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/ November 2023
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DOI: https://doi.org/10.34069/AI/2023.71.11.15
How to Cite:
Ismayilova, P. (2023). International standards and domestic legislation on human organ donation and transplantation. Amazonia
Investiga, 12(71), 175-187. https://doi.org/10.34069/AI/2023.71.11.15
International standards and domestic legislation on human organ
donation and transplantation
Міжнародні стандарти та вітчизняне законодавство про донорство та трансплантацію
людських органів
Received: October 14, 2023 Accepted: November 29, 2023
Written by:
Parvina Ismayilova1
https://orcid.org/0000-0002-2709-3660
Abstract
The article analyzes international standards for
the quality and safety of organs for
transplantation. Azerbaijan, like other countries,
strictly prohibits organ trade. It criminalized the
forcible removal of organs, fraud or coercion,
and the buying or selling of organs. The objective
of the work is to analyze the Oviedo Convention
and the Council of Europe Convention on
Combating Trafficking in Human Organs, as
well as other legal acts, in comparison with the
criminal and administrative laws of Azerbaijan.
To achieve the objectives of the research, the
author of the article used such methods as
analysis and synthesis, the formal-legal method
and the comparative-legal method. As a result of
the research carried out, it was concluded that
Azerbaijan should improve its relevant
legislation taking into account the norms of these
conventions. In particular, the State's priority
should be to emphasize the donation of artificial
organs and tissues instead of human donation.
Keywords: transplantation, trafficking in human
organs, human rights, the principle of dignity,
Azerbaijani legislation.
Introduction
Human organ transplantation entered a new stage
of development that has created a new field of
science – transplantology. Despite the
transplantation research was conducted for the
first time in Europe (Grigoriev et al., 2001), the
first successful kidney transplant was performed
in the United States in the 50s of the last century.
1
PhD in Law, doctoral candidate and lecturer on “Human rights and Information Law” UNESCO department, Baku State University,
Azerbaijan.
For the first time a heart was transplanted from a
dying person to a patient in the 60s of the last
century. Transplantology, as one of the
promising fields of medical science, was formed
with regard to the transplantation of human
organs and tissues.
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Since then, transplantology has turned into a
powerful branch of medicine, but criminal
activity related to transplantology has also gained
serious scale.
The international legal fight against crime in this
field should be ensured together with
organizational, economic and educational
measures, as stated in the National Action Plan
for 2020-2024 on the fight against human
trafficking in the Republic of Azerbaijan. A more
appropriate policy should be the donation of
artificial organs and tissues, which should be
established in light of the objectives of the
Oviedo Convention and its Protocol, rather than
human donation.
The research tasks:
Evaluate the Discrepancies Between National
Legislation of Azerbaijan and the Protocol on
Transplantation:
Conduct a comprehensive analysis of the
Protocol concerning Transplantation of Organs
and Tissues of Human Origin.
Compare the provisions of the Protocol with the
applicable Law of the Republic of Azerbaijan
related to organ and tissue transplantation.
Assess the extent to which the internal legislative
act aligns with the Protocol and identify any
areas where the Protocol provides superior
regulation.
Addressing the "Right to Personal Inviolability"
and Prevention of Criminal Interests:
Propose amendments to Article 17 of the
Protocol to include a provision stating that
human organs and tissues transplantation is
prohibited in the absence of the deceased person's
will.
Examine the implications of such an amendment
on preventing criminal interests and protecting
the "right to personal inviolability" of the
deceased person.
Critical Examination of Protocol Wording for
Safeguarding Human Dignity:
Evaluate the wording of Article 21.1 of the
Protocol and its implications in safeguarding
human dignity.
Recommend changes to Article 21.1, specifically
proposing a modification to broaden the scope of
the norm to include various aspects such as social
and physiological factors.
Addressing Gaps in National Legislation Against
Illegal Organ Trafficking:
Analyze the existing criminal and administrative
legislation of the Republic of Azerbaijan related
to illegal organ transplantation.
Identify gaps in coverage and propose
amendments to strengthen the legal framework,
considering the transnational nature of organ
trafficking.
Assess the need for and implications of
recognizing the Convention against Trafficking
in Human Organs by the Republic of Azerbaijan.
Promoting International Legal Cooperation in
Combating Organ Trafficking:
Evaluate the effectiveness of international legal
cooperation in combating illegal transplantation
of human organs and tissues.
Analyze the role of criminal and administrative
legislation in the Republic of Azerbaijan in
supporting international efforts.
Propose strategies for enhancing international
legal cooperation against transnational crimes
related to organ trafficking.
Exploring Comprehensive Approaches to
Prevent Organ Trafficking:
Examine the limitations of relying solely on
international legal cooperation in addressing the
increasing pace of trade in human organs.
Identify additional measures beyond legal
frameworks, such as public awareness
campaigns or ethical guidelines, to prevent and
combat illegal organ transplantation.
Assess the feasibility and potential effectiveness
of these additional measures in complementing
legal efforts.
Theoretical Framework or Literature Review
This section delves into the multifaceted
challenges surrounding organ donation and
trafficking globally. The authors shed light on
diverse issues, ranging from the lack of
standardization in defining brain death and organ
donation criteria to the role of healthcare
professionals in perpetuating illegal organ
transplantation. The findings underscore the
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urgency for international cooperation, legal
reforms, and responsible AI frameworks to
address these challenges and enhance organ
donation practices while curbing illicit organ
trafficking.
