Reproductive Medicine Ordinance
(RMO)

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.

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; and

the can­ton­al li­cence to prac­tise as an in­de­pend­ent pro­fes­sion­al.

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.

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; 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 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.

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.

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.

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.

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.

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 ...⁹

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.

The li­cence shall ex­pire when the li­censed activ­it­ies are dis­con­tin­ued. Dis­con­tinu­ation of activ­it­ies is to be no­ti­fied to the su­per­vis­ory au­thor­ity.

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.

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.

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.

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.

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).

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 or her wife:¹⁹

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.

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.

³Data may be trans­mit­ted in ac­cord­ance with Art­icle 24 of the Act and Art­icle 17 of this Or­din­ance by re­gistered post or by private cour­i­er.

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 2010²² 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 2016²³ on Elec­tron­ic Sig­na­tures.²⁴

⁴ 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.

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.

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.

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.

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 1992²⁸ 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

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.

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.³⁰

³ 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.³¹

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.

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.

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.

The charges and ex­penses in the dis­clos­ure pro­ced­ure shall be based on the Or­din­ance of 27 Oc­to­ber 1999³⁴ on Civil Status Fees.

...³⁵

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.

This Or­din­ance comes in­to force on 1 Janu­ary 2001.