(Full Report) Preparations for the Health Council in Luxembourg on 26 June

Brussels, 25 June 2002

(Thorsten Münch, Per Haugaard)

Commissioners David Byrne, responsible for Health and Consumer Protection, and Erkki Liikanen, responsible for Enterprise and Information Society, will represent the Commission at the Health Council in Luxembourg on 26 June. The Council will be a good opportunity to provide updates on the state-of-play on a number of important issues for example in the field of tobacco control, the revision of the pharmaceutical legislation, quality and safety standards for cells and tissues, mobility of patients, and the G10 Medicines High Level Group.

Tobacco Control Strategy (TM)

Three agenda items of the Health Council deal with tobacco control issues: Commissioner Byrne will inform Ministers about the state-of-play of the negotiations at the World Health Organisation (WHO) for a legally binding WHO Framework Convention on Tobacco Control. The next WHO round of negotiations take place 13-25 October. The Presidency will update on the state-of-play of the discussion on the Commission's proposal for a Directive on tobacco advertising and sponsorship (see IP/01/702 ). Commissioner Byrne will then present the Commission's proposal for a Council Recommendation on the prevention of smoking and on initiatives to promote tobacco control (see IP/02/873 ).

Human cells and tissues (TM)

Commissioner Byrne will present the Commission's proposal for a Directive on safety and quality standards for human cells and tissues used in therapy throughout the European Union (see IP/02/894 ). The measure aims to ensure comprehensive binding requirements for these human substances from donor to patient. EU action in this area is needed because each year in Europe, hundreds of thousands of patients undergo some form of therapeutic treatment based on the use of human tissues and cells. The establishment of quality and safety standards throughout the EU will help to reassure the public that human tissues and cells derived from donations in another Member State nonetheless carry the same guarantees as those in their own country. It falls under the responsibility of Member States to decide which cells are permitted. These safety and quality standards will only be applied to the cells and tissues which Member States decide to permit. The proposal fully respects the existing ethical orientations of the Charter of Fundamental Rights, the advice of the European Group on Ethics and the Council of Europe. However, binding ethical rules are strictly the responsibility of the Member States.

Drug Dependence (TM)

Commissioner Byrne will present the draft Council Recommendation on the prevention and reduction of risks associated with drug dependence. The Commission adopted the draft in early May with a view to have it adopted by the Council under the Danish Presidency. The Recommendation addresses one of the main public health targets of the EU drugs strategy 2000-2004: to reduce substantially over five years the incidence of drug-related health damage and the number of drug-related deaths. It recommends Member States to provide information and counselling to drug users, availability of outreach work, provision of substitution treatment, promotion of hepatitis B vaccination, access to condoms, needles and syringes, and appropriate integration and evaluation of preventive services. The proposal supports the development of evidence-based evaluation in the field of drug prevention and the reduction of health related risks.

Health Security (TM)

Health Ministers and the Commission will have an exchange of views on health security and Commissioner Byrne will provide an update on activities at EU and international levels as a follow-up to the 14 November 2001 Health Council guidelines: Work with the Health Security Committee, adoption of an action programme of co-operation on preparedness and response to biological and chemical agent threats, progress with the implementation of this programme, work under other EU policies: civil protection, research, trade, external relations, progress with the Ottawa global health security initiative (G7+Mexico+Commission), co-operation with the WHO and accession candidates in the area of health security (see also MEMO/02/122 ).

Revision of pharmaceutical legislation (PH)

The Commission will brief the Council on proposals to extend the scope of the centralised procedure for the authorisation of medicinal products (see IP/01/10 ), and on the composition of the Management Board of the European Medicines Evaluation Agency (EMEA).

Scope of the centralised marketing authorisation procedure

The Commission proposes to extend compulsory use of the centralised procedure to cover all new active substances. This is expected to add 7 more products per year to the 18 per year currently authorised via the centralised procedure. By pooling their best scientific expertise to conduct a single scientific assessment of each active substance at the EMEA, Member States enable the Commission to grant a single marketing authorisation, valid throughout the Union, and thereby ensure that citizens across the Union get rapid access to innovative treatment.

A centralised procedure that covered all new active substances should also strengthen the EU's scientific and regulatory role internationally, by enabling it to do scientific assessments as fast as, or faster than, the US FDA. Globalisation is stimulating healthy competition not only among pharmaceutical companies, but also among regulatory bodies.

