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HUMAN RIGHTS AND BIOMEDICINE:
Ethical and legal aspects of organ donation
International Conference
organised by the Ministry of Health of the Russian Federation and
the Council of Europe
on the occasion of the 20th anniversary of the membership of
the Russian Federation in the Council of Europe
24 Rusakovskaya str., Moscow (Holiday Inn hotel).
26 April2016
PROCEEDINGS
PROGRAMME
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09.00-09.30 |
Registration of participants |
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09.30-10.00 |
OPENING |
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10.00-12.30 |
SESSION 1 - HUMAN RIGHTS AND BIOMEDICINE |
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Chair: Ms Lyalya A. Gabbasova, Advisor to the Minister, Ministry of Health of the Russian Federation |
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Mr Daniel Tarschys, former Secretary General of the Council of Europe and former Chair of the Swedish national council on medical ethics (SMER), Professor of Political Science at Stockholm University, Sweden |
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Mr Dmitriy V. Kostennikov, State Secretary-Deputy Minister, Ministry of Health of the Russian Federation |
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10.40-11.15 |
COFFEE BREAK[1] |
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Chair: Ms Elena V. Bryzgalina, Head of the Philosophy of education Division, Department of Philosophy, Moscow State University (Russian Federation), member of the Council of Education and Science under the Chairmen of the State Duma (Parliament) of the Russian Federation |
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Mr Boris G. Yudin, member of the Russian academy of sciences; representative of the Russian Federation to the Committee on Bioethics (DH-BIO), Council of Europe |
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Mr Mark Bale, Deputy Director of Genomics Science & Emerging Therapies Health Science & Bioethics Division, Department of Health (United Kingdom), Chair of the Committee on Bioethics (DH-BIO), Council of Europe |
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Ms Antonina Yu. Chuprova, Professor of Criminal Law and Criminology department of the All-Russia State University of Justice |
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Mr Mikhail B. Lobov, Head of the Human Rights Policy and Co-operation Department, Council of Europe |
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Discussion |
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12.30-13.30 |
SESSION 2 - HUMAN RIGHTS AND ORGAN DONATION – ETHICAL AND LEGAL PERSPECTIVES |
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Chair: Mr Anatoly I. Kovler, former judge of the European Court of Human Rights elected in respect of Russia, Professor of the Moscow State University (Russian Federation) |
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Mr Javier Arias-Diaz, Professor of Surgery at the Clinic Hospital - Complutense University of Madrid, in 2006-2016 member of the Spanish Delegation at the Committee on Bioethics (DH-BIO), Council of Europe |
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Ms Viktoriya A. Maradudina, Senior Lawyer, European Court of Human Rights |
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Ms Lyalya A. Gabbasova, Advisor to the Minister, Ministry of Health of the Russian Federation |
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Discussion |
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13.30-15.00 |
LUNCH BREAK |
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15.00-15.45 |
SESSION 3 - PROTECTING HUMAN RIGHTS THROUGH GOOD PRACTICES IN ORGAN DONATION AND TRANSPLANTATION SYSTEMS |
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Chair: Ms Eliana Porta, Vice-Chair of the European Committee on Organ Transplantation (CD-P-TO) |
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Mr Axel Rahmel, Medical Director, German Organ Transplantation Foundation; member of the European Committee on Transplantation of Organs (CD-P-TO), Council of Europe |
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Mr Sergey V. Gautier, Chief Transplant Surgeon, Ministry of Health of the Russian Federation; Director of the Federal Scientific Center for Transplantation and Artificial Organs n. a. academician V. I. Shumakov |
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Discussion |
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15.45-16.00 |
COFFEE BREAK |
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16.00-17.30 |
SESSION 4 - ADDRESSING TRAFFICKING IN HUMAN ORGANS |
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Chair: Mr Mark Bale, Deputy Director of Genomics Science & Emerging Therapies Health Science & Bioethics Division, Department of Health (United Kingdom), Chair of the Committee on Bioethics (DH-BIO), Council of Europe |
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Mr Jose Núñez, Advisor on Medical Products of Human Origin, World Health Organisation |
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Mr Francis L. Delmonico, MD, FACS, Professor of Surgery, Harvard Medical School, Advisor to the World Health Organization on Transplantation |
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Ms Joana Ferreira, Vice-president of the Committee of Experts on the Operation of European Conventions on Co-Operation in Criminal Matters (PC-OC), Council of Europe |
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Mr Sergey I. Vinokurov, Ph.D., scientific associate at the Academy of Prosecutor General Office |
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Discussion |
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17.30-18.00 |
CLOSING SESSION |
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LINK TO THE VIDEO OF THE CONFERENCE
http://tv.coe.int/COE/video.php?v=20160426emten
OPENING
Dmitry V. Kostennikov
State Secretary - Deputy Minister of Health of the Russian Federation
Dmitry Kostennikov graduated from the Leningrad State University by Zhdanov (Jurisprudence). Between 1982 and 1984 – serving in the Armed Forces of the USSR. He was Head of the Legal Department of the Plenipotentiary of the President of the Russian Federation in the North -West Federal District, Head of the Legal Department of the State Committee for Control of Narcotic Drugs and Psychotropic Substances, Head of the International Law Department of the Federal Service for Drug Control. Between 2008 and 2012 he was State Secretary - Deputy Minister of Justice of the Russian Federation. In July 2013 Dmitry Kostennikov was appointed State Secretary - Deputy Minister of Health of the Russian Federation. He is Honored Lawyer of the Russian Federation.
Philippe Boillat
Director General, Directorate General Human Rights and Rule of Law, Council of Europe
Philippe Boillat was born on 31 July 1952 in Switzerland. He holds a Master in Law from the University of Lausanne.
He started his legal career in 1978 at the Federal Ministry of Justice in Bern. Between 1997 and October 2005, he was Deputy Director of the Federal Ministry of Justice, Head of International Affairs Department and the Swiss Government Agent to the European Court of Human Rights and UN Committee against torture.
He has been Chairperson of several major intergovernmental Committees: the Human Rights Committee for the Protection of National Minorities, the Ad Hoc Committee for the Protection of National Minorities, the European Committee responsible for drawing-up “Guidelines on Human Rights and the fight against terrorism” and “Guidelines on the protection of victims of terrorist acts”, the Group which drew up Protocol No.14 amending the European Convention on Human Rights and the Steering Committee for Human Rights.
In May 2006, he was appointed Director General of Human Rights in the Council of Europe, and since May 2007, Director General of the Directorate General Human Rights and Rule of Law.
Philippe Boillat has published several feature articles in the legal and human rights sectors.
Opening speech of Mr Philippe Boillat
Dear Minister,
Ladies and Gentlemen,
Dear Colleagues,
Distinguished Guests,
It is an honor and privilege for me to welcome you on behalf of the Council of Europe, which co-organised this Conference together with the Ministry of Health of the Russian Federation. At the outset, I would like to warmly thank you, Ms Skvortsova, for the interest manifested by the Ministry of Health in the activities conducted by my Directorate General and for your personal support given to today’s conference. I would also like to thank, through you, the staff of your Ministry for their excellent cooperation in the organization of the Conference.
We are all the more delighted to be in Moscow today as our high-level Conference is associated with the celebration of the 20th anniversary of the Russian Federation’s accession to the Council of Europe.
May I reiterate, Madame Minister, that we see this accession as a highly important milestone in the European history. I seize this occasion to welcome our former Secretary General, Mr Daniel Tarschys, who has joined our event today: we all remember how much you did for this accession to happen. I am convinced that 20 years ago we went through a turning point to anchor the Pan-European dimension of the Council of Europe.
Russia’s 20-year membership with the Organisation has been active and effective in practice. The Russian Federation has signed and ratified 60 Conventions of the Council of Europe, thus becoming an integral part of the European legal space. There is no disagreement about this and I note that the Russian Constitutional Court reiterated it once again last week. The Council of Europe conventions, taken in conjunction with the practice of its judicial and monitoring bodies, constitute today an integral part of Russian law.
Moreover, some of those Conventions have been sponsored and actively promoted by Russia itself. The protection of human rights in the biomedical field is one of the areas where Russian contribution was and remains of great relevance and importance. I will limit myself only to two examples.
