By Shail Patel
The race to finalize the long-stalled India-EU Free Trade Agreement by the end of 2025 masks a potentially devastating threat to global health access. Concealed behind the optimistic language of strengthened economic ties lies a crisis far more dangerous than any trade war it may prevent. Specifically, the agreement’s proposed intellectual property provisions aim to justify high R&D costs and preserve EU market control. However, these measures severely undermine India’s critical role as a “pharmacy [for] the developing world,” with profound consequences for millions of patients across the globe.
Prime Minister Modi and European Commission President Ursula von der Leyen announced the accelerated timeline on February 28th, 2025, establishing the agreement as an economic safeguard and justification of the global financial status quo. In light of growing uncertainties across the international landscape, particularly with Donald Trump’s proposed 25% tariff on EU goods looming large, European officials have scrambled to expand business relationships beyond the unpredictable American market. Thus, while the geopolitical rationale appears logical, the rushed negotiations inherently risk sacrificing global health security for economic gains.
The significance of India’s generic pharmaceutical industry cannot be overstated, as most of the world remains oblivious to its contributions. India currently produces 20% of global generic exports, supplies 40% of U.S. generic demand, and manufactures 50% of vaccines globally. Far more than mere statistics, these figures represent a lifeline for patients in low and middle-income countries. The industry’s impact is perhaps most evident in HIV/AIDS treatment, where Indian manufacturers have transformed once-prohibitively expensive therapies costing $10,000 annually into accessible medications priced below $80—a 99% reduction that has revolutionized treatment accessibility.
“Our reliance on Indian generic drugs for treating patients with HIV/AIDS across all our programs is particularly acute—around 80 percent of the AIDS medicines we use are generic drugs made by Indian companies,” explains Janice Lee, a pharmacist with Médecins Sans Frontières (MSF). “But it’s not just AIDS. In other projects too, we also routinely use Indian generic drugs to treat other diseases, such as TB, malaria, and a wide range of infectious diseases.”
This remarkable achievement stems from India’s carefully calibrated intellectual property framework established in the 1970s, which allowed patenting of pharmaceutical processes but not products. This strategic policy decision enabled India to build robust manufacturing capacity while ensuring public health priorities were not subordinated to commercial interests. The approach has enabled Indian companies to pioneer fixed-dose combinations that simplify treatment regimens and improve patient adherence in challenging healthcare environments.
Nonetheless, published 2022 documents from the trade negotiations reveal intellectual property provisions that would fundamentally disrupt this system, the most concerning of which regards data exclusion. If agreed to, the policy would prevent Indian regulators from utilizing existing clinical trial data when approving generic versions of medications. This effective secondary monopoly system would force Indian manufacturers to either wait additional years or replicate costly clinical trials—an unnecessary, unethical, and financially prohibitive requirement.
The FTA also proposes patent term extensions through supplementary certificates extending monopoly protections beyond the standard 20-year period. These provisions and enforcement mechanisms exceeding current World Trade Organization requirements would create significant legal barriers to generic production. As a result, generic medicines would reach the markets anywhere between five and ten years later, resulting in countless preventable deaths and suffering.
Previous incidents already demonstrate the potential for disruption. Indian generic medications have been seized in EU countries during transit to other destinations, interrupting supply chains even when no laws were violated. The proposed investment protection clauses would further empower pharmaceutical companies to sue governments over policies favoring public health, as exemplified by Eli Lilly’s $500 million lawsuit against Canada in 2013.
The consequences would reverberate throughout global health systems. Healthcare providers in resource-constrained settings would face impossible choices as medication costs rise. MSF warns that while generic second-line HIV treatment costs approximately $465 annually, branded alternatives cost hundreds more. For third-line treatments, where patents already limit generic production, costs exceed $3,200 annually—utterly unaffordable for most patients in developing countries. Children would be particularly vulnerable to these changes. “Most AIDS medicine formulations for children only come from generic manufacturers in the first place,” notes Lee. “Currently, the most commonly used generic fixed-dose combination for treatment of HIV/AIDS in children costs $55 to treat a child for one year.” Without these affordable pediatric formulations, treatment options for children would become severely limited.
Humanitarian organizations would also find their operations significantly constrained. Major international treatment providers, including the Global Fund, PEPFAR, and UNICEF, rely heavily on affordable Indian generics to extend their limited resources. During a time when funding for global health programs is already shrinking, maintaining the flow of affordable medications becomes even more critical.
The India-EU negotiations need not produce this zero-sum outcome. Alternative approaches should balance legitimate commercial interests with public health imperatives. The agreement could explicitly preserve the flexibilities outlined in the Doha Declaration on TRIPS, maintaining policy space for public health measures, including compulsory licensing. Specific carve-outs could be established for essential medicines, applying standard TRIPS requirements rather than enhanced protections to medications on the WHO Essential Medicines List.
Moreover, the agreement could promote technology transfer and research collaboration between European and Indian pharmaceutical firms, creating mutual benefits while strengthening rather than undermining India’s pharmaceutical sector. Precedents for such balanced provisions exist in other trade agreements addressing public health concerns, such as the US-Peru Trade Promotion Agreement.
As negotiations accelerate toward the fast-approaching end-of-2025 deadline, policymakers must consider the far-reaching implications of their decisions. The current trajectory risks triggering a public health crisis far more devastating than the economic challenges the agreement seeks to address. India and the EU face a critical opportunity to demonstrate that trade agreements can strengthen rather than undermine global health security, setting a valuable precedent for future negotiations.
The stakes are unambiguously high. For millions of patients dependent on affordable medications, the technical details of intellectual property provisions in a trade agreement represent not abstract policy but the difference between life and death. In their haste to counteract economic uncertainties, negotiators must not inadvertently sacrifice the health security of the world’s most vulnerable populations.
