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A. Draft
recommendation
(open)
Report | Doc. 15022 | 03 January 2020
Combating trafficking in human tissues and cells
Committee on Social Affairs, Health and Sustainable Development
Summary
Human cells and tissues are routinely used for medical purposes, transplantation and research. This includes corneas, heart valves, skin, stem cells, sperm and oocytes. New technologies help save lives, improve quality of life and help individuals to become parents. However, such use raises ethical and legal questions.
The principles of prohibition of financial gain, free and informed consent and the prevalence of the interests of the human being over those of society are enshrined in the international legal framework. However, cases of procurement without consent, inadequate testing, false donor files, irresponsible allocation and illegal trade have been reported. The absence of an internationally accepted definition of “trafficking of human tissues and cells”, cross-border situations, differences in national legislation and the rapid evolution of technologies make it difficult to prosecute illicit activities.
The Council of Europe has a mandate to protect human rights as well as expertise on human tissues and cells. It is therefore well placed to support decision making on what activities should be criminalised and ensuring that these decisions are respected. The Parliamentary Assembly should thus call on the Committee of Ministers to take the lead and develop a binding legal instrument on combating trafficking in human tissues and cells.
A. Draft
recommendation 
(open)1. Advances in technology in human
tissue and cell transplantation can save lives, restore essential
bodily functions, improve quality of life and help individuals to
become parents. Today, human substances, ranging from musculoskeletal,
cardiovascular and ocular tissues, to many types of cells and gametes,
are used routinely for medical purposes, therapy and research. Within
the European Union alone, over 2 million human tissue and cell units
were distributed for medical use in 2016. At the same time, the
use of substances of human origin for transplantation and research
raises many ethical and legal questions.
2. The Council of Europe Convention on Human Rights and Biomedicine
(Oviedo Convention, CETS No. 164) stipulates that the “human body
and its parts shall not, as such, give rise to financial gain”,
that an “intervention in the health field may only be carried out
after the person concerned has given free and informed consent to
it” and that the “interests and welfare of the human being shall
prevail over the sole interest of society or science.” Today, these
principles are in danger of being bypassed and watered down.
3. In contrast to the field of organs, limited attention has
been paid to illicit and unethical activities associated with the
procurement, processing and clinical use of human tissues and cells.
This is perhaps because society is less familiar with tissue and
cell transplantation compared with organ transplantation, although
the latter happens far less often.
4. When illicit and unethical activities involve donors, they
frequently relate to recently deceased persons. Illicitly obtained
tissues from one deceased person can reach up to 90 recipients.
Various ethical and safety-related scandals have been reported,
such as procurement without consent or authorisation, inadequate testing,
inaccurate or false donor files, irresponsible allocation and illegal
trade. Hearings, lawsuits, resignations and closures of tissue establishments
have followed. However, knowledge about the true extent of these
illicit activities remains limited. Little information is available
from official sources.
5. Furthermore, there are activities that, in addition to their
illicit and unethical component, could seriously jeopardise the
quality and safety of tissues and cells, and thus the recipients’
health.
6. When illicit and unethical practices occur in the form of
financial inducement to donors (or their families), there may be
a risk of potential living donors not adequately considering the
risks related to the donation procedure or the families of deceased
donors not disclosing relevant medical or behavioural information
that would, under normal circumstances, preclude donation. This
can also motivate intermediaries to withhold information for fear
of losing fees.
7. Excessive compensation for donation may endanger the health
of vulnerable donors who may be enticed to donate driven by financial
need. This may be of particular concern in the case of oocyte donors, where
financial inducements can prompt women to provide multiple donations
in different clinics without proper follow-up and medical care,
and thus risks for their health and fertility. The risk of excessive
donation is increased in the case of cross-border donations, where
financial disparities between countries may render originally appropriate
compensations in one jurisdiction into real inducements for donation
for donors from less affluent countries.
8. Desperation may also lead patients to search for alternative
therapies for various diseases, including cell-based experimental
treatments promoted without clinically demonstrated safety and efficacy.
9. Illicit and unethical practices undermine public trust and
support. Scandals related to such practices cause a drop in confidence
in all types of donor-derived substances and result in reluctance
among the general population to donate bodily materials. Ultimately,
this will affect the availability of tissue and cell grafts, and
can jeopardise the availability of organ and blood donors as well.
10. The existing international legal framework – developed by
the World Health Organization, the EU and the Council of Europe
– includes ample provisions to ensure the quality and safety of
tissues and cells, by specifying the principles of consent, prohibition
of financial gain and authorisation requirements. These principles,
however, are not fully implemented and their violations are not
systematically prosecuted. The prohibition of financial gain, which
is a universally accepted principle for such donations, is not always
easy to uphold. Income disparities between and within different
countries, together with the fact that tissues and cells can be
easily stored and shipped, create opportunities for profit-making
and abuse.