- Five years ago, in Moscow, we opened to signature together with the then Minister of Health and the Minister of Foreign Affairs the Medicrime Convention, known also as Moscow Convention. It was the first legal document criminalizing the production and distribution of counterfeit medical products;
- As late as last autumn, the Russian Federation signed the Council of Europe Convention against Trafficking in Human Organs. We are grateful to the Russian authorities for their active participation to the drafting of this new European instrument and for their commitment to prevent and deter criminal acts of human organs’ trafficking at both European and national level.
All this to say, Madame Minister, that Russia’s 20-year membership with the Council of Europe has never been a “one-way road”. Nor has it been at all times an easy road. However the numerous and tangible results we have achieved in this way speak for themselves, not least in the legal and judicial fields. And I trust that our current and future cooperation will further contribute to the common legal space that holds our large continent together. I am also convinced that today’s conference will open new ways of strengthening the Russian contribution to the Council of Europe’s activities in the relevant areas.
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Dear Minister,
Ladies and Gentlemen,
This conference is dedicated to bioethics, which is commonly understood as protection of human rights in the field of biology and medicine. Scientific developments lead to better protection of human health, opening possibilities for new medical treatment, diagnostic and preventive measures. At the same time, they give rise to concern about possible misuse and abuse to the detriment of the integrity and autonomy of patients, as well as their privacy. There is also a risk that medical practices lead to violations of human dignity.
Issues arising in the biomedical field are often complex and sensitive. The related human rights challenges need to be addressed at both national and international level to build trust and promote practices that are both effective and respectful of human beings. Organ donation and transplantation, which are specifically addressed during this Conference, demonstrate a genuine need for synergy and interaction to be developed between the protection of human rights and the promotion of new medical technologies.
Organ transplantation is an eminent medical technique which makes it possible to save lives in critical situations. But its misuse may also endanger human life, wellbeing and dignity of both donors and recipients. The Council of Europe has therefore developed a substantial arsenal of legal tools based on the Convention on Human Rights and Biomedicine (the Oviedo Convention) and its Additional Protocol concerning transplantation of organs and tissues of human origin. These were the first international legally binding instruments in this field. A further important step was achieved in 2015 through the adoption of the Convention against Trafficking in Human Organs which I mentioned earlier.
I note that the multidisciplinary nature of the ethical and legal issues raised by organ transplantation,- and by bioethics in general, - has prompted leading experts in philosophy, medicine and law to attend our Conference. It will give us a unique opportunity to look into ethical and legal aspects of organ donation from three perspectives: the perspective of patients, that of medical professionals, and the views of legal professionals. I would like to seize this occasion to welcome the very numerous representatives of medical institutions, lawyers and all others concerned by bioethics.
I am sure that both the Conference and our following joint actions will be mutually enriching. They will contribute to the continued cooperation within the Council of Europe and facilitate the ongoing preparatory work for signature and ratification of the relevant Council of Europe Conventions by the Russian Federation, including the Oviedo Convention on Human Rights and Biomedicine. I see this also as an important step forward in the dialogue we need to enhance between the legal and the medical professionals on issues of common concern.
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Dear Minister,
Ladies and Gentlemen,
Let me conclude by highlighting once again the Council of Europe method and approach. We strongly believe that dialogue and cooperation are essential to pursue the ultimate goal of our Organisation as it is reflected in the Statute: to achieve a greater unity between our member States with a view to safeguarding and realising our common European heritage. This is what makes our raison d’être and our main difference. Indeed, the Council of Europe is engaged in direct cooperation and interaction with national authorities in numerous fields to promote best practices and thus to facilitate the implementation of our common legal standards.
Technical cooperation is an important component of the Council of Europe strategy, our main added-value. Training of legal professionals plays an increasing role in that regard, as you may know through our very prominent HELP Programme – the only pan-European prorgamme for training of legal professionals which has been successfully implemented since last year in the Russian Federation. My Directorate General values very much our continuous cooperation with the Supreme Court, Constitutional Court, the General Prosecutor’s Office, and the Ministry of Justice of the Russian Federation. We are extremely pleased that this conference provides hopeful ground for further development of our fruitful cooperation with the Ministry of Health, which I commend once again for their genuine interest in the issues on our common agenda.
I am looking forward to our open and topical discussions today and to our continued cooperation with all Russian authorities concerned.
Thank you!
Lyalya A. Gabbasova
Chair
Lyalya Gabbasova studied in the Chelyabinsk State Medical Institute, in the Chita State Medical Institute, as well as in the Ural State Medical Academy of continuing education. She worked in the Ural State Medical Academy of continuing education, where she was Professor of the Therapy, Clinical Pharmacology and Endocrinology Department. In 1997 she defended the thesis in Cardiology, in 2006 – the doctoral thesis in Pharmacology, Clinical Pharmacology. He has more than 60 scientific papers. From 2004 to 2008 Lyalya Gabbasova worked in the Ministry of Health of the Chelyabinsk region. From 2008 to 2012 – in the Ministry of Health and Social Development of the Russian Federation, where she was Director of the Department of High-Technology Medical Care. From 2012 to 2013 she was Director of the Department of Specialized Medical Care and Standardization in Health in the Ministry of Health of the Russian Federation. In April 2013 Lyalya Gabbasova was appointed Advisor to the Minister of Health of the Russian Federation.
Daniel Tarschys
Former Secretary General of the Council of Europe and former Chair of the Swedish national council on medical ethics (SMER)
Professor of Political Science at Stockholm University (Sweden)
Daniel Tarschys is professor emeritus in Political Science at the University of Stockholm.
He has been a member of the Swedish Parliament and Chair of its Committees on Social Affairs and Foreign Affairs, State Secretary and Head of the Prime Minister’s Office and Vice President of the International Political Science Association (IPSA). A member of the Parliamentary Assembly of the Council of Europe for ten years, he became Chair of its Liberal Group and Secretary General of the Council of Europe from 1994 to 1999.
He later served as Chair of the Swedish National Council on Medical Ethics and Chair of the European Conference of National Ethics Committees (Cometh).
Tarschys holds a law degree from Stockholm University and PhDs in political science from Stockholm University and Princeton University. In 1966, he was an exchange student at the Law Faculty of Leningrad University.
Elena V. Bryzgalina
Chair
Head of the Philosophy of Education Division, Department of Philosophy, Moscow State University
Member of Committee on Science and Education under the Chairman of the State Duma of the Federal Assembly of the Russian Federation
Elena Bryzgalina is Head of the Philosophy of Education Division, Department of Philosophy, Moscow State University and member of Committee on Science and Education under the Chairman of the State Duma
of the Federal Assembly of the Russian Federation. She is also member of the Commission on Bioethics Moscow State University of Lomonosov and Head of the specialist group «The conceptual framework of social and humanitarian support of biobank» in the project's boundaries «Scientific basis of the national biobank - depository of the living systems».
Her academic interests are centred around problems based on the findings of modern biomedical research: categorical system of the problems of human nature studies, scientific approach to ‘individiaulity’, biosocial research of asocial behavior, ethical and legal aspects of biomedical academic research, scientific influence on the legal system, etc. Elena V. Bryzgalina has developed an academic course «Bioethics» at the Faculty of Fundamental Medicine of Lomonosov Moscow State University. She participated in a number of international forums on the philosophy of science and bioethics.
Boris G. Yudin
Member of the Russian academy of sciences
Representative of the Russian Federation to the Committee on Bioethics (DH-BIO), Council of Europe
Boris Yudin, PhD., Professor, Corresponding member of the Russian Academy of Sciences, Main Research Fellow, Institute of Philosophy, Russian Academy of Sciences.
Vice-Chairman of the Russian Committee on Bioethics under aegis of Commission of the Russian Federation for UNESCO.
Russian representative in the Committee on Bioethics of the Council of Europe.
Editor-in-Chief, Bi-Monthly Journal “Chelovek” (the Human Being). More than 450 publications in philosophy and sociology of science; ethics of science; bioethics.
Participant of many World Philosophical Congresses, World Congresses on Bioethics, Russian and international scientific congresses, conferences and seminars.
PI of the research project “Humanitarian analysis of Biothechnolgical Projects of Human Enhancement”, supported by the Russian Scientific Foundation– 2015-2017.