In the article «Worldwide Barriers to Organ
Donation» Ivan Rocha Ferreira Da Silva and
Jennifer A. Frontera (2015) claim, that the lack
of standardization of brain death and organ
donation criteria worldwide contributes to a loss
of potential donors. Major barriers to donation
include variable clinical and legal definitions of
brain death; inconsistent legal upholding of brain
death criteria; racial, ethnic, and religious
perspectives on organ donation; and physician
discomfort and community misunderstanding of
the process of donation after cardiac death.
Limited international legislation and oversight of
organ donation and transplant has contributed to
the dilemma of organ trafficking. The authors
sum up, that an urgent need exists for a global
standard on the definition of brain death and
donation after death by cardiac criteria to better
regulate organ donation and maximize
transplantation rates. Unified standards may have
a positive effect on limiting organ trafficking.
In the article «A Responsible AI Framework for
Mitigating the Ramifications of the Organ
Donation Crisis» Salih Tutun, Antoine
Harfouche, Abdullah Albizri, Marina E. Johnson
& He Haiyue (2022) proposed a responsible AI
framework that integrates network science and
artificial intelligence to identify consent
outcomes for organ donation. The proposed
framework includes three phases: collecting and
pre-processing data, creating new features and
identifying root causes of family refusal, and
training and testing models to predict the
probability of families granting consent for organ
donation. The designed artifact included
collaborative decisions and network measures,
increasing explainability through network
science. It integrated human reviews and
assessment of risks which increases correct and
interpretable predictions. The authors believe
that results can help encourage organ donations
and reduce the illegal organ trade.
In the article «Formula to Stop the Illegal Organ
Trade: Presumed Consent Laws Formula to Stop
the Illegal Organ Trade: Presumed Consent Laws
and Mandatory Reporting Requirements for
Doctors and Mandatory Reporting Requirements
for Doctors» Sheri R. Glaser (2005) claims that
currently the international community has not
adequately responded to this problem. To reduce
or eliminate organ trafficking, countries should
(1) strengthen their laws against this crime and
remove any loopholes that encourage corruption;
(2) adopt presumed consent laws to increase
organ supply legally, which would reduce the
number of organs obtained on the illegal black
market; and (3) impose mandatory reporting
requirements on doctors who suspect that a
patient has obtained an organ from a trafficked
person. If these recommendations are not
followed, organ trafficking will continue to
persist, exploiting the less fortunate and violating
the autonomy of its victims.
In his article «Organ Trafficking: Why Do
Healthcare Workers Engage in It?» Trevor
Stammers (2022) considers organ trafficking in
all its various forms is an international crime
which could be entirely eliminated if healthcare
professionals refused to participate in or be
complicit with it. Types of organ trafficking are
defined and principal international declarations
and resolutions concerning it are discussed. The
evidence for the involvement of healthcare
professionals is illustrated with examples from
South Africa and China. The ways in which
healthcare professionals directly or indirectly
perpetuate illegal organ transplantation are then
considered, including lack of awareness, the
paucity of both undergraduate and postgraduate
education on organ trafficking, turning a blind
eye, advocacy of organ commercialism, and the
lure of financial gain.
In her article «Understanding the challenges to
investigating and prosecuting organ trafficking: a
comparative analysis of two cases»
Frederike Ambagtshee (2021) aims to explain the
legal, institutional and environmental factors that
affected the investigation and prosecution of two
organ trafficking cases: the Netcare case,
exposed in South Africa and the Medicus case,
exposed in Kosovo. Both cases constituted
globally operating criminal networks involving
brokers and transplant professionals that
colluded in organizing illegal transplants.
Recommendations to improve enforcement of
organ trafficking include improving
identification of suspicious transplant activity,
strengthening cross-border collaboration and
enhancing whistleblower protection laws.
Summary of Main Findings:
"Worldwide Barriers to Organ Donation":
Authors Ivan Rocha Ferreira Da Silva and
Jennifer A. Frontera (2015) emphasize the need
for standardized criteria for brain death and organ
donation globally. Barriers include variable
definitions of brain death, legal inconsistencies,
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and cultural perspectives. They argue for unified
international standards to regulate organ
donation, reduce physician discomfort, and
address the organ trafficking dilemma.
"A Responsible AI Framework for Mitigating the
Ramifications of the Organ Donation Crisis":
Salih Tutun et al., (2022) propose an AI
framework integrating network science to predict
consent outcomes for organ donation. The three-
phase framework enhances explainability and
incorporates collaborative decisions and risk
assessment. The authors believe this approach
can encourage organ donation, mitigate the
crisis, and combat illegal organ trade.
"Formula to Stop the Illegal Organ Trade":
Sheri R. Glaser (2005) argues for legal reforms
to combat organ trafficking, advocating for
strengthened laws, presumed consent, and
mandatory reporting by doctors. The author
warns that failure to implement these measures
may perpetuate organ trafficking, exploiting
vulnerable populations and violating individual
autonomy.
"Organ Trafficking: Why Do Healthcare
Workers Engage in It?":
Trevor Stammers (2022) explores the
involvement of healthcare professionals in organ
trafficking, discussing types of organ trafficking
and the role of professionals in perpetuating
illegal transplantation. Factors such as lack of
awareness, inadequate education, and financial
motives contribute to this issue. Stammers
suggests that healthcare professionals refusing to
participate could eliminate organ trafficking.
