Brussels 10 May 2006 - Eucomed, the European medical technology industry association, welcomes the Commission Proposal for a Regulation on Advanced Therapies [1]. This text lays down the long-awaited harmonized rules for the approval and marketing of human tissue engineered products. Many of these products are not available to patients today because of the absence of EU-wide legislation.
After in-depth technical and scientific analysis of the proposed text, Eucomed has made recommendations on six aspects of the proposed Regulation, namely its field of application, the evaluation procedure, the transition period for implementing the new provisions, ethics, the technical annexes and product coverage.
"Today Europe is in the lead in the highly innovative sector of human tissue engineering. All aspects of the Regulation should be carefully assessed. It is indispensable to get it absolutely right for the future, to safeguard the innovativeness and competitiveness of the European industry", commented Eucomed Director-General Maurice Wagner.
Eucomed represents 4500 designers, manufacturers and suppliers of medical technology as well as pioneers in human tissue engineering, mostly small and medium-sized companies and start-ups. The world-wide market for human tissue engineered products has been estimated at up to € 400 billion per year.
SCOPE OF THE REGULATION
Patients should be assured that the treatments they receive are safe, are of high-quality, and perform as intended, no matter who prepares the treatment. Hospitals should clearly be covered by the Regulation.
EMEA COMMITTEE ON ADVANCED THERAPIES
It should be the European experts in this highly specialized and innovative field that are responsible for evaluating the new treatments and making scientific recommendations for a marketing authorisation. The role and constitution of the new Committee for Advanced Therapies, to be created within the European Medicines Agency, should be enhanced to reflect this need.
TRANSITION PERIOD
The text currently proposes an unworkably short transition period of only 2 years. Patients that are currently being treated with products that will in future be covered by this Regulation could have their treatment interrupted.
ETHICAL ISSUES
According to the proposed Regulation, countries retain the right to establish national ethical standards. While this is understandable, the Regulation should require that Member States be transparent and give notice of the human or animal cells that will be prohibited on their territory.
TECHNICAL ANNEXES
The new legal framework should be developed with the highest level of technical expertise to ensure it is appropriate and workable. Modifying the Clinical Practice Directive (2005/28/EC) is insufficient. The Clinical Trials Directive (2001/20/EC) and the Good Manufacturing Practices Directive (2003/94/EC) should also be amended. As many key players in the development of human tissue engineered products are part of its membership, Eucomed would welcome the opportunity to play an active role in developing the new legal framework.
Mark Grossien
Communications Director
mark.grossien(at)eucomed(dot)be
+32 (0)2.775.92.24
_____________________________
[1] Human tissue engineering and beyond: Proposal for a community regulatory framework on advanced therapies
