Economic Times, India
India, EU settle generics dispute, pave way for FTA talks in April
15 March 2011
By Amiti Sen, ET Bureau
NEW DELHI : India has sorted out most of its differences with the European Union on production of low-cost generic medicines, ahead of a crucial meeting on a proposed free-trade pact next month, a government official told ET. Civil society groups, however, warn that India should be on its guard to ensure that the intellectual property rights (IPR) regime is not changed to allow extension of patents.
The EU has been pushing India to adopt more stringent IPR standards to match the strong patent protection given by it to its industry. "We did discuss IPR issues as well and it was clarified that we would not go beyond the commitments that have already been made under the international IPR agreement (TRIPS)," the official said.
Top officials from India will travel to Brussels next month to give final touches to the bilateral free-trade deal talks that began in 2006. Commerce secretary Rahul Khullar will be in Brussels on April 7-8 to wrap up the comprehensive agreement that will cover trade in goods, services and investments. The proposed broad-based trade and investment agreement will lower tariff barriers on a large number of goods, liberalise rules on investments and provide more opportunities for services.
But the two sides had trouble narrowing down their differences on the intellectual property issue. The EU has been demanding data exclusivity in all its FTAs, a demand civil society groups say will undermine the country’s ability to produce generics that are cheap but effective copies of medicines that no longer have patent protection in India. Data exclusivity refers to exclusive rights of a company over the clinical data for its drugs.
In absence of such a data, a rival will not be able to launch a cheaper generic even if the drug does not have patent protection. Effectively, data exclusivity can be used to enhance the patent life of a drug through minor modifications in drugs and securing rights on the relevant. Such exclusivity is usually given for five to 10 years. "Data exclusivity has proven to be damaging to public health in free-trade agreements in other countries," said Anand Grover , the UN special rapporteur on the right to health.
Although both India and the EU had released an official statement at the recent India-EU summit confirming that India’s right to produce and export generics will not be undermined by the proposed agreement, activists say it cannot be taken at face value. Civil society groups from Asean ( Association of Southeast Asian Nations )) nations also want India to hold its ground on the issue of IPR, as giving in to the demand would allow the EU to put pressure on them to change their regime. "We in the Asean look up to India to put up a fight against the EU," a representative from a Philippines-based civil society organization said.