EU agrees to modify customs regulations for generic drugs from India

The European Commission agreed to India's request to amend its customs regulations and to stop confiscating generic drugs being transported for sale in African and Latin American countries. According to a government official, "the EU trade commissioner categorically stated that EC regulation 1383 will be amended to take care of India's concerns related to seizures."
Although the details of the plan have yet to be determined, it is thought to include a clause that would extend patent terms beyond 20 years, and would require Indian drugmakers to carry out their own clinical trials instead of relying on existing data. Medical rights campaigners contend that these provisions could impede future supplies of generic therapies for HIV/AIDS and other conditions. "Unless the attacks by the European Commission on the future of generic production in India are stopped, costs will rise, [anti-retrovirals] access will be rationed and patients will die," remarked Hussein Kerrow of Medecins sans Frontieres.
The deal, which effectively resolves a case brought to the World Trade Organization in 2009 by officials from India, is expected to be finalised in spring 2011. In the interim, the European Commission agreed that no further seizures will take place at European ports, the government official noted.
In the last two years, at least 17 cases of seizures of generic drugs have been reported in ports in the Netherlands, Germany and France following complaints by drugmakers that hold patents to the original products in Europe, but not in their destination of countries in Africa and Latin America. India, which has a Rs 40,000-crore generic drug export industry, claimed that the confiscations were illegal as the generics were off patent in India and were not intended for sale in the EU.
A similar case brought by Brazilian officials has yet to be negotiated.

Reference Articles
India-EU generic drug row 'resolved' at Brussels summit - (BBC News)
Kenyans rally against EU-India deal on AIDS drugs - (Forexpros)
India and EU resolve dispute over generic drugs - (The Economic Times)
Indian generics to be safe from seizure while passing through EU - (The Economic Times)
Generic drug supply may be slashed in EU-India deal - (USA Today)

**Published in "First Word"