National Regulation of Genetic Counselling

Released Januari 2008

Contact persons:

• Sirpa Soini, LL.M

  University of Helsinki

  Faculty of Law/Medical and Biolaw

  Sirpa Soini

• Professor Helena Kääriäinen
• Research assistant Elina Rantanen
• Senior researcher Marja Hietala

  Department of Medical Genetics

  University of Turku

  E-mail: firstname.surname@utu.fi (ä => a)

Council of Europe has so far created the most central European international legal document in the health field, that is Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine CETS No.: 164 (1997), later referred to as “The European Convention on Human Rights and Biomedicine”. Its Article 5 sets a general rule that a person shall, prior to any intervention in the health field, be given appropriate information as to the purpose and nature of the intervention as well as on its consequences and risks. Article 4 of the Convention states that any intervention in the health field, including research, must be carried out in accordance with relevant professional obligations and standards. In consequence, non-legal professional codes and guidelines concerning e.g., genetic counselling, shall be followed. As to predictive genetic testing, article 12 requires appropriate genetic counselling:

“Tests which are predictive of genetic diseases or which serve either to identify the subject as a carrier of a gene responsible for a disease or to detect a genetic predisposition susceptibility to a disease may be performed only for health purposes or for scientific research linked to health purposes, and subject to appropriate genetic counselling.”

The Convention on Human Rights and Biomedicine is nationally applicable law in the countries that have ratified it usually on two bases:

1. it is directly valid and effective due to a constitutional norm or
2. the country has issued a national law to implement the convention.

Therefore, if later below is indicated that a country has ratified the convention, its provisions are applicable unless some reservations were made at the time of the ratification.

Also those countries who have only signed the convention can be morally held obliged to take further steps to make it nationally binding. The state of signatures and ratifications is based on the information on the Council of Europe’s website http://conventions.coe.int as of December 2007.

Council of Europe is at the process of finalising a Draft Additional Protocol to the Convention on Human Rights and Biomedicine concerning genetic testing for health purposes (CDBI/INF (2007) 5). The Protocol was approved by the Steering Committee on Bioethics (CDBI) on 8 June 2007, and in 26th September 2007 it was presented to the Committee of Ministers. Articles 8-12 of the Draft Protocol enlarge upon information, genetic counselling and consent with respect of genetic tests.

The following list presents only laws and governmental orders, if they contain an explicit provision on genetic counselling. The relevant laws and governmental orders are found at the governmental websites. Many of the other laws (e.g. general patients’ rights acts; biomedical research acts, etc.) tend to include detailed provisions of information given to the patient, referring mostly to the concept of the informed consent, and they do not usually relate to individual diagnostic situations and/or they are not extensive enough to cover the provision of the genetic counselling. In addition to the EU Countries, Norwegian and Swiss regulation will be presented.

Austria

Austrian Gene Technology Act – Gentechnikgesetz, BGBl. Nr. 510/1994. According to § 69, non-directive genetic counselling is mandatory before and after genetic testing. Counselling shall cover medical facts, test results as well as social and psychological consequences. The rule concerns both predictive and carrier (post- and prenatal) genetic testing. Austria has not signed the Convention on Human Rights and Biomedicine.

Belgium

No provisions of genetic counselling in law at present. Belgium has not signed the Convention on Human Rights and Biomedicine

Bulgaria

No provisions of genetic counselling in law at present, but the Convention on Human Rights and Biomedicine was ratified and entered into force in 2003.

The Republic of Cyprus

No provisions of genetic counselling in law at present, but the Convention on Human Rights and Biomedicine was ratified and entered into force in 2002.

Czech Republic

No provisions of genetic counselling in law at present. A proposal for an Act on Health Care is in progress and it contains a chapter on Medical Genetics that would include a provision of genetic counselling. The Convention on Human Rights and Biomedicine was ratified and entered into force in 2000.

