Updated – February 14, 2024 at 06:58 PM.

Red flags possibility of TRIPS-plus IP features being discussed

India may be forced to change its patent and drug regulatory laws, there by setting a precedent for other trade deals, say experts

India may be forced to change its patent and drug regulatory laws, there by setting a precedent for other trade deals, say experts

Switzerland is home to multinational drugmakers and India is a key producer of generic medicines, but a trade deal between the two regions has raised concerns among patient advocacy groups, involving certain Intellectual Property Rights (IPR)-linked features that are possibly on the table for discussion.

Access to affordable medicine, especially newer ones to treat tuberculosis, diabetes or Hepatitis C, to name a few, could be at risk for patients in India and around the world, they said, if India conceded on certain Trade-Related Aspects of Intellectual Property Rights (TRIPS)-plus features, including data exclusivity (DE), for example, they said.

Thorny clause

Pointing to leaked information, reportedly from the text under discussion between India and the European Free Trade Association (EFTA) for a trade deal, organisations including Doctors Without Borders/Médecins Sans Frontières (MSF), Public Eye and Delhi Network of Positive People cautioned against retaining “the currently-included harmful intellectual property proposals” — in the interest of public health. India may be forced to change its patent and drug regulatory laws, there by setting a precedent for other trade deals, they cautioned.

The EFTA comprises Iceland, Liechtenstein, Norway and Switzerland. In 2009, Iceland and Norway said they would not press for TRIPS-plus provisions, says Gopa Kumar, Legal Advisor and Senior Researcher with the Third World Network. Calling on the Indian government to not relent on watering-down the IP protection that India had in place, he pointed to the path-breaking IP incidents that played out in India involving Novartis’ blood cancer drug Glivec and Roche’s breast cancer drug trastuzumab — both Swiss drugmakers.

Leena Menghaney, Global IP Advisor, MSF Access Campaign, said they had written to Prime Minister Modi, raising their concerns. The DE clause would delay the registration of generic versions of new medicines or new formulations for a set period (six years, by some estimates), even when there is no patent on the medicine, a note on the briefing explained. So even if patients win a pre-grant opposition at the Patent Office, they would not be able to supply the product in India, unless it is registered here, Menghaney told businessline.

Making an appeal for patients dependent on newer drugs, Loon Gangte, Founder, Delhi Network of Positive People, said, he was not interested with the trade or the politics, but was “fighting for (the) life” of patients seeking newer medicines to stay alive.

Nearing conclusion?

The India-EFTA negotiations have been underway since 2006, for a “Trade and Economic Partnership Agreement” (TEPA). “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 IP chapter of the EFTA trade deal ahead of April 2024,” a note on the issue said.

In Jordan, for example, where data exclusivity was introduced as part of the US-Jordan FTA, a study found that of the 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, the note pointed out.

Relying on India

For MSF, possible changes to India’s national patents and drug regulatory laws could have a significant impact for the future supply of potentially lifesaving medicines, the note said. “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 per cent for HIV, 90 per cent for hepatitis C antivirals, 36 per cent on TB treatments, and 30 per cent on vaccines,” it added.

Dr Farhat Mantoo, Executive Director, MSF South Asia, said, “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”

Patrick Durisch, Health Policy, Public Eye (Switzerland) added, “Whereas India represents less than 1 per cent of the total Swiss pharmaceutical product exports, Switzerland’s persistent demands behind closed doorsfor 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.” He called for a sustainable Swiss foreign economic policy.

Gangte, further added, “People may see this as a $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… Let’s remember that prices of newer medicines drop by over 90 per cent when there is generic competition from India.” Pointing out that India had been through negotiations before, where “similarly harmful provisions” undermining access to medicines were rejected and withdrawn, he said, “ I appeal to my government of India to stand firm again.”

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