Table 2.
Regulations (legally binding rules enacted by a national government authority) addressing genetic counselling in EU Member States.
| Defined in National Regulation? |
||||
|---|---|---|---|---|
| Country | National Regulation | Who can provide genetic counselling | What must be discussed during genetic counselling | When must genetic counselling be provided |
| Austria | Quality Standard for Genetic Counselling and Diagnostics (2015) | Yes | Yes | Yes |
| Belgium | Royal Decree establishing the standards to be met by centres for human genetics (1987) | – | Yes | – |
| Ministerial Decree amending the Ministerial Decree of 23 of May 2017 establishing special criteria for recognition of physician specialists, internship masters and internship services in clinical genetics (2018) | Yes | Yes | – | |
| Bulgaria | Medical Standards for Medical Genetics (2010) | Yes | Yes | Yes |
| Croatia | – | – | – | – |
| Cyprus | – | – | – | – |
| Czech Republic | – | – | – | – |
| Denmark | – | – | – | – |
| Estonia | – | – | – | – |
| Finland | – | – | – | – |
| France | Order of 27 May 2013 defining the rules of good practice applicable to the examination of a person’s genetic characteristics for medical purposes | Yes | Yes | Yes |
| Decree no. 2022-1488 of November 29, 2022 on the conditions for prescribing certain medical biology examinations and communicating their results by genetic counsellors | Yes | – | – | |
| Germany | – | – | – | – |
| Greece | – | – | – | – |
| Hungary | Directive of the Ministry of Human Resources on genetic counselling, ID: 002092 (2020) | Yes | Yes | Yes |
| Ireland | – | – | – | – |
| Italy | Guidelines for Medical Genetics (2004) | Yes | Yes | Yes |
| General Authorisation No. 8/2014 for the Processing of Genetic Data (updated 2016) | Yesa | Yes | Yes | |
| Latvia | Regulation No. 555, Adopted 28 August 2018—Procedures for the Organization of and Payment for Health Care Service under Medical Treatment Law (1997) | – | – | Yes |
| Lithuania | Order of the Ministry of Health V-745 (2012) | Yes | – | – |
| Order of the Ministry of Health V-1458 (2014) | Yes | – | Yes | |
| Luxembourg | – | – | – | – |
| Malta | – | – | – | – |
| Netherlands | Planning Decision on Clinical Genetic Research and Genetic Counselling (1998) | Yes | – | – |
| Poland | Order of the Minister of Health of 21st July 2022 amending the Regulation on guaranteed benefits in the field of ambulatory care for families with high risk of hereditary cancer | Yes | Yes | Yes |
| Portugal | Order of the Ministry of Health #5411/97 | Yes | – | – |
| Romania | Establishment of the Medical Genetics Network (2014) | Yes | – | – |
| Order no. 774 of September 18, 2023 | – | – | – | |
| Appendices no. 1 and 2 to Government Decision no. 521/2023 for approval of the service packages and the framework contract that regulates the conditions for the provision of medical assistance, medicines and medical devices, within the social health insurance system | Yes | Yes | – | |
| Slovakia | The Concept of Healthcare in the Field of Medical Genetics (2014) | Yes | Yes | Yes |
| Slovenia | Clinical pathway and scope of work of a genetic consultant in the process of treating a patient in the Oncology Genetic Counselling and Testing Clinicb | Yes | Yes | Yes |
| Spain | – | – | – | – |
| Sweden | – | – | – | – |
See Supplementary table S3 for further details regarding specific sections of national regulations judged to address ‘who’, ‘what’ and ‘when’ considerations.
a
Specifies that genetic counselling must be provided by ‘genetic consultants’ but does not specify the training or specialization needed to qualify for this distinction.
b
Legally binding clinical pathway issued by the Oncology Institute Ljubjana, a non-government source, but included in this table for reference due to its legal weight.