Open consultation on tissue engineering - to 30.9.2002

Enterprise Europe (Brussels, 4 July 2002).

The Enterprise DG invites comments on the need for, and ideas for the possible content of, a Community legal framework on human tissue engineered products.

Tissue engineering is new, fast-developing and largely unregulated. It aims to restore, maintain or improve the function of human tissues and organs. It differs from standard therapies in that tissue engineered products become integrated within the patient, affording a potentially permanent and specific cure for disease, injury or impairment.

Typical applications are orthopaedic prostheses (bones), cardio-vascular prostheses (heart valves, blood vessels, arteries), neurological tissue repair, skin repair, muscle repair, liver or pancreas regeneration or prosthesis, and prosthesis for the urinary tract.

At present, neither the development of knowledge and technology nor the potential risks are fully foreseeable. Potential benefits for patients however, are thought to be huge.The challenge for the regulators is to enable patients to gain rapid access to new and highly promising types of products, under optimal safety and quality conditions.

The Commission's Scientific Committee on Medicinal Products and Medical Devices⁽¹⁾, feels that while tissue engineered products bear some similarities to both medical devices and pharmaceuticals (e.g. cell therapy products), they differ sufficiently from both to justify a specific regulatory system.

Lacking an EU-wide legal framework, Member States are beginning to take national measures. However, disparities among states could prevent patients from having equal access to tissue-engineered products across the Union, and undermine confidence in these products.

Tissue engineering companies must also have a clear legal framework to provide certainties with regard to the laws protecting their investments and activities.

The potential worldwide market for tissue engineered products is estimated at almost Euro 100 billion per annum (source: Pittsburgh Tissue Engineering Initiative).

Tissue engineering consultation document