Na podlagi prve in tretje alinee petega odstavka 75. člena Zakona o zunanjih zadevah (Uradni list RS, št. 113/03 – uradno prečiščeno besedilo) izdaja Vlada Republike Slovenije
U R E D B O
O RATIFIKACIJI DODATNEGA PROTOKOLA O PRESADITVI ČLOVEŠKIH ORGANOV IN TKIV H KONVENCIJI O ČLOVEKOVIH PRAVICAH V ZVEZI Z BIOMEDICINO
1. člen
Ratificira se Dodatni protokol o presaditvi človeških organov in tkiv h Konvenciji o človekovih pravicah v zvezi z biomedicino, sklenjen v Strasbourgu 24. januarja 2002.
2. člen
Besedilo protokola se v izvirniku v angleškem jeziku ter v prevodu v slovenskem jeziku glasi:
ADDITIONAL PROTOCOL
TO THE CONVENTION ON HUMAN RIGHTS
AND BIOMEDICINE CONCERNING TRANSPLANTATION OF ORGANS AND TISSUES OF HUMAN ORIGIN
Strasbourg, 24.I.2002
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 “Convention on Human Rights and Biomedicine”),
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;
Considering that progress in medical science, in particular in the field of organ and tissue transplantation, contributes to saving lives or greatly improving their quality;
Considering that transplantation of organs and tissues is an established part of the health services offered to the population;
Considering that, in view of the shortage of organs and tissues, appropriate action should be taken to increase organ and tissue donation, in particular by informing the public of the importance of organ and tissue transplantation and by promoting European co-operation in this field;
Considering moreover the ethical, psychological and socio-cultural problems inherent in the transplantation of organs and tissues;
Considering that the misuse of organ and tissue transplantation may lead to acts endangering human life, well being or dignity;
Considering that organ and tissue transplantation should take place under conditions protecting the rights and freedoms of donors, potential donors and recipients of organs and tissues and that institutions must be instrumental in ensuring such conditions;
Recognising that, in facilitating the transplantation of organs and tissues in the interest of patients in Europe, there is a need to protect individual rights and freedoms and to prevent the commercialisation of parts of the human body involved in organ and tissue procurement, exchange and allocation activities;
Taking into account 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 rights and fundamental freedoms of the individual with regard to organ and tissue transplantation,
Have agreed as follows:
Chapter I – Object and scope
Article 1 – Object
Parties to this Protocol shall protect the dignity and identity of everyone and guarantee, without discrimination, respect for his or her integrity and other rights and fundamental freedoms with regard to transplantation of organs and tissues of human origin.
Article 2 – Scope and definitions
1 This Protocol applies to the transplantation of organs and tissues of
human origin carried out for therapeutic purposes.
2 The provisions of this Protocol applicable to tissues shall apply
also to cells, including haematopoietic stem cells.
3 The Protocol does not apply:
a to reproductive organs and tissue;
b to embryonic or foetal organs and tissues;
c to blood and blood derivatives.
4 For the purposes of this Protocol:
– the term “transplantation” covers the complete process of removal
of an organ or tissue from one person and implantation of that organ or
tissue into another person, including all procedures for preparation,
preservation and storage;
– subject to the provisions of Article 20, the term “removal” refers
to removal for the purposes of implantation.
Chapter II – General provisions
Article 3 – Transplantation system
Parties shall guarantee that a system exists to provide equitable access to transplantation services for patients.
Subject to the provisions of Chapter III, organs and, where appropriate, tissues shall be allocated only among patients on an official waiting list, in conformity with transparent, objective and duly justified rules according to medical criteria. The persons or bodies responsible for the allocation decision shall be designated within this framework.
In case of international organ exchange arrangements, the procedures must also ensure justified, effective distribution across the participating countries in a manner that takes into account the solidarity principle within each country.
The transplantation system shall ensure the collection and recording of the information required to ensure traceability of organs and tissues.
