Brussels, 19/10/2005 (Agence Europe) - Following the vote of the European Parliament at first reading on 7 September, the Council has begun a technical-level examination of the proposed regulation on paediatric medicines, ahead of the adoption of a common position at the meeting of health ministers due to take place on 9 December. If it is true to say that the vote of the European Parliament put the final nail in the coffin of the debate on the compensation (six months of additional protection) which laboratories would receive for carrying out paediatric clinical trials, it failed to resolve all the problems. The hope of adoption after the first reading may be scuppered due to differences of opinion which are emerging, and which may lead to Council to reject a number of the Parliament's amendments.
On a number of important points, the vast majority of the Member States chose to go back to the text of the European Commission's proposal. This means that at the vote of the Parliament, industry managed to get the time limit to table a request for a paediatric indication extended to six months before the protection certificate expires, whereas the proposal provided for this request to come in no more than two years before the certificate expires. The Council is likely to return to the Commission's text, and with it a balance which swings slightly more in favour of the producers of generic drugs. The ministers are likely also to return to the timetable proposed by the Commission for the trials to be carried out. Here again, as regards checks on paediatric conformity, which is at the heart of the system as it is the basis for whether or not compensation is granted, the Member States are likely to agree on a systematic opinion of the paediatric committee of the European Medicines Agency. This intervention by the paediatric committee was justified by the need to make sure of a certain level of uniformity in validating paediatric trials. The intention is to avoid overly great disparities in the implementation of the system by the national agencies. Although a majority seems to be forming in favour of transparency of clinical data, problems remain on this controversial aspect, which is important as it will avoid the needless duplication of clinical trials on children. This transparency, which is called for by associations of patients and of parents of sick children, which would be applied on the basis of guidelines laid down by the London-based agency, seems acceptable to the pharmaceutical industry, under a number of conditions. For the time being, however, this transparency, which is supported by countries such as France, the United Kingdom and Sweden, is still beset by the reluctance of other Member States, such as Denmark, Poland and Ireland, which feel the subject should be dealt with when the 2001 directive on clinical trials is revised. Lastly, the clause on revision after 10 years, which was introduced into the proposed regulation to allow the system and, more particularly, the compensation mechanism, to be assessed, should be accompanied by the possibility of an examination after six years, in answer to a request by various countries of Central Europe, which continue to have concerns about extra costs on their health care services, due to the relatively late arrival of generic drugs on the market.