EU pact won’t be tighter against drugs

EU pact won’t be tighter against drugs

New Delhi: India and the European Union (EU) have agreed that the comprehensive bilateral trade agreement being negotiated by the two will not result in an intellectual property regime that restricts the ability of Indian pharmaceutical firms to export generic or off-patent drugs by being far more stringent than the TRIPS regime of the World Trade Organization.

India’s pharma firms and activist groups have been vociferous opponents of the proposed bilateral pact on the grounds that it will require India to make a so-called TRIPS-plus (more stringent than TRIPS) commitment, which will, in turn, limit its capability in terms of producing and exporting low-cost drugs. TRIPS refers to trade-related aspects of intellectual property (IP) rights.

The two sides agreed to this at a meeting between Indian trade minister Anand Sharmaand his counterpart in the European Commission (EC), Karel De Gucht, at Brusselson 29 November, said a senior commerce ministry official on condition of anonymity.

“The agreement will in no way limit India’s scope for developing and exporting life-saving medicines. Specifically, it will not stop India from using its flexibilities under the agreement on TRIPS, in particular, the possibility of manufacturing generic medicines under compulsory licence for export to other developing countries facing public health problems," this person said. Mint couldn’t independently confirm the change in the EU’s stance. The EU’s spokesperson in India didn’t respond to an email seeking comment.

The EU and most other developed countries believe a TRIPS-plus pact is a must for tackling the problem of counterfeit drugs. In a related but separate issue, India’s generics manufacturers have previously faced some problems in the EU with some of their shipments to other countries being routed through European ports being seized. India’s position is that these seizures are the result of a misinterpretation of TRIPS. India and the EU are separately working on addressing this issue.

The commerce ministry official said that a declaration on the comprehensive bilateral pact not having any TRIPS-plus riders will likely be made during the EU-India summit on 10 December at Brussels, which will be attended by Prime Minister Manmohan Singh.

An activist said she would await the text of this announcement. Leena Menghaney, campaign co-ordinator (India) of Médecins Sans Frontières (MSF), said there is still ambiguity shrouding the issue and both sides need to clarify further. “At this point, it is important to confirm that the announcement by India and the EC on IP at the forthcoming EU-India summit in Brussels states clearly that all the EC demands on data exclusivity, investment rules, border measures and other enforcement measures like judicial injunctions and third-party liability are out of the negotiating text," she said.

India is a leader in the manufacture of low-cost generic drugs, and exports affordable life-saving medicines to the tune of Rs35,000 crore every year to countries in Asia, Africa and Latin America.

“MSF, like several other developing countries, directly relies on the Indian manufacture and supply of generic medicines at affordable prices. EC in the India-EU FTA (free-trade agreement) has made demands vis-à-vis intellectual property and investment that directly undermine the production and access to these generic medicines," Menghaney added.

A representative of the Indian Pharmaceutical Alliance (IPA), an industry lobby, said he had asked the commerce ministry not to change its current IP regime. “It is for the government to weigh concerns related to public health, domestic industry and giving in to EU pressure. As of now, we are happy with what the ministry is saying," said D.G. Shah, secretary general of IPA.

The commerce ministry official said that the government believes that “nothing should prevent the poorest people from accessing life-saving medicines. This remains a core principle and will be reflected explicitly in the trade agreement".

Deal in 2011

India and the EU are also expected to release a status report on the deal at the Brussels summit. Reuters quoted Indian trade minister Sharma on 3 December saying that negotiations will be completed in the first half of 2011, if not earlier, and that both sides are giving “finishing touches" to the agreement.

The trade agreement, negotiations for which started in 2007, is set to be India’s most ambitious bilateral trade pact because the EU is already its largest trading partner. Annual bilateral trade between the two sides totals around €77 billion (Rs4.6 trillion) and India ranks ninth on the EU’s list of major trading partners.

India has demanded asymmetric tariff reduction in goods given the different level of development between the two. The EU wants tariff liberalization of customs duties on a large number of agricultural products to which India is firmly opposed, given the sensitivity of the issue at home. India is expected to be a significant beneficiary if the EU agrees to liberalize its services sector, allowing more Indian professionals to work within the bloc. EU trade commissioner Gucht had said earlier this year that the demand for greater market access by European firms, public procurement and services are the issues pending resolution.

India and the EU are likely to conclude a comprehensive market-opening trade pact by March 2011, Sharma said in Delhi on Tuesday, PTI reported.

Radhieka Pandeya and PTI contributed to this story.