EU rules to govern tissue engineering

Tissue engineering - already used to build skin and bone - still holds enormous medical potential. The Commission plans to release a comprehensive package of EU rules to govern this promising field.

The Commission completed an on-line consultation <link to section more information> that attracted a wide range of contributions for possible future rules for the marketing of human tissue engineered products – which is currently a relatively grey legal area.

Tissue engineering is an evolving technique that holds a great deal of medical promise. It is already being used to construct entire sheets of skin to treat burns victims, and to grow bone. Although it remains the material of science fiction, scientists hope, one day, to be able to ‘grow’ entire organs in the laboratory to help overcome the shortage of organ donors.

According to a recent EU report, there are over 100 tissue-engineering biotechnology companies in the European Union, concentrated mainly in Germany and the UK. Although new EU regulations on the safe and ethical use of human tissues and cells recently came into force, they do not fully cover the marketing aspect of this emerging sector. The Commission plans to release – widely expected in mid-June – proposals for new legislations to overcome this shortcoming.

Rules of engagement

After 18 months of debate in the Council of Ministers and the European Parliament, the Council gave the green light, in March, to new minimum health and safety standards for the donation, storage and use of human tissues and cells across the EU.

The new regimen prohibits the commercial sale of human tissues and cells – donors need to make their donations voluntarily and can only claim expenses. It also requires that data on the donation, transfer and use of human tissues and cells be retained for at least 30 years

The new legislation – which does not, for instance, apply to blood or organ donations –leaves plenty of space for Member States to define their own national terms. The Commission immediately welcomed the new rules.

“This is positive news for hundreds of thousands of patients in Europe who, every year, undergo some form of therapeutic treatment based on the use of human tissues and cells,” observed Health and Consumer Protection Commissioner David Byrne, in March. “Patients can now be sure that human tissues and cells derived from donations in another Member State, nonetheless, carry the same guarantees as those in their own country.”