Mark Bale
Deputy Director of Genomics Science & Emerging Therapies Health Science & Bioethics Division, Department of Health (United Kingdom)
Chair of the Committee on Bioethics (DH-BIO), Council of Europe
Mark Bale, PhD, leads on a number of key emerging healthcare science areas and their ethical, legal and policy implications, with a particular emphasis on genomics and regenerative medicine. He is also Deputy Chief Scientific Adviser and Head of Profession for Scientists and Engineers for the Department of Health.
His current priorities are supporting the delivery of the Prime Minister’s 100K genomes initiative, the Regenerative Medicine Expert Group and the UK Rare Diseases Strategy. He has previously led work on legislation on human organs and tissue, increasing organ and stem cell donation and legislation on the derivation of embryonic stem cells.
His wider Division’s priorities include embryology and assisted conception and responsibility for NHS Blood and Transplant, the Human Tissue Authority and the Human Fertilisation and Embryology Authority.
He also represents the UK on bioethics, genomics and biotechnology at international committees. He is currently the Chair of the Committee on Bioethics at the Council of Europe.
Mark has a research background in microbial genetics and joined the Department of Health in 1999 after working on the occupational safety of GMOs and pathogens.
Antonina Yu. Chuprova
Professor of Criminal Law and Criminology department of the All-Russia State University of Justice (Russian Federation)
Antonina Chuprova has a degree in Law and a degree in Economics. She is Doctor of Law. She is Professor of the Criminal Law and Criminology Department of the All-Russian State University of Justice. Research interests: economic crime, corruption crime, crime in the area of e-commerce, crime in the area of health.
Mikhail B. Lobov
Head of the Human Rights Policy and Co-operation Department, Council of Europe
Mikhail Lobov received his legal degree in 1992 from Moscow State Institute of International Relations (MGIMO-University). In 1995, he earned a master’s degree (D.E.A) in international law from Robert Schuman University (Strasbourg), and in 2004, an LL.M. from Columbia University Law School (New York).
He joined the Council of Europe in 1997 where he served successively as a Legal Officer at the Department for the Execution of judgments of the European Court of Human Rights and Head of Legal Division at the Court’s Registry. Since 2014 he leads the Human Rights Policy and Cooperation Department at the Directorate General of Human Rights and Rule of Law. In 1995-1997, he taught constitutional law at Robert Shuman University of Strasbourg. His academic record also includes numerous lectures and publications on the implementation of the European Convention on Human Rights.
Anatoly I. Kovler
Chair
Former judge of the European Court of Human Rights elected in respect of Russia
Professor of the Moscow State University (Russian Federation)
Anatoly Kovler is a soviet and Russian law specialist, judge of the European Court of Human Rights from 1998 to 2012, professor.
In 1971 he graduated from the Moscow State Institute of International Relations (MGIMO) of the Ministry of Foreign Affairs of the former USSR and completed post-graduate studies at the International Workers' Movement Institute (IMRD) of the Academy of Sciences. He underwent study courses (in Italy, France, Belgium, Great Britain and Ireland) and taught in Brussels, Milan, Geneva, Washington, Paris and other cities. In 1977-1978 he edited the IMRD yearbook "Sorevnovaniye Dvukh Sistem" ["Competition of the two systems"].
From 1979 he worked at the Centre of Comparative Law of the Institute of State and Law of the Russian Academy of Sciences, being promoted through all levels, from junior researcher to senior researcher, head of the foreign information section and director (in 1992-1999).
In 1996-1999 he was editor-in-chief of the "Gosudarstvo i pravo" ["State and law"] journal.
In 1991-1993 he was an expert of the Constitutional Court of the Russian Federation, participating in work on the Russian Constitution of 1993 as well as on draft legislation on political parties and elections.
In 1988-1992 he taught in the sociology faculty of Moscow State University and the Moscow State Institute of International Relations, and in 1992-1995 at the Russian Academy of Sciences.
In 1999 he was elected by the Parliamentary Assembly of the Council of Europe as the first Russian judge in the reformed European Court of Human Rights and re-elected for a new six-year term of office in 2005.
In 2013, after leaving the ECHR, he became an adviser to the Constitutional Court as well as a staff member of the constitutional and municipal law department of the law faculty of Moscow State University, teaching a specialist course on the European Court of Human Rights.
Javier Arias-Diaz
Professor of Surgery at the Clinic Hospital - Complutense University of Madrid (Spain)
Member (in 2006-2016) of the Spanish Delegation at the Committee on Bioethics (DH-BIO), Council of Europe
Javier Arias has been Deputy Director of the Instituto de Salud Carlos III (ISCIII), and Director of the Spanish National Stem Cell Bank (BNLC), both reporting to the Spanish Ministry of Health and the Spanish Ministry of Science and Innovation. As part of his duties, he has been involved in several key emerging healthcare science areas and their ethical, legal and policy implications, with a particular emphasis on cell therapy, regenerative medicine, health data records and tissue biobanks.
He is also experienced in public health policies, and he has been responsible for the Spanish National School of Health and the Spanish National School of Occupational Medicine.
He has been member of the Spanish Delegation at the Committee on Bioethics (DH-BIO) of the Council of Europe, since 2006. At national level, he has been Chair of the Research Ethics Committee and the Animal Wellfare Committee of the ISCIII, Secretary of the Spanish National Committee on Bioethics, and Vice president of the Spanish Association of Research Ethics Committees (ANCEI). He also works as a member of the Research Ethics Committee of the San Carlos Clinic Hospital.
As a surgeon, his main areas of expertise have been hepato-bilio-pancreatic surgery, as well as transplantation of the liver and kidney. He has pioneered transplanting islet of Langerhans to type I diabetic patients, and the use of organs from non-heart-beating donors for clinical transplantation.
As a researcher, his main interests have been the inflammatory response to sepsis and the reperfusion injury of organs.
Viktoriya A. Maradudina
Senior Lawyer, European Court of Human Rights
Graduate of the Law Faculty of the Belgorod State University Russia (2001), holder of the Master's Degree from Human Rights Program of the Law Faculty in the Central European University, Budapest, Hungary; since April 2004 a lawyer in the European Court of Human Rights of the Council of Europe
Eliana Porta
Chair
Italian National Transplant Centre
Vice-Chair of the European Committee on Organ Transplantation (CD-P-TO), Council of Europe
Eliana Porta graduated as M.D. at the University of Milano (Italy) and spent her residency in Infectious Diseases at the University of Pavia. Since 2002 she is working for the Italian National Transplant Centre (CNT) mainly as senior inspector for Tissue Establishments and ART centres and as coordinator, trainer and tutor at training courses for Tissue Establishment CNT inspectors and for ART inspectors of the regional Competent Authorities. She is coordinator, trainer and tutor at training courses for Tissue Bank and ART Centres professionals according to the Directive 2004/23/EC and its implementing directive 2006/86/EC requirements.
She is responsible in the Italian vigilance and surveillance programme for Tissue Banks and ART Centres.
In the last years she actively participated with CNT in many European projects as Eustite, SOHO V&S, Eurocet and Vistrat. She participated in the Phare Twinning Programme ‘Improvement of the safety, quality and availability of organs, tissues and cells for transplatation’ in Slovakja and in the Twinning Project ‘Strengthening the Institutional Capacity for Blood, Tissues and Cells‘ in Croatia.
Since 2015 she is Co-chair at the Council of Europe European Committee on Organ Transplantation (CD – P – TO).
Before her activity at CNT she worked at Nord Italian Transplant program on Organ and tissue donor evaluation, Donor procurement management and Training courses for procurement management.
Axel Oswald Rahmel
Medical Director, German Organ Transplantation Foundation
Member of the European Committee on Transplantation of Organs (CD-P-TO), Council of Europe
After his medical medical studies at the Georg-August-University of Goettingen, Germany, Dr. med. Axel Oswald Rahmel, worked as Research Fellow at the Max Planck Institute for Experimental Medicine, Department of Physiology in Goettingen in the department of Prof. J. Piiper. Analysis of the physiological mechanisms of cardio-pulmonary adaptation to exercise in heart transplant recipients brought him in contact with the field of organ donation and transplantation. From 1992-97 was trained as resident in Internal Medicine and Cardiology at the Westfaelische-Wilhelms-University of Muenster in the Department of Cardiology and Angiology of Prof. G. Breithardt, his main clinical focus during this time were patients with end-stage heart failure prior to and after heart transplantation. He continued this work as a cardiologist in the heart failure and heart transplant program of the University of Leipzig / Heart Center.
