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
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