type: legislation

jurisdiction: Switzerland

text: 810.11 English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.Federal Acton Medically Assisted Reproduction(Reproductive Medicine Act, RMA)of 18 December 1998 (Status as of 1 September 2017)The Federal Assembly of the Swiss Confederation,on the basis of Articles 119 paragraph 2 and 122 paragraph 1 of the Federal Constitution1,2and having considered the Dispatch of the Federal Council dated 26 June 19963,decrees:1 SR 1012 Amended by No I of the FA of 12 Dec. 2014, in force since 1 Sept. 2017 (AS 2017 3641; BBl 2013 5823).3 BBl 1996 III 205Chapter 1 General Provisions  Art. 1 Subject and purpose  1 This Act specifies the conditions under which the techniques of medically assisted reproduction may be used in humans.2 It protects human dignity, personality and the family and prohibits misuses of biotechnology and gene technology.3 It provides for the establishment of a national ethics commission.Art. 2 Definitions  In this Act:a.techniques of medically assisted reproduction (assisted reproductive techniques) means methods of establishing a pregnancy without sexual intercourse – in particular, insemination, in vitro fertilisation with embryo transfer and gamete transfer;b.insemination means the introduction, by means of instruments, of sperm cells into the female reproductive organs;c.in vitro fertilisation means the bringing together of an ovum and sperm cells outside the woman’s body;d.gamete transfer means the introduction, by means of instruments, of sperm cells and ova into the uterus or a Fallopian tube;e.reproductive cells (gametes) means sperm cells and ova;f.germline cells means reproductive cells (including their precursor cells), impregnated ova and embryonic cells whose genetic material can be passed on to offspring;g.impregnation means causing a sperm cell to penetrate into the cytoplasm of an ovum, in particular by insemination, gamete transfer or in vitro fertilisation;h.impregnated ovum means the fertilised ovum before pronuclear fusion;i.embryo means the developing offspring from the time of pronuclear fusion until the end of organogenesis;j.foetus means the developing offspring from the end of organogenesis until birth;k.surrogate mother means a woman who is prepared to become pregnant by means of an assisted reproductive technique, to carry the foetus to term and to surrender the child permanently to third parties after delivery;l.cloning means the artificial production of genetically identical organisms;m.chimera formation means the fusion of totipotent cells from two or more genetically different embryos. Embryonic cells are totipotent if they are capable of developing into any type of specialised cell;n.hybrid formation means causing a non-human sperm cell to penetrate into a human ovum, or a human sperm cell into a non-human ovum.Chapter 2 Techniques of Medically Assisted Reproduction  Section 1 Principles  Art. 3 Well-being of the child  1 Assisted reproductive techniques may be used only if the well-being of the child is ensured.2 They may only be used in couples:a.where a basis for a parent-child relationship exists in accordance with Articles 252–263 of the Swiss Civil Code4 (CC) andb.5who, on the basis of their age and personal circumstances, are likely to be able to care for and bring up the child until it reaches the age of majority.3 Only married couples may use donated sperm cells.4 Reproductive cells or impregnated ova may not be used after the death of the person from whom they were obtained. The foregoing does not apply to sperm cells from sperm donors.65 Impregnated ova and embryos in vitro may no longer be used following the death of any one oft he couple concerned.74 SR 2105 Amended by Annex No 20 of the FA of 19 Dec. 2008 (Adult Protection, Law of Persons and Law of Children), in force since 1 Jan. 2013 (AS 2011 725; BBl 2006 7001).6 Amended by No I of the FA of 12 Dec. 2014, in force since 1 Sept. 2017 (AS 2017 3641; BBl 2013 5823).7 Inserted by No I of the FA of 12 Dec. 2014, in force since 1 Sept. 2017 (AS 2017 3641; BBl 2013 5823).Art. 4 Prohibited practices  Ovum and embryo donation and surrogate motherhood are prohibited.Art. 58 Authorisation requirements for reproductive techniques  Assisted reproductive techniques may be used only if:a.the aim is to enable a couple to overcome infertility and other treatment methods have failed or offer no prospect of success; orb.there is no other way of avoiding the risk of transmitting a serious disease to the offspring.8 Amended by No I of the FA of 12 Dec. 2014, in force since 1 Sept. 2017 (AS 2017 3641; BBl 2013 5823).Art. 5a9 Analysis of the genetic material of reproductive cells and embryos in vitro and their selection  1 The analysis of the genetic material of reproductive cells and their selection to influence the sex or other characteristics of the child are only permitted in order to identify chromosomal properties that may inhibit the development capacity of the embryo to be created, or if there is no other way of avoiding the risk of transmitting a predisposition for a serious disease. Article 22 paragraph 4 is reserved.2 The analysis of the genetic material of embryos in vitro and their selection according to sex or according to other characteristics are only permitted if:a.there is no other way of avoiding the risk of an embryo with a hereditary predisposition for a serious disease from implanting in the uterus;b.it is probable that the serious disease will occur before the age of 50;c.no effective or expedient therapy is available for combating the serious disease; andd.the couple have informed the physician in writing that they are not prepared to accept the risk in terms of letter a.3 They are also permitted in order to identify chromosomal properties that may inhibit the development capacity of the embryo.9 Inserted by No I of the FA of 12 Dec. 2014, in force since 1 Sept. 2017 (AS 2017 3641; BBl 2013 5823).Art. 5b10 Consent of the couple  1 Reproductive techniques may only be used if the couple concerned have given their written consent after being given sufficient information and counselling.. After three unsuccessful treatment cycles, renewed consent and a further period for reflection are required.2 The couple’s written consent is also required for the reactivation of preserved embryos and impregnated ova.3 If an assisted reproductive technique involves an increased risk of multiple pregnancy, the procedure may be carried out only if the couple are prepared to accept a multiple birth.10 Inserted by No I of the FA of 12 Dec. 2014, in force since 1 Sept. 2017 (AS 2017 3641; BBl 2013 5823).Art. 6 Information and counselling  1 Before an assisted reproductive technique is used, the physician must adequately inform the couple about:11a.the various causes of infertility;b.the medical procedure, including the prospects of success and the risks involved;c.the risk of a multiple pregnancy;d.possible psychological and physical stresses; ande.the legal and financial aspects.2 In the counselling session, appropriate reference should also be made to alternative ways of living and other family-building options.3 There must be an appropriate period for reflection, generally lasting four weeks, between the counselling session and treatment. It must be pointed out that the couple may also seek independent advice.4 Psychological support must be offered before, during and after treatment.11 Amended by No I of the FA of 12 Dec. 2014, in force since 1 Sept. 2017 (AS 2017 3641; BBl 2013 5823).Art. 6a12 Additional duties to provide information and counselling  1 Before reproductive techniques with the 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 disease are carried out, the physician shall, in addition to the provision of information and counselling in accordance with Article 6, ensure that the couple concerned receive non-directive, expert genetic counselling. In this connection, the couple must receive sufficient information on:a.the frequency, significance and probability of contracting the disease and its potential symptoms;b.prophylactic and therapeutic measures that may be taken against the disease;c.ways of organising the life of a child that suffers from the disease;d.the informative value of and risk of error in the analysis of the genetic material;e.risks that reproductive techniques carry for offspring;f.associations for parents of children with disabilities, self-help groups and information and counselling centres in terms of Article 17 of the Federal Act of 8 October 200413 on Human Genetic Testing (HGTA).2 Counselling may only concern the individual and family situation of the couple concerned and not the interests of society as a whole.3 The physician carries out the selection of one or more embryos for transfer to the uterus following a further counselling session.4 The physician must keep records of the counselling sessions.12 Inserted by No I of the FA of 12 Dec. 2014, in force since 1 Sept. 2017 (AS 2017 3641; BBl 2013 5823).13 SR 810.12Art. 6b14 Protection and disclosure of genetic data  The protection and disclosure of genetic data is governed by Articles 7 and 19 HGTA15.14 Inserted by No I of the FA of 12 Dec. 2014, in force since 1 Sept. 2017 (AS 2017 3641; BBl 2013 5823).15 SR 810.12Art. 716 16 Repealed by No I of the FA of 12 Dec. 2014, with effect from 1 Sept. 2017  (AS 2017 3641; BBl 2013 5823).Section 2 Licensing requirements  Art. 817 Principles  1 A cantonal licence is required by any person who: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.2 Laboratories that conduct analyses of genetic material in connection with reproductive