Article 4 – Professional standards
Any intervention in the field of organ or tissue transplantation must be carried out in accordance with relevant professional obligations and standards.
Article 5 – Information for the recipient
The recipient and, where appropriate, the person or body providing authorisation for the implantation shall beforehand be given appropriate information as to the purpose and nature of the implantation, its consequences and risks, as well as on the alternatives to the intervention.
Article 6 – Health and safety
All professionals involved in organ or tissue transplantation shall take all reasonable measures to minimise the risks of transmission of any disease to the recipient and to avoid any action which might affect the suitability of an organ or tissue for implantation.
Article 7 – Medical follow-up
Appropriate medical follow-up shall be offered to living donors and recipients after transplantation.
Article 8 – Information for health professionals and the public
Parties shall provide information for health professionals and for the public in general on the need for organs and tissues. They shall also provide information on the conditions relating to removal and implantation of organs and tissues, including matters relating to consent or authorisation, in particular with regard to removal from deceased persons.
Chapter III – Organ and tissue removal from living persons
Article 9 – General rule
Removal of organs or tissue from a living person may be carried out solely for the therapeutic benefit of the recipient and where there is no suitable organ or tissue available from a deceased person and no other alternative therapeutic method of comparable effectiveness.
Article 10 – Potential organ donors
Organ removal from a living donor may be carried out for the benefit of a recipient with whom the donor has a close personal relationship as defined by law, or, in the absence of such relationship, only under the conditions defined by law and with the approval of an appropriate independent body.
Article 11 – Evaluation of risks for the donor
Before organ or tissue removal, appropriate medical investigations and interventions shall be carried out to evaluate and reduce physical and psychological risks to the health of the donor.
The removal may not be carried out if there is a serious risk to the life or health of the donor.
Article 12 – Information for the donor
The donor and, where appropriate, the person or body providing authorisation according to Article 14, paragraph 2, of this Protocol, shall beforehand be given appropriate information as to the purpose and nature of the removal as well as on its consequences and risks.
They shall also be informed of the rights and the safeguards prescribed by law for the protection of the donor. In particular, they shall be informed of the right to have access to independent advice about such risks by a health professional having appropriate experience and who is not involved in the organ or tissue removal or subsequent transplantation procedures.
Article 13 – Consent of the living donor
Subject to Articles 14 and 15 of this Protocol, an organ or tissue may be removed from a living donor only after the person concerned has given free, informed and specific consent to it either in written form or before an official body.
The person concerned may freely withdraw consent at any time.
Article 14 – Protection of persons not able to consent to organ or tissue removal
1 No organ or tissue removal may be carried out on a person who does
not have the capacity to consent under Article 13 of this Protocol.
2 Exceptionally, and under the protective conditions prescribed by law,
the removal of regenerative tissue from a person who does not have the
capacity to consent may be authorised provided the following conditions are
met:
i there is no compatible donor available who has the capacity to
consent;
ii the recipient is a brother or sister of the donor;
iii the donation has the potential to be life-saving for the
recipient;
iv the authorisation of his or her representative or an authority
or a person or body provided for by law has been given specifically and in
writing and with the approval of the competent body;
v the potential donor concerned does not object.
Article 15 – Cell removal from a living donor
The law may provide that the provisions of Article 14, paragraph 2, indents ii and iii, shall not apply to cells insofar as it is established that their removal only implies minimal risk and minimal burden for the donor.
Chapter IV – Organ and tissue removal from deceased persons
Article 16 – Certification of death
Organs or tissues shall not be removed from the body of a deceased person unless that person has been certified dead in accordance with the law.
The doctors certifying the death of a person shall not be the same doctors who participate directly in removal of organs or tissues from the deceased person, or subsequent transplantation procedures, or having responsibilities for the care of potential organ or tissue recipients.
