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Recommendation 2173 (2020)
Combating trafficking in human tissues and cells
1. Advances in technology in human
tissue and cell transplantation can save lives, restore essential
bodily functions, improve the 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, ETS 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 with 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 transform originally
appropriate compensation 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
may jeopardise the availability of organ and blood donors as well.
10. The existing international legal framework – developed by
the World Health Organization, the European Union 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 violations of
them 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
European Union, 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) “Towards
a Council of Europe convention to combat trafficking in organs,
tissues and cells of human origin”, 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 road map 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 “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. initiate
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;
16.2. ensure 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. call 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, the Convention on Action
against Trafficking in Human Beings (CETS No. 197) and the Convention
against Trafficking in Human Organs, to do so as a matter of priority,
and as a contribution to the United Nations Agenda for Sustainable Development
Goal 3: Good health and well‑being and Goal 16: Promote peace, justice
and strong institutions.