11. Most importantly, the absence of an internationally agreed
definition of what constitutes trafficking in tissues and cells
on the one hand, and the diversity of legal provisions within the
EU, Council of Europe member states and third countries, on the
other hand, make it difficult to prosecute illicit and unethical
activities.
12. The Assembly recalls that in its Recommendation 2009 (2013) on “Towards
a Council of Europe convention to combat trafficking in organs,
tissues and cells of human origin”, adopted in 2013, it suggested that
the issue of trafficking in human tissues and cells was different
from trafficking in human organs, and that the two issues had to
be addressed through two distinct legal instruments. The Assembly
thus called upon the Committee of Ministers to decide on a roadmap
for the preparation of an additional protocol on trafficking of human
tissues and cells to the proposed Convention against Trafficking
in Human Organs.
13. Since then, the Council of Europe Convention against Trafficking
in Human Organs (CETS No. 216) has been opened for signature and
ratification. It has been ratified by nine countries and signed
(but not yet ratified) by 15 further countries. It entered into
force in 2018. The committee of the parties will be convened following the
10th ratification. As foreseen, this
Convention does not address the issue of tissues and cells.
14. With respect to the trafficking in human cells and tissues,
the Assembly welcomes the work of the European Committee on Organ
Transplantation, and in particular its report on “Illicit and unethical
activities with human tissues and cells: addressing the need for
the elaboration of an international legal instrument to protect donors
and recipients” prepared in 2018. The report identified gaps in
international legal frameworks, reiterated the Committee’s concern
with respect to lack of agreement on what constituted illicit activities
in this area and stressed the need for a new legal instrument to
address such activities.
15. The Assembly takes note of the progress made so far, as well
as of the remaining challenges. It is convinced that stronger action
is needed in this area on the part of the Council of Europe member
states.
16. In the light of the above, the Assembly recommends that the
Committee of Ministers:
16.1. initiates
the drafting of a legally binding Council of Europe instrument against
trafficking in human tissues and cells, possibly in the form of
an additional protocol to the Convention against Trafficking in Human
Organs (CETS No. 216);
16.2. ensures that such a legal instrument:
16.2.1. provides a definition of illicit
activities in this area, and is based on a comprehensive approach
covering crime prevention and repression, victim protection, promotion
of appropriate policies, as well as national and international co-operation;
16.2.2. includes mechanisms for regular data collection and analysis
on trafficking in human cells and tissues, in compliance with democratic
governance structures, as well as transparent, authoritative and
effective monitoring and implementation;
16.3. calls on the Council of Europe member states that have
not yet ratified the treaties related to this area, such as the
Convention on Human Rights and Biomedicine (Oviedo Convention; ETS No. 164), the
Convention on Action against Trafficking in Human Beings (CETS No. 197)
and the Convention against Trafficking in Human Organs (CETS No. 216),
to do so as a matter of priority, and as a contribution to the UN
Agenda for Sustainable Development Goal 3: Good health and well‑being
and Goal 16: Promote just, peaceful and inclusive societies.
B. Explanatory memorandum by Ms Reina de Bruijn-Wezeman, rapporteur
(open)1. Introduction
1. Today, human tissues and cells
are routinely used for medical purposes, therapy, plastic surgery
and research. Within the European Union, more than 2.1 million human
tissue and cell units were reported to have been distributed for
medical use in 2016.
2. Advances in technology in human tissue and cell transplantation
can save lives (e.g. haematopoietic stem cell transplantation),
restore essential bodily functions and improve quality of life (e.g.
restoring sight with cornea; transplantation of muscles, bones,
joints, tendons, and/or ligaments in patients with musculoskeletal disorders
that require orthopaedic surgery) and help individuals in their
desire to become parents (e.g. through gamete and embryo donation).
However, this is a relatively little-known area of medicine, and
the public remains largely unaware of the opportunities and the
risks that it entails. At the same time, an efficient system of
tissue and cell donation depends heavily on public trust. It is
essential to ensure that this trust is not blind and is based on
reliable information.
3. While a lot has been done to address illicit activities in
organ donation, much less attention has been given to donation of
other substances of human origin. Regretfully, as of today, there
is no internationally agreed definition of what constitutes “trafficking
in human tissues and cells” and therefore what practices should
be considered illegal and prosecuted in this context. What is considered
illegal in one country can be perfectly legal in another. Official
information on trafficking in human tissues and cells is very limited,
most of what we know comes from estimates or investigative media
reports.
4. So, what exactly is trafficking in human tissues and cells?
To what extent is this a problem in Europe today? And how can we
make full use of the unprecedented developments in medical science
and practice, without compromising public interest and respect for
human dignity? With these questions in mind, I will explore the
past and current challenges in the use of human tissues and cells,
the existing international standards and remaining gaps, as well
as possible ways of strengthening relevant policy frameworks.
