Na podlagi druge alinee prvega odstavka 107. člena in prvega odstavka 91. člena Ustave Republike Slovenije izdajam

Razglašam Zakon o ratifikaciji Dodatnega protokola h Konvenciji o človekovih pravicah v zvezi z biomedicino glede genetskega testiranja za zdravstvene namene (MDPKČPB), ki ga je sprejel Državni zbor Republike Slovenije na seji 15. julija 2009.

Ratificira se Dodatni protokol h Konvenciji o človekovih pravicah v zvezi z biomedicino glede genetskega testiranja za zdravstvene namene, sestavljen v Strasbourgu 27. novembra 2008.

Besedilo dodatnega protokola se v izvirniku v angleškem jeziku in v prevodu v slovenskem jeziku glasi:

Preamble
The member States of the Council of Europe, the other States and the European Community, signatories to this Additional Protocol to the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine (hereinafter referred to as “the Convention on Human Rights and Biomedicine”, ETS No. 164),
Considering that the aim of the Council of Europe is the achievement of greater unity between its members and that one of the methods by which this aim is pursued is the maintenance and further realisation of human rights and fundamental freedoms;
Considering that the aim of the Convention on Human Rights and Biomedicine, as defined in Article 1, is to protect the dignity and identity of all human beings and guarantee everyone, without discrimination, respect for their integrity and other rights and fundamental freedoms with regard to the application of biology and medicine;
Bearing in mind the Convention for the Protection of Individuals with regard to Automatic Processing of Personal Data (ETS No. 108) of 28 January 1981;
Bearing in mind the work carried out by other intergovernmental organisations, in particular the Universal Declaration on the Human Genome and Human Rights, endorsed by the General Assembly of the United Nations on 9 December 1998;
Recalling that the human genome is shared by all human beings, thereby forming a mutual bond between them while slight variations contribute to the individuality of each human being;
Stressing the particular bond that exists between members of the same family;
Considering that progress in medical science can contribute to saving lives and improving their quality;
Acknowledging the benefit of genetics, in particular genetic testing, in the field of health;
Considering that genetic services in the field of health form an integral part of the health services offered to the population and recalling the importance of taking appropriate measures, taking into account health needs and available resources, with a view to providing equitable access to genetic services of appropriate quality;
Aware also of the concerns that exist regarding possible improper use of genetic testing, in particular of the information generated thereby;
Reaffirming the fundamental principle of respect for human dignity and the prohibition of all forms of discrimination, in particular those based on genetic characteristics;
Taking into account national and international professional standards in the field of genetic services and the previous work of the Committee of Ministers and the Parliamentary Assembly of the Council of Europe in this field;
Resolving to take such measures as are necessary to safeguard human dignity and the fundamental rights and freedoms of the individual with regard to genetic testing for health purposes,
Have agreed as follows:

Parties to this Protocol shall protect the dignity and identity of all human beings and guarantee everyone, without discrimination, respect for their integrity and other rights and fundamental freedoms with regard to the tests to which this Protocol applies in accordance with Article 2.

1 This Protocol applies to tests, which are carried out for health purposes, involving analysis of biological samples of human origin and aiming specifically to identify the genetic characteristics of a person which are inherited or acquired during early prenatal development (hereinafter referred to as “genetic tests”).
2 This Protocol does not apply:
a to genetic tests carried out on the human embryo or foetus;
b to genetic tests carried out for research purposes.
3 For the purposes of paragraph 1:
a “analysis” refers to:
i chromosomal analysis,
ii DNA or RNA analysis,
iii analysis of any other element enabling information to be obtained which is equivalent to that obtained with the methods referred to in sub-paragraphs a.i. and a.ii.;
b “biological samples” refers to:
i biological materials removed for the purpose of the test concerned,
ii biological materials previously removed for another purpose.

The interests and welfare of the human being concerned by genetic tests covered by this Protocol shall prevail over the sole interest of society or science.

1 Any form of discrimination against a person, either as an individual or as a member of a group on grounds of his or her genetic heritage is prohibited.
2 Appropriate measures shall be taken in order to prevent stigmatisation of persons or groups in relation to genetic characteristics.

