Intellectual Property Watch | 27 April 2010

EU-India trade talks resume under cloud of concern for public health

By Monika Ermert for Intellectual Property Watch

BRUSSELS – Negotiations on the EU-India free trade agreement continue tomorrow in Brussels amid warnings from nongovernmental organisations from India and Europe about possible negative consequences for the public health of poor citizens in India. But European negotiators sought to assuage fears.

Patient and medical humanitarian organisations in India and the EU are concerned that provisions on patent term extension and data exclusivity will delay the supply of generic drugs for patients in India and in many developing countries. Millions of lives are at stake, Médecins sans Frontières (MSF, or Doctors without Borders) said in an appeal to negotiators in Brussels yesterday. Anand Grover, director of the Lawyers Collective on HIV/AIDS in India and UN Special Rapporteur for Access to Health, appealed to both India and the EU to not push for new IP rights at the cost of patients.

For MSF, the difference between the current situation and an FTA regime can be measured in prices. Before there was competition by generic drugs it cost $12,000 dollars per year for antiretroviral drugs for one patient, once generic alternatives entered the market the price was reduced to $350 dollars a patient per year. By this margin, the prices for HIV drugs went down once the big pharmaceutical companies faced competition from generic drug manufacturers. “We could treat more patients” said Michelle Childs, Director of Policy and Advocacy, MSF Campaign for Access to Essential Medicines.

Three EU-India FTA provisions would endanger or at least massively delay competition, they claim. Patent term extensions (Article 17.2 of the draft agreement) to compensate for the time necessary to check on applications would delay market entry of generic drugs. So would data exclusivity (Article 18), a concept that would make clinical test data off limits (for possibly 10 years) for regulations when they do another check on an application for a generic drug using the same substances. The agreement is still confidential.

UN Special Rapporteur Grover said it is unethical to push for additional clinic trials for drugs that are equivalent to approved ones. It would serve to withhold treatment with a drug that had been established as effective and safe.

“Life is not for trade”

“Our life is not for trade,” said Loon Gangte, president of the Delhi Network of Positive People (DNP+), who had travelled to Brussels to voice the concerns by patient groups and activists in India. The FTA has been negotiated behind closed doors, but leaks of the text did confirm the push from the EU for a series of higher IP-standards antagonistic to flexibility in enforcement of IP-standards, according to Childs of MSF. Gangte said: “It is undermining our right to life, and this is not acceptable to us. We will keep fighting,” Gangte said.

Thirty-five Indian NGOs from the Adhar Trust to the Udann Trust signed a letter to the Indian Minister of Commerce and Industry, Shri Anand Sharma, and other parts of the Indian administration responsible for the deal. “India must not yield to any standards that go beyond the requirements of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS),” the signatories demanded.

“If the government of India yields to the pressure exerted by developed countries and provides for higher intellectual property standards by committing India through such FTAs, we will lose the ground we have gained over the past decades,” they wrote. Patients in developing countries would “once again have to rely on ‘charity’ and discounts from multinational pharmaceutical companies in order to ensure that medicines are available to those who need them.”

EU negotiators seek to settle concerns

The European Commission answering questions from Intellectual Property Watch sought to dispel all doubts. “The Commission would like to give full reassurance that negotiations on intellectual property rights (IPR) are taken forward in the spirit of the Doha Declaration on the TRIPS Agreement and Public Health,” Commission officials wrote. “The Commission has made it very clear that the provisions on IPR, in particular those on patents, must be implemented and interpreted in a way that does not impair the capacity of both parties to promote access to medicines in the developing world.”

A reference to the Doha Declaration was integrated in the FTA text to make this clear. “Nothing in this agreement shall be construed as to impair the capacity of the Parties to promote access to medicines,” reads Article 9.2 in the leaked version of the draft agreement from 20 February.

While work on the IPR chapter is still in progress and discussions are progressing without prejudice to the final outcome, the Commission is “fully committed to ensuring that the final chapter to be agreed with India does not affect the flexibilities granted by the TRIPS Agreement,” a Commission person said. “This means that the IPR provisions will not prevent India from continuing producing medicines for export to other developing countries.”

In fact, “India’s capacity to issue compulsory licences on pharmaceutical products, including for export to other developing countries and least-developed countries, would be unaffected,” according to the Commission. India would certainly not have “to violate its obligations to provide access to health for their population.” Some TRIPS-plus provisions in fact were in the EU-India agreement, for example, cooperation and recognition of geographical indications and provisions on traditional knowledge or industrial designs.

NGOs still wary of future for poor patients

NGOs did not appear satisfied by the Commission explanation. “If it signs the FTA, then the Indian government will be obligated to introduce changes in national laws,” said Leena Menghaney project manager at the MSF India Campaign for Access to Essential Medicines.

Childs, meanwhile, said it is incomprehensible to the campaigners why EU Commission and Trade Commissioner Karel De Gucht had acknowledged that something needs to be done about EU border provisions (Article 36 of the draft) to make sure that generic drugs transiting through EU ports are not held up on their way to poor patients. “Why export what they already know are flawed provisions?” she said. Both parties did not really commit to keeping barriers for generic drugs off the negotiating table, she said. On the contrary, “the provisions are still there in the most recent draft from last week.”

Grover told Intellectual Property Watch he would appeal “that both the EU and the Indian government be transparent in their negotiations and that no new IP standards should be introduced that are TRIPS-plus, and that TRIPS flexibilities introduced in patent law should remain intact.” He also said, “In my opinion, developed countries in general should not enter into trade agreements that oblige developing countries to violate their responsibility to grant access to health for their people.” But he said this is what FTAs in general are doing.

Asked if he would trust the commitments by Commissioner de Gucht to members of the EU Parliament that the EU would protect access to medicine, Grover said: “That is good, but the unfortunate part is that bureaucrats sometimes seem to be more kind to the lobbyists of big pharmaceutical companies – not the public whom they are meant to serve.”

“They do not appear to be bothered even by what the Parliament says,” he added. “I see a situation similar to the EU in the US, with regards to the US Trade Representative and its continuing use of the heavy handed Special 301 process to unilaterally punish countries who chose to exercise their legal rights under TRIPS.”

From what Grover could determine from the general trend of FTAs, people would not see a net benefit. “Only the elite in both the territories will,” he said. Beside the EU-India FTA, there are several others on the way, including the EFTA-India, EU-Mercosur, EU-Singapore and EU-Vietnam FTAs.

Another petition addressed to the negotiators was called “Civil Society against the EU-India Free Trade Agreement” and was prepared by the Working Group of Intellectual Property (GTPI) of the Brazilian Network for the Integration of People (REBRIP). It was supported by 651 people from various countries. Some 92 percent of HIV patients receive generic drugs, many of them manufactured in India.