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Global Action Over the Challenge to India's Patent Laws

March/April 2012

From 6-10 February 2012, activists from Delhi to New York, Johannesburg to London took to the streets to appeal to the Indian government and European Commission (EC) to act to ensure that the developing world continues to have access to affordable medicines.

Currently, the EU is pushing for India to adopt measures that would choke generic production in the country, and by restricting generic exports, threaten access to medicines for millions of people worldwide. Negotiations on the proposed India-EU Free Trade Agreement (FTA) were expected to culminate at the EU-India Summit, which took place in New Delhi on 10 February 2012.

The Summit was expected to be the climax of a five-year-long negotiation process over an EU-India Free Trade Agreement (FTA). The agreement seeks to strengthen trade relations between the two economies and holds promise of huge development for many Indian industries. It also, however, is a source of concern for the global health because India is the world's largest producer of generic medicines making it the "pharmacy of the developing world".

India currently produces 80% of ARVs used in the developing world and 90% of paediatric HIV medicines. Despite curtailment of generic production following India's inclusion into the World Trade Organisation in 2005, the country has successfully utilised TRIPS flexibilities to ensure that it still produces affordable medicines for for the world's poorest countries.

The FTA, however, threatens to over rule India's national patent laws and increase restrictions on generic pharmaceutical production from within the country.

One of the most harmful provisions within the agreement -- that of data exclusivity -- was the focus of activist pressure throughout 2011. The provision (known as data monopolies in the US) requires manufacturers of all generic formulations to conduct new clinical trials rather than simply demonstrating equivalence to the innovator drug, even though the FDA recognises the scientific safety and rigour of bioequivalence studies. If these trials are not conducted the generic company would be required to wait 10 years to gain access to the original trial data.

Following widespread pressure from global health advocates and activists and resistance from the Indian government the EC announced that this provision has been removed from the agreement. Despite this assurance the newer drafts of the agreement indicate that similar provisions, albeit in subtler wordings, are being pushed to be included in the final agreement.

Further harmful inclusions into the agreement include:

  • Border measures -- restricting the exportation of generic drugs out of the country.
  • Intellectual Property enforcement measures -- putting third parties such as treatment providers at risk of court cases and police action.
  • The 'Investment Chapter' that would remove the Indian government's right to place public health before private profits by allowing companies to directly sue the government in disputes over IP rights.

In the end, no agreement was reached on 10th February and the negotiations between the EC and India are ongoing. As pressure grows to come to an agreement in the near future there is increasing concern that provisions harmful to access to medicines may be slipped into the FTA. The consultation process is being conducted with little sign of accountability or transparency, leaving activists largely in the dark about these worrying provisions. Ongoing pressure is essential to protect India's generic industry and ensure that the developing world retains access to the affordable medicines it needs.

For more information, and to become involved in the campaign please see:

Pictures of the Global Week of Action are online:

The Stop AIDS Campaign is an initiative of the UK Consortium on AIDS and International Development.

What Can You Do

Sign on to MSF initiated letter to Commissioner De Gucht, DG Trade:

Video Demonstrations





South Africa


Report shown on Sky News

Links to external websites are current at time of posting but not maintained.

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This article was provided by HIV i-Base. It is a part of the publication HIV Treatment Bulletin. Visit HIV i-Base's website to find out more about their activities, publications and services.
See Also
More on HIV/AIDS Treatment in India

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