Medical groups raise concerns around India-EFTA after leaked documents

Recently leaked documents have exposed the potential consequences of the India-European Free Trade Association (EFTA) trade deal on affordable medicines. Millions of people around the world could lose access to affordable medicines if the trade deal between India and EFTA is finalised in its current form, medical aid groups warned on Wednesday.

Doctors Without Borders (MSF), Public Eye, and Delhi Network of Positive People expressed concern that the deal, which is nearing completion, includes harmful intellectual property (IP) proposals that would force India to amend its national laws. 

The current Indian patent framework in section 107A stipulates that at any point during the patent's validity, a generic company has the right to secure marketing approval. Modifying this section could render it redundant, potentially impacting the availability of generic medicines.

The ongoing negotiations, spanning since 2006, between India and the EFTA, comprising Iceland, Liechtenstein, Norway, and Switzerland, are nearing a conclusion. The negotiations include a Trade and Economic Partnership Agreement (TEPA), with focus on intellectual property. The concern arises from the leaked text revealing provisions that go beyond international trade rules, potentially forcing India to amend its national patents and drug regulatory laws.

Of particular concern is the proposal to introduce "data exclusivity", an additional IP barrier that could impact the approval and availability of generic medicines. This could grant pharmaceutical companies a monopoly on data they submit for drug registration, even after the patent expires. Data exclusivity could delay the registration of generic versions of new medicines, even when there is no patent, leading to increased costs and potential delays in patients' access to treatments. In the past, India's lack of data exclusivity facilitated affordable entry of medicines for diseases such as HIV, tuberculosis, and viral hepatitis.

A leaked version of the TEPA, reveals a provision mandating signatory countries to incorporate a specific duration within six months of the agreement's signing. This stipulated time frame pertains to pharmaceutical companies (applicants) seeking regulatory approval to market a drug within a signatory country. During this period, these applicants are prohibited from relying on undisclosed test data, information related to the drug's effectiveness and impact on individuals, to obtain market approval, with a specified duration of at least six years.

Speaking on this, Farhat Mantoo, Executive Director, MSF South Asia, stated “MSF has appealed to the Indian government, through a letter to the Prime Minister, to continue rejecting the inclusion of intellectual property provisions in 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.”

MSF relies heavily on affordable generic medicines from India to treat patients with HIV, hepatitis C, tuberculosis, and other diseases. The group estimates that 95 per cent of its HIV medications, 90 per cent of hepatitis C antivirals, 36 per cent of TB treatments, and 30 per cent of vaccines come from India.

Patrick Durisch of Public Eye, a Swiss health policy organisation, criticised Switzerland, which is home to many multinational pharmaceutical companies, for pushing for stricter IP rules in the trade deal. "Switzerland's persistent demands behind closed doors for more restrictive intellectual property provisions, even though India’s patent law is complaint with the World Trade Organisation's (WTO's) agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). This will unduly strengthen the monopoly rights of its pharmaceutical industry at the expense of patients in India and beyond," Durisch said. "This is a blatant example of Switzerland putting corporate profits over public health and human rights," he added.

Loon Gangte, founder of the Delhi Network of Positive People, a non-profit organisation representing people living with HIV in India, urged the government to reject the deal.

"People may see this as a $100bn investment deal, but for me, and other people living with HIV, we see this FTA as a direct threat to our lives. If this goes through, then those who will suffer will be people like us who rely on affordable generics from India." Gangte said. 

"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. The country 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,” added Gangte.

In a briefing note from March 2006, the World Health Organization (WHO) addressed the intricate relationship between intellectual property laws and drug registration regulations, emphasising the need to balance innovation with the right to access affordable medicines. WHO recommended countries avoid "TRIPS-plus" measures, limit the scope and duration of data protection, and allow reliance on originator data in case of compulsory licensing for public health reasons. WHO also stated that while data protection is required by international law, data exclusivity is not, and warned that it can harm access to medicines.