioned above, geographical constraints, supply chain constraints, trade barriers etc. are all problems aspiring vaccine makers will have to tackle. To effectively combat the pandemic crisis, all these issues should be holistically solved so that we can reach a conclusion agreed upon by everyone.

Author: Imran Rizvi, Legal Intern at PA Legal.

In case of any queries, kindly contact us here.