Revue Prescrire, article en une, Medicines in Europe March 2003 (2)
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Medicines in Europe:
Commission-Council compromise procedure
Detailed update On 4 February 2003
Points that appear to have been adopted
 
Preparatory work for the Council of Ministers meeting in June 2003 includes a search for compromises between member state representatives and the European Commission. A good deal of work had been done by 4 February 2003, but some important points remained to be settled.
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Points that must still be defended

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Medicines in Europe: campaigning goes on!
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Operational transparency of the European Medicines Evaluation Agency (EMEA)

- Information on refusals to grant marketing authorisation, and on negative opinions expressed by the licensing Committee (current CPMP), will, in principle, be made public (amendment 36 articles 11-2a). Moreover, refusal of a centralised marketing authorisation would imply prohibition of the product concerned in all Member States (art. 11-2);

- documents describing scientific conflicts between the European Medicines Evaluation Agency and national or European scientific committees will be made public (amendments 98 and 99, articles 53-3 and 4);

- the public database of medicinal products, for which EMEA will be responsible, will be extended to include all drugs marketed in the European Union, regardless of the procedure through which they were authorised (amendment 95 article 51-2);

- members of EMEA committees and advisory boards will list their conflicts of interest on a yearly basis. This list will be available to the public, but only on request to the Agency (amendment 110 articles 56-2-1, 1a and 2) (point to defend, see below);

- the European Court of Auditors will write annual reports on EMEA activities (amendment 125 article 60-9);

- companies will have to inform the Agency, at least two months in advance, of their intention to cease marketing a drug (temporarily or permanently) (article 12-4);

- EMEA will have to inform national medicines agencies whenever a company abandons a marketing application, along with the underlying reasons, which the firm will be obliged to provide to the Agency (amendment 153 article 10a);

- national medicines agencies will be obliged to inform health professionals, notably via professional bodies (amendment 50 article 18-4a);

- fines inflicted on companies for non-compliance with certain statutory obligations will be made public, along with the names of the companies concerned (amendment 135 article 74-3).

EMEA functioning

- the time allotted for administrative procedures during evaluation of marketing applications will be shortened, which should provide more time for scientific assessment (amendments 30, 32 and 33, articles 9-3, 10-1-1 and 10-2-2a); the total period will remain 210 days (or 150 days for the accelerated procedure).

Evaluation of medicinal products

- special conditions will be created for small and medium-sized pharmaceutical companies (especially with regard to Agency fees), in order to facilitate their access to the centralised procedure (amendments 1, 13 and 129, recitals 8 and 20, and article 61-1a);

- it will be verified that clinical trials conducted outside the European Union for drugs authorised by the EU followed good clinical practices and ethical standards equivalent to those applying in the EU (amendment 4, new recital 12a);

- all marketing authorisations will be re-assessed after five years, and will not initially be valid for a unlimited period as initially proposed by the Commission (amendments 163 and 165, recital 29, and article 13-1). However, this point is still under discussion, with some Member States requesting more than one reassessment.

Pharmacovigilance

- the Commission rejected the amendment aimed at obliging companies to contribute to funding the Agency's pharmacovigilance activities (amendment 67, new article 25b); this decision is welcome, as it will offer the Agency a minimum of independence, at least in this very sensitive area;

- drugs will have to be withdrawn from the market whenever they present a "negative benefit/risk balance under normal conditions of use", and not simply an "unacceptable level of risk" as initially proposed (amendment 14 recital 24);

- the tasks of the EMEA will be explicitly extended to include "verification of compliance with pharmacovigilance obligations" (amendment 90 article 51-1-g).

Compassionate use

- pharmaceutical companies will be obliged to ensure that patients with no therapeutic alternatives have continuous access to drugs that have not yet been authorised, within the framework of compassionate use programs, until the drug is effectively marketed (and no longer simply until marketing authorisation is granted) (amendment 134 article 73-7a);

- the Commission rejected an amendment proposing that the cost of compassionate use be met by the companies concerned (amendment 133 article 73-6), considering that public funding could not be ruled out.

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