Strasbourg - 25 April 2007 – Eucomed, the European Medical Technology Industry Association, welcomes the adoption by the European Parliament today of the first reading report on the proposed Advanced Therapy Medicinal Products Regulation. The vote sets the basis for a balanced harmonized regulatory framework for the evaluation, authorization and marketing of human tissue engineered products, as well as gene therapy and somatic cell therapy products, which are fast evolving areas of biomedical technology.
“The vote is good news for European patients. Europe is one step closer to making a variety of cutting-edge treatments more widely available. It is also good news from the perspective of the Lisbon Agenda: a harmonized regulatory framework will help to boost medical technology research and innovation, and the competitiveness of Europe on the world stage”, commented Maurice Wagner, Director General of Eucomed.
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 tissue engineered products. Small and medium sized companies make up more than 80% of this sector. The European medical technology industry invests some €3,7 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.
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.
In the future, tissue engineering will provide a solution to overcome the shortage of donor organs for transplantation.
Mark Grossien
Communications Director
mark.grossien(at)eucomed(dot)be
+32 (0)2.775.92.24