"Understanding the challenges to investigating
and prosecuting organ trafficking":
Frederike Ambagtshee (2021) analyzes two
organ trafficking cases, the Netcare case in South
Africa and the Medicus case in Kosovo,
highlighting legal, institutional, and
environmental factors affecting investigation and
prosecution. Recommendations include
improving identification of suspicious activity,
enhancing cross-border collaboration, and
strengthening whistleblower protection laws to
combat organ trafficking globally.
Methodology
This article undertakes a comprehensive
examination of the legal framework governing
organ transplantation in the Republic of
Azerbaijan, employing a range of scientific
research methods. The primary focus is on
evaluating the adequacy of domestic legislation
concerning organ transplantation in comparison
to the international standards outlined in the
Protocol on Transplantation of Human Organs
and Tissues. The author utilizes analysis and
synthesis, formal legal methods, and the
comparative legal method to scrutinize existing
laws, identify deficiencies, and propose specific
amendments to enhance the legal landscape for
organ transplantation.
Analysis and synthesis:
Analysis: The author conducts an analysis of the
Protocol on Transplantation of Human Organs
and Tissues and the legislation of the Republic of
Azerbaijan. The analysis reveals that, despite the
initial conclusion about more complete
regulation of the domestic legislation, there is a
higher level of regulation in the Protocol.
Synthesis: Based on the analysis, a conclusion is
made about the need to adapt the national
legislation of Azerbaijan to the Protocol, in
particular, the article states that the adaptation
should continue.
Formal and legal method:
The author uses the formal legal method to argue
for making specific changes to the text of the
Protocol. For example, the author proposes to
include the rule that transplantation of human
organs and tissues is prohibited in the absence of
the donor’s will. This approach is supported from
the point of view of the "right to personal
integrity" of the deceased person.
Comparative legal method:
The author compares the provisions of the
Protocol with the internal legislation of the
Republic of Azerbaijan and concludes that the
regulation in the Protocol is superior. It also
compares the provisions of specific articles with
changes that, in the author's opinion, can improve
the protection of the rights and dignity of
individuals in the context of organ
transplantation.
These methods allow the author to identify
shortcomings in the current legislation, point out
the advantages of the Protocol and propose
specific changes to improve the situation in the
field of organ transplantation. Analysis and
synthesis help to reveal the problem and
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highlight the need for changes, the formal-legal
method is used to substantiate specific proposals,
and the comparative-legal method helps to
establish the differences between various norms
and determine the optimal way to achieve the
goal.
Rigor of the Study:
Source Selection: The study relies on primary
sources, including the Protocol on
Transplantation of Human Organs and Tissues,
and the domestic legislation of Azerbaijan. The
selection of these sources is crucial for a
thorough understanding of the legal framework.
Quality Evaluation: The quality of sources is
assessed based on their relevance to the topic and
the authority of the legal documents. The use of
internationally recognized standards, such as the
Protocol, adds credibility to the study.
Results Interpretation: The author interprets the
results by critically evaluating the identified
shortcomings in domestic legislation,
highlighting the Protocol's advantages, and
proposing specific changes. The conclusion
underscores the urgency of continuous
adaptation to international standards in the field
of organ transplantation.
In essence, the combination of analysis,
synthesis, formal legal methods, and comparative
legal methods employed in this study offers a
robust foundation for identifying, understanding,
and rectifying deficiencies in the current legal
framework for organ transplantation in
Azerbaijan.
Results and Discussion
1. Transplantology and the legal aspects
Transplantology is a field of biology and
medicine that studies the problems of
transplantation and develops methods of
preservation of organs and tissues, creation and
use of artificial organs. As a field of science, it
covers surgery, resuscitation (restoration),
anesthesiology (sedation, pain relief),
immunology (medicine that studies
inviolability), pharmacology and other
biomedical and medical technologies. It mainly
involves the regeneration of diseased organs and
tissues as a form of fighting against human
diseases.
As human organs and tissues transplantation also
covers the problems having legal, as well as
personal, somatic (comes from the Greek) nature,
so its legislative solution has also emerged as a
special problem. Since many legal and criminal
problems arise in the process of transplantation,
its complex legislative regulation and issues of
international legal cooperation in a transnational
context should also be resolved. Since the
transplantation and donation of human organs
and tissues is a matter of human rights and
freedom, dignity and privacy, the norms of the
Universal Declaration of Human Rights (United
Nations, 1948), the International Covenant on
Economic, Social and Cultural Rights (1966b),
the International Covenant on Civil and Political
Rights (1966a), which contain universally
recognized standards must be taken into
consideration for the creation and interpretation
of special rights. Norms containing universally
recognized standards determine the direction of
other, specific areas by creating international
human rights law (Guseinov, 1998; Toebes,
2001). The right to receive health and medical
care, which is expressed in international acts
(e.g., Article 25 of the Universal Declaration of
Human Rights; Article 12 of the International
Covenant on Economic, Social and Cultural
Rights, etc.) has led to the adoption of new
international acts.
Since it is mainly in the category of economic
and social rights, states participate in
international cooperation in this field (e.g., the
1981 Declaration of Lisbon on the Rights of
Patients on the ethical criteria of doctors
regarding the rights of patients; the 2005
UNESCO Universal Declaration on Bioethics
and Human Rights, etc.) under the norms that do
not create a binding obligation. In the personal
rights category, conventional norms on personal
rights, personal integrity, respect for human
dignity, etc. could not achieve
comprehensiveness. For example, the
Convention for the Protection of Human Rights
and Dignity of the Human Being with regard to
the Application of Biology and Medicine has not
been ratified even by the member states of the
Council of Europe (UK, FRG, etc.) up to this
date. In this field, universal recognition of
adopted international obligations is delayed.
