Activists worry drug access may be sacrificed in trade deals

When the European Union and India decided to relaunch trade talks in 2022, activists were surprised to see the EU insert some intellectual property protections that go beyond minimum internationally agreed practices in its proposal. During an earlier round of negotiations that stalled in 2013, India had pushed back against similar provisions. Activists, too, warned that they would curb affordable access to medicines and medical products because they would extend the period before competitors could start producing lower-priced generic versions. The revived negotiations, with talks set to continue in Brussels in October, have rekindled those concerns. The EU has proposed lengthening patent periods and expanding protections over critical data, making it more difficult for generic companies to replicate new products. If New Delhi were to concede to the EU proposals, Roshan Joseph, an analyst with Médecins Sans Frontières’ Access Campaign, warns of international consequences — particularly in the global south. India produces 20% of the world’s generic medicines and serves as the single-largest supplier of pharmaceutical products in Africa. “This is the pharmacy of the developing world,” he said. If the new restrictions are introduced, it will delay competition and leave generic producers unable “to manufacture that drug in India and export it outside.” Ongoing negotiations The protections regularly crop up in trade discussions, as countries and regions that are home to pharmaceutical companies try to lengthen IP protections and secure the industry additional profit. For instance, in separate negotiations, the United Kingdom is asking India for even stricter controls than the EU. And in ongoing discussions with Indonesia, the EU is also seeking strict IP protections. The World Trade Organization’s 1995 agreement on Trade-Related Aspects of Intellectual Property, or TRIPS, lays out a minimum set of protections meant to strike a balance between access to medicines and protecting IP so that companies can profit from their inventions. The agreement extends beyond medicines and pharmaceutical products, but the limits placed on those items — including patent periods that last 20 years — have been fiercely contested by activists, who argue that they unnecessarily limit access to products that could save or improve people’s lives. That has not stopped pharmaceutical companies and allied governments from pushing for even stricter protections, known as TRIPS-plus provisions. They say the protections are about more than securing profits. “The EU has included several provisions that … are necessary to ensure that appropriate incentives for pharmaceutical innovation are in place,” a spokesperson from the European Commission told Devex in an email about the ongoing discussions with India and Indonesia. “These provisions are subject to ongoing negotiations.” In the documents that are publicly available related to the India proposal, the EU is pushing to extend patent terms to compensate for the period when products are undergoing regulatory approval and certification. The argument is that these processes, which can take years, shrink the 20-year patent window when companies can sell the products. The EU is requesting a supplementary protection certificate to extend the patent up to an additional five years. The EU proposals in India and Indonesia also attempt to introduce data exclusivity on the regulatory and other data that a company must submit to secure a patent. It includes, for example, clinical trial information. Generic manufacturers often use that information to work backward and ensure that their product is bioequivalent to the original. Limiting access to regulatory data would curb the ability of generic companies to develop products, activists say. It would “mean that generic companies, to enter the market, would need to do all the trials from scratch,” Joseph told Devex. “That would take time and a lot of money would be spent again.” Limited leverage Civil society groups warn that if countries ultimately accede to the measures, they will unnecessarily delay access to affordable generic versions of medicines. But they say they have little leverage over the discussions, which are conducted in secrecy with scant updates on what is being discussed or the status of the TRIPS-plus provisions. “We never know exactly what is being negotiated, and during the negotiating round, we do not have a chance to become an observer or to have a dialogue with the negotiators,” said Aditya Wardhana, executive director of the Indonesia AIDS Coalition. The EC spokesperson defended the bloc’s approach, writing that the proposed agreements are not impinging on flexibilities included in the TRIPS agreement that allow countries ways around patents in a health emergency. These flexibilities include permitting governments to issue licenses to produce a medicine or medical product without the consent of the patent holder, so long as they are ultimately compensated. In the past, though, the United States and governments of other high-income countries have threatened to introduce sanctions against countries that take this step — known as issuing a compulsory license — which has limited their use. At the same time, compulsory licenses are not particularly helpful in situations where countries need access to emerging technologies — such as messenger RNA vaccines or new long-acting injectable HIV medicines. Producing those would require a broader transfer of technology, Carlos Passarelli, an access to medicines expert at UNAIDS, explains to Devex. “The license is only one of the steps in the technology transfer,” he said. And if the push for TRIPS-plus provisions is shifting the balance even further toward IP protections and away from access, he said there is an increasing need to consider other means of encouraging companies to share this technology, such as more platforms that reward voluntary licensing. In the meantime, Passarelli said he suspected India would maintain its hardline against TRIPS-plus provisions in its ongoing negotiations with the U.K. and the EU. But activists worry that even if the Indian government holds out against the demands, other nations might be willing to accept tougher IP restrictions — as countries such as Jordan and Guatemala have done before. In Indonesia, Wardhana worries that the government might allow stricter IP protections in return for increased sales of goods such as palm oil. If that happened, “It could hamper access for thousands, hundreds of thousands, even millions of people to affordable medicines,” he said.