Regulation of stem cell research in Greece

Greek flagBy Dr Katerina Sideri

I- Research on human stem cells

A. Current legal position

There is no specific law regulating research on human stem cells in Greece.

Biobanks related legislation is relevant though. The term ‘biobank’ has not been officially defined in Greek law. The National Bioethics Commission defines biobanks as “any collection of human biological material.” The biological specimens may include tissues, cells, blood or DNA.... and may have been collected for medical or educational or research purposes by public or private agencies.”

Biobanks are licensed following the procedure of Article 6 (1) Presidential Decree 26/2008 according to which the Hellenic Transplant Organization makes a proposal and the final decision is made by the Minister of Health and Social Solidarity and the co-competent Ministers.

Data protection Act 2472/97  (http://www.dpa.gr/pls/portal/docs/PAGE/APDPX/ENGLISH_INDEX/LEGAL%20FRAMEWORK/LAW%202472-97-APRIL010-EN%20_2_.PDF) and the national bioethics committee) requires informed consent on collection and processing of samples and data. Anonymised data do not fall under the remit of the data protection act—article 7 (f).  -- For the purposes of Article 2a of Act 2472/97, ‘personal data’ shall mean any information relating to the data subject. After being anonymised, data are non-personal and thus their protection is not within the scope of the Act. Τhe new General Data Protection Regulation will add more safeguards (and is directly applicable in Member States from 2018).

Generally Article 16 (1) of the Greek Constitution protects freedom of research.

Also, see Law 2619/1998 (ΦΕΚ Α'132) which ratifies the Oviedo Convention of the Council of Europe for the protection of human rights and dignity in relation to the applications of biology and medicine: the Convention on Human Rights and Biomedicine.

B. Ethical and regulatory oversight

There is no special Tissue Authority approving relevant research.

Research projects are review by local Research Ethics Committees in hospitals, research centres (for example, the Foundation for Research and Technology - FORTH, the Biomedical Research Foundation of the Academy of Athens), and higher education institutions (for example, Medical Faculties etc.)

 

II- Research on human embryonic stem cells

Embryonic stem cells can be derived legally from surplus IVF embryos, for medical and research purposes.

A. Current legal position

Article 1459 of Law 3089/2002 on medically assisted human reproduction allows the use of surplus reproductive material for research, subject to the consent of the donors. Embryos can be frozen and stored for up to five years, after which they must either be destroyed or used for therapeutic or research purposes. Fertilized eggs that have not been frozen have to be destroyed 14 days after fertilization.

Human reproductive cloning is expressly prohibited (law 3089/2002, Article 1455) and carries a penalty of up to 15 years’ imprisonment for offenders. There is no direct mention to therapeutic cloning. In addition, Ministerial Decision Φ.0546/1/ΑΣ 723/ Μ.4898 incorporated into Greek legislation the Additional Protocol on the Prohibition of Cloning Human Beings to the Oviedo Convention .

Law 3305/2005 on medically assisted reproduction techniques regulates clinical and scientific procedures, including the availability and handling of genetic material, and the operation of assisted-reproduction clinics and biobanks.

According to the provision of paragraph 4 of Article 26 of Law 3305/2005: "Anyone who creates fertilized ova for research purposes ... shall be punished by imprisonment of up to ten (10) years."

Law 2472/1997 regulates the use of personal medical and genetic data, and Ministerial Decision ΔΥΓ/89292 harmonized Greek legislation with the EU Directive 2001/20, which regulates experimentation in human subjects and clinical trials. More recently, Greece implemented changes in its legislation in accordance with EU Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on the clinical trials of medicinal products for human use in MINISTERIAL DECISIONS G5a/59676/21.11.2016 (GOVERNMENT GAZETTE ISSUE NO 4131/B/22.12.2016).

B. Ethical and Regulatory Oversight

The Hellenic National Bioethics Commission was set up in 1999 to advise and issue opinions on medical and scientific issues that may have implications for human health and society.

The National Transplantation Organization oversees the transplantation of organs and tissues in Greece, under law 3984/2011.

 

III- Selected bibliography

Laws, regulations, guidelines

Law 3089/2002 on medically assisted human reproduction

Law 3305/2005 on medically assisted reproduction techniques

Presidential Decree 10/2016 (Government Gazette A 20 / 18.02.2016). "License for Establishment and Operation of Medical Assisted Reproduction Units (MIC). Terms and conditions".

Ministry Decision 6901 / 26-11-2015 (Government Gazette B 2639 8.12.2015) "Establishment and operation of Cryopreservation Banks. Terms and conditions".



Law 3984/2011, Government Gazette A 150 "Organ donation and transplantation and other provisions"

Presidential Decree NUMBER 26 Government Gazette A 51 / 24.3.2008-Harmonization of Greek Legislation with Directive 2004/23 / EC of the European Parliament and of the Council of 31 March 2004 on standards, quality and safety for the donation, procurement, testing, processing, preservation, storage and disposal of dangerous substances Distribution of human tissues and cells (EEL102 / 7.4.2004) and the related Directives 2006/17 / EC (EEL 38 / 9.2.2006) and 2006/86 / EC (EEL 294 / 25.10.2006).