From 2005 to 2014 he was Medical Director of the Eurotransplant International Foundation in Leiden, the Netherlands. This organization is responsible for the allocation of deceased donor organs in eight European countries (Austria, Belgium, Croatia, Germany, Hungary, Luxembourg, Slovenia and The Netherlands). Since 2014 he is Medical Director of the German Foundation for Organ Transplantation, the German organ procurement organization which has its headquarters in Frankfurt/Main, Germany. He is member of Council of Europe expert committee for organ transplantation since 2005.
Sergey V. Gautier
Director of Russian Federal Research Center of Transplantology and Artificial Organs
Chief specialist on transplantology of Ministry of health of Russia
Chairman of Russian Transplantation Society
Professor Gautier was the first in Russia who started clinical liver transplantation program in 1990. In 1997 he was the first surgeon who used the right hepatic lobe of living donor. The same year he performed the first pediatric liver transplantation in Russia. Prof. S.Gautier started pancreatic and small bowel transplantation in Russia and became the first Russian surgeon who performed successful heart-lung transplantation.
Prof. Gautier is Chief Editor of Russian Journal of Transplantology and Artificial Organs, member of Editorial Board of “Annals of Surgical Hepatology” and “Annals of Transplantology”. He is an author of more than 650 scientific papers and 25 books.
Since 2008 S.Gautier got the position of the Director of National Research Center of Transplantology and Artificial Organs. Now the Center performs about 350 transplant procedures per year including approximately 100 heart and 130 liver transplants.
Sergey Gautier is a member of Declaration of Istanbul Custodian Group.
José R. Núñez
Advisor on Medical Products of Human Origin, Heath Systems and Innovation Cluster, World Health Organization (Geneva)
Full Professor of Surgery, Faculty of Medicine, Complutensis University, Madrid (Spain)
José R. Núñez (1958) studied Medicine (1980, cum laude) at the Complutensis University and defended his Ph.D thesis in 1993 (cum laude). He did his training as a general surgeon at Madrid University Hospital and the Mayo Clinic, USA. He has been a member of the Department of Surgery at Madrid University Hospital for 32 years and Senior Consultant since 1996. Dr Nuñez started teaching surgery as an Assistant Professor in 1986 and became full Professor in 1995. For the last 18 years, he has worked in the field of Transplantation as Chief of the coordination unit and Director of the tissue bank in Madrid, developing the biggest programme on uncontrolled donation after cardio-circulatory arrest, being a member of the team that performed the first lung transplant in the world using lungs from an uncontrolled donor. He has been involved in much transplant-related research and training programmes worldwide, with several recognitions, such as the award of the National Health System on Quality Programmes and the award for Excellence and Quality in a Public Service. As a surgeon, he has been involved in international emergency response teams moving to disaster areas, such as following Haiti’s earthquake.
In January 2013, he joined the World Health Organization as a Medical Officer for transplantation and, since 2015 has been leading the initiative on medical products of human origin at WHO headquarters in Geneva.
Francis L. Delmonico
Professor of Surgery, Harvard Medical School (USA)
Advisor to the World Health Organization on Transplantation
Francis L. Delmonico, M.D. FACS is Professor of Surgery Harvard Medical School at the Massachusetts General Hospital, where he is Emeritus Director of Renal Transplantation.
He has been a member of the MGH Department of Surgery for 35 years. He is the Immediate Past-President of The Transplantation Society (2012-2014) and appointed as an Advisor to the World Health Organization in matters of organ donation and transplantation since 2006.
Dr. Delmonico is the Chief Medical Officer of the New England Organ Bank. He is the Senior Advisor and former Executive Director of the Declaration of Istanbul Custodian Group: http://www.declarationofistanbul.org/.
In 2005, Dr. Delmonico was elected President of the United Network for Organ Sharing (UNOS), the federally designated Organ Procurement Transplant Network (OPTN) that oversees the practice of transplantation in the United States.
Dr. Delmonico is a former Board member of the National Kidney Foundation and a recipient of the NKF’s David M. Hume Lifetime Achievement Award. He was a co-recipient of the Prince of Asturias award on behalf of The Transplantation Society in 2010 for his efforts in the establishment of the Declaration of Istanbul.
Dr. Delmonico is the recipient of the Shumakov Medal and the Gold Medal of the Catalan Transplantation Society. As a former Councilor of the American Society of Transplantation, Dr. Delmonico was also a recipient of the AST’s Senior Clinician Award.
Joana Gomes Ferreira
Vice-president of the Committee of Experts on the Operation of European Conventions
on Co-Operation in Criminal Matters (PC-OC), Council of Europe
Joana Gomes Ferreira is a Portuguese Prosecutor. After receiving her Law degree at the Catholic University she was admitted to the Centre for Judicial Studies in Lisbon in 1986, and after a 3-year training she started her professional career.
Joana Gomes Ferreira worked as a Prosecutor in the regional Courts of Sintra, Moura, Golegã and Barreiro.
Since 1999 she is the Coordinator of the International Cooperation Unit of the Prosecutor’s General’s Office, the Portuguese central authority for international cooperation in criminal matters.
An expert of the Council of Europe for international cooperation in criminal matters (missions in Croatia, Bosnia, Albania and Kosovo as well as reporter for the CCPE) Joana Gomes Ferreira is, since 2002, the Portuguese delegate at the Council of Europe Committee of Experts on the Operation of European Conventions on Co-Operation in Criminal Matters (PC-OC), which she chaired (2013-2015). She is currently vice-chair.
Joana Gomes Ferreira is since 2000 a contact point of the European Judicial Network, group that she chaired during the Portuguese Presidency of the EU in 2007, as well as a founding member of the IberRed (2004) and a contact point of the CPLP Network (2005). She is the national correspondent, for Portugal, of EUROJUST since 2014.
Joana Gomes Ferreira was part of the Portuguese delegation that negotiated several international instruments on international cooperation in criminal matters (with China, Algeria, Morocco and the Community of Portuguese Language Countries). As an expert, she was part of the team that evaluated Germany (2006) and Romania (2008) on the European Arrest Warrant
Joana Gomes Ferreira is a regular lecturer at the Centre for Judicial Studies (Lisboa) as well as at the European Judicial Training network (Brussels) and the Academy of European Law in Trier (Germany).
SESSION 1 – HUMAN RIGHTS AND BIOMEDICINE
Daniel Tarschys
Human rights and biomedicine:
A Council of Europe perspective
Thank you first of all for inviting me to this important conference.
A few years ago, I attended the very moving funeral of a young man who had been on the waiting list for a heart transplant for some time but never made it. The appropriate organ did not turn up. Many people share his fate; the vital organs are in short supply. But others are cured and saved. Since the first successful transplantations half a century ago, this miraculous therapy has given a new lease on life to thousands of patients. Yet as we know, it has also raised a batch of moot questions.
Some of these are diagnostic and prognostic. What are the chances of success? When physicians and their patients are confronted with badly damaged organs they must make difficult choices, on the basis of scientific evidence, medical experience and available resources.
Other questions are technical and organisational, not least logistic. There are many fields in medicine where speed is decisive, and this is one of them. Thus no room for improvisation. Some countries have been particularly successful in saving organs for transplantation, and others seek to learn from their experience. I believe Spain is still an admired model.
And then there are all the ethical issues, of several different kinds. A key condition for transplantation is consent, whether the donor is alive or deceased. But deciding whether this condition is fulfilled poses entirely different problems in the two cases.
With living donors who are close relatives to the intended recipient, can we trust that the agreement was given without undue pressure? And with living donors that are not relatives, is it at all acceptable that organs are extracted and transmitted in exchange for economic compensation? From the ethical councils and legislatures that have dug into this question and the connected phenomenon of organ trafficking the answer is a resounding "no",but this "no" has not given the desired effect. We know perfectly well that such transactions occur and that sinister black markets have evolved. We also hear of even more appalling crimes, as when people are killed for the sake of organ harvesting. This calls for concerted international action. A new Council of Europe Convention against Organ Trafficking opened for signatures last year in Santiago de Compostela, but has not yet entered into force.
