EGA Press Release

Wednesday, 29 September 2004

EU Paediatric Medicines Proposal: EGA Urges Measures to Maximise Benefits to Children

In line with our previous support for the introduction of EU wide measures to promote better use of medicines for children, the EGA welcomes the European Commission’s initiative to propose a Regulation in this area.

Currently over half of all medicines administered to children have not been tested specifically for use in child populations. Research costs and ethical issues are the main reasons for the absence of specific clinical trials on children.

Although the Commission’s proposed Regulation contains many helpful provisions, certain incentive measures will need amendment.

In the off-patent sector the measures proposed would need to be improved to ensure development of indications or formulations for children especially where small paediatric populations are involved. The off-patent sector has been identified as most in need of support for new investigations for children.

A setback for developing child medicines in the off-patent sector is the absence of an EU paediatric research fund. Supporters of paediatric medicines deemed such a fund essential to maximise the benefits of medicines for children — especially where small paediatric populations are involved.

The proposal to grant a 10-year data exclusivity period to paediatric versions of patent-expired original and generic medicines is partially helpful. Unfortunately, the provision does not create an assured market exclusivity period as in the successful Orphan Medicinal Products Regulation.

The extent of the patent/SPC extension proposed for “in-patent products” also needs closer scrutiny. Although it may be acceptable in this case to grant an additional period of market exclusivity to compensate for additional costs, the protection should be reasonable — reflecting the cost of the trials — and should not be unnecessarily expensive for health care budgets.

Other proposals, such as extending the market exclusivity for orphan medicines in exchange for developing paediatric data, the creation of the Paediatric Board, the collection of existing data on paediatric use of medicines and the introduction of measures to prevent unnecessary testing on children are welcome.

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