Only 28 countries have met the legislative
requirement set by the 2010 Nagoya Protocol on
Access to Genetic Resources and the Fair and
Equitable Sharing of Benefits Arising from their
Utilization to the Convention on Biological
Diversity (World Health Organization, 2016).
In terms of adoption of binding legal documents,
the main exceptions are acts of the European
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Union (e.g., the 2002 European (Brussels)
Charter on Patients' Rights). Currently, one of the
international legal acts that stands out for its
unifying importance is the Convention for the
Protection of Human Rights and Dignity of the
Human Being with regard to the Application of
Biology and Medicine of April 4, 1997 (the
Republic of Azerbaijan is not a signatory to the
Convention). It is also known as the Oviedo
Convention because it was adopted in Oviedo,
Spain. The Convention (Art.1) specifies the
necessary legislative measures to be
implemented for the safeguard human rights and
dignity (Council of Europe, 1999). During the
application of biology and medicine, the
concerned parties can define more
comprehensive rules compared to the
Convention regulation (Art.27). The application
of biology and medicine not only benefit
humanity, but may lead to acts endangering
human life, wellbeing or dignity through genetic
processes (Sollie, & Duwell, 2009).
Another important aspect of the Convention is
the obligation of states to be open to public
discussions and consultations during the
application of biology and medicine. For
fulfilling this obligation, the concerned parties
can establish their own procedures. In particular,
the domestic legislation (Constitution of the
Republic of Azerbaijan, 1995, Art.29) envisages
increasing the role of medical personnel,
teachers, and society in the application of biology
and medicine by establishing ethical
commissions for organ donation and
transplantation (Art.28). Subordination of
professional standards in the healthcare system to
human interests, safeguard rights and dignity, the
primacy of human dignity with regard to any
commercial or scientific interest should find its
expression in the domestic legislation. The
primacy of human rights and dignity in the
Convention (Art.2); ensuring equitable access to
health care (Art.3); development of professional
standards (Art.4), protection of each individual
as a representative of the human race should be
ensured in the course of research (Mammadov, &
Mustafayeva, 2013). The Convention only
regulates preventive, diagnostic, therapeutic and
scientific research activities covering human
biology and medicine.
The activity of European international judicial
bodies (the "Sunday Times" case of the European
Court of Human Rights, 1979 (Janis et al., 2008;
R.R. v. Poland-HUDOC, 2011) and the "Brustle
v. Grenpes" case of the European Court of
Justice, 1997 (European Union, 2011) pertaining
to the primacy of human health in biotechnology
and medicine over any scientific research and
commercial activity is expanding the general
practice on the need to safeguard rights and
freedoms.
Convention for the Protection of Human Rights
and Dignity of the Human Being with regard to
the Application of Biology and Medicine was
enacted as an act of the Council of Europe in the
context of the 1950 European Convention for the
Protection of Human Rights and Freedoms
(Council of Europe, 1997). It means that the
limit of individual rights expressed in Article 8.2
of the 1950 European Convention for the
Protection of Human Rights and Freedoms is also
valid for the Oviedo Convention. It is true that in
the Oviedo Convention (Art.7) these exceptions
have particularity. In this sense, the exceptions
stated in Article 8 of the European Convention
for the "protection of the country's economic
stability, public order or morality and national
security" are not covered by the general
exceptions of the Oviedo Convention (Art.7.1). It
appears that, in the context of the Oviedo
Convention, it is not appropriate to make the
realization of fundamental rights mainly relating
to the protection of human rights in the field of
health, dependent on the country's economic
well-being, public order or morals, and national
security.
The Oviedo Convention establishes the
framework principles for the realization of
human rights and human dignity of the human
being with regard to the application of biology
and medicine. For this reason, it has specific
annexes according to the subject of regulation,
one of which is the 2002 Protocol to the
Convention on Transplantation of Human
Organs and Tissues (the Protocol entered into
force in 2006, the Republic of Azerbaijan is not
a signatory to this Convention).
This Protocol applied to the transplantation of
human organs and tissues carried out for
therapeutic purposes and also haematopoietic
stem cells (Art.2). Reproductive organs and
tissues, embryonic organs, blood elements are
not regulated by the Protocol (Council of Europe,
2002). In this field, the Republic of Azerbaijan is
also in the stage of development of its own
legislation. For example, the 1997 Law of the
Republic of Azerbaijan "On Protection of
Population Health" coincided with the adoption
of the Oviedo Convention. Subsequently, the
1999 Law "On Transplantation of Human Organs
and Tissues" (Law No. 360-IQ, 1997; Law
No. 726-IG, 1999), which was replaced by a new
legislative act, established a specific legal
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regulation in this area. Given the application of
biotechnology development in the field of
medicine, on October 20, 2020, a new Law of the
Republic of Azerbaijan “On Donation and
Transplantation of Human Organs and Tissues”
was adopted. The new law was enacted as of
January 1, 2022. Article 3.3 of the Law
prescribes the areas covered by it as per the
subject of regulation of the Protocol.
Besides some legal instruments (the Constitution
of the Republic of Azerbaijan, the Law of the
Republic of Azerbaijan "On Protection of
Population Health", this Law, along with other
regulatory acts), Article 2 of the Law mentions
the international agreements on organ donation
and transplantation that the Republic of
Azerbaijan is a party. Although the Republic of
Azerbaijan is not bound by the Oviedo
Convention and its Protocol, it ensures the
harmonization of its domestic acts with
international norms. In particular, scientific and
technical cooperation with foreign countries and
international organizations in organ donation and
transplantation in accordance with international
law; the organs and tissues exchange
arrangements are specified in the Law (Art.33).
