Millions of peoples’ access to affordable medicines at risk if India-EFTA trade deal finalised as is: MSF

MSF has appealed to the Prime Minister to continue rightfully rejecting the inclusion of intellectual property provisions in the EFTA negotiations

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.

Explaining the situation, Dr Farhat Mantoo, Executive Director, MSF South Asia informed that MSF has appealed to the Indian government through a letter to the Prime Minister to continue rightfully rejecting the inclusion of intellectual property provisions in the EFTA negotiations that are harmful for access to affordable medicines from India. “If accepted, these IP provisions will have drastic consequences on access to medicines and the health of patients in India and beyond. Millions of lives depend on India putting people’s health first and being able to continue supplying generic medicines globally,” according to Dr Mantoo.

Patrick Durisch, Health Policy, Public Eye, Switzerland pointed out, “Whereas India represents less than 1 per cent of the total Swiss pharmaceutical product exports, Switzerland’s persistent demands behind closed doors for more restrictive intellectual property provisions, even though India’s patent law is TRIPS-compliant, will unduly strengthen the monopoly rights of its pharmaceutical industry at the expense of patients in India and beyond. This is a blatant example of Switzerland putting corporate profits over public health and human rights – and it underlines the urgent need for a sustainable Swiss foreign economic policy.”

Giving the patient perspective, Loon Gangte, Founder, Delhi Network of Positive People, India said, “People may see this as a US$100 billion investment deal with Switzerland and Norway but for me, and other people living with HIV, we see this FTA as a direct threat to our lives. If this FTA goes through with provisions like data exclusivity introducing new IP barriers in India, then those who will suffer will be people like us across low- and middle-income countries who rely on affordable, generic versions of new drugs for treatment. Let’s remember that prices of newer medicines drop by over 90 per cent 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.”

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 under their care, with its spending on generic medicines procured from India estimated at 95 per cent for HIV, 90 per cent for hepatitis C antivirals, 36 per cent on TB treatments, and 30 per cent on vaccines.

In a background note, MSF explains that 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. Implementing data exclusivity now has the potential to jeopardise 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 per cent had no competition from a generic equivalent because of data exclusivity.