Brussels, 06/06/2000 (Agence Europe) - Since the start of the year, the European Commission launched several workshops in view of reviewing industrial policy in the medicine sector.
The most important work concerns the review of the approval system for marketing, which presently involves a centralised procedure, through the European Agency for the Evaluation of Medicinal Products (EMEA) in London, and a mechanism for mutual recognition. The centralised procedure is generally appreciated for its efficiency, but could still be improved and extended to new product families. On the other hand, the system of mutual recognition has been the object of numerous criticisms. It should be rationalised. The system (procedure and mechanism) date back to 1995.
Formally launched last February, an audit, entrusted to the cabinets of Cameron McKenna and Andersen Consulting, will involve consultation with the competent businesses, national and Community authorities (the EMEA), professional organisations for doctors and chemists and patients associations. The study relates to both the efficiency and speed of the two approval procedures for medicines, but also on aspects such as pharmacovigilance and compassionate use (possibility for a patient affected by a serious illness to benefit from a treatment before formal approval of a medicine). An interim report, which relates to the first part of the hearings, was transmitted to the Commission services. It should allow for the redefining of the process. The final report is expected by the end of the month of October. It will act as a basis for the drafting of the report and the legislative proposals that the European Commission should present towards the end of the year. These proposals should enable to (1) adapt the marketing approval system to the enlargement of the EU. EUROPE believes that it could mean the modifying the representation of Member States in the various committees so as to avoid their becoming overcrowded; (2) reduce the procedures so as to make them more efficient, faster and more transparent. The system of mutual recognition is central, but it is also a case of avoiding, in the future, that the products are treated in ways that are too different. This could pass through an extension of the centralised procedure to other families of medicines; (3) ensure a better inclusion of new therapies; (4) strengthen pharacovigilance.
The second workshop concerns innovation and generic medicines. The European Commission is conscious of the need to develop, in Europe, all the conditions that relate to research and innovation. Referring to the communication from Commissioner Busquin on the creation of a European Research Area, but also that, which must soon be presented to Commissioner Bolkenstein on the Community patent. More particularly concerning the pharmaceutical sector, the services of the Directorate General "Companies" of Commissioner Liikanen also studied the possibility of adapting by homogenising the rules protecting data. In the framework of the system of mutual recognition, the protection of clinical data remains very variable from one Member State to the other: for example five years in Denmark against 10 years in France. Such a situation hinders the free movement of generic medicinal goods. However, the Commission services see in the development of the generic markets a possibility of freeing resources for the favouring of a true innovation dynamic. The objective followed is that of the creation of a true single market for medicines were all the products benefit from the same protection everywhere. Nevertheless, the stakes are huge for companies that try to maximise the delay in the appearance of copies on the markets, but also for the national authorities that loose part of their control on their respective markets.
Another dossier especially worries the industry. It concerns parallel imports that are much talked about and which have the favour of the Commission through the principal of the free movement of goods. Today the industry feels that this phenomenon could take on dramatic proportions with enlargement of the EU. Nevertheless, Community sources reminded that at this time the loss of profits by the industry linked to parallel imports are of little significance if compared, for example, with advertising budgets by the companies concerned. These losses will not exceed 3 to 6% of their turnover. Also notable is the fact that prices in Poland are not far from prices in Portugal for the same products. A solution could consist of the implementation, in the framework of enlargement, of a dispensation to the rule of the expiry of rights so as to enable the Member State to oppose imports for a certain amount of time (a similar provision was applied during the seven years after the accession of Spain and Portugal).