EU must drop all intellectual property provisions that go beyond WTO requirements in trade negotiations with India, as recommended in today’s SIA report

Millions of people around the world rely on affordable generic medicines and vaccines produced in India, the ‘Pharmacy of the Developing World’ 

Brussels/Delhi, 29 February 2024 – Doctors Without Borders/Médecins Sans Frontières (MSF) welcomes the important recommendations put forth in yesterday’s Trade Sustainability Impact Assessment (SIA) report that was requested by the European Commission to analyse the impacts of Free Trade Agreement (FTA) and Investment Protection Agreement (IPA) negotiations between the European Union (EU) and the Republic of India. The SIA report makes a clear recommendation to the current text of the EU-India FTA that, “In order to ensure access to medicines for patients in developing countries, the current intellectual property (IP) Chapter should be modified to not go beyond the minimum standards of IP protection under the World Trade Organization (WTO) TRIPS Agreement.” The SIA report also directs the European Commission to, “Amend legal provisions (as currently tabled in the EU textual proposal) regarding patent protection and data exclusivity, in line with the WTO TRIPS standards, not going beyond the minimum standards of IP protection.” 

Dimitri Eynikel, EU Policy Advisor, MSF Access Campaign: 

“We are pleased to see that the Trade Sustainability Impact Assessment report, which is an independent analysis requested by the European Commission itself, echoes the longstanding call by health activists and civil society around the world to remove all problematic intellectual property provisions from the EU-India FTA that go beyond the rules enshrined in the WTO TRIPS Agreement and could have a negative impact on millions of people globally. Considering the recommendations in the SIA report, we call on the EU to retract all detrimental provisions in the ongoing trade negotiations with India, including patent term extensions and data exclusivity, in line with previous commitments made by the EU.” 

“We also urge the EU not to introduce problematic intellectual property enforcement measures that could result in wrongful seizure of generic medicines. It is high time for the EU to prioritise people’s access to lifesaving treatments over pharmaceutical monopolies, and stop pushing for ever-higher levels of monopoly protection of medicines in free trade agreements with other countries. Medicines shouldn’t be a luxury.” 

Leena Menghaney, South Asia Head, MSF Access Campaign: 

“In our medical programmes all over the world, MSF has again and again witnessed the negative impact that intellectual property monopolies have on people’s lives by making unaffordable the lifesaving medicines, tests and vaccines used to treat and prevent diseases like HIV, drug-resistant tuberculosis (DR-TB), hepatitis C, and pneumonia. The harmful draft provisions of data exclusivity and patent term extensions, proposed by the EU in the trade negotiations, pose a significant threat to India's future capacity to produce and export affordable generic versions of newer, lifesaving medicines needed by millions of people, particularly in low- and middle-income countries. This is because the overly intrusive intellectual property enforcement measures proposed limit judicial discretion, undermining the ability of the courts to balance intellectual property and people’s right to health. 

“We urge the Indian government to continue rejecting the harmful provisions in such trade negotiations. India has historically and rightfully resisted pressure in other FTA negotiations to reject data exclusivity and any provision that undermines its efforts nationally to prevent abuse of the patent system, recognizing its potential to create barriers to affordable generic medicines. Just last month, MSF welcomed India’s latest refusal to include harmful IP provisions in the EFTA negotiations, a move that we consider a win for millions of patients around the world.” 

_{*The EU is currently negotiating FTAs with India, Indonesia, Philippines and Thailand.}   

_Background: 

In June 2022, the EU and India relaunched negotiations on this FTA*, which includes a chapter related to IP issues, including for pharmaceuticals. The draft EU-India FTA text published by the EU in July 2022 revealed that the EU had brought back some of the harmful provisions that were removed in earlier negotiations due to strong pushback, including by MSF and patient groups, and a refusal by the Indian government to accept those previously tabled provisions.  

The most damaging provision, so-called ‘data exclusivity,’ would – if accepted – delay the registration of often more affordable generic versions of medicines, even for medicines that have no patents. Another harmful provision is ‘patent term extension’ or ‘supplementary protection,’ which would extend drug companies’ patent terms beyond the existing 20-year term and block the entry of generic competition for newer treatments for several years. The text also contained provisions on IP enforcement that could hinder legitimate trade in generic medicines and limit the ability of judicial authorities to safeguard peoples’ right to health.  

MSF has long called for trade and investment agreements not to enforce IP provisions beyond WTO TRIPS standards due to their negative impact on access to affordable generic medicines. Most recently, MSF and other CSOs appealed to the Indian government to continue rightfully rejecting the damaging intellectual property provisions in the India-EFTA negotiations, as they can block production and supply of affordable generic medicines sourced from India. 

For interviews, please contact Morag McKenzie, [email protected]