Parties shall take the necessary measures to ensure that genetic services are of appropriate quality. In particular, they shall see to it that:
a genetic tests meet generally accepted criteria of scientific validity and clinical validity;
b a quality assurance programme is implemented in each laboratory and that laboratories are subject to regular monitoring;
c persons providing genetic services have appropriate qualifications to enable them to perform their role in accordance with professional obligations and standards.

Clinical utility of a genetic test shall be an essential criterion for deciding to offer this test to a person or a group of persons.

1 A genetic test for health purposes may only be performed under individualised medical supervision.
2 Exceptions to the general rule referred to in paragraph 1 may be allowed by a Party, subject to appropriate measures being provided, taking into account the way the test will be carried out, to give effect to the other provisions of this Protocol.
However, such an exception may not be made with regard to genetic tests with important implications for the health of the persons concerned or members of their family or with important implications concerning procreation choices.

1 When a genetic test is envisaged, the person concerned shall be provided with prior appropriate information in particular on the purpose and the nature of the test, as well as the implications of its results.
2 For predictive genetic tests as referred to in Article 12 of the Convention on Human Rights and Biomedicine, appropriate genetic counselling shall also be available for the person concerned.
The tests concerned are:
– tests predictive of a monogenic disease,
– tests serving to detect a genetic predisposition or genetic susceptibility to a disease,
– tests serving to identify the subject as a healthy carrier of a gene responsible for a disease.
The form and extent of this genetic counselling shall be defined according to the implications of the results of the test and their significance for the person or the members of his or her family, including possible implications concerning procreation choices.
Genetic counselling shall be given in a non-directive manner.

1 A genetic test may only be carried out after the person concerned has given free and informed consent to it.
Consent to tests referred to in Article 8, paragraph 2, shall be documented.
2 The person concerned may freely withdraw consent at any time.

Subject to Article 13 of this Protocol, a genetic test on a person who does not have the capacity to consent may only be carried out for his or her direct benefit.
Where, according to law, a minor does not have the capacity to consent, a genetic test on this person shall be deferred until attainment of such capacity unless that delay would be detrimental to his or her health or well-being.

1 When a genetic test is envisaged in respect of a person not able to consent, the person, authority or body whose authorisation is required shall be provided with prior appropriate information in particular with regard to the purpose and the nature of the test, as well as the implications of its results.
Appropriate prior information shall also be provided to the person not able to consent in respect of whom the test is envisaged, to the extent of his or her capacity to understand.
A qualified person shall be available to answer possible questions by the person, authority or body whose authorisation is required, and, if appropriate, the person in respect of whom the test is envisaged.
2 The provisions of Article 8, paragraph 2, shall apply in the case of persons not able to consent to the extent of their capacity to understand.
Where relevant, appropriate support shall be available for the person whose authorisation is required.

1 Where, according to law, a minor does not have the capacity to consent to a genetic test, that test may only be carried out with the authorisation of his or her representative or an authority or a person or body provided for by law.
The opinion of the minor shall be taken into consideration as an increasingly determining factor in proportion to his or her age and degree of maturity.
2 Where, according to law, an adult does not have the capacity to consent to a genetic test because of a mental disability, a disease or for similar reasons, that test may only be carried out with the authorisation of his or her representative or an authority or a person or body provided for by law.
Wishes relating to a genetic test expressed previously by an adult at a time where he or she had capacity to consent shall be taken into account.
The individual concerned shall, to the extent of his or her capacity to understand, take part in the authorisation procedure.
3 Authorisation to tests referred to in Article 8, paragraph 2, shall be documented.
4 The authorisation referred to in paragraphs 1 and 2 above may be withdrawn at any time in the best interests of the person concerned.