In the case of deceased donors, the expression of consent can be handled in different ways. Ideally, people should be asked about their attitudes while they are alive and their response should be recorded in a register, or a donor card. Many such systems have been set up but it is not easy to motivate people to respond to something they do not really want to think about. Could the question perhaps be raised on some suitable occasion, as when people ask for a driver's licence? Or could it be turned around so that only negative positions are registered? This idea is catching on, and some countries are adapting their legislation in this direction.
When no position of the deceased person has been recorded it has often been up to the next of kin, not to give or withhold consent, but to interpret the attitude of their dead relative. There, many things can go wrong. The relatives cannot be found, or express different views. And time is pressing. The lives that have been lost in such situations certainly lend support to the doctrine of "presumed consent" in the context of transplantations.
Another question with many ethical dimensions is that of waiting lists. When the demand for particular organs exceeds the demand, as is often the case, who should be first in the queue? The patient with the most prestigious and best-connected doctor? The richest patient, or the patient from the richest country? The longest-waiting patient, or the patient with the longest life expectancy? Plenty of questions there.
Priority-setting headaches recur in the context of many diseases and medical interventions, and not least in the allocation of scarce resources between different illnesses and medical interventions. In health care systems built on private funding such problems may partly be left to the individual, but even the most capitalist countries depend heavily on taxation to finance their medical services. And since taxes are finite, this creates many dilemmas of distributive justice.
Which drugs should be subsidised, and which self-financed? What if the new drug is 10 percent better at 10 times the costs of the old one? Which surgical interventions are medically motivated, and which are rather a matter of esthetic preferences? Which treatments are so dangerous that they should be really outlawed - and if they are, how do we deal with people going abroad for treatment? How far do parental rights extend when it comes to cures that are taboo to some religious sects? To what extent should we accept genetic engineering, with potential effects on future generations? The Swedish National Council on Medical Ethics, which I chaired for 11 years, is knee-deep into such types of problems.
This Council has just celebrated its 30th anniversary and was the second such body to be set up after the pioneering Comité Consultatif National d'Éthique in France. Today, all European countries have some kind of national bioethical committee or council, perhaps with one or two exceptions. In addition, there is a dense sub-vegetation of ethical councils in regions, hospitals and medical faculties. The remit differs a bit between different countries: some cover the whole bioethical field including animals and plants, while others concentrate on humans. Some include or concentrate on research, while others focus more specifically on the health care system. Most of these councils include experts from a variety of disciplines, extending from theology and humanities over the social sciences to the medicine and the natural sciences. Health care professionals play an important part.
Why, then, this proliferation of ethical bodies in the last few decades? And why so much European and global cooperation? There is certainly a bit of mimesis involved here, with inspiration spreading among professionals and one country copying another one, but this diffusion would hardly have come about without the powerful drivers of medical research. Life expectancy is growing, 70 is the new 50. The breath-taking speed of scientific and technological breakthroughs confronts politicians and medical practitioners alike with so many possibilities and opportunities. But out of everything that could be done, what should be done? What if the health gains for some patients generate risks for others, or for future generations? So many questions defy simple answers.
As an organisation devoted to the respect for human rights, the strengthening of the rule of law and the promotion of democracy, the Council of Europe has long served as an arena for discussion of common European concerns. The field of health care is full of such dilemmas. Many of these are connected to the beginning of life - just think of abortions, genetic testing and medically assisted procreation - while others revolve around sensitive end-of-life decisions. But between birth and death there are plenty of other ethical issues, connected to the prevention and treatment of particular diseases.
Many of them are linked to the process of globalisation, to the phenomenon of medicine without borders. Take medical and pharmacological innovation! In the testing of new drugs there are not only tremendous costs involved but also tough ethical challenges. In history, horrendous crimes have been committed in the name of scientific progress. Today's evidence-based research methods may have been become very refined, but even the use of double-blind testing and control groups raises serious questions about the respect for human rights. And if the decent principles we have agreed upon are respected only in some parts of the world while the dangerous tests are exported to poor countries, we have every reason to see that as a new and despicable form of colonial oppression.
The Council of Europe has a vigorous Committee on Bioethics that you will certainly hear more about today. But let me seize on this occasion to underline that bioethical issues are dealt with much more broadly in the organisation.
The wide-ranging intergovernmental cooperation of the Council is overseen by the Committee of Ministers. This is the body that adopted the Oviedo convention and its four additional protocols - on cloning, transplantation, biomedical research and genetic testing. It has also adopted three recommendations, on xenotransplantation, research on biological materials of human origin and respect for persons with mental disorders.
These bioethical instruments have also left their mark on the jurisprudence of the European Court of Human Rights. The 65 year old European Convention Human Rights is relatively laconic and abstract, but its guidance has become much more pointed and specific though the rich case-law that has been accumulated over the years. Europeans have appealed to the court on many issues such as the rules for medical treatments, the removal of organs or tissues, prenatal diagnosis, the right to abortion, the retention of biological data and the right to know one's biological origin. You will hear more about this from Ms. Maradudina.
The Commissioner for Human Rights and the Venice Commission are other bodies within the Council dealing with bioethical issues, such as the legal status of vulnerable groups, or children, or persons with disabilities. In the Congress of Regional and Local Authorities there are many politicians with responsibilities for health care. Some 400 European civil society associations enjoy consultative status with the Council, many of them deeply concerned about ethical issues. There is also a Conference of National Ethics Committees in the Council that unfortunately has been slumbering for some time. A wake-up call would be useful, because there is a lot of important work going in these Committees and they have much to learn from each other.
Last but not least, let me mention the Parliamentary Assembly. Both media and the Assembly’s own members often give the impression that this is the only voice of the Council of Europe. That's not the case, but it is certainly quite influential. When the Council was set up in 1949 the Consultative Assembly as it was then called was not intended to play such a prominent role, at least not by the governments. But parliamentarians are not easy to deal with. The Assembly changed its own name, began to assert itself and has gradually managed to increase its political weight, in much in the same way as the European Parliaments has systematically extended its influence and impact.
Of the more than two hundred conventions adopted by the Council of Europe since its start, more than half are said to have originated in the Assembly. That is certainly the case for bioethics, where both the Oviedo convention and several other instruments grew out of discussions among the parliamentarians. An initiator of the Oviedo Convention was Dr. Marcelo Palacios, a parliamentarian from Gijon in Asturias, which is a city neighbouring on Oviedo. For years there was an intra-Spanish battle as to whether we should speak of the Asturias convention or the Oviedo convention. That is local politics.
Back in 1989, it was also the parliamentarians not the governments that initiated the opening of the Council of Europe towards the east. The Parliaments in non-member states that were at this time experimenting with new forms of pluralism were invited to send special guest delegations to the Parliamentary Assembly and take part in all its discussions. The USSR Supreme Soviet did so, and then of course all the parliaments in the new independent states.
I was personally involved in this process in several ways, first as Rapporteur in 1991 on the Council's relations with the new sovereign republics, then as rapporteur on Russia's application for membership and then finally as Secretary General when accession eventually took place in February 1996.
There are good reasons to celebrate this 20th anniversary. I belong to those who refuse to speak of Russia and Europe, since Russia is part and parcel of Europe. Many things have of course changed in those 20 years, and not all of them for the better. The idea of creating a continent without dividing lines may seem distant today with all the new walls being erected, but I see no reason to give up that ambition. Or any of the other values that the Council of Europe stands for. The lack of respect for them that we observe all across the continent is just a reminder of all the unfinished work out there. To get back on track, we need continued contacts at all levels and a vibrant and truly independent civil society. Making borders in Europe irrelevant remains an excellent objective.
As for Russia's involvement in the Council of Europe, I believe it is wider and more ramified than many people imagine. The country has signed some 80 and ratified some 60 conventions. It also takes active part in many of the partial agreements.
In bioethics as in many other policy areas, there is a strong case for more not less international cooperation. The forte of the Council of Europe in this context is its combination of legal obligations and softer forms of cooperation, its many fora for deliberations and mutual learning, the reminders it can serve in various directions through its monitoring and evaluation mechanisms, and the constructive pressure it can apply when pledges are not kept. The general experience among member states is that criticisms hurt and irritate in the short term but are very useful in the longer perspective. They stimulate reflections and reforms.
Let me conclude by wishing every success to this conference and to Russia's continued involvement in the many bodies of the Council of Europe.
