Commission launches consultation on human tissue engineering
The European Commission has launched a public consultation on a draft regulatory framework for the emerging biotechnology area of human tissue engineering. This new field of regenerative medicine, which combines various aspects of medicine, cell and molecular biology, materials science and engineering, in order to repair, regenerate or replace diseased tissues, currently lies outside any legislative framework. Existing applications include treatment for skin, cartilage and bone diseases or injuries, but are expected to soon include heart valves or blood vessels. The Commission is therefore working on a clear regulatory framework and is inviting the general public to comment, before 20 June, on a draft regulatory framework for authorisation, supervision and post-authorisation vigilance of advanced therapies (tissue engineering, cell and gene therapy). The consultation will be used as part of an impact assessment of the upcoming proposal. 'Biotechnology is a booming sector creating new opportunities European society and economy cannot afford to miss,' says Commission Vice-President Günter Verheugen. 'We intend to guarantee the highest level of health protection. At the same time we want to foster the competitiveness of companies and provide legal certainty for all actors.' At present, due to the lack of an EU-wide classification and authorisation process, human tissue-engineered products cannot move freely between EU Member States, which hinders patients' access to these innovative therapies. The proposed regulation respects fundamental human rights and takes account of the convention for the protection of human rights and dignity of the human being with regard to the application of biology and medicine. Decisions concerning the use or non-use of any specific type of human cells, however, are left to the competence of Member States. The main elements of the draft regulation include: - a centralised marketing authorisation procedure to benefit from the pooling of expertise at European level and direct access to the EU market; - a new expert committee (Committee for Advanced Therapies) within the European Medicines Agency (EMEA) to assess advanced therapy products and follow scientific developments in the field; - tailored technical requirements adapted to the particular scientific characteristics of these products; - detailed guidance for the application of good manufacturing practice and good clinical practice to advanced therapies; - strengthened requirements for risk management and post-authorisation traceability; - a system of low-cost, top-quality scientific advice for the industry, provided by the EMEA; - financial and administrative incentives for small and medium-sized enterprises (SMEs) developing advanced therapies; - ethical aspects regarding human tissues and cells.