Europees akkoord over veiligheid pharmaceutische producten (en)
Agreement has been reached, following the second reading in the European Parliament yesterday, on far-reaching reforms to the EU's regulatory framework for pharmaceuticals. These reforms guarantee a high level of health protection for European citizens. They also strengthen the internal market for pharmaceutical products, reinforce the competitiveness of Europe's pharmaceutical industry and help meet the twin challenges of enlargement and globalisation. The new rules will improve and speed up access to new and innovative pharmaceutical products, building on the proven success of the European Medicines Evaluation Agency (EMEA) set up in 1995. Changes include a new fast-track authorisation procedure, the possibility of conditional authorisation for products and a harmonised period during which test and other data is protected in order to reward innovation. The generic pharmaceutical industry also benefits through clearer rules and procedures and the possibility for them to start testing their products in advance of patent expiry. Finally, the new rules should streamline procedures and reduce red-tape, while at the same time strengthening the supervision of pharmaceutical products. This is a tangible deliverable of the G-10 process initiated by the Commission and fully endorsed by the Competitiveness and Health Council under the Italian Presidency.
Erkki Liikanen, Enterprise Commissioner, said: "This is an important day for European Patients and the European Pharmaceutical Industry. Yesterday's vote will ensure a high level of protection for public health, while improving access to medicines and boosting the competitiveness of the European pharmaceutical industry. The agreed approach builds on the strengths of the existing system, including the undoubted success of the European Medicines Evaluation Agency and the centralised system for authorising new medicines at a European level. I am delighted that the hard work of the Council and European Parliament with the help of the Commission has delivered this agreement, which will improve the performance of the sector in the face of an enlarged Union and a global pharmaceutical market."
Objectives of the reforms
This comprehensive reform of the EU pharmaceutical legislation was proposed in July 2001 (see IP/01/1027 and MEMO/01/267). These reforms aim to continue to guarantee a high level of health protection for European citizens, to complete the internal market for pharmaceutical products in a context that favours the competitiveness of the European pharmaceutical industry and which meets the challenges of globalisation, and to prepare for the future enlargement of Europe. The reforms include important changes to improve, rationalise and simplify the current regulatory processes.
These should also improve the transparency of procedures and decision making without changing the basic principles of the existing system in which two regulatory procedures (a centralised authorisation procedure and a decentralised procedure based on mutual recognition) co-exist.
Reinforcing the success of the EMEA
The new rules build on the success of the European Medicines Evaluation Agency and the centralised European procedure for the authorisation of pharmaceuticals which has been in place since 1995. While keeping the underlying principles of the existing system, the revised legislation reinforces its strengths. The changes include: the opening of the centralised procedure to more types of new medicines. Currently, the centralised procedure must be used for the authorisation of biotechnology products. Under the new rules the centralised procedure will become mandatory for medicines to treat AIDS, cancer, diabetes, neurodegenerative disorders and orphan diseases and after 4 years this will be further extended to cover medicines for autoimmune diseases and viral diseases. A general review clause will enable further extension to other diseases. In addition, the role of scientific advice in the process is strengthened, as is the EMEA's in relation to scientific matters relating to medicinal products, international activities and its role in providing early scientific advice to companies before they embark on the trials and tests necessary to obtain an authorisation for their products.
Increasing and accelerating the availability of products
In terms of concrete benefits for patients, the opportunity has been taken to respond to several challenges. The revised legislation aims to increase the availability and speed of access of new and innovative medicines to the European market, while at the same time ensuring that the basic criteria of safety, quality and efficacy are met. A "fast-track" registration procedure for products of significant therapeutic interest has been introduced allowing these products to be assessed and authorised in an expedited way. This mirrors a similar possibility that exists in the US market. In addition the possibility of a conditional marketing authorisation has been introduced, which allows for a one-year authorisation to be granted provided that there is an important expected health benefit for the patients concerned and that the company agrees to carry out additional monitoring and clinical studies, which will be reviewed at the end of this period. Finally, subject to further additional provisions, a European wide system to make medicinal products available in advance of authorisation for a "compassionate use" will also be possible. This will help to ensure that patients are not discriminated against on the basis, in particular, of the location of the clinical trials performed by a particular company.
In addition to the first two provisions, specific measures concerning the availability of veterinary medicinal products are also proposed as well as an incentive scheme to encourage companies to broaden the use of older products for example to cover other species.
Moving with the times better access to information for patients
This revised legislation provides for an overall increase in transparency and improves access to the results of the pharmaceutical decision making process, including assessment reports and the summaries of product characteristics.
Promoting the competitiveness of the European pharmaceutical industry in a global context
The revised legislation introduces mechanisms to improve the competitiveness of innovative pharmaceutical, generic and OTC sectors. Concerning data submitted by companies for the approval of medicines, the legislation harmonises the rules governing data protection (data exclusivity). Following transposition of the legislation, whatever the authorisation procedure used, it will not be possible to market generics until ten years have elapsed. This can be extended by a further year if a further innovative indication for the medicine is authorised. This removes current ambiguities of application and allows the innovative pharmaceutical industry more time to recoup its investments before a generic product may be authorised. For the generic pharmaceutical sector, the new rules introduce the possibility for companies to perform tests to support generic medicine authorisation in Europe and to obtain a marketing authorisation before the end of the data exclusivity period. In addition, a new definition of generic medicines should provide greater legal security and better application of the regulatory procedures for generic medicines. In addition, for "copies" of biological products, a proper definition of these products, so-called "bio-similar" medicinal product, is introduced. For the Over The Counter (OTC) sector, one year of data exclusivity will be granted on the studies that allowed the switch of medicinal products from prescription only to OTC.
Additionally, the revised legislation introduces the new possibility for an additional period of data protection in case of re-classification of a product as non-prescription ("switch") and in case of a new indication granted to a well-established product. In both cases, the protection will be of one year.
Cutting the red-tape and strengthening surveillance
The revised legislation includes important changes aiming to optimise, simplify and rationalise the current regulatory processes. The changes reduce the requirement to renew marketing authorisations while reinforcing pharmacovigilance and information sharing provisions. They also include measures to accelerate the Commission's decision making process so that the period between the scientific assessment and marketing a product is shortened.
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