Euro Brief 21
1-15 December 2003 No.21/2003
- Health Council, 2 and 3 December 2003
- European Centre for Disease Control
- Health claims on food
- Medical devices
- Pharmaceuticals and patients
- Tobacco control policy
- Patient mobility
- Free movement of doctors
- Inter-government conference
Health Ministers met on 2 and 3 December 2003 to adopt Council Conclusions on “Healthy Lifestyles; Education, Communication and Information” as well as a Council Recommendation on Cancer Screening. Other items on the agenda included;
European Centre for Disease Control
The Health Council held a lengthy policy debate on the Commission’s proposals for a Regulation setting up a European Centre for Disease Control. There was general consensus for the idea and the Presidency urged Ministers to adopt the proposal in the first half of 2004.
A Report written by John Bowis MEP in the European Parliament on the Commission’s proposal is due to be adopted at First Reading in February, which opens the way for Council to take into account amendments before its own First Reading shortly after.
The Regulation is expected to apply from early 2005.
The Council agreed that the role of the Centre should be limited to communicable diseases and health threats whose origins are as yet unknown and any expansion in the field of work could be countenanced in a later review. The Council made some initial changes to ensure the Centre had no regulatory powers. Other aspects discussed included voting rules, composition of the management board and the budget.
The legal basis for this proposal (art 152(4) of the EC Treaty) means a Qualified Majority is needed to adopt.
John Bowis is keen for early adoption and has signalled to MEPs at the European Parliament Health Committee on 1st December that he would not welcome any controversial amendments to widen the scope to include non-communicable diseases.
The Report argues the case for the Parliament and Interested Parties to be represented on the Management Board. However, the Council may propose that experts be confined to the Advisory Board while each of the 25 national Governments would take seats on the Management Board.
The Commission’s aim is to reinforce the existing Communicable Diseases Network which has revealed weaknesses in how it operates in two external evaluations since it was set up in 1999.
Health claims on food
EU Health Commissioner, David Byrne urged Member States to lift their general scrutiny reservation in order to fast-track certain technical questions regarding his proposal to limit certain health claims.
The main objectives are to increase voluntary information beyond the mandatory information required by EU regulation, ensure fair competition in the food market and restrict any outlandish or misleading claims that are designed to influence the consumer that the product is good for their health.
The Regulation would allow health claims under strict conditions after independent case-by-case scientific assessment and EC authorisation.
The legal basis is Article 95 of the Treaty (internal market measure) and requires qualified majority. Italian MEP, Nobilia is expected to report in the Parliaments Health Committee in January and the Parliament due to give its Opinion in February.
Medical devices
The Council adopted Conclusions on the Commission’s Communication on Medical Devices which increases “transparency and trust in relation to the placing on the market and putting into use of medical devices”. The proposal aims to improve surveillance, Notified Bodies, clinical evaluation and regulatory clarification.
Member States will be encouraged to improve reporting mechanisms where medical devices contain medicinal products or human blood derivatives, clinical investigation and vigilance.
The Council welcomed the launch of a study on innovation, public health impact and competitiveness and the Commissions intention to promote health aspects of medical devices under the Community’s Public Health Programme.
Pharmaceuticals and patients
The Council adopted a Resolution calling on Member States and the Commission to consider ways data on medicines should be communicated directly to the patient.
This Resolution follows a Report by the G10 High Level Group on the Innovation and Provision of Medicines”. The Report in March 2002 made 14 Recommendations. This Resolution takes many Recommendations into account but emphasises that EU countries must make progress in providing better and more accessible information to patients to promote the rational use of medicines (and avoid waste of drugs). It also calls for the reinforcement of pharma-covigilance, increasing affordability and availability of medicines and safer and higher quality medicines.
Tobacco control policy
The French Government wants the Council to address the price policy on tobacco as a health issue rather than a financial one. Following the French Tobacconists strike in reaction to proposals to increase tobacco tax, France wants the EU to harmonise tobacco taxes within the Community.
Patient mobility
Measures to improve access to healthcare across borders within the EU were revealed in a report on patient mobility on 8 December.
A High Level Reflection Process on Patient Mobility made 19 recommendations to broaden patient choice rights in the Single Market while making sure national healthcare finances are not undermined.
The Reflection Group has been considering European Court of Justice judgements on patient mobility as well as the implications of enlargement to many East European states in May. Many new EU states fear soaring health costs as patients cross borders for hospital care in better resourced countries. Cross-border patients could expect, under some conditions, reimbursement from their health insurers back home. Many countries want to close down loopholes exploited by so-called “transplant tourists”
The reflection group, which came about as a result of a Health Council in June 2002 and is made up of health ministers from EU-25, healthcare professionals, health insurers, managers and patients. The Commission will now come forward with legislative proposals in 2004.
Free movement of doctors
MEPs have postponed the First Reading Vote of the Zappala Report on the recognition of professional qualifications to January. Parliament was due to vote on 17 December.
Inter-government conference
The Italian Presidency of the EU produced a compromise text on EU health powers for Foreign Ministers and Heads of State to consider at the Brussels Summit on 12-13 December.
It adds to Para 2 of the Health Article – Art III- 179 that the EU shall “encourage co-operation between Member States to improve the complementarity of their health services in cross border services”. But the Italians also make clear that member states would be responsible for the management of health services and the allocation of resources to medical care.