Exceptionally, and by derogation from the provisions of Article 6, paragraph 1, of the Convention on Human Rights and Biomedicine and of Article 10 of this Protocol, the law may allow a genetic test to be carried out, for the benefit of family members, on a person who does not have the capacity to consent, if the following conditions are met:
a the purpose of the test is to allow the family member(s) concerned to obtain a preventive, diagnostic or therapeutic benefit that has been independently evaluated as important for their health, or to allow them to make an informed choice with respect to procreation;
b the benefit envisaged cannot be obtained without carrying out this test;
c the risk and burden of the intervention are minimal for the person who is undergoing the test;
d the expected benefit has been independently evaluated as substantially outweighing the risk for private life that may arise from the collection, processing or communication of the results of the test;
e the authorisation of the representative of the person not able to consent, or an authority or a person or body provided for by law has been given;
f the person not able to consent shall, in proportion to his or her capacity to understand and degree of maturity, take part in the authorisation procedure. The test shall not be carried out if this person objects to it.

When it is not possible, with reasonable efforts, to contact a person for a genetic test for the benefit of his or her family member(s) on his or her biological material previously removed for another purpose, the law may allow the test to be carried out in accordance with the principle of proportionality, where the expected benefit cannot be otherwise obtained and where the test cannot be deferred.
Provisions shall be made, in accordance with Article 22 of the Convention on Human Rights and Biomedicine, for the case where the person concerned has expressly opposed such test.

A genetic test for the benefit of other family members may be carried out on biological samples:
– removed from the body of a deceased person, or
– removed, when he or she was alive, from a person now deceased, only if the consent or authorisation required by law has been obtained.

1 Everyone has the right to respect for his or her private life, in particular to protection of his or her personal data derived from a genetic test.
2 Everyone undergoing a genetic test is entitled to know any information collected about his or her health derived from this test.
The conclusions drawn from the test shall be accessible to the person concerned in a comprehensible form.
3 The wish of a person not to be informed shall be respected.
4 In exceptional cases, restrictions may be placed by law on the exercise of the rights contained in paragraphs 2 and 3 above in the interests of the person concerned.

Biological samples referred to in Article 2 shall only be used and stored in such conditions as to ensure their security and the confidentiality of the information which can be obtained therefrom.

Where the results of a genetic test undertaken on a person can be relevant to the health of other family members, the person tested shall be informed.

A health screening programme involving the use of genetic tests may only be implemented if it has been approved by the competent body. This approval may only be given after independent evaluation of its ethical acceptability and fulfilment of the following specific conditions:
a the programme is recognised for its health relevance for the whole population or section of population concerned;
b the scientific validity and effectiveness of the programme have been established;
c appropriate preventive or treatment measures in respect of the disease or disorder which is the subject of the screening, are available to the persons concerned;
d appropriate measures are provided to ensure equitable access to the programme;
e the programme provides measures to adequately inform the population or section of population concerned of the existence, purposes and means of accessing the screening programme as well as the voluntary nature of participation in it.

Parties shall take appropriate measures to facilitate access for the public to objective general information on genetic tests, including their nature and the potential implications of their results.

As between the Parties, the provisions of Articles 1 to 20 of this Protocol shall be regarded as additional articles to the Convention on Human Rights and Biomedicine, and all the provisions of the Convention shall apply accordingly.

None of the provisions of this Protocol shall be interpreted as limiting or otherwise affecting the possibility for a Party to grant persons concerned by genetic testing for health purposes a wider measure of protection than is stipulated in this Protocol.

In order to monitor scientific developments, the present Protocol shall be examined within the Committee referred to in Article 32 of the Convention on Human Rights and Biomedicine no later than five years from the entry into force of this Protocol and thereafter at such intervals as the Committee may determine.

This Protocol shall be open for signature by Signatories to the Convention on Human Rights and Biomedicine. It is subject to ratification, acceptance or approval. A Signatory may not ratify, accept or approve this Protocol unless it has previously or simultaneously ratified, accepted or approved the Convention. Instruments of ratification, acceptance or approval shall be deposited with the Secretary General of the Council of Europe.

1 This Protocol shall enter into force on the first day of the month following the expiration of a period of three months after the date on which five States, including at least four member States of the Council of Europe, have expressed their consent to be bound by the Protocol in accordance with the provisions of Article 24.
2 In respect of any Signatory which subsequently expresses its consent to be bound by it, the Protocol shall enter into force on the first day of the month following the expiration of a period of three months after the date of the deposit of the instrument of ratification, acceptance or approval.

