PROTOCOL ON TRANSPLANTATION OF ORGANS
AND TISSUES OF HUMAN ORIGIN
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
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
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 fundamental rights and freedoms of the
individual with regard to organ and tissue transplantation,
Have agreed as follows:
– 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
b. to embryonic or foetal
organs and tissues;
c. to blood and blood
4. For the purposes of
"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 19, 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 which ensures that
organs and tissues are allocated in conformity with transparent and duly justified
rules taking particular account of medical criteria and the individual health benefits for the patients in question.
The persons or bodies responsible for the allocation decision shall be
designated within this framework.
The transplantation system shall ensure the collection and
recording of the information required to ensure traceability of organs and
– 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
7 - Medical follow-up
follow-up shall be offered to living donors and recipients after
Article 7 – 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.
III – Organ and tissue removal from living persons
Article 8 – General rule
Removal of organs or tissues from a living person may be
carried out solely for the therapeutic benefit of a 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 9 – 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 10 – Evaluation of risks for the
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 removal may not be carried out if there is a serious risk to the life or health of the donor.
Article 11 – Information for the donor
The donor and, where appropriate, the person or body providing
authorisation according to Article 13, 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 12 – Consent of the living donor
Subject to Articles 13 and 14 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
The person concerned may freely withdraw consent at any time.
Article 13 – 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 12 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;
the potential donor concerned does not object.
Article 14 – Cell removal from a living donor
The law may provide that the provisions of Article 13,
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
IV – Organ and tissue removal from deceased persons
Article 15 – Certification
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 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 16 – 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
The removal shall not be carried out if the deceased person had
objected to it.
Article 17 – 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
Article 18 – Promotion
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
Article 19 – 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/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.
VI – Prohibition of financial gain
Article 20 – Prohibition of financial gain
1. The human body and its
parts shall not, as such, give rise to financial gain or comparable advantage.
provision shall not prevent payments which do not constitute a financial gain
or a comparable advantage, in particular:
of living donors for loss of earnings and any other justifiable expenses caused
by the removal or by the related medical examinations;
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.
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 21 – Prohibition of organ and tissue trafficking
Organ and tissue trafficking shall be prohibited.
VII – Confidentiality
Article 22 – 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.
VIII – Infringements of the provisions of the Protocol
Article 23 – 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 24 – 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 25 – Sanctions
Parties shall provide for appropriate sanctions to be
applied in the event of infringement of the provisions contained in this
IX – Co-operation between Parties
Article 26 – 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
– Relation between this Protocol and the Convention, and re-examination of
Article 27 – Relation between this Protocol
and the Convention
As between the Parties, the provisions of Articles 1 to 26
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
Article 28 – 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.
XI – Final clauses
Article 29 – 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 30 – Entry
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
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 31 – 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
Article 32 – Denunciation
Any Party may at
any time denounce this Protocol by means of a notification addressed to the
Secretary General of the Council of Europe.
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 33 – 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:
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 30 and 31;
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 …, this …, in English and 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.
TO THE DRAFT ADDITIONAL
PROTOCOL TO THE CONVENTION
ON HUMAN RIGHTS AND
ON TRANSPLANTATION OF
ORGANS AND TISSUES OF HUMAN ORIGIN
This document contains the
draft explanatory report to the draft additional Protocol on transplantation of
organs and tissues of human origin, as modified by the Secretariat following
the 18th meeting of the CDBI, according to the instructions given by
the Committee during this meeting and taking into account the comments sent by
delegations to the Secretariat after the meeting and the changes made by the
Rapporteur Group on legal affairs.
Changes made following the meeting of the Rapporteur Group
on legal affairs held on 11 June 2001 appear in paragraphs 9, 35, 56, 88, 105
DRAFT EXPLANATORY REPORT TO
DRAFT 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,
ON TRANSPLANTATION OF ORGANS
AND TISSUES OF HUMAN ORIGIN
This draft Explanatory
Report to the draft additional Protocol to the Convention on human rights and
biomedicine, on transplantation of organs and tissues of human origin, was
drawn up under the responsibility of the Secretary General of the Council of
Europe, on the basis of a draft prepared, at the request of the Working
Party, by Dr Peter DOYLE (United Kingdom), member of the Working Party. It
takes into account the discussions held in the CDBI and its Working Group
entrusted with the drafting of the additional Protocol; it also takes into
account the remarks and proposals made by Delegations.
The Committee of
Ministers has authorised the publication of this draft Explanatory Report on
The draft Explanatory
Report is not an authoritative interpretation of the draft Protocol.
Nevertheless it covers the main issues of the preparatory work and provides
information to clarify the object and purpose of the draft Protocol and to
better understand the scope of its provisions.
Additional Protocol to the Convention on Human Rights and Biomedicine on the
Transplantation of Organs and Tissues of Human Origin amplifies the principles
embodied in the Convention, with a view to ensuring protection of people in the
specific field of transplantation of organs and tissues of human origin.
2. The purpose
of the Protocol is to define and safeguard the rights of organ and tissue
donors, whether living or deceased, and those of persons receiving implants of
organs and tissues of human origin.
Drafting of the
3. In 1991 in
its Recommendation 1160, the Council of Europe Parliamentary Assembly
recommended that the Committee of Ministers "envisage a framework
convention comprising a main text with general principles and additional
protocols on specific aspects". The same year, the Committee of Ministers
instructed the CAHBI (ad hoc Committee
of Experts on Bioethics), re-designated the CDBI (Steering Committee on
Bioethics) "to prepare, … Protocols to this Convention, relating to, in a
preliminary phase: organ transplants and the use of substances of human origin;
medical research on human beings".
4. At its 14th
meeting (Strasbourg, 5-8 November 1991), the CAHBI appointed the Working Party
on Organ Transplantation, responsible for preparing the draft Protocol.
The CAHBI-CO-GT1, later the CDBI-CO-GT1, chaired by Mr Peter THOMPSON (United
Kingdom), held its first meeting in January 1992 and began its activities
concurrently with the CDBI's work on the Convention.
5. At the
second meeting of the CDBI in April 1993 the Working Party submitted a draft
Protocol on Organ Transplantation and in June 1994, the Ministers'
Representatives agreed to declassify this document. However, as CDBI focused
its efforts on the preparation of the Convention, the work on the draft
Protocol was postponed until January 1997.
Convention on Human Rights and Biomedicine was adopted by the Committee of
Ministers on 19 November 1996 and was opened for signature on the 4 April 1997
in Oviedo (Spain). The CDBI, at its 11th meeting in June 1996, decided to give
the CDBI-CO-GT1, chaired by
Dr Örn BJARNASON (Iceland), extended terms of reference to examine the draft
Protocol on transplantation in the light of the Convention provisions.
Protocol extends the provisions of the Convention on Human Rights and
Biomedicine in the field of transplantation of organs, tissues and cells of
human origin. The provisions of the Convention are to be applied to the
Protocol. For ease of consultation by
its users, the Protocol has been drafted in such a way that they need not keep
referring to the Convention in order to understand the scope of the Protocol's
provisions. However, the Convention contains principles which the Protocol is
intended to develop. Accordingly, systematic examination of both texts may
prove helpful and sometimes indispensable.
8. The draft
Protocol, which was examined by the CDBI at its 15th meeting (7-10
December 1998), was declassified by the Committee of Ministers at its 658th
meeting (2-3 February 1999, item 10.1) for the purposes of consultation. Those
consulted, including member States, relevant European non-governmental
organisations and particularly the Parliamentary Assembly (specifically the
Social, Health and Family Affairs Committee, the Committee on Science and
Technology and the Committee on Legal Affairs and Human Rights) have contributed
to the development of the text. After re-examination, the CDBI finalised the
text of the Protocol during its meeting from 5 to 8 June 2000.
