Info Justice - 29 November 2022
India-UK FTA leaked draft reveals nobody’s gain except big pharma
By Shirin Syed
On November 4, 2019, India famously retracted its decision to sign the Regional Comprehensive Economic Partnership (RCEP) after negotiating for seven years. India was concerned that RCEP would harm the domestic market, which would face competition from foreign producers. However, it has more recently been observed to have made a turnaround on “vocal for local” by prioritizing imported goods over the domestic ones. Enter the India-UK FTA.
The leaked draft on October 31 of the UK-India Free Trade Agreement (FTA), the chapter on intellectual property, reveals that there are several TRIPS-plus provisions which will devastate the global supply of generic medicines.
The FTA contains harmful IP provision such as diluting the patentability standards, overriding section 3(d) of the Indian Patents Act and eliminating pre-grant opposition. If implemented, these provisions would pose a serious threat to the accessibility and affordability of medicines in India and globally.
The language of the text affects other types of intellectual property such as Copyrights, Trademarks and Trade Secrets, which potentially undermines other accessibility rights related to research, trade and information sharing. However, an overview of the provisions that restrict access to medicines is given below:
Requires the exchange of information between the British and Indian intellectual property offices, or other agencies or institutions. This coherence creation will influence patent examination neutrality.
Article B.3 & B.4
Forms working groups and to share and use search and examination results of each Parties’ patent offices. This could potentially harm India’s public interest approach to examination.
Eliminates the patent exhaustion provided under the TRIPS Agreement.
Section E 2.2
Waives patentability requirements and establishes that neither Party will require proving the enhanced efficacy of the substance/composition for a new medical use or form for a known substance. This directly aims to revoke the criteria of section 3(d) of the Indian Patent Act, which expressly prohibits patents on the mere discovery and use of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance.
Restricts the regulatory review exception (Bolar exception) to pharmaceutical products. The current India Patent Act (sec. 107-A) has a broader scope i.e., for all patented inventions.
Confusingly refers to other use of a patent without the authorisation of the right holder, however, it does not place any acknowledgement of Article 31 of the TRIPS agreement that allows for other use of a patent by the government or third parties authorized by the government.
Eliminates the opportunity to oppose pre-grant opposition.
Eliminates the disclosure requirement of the patent with the exception of patents subject to compulsory license applications. Besides eliminating the right to require working information, it discourages compulsory licensing by adding an extra step of obtaining a working requirement disclosure in the existing complex compulsory license filing procedure.
Provides sui generis extension of the patent term to compensate for the regulatory delays.
Extends the protection term/data exclusivity for agricultural products up to ten years
Extends the protection term/data exclusivity for pharmaceutical products up to six years involving chemical entities (usually used for therapeutics) and biologics (used for products such as vaccines).This will further delay entry of generics in the market.
Extends protection on designs to 25 years against the maximum validity of 15 years as prescribed under (Indian) Designs Act, 2000. This will be complicate access medical devices important for public health. E.g., Face masks, ventilators, etc.
Requires judicial authorities to issue injunctions on goods which are suspected to infringe the IP rights against the alleged infringer and the intermediary whose services are suspected to be used for the alleged infringement. It also mandates judicial authorities to block the bank accounts and other assets in case of alleged infringement being carried out on a commercial scale.
The text requires an extended term of data exclusivity that will keep prices artificially high longer than the original patent term of 20 years. Moreover, it eliminates the useful mechanism of pre-grant patent opposition which enables block the grant of unjustified patents. Removal of this safeguard mechanism will result in the granting of spurious patents, and preventing manufacture of generics. Another point of concern is mandating grant of injunctions on mere suspicion and without any concrete grounds of infringement.
Interestingly, the UK was vehemently opposing the TRIPS waiver, arguing that the flexibilities in the TRIPS agreement were a viable option to address the IP roadblocks in access to medicines during the pandemic. However, the FTA kills the same flexibilities which the UK claimed was a better alternative to the TRIPS waiver. The provisions of the FTA will do away with these flexibilities and will be a death blow to India’s capacity to produce affordable lifesaving drugs.
This will have tremendous repercussions for saving the lives of patients in India but also in the UK and around the world. India supplies 25% of medicines to the British NHS for a range of conditions from cancer, and HIV to heart disease. Experts have warned that implementing the FTA would be like signing its own death warrant. They argue that NHS costs would have a significant increase if India is forced to adopt the IP provisions of the FTA. Rationally thinking, the changes through the FTA provisions are not only harmful for India, but they also harm the UK by pushing up drug prices for the NHS, further adding burden to its already stressed budget.
Therefore, the FTA provisions favor neither India nor the UK except the pharma industry in a big way. It defeats the firm stand taken by the Indian Prime Minister three years ago when he decided to pull out of the RCEP against the corporate interests over people’s lives. The pandemic and subsequent recession has proved that health and business do not exist in watertight compartments. It is time to stand up again to choose health over corporate gains.