Revue Prescrire, article en une, Medicines in Europe Council of Ministers December 2002
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Medicines in Europe: the EU Council of Health Ministers' initial conclusions
On 2-3 December 2002, despite a heavy timetable, EU Ministers of Health and Welfare examined three important items of the draft Regulation on medicines. The remaining items of the Regulation, and the whole Directive, will be examined in the first half of 2003, during the Greek presidency.
More information
Key issues of the campaign, texts adopted, votes and minutes of plenary session of European Parliament

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Medicines in Europe: campaigning goes on!
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Euro members of Parliament opted for public health
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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 practice.

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.

Five-year reassessments: 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 still needed

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 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.