European medicines policy: state the priorities of medicines agencies and provide them with the necessary means

The Commission once again confirms its pro-industry stance by rejecting the first amendment voted by European parlementarians stating that "drugs are not just another consumer product". It considers that this statement is unnecessary and irrelevant to the purposes of the Directive. Yet this recital was simply intended as a baseline, to counter excessive support for purely industrial interests.
Recital 1 (new amendment 1) must be upheld, as a sign that European citizens' best interests are taken into account in the Directive.

The Commission opposes several key amendments concerning the implementation of European medicines policy. It rejects the notion that national medicines authorities be obliged to respect principles of independence and transparency (such as obligatory declaration of conflicts of interest by all high-level administrators and experts), on the grounds that this is a matter for the individual national authorities. However, the Forum considers that the Directive should set the example the key issues of independence and transparency, and that each member state should adopt the underlying principles within their own regulatory framework.
Article 1 point 68a (amendment 129) must be upheld.

As regards relationships between national agencies and the European Medicines Evaluation Agency, one amendment requires that the European Committee for Proprietary Medicinal Products (CPMP) be systematically informed when member states' opinions diverge on marketing authorisation, or market suspension or withdrawal of drugs authorised through the mutual recognition procedure (amendments 64 and 65, article 1 point 24). The Commission rejects this obligation that, in its opinion, would overload the European agency. But the Forum does not see this as a valid argument: all medicines agencies, both national and European, must be provided with the means required to fulfil their tasks if a harmonised European medicines policy is to become a reality.
Article 1 point 24 (amendments 64 and 65) must be upheld.

©La revue Prescrire, for the Medicines in Europe Forum 7 April 2003