Source: EURLEX
Language: en
Format: md

[**Avis juridique important**](../../../editorial/legal_notice.htm)

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# 92000E3299

**WRITTEN QUESTION E-3299/00 by Eryl McNally (PSE) to the Commission. Generic Medicines.** 
  
*Official Journal 151 E , 22/05/2001 P. 0126 - 0127*

  

WRITTEN QUESTION E-3299/00

by Eryl McNally (PSE) to the Commission

(25 October 2000)

Subject: Generic Medicines

Generic medicines are playing an important role within EU public healthcare but in contrast to most of the generic industries outside the EU, EU-legislation does not allow for experimental use and testing for registration purposes. The European Parliament has asked for similar legislation which would mean saving 13 000 jobs in the EU and permitting it to be competitive.

The Commission in its Communication on the Single Market in Pharmaceuticals (COM(98) 588) committed itself to ensuring that consumers have access to lower-prices generic medicines as soon as possible after the patent protection of the originator product expires.

What action is the Commission taking to introduce legislation to ensure that European generic manufacturers remain internationally competitive and that patients have access to affordable medicines?

Answer given by Mr Liikanen on behalf of the Commission

(8 December 2000)

The Commission is currently undertaking a review of the regulatory process, and a final report is expected shortly. As regards the effects of patent protection, it should be noted that it is possible to register a generic product using data generated elsewhere, which means that generic products are often able to come to market within the Community immediately upon patent expiry. The Commission currently has no plans to propose changes to the patent position, although it naturally remains open to the views of producers and consumers of pharmaceutical products on this question.

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