techniques in terms of Article 5a require a licence in terms of Article 8 paragraph 1 HGTA183 No licence is required for insemination using a partner’s sperm cells.17 Amended by No I of the FA of 12 Dec. 2014, in force since 1 Sept. 2017 (AS 2017 3641; BBl 2013 5823).18 SR 810.12Art. 9 Use of assisted reproductive techniques  1 A licence in accordance with Article 8 paragraph 1 letter a shall only be granted to physicians.192 They must:a.have the necessary training and experience in the methods of medically assisted reproduction;b.ensure that such activities are carried out with due care and in compliance with the law;c.together with staff, ensure that the persons to be treated receive comprehensive counselling and support with regard to the medical, reproductive biological and socio-psychological aspects of the procedure;d.have the necessary laboratory equipment;e.20ensure that the reproductive cells, impregnated ova and embryos in vitro are preserved according to the state of the art in science and practice.3 If the genetic material from reproductive cells or embryos in vitro is analysed as part of the reproductive technique, they must also:a.demonstrate they have sufficient knowledge of medical genetics; andb.guarantee that the procedure and cooperation with the laboratories concerned accords with the state of the art in science and practice.2119 Amended by No I of the FA of 12 Dec. 2014, in force since 1 Sept. 2017 (AS 2017 3641; BBl 2013 5823).20 Amended by No I of the FA of 12 Dec. 2014, in force since 1 Sept. 2017 (AS 2017 3641; BBl 2013 5823).21 Amended by No I of the FA of 12 Dec. 2014, in force since 1 Sept. 2017 (AS 2017 3641; BBl 2013 5823).Art. 10 Preservation and supply of reproductive cells, impregnated ova and embryos in vitro22  1 A licence in accordance with Article 8 paragraph 1 letter b shall only be granted to physicians.232 They must:a.ensure that such activities are carried out with due care and in compliance with the law;b.together with staff, ensure that sperm donors are carefully selected; andc.24ensure that reproductive cells, impregnated ova and embryos in vitro are preserved according to the state of science and practice.22 Amended by No I of the FA of 12 Dec. 2014, in force since 1 Sept. 2017 (AS 2017 3641; BBl 2013 5823).23 Amended by No I of the FA of 12 Dec. 2014, in force since 1 Sept. 2017 (AS 2017 3641; BBl 2013 5823).24 Amended by No I of the FA of 12 Dec. 2014, in force since 1 Sept. 2017 (AS 2017 3641; BBl 2013 5823).Art. 11 Reporting  1 Persons holding a licence in accordance with Article 8 paragraph 1 must submit an annual report on their activities to the cantonal licensing authority.252 The report must provide information on:a.the number and type of treatments;b.the type of indications;c.the use of donated sperm cells;d.the number of pregnancies and their outcome;e.26the preservation and use of reproductive cells, impregnated ova and embryos in vitro;f.the number of surplus embryos.3 It must not contain any information revealing the identity of specific people.4 The cantonal licensing authority shall transmit the data to the Federal Statistical Office for evaluation and publication.2725 Amended by No I of the FA of 12 Dec. 2014, in force since 1 Sept. 2017 (AS 2017 3641; BBl 2013 5823).26 Amended by No I of the FA of 12 Dec. 2014, in force since 1 Sept. 2017 (AS 2017 3641; BBl 2013 5823).27 Amended by No I of the FA of 12 Dec. 2014, in force since 1 Sept. 2017 (AS 2017 3641; BBl 2013 5823).Art. 1228 Supervision  1 The licensing authority shall verify whether:a.the requirements for granting a licence have been met;b.the obligations and any conditions have been fulfilled2 It shall carry out inspections and may enter properties, business premises and rooms. The licence holder must provide the licensing authority with the required information and documents and any other support on request and free of charge.3 It may take any measures that are required to enforce this Act. In particular, in the case of serious infringements of this Act, it may prohibit the use of rooms or facilities, close business premises and suspend or revoke licences.4 The Federal Council may delegate enforcement tasks, and in particular inspection tasks, to public or private organisations and persons. It shall ensure that payment is made for the delegated tasks.28 Amended by No I of the FA of 12 Dec. 2014, in force since 1 Sept. 2017 (AS 2017 3641; BBl 2013 5823).Art. 1329 29 Repealed by Annex No 87 of the FA on the Federal Administrative Court of 17 June 2005, with effect from 1 Jan. 2007 AS 2006 2197 1069; BBl 2001 4202).Art. 14 Implementing provisions  The Federal Council shall enact the implementing provisions concerning the granting and withdrawal of licences, and reporting and supervision.Section 2a30 Evaluation 30 Inserted by No I of the FA of 12 Dec. 2014, in force since 1 Sept. 2017 (AS 2017 3641; BBl 2013 5823). Art. 14a 1 The Federal Office of Public Health (FOPH) shall ensure that the impact of the provisions of this Act relating to the analysis of the genetic material of embryos in vitro and their selection is evaluated.2 The evaluation shall relate in particular to:a.the compatibility of the indications reported in accordance with Article 11 paragraph 2 letter b in respect of reproductive techniques with analysis of the genetic material of embryos in order to prevent transmitting the predisposition for a serious disease on the one hand with the authorisation requirements in accordance with Article 5a paragraph 2 on the other;b.the survey of the number of couples and the procedures carried out as well as the results;c.the procedures relating to enforcement and supervision;d.the impacts on society.3 The holders of a licence in accordance with Article 8 paragraph 1 must on request provide the FOPH and the person appointed to conduct the evaluation with the data required for the evaluation in anonymised form.4 The Federal Department of Home Affairs shall provide the Federal Council with a report on conclusion of the evaluation and make proposals for further action.Section 3 Handling of Reproductive Material  Art. 15 Preservation of reproductive cells  1 Reproductive cells may be preserved only with the written consent of the person from whom they were obtained, and for a maximum of five years. At the request of this person, the preservation period shall be extended by a maximum of five years.312 A longer preservation period may be agreed with persons who have their reproductive cells preserved with a view to producing their own offspring at a later date because medical treatment they undergo or an activity they carry out could lead to infertility or damage to their genetic material.3 The person from whom the reproductive cells are obtained may, at any time, in writing, revoke consent to their preservation and use.4 If consent is revoked or the preservation period expires, then the reproductive cells are to be destroyed immediately.31 Amended by No I of the FA of 12 Dec. 2014, in force since 1 Sept. 2017 (AS 2017 3641; BBl 2013 5823).Art. 16 Preservation of impregnated ova and embryos in vitro32  1 Impregnated ova and embryos in vitro may only be preserved if:33a.34the couple concerned give their written consent; andb.preservation is intended to permit subsequent establishment of a pregnancy.2 The preservation period is limited to five years. At the request of the couple concerned, the preservation period shall be extended by a maximum of five years.353 Either partner may revoke his or her consent at any time in writing.4 If consent is revoked and the preservation period expires, then the impregnated ova and the embryos in vitro shall be be destroyed immediately. The provisions of the Stem Cell Research Act of 19 December 200336 are reserved.375 …3832 Amended by No I of the FA of 12 Dec. 2014, in force since 1 Sept. 2017 (AS 2017 3641; BBl 2013 5823).33 Amended by No I of the FA of 12 Dec. 2014, in force since 1 Sept. 2017 (AS 2017 3641; BBl 2013 5823).34 Amended by No I of the FA of 12 Dec. 2014, in force since 1 Sept. 2017 (AS 2017 3641; BBl 2013 5823).35 Amended by No I of the FA of 12 Dec. 2014, in force since 1 Sept. 2017 (AS 2017 3641; BBl 2013 5823).36 SR 810.3137 Amended by No I of the FA of 12 Dec. 2014, in force since 1 Sept. 2017 (AS 2017 3641; BBl 2013 5823).38 Repealed by No I of the FA of 12 Dec. 2014, with effect from 1 Sept. 2017  (AS 2017 3641; BBl 2013 5823).Art. 17 Development of embryos  1 The number of impregnated ova developed into embryos outside the woman’s body within one treatment cycle must not be greater than is required for medically assisted reproduction or for the analysis of the genetic material of the embryos; the maximum number shall be twelve.392 The embryo may only be developed outside the woman’s body to the extent that is essential in order to permit implantation in the uterus.3 …4039 Amended by No I of the FA of 12 Dec. 2014, in force since 1 Sept. 2017 (AS 2017 3641; BBl 2013 5823).40 Repealed by No I of the FA of 12 Dec. 2014, with effect from 1 Sept. 2017 (AS 2017 3641; BBl 2013 5823).Section 4 Sperm Donation  Art. 18 The donor’s informed consent  1 Donated sperm cells may only be used in legitimate assisted reproductive techniques and for purposes to which the donor has given his written consent.2 Before donating sperm, the donor must be informed in writing about the legal situation, and in particular the right of the child to obtain information on the donor’s records (Art. 27).Art. 19 Selection of donors  1 Donors must be carefully selected according to medical criteria; in particular, health risks for the recipient of the donated sperm cells must be excluded as far as possible. Other selection criteria are prohibited.2 The donor may provide his sperm cells to only one centre; he must be expressly informed of this restriction prior to donation.Art. 20 Supply of donated sperm cells  1 Donated sperm cells may only be supplied to persons who have a licence to use assisted reproductive techniques; the data specified in Article 24 paragraph 2 is also to be provided.2 Any person who receives donated sperm cells must ensure compliance with Article 22 paragraph 2.Art. 21 Non-remuneration  No payment shall be made for sperm donation as such.Art. 22 Use of donated sperm cells  1 Sperm cells from different donors must not be used within one cycle.   