Prenatal and genetic tests are becoming increasingly popular, which brings with it an increased need to regulate the associated risks. One such risk area concerns the protection of the data of persons lacking capacity. The Human Genetic Testing Act (HGTA, SR 810.12), which came into force on 15 June 2018 and was revised on 1 December 2022, regulates how genetic data collected in the course of tests on unborn persons or persons lacking capacity should be handled. This article discusses how genetic tests can be carried out correctly in compliance with the data protection provisions of the GUMG and, where applicable, the DSG and the cantonal data protection provisions.
1. Scope of application of the Act on Human Genetic Testing
The scope of the Human Genetic Testing Act (HGTA, SR 810.12) extends to all genetic and prenatal testing in humans. According to Art. 1 HGTA, the law serves to protect human dignity and personal rights. It is also intended to ensure the quality of the tests carried out and to prevent the misuse of genetic data when carrying out tests and handling this data.
2. General principles
The GUMG contains three general principles:
- Firstly, genetic and prenatal tests may only be carried out with the prior consent of the person concerned in accordance with Art. 5 HGTA and after sufficient information has been provided. According to the principles of the Federal Act on Data Protection (FADP, SR 235.1), this consent can be withdrawn at any time.
- Secondly, Art. 6 GUMG grants every data subject the right not to know, which allows them to refuse the disclosure of their genetic data. The results of the test are subject to medical confidentiality and may only be disclosed to the person concerned and not to third parties.
- Finally, the protection of genetic data in accordance with Art. 7 HGTA is also ensured by medical confidentiality. In order to protect genetic data, the right to self-determination must be respected and the tests may only be carried out by doctors who are authorised to practise their profession independently.
3. Data protection for genetic tests
The GUMG demands higher requirements for consent and the storage of data, thereby strengthening data protection and the right to self-determination of the person concerned. The general provisions of the FADP are concretised in the GUMG, whereby the special statutory data protection provisions of the GUMG take precedence over those of the FADP.
4. Informational self-determination
The protection of informational self-determination is part of the constitutional protection of personality rights (Art. 13 FC), in particular the protection of privacy and the guarantee of private life.
The special feature of this guarantee is that its protection is linked to the attribution of information to a person, irrespective of whether the content of the information is of a private nature. It is based on the idea that the individual has control over the information concerning them.
The right to informational self-determination ensures that every person is fundamentally entitled to decide for themselves to whom and when they disclose personal circumstances and to what extent this information is processed. By enshrining the right to informational self-determination in the constitution and concretising it in the data protection laws of the Confederation and the cantons, the growing risk potential of modern information technologies is taken into account.
5. Dealing with surplus information
The revised GUMG contains explicit regulations on surplus information. According to Art. 3 lit. n HGTA, surplus information refers to the results of genetic tests that are not required for the actual purpose of the test. Excess information must be avoided as far as possible in accordance with the principle of proportionality. The test method that generates no or less excess information must be selected. In many cases, it is not possible to completely prevent the generation of this non-targeted information. It is therefore important to point out the possibility of excess information being generated during the clarification process.
The right to informational self-determination can be used to determine the entitlement to data created from this as well as surplus information. According to the right to informational self-determination, a person who is capable of judgement has the right to know all data of the examination as well as excess information, as far as examinations in the medical field are concerned.
6. Persons incapable of judgement
In the case of examinations of persons lacking capacity, in particular prenatal examinations in accordance with Art. 17 HGTA, special requirements apply to the communication to the person authorised to represent them. In these cases, the information may only be disclosed if it is necessary to protect the health of the person capable of judgement (e.g. the mothers) or if it concerns information about a serious hereditary disease in the family. Otherwise, the genetic data may not be disclosed to persons authorised to represent the child – in particular not to holders of parental custody.
The genetic data and samples may only be stored for their protection under certain conditions and only for as long as is necessary to carry out the examination or to maintain patient files. The samples and genetic data may only be used for any other purpose with the express and informed consent of the person concerned.
In this case, consequences under criminal law within the meaning of Art. 56 and 57 HGTA are also conceivable.
7. Critical appraisal
If the holders of parental custody want to take precautions for their child, e.g. because they are convinced that they can store data more securely than a doctor or hospital, they are not allowed to do so. In our opinion, this seems objectionable and should be reconsidered.