Brussels, 08 Mar 2005

The healthcare biotechnology industry has published a paper setting out its ideas on how the orphan medicines system in Europe should be reformed. Recommendations include facilitating clinical trials and coordinating EU research on rare diseases.

Orphan medicines are used to treat rare diseases, also known as 'orphan diseases'. EU-wide regulations have been in place since 1999, ensuring prompt access to therapies for patients with such diseases, and encouraging industry to develop these therapies through incentives.

Emerging Biopharmaceutical Enterprises (EBE) and the European Association for Bioindustries (EuropaBio) believe that changes are now needed to the legislation in order to strengthen it.

At EU level, three Directorates-General are involved in policies on rare diseases: DG Research, DG Enterprise and Industry, and DG Health and Consumer Protection. Other bodies such as the European Medicines Agency are also involved, and more coordination and streamlining between all is now required, the industry believes.

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The Clinical Trials Directive, implemented in May 2004, should also be simplified, according to the paper. 'In spite of its main aims to protect individual patients in clinical trials and to increase harmonisation of clinical trials across the EU, the flexibility required to handle clinical trials for the affected patient groups may be challenged by the rigour of the Directive,' claim EBE and EuropaBio.

The paper also calls for the establishment of post-approval clinical trials, which should enable companies to recover their costs.

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Other recommendations put forward in the paper relate to the establishment of an EU-wide network for diagnostic testing for rare diseases; awareness raising; the provision of orphan medicines; incentives for drug development; understanding the regulation at national level; and a review of the disincentives to orphan drug development.

For further information, please consult the following web address:
%20Medicines%20White%20Paper_FINAL.doc

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