Subject: Trade agreements and generic medicines
The Commission is currently negotiating a new free trade agreement with India. There are concerns that proposals within the draft agreement regarding data exclusivity may limit the right of Indian pharmaceutical companies to produce generic drugs based on the results of clinical trials carried out by European and American pharmaceutical companies. Limiting India’s pharmaceutical industry in such a way would risk limiting the flow of cheap but effective life-saving drugs to the developing world.
Can the Commission clarify if it is negotiating a deal which includes provisions that go beyond what is required by agreements of the World Trade Organisation concerning data exclusivity, patent extension and border protection measures? Further, will the Commission be publishing a draft of the Free Trade Agreement, and if so, when?
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Parliamentary questions 10 January 2011
As is the case for all Free Trade Agreements (FTAs) negotiated by the EU, the FTA with India will include provisions on Intellectual Property Rights (IPR), including on patents.
The Commission fully recognises India’s important role as source of affordable generic medicines for the world’s poorest people. Consequently, the FTA to be concluded with India will not undermine this commitment and will contain the necessary safeguards to ensure that the IPR chapter will maintain such access to affordable medicines.
For example, there will be nothing in this agreement which will prevent India from using compulsory licensing for the manufacture and export of medicines to other developing countries in need. To this effect, the Commission has already proposed an explicit reference to the Doha Declaration on the TRIPS(1) Agreement and Public Health, so as to ensure that the flexibility granted by the TRIPS Agreement, especially as regards patents on medicines, can be fully used by India. Moreover, the Commission has proposed a clarification in the draft IPR chapter stating that nothing in this Agreement shall be construed as to impair the capacity of the Parties to promote access to medicines.
As regards the issue of patent extension, it should be noted that the Commission is no longer requesting India to extend the duration of patents.
Concerning data protection, the issue is still under negotiation. However, it is clear that the Commission will take into account the specificities of the Indian legal system, the policy developments on this issue within India, its developing country status and the role it plays with regard to production of essential generics for the developing world.
With respect to potential provisions on enforcement of IPR and border measures, the agreement will not interfere with the trade of generic medicines in transit. The enforcement provisions will be construed in a way so as to ensure the smooth flow of generics in transit, thereby not deterring generic competition nor making export of medicines from India to other developing countries difficult.
As regards transit through the EU, Regulation 1383/2003 concerning customs action against goods suspected of infringing certain intellectual property rights(2) is currently being revised. In this context, the Commission is ready to consider modifications to the Regulation that may be necessary to clarify the procedures relating to generic medicines in transit to ensure that they are not unnecessarily affected when merely transiting the EU. This will also be reflected in the IPR chapter to be agreed with India.
As regards publication of the FTA, the Commission will make the initialled agreement available at the end of the negotiations on its website. In the meantime, it is clear that the Commission will keep the Parliament immediately and fully informed at all the stages of the negotiation, in line with the provisions of the revised Framework Agreement on relations between the Parliament and the Commission.
|Agreement on Trade Related aspects of Intellectual Property Rights.|
|(2)||Council Regulation (EC) No 1383/2003 of 22 July 2003 concerning customs action against goods suspected of infringing certain intellectual property rights and the measures to be taken against goods found to have infringed such rights, OJ L 196, 2.8.2003.|