Guidelines

(1) An interdisciplinary, independent Genetic Diagnostics Commission is established at the Robert Koch Institute, composed of 13 experts from the fields of medicine and biology, two experts from the fields of ethics and law, and three representatives of the organisations at federal level responsible for representing the interests of patients, consumers, and the self-help of persons with disabilities. The members and alternate members of the Genetic Diagnostics Commission are appointed by the Federal Ministry of Health for a term of three years. The Commission adopts rules of procedure setting out further details of its procedure and the involvement of external experts; the rules of procedure require the consent of the Federal Ministry of Health. Representatives of the Federal Ministry of Health, and further representatives of federal and Land authorities, may take part in meetings in an advisory capacity.
(2) The Genetic Diagnostics Commission draws up guidelines, in relation to the generally recognised state of the art in science and technology, in particular for 1. the assessment of genetic characteristics as regards a) their significance for diseases or health disorders and the possibilities of avoiding, preventing or treating them, b) their significance for the effect of a medicinal product in treatment, c) the necessity of a genetic examination under section 14(1) number 1, to avoid, treat or prevent a genetically caused disease or health disorder, or under section 14(2) number 1, to clarify whether a particular genetically caused disease or health disorder may occur in a future descendant of the genetically related person, d) their significance under section 15(1) sentence 1 for an impairment of the health of the embryo or foetus during pregnancy or after birth, e) their significance for the conditions decisive under section 20(3) for issuing a statutory ordinance, 2. the requirements for qualification a) for genetic counselling under section 7(3), b) of medical and non-medical experts experienced in the field of parentage assessment under section 17(4), 3. the requirements for the content of the information and of genetic counselling, 4. the requirements for carrying out genetic analyses of genetic samples, in particular the suitability and reliability of the analysis methods, the reliability of the analysis results and the findings report, and the necessary quality-assurance measures, including the type, scope and frequency of external quality-assurance measures, 5. the requirements for carrying out the prenatal risk assessment and for the quality-assurance measures necessary in that respect, 6. the requirements for carrying out genetic screening examinations.
(3) The Robert Koch Institute publishes the guidelines of the Genetic Diagnostics Commission, as well as its opinions under section 16(2) on genetic screening examinations.
(4) The Genetic Diagnostics Commission assesses developments in genetic diagnostics in an activity report. The report must be prepared every three years, for the first time by the end of 2012, and published by the Robert Koch Institute.
(5) At the request of persons or institutions that carry out genetic examinations or analyses, the Genetic Diagnostics Commission may issue expert opinions on individual questions concerning the interpretation and application of its guidelines.