Left Unchanged, Trade Deal Threatens Global Access to Affordable Medicines
Leaked text reveals trade implications for global medicine access.
By Anmol Gupta
Often considered the world’s pharmacy, India is the third largest pharmaceutical producer, manufacturing 20% of the world’s generic medicines and 50% of the world’s vaccines. India’s robust generic medicine sector has developed, in part, due to its distinct patent laws, dating back to the 1970s. Yet today, a proposed bilateral free trade agreement between India and the United Kingdom (UK) threatens to jeopardize this 50-year-old generic industry and the provision of affordable medicines for patients around the world.
India and the UK began bilateral trade negotiations in early 2022. Estimated to double commerce between the world’s fifth and sixth largest economies respectively, a new free trade agreement will be of major consequence to both nations, symbolizing one of Britain’s biggest deals post-Brexit and strengthening India’s economic significance in the Indo-Pacific. The negotiations, however, have been unusually riddled with controversy—from missed deadlines and elusive consensus on scotch whiskey tariffs to provocative comments from Britain’s Home Secretary on Indian immigrants overstaying their visas—and have teetered on the verge of collapse. On October 31, another controversy was added to the list, this time in the form of a leaked chapter from the ongoing negotiations.
Leaked Text
Published by bilaterals.org, the leaked chapter on intellectual property (IP) exposes efforts by the British government to expand what constitutes a novel innovation worthy of patent protection. It goes far beyond international IP rulesgoverned by the World Trade Organization (WTO). If ratified, the UK’s proposal will allow drug companies to patent new medical uses for existing drugs. Under the trade agreement, manufacturers will be able to obtain new patents for identifying new medical uses of existing products—a practice already common in the western hemisphere—that India will be forced to recognize and respect. For example, AstraZeneca’s Farxiga, initially developed for the treatment of type 2 diabetes, has gained 15 years of additional market exclusivity after being found useful in the treatment of heart failure.
The draft text also reveals that the UK is seeking India to require that patentable “improvements” need not prove an increase in efficacy or value. This would leave the door open for corporations to liberally patent trivial changes in order to expand their market exclusivity. This practice, termed evergreening, is pervasive in the industry and often used to thwart generic competition that is critical for bringing down the cost of medicines.
Other proposals outlined in the leaked text would force India to extend patent monopolies by several years, change the ways in which its courts can adjudicate patent disputes, and restrict the ability of third parties to challenge patent applications. The language offered by the UK also reverses several WTO-granted rights that allows India to award licenses to generic manufacturers to produce patented medicines.
Left unchanged, the proposed measures will invalidate major parts of Indian patent law which has, until now, made it difficult for companies to claim market exclusivity on old products with inconsequential changes. India’s approach to IP has fueled the development of a robust generic industry that countries of the Global South and large NGOs, like Médecins Sans Frontièrs (MSF), have relied upon to affordably treat people with HIV, tuberculosis and malaria. Yet, if the UK government has its way, India may no longer remain the reliable source of reasonably priced essential medicines that millions depend on.
Status Quo as Usual
Rather ironically, the UK’s National Health Service (NHS) will not be immune from the proposals outlined by its own government: UK citizens depend on India for supplying roughly 25 percent of their drugs. Amid an ongoing NHS workforce crisis and an unprecedented cost of living crisis, the loss of this reliable and affordable supply of critical generic medicines will likely have an alarming effect on the financial and operational health of the NHS.
Nevertheless, the UK’s position should come as no surprise. The government has a record of protecting the business interests of some of the world’s largest brand-name pharmaceuticals, like GlaxoKlineSmith and AstraZeneca, that call England home. More recently, Britain was one of a handful of nations to use its power to block a proposed IP waiver that would temporarily allow countries access to the knowledge and technology needed to manufacture their own COVID-19 therapeutics and vaccines. Instead, political leaders in London held over a hundred meetings with pharmaceutical lobbyists during the course of the pandemic and propped up dubious arguments that such a waiver would stifle private pharmaceutical revenue and investments, ignorant of pharmaceutical companies’ record profit parades and the overwhelming use of public funds to finance the development of COVID-19 vaccines.
The leaked draft chapter highlights a continuation of the status quo and another attempt from Britain to enact protectionist policies on behalf of its $26 billion pharmaceutical industry, even if at the potential cost to its own citizens and global health.
Hope for a Better Deal
After five rounds of negotiations, a deal between the two countries has yet to be reached. With another new Prime Minister at the helm of the UK, there is promise for a final agreement by spring next year. But in light of the leaked draft, all eyes are on India and if it will prove able to remove the proposed patent barriers and steadfastly protect its own generic industry. And as the Modi government rolls out its own policy to strengthen small pharmaceutical manufacturers at home, a fresh opportunity emerges for Indian negotiators to better align domestic and foreign interests.
With the backdrop of an ongoing debate on medicine access spurred by the global inequities of the pandemic, the leaked draft is another stark reminder that free trade is of critical importance for the development of a fair and inclusive drug supply. As members of the multilateral international order continue to debate changes to an outdated patent system governed at the WTO, modern bilateral trade agreements represent an opportunity for individual states to spur policy innovation and piecemeal reform a system that has long been out of balance.
Now India, with public scrutiny on its side, has a renewed chance to try and do so.
Anmol Gupta is a Master of Public Policy candidate at McGill’s Max Bell School and a Doctor of Medicine candidate in the United States. Anmol has an interest in improving global health governance and using policy to increase equitable access to medicines.