Human Cells and Tissue Banking for Clinical Use

Human Cells and Tissue Banking for Clinical Use

Collections of human cells and tissue for clinical use are regulated in Greece, according to

a) The Directive 2004/23 (incorporated by the Presidential Decree 26/2008) relevant to the storage of all kinds of human biological material

b) The Law 3305/2005, relevant to the storage and use of reproductive material (gametes and embryos)

c) The Law 3984/2011, relevant to the storage of grafts for transplantations

All the above provisions comprise some basic standards for human tissue banking, that is, specific prerequisites for informed consent of the donors, for guarantees on appropriate conditions of storage, quality of services and certification of the personnel involved (medical doctors, biologists, etc). The GDPR legislation on data protection is also applicable therefore a DPO responsible is also involved to make sure that processing of the relevant data is in compliance with conditions of confidentiality. For reproductive material, the National Authority on Medically Assisted Reproduction is responsible for Gamete and Embryo Banks control, both by licensing their establishment and by imposing administrative sanctions in case of malpractice. In Greece, the establishment of public or private umbilical cord blood banks is allowed and regulated by the Law 3984/2011, providing specific criteria, the compliance with which is controlled by the National Transplant Organization.

Our services: The experience of our team in the field includes contribution to the drafting of laws on assisted reproduction and umbilical cord blood banking, participation in the board of the National Transplant Organization. Services we are offering are related to:

- Preparation of legally sound information documents and consent forms regarding biological material donation, for any of the above clinical uses

- Preparation of contract templates to be used in banks/donors relationships

- Consultation on regulatory issues, particularly regarding professional liability of medical doctors, biologists and other experts acting as owners or employees in human tissue banks

- GDPR compliance and DPO services, including impact assessment