2. The rights of a living donor, the problem of
donation of a deceased person (non-living or
deceased donors) and the principle of
dignity.
Both domestic legislation and international legal
norms have set specific rules and conditions for
the removal of donor organs for transplantation
from a living donor. One of the issues of special
importance of the Protocol and not established in
the legislation is the risk assessment mechanism
for the donor. Article 12 of the Protocol specifies
the right to have access to independent advice by
a competent health professional having
appropriate experience and who is not involved
in the transplantation, on the assessment of
possible risks during organ transplantation.
Specifically, information on the "right to
independent advise" is defined as an international
legal obligation for the concerned parties in the
Protocol. Although the rights and duties of the
living donor are listed in Article 19 of the Law
and the right to "receive complete and objective
information about transplantation from a health
care institution, including possible
complications" is established in Article 19.1.1, it
cannot be considered the same as the "right to
receive independent advice" provided for by the
Protocol.
It is true that Article 19.1.1 of the Law specifies
to "...get complete and objective information
about complications." However, it has
substantive legal content. An "independent
expert" is needed for its provision. In this sense,
the Law should include the rule "to receive
complete and objective information about
complications from an independent professional
having medical ability and knowledge." The
relevant rule is one of the procedural conditions
before transplantation. The next issue is that the
right to "...informed consent" in Article 17 of the
Law is given as the right to "consent of the living
donor" in Article 13 of the Protocol. "Consent"
should mean that it is not only against legality or
personal rights, but also not against morality
(Koru, 2021). Note that, a detailed definition of
"informed consent" is expressed in the Law (in
the Article of basic concepts, Art.1.1.10)
compared to the Protocol.
Subject to this article, the following are the
absolute conditions:
▪ prohibition of forcing the removal of any
personal organs;
▪ complying with the principle of
voluntariness in the transplantation of
organs from the living donor;
▪ certified application of the informed consent
of the living donor in writing;
▪ special form of the informed consent
application;
▪ notarized testimony of close relatives during
organ transplantation from the living donor;
▪ entering information on the informed
consent of the living donor into the register
of living donors (Art.17.2).
As an established part of the right to informed
consent of the living donor, Articles 19 and 20 of
the Law also cover the living donor's medical
(Art.19.1.4; Art.20), labor (Art.19.1.5), social
(Art.19.1.6) and other state guarantees. The right
to informed consent of the living donor is one of
the basic somatic (medical) rights and is
generally guaranteed by the individual's
constitutional right to "freedom of information."
The right to "informed consent" in the field we
have studied ensures the safeguard rights of
donors in the donor-doctor relationship by
determining the doctor's responsibility (Law
No. 360-IQ, 1997). The exception to this right in
special cases is compatible with the convention
norm (Art.26) (Council of Europe, 1999) and the
legislative norm (Art.28).
The legislation of the Republic of Azerbaijan on
the organs and tissues transplantation of the
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living donor envisages a more comprehensive
regulation than the Convention, with very few
exceptions (for example, the "right to
independent advice" in Article 12 of the
Protocol).
3. The problem of deceased person (corpse)
donation and the principle of dignity
As mentioned, since the human organs and
tissues transplantation is related to a number of
serious ethical, psychological, and religious
issues, its legal and legislative solution also has
diversity in the legislation of individual states,
and this diversity is changing day by day. For
example, in the Swiss Confederation, the
previous Law of 2004 established the exact
opposite concept with a new amendment. With
the new Law "On Transplantation and Donation
of Human Organs" adopted as a result of the
referendum held on May 15, 2022 (60.2% vote),
donation is based on the presumed "silent
consent". This trend is also found in other
countries. The United Kingdom, which stands
out for its conservatism, with the recent 2020
(Carey and Max law) legislative change,
automatically considers people aged 18 and over
to be organ donors, provided that the person has
not expressed objection to organ donation in
writing before their death.
According to anti-donation model applicable in
the vast majority of states (e.g., Swiss Transplant
Act of 1988; US National Organ Transplant Act
of 1984; the Federal Law of Germany on
Donation, Collection and Transplantation of
Organs and Tissues of 1997 as amended on May
25, 2012, if a person has not given voluntary
consent for donation before his/her death, his/her
organs cannot be taken even after his or her
death.
The presumed "silent consent" in donation,
which we can express as the Swiss model, is
established in the legislation of the states
mentioned, including the legislation of the
Republic of Azerbaijan (e.g., the 1997 Law of the
Republic of Azerbaijan “On Protection of
Population Health”; the 1999 Law “On
Transplantation of Human Organs and Tissues,
etc.) against the presumed "consent" or
"requested consent." The presumed "consent" or
"requested consent" requires the documented
consent of the persons before their death and of
their relatives after their death for organ and
tissue transplantation. For example, under the US
National Organ Transplant Act of 1984 (US
Congress, 1984), the consent document is known
as a "donor note." According to the “presumed
consent” applied in the United States and
Australia, it is considered an objection to donate
if it cannot be proven otherwise (e.g., there is no
registration in the donor database, registration of
consent for donation in the passport) according to
the "presumed consent" applied in Australia.
