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Indian pharma firms, NGOs oppose EU free trade deal

Published 14 March 2011 - Updated 17 March 2011
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Indian pharmaceutical industry representatives and NGOs have voiced opposition to an imminent EU-India free trade agreement (FTA) which they claim would limit the emerging nation's ability to produce generic drugs.

Opposition focused on an EU request for a 'data exclusivity' clause which opponents claim would prevent India from producing cheap generics.

Speaking to EurActiv, Dilip Shah, secretary-general of the Indian Pharmaceutical Alliance, which represents some of India's largest pharmaceutical companies, accused the EU of "using high-pressure tactics to force India to agree to data exclusivity".

Data exclusivity refers to a period during which drug producers can maintain a monopoly on production. Drug companies claim the period is necessary to recoup the high cost of developing new drugs.

Protests in India

Over two thousand protesters, including sufferers of HIV, took to the streets in downtown New Delhi and other Indian cities on 2 March. They are concerned in particular that the EU-India FTA would limit their access to affordable life-prolonging drugs.

John Clancy, spokesperson for EU Trade Commissioner Karel de Gucht, stressed that regarding data exclusivity the EU wanted mutual recognition.

"Should the Indian government at some point put forward legislation for data protection in respect of Indian companies, all the EU is seeking is reciprocity in respect of European companies. That is to say a fair and level playing field for both Indian and European companies," he told EurActiv.

The protests began following the resumption of longstanding trade negotiations between the EU and India. Bilateral negotiations for a FTA between the EU and India began in 2007 and are expected to be concluded in spring 2011.

The EU is India's largest trading partner with trade in goods and services in 2009 being estimated at just under €69 billion.

Positions: 

Brian Ager, director-general of the European Federation of Pharmaceutical Industries and Associations (EFPIA), said in an interview with EurActiv that "there is no way that anything in the India-EU FTA could or should have any impact on Indian generic companies being able to supply the developing world or their own country with generics".

He added that "there were similar murmurings before India passed its 2005 Patent Act. MSF [Médecins sans frontières] and Oxfam were expressing very worried opinions about the same thing and it didn’t come to pass".

A group of South African NGOs issued a statement opposing provisions in the FTA that "threaten the sustainable supply of affordable medicines to millions of people in the developing world".

The statement quotes Mara Kardas-Nelson of Médecins Sans Frontières South Africa as saying that "more than 80% of the [anti-HIV] drugs our medical practitioners use to treat 175,000 people in developing countries are affordable generics from India".

She added, "we cannot afford to let our patients' lifeline be cut".

UN Special Rapporteur on the Right to Health Anand Grover joined the protestors in their demonstrations. "It would be a colossal mistake to introduce data exclusivity in India, when millions of people across the globe depend on the country as the 'pharmacy of the developing world'," he said.

Next steps: 
  • Spring 2011: Expected conclusion of EU-India free trade talks.
Background: 

The Indian pharmaceutical industry is the world’s third-largest by volume but only the fourteenth in terms of value. It plays a critical role in supplying cheap generic drugs to people in India and other developing countries.

Developed countries and the WTO have long urged India to adopt a comprehensive intellectual property rights regime, which they claim would spur innovation in pharmaceuticals. In 2005, India passed a landmark patent law which had seen major opposition from NGOs.

'Data exclusivity' refers to the clinical test data showing the safety and efficacy of a new drug before it can be commercialised. It provides a period during which the new drug's producer has a monopoly on production, unless potential competing generics companies submit similar test data.

Drug companies involved in research argue data exclusivity period is necessary to recoup the high costs of conducting extensive clinical trials.

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