2 Sperm cells from one donor may be used to produce a maximum of eight children.3 When an assisted reproductive technique is used, the relationship between the persons from whom the reproductive cells are obtained must not constitute an impediment to marriage in accordance with Article 95 CC41.4 When donated sperm cells are selected, only the donor’s blood group and similarity in physical appearance to the man with whom filiation is to be established shall be taken into account.41 SR 210Art. 23 Filiation  1 A child conceived through sperm donation in accordance with the provisions of this Act cannot contest filiation with the husband of his or her mother. An action contesting paternity by the husband is subject to the provisions of the CC42.2 If a child has been conceived through sperm donation, a paternity action against the sperm donor (Art. 261 ff. CC) is not permitted; however, such an action is permissible if the donor knowingly donated sperm at the place of a person who was not licensed to use assisted reproductive techniques or to preserve and supply donated sperm cells.42 SR 210Art. 24 Documentation requirements  1 Any person who receives or uses donated sperm cells must document the donation in a reliable manner.2 In particular, the following data about the donor is to be recorded:a.family name and first name, date and place of birth, place of residence, place of origin in Switzerland or nationality, occupation and education;b.date of the sperm donation;c.results of the medical examination;d.information about physical appearance.3 Concerning the woman for whom the donated sperm cells are used and her husband, the following data is to be recorded:a.family name and first name, date and place of birth, place of residence, place of origin in Switzerland or nationality;b.date on which the sperm cells are used.Art. 25 Transmission of data  1 Immediately after the birth of the child, the physician who carried out the reproductive procedure must transmit the data specified in Article 24 to the Federal Civil Status Office (Federal Office).2 If the physician has not been informed of a birth, then he or she must transmit the data immediately after the calculated date of birth, unless it has been established that the treatment was unsuccessful.3 The Federal Council shall enact the necessary provisions on data protection.Art. 26 Retention of data  The Federal Office shall retain the data for 80 years.Art. 27 Information  1 Once the child has reached 18 years of age, he or she may request information from the Federal Office about the donor’s physical appearance and personal data (Art. 24 para. 2 lets. a and d).2 In addition, the child may at any time request information on all the data relating to the donor (Art. 24 para. 2) if he or she has a legitimate interest in obtaining it.3 Before the Federal Office discloses personal data, it shall inform the donor if possible. If the donor does not wish to have personal contact, then the child must be informed and made aware of the donor’s rights of privacy and his family’s entitlement to protection. If the child insists on his or her right to obtain information under paragraph 1, the information shall be provided.4 The Federal Council may assign responsibility for handling requests for information to a specialised federal commission.5 ...4343 Repealed by Annex No 87 of the FA on the Federal Administrative Court of 17 June 2005, with effect from 1 Jan. 2007 (AS 2006 2197 1069; BBl 2001 4202).Chapter 3 National Ethics Commission  Art. 28 1 The Federal Council shall establish a national ethics commission.2 The commission shall monitor developments in assisted reproductive techniques and gene technology in the area of human medicine and comment from an ethical perspective, in an advisory capacity, on associated social, scientific and legal issues.3 In particular, the commission shall have the following tasks:a.to draw up additional guidelines relating to this Act;b.to identify gaps in the legislation;c.to advise the Federal Assembly, the Federal Council and the cantons on request;d.to inform the public about important findings and to promote debate on ethical matters within society.4 The Federal Council shall determine the other tasks to be carried out by the commission in the area of human medicine. It shall enact implementing provisions.Chapter 4 Criminal Provisions  Art. 2944 Production of embryos for illegitimate purposes  1 Any person who produces an embryo by impregnation with the intention of using it or having it used for purposes other than the establishment of a pregnancy shall be liable to a custodial sentence not exceeding three years or to a monetary penalty.2 The same penalty shall apply to any person who preserves an impregnated ovum or an embryo in vitro with the intention of using it or having it used for purposes other than the establishment of a pregnancy.44 Amended by No I of the FA of 12 Dec. 2014, in force since 1 Sept. 2017 (AS 2017 3641; BBl 2013 5823).Art. 30 Development of embryos outside the woman’s body  1 Any person who allows an embryo to develop outside the woman’s body beyond the point at which implantation in the uterus remains possible shall be liable to a custodial sentence not exceeding three years or to a monetary penalty.452 The same penalty shall apply to any person who transfers a human embryo to an animal.45 Amended by No I of the FA of 12 Dec. 2014, in force since 1 Sept. 2017 (AS 2017 3641; BBl 2013 5823).Art. 31 Surrogate motherhood  1 Any person who uses an assisted reproductive technique in a surrogate mother shall be liable to a custodial sentence not exceeding three years or to a monetary penalty.462 The same penalty shall apply to any person who acts as an intermediary for surrogate motherhood.46 Amended by No I of the FA of 12 Dec. 2014, in force since 1 Sept. 2017 (AS 2017 3641; BBl 2013 5823).Art. 3247 Misuse of reproductive material  1 Any person who uses reproductive material obtained from an embryo or foetus to bring about impregnation or further development into an embryo shall be liable to a custodial sentence not exceeding three years or to a monetary penalty.2 Any person who purchases or sells human reproductive material or products derived from embryos or foetuses shall be liable to custodial sentence not exceeding three years or to a monetary penalty.3 If the offender acts in a professional capacity, the penalty shall be a custodial sentence not exceeding three years or to a monetary penalty. A custodial sentence must be combined with a monetary penalty47 Amended by No I of the FA of 12 Dec. 2014, in force since 1 Sept. 2017 (AS 2017 3641; BBl 2013 5823).Art. 3348 Analysis of the genetic material and selection of reproductive cells and embryos in vitro  Any person who in the course of a reproductive technique analyses the genetic material of reproductive cells or embryos in vitro and selects them according to their sex or according to other characteristics without overcoming infertility or avoiding the transmission of the predisposition to a serious disease to the offspring shall be liable to a custodial sentence not exceeding three years or to a monetary penalty.48 Amended by No I of the FA of 12 Dec. 2014, in force since 1 Sept. 2017 (AS 2017 3641; BBl 2013 5823).Art. 3449 Acting without consent or a licence  1 Any person who uses an assisted reproductive technique without the consent of the person from whom the reproductive cells are obtained or of the couple being treated shall be liable to a custodial sentence not exceeding three years or to a monetary penalty.2 The same penalty shall apply to any person who, acting without a licence or having obtained a licence by fraudulent means, uses assisted reproductive techniques or preserves or supplies reproductive cells, impregnated ova or embryos in vitro or arranges analyses of the genetic material of embryos in vitro.49 Amended by No I of the FA of 12 Dec. 2014, in force since 1 Sept. 2017 (AS 2017 3641; BBl 2013 5823).Art. 35 Germ-line modifications  1 Any person who genetically modifies a germline cell or an embryonic cell shall be liable to a custodial sentence not exceeding three years or to a monetary penalty.502 The same penalty shall apply to any person who uses a genetically modified reproductive cell for impregnation or uses a similarly modified impregnated ovum for further development into an embryo.3 Paragraph 1 does not apply if the modification of germline cells is an unavoidable concomitant effect of chemotherapy, radiotherapy or another medical treatment that a person is undergoing.50 Amended by No I of the FA of 12 Dec. 2014, in force since 1 Sept. 2017 (AS 2017 3641; BBl 2013 5823).Art. 36 Cloning, chimera and hybrid formation  1 Any person who creates a clone, a chimera or a hybrid shall be liable to a custodial sentence not exceeding three years or to a monetary penalty.512 The same penalty shall apply to any person who transfers a