Drug evaluation

We applaud:
• the Commission accepted that special conditions be created for small and medium-sized drug companies, especially regarding fees, in order to facilitate their access to the centralised marketing authorisation procedure (amendments 1, 13 and 129, recitals 8 and 20, and article 61-1bis);

• the Commission accepted the principle that clinical trials conducted outside the European Union, for drugs authorised by the EU, be verified to ensure they respect good clinical practices and ethical standards equivalent to those applied within the EU (amendment 4, new recital 12bis);

• the Commission accepted that all marketing authorisations be re-evaluated after five years, rather than being granted permanently as initially proposed (amendments 163 and 165, recital 29, article 13-1).

We deeply regret:
• the Commission did not accept the amendment recommending that marketing applications include a comparison with existing drugs used in the same indication(s), considering that comparative efficacy cannot be considered a criterion for authorisation. It is unacceptable that the Commission should reject such an important point out of hand. The amendment in question (amendment 25, article 6-1-2), which had already been watered down before the Parliamentary vote, simply stipulates that applications may be accompanied (no obligation) in the expert report, by a comparison between the new drug and drugs previously authorised for the same indications;

• the Commission rejected amendments allowing at least 90 days for the scientific assessment of marketing applications in the standard procedure, with the possibility that this period be prolonged in special cases (amendments 175 and 45, articles 6-3-1bis, 1ter and 1quarter, 13-6-2bis and 2ter). The Commission considered this as simple 'details' of the scientific committees' internal rules of procedure. In our opinion, however, this is one important way of helping to guarantee the quality of the scientific assessment.

• the Commission stated that it accepted, in principle, amendments referring to relative efficacy (of a new drug relative to available therapeutic options) (amendments 4 and 100, recital 11, article 53bis). It even went so far as to recall that the European Council of Ministers had underlined (on 29 June 2000) the importance of identifying drugs with added therapeutic value.
But according to the Commission, this assessment should not be conducted within the marketing authorisation framework; in other words, in the Commission's opinion, the only valid criteria for licensing a new drug are its quality, safety and efficacy. The Commission simply recommended a vague survey of the methods used by Member States to estimate the benefit offered by new drugs (even though these methods have been known for many years), without stating what purpose this survey might serve.
It should be recalled that those EU parliamentarians who recommended that the added therapeutic value of new drugs be assessed during the application process (and also at the five-year re-assessment) did not make this a criterion for marketing approval but simply suggested that the licensing commission's report, and possibly the summary of product characteristics, should include this information;

• the Commission also rejected an amendment stipulating that the marketing authorisation committee's opinion be justified, indication by indication, arguing that this was already the case. This may be so, but we would prefer it to be made obligatory.

©La revue Prescrire 15 January 2003