Article 17 – Consent and authorisation
Organs or tissues shall not be removed from the body of a deceased person unless consent or authorisation required by law has been obtained.
The removal shall not be carried out if the deceased person had objected to it.
Article 18 – Respect for the human body
During removal the human body must be treated with respect and all reasonable measures shall be taken to restore the appearance of the corpse.
Article 19 – Promotion of donation
Parties shall take all appropriate measures to promote the donation of organs and tissues.
Chapter V – Implantation of an organ or tissue removed for a purpose other than donation for implantation
Article 20 – Implantation of an organ or tissue removed for a purpose other than donation for implantation
1 When an organ or tissue is removed from a person for a purpose other than donation for implantation, it may only be implanted if the consequences and possible risks have been explained to that person and his or her informed consent, or appropriate authorisation in the case of a person not able to consent, has been obtained.
2 All the provisions of this Protocol apply to the situations referred to in paragraph 1, except for those in Chapter III and IV.
Chapter VI – Prohibition of financial gain
Article 21 – Prohibition of financial gain
1 The human body and its parts shall not, as such, give rise to
financial gain or comparable advantage.
The aforementioned provision shall not prevent payments which do not
constitute a financial gain or a comparable advantage, in particular:
– compensation of living donors for loss of earnings and any other
justifiable expenses caused by the removal or by the related medical
examinations;
– payment of a justifiable fee for legitimate medical or related
technical services rendered in connection with transplantation;
– compensation in case of undue damage resulting from the removal of
organs or tissues from living persons.
2 Advertising the need for, or availability of, organs or tissues, with
a view to offering or seeking financial gain or comparable advantage, shall
be prohibited.
Article 22 – Prohibition of organ and tissue trafficking
Organ and tissue trafficking shall be prohibited.
Chapter VII – Confidentiality
Article 23 – Confidentiality
1 All personal data relating to the person from whom organs or tissues have been removed and those relating to the recipient shall be considered to be confidential. Such data may only be collected, processed and communicated according to the rules relating to professional confidentiality and personal data protection.
2 The provisions of paragraph 1 shall be interpreted without prejudice to the provisions making possible, subject to appropriate safeguards, the collection, processing and communication of the necessary information about the person from whom organs or tissues have been removed or the recipient(s) of organs and tissues in so far as this is required for medical purposes, including traceability, as provided for in Article 3 of this Protocol.
Chapter VIII – Infringements of the provisions of the Protocol
Article 24 – Infringements of rights or principles
Parties shall provide appropriate judicial protection to prevent or to put a stop to an unlawful infringement of the rights and principles set forth in this Protocol at short notice.
Article 25 – Compensation for undue damage
The person who has suffered undue damage resulting from transplantation procedures is entitled to fair compensation according to the conditions and procedures prescribed by law.
Article 26 – Sanctions
Parties shall provide for appropriate sanctions to be applied in the event of infringement of the provisions contained in this Protocol.
Chapter IX – Co-operation between Parties
Article 27 – Co-operation between Parties
Parties shall take appropriate measures to ensure that there is efficient co-operation between them on organ and tissue transplantation, inter alia through information exchange.
In particular, they shall undertake appropriate measures to facilitate the rapid and safe transportation of organs and tissues to and from their territory.
Chapter X – Relation between this Protocol and the Convention, and re-examination of the Protocol
Article 28 – Relation between this Protocol and
the Convention
As between the Parties, the provisions of Articles 1 to 27 of this Protocol shall be regarded as additional articles to the Convention on Human Rights and Biomedicine, and all the provisions of that Convention shall apply accordingly.
Article 29 – Re-examination of the 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.
Chapter XI – Final clauses
Article 30 – Signature and ratification
This Protocol shall be open for signature by Signatories to the Convention. 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.
Article 31 – Entry into force
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 30.
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.
Article 32 – Accession
1 After the entry into force of this Protocol, any State which has acceded to the Convention 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.
Article 33 – Denunciation
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.
Article 34 – Notification
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 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 31 and 32;
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 24th day of January 2002, 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 and to the European Community.
DODATNI PROTOKOL
O PRESADITVI ČLOVEŠKIH ORGANOV IN TKIV H KONVENCIJI O ČLOVEKOVIH PRAVICAH V ZVEZI Z BIOMEDICINO
Strasbourg, 24.I.2002
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 imenovane »Konvencija o človekovih pravicah v zvezi z biomedicino«), so se
ob upoštevanju, da je cilj Sveta Evrope tesneje povezati svoje članice in da je eden od načinov za doseganje tega cilja ohranjanje in nadaljnje uresničevanje človekovih pravic in temeljnih svoboščin;
ob upoštevanju, da je cilj Konvencije o človekovih pravicah v zvezi z biomedicino, kot je opredeljen v 1. členu, varovati dostojanstvo in identiteto vseh ljudi in vsakomur brez razlikovanja jamčiti spoštovanje njegove nedotakljivosti in druge pravice ter temeljne svoboščine v zvezi z uporabo biologije in medicine;
ob upoštevanju, da napredek medicinske znanosti, zlasti na področju presajanja organov in tkiv, prispeva k reševanju življenj ali bistveno boljšemu življenju;
ob upoštevanju, da je presaditev organov in tkiv uveljavljen del zdravstvenih storitev, ki so na voljo prebivalstvu;
ob upoštevanju, da je zaradi pomanjkanja organov in tkiv treba sprejeti primerne ukrepe, s katerimi bi povečali darovanje organov in tkiv, predvsem s seznanjanjem javnosti s pomembnostjo presajanja organov in tkiv in s spodbujanjem evropskega sodelovanja na tem področju;
tudi ob upoštevanju etičnih, psiholoških in socialno-kulturnih vprašanj, povezanih s presajanjem organov in tkiv;
ob upoštevanju, da bi neustrezna uporaba presajanja organov in tkiv lahko privedla do dejanj, ki bi ogrozila človekovo življenje, blaginjo ali dostojanstvo;
ob upoštevanju, da bi presajanje organov in tkiv moralo potekati v razmerah, v katerih so zavarovane pravice in svoboščine darovalcev, možnih darovalcev in prejemnikov organov in tkiv in da morajo ustanove pomagati pri zagotavljanju takih razmer;
zavedajoč se, da je ob pospeševanju presajanja organov in tkiv v korist bolnikov v Evropi treba zaščititi pravice in svoboščine posameznika in preprečiti trgovanje z deli človeškega telesa pri pridobivanju, izmenjavi in dodeljevanju organov in tkiv;
ob upoštevanju predhodnega dela Odbora ministrov in Parlamentarne skupščine Sveta Evrope na tem področju;
odločene, da v zvezi s presajanjem organov in tkiv sprejmejo ukrepe, potrebne za zaščito človeškega dostojanstva ter temeljnih pravic in svoboščin posameznika,
sporazumele o naslednjem:
I. poglavje – Predmet in področje uporabe
1. člen – Predmet
Pogodbenice tega protokola ščitijo dostojanstvo in identiteto vsakogar in vsakomur brez razlikovanja jamčijo spoštovanje njegove nedotakljivosti ter druge pravice in temeljne svoboščine v zvezi s presaditvijo človeških organov in tkiv.
2. člen – Področje uporabe in opredelitve
1. Protokol se nanaša na presajanje človeških organov in tkiv, ki se
izvaja v zdravstvene namene.
2. Določbe protokola, ki se uporabljajo za tkiva, se uporabljajo tudi za
celice, ki vključujejo krvotvorne matične celice.
3. Protokol ne velja za:
a. reproduktivne organe in tkiva,
b. organe in tkiva zarodkov in plodov
c. kri in krvne pripravke.
4. Pri tem protokolu:
– izraz »presaditev« obsega celoten postopek odvzema organa ali
tkiva pri neki osebi in presaditev takega organa ali tkiva na drugo osebo in
vključuje vse postopke v zvezi s pripravo, konzerviranjem in shranjevanjem;
– ob upoštevanju določb 20. člena se izraz »odvzem« nanaša na odvzem
zaradi presaditve.
II. poglavje – Splošne določbe
3. člen – Sistem presaditve
Pogodbenice jamčijo, da obstaja sistem, ki zagotavlja vsem bolnikom pravičen dostop do storitev presaditve.
Ob upoštevanju določb III. poglavja se organi in, kjer je primerno, tkiva dodeljujejo samo bolnikom, ki so na uradnem seznamu čakanja na organe, v skladu z jasnimi, objektivnimi in primerno utemeljenimi pravili medicinskih meril. Osebe ali organi, odgovorni za odločanje o dodelitvi, so imenovani v tem okviru.
Pri mednarodnih dogovorih o izmenjavi organov morajo postopki tudi zagotoviti utemeljeno in učinkovito razdeljevanje med državami udeleženkami ob upoštevanju načela solidarnosti znotraj vsake države.
Sistem presaditve zagotavlja zbiranje in zapisovanje potrebnih podatkov, ki zagotavljajo sledljivost organov in tkiv.
4. člen – Poklicne norme
Vsak poseg na področju presajanja organov ali tkiv mora biti izveden v skladu z ustreznimi poklicnimi dolžnostmi in normami.
5. člen – Obveščanje prejemnika
Prejemnik in, kjer je primerno, oseba ali organ, ki priskrbi dovoljenje za vsaditev, prejmejo predhodno ustrezno obvestilo o namenu in vrsti vsaditve, njenih posledicah in nevarnostih kot tudi o drugih možnih načinih zdravljenja.
6. člen – Zdravje in varnost
Vsi strokovnjaki, vključeni v presaditev organov ali tkiv, sprejmejo vse razumne ukrepe, da bi čim bolj zmanjšali nevarnost prenosa kakršne koli bolezni na prejemnika in da bi se izognili vsakemu dejanju, ki bi lahko škodilo ustreznosti organa ali tkiva za presaditev.
7. člen – Zdravstveni nadzor
Po presaditvi se živim dajalcem in prejemnikom zagotovi ustrezen zdravstveni nadzor.
8. člen – Obveščanje zdravstvenih strokovnjakov in javnosti
Pogodbenice obveščajo zdravstvene strokovnjake in širšo javnost o potrebah po organih in tkivih. Seznanjajo jih tudi s pogoji, ki se nanašajo na odvzem in vsaditev organov in tkiv, vključno z zadevami, ki se nanašajo na privolitev ali dovoljenje, zlasti ko gre za odvzem pri umrlih osebah.
III. poglavje – Odvzem organov in tkiv
pri živih osebah
9. člen – Splošno pravilo
Organi ali tkiva se smejo odvzeti živemu darovalcu samo zaradi zdravljenja prejemnika in če ni na voljo primernega organa ali tkiva umrle osebe niti nobenega drugega možnega primerljivo učinkovitega načina zdravljenja.
10. člen – Možni darovalci organov
Organ se sme odvzeti živemu darovalcu v korist prejemnika, s katerim je darovalec v tesnem osebnem razmerju, opredeljenim z zakonom, če pa takega razmerja ni, pa le pod pogoji, ki so opredeljeni z zakonom in z odobritvijo ustreznega neodvisnega organa.
11. člen – Ocena nevarnosti za darovalca
Pred odvzemom organa ali tkiva se opravijo primerne medicinske preiskave in posegi, s katerimi se ocenijo in zmanjšajo fizične in psihološke nevarnosti za zdravje darovalca.
Odvzema ni mogoče opraviti, če sta življenje ali zdravje darovalca izpostavljena resni nevarnosti.
12. člen – Obvestitev darovalca
Darovalec in, kjer je primerno, oseba ali organ, ki priskrbi dovoljenje v skladu z 2. odstavkom 14. člena tega protokola, prejmejo predhodno ustrezno obvestilo o namenu in vrsti odvzema kot tudi o njegovih posledicah in nevarnostih.
Obveščeni so tudi o pravicah in jamstvih, ki jih predpisuje zakon v zvezi z zaščito darovalca. Posebej so obveščeni o pravici, da si o teh nevarnostih pridobijo neodvisno mnenje zdravstvenega strokovnjaka, ki ima primerne izkušnje in ki ni vključen v odvzem organa ali tkiva ali v poznejši postopek presaditve.
13. člen – Privolitev živega darovalca
Ob upoštevanju 14. in 15. člena protokola se organ ali tkivo lahko odvzame živemu darovalcu šele potem, ko je bila oseba, ki jo to zadeva, o odvzemu poučena in je vanj izrecno in prostovoljno privolila, bodisi v pisni obliki ali pred uradnim organom.
Oseba, ki jo to zadeva, lahko privolitev kadar koli svobodno prekliče.
14. člen – Varstvo oseb, ki niso sposobne privoliti v odvzem organa ali tkiva
1. Noben organ ali tkivo se ne sme odvzeti osebi, ki ni sposobna
privoliti v skladu s 13. členom tega protokola.
2. Izjemoma in pod varovalnimi pogoji, ki jih predpisuje zakon, se lahko
dovoli odvzem obnovljivega tkiva osebi, ki ni sposobna privoliti, če so
izpolnjeni naslednji pogoji:
i. da ni na voljo nobenega biološko ustreznega darovalca, ki je
sposoben privoliti;
ii. da je prejemnik brat ali sestra darovalca;
iii. da gre za darovanje, ki lahko reši življenje prejemnika;
iv. da je bilo dano dovoljenje zastopnika te osebe ali zavoda ali
osebe ali organa posebej za ta namen in v pisni obliki, kot predpisuje
zakon, in z odobritvijo pristojnega telesa;
v. da možni darovalec, ki ga to zadeva, ne nasprotuje.
15. člen – Odvzem celice pri živem darovalcu
Zakon lahko določi, da se določbe iz ii. in iii. alinee 2. odstavka 14. člena ne nanašajo na celice, če se ugotovi, da njihov odvzem pomeni za darovalca le minimalno nevarnost in minimalno žrtev.
IV. poglavje – Odvzem organov in tkiv pri umrlih osebah
16. člen – Ugotovitev smrti
Organi ali tkiva se odvzamejo iz telesa umrle osebe samo takrat, če je ugotovljena smrt te osebe v skladu z zakonom.
Zdravniki, ki ugotovijo smrt te osebe, ne smejo biti isti zdravniki, ki bodo neposredno udeleženi pri odvzemu organov ali tkiv umrle osebe ali v poznejših postopkih presaditve ali če so odgovorni za zdravljenje možnih prejemnikov organov ali tkiv.
17. člen – Privolitev in dovoljenje
Organi ali tkiva se smejo odvzeti iz telesa umrle osebe samo takrat, če sta pridobljena privolitev ali dovoljenje, zahtevana z zakonom.
Odvzem se ne more izvršiti, če je umrla oseba temu nasprotovala.
18. člen – Spoštovanje človeškega telesa
Med odvzemom je treba človeško telo obravnavati spoštljivo in storiti vse potrebno v mejah možnosti, da se truplu vrne prvoten videz.
19. člen – Spodbujanje darovanja organov in tkiv
Pogodbenice sprejmejo vse primerne ukrepe za spodbujanje darovanja organov in tkiv.
V. poglavje – Presaditev organa ali tkiva, odvzetega za drug namen kot za darovanje za presaditev
20. člen – Presaditev organa ali tkiva, odvzetega za drug namen kot za darovanje za presaditev
1. Ko se osebi odvzame organ ali tkivo za drug namen kot za darovanje za presaditev, se ta organ ali tkivo sme vsaditi samo, če je bila ta oseba poučena o posledicah in možnih tveganjih in če je bila pridobljena njena poučena privolitev oziroma ustrezno dovoljenje, če gre za osebo, ki ni sposobna privoliti.
2. Vse določbe tega protokola se nanašajo na okoliščine, navedene v 1. poglavju razen tistih, navedenih v III. in IV. poglavju.
VI. poglavje – Prepoved pridobivanja premoženjske koristi
21. člen – Prepoved pridobivanja premoženjske koristi
1. Človeško telo in njegovi deli sami po sebi ne smejo biti predmet
pridobivanja premoženjske koristi ali primerljive koristi.
Prej omenjena določba ne preprečuje plačil, ki ne pomenijo
premoženjske koristi ali primerljive koristi, zlasti:
– nadomestil živim darovalcem za izgubo zaslužka in vseh drugih
utemeljenih stroškov, nastalih zaradi odvzema ali s tem povezanih
zdravniških pregledov;
– plačila upravičenih stroškov za izvedbo zakonitih medicinskih ali
sorodnih tehničnih storitev, opravljenih v zvezi s presaditvijo;
– odškodnine za neupravičeno škodo, nastalo zaradi odvzema organov
ali tkiv pri živih osebah.
2. Prepovedano je oglaševanje potreb po organih ali tkivih oziroma
njihove razpoložljivosti z namenom ponujanja ali iskanja premoženjske
koristi ali primerljive koristi.
22. člen – Prepoved trgovanja z organi in tkivi
Trgovanje z organi in tkivi je prepovedano.
VII. poglavje – Zaupnost
23. člen – Zaupnost
1. Vsi osebni podatki, ki se nanašajo na osebo, ki so ji bili odvzeti organi ali tkiva in tisti, ki se nanašajo na prejemnika, veljajo za zaupne. Takšni podatki se lahko zbirajo, obdelujejo in sporočajo samo v skladu s pravili, ki se nanašajo na poklicno zaupnost in na varstvo osebnih podatkov.
2. Določb 1. odstavka se ne razume na škodo določb, ki ob primernih jamstvih omogočajo zbiranje, obdelavo in sporočanje potrebnih podatkov o osebi, ki so ji bili odvzeti organi ali tkiva ali o prejemniku oziroma prejemnikih organov in tkiv, če je to potrebno iz medicinskih razlogov, vključno zaradi sledljivosti, kot je predvideno v 3. členu tega protokola.
VIII. poglavje – Kršenje določb protokola
24. člen – Kršenje pravic ali načel
Pogodbenice zagotavljajo primerno sodno varstvo za takojšnjo preprečitev ali ustavitev nezakonitega kršenja pravic in načel, navedenih v tem protokolu.
25. člen – Odškodnina za neupravičeno škodo
Oseba, ki je zaradi postopka presaditve utrpela neupravičeno škodo, ima pod pogoji in na način, ki ga določa zakon, pravico do pravične odškodnine.
26. člen – Sankcije
Pogodbenice predvidijo ustrezne sankcije, ki jih je treba uporabiti, če se kršijo določbe tega protokola.
IX. poglavje – Sodelovanje med pogodbenicami
27. člen – Sodelovanje med pogodbenicami
Pogodbenice sprejmejo primerne ukrepe, s katerimi zagotovijo učinkovito medsebojno sodelovanje na področju presajanja organov in tkiv, med drugim z izmenjavo podatkov.
Posebej sprejmejo ustrezne ukrepe, s katerimi bodo olajšale hiter in varen prevoz organov in tkiv na njihovo ozemlje in iz njega.
X. poglavje – Razmerje med tem protokolom in konvencijo ter ponovna presoja protokola
28. člen – Razmerje med tem protokolom in
konvencijo
Pogodbenice štejejo določbe 1. do 27. člena tega protokola kot dodatne člene h Konvenciji o človekovih pravicah v zvezi z biomedicino, pri čemer se vse določbe te konvencije ustrezno uporabljajo.
29. člen – Ponovna presoja protokola
Da bi sledili razvoju znanosti, bo odbor, imenovan v 32. členu Konvencije o človekovih pravicah v zvezi z biomedicino, ponovno presodil ustreznost protokola najpozneje pet let po začetku njegove veljavnosti, nato pa v takih presledkih, kot bo določil odbor.
XI. poglavje – Končne določbe
30. člen – Podpis in ratifikacija
Ta protokol je na voljo za podpis podpisnicam konvencije. Treba ga je ratificirati, sprejeti ali odobriti. Podpisnica ne sme ratificirati, sprejeti ali odobriti tega protokola, če ni pred tem ali sočasno ratificirala, sprejela ali odobrila konvencije. Listine o ratifikaciji, sprejetju ali odobritvi so shranjene pri generalnem sekretarju Sveta Evrope.
31. člen – Začetek veljavnosti
1. Protokol začne veljati prvi dan meseca, ki sledi izteku trimesečnega obdobja po dnevu, ko je pet držav, od katerih so najmanj štiri države članice Sveta Evrope, privolilo, da jih protokol zavezuje v skladu z določbami 30. člena.
2. Za vsako podpisnico, ki pozneje privoli, da jo protokol zavezuje, začne ta veljati prvi dan meseca, ki sledi izteku trimesečnega obdobja po dnevu vložitve njene listine o ratifikaciji, sprejetju ali odobritvi.
32. člen – Pristop
1. Po začetku veljavnosti protokola lahko vsaka država, ki je pristopila h konvenciji, pristopi tudi k temu protokolu.
2. Pristop se opravi z vložitvijo pristopne listine pri generalnem sekretarju Sveta Evrope, ki začne veljati prvi dan meseca, ki sledi izteku trimesečnega obdobja po dnevu njene vložitve.
33. člen – Odpoved
1. Vsaka pogodbenica lahko protokol kadar koli odpove z notifikacijo, naslovljeno na generalnega sekretarja Sveta Evrope.
2. Taka odpoved začne veljati prvi dan meseca, ki sledi izteku trimesečnega obdobja po dnevu, ko je generalni sekretar prejel tako notifikacijo.
34. člen – Notifikacija
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:
a. vsakem podpisu,
b. vložitvi vsake listine o ratifikaciji, sprejetju, odobritvi ali
pristopu,
c. vsakem datumu začetka veljavnosti protokola v skladu z 31. in 32.
členom,
d. vsakem drugem dejanju, notifikaciji ali obvestilu v zvezi s tem
protokolom.
V potrditev tega so podpisani, ki so bili za to pravilno pooblaščeni, podpisali ta protokol.
Sklenjeno v Strasbourgu 24. januarja 2002, v angleščini in francoščini, pri čemer sta obe besedili enako verodostojni, v enem samem izvodu, ki je shranjen v arhivu Sveta Evrope. Generalni sekretar Sveta Evrope pošlje overjeno kopijo vsaki državi članici Sveta Evrope, državam nečlanicam, ki so sodelovale pri pripravi tega protokola, vsaki državi, ki je bila povabljena, da pristopi h konvenciji, in Evropski skupnosti.
3. člen
Za izvajanje protokola skrbi Ministrstvo za zdravje.
4. člen
Ta uredba začne veljati petnajsti dan po objavi v Uradnem listu Republike Slovenije – Mednarodne pogodbe.
Št. 00724-104/2005/4
Ljubljana, dne 17. novembra 2005
EVA 2005-1811-0034
Vlada Republike Slovenije
Janez Janša l.r.
Predsednik