1 After the entry into force of this Protocol, any State which has acceded to the Convention on Human Rights and Biomedicine may also accede to this Protocol.
2 Accession shall be effected by the deposit with the Secretary General of the Council of Europe of an instrument of accession which shall take effect on the first day of the month following the expiration of a period of three months after the date of its deposit.

1 Any Party may at any time denounce this Protocol by means of a notification addressed to the Secretary General of the Council of Europe.
2 Such denunciation shall become effective on the first day of the month following the expiration of a period of three months after the date of receipt of such notification by the Secretary General.

The Secretary General of the Council of Europe shall notify the member States of the Council of Europe, the European Community, any Signatory, any Party and any other State which has been invited to accede to the Convention on Human Rights and Biomedicine of:
a any signature;
b the deposit of any instrument of ratification, acceptance, approval or accession;
c any date of entry into force of this Protocol in accordance with Articles 25 and 26;
d any other act, notification or communication relating to this Protocol.
In witness whereof the undersigned, being duly authorised thereto, have signed this Protocol.
Done at Strasbourg, this 27th day of November 2008, in English and in French, both texts being equally authentic, in a single copy which shall be deposited in the archives of the Council of Europe. The Secretary General of the Council of Europe shall transmit certified copies to each member State of the Council of Europe, to the non-member States which have participated in the elaboration of this Protocol, to any State invited to accede to the Convention on Human Rights and Biomedicine and to the European Community.

Preambula
Države članice Sveta Evrope, druge države in Evropska skupnost, podpisnice tega dodatnega protokola h Konvenciji o varstvu človekovih pravic in dostojanstva človeškega bitja v zvezi z uporabo biologije in medicine (v nadaljnjem besedilu »Konvencija o človekovih pravicah v zvezi z biomedicino«, ETS št. 164), so se,
ker je cilj Sveta Evrope ustvariti večjo enotnost med njegovimi članicami in ker je eden od načinov za uresničevanje tega cilja ohranjanje in nadaljnje uveljavljanje človekovih pravic in temeljnih svoboščin;
ob upoštevanju, da je cilj Konvencije o človekovih pravicah v zvezi z biomedicino, kakor je opredeljen v 1. členu, varovati dostojanstvo in identiteto vseh človeških bitij ter vsakomur brez razlikovanja jamčiti spoštovanje njegove duševne in telesne nedotakljivosti ter drugih pravic in temeljnih svoboščin v zvezi z uporabo biologije in medicine;
ob upoštevanju Konvencije o varstvu posameznikov glede na avtomatsko obdelavo osebnih podatkov (ETS št. 108) z dne 28. januarja 1981;
ob upoštevanju dela, ki so ga opravile druge medvladne organizacije, zlasti pa Splošne deklaracije o človeškem genomu in človekovih pravicah, ki jo je 9. decembra 1998 sprejela Generalna skupščina Združenih narodov;
ker se sklicujejo na to, da je človeški genom skupen vsem človeškim bitjem, kar jih medsebojno povezuje, drobne razlike pa pripomorejo, da ima vsako človeško bitje lastno individualnost;
ker poudarjajo posebno vez, ki obstaja med člani iste družine;
ob upoštevanju, da lahko napredek v medicini pripomore k reševanju življenj in izboljšanju kakovosti življenja;
ob priznavanju koristi genetike, posebej še genetskega testiranja, na področju zdravstva;
glede na to, da so genetske storitve na področju zdravstva sestavni del javne zdravstvene ponudbe, in ob opozarjanju na pomen ustreznih ukrepov, ki jih je treba sprejeti ob upoštevanju zdravstvenih potreb in razpoložljivih virov, da se zagotovi enakopraven dostop do genetskih storitev ustrezne kakovosti;
ker se zavedajo tudi pomislekov glede možne nepravilne uporabe genetskega testiranja, še posebej pa s tem pridobljenih informacij;
ker ponovno potrjujejo temeljno načelo spoštovanja človeškega dostojanstva in prepoved vseh oblik diskriminacije, zlasti še tistih, ki temeljijo na genetskih značilnostih;
ob upoštevanju državnih in mednarodnih strokovnih standardov na področju genetskih storitev ter preteklega dela Odbora ministrov in Parlamentarne skupščine Sveta Evrope na tem področju;
odločene, da sprejmejo take ukrepe, kot so potrebni za zaščito človeškega dostojanstva ter temeljnih pravic in svoboščin posameznika v zvezi z genetskim testiranjem za zdravstvene namene,
sporazumele o naslednjem:

