EU boost to skin, bone and cartilage health

By Emily Smith

Date: 27/10/05

The European Commission is aiming to boost the EU's ability to fight illnesses ranging from heart disease to arthritis with the publication next month of a proposed regulation on human tissue engineering. The 'advanced therapies' proposal is currently scheduled for adoption by the Commission on 15 November.

Tissue engineering is a branch of biotechnology used to generate skin, bone and cartilage from human cells. It is currently used in particular to treat sporting injuries and age-related problems, such as osteoporosis, but no legislation covering its use exists at EU level.

In theory the regulation will make it easier for all Europeans to benefit from tissue therapy by setting out standard rules for advanced therapy procedures across the EU. It should also speed up the development of new tissue therapies by pushing member states to share their knowledge of the emerging technology.

The proposal will also set up a committee for advanced therapies (CAT) to oversee the sector and assess new discoveries. The Commission is expected to publish manufacturing and clinical guidelines soon, while the European agency for the evaluation of medical products (EMEA) will draw up traceability guidelines.

Most tissue engineering starts with cells donated by humans and developed in a laboratory. Under EU law, donors have to be unpaid volunteers. Therapies based on animal tissues are considered too controversial to be covered by the new regulation.

Hospitals practising small-scale tissue therapy will also be exempt from the regulation and allowed to carry on with their own guidelines. Small- and medium-sized enterprises, which develop most advanced tissue therapy products, will be covered but will get help with administration and will pay less than large-scale industries for outside scientific advice.

The advanced therapies proposal also covers gene and cell therapy, but as these are already regulated by EU medical law the new legislation should make little or no difference to companies working in this field.

The controversial field of embryonic stem cell research - in which cells are taken from embryos at an early stage before their role in the body has been determined - will also come under the scope of the regulation. It is proposed that member states will be able to decide themselves whether or not to allow this type of research.

Heidi De Wit of biotech company Genzyme said she was "very happy" that an EU-wide proposal was imminent. She said that there was so far little evidence of opposition to the idea of a regulation: "Everyone involved in the debate seems to agree that we need legislation in this field now."

Article reports on an initiative of the European Commission to boost the EU's ability to fight illnesses ranging from heart disease to arthritis. The publication of a proposed regulation on human tissue engineering was expected for adoption by the European Commission on 15 November 2005.