Core Principles of Bioethics
In this contribution I will be looking at not so much the principles of bioethics as such, as the role they play in resolving moral issues which have to be dealt with extremely frequently both in medical practice and in the planning and implementation of biomedical research. One of the areas in which those moral issues are particularly critical is transplantation.
The most widely recognised work in the bioethics sphere is the tract setting out principles for it proposed by Tom Beauchamp and James Childress . It lays down four principles:
- respect for autonomy,
- non-maleficience,
- beneficience,
- justice.
All those principles, together with the rules they underpin, such as rules on informed consent, truthfulness, confidentiality and so on, are used as the foundation for specific decisions that have to be taken in situations occurring in medical practice. They also play a key role in the standard-setting instruments drawn up by the Council of Europe's Committee on Bioethics, including the Bioethics Convention and its Additional protocol concerning Transplantation of Organs and Tissues of Human Origin .
Principle of respect for autonomy
In accordance with the principle of respect for autonomy it is the choice, let us say, of a given treatment method made by the patient (or by the subject in biomedical research), were they to disagree with the doctor /researcher, which must determine the doctor's/researcher's actions. This choice is termed autonomous. Generally speaking, an individual's choice will be considered autonomous if it is a deliberate choice, in other words if it is in accordance with a degree of the individual's own intent and deliberation, with the understanding of exactly what they are doing. In that process, one of the obligations of the doctor/researcher is to ensure that they have that understanding. In addition, autonomous decisions are taken without any outside influences (such as coercion or withholding of important information) that would affect the outcome.
The prime consequence of the principle of respect for autonomy is the informed consent rule whereby any medical intervention may take place only after receiving the patient's/subject's voluntary, free and conscious consent to it. Informed consent comprises two elements: informing, which, as already pointed out, is the obligation of the doctor or researcher, and consent in their own right. Informing the patient/subject is not simply a matter of providing them with certain medical information. The doctor/researcher must be sure that the patient/subject correctly understands the information they receive.
In certain generally clear-cut cases, the autonomy of the individual may be subject to restrictions. If a patient, such as a young child, is not legally competent, permission will be necessary from their legal representative, usually a parent, to carry out medical intervention. There also exists the moral norm of "therapeutic privilege" - if the doctor is certain that revealing truthful information about the diagnosis or prognosis may cause the patient serious harm, the doctor is entitled to withhold that information from the patient. If medical care is provided to a patient in an emergency and there is no time to provide any kind of detailed information, the principle of deferred information and consent obtained when possible is applied.
There is another norm that is highly debatable from the ethical viewpoint, namely the use of placebos, which involves deceiving a patient/subject, giving them some innocuous but essentially useless substitute while passing it off as a real pharmaceutical preparation. It is considered that the use of a placebo to exert psychological influence on a patient frequently yields positive results. Using a placebo in biomedical research is justified by the need for experimental integrity: if one group of subjects is given the test substance and the other receives a harmless substitute, with neither the subjects nor the researchers knowing which of the subjects is in which group, this makes it possible to rule out the distortion of results through the placebo effect. This occurs as a result of the subjects, who do not know that they are not in the test group but in a control group, believing that they have taken the new substance being tested. Since this supposes that the test subjects are being directly deceived, this practice is considered morally questionable, and its use is permitted only in exceptional, strictly stipulated cases.
The principle of respect for autonomy, like the rule on informed consent, is expressed in numerous articles of the Convention on Bioethics and the Additional protocol on transplantation. In Article 19 paragraph 2 of Chapter VI of the Convention covering the removal of tissues from living donors for the purpose of transplantation, for example, it is directly stated that the donor's consent "must have been given expressly and specifically either in written form or before an official body". And in Article 20 which follows, it is stated that no organ or tissue removal may be carried out on a person who does not have the capacity to consent.
Where the Additional protocol on transplantation is concerned, the principle of respect for autonomy underpins a whole host of standards laid down in it, beginning with Article 1 stating the purpose of the Protocol: "Parties to this Protocol shall protect the dignity and identity of everyone and guarantee, without discrimination, respect for his or her integrity and other rights and fundamental freedoms with regard to transplantation of organs and tissues of human origin". The protection of a person's dignity and identity as well as their corporal integrity can all be seen as embodying the principle of respect for autonomy.
The different aspects of information and consent for the donor and the recipient are elucidated in Articles 5 (information for the recipient), 12 (information for the donor), 13 (consent of the living donor), 14 (protection of persons not able to consent to organ or tissue removal) and 17 (consent and authorisation for the removal of organs or tissues from the body of a deceased person) of the Protocol. Article 23 of the Protocol is devoted to the issue of confidentiality, ie the protection of the personal data of both donor and recipient. Personal data protection is one of the key aspects of respect for individual autonomy.
Principle of non-maleficience
This principle has an extremely long history, going back to the famous ancient Greek doctor Hippocrates. In the medical oath attributed to him the practitioner swears to refrain from "causing any harm or wrong-doing". We all frequently apply the principle of non-maleficience in our own day-to-day lives, well outside the framework of doctor-patient relations. As a matter of fact, this principle by no means rules out causing harm to a patient; the idea here is merely that such harm must firstly be necessary and secondly kept to a minimum.
Indeed, interaction with a doctor entails various types of harm for a patient, ranging from the need to spend time consulting a doctor to the necessity of undergoing painful procedures that might go as far as removing an organ for example, whereas a patient suffering from an incurable disease may take the view that a quick and painless death would do them less harm than ongoing treatment. Here, we can only talk about keeping unavoidable harm to a minimum. There are distinct forms of harm to patients linked to the provision of information, which may entail withholding essential information, providing them with upsetting information or disclosing information about them to third parties; all these are forms of moral injury.
Looking from the doctor's viewpoint, we can talk about kinds of patient harm such as harm caused by a doctor's failure to act or non-provision of assistance, harm caused by carelessness or malintent, harm caused by incorrect or unqualified intervention and, finally, harm caused by reasonably required actions in a given situation, this latter form of harm being the only acceptable one; all the others are struck off by the principle of non-maleficience.
How the principle of non-maleficience is applied in actual practice and how it interacts with the principle of respect for autonomy is well illustrated by the following example. O.I. Kubar wrote about a thyroid gland transplant carried out by the chief doctor of the Kolomenskiy engineering works, B.V. Dmitriyev, who consulted the authoritative Russian law expert A.F. Kony . Considering the ethical and legal aspects of the doctor's right to transplant tissues and organs from one person to another, Dmitriyev raised the question: does a doctor have the right to inflict even insignificant and transient harm to a healthy person to benefit someone else? It should be noted that it is this factor of causing harm to a healthy individual is what sets the transplantation of organs and tissues from a living donor apart from an ethical viewpoint.
By way of a reply to this question Dr Dmitriyev devised what is to all intents and purposes a fully acceptable and sufficient set of standards, even by today's strictest benchmarks, for informed and conscious consent by a donor, set out in the following form in his article: the doctor must refrain from removing for transplant purposes a part of the body of a minor or a mentally incompetent person. Material for the homoplastic transplantation of living tissue may be taken only from the body of a fully competent adult. It is essential that the damage caused by the removal of part of the body be transient, in the opinion of the doctor based on precise scientific data. The doctor must provide the donor with a clear and exhaustive explanation of all the possible outcomes and the danger presented by the pending operation and obtain the donor's consent after doing so."
Moreover, as Dmitriyev points out, obtaining written consent, including in the presence of witnesses, safeguards the interests not only of the patient but also of the doctor, protecting him from possible blame in the future.
The article also includes a consent form given by the patient, Ye.P.: “I, the undersigned Ye.P, by myself, without any external influences, offered a piece of my thyroid gland for transplantation. The piece would be of the size required for successful transplantation (approximately up to one-eighth of the gland’s volume). I have had all the details explained to me and I am aware of all the risks to which I am subject".
Coming back to the Protocol on transplantation, it must be pointed out that the principle of non-maleficience lies at the heart of many of the standards it enshrines. This is particularly apparent already in Article 1, which states the purpose of the Protocol as the prevention of harm in the transplantation sphere that might be caused to the dignity and identity of everyone and respect for corporal integrity and other rights and fundamental freedoms. The requirements of Article 6, relating to protection of health and safety, are clearly geared to minimising possible harm to the patient. Minimising harm to the donor is the objective sought by Articles 11 (evaluation of risks for the donor), 12 (information for the donor), 13 (consent of the living donor), 14 (protection of persons not able to consent to organ or tissue removal) and also Articles 21 and 22, devoted to the prohibition of financial gain.
