‘Can hamper entry of new drugs’ — groups raise alarm over IP proposals part of India-EFTA talks

New Delhi: Several organisations working to promote access to life-saving drugs on Wednesday warned if the final text of the India and the European Free Trade Association (EFTA) agreement retained the currently-included “harmful” intellectual property proposals, access to affordable medicines for millions of people around the world may be severely undermined.

ThePrint had reported on 7 February that  three of the key government departments involved in the free trade agreement (FTA) negotiations with European countries have split views on issues related to pharmaceutical products. 

As reported by ThePrint, a leaked draft of the TEPA, available on the website bilaterals.org, an organisation which tracks international free trade agreements, confirmed that the clause related to regulatory data protection or data exclusivity was on the negotiation table. 

This protection, if introduced as part of TRIPS-plus provision, would mean that India’s drug regulator cannot rely on the originator company’s data for approval of a second and subsequent manufacturer’s application for a specified period from the date of marketing approval to the innovator.

In other words, generic versions of a drug cannot be approved for clinical trial data of the innovator drug.

TRIPS-plus is an informal term for protection of intellectual property (IP) rights that goes beyond the requirements of the trade-related aspects of IP rights (TRIPs) agreement. These are norms for higher levels of protection, strongly supported by developed countries but not prescribed by the World Trade Organisation (WTO)’s TRIPs regime.

As part of the proposed measures, says the leaked TEPA text, within six months after entry into force of the agreement, pharmaceutical companies applying to their country’s regulators for permission to sell a drug would not rely on “undisclosed test data” to gain market approval for at least six years.

A joint statement by Doctors Without Borders, Switzerland-based Public Eye, and a Delhi-based network of HIV-affected people said the proposal, if implemented, 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,” said the statement, adding that in cases where a new medicine is patented, data exclusivity could block compulsory licences that may be granted to generic manufacturers to produce medicines at lower prices.

‘Can hamper entry of new drugs’

The statement also said that 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.

Implementing data exclusivity now has the potential to jeopardise access to essential medicines in general, as well as delay the approval of generic versions of newer medicines, such as pediatric formulations for new TB drugs for which patents have expired. 

The statement cited the example of Jordan where data exclusivity was introduced as part of the US-Jordan FTA, and a study later showed that of 103 medicines registered and launched between 2002 to 2006 that had no patent protection in Jordan, 79 percent had no competition from a generic equivalent because of data exclusivity. 

The negotiations between India and EFTA for TEPA have been ongoing since 2006. After a five-year hiatus, trade talks were revived in recent months 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. 

“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,” the statement said. 

A separate letter, which is being sent to the Prime Minister’s Office by public health experts and various civil society organisations, also, said they feared India was facing pressure to accept provisions that could jeopardise access to affordable medicines. 

ThePrint has seen a copy of the letter. 

“Similar concerns arise from FTAs with the United Kingdom and the European Union, as they also contain TRIPS Plus clauses. Yielding to such demands would severely compromise India’s self-sufficiency in the pharmaceutical sector, adversely affecting the government’s ability to provide affordable medicines, including under flagship programs like the Pradhan Mantri Bharatiya Janaushadhi Pariyojana,” the letter said.

It also stressed the incorporation of TRIPS flexibilities into the Indian Patents Act and the resistance against demands from pharmaceutical transnational corporations (TNCs) have been instrumental in minimising the adverse impact of product patent protection in India. 

For instance, the absence of patent term extension enabled thousands of women suffering from the metacystic stage of HR-positive HER-2 negative breast cancer — a specific type of breast cancer — to access Palbociclib from January 2023. 

“The expiry of the patent resulted in generic entry of Palbociclib and reduced the price from Rs 1,00,000 to Rs 3,500-10,000. While the patent holder (Pfizer) opted for the patent term extension in the US to exploit patent monopoly, such extension was not feasible in India due to the absence of provisions for patent term extension,” the letter pointed out.

Underlining that the government of Switzerland and foreign pharmaceutical firms were pressing for data exclusivity through the EFTA-India FTA, the letter reminded the government that currently, there was no international obligation to provide any data protection to biologics — a new class of medicines that are made from living cells — under the TRIPS Agreement. 

“It is also important to note that the call for data exclusivity on biologics is coming at a time when the World Health Organisation (WHO) is putting efforts to address regulatory barriers hindering the entry of generic versions of biologics, referred to as biosimilars,” it said. 

(Edited by Tikli Basu)

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