Child medicine plan misses mark

Date: 21/04/05

Patient organisations yesterday (20 April) called for a rethink of the European Commission's public consultation exercises after a survey revealed that 70% of health campaign groups with an interest in child medicine were "completely unaware" of the Commission's proposed regulation on medicinal products for paediatric use.

The draft regulation, which came out in September 2004, seeks to encourage pharmaceutical companies to develop medicines for children through a combination of financial inducements and legal obligations. It has been welcomed by doctors and pharmaceutical groups, but certain patients organisations, including the Dutch Genetic Alliance, the European Forum for Good Clinical Practice and the Health and Social Campaigners' (HSC) Network International, were concerned about the low number of groups that were involved in the consultation and commissioned a survey to seek input from other groups.

Alex Wyke of HSCNetwork International said that the survey was originally intended to be about children's health more generally, but the fact that so few groups had even heard about a regulation which "could potentially have such a dramatic effect on them" was "quite amazing".

In Wyke's opinion, the survey demonstrates that "a lot of the grass-roots feel remote from the Brussels experience" and questions needed to be asked about whether the groups that take part in the Commission's public consultations were "effectively representing their constituents".

The survey also found that, once they had been informed of the contents of the proposal, many groups voiced concerns about certain elements. Mental health groups questioned the wisdom of offering financial inducements to companies to produce medicines for children, fearing that it might result in a "pharmaceutical market for children's medicines" when "drugs should never be given to children if there are any alternatives". Similarly, a patients' group from Romania argued that a top-down EU approach to children's medicines risked glossing over regional disparities in in child nutrition and health.

But the greatest concern for most of the groups surveyed was over the lack of proper Europe-wide ethical guidelines on research into children's medicines. They expressed surprise that the Commission has not dealt with this issue specifically.

The Commission strongly denied the allegation that the consultation procedure was insufficient. A spokeswoman said that they found the suggestion very puzzling because the regulation in question was actually the start of a new regime of more intense consultations. She said that the consultations themselves were very wide-ranging.

Patient organisations on 20 April 2005 called for a rethink of the European Commission's public consultation exercises after a survey revealed that 70% of health campaign groups with an interest in child medicine were 'completely unaware' of the Commission's proposed regulation on medicinal products for paediatric use.

• Primary Source

European Commission: DG Enterprise and Industry: Pharmaceuticals Unit: Unit activities: Medicines for children http://pharmacos.eudra.org/F2/Paediatrics/index.htm

European Commission: Memo: MEMO/04/226 http://europa.eu/rapid/pressReleasesAction.do?reference=MEMO/04/226&format=HTML&aged=0&language=EN&guiLanguage=en

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