Federal Act on Human Genetic Testing

¹This 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.

²It 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 2003¹ ap­plies to the use of DNA pro­files in crim­in­al pro­ceed­ings and for the pur­pose of identi­fy­ing un­known or miss­ing per­sons.

³This Act does not ap­ply to ge­net­ic test­ing per­formed for re­search pur­poses.²

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.

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.

No one may be dis­crim­in­ated against on grounds of his or her ge­net­ic ma­ter­i­al.

¹Ge­net­ic 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.

²If 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.

³Con­sent may be with­drawn at any time.

Every per­son has the right to re­fuse to re­ceive in­form­a­tion about his or her ge­net­ic status sub­ject to Art­icle 18 para­graph 2.

The pro­cessing of ge­net­ic data is sub­ject to:

a.

pro­fes­sion­al secrecy as stip­u­lated in Art­icles 321 and 321a of the Swiss Crim­in­al Code¹; and

b.

fed­er­al and can­ton­al data pro­tec­tion reg­u­la­tions.

¹Any per­son who wishes to per­form cyto­gen­et­ic or mo­lecu­lar ge­net­ic tests re­quires au­thor­isa­tion from the com­pet­ent fed­er­al au­thor­ity.

²The 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.

³The 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.

⁴DNA 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.

¹It 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.

²The 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.

¹Ge­net­ic 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.

²A 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.

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.

¹Screen­ing may only be per­formed if the pro­gramme has been au­thor­ised by the com­pet­ent fed­er­al au­thor­ity.

²Au­thor­isa­tion can be gran­ted if:

a.

early treat­ment or pro­phy­lax­is is pos­sible;

b.

the test meth­od has been shown to pro­duce re­li­able res­ults; and

c.

ap­pro­pri­ate ge­net­ic coun­selling is provided.

³Be­fore 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.

⁴The Fed­er­al Coun­cil may make pro­vi­sion for fur­ther con­di­tions. It des­ig­nates the com­pet­ent fed­er­al au­thor­ity and reg­u­lates the pro­ced­ure for is­su­ing au­thor­isa­tions, over­sight and fees.

¹Ge­net­ic tests may only be pre­scribed by med­ic­al doc­tors who are au­thor­ised to prac­tice their pro­fes­sion in­de­pend­ently or un­der the su­per­vi­sion of such.

²Presymp­to­mat­ic 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.

³The doc­tor who pre­scribes a ge­net­ic test un­der the terms of para­graph 2 en­sures that the per­son con­cerned re­ceives ge­net­ic coun­selling.

¹Presymp­to­mat­ic 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.

²Coun­selling 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.

³The 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.

⁴A suf­fi­cient peri­od of time for re­flec­tion must be al­lowed between the coun­selling ses­sion and the test.

⁵In screen­ing test­ing the coun­selling must be ad­ap­ted to the cir­cum­stances.

¹The preg­nant wo­man must be in­formed ex­pressly about her right to self-de­term­in­a­tion both be­fore and after a pren­at­al ge­net­ic test.

²The 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.

³If 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.

⁴The wo­man's hus­band or part­ner should be in­volved in the ge­net­ic coun­selling if pos­sible.

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; and

d.

in­form­a­tion and coun­selling centres as defined in Art­icle 17.

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 1981¹ on Preg­nancy Ad­vis­ory Centres).

³The 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.

¹Hav­ing 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; and

c.

what con­clu­sions he or she wishes to draw from the test res­ult.

²The 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.

³Con­sent 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.

⁴If the per­son con­cerned is in­cap­able of judge­ment, his or her leg­al rep­res­ent­at­ive shall de­cide.

¹The 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.

²If 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.

³If con­sent is denied, the doc­tor may ap­ply to the com­pet­ent can­ton­al au­thor­ity as stip­u­lated in Art­icle 321 num­ber 2 of the Swiss Crim­in­al Code¹ 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.

¹A sample may only be used for fur­ther pur­poses to which the per­son con­cerned has con­sen­ted.

²and ³ …¹

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.

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 1981¹ 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.

¹The test can only ad­dress the ge­net­ic pre­dis­pos­i­tion rel­ev­ant to the par­tic­u­lar post. At­tempt­ing to ac­quire oth­er ge­net­ic data is for­bid­den.

²Ge­net­ic coun­selling as stip­u­lated in Art­icle 14 must be provided be­fore and after the test.

³The sample must be des­troyed on com­ple­tion of the test.

¹The 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.

²If the oc­cu­pa­tion­al health ex­am­in­a­tion is man­dated by Suva, this body pays for the test; in oth­er cases the em­ploy­er bears the costs.

If the ex­ec­ut­ive bod­ies des­ig­nated by the Em­ploy­ment Act of 13 March 1964¹ or the Fed­er­al Act of 20 March 1981² on Ac­ci­dent In­sur­ance ob­serve vi­ol­a­tions of Art­icles 21-24, they are bound by vir­tue of their of­fice to in­ter­vene.

In­sur­ance pro­viders may not re­quire either presymp­to­mat­ic or pren­at­al ge­net­ic tests pri­or to provid­ing in­sur­ance.

¹In­sur­ance 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 2000¹ 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.

²If 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.

¹Be­fore 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; and

b.

the sci­entif­ic value of the test for the cal­cu­la­tion of premi­ums has been demon­strated.

²The des­ig­nated doc­tor may in­form the in­sur­ance pro­vider only of the risk group to which the ap­plic­ant must be as­signed.

³The des­ig­nated doc­tor may only re­tain the res­ults of the test if they are rel­ev­ant for the con­clu­sion of the con­tract.

⁴The test res­ults must be used solely for the pur­pose for which they were ob­tained from the ap­plic­ant.

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.

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.

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.

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.

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.

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 Code¹ 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.

¹The Fed­er­al Coun­cil shall ap­point an Ex­pert Com­mis­sion for Hu­man Ge­net­ic Test­ing.

²The 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.

³The Com­mis­sion shall ful­fil its tasks in­de­pend­ently.

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.¹

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.¹

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. ¹

²If the act is com­mit­ted for com­mer­cial gain, the pen­alty shall be a cus­todi­al sen­tence not ex­ceed­ing three years or to a mon­et­ary pen­alty.²

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; or

b.

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.¹

Any per­son who, in the con­text of in­sur­ance, wil­fully:

a.

in con­tra­ven­tion of Art­icle 26, re­quires presymp­to­mat­ic or pren­at­al ge­net­ic tests to be per­formed; or

b.

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. ¹

¹The can­tons shall be re­spons­ible for the pro­sec­u­tion and as­sess­ment of crim­in­al acts un­der the terms of this Act.

²Art­icles 6 and 7 (of­fences com­mit­ted with­in a com­pany) and 15 (for­gery, ob­tain­ing a false cer­ti­fic­ate by fraud) of the Fed­er­al Act of 22 March 1974¹ on Ad­min­is­trat­ive Crim­in­al Law ap­ply.

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.

Screen­ing pro­grammes which have already been im­ple­men­ted by the time this Act comes in­to force do not re­quire au­thor­isa­tion.

¹ This Act is sub­ject to op­tion­al ref­er­en­dum.

² The Fed­er­al Coun­cil shall de­term­ine its com­mence­ment date.