Luxembourg, 26/06/2002 (Agence Europe) - As Commissioner Erkki Liikanen recalled, on Wednesday in Luxembourg, one of the aims of the European Commission within the framework of review of pharmaceutical legislation is to ensure that new medicines are available more rapidly in all Member States. Eight ministers (Sweden, United Kingdom, Ireland, Portugal, Spain, Germany, Denmark and Netherlands) clearly said "no" during the Health Council which, for the first time, raised this essential public health issue. While the Commission proposes to make the marketing authorisation procedure compulsory for all new active susbstances, they took a stance in favour of a system that would leave laboratories the choice between this procedure before the European Agency for the Evaluation of Medicinal Products (EMEA) and authorisation of these medicines by national agencies. This direction fully complies with the wishes of a large part of industry which sees in it the opportunity to give preference to more profitable markets. Laboratories could thus choose to market their products, solely or more rapidly, in countries where sales may reach the most advantageous levels - which is tantamount to allowing the industry the choice of patients to benefit from new medicines. The main arguments put forward by ministers are based on the defence of SME which would be badly tooled for going before the European Agency in London and would find it easier to go before their national agency. As Mr Liikanen recalled, this possibility means there must be good functioning of the mutual recognition procedure, whose efficiency remains limited at present, but also means that they would have to go successively through fifteen national procedures. The other motivation of ministers concerns the loss of national expertise and the weakening of national agencies. This argument is also challenged by the Commission. On one hand, the experts taking part in the work of the EMEA come from national agencies with which the London Agency works in network and, on the other, the requests for marketing authorisation concern medicines containing new active principles number 15 to 20 per year.
As we mentioned (EUROPE of 24 June, p.9), France, Italy, Belgium, Austria and Finland back the Commission's proposal. "In an area that wants to be egalitarian (…) we must move towards a centralised procedure", said the new French Minister of Health, Jean-Fancois Mattei, stressing that the EMEA needed providing with the same means as those at the disposal of the American FDA for evaluating medicines. The Italian and Spanish ministers also pleaded in favour of enhancing the EAMA's capabilities. A majority of countries spoke against the new composition proposed by the Commission for the EMEA Board of Administration, said Council President Celia Villaloboos, stressing that ministers had opposed the presence of a representative of industry. Here too, France distinguishes itself by providing its backing for the Commission proposal. The other major topic was patient mobility and the Council adopted conclusions that rekindle the reflection process begun in Malaga. Ms. Villalobos and Commissioner David Byrne welcomed this decision. The work should last a year, within a group bringing together the "G10", but where all Member States would be represented, said Mr. Byrne. The Commission will present a communication at the end of that exercise, he stipulated. This subject is especially dear to German Minister Ulla Schmidt, who had already been very active in Malaga. While stressing that the issue would demand reflection on the harmonisation of the quality of care and the question of financing, Mr. Mattei said he was optimistic, considering that "it is the beginning of a large site: we are entering in vast domain, new for Europe".