Pogodbenice tega protokola varujejo dostojanstvo in identiteto vseh človeških bitij ter vsakomur brez razlikovanja jamčijo spoštovanje njegove duševne in telesne nedotakljivosti ter drugih pravic in temeljnih svoboščin v zvezi s testiranji, za katera skladno z 2. členom velja ta protokol.

1 Protokol velja za teste, ki se izvajajo za zdravstvene namene, vključujejo analizo bioloških vzorcev človeškega izvora in so namenjeni posebej ugotavljanju genetskih značilnosti posameznika, ki so dedne ali pridobljene v zgodnjem obdobju razvoja zarodka (v nadaljnjem besedilu »genetski testi«).
2 Protokol ne velja za:
a genetske teste, ki se izvajajo pri človeškem zarodku ali plodu;
b genetske teste, ki se izvajajo za raziskovalne namene.
3 V prvem odstavku:
a »analiza« pomeni:
i kromosomsko analizo,
ii analizo DNK ali RNK,
iii analizo katerega koli drugega elementa, ki omogoča pridobitev informacij, enakovrednih tistim, pridobljenim s pomočjo metod iz točk i in ii pododstavka a;
b »biološki vzorci« pomenijo:
i biološke vzorce, odvzete za namen zadevnih testov,
ii biološke vzorce, odvzete predhodno za drug namen.

Koristi in skrb za človeško bitje, pri katerem se izvajajo genetski testi iz tega protokola, morajo prevladati nad izključno koristjo družbe ali znanosti.

1 Vsaka oblika diskriminacije osebe kot posameznika ali člana skupine na podlagi njene genetske zasnove je prepovedana.
2 Sprejmejo se ustrezni ukrepi za preprečevanje stigmatizacije oseb ali skupin v zvezi z genetskimi značilnostmi.

Pogodbenice sprejmejo potrebne ukrepe za zagotavljanje genetskih storitev ustrezne kakovosti. Še zlasti poskrbijo:
a da genetski testi izpolnjujejo splošno sprejeta merila znanstvene in klinične veljavnosti;
b da se v vsakem laboratoriju uvede program zagotavljanja kakovosti, v laboratorijih pa se opravlja redni nadzor;
c da so osebe, ki izvajajo genetske storitve, ustrezno usposobljene, da lahko opravljajo svoje naloge skladno s strokovnimi zahtevami in standardi.

Klinična korist genetskih testov mora biti temeljno merilo pri odločanju, ali naj se neki osebi ali skupini oseb ponudi to testiranje.

1 Genetski test za zdravstvene namene se sme opraviti le pod individualiziranim zdravniškim nadzorom.
2 Pogodbenica lahko dovoli odstopanje od splošnega pravila iz prvega odstavka, če so ob upoštevanju načina izvedbe testa zagotovljeni ustrezni ukrepi, ki omogočajo izvajanje drugih določb tega protokola.
Tako odstopanje pa ni dopustno pri genetskih testih s pomembnim vplivom na zdravje zadevnih oseb ali njihovih družinskih članov oziroma s pomembnim vplivom na odločanje glede izbire pri oploditvi.

