A draft Regulation on paediatric drugs, highly favourable to the sole interests of the pharmaceutical industry, was drawn up by the European Commission. It is currently being debated by the European Parliament.

The Medicines in Europe Forum has closely examined the European Commission's draft, and has sent its remarks and proposed amendments to European members of Parliament.

End result: the Commission had expected the text to pass through Parliament unmodified, but 289 amendments, most of which correspond to the Forum's proposals, have been submitted by European members of Parliament to the Committee on Environment, Public Health and Food Safety of the EU Parliament.

Given the pressure exerted by certain lobbies, these amendments will not go through unchallenged by opponents and the Council of Ministers. But it is encouraging to see that patients' interests (in this case children's interests) have been taken into account. This is further proof that citizens' voices (whenever they exist) can be heard by European institutions.

Timetable for next steps:
The vote by the Committee on Environment, Public Health and Food Safety of the European Parliament, originally scheduled for 14 June, has been postponed until mid-July; as a result, the plenary vote by the European Parliament will not take place before the autumn recall.

Watch this space...

©Medicines in Europe Forum, 1 July 2005