The main argument of the initiators of the 2022
Act of the Swiss Confederation, which should
enter into force no earlier than 2024, as well as
the recent 2020 Carey and Max Act of Great
Britain, is that there are serious problems in
securing donations. For preventing abuses, the
new Swiss legislation has also significantly
enhanced the role of relatives of deceased
persons in relation to donation. However, these
arguments cannot be considered fair in terms of
safeguard personal rights and dignity. Until
recently, in some countries (Latvia) clandestine
removal of tissues and organs from corpses for
commercial purposes in exchange for medical
equipment (from Germany) was observed as well
(Neethu R. Elberte v. Latvia, 2015). At the
beginning of 2005, the European Parliament
announced a list of countries where trafficking in
human organs is widespread (Moldova, Ukraine,
Romania, Estonia, Central Asia). In the current
chaos caused by Russia's military aggression
against Ukraine, it is possible that this problem
will deepen.
As a rule, relatives do not give consent to the
donation of a dying person, but wish for his/her
recovery. The last thing they may think about is
the "obligation" of the relatives to inform the
competent authority about the donation consent.
Of course, cases of consent to the removal of
organs from a person (potential donor) whose
death is obvious (for example, in cases of serious
accidents) may constitute an exception. In this
sense, the provision of data privacy in the secure
national online registry, which allows access to
donation consent before the death of all persons
who have reached the age of 16 in the Swiss
legislation we have described, also seems
problematic. The inability to express objection in
advance for various reasons, the existence of
cases of abuse, including criminal cases, does not
exclude that this model leads to more serious
dangers in societies where democratic values and
human rights have not been fully established.
Murder for organ removal is also seen in legal
states. As proof of this is the "Doctor's case" in
the U.S. California Supreme Court in 2008
(Mustafaeva, & Mamedov, 2010). Illegal
transplants have also been found in India, Brazil,
Ukraine, Croatia, Bulgaria, Venezuela and other
countries.
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As a rule, there are no unloved relatives at the
hospital, and what beloved relative would think
about a transplant at this moment? They are
praying for healing at this time. That is what is
ethical.
The European Court of Human Rights, in a
number of its decisions, drew attention to the
uncertainty in the legislation of the states in the
decision mechanism of relatives. For example, in
2015, the European Court of Human Rights
(ECHR) in its decision on the case "Petrova v.
Latvia" noted the non-realization of the right of
relatives to consent due to the absence of the
obligation to ask the consent of the medical
personnel in the legislation (Petrova v. Latvia,
2014; Neethu R. Elberte v. Latvia, 2015).
We believe that (as noted by the Non-Party
Committee of the Swiss Parliament (Swissinfo,
2022) "silent donation" contradicts the principle
of inviolability of human dignity. It is not
inconceivable that in this way the commercial
removal of organs from people who did not
consent to donation Elbert v. Latvia
(Neethu R. Elberte v. Latvia, 2015) will not be
carried out, and this situation will not lead to the
creation and increase of criminal cases.
The inviolability of a person is related to his/her
dignity. Dignity is a person's right to
respect...quality. It is achieved by the
development of a personality that has realized its
freedom, equality and protection. Dignity is the
right of a person to be valued and respected for
their own sake, and to be treated ethically. The
donation problem should be solved taking into
consideration of the general position of the
European Court of Human Rights on
"inviolability of personality", as well as
international acts (The International Covenant on
Civil and Political Rights (Art. 7): ... no one shall
be subjected without his free consent to medical
or scientific experimentation; the norms on
dignity of the Oviedo Convention for the
Protection of Human Rights and Dignity of the
Human Being with regard to the Application of
Biology and Medicine (Art.1; 2) (the Republic
of Azerbaijan is not a signatory to this
Convention) and the 2002 Additional Protocol to
the Convention on Human Rights and
Biomedicine concerning Transplantation of
Organs and Tissues of Human Origin.
The new Law of the Republic of Azerbaijan “On
Donation and Transplantation of Human Organs
and Tissues” adopted on October 20, 2020 is
based on the "requested consent" model. The
legislation of the Republic of Azerbaijan was
established based on the content of the 1997
Oviedo Convention and its Protocol on the
Transplantation of Human Organs and Tissues to
solve this problem. The new legislation of the
Republic of Azerbaijan has undergone a
conceptual change in accordance with the
Oviedo Convention and its Protocol. Thus, in the
new Law, the institution of donation of human
organs and tissues envisages "removal of organs
from a deceased person." And organ donation
from a living person contains a special case.
The Protocol specifies the cases in which it is not
allowed to remove an organ from a deceased
person. However, the new legislation of the
Republic of Azerbaijan regulates "removal of
organs from a corpse" in more detail than the
Protocol. Subject to the first part of Article 16 of
the Protocol, organs or tissues shall not be
removed from the body of a deceased person
unless that person has been certified dead in
accordance with the law. Subject to the second
part of Article 16 of the Protocol, the next
restriction condition is provided. According to
that article, 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 (Council of Europe,
2002). Article 25 of the Law “On Donation and
Transplantation of Human Organs and Tissues”
further expands the scope of restrictions on organ
and tissue donation. The Protocol does not
specify the mechanism for determining
biological death or brain death. The rules for
solving this issue are provided in the 1997 Law
of the Republic of Azerbaijan "On Protection of
the Population Health." (Law No. 360-IQ, 1997)
In accordance with the Law "On Protection of
Population Health", the decision of the medical
council and the consent of the health care
institution are taken as the basis for biological
death. For excluding abuse or any illegal interest
factor, as in the relevant article of the Protocol,
the Law prohibits the participation of the
transplant doctor and transplant coordinator in
confirming the moment of death of the donor.