1 Kadar se predvideva genetsko testiranje, se zadevni osebi predhodno dajo ustrezne informacije, zlasti še o namenu in naravi testiranja ter posledicah dobljenih izsledkov.
2 Pri napovednih genetskih testih iz 12. člena Konvencije o človekovih pravicah v zvezi z biomedicino mora biti zadevni osebi na razpolago tudi ustrezno genetsko svetovanje.
Ti testi so:
– testi za napovedovanje monogenskih bolezni,
– testi za odkrivanje genetske nagnjenosti ali dovzetnosti za bolezen,
– testi za prepoznavo zdravega subjekta, ki je nosilec gena, odgovornega za pojav neke bolezni.
Oblika in obseg tega genetskega svetovanja se določata glede na posledice izsledkov testa in njihov pomen za zadevno osebo ali njene družinske člane, vključno z mogočim vplivom na odločanje glede izbire pri oploditvi.
Genetsko svetovanje se izvaja na način, ki ni usmerjajoč.

1 Genetsko testiranje se sme izvesti le, če je zadevna oseba vanj prostovoljno privolila na podlagi prejetih pojasnil.
Privolitev v testiranje iz drugega odstavka 8. člena se dokumentira.
2 Zadevna oseba lahko svojo privolitev kadar koli svobodno prekliče.

Ob upoštevanju 13. člena tega protokola se sme opraviti genetski test pri osebi, ki ni sposobna dati privolitve, samo kadar je to v njeno neposredno korist.
Kadar v skladu z zakonom mladoletna oseba ni sposobna dati privolitve, se genetski test pri njej odloži, dokler ne postane opravilno sposobna, razen če bi tak odlog škodil njenemu zdravju ali dobrobiti.

1 Kadar se predvideva genetsko svetovanje pri osebi, ki ni sposobna dati privolitve, se osebi, zavodu ali organu, katerega dovoljenje je potrebno, predhodno dajo ustrezne informacije, zlasti še o namenu in naravi testiranja ter posledicah dobljenih izsledkov.
Osebi, pri kateri je predvideno testiranje in ni sposobna dati privolitve, se da ustrezna predhodna informacija v obsegu, ki ustreza njeni zmožnosti razumevanja.
Na razpolago mora biti usposobljena oseba, da odgovarja na morebitna vprašanja osebe, zavoda ali organa, katerega dovoljenje je potrebno, in če je primerno, tudi osebe, pri kateri je predvideno testiranje.
2 Za osebe, ki niso sposobne dati privolitve, določbe drugega odstavka 8. člena veljajo v obsegu, ki ustreza njihovi zmožnosti razumevanja.
Kadar je to pomembno, mora biti na razpolago ustrezna podpora osebi, katere dovoljenje je potrebno.

1 Kadar v skladu z zakonom mladoletna oseba ni sposobna privoliti v genetsko testiranje, se to lahko opravi le z dovoljenjem njenega zastopnika ali zavoda ali osebe ali organa, kakor je določeno z zakonom.
Pri tem je treba upoštevati mnenje mladoletne osebe, ki je toliko bolj zavezujoče, kolikor starejša in zrelejša je ta oseba.
2 Kadar v skladu z zakonom odrasla oseba ni sposobna privoliti v genetsko testiranje zaradi zmanjšane duševne zmožnosti, bolezni ali podobnih razlogov, se to lahko opravi le z dovoljenjem njenega zastopnika ali zavoda ali osebe ali organa, kakor je določeno z zakonom.
Želje glede genetskega testiranja, ki jih je odrasla oseba izrazila, ko je še bila sposobna dati privolitev, se upoštevajo.
Zadevni posameznik glede na svoje zmožnosti razumevanja sodeluje v postopku pridobitve dovoljenja.
3 Dovoljenje k testom iz drugega odstavka 8. člena se dokumentira.
4 Dovoljenje iz prvega in drugega odstavka tega člena je mogoče kadar koli preklicati, če je to v korist zadevne osebe.

