PUNE, INDIA – Commerce minister Sunil Barthwal has clarified that India will not sign a new trade agreement with the European Free Trade Association (EFTA) that would limit access by the country’s thriving generic medicine industry to new drug formulations for critical diseases.

India is currently negotiating a new trade deal with the EFTA, which includes Iceland, Liechtenstein, Norway, and Switzerland. And leaked excerpts of the draft agreement had raised concerns among patients and advocates due to provisions limiting access and use by generic manufacturers of clinical trial data from originators’ drug trials, for a period of “up to six years.”

Such data exclusivity provisions means that generic manufacturers either need to wait out the exclusivity period or repeat expensive clinical trials, something that can impede the approval of generic brands in countries that cannot afford original, patented drug versions.

In cases where the patent for a new medicine has also been registered in a developing country, such as India, data exclusivity provisions also could slow or block government issuance of  ‘compulsory licenses’ to generic manufacturers to produce a medicine at a lower price.

Barthwal ‘we rejected their demand’

“They want that there should be data exclusivity, we rejected their demand. We are with our generic industry,” Indian media reports quoted Barthwal as saying of the EFTA pressures, which reportedly were led by Switzerland, home to several major pharma companies, including Novartis and Roche.

India’s clarification came as a relief to medicines access groups.

“We welcome the Indian Commerce Ministry’s strong stand against the inclusion of data exclusivity in its trade talks with EFTA that benefits patients across the world,” Dr Farhat Mantoo, Executive Director of Médecins Sans Frontières (MSF) South Asia said in a statement.

We welcome Indian govt’s strong stand against data exclusivity provision in EFTA trade talks.

India must continue to reject all harmful intellectual property provisions (also in other trade deals) that may limit India's supply of affordable generic meds to millions of people. https://t.co/SXifKPkjgw

— MSF South Asia (@MSF_SouthAsia) February 15, 2024

In a press briefing Wednesday, MSF, Public Eye, and Delhi Network of Positive People had raised concerns about the precedent that India’s agreement to a data exclusivity clause could trigger a cascade of impacts on access to affordable medicines.

India is the world’s largest producer of generic drugs 

Loon Gangte, founder of Delhi Network of Positive People has lived with HIV for nearly two decades, and relied on cheap generic medicines produced by the Indian companies to maintain his health. India is the world’s largest producer and exporter of generic medicines.

The absence of data exclusivity provisions in the country’s patent laws, until now, has been a key factor enabling the affordable entry of new drugs for HIV, tuberculosis (TB) and viral hepatitis, he said in Wednesday’s press briefing.

Gangte, who has been living with Hepatitis C and TB, as well as HIV, noted that in the past two decades his medications changed several times. “The drugs which we took five years ago, we are not taking today because we have developed resistance or because of the side effects. It keeps on changing,” he said.

It is the development of generic formulations that have allowed him to keep up and have continued access to effective drugs.

Switzerland led pressures for exclusivity clause inclusion 

The World Trade Organization’s Trade-Related Aspects of Intellectual Property Rights or TRIPS agreement gives member countries freedom to formulate their own national patent laws while setting some ground rules on intellectual agreements. India’s patent laws has so far allowed for generic competition to flourish and that has also benefited patients in many other countries, notably in Africa as well as Asia.

India has traditionally resisted the incorporation of such intellectual property restraints in almost all of the free trade agreements it negotiates, Leena Menghaney, MSF’s South Asia head said, despite being under immense pressure for years.

In the case of the new EFTA agreement, Switzerland has been the country leading the push for the new data exclusivity provisions, Meghaney said in the briefing.

Although India represents less than 1% of the total Swiss pharmaceutical product exports, it is home to pharmaceutical giants like Novartis and Roche – which increasingly have their eyes on the Indian domestic market as emerging markets elsewhere – where Indian generic exports may dominate, said Patrick Durisch of the Swiss-based medicines advocacy group Public Eye.

A decade ago, Novartis fought and lost a case over a patent for its cancer drug Glivec in India’s Supreme Court. Roche, meanwhile, failed to win patent protection for its lung cancer drug, Tarceva.

India represents a huge and untapped market

India, with the world’s largest population, thus represents a huge and untapped drug market for innovative pharmaceutical companies, even though currently, the market continues to be dominated by cheaper generic drugs.

This is all the more the case as the country develops economically and the burden of non-communicable diseases rise across low- and middle-income countries with consequent new demands for drugs.

Against that landscape, however, Switzerland’s persistent demands for restrictive intellectual property provisions would “strengthen the monopoly rights of its pharmaceutical industry at the expense of patients in India and beyond – even though India’s patent law is TRIPS-compliant,” Durisch said.

“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,” he added.

Swiss government officials, asked by Health Policy Watch for comment, did not respond as of publication.

India is, meanwhile, set to hold national elections in May, in which Prime Minister Narendra Modi is vying for another five-year term – after ten years already in office.

The government has been keen to wrap up the trade negotiations before that. Meanwhile, pharma industry pressures on the national government have increased.

The Indian pharma manufacturers that forged new collaborations with large pharma firms abroad, during and post-COVID, are leveraging more influence. Organizations like the OPPI which represents big pharma have been lobbying hard in New Delhi.

But apparently, that has not been enough to tip the barrel against generics manufacturers and the public that they represent.

Data exclusivity and access

From the innovative pharma industry point of view, restricting access to clinical trial data protects the huge investments that need to be made into new drugs – thus supporting new drug investments and innovation.

“Data exclusivity provisions make sure other companies are not able to rely on this original data to submit a copy of this medicine for approval without permission, within a limited period of time,” Guilherme Cintra, Innovation Policy Director of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) told Health Policy Watch. “Such measures are critical in making sure that the right incentives are in place for companies to invest in the development of new medicines and vaccines.”

Critics, however, argue that current evidence around data exclusivity is not encouraging from the perspective of access.

“Contrary to industry’s arguments, it is unlikely that data exclusivity will promote innovation, especially in developing countries. Moreover, the industry’s appeal to a property rights claim over clinical test data and the idea that data exclusivity can prevent the generic competitors from ‘free‐riding’ encounters some important problems: Neither legitimize excluding all others,” concluded a 2016 article by a team of researchers at the University of Ghent, Belgium.

In Jordan where data exclusivity was introduced as part of the US-Jordanian Free Trade Agreement, 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 patients like Gangte, it is ultimately affordability that is important, and what generics make possible, saying: “We are not against big pharma or we are not pro-generics. If big pharma company gives us a medicine cheaper than the Indians generics, we will buy your medicine.”

Image Credits: Unsplash.