EN Official Journal of the European Union CE 88/589

(2004/C 88 E/0601)

WRITTEN QUESTION E-0130/03

by Margrietus van den Berg (PSE) to the Commission

(28 January 2003)

Subject: Implementing paragraph 6 of the Doha Declaration on TRIPS and public health

Paragraph 4 of the Doha declaration states that ‘ … the TRIPs Agreement does not and should not prevent members from taking measures to protect public health’ and that ‘the [TRIPs] Agreement can and should be interpreted and implemented in a manner supportive of WTO members' right to protect public health and, in particular, to promote access to medicines for all’.

Furthermore, paragraph 5(b) of the Declaration reaffirms the right to grant compulsory licences and the freedom of each WTO Member to determine the grounds upon which such licences are granted.

Does the Commission recognise that neither the Doha Declaration nor the TRIPs Agreement restricts the application of these principle to certain types of public health problem, to the exclusion of others; nor do they limit eligibility to certain types of country?

Does the Commission recognise the intention of paragraph 6 of the Doha Declaration to ensure that WTO members without adequate manufacturing capacity benefit in full from the provisions of that declaration, on the same terms as WTO members who do have such capacity?

Does the Commission therefore recognise that to impose additional or new constraints as part of the solution to the paragraph 6 problem would violate the spirit of the Doha Declaration, and be justifiably seen by developing countries as evidence of bad faith?'

Answer given by Mr Lamy on behalf of the Commission

(25 February 2003)

The Doha Declaration on the Trade Related Intellectual Property Rights (TRIPs) Agreement and Public Health confirmed and clarified the existing flexibilities under the TRIPs Agreement, especially compulsory licences and parallel import, and re-affirmed the importance of Articles 7 and 8 of the TRIPs Agreement in its interpretation. It has an important legal value as it gives guidance to the interpretation of the TRIPs Agreement.

Paragraph 6 of the Declaration deals with an issue that could not be resolved in Doha, and for which the TRIPs Agreement does not provide a tailor-made solution. So, strictly speaking, paragraph 6 is not about implementing the Doha Declaration. The Doha Declaration in itself can be implemented by all members without need for further international legal instruments. Paragraph 6 is about adding an additional layer of flexibility to the TRIPs Agreement and to the Doha Declaration. It purports to creating new possibilities under the TRIPs Agreement in order to resolve the problems of countries without manufacturing capacities in the pharmaceutical sector, by allowing them to have effective recourse to compulsory licensing.

The major difference with compulsory licensing as already provided for under the TRIPs Agreement is that production takes place in one country, and that the entirety of the production is then exported to another country (under the current rules of TRIPs, production and consumption of a predominant part of the production must take place in the same country). Therefore, the conditions attached to the use of such licences must be adapted to this reality. So this is not a question of imposing additional and burdensome constraints, but to adapt conditions to different circumstances. This is what has been done in the draft decision of 16 December 2002 (1), which contains minimal safeguards against trade diversion and which, moreover, specifies (as proposed by the Union) that such measures should be proportionate to the administrative capacities of the countries concerned. This arrangement, which has been endorsed by all World Trade Organisation (WTO) Members (minus one), and which would effectively allow countries without manufacturing capacities to benefit from compulsory licences, fully respects the spirit of the Doha Declaration.

As the Honourable Member knows, the Union fully endorsed the 16 December 2002 text, including its disease scope by reference to paragraph 1 of the Doha Declaration. The Commission regrets that the United States did not join the consensus and the Union will continue its efforts in order to secure a multilateral solution as soon as possible. It cannot accept that these negotiations end in failure. WTO Members have taken the commitment in Doha to find a multilateral solution, so this commitment must be upheld. To this effect, the Union has recently taken the initiative to propose recourse to the World Health Organisation in order to guarantee flexibility in applying the system, in line with the scope of the Doha Declaration.

(1) Draft Decision of the President of the TRIPs Council of the WTO (Reference: JOB (02) 217).