Revue Prescrire, article en une, Medicines in Europe Directive May 2003 (2)
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Medicines in Europe:
Areas in which the Directive remains to be reinforced
 
The Medicines in Europe Forum demands that the Directive be reinforced in the following areas.
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Areas in which the draft Directive remains to be reinforced, as of 7 April 2003
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Medicines in Europe: campaigning goes on!
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Drug evaluation: towards trustworthy drugs

The Commission rejects the amendment that stipulates that marketing applications should include data from at least one clinical trial comparing the new drug with another drug used in the same indication. According to the Commission, there is no need to compare drug efficacy at this stage: any such comparison should only be made when decisions on pricing and refunding are made. Once again, Enterprise Directorate-General is clearly acting in favour of the drugs industry, seeking to facilitate their regulatory obligations. The Forum asks how individual member states could possibly conduct the comparative clinical trials of all newly authorised drugs in order to determine their added therapeutic value. Social security and mutual insurance systems need comparative data, and so do health professionals and patients: they all seek to use the safest and most effective drugs available.
Amendment 29, article 1 point 6 must be upheld.

On another amendment, the Commission states peremptorily that the aim of determining risk-benefit ratios is not to compare one drug with another (amendment 126, article 1 point 66). Further, it opposes any comparative assessment on the grounds that current texts do not require such evaluation. But the objective of all new Directives is to reorient European policy in a given area. Member states increasingly need comparative data on which to base treatment choices. European parliamentarians underlined this by adding the word "comparative" to amendment 86 article 1 point 21, which relates to the five-year re-evaluation. And this latter amendment has not been challenged by the Commission.
Amendment 126, article 1 point 66 must be upheld.

The Commission also rejects the notion that long-term clinical trials be obligatory for drugs designed for long-term use. Amendment 176, article 1 point 6b offers greater guarantees for patients with chronic health problems.
Amendment 176, article 1 point 6b must be upheld.

The Forum once again draws health ministers' attention to a point, mentioned in both the Directive and the Regulation, that conditions the quality of drug evaluation: namely the time that CPMP experts are allowed to analyse all relevant scientific data (and not only those provided by the company concerned). The Forum demands that rapporteurs be explicitly given a 90-day period in which to do their job properly, for both European centralised and national procedures. In its responses to the amended Regulation, the Commission stated that this issue was a simple "detail" that could be dealt with through internal procedures.

In its discussion of the draft Directive, the Commission pretends not to understand the amendment (which may be somewhat clumsily worded), and states that it initially proposed a period of 120 days. But this 120-day period covers the time required to prepare the final assessment report and the final version of the summary of product characteristics (a sort of "drug identity card"). It therefore includes the time taken by the rapporteur to analyse the scientific data; deliberations by the CPMP; preparation of questions posed to the company; the company's responses and their analysis; and preparation of administrative documents, etc.; which means the time allotted for scientific data analysis, the key phase, is not protected.
Amendment 49, article 1 point 15 must be upheld (but possibly better worded) so that rapporteurs' scientific mission can be done thoroughly.

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