chimera or a hybrid to a woman or to an animal.51 Amended by No I of the FA of 12 Dec. 2014, in force since 1 Sept. 2017 (AS 2017 3641; BBl 2013 5823).Art. 37 Contraventions  Any person who wilfully:a.uses an assisted reproductive technique in a woman in contravention of Article 3 paragraph 2 letter a and paragraph 3;b.52uses reproductive cells obtained from a person who is deceased, with the exception of the sperm cells of a deceased sperm donor;bbis 53uses impregnated ova or embryos in vitro obtained from a couple one of whom is deceased;c.uses donated ova, develops an embryo using donated ova and donated sperm cells, or transfers a donated embryo to a woman;d.uses assisted reproductive techniques in the absence of a permissible indication;e.54…f.preserves reproductive material in contravention of Articles 15, 16 and 42;g.develops embryos in contravention of Article 17 paragraph 1;h.donates sperm cells to several holders of licences under Article 8 paragraph 1;i.uses donated sperm cells in contravention of Article 22 paragraphs 1–3;j.incorrectly or incompletely records data required in accordance with Article 24;shall be liable to a fine not exceeding 100,000 francs.5552 Amended by No I of the FA of 12 Dec. 2014, in force since 1 Sept. 2017 (AS 2017 3641; BBl 2013 5823).53 Inserted by No I of the FA of 12 Dec. 2014, in force since 1 Sept. 2017 (AS 2017 3641; BBl 2013 5823).54 Repealed by No I of the FA of 12 Dec. 2014, with effect from 1 Sept. 2017  (AS 2017 3641; BBl 2013 5823).55 Amended by No I of the FA of 12 Dec. 2014, in force since 1 Sept. 2017 (AS 2017 3641; BBl 2013 5823).Art. 38 Competent authority  The prosecution and adjudication of offences under this Act is the responsibility of the cantons.Chapter 5 Final Provisions  Section 1 Amendment of Current Legislation  Art. 39 …5656 The amendment may be consulted under AS 2000 3055.Section 2 Transitional Provisions  Art. 40 Licensing  1 Any person who requires a licence according to Article 8 paragraph 1 must submit an application, together with the required documents, to the licensing authority within three months after the commencement of this Act.2 Any person who does not submit the application within the specified period must discontinue the activities concerned.Art. 41 Information  1 Articles 18 and 24–27 also apply if sperm cells have been donated before, but are only used after, the commencement of this Act.2 In all other cases, physicians who have used assisted reproductive techniques using donated reproductive cells must provide information, with the provisions of Article 27 applying mutatis mutandis.Art. 42 Storage of embryos  1 Any person who is storing embryos when this Act commences must inform the licensing authority accordingly within three months. Article 11 applies.2 ...5757 Amended by No I of the FA of 3 Oct. 2003, in force until 31 Dec. 2008 (AS 2003 3681; BBl 2003 1163).Art. 43 Filiation  Article 23 also applies to children conceived before the commencement of this Act by means of an assisted reproductive technique using donor sperm.Art. 43a58 Transitional Provision to the Amendment of 12 December 2014  The submission of reports and proposals in accordance with Article 14a paragraph 4 shall take place for the first time five years after the Amendment of 12 December 2014 comes into force.58 Inserted by No I of the FA of 12 Dec. 2014, in force since 1 Sept. 2017 (AS 2017 3641; BBl 2013 5823).Section 3 Referendum and Commencement  Art. 44 1 This Act is subject to an optional referendum.2 The Federal Council shall determine the commencement date.Commencement date: 1 January 20015959 Federal Council Decree of 4 Dec. 2000


text: 810.112.2 English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.Reproductive Medicine Ordinance(RMO)of 4 December 2000 (Status as of 1 January 2019)The Swiss Federal Council,based on Articles 14 and 25 paragraph 3 of the Reproductive Medicine Act of 18 December 19981 (the Act),ordains:1 SR 810.11Chapter 1 Licensing  Section 1 Subject Matter  Art. 12 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.2 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. 23 Evidence of qualifications for the use of assisted reproductive techniques  1 Any person who uses assisted reproductive techniques requires:the Swiss obstetrics and gynaecology specialist title with the gynaecological endocrinology and reproductive medicine specialty or an equivalent recognised foreign specialist title; and the cantonal licence to practise as an independent professional.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; andthe cantonal licence to practise as an independent professional.3 Amended by No I of the O of 21 June 2017, in force since 1 Sept. 2017 (AS 2017 3651).Art. 34 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.4 Amended by No I of the O of 21 June 2017, in force since 1 Sept. 2017 (AS 2017 3651).Art. 45 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 20066 or a masters in the field of biology or chemistry from a tier-one university accredited under the Higher Education Act of 30 September 20117 or a state-recognised or accredited foreign tier-one university;2.has received postgraduate training that the supervisory authority regards as suitable; and3.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 international or technical developments. In consultation with the Federal Department of Economic Affairs, Education and Research, it shall make updates that may have the effect of being technical barriers to trade.5 Amended by No I of the O of 21 June 2017, in force since 1 Sept. 2017 (AS 2017 3651).6 SR 811.117 SR 414.20Art. 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. 68 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.8 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 …99 Repealed by No I of the O of 21 June 2017, with effect from 1 Sept. 2017  (AS 2017 3651).Art. 1010 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 199611, 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.10 Amended by No I of the O of 21 June 2017, in force since 1 Sept. 2017 (AS 2017 3651).11 SR 946.512Art. 11 and 1212 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. 14a13 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.13 Inserted by No I of the O of 21 June 2017, in force since 1 Sept. 2017 (AS 2017 3651).Chapter 2 Data on Biological Origins  Section 1 Donor Data Register14 14 Amended by No I of the O of 31 Oct. 2012, in force since 1 Jan. 2013 (AS 2012 6097). Art. 1515 Competent authority  1 The Federal Civil Status Office (Federal Office) shall keep a register for storing the sperm donor data specified in Article 24 of the Act (donor data register).2 The Federal Office shall issue processing regulations governing the establishment and management of the donor data register, and defining in particular the structure, procedures and access rights.15 Amended by No I of the O of 31 Oct. 2012, in force since 1 Jan. 2013 (AS 2012 6097).Art. 15a16 Online management  1 The donor data register is kept electronically.2 The transmitted data are stored in electronic form.3 The electronic system for the management of the register and for storing the data must meet the following requirements:a.the long-term existence and quality of the data are guaranteed.b.the data are secured in accordance with recognised standards and the current state of the art;c.the programming and the file format for the data are documented.16 Inserted by No I of the O of 31 Oct. 2012, in force since 1 Jan. 2013 (AS 2012 6097).Art. 15b17 Structure of the donor data register  1 The register contains a directory of the sperm donors.2 Each sperm donor file contains the following information:a.the data transmitted by the attending doctor with the registration form for the sperm donor data (Art. 16 para. 1);b.the results of the medical examinations (Art. 16 para. 1);c.other donor data stored at the request of the sperm donor (Art. 17).17 Inserted by No I of the O of 31 Oct. 2012, in force since 1 Jan. 2013 (AS 2012 6097).Art. 1618 Transmission of the data to the Federal Office  1 The data are transmitted by the attending doctor to the Federal Office in accordance with Articles 24 and 25 of the Act at the same time as the report of the sperm donor data; the form may be transmitted on paper (Art. 16a) or electronically (Art. 16b); the Federal Office issues the form.2 The other data may be transmitted at a time later than that specified in paragraph 1.3 The registration form for sperm donor data contains the following data:a.relating to the donor:1.name and first name, date of birth and place of birth, place of residence, place of origin or nationality, occupation and education,2.date of the sperm donation,3.results of the medical examinations,4.description of the physical appearance: stature, size, hair colour, eye colour, skin colour, special features;b.relating to the recipient of the sperm donation and her husband:1.name and first name, date of birth and place of birth, place of residence, place of origin or nationality,2.date of the insemination or the embryo transfer;c.relating to the child, if known by the attending doctor: name and first name, date of birth and place of birth, sex, place of residence; if details of the birth are not known: the probable date of birth;d.relating to the doctor who stored or arranged the sperm donation, where this doctor is not the attending doctor: name and address.18 Amended by No I of the O of 31 Oct. 2012, in force since 1 Jan. 2012 (AS 2012 6097).Art. 16a19 Transmission in paper form  1 If the form is completed by hand, it must be completed legibly in block capitals and signed.2 If the form is illegible, incomplete, not signed or defective in some other way, the Federal Office may return it to the doctor, giving notice that he or she will be in breach of the obligation under Article 25 of the Act to transmit the data if the noted defects are not rectified.3 Data may be transmitted in accordance with Article 24 of the Act and Article 17 of this Ordinance by registered post or by private courier.19 Inserted by No I of the O of 31 Oct. 2012, in force since 1 Jan. 2012 (AS 2012 6097).Art. 16b20 Transmission in electronic form  1 The Federal Office may request doctors who wish to transmit the data electronically that they register with a recognised platform for the secure service in accordance with Article 2 the Ordinance of 18 June 201021 on Electronic Service in Civil and Criminal Proceedings and Debt Enforcement and Bankruptcy Procedures.2 The doctors shall use the electronic form provided by the Federal Office on its website, on the secure service platform or by post.3 The form must bear a qualified electronic signature in accordance with Article 2 of the Federal Act of 18 March 201622 on Electronic Signatures.234 A certified electronic signature is not required if identification of the sender and the integrity of the transmission is guaranteed in some other suitable way.5 The result of the medical examinations is transmitted to the Federal Office in PDF/A format.6 The doctors shall send documents that are not electronically transmitted by registered post or by private courier to the Federal Office.7 The electronic files shall be transmitted to the electronic postal address of the Federal Office and encrypted using its public key.8 Registration with the secure service platform is deemed to be consent to the Federal Office serving documents electronically. Consent may be revoked at any time.9 The principles relating to the detection and rectification of defects in forms transmitted on paper (Art. 16a para. 2) apply mutatis mutandis.20 Inserted by No I of the O of 31 Oct. 2012, in force since 1 Jan. 2013 (AS 2012 6097).21 SR 272.122 SR 943.0323 Amended by Annex No II 8 of the O of 23 Nov. 2016 on Electronic Signatures, in force since 1 Jan. 2017 (AS 2016 4667).Art. 17 Storage of additional donor data  At the request of the sperm donor, additional donor data, in particular photographs of the donor, shall be stored as well as the data specified in Article 24 of the Act.Art. 1824 Updating of stored data  At the request of the treated couple, the data held in the donor data register shall be updated. The couple shall provide the information required for this purpose.24 Amended by No I of the O of 31 Oct. 2012, in force since 1 Jan. 2013 (AS 2012 6097).Art. 1925 Security of stored data  1 The Federal Office shall ensure that the data in the donor data register and the data in accordance with Article 15b paragraph 2 are securely stored in accordance with the principles of data protection legislation. 2 In particular, it shall ensure protection against fire, water, theft and unauthorised processing of the data.25 Amended by No I of the O of 31 Oct. 2012, in force since 1 Jan. 2013 (AS 2012 6097).Art. 19a26 Electronic data carriers  1 The files transmitted in paper form shall be digitalised and stored in electronic form. Following digitalisation, the paper copies shall be destroyed.2 The Federal Office may delegate these duties to an external agency, which undertakes in terms of a written agreement to record all the data electronically, treat it as confidential and guarantee its security. Article 10a of the Federal Act of 19 June 199227 on Data Protection applies mutatis mutandis.3 The Federal Office shall confirm on request that the digitalised documents correspond to their originals in paper form 26 Inserted by No I of the O of 31 Oct. 2012, in force since 1 Jan. 2013 (AS 2012 6097).27 SR 235.1Art. 2028 Archiving and destruction of the data  1 On expiry of the retention period of 80 years (Art. 26 of the Act), the data in the donor data register and the data under Article 15b paragraph 2 shall be offered to the Federal Archives for archiving.2 The data regarded by the Federal Archives as not worthy of archiving shall be destroyed.28 Amended by No I of the O of 31 Oct. 2012, in force since 1 Jan. 2012 (AS 2012 6097).Section 2 Procedure for Disclosure of Information  Art. 21 Request for information  1 The child must submit to the Federal Office a written request for information in accordance with Article 27 paragraph 1 or 2, specifying the mother’s personal data.2 The child must provide evidence of his or her identity in the form of a copy of a passport, identity card or an equivalent identity document and demonstrate that the requirements specified in Article 27 paragraph 1 or 2 of the Act are met.293 If the child is evidently incapable of acting on his or her own behalf, the Federal Office may request him or her to enlist a representative.3029 Amended by No I of the O of 14 Nov. 2018, in force since 1 Jan. 2019 (AS 2018 4681).30 Amended by No I of the O of 14 Nov. 2018, in force since 1 Jan. 2019 (AS 2018 4681).Art. 22 Notification of the sperm donor  1 If the child fulfils the requirements specified in Article 27 paragraph 1 or 2 of the Act and requests information on the personal data of the sperm donor, the Federal Office shall ascertain the latter’s current address. In doing so, the Federal Office shall as far as possible avoid indicating the purpose of the inquiry.2 Federal, cantonal and communal authorities that can provide the relevant information are obliged to assist the Federal Office at its request.3 The Federal Office shall inform the sperm donor of the fact that his personal data are to be disclosed to the child. It shall grant him an appropriate period to express his wishes concerning personal contact with the child.Art. 2331 Provision of information to the child  1 If the requirements of Article 27 paragraph 1 or 2 of the Act are met, the child may choose whether to be provided information:a.by communication by post;b.by a doctor, a person trained in social psychology, or a specialist organisation of the child’s choice.2 The personal details of the sperm donor shall be provided to the child in a written report.3 If the requirement in Article 27 paragraph 1 of the Act is not met, the Office shall inform the child in writing that he or she is not yet entitled to be provided with information.4 If the requirement in Article 27 paragraph 2 of the Act is not met, the Office shall inform the child in writing that he or she has no legitimate interest and, provided the requirement in Article 27 paragraph 1 of the Act is met, that he or she may choose how information is provided in accordance with paragraph 1.5 The Office shall notify the child if the donor could not be found or could not be reliably identified, failed to answer or declined any personal contact.6 It shall advise the child with regard to the counselling options available.31 Amended by No I of the O of 14 Nov. 2018, in force since 1 Jan. 2019 (AS 2018 4681).Art. 2432 32 Repealed by No I of the O of 14 Nov. 2018, with effect from 1 Jan. 2019 (AS 2018 4681).Art. 25 Data protection  1 In any contacts with the sperm donor or with the child, strict confidentiality shall be observed by the persons and authorities concerned.2 Before any contacts with the sperm donor, his identity must be securely established.Art. 26 Charges  The charges and expenses in the disclosure procedure shall be based on the Ordinance of 27 October 199933 on Civil Status Fees.33 SR 172.042.110Chapter 3 Final provisions  Art. 27 Amendment of existing legislation  …3434 The amendments may be consulted under AS 2000 3068.Art. 2835 Transitional provisions to the Amendment of 21 June 2017  1 Licence holders under Article 8 paragraph 1 letter a of the Act who are already using reproductive techniques when the Amendment of 21 June 2017 comes into force and who wish to continue with such activities must submit an application to the supervisory authority within three years containing proof that they meet the requirements under Article 4 paragraph 1 hereof. They may continue their activities until the decision of the supervisory authority takes full effect.2 Licence holders under Article 8 paragraph 1 letter a of the Act who are already using reproductive techniques with analyses of genetic material from reproductive cells when the Amendment of 21 June 2017 comes into force and who wish to continue with such activities must submit an application to the supervisory authority within three years containing proof that they meet the requirements under Article 9 paragraph 3 of the Act and Articles 4 paragraph 1 and 6 paragraph 2 hereof. They may continue their activities until the decision of the supervisory authority takes full effect.35 Amended by No I of the O of 21 June 2017, in force since 1 Sept. 2017 (AS 2017 3651).Art. 29 Commencement  This Ordinance comes into force on 1 January 2001.Annex 136 Annex 237 36 Originally: Annex. Repealed by No II of the O of 31 Oct. 2012, with effect from 1 Jan. 2013 (AS 2012 6097).37 Inserted by No II of the O of 21 June 2017, in force since 1 Sept. 2017 (AS 2017 3651).(Art. 4 para. 1 let. c)Quality management system European Standard ISO/IEC 17025:2005 (General Requirements for the Competence of Testing and Calibration Laboratories) or ISO 15189:2012 (Medical Laboratories – Requirements for Quality and Competence)38.38 The standards may be inspected at the Federal Office of Public Health, Schwarzenburgstrasse 157, 3003 Bern, or obtained from the Swiss Association for Standardisation, Sulzerallee 70, 8404 Winterthur; www.snv.ch.


text: 810.12 English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.Federal Acton Human Genetic Testing(HGTA)of 8 October 2004 (Status as of 1 January 2014)The Federal Assembly of the Swiss Confederation, in accordance with Article 98 paragraph 3, 110 paragraph 1, 113 paragraph 1, 117 paragraph 1, 119 paragraph 2 f, 122 paragraph 1 and 123 paragraph 1 of the Federal Constitution1, and having considered the Dispatch of the Federal Council dated 11 September 20022,decrees:1 SR 1012 BBl 2002 7361 Chapter 1: Scope, Purpose and Definitions  Art. 1 Scope  1 This Act stipulates the conditions under which human genetic testing may be performed:a.in the medical context;b.in the context of employment;c.in the context of insurance;d.in the context of liability.2 It also regulates the creation of DNA profiles for the purpose of determining the filiation or identity of an individual. The DNA Profiling Act of 20 June 20033 applies to the use of DNA profiles in criminal proceedings and for the purpose of identifying unknown or missing persons.3 This Act does not apply to genetic testing performed for research purposes.43 SR 3634 Amended by Annex No 3 of the Human Research Act of 30 Sept. 2011, in force since 1 Jan. 2014 (AS 2013 3215; BBl 2009 8045).Art. 2 Purpose  This Act aims:a.to protect human dignity and personality;b.to prevent improper genetic testing and the improper use of genetic data;c.to ensure the quality of genetic tests and the way their results are interpreted.Art. 3 Definitions  In this Act:a.genetic test means cytogenetic and molecular genetic tests to determine hereditary characteristics of human genetic material or characteristics of human genetic material acquired during the embryonic phase, and all other laboratory tests whose immediate purpose is to provide such information about genetic material;b.cytogenetic tests means tests to determine the number and structure of chromosomes;c.molecular genetic tests means tests to determine the molecular structure of nucleic acids (DNA and RNA) and the immediate gene product;d.presymptomatic genetic tests means genetic tests whose purpose is to identify predisposition to disease before clinical symptoms emerge, with the exception of tests designed solely to determine the effect of a planned therapy;e.prenatal tests means prenatal genetic testing and prenatal risk assessment;f.prenatal genetic tests means genetic tests during pregnancy to determine characteristics of the genetic material of the embryo or foetus;g.prenatal risk assessment means laboratory tests which provide information about the risk of the embryo or foetus having a genetic anomaly, and investigations of the embryo or foetus using imaging techniques; h. testing for family planning purposes means genetic tests to determine a genetic risk for future offspring;i.screening means genetic tests offered systematically to the entire population or to certain groups of individuals in the population without there being a suspicion that the individual may have the characteristics being sought;j.genetic in vitro diagnostic medical devices means ready-to-use products for the determination of characteristics of human genetic material;k.DNA profile means information specific to an individual which is obtained from the non-coding sequences of their DNA using molecular genetic techniques;l.genetic data means information about the genetic material of a person that is obtained from a genetic test, including their DNA profile;m.sample means biological material collected for a genetic test;n.person concerned means a person whose genetic material is tested or for whom a DNA profile is created and from whom corresponding samples or genetic data exist; in the context of prenatal testing: the pregnant woman.Chapter 2: General Principles of Genetic Testing  Art. 4 Non-discrimination  No one may be discriminated against on grounds of his or her genetic material.Art. 5 Consent  1 Genetic and prenatal testing, including screening, may not be performed unless the person concerned has been provided with adequate information about the testing and has given his or her voluntary consent. This shall not apply to exceptions stipulated in a federal law.2 If the person concerned is incapable of judgement, that person’s legal representative shall provide consent on his or her behalf. In the medical context the limitations of Article 10 paragraph 2 must be observed.3 Consent may be withdrawn at any time.Art. 6 Right not to know  Every person has the right to refuse to receive information about his or her genetic status subject to Article 18 paragraph 2.Art. 7 Protection of genetic data  The processing of genetic data is subject to:a.professional secrecy as stipulated in Articles 321 and 321a of the Swiss Criminal Code5; andb.federal and cantonal data protection regulations. 5 SR 311.0Art. 8 Authorisation to perform genetic testing  1 Any person who wishes to perform cytogenetic or molecular genetic tests requires authorisation from the competent federal authority.2 The Federal Council:a.nominates the competent federal authority;b.regulates the requirements and the procedure for granting the authorisation;c.defines the duties of the holder of the authorisation;d.regulates oversight and, in particular, makes provision for unannounced inspections;e.determines the fees.3 The Federal Council may, having consulted the Expert Commission for Human Genetic Testing (Art. 35):a.require authorisation to be obtained for other genetic tests or prenatal risk assessment if these have to fulfil the same requirements in terms of quality assurance and interpretation of their results as cytogenetic and molecular genetic tests;b.exempt from the requirement for authorisation genetic tests which do not need to fulfil any special requirements in terms of performance and interpretation of their results.4 DNA profiles within the meaning of this Act may only be created by laboratories recognised by the federal government. The Federal Council regulates the requirements and the procedure for recognising such laboratories and for oversight.Art. 9 Genetic in vitro diagnostic medical devices  1 It is forbidden to supply genetic in vitro diagnostic medical devices to individuals for a purpose which cannot be considered part of those individuals’ professional or commercial activities.2 The Federal Council may, having consulted the Expert Commission for Human Genetic Testing, make provision for exceptions to this prohibition provided the products are used under medical supervision and misinterpretation of the test result is not possible.Chapter 3: Genetic Testing in a Medical Context  Art. 10 Genetic testing of individuals  1 Genetic tests may only be performed on individuals if they serve a medical purpose and the right to self-determination according to Article 18 is ensured.2 A genetic test may only performed on a person incapable of judgement if the test is necessary to protect that person’s health. Exceptionally, a test of this kind is permissible if there is no other way of identifying a severe hereditary disorder in the family or a corresponding predisposition and the burden on the person concerned is minimal.Art. 11 Prenatal tests  It is forbidden to perform prenatal tests whose purpose is:a.to determine characteristics of the embryo or foetus which do not directly impair its health; or b.to determine the sex of the embryo or foetus for a purpose other than diagnostic.Art. 12 Screening   1 Screening may only be performed if the programme has been authorised by the competent federal authority.2 Authorisation can be granted if:a.early treatment or prophylaxis is possible;b.the test method has been shown to produce reliable results; andc.appropriate genetic counselling is provided.3 Before the competent federal authority issues the authorisation, it consults the Expert Commission for Human Genetic Testing and, where necessary, the Swiss National Advisory Commission on Biomedical Ethics.4 The Federal Council may make provision for further conditions. It designates the competent federal authority and regulates the procedure for issuing authorisations, oversight and fees.Art. 13 Right to prescribe genetic tests  1 Genetic tests may only be prescribed by medical doctors who are authorised to practice their profession independently or under the supervision of such.2 Presymptomatic and prenatal genetic tests and tests for the purpose of family planning may only be prescribed by doctors who have received appropriate post-graduate training or who, during their post-graduate training, work under the supervision of doctors who have received appropriate post-graduate training.3 The doctor who prescribes a genetic test under the terms of paragraph 2 ensures that the person concerned receives genetic counselling.Art. 14 Genetic counselling in general  1 Presymptomatic and prenatal genetic tests and tests for the purpose of family planning must be preceded and followed by non-directive genetic counselling provided by a qualified person. The counselling session must be documented. 2 Counselling must address only the individual and family situation of the person concerned; it must not take public interest into consideration. It must take into account the possible psychological and social impact of the test results on the person concerned and his or her family.3 The person concerned or, if he or she is not capable of judgement, his or her legal representative must be informed specifically of:a.the purpose, nature and significance of the test and of any complementary measures;b.any risks which may be associated with the test and the frequency and nature of the disorder being diagnosed;c.the possibility of an unexpected test result;d.the possible physical and psychological burden;e.third-party payment options for the cost of the test and of subsequent measures;f.support available in connection with the test result;g.the severity of the anomalies which may be detected and the possible therapeutic and prophylactic measures.4 A sufficient period of time for reflection must be allowed between the counselling session and the test.5 In screening testing the counselling must be adapted to the circumstances.Art. 15 Genetic counselling for prenatal genetic tests  1 The pregnant woman must be informed expressly about her right to self-determination both before and after a prenatal genetic test.2 The woman must be made aware if there is a high probability that the proposed test will not lead to any therapeutic or prophylactic options; she must also be informed of the opportunity to contact an information and counselling centre for prenatal testing.3 If a severe, incurable disorder is detected, the woman must also be informed about alternatives to termination of the pregnancy and made aware of the existence of associations of parents of disabled children and self-help groups.4 The woman’s husband or partner should be involved in the genetic counselling if possible.Art. 16 Information in connection with prenatal risk assessment  Before a laboratory test which provides information about the risk of the embryo or foetus having a genetic anomaly, and before investigations of the embryo or foetus using imaging techniques, the pregnant woman must be informed of the following:a.the purpose and significance of the test;b.the possibility of unexpected test results;c.the possible complementary tests and interventions; andd.information and counselling centres as defined in Article 17.Art. 17 Information and counselling centres for prenatal testing  1 The cantons shall ensure that there are independent information and counselling centres for prenatal testing, with personnel with the required competency.2 They may set up centres of this kind jointly or delegate their tasks to the recognised pregnancy advisory centres (Federal Act of 9 October 19816 on Pregnancy Advisory Centres).3 The centres provide general information and counselling on prenatal testing and, if requested to do so, put clients in touch with associations of parents of disabled children or self-help groups. 6 SR 857.5Art. 18 Right to self-determination  1 Having been provided with adequate information, the person concerned is free to decide:a.whether to undergo a genetic or prenatal test and, where appropriate, a subsequent test;b.whether to know the result of the test; andc.what conclusions he or she wishes to draw from the test result.2 The doctor must immediately inform the person concerned of the test result if there is an immediate physical danger to the person, to the embryo or to the foetus, which could be averted.3 Consent for presymptomatic or prenatal genetic testing and for tests for the purpose of family planning must be obtained in writing, with the exception of screening tests.4 If the person concerned is incapable of judgement, his or her legal representative shall decide.Art. 19 Disclosure of genetic data  1 The doctor may disclose genetic test results only to the person concerned or, if he or she is incapable of judgement, to his or her legal representative.2 If the person concerned gives his or her express consent, the doctor may disclose the test result to the person’s family members, spouse or partner.3 If consent is denied, the doctor may apply to the competent cantonal authority as stipulated in Article 321 number 2 of the Swiss Criminal Code7 to be released from his or her duty of professional secrecy, should the protection of the overriding interests of the family members, spouse or partner require that they receive this information. The authority may request an opinion from the Expert Commission for Human Genetic Testing.7 SR 311.0Art. 20 Further use of biological material  1 A sample may only be used for further purposes to which the person concerned has consented.2 and 3 …88 Repealed by Annex No 3 of the Human Research Act of 30 Sept. 2011, with effect from 1 Jan. 2014 (AS 2013 3215; BBl 2009 8045).Chapter 4: Genetic Testing in the context of Employment  Art. 21 Principle  At hiring and during a professional relationship, the employer and his or her medical consultant may not:a.require presymptomatic genetic tests to be performed;b.require the results of prior presymptomatic genetic tests to be disclosed nor make use of such results;c.require genetic tests to be performed with the intention of detecting personal characteristics of the employee which do not relate to his or her health.Art. 22 Exceptions for presymptomatic genetic tests to prevent occupational diseases and accidents  At hiring and during a professional relationship, the occupational health or designated doctor may prescribe a presymptomatic genetic test if the following conditions are met:a.Suva has ruled that the post is subject to occupational health monitoring, or other federal regulations require the employee to undergo a medical examination to ascertain his or her suitability for the job because there is a danger of an occupational disease or severe environmental contamination occurring or there is a serious risk of accident or health hazards for third parties. b.Workplace-related measures within the meaning of Article 82 of the Federal Act of 20 March 19819 on Accident Insurance or other legal provisions are not sufficient to preclude these risks.c.Available scientific knowledge has established a causal relationship between a specific genetic predisposition of the person carrying out the job and occupational disease, danger of environmental contamination or a risk of accident or health hazards to third parties.d.The Expert Commission for Human Genetic Testing has confirmed the causal relationship and has deemed the type of test to be reliable in identifying the relevant genetic predisposition.e.The person concerned has given his or her written consent to the test.9 SR 832.20Art. 23 Performance of the test  1 The test can only address the genetic predisposition relevant to the particular post. Attempting to acquire other genetic data is forbidden.2 Genetic counselling as stipulated in Article 14 must be provided before and after the test.3 The sample must be destroyed on completion of the test.Art. 24 Disclosure of the test result and assumption of the costs  1 The doctor transmits the result of the test to the person concerned. The employer is only informed whether the person concerned can or cannot be considered for the intended activity.2 If the occupational health examination is mandated by Suva, this body pays for the test; in other cases the employer bears the costs.Art. 25 Regulatory intervention  If the executive bodies designated by the Employment Act of 13 March 196410 or the Federal Act of 20 March 198111 on Accident Insurance observe violations of Articles 21-24, they are bound by virtue of their office to intervene.10 SR 822.1111 SR 832.20Chapter 5: Genetic Testing in the context of Insurance  Art. 26 Prohibition of testing  Insurance providers may not require either presymptomatic or prenatal genetic tests prior to providing insurance.Art. 27 Prohibition of further enquiries  1 Insurance providers may neither require the disclosure of, nor utilize, results of prior presymptomatic or prenatal genetic tests or tests for family planning purposes, from applicants for the following:a.insurance which is subject either in part or as a whole to the terms of the Federal Act of 6 October 200012 on General Aspects of Social Insurance Law;b.mandatory occupational insurance or voluntary occupational insurance that goes beyond the scope of the mandatory insurance;c.insurance relating to the obligation to continue paying the individual’s salary in case of illness or maternity;d.life insurance with an insured sum up to a maximum of CHF 400,000;e.voluntary invalidity insurance with an annuity not exceeding CHF 40,000.2 If an individual takes out several life or invalidity insurance policies, the maximum amount stipulated in para. 1 d or e is valid for the sum of the policies. The applicant must provide the insurance provider with the relevant information.12 SR 830.1Art. 28 Permissible further enquiries about results of prior presymptomatic genetic tests  1 Before a private insurance policy not covered by Article 27 is taken out, insurance providers may only require the applicant to disclose the results of prior presymptomatic genetic tests to the designated doctor if:a.the test in question provides reliable results both technically and in medical practice; andb.the scientific value of the test for the calculation of premiums has been demonstrated.2 The designated doctor may inform the insurance provider only of the risk group to which the applicant must be assigned.3 The designated doctor may only retain the results of the test if they are relevant for the conclusion of the contract.4 The test results must be used solely for the purpose for which they were