Brussels, 13 November 2008 – Eucomed welcomes the publication of the Commission Communication and Proposal for Recommendation on Rare Diseases. These two documents are the result of a public consultation "Rare Diseases: Europe's Challenges" to which Eucomed contributed in February 2008.
"Eucomed is pleased with the Communication and is confident that the medical technology industry, as a driver of innovation, will contribute to improving the lives of people suffering from rare diseases," said John Wilkinson, Chief Executive of Eucomed.
The European Union defines rare diseases as disorders that occur in less that 5 out of 10,000 people. This means that, still today, 29 million people within the EU suffer from a rare disease. It is therefore important to improve the prevention and diagnosis of rare diseases, and to assure equitable access to treatment throughout the member states.
The main focus of the Communication is to exchange resources and expertise among the member states, and to come to a unified action plan. In this respect, the Commission recognizes the important role of medical devices as a means to improve access to qualitative treatment.
By possibly introducing an Orphan Medical Device policy (similar to the Orphan Medicinal Product Regulation), the Commission would like to see specific technology being developed for a specific disease which would otherwise not be economically beneficial for the medical device manufacturer. Eucomed believes however that the current Medical Device Directives already allows for these particular devices to be developed and produced effectively. The rationale behind the Orphan Medicinal Product Regulation is not applicable on the medical technology industry. Rather, Eucomed believes the EU should create more incentives for research, which could have a bigger impact on the development of these particular medical devices. A possible avenue should be explored to deal with a simplified procedure for devices intended for particular anatomic characteristics that a very limited number of patients might present.
The Commission also sees an important role for e-Health, more specifically through the use of:
Eucomed is the Voice of the medical technology industry in Europe. Eucomed represents directly and indirectly 4500 designers, manufacturers and suppliers of medical technology used in the diagnosis, prevention, treatment and amelioration of disease and disability. Small and medium sized companies make up more than 80% of this sector. The European medical technology industry invests some EUR 3.8 billion in research and development and employs near to 435,000 highly skilled workers. The mission of Eucomed is to improve patient and clinician access to modern, innovative and reliable medical technology.
Mark Grossien
Director Communications and External Affairs
mark.grossien(at)eucomed(dot)be
+32 (0)2.775.92.24
