Brussels, 01/06/2005 (Agence Europe) - During their meeting on 3 June in Luxembourg, health ministers will focus debates on their draft regulation on medicines used in paediatrics. The Luxembourg presidency plans to organise the debate around two issues: the kind of incentives to laboratories carrying out studies on the paediatric use of medicines and the level of access to clinical trial data bases.
The Commission proposal aims, like the US model, to provide an additional six months for data protection in an effort to compensate paediatric trials and which has very wide support. Generic medicines, however, have launched an offensive against extending the protection of medicines because it wants to copy them as soon as possible. This offensive, which has already got results at the European Parliament industry committee EUROPE 8955) and at Coreper through a Latvian proposal to provide variable additional protection ranging from three or six months depending on product sales. To simplify, a product generating significant “blockbuster” sales will only have three additional months of protection whereas a product that has weaker sales could have six months extra, which is the case in the USA. This proposal benefits from the support of Central European countries like Poland and Hungary, which have a generic medicines industry but which above all fear surcharges for their health services caused by extended medicines protection. Most of the older Member States, as well as the Czech Republic and Cyprus continue to support the Commission's proposal. Germany and the Netherlands have expressed reservations.
France and the United Kingdom propose the expansion of data basis access on clinical trials created by a 2001 directive which is also expected to deal with paediatric trials as well as the agencies on medicines. Certain reservations were expressed, by Ireland, for example.
Ministers will also focus much of their time on new regulations on foodstuffs (see other article) and the action programme on health and consumer protection. During lunch, Commissioner Markos Kyprianou is expected to examine the work on improving Union and Member State preparations for the next flu pandemic. The new European Centre for the Control and Prevention of Infectious Diseases is expected to be very soon able to make a contribution in terms of early warnings but it will not provide Member States with the significant supplies and distribution of anti-virals and vaccine in the event of this outbreak. Some Member States may get aid. In the wake of the Non-Smoking Day, the Commissioner is expected to help reinforce the fight against smoking at a national level by using the means implement in the European “Help” Campaign.
The Council is also expected to adopt conclusions on:
Fighting HIV/AIDS: the Council is expected to welcome the Vilnius Declaration, adopted after the ministerial conference “Europe and HIV/AIDS - New Challenges, New Opportunities” in which the need to pool efforts is underlined for supporting global prevention activities, including staff training and setting up infrastructure for sustainable health in order to ensure universal health care access for all with the assistance and treatments set up by efficient partnerships between governments, civil society, the private sector and other international partnerships; it is also expected to welcome the orientation elements provided by the informal ministerial meeting on 13-14 April in Paris on the European research into an anti-HIV vaccine, 2) helping people who are contaminated with HIV/AIDS, their families, friends and creating and building a society, through appropriate legislative provisions or other means, an environment and a behaviour based on respect, non-discrimination and acceptance of people who are contaminated by the virus, 3) strengthening of cooperation between clinical trials on research into vaccines and microbicides against HIV. The Commission is expected to support these efforts.
Obesity, nutrition and physical activity: the Council is expected to point out a worrying increase in the prevailing rates of obesity in the EU, particularly among children, as well as the negative consequences for cardiovascular health and type 2 diabetes; 2) it is expected to welcome the recent setting up by the Commission of the European platform on Food, Physical Exercise and Health. It is expected to encourage Member States to launch national initiatives, where necessary, and work in synergy with the European Platform; the Council is expected to welcome the Commission's plan to unveil a Green Paper on Nutrition, Physical Exercise and Health by the end of the year. At the end of 2006, a Communication may be unveiled on the outcome of the public consultation exercise launched by the Green Paper.
EU action on mental health. In its conclusions, the Council will welcome the Commission's plan to publish a Green Paper on Mental Health in September 2005 along with suggested initiatives at both EU and Member States level to provide information, promote mental health and prevent mental health problems; the Member States will be urged to pay the necessary attention (in line with national needs) to implementing the WHO European Ministerial Conference's Mental Health Action Plan.