EP votes to regulate advanced therapies

The European Parliament has voted on a Commission proposal to regulate new medical products based on genes, cells and tissues. These advanced therapies herald revolutionary treatments of a number of diseases or injuries, such as skin in burn victims, Alzheimer's, cancer or muscular dystrophy, noted a Commission statement.

However, harmonized European Union rules are urgently needed to ensure uniform access to treatments for patients and support the development of this emerging biotechnology industry, it said. The Parliament endorsed the Commission's intention to address all advanced therapies within a single European framework, and introduced a compromise package of amendments designed to further improve the text without altering its fundamental elements. The compromise package is fully acceptable to the Commission, and will now be examined by the Council of Member States.

The Commission proposed an EU Regulation on all advanced therapies in November 2005. The objectives are to ensure the free movement of such products within Europe, facilitate access to market and foster the competitiveness of EU companies in the field, while guaranteeing the highest level of health protection for patients.