European Commission Response

 
Brussels, 6th JAN, 2011

Subject: Letter of 6 November 2010 from Latin America to European Union - India-

EUFTA

Dear Ms. Di Giano,

I refer to the petition that you sent me on 8 November 2010 in which you express concern

about the potential impact of the intellectual property provisions in the EU-India Free Trade

Agreement (FTA) on access to medicines.

The Commission recognises that India is an important source of generic medicines which the

world's poorest heavily depend on. And I can reassure you that this is duly taken into account

in the bilateral trade negotiations between the EU and India.

First of all, the agreement under negotiations will not undermine India's right to protect the

public health and interests of its citizens, as the petition is suggesting. Nothing in the

agreement will prevent India from using compulsory licensing for 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 Agreement and Public

Health so as to ensure that the flexibilities granted by the TRIPS Agreement, especially as

regards patents on medicines, can be fully used by India. Moreover, the Commission has

proposed a provision stating that "nothing in this Agreement shall be construed as to impair

the capacity of the Parties to promote access to medicines".

Furthermore, with regard to so-called "TRIPS Plus provisions", it is important to differentiate

between the potential provisions you may have in mind. While the issue of patent term

extension is no longer under negotiation with India, the issue of data exclusivity is still being

discussed. The purpose of data exclusivity is to taL· into account the fact that the development

and marketing of a new medicine requires the originator to conduct extensive research and

testing. In these ongoing discussions, the EU will fully taL· 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.

Regarding potential provisions on enforcement of intellectual property rights and border

measures, the agreement will not hamper 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 more difficult.

To conclude, I hope I could reassure you that the reality of the negotiations with India should

not give raise to concerns set out in the petition. The intellectual property chapter of the FT A

with India is still under negotiation. Certain elements have been put on the table for

discussion, and the Commission together with India is looking into these elements in order to

reach afinal outcome which will satisfy both sides.

Promoting access to medicines is an essential pillar of the Commission's policy on intellectual

property, and I assure you that it is also fully taken into account in the negotiations with

India.

Yours sincerely,

Karel DE GUCHT

 MH/amw/A res