Commission unveils new rules to support gene, cell or tissue based therapies

Brussels, 16 November 2005

Today, the European Commission has proposed new EU wide rules to facilitate gene, cell and tissue-based therapies. These so-called advanced therapies enable revolutionary treatment of a number of diseases or injuries, such as cancer, Parkinson’s disease, skin in burn victims or serious cartilage damage. With this proposal the Commission covers all advanced therapies within a single, integrated and tailored European regulatory framework. The current lack of an EU-wide framework leads to divergent national approaches as to the legal classification and authorisation of advanced therapy products, which ultimately negatively affects the EU’s innovative capacity and competitiveness in this key area of biotechnology. To address these problems, the Commission proposes a centralised marketing authorisation procedure, a new expert Committee, strengthened requirements for risk management and traceability and top-quality scientific advice. Ethical decisions about the use or non-use of germ cells or embryonic stem cells remain under the full responsibility of individual Member States.

Commission Vice President Günter Verheugen stated: “Advanced therapies have a huge potential, both for patients and industry. With this proposal we guarantee the highest level of health protection for patients At the same time we give the biotech industry a coherent EU-wide framework which allows them to innovate, grow and create jobs.”

Breakthrough developments in the area of advanced therapies herald new treatment opportunities for patients. Tissue engineering, in particular, combines various aspects of regenerative medicine and bioengineering to repair or replace diseased tissues. Even more innovative products – such as heart valves or blood vessels - are already in the pipeline.

The main elements of the Commission proposal:

• 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;
• Tailor-made technical requirements, which are adapted to the particular characteristics of these products;
• Strengthened requirements for risk management and traceability;
• A system of low-cost, top-quality scientific advice provided by EMEA;
• Special incentives for small and medium-sized enterprises.

This proposal is based on extensive public consultation with all stakeholders and a comprehensive impact assessment. It takes into account a number of suggestions provided by stakeholders during this consultation, such as early EMEA support to undertakings through scientific advice, or guidance for the regulatory classification of borderline products.

The Commission proposal will now be forwarded to the European Parliament and Council for co-decision.

Ethical aspects regarding human tissues and cells

The proposal fully respects fundamental human rights and observes the principles reflected in the EU Charter of Fundamental Rights. It also takes into account the Convention for the protection of human rights and dignity of the human being with regard to the application of biology and medicine (‘Oviedo’ Convention).

In accordance with the subsidiarity principle, the proposal also fully respects national competence as regards the use or non-use, for ethical reasons, of certain types of human cells (e.g. germ cells or embryonic stem cells). Decisions on such use or non-use remain a national responsibility.

The Commission is of the opinion that 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.
Additional information, including the Commission proposal, can be found at:

http://pharmacos.eudra.org/F2/advtherapies/index.htm

Item source: IP/05/1428 Date: 16/11/2005 Previous Item Back to Titles Print Item