Top Pharma Firms Urge Govt Not To Amend Patents Law, Fearing The Effect Of Cheap Medicines

The top Indian pharmaceutical companies have urged the Union government to maintain its stance on the Patents Act as it negotiates proposed Free Trade Agreements (FTAs) with the United Kingdom, the United States, and the European Union, expressing concerns that such agreements will harm affordable healthcare.

For some months, India has been negotiating FTAs with the United Kingdom, the United States, and the European Union, with the agreement with the United Kingdom scheduled to be signed this year. When India signs these treaties, it shall be obliged to amend its patent legislation. The FTA will also supersede India's trade responsibilities under the World Trade Organization's agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

The Patents Act of 1970 assures that patents are not used against the national interest and shortens product patent durations. Furthermore, as a TRIPS-compliant country, India provides 20 years of protection to any pharmaceutical product from the date of the patent application.

Drug companies stated in a letter sent last month to the Union Ministry of Health and the Department of Pharmaceuticals (DoP) following the recent discussion, there is a provision to extend the monopoly of patent holders by extending the life of a patent on medicine beyond 20 years, thereby delaying the entry of generic medicine." 

According to the representation, some innovative businesses produce small changes to proprietary medications, seek another "full" term of patent protection on these minor modifications, and repeat this procedure for as long as possible.

According to media sources, there is also a discussion going on, of implementing the Regulatory Data Protection regime, sometimes referred to as "data exclusivity," for new medications in trade accords with the United States, the United Kingdom, and the European Union.

Data exclusivity is a sort of intellectual property protection that ensures that a generic medication maker cannot depend on an innovator firm's data for a specified period to get drug approvals, slowing the market entry of generic drugs.

"This goes beyond the TRIPS agreement, which stipulates the protection of test and other data for new chemical entities required to be submitted for regulatory approval from unfair commercial use," Indian firms warned in a letter to the government.

According to government data, India is one of the leading suppliers of generic medications, accounting for roughly 20% of global exports.