5. I would like to mention that the preparation of this report
was initiated by Mr Serhii Kiral (Ukraine, EC), who had been an
active member of the Committee on Social Affairs, Health and Sustainable
Development for many years. A fact-finding visit by Mr Kiral to
the French National Agency for Medicines and Health Products Safety
(ANSM) was useful for discussing the perspectives of relevant authorities.
Valuable information was received at an exchange of views held in
Paris on 13 September 2019, with the participation of Mr Jacinto Sánchez
Ibáñez, Director of Tissue Establishment and Cryobiology Unit in
the University Hospital, A Coruña (Spain), and Mr Givi Javashvili,
Chairman of the National Council on Bioethics, Professor and Head
of Family Medicine Department in the Tbilisi State Medical University
(Georgia). Substantial written feedback was received from Mr Fewzi
Teskrat, expert on human tissues and cells products (Malta). Following
the elections in Ukraine in July 2019, Mr Kiral left the Assembly,
and I was subsequently appointed rapporteur for this report on 2
October 2019.
6. In the preparation of this report I looked at media reports,
academic literature and documents of the EU competent authorities
and Council of Europe bodies, such as the European Committee on
Organ Transplantation.
2. Definitions and scope
7. First of all, and, bearing
in mind the rather technical nature of this subject, I would like
to clarify what exactly “human tissues and cells” are and what is
generally understood by “trafficking” in this context.
8. The “cell” is the smallest transplantable and functional unit
of life (for example: a haematopoietic stem cell, a hepatocyte,
a sperm or an oocyte). “Cells” means individual human cells of a
collection of human cells when not bound by any form of connective
tissue. Today, the isolation of cells from almost all body tissues represents
new therapeutic opportunities. “Tissue” is an aggregate of cells
joined together by, for example, connective structures and performing
a function (for example: corneas, heart valves or skin). “Tissue”
means all constituent parts of the human body formed by cells. Different
types of cells and tissues can be removed either from living or
deceased donors.
9. As previously pointed out, there is no internationally agreed
definition of trafficking, illicit, illegal and fraudulent activities
in human tissues and cells. For the purposes of this report, I will
consider that such activities include any practice performed in
violation of one or more guiding principles as set down in international
legal instruments. These principles include: 1) consent, 2) non-violation
of bodily integrity beyond the necessary, 3) licensed processing, 4) respect
of legal requirements, 5) altruistic donation and prohibition of
financial gain; 6) promotion of experimental treatments without
evidence of safety and efficacy. While acknowledging that there is
no agreed definition, I will use the terms “trafficking in human
tissues and cells” and “illicit activities with human tissues and
cells”, when talking about such practices in this report.
While acknowledging that there is
no agreed definition, I will use the terms “trafficking in human
tissues and cells” and “illicit activities with human tissues and
cells”, when talking about such practices in this report.10. Furthermore, a distinction needs to be made between trafficking
in human beings and trafficking in human organs, tissues and cells. The two crimes overlap, but differ
in scope. “Trafficking in human beings” means “the recruitment,
transportation, transfer, harbouring or receipt of persons, by means
of the threat or use of force or other forms of coercion, of abduction,
of fraud, of deception, of the abuse of power or of a position of
vulnerability or of the giving or receiving of payments or benefits
to achieve the consent of a person having control over another person,
for the purpose of exploitation”. Trafficking in human beings is a combination
of three elements – action (taking someone away), means (coercion)
and purpose (exploitation). The exploitation of an individual is
the central aspect of such trafficking.
The two crimes overlap, but differ
in scope. “Trafficking in human beings” means “the recruitment,
transportation, transfer, harbouring or receipt of persons, by means
of the threat or use of force or other forms of coercion, of abduction,
of fraud, of deception, of the abuse of power or of a position of
vulnerability or of the giving or receiving of payments or benefits
to achieve the consent of a person having control over another person,
for the purpose of exploitation”. Trafficking in human beings is a combination
of three elements – action (taking someone away), means (coercion)
and purpose (exploitation). The exploitation of an individual is
the central aspect of such trafficking.11. Some cases of trafficking in organs, tissues and cells result
from trafficking in human beings. Only when organs, tissues and
cells are removed from living donors can these cases relate to trafficking
in human beings (but not when they are removed from deceased persons).
However, trafficking in human organs, tissues and cells does not
necessarily involve trafficking in human beings. For example, when
human tissues are procured from a deceased person without due consent
on the part of the family members, this is considered as an occurrence
of trafficking in human tissues.
12. While currently there are no official statistics on trafficking
in human tissues and cells, experts believe that the largest instances
of tissue trafficking occur with respect to deceased donors.
13. With respect to the scope of my report, I would like to point
out that I will focus primarily on the trafficking in human tissues
and cells for the purposes of transplantation and research. While
the use of tissues and cells in the development of medical products
can be a highly lucrative area, and important ethical concerns are currently
raised by researchers on this subject, this is a highly complex issue,
which is very different from transplantation and research. It will
require a different type of policy response and deserves a separate
report by the Assembly.
this is a highly complex issue,
which is very different from transplantation and research. It will
require a different type of policy response and deserves a separate
report by the Assembly.14. Finally, this report will not cover the issue of trafficking
in blood and its derivatives, as this issue is also substantially
different and also requires a different approach.