Denmark

No provisions of genetic counselling in law at present. The Ministry of internal and health affairs has issued guidelines for prenatal genetic information, counselling and examinations that came into force in 2007 (VEJ 60310 - Vejledning om prænatal genetisk information, rådgivning og undersøgelse 1.1.1994). The Convention on Human Rights and Biomedicine was ratified and entered into force in 1999.

Estonia

According to Article 11 (4) of the Human Gene Research Act (2000) gene donors have a right to genetic counselling upon accessing their data in the Genebank. No other provisions of genetic counselling in law at present, but the Convention on Human Rights and Biomedicine was ratified and entered into force in 2002.

Finland

No provisions of genetic counselling in law at present. The European Convention on Human Rights and Biomedicine has been signed in 1997, and ratification is in process.

France

Code civil and code de la santé publique regulates many of the bioethical issues in France. The latest big law reform, Law on Bioethics (LOI no 2004-800 du 6 août 2004 relative à la bioéthique), does not explicitly mention the counselling, but Article 4 modifies the relevant article 16-10 in the Code Civil regarding testing for genetic condition so that the patient has to be informed of the nature and the finality of the test before it. Provisions on genetic counsellors’ competence and their working conditions were set by article L 1132-1 de la loi 2004-806 du 9 août 2004 dite loi de Santé Publique. The European Convention on Human Rights and Biomedicine has been signed in 1997.

Germany

A draft law on genetic tests (Gendiagnostikgesetz – GenDG, BT-16/3233) is currently under reading in the Parliament. The draft article 12 sets explicit requirements for genetic counselling. Germany has not signed the Convention on Human Rights and Biomedicine.

Greece

No provisions of genetic counselling in law at present. The European Convention on Human Rights and Biomedicine was ratified in 1998 and entered into force in 1999.

Hungary

No provisions of genetic counselling in law at present, but a draft for a law on genetic screening, testing and biobanking including genetic counselling has been sent to the Parliament in 2005. The European Convention on Human Rights and Biomedicine was ratified and entered into force in 2002.

Ireland

No provisions of genetic counselling in law at present. Ireland has not signed the European Convention on Human Rights and Biomedicine

Italy

No provisions of genetic counselling in law at present, but specific governmental guidelines on medical genetics were approved in 2004 (Linee-guida per le attività di genetica medica G.U. n. 224 - 23/9/2004) that contain provisions of genetic counselling. The European Convention on Human Rights and Biomedicine has been signed in 1997.

Latvia

No provisions of genetic counselling in law at present.The European Convention on Human Rights and Biomedicine has been signed in 1997.

Lithuania

No provisions of genetic counselling in law at present. The Ministry of Health Care has issued a governmental order to establish national standards for genetic counselling and clinical geneticists (V-220/2003). The European Convention on Human Rights and Biomedicine was ratified in 2002 and entered into force in 2003.

Luxembourg

No provisions of genetic counselling in law at present. The European Convention on Human Rights and Biomedicine has been signed in 1997.

Malta

No provisions of genetic counselling in law at present. Malta has not signed the Convention on Human Rights and Biomedicine.

The Netherlands

No provisions of genetic counselling in law at present. The Health Council acts as an advisory board for the Minister of Health, Welfare and Sport. In 1999, the Standing Committee on Genetics of this advisory board published an advisory report Clinical Genetic Testing and Counselling (Health Council of the Netherlands: publication no. 1999/07). According to this report, regulations on clinical genetic testing and counselling in the Netherlands apply to "postnatal and prenatal chromosome, biochemical and DNA testing, the clinical removal of foetal material, advanced ultrasound scanning for foetal abnormalities and complex genetic counselling". The Convention on Human Rights and Biomedicine was signed in 1997.

Norway

Lov om humanmedisinsk bruk av bioteknologi m.m. (Bioteknologiloven) 2003 (100). This law covers all kinds of genetic tests and examinations. Article 4.4 stipulates genetic counselling in case of a prenatal genetic diagnosis to be given to a pregnant woman or a couple. Article 5.5 § requires genetic counselling before, during and after presymptomatic and predictive tests as well as tests to detect a carrier status. If the child under 16 years of age is concerned, the counselling shall be given also to the parents. Norway ratified the Convention on Human Rights and Biomedicine in 2006 and it entered into force in 2007.

