Commission launches public consultation on need for tissue-engineered products legislation
The European Commission has launched a public consultation on the need for a Community legal framework on human tissue-engineered products. Tissue engineering is a new and rapidly developing technology, the aim of which is to produce viable substitutes that restore, maintain or improve the function of human tissues or organs. It is different from standard therapies in that the engineered products become integrated within the patient, offering the possibility of a potentially permanent and specific cure for a disease, injury or impairment. Examples of tissue-engineered products include orthopaedic prostheses (bones), cardio-vascular prostheses (heart valves, blood vessels), neurological tissue repair, skin repair, muscle repair, and liver or pancreas regeneration. The Commission sets out a number of reasons why tissue engineering and tissue-engineered products could be covered by a Community legal framework: - The high complexity, variability and permanent evolution of living cells and tissues along with the complexity of their processing means that risk evaluation is a difficult process. A legislative framework could allow patients to benefit from the technological evolution with the highest levels of safety. - Member States have begun implementing polices at a national level. As these policies differ between Member States, patients' access to tissue-engineered products may not be guaranteed throughout the Community. - From an industrial point of view, the Community needs to provide tissue engineering companies with a transparent legal framework in order to create the legal certainty needed to protect their investments and activities, and to offer European citizens access to the new technology.