Brussels, 19 May 2005
A new biotechnology area has emerged: human tissue engineering, which combines various aspects of medicine, cell and molecular biology, materials science and engineering, for the purpose of regenerating, repairing or replacing diseased tissues. Current applications of this nascent field of “regenerative medicine” include treatment for skin, cartilage and bone diseases or injuries. More complex products – such as heart valves or blood vessels – are already in the pipeline. Tissue engineered products currently lie outside any legislative framework. This is why the European Commission is working on a clear regulatory framework. Before tabling a formal proposal later this year, the Commission has now invited the general public to comment on a draft regulatory framework for authorisation, supervision and post-authorisation vigilance of advanced therapies (tissue engineering, cell and gene therapy). This consultation is part of the impact assessment of the upcoming proposal.
Commission Vice President Günter Verheugen stated: “Biotechnology is a booming sector creating new opportunities European society and economy cannot afford to miss. 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.”
The lack of an EU-wide classification and authorisation process leads to divergent approaches across Member States, which impairs the free movement of human tissue engineered products, thereby hindering patients’ access to these innovative therapies.
The main elements of the draft:
- A centralised marketing authorisation procedure, to benefit from the pooling of expertise at European level and direct access to the EU market;
- A new and multidisciplinary 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, which are 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 European Medicines Agency;
- Financial and administrative incentives for small and medium-sized enterprises developing advanced therapies.
The proposed Regulation should respect fundamental human rights and observes the principles reflected in the Charter of Fundamental Rights of the EU. It should also take into account, as appropriate, 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, e.g. germ cells and embryonic stem cells, are entirely under the competence of Member States.
Human tissue- and cell- based products should be founded on the philosophy of voluntary and unpaid donation, anonymity of both donor and recipient, altruism of the donor and solidarity between donor and recipient.
Comments by all interested parties are welcome until 20 June 2005 at: