Reproductive Medicine Ordinance (RMO) (RMO)
English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.
Section 1 Subject Matter
Art. 1
A licence as specified in Article 8 paragraph 1 of the Act is required by any person who, as holder of a cantonal professional practising licence, independently or as a team leader: a. uses assisted reproductive techniques; b. receives reproductive cells, impregnated ova or embryos in vitro for preservation or arranges the supply of donated sperm cells without personally using assisted reproductive techniques.
Art. 1 — Amended by No I of the O of 21 June 2017, in force since 1 Sept. 2017 (AS 2017 3651).
Section 2 Licence Requirements
Art. 2 Evidence of qualifications for the use of assisted reproductive techniques
Any person who uses assisted reproductive techniques requires: a. a Swiss obstetrics and gynaecology specialist title or a corresponding recognised foreign specialist title; b. the qualifications to use the techniques according to the state of the art; and c. the cantonal licence to practise as an independent professional. 1bis It may be assumed that a person has the qualifications specified in paragraph 1 letter b if he or she meets the requirements of Annex 3. 1ter The Federal Department of Home Affairs may amend Annex 3 if amendments to the professional requirements for the use of assisted reproductive techniques so require. 2 Any person who limits the activity to insemination with sperm cells from a third party requires: the Swiss obstetrics and gynaecology specialist title or an equivalent recognised foreign specialist title; and the cantonal licence to practise as an independent professional.
Art. 2 — Amended by No I of the O of 21 June 2017, in force since 1 Sept. 2017 (AS 2017 3651). Para. u1 let. c — Amended by Annex 6 No II 2 of the O of 23 Sept. 2022 on Human Genetic Testing, in force since 1 Dec. 2022 (AS 2022 585). Para. 1bis — Inserted by Annex 6 No II 2 of the O of 23 Sept. 2022 on Human Genetic Testing, in force since 1 Dec. 2022 (AS 2022 585). Para. 1ter — Inserted by Annex 6 No II 2 of the O of 23 Sept. 2022 on Human Genetic Testing, in force since 1 Dec. 2022 (AS 2022 58
Art. 3 Evidence of qualifications to preserve and supply reproductive material
Any person who receives reproductive cells, impregnated ova or embryos in vitro for preservation or arranges the supply of donated sperm cells without personally using assisted reproductive techniques requires: a Swiss or a recognised foreign medical specialist title; and the cantonal licence to practise as an independent professional.
Art. 3 — Amended by No I of the O of 21 June 2017, in force since 1 Sept. 2017 (AS 2017 3651).
Art. 4 Reproductive medicine laboratory
1 Any person who uses reproductive techniques requires a reproductive medicine laboratory that meets the following requirements: a. It is managed by a person who: 1. has completed a university course of studies in accordance with the Medical Professions Act of 23 June 2006 or a masters in the field of biology or chemistry from a tier-one university accredited under the Higher Education Act of 30 September 2011 or a state-recognised or accredited foreign tier-one university; 2. has received postgraduate training that the supervisory authority regards as suitable; and 3. is familiar with the current state of the art as a result of receiving suitable continuing professional training. b. The staff have the required professional skills and qualifications. c. The laboratory operates a quality management system that is commensurate with the procedures offered and which is based on the standards specified in Annex 2. 2 The Federal Department of Home Affairs may update Annex 2 in line with inte
Art. 4 — Amended by No I of the O of 21 June 2017, in force since 1 Sept. 2017 (AS 2017 3651). Para. 1 let. a let. 1 — SR 811.11 Para. 1 let. a let. 1 — SR 414.20
Art. 5 Use of donated sperm cells
1 Any person wishing to use assisted reproductive techniques using donated sperm cells must indicate in the application: a. how donors are to be recruited and informed about the legal situation (Art. 18 para. 2 of the Act); b. how health risks for the recipient are to be avoided. 2 Any person wishing to supply donated sperm cells must indicate: a. what charge will be made to defray expenses; b. how it will be ensured that data is duly recorded in accordance with Article 24 of the Act and Article 17 of this Ordinance. 3 Any changes are to be notified to the supervisory authority.
Art. 6 Counselling and care
1 Together with the application for a licence to use assisted reproductive techniques, plans must submitted for the provision of social psychological counselling and support, as specified in Article 9 paragraph 2 letter c of the Act. 2 Where it is planned to use reproductive techniques with an analysis of the genetic material of reproductive cells or embryos in vitro or with the selection of donor sperm cells to prevent the transmission of a serious illness, a proposal with regard to genetic counselling in accordance with Article 6a of the Act must be submitted.
Art. 6 — Amended by No I of the O of 21 June 2017, in force since 1 Sept. 2017 (AS 2017 3651).
Art. 7 Information on scientific staff
1 The personal data and training certificates of scientific staff must be enclosed with the application for a licence. 2 Any changes are to be notified. The supervisory authority may provide for exceptions in the licence.
Section 3 Licensing and Supervision
Art. 8 Responsibility
1 The body responsible for licensing and supervision shall be the department responsible for healthcare in the canton where the activity specified in Article 8 paragraph 1 of the Act is carried out. 2 The cantons may designate another authority which has the necessary expertise.
Art. 9 Licensing
1 The licence to use assisted reproductive techniques may be restricted to certain techniques. 2 The licence may be granted for a limited term and subject to conditions. 3 ...
Para. 3 — Repealed by No I of the O of 21 June 2017, with effect from 1 Sept. 2017 (AS 2017 3651).
Art. 10 Supervision
1 Within a year of granting a licence, the supervisory authority shall arrange for an inspection to be carried out by an expert. Thereafter, an inspection shall be carried out as often as necessary, but at least once every three years. 2 The supervisory authority may consult an independent expert. 3 Persons charged with carrying out an inspection shall be granted access at all times to the premises and facilities used to perform the activities concerned. 3 If the laboratory is accredited under the Accreditation and Designation Ordinance of 17 June 1996, the supervisory authority may dispense with all or part of the review of the quality management system. 4 The Swiss Accreditation Service shall notify the supervisory authority within an appropriate period of accreditations that have been granted or renewed as well as of any that have been suspended or revoked.
Art. 10 — Amended by No I of the O of 21 June 2017, in force since 1 Sept. 2017 (AS 2017 3651). Para. 3 — SR 946.512
Art. 11 and 12
Repealed by No I of the O of 21 June 2017, with effect from 1 Sept. 2017 (AS 2017 3651).
Art. 13 Expiry
The licence shall expire when the licensed activities are discontinued. Discontinuation of activities is to be notified to the supervisory authority.
Art. 14 Reporting
1 Licence holders must submit an annual report on their activities, as specified in Article 11 of the Act, to the supervisory authority by no later than 1 May of the following year. 2 The supervisory authority shall transmit the anonymised data to the Federal Statistical Office by no later than 1 July of the year in question for evaluation and publication. The data must not include any indication of the centres of reproductive medicine. 3 The Federal Statistical Office shall provide the supervisory authorities with a form for standardised data collection. This may also be used for the annual report on activities referred to in paragraph 1.
Art. 14a Evaluation
The supervisory authority shall on request send the Federal Office of Public Health the data required for the evaluation in accordance with Article 14a paragraph 2 letter c of the Act together with the contact details for licence holders in accordance with Article 8 paragraph 1 of the Act.
Art. 14a — Inserted by No I of the O of 21 June 2017, in force since 1 Sept. 2017 (AS 2017 3651).