3. Ethical and safety scandals – a thing of the past?
15. In the past, a lack of relevant
legal frameworks or their weak enforcement and insufficient oversight
have led to a number of high-profile scandals across the world.
I include below some of the most striking examples of the last 40
years, which show the scale of the
damage caused, be it in pursuit of profit, due to lack of diligence,
or in the name of science and based on the paternalistic assumption
that “doctors know best”.
which show the scale of the
damage caused, be it in pursuit of profit, due to lack of diligence,
or in the name of science and based on the paternalistic assumption
that “doctors know best”.Alder Hey hospital, United Kingdom, 1988-1995
16. In 1999, an inquiry was launched
into the allegations that the Alder Hey Children’s Hospital was
involved in the unauthorised removal, detention and disposal of
body parts of their patients in 1988-1995, for the purposes of research.
The 540-pages enquiry report published in 2001 discovered the long-standing
practice of organ retention without consent from the next of kin
of the deceased children. It was found that other hospitals were
involved as well. This
approach was assumed to be in the best interest of the parents.
This was aggravated in the case of the Alder Hey hospital, where
pathologist Dick van Velzen had ordered the “stripping of every
organ from every child who had had a post-mortem” during his time
at the hospital, even for children whose parents specifically stated
that they did not want a full post-mortem. Following the inept handling of
the return of organs after the scandal erupted, some parents received
their children’s organs piecemeal and third or fourth burials had
to be held. The enquiry report made detailed recommendations on different
aspects of this case. The 1961 Human Tissue Act was subsequently
reviewed. The Human Tissue Act 2004 created the Human Tissue Authority.
In 2005, Dick van Velzen was found guilty of serious professional
misconduct by the General Medical Council and struck off the UK
medical register.
This
approach was assumed to be in the best interest of the parents.
This was aggravated in the case of the Alder Hey hospital, where
pathologist Dick van Velzen had ordered the “stripping of every
organ from every child who had had a post-mortem” during his time
at the hospital, even for children whose parents specifically stated
that they did not want a full post-mortem. Following the inept handling of
the return of organs after the scandal erupted, some parents received
their children’s organs piecemeal and third or fourth burials had
to be held. The enquiry report made detailed recommendations on different
aspects of this case. The 1961 Human Tissue Act was subsequently
reviewed. The Human Tissue Act 2004 created the Human Tissue Authority.
In 2005, Dick van Velzen was found guilty of serious professional
misconduct by the General Medical Council and struck off the UK
medical register.New-York body snatching scandal, 2000-2004, US
17. In late 2005, a “New-York body
snatching scandal” gripped the United States (US). For almost four years,
Biomedical Tissue Services (BTS) supplied bones and other tissue
illegally “harvested” from 1,077 corpses to RTI Donor Services (a
nonprofit subsidiary of the Regeneration Technologies, Inc. (RTI), which
is a Florida-based processor of orthopedic, cardiovascular and other
biologic implants) and four other US companies. During this period
the company earned around 4.7 million dollars. Bodies were dissected
in funeral parlors in New York, Rochester, New Jersey and Philadelphia.
Consent forms and personal records were falsified. In the scandal that followed, partner
tissue banks recalled 25,000 products – 2,000 of which had been
sold to Australia, South Korea, Turkey, Switzerland and other countries. The perpetrators were charged with
122 counts of stealing bodies, illegal dissection, enterprise corruption,
grand larceny, and forgery, among other crimes. Michael Mastromarino
– the mastermind behind the plot – was sentenced to 15 to 30 years
in prison and agreed to pay $4.6 million, to be distributed among
the victims’ relatives.
In the scandal that followed, partner
tissue banks recalled 25,000 products – 2,000 of which had been
sold to Australia, South Korea, Turkey, Switzerland and other countries. The perpetrators were charged with
122 counts of stealing bodies, illegal dissection, enterprise corruption,
grand larceny, and forgery, among other crimes. Michael Mastromarino
– the mastermind behind the plot – was sentenced to 15 to 30 years
in prison and agreed to pay $4.6 million, to be distributed among
the victims’ relatives. Illicit practices in human reproduction, Cyprus and Romania, 2005
18. In 2005, the European Parliament
condemned the practice of the US-Israeli GlobalART Clinic in Romania,
which provided oocytes to the UK, the US and Israel. Romanian donors
received 100-250 US dollars as financial compensation. At least
2 Romanian women suffered from acute ovarian hyper stimulation syndrome
and did not receive the necessary medical care. Around the same
time, Petra Health Clinic in Cyprus sourced oocytes from women from
Eastern Europe (who were flown to Cyprus for 500 Euros), and recruited oocyte
donors among immigrants who live in Cyprus.