Principle of beneficience
The obligations of the doctor vis-à-vis the patient cannot be limited to merely not causing harm. Much more is required of the doctor, in terms of positive action to prevent possible harm to the patient or remedying or minimising harm already caused. In dealing with the patient the doctor acts in a professional capacity, meaning that they possess the kind of knowledge and skills that the patient will not have.
However, doctors' professional expertise not only guarantees their authority but also places them under serious moral obligations, the paramount of these being the requirement to carry out actions as far as possible which will be of benefit to the patient. When we talk about the transplantation of human organs and tissues, the benefits expected by the recipient are particularly significant. There are many cases where a donor organ transplant is the only means of saving the recipient's life and really improving the quality of their life. Furthermore, in the sphere of transplantation, the recipient also benefits not only from the efforts of the doctor and all those involved in procuring and preserving and ultimately transplanting the organ or tissue but also from the contribution of the donor.
Moreover article 9 of the Protocol on transplantation, under Chapter III on Organ and tissue removal from living persons, expressly stipulates that removal may be carried out solely for the benefit of a recipient and where there is no suitable organ or tissue available from a deceased person and no other alternative therapeutic method of comparable effectiveness. The benefit received by a recipient from the donor in such a situation is made conditional on minimising the harm caused to the living donor. Articles 10-13 of the Protocol pursue a similar purpose.
The ethical standard contained in Article 19 of the Protocol is to promote the practice of organ and tissue donation after death as a practice underpinned by the provision of a benefit to the recipient by the donor. The standards of Chapter VI, geared to prohibiting financial gain, are aimed at making a firm legal distinction between the encouraged practice of unpaid donation on the one hand and morally unacceptable trade in donor organs and tissues. In 2015 the Council of Europe adopted another legal instrument with the same focus: the Convention against Trafficking in Human Organs .
Principle of justice
Problems of social injustice are now more acute than ever in the sphere of organ and tissue transplantation. The resources available in this sphere to any country, even the wealthiest States, are limited. There is not only a deficit of the qualified specialists and high-tech equipment needed for the procuring, preservation, transportation and implantation of organs and tissues but also and above all a lack of actual organs and tissues. Efforts to create artificial organs and other research into xenotransplantation (using animal organs as donor material) and genetic methods to "grow" organs and tissues have not yet yielded clinically significant results.
In this connection there is a truly chronic problem of the fair allocation of donor material where, in many cases, a handful of patients are offered the chance of staying alive while others are deprived of that possibility. In concrete real-life situations this is a problem that, sadly, cannot be resolved to everyone's satisfaction. However, ethics can suggest sufficiently comprehensible and logically clear-cut criteria, rules and procedures that would do away with injustice in the allocation of donor organs and tissues.
An important factor in this respect is the transparency of the system for procuring and allocating donor material. This is covered, in particular, by Article 3 of the Protocol whereby the actual transplantation system exists in order to provide equitable access to transplantation services for patients. Furthermore, organs and tissues "shall be allocated only among patients on an official waiting list, in conformity with transparent, objective and duly justified rules according to medical criteria", and the transplantation system "shall ensure the collection and recording of the information required to ensure traceability of organs and tissues". It is worth pointing out that the latter standard is significant not only from the viewpoint of fairness but also in terms of minimising potential damage in the event of poor-quality donor material being transplanted.
In the context of social justice, there is also the standard in Article 8 on the provision of information for the public in general on the need for organs and tissues, as well as the conditions governing the removal and implantation of organs and tissues. Chapter VI of the Protocol, prohibiting financial gain and trade in organs and tissues, is also highly important for ensuring social justice. The standards set out in Chapter VIII provide for possibilities of restoring social justice where it is infringed.
The Convention on Human Rights and Biomedicine – an introduction
It is an honour to be invited to represent the Council of Europe Committee on Bioethics – which I currently chair – at this important conference celebrating the 20th anniversary of the Russia joining the Council of Europe. It is also my pleasure to be able to follow my colleague Professor Boris Yudin who has outlined the bioethical principles that underpin the Convention on Human Rights and Biomedicine, more commonly known as the Oviedo Convention.
The Convention was nearing completion when Russia joined the Council of Europe and was opened for signature in Oviedo, Spain in 1997. To date it has been signed by 35 countries and ratified by 29 of them. I will outline some of the reasons why we can describe the convention as both a crowning achievement in the codification of bioethical principles as well as the starting point for much more than that.
It was a major achievement in that is it the first legally binding international instrument spanning the whole range of bioethics. The Convention’s full title – “The Convention on the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine” - indicates the wide range of ethical and legal principles that are applicable to medical acts and to other, then new, biomedical technologies.
It is founded on the principles of the European Convention on Human Rights (ECHR) and many of the principles, concepts and terminology is based on the ECHR. In this respect, it should be noted that Article 29 of the Oviedo Convention specifically allows for the European Court on Human Rights to issue opinions on legal questions concerning the interpretation of the Convention at the request of the Parties.
It is also a starting point in this area because the Oviedo Convention is provides a framework for the elaboration of further detailed principles through the development of Additional Protocols. I will touch on these later and there are some important examples in the field of organ donation and transplantation that my former colleague, Dr Javier Arias, will detail.
Returning to the core legal and ethical principles, the Oviedo Convention lays down a number of principles that are directly relevant to individual rights, for example Article 5 which deals with the requirement for consent. In other areas the Convention introduces obligations on the State through legal measures to give effect to the principles. One example might be Article 3 which requires States to take appropriate measures to provide equitable access to healthcare within their jurisdictions.
Through this focus on the rights of the individual and the duties of the State in the application of medicine I would argue that the Convention is in essence a “patient rights” treaty. It is a codification of the long-standing principles that apply to medical practice. These have emerged from the Hippocratic Oath through to the modern canon of international principles applying to medical practice. The Convention provides a common framework for the protection of human rights in the fields of medicine and biology. The tone is established in Article 1 which states:
“Parties to this Convention shall protect the dignity and identity of all human beings and guarantee everyone, without discrimination, respect for their integrity and other rights and fundamental freedoms with regard to the application of biology and medicine.”
The Convention provides a legal framework for many of the ethical principles that apply to any medical act. The four main bioethical principles outlined by Professor Yudin and enshrined in articles that focus on the primacy of the human being, the provision of equitable access to healthcare, the principle of consent (and protections for those unable to consent) and for confidentiality – the protection of privacy and the provision of information.
Specialist areas of biomedicine
These are the core principles safeguarding patients and citizens. The Convention also addressed many of the major developments in biomedicine which continue to be relevant nearly 20 years on. These main chapters cover genetics, biomedical research and organ donation and transplantation. I will touch on the first two and others will cover the transplantation provisions in more detail. But I would just note that the Convention laid the basis for the more detailed Additional Protocol on organ donation and transplantation as well as the recent Convention against trafficking in human organs.
On genetics the Convention laid down some key principles which remain highly topical in 2016. These include a requirement for predictive genetic tests to be only carried out for health purposes and with an appropriate counselling. This has a strong relevance to current concerns about the use of predictive genetic information by insurers.
There is an important prohibition on modifying the genome of future children – this is very relevant given the current debate on gene editing. The ban on sex selection through medically assisted procreation is again in sharp focus across Council of Europe member states. On biomedical research there are specific and detailed requirements both permitting and supporting biomedical research but also on laying down the key principles for independent scrutiny of the balance of risks and benefits and for ensuring the informed consent of the patient or subject.
Although the Convention has considerable detail in these matters there have been Additional Protocols on cloning (1998), on transplantation of organs (2002); on biomedical research (2005) and on genetic testing (2008). The Convention also provides a key basis for Recommendations on biobanking and on insurance uses of medical information.
Legal and ethical aspects
As a framework international legal instrument, the Convention seeks to establish common legal and ethical principles but to leave room for national legislation to apply these in the light of local considerations. However, Article 26 lays down some important safeguards limiting the purposes for which the exercise of rights or protective provisions might be restricted and prohibiting such restriction for some essential principles such as the requirements for consent for biomedical research and organ transplantation.
