Brussels, 06/01/2005 (Agence Europe) - The "Medicines in Europe Forum", which brings together health professionals and patients' associations, has welcomed the European Commission's initiative to provide medicines for children and their carers. It is, however, critical of the draft regulation on medicines for paediatric use. Medicines in Europe Forum stated that, "As is usually the case with texts proposed by Directorate General enterprise of the European Commission, this draft focuses on the financial concerns of pharmaceutical companies and the technical measures likely to respond to these concerns. It leaves the initiative entirely up to the firms, distancing itself from the objective of public health and the means for better care for children". The association also added that if the draft regulation on paediatric medicines were adopted in its current form, it would lead to the development of a paediatric market that did not respond to the needs of groups of children most in need of treatment and would increase consumption of ineffective medicines and put other children at risk.
Medicines in Europe Forum considers that the draft should be centred on the objective of primary public health for improving the health of the EU's children. A sharp reorientation on real needs has to be carried out by an independent body on the basis of public funding for directing research. Incentives for research should involve public institutions as well as private companies. The initiative should not be left to the good will of private pharmaceutical firms alone, asserted Medicines in Europe Forum, which also declared that the advantages offered by the draft regulation on carrying out paediatric trials had to be in proportion to the efforts made in research and development on medicines that were genuinely needed. It also stated that monitoring of the pharmaceutical sector had to be strengthened.
Medicines in Europe Forum is calling for the immediate setting up, in the framework of this regulation, of the European Medicines Investigation for the Children of Europe programme (MICE), which was contained in the preliminary draft and which was erased in order to avoid preparations of the next research framework programme from being disturbed. It considers that this would be the best way of providing a new boost for paediatric research for discovering medicines that were adapted to needs that had not yet been covered.
The association points out that a large proportion of the 100 million children living in the European Union are in good health thanks to pre and post natal care, vaccinations, access to drinking water etc. It explains that their priority was always primary prevention, particularly with regard to nutrition, to prevent obesity and diabetes. The forum added that many infections needed medical treatment and that a significant number of child-adapted medicines were already on the European market. It explained that contrary to the situation described by some of the media during the launch of the European initiative on paediatric medicines, there was no "therapeutic desert". Some medicines were sometimes over-used or badly used when treating children. Therefore, to provide a few examples: antibiotics administered over-systematically in some countries were creating fears of increased bacterial resistance; anti-asthma drugs prescribed in increasingly bigger doses, following a cursory diagnosis, were provoking negative effects; anti-depressants used more often were creating fears of an increase in self-harmers and suicidal behaviour; Ritalin used more even when the diagnosis of hyperactivity has not been established. In these areas, the priority will be on a return to a reasonable use of medicines that were already available.