19. Since then, some countries have developed or improved their
legal frameworks and put in place monitoring procedures. But have
all the problems been resolved?
4. Progress achieved at the national level: case study – France
20. Many European countries have
developed comprehensive legal frameworks and set up safeguards against
trafficking in human tissues and cells in the past decades. Within
the European Union, strict control measures were introduced to ensure
quality and avoid illicit activities. Mr Kiral was advised that
a fact-finding visit to France would be a good way for him to become
familiar with the current situation in this field.
21. In June 2019, Mr Kiral met representatives of the French National
Agency for Medicines and Health Products Safety (ANSM), to discuss
the latest developments in processing human tissues and cells. This Agency
took part in a project on “Vigilance and surveillance of substances
of human origin” (SoHO V&S, 2011), co-funded by the EU, which
developed the Guidance on the detection and investigation of suspected
illegal and/or fraudulent activity (IFA) related to tissues and
cells. During his visit, he discovered that today the use of human
tissues and cells for transplantation and research is well-established
and thoroughly regulated in France.
22. The EU Directives 2004/23/EC ,
2006/17/EC ,
2006/86/EC and
2015/565/EC provide a common European framework
for the donation, procurement, testing, processing, storage and
distribution of human cells and tissues. These standards are transposed
in the national French legislation.
,
2006/17/EC ,
2006/86/EC and
2015/565/EC provide a common European framework
for the donation, procurement, testing, processing, storage and
distribution of human cells and tissues. These standards are transposed
in the national French legislation.23. The French Ministry of Solidarity and Health (Directorate
General on Healthcare) oversees policies and their implementation.
Procurement is the responsibility of regional agencies under the
Ministry of Solidarity and Health. The Agency for Biomedicine supervises,
accompanies, evaluates and informs other relevant bodies with a
view to improving access to care and quality of life for patients
in several areas, including organ and tissue collection and transplantation.
The ANSM gives authorisation starting from procurement to distribution of
tissues and cells, including import and export. Regular inspections
are organised, and meetings are held with relevant law enforcement
agencies.
24. In France, there are about 70 establishments, half of which
are tissue banks (22 of which are public and 9 are private) and
the other half – cells banks (all of which are public). Private
tissue banks export a lot of tissue outside of Europe, mainly to
the Middle East and North Africa. Nevertheless, their work is oriented
primarily towards the national market. Registries are maintained
in accordance with relevant regulations. Public tissue banks aim
to meet the public need. The trend is that public needs remains
stable, while exports are growing. A lot of innovation takes place
in the private sector.
25. The ANSM interlocutors felt that there was little margin for
illicit and fraudulent activities in France, as the regulations
were strict, and it was impossible to pay for human tissues and
cells. Furthermore, autologous donations (from the patients themselves)
were given precedence to the allogenic ones (from a donor to the patient)
whenever possible. While imports were common in the past, today
they are no longer needed, except for reasons of compatibility between
donors and recipients. France was therefore largely self-sufficient
and, in most cases, did not depend on other countries (which could
have lower levels of protection against abuse). Co-operation within
the EU allowed to work with countries with a similar level of quality
assurance.
26. It is possible for the ANSM to co-operate with entities outside
of the EU. In this case, relevant documentation needs to be submitted
by such partners. A system of assessment of the relevant processes
is established, including the possibility of inspections.
27. Public awareness plays an important role in promoting public
trust in donations and ensuring national self-sufficiency in this
area. National awareness campaigns are organised by the Agency for
Biomedicine. The National Day of Reflection on Organs and Tissues
Donation and Transplantation, and Donor Recognition is held annually
on 22 June.
5. Progress achieved at the European and international level
28. Inequalities among different
countries and regions provide opportunities for illicit and fraudulent activities.
Tissues and cells of human origin can be easily transported (without
being recognised as such), and people can travel for the purposes
of transplantation. Thus, high moral and ethical standards should
be ensured not only for tissues and cells procured and used in one
jurisdiction, but also for those brought in from (and exported to)
other countries.
29. It is therefore of utmost importance to ensure that basic
common approaches and rules are agreed upon and respected in practice.
While international standards have been developed on trafficking
in human organs, trafficking in human tissues and cells has proved
more difficult to tackle. Nevertheless, a number of important steps
have been taken in this direction.
30. The World Health Organization (WHO) sets out international
standards in its Guiding Principles on human cell, tissue and organ
transplantation, which include consent requirements; prohibition
of financial gain; allocation guided by clinical criteria and ethical
norms; self-sufficiency of countries; altruistic donation; equal access
to grafts; and efficiency, safety and quality. Although
these Guiding Principles are not legally binding, they influence
national legislation and professional codes of practice.
