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The current pandemic has rudely exposed our under-preparedness in the health sector be it provision for sufficient oxygen plants, beds, drugs or vaccines. Patients are dying gasping for breath and forced to approach the Courts for simple things like covid drugs, beds, oxygen or other items which should otherwise be a given. Court intervention in many cases has given some relief; though it is only partial relief and not a substitute for healthy medical infrastructure.

Could this Tsunami have been averted? May be, may not be. But when vaccine emerged as a trump card and was rolled out in Jan 2021, it should have been our endeavour to swift and speedily vaccinate the entire population instead of part-vaccination and indulging in vaccine diplomacy.  Unless we change gears and move towards quickly vaccinating the population, the pandemic will reincarnate itself in several waves and continue to devour us mercilessly.

Be that as it may, the announcement from the Biden administration on waiver of IP rights for vaccines comes as a ray of hope. Would this solve the problem on hand? 

While IP waiver would help to democratize vaccine production, it is not the panacea to our present problem we will still need to do much more including ramping up our manufacturing capacities, arrange raw materials, etc. Hence apart from IP waiver, we also need a waiver of rights on raw materials, open access to the latent knowledge which is in the form of trade secrets and know-how of the vaccines.

Taking a few steps back, the current situation is one where the demand for vaccine of more than 2 billion doses far exceeds our home annual capacity which is not more than 100 million; this does not take into account the commitment the companies such as Serum Institute may have with their partner Astra Zeneca. Largely disproportionate.

Therefore we urgently need to distribute & diversify manufacturing – be it of vaccines or covid- drugs, diagnostic kits and devices and accelerate manufacture and distribution. And what better than the tool of Compulsory licence which is inbuilt in the Patents Act, 1970 comes. Remember, the Biden statement is only on vaccine; covid drugs and testing kits may not be included. 

The Patents Act envisages two categories of compulsory licence- a) voluntary licence b) licence granted under conditions of ‘national emergency’, ‘public health crisis’ or ‘extreme urgency’ i.e a situation of the kind that we are faced with. c) use of inventions by the Government i.e where the government takes over the invention in return for compensation paid to the Patent owner. The compulsory licence could also operate for a limited period or the entire term of the Patent.

Given that we already have a pandemic on our hands and it is a national emergency, as contemplated under section 92 of the Patents Act, this is a classic case where the Government should not hesitate to exercise its powers under this provision and empower as many entities as possible to manufacture covid drugs, vaccines and testing kits, subject to appropriate regulatory approval. This way one can diversify the manufacture and empower generic manufacturers to produce generic versions of the drug, without fear of unnecessary and prolonged patent litigation.

Russia has lead by example and using similar provisions, has already granted a compulsory licence for remdesivir. Gilead has challenged this in a lawsuit. The same is with Hungary who has granted a compulsory licence for remdesivir.

On similar lines, it is open to India to issue a compulsory licence for remdesivir, favipiravir, baricitinib or even tocilizumab as it these currently protected by layers and layers of patents. Not only would the circulation of the product increase, but would ensure access and availability as the entry of multiple has a price lowering effect. Companies may also apply for a compulsory licence as there are enough grounds to justify such a grant in the current situation.

As for vaccines, the patent on Covishield of  Astra-Oxford licensed to Serum Institute is pending. Bharat Biotech’s vaccine is apparently partially funded by the Government of India and probably licensed to public sector undertakings for manufacture. Moderna has publicly committed that it would not be enforcing its patents. And Russia has given voluntary licence to several entities. This being the position, we still do not have many takers – and that is the area to be worked on.

Big Pharma’s argument that if a compulsory licence is issued, there is no incentive for anyone to invest in newer drugs is entirely misconceived, to say the least. Pfizer’s vaccine originates from the University Of Pennsylvania. The Astra vaccine has its origin in Oxford University. ICMR (Indian Council of Medical Research) had an important role to play in the development of Bharat Biotech’s vaccine. Thus, most of the vaccines are publicly funded. They did take a risk while exploring these vaccines for which modest compensation is being offered. Therefore, the no-incentive theory has no room.

Greater than the amount of compensation to Big Pharma, their investment or risks are undertaken, there is a more critical question: can profiteering gain prominence over the lives of people at the time of a pandemic?  Whither public good and right to health, right to life guaranteed under Art 21? Is it only on paper? What is the final purpose of the drugs and vaccines – is it not for people?

Because the Government and people started celebrations too early after the first wave of the pandemic, the ‘pharmacy of the world’ has had to import drugs and vaccines for its citizens.  Limited use of this powerful weapon of compulsory licence to many entities would free vaccine and drugs from IP stranglehold and distribute to other entities. The Supreme court and the Delhi High Court have given enough hints to the Government to consider the use of these provisions. 

Anticipating the use of such emergency powers, Katherine Tai, US ambassador has announced that the US would consider patent waiver on vaccines. EU, New Zealand and few other countries have joined patent-waiver bandwagon; it is not clear as yet whether this is a simple announcement and whether it would be followed by concrete steps. As we all know, unless there is a bilateral agreement between the US and India on these issues, and a strong signal is sent to Big Pharma, announcements are nothing short of lip service. Of course, at WTO, the negotiations may take months and one could see some outcome later in the year.

Close on heels of the announcement of a patent waiver on vaccines, and in order to avoid compulsory licence, Big Pharma should consider voluntary licensing and also put brakes on the infringement suits filed across the country to enforce their patent rights, be it on vaccines, drugs or testing kits. It would not only reinforce the confidence of the public in their products but is also the right medicine for the needy. A voluntary licence would also provide access to know-how and technology which is vital at this hour.

Apart from patents and IP, the Government must consider granting expeditious regulatory approval to covid related drugs or vaccines.  

Every life counts. Every life is precious. Let's not rest until the mission to ensure drugs for all is achieved- we, the government and the people.