Intellectual property rights experts are raising alarm over provisions in the recently concluded India-UK Free Trade Agreement that they say could significantly weaken India's ability to ensure access to affordable medicines during public health emergencies. The concerns center on changes to compulsory licensing mechanisms, a critical tool that allows governments to override patent protections in the public interest.
Compulsory Licensing Under Scrutiny
The FTA's intellectual property chapter has drawn criticism for its explicit preference for voluntary licensing arrangements over compulsory licenses. "The explicit preference given to voluntary licenses over compulsory licenses in the IP chapter leaves access to medicines in the hands of market forces and undermines the role of the government in facilitating access to medicines," said Biswajit Dhar, Distinguished Professor at the Council for Social Development.
Compulsory licensing allows governments to permit third parties to produce patented products without the patent holder's consent, typically in exchange for royalty payments. This mechanism is usually invoked when patent holders fail to adequately meet public needs, particularly during national emergencies or public health crises.
The UK-India FTA states that "The parties recognise the preferable and optimal route to promote and ensure access to medicines is through voluntary mechanisms, such as voluntary licensing, which may include technology transfer on mutually agreed terms."
Impact on Generic Drug Production
KM Gopakumar, Co-Convenor of the Working Group on Access to Medicines and Treatment, characterized the agreement as providing "backdoor entry to TRIPS (Trade Related Intellectual Property Rights) plus provisions" that exceed World Trade Organization minimum standards. He noted that the provisions "tilt the balance in favour of the patent owner and undermines access to medicines."
Under India's Patent Act, the country has historically maintained the right to invoke compulsory licenses for life-saving medicines and vaccines, enabling domestic generic manufacturers to supply these products during national emergencies. However, India has issued only one compulsory license to date - to Natco Pharma for Bayer's kidney cancer drug sorafenib.
Dhar emphasized the limitations of voluntary licensing compared to compulsory licensing: "Often voluntary license contains onerous conditions on the licensee and fails to bring a sharp price reduction compared to the compulsory licenses." He warned that the FTA's emphasis on voluntary mechanisms "gives a signal to the potential compulsory license applicant that you are not welcome."
Transparency and Disclosure Changes
Another contentious provision allows disclosure of commercial patent working once every three years instead of annually, without requiring public disclosure. "This relaxation limits the ability to prove that demands are unmet because of the patents, which is the main ground for compulsory license," Gopakumar explained.
Ajay Srivastava from GTRI warned that "The FTA's emphasis on transparency, adequate royalties, and voluntary mechanisms could subject India's licensing decisions to greater scrutiny, both domestically and internationally. It shifts India from being a defender of public health exceptions to a rule-taker in IP enforcement, compromising its ability to act swiftly in future emergencies."
Government Response
The Commerce & Industry Ministry has pushed back against these concerns, stating that the FTA's reference to voluntary licensing "simply acknowledges global best practices that encourage collaborative solutions" and "does not limit or dilute India's well-established right to issue compulsory licences."
The government maintains that the IP chapter "represents a balanced and forward-looking approach—fully aligned with India's legal framework, TRIPS flexibilities, and public health priorities." Officials emphasized that the provisions are "fully consistent with India's existing legal regime and the evolving needs of a modern innovation ecosystem."
Balancing Innovation and Access
Some patent experts suggest the FTA attempts to balance India's current intellectual property regime with public health considerations while accommodating the UK's preference for stronger IP protections. The agreement establishes a Working Group on IPR to address ongoing concerns.
Notably, key safeguards in India's patent system, including Section 3(d) of the Indian Patent Act which prevents patent evergreening, and opposition mechanisms, remain intact under the FTA. These provisions are considered crucial for maintaining India's status as a leading generic drug manufacturer and protecting domestic access to medicines.
The debate reflects broader tensions between intellectual property protection and public health access, particularly relevant as India continues to serve as the "pharmacy of the world" for affordable generic medicines.