As per Article 17 (consent and authorization) of
the Protocol on transplantation of human organs
and tissues, the appropriate wording of the Law
attracts attention due to its wider content.
Legislation of the Republic of Azerbaijan does
not rely on the "silent consent" or "soft model"
formula established in European countries, but
on the "presumed consent." It is Article 21.1 of
the Law that states the principle of consent to the
removal of donor organs from a deceased person
for transplantation. If a person during his/her
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lifetime gives his/her written consent to the
transplantation of his/her organs, for educational
and scientific purposes, in accordance with
Article 22.1 of this Law, after his/her death,
his/her donor organs can be used for
transplantation, educational and scientific
purposes. Article 22 specifies the position of a
person regarding his/her consent to the removal
of his/her organs and tissues for transplantation
after death or his/her objection to remove his/her
organs.
Note that subject to the requirement of Article
22.1 (the consent to the removal of organs for
transplantation after the death of a fully
functional adult during his/her lifetime or the
objection to remove organs is executed by an
application approved in accordance with Article
22.6 of this Law...) donation institution is based
on the “presumed consent.” Why "consent"?
Such a form of consent to the removal of a
person's organs after death for transplantation or
the objection to the removal is subordinated to
the requested consent form. That is, there is a
necessity of formalization for the waiver
application. Subject to the previous legislation, it
was possible to become a donor by registering a
person with the national health care bodies based
on an approved official donor document.
Donation was not possible if there was no such
document.
What does the non-declaration of will on
donation mean? Article 21.3 of the Law states
that if a person refuses to donate in writing during
his/her lifetime, it is not allowed to take organs
from his/her corpse for transplantation after
his/her death. Contrary to this norm, if a person
did not refuse donation in writing during his/her
lifetime, if is it possible to remove his/her organs
from his/her corpse for transplantation after
his/her death? Non-declaration of will on
donation replaces the former "strict" or
"requested consent" model by the new one (e.g.,
according to the Swiss model), which
"automatically becomes a donor if there is no
written objection to donate organs."
This situation is also confirmed by Article 21.4
of the Law (In case of brain death as a result of
an accident and natural disaster, it is allowed to
take organs for transplantation from the deceased
persons who did not object donation in writing
during their lifetime and who are not relatives
specified in Article 21.2 of this Law). Such a rule
is based on the written “presumed consent"
specified in Article 21.1 of the Law, as well as
the Constitution of the Republic of Azerbaijan (...
medical, scientific and other experiments cannot
be carried out on anyone without their voluntary
consent) (Constitution of the Republic of
Azerbaijan, 1995). It contradicts Article 46.III
and can be considered as an unethical, moral
aspect of the Law. Thus, there is a tendency of
discrimination in relation to the deceased persons
who did not consent to donation during their
lifetime or did not declare their will about it or
did not have the opportunity to do so. Universal
international law (e.g., Article 130 of the 1949
Fourth Geneva Convention relative to the
Protection of Civilian Persons in Time of War
requires detaining authorities to ensure that
internees who die while interned are honorably
buried, if possible according to the rites of the
religion to which they belonged...) (International
Humanitarian Law Databases, 1949) expressed
to respect the deceased persons after their death
in the context of universally recognized human
rights. Acceptance of the deceased person's body
as a donor despite the absence of a direct
expression of will contradicts Article 2 of the
Oviedo Convention (the interests and … of the
human being shall prevail over the sole interest
of society or science). Article 18 of the Protocol
states that during removal the human body must
be treated with respect. However, this obligation
cannot be considered sufficient in terms of the
protection of human dignity. The “presumed
consent" in the Protocol should be safeguarded
against all abuses. Note that although donation is
considered normal for health care institutions,
being a donor is related to a psychological
process. The original basis of the principle of
informed consent can be linked to the
inseparability of human rights and freedom
established by the French bourgeois revolution.
According to the Civil Code of France
(Napoleonic Code) (chapter on the inviolability
of the person, Art.16.3) (Trans-Lex, 2016), there
may be no infringement of the integrity of the
human body. The consent of the concerned
person must be obtained beforehand.
According to the Protocol (Art.19), parties may
take all appropriate measures to promote the
donation of organs and tissues. As mentioned, the
Protocol is based on the principle of respect for
human dignity in the legal regulation of organs
and tissues transplantation (Art.1). Although
some legal issues of human organs and tissues
transplantation (e.g., "human organs and tissues
transplantation in the absence of a declaration of
will) are within the competence of the domestic
legislation of individual states. In this regard, the
Oviedo Convention (Art.36) does not interfere
with the unilateral regulatory authority of states.
However, in terms of ensuring the content
richness of the principle of respect for human
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dignity in the Protocol, there is also a need for a
law-making process. In Article 17 of the Protocol
(except for "the removal shall not take place if
the deceased person had objected to it"), the rules
and conditions of "consent and authorization" are
left to the domestic legislation.
For preventing the criminal interests in the
human organs and tissues transplantation and
ensuring the "right to personal inviolability" of
the deceased person, the norm " human organs
and tissues transplantation is prohibited in the
absence of will" can be included as part 2 of
Article 17 of the Protocol. Such a norm would
also serve the principle of dignity.
In accordance with the principle of respect for
human dignity, as in Chapter VII of the Oviedo
Convention, Protocol (21.1) states that “the
human body and its parts shall not, as such give
rise to financial gain or to obtain a comparable
advantage." Here, the formula "... as such give
rise to obtain a comparable advantage " should
also be considered flawed. It should be noted that
"...to obtain any, including social, physiological
etc. comparative advantages.”