Although
these Guiding Principles are not legally binding, they influence
national legislation and professional codes of practice.31. The Charter of Fundamental Rights of the European Union (EU)
sets out the principle that making the human body and its parts,
as such, a source of financial gain must be prohibited (Article
3). The three previously mentioned European Commission Directives
provide the legal framework for tissue donation, banking and usage
in the EU. While these Directives provide useful guidance and have
significant influence on the development of national legislation,
it is up to the member States to put them into practice.
32. The Council of Europe Convention on Human Rights and Biomedicine
(Oviedo Convention; ETS No. 164), opened for signature in 1997,
reaffirmed the principle that the human body and its parts should
not give rise to financial gain, defined consent requirements, and
introduced a requirement for public debate. To date, 29 member States
are bound by it. With respect to financial gain, it is worth mentioning
a recent publication of a “Guide for the implementation of the principle
of prohibition of financial gain with respect to the human body
and its parts from living or deceased donors”, which was prepared
to support the implementation of the Oviedo Convention.
33. An Additional Protocol to the Oviedo Convention on Transplantation
of Organs and Tissues of Human Origin (ETS No. 186) was opened for
signature in 2002. To date, 15 member States are bound by it. The Protocol
covers transplantation (but not research or development of medical
products). It covers both tissues and cells. However, the Additional
Protocol is not a criminal law instrument and it does not provide
clarity on which practices constitute trafficking in human cells
or tissues and should be criminalised. The Protocol is to be regularly
re-examined to ensure that it reflects relevant scientific developments.
The Steering Committee on Bioethics (CDBI), which was initially
responsible for re-examinations foreseen in the Convention and its Additional
Protocols, was replaced by the Committee on Bioethics (DH-BIO).
34. The Council of Europe Convention on Action against Trafficking
in Human Beings (CETS No. 197) was adopted in 2005 and entered into
force in 2008. It is ratified by all Council of Europe member states
except for the Russian Federation (and is also in force in Belarus).
The forms of exploitation covered by the Convention include the
removal of organs. GRETA – the Group of Experts on Action against
Trafficking in Human Beings – is responsible for monitoring the
implementation of this Convention. It is not entirely clear to what
extent trafficking in human tissues and cells could be addressed
under this Convention, and in the context of trafficking in human
beings more generally.
35. In 2009, the Council of Europe and the United Nations produced
a joint study, which stressed the need to distinguish clearly between
trafficking in human beings and trafficking in organs, tissues and
cells. It provided an overview of the legal and factual situation
and made recommendations (e.g. to pass legislation in conformity with
the prohibition of financial gains, to promote organ donations and
to collect reliable data). Furthermore, the study pointed out the
need for an international legal instrument setting out a definition
of “trafficking in organs, tissues and cells” and “the measures
to prevent such trafficking and protect the victims, as well as
the criminal-law measures to punish the crime”.
36. A report on illicit and fraudulent activities
prepared under an EU funded project entitled ‘Vigilance and Surveillance
of Substances of Human Origin’ (SoHO V&S) aimed at providing to the EU Member
States National Competent Authorities responsible for tissues and
cells, guidance for detecting, investigating, managing and communicating
on such activities. A questionnaire was sent to all National Competent Authorities.
The report noted, inter alia,
that there was significant diversity throughout the EU with respect
to the management of suspected illicit and fraudulent activities
in the context of tissues and cells and that there was a lack of
specific training dealing with how to identify and handle such activities.
on illicit and fraudulent activities
prepared under an EU funded project entitled ‘Vigilance and Surveillance
of Substances of Human Origin’ (SoHO V&S) aimed at providing to the EU Member
States National Competent Authorities responsible for tissues and
cells, guidance for detecting, investigating, managing and communicating
on such activities. A questionnaire was sent to all National Competent Authorities.
The report noted, inter alia,
that there was significant diversity throughout the EU with respect
to the management of suspected illicit and fraudulent activities
in the context of tissues and cells and that there was a lack of
specific training dealing with how to identify and handle such activities.37. In 2013, the Assembly adopted two texts related to the draft
Convention against Trafficking in Human Organs and recommended that,
“[…] at this stage, it has not been considered advisable to prepare
an additional protocol against trafficking in human tissues and
cells, largely due to the absence at both national and international
levels of complete and harmonised regulation of the removal and
use of tissues and cells.” Instead, it proposed a step-by-step approach
and suggested that the Committee of Ministers decide on a roadmap
for the preparation of the additional protocol.
Instead, it proposed a step-by-step approach
and suggested that the Committee of Ministers decide on a roadmap
for the preparation of the additional protocol. 38. The Council of Europe Convention against Trafficking in Human
Organs (CETS No. 216) was opened for signature in 2015 and entered
into force on 1 March 2018. This Convention is a criminal law instrument
and provides a definition of trafficking in human organs as well
as clarity on which practices need to be criminalised. However,
this Convention does not address the issue of tissues and cells.
To date, nine countries are bound by it and 15 countries have signed
but have not ratified it. The Committee of Parties, which is the
body responsible for overseeing the implementation of this Convention,
is yet to be established (it requires 10 ratifications).