Izjemoma in z odstopanjem od določb prvega odstavka 6. člena Konvencije o človekovih pravicah v zvezi z biomedicino in 10. člena tega protokola je po zakonu lahko dovoljeno opraviti genetski test pri osebi, ki ni sposobna dati privolitve, kadar je to v korist družinskih članov, če so izpolnjeni naslednji pogoji:
a namen testa je omogočiti zadevnemu družinskemu članu ali članom preventivno, diagnostično ali terapevtsko korist, ki je po neodvisni oceni pomembna za njihovo zdravje, ali jim omogočiti, da sprejmejo odločitev glede izbire pri oploditvi na podlagi prejetih pojasnil;
b predvidena korist se ne da doseči brez tega testa;
c tveganje in breme posega sta za osebo, pri kateri se opravi ta test, minimalni;
d po neodvisni oceni pričakovane koristi bistveno presegajo tveganje za zasebno življenje, do katerega bi lahko prišlo zaradi zbiranja, obdelave ali sporočanja izsledkov testiranja;
e pri osebi, ki ni sposobna dati privolitve, je dovoljenje dal njen zakoniti zastopnik ali zavod ali oseba ali organ, kakor je določeno z zakonom;
f oseba, ki ni sposobna dati privolitve, skladno s svojimi zmožnostmi razumevanja sodeluje v postopku pridobitve dovoljenja. Test se ne opravi, če ta oseba temu nasprotuje.

Kadar kljub smiselnim prizadevanjem ni mogoče vzpostaviti stika z osebo za izvedbo genetskega testa v njeno korist ali korist njenih družinskih članov na njenem biološkem materialu, odvzetem predhodno za kak drug namen, je zakonsko dopustno opraviti testiranje v skladu z načelom sorazmernosti, kadar pričakovane koristi ni mogoče doseči kako drugače in se test ne da odložiti.
Skladno z 22. členom Konvencije o človekovih pravicah v zvezi z biomedicino se predvidi tudi možnost, kadar zadevna oseba izrecno nasprotuje takemu testiranju.

Genetski test v korist drugih družinskih članov se lahko opravi na bioloških vzorcih:
– odvzetih s/iz telesa umrle osebe ali
– odvzetih umrli osebi še za časa njenega življenja, samo če je bila pridobljena privolitev ali z zakonom predpisano dovoljenje.

1 Vsakdo ima pravico do spoštovanja svojega zasebnega življenja, zlasti še do varovanja svojih osebnih podatkov v zvezi z genetskimi testi.
2 Vsakdo, pri katerem se opravi genetski test, ima pravico do katerih koli informacij o svojem zdravju, ki so bile zbrane s pomočjo tega testa.
Ugotovitve na podlagi tega testa morajo biti zadevni osebi dostopne v razumljivi obliki.
3 Željo osebe, ki ne želi biti obveščena, je treba spoštovati.
4 Izjemoma se lahko v korist zadevne osebe zakonsko omeji uveljavljanje pravic iz drugega in tretjega odstavka tega člena.

Biološki vzorci iz 2. člena se smejo uporabljati in shranjevati le pod pogoji, ki zagotavljajo njihovo varnost in zaupnost podatkov, ki jih je mogoče pridobiti iz teh vzorcev.

Kadar so lahko izsledki genetskega testa, opravljenega pri neki osebi, pomembni za zdravje drugih družinskih članov, je treba testirano osebo o tem obvestiti.

Zdravstveni program presejanja, ki vključuje uporabo genetskih testov, se sme izvajati, samo če ga je odobril pristojni organ. Ta odobritev pa lahko temelji samo na neodvisni oceni etične sprejemljivosti in izpolnjevanja teh posebnih pogojev:
a program je priznan kot pomemben za zdravje celotnega prebivalstva ali dela zadevnega prebivalstva;
b ugotovljeni sta znanstvena veljavnost in učinkovitost programa;
c zadevni osebi so na razpolago ustrezni preventivni ali terapevtski ukrepi za bolezen ali motnjo, ki je predmet presejanja;
d na razpolago so ustrezni ukrepi za zagotavljanje enakopravnega dostopa do programa;
e program vključuje ukrepe za ustrezno obveščanje prebivalstva ali dela zadevnega prebivalstva o obstoju in namenu programa presejanja ter načinu dostopa do njega in o prostovoljni naravi sodelovanja v njem.

