EU-India Summit Kicks Off Amidst Warnings Of Impact On Medicines Access

The European Union and India today are engaging in a high-level meeting in New Delhi with an agenda that includes energy and climate, research and development, and information and communications technologies. But as they enter the meeting, an international health agency and a powerful health advocacy group have issued statements of concern that intellectual property provisions in a bilateral free trade agreement under negotiation will stifle critical generic medicines production in India, putting thousands of poor patients at risk worldwide.

The groups, UNITAID – a World Health Organization affiliate drug-purchasing mechanism – and Médecins Sans Frontières (MSF, Doctors without Borders), issued separate statements on the eve of the EU-India summit.

The European Commission this week issued a fact sheet and statement entitled, EU-India summit – A partnership for prosperity.

A joint declaration on energy cooperation is due to be adopted, the Commission said. In addition, the two sides will discuss “intensified cooperation in the area of research and innovation,” and leaders will endorse a joint declaration on this.

“The joint declaration on ‘Indo-European research and innovation partnership’ to be adopted at the summit will set a strategic agenda to identify common challenges, shared objectives, priority areas and instruments of cooperation between India and the EU for the near future,” the Commission said. “Beyond water and bio-resources, energy, health and information and communication technologies may be identified as priority areas.”

Under the EU’s seventh research framework programme (FP7), cooperation is increasing, it said, both in EU-financed and co-funded initiatives. Indian researchers and organisations are participating in 135 FP7 projects compared to 97 projects under FP6, it said. Areas of “particularly strong” cooperation are health, information and communication technologies, environment, food, agriculture and biotechnology, and social sciences and the humanities.

The joint declaration on ‘Indo-European research and innovation partnership’ to be adopted at the summit “will set a strategic agenda to identify common challenges, shared objectives, priority areas and instruments of cooperation between India and the EU for the near future,” the EU said. “Beyond water and bio-resources, energy, health and information and communication technologies may be identified as priority areas.”

UNITAID this week circulated a document [pdf] from 2010 entitled, “A lifeline to treatment: the role of Indian generic manufacturers in supplying antiretroviral medicines to developing countries,” that showed that Indian manufacturers of generic antiretroviral (ARVs) medicines accounted for more than 80 percent of annual purchases from 2003 to 2008. During that time the number of Indian generic drug-makers supplying ARVs increased from 4 to 10, and the number of Indian-made generics rose from 14 to 53. Some 96 of 100 countries examined purchased Indian generics.

A key aspect of generics is that they significantly lower the cost of the medicines, making them far more accessible in developing countries. But India’s 2005 implementation of the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) is threatening to undermine its ability to produce generics, activists and others say.

“Rather than agreeing to inappropriate intellectual property obligations through free trade agreements,” the study concluded, “India and its trade partners – plus international organizations, donors, civil society and pharmaceutical manufacturers – should ensure that there is sufficient policy space for Indian pharmaceutical manufacturers to continue their central role in supplying developing countries with low-priced, quality-assured generic medicines.”

MSF International President Unni Karunakara sent an open letter on 8 February to Indian Prime Minister Manmohan Singh raising concern about “harmful provisions” in the proposed intellectual property and investment chapters of the free trade agreement, “that if included would have serious implications for access to affordable medicines in India and throughout the developing world.”

In the enforcement provisions, according to MSF’s Karunakara, Europe is seeking to expand enforcement to allow medicines alleged to be trademark infringing to be detained or destroyed at the border, even if they were legitimate. In addition, penalties for alleged patent and trademark infringement would be substantially increased, it said, in a way that could cause generic suppliers to face a production ban, delay or destruction of products, or disproportionate damages – based only on allegations.

Other worrying enforcement provisions, according to MSF, are limits on Indian courts’ abilities to recommend alternative remedies rather than “routinely” granting provisional injunctions, and an extension of liability to third parties, such as suppliers of ingredients, distributors, non-governmental organisations like MSF, funders, or drug regulatory authorities, he said.

The Commission also has stirred debate for pushing to include investment in the agreement, including intellectual property rights and establishing an investor-state mechanism that allows the private sector to directly challenge the governments’ actions on the grounds that they harmed their investment expectations. This would allow challenges to domestic health policies and measures to reduce medicines prices, MSF said.

“Pharmaceutical companies must be given no additional avenues to pressure India on policies and laws that promote access to medicines,” it said. “India is already reeling from multiple litigations filed by companies like Novartis and Bayer against health safeguards enshrined in India’s patent law.”

Karunakara offered several suggestions, such as withdrawing IP enforcement measures and deleting patents from the entire scope of the enforcement section; withdrawing third party liability and provisions on injunctions (in order to preserve flexibilities); limiting border enforcement to TRIPS requirements (excluding exports and trademark infringements); and withdrawing the IP and investor-state mechanism from the investment chapter.

Karunakara also praised India for standing up against pressure to accept data exclusivity provisions that would delay the time of entry into the market of generic medicines by preventing access to marketing data until later in the life of the patent.

But Northeastern University (US) Prof. Brook Baker commented on a listserv that pressure continues for proponents of stronger data exclusivity, with a new twist to include the language of TRIPS Article 39.3.

“Big Pharma and Europe are persistent,” he said. “On its face, [Art. 39.3] merely demands protection against unwarranted disclosure of test data and against ‘unfair commercial use.’ However, this demand, seemingly innocuous (after all, why shouldn’t India accept what it is already bound to do under the 1994 WTO TRIPS Agreement?), is in fact dangerous. Why? Because the EU, like the US, willfully and consistently misinterprets Art. 39.3 to require data exclusivity/monopolies.”

“Because Europe would be permitted to initiate direct trade disputes against India under a ratified FTA,” Baker said, “it would have a greater chance of winning approval for its interpretation of Art. 39.3 in a bilateral panel than it would in a multilateral WTO panel.”