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'.
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.
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).
The overall objectives of the pharma review as outlined by the Commission were to:
- guarantee a high level of public health protection for Europeans;
- complete the internal market in pharmaceutical products;
- meet the challenges of EU enlargement;
- rationalise and simplify the medicines authorisation system as far as possible.
Main issues touched upon in this review:
Authorisation and supervision of medicinal products - the Regulation aims to improve the operation of centralised and decentralised authorisation procedures for the marketing of medicinal products in the EU. It also amends administrative aspects of the European Medicines Agency. The review has made centralised authorisation compulsory for high-technology medicinal products (eg gene therapy), orphan medicinal products, products containing a new active substance, cancer, neurodegenerative disorder or diabetes, etc.
"Borderline products" - The Directives provide a clear definition of what a 'medicinal product' is in order to draw a borderline with food, food supplements, medical devices, cosmetics, etc.
Regulatory Data Protection - set at 8+2+1 years, meaning that generic manufacturers can introduce an authorisation request 8 years after an innovative medicine is first put on the market but will only be allowed to start the marketing of the generic copy after 10 years. If new therapeutic indications are authorised, the protection of data can be extended to 11 years.
Information to patients - One of the most controversial issues in this review was a proposal to modify the current ban on advertising prescription medicines directly to consumers, in order to allow Member States to authorise pharma companies to provide information directly to patients suffering from AIDS, asthma or diabetes. This proposal was dropped in first reading although Erkki Liikanen, Commissioner for Enterprise in the Prodi Commission, said that he was in favour as long as the information was only provided on request and under the supervision of the EMEA.
The European Federation of Pharmaceutical Industries and Associations (EFPIA) welcomed the outcome of the review. Following the adoption of the pharma package by the Council, EFPIA said in a press release that "this reform will encourage pharmaceutical research and provide more rapid access by patients to new medicinal products".
"All sides of industry should benefit from the new system," said Greg Perry, Director-General of the European Generic medicines Association (EGA). In particular, the EGA welcomed the fact that existing products would not be able to claim additional data exclusivity retrospectively as the increased data protection period will only apply to new products submitted after the law comes into force.
Eucomed, the European Medical Technology Industry Association regretted that an amendment was approved - following the second reading in the European Parliament (17 December) - which suggested the primacy of the revised directive 2001/83/EC on medicinal products for human use in case of doubt over whether a certain product belonged in the category of food, cosmetics or medical devices. Eucomed has argued that only products exerting a pharmacological action as their primary intended mode of action should fall under the scope of the new directive.
The Pharmaceutical Group of the European Union (PGEU) has welcomed the European Parliament's "no" as regards information on medicines for AIDS, asthma and diabetes coming directly from the producer. The PGEU feels that there is no guarantee in place to prevent "information" from becoming "advertising". In addition, the PGEU is in favour of making the Patient Information Leaflet that accompanies medicines more patient-friendly.
The European Consumers Organisation (BEUC) was also strongly opposed to the Commission's proposal to allow information on prescription medicines. It argues that this type of advertising leads to huge increases in spending on medicines and distorts prescribing behaviour, while not informing patients better. "[Pharmaceutical companies] are not the best judges of what patients need to know about side effects, about alternatives to drug therapy, or about other cheaper or more effective medicines," stated Jim Murray, director of BEUC.
Both Health Action International (HAI) and the European Public Health Alliance (EPHA) have expressed their opposition to any legislation that would weaken the ban on Direct-to-Consumers Advertising.
- Nov 2005: The new EU pharmaceutical legislation came into force.
- 2006: As a follow-up to the G10 Medicines Group, a European High Level Pharmaceutical Forum was set up in 2006 to provide a high-level platform for discussion on the effects of pharmaceutical innovation on national health systems in Europe. The Forum has three main issues for discussion: pricing and reimbursement of drugs, information to patients on new drugs and the cost and clinical effectiveness of medicines.
- Summer 2007: The Commission held a consultation on future of pharmaceuticals for human use.
- 2 Oct. 2008: Final Conclusions and Recommendations of the High Level Pharmaceutical Forum presented.
- Nov. 2008: The Commission is expected to adopt a pharmaceuticals package consisting of
- a communication on the future of the single market in pharmaceuticals for human use;
- a proposal for a directive on pharmaceuticals - information to patients; and
- a proposal for a directive on strengthening and rationalising EU pharmacovigilance.