France's Afssaps wants key EU role in paediatric drugs

The French Health Products Safety Agency (Afssaps) wants to retain an important role in the area of paediatric drugs, following the entry into force in January of new European regulations on the issue, its director general, Jean Marimbert, has said.

The adaptation of the European regulation on paediatric medicines will require 'impetus from the national health authorities', particularly in view of the fact that the European Medicines Agency (EMEA) has high expectations for the national authorities in terms of this, he explained.

France has strongly supported the implementation of the European regulation, which specifies new obligations for pharma companies in terms of paediatric drugs, in exchange for rewards and incentives, Marimbert said.

The legislation stipulates, for example, pharma companies' obligation to submit a paediatric research plan (PIP) for all new marketing approval applications or for modifications of marketing approval. This plan should include the development programme and the measures envisaged to adapt the treatment to paediatric form.

This PIP will have to be approved by the EMEA's paediatric committee, operational in July, and will bring together the members of the Committee for Medicinal Products for Human Use (CHMP), paediatrics experts from the Member States, public health specialists and representatives of patient associations.

The European regulation provides for the development of a European paediatrics research network, aimed at facilitating the conducting of high-quality clinical trials in paediatrics. Since 2001, the Afssaps has created a mission group, which has subsequently become a 'paediatric medicines' unit, and a paediatric guidance committee.

The agency plans to continue its action in favour of the development of paediatric medicines by becoming significantly involved in the evaluation of the PIPs. The agency plans to create a working group within itself, for the specific evaluation of the PIPs. The EMEA's paediatric committee will only be able to keep up-to-date with the evaluations of the PIPs if the national agencies get involved, particularly in the role of rapporteurs, Marimbert said.

France also wishes to collaborate actively in the evaluation of the PIPs by participating significantly in the work of the EMEA's paediatric committee.

Apart from the evaluation of the PIPs, the Afssaps - as is the case for all Member States - will have to carry out a series of other tasks. It will therefore list an inventory of drugs developed for adults and used off-label in paediatrics, and is to organise the 'insertion of a pictogram on the packaging of drugs that have been developed and authorised specifically for paediatric indications' from 2008.

It will also participate in establishing the European paediatrics research network in France in collaboration with the network of paediatric research on health products (RIPPS), set up jointly by the French national institute for health and medical research (Inserm) and the French paediatrics society.

The agency says that it plans 'to accentuate the strategic guidance role of the paediatric guidance committee' and in particular to 'continue to evaluate children's needs in terms of treatment'.