New medicines legislation


A high level of public health protection and the completion of the internal market were the main objectives of the comprehensive reform of the EU's pharmaceutical legislative framework. The review, which started in July 2001 and ended in March 2004, touched upon contentious issues, such as authorisation procedures, information to patients, regulatory data protection and 'pharmaco-vigilance'.

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The first European pharmaceutical directive (Directive 65/65/EEC1) was a reaction to the "thalidomide disaster" in the early 1960s. It aimed to establish and maintain a high level of protection for public health. A decade later, two landmark Directives (75/318/EEC2; 75/319/EEC3) introduced the mutual recognition, by Member States, of their respective national marketing authorisations. 

Since 1985, a number of directives have been adopted with the aim of achieving a single, EU-wide market for pharmaceuticals. A new European system for authorising medicinal products came into effect in January 1995 (Regulation 2309/936; Directive 93/41/EEC). It offered two routes for authorising medicinal products: a "centralised" procedure, through the European Medicines Evaluation Agency (EMEA); and a "mutual recognition" procedure in the Member States selected by the applicant and then by mutual recognition of national marketing authorisations.

The Council adopted directives in 1992 on the wholesale distribution, cl assification for supply, labelling and packaging, and advertising of medicinal products for human use. The EU also introduced pharmaco-vigilance (the surveillance of the safety of a medicinal product during its life on the market), requiring Member States to establish national systems to collect and evaluate information on adverse reactions to medicinal products and to take appropriate action where necessary.

"Review 2001"

The Pharmaceuticals Review, launched in 2001, incorporates the recommendations of the "High Level Group on Innovation and Provision of Medicines" or the G10 Medicines Group, which was set up by Enterprise Commissioner Erkki Liikanen and Health Commissioner David Byrne in March 2001. On 26 February 2002, the G10 Medicines Group adopted recommendations to enhance competitiveness in the pharmaceutical industry while maintaining high public health standards (see EurActiv, 1 March 2002). The final report of the G10 Medicines Group was published on 7 May 2002. The Commission presented a Communication on this final report on 1 July 2003 (see also EurActiv, 2 July 2003) and the Council adopted its own conclusions on 22 September 2003 (see also EurActiv, 23 September 2003). The G-10 Medicines Group consisted of the two EU commissioners, a number of European health and industry ministers, as well as leaders of the pharmaceutical and health insurance industry and patient representatives. 

In July 2001, the  Commission adopted a proposal  for a comprehensive reform of the EU pharmaceutical legislation. The Commission's proposal for reform particularly concerns Regulation 2309 (1993) that provides the legislative framework regulating medicinal products, Directive 2001/83 (on human medicines), and Directive 2001/82 (on veterinary medicines).