New regulations for genetic testing in the medical field
Health / Life Sciences
An overview of the most important new provisions for genetic testing in the medical field according to HGTA and HGTO.
How can genetic testing within and outside the medical field be differentiated?
Genetic tests providing information about current or future health impairments or concerning other medically relevant characteristics fall into the medical field. This includes, for example, tests for chromosomal disorders such as trisomy 21 or hereditary diseases such as cystic fibrosis.
On the other hand, genetic tests, the results of which do not provide any information on diseases, disease risks or other medically relevant characteristics, are classified as non-medical.
In order to distinguish between genetic tests within and outside the medical field, it is first necessary to determine the nature of the medical property to be examined. The question is therefore whether the property to be examined provides information about current or future possible health impairments or other medically relevant properties of the person concerned. In this case, it is a genetic test in the medical field. The purpose of the examination is also relevant. If the test is carried out for medical reasons or based on a medical indication, it is also a genetic test in the medical field.
Who is allowed to order genetic tests in the medical field?
The following individuals are allowed to order genetic tests in the medical field based on the revision of the HGTA (Art. 5 - 8 HGTO):
Physicians who are authorised to practise their profession on their own professional responsibility in the field of human medicine;
Dentists who are authorised to practise their profession on their own professional responsibility in the field of dentistry;
Pharmacists who are authorised to practise their profession on their own professional responsibility in the field of pharmacy; and
Chiropractors who are authorised to practise their profession on their own professional responsibility in the field of chiropractic.
What are the new requirements for laboratories?
As before, laboratories that carry out genetic tests in the medical field require a licence from the Federal Office of Public Health (FOPH). In addition, cytogenetic or molecular genetic tests in the medical field now also require accreditation in accordance with the Accreditation and Designation Ordinance (Art. 9 HGTO). Accreditation is issued by the Swiss Accreditation Service (SAS).
Furthermore, laboratories must now have a data security concept in place so that the extended protection of genetic data can be warranted (Art. 24 and 54 HGTO).
How should samples from genetic tests be handled?
When processing genetic data, their protection must always be ensured. This applies in particular to the unauthorised or unintentional disclosure, modification, deletion, destruction, creation of copies or loss of genetic data. Data protection must be guaranteed by means of appropriate technical and organisational measures (Art. 3 HGTO).
When may the sex of the unborn child be disclosed?
As before, prenatal examinations may be carried out, provided that only properties of the embryo or foetus that affect health are examined. With the revision, however, it is now explicitly prohibited to inform the expectant parents of the sex of the unborn child before the 12th week of pregnancy. Clarification of the sex of the unborn child is only permissible prior to this time if it is essential for the diagnosis of a disease (Art. 17 para. 2 HGTA).
What is excess information and how should it be handled?
The comprehensively revised HGTA now regulates the handling of so-called excess information. Excess information is information that is not required for the purpose of the examination (Art. 3 lit. n HGTA). Since state-of-the-art technologies are used in genetic examinations, it is possible that more and more additional information about the genetic material of the person being examined is collected.
The physician must inform the person concerned of the possibility that excess information may arise. However, the individual concerned decides for themselves which information is to be disclosed to them (Art. 27 para. 1 HGTA). If the genetic test is ordered by a non-medical specialist (e.g. pharmacist), the person concerned must not be informed of any surplus information.
Can genetic tests in the medical field also be carried out abroad?
In principle, it is possible to carry out a sample abroad. Particularly in the case of rare diseases, the analysis of a sample abroad at a specialised laboratory is an option. However, if a genetic test is to be carried out at a laboratory abroad, certain requirements must be met, in particular pursuant to data protection. In particular, the person concerned must have provided written consent (cf. Art. 29 HGTA).
Is it permissible to publicly advertise examinations in the medical field?
Advertising for genetic testing in the medical field to the public is prohibited.
Are there criminal sanctions for breaches of these regulations?
The HGTA provides for custodial sentences not exceeding three years or monetary penalties for offences and fines for violations (Art. 56 and 57 HGTA).