Genetic Diagnostics Act
| Basic data | |
|---|---|
| Title: | Human Genetic Studies Act |
| Short title: | Genetic Diagnostics Act |
| Abbreviation: | GenDG |
| Type: | Federal law |
| Scope: | Federal Republic of Germany |
| Issued on the basis of: | Art. 74 para. 1 no. 26 GG |
| Legal matter: | Administrative law , data protection law |
| References : | 2121-63 |
| Issued on: | July 31, 2009 ( BGBl. I p. 2529 , ber.p. 3672 ) |
| Entry into force on: | February 1, 2010 (Section 27 Paragraph 1) |
| Last change by: |
Art. 23 G of November 20, 2019 ( Federal Law Gazette I p. 1626, 1644 ) |
| Effective date of the last change: |
November 26, 2019 (Art. 155 G of November 20, 2019) |
| GESTA : | B030 |
| Please note the note on the applicable legal version. | |
The Genetic Diagnostics Act defines the requirements for genetic examinations in humans and for the genetic analyzes carried out as part of these examinations as well as the use of genetic samples and data in Germany. The law regulates the performance of genetic tests for medical purposes, to clarify parentage, as well as in the insurance sector and in working life . It only applies to examinations of living people and of embryos and fetuses during pregnancy . It came into force on February 1, 2010.
Content
The law consists of 8 sections:
- "General Regulations", which contain definitions and requirements for quality assurance;
- Regulations for "genetic examinations for medical purposes", in which the essential specifications for all genetic analyzes are also made for the other areas of application;
- Regulations for "genetic examinations to clarify parentage";
- Regulations for "Genetic Tests in the Insurance Sector";
- Regulations for "Genetic Examinations in Working Life";
- Requirements for the "generally recognized state of the art of science and technology", in which the establishment of the genetic diagnosis commission (GEKO) at the Robert Koch Institute is described;
- Specifications on "penalty and fine regulations";
- "Final provisions" with specifications for the entry into force of the individual parts of the law.
A prerequisite for any genetic examination is a prior genetic consultation , which is carried out in the case of a diagnostic genetic examination by doctors and, in the case of a predictive genetic examination, by doctors specializing in human genetics or by doctors who are particularly qualified for these examinations in their field must be done. The same requirements also apply to the performance of diagnostic or predictive genetic examinations.
The basic principle of informational self-determination applies in order to prevent dangers and genetic discrimination, but to preserve the chances of using genetic analyzes . This results in both the right to know one's own findings and the right not to know the findings. The legally effective consent of the data subject is required for the investigation. This consent can be revoked at any time for the future, i. This means that a revocation is no longer possible if the results of the investigation are already available and have been communicated. The law also regulates how to proceed with persons unable to give their consent.
Genetic examinations to clarify the parentage are only permitted if the persons from whom a genetic sample is to be examined have consented to the examination; in the case of underage children, these are the persons with custody. If consent is not given, it can be replaced by the family court according to §1598a BGB. The identity of the persons from whom the genetic samples were taken must be documented by the responsible person (doctor or qualified expert). Prenatal genetic examinations to determine parentage are only permitted if, according to medical knowledge, the pregnant woman is the victim of child sexual abuse , sexual assault, sexual coercion or rape and there are urgent reasons to believe that the pregnancy is based on the fact. Genetic tests to clarify the parentage may only be carried out by laboratories that are accredited according to the DIN standard ISO / IEC 17025 .
Violations of the law are prosecuted and punished as administrative offenses or criminal offenses.
history
The study commission “Law and Ethics of Modern Medicine” of the German Bundestag carried out preliminary work in the area of genetic tests in the 14th legislative period and made recommendations in its final report.
The parliamentary group of CDU / CSU in the 14th German Bundestag demanded in their application of July 3, 2001 the submission of a government draft for a genetic testing law. This motion did not find a majority.
The CDU / CSU parliamentary group also called for this in the 15th German Bundestag with regard to a genetic diagnostics law in its application of March 11, 2003. In the 15th legislative period, a draft law was prepared and discussed within the framework of a working group of the red-green government coalition. The internal coalition working group met from October 2004 and broke off its work in May 2005 because of the early elections.
In the 16th legislative period, the Bundestag faction of Bündnis 90 / Die Grünen presented a draft for a gene diagnostics law based on the red-green preparatory work from the 15th legislative period.
Since April 16, 2008, the Federal Government has had a key issues paper for a Genetic Diagnostics Act, which should be passed in the 16th legislative period of the German Bundestag. On June 30, 2008, a first draft was presented to the public by the lead Federal Ministry of Health .
On August 29, 2008, the federal government introduced the government draft for a genetic diagnostics law to the Federal Council. Since then, this draft has been in parliamentary discussion. On January 21, 2009, a public hearing took place before the Committee on Health of the German Bundestag. The German Bundestag passed the law on April 24, 2009.
Federal states
Since the area of application of the Genetic Diagnostics Act as a result of the federalism reform in working life only applies to federal civil servants, the Free and Hanseatic City of Hamburg was the first federal state to make section 10 (3) of the Hamburg Civil Service Act (HmbBG) applicable to its state civil servants and trainee lawyers. The regulation came into effect at the same time as the federal regulation came into force on February 1, 2010.
