Creating a win-win climate for orphan drugs
Over the next couple of months the European Commission will launch a public consultation exercise to assess stakeholder views on five years of European orphan drugs regulation, ahead of its report to the European Parliament on the impact of the Regulation, due in early 2006. Formal feedback on the Regulation’s impact (see Spotlight) has generally been positive. In addition, the recent European Parliament vote in support of the proposed draft paediatric medicines directive, inspired in part by the success of the orphan legislation, is a sign that government decision-makers are willing to work with industry to create a win-win climate for patients and drug developers alike.
The inventory of national incentives to support rare diseases and orphan drugs is currently being updated, in line with Article 9 of the Regulation. This inventory will be published by the end of the year and should give an idea of which member states have evolved over the five years of the Regulation in their support of rare diseases and orphan drugs. However, the early results of this update have made clear that there is still much room for progress. In spite of the positive impact of the Regulation at the European level, national governments have, more than ever, a responsibility to ensure that orphan drugs are made available to those in need of them and that rare diseases, and those suffering from them, are not relegated to the bottom of their list of priorities. In addition, the ongoing update has highlighted the difficulty of identifying central points of information on rare disease initiatives in each country, reinforcing the argument for more co-ordinated networking between those working in the field in Europe, whether patients, industry, academics or government.
This newsletter is one way of ensuring that information about initiatives in support of rare diseases in Europe are shared across the community – but only if you let us know about them…
Deadline for submissions |
We welcome your contributions to OrphaNews Europe.
Please send your ideas for articles by contacting the editor here.
The next edition will appear in mid-October.
Deadline for the next issue is 7 October 2005.