Trade-Related Aspects of Intellectual Property Rights (TRIPS) is an international agreement binding all the members of the World Trade Organization (WTO). TRIPS came into effect on January 1st, 1995. The agreement specifies the minimum standards of protection of Intellectual Property (IP), enforcement procedure, remedies, and mechanism for dispute resolution. Intellectual Property needs to be protected as it incentivizes the innovator which encourages the inventors to invent more and more and not incentivizing the same would discourage and disincentivize them. The Indian Patent Act, 1970 granted only process patents in the field of drugs, cosmetics, and foods till 01-01-2005. This regime made India World’s Pharmacy in generic medicines. However, Indian Patent Law was amended after the signing of TRIPS following which India shifted to satisfy the minimum criteria given – from process patents to product & process patents and introduced 20 years term for protection for patents in all fields of technology. Currently, we are facing a shortage of medicines, vaccines, and therapeutic equipment needed for the treatment of Covid-19 and since these are patent protected, they are not easily accessible and affordable for many. This is of larger concern as less than 15% of the Global population is fully vaccinated. So, the remaining 85% are still in danger.
In October 2020, India and South Africa together proposed to WTO to waive certain provisions of the TRIPS Agreement on Covid-19 vaccines, therapeutics, and drugs. These provisions are sought to be waived so that the Developing Countries and Least Developed Countries can also access and afford vaccines, therapeutics, and drugs.
The waiver is being advocated by the government on a global platform because in the regular course (without waiver) it would take a minimum of three years and up to seven years to achieve Global immunity through vaccines by the Least Developed Countries. One of the important reasons for a patent waiver would be that the government may not need to issue a Compulsory License (CL) as the government will be able to give several licenses as rights of the patent holders will be put on temporary hold. While talking about compulsory license, we need to note that compulsory license can only be given at places where patents are already registered. The Government of India has filed an affidavit in the Supreme Court that the government is not considering giving compulsory license as compulsory license alone will not enable actual drug manufacturing
Today, the number of vaccine manufacturers are less than what we initially expected because of the lack of manufacturing capacity. So, does that mean the waiver will ramp up the production? Well, the answer will be that “To ramp up the production we will need more licensing and more transfer of technology” The waiver will give access to the process but there are many essential elements that can be accessed only with co-operation.
The invention as filed in a patent application can also be used by the Central Government for government use without payment of royalty for the interest of the general public[1]. This can be done for Bharat Biotech’s COVAXIN Vaccine as well. The waiver will be useful in many countries (especially LDC’s) but will not be of much use in India as Bharat Biotech’s COVAXIN is government-funded and it can give compulsory license and help in vaccinating more and more people.
We have around 4 original vaccine manufacturers AstraZeneca/Oxford, Pfizer, Sputnik V, Bharat Biotech/ICMR, and Moderna (Many more are also coming up). Whereas, AstraZeneca made it clear last year that they would not enforce the Covid-19 related patents against vaccine producers and would also offer voluntary licenses. Apropos, they have given voluntary license to many manufactures in India including The Serum Institute of India with Rs. 75 per jab. As demonstrated by Pfizer, “it takes “280 components from 86 suppliers and highly specialized manufacturing equipment.” This will consume a lot of time for generic manufacturers to manufacture efficiently as a lot of different components as well as trade secrets are involved which cannot be bound by a compulsory license. According to a Reuters report, Pfizer is willing to manufacture its vaccine in India if it is assured freedom to price and export the vaccine which may not be suited to India’s population. Sputnik V is exported from Russia and is not providing any voluntary license. Further, Moderna is selling vaccines at their price and Bharat Biotech vaccines are being sold at government price.
Let us consider that the WTO General Council accepts the waiver, then what? We will need the support of the global vaccine manufacturers to manufacture in India as we are not familiar with the technology, process, and ingredients. The generic manufacturers will need time to reverse engineer the vaccine manufacturing process and produce a bioequivalent drug which would take from months to a year after which they will need to undergo clinical trials, the process which would be quite lengthy and time-consuming. Time is of the essence here. Also, as earlier stated, the vaccine manufacturing has multiple trade secrets which would make it difficult to reverse engineer the process.
This crisis that we are facing today is unprecedented. A global pandemic has been going on since 2019. To fight the global pandemic, we need a global solution. The only way to stop the spread further is by achieving Global Herd Immunity. To achieve this, we need to vaccinate more and more people, which, in turn, will need an uninterrupted supply of vaccines, and to manufacture vaccines by the companies we need a continuous supply of raw materials. Now, with the high demand for therapeutics, drugs, and most important vaccines, they need to be produced on a larger scale. One single company cannot produce for the entire country and meet the requirements.
Countries that don’t have the manufacturing capacity can’t develop even after the patents are waived. Even countries like India will be dependent on the actual manufacturing companies for technology transfer and technical know-how to manufacture vaccines including all the technical devices that are needed to manufacture the vaccine.
TRIPS waiver is opposed by many vaccine manufacturing companies like Pfizer, because they won’t have the same profit as they are having now, and another important aspect put forward is that Intellectual Property should be preserved and rewarded and not exploited.
The proposal submitted by India and South Africa has identified that Article 31 bis is unworkable in the present scenario. The proposal is for a larger good, not only for India but many Least Developed Countries where 100% vaccination may take years altogether. The existing lengthy and bulky procedure would only delay in achieving the Global Herd Immunity as the procedure would slow the vaccine export which is need of the hour.
However, we can be fair to say that the TRIPS waiver is not a complete solution for every country as it might give us access to the vaccines, but we will need the original manufacturers for trade secrets, technology transfer, and technical know-how. To achieve Global herd immunity, we need to be proactive in giving Voluntary licenses and reduce regulatory risks for vaccine suppliers to operate in India rather than routing for Compulsory Licenses. This can help the vaccine manufacturers to expand production and reduce administrative inefficiencies in procurement and distribution. As the World Health Organization has rightly said, “With a fast-moving pandemic, no one is safe, unless everyone is safe.” So, this strengthens the demand for TRIPS Relaxations.
The authors are – Dr. W. M. Dhumane, DPIIT-IPR Chair Professor at MNLU Mumbai and Gunjan Deshpande, Research Assistant to the Chair. (Opinions are personal)
Image from here
[1] Section 100 of Patents Act, 1970.
