Brussels, 31 May 2007 - EU Health Ministers have today adopted the Advanced Therapy Medicinal Products (ATMP) Regulation, accepting the compromise package adopted on 25 April by the European Parliament. This is good news, according to Eucomed, the European Medical Technology Industry Association. The new Regulation will provide the long-awaited harmonized framework for the evaluation, authorization and marketing of human tissue-engineered products in the European Union.
The text adopted today appropriately excludes from the scope of the ATMP Regulation tissue engineered products containing or made exclusively from non-viable human or animal cells that do not act as pharmaceuticals. Such products could, in the view of Eucomed, be covered by legislation based on the principles of the Medical Devices Directives, thus benefiting from the pooling of expertise in the tissue engineering area created by the ATMP regulation. This could also be the case for some combination products associating a medical device (hip or dental implant, for example) and a coating made with human tissues or cells (added for biocompatibility and/or better integration).
The regulatory principles contained in the Medical Devices Directives allow research and innovation to be encouraged and sustained whilst at the same time ensuring a high level of patient safety and equitable access to treatment.
In its 2007 work programme, the European Commission has already envisaged the necessary steps to build a regulatory framework for products excluded from the ATMP Regulation.
We are looking forward to sharing our experience and knowledge with the European Commission, the European Medicines Evaluation Agency (EMEA) and other stakeholders in order to develop the most appropriate regulatory regime.
Human tissue-engineering and the use of "smart" biomaterials that promote self-repair of damaged tissues offer tremendous promise for improved patient treatment, faster recovery, improved prognosis and a more biologically favourable situation where the body can be stimulated to heal itself. Regenerative medicine products are already beginning to change medical practice today. Human tissue-engineered skin and tissue-engineered cartilage were amongst the first to be used, for the treatment of chronic wounds and burns, and joint degeneration and injury, respectively. Other regenerative techniques are being developed to repair bone, the cornea, the bladder and several other common medical conditions.
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, including ATMPs. Small and medium sized companies make up more than 80% of this sector. The European medical technology industry invests some €3,8 billion in R&D 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
Communications Director
mark.grossien(at)eucomed(dot)be
+32 (0)2.775.92.24
