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Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.
Ongoing Free Trade Agreement (FTA) negotiations between the EU and India have hit a hurdle as some stakeholders urge the Indian government to fight against certain provisions in the FTA amid fears that access to generic drugs may be affected.
Ongoing Free Trade Agreement (FTA) negotiations between the EU and India have hit a hurdle as some stakeholders urge the Indian government to fight against certain provisions in the FTA amid fears that access to generic drugs may be affected. According to a statement from Doctors Without Borders, the EU is “pushing for harmful intellectual property provisions” to be included in the FTA that will “hinder access to quality, affordable generic medicines produced in India.”
India produces an enormous number of generic products, many of which are particularly popular in developing countries as cheaper alternatives to branded medicines. The country has been able to produce so many affordable versions of medicines patented elsewhere because it did not grant patents on medicines until 2005.
“The EU is pushing for intellectual property provisions in the FTA that exceed what international trade rules require. The most damaging measure is so-called ‘data exclusivity,’ which would act like a patent and block more affordable generic medicines from the market, even for drugs that are already off patent, or do not merit a patent to begin with,” explained Doctors Without Borders.
India and the EU have been discussing an FTA since 2007. India is one of the EU’s most important trade partners; however, India still maintains “substantial tariff and nontariff barriers that hinder trade with the EU," according to the European Commission. A FTA would help to increase trade in both goods and services, but the EU has outlined a number of provisions that India must submit to, including, among others, strengthening its patent laws, which some believe will affect the supply of generic medicines.
A release from the EU Delegation to Tanzania acknowledged these fears, but believes they are based on a misunderstanding of the EU’s objectives and negotiation position. According to the statement, the EU has proposed a clause in the negotiations to ensure that nothing in the FTA prevents India from producing and exporting medicines to developing countries. “The EU is fully aware that India is an important provider of generic medicines to other developing countries; the Free Trade Agreement currently under negotiations between India and EU is certainly not intended to restrict the ability of India to continue doing the same for domestic and international consumption.”
The EU–India FTA is expected to be finalized in spring 2011.
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Generics Dispute EU-India Trade Negotiations (PharmTech Europe)