Generic Drug Production to be Impacted by UK-India FTA? 

Generic Drug Production to be Impacted by UK-India FTA? 

Serena Nath is an IPilogue Writer and a 2L JD candidate at Osgoode Hall Law School.

Recently, a controversial trade deal proposal between India and the United Kingdom (UK) was leaked.  The leaked portion pertains to the trade of intellectual property between the two countries.

UK-India Free Trade Agreement

In January 2022, India and the UK began negotiating a free trade agreement (FTA), aiming to double bilateral trade to $100 billion by 2030 via reduction or elimination of import-export tariffs between the two countries. Despite several setbacks, including but not limited to the high turnover of UK Prime Ministers, the deal seems to still be in the works.

The impugned IP portion of the proposal outlines demands by the UK to harmonize India’s patent and drug regulatory laws with those of the UK. These demands are far beyond what is mandated by  international trade rules.. The demands seem to be aimed at tightening regulations on producing, supplying, and exporting generic medications from India. Article E.10 of the IP chapter of the leaked proposal effectively prohibits pre-grant oppositions. This means that India would not be able to stop challenges to weak or invalid patents until after the granting of the patent. Article J.11 gives power to Customs officials to block generic drugs from leaving India for developing countries if a pharmaceutical corporation was to claim that their patent infringement by India-made generic drugs. Lastly, both Articles J.5 and J.7 seek to modify how courts adjudicate IP disputes, which are likely to “impact [Indian] judicial discretion.”

Implications of a Reduction in Generic Drugs

Due to these proposed modifications, many are concerned about the global supply of generic medicines because India is a dominating force for generic drug manufacturing. A decrease in the supply of generic medicines could have devastating impacts on global health, especially countries where medicine has historically been less accessible due to high costs — generic drugs are significantly cheaper than their brand-name counterparts, while having identical active ingredients. In fact, many studies suggest that brand name medications are not superior to generic medications.  With these potential impacts being so devastating, the medical humanitarian organization Doctors Without Borders/ Médecins Sans Frontières has asked both the UK and India to remove these provisions from their FTA.

At the time of writing this article, FTA negotiations continue. Hopefully, criticism of these provisions will lead to their modification or, if still found to be more harmful than helpful, their removal.