The EMEA decision-taking process currently averages 180 days, well within the 210-day limit imposed by EU legislation. Some Member States already find it difficult to match this performance at national level. As the mutual recognition procedure (whereby Member States recognise each others' authorisations), is likely to become increasingly unwieldy an enlarged EU of 25 Member States, the centralised procedure looks the best way to ensure equal treatment of patients and rapid access to medicines across Europe.

Finally, for small and medium-sized biotechnology enterprises, gaining simultaneous access to all EU markets, via a single authorisation, may be the only way to recoup costly R&D investment. All biotech products are already required to undergo the centralised procedure, and no serious problems have been reported to date.

Composition of the EMEA Management Board

The Commission proposes that a new Advisory Board be created to advise the EMEA on all matters to do with the authorisation procedures. All Member States would be represented on this Board. The Commission sees no reason to include representatives of every Member State in the EMEA Management Board, whose tasks are exclusively administrative and budgetary. However, it will be prepared to re-examine the question of the Management Board's composition in the light of the opinions of the Council and the European Parliament.

Proposal for a directive amending Directive 2001/83 on traditional herbal medicinal products (PH)

This proposal (see IP/02/85 ) aims to ensure that all traditional herbal medicinal products placed on the market within the EU meet the same stringent quality requirements as any other medicinal product. In the interests of public health, it would subject them to an appropriate regulatory regime within the pharmaceutical legal environment. This regime would include a simplified registration procedure, open to herbal medicines with therapeutic indications that do not require a medical prescription. Registration would be "simplified" in so far as the applicant could demonstrate the product's safety and efficacy by reference to information from at least 30 years' traditional use. Where a competent authority does not consider this information sufficient, it will request further data.

A new committee to be established within the European Medicines Evaluation Agency would assist in evaluating herbal medicinal products. Although marketing authorisations for these products would continue to be granted by individual EU Member States, the committee's evaluation would provide a common European basis for their decisions. Prescription-only medicines, by contrast, will continue to require a full authorisation even if the active substance is of herbal origin, because they have a different safety profile. The competent European Parliament committee will discuss the proposal in July.

Council conclusions on medical devices in the field of public health (PH)

The text highlights the importance of medical devices for health policy, and stresses the need for Member States to adopt complementary measures as part of national health policy, such as training of hospital staff, follow-up of patients, etc. The conclusions welcome the review process of the medical devices directive and the action already undertaken by Member States and Commission to improve its implementation.

Revision of Directive 93/42 on medical devices (PH)

The Commission will inform the Council of a recent expert report finding that whilst Directive 93/42 on medical devices provides a sound legal framework for safety and technological progress, action is needed in several areas to improve its implementing arrangements. These areas include Member State monitoring of the EU's 60 notified bodies (which check that devices conform to the Directive's requirements), reclassifying devices (to subject them to suitably stringent assessment rules), and meeting clinical data and quality assurance requirements. The Commission will present a communication, before the end of 2002, highlighting the policy conclusions to be drawn from this report, which is available on http://europa.eu.int/comm/enterprise/me dical_devices/index.htm .

G10 medicines (PH, TM)

Commissioners Liikanen and Byrne will update the Council on the work of High Level Group on Innovation and Provision of Medicines G10 Medicines which presented its report to President Prodi on 7 May (see IP/02/670 ). This report examined how to improve pharmaceutical industry competitiveness, and stimulate innovation, in line with EU public health and social objectives.

The Commission will respond formally to the report in a Communication to be approved in the first half of next year. However, it meanwhile intends to pursue the search for practical and preferably non-legislative measures to implement the report's recommendations. These include a proposal for a benchmarking exercise to set performance indicators with which to measure competitiveness and health outcomes. This exercise will also help to measure the impact of the implementation of the other recommendations, and to disseminate best practice. Preparatory implementation work will begin shortly with a Working Group on Information to consider ways of providing high quality information to patients. The Transparency Committee will also meet shortly to consider transparency of national pricing and reimbursement decisions.

Report: http://pharmacos.eudra.org/F3/g10/g10ho me.htm

DN: MEMO/02/150 Date: 25/06/2002