|On 2-3 June 2003 the European Council of health ministers
will give an opinion on the Directive and Regulation that will form
the legal framework for human medicines throughout the European Union
in years to come. The wording of these texts will have enormous implications
for patients, health professionals, and health insurance systems (social
security and mutual insurance).
has examined the amendments to the drafts that were voted by the
European Parliament at the first reading on 23 October 2002 (For
further information: The European Parliament opts for public health
at first reading Click
here). It is currently examining the responses of Enterprise
Directorate-General of the European Commission to these amendments.
The Commission prepared the initial draft texts and is actively
seeking to influence the final documents.
Commission's responses to the proposed amendments to the draft Regulation
were drafted rapidly, as they were made public on 10 December 2002.
The Medicines in Europe Forum analysed these responses and informed
the Council of Ministers of its concerns in a public alert dated
20 February 2003 (For further information: The European Commission
counter-attacks with its second draft Regulation Click here).
Commission has taken far longer to release its responses to the
proposed amendments to the draft Directive. They have been submitted
to the Council of Ministers (1) rendered public on 25 April 2003
(For further information: The European Commission counter-attacks
with its second draft Directive (pdf, 313 Ko): Click here).
therefore have less than two months to examine the Commission's
opinion and to offer our own views; this is very short, given that
the Commission is challenging some principles of public health that
were endorsed by the European Parliament.
Commission has reached a favourable opinion on several important
measures, such as non acceptance of data from clinical trials conducted
in developing countries unless the local population is likely to
derive a direct benefit; re-evaluation of marketing authorisation
after five years (this is crucial, given the limitations of the
initial marketing procedure); unannounced inspection of company
premises; validation of patient information leaflets by groups of
potential users; the principle that companies must guarantee uninterrupted
supplies of their drugs; and advance announcement of marketing withdrawals,
the Commission is intending to reject key measures essential to
maintain quality of care. As usual, the Commission's main concern
seems to be the interests of drug companies.
©La revue Prescrire, for the Medicines
in Europe Forum 1 May 2003
1-Commission of the European Communities "Modified draft directive
of the European Parliament and Council on medicinal products for
human use" 2001/0253 (COD), 3 April 2003: 28 pages.