As the Corona vaccines are innovative products, they are protected by patents and intellectual property rights. It is natural to avail of the benefits of innovation by a company so as to recover the heavy investments made in research and development. However, in extraordinary times, the innovative companies can co-operate with other companies to scale up the manufacturing of innovative products and to save lives. The US government supports the IP waiver for vaccines and the World Trade organisation (WTO) of UNO will have to do the negotiations with the vaccine patent holders and others. This move has come in response to a joint proposal put forth by India and South Africa at the WTO to suspend the IP rights for vaccine-related technologies under TRIPS for a yet-to-be-specified time period. A consensus must be reached to scale up the production and make timely availability of vaccines possible. Pharma companies are not likely to be amused, as their rights are adversely affected. However, for the greatest good of maximum number of people, a trade off is called for.
Still things are not easy. Vaccines are not chemical products which could be copied easily. They are biological products and the manufacturing process is complex. A slight glitch can render the whole batch ineffective. There are different cell lines, adjuvants and equipment. At the very best, the companies must have access to cell lines of the innovator company. IP is not enough. The innovative company has to partner with the other companies to pass on the know-how and develop the process. Even after patent waiver and know-how transfer, there could be a time gap, say nine months to a year to make an mRNA vaccine.
After making the drug substance, capacities are to be built. Reverse engineering of the vaccine is difficult. It also requires fresh clinical trials before regulatory approval. The process is very sensitive. Minor changes can affect the output. Lengthen the fermentation and the output fails. Every nuance counts.
Indian Government should have made investments in the vaccine companies at the right time as the US government did — it ploughed $ 10 billion at the stage of concept development. India did not make similar investment till the vaccines were scientifically proven and received approval.
IP is not a barrier, as it is made out to be.
It is necessary to focus on vaccine distribution. The limiting factors are the new technology and global limits on supplies. There is no mRNA in manufacturing capacity in the world. It is a new technology and limited manpower is available to harness it. Even if the manpower is available, mRNA vaccine manufacture process is to be developed, its machines have to be bought, its verification processes and its analytical processes are put in place. It requires funding and new manufacturing sites. There should be expertise transfer to the new manufacturer.
What if the manufacturer uses the technology in areas outside of Covid-19? Can restrictions be placed on such use? Even if placed, can they be enforced?
Even if the waiver is adopted at WTO, it is possible that vaccine innovators would negotiate for some payment, though lesser than what they would have paid under the licensing arrangement.
India has urged EU leaders to support TRIPS waiver at WTO. The PM has sought support from G7 nations for TRIPS waiver. India’s IP waiver proposal is backed by over 60 countries. In July 2021, WTO ambassadors will be given a report.