9. The Protocol was approved by the CDBI on 8 June 2000 under
the chairmanship of Dr Elaine GADD (United Kingdom). The Parliamentary Assembly gave an opinion on the Protocol,
Opinion N° 227 (2001) of 25 April 2001, Professor Jean-François MATTEI being
the Rapporteur. The Protocol was
adopted by the Committee of Ministers on … .
10. The Protocol
is accompanied by this explanatory report, drawn up under the responsibility of
the Secretary General of the Council of Europe on the basis of a draft
prepared, at the request of the Working Party, by its member Dr Peter DOYLE
(United Kingdom). It takes into account the discussions held in the CDBI and
its Working Party entrusted with the drafting of the Protocol; it also takes
into account the remarks and proposals made by Delegations. The Committee of
Ministers has authorised its publication on … . The explanatory report is not
an authoritative interpretation of the Protocol. Nevertheless it covers the
main issues of the preparatory work and provides information to clarify the
object and purpose of the Protocol and make the scope of its provisions more
Comments on the
provisions of the Protocol
11. The title
identifies this instrument as the "Additional Protocol to the Convention
for the Protection of Human Rights and Dignity with regard to the Application
of Biology and Medicine, on Transplantation of Organs and Tissues of Human
expression "of human origin" underlines the exclusion of
xenotransplantation from the scope of the Protocol.
13. The Preamble
highlights the fact that Article 1 of the Convention on Human Rights and
Biomedicine protecting the dignity and
the identity of all human beings and guaranteeing everyone respect for their
integrity, forms a suitable basis on which to formulate additional standards
for safeguarding the rights and freedoms of donors, potential donors and
recipients of organs and tissues.
14. In November
1987 the Third Conference of European Health Ministers convened in Paris dealt
with organ transplantation, and a number of guidelines on the subject were
adopted as a result. This Preamble echoes the main introductory paragraphs of
their Final Declaration: while the transplantation of organs and tissues is an established part of the health services
offered to the population, helping to save lives or improve their
quality, emphasis is placed on the need to take specific measures to promote
organ and tissue donation but also to prevent misuse of transplantation and the
risk of commercialisation.
15. In addition,
the Preamble stresses that it is important to take into account previous work
of the Committee of Ministers and the Parliamentary Assembly of the Council of
Europe on transplantation of organs and tissues, in particular Committee of
Ministers Resolution (78) 29 on harmonisation of legislation of member States
relating to removal, grafting and transplantation of human substances and on
the management of organ transplant waiting lists and waiting times,
Recommendation no. REC (2001)5.
Chapter I – Object and scope
Article 1 – Object
16. This Article
specifies that the object of the Protocol is to 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.
17. The term
"everyone" is used in Article 1 because it is seen as the most
concordant with the exclusion of embryonic and foetal organs or tissues from
the scope of the Protocol as stated in Article 2 (see paragraph 24 below). The
Protocol solely concerns removal of organs and tissues from someone who has
been born, whether now living or dead, and the implantation of organs and
tissues of human origin into someone else who has likewise been born.
Article 2 – Scope and definitions
18. This article
sets out the scope of the Protocol and defines the main terms used.
19. The Protocol
applies solely to the transplantation of organs, tissues and cells of human
origin (see paragraph 22 below). Organs,
tissues and cells used for implantation are normally obtained from any one of
the following three sets of circumstances:
a. a living person
may, under certain conditions, consent to the removal of an organ or tissue for
the purpose of implantation into another person; Chapter III was therefore
drafted with the aim of protecting living donors from the psychological and
physical risks and the consequences of implantation, particularly with regard
to confidentiality and burdens arising from the requirements of traceability;
b. organs or tissues may be removed from a deceased person and
implanted into another person; Chapter IV was designed to regulate the various
stages of removal from deceased persons and to guarantee in particular that no
removal is carried out if the deceased person had objected to it;
c. a person who is undergoing a procedure for his/her own
medical benefit may consent to any removed organ or tissue being implanted into
another person; Chapter V was designed to specify the conditions under which
such organs or tissues may be implanted, in particular by stipulating that
specific information must be provided and informed consent or appropriate
20. The second
paragraph of Article 2 states that the provisions of this Protocol applicable
to tissues shall also apply to cells. Indeed Chapter VI of the Convention enunciates the fundamental principles with
regard to removal of organs and tissues from living donors for the purpose of
transplantation, but none of these provisions mention the term “cells”.
However, in many respects, transplantation of cells poses problems,
particularly the consequences of testing and traceability, which are the same
as those relating to the transplantation of tissues. Therefore, subject to
Article 15, the Protocol applies the same regulations to the transplantation of
cells as it does to the transplantation of tissues. In particular, the
provisions concerning informed consent or authorisation by or on behalf of the
donor, confidentiality, health and safety, and the prohibition of profit apply
as for tissues.
transplantation of haematopoietic stem cells, whatever their origin, comes
within the scope of the Protocol, as does the transplantation of any kind of
cells other than those that have been specifically excluded (see paragraphs 23
to 25 below). It should be emphasised that Recommendation No. R (98) 2 of the
Committee of Ministers to member States on provision of haematopoietic
progenitor cells is also relevant.
22. This Protocol
does not apply to organs or tissues, whether genetically modified or not,
removed from animals. These types of treatment are largely theoretical or at
best experimental in the present state of scientific knowledge, and raise
particular ethical problems. One should note that it is moreover foreseen that
the issue of xenotransplantation will be addressed in another instrument
presently under preparation. Thus it was agreed to place xenotransplantation
outside the Protocol's scope.
organs and tissues (comprising ova, sperm and their precursors) are excluded
from the scope of the Protocol because organ and tissue transplantation is
deemed to have different implications from those of medically assisted
procreation and therefore should not be governed by the same rules. Therefore
ovaries and testes are excluded but the uterus is not.
of embryonic and foetal organs and tissue, including embryonic stem cells are
also excluded from the scope of this Protocol. It is foreseen that these
subjects will be addressed in another Protocol now being prepared on protection
of the human embryo and foetus.
25. Blood and its
derivatives covers blood and the products derived from blood for use in
transfusion medicine. Blood and such products are thus subject to specific
regulations, or specific standards, such as Recommendation R(95) 15 on the
Preparation, use and quality assurance of blood components. Blood and its
derivatives are therefore excluded from the scope of the Protocol.
26. Implantation, in its traditional sense,
does not include utilisation of tissues of human origin in the form of medical devices or pharmaceuticals; nevertheless, it was agreed
that professional standards imply that the principles contained in this
Protocol regarding namely safety, traceability, information and consent for
such uses should be applicable mutatis
27. It is not a
simple matter to decide what terms to use to signify the grafting or
implantation of organs and tissues. In normal usage organs are
"grafted" and tissues "implanted", or we refer to the "implantation
of a graft”. For the purposes of this Protocol it was agreed that in English
"implantation" best described the surgical procedures involved.
28. There is also
difficulty in agreeing on a scientifically precise definition of
"organ" and "tissue". Traditionally an "organ"
has been described as part of a human body consisting of a structured
arrangement of tissues which, if wholly removed, cannot be replicated by the
body. In 1994 the Committee of Ministers adopted a definition of tissues as being
"All constituent parts of the human body, including surgical residues, but
excluding organs, blood, blood products as well as reproductive tissue such as
sperm, eggs and embryos. Hair, nails, placentas and body waste products also
excluded" (Recommendation No. R (94) 1 of the Committee of Ministers to
member States on human tissue banks). These were useful definitions in the
early days of transplantation when only a few solid organs were transplanted
e.g. kidney, heart and liver. However, developments in transplantation have
given rise to difficulties of definition. For example, only a part of an adult
liver may be removed and transplanted into a child and the residual liver will
re-grow and the transplant will grow to adult size. This is a liver transplant but is clearly not an "organ"
transplant according to the traditional definitions. Conversely, if a whole
bone is removed and transplanted, the body cannot replicate the bone, but bone
is normally considered to be a tissue not an organ.
29. The Protocol
sets out to overcome this difficulty by using the terms "organs" and
"tissues" throughout the text, except in Article 10 (see paragraphs
30 to 32 below), so that all provisions apply to all parts of the body. The distinction between the removal of “tissues”
and “cells” is also difficult. In effect, more than one cell may be considered
to be a tissue. Similarly, the Protocol sets out to overcome this difficulty by
stating that the provisions applicable to tissues shall also apply to cells. In
the same way, unless specifically stated, explanations relating to tissues in
this explanatory report also apply to cells.
30. It is
nevertheless possible to distinguish between vascularised grafts that is organs
or parts of organs which need re-connection of their blood supply, e.g. heart,
lungs, liver, kidney, pancreas, bowel, from non vascularised tissue grafts and
cells. The former, once removed from the body, normally only remain viable for
relatively short periods and need to be transplanted within a few hours. Thus
they cannot currently be processed and stored as can most tissues and cells.
For this reason the rules relating to transplantation of vascularised
"organs" may differ from those applying to tissues and cells.
31. Live organ
donation is currently confined primarily to kidneys, lobes of either liver or
lung, and isolated sections of small bowel. Their removal is a major procedure
which carries a high risk. On the other hand, removal of tissues from a living
donor generally carries a low risk of harm, and removal of cells might in
certain cases involve an even smaller risk (see paragraph 90 below). These
differences justify different rules; for this reason Article 10 deals with the
specific case of organ removal from a living person and Article 15 with the
case of cell removal from a living person.
32. For the
purposes of this Protocol, the term "organ" is accordingly applied to
vascularised organs or parts of organs which require a major surgical procedure
for removal and which need to be transplanted rapidly. The terms
"tissues" and "cells" cover all other parts of the body
except those specifically excluded.
is defined as the whole process starting with removal of an organ or tissue
from one person and ending with implantation of that organ or tissue into a
different person. The person from whom the material is removed is generally
designated by the word donor and the person into whom the material is implanted
by the word recipient. Furthermore tissues such as bone may be processed and
the resulting products implanted into more than one recipient. Similarly, cells
may be cultured to supply more than one recipient. Increasingly livers removed
from a deceased person are split so that even in the case of organ transplantation there may be more than one recipient. The
safeguards in the Protocol apply to all possible steps in the transplant
process and to all possible recipients. Moreover, they apply to the entire
process of each step in transplantation; for example the word “removal” refers
to all the medical interventions necessary for the removal, including
investigation and preparation of the donor.
provisions of this Protocol concerning removal apply if its purpose is
transplantation. Removal of tissue carried out for any other purpose is not
covered by the Protocol. Nevertheless, as stated in Article 20, when in the
course of an intervention an organ or tissue is removed for a purpose other
than donation for implantation, it may be suitable for implantation but may
only be so used if the consequences and possible risks have been explained to that person and informed consent or,
in the case of a person who is not able to consent, appropriate authorisation,
has been obtained (see paragraphs 108 to 111 below). Besides, the protection
afforded to recipients by this Protocol applies to all transplanted human
material irrespective of why it was removed.
– General provisions
– Transplantation system
35. Parties to
the Protocol undertake to ensure that a transplant system exists in their State
within which transplant services operate. The nature or organisation of the
system is not defined in this Protocol; it rests with individual States to
decide whether to use local, regional, national or international organisations
to meet the requirements of this article.
As indicated in the 9th paragraph of
the Preamble, institutions must be instrumental in ensuring that conditions
protecting the rights and freedoms of donors, potential donors and recipients
requirements of this Article are that access to a transplant service is
equitable - that is, all people, whatever their condition or background, must
be equally able to be assessed by whatever transplant services are available.
The concern is to ensure that there is no unjustified discrimination against
any person within the jurisdiction of the Party who might benefit from a
transplant. It has to be emphasised that there is a severe shortage of most
organs and some of the tissues which can be transplanted. Scarce organs and
tissues should be allocated so as to maximise the benefit of transplantation.
The State-recognised system will be responsible for ensuring equitable access
to assessment for transplantation and to transplant waiting lists.
transplantation system should also ensure that organ and tissue allocation is according to rules which are both transparent and duly
justified. Transparency requires that the allocation criteria are open and
understandable. The criteria used must also be justified in terms of fairness,
accuracy and reproducibility and conform with the ethical principles enshrined
in the Convention on Human Rights and Biomedicine. For example, medical
criteria such as tissue matching which affect the likelihood of success of the
transplant will be arguably the most important criteria but other factors such
as time on the waiting list may have to be included if allocation is to be seen
to be fair. Additionally, the transplant system should ensure that people are
not on more than one transplant waiting list so as not to prejudice the chances
of others; however this principle does not preclude a system in which a patient
is registered on a local waiting list which is part of a national waiting list.
The criteria by which organs and tissues are allocated should be determined in
advance but be capable of amendment, be evaluated regularly and modified if or
when circumstances change. The system governing transplantation may lay down
different criteria according to the type of graft because of the particular
characteristics and availability of the different organs and tissues.
38. In order to
ensure the allocation rules are transparent and well founded, they should state
clearly who, within the system recognised by the member State, has the
responsibility for the determination and the application of these rules. The
person(s) or body(ies) responsible for organ and tissue allocation should be
accountable for their decisions.
means being able to track all organs or tissues from donor to recipient and
vice versa. It is required because it is impossible to eliminate entirely the
risks of transmission of disease from donor to recipient and contamination of
preserved material. Furthermore, new diseases or disease risks may emerge.
Therefore for both public health reasons and the need to inform donors or
recipients of potential problems that come to light following transplantation,
it is important that any transplant material can be traced forward to
recipients and back to the donor. For example, bone may be processed and turned
into a variety of products with a long storage life available to treat multiple
recipients. If a transmissible disease had been detected not at the outset but
later in a recipient, donors would have to be traced to identify the one who
transmitted the disease and unused products withdrawn. When seeking consent,
both donors and recipients should be warned of such long-term consequences of
transplantation and the possible need for prolonged surveillance. In addition,
it may be necessary to analyse how organs and tissues were used to detect
illegal or unethical use of such material, prevent organ and tissue trafficking
and to validate allocation systems. For these reasons the transplant system must
ensure a comprehensive system to enable all transplant material to be traced,
without prejudice to the provisions on confidentiality set out in Article 23
(see paragraphs 122 and 123).
40. The question
of methods for verifying the effectiveness with which the Parties implement
systems for applying the various principles set out in article 3 is related to
the general issue of Parties' honouring of the obligations in the Convention on
Human Rights and Biomedicine, or any of its Protocols. In this context, reference
should be made to i) the second paragraph of Article 1 of the Convention, which
stipulates that "Each Party shall take in its internal law the necessary
measures to give effect to the provisions of this Convention", ii) Article
28 of this Protocol, according to which Articles 1 to 27 are regarded as
additional articles to the Convention, and iii) Article 30 of the Convention,
which empowers the Secretary General to request any Party to "furnish an
explanation of the manner in which its internal law ensures the effective
implementation of any of the provisions of the Convention".
Article 4 – Professional standards
provisions here use the wording of Article 4 of the Convention and apply to all
health care professionals whether involved in the decision-making process or in
performing a transplant. The text of the explanatory report of the Convention
also applies in general, but some further explanation is required for the
purposes of this Protocol.
42. The term
"intervention" must be understood here in a broad sense. It covers
all medical acts performed in connection with transplantation of organs or
tissue for purposes of treating a patient. An intervention carried out in
connection with experimental transplantation must furthermore comply with the
rules governing research.
43. The relevant
professional obligations and standards in accordance with which all
interventions must be performed, are those laws, specific or general and any
codes of practice or rules of conduct in force in the member State. Such codes
or rules may take various forms such as health legislation, a code of
professional practice or accepted medical ethical principles. Specifically,
transplants should only be performed in accordance with the agreed allocation
criteria. The rules and criteria may differ somewhat between countries but the
fundamental principles of medical practice apply in all countries.
competence of a doctor or other health care worker to take part in a transplant
procedure must be determined in relation to the scientific knowledge and
clinical experience appropriate to transplantation of organs or tissue at a
given time. However, it is accepted that medical knowledge is rarely absolute
and while acting according to the highest professional standards more than one
therapeutic option may be perfectly justified. Recognised medical practice may
therefore allow several alternative forms of intervention leaving some
justified clinical freedom in the choice of methods or techniques. However, the
choice of technique may affect the risk of inducing disease in the recipient,
e.g. lymphoma or graft versus host disease, and such considerations should also
be taken into account and the safest transplantation technique used.
standards also require that organ
and tissue implantation is only performed in accordance with a clear and
specific medical indication for the
recipient and not for any other reason such as a perceived social benefit. The
recipient must have a defined medical problem which should be improved by a
successful transplant before a transplant can be performed. The potential
benefit of the procedure to the recipient must outweigh any risk. At all times,
a decision to transplant must be taken only in the best interests of the patient.
46. Professional standards related to live
transplantation require that, even if there is only one transplant team,
different clinicians take responsibility for the care of the donor and the
recipient, to ensure that the clinical needs of each party are properly and independently managed. In addition, it may be
advisable to offer donors systematic long-term follow-up.
Article 5 – Information for the recipient
47. his article
sets forth the recipient's right to be properly informed prior to implantation.
Even though a transplant is intended to improve the health or even save the
life of the recipient, the fact remains that the recipient shall be informed
beforehand of the purpose and nature of the implantation, its consequences and
risks, as well as on the alternatives to the intervention. This information
must be as exact as possible and couched in terms which the recipient can
understand. Information should be provided in a format appropriate to the needs
of the recipient. In addition to proper discussion, written information which
the recipient can study when there is adequate time may be particularly
helpful. When the recipient is too ill to be able to give informed consent, in
particular in emergency cases, the information shall also be given to the
person or body providing the authorisation to the implantation, as foreseen by
Article 6 of the Convention of Human Rights and Biomedicine.
Article 6 – Health and safety
48. This article
deals with the health and safety aspects of the transplant process. It places
an obligation on all those involved in the transplant process of organ and
tissue to do everything that can be reasonably expected of them to ensure that
organs and tissues are healthy and undamaged, that they are handled,
transported and where appropriate preserved and stored by means that maximise
their viability and minimise the risk of contamination. These measures will
ensure that when grafted into a recipient, the risk to the health of the
recipient has been minimised. However, it recognises that the risk of
transmission of disease cannot be entirely eliminated. Furthermore,
circumstances may arise when some risk of transmission of disease to the
recipient, or of failure of the organ or tissue graft, is acceptable if the
consequence of not grafting is more serious. In some cases, it may be
acceptable to transmit a disease if the alternative is certain death. Equally
it might be acceptable to implant an organ or tissue affected by some
infectious diseases if the recipient already suffers from the same pathology,
or the appropriate preventive measures have been started. A risk assessment
should be made on a case by case basis.
expression "transmission of any disease" covers also the transmission
of a pathology to the recipient which may or may not later develop into the
disease (for instance, in the case of hepatitis C virus, the recipient might be
infected but never develop overt disease).
50. The ultimate
responsibility for deciding whether to use a particular graft lies with the recipient's
implant team. However, it is essential that, in deciding whether to proceed
with a graft, the practitioner has access to all the relevant information
pertaining to the likely viability of the graft and the risk of transmission of
disease. It is the responsibility of everyone involved to ensure that accurate
information about the donor and the graft are collected, recorded and accompany
the graft. The practitioners responsible for the removal of an organ or tissue have a duty to ensure that the donor is properly
screened for transmissible diseases, both infectious and malignant. They are
responsible for ensuring that a proper medical history has been obtained and
that appropriate tests have either been performed or the necessary samples
collected for testing.
organ transplantation sometimes has to be carried out in difficult
circumstances as a matter of extreme urgency without having all the necessary
information or knowing whether there is a risk for the recipient. In such
circumstances, the doctor in charge should balance the risks and benefits and
consequently, the implant should only be performed if the benefits to the
recipient outweigh the risks and appropriate consent or authorisation has been
because of the shortage of organs and some tissues, even when a disease risk is
detected, it may not be appropriate to reject the donor without first checking
whether there is a suitable recipient. The more urgent the type of transplant,
the more essential it is to assess the risk and check whether there is any
recipient who could benefit. For example in fulminant liver failure, the
patient may only have a few hours to live and even a high risk organ may be
considered preferable to almost certain death. In the case of tissue
transplants which, except for bone marrow, are rarely if ever life saving,
donor screening and testing should be more rigorous and disease transmission as
far as possible prevented. Consequently, it may still be reasonable to bank
tissues, i.e. keep them in quarantine, awaiting the outcome of further
investigations such as a post mortem or retesting of a living donor.
53. It is the
responsibility of the persons involved in the removal of organs and tissues to
use the highest standards of removal, preservation and, where appropriate,
storage. They shall also take reasonable steps to ensure the continued quality
and safety of the organs and tissues to minimise the risk of damage to the
graft and to maximise its viability. In the case of organs this also means
ensuring transport is available to minimise delays.
involved in the transport, preservation and storage of grafts are also
responsible for ensuring that all relevant information has been obtained,
checked, and accompanies the graft to the recipient, albeit nothing in this
provision overrides the obligation of confidentiality as stated in Article 23.
should also take account of other
relevant national or international instruments in the field of health and
safety, for example, guidance on the avoidance of transmission of infectious or
malignant diseases during transplantation produced under the auspices of the
European Health Committee.
New Article 7 – Medical follow-up
56. Developing the principle of equitable access to healthcare
enunciated in Article 3 of the Convention, Article 7 of the Protocol states
that a medical follow-up must be offered to living donors and recipients after
transplantation. This is also a further
specification of a principle of professional standards. The nature and duration
of such follow-up should depend on the nature of the intervention and its
potential impact on the individual's health. Short term follow up is essential to ensure recovery
from the procedure. Life long follow up is essential for
recipients requiring immunosupressive therapy.
It is also desirable for living organ donors to identify any long term
effects of the donation. However, living donors and even recipients cannot be
forced to accept long term follow up.
Article 8 (former Article 7) – Information for
health professionals and the public
57. It is for
Parties to the Protocol to ensure that adequate and appropriate information
about organ and tissue transplantation is made available to health
professionals and to the general public. The information should cover all the relevant medical, legal, social,
ethical and other issues concerned, particularly sensitive issues such as the
means of certifying death. In view of the organ shortage it is seen as
advisable to inform all health care workers about the success and benefits of
transplantation because of their ability to inform the general public. Parties
should also use every opportunity to inform the general public directly of
those same benefits and successes. Informing the general public is important in
promoting organ and tissue donation but it is also important that people make
up their minds on the issues in full knowledge of the facts. This should
include the consequences and risks of organs or tissues being implanted into another
person. Testing may reveal unrecognised diseases which may have implications
for any living donor and possibly for the relatives of deceased persons from whom organs and tissues
are removed. The need to ensure traceability should also be explained as the
consequences may not be realised until some time in the future. It is
particularly important that such information is made available for people who
may opt to become organ donors.
58. There is a
very specific duty for the Parties, that is to ensure that the rules on consent
and/or authorisation for organ or tissue retrieval and transplantation are well
known and acceptable to the society. It is important to establish a
relationship of trust between potential donors and the transplantation system.
Transplant issues are constantly changing so the provision of information is an
ongoing responsibility, not just an occasional one.
Chapter III – Organ
and tissue removal from living persons
Article 9 (former Article 8) – General rule
59. According to
the first principle set out in the text, organs or tissues should be removed
from deceased persons rather than from living donors whenever possible.
Removing organs or tissues from living donors for implantation purposes always
has consequences and may carry
some risk for that donor.
This implies that organs and tissues from living persons should not be used where an appropriate organ or tissue from a
deceased person is available.
60. The second
condition in the case of living donors is that there exists no alternative
therapeutic method of comparable effectiveness. In view of the risk involved in
any organ and tissue removal, there is indeed no justification for resorting to
this if there is another way of bringing the same benefit to the recipient,
such as the use of artificial skin for instance. The transplant must therefore
be necessary in the sense that there is no other treatment that would produce
similar results. In this respect dialysis treatment is not considered to
provide results in terms of the patient's quality of life comparable with those
obtained by a kidney transplant.
61. However, if
the results of a living donor transplantation are expected to be significantly
better than those expected utilising a graft removed from a deceased person, live donation may be the preferred therapeutic
option for a particular recipient.
Article 10 (former Article 9) – Potential organ
62. This article
is specific to the removal of organs as defined in Article 2. It does not apply
to the removal of tissues or cells. It defines the conditions under which, in
addition of those of Article 9, living donation of an organ may be performed.
conditions would normally require that a close personal relationship, based on
the principle of mutual aid, exists between the donor and recipient. The exact
nature of the relationship is a matter for national law to determine and may
depend on cultural or other local factors. Those with a close personal
relationship with the recipient may include for instance members of the
recipient's immediate family, parents, brothers, sisters, spouses or
long-standing partners, godparents or close personal friends. Most countries
have laws defining the nature of the relationship which is required to exist
between donor and recipient and which makes live donation acceptable. The
intention of such laws and this Article is to prevent undue pressure to donate
being brought to bear on people without a strong emotional relationship with
64. However, not
all national laws define close personal relationship, and where relationships
are defined, the question of donation by a person not in such a relationship
may be proposed. As there is some evidence that, despite the risks incurred,
there may be perceptible long-term psychological benefit to organ donors who,
even if not closely related, have helped improve the health or even save the
life of a recipient, this Article allows such circumstances to be taken into
account. But they may only be considered when the national law sets out the
conditions under which such circumstances may be considered. Those conditions
include the provision of an appropriate independent body, for example an ethics
committee, to consider each case. The body is responsible for ensuring that the
other conditions required by law have been met, and that, for
example, no coercion or inducement is involved. These provisions are thus an
important safeguard against potential organ trafficking or the use of
independent body required under this Article is not the same as the official
body identified in Article 13 before which the living donor can give his/her
consent. However, the law may provide for the independent body provided for by
Article 10 to be the same as the competent body identified in Article 14, even
if their responsibilities are different (see paragraph 87 below).
66. The reason
for excluding tissues from this Article is that the therapeutic interests of a
recipient who may not be known at the time of removal have to be taken into
account. Here, the principles of Recommendation No. R (94) 1 of the Committee
of Ministers to member States on human tissue banks are relevant.
Article 11 (former Article 10) – Evaluation of risks
for the donor
67. This article
deals with evaluation of risk to the donor, which must be kept to a minimum.
The health care professional's role here is twofold: to carry out whatever
investigations may be required to evaluate the donor's state of health and
therefore the potential risk of donation and, second, to take all reasonable
measures to limit the risks to the donor without compromising the quality or
viability of the organ or tissue removed for transplantation. The principal
risks for the donor are the physical risks arising for the surgical procedure.
However, there are also short and long-term psychological risks that also need to be fully assessed.
68. Whereas the
word "investigation" covers all the examinations or tests to be
performed, the word "intervention" is to be understood in a broad sense
as covering all relevant medical acts.
69. The article
places a ban on removal from a living donor where there is serious risk to the
donor's life or health. This raises questions as to what a serious risk to the
donor is and who judges the risk to be a serious one. Essentially there are
three possible parties who may deem it a serious risk, the donor, the recipient
or the medical team. Of these, the first two are already covered by the articles on consent: consent should not be given
for donation if the risk is considered to be unacceptable. For the purposes of
this article, the decision about the risk is a matter for the transplant
medical team looking after the donor or the body authorising the donation. In
judging the risks involved, the donor's interests must take precedence,
although in some circumstances the balance of risk to the donor compared to
potential benefit to the recipient may be taken into consideration. The
donation being acceptable or not depends not just on the physical risk associated
with the procedure but must include psychological factors. Thus, the donor's
emotional status should be independently assessed. An example of psychological
harm is if the donor develops an undue sense of ownership towards the recipient
or the recipient feels unduly obligated to the donor. If, following full
assessment, the medical team looking after the donor judge there to be a
significant risk of death or long term severe disability to the donor, the
donation procedure should not go ahead.
Article 12 (former Article 11) – Information for the
70. This article
sets out the donor's right to be given appropriate information. In the case of
donation of regenerative tissue, the most common instance is bone marrow
transplantation between brothers and sisters, where the donor may be a minor.
It is specifically to cater for this type of donation that the article requires
the supply of information also to
the representative, authority, person or body providing authorisation according
to Article 14.2 of this Protocol.
71. There are two
main requirements in the first part of the article. The information should be
appropriate to explain the purpose and nature of the proposed removal as well
as its consequences and risks, and the need for appropriate testing prior to
the removal. It must be given prior to consent or authorisation and removal.
Thus the information has to be as accurate as possible and given in terms the
donor can understand, e.g. comparing the risks of a complication with other
risks encountered in everyday life. In particular, in cases where the donor is
a very young child, the content and form of the information presented must be
adapted to his or her age and capacity for understanding. The donor must be
given adequate time to fully consider the information provided and discuss it
with friends and/or relatives. In addition to proper discussion, written
information which the donor can study when there is adequate time may be
particularly helpful. If the donation requires an authorising party under
Article 14.2 those discussions will normally include the potential donor.
72. The second
paragraph defines a more specific right for the donor in that it requires all
concerned to inform the potential donor of his/her rights and safeguards under
domestic and international law. In particular, it states that the donor shall
be informed of the right to have access to a source of independent advice about
the risks of the removal procedure. This source of information, who may be a
doctor or other suitably qualified health care worker, must be independent of
the team or teams involved in the transplant. However, that person must have
appropriate experience of the risks associated with donation and
transplantation to be able to give proper advice. This advice can be requested
by the donor if he/she wishes. An authorising party under Article 14.2 should
have the same access to independent advice.
Article 13 (former Article 12) – Consent of the
73. This article
is based on Article 5 of the Convention and requires that interventions in the
field of organ and tissue transplantation can only be performed after a person
has given free and informed consent which can be freely withdrawn at any time.
In order to avoid undue pressure on the donor, he/she should be assured that
he/she can refuse to donate or withdraw his/her consent at any time in complete
confidence. To that end, the donor should be interviewed in private and helped
to cope with the consequences of his/her decision.
74. In seeking
the consent of the donor it is essential to discuss what should happen if for
any reason the proposed recipient can not accept the donation. Any possible
alternative use for the donated organ or tissue should be considered prior to
75. This Article
does not apply to persons who do not have capacity to consent to the removal of
an organ, such persons being protected by
the provisions of Article 14 and 15 of this Protocol.
76. The first
paragraph of this article is more stringent than Article 5 of the Convention in
that, for organ or tissue removal, the donor's consent must also be specific
and given in written form or before an official body, a court, a judge or an
official notary for example. The responsibility of this body is to ensure that
consent is adequate and informed.
77. The second
paragraph provides the freedom to withdraw consent to the removal at any time.
There is no requirement for withdrawal of consent to be in writing or to follow
any particular form. The donor need simply say no to the removal at any time,
even if a procedure performed under local anaesthetic has commenced. Article 14
affords the same protection to donors of regenerative tissue lacking capacity
to consent to their removal. However, professional standards and obligations
may require that the team continue with the procedure if not to do so would
seriously endanger the health of the donor.
78. This article
concerning consent of the living donor is included in Chapter III "Organ
and tissue removal from living persons". The consent, as well as
withdrawal of consent, therefore only applies to the removal process. If,
exceptionally, the donor seeks to withdraw consent to the agreed implantation
after removal, national law or professional standards should provide a means of
resolving such problems.
Article 14 (former Article 13) – Protection of
persons not able to consent to organ or tissue removal
relating to consent to organ or
tissue removal for implantation
apply in the case of live donors having the capacity to consent. Those relating
to authorisation apply where a
potential donor cannot formally give consent on account of incapacity.
80. Article 14
deals specifically with the question of the removal of organs or tissues from a
living person not having the capacity to give consent. The principle is that
this practice is prohibited. Article 14 follows the wording of Article 20 of
81. Only in very
exceptional circumstances may derogations
be made to this rule and only for the removal of regenerative tissues.
Within the meaning of this article, regenerative tissue is that capable of
reconstituting its tissue mass and function after partial removal. These
exceptions are justified by the fact that regenerative tissue, in particular
bone marrow, can only be transplanted between genetically compatible persons,
often brothers and sisters.
Furthermore, Article 15 provides that Article 14, paragraph
2, indents ii. and iii. might not be applied, only in cases in which cell
removal implies minimal risk and minimal burden for the donor.
82. If at the
present time bone marrow transplants among brothers and sisters is the most
important situation which meets the condition of this article, the formula
"regenerative tissue" takes into account future developments in
83. Paragraph 2
therefore permits removal of bone marrow from a minor for the benefit of his or
her brother or sister. The principle of mutual aid between very close members
of a family and the possibility for psychological benefits to the donor arising
from donation can justify, subject to certain conditions, an exception to the
prohibition of removal which is intended to protect the persons who are not
able to give their consent. This exception to the general rule is qualified by
a number of conditions designed to protect the person who is incapable of
giving consent, and these may be supplemented by national law. The conditions
stated in the general rule of Article 9 also apply.
84. The first
condition is the absence, within reasonable limits, of a compatible donor who
is able to consent.
removal is only authorised on the condition that, in the absence of the
donation, the life of the recipient is in danger. It goes without saying that
the risks to the donor should be acceptable; the professional standards of
Article 4 naturally apply, in particular as regards the balance between risk
86. It is also
required that the beneficiary be a brother or sister. This restriction is
intended to avoid both family and doctors going to extreme lengths to find a
donor at any price, even if kinship is distant and the chances for a successful
transplant are not very likely because of tissue incompatibility.
in keeping with Article 6 of the Convention, the authorisation of the
representative of the person not able to consent or the authorisation of the
authority or person or body provided for by law is needed before the removal
can be carried out.
88. The agreement
of the competent body is also required. The intervention of such a body (which
might be a court, a professionally qualified body, an ethics committee, etc.)
aims to guarantee that the decision to be taken is impartial. When the
donor is an adopted person, it is for this body to verify that there has not
been any misuse of the adoption process to enable a removal which would
otherwise be forbidden. In this
respect, it is important to note the important guarantees established in
Article 14 for the protection of incapable persons and reinstated in the above
paragraphs 80 to 86.
89. Finally, the
removal may not be carried out if the potential donor objects in any way. This
opposition, in whatever form, is decisive and must always be observed.
Article 15 (former Article 14) – Cell removal from a living donor
transplantation procedures for cells generally pose problems similar to those
related to the transplantation of tissues, there may however be a significant
difference with regard to the risks arising from the removal of cells in comparison
with removal of tissues. In certain cases such as obtaining a limited number of
cells from the skin, the procedure itself may not involve more than minimal
risk and minimal burden for the donor. In such cases, and only in such cases,
it is foreseen that the Parties to the Protocol can choose not to apply the
provisions of Article 14, paragraph 2, indents ii. and iii. The purpose of
those provisions is to protect the donor from physical risks and from
instrumentalisation contrary to their dignity, but where the risks and burdens
are minimal it may not be appropriate to prohibit, for example, a minor
donating cells to a family member other than a sibling.
91. One should
also emphasise that the requirements of Article 14, paragraph 2, indents i.,
iv. and v. remain applicable. If compatibility is not medically required, it
will always be possible to obtain a donor with capacity to consent. It is
therefore not envisaged that cell removal be carried out on persons not able to
consent outside of the immediate family circle.
provision is an option for States, not an obligation; States can make use of
this option at the time of ratification of the Protocol or at a later stage,
depending on scientific and technical developments. Moreover, having in mind
that technical developments in the future could permit the reconstitution of
tissue in the laboratory from a limited number of cells, the inclusion of this
option in the Protocol alleviates the potential need to amend it later if these
foreseeable developments become reality.
93. Moreover, in
recognition of the need to monitor the appropriate use of this provision, it
was decided during the adoption of the draft Protocol by the CDBI that the
States utilising this option would be requested to inform the other Parties by
a notification addressed to the Secretary
Chapter IV – Organ
and tissue removal from deceased persons
Article 16 (former Article 15) – Certification of
94. According to
the first paragraph, a person's death must have been established before organs
or tissues may be removed "in accordance with the law". It is the
responsibility of the States to legally define the specific procedure for the
declaration of death while the essential functions are still artificially
maintained. In this respect, it can be noted that in most countries, the law
defines the concept and the conditions of brain death.
95. The death is
confirmed by doctors following an agreed procedure and only this form of death
certification can permit the transplantation to go ahead. The retrieval team
must satisfy themselves that the required procedure has been completed before
any retrieval operation is started. In some States, this procedure for
certification of death is separate from the formal issuance of the death
96. The second
paragraph of Article 16 provides an important safeguard for the deceased person
by ensuring the impartiality of the certification of death, by requiring that
the medical team which certifies death should not be the same one that is
involved in any stage of the transplant process. It is important that the
interests of any such deceased person and the subsequent certification of death
are, and are seen to be, the responsibility of a medical team entirely separate
from those involved in transplantation. Failure to keep the two functions
separate would jeopardise the public's trust in the transplantation system and
might have an adverse effect on donation.
97. For the
purposes of this Protocol, neonates including anencephalic neonates receive the
same protection as any person and the rules on certification of death are
applicable to them.
Article 17 (former Article 16) – Consent and
98. Article 17
bars the removal of any organ or tissue unless the consent or authorisation
required by national law has been obtained by the person proposing to remove
the organ or tissue. This requires member States to have a legally recognised
system specifying the conditions under which removal of organs or tissues is
authorised. Furthermore, by virtue of Article 8, the Parties should take
appropriate measures to inform the public, namely about matters relating to
consent or authorisation with regard to removal from deceased persons (see
paragraph 58 above).
99. If a person
has made known their wishes for giving or denying consent during their
lifetime, these wishes should be respected after his/her death. If there is an
official facility for recording these wishes and a person has registered
consent to donation, such consent should prevail: removal should go ahead if it
is possible. By the same token, it may not proceed if the person is known to
have objected. Nonetheless, consultation of an official register of last wishes
is valid only in respect of the persons entered in it. Nor may it be considered
the only way of ascertaining the deceased person's wishes unless their
registration is compulsory.
100. The removal of
organs or tissues can be carried out on a deceased person who has not had,
during his/her life, the capacity to consent if all the authorisations required
by law have been obtained. The authorisation may equally be required to carry
out a removal on a deceased person who, during his/her life, was capable of
giving consent but did not make known his wishes regarding an eventual removal
anticipating the system to be introduced, the Article accordingly provides that
if the deceased person's wishes are at all in doubt, it must be possible to
rely on national law for guidance as to the appropriate procedure. In some
States the law permits that if there is no explicit or implicit objection to
donation, removal can be carried out. In that case, the law provides means of
expressing intention, such as drawing up a register of objections. In other countries,
the law does not prejudge the wishes of those concerned and prescribes
enquiries among relatives and friends to establish whether or not the deceased
person was in favour of organ donation.
102. Whatever the
system, if the wishes of the deceased are not sufficiently established, the
team in charge of the removal of organs must beforehand endeavour to obtain
testimony from relatives of the deceased. Unless national law otherwise
provides, such authorisation should not depend on the preferences of the close
relatives themselves for or against organ and tissue donation. Close relatives
should be asked only about the deceased persons expressed or presumed wishes.
It is the expressed views of the potential donor which are paramount in
deciding whether organs or tissue may be retrieved. Parties should make clear
whether organ or tissue retrieval can take place if a deceased person's wishes
are not known and cannot be ascertained from relatives or friends.
103. When a person
dies in a country in which he/she is not normally resident, the retrieval team
shall take all reasonable measures to ascertain the wishes of the deceased. In
case of doubt, the retrieval team should respect the relevant applicable laws
in the country in which the deceased is normally resident or, by default, the
law of the country of which the deceased person is a national.
Article 18 (former Article 17) – Respect for the
104. A dead body is
not legally regarded as a person, but nonetheless should be treated with
respect. This Article accordingly provides that during removal the human body
must be treated with respect and after removal the body should be restored as
far as possible to its original appearance.
Article 19 (former Article 18) – Promotion of
cadaveric organs will increase the pressure to perform live donations and the
possibility that desperate people may try to find other ways of obtaining an
organ or tissue for transplantation. As transplantation using cadaveric organs
and tissues is the preferred option, this article lays an obligation on all
Parties to take all appropriate measures to promote organ and tissue procurement from deceased persons. Because of
the shortage of available organs, this
Article makes a provision for Parties to take all appropriate measures to
promote the donation of organs and tissues.
"appropriate" measures are not defined but will include the
provisions on information to be provided to health professionals and to the
public (Article 8), the need to set up a transplant system (Article 3) and to
have recognised means of giving consent or authorisation (Article 17).
107. It is also
appropriate to remember in this
article that organ and tissue
removal from deceased persons has to be given priority if living donation is to
be minimised, in conformity with Article 9.
However, organ and tissue removal from deceased persons must itself carry
safeguards and these are set out in Chapter IV.
Chapter V – Implantation
of an organ or tissue removed for a purpose other than donation for
Article 20 (former
Article 19) – Implantation of
an organ or tissue removed for a purpose other than donation for implantation
108. In principle,
this Protocol applies to the removal of
organs or tissues for transplantation purposes. There are particular
circumstances, however, in which those organs or tissues are removed for
another purpose than donation for implantation but will nevertheless be donated
at a later stage. The classic situation is the so-called "domino"
transplant. When for instance a person needs a heart, or more often a lung
transplant, it may be technically easier to remove their heart and lungs en
bloc and replace them with a donor heart/lung block. Depending on the reason
for the transplant, it is possible that the explanted heart, or at least the
heart valves, will be in good condition and suitable for transplantation into
another recipient. In this way the first recipient becomes a live donor for the
second recipient. In the case of a "domino" heart transplant, the
heart valves might be harvested from the second recipient's heart and be
transplanted into a third person.
109. This Article
is also applicable where, in the course of a medical intervention, tissues are
removed then processed and re-implanted into someone else, even if they are
regarded as discarded tissues at the time of the intervention. In this respect,
one could mention the following examples: the use of bone from femoral heads
removed during hip replacement; the implant of a kidney removed for medical
reasons; the use of vessels obtained from placentae or haematopoietic stem
cells from cord blood.
110. The first
paragraph of the Article stresses the need to inform a person from whom organ
or tissue have been removed for a purpose other than donation for implantation
of the consequences associated with implantation of the organ or tissue into
another person, namely the need for appropriate testing and recording of
information which ensures the traceability of the organs or tissues; the
information must include potential risks,
for instance any modification, even minor, of the surgical procedure needed to
retrieve the organ or tissue in the best possible condition for implantation.
The first paragraph also stresses the need to obtain the informed consent of
the person from whom organ or tissue have been removed or appropriate authorisation for the use of the organ
or tissue for implantation. The first recipient of a heart can for instance be
a child. In turn his/her heart or the valves which are removed can be implanted
in another child, if the persons providing authorisation have agreed after
being duly informed.
111. As indicated
in Article 2, the second paragraph of Article 20 provides that all the
provisions of this Protocol, except for those in Chapters III and IV, which
concern issues relating to removal for implantation purposes, apply to the
situations referred to in paragraph 1. Indeed, the general provisions of
the Protocol that guarantee fundamental rights (with regard namely to safety,
confidentiality, non-commercialisation) will apply to the cases referred to in
Chapter VI – Prohibition
of financial gain
Article 21 (former Article 20) – Prohibition of
112. This article
applies the principle of human dignity as laid down in Article 1 of this
113. It states in
particular that the human body and its parts must not, as such, give rise to
financial gain or comparable advantage. Under this provision, organs and
tissues should not be bought or sold or give rise to direct financial gain for
the person from whom they have been removed for a third party. Nor should the
person from whom they have been removed, or a third party, gain any other
advantage whatsoever comparable to a financial gain such as benefits in kind or
promotion for example. A third party involved in the transplant process such as
a health professional or a tissue bank may not make a profit from organs or
tissues or any products developed from them (but see paragraph 115 below).
Article 21 states that certain payments that a donor may receive are not to be
treated as financial gain within the meaning of this Article. Essentially,
apart from the last indent, these provide examples of expenses that may be
incurred during or as a result of donation or other parts of the transplant
process. This paragraph does not make exceptions to the principle laid down but
gives examples of compensation to avoid possible financial disadvantage which
may otherwise occur. In the case of the donor it allows for compensation for
loss of earnings and other justifiable expenses.
115. The second
indent of the first paragraph refers to payment of a justifiable fee for
medical or technical services performed as part of the transplant process. Such
acts might include the cost of retrieval, transport, preparation, preservation
and storage of organs or tissues, which may legitimately give rise to
116. The third
indent allows donors to receive compensation for undue damage resulting from
the removal. By undue damage is meant any harm whose occurrence is not a normal
consequence of a transplant procedure. This provision refers to the
compensation provided for in Article 25.
117. The second
paragraph of this Article makes it clear that any attempt to advertise anything
to do with organ or tissue transplantation with a view to financial or
equivalent gain for any party is prohibited.
118. This Article
refers solely to organs and tissues covered by the Protocol. The provision does
not refer to such products as hair and nails for example, which are discarded
tissues, and the sale of which is not an affront to human dignity.
Article 22 (former Article 21) – Prohibition of
organ and tissue trafficking
119. As stated by
Article 21 of the Convention, the human body and its parts shall not, as such,
give rise to financial gain. Any trade in organs and tissues for direct or
indirect financial gain, as defined by Article 21 of this Protocol is
prohibited. Organ trafficking and tissue trafficking are important examples of
such illegal trading and of direct financial gain. Organ or tissue traffickers
may also use coercion either in addition to or as an alternative to offering
inducements. Such practices cause particular concern because they exploit
vulnerable people and may undermine people's faith in the transplant system.
This is why the prohibition of trafficking in organs and tissues is
specifically referred to in Article 22.
120. This does not
in any way reduce either the seriousness of infringements of other rights and
principles enshrined in the Protocol, or the force of the prohibition of
infringements of these rights and principles, as laid down in Articles 24 and
121. In conformity
with Article 26 of this Protocol, Parties shall provide for appropriate
sanctions to deter organ and tissue trafficking or any attempt at commercial
trade in organs or tissues.
Chapter VII – Confidentiality
Article 23 (former Article 22) – Confidentiality
122. Article 23
lays down the principle of confidentiality. Preserving the anonymity of the
person from whom organs or tissues have been removed may be impossible in
certain circumstances, for example because of the requirement of an appropriate
relation between the latter and the recipient in the case of living organ
donation. However, personal data concerning persons from whom organs or tissues
have been removed and recipients must nonetheless be treated as confidential
and handled in accordance with the rules on professional confidentiality
and personal data protection. Here, the principles laid down in the Convention
for the Protection of Individuals with regard to Automatic Processing of
Personal Data of 28 January 1981 (ETS 108) must be observed. In particular,
Article 5.b of Convention 108 provides that personal data are "stored for specified and legitimate
purposes and not used in a way incompatible with those purposes".
Parties should take account of other national or international instruments,
such as Recommendation (97) 5 of the Committee of Ministers to the member
States on the protection of medical data and, where applicable,
Directive 95/46/EC of the European Parliament and of the
Council of 24 October 1995 on the protection of individuals with regard to the
processing of personal data and on free movement of such data.
transplantation, it is nevertheless essential that the principle of
confidentiality should not prevent the medical team involved in any transplant
process from obtaining the necessary information on the person from whom organs
or tissues have been removed and the recipient, and keeping track of the
exchange of organs or tissues between them, subject to appropriate safeguards
to ensure adequate data protection. One such person may in fact supply several
organs or tissues to be implanted in more than one recipient. If a disease is
subsequently detected in that person, the recipients must be traceable.
Equally, if a recipient of a transplant develops a disease which may have been
transmitted, the person from whom organs or tissues had been removed must be
identified, again to trace any other recipients. The rules applicable to
traceability of organs and tissues are as set out in Article 3 paragraph 3 of
Chapter VIII – Infringements
of the provisions of the Protocol
Article 24 (former Article 23) – Infringements of
rights or principles
124. This article
requires the Parties to make available a judicial procedure to prevent or put a
stop to an infringement of the principles set forth in the Protocol. It
therefore covers not only infringements which have already begun and are
ongoing but also the threat of an infringement.
125. The requisite
judicial protection must be appropriate and proportionate to the infringement
or the threats of infringement of the principles. Such is the case, for
example, with proceedings initiated by a public prosecutor in cases of
infringements affecting several persons unable to defend themselves, in order
to put an end to the violation of their rights.
126. Under the
Protocol, the appropriate protective machinery must be capable of operating
rapidly as it must ensure that an infringement is prevented or halted at short
notice. This requirement can be explained by the fact that, in many cases, the
very integrity of an individual has to be protected and an infringement of this
right might have irreversible consequences.
127. The judicial
protection thus provided by the Protocol applies only to unlawful infringements
or to threats thereof.
Article 25 (former Article 24) – Compensation for
128. This Article
sets forth the principle that the person
who has suffered undue damage resulting from a transplantation is entitled to
fair compensation. Like the Convention, the Protocol uses the expression
"undue damage" because there can be damage which is inherent in the
129. The due or
undue nature of the damage will have to be determined in the light of the
circumstances of each case. The cause of the damage must be either an act or an
omission during the transplantation procedure. In order to give entitlement to
compensation, the damage must result from the transplantation. Potential donors
might be wronged during investigations to determine their suitability, as might
recipients. In view of the altruistic nature of live organ donation, particular
attention should be paid to the rights of donors and potential donors to an
adequate compensation for damage resulting from transplantation.
conditions and procedures are not prescribed in this Article. In many cases,
the national law establishes a system of individual liability based either on
fault or on the notion of risk or strict liability. In other cases, the law may
provide for a collective system of compensation irrespective of individual
131. On the subject
of fair compensation, reference can be made to Article 41 of the European
Convention on Human Rights, which allows the Court to afford just satisfaction
to the injured party.
132. Article 21 of
this Protocol makes reference to the aforementioned compensation in such terms
as to exclude it from any payments constituting a financial gain or a
Article 26 (former
Article 25) – Sanctions
133. Since the aim
of the sanctions provided for in Article 26 is to guarantee compliance with the
provisions of the Protocol, they must be in keeping with certain criteria,
particularly those of necessity and proportionality. As a result, in order to
measure the expediency and determine the nature and scope of the sanction,
domestic law must pay special attention to the content and importance of the
provision to be complied with, the seriousness of the offence and the extent of
its possible repercussions for the individual and for society.
Chapter IX – Co-operation
Article 27 (former Article 26) – Co-operation
co-operation in transplantation matters is important for two main reasons. The
first is that information about the organisation and effectiveness of services,
successful methods of e.g. informing and educating the public or procuring
organs, success rates and new developments should all be freely exchanged to
help all States achieve the most effective transplant services possible within the
difficulties of tissue matching or the urgency of the clinical condition may
require access to a large or very large population if the transplant is to be
successful. For example, matching for unrelated bone marrow transplants
requires a very large pool of donors. People with fulminant liver failure may
need a suitable organ within a few hours if they are to survive. If an organ
becomes available in a country which has no suitable patient on its waiting
list, there must be arrangements in place to allow that organ to be offered
rapidly to patients on other transplant waiting lists if the organ is not to be
wasted. States Party to this Protocol are expected to set up transborder links so as to
facilitate the exchange of information and
the transportation of organs and tissues between States but without
prejudice to public safety as
specified in Article 6 and the need
for confidentiality as specified in Article 23.
Chapter X – Relation
between this Protocol and the Convention, and re-examination of the Protocol
Article 28 (former Article 27) – Relation between this Protocol and the Convention
136. As a legal
instrument, the Protocol supplements the Convention. Once in force, the
Protocol is subsumed into the Convention vis-à-vis Parties having ratified the
Protocol. The provisions of the Convention are therefore to be applied to the
137. Thus, Article
36 of the Convention, which sets out the conditions under which a State may
make a reservation in respect of any particular provision of the Convention,
will also apply to the Protocol. Using this provision States may, under the
conditions set out in Article 36 of the Convention, make a reservation in
respect of any particular provision of this Protocol.
Article 29 (former
Article 28) – Re-examination of
138. This article
provides that the Protocol shall be re-examined no later than five years from
its entry into force and thereafter at such intervals as the Committee in
charge of the re-examination may determine. Article 32 of the Convention
identifies this Committee as the Steering Committee on Bioethics (CDBI), or any
other Committee so designated by the Committee of Ministers. The provisions of
the Protocol to be re-examined would especially concern aspects of
transplantation where scientific developments would give rise to particular
ethical or legal issues; for example,
it is conceivable that the question of removing cells from a living person will
need to be reconsidered after a few years.
Chapter XI – Final
Article 30 (former
Article 29) – Signature and
139. Only States
which have signed or ratified the Convention may sign this Protocol.
Ratification of the Protocol is subject to prior or simultaneous ratification of
the Convention. Under the provisions of Article 31 of the Convention, a State
which has signed or ratified the Convention is not obliged to sign the Protocol
or, if applicable, to ratify it.