WRITTEN QUESTION E-2409/01

by Imelda Read (PSE) to the Commission

(21 August 2001)

Subject: Single Market in Pharmaceuticals

In April 1999 the European Parliament adopted its resolution on the Communication from the Commission on the Single Market in Pharmaceuticals(1). In its resolution the European Parliament expressed its belief that it is vital to complete the internal market in pharmaceuticals and asked the Commission when making its proposals, to include a time-frame for evaluation of progress in achieving the single market.

Can the Commission specify what action it proposes to take and when it will be putting forward proposals?

(1) COM(98) 0588.

Answer given by Mr Liikanen on behalf of the Commission

(29 October 2001)

Significant progress has been made in improving the operation of the single market in pharmaceutical products with respect to the following three strategic areas:

- the development of a European procedure for marketing authorisations,

- the development of high levels of protection for intellectual property and

- the development of the pharmaceutical market itself.

As regards marketing authorisations, the EU will in future have a centralised system which, whilst ensuring safety and public confidence, will also enable a time to market that can be described as certainly the shortest in the world.

Nevertheless, it is always possible to improve the system. This is why, as planned, the Commission carried out a detailed assessment of the operation of the system in the course of 2000 in order to specify new procedures which would make it even more efficient. Following this assessment, a draft revision of the pharmaceutical legislation was finalised, and this will shortly be sent to Parliament and the Council. This is of prime importance as a contribution to further improving public health in the EU.

As regards intellectual property, the proposed reform of pharmaceutical legislation provides for a system which both encourages the production of new medicines and stimulates competitiveness, through provisions which promote the development of generic products. These measures are supplemented by the legislation agreed by the Community institutions in 1998, which had already introduced the possibility of patenting innovations in the field of biotechnology the key field par excellence for this sector.

These important proposals have recently been followed up with the creation of a high-level group on innovation and the supply of medicines, more commonly called G10. This group is composed of the Member of the Commission responsible for enterprise policy and the Member responsible for health and consumer protection, together with health ministers and representatives of the pharmaceutical industry, patient associations and social security bodies.

This group is charged with eliciting proposals which encourage innovation and competitiveness whilst ensuring a high level of public health.

The final report will be structured around the following three issues:

- the supply of medicines for patients,

- the single market, competitiveness, regulation and

- innovation.

This report will be presented in April 2002.

Following the second G10 meeting on 26 September 2001, it was decided, in the interests of transparency, to launch an extensive consultation exercise. This will be concluded on 23 November 2001. The consultation document and all documents relating to the G10 Medicines are available at the following website: http://pharmacos.eudra.org, under the heading G10.