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EU “pushing” India over generics in “secret” trade talks

Pharma Times | 04 February 2010

EU “pushing” India over generics in “secret” trade talks

The European Union (EU) and India have resumed Free Trade Agreement (FTA) talks, amid claims that the EU is trying force India to accept pharmaceutical patent terms that go beyond world trade agreements.

The eighth round of the FTA talks which took place in Mumbai last week have been strongly criticised in India for their secrecy and lack of consultation with the national parliament and state governments. The text of the draft agreement has not been published, nor have any details of how India’s concerns over a range of issues including intellectual property protection (IPP) were addressed in the meetings.

However, local sources say the EU negotiators have called on India to accept 20-year patent extensions – a five-year increase on current levels – and data exclusivity provisions that go further than those included in the World Trade Organisation (WTO) Trade-Related Aspects of Intellectual Property rights (TRIPs) agreement.

In the new European Commission, which is due to start work this month, Commissioner-designate for Trade Karel De Gucht has already emphasised the need for trade policy to “work for people,” both in the EU and especially in developing countries. At his pre-appointment hearing before the European Parliament’s Committee on International Trade, Prof de Gucht – a former Deputy Prime Minister of Belgium and European Commissioner for Development and Humanitarian Aid – said that, in addition to economic benefits, trade policy can promote “European values” such as human rights, social justice and the protection of the environment.

Asked by UK Labour Member of the European Parliament (MEP) David Martin if he will put an end to EU policies which stop generics getting to customers in developing countries, Prof De Gucht replied that while access to medicines should be a fundamental right, IPP must also be respected.

He pledged to “take care” that the finalized EU/India FTA would not impede free trade in generics but would not rule out the fact that “for specific products there can be specific problems” which can result in a need for IPR.

“I believe it is possible to have specific provisions for specific products, which can be compensated for by parallel imports,” he told Mr Martin.

Mr Martin is chairman of the Parliament’s new working group on innovation, access to medicines and poverty-related diseases, which was launched in Brussels on January 27. At the launch meeting, Mr Martin stated that the data exclusivity provisions reportedly contained within the draft EU/India FTA are “not just bad news for India” but also “bad news for those countries to which generic medicines from India are provided.”

“Thousands of men, women and children with treatable diseases die every week in developing countries because the medicine they need is simply too expensive. At the same time customs officers, following requests by pharmaceutical companies fearing patent infringement, are seizing perfectly legitimate generic drugs destined for these countries” he says.

“It is vital that the EU adopts appropriate measures to improve access to existing medical tools and stimulate R&D into methods for treating the suffering poor of developing countries,” Mr Martin told the working group’s launch.

India is “the pharmacy of the developing world,” said Tido von Schoen-Angerer, a spokesman for the international aid agency Médecins Sans Frontières (MSF). This agency is working with the new parliamentary group which, he said, will provide a counterbalance to the pharmaceutical industry’s influence over the Commission, adding that this has been particularly in evidence in the EU/India FTA talks, according to a report from Intellectual Property Watch.

Negotiations for the FTA began in 2007, and both sides are reportedly anxious to have the deal concluded by the end of this year. In 2009, a study on the agreement by the European Parliament’s Trade Committee called for “a comprehensive, ambitious and balanced” deal, encouraged India to develop “appropriate” data protection legislation and welcomed the nation’s commitment to strong IPP and the use of TRIPS flexibilities to meet certain public health obligations.

“Once again, we should all be aware that too many obligations on public health can often leave citizens in poorer countries unable to access medicines, because there is no incentive for pharmaceutical companies to develop medicines for those countries,” the Committee report added.

And a report by IP expert Carlos Correa, commissioned last year by Oxfam Germany and the Church Development Service, warns that the higher IPP standards sought by the EU negotiators for the FTA are “explicit… despite the European Parliament’s repeated calls on the European Commission not to seek TRIPS-plus standards of protection in developing countries, as they may affect access to medicines.”

By Lynne Taylor

 source: Pharma Times