Text leaked yesterday shows India-EFTA trade deal includes excessive intellectual property provisions that may require India to gut pro-public health national laws.
Geneva/New Delhi, 14 February 2024 — Following news that India and the European Free Trade Association (EFTA) – which comprises Iceland, Liechtenstein, Norway, and Switzerland – are close to finalising a trade deal, Doctors Without Borders/Médecins Sans Frontières (MSF), Public Eye, and Delhi Network of Positive People warned that if the final text retains the currently-included harmful intellectual property proposals, access to affordable medicines for millions of people around the world may be severely undermined.
Let's remember that prices of newer medicines drop by over 90% when there is generic competition from India. So, for the multinational pharmaceutical industry, data exclusivity will expand their monopolies and profiteering by blocking the availability of generics from India. India has been through this before with the EU-India trade agreement and other FTAs, where similarly harmful provisions undermining access to medicines were rejected and withdrawn. I appeal to my government of India to stand firm again.
Background:
The negotiations between India and EFTA for a “Trade and Economic Partnership Agreement” (TEPA) have been ongoing since 2006. After a five-year hiatus, trade talks were revived in recent weeks and are nearing conclusion according to the Swiss Federal Department of Economic Affairs, Education and Research, with Switzerland, home to many multinational pharmaceutical corporations, and India, a key manufacturer of generic medicines, aiming to finalise negotiations on the intellectual property (IP) chapter of the EFTA trade deal ahead of April 2024. Alarmingly, the IP proposals currently on the table go beyond what is required in international trade rules, and may result in India being forced to change its national patents and drug regulatory laws.
One of the key concerns is the proposal to introduce an additional IP barrier called “data exclusivity” (DE), as DE would delay the registration of generic versions of new medicines or new formulations for a set period, even when there is no patent on the medicine. This would result in generic manufacturers either needing to wait out the exclusivity period or repeat expensive clinical trials. In cases where a new medicine is patented, data exclusivity could block compulsory licenses that may be granted to generic manufacturers to produce medicines at lower prices.
Over the last two decades, the fact that India did not have data exclusivity in its law facilitated the affordable entry of new drugs for HIV, tuberculosis (TB) and viral hepatitis, which MSF has been able to use to treat people in our care. Implementing data exclusivity now has the potential to jeopardize access to essential medicines in general, as well as to delay the approval of generic versions of newer medicines, such as paediatric formulations for new TB drugs for which patents have expired. In Jordan, for example, where data exclusivity was introduced as part of the US-Jordan FTA, a study found that of 103 medicines registered and launched between 2002 to 2006 that had no patent protection in Jordan, 79% had no competition from a generic equivalent because of data exclusivity.
For MSF in particular, these possible changes to India’s national patents and drug regulatory laws could have a significant impact for the future supply of potentially lifesaving medicines. This is because MSF relies on quality-assured vaccines and medicines made in India to treat the people in our care, with its spending on generic medicines procured from India estimated at 95% for HIV, 90% for hepatitis C antivirals, 36% on TB treatments, and 30% on vaccines.
-
Related:
- Access to Medicines
