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
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