Both the Protocol (Art.22) and the domestic
legislation prohibit the commercialization of
human organs and tissues transplantation, and
state that the human organs and tissues
transplantation is free of charge. Article 4 of the
Law of the Republic of Azerbaijan “On Donation
and Transplantation of Human Organs and
Tissues” states that legality, humanism,
volunteerism, solidarity, compassion and
disinterestedness are the principle directions of
organ donation and transplantation. However, as
mentioned, organ donation is often accompanied
by moral and ethical problems. According to the
position of experts, although the human organs
and tissues transplantation from one relative and
implantation of them into another person is
legally free, it is also a transaction. There are
different theories on the fair distribution of these
scarce resources, and sometimes preference is
given to individuals of "higher" social
importance (Mustafaeva, & Mamedov, 2010). As
stated in the Council of Europe Convention
Against Trafficking in Human Organs (Council
of Europe, 2015), enacted in 2018, and Article 22
of the Protocol ("prohibition of financial gain"),
trade in organs is prohibited in the legislation of
the Republic of Azerbaijan. Article 32 of the Law
states that the purchase and sale, as well as
advertising the need for donor organs is
prohibited. Organ trafficking has a number of
inexcusable moral ugliness.
The purchase and sale of the human body, with
its transformation into an object, leads to the
violation of the special social status of the person
in the society, depersonalization and
demoralization of the person. Trade in organs as
a new form of exploitation increase social
injustice in society and the rich literally survive
at the expense of the poor. Since it is impossible
due to various objective and subjective reasons,
it should be a matter of special legislation not to
eliminate this injustice, but to ensure control over
it.
In world practice, there are several legal types of
organ removal from a deceased person (corpse).
As noted in the literature the cultural, religious,
etc. specifics of the region taken separately while
establishing the states’ domestic legislation on
transplantation should be taken inti consideration
Mainly, the form of organ collection based on the
consent given by the potential donor during
his/her lifetime, which is used in some American
states, as well as in the Netherlands, Portugal and
several other European countries, contains moral
and ethical values. It is based on the fundamental
rights of the individual, such as self-
determination and independence, with informed
consent. A person retains the right to dispose of
his life and body even after death. In medicine,
this is considered a more democratic method.
Doctors do not have the right to use the body of
a deceased person at own discretion. In medicine,
this is considered a more democratic method. In
this case, the flexible preparation and
transplantation of organs and tissues, the
establishment of rapid, stable relationships of
mutual trust between the doctor and the patient's
relatives and the time required lead to
psychological difficulties for doctors. In this
case, the doctor collects the organs not by his/her
personal will and desire, but according to the law.
In terms of prevention of criminal cases,
inviolability of personality, and the principle of
dignity, as stated above, this form may be
deemed as a form of universal regulation based
on the rule of international law.
The main points of legislation related to the
removal of organs from the corpse for
transplantation are:
▪ the principle of written consent in
contradictory (exceptional) form to the
removal of donor organs from the corpse for
transplantation;
▪ use of donor organs for transplantation,
educational and scientific purposes;
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▪ donation is a declaration of will during the
lifetime of a fully functional person who has
reached the age of majority;
▪ formalization of consent to removal of
organs or objection of removal of organs
with a special application form;
▪ inclusion of donation information in the
register of persons who consented to
donation, in the unified state database;
▪ the possibility to change the expression of
will regarding donation at any time after the
person's death;
▪ responsibility of the medical setting and the
coordinating institution should be stated for
ensuring the confidentiality of information
related to the consent to organ
transplantation or the objection of removal
of organs.
Conclusions
In case of comparison of the Protocol concerning
Transplantation of Organs and Tissues of Human
Origin with applicable Law of the Republic of
Azerbaijan, despite the initial conclusion that the
internal legislative act has a more comprehensive
regulation, there is a superior regulation in the
Protocol. In this sense, the adaptation of the
legislation to the Protocol (Article 12) should be
continued.
For preventing criminal interests in the
transplantation of human organs and tissues and
in terms of ensuring the "right to personal
inviolability" of the deceased person, the norm "
human organs and tissues transplantation is
prohibited in the absence of will" can be included
as part 2 of Article 17 of the Protocol. The
wording of Article 21.1 of the Protocol
("...cannot be taken to gain comparable
advantage") should also be considered flawed.
Changing this norm as "...any, including social,
physiological, etc. cannot be taken to gain
comparable advantage" would be more logical in
terms of safeguard human dignity.
Since the trafficking in human organs is a
transnational crime that violates human rights
and freedoms, human dignity, and threatens
public and national security, the fight against it
can only be effective with international legal
cooperation. Criminal and administrative
legislation of the Republic of Azerbaijan is being
developed for toughening of punishments.
Analysis of criminal legislation shows that all
forms of illegal organ transplantation are not
fully covered. Therefore, recognition of the
Convention against Trafficking in Human
Organs by the Republic of Azerbaijan would
make the fight against the criminal donation and
transplantation effective and promote
international legal cooperation against this
transnational crime.
On the background of international legal
cooperation against the illegal transplantation of
human organs and tissues, establishment of the
norms of responsibility in the domestic
legislation of the states, including criminal
liability, and toughening the punishments are of
course important in preventing criminal activity.
However, these measures are not the only way
out. It seems impossible to prevent the problem
using the international legal fight due to the
increasing pace of trade in human organs.
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