39. In the Council of Europe framework, a comprehensive Guide
to the quality and safety of tissues and cells for human application
was published first in 2013 and in its fourth edition in 2019, partly
funded by the European Union, provides healthcare professionals
with a comprehensive overview of recent advances in the field as
well as with technical guidance on ensuring the quality and safety
of human tissues and cells applied to patients.
40. Trafficking in human cells and tissues has also been addressed
by the European Court of Human Rights. In the case of Elberte v. Latvia, body tissue was
removed from Ms Elberte’s deceased husband, without her knowledge
or consent. Tissue from her husband’s body was sent to a pharmaceutical
company in Germany for the creation of bio-implants, in accordance
with a State-approved agreement, and as part of a wide scale method
of operation. The domestic authorities did not establish any elements
of a crime in this case. The European Court of Human Rights, however,
concluded that the removal of tissue from a deceased man’s body without
the knowledge or consent of his wife amounted to degrading treatment.
41. In October 2018, the European Committee on Organ Transplantation
(CD-P-TO) adopted a report on “Illicit and unethical activities
with human tissues and cells: Addressing the need for the elaboration
of an international legal instrument to protect donors and recipients”. This report takes stock of the existing international
treaties, identifies the gaps, and calls on the Council of Europe
decision-making bodies to develop an additional protocol to the
Council of Europe Convention against Trafficking in Human Organs
on combatting trafficking in human cells and tissues.
This report takes stock of the existing international
treaties, identifies the gaps, and calls on the Council of Europe
decision-making bodies to develop an additional protocol to the
Council of Europe Convention against Trafficking in Human Organs
on combatting trafficking in human cells and tissues.6. Concerns remain
42. While substantial progress
has been achieved, important concerns remain. Indeed, the EU Directives have
established a common European framework in this area and play an
essential role in ensuring quality and developing public trust.
However, these Directives leave ethical issues aside, which are
relegated to a great extent to the EU member states.
43. The issue of compensation of tissues and cells donors is quite
different from that in the field of organ donors. For example, the
Organs EU Directive states: “Member States shall ensure that donations
of organs from deceased and living donors are voluntary and unpaid”,
while the Tissues and Cells EU Directives state “Member States shall
endeavour to ensure voluntary and unpaid donations of tissues and
cells”. In the latter Directive it is also stated that “donors may
receive compensation, which is strictly limited to making good the expenses
and inconveniences related to the donation.” The calculation of
the financial compensation for such inconveniences is the responsibility
of national competent authorities. To what extent the safeguards
against possible abuse are in place? What are the mechanisms for
the oversight and how effective are they?
44. More generally, how can one ensure that altruistic donations
are not used by private actors for financial gain? And how can one
be sure that such donations are used to meet public health needs
rather than for making profit?
45. Differences in legislation and regulations in different parts
of the world create loopholes for illicit activities in this area.
What mechanisms could be used to support harmonisation of relevant
standards? From the Council of Europe perspective, how could co-operation
be facilitated between EU and non-EU member States that are members
of the Council of Europe?
46. In the current context of growing poverty in some parts of
the world and in Europe in particular, how can one prevent exploitation
of vulnerable people for the purposes of trafficking in human tissues
and cells? Are the existing mechanisms sufficient to protect them
from coercion, fraud and abuse? Not only are such illicit activities
human rights violations, they are also a threat to public health,
as quality and safety requirements are often not respected in this
context, which might lead to the transmission of infectious diseases
and other serious adverse reactions for the patients.
47. Many occurrences of trafficking in human cells and tissues
are related to the issue of consent and importation. For example,
it is not uncommon in some countries that residual material obtained
during diagnostic procedures or surgery is used for research without
the patients’ consent. In other cases, tissues collected for the
purpose of research are used for military research purposes or cosmetics
research and diagnosis (without this being specified when consent
is provided). The Committee of Ministers Recommendation CM/Rec(2016)6
on research on biological materials of human origin includes detailed guidelines on
this topic, including with respect to persons not able to give their
consent (which can be done exceptionally under certain circumstances).
It is important to ensure that the principles underlying these guidelines
are applied in practice by means of solid and systematic oversight
procedures.
includes detailed guidelines on
this topic, including with respect to persons not able to give their
consent (which can be done exceptionally under certain circumstances).
It is important to ensure that the principles underlying these guidelines
are applied in practice by means of solid and systematic oversight
procedures.48. The WHO principle is that the distribution of tissues and
cells should be guided by clinical criteria and ethical norms, and
distribution rules should be equitable, justified and transparent.
How effective are we at respecting this principle?
49. Currently, in many countries there are long waiting lists
for medically assisted reproduction treatments involving oocytes
and sperm. Medically assisted reproduction might not be available
for all the population (often it is only married heterosexual couples
who are given access). This creates a great demand for such treatments,
leading some patients (who can afford to) to travel to other countries
for this purpose. Furthermore, there are websites where sperm can
be purchased by private individuals from companies in Europe and
third countries and shipped by post directly to the final user.
