|The working party preparing the decisive meeting
of the Council of Ministers on 2-3 June 2003 is meeting regularly
and productively, but several key matters concerning public health
have not yet been taken into account.
The Medicines in Europe Forum recalls the areas in which the European
draft Regulation on human medicines must be improved.
On 27 January
2003, Costas Stefanis, the Greek health minister, confirmed to the
European parliamentary Committee on the Environment, Public Health
and Consumer Policy that the Greek Presidency would do its utmost
to ensure that a regulatory framework for medicinal products is
adopted before EU enlargement in 2004 (1).
working party preparing the decisive meeting of the Council of Ministers
on June 2&3, 2003, together with permanent representatives,
are trying to reconcile the amendments voted by the European Parliament
on 23 October 2002, and the new, softer proposals made by the European
Commission. (The new draft Regulation was made public on 10 December;
the Directive is due by mid March 2003.)
working party meets regularly and productively, but a number of
key points guaranteeing public health interests have not yet been
taken into account in the latest draft Regulation dated 4 February
time is pressing with the forthcoming EU enlargement, as repeatedly
stressed by the European Commission (DGE) and the European Federation
of Pharmaceutical Industries and Associations (EFPIA). But this
urgency must not be allowed to overshadow the overriding principles
of the EU Treaty, i.e. to guarantee that European citizens have
the highest possible level of protection, and that patients have
access to the best medical treatments.
©La revue Prescrire for the Medicines
in Europe Forum 1 March 2003
1- Mr Costas N. Stefanis, Greek Minister for Health and Welfare
"Presentation and questions" European Parliament -
Committee on the environment, Public health and Consumer policy
27 January 2003: 2 pages.