Brussels, 12/03/2001 (Agence Europe) - The long phase of preparation for the revision of the European Union's pharmaceutical legislation, which we discussed last June (see EUROPE of 7 June 2000, p.12), is coming to an end.
In a discussion paper published last 22 January, the European Commission underlined that the revision of the pharmaceutical legislation is now following seven main avenues: - ensure a high level of protection for the health of European citizens, notably by making available to patients, as quickly as possible, innovative and safe products; - ensure greater monitoring of the market, notably through a strengthening of pharacovigilance procedures; - improve the level of animal health by increasing the number of veterinary medicines available; - complete the single market for pharmaceutical products by taking into account the stakes of globalisation; - establish a legal framework favouring the competitiveness of European industry; - rationalise and simplify the system, while improving its general coherence, its visibility and the transparency of the procedures and decision-making. This document, which is still presented in the form of multiple options, describes various possibilities for the modification of the scope of application of the centralised marketing authorisation procedure governed by the Medicines Agency (EMEA). In the proposal that it must soon adopt, the Commission should nevertheless chose to extend the competence of the EMEA, by imposing the centralised procedure on a new molecule whatever its type (biotechnological or not), in order to allow for a Community approach covering all new innovative medicines. Other changes cover:
Generic medicines: at present, a generic must be authorised according to the same procedure and by the same authority that authorised the medicine of which it is a copy. It is proposed that the future generics of products authorised through the centralised procedures (thus generics as of 2005) may be authorised either at the central level or through a decentralised procedure. In this case, the national generic authorisations should be, in every way, similar to the reference of centralised authorisation.
Scientific advice: the proposal should foresee a strengthening of the role of scientific advisor played by the Medicines Agency, in order to help companies avoid mistakes in the initial stages of the development of a new molecule.
An emergency procedure: this concerns the establishment of a "fast-track approval procedure" for medicines that have a significant therapeutically impact and which are awaited by patients. Such an instrument already exists in the United States and Japan.
Compassionate use: this concerns the introduction of a European system of compassionate use allowing, under certain conditions, the making available of medicine, as yet unauthorised, to certain groups of patients.
With regards to the decentralised procedure, the Commission recognises that the system is more suited to a "non mutual recognition" of initial national authorisation than for the mutual recognition that it should have lead to. As for the arbitration procedures, they are completely inoperable. Under these conditions, it has become necessary to improve the functioning of information networks between the Member States and to intensify the systematic communication between scientific experts. Any procedure having given rise to a refusal of mutual recognition or a withdrawal for an authorisation request, in at least one Member State, should, in the future, automatically initiate an arbitration procedure. In certain cases, the result of this arbitration could translate directly into the issuing of a Community authorisation, and no longer, as is presently the case, to a decision by the Commission calling on the Member States to issue harmonised national authorisations. This possibility will not be used for generic medicines, where a "conventional" arbitration remains necessary.
To adapt the Medicines Agency, it is proposed, in view of enlargement, to bring one representative per Member State, to form the scientific committees and the administration Council. The creation of specialised scientific panels should enhance the internal expert capabilities and the possibilities for providing scientific advice to companies. Other measures concern the improvement of the decision-making process. They notably aim to reduce the use of procedures including a comitology mechanism and to replace the regulation procedure with a consultation procedure there where comitology would remain enforced. A reduction in the time permitted for Member States to rule and internal measures within the Commission should also contribute towards accelerating the procedures.
EUROPE has reason to believe that the Commission's proposal will also contain a provision aimed at rationalising the system for the protection of clinical pharmacological data. Such protection, which ranges from five to ten years in the EU Member States and which was introduced only very recently in the candidate countries, is highly important in so far as access to this data conditions the marketing of generic medicines. The Commission is expected to propose harmonisation of the duration of protection afforded to clinical data over a period of ten years.
Furthermore, Commissioners David Byrne and Erkki Liikanen are soon to establish a high level group on the price of medicines. This group, to be composed of ten well-known personalities, should tackle this issue while seeking to reconcile the imperatives of public health and access to care, on one hand, and, on the other, requirements linked to the funding of research and innovation in the general context of industrial competitiveness.