Table 1.
Definitions of genetic testing and their documents
| European Union (EU27) Institutions and Council of Europe (CoE) | ||
| EC | Opinion of the Group of Advisers on the Ethical Implications of Biotechnology to the European Commission | ✓ |
| EC | Opinion on the Ethical Aspects of Genetic Testing in the Workplace (Opinion No. 18) | ✓ |
| CoE | Recommendation No. R (92) 3 on Genetic Testing and Screening for Health Care Purposes (Feb. 10, 1992) | ✓ |
| CoE | Convention for the Protection of Human Rights and Dignity of the Human Being (Oviedo, 1997) | ✓ |
| CoE | Additional Protocol to the Convention on Human Rights and Biomedicine Concerning Genetic Testing for Health Purposes (CETS No. 203) | ✓ |
| European Union (EU27) Member States | ||
| Austria | Austrian Gene Technology Act | ✓ |
| Austria | Book of Gene Technology | ○ |
| Belgium | Genetics and Insurance | ○ |
| Belgium | Royal Decree | ✓ |
| Belgium | Act on Medically Assisted Procreation and the Disposition of Supernumerary Embryos and Gametes, of 6 July 2007 | ○ |
| Bulgaria | Bulgarian Health Act | ✓ |
| Cyprus | The Safeguarding and Protection of Patients’ Rights Law, 2004 | ✓ |
| Czech Republic | – | ■ |
| Denmark | Health Act No. 546, of 24 June 2005 | ✓ |
| Denmark | Law on Artificial Fertilization in Connection with Medical Treatment, Diagnosis, and Research (Research on Embryonic Stem Cells) | ✓ |
| Denmark | Act on the Use of Health Data…on the Labour Market | ✓ |
| Estonia | Human Genes Research Act | ✓ |
| Finland | Act on the Protection of Privacy in Working Life | ✓ |
| France | Penal Code | ✓ |
| France | Decree No. 2008-321, of 4 April 2008, on the Examination of the of Genetic Characteristics of a Person and the Identification of that Person by Genetic Fingerprints for Medical Purposes | ○ |
| France | Criminal Procedure | ✓ |
| Germany | Predictive Health Information in the Conclusion of Insurance Contracts | ✓ |
| Germany | Law and Ethics in Modern Medicine | ✓ |
| Germany | Genetic Diagnosis Before and During Pregnancy | ✓ |
| Germany | Genetic Diagnosis Act—GenDG | ✓ |
| Greece | Code of Medical Ethics | ○ |
| Greece | Opinion on Prenatal and Pre-Implantation Diagnosis | ✓ |
| Greece | Recommendation on the Collection and Use of Genetic Data | ✓ |
| Hungary | Health Care Act | ✓ |
| Hungary | Proposal to the Government on the Draft Bill on the Protection of Human Genetic Data and the Rules for Genetic Tests and Research | ✓ |
| Ireland | A Guide to Ethical Conduct and Behaviour (6th edition) | ✓ |
| Ireland | Disability Act 2005 | ✓ |
| Italy | Bioethical Guidelines For Genetic Testing | ✓ |
| Latvia | Human Genome Research Law | ✓ |
| Lithuania | – | ■ |
| Luxemburg | – | ■ |
| Malta | – | ■ |
| Poland | – | ■ |
| Portugal | Personal Genetic Information and Health Information (Law 12/2005, of 26 January) | ✓ |
| Romania | – | ■ |
| Slovakia | ACT on the Application of Deoxyribonucleic Acid for the Identification of Persons | ✓ |
| Slovenia | – | ■ |
| Spain | Law on Biomedical Research | ○ |
| Sweden | Act on Genetic Integrity | ✓ |
| Sweden | Ordinance No. 358, of 18 May 2006, on Genetic Integrity | ○ |
| Sweden | Biobanks in Medical Care Act | ✓ |
| The Netherlands | Policy Document: The Application of Genetics in the Health Care Sector | ✓ |
| UK | Human Tissue and Embryos Bill | ✓ |
| UK | Code of Practice and Guidance on Human Genetic Testing Services Supplied Direct to the Public | ✓ |
| UK | Discrimination Law Review. A Framework for Fairness: Proposals for a Single Equality Bill for Great Britain | ✓ |
| UK | Concordat and Moratorium on Genetics and Insurance | ✓ |
| UK | Draft Code of Practice: The use of Personal Data in Employer/Employee Relationships | ✓ |
| UK | Our Inheritance, Our Future: Realising the Potential of Genetics in the NHS | ✓ |
| UK | Code of Practice and Guidance with Respect to Genetic Paternity Testing Services | ✓ |
| UK | Laboratory Services for Genetics | ✓ |
| UK | ||
| (Northern Ireland) | The Human Organ Transplants (Establishment of Relationship) Regulations Statutory Rule, 1998 | ✓ |
| UK | Human Tissue Act, 2004 | ✓ |
| Other (Non-EU) European Countries | ||
| Albania | – | ■ |
| Belarus | - | ■ |
| Bosnia-Herzegovina | – | ■ |
| Croatia | – | ■ |
| Georgia | Law of Georgia, of 5 May 2000, on the Rights of Patients | ✓ |
| Iceland | Regulations on the Keeping and Utilisation of Biological Samples in Biobanks | ✓ |
| Lichtenstein | – | ■ |
| Macedonia | – | ■ |
| Moldova | – | ■ |
| Monaco | – | ■ |
| Norway | Act No. 100, of 5 December 2003, Relating to the Application of Biotechnology in Human Medicine… | ✓ |
| Norway | The Medical Use of Biotechnology | ✓ |
| Russia | – | ■ |
| Serbia | – | ■ |
| San Marino | – | ■ |
| Switzerland | Ordinance of 31 May 2000, on the Information System Based on DNA Profiles (Ordinance on DNA) | ✓ |
| Switzerland | Swiss Federal Law on Human Genetic Analysis, 2004 | ✓ |
| Turkey | – | ■ |
| Ukraine | – | ■ |
| Non-European Countries | ||
| Australia | Genetic Testing—Guidelines for Prioritising Genetic Tests | ✓ |
| Australia | Ethical Guidelines on the Use of Assisted Reproductive Technology in Clinical Practice and Research (as revised in 2007 to take into account the changes in legislation) | ✓ |
| Australia | Genetic Testing and Storage of Genetic Material/Information | ✓ |
| Australia | ALRC 96, Essentially Yours: The Protection of Human Genetic Information in Australia (this report reflects the law, as at 14 March 2003) | ✓ |
| Canada | Genetic Testing and Privacy | ✓ |
| Canada | CCMG Molecular Genetics Guidelines | ✓ |
| Japan | Guidelines For Genetic Testing | ✓ |
| Japan | Guidelines for Genetic Testing, Using DNA Analysis | ✓ |
| USA | Executive Order, To Prohibit Discrimination in Federal Employment Based on Genetic Information | ✓ |
| USA | Genetic Information Non-Discrimination Act of 2008 | ✓ |
| USA | Genomics and Personalized Medicine Act of 2007 (Introduced in Senate) | ✓ |
Definitions or relevant text describing “genetic testing” in these legal documents and its URLs are provided as Supplementary Material
(✓) definitions found and analysed, (○) no definitions included or no translation available, (■) no legal documents found