ABSTRACT

In the Treaties establishing the European Union, the organisation and delivery of health services and medical care are principally the responsibility of the Member States (25 in May 2004). The Community has the responsibility to set a high level of health and to co-ordinate public health issues. To complement national policies directed towards improving public health, Community actions are undertaken under the responsibility of DG Health and Consumer protection, (DG Sanco, one of the Directorates General of the European Commission). The other major aspect of health services and medical care falling under shared competence is marketing authorisation and monitoring of medicinal products. For Community authorisations, it is under the responsibility of DG Enterprise, reflecting the aim to provide not only the European citizens with medicinal products fulfilling the criteria of quality, safety and efficacy, but also the European pharmaceutical industry with faster access to the market.