The Council of European Health Ministers meets only a few times
during each six-month rotating presidency and, as a result, always
has a heavy agenda. The meeting held on 2-3 December 2002, under
Danish presidency, was no exception: about 30 questions were dealt
with, 3 of which concerned consumer matters, 9 health and 18 employment
and welfare. Medicines policy was one of the health-related matters.
It was decided during preparation of the Council to examine first
the draft Regulation on medicines, which mainly concerns EU market
authorisation procedures and safety monitoring, and the operations
of the European Medicines Evaluation Agency. The draft Directive
was postponed in 2003, under the Greek and, if necessary, the Italian
presidencies. Admittedly the Directive tackles more complex and
politically provocative issues than the draft Regulation, notably
the direct-to-consumer advertising affair.
Accent on consumers
A centralised marketing authorisation
procedure: a slight majority against
Five-year reassessments: a majority in favour
EMEA management board: one representative
per Member State, but no agreement on representation of civil society
Follow up and action still needed
Accent on consumers
The principles re-stated in the resolution on consumer policy (2002-2006)
adopted by the Council on 2 December 2002 concern health protection,
safety, and consumer information. The Council also stressed that
consumer organisations are to be more strongly involved in EU policies
and in monitoring their implementation.
No doubt the umbrella organisation 'Medicines in Europe Forum',
together with other bodies involved in the debate on EU medicines
policy, will ensure that these Council's declarations are put into
A centralised marketing
authorisation procedure: a slight majority against
The first item of the Regulation to be discussed by the Council
of Health Ministers was the marketing authorisation procedure. At
the first reading, members of the European Parliament had endorsed
the recommendation that all new drug substances should follow the
centralised procedure. This procedure, which helps to harmonise
drug evaluation throughout the EU, optimise its efficiency (all
EU experts can be involved), and increase its transparency, is supported
by Medicines in Europe Forum.
The Health Council's report does not state the respective positions
of the different Member States, but mentions that the majority against
adopting the centralised procedure for medicines for human use was
small. Reports of the Council's preparatory discussions state that
Austria, Belgium, Greece, France, Italy and Portugal favoured centralisation,
whereas Germany, Denmark, Spain, The Netherlands and the UK wanted
to maintain the choice (optionality) between the centralised and
mutual recognition procedures.
The European Commission, which participates in the Council's process,
still favours the centralised procedure, at least for medicines
for human use; a compromise may be reached by allowing optionality
of procedure for veterinary drugs.
Member States opposed to the centralised procedure fear that their
national drugs agencies will lose a substantial part of their activity
and income, and that their national expertise (which they consider
superior to that of some other Member States) will be under-exploited.
However, off the record, representatives of these Member States
admit that the trend towards centralisation is inevitable.
a majority in favour
The European Commission had recommended that marketing authorisation
be granted permanently, but this idea was rejected at the first
reading by the European Parliament, who voted in favour of a thourough
reassessment of risk-benefit ratios after 5 years on the market,
prior to marketing authorisation renewal.
At the meeting of the Council of Ministers, some Member States were
clearly opposed to the principle of permanent marketing authorisation,
while others were willing to accept it, but only after one or two
re-assessments. In the end, a majority of Ministers opted for a
five-year reassessment, which would be followed by permanent authorisation
(subject to new, unfavourable pharmacovigilance data). It appears
that a number of Member States were undecided on this point, although
this was not explicitly stated in the public report of the meeting.
It therefore appears that the principle of reassessment is accepted,
and that the European Commission will have to amend its draft on
this key point. Medicines in Europe Forum has stressed the need
to reassess all new drugs, particularly relative to existing alternatives,
in order to guarantee that patients receive the best available treatment.
A second reassessment after 10 years, recommended by some Member
States, would be welcome, especially when marketing authorisation
is granted very prematurely.
EMEA management board:
one representative per Member State, but no agreement on representation
of civil society
The composition of the EMEA management board was hotly debated by
the European Parliament in the current context of European enlargement.
A majority of Ministers favoured having one representative of each
Member State on the EMEA board, even after enlargement. It seems
likely that the European Commission will also be represented. None
of the ministerial delegations appears to have supported pharmaceutical
industry representation on the management board, and some came down
firmly against such representation. Member States remained divided
on the representation of consumer and patient organisations as well
as mutual health insurers. No conclusion was drawn on this point.
The potential benefits of having representatives of civil society
in EU institutions needs to be better explained. The Council, despite
reiterating the need to involve consumers in EU policies (see above),
seems to be reluctant to put this into practice.
Follow up and action
The meeting of the Council of Ministers shows how hard it is to
make the public's point of view heard by politicians busy with many
issues and day-to-day affairs. Few Members States, and few Ministers,
are actively engaged in reforming European medicines policy.
Drug regulation is wrongly perceived as being excessively complex
and technical, and most decision-makers, including some Health Ministers
and their counsellors, have a poor grasp of the problem. Those seeking
to orient EU medicines policy towards the best interests of patients
and public health must therefore continue to explain and clarify
these issues, carefully follow up the ongoing review process, and
must intervene when necessary.
The draft Regulation on medicines will again be discussed by EU
Health Ministers in 2003, together with the draft Directive.
The European Commission has amended both draft texts following the
parliamentary vote, and should publish its new proposals in late
2002 or early 2003. We have been told that parts of the draft Directive
dealing with direct-to-patient advertising by drugs companies will
be substantially redrafted. It will also make specific proposals
on communication via the Internet.
All those seeking to ensure that European drugs policy favours the
interests of patients and public health must remain vigilant and
active in 2003!
©La revue Prescrire/Medicines in Europe
Forum 15 December 2002
1- 2470th Council meeting "Employment, social policy, health
and consumer affairs" Brussels 2-3 December 2002 - 14892/02
(Presse 376), available from http://ue.eu.int/: 56 pages.
2- Council of the European Union "Progress report" Brussels
25 November 2002 - Interinstitutional file 2001/0252 (COD) 14143/1/02
Rev 1: 6 pages.
3- Council of the European Union "Outcome of proceedings"
Brussels 26 November 2002 - Interinstitutional File 2001/0252 (COD)
14144/02 Limite: 73 pages.