Poland

No provisions of genetic counselling in law at present. The European Convention on Human Rights and Biomedicine has been signed in 1997.

Portugal

Portugal is in the process of adopting a Law on Genetic Information (12/2005) that would require carrier, presymptomatic and susceptibility testing be preceded by genetic counselling and written informed consent. Presymptomatic, susceptibility and preimplantation diagnosis should only be performed in persons that can fully appreciate all their implications and give their consent. In case of risk for a severe, late-onset disease that has no effective treatment, any predictive testing should be preceded by a psychosocial evaluation and followed after the delivery of the results. The European Convention on Human Rights and Biomedicine was ratified and entered into force in 2001.

Romania

No provisions on genetic counselling in law at present, but the Convention on Human Rights and Biomedicine was ratified and entered into force in 2001.

Slovakia

No provisions of genetic counselling in law at present, but legislation on genetic testing and biomedical issues is under preparation. The European Convention on Human Rights and Biomedicine was ratified in 1998 and entered into force in 1999.

Slovenia

No provisions of genetic counselling in law at present. The European Convention on Human Rights and Biomedicine was ratified in 1998 and entered into force in 1999.

Spain

New national law on biomedical investigations (Ley 14/2007, de 3 julio, de Investigación biomedical) contains an explicit requirement of an appropriate genetic counselling in Article 55. The law covers broad field of medical interventions and treatment. In addition, the autonomous community of Andalucia issued a law that regulates, inter alia, genetic counselling in the context of genetic analyses and Andalucian human biobanks (Ley 11/2007, de 26 noviembre, reguladora del consejo genético, de protección de los derechos de las personas que se sometan a análisis genéticos y de los bancos de AND humano en Andalucia). The Convention on Human Rights and Biomedicine was ratified in 1999 and entered into force in 2000.

Sweden

No provisions of genetic counselling in law at present. The Guidelines issued by the National Board of Health and Welfare (Socialstyrelsen) set broad requirements on genetic counselling in the context of all genetic testing (SoS-rapport 1999:12). The Convention on Human Rights and Biomedicine was signed in 1997.

Switzerland

Switzerland is evidently going to have very explicit provisions on genetic counselling in 2006. Swiss parliament approved the Federal Law on the Genetic Testing of Humans in October 2004 (Loi fédérale sur l'analyse génétique humaine (LAGH) FF 2004 5145), expected to become in force in 2006. The Article 14 of the Law contains an explicit and specified provision of a non-directive genetic counselling, to be given by a qualified person, before and after a test performed for presymptomatic, prenatal or family planning situations. Furthermore, the law requires individual and familial approach, and attention shall be made to possible psychological and social repercussions. The law contains a specific list of different aspects that shall be informed to the patient(s) or his or her representative during the counselling. Moreover, a reflection period between counselling and testing shall be provided. Article 15 of the Law contains particular provision on counselling in prenatal genetic testing. For instance, a woman shall be expressly informed about her autonomy to make any decisions before and after the testing. The European Convention on Human Rights and Biomedicine has been signed in 1999, but ratification is in process.

United Kingdom

No provisions of genetic counselling in law at present, but with a reference to Section 13 (6) of the Human Fertilisation and Embryology Act (1990), the HFEA has issued guidance that require proper genetic counselling in the context of PGD. People seeking PGD are expected to have access to both clinical geneticists and genetic counsellors (HFEA PGD Guidance CH(03)04). The HFEA has a statutory duty under the HFE Act to produce a Code of Practice that gives guidance to fertility clinics about the proper conduct of HFEA-licensed activities. The 7th edition of the Code of Practice came into force on the 5th July 2007. UK has not signed the Convention on Human Rights and Biomedicine.