Federal Office of Public Health
Bern, 01.12.2022 – The offer of tests providing genetic information is constantly increasing. To prevent misuse and ensure personality protection, the revised version of the Federal Law on Human Genetic Analysis (LAGH) comes into force on December 1, 2022. It provides a new legal framework for virtually all genetic tests. A new website of the Federal Office of Public Health (OFSP) informs those interested.
The importance of genetic tests in the medical field is growing at the same time as the offer of tests carried out without a medical prescription (tests offered directly to consumers or DPT tests [direct to consumer]). Analyzes carried out for genealogical purposes and to find a suitable diet are particularly part of this. To take this development into account, the law has been completely revised.
Sensitive information
Not all relating to the same genetic characteristics, genetic tests do not benefit from a uniform legal framework. A test done to rule out an inherited disease is different from a test to examine taste perception. In other words, some information is more sensitive than others and therefore requires better protection once morest misuse. The more sensitive the information, the stricter the regulations applied. In addition, tests carried out on people incapable of discernment, such as young children, are subject to strict rules. The highest requirements apply to genetic analyzes in the medical field and used to establish DNA profiles.
Genetic tests in the medical field
Until now, medical genetic tests might only be ordered by doctors. In the future, some of them may also be prescribed by dentists, pharmacists and chiropractors in their respective fields of expertise, for example to identify drug intolerance. In addition, an accreditation requirement will now apply to genetic laboratories in the medical field.
Genetic testing outside the medical field
Outside the medical field, the law distinguishes two categories of tests. The first includes analyzes for which personality protection must be taken into account, such as tests related to lifestyle and concerning eating habits, sports skills, ethnic origin or other characteristics such as personality, intelligence or skills. In the future, these tests must be ordered by a health professional: doctor, pharmacist, druggist, dietitian, physiotherapist, psychologist, chiropractor or osteopath. The laboratories carrying out these analyzes must hold the corresponding authorisation.
The second category includes tests that do not provide any particularly sensitive information, such as genetic analysis of hair color or taste perception. These can be delivered directly to customers or ordered over the Internet.
No testing without consent
Certain essential rules apply to all genetic tests. The person concerned must consent to the test. Therefore, no analysis can be carried out on a third party without their knowledge. Only medically necessary tests may be carried out on persons incapable of discernment, such as young children.
Paternity tests
As hitherto, the establishment of DNA profiles aimed at determining descent or for identification purposes is subject to strict rules. Thus, the person undergoing the test must provide proof of their identity and consent. Similarly, laboratories must have the corresponding accreditation.
Prenatal diagnosis
The law also regulates prenatal diagnoses, i.e. all analyzes carried out on unborn children. It provides that before birth, only health-related tests are permitted. The sex of the child can be determined only if it is necessary for the diagnosis of a disease. Parents cannot be informed before the end of the 12th week of pregnancy.
Information for the population
A new FOPH website offers the population an overview of the different types of tests and informs them of the benefits and risks associated with them.
Address for sending questions
Federal Office of Public Health, Communication, +41 58 462 95 05, [email protected]
Auteur
Federal Office of Public Health
http://www.bag.admin.ch
