UK-India Free Trade Agreement favoring pharmaceutical patent owners, suggest specialists
The recently signed India-UK Free Trade Agreement (FTA) has raised concerns among experts and advocacy groups regarding the potential impact on India's ability to issue compulsory licenses (CLs) for life-saving medicines.
The FTA explicitly preserves India's authority to issue CLs without introducing any new preconditions or limitations beyond existing laws. However, some fear that certain provisions in the Intellectual Property (IP) chapter of the agreement could subtly tilt the balance in favour of patent owners, potentially imposing greater scrutiny or obligations when issuing CLs in future crises.
Compulsory licensing is a process where a government allows someone else to produce a patented product or process without the consent of the patent owner, usually by paying a royalty. This mechanism has been crucial for ensuring access to affordable life-saving medicines during public health emergencies.
The agreement references voluntary licensing and technology transfer on mutually agreed terms as a preferred mechanism, which aligns with global best practices. However, critics argue that this preference undermines the role of the government in facilitating access to medicines and could leave the access to medicines in the hands of market forces.
One of the contentious provisions is the disclosure of commercial working of patents once in three years instead of annually, and not putting it in the public domain. This could limit the ability to prove that demands are unmet because of the patents, which is the main ground for compulsory license.
Ajay Srivastava, from the GTRI, has expressed concern 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. He also suggests that the FTA 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.
Biswajit Dhar, a Distinguished Professor at the Council for Social Development, shares similar concerns. He points out that the explicit preference given to voluntary licenses over compulsory licenses in the IP chapter leaves access to medicines in the hands of market forces. He also explains that the onerous conditions in voluntary licenses often fail to bring a sharp price reduction compared to compulsory licenses.
Despite these concerns, the government asserts that the provisions of the FTA are fully consistent with India's existing legal regime and the evolving needs of a modern innovation ecosystem. They argue that the reference to voluntary licensing acknowledges global best practices and does not limit India's right to issue compulsory licences.
In summary, while the official position confirms that compulsory licensing rights remain intact to support affordable access to essential medicines, there are nuanced provisions in the agreement that may introduce indirect challenges or future risks regarding how compulsory licenses could be implemented or perceived internationally under this FTA framework. It is essential to monitor the implementation of these provisions closely to ensure that India's ability to issue CLs remains uncompromised in the future.
- The FTA's emphasis on transparency and adequate royalties in the Intellectual Property (IP) chapter may subject India's compulsory licensing decisions to greater scrutiny, potentially affecting its ability to act swiftly in future emergencies.
- The government's subscription to best practices in the FTA's reference to voluntary licensing doesn't limit India's right to issue compulsory licenses, as asserted, but concerns remain about its potential impact on access to essential medicines.
- The disclosure of commercial working for patents once in three years instead of annually, as outlined in the FTA, could hinder the ability to prove that demands are unmet due to patents, which is a key ground for compulsory licenses.
- In the business and finance landscape, the FTA's explicit preference for voluntary licenses over compulsory licenses may leave access to life-saving medicines in the hands of market forces, which could ultimately undermine the role of the government in facilitating such access.
- The India-UK Free Trade Agreement (FTA) raises questions in the education-and-self-development sector, as the agreement could compromise India's ability to issue compulsory licenses for life-saving medicines in future crises due to the subtle tilt towards patent owners and the onerous conditions in voluntary licenses.