obtained from the applicant.Chapter 6: Genetic testing in the context of Liability  Art. 29 Prohibition of presymptomatic genetic testing  1 Performing presymptomatic genetic tests for the purpose of calculating claims or determining compensation is forbidden, except in cases involving a genetic anomaly acquired during the embryonic phase and for which compensation or restitution is being claimed.2 Requesting or utilizing the results of prior presymptomatic or prenatal genetic tests or tests for family planning purposes, for the purpose of calculating claims or determining compensation, is forbidden.Art. 30 Detection of diseases  Genetic tests to diagnose a disease with the aim of calculating claims or determining compensation may only be performed with the written consent of the person concerned or by order of the court.Chapter 7: DNA profiling to determine Filiation or Identity  Art. 31 Principle  1 When creating DNA profiles to determine filiation or for identification purposes it is not permitted to seek information concerning health or other personal characteristics, with the exception of the sex of the person concerned.2 The sample must be taken by the laboratory which will perform the DNA profiling or by a doctor mandated by the laboratory. The person concerned must provide proof of his or her identity.3 The samples may not be used for other purposes.Art. 32 Civil proceedings  1 In civil proceedings, DNA profiling of parties or third parties may only be performed by order of the court or with the written consent of the person concerned.2 The laboratory must retain the samples obtained in the course of the proceedings. The court which ordered the test ensures that the samples are destroyed immediately after the implementation of the final judgment, unless a person concerned has requested in writing that his or her samples be retained for a further period.Art. 33 Administrative proceedings  1 If in administrative proceedings there are justified doubts about the filiation or the identity of a person which cannot be dispelled in any other way, the competent authority may make the granting of authorisation or benefits conditional to DNA profiling.2 DNA profiling may only be performed with the written consent of the persons concerned.3 The samples must be retained by the laboratory. The authority ensures that the samples are destroyed immediately after the implementation of the decision.Art. 34 Determination of origin outside administrative proceedings  1 Outside the context of administrative proceedings, DNA profiling to determine filiation may be performed only with the written consent of the persons concerned; a child incapable of judgement and whose filiation with a certain person must be determined, may not be represented by that person.2 The laboratory that performs the DNA profiling must, before undertaking the test, inform the persons concerned in writing about the provisions of the Civil Code13 concerning the determination of filiation and draw their attention to the possible psychological and social impact of the test.3 The person concerned or, if he or she is incapable of judgement, his or her legal representative, shall decide whether his or her sample shall be retained or destroyed.4 Prenatal DNA profiling to establish paternity may not be prescribed by a doctor unless the pregnant woman has previously had a thorough discussion addressing in particular, her reasons for wanting to perform the test, the risks associated with obtaining the sample, the psychological, social and legal aspects associated with the pregnancy, any subsequent measures that may be taken following the result and the possibility of obtaining support. The counselling session must be documented.13 SR 210Chapter 8: Expert Commission for Human Genetic Testing  Art. 35 1 The Federal Council shall appoint an Expert Commission for Human Genetic Testing.2 The Expert Commission shall have the following tasks in particular:a.to develop standards for the quality control of genetic tests with respect to the granting of authorisations (Art. 8 para. 2) and to submit recommendations to the Federal Council on whether certain genetic tests should be exempted from or subjected to the requirement for authorisation (Article 8 para. 3);b.at the request of the competent federal authority, to comment on requests for authorisation and to participate in inspections (Art. 8 para. 1 and 2);c.to make recommendations on whether certain genetic in vitro diagnostic medical devices should be exempted from the prohibition stipulated in Article 9 paragraph 1;d.to advise on screening programmes (Art. 12);e.where necessary, to make recommendations on post-graduate training as stipulated in Article 13 paragraph 2; f.to make recommendations on genetic counselling (Art. 14 and 15) and information relating to prenatal risk assessment (Art. 16);g.to advise, on request from the competent cantonal authority, on applications for release from the duty of professional secrecy (Art. 19 para. 3);h.to provide confirmations as stipulated in Article 22 letter d;i.to make recommendations on DNA profiling;j.to follow the scientific and practical development of genetic testing, to make recommendations and to highlight gaps in the legislation in this field.3 The Commission shall fulfil its tasks independently.Chapter 9: Criminal Provisions  Art. 36 Genetic tests performed without consent  Any person who wilfully prescribes or performs a genetic test without obtaining the consent of the person being tested, as required by this Act, shall be liable to a custodial sentence not exceeding three years or to a monetary penalty.1414 Amended by Art. 333 of the Swiss Criminal Code (SR 311.0) in its version in the Federal Act of 13 Dec. 2002, in force since 1 Jan. 2007 (AS 2006 3459).Art. 37 Genetic testing without authorisation  Any person who wilfully performs a genetic test on a third party without the authorisation stipulated in Article 8 shall be liable to a fine.1515 Amended by Art. 333 of the Swiss Criminal Code (SR 311.0) in its version in the Federal Act of 13 Dec. 2002, in force since 1 Jan. 2007 (AS 2006 3459).Art. 38 Supply of genetic in vitro diagnostic medical devices  1 Any person who, in contravention of Article 9 paragraph 1, wilfully supplies genetic in vitro diagnostic medical devices to individuals for a purpose which cannot be considered part of those individuals’ professional or commercial activities shall be liable to a fine. 162 If the act is committed for commercial gain, the penalty shall be a custodial sentence not exceeding three years or to a monetary penalty.1716 Amended by Art. 333 of the Swiss Criminal Code (SR 311.0) in its version in the Federal Act of 13 Dec. 2002, in force since 1 Jan. 2007 (AS 2006 3459).17 Amended by Art. 333 of the Swiss Criminal Code (SR 311.0) in its version in the Federal Act of 13 Dec. 2002, in force since 1 Jan. 2007 (AS 2006 3459).Art. 39 Abuse in the context of employment  Any person who, in contravention of Article 21 and in the context of employment, wilfully:a.requires a presymptomatic genetic test or a genetic test to determine personal characteristics which are not related to health; orb.requires the results of prior presymptomatic genetic tests to be disclosed or asks about them during an employment-related medical examination or makes use of such results.shall be liable to a custodial sentence not exceeding three years or to a monetary penalty.1818 Amended by Art. 333 of the Swiss Criminal Code (SR 311.0) in its version in the Federal Act of 13 Dec. 2002, in force since 1 Jan. 2007 (AS 2006 3459).Art. 40 Abuse in the context of insurance  Any person who, in the context of insurance, wilfully:a.in contravention of Article 26, requires presymptomatic or prenatal genetic tests to be performed; orb.in contravention of Article 27, requires the disclosure of the results of prior presymptomatic or prenatal genetic tests or tests for family planning purposes, or asks about these in the context of a medical risk assessment, or makes use of such results.shall be liable to a custodial sentence not exceeding three years or to a monetary penalty. 1919 Amended by Art. 333 of the Swiss Criminal Code (SR 311.0) in its version in the Federal Act of 13 Dec. 2002, in force since 1 Jan. 2007 (AS 2006 3459).Art. 41 Competent authority and administrative criminal law  1 The cantons shall be responsible for the prosecution and assessment of criminal acts under the terms of this Act.2 Articles 6 and 7 (offences committed within a company) and 15 (forgery, obtaining a false certificate by fraud) of the Federal Act of 22 March 197420 on Administrative Criminal Law apply.20 SR 313.0Chapter 10: Final Provisions  Art. 42 Authorisation to perform genetic testing  1 Any person who requires an authorisation as stipulated in Article 8 must submit the request to the competent federal authority within three months of this Act coming into force.2 Any person who does not submit the request within the deadline must cease his or her activity.Art. 43 Screening   Screening programmes which have already been implemented by the time this Act comes into force do not require authorisation.Art. 44 Referendum and commencement  1 This Act is subject to optional referendum.2 The Federal Council shall determine its commencement date.Commencement date: 1 April 20072121 Federal Council Decree of 14 February 2007 (AS 2007 649)