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Trade Negotiations Between EU, India Could Affect Access To Low-Cost Generic Drugs

The Associated Press examines the ongoing free-trade negotiations between the EU and India – a country that according to PricewaterhouseCoopers currently “makes one-fifth of the world’s generics.” The negotiations “could make it harder for millions … across the developing world to get lifesaving drugs. The deal is taking shape as India tries to transform itself from a generics powerhouse into a base for drug discovery – a trend that could ultimately do more than any trade agreement to curtail its reign as a pharmacy to the poor.” 

The article explores the country’s history as “a drug producer for the developing world, revolutionizing the treatment of diseases like AIDS, tuberculosis and malaria with low-cost generics,” dating back to the 1970s. The piece also includes comments by critics of the negotiations  – who posit any change could reduce the poor’s access to drugs – and a representative of the EU, who “maintains that nothing in the agreement would prevent India from continuing to play this role and that it has no desire to force measures on India that it is not ready to espouse.”

EU-India negotiations, which are being held in private, are scheduled to continue “April 28 in Brussels, with the goal of signing a completed agreement by October,” the AP writes.

According to the AP, a “leaked draft of the negotiating text from February 2009, … contains controversial measures that would extend patent protection up to five years to compensate for drug-approval delays and introduce the concept of ‘data exclusivity,’ which restricts the ability of generics companies to rely on data from brand-name companies, potentially forcing them to do their own costly, time-consuming clinical trials” (Kinetz, 4/26).

The Economic Times also examines reactions to the EU-India free-trade negotiations: “A letter, dated April 22, from the recently established working group in the European Parliament on Innovation, Access to Medicines and Poverty-Related Diseases to the European commissioner for international trade, expressed concern that the EU-India FTA [free-trade agreement] may contain provisions – such as data exclusivity, patent term extensions and enforcement of IP rights and border measures – that reverse the advances made on access to medicines, which could have dire consequences for patients in India and in the rest of the developing world. … Despite these negotiations having such far-reaching consequences, there have been no consultations with civil society and other stakeholders …” (4/27).