Euro Brief
1-15 October 2004, No.17/2003
- Council support for increasing competitiveness of pharmaceuticals
- New research projects to combat heart disease
- Euro 100 million for cancer research
- Parliament set to raise stakes over embryonic stem cell research
- International Day of the Older Persons
The Council of 15 Member States has agreed a Common Position on a package of three legislative proposals to improve competitiveness in the pharmaceutical sector.
The proposals, collectively known as The Pharma Review will now start its Second Reading in the European Parliament.
The Council agreed by qualified majority (with Belgium and Holland voting against and Germany abstaining) on a regulation on the authorisation and supervision of medicinal products.
The majority of member states also supported a directive specifically aimed at human consumption (modifying directive 2001/83/EC) and another directive on veterinary medicines.
Parliament hopes to adopt the legislation before EU enlargement on May 1st next year. However there is some controversy over proposed increased data protection for medicines. Health Ministers from acceding countries believe this would negatively affect the patients, the national health insurance fund and the generic pharmaceutical industries in their countries.
New research projects to combat heart disease
The European Commission announced it is about to launch two major Heart Disease projects.
Costing a total of 17m Euros, the studies will come on top of 24 cardiovascular projects the Commission has funded in the last four years, totalling 35.5m Euro.
An Integrated Project will investigate the
genomics of platelets in relation to coronary heart disease. The second project aims to improve co-ordination of European research in the field of vascular research through a Network of Excellence. Both projects aim to improve diagnosis and treatment of cardiovascular patients.
The Integrated Project addresses genetic factors modulating platelet aggregation in large patient populations. The research will lead to the development of markers that can help identify patients at risk of thrombotic events. It will also offer an insight into novel molecular targets for the
development of medicines.
The Network of Excellence looks at defects in the function of the lining of blood vessels, the instability of plaques and therapies aimed at the growth of new blood vessels which can help recover heart tissue damaged by an infarct.
Euro 100 million for cancer research
To mark the European week against Cancer, the European Commission has announced that 19 cancer research projects have been selected to share Euro 100m EU funding. They will look into the link between genomics and cancer, developing imaging, radiotherapy, clinical trials for breast cancer and leukemia and help create bio-banks and cancer registers.
The funds come from the Sixth Framework Programme(2002-2006) through a series of funding schemes such as Integrated Projects and Networks of Excellence. It forms part of a Euro 400m total that the EU is investing in cancer research in the next four years towards a "European Cancer Research Area". Altogether, over 1bn Euro is earmarked for combating major diseases in the Framework Programme.
The Commission, in the middle of next year, will publish two further calls for proposals covering pre-clinical tests, new therapies, cancer in high risk populations, familial cancers and uncommon cancers, immunological control of tumours and molecular detection and treatment of minimal diseases.
Parliament set to raise stakes over embryonic stem cell research
As the Tissues and Cells Safety Directive enters its Second Reading in Parliament, signs are emerging that the Dr Peter Liese MEP, Rapporteur of the Parliament’s Report is heading for a showdown with the European Commission over the ethics of embryonic stem cells.
The Parliament’s Environment committee met on 6th October to discuss 59 new amendments to the Directive and consider the opinion of the Commission and the Common Position of the Council regarding ethical aspects of tissues and cells research and therapy.
The Commission and the Council said it was outside the remit of the EU to legislate on ethical grounds and given that the legal powers for this directive were based on the EU Treaty Article 152 (health powers) provisions must relate to health protection.
The new raft of amendments reveal that the Rapporteur has found a way round this limitation set by the Commission without backing down on the amendments that were passed by Parliament in the first reading. The original “ethical” amendments have simply been re-labelled “safety concerns” to the point that women being asked to donate “thousands of eggs” was now a safety concern.
Liese is insisting the Parliament has right to legislate on sensitive issues such as the use of embryos in research, therapeutic cloning and restrictions of in vitro research.
The Committee will vote on 4th November.
For further information, please contact Kevin Doran: kdoran@bma.org.uk
International Day of the Older Persons
On 1st October, the World Health Organisation highlighted the needs of older people. It pointed out that in Southern Europe, caring for dependent and sick individuals is mostly done by older women.
The European Social Agenda which is attached to the EU’s Nice Treaty urges Member States to tackle the economic and social implications of ageing through proactive employment and social protection policies.
According to the 2002 UN World Population Prospects, Europe is the only region whose population is set to decrease. The proportion of children is set to decline from 17% in 2000 to 15% in 2050 by which time life expectancy is set to be 80.5 years compared to 73.2 years today. One third of Europe’s population will be over 60 by 2050.
The European Food Supplements industry met in Brussels on 7th and 8th of October to discuss draft legislation on the assessment of herbal medicines which is part of the EU’s Pharma Review and other EU proposals on health claims on food packaging and fortified food. Mr Mauro Nobilia MEP has recently been named as the Rapporteur for the directive on health claims and is due to report in January. He was a keynote speaker at the conference as was Prof. Guiseppe Nistico MEP, rapporteur on herbal medicines. The industry is concerned that EU measures may be too restrictive.
· The European federation of Public Sector Unions (EPSU) kick-started its pre-Social Dialogue in the Hospital Sector this month. EPSU want to build formal constituted relations between employers and employees in the hospital sector. An informal meeting raised some issues for possible consideration. EPSU want to protect hospitals from the Internal Market by maintaining their status as services of General Interest.
· Over 550 participants attended the annual gathering of European policy experts and decision makers in the health policy field in Gastein on 1-4 October. The theme of the conference was Health and Wealth.