Other states
In Switzerland there is the “Federal Act on Genetic Examinations in Humans (GUMG)” and the “Ordinance on Genetic Examinations in Humans (GUMV)”. The GUMG stipulates, among other things, prohibitions on the use of genetic data in the field of work, insurance and liability.
In Austria there is a Genetic Engineering Act which also includes genetic analyzes and gene therapy in humans and, in particular, Section 67 bans the collection and use of data from genetic analyzes for certain purposes: “Employers and insurers including their agents and employees are prohibited To collect, request, accept or otherwise exploit the results of genetic analyzes from their employees, jobseekers, policyholders or insurance advertisers. This prohibition also includes the request for the delivery and acceptance of body substance for genetic analysis purposes. ”The law was promulgated as Article I“ Federal law, with working with genetically modified organisms, releasing and placing genetically modified organisms on the market and using them Gene analysis and gene therapy in humans are regulated (Genetic Engineering Act - GTG) and the Product Liability Act is changed ”.
Criticism from the insurance industry
Above all, the General Association of the German Insurance Industry turned against regulations for the insurance sector in the German Genetic Diagnostics Act . He considered the existing declaration of self-commitment to be sufficient. Moreover, not using the results of genetic tests would in any case lead to information asymmetry with the risk of anti- selection (also known as adverse selection ).
On the basis of the Genetic Diagnostics Act, when an insurance contract is concluded, neither a genetic test nor information about tests that have already been carried out may be requested. However, in order to avoid misuse, the results of genetic tests that have already been carried out must be presented if an insurance policy with a very high insured sum is to be taken out ( Section 18 GenDG).
Worker protection
In labor law, genetic tests are generally prohibited at the request of the employer. For occupational health and safety, genetic examinations as part of preventive medical examinations should only be permitted under strict conditions.
Genetic Diagnostics Commission Cost Ordinance
On June 26, 2010, the cost ordinance for the statements of the genetic diagnosis commission according to the genetic diagnosis law (Gendiagnostik-Kommission -kostenverordnung) came into force ( Federal Law Gazette I p. 810 ). The ordinance, which consists of three paragraphs, stipulates that the Robert Koch Institute can charge fees between 100 and 2000 euros for comments.
literature
- Angie Genenger: The new genetic diagnostics law. In: Neue Juristische Wochenschrift 3/2010, pp. 113–117.
- Burkard Lensing: Genetic diagnostics in the insurance industry. In: Consumer and Law 11/2009, pp. 411–418.
- Gunnar Duttge, Wolfgang Engel, Barbara Zoll (eds.): The genetic diagnosis law in the field of tension between human genetics and law (= Göttingen writings on medical law; Volume 11), Göttingen: Göttinger Universitätsverlag 2011, ISBN 978-3-86395-025-5 , online (PDF, 1.04 MB) .
- Bernd-Rüdiger Kern, GenDG. Commentary , Beck, Munich 2012, ISBN 978-3-406-63277-8 .
Web links
- Text of the Genetic Diagnostics Act
- Homepage of the Gendiagnostik-Kommission (GEKO) at the Robert Koch Institute with information and guidelines on the law
- Opinions on the draft of the Genetic Diagnostics Act
swell
- ^ The Gendiagnostik -ommission (GEKO) . Retrieved July 18, 2019.
- ↑ https://www.gesetze-im-internet.de/bgb/__1598a.html
- ↑ BT-Drs. 14/9020 Download (PDF; 1.8 MB)
- ↑ BT-Drs. 14/6640 Download (PDF; 55 kB)
- ↑ BT-Drs. 15/543 Download (PDF; 187 kB)
- ↑ BT-Drs. 16/3233 Download (PDF; 788 kB)
- ↑ Bill for a Genetic Diagnostics Act and key points
- ↑ BR-Drs. 633/08 Download (PDF; 264 kB)
- ^ Committee on Health ( Memento of the original dated February 8, 2009 in the Internet Archive ) Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice.
- ↑ FAZ: Genetic Diagnostics Act passed
- ↑ Bundestag passes Genetic Diagnostics Act. (No longer available online.) German Bundestag, May 4, 2009, archived from the original on April 29, 2009 ; accessed on May 12, 2009 : “Alliance 90 / The Greens voted against the new set of rules. With the changes to the law passed on Friday, April 24, 2009, genetic examinations and the handling of their results are regulated for the first time. The law, which was passed with votes of the coalition against the votes of Bündnis 90 / Die Grünen and with abstention from FDP and Die Linke, is intended to strengthen the right to informational self-determination in genetic diagnostics tests and protect against misuse of the results. On the other hand, the parliament rejected a bill by Bündnis 90 / Die Grünen, which, among other things, called for a general ban on discrimination and the establishment of the “right not to know”. ” Info: The archive link was automatically inserted and not yet checked. Please check the original and archive link according to the instructions and then remove this notice.
- ↑ GAL closes a loophole in the Gendiagnostikgesetz ( Memento of the original dated November 16, 2009 in the Internet Archive ) Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice.
- ↑ GUMG Download (PDF; 509 kB)
- ↑ GUMV Download (PDF; 128 kB)
- ↑ GTG download
- ↑ Statement on the public hearing Download ( page no longer available , search in web archives ) Info: The link was automatically marked as defective. Please check the link according to the instructions and then remove this notice.
