'Letter to UK Secretary of State for Business and Trade', 30 August 2023

We are writing to you as civil society organisations, health providers, and medical professionals from low and middle-income countries. Pharmaceutical companies often deny our patients timely, affordable access to the medicines they desperately need. In this context, cheaper, generic medicines provide us with a lifeline. We write to you to warn that your government could be about to cut this lifeline short. The United Kingdom is negotiating a free trade agreement with India, a global epicentre of generics production. India’s generics industry is underpinned by a legal system which seeks to balance intellectual property rights with the right to health. However, a leaked government paper has revealed that the UK wants to introduce sweeping changes to these laws as part of any agreement. The UK proposals include:

• Patent term extension: India would be required to extend patent monopolies beyond the 20 years agreed under the TRIPS Agreement, by several years. This would lead to further delays in introducing price-lowering generic competition.
• Data exclusivity: The UK’s proposal asks India to introduce new rules that delay the registration of generic versions of medicines for six years, even when there is no patent on that medicine or even if the generic product meets the quality standards prescribed by the national drug regulatory authority. This is far beyond the TRIPS agreement’ requirements.
• Lowering the bar of patent examination on medicines: The UK proposal asks India to introduce and allow patenting on trivial changes of known medicines, which can lead to longer monopolies and delay generic entry.
• Removing pre-grant patent oppositions: The UK proposal asks India to remove a “pre-grant opposition” mechanism, a democratic procedure in Indian law that allows anybody to submit evidence opposing or challenging the validity of a patent application at any time before the patent office makes a decision.

These measures could threaten the supply of generic medicines to low and middle-income countries. Patients may have to wait years longer before they can access certain medicines, and countless lives could be lost as a result...