Advanced therapies regulation adopted
The EU's Member States have unanimously approved a proposal from the European Commission to regulate new medical products derived from genes, cells and tissues. The new, advanced therapies could lead to revolutionary treatments for a number of diseases or injuries. Researchers hope to develop, for example, skin grafts for burn victims and treatments for conditions such as Alzheimer's, cancer and muscular dystrophy. 'The unanimous agreement by the Member States, after quick and broad support by the European Parliament earlier on, confirms that our proposal has found the right balance,' said EU Enterprise and Industry Commissioner Günter Verheugen. 'Both patients and industry have been waiting for it, as it unleashes an EU potential for innovation, often driven by small and medium-sized enterprises [SMEs], whilst respecting decisions of Member States on ethical concerns.' The EU Association for Bioindustries, EuropaBio, also welcomed the decision. 'The Advanced Therapies Regulation provides Europe with a great advantage to attract the leading companies researching and developing these innovative therapies and providing the scientific community, patients and industry with a predictable and clear legal framework,' said Andrea Rappagliosi, Chair of the Healthcare Council at EuropaBio. The Commission believed that harmonised EU rules were needed in order to ensure that patients around Europe have uniform access to treatments and support. The proposal was also intended to support the development of the fast-growing biotechnology industry, which is a key string to the EU's competitiveness bow. The key elements of the new Regulation are as follows: - a centralised marketing authorisation procedure; - a new and multidisciplinary expert committee within the European Medicines Agency (EMEA) to assess advanced therapy products and follow scientific developments; - technical requirements that are tailored to the therapies; - strengthened requirements for risk management and traceability; - incentives for SMEs. On ethical issues, the Commission decided to not intervene in decisions made by the Member States on whether certain types of cells, including embryonic stem cells, can be used for therapeutic purposes. The proposal did however observe the principles reflected in the EU Charter of Fundamental Rights, and takes into account the 'Convention for the protection of human rights and dignity and of the human being with regard to the application of biology and medicine', according to the Commission. Some MEPs had called for stronger ethical safeguards to be included in the proposal, but a compromise agreement drawn up by a small group of MEPs with representatives from the Council and the Commission overcame this slight delay. The next stage will see the development of the secondary-level implementing legislation and the Technical Guidelines.