Zell- und Gewebetechnik (Tissue Engineering)

Human tissue engineering and beyond: Proposal for a community regulatory framework on advances therapies

DG Enterprise consultation paper

The EKD (Protestant Church in Germany) welcomes the invitation to comment on the proposal of the European Commission for a community regulatory framework on advanced therapies covering gene therapy, cell therapy and human tissue engineered products.

We acknowledge that this field of “regenerative medicines” is very promising for a better treatment of skin, cartilage and bone diseases or injuries.

EKD favours the approach chosen by the Commission to complete the regulatory framework for advanced therapies building especially on directive 2004/23/EC which lays down the basic quality and safety requirements on human tissues and cells. Only a free movement of these products allows patients to have access to these innovative therapies. Therefore we support the Commission in addressing all advanced therapies throughout Europe in one single Regulation paying particular attention to a high level of health protection and the respect of ethical principles.

We are also supportive to the proposed exclusion of tissue engineered products derived exclusively from cells or tissues of animal origin from the scope of the Regulation (in Art. 2 paragraph 2b) as these products still raise a number of safety and ethical issues.

EKD acknowledges the concerns of the Commission to guarantee post-authorisation traceability, long-term patient follow-up and a thorough post-authorization risk management strategy in order to monitor the safety of the advanced therapy products.

Concerning the establishment of a Committee for Advanced Therapies (CAT) to assess of advanced therapy products we welcome the multi-disciplinary approach of the Commission to ensure appropriate coverage of all the scientific areas relevant to advanced therapies. As the consultation paper indicates there are many ethical questions involved and the CAT is supposed to be open to interested parties. Therefore we would like to suggest that ethicists specialised in the field of bioethics should also be part of CAT.

Finally we are very much in favour of including a provision in the Regulation stating the respect towards fundamental human rights, especially the principles reflected in the Charter of Fundamental Rights of the European Union and the Convention on Human Rights and Biomedicine.

As the consultation paper stresses the use/non-use of any specific type of human cells, e.g. germ cells and embryonic stem cells, are entirely under the competence of each Member State. This statement asks for further clarification in the Regulation. In order to provide legal certainty the EKD would support a clear provision dealing with this subject.

The diverging legal regulations on embryonic stem cells in the Member States of the European Union should be taken into account. Germany and Italy have regulations which restrict human embryonic stem cell research, whereby such research is prohibited in Austria, Ireland, Latvia and Poland. Moreover the on-going ethical debate on this issue should be reflected. Therefore we would suggest the inclusion of a provision similar to article 1 paragraph 2b) of the proposal on tissue engineered products of animal origin. Any human tissue engineered products containing or derived from embryonic stem cells should be excluded from the scope of the directive.

We should be grateful if our concerns were taken into consideration.

Sabine von Zanthier (Head of the EKD-Office Brussels)