Revue Prescrire, article en une, Medicines in Europe: Appeal to EU Ministers March 2003 (11)
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Medicines in Europe:
Appeal to EU Ministers: don't forget the fundamentals!
 
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.
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Areas in which the draft Regulation remains to be improved, as of 4 February 2003
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Medicines in Europe: campaigning goes on!
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Five-year re-evaluation of marketing authorisation: not a simple formality

The need to re-evaluate new drugs was underlined by the EU Parliament and endorsed by EU health ministers. Several countries question the need for a second re-evaluation after 10 years, favouring a single re-evaluation after 5 years on the market. One country proposed routine re-evaluation at 5 years and a further re-evaluation 5 years after any change made to the licensing terms for pharmacovigilance reasons; this seems to be a reasonable compromise.

However, the conditions of this re-evaluation are still too vague. If it is not simply to be a matter of administrative formality, rapporteurs must have sufficient time to analyse the scientific data. They must also take into account all new data that accumulate during the first five years on the market, and not only those offered by the marketing authorisation holder. The Agency must conduct a thorough data search of the international literature and the databases of other national medicines agencies and health technology assessment bodies. All clinical trials conducted after initial granting of marketing authorisation ("phase IV" trials) must be taken into account (whether or not they were initiated by the licence holder), and especially trials comparing the new drug with a reference treatment.

Article 13-1a must be modified accordingly; once again, these points are in no way simple "details". Recital 29 must also be more explicit on this matter.

©La revue Prescrire for the Medicines in Europe Forum 1 March 2003