In the absence of appropriate monitoring, traceability and follow-up,
all these possibilities create risks for both donors and recipients
and need to be addressed.
50. Another area of concern is the promotion of experimental treatments
without clinically demonstrated safety and efficacy. While haematopoietic
progenitor cell transplantation has been used for many years without controversy,
and research is underway to apply progenitor-cell treatments for
neurodegenerative diseases and conditions such as diabetes and heart
disease, among others, some health agencies also promote the use
of these cells for the cure of Parkinson’s disease, autism, dementia,
depression, multiple sclerosis, cerebral palsy, traumatic brain
injury, heart disease, macular degeneration, chronic kidney disease,
osteoarthritis, and strokes. Anti-aging treatments are also advertised.
In most cases, there is not sufficient evidence on the benefits
of such treatments.
51. The absence of a binding international legal instrument on
trafficking in human tissues and cells, which would include a definition
of what falls within the scope of illicit activities in this area,
makes it difficult to combat and prevent such activities.
7. Conclusions and recommendations
52. Medical use of human cells
and tissues is a rapidly evolving area, which creates new opportunities
and challenges for our societies. A lot of progress has been achieved
at national, European and global levels, with respect to developing
standards for quality and safety and ethically sound medical procedures
and research. Nevertheless, important challenges remain.
53. At present, there is little official information on trafficking
in human cells and tissues. Most of what we know about this phenomenon
is based on estimates or on investigative media reports. Reliable
data on the trafficking of human cells and tissues needs to be collected
at a national and European level, to allow for an in-depth understanding
of the latest challenges and possible solutions.
54. Discrepancies in legislative frameworks as well as in economic
development in different countries (within the EU, in the Council
of Europe geographical area and in third countries) provide opportunities
for illicit activities in this area. Harmonisation of relevant policies
and practices across Europe, including outside of the European Union,
is an important element of combating trafficking in human cells
and tissues. In those instances where tissues and cells travel,
equivalent quality and ethical standards should be ensured. To the extent
possible, national (and European) self-sufficiency should be further
promoted in order to meet the need of the patients.
55. When preparing this report, I was struck by how little we
know about the advances in science and medicine in this area, about
the scale of their current application and about both benefits and
challenges that they can create. It is important to ensure that
there is a broad public awareness about this issue in our societies. Furthermore,
it is important to ensure that health and other relevant professionals
are duly trained and intrinsically motivated to care about vulnerable
persons, who are patients or research participants, identify masked
forms of coercion and avoid incentives offered to them which may
undermine their judgment.
56. While the absence of a common definition of trafficking in
human cells and tissues is a major challenge for successful combating
of illicit and fraudulent activities in this area, biomedicine is
developing very fast, and it is difficult to anticipate the possible
forms of such activities. This means that such a definition, ideally
adopted in the framework of an international legal text, should
then be applied to specific cases, and further interpreted with
respect to the relevant developments in science, research and health-care
services.
57. There is clearly a need for strengthening international co-operation
in this area. A reputable international body needs to be entrusted
with systematic monitoring of the member states’ activities in this
area, in order to allow for on-going standard setting and implementation
and exchange of good practice. Such an international body could
produce “case-law” on what falls within the scope of trafficking
and should therefore be prosecuted. This would facilitate significantly
the development of relevant national policies, as well as the work
of law-enforcement bodies. It would be important to ensure that
the members of such a body have no conflict of interest in the domain
of human cells and tissues.
58. The Council of Europe has the advantage of already possessing
a binding treaty in the related field of organ trafficking, as well
as the necessary expertise in the criminal law area, and technical
expertise through the European Directorate for the Quality of Medicines
& HealthCare. As a regional organisation, its reach is necessarily
limited by geography, a drawback which can, however, be overcome
by opening any legal instrument to be developed to non-member States.
59. Based on the above-mentioned considerations, the Parliamentary
Assembly should invite the Committee of Ministers to consider the
drafting of a binding legal instrument on combating trafficking
in human tissues and cells, possibly in the form of an additional
protocol to the Convention against Trafficking in Human Organs (CETS
No. 216).
60. Furthermore, the Parliamentary Assembly should invite the
Council of Europe member states that have not ratified the important
Council of Europe legal instruments related to this area – such
as the Convention on Human Rights and Biomedicine (Oviedo Convention;
ETS No. 164), the Convention on Action against Trafficking in Human
Beings (CETS No. 197) and the Convention against Trafficking in
Human Organs (CETS No. 216) – to do so as a matter of priority.
This would also be an important European contribution to the UN Agenda
for Sustainable Development Goal 3: Good health and well-being and
Goal 16: Promote just, peaceful and inclusive societies (with respect
to human trafficking).