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
|