Pogodbenice sprejmejo ustrezne ukrepe, da javnosti omogočijo dostop do objektivnih splošnih informacij o genetskih testih, vključno z njihovo naravo in mogočimi posledicami njihovih izsledkov.

Med pogodbenicami velja, da se vse določbe od 1. do 20. člena tega protokola obravnavajo kot dodatni členi Konvencije o človekovih pravicah v zvezi z biomedicino, vse določbe konvencije pa se uporabljajo skladno s tem.

Nobena določba tega protokola se ne razlaga, kot da omejuje ali drugače vpliva na možnost pogodbenice, da osebam, na katere se nanaša genetsko testiranje za zdravstvene namene, zagotovi večje varstvo, kot je določeno v tem protokolu.

Da bi spremljali razvoj znanosti, odbor iz 32. člena Konvencije o človekovih pravicah v zvezi z biomedicino pregleda ta protokol najpozneje po petih letih od začetka njegove veljavnosti in nato v presledkih, ki jih lahko določi odbor.

Protokol je na voljo za podpis podpisnicam Konvencije o človekovih pravicah v zvezi z biomedicino. Treba ga je ratificirati, sprejeti ali odobriti. Podpisnica ga ne sme ratificirati, sprejeti ali odobriti, razen če ni prej ali sočasno ratificirala, sprejela ali odobrila konvencije. Listine o ratifikaciji, sprejetju ali odobritvi se deponirajo pri generalnem sekretarju Sveta Evrope.

1 Protokol začne veljati prvi dan meseca po poteku treh mesecev po dnevu, ko je pet držav, od katerih so najmanj štiri države članice Sveta Evrope, v skladu z določbami 24. člena privolile, da jih protokol zavezuje.
2 Za vsako podpisnico, ki pozneje privoli, da jo protokol zavezuje, začne protokol veljati prvi dan meseca, ki sledi izteku treh mesecev od dneva deponiranja listine o ratifikaciji, sprejetju ali odobritvi.

1 Po začetku veljavnosti tega protokola lahko vsaka država, ki je pristopila h Konvenciji o človekovih pravicah v zvezi z biomedicino, pristopi tudi k temu protokolu.
2 Za pristop se pri generalnem sekretarju Sveta Evrope deponira listina o pristopu, veljati pa začne prvi dan meseca po poteku treh mesecev po dnevu deponiranja.

1 Vsaka pogodbenica lahko ta protokol kadar koli odpove z uradnim obvestilom, naslovljeno na generalnega sekretarja Sveta Evrope.
2 Odpoved začne veljati prvi dan meseca po poteku treh mesecev po dnevu, ko generalni sekretar prejme uradno obvestilo.

Generalni sekretar Sveta Evrope uradno obvesti države članice Sveta Evrope, Evropsko skupnost, vsako podpisnico, vsako pogodbenico in vsako drugo državo, ki je bila povabljena, da pristopi h Konvenciji o človekovih pravicah v zvezi z biomedicino, o:
a vsakem podpisu;
b deponiranju vsake listine o ratifikaciji, sprejetju, odobritvi ali pristopu;
c vsakem datumu začetka veljavnosti tega protokola v skladu s 25. in 26. členom;
d vsakem drugem dejanju, uradnem obvestilu ali sporočilu v zvezi s tem protokolom.
V potrditev tega so podpisani, ki so bili za to pravilno pooblaščeni, podpisali ta protokol.
Sestavljeno v Strasbourgu 27. novembra 2008 v angleškem in francoskem jeziku, pri čemer sta besedili enako verodostojni, v enem izvodu, ki se hrani v arhivu Sveta Evrope. Generalni sekretar Sveta Evrope pošlje overjene kopije državam članicam Sveta Evrope, državam nečlanicam, ki so sodelovale pri pripravi tega protokola, vsaki državi, ki je povabljena, da pristopi h Konvenciji o človekovih pravicah v zvezi z biomedicino, ter Evropski skupnosti.

Za izvajanje dodatnega protokola skrbi Ministrstvo za zdravje.

Ta zakon začne veljati naslednji dan po objavi v Uradnem listu Republike Slovenije – Mednarodne pogodbe.