Another important provision is Article 30 which requires Member States – upon request of the Secretary General of the Council of Europe – to provide reports on the operation of national legislation implementing any provisions of the Convention. A good example of this was in 2002 regarding a survey on legal and organisational measures to prevent and fight organ trafficking.
The Committee on Bioethics
As well as these legal principles there is an important provision to encourage wider co-operation. I would argue that one of the most important elements of the Convention is Article 32 which sets out the arrangements for the “… Steering Committee on Bioethics (CDBI), or … any other committee designated … by the Committee of Ministers”. Since 2012, and the reorganisation of steering committees, the committee responsible is the Committee on Bioethics (DH-BIO).
It is a world renowned committee consisting of representatives of the 47 Member States of the Council of Europe and observers States: Australia, Canada, the Holy See, Israel, Japan, Mexico and the United States of America. It also has representatives from the other key Council of Europe intergovernmental committees, from the Parliamentary Assembly of the Council of Europe and from key international intergovernmental organisations such as the European Union, the World Health Organisation (WHO), the United Nations Educational Scientific and Cultural Organisation (UNESCO) and the Organisation for Economic Cooperation and Development (OECD).
The Committee on Bioethics plays a key role in the exchange of information across this important range of expertise. The Committee is the body that is responsible for the development, in additional protocols, of the principles laid down in the Convention. But it is also in charge of the regular re-examination of the Convention and its additional protocols in light of scientific development, and presentation of possible amendments to the Council of Ministers.
I would like to give just a few examples of the current issues and challenges that the Committee is addressing. We are currently considering the rapidly emerging, and converging, technologies and the concerns they raise for human rights. We have recently conducted some fascinating and thought-provoking work on developments in areas such as genomics, neurosciences, nanotechologies and information technologies which are being rapidly combined into new ‘smart’ devices and powerful diagnostic and predictive databases. Many of these are happening in global entities outside of the traditional boundaries reflected in the scope of national and regional legal instruments. Whilst we can see many positive developments in these fields we can also anticipate threats to individual human rights and to the principles of consent, autonomy, privacy and justice that has been described earlier.
The Committee is working actively to provide additional legal tools and guidance materials in areas such as the protection of persons with mental disorders; the processing of health-related data by insurance companies and the development of biobanks for biomedical research.
We have focussed also on guidelines on sensitive matters such as the role of members of research ethics committees, on decision-making concerning medical treatment in end of life situations and on training materials for legal and other professions.
We are always alert to the opportunities for cooperation, especially working with one or more Member States to address specific problems or to encourage wider participation in action to tackle problems such as organ trafficking. We are also active in promoting cooperation with other key international agencies such as WHO and UNESCO.
It is worth noting in this context that Article 28 of the Convention places an important emphasis on public debate. It requires that “Parties to this Convention shall see to it that the fundamental questions raised by the developments of biology and medicine are the subject of appropriate public discussion in the light, in particular, of relevant medical, social, economic, ethical and legal implications, and that their possible application is made the subject of appropriate consultation. “ This is a particularly relevant principle in relation to new legislation such as the draft legislation currently developed in Russia that we will hear more about today. It is crucially important in the newer areas of biomedicine that I referred to earlier.
So in conclusion I would return to my original premise that the Oviedo Convention is a landmark achievement as it is the first and only international legally binding instrument in its field and as such a crucial “patient rights” instrument as well as part of the human rights canon. But it is also a reference for other wider debates such as new technologies, wider international treaties and declarations and the basis of national legislation on the necessary protections to allow vital medical technologies like organ transplantation to be delivered safely and ethically.
I hope that this rapid introduction provides a basis for the rest of the more detailed examination of national and international actions on organ donation, transplantation and the fight against organ trafficking.
Antonina Yu. Chuprova
Criminal Responsibility and Bioethics
The reform of Russian legislation on health started up at the beginning of the 1990s and has continued to the present day, which is fully understandable. Quite apart from the notoriously slow pace of the legislative process, which guarantees its stability, legislation cannot fail to respond to the changes occurring in society and proposes regulatory frameworks for the new social relations that arise as society evolves.
However, the continual adding of new legislative chapters as biological and medical advances are made in the health field, to make legislation more effective and of higher quality, frequently yields the reverse result – incoherent legal material and complexity in applying it in practice owing to the inadequacy of individual legal provisions in terms of content and construction, giving rise to legal nihilism and ignorance of legal systems by the entities in the legal relationships they govern. Intentional or unintentional infringements of the law in the sphere of medicine jeopardising the most fundamental human rights, to life and health, incur legal and more often than not criminal liability. But the question arises as to what are the real possibilities of applying criminal law when fundamental principles of bioethics are infringed?
The criminal law in force takes as its starting point the priority of the rights of the individual stated in Article 2 paragraph 1 of the Russian Federation Criminal Code. Moreover, it cannot go unmentioned that criminal law is a fairly conservative instrument. The prohibitions set out in it are based on notions of acceptable or reprehensible conduct forged in the course of a century. Many of the new directions in contemporary medicine are themselves the result of obtaining new knowledge. The significance of these medical technologies and the scale of the social and ethical problems that may arise in their practical application are not always obvious and, for that reason, the law lags behind and contains legal loopholes, with only time to fill them.
At the same time, criminal law has a defined spectrum of remedies for resolving problem situations arising both in the sphere of practical health care and in the sphere of application of new medical technologies. However, the criminal law means of regulating different groups of relations, including in the provision of medical assistance, are some of the harshest enforcement measures against offenders used by the State. The application of criminal law against any individual attaches a stigma to them that is virtually impossible to remove. Accordingly, criminal law is used only in extreme cases, when there are infringements of the most important rights and interests of any individual and of the State as a whole – and the range of these is fairly limited.
It must be pointed out that, alongside its punitive function, criminal law has a significant preventive potential. By prohibiting strictly defined types of conduct, it sends out a message to potential offenders that committing such acts is not tolerated by society and the State and will incur adverse legal consequences. When it is a matter of prohibiting traditional criminal offences, the content of that prohibition is clear to everyone and requires no further comment. But in situations where a prohibition in criminal law relates to the exercise of a professional activity, particularly in the healthcare field, problems arise, regarding the offender's understanding of the essence of legislative restrictions introduced, for example, or the application of specific standards.
One source of particularly serious limitations on the preventive capability of criminal liability is the inconsistencies of criminal and positive law, some of whose provisions are quite literally the cause of criminal infringements. Since this conference focuses mainly on the legal problems of organ donation and transplantation, let us consider the draft law, long discussed in both medical and legal circles, "On the donation of human organs and their transplantation" as regards its correlation with criminal legislation and the existence of potential problems of application.
The Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, adopted in Oviedo on 4 April 1997, lays emphasis in Article 3 on the obligation of the State to provide equitable access to health care for all members of society. Article 5 of Federal Law no. 323 of 21 November 2011 "On the bases of public health protection in the Russian Federation" stipulates that health protection measures shall be carried out on the basis of recognition of, respect for and protection of the rights of citizens and the State, acting in accordance with the universally recognised principles and standards of international law, and shall afford health protection to citizens irrespective of their gender, race, age, ethnicity, language, diseases suffered, condition, origin, material and official status, place of residence, attitude to religion, convictions or membership of public associations. The current version of Federal Law no. 4180-I of 22 December 1992 "On the transplantation of human organs and/or tissues" contains no provisions contradicting Article 5 of Federal Law no. 323.
At the same time, in all the versions of the draft law on transplantation of organs, notably in Article 56 paragraph 2 of the draft law "On the donation of human organs and their transplantation" posted on the official website of the Ministry of Health, it is stated that Russian Federation citizens shall be entitled to be included on the waiting list to receive donor organs, with the exception of adult citizens of the Russian Federation with legal capacity having expressed their disagreement with the removal of their organs after their death for transplantation, which has been recorded in the Register of declared wishes of citizens.
So the draft law has from the outset ruled out access to modern high-tech medical care in the form of implantation of a donor organ for a substantial number of Russian citizens on grounds of their beliefs or affiliation to certain faiths stipulating non-violation of corporal integrity and, therefore, the removal of organs. If we extrapolate the data of interactive surveys and sociological research, over 60% of citizens fall into this category. As we can