While it is still early days for Natco’s application, sources indicated that a blanket use of compulsory licence – a provision available in WTO’s TRIPS agreement – may not be a good idea.
Amid suggestions to use the tool for Remdisivir and Tocilizumab, two drugs that are being used, government sources said that it made little sense to invoke compulsory licensing provisions, given that the active pharmaceutical ingredient (API) is not available in the country. “It will not solve any purpose as you will need the basic chemicals too,” said a government source.
Under India’s Patent Act, relaxations can be given under half-a-dozen situations. Natco has used among the more controversial section 92, which allows the Centre to invoke compulsory licensing provisions in case of due to a national emergency, circumstances of extreme urgency or in case of public non-commercial use.
The use of the provision to waive Bayer’s rights over a cancer drug almost a decade ago had generated considerable controversy with the US expressing its displeasure. Over the years, the commerce and industry ministry has resisted pressure from the health ministry to use the clause, arguing that it’s to be used in the rarest of rare cases. Officials said that this is time consuming as well.
Former PM Manmohan Singh had recently pointed to possible use of compulsory licence and other flexibility under the Patents Act to boost vaccine output.
There are other provisions too, which are simpler. For instance, section 47 allows the government to import patented drugs for its use or for use in hospitals and dispensaries, which is seen as a non-controversial use. Similarly, under section 100 it has powers to use certain inventions either before a patent has been granted or even after the rights have been given to the inventor.
Sources indicated that while the government has powers to use compulsory licence as a tool, especially when WTO members such as the European Union have supported its use, it will prefer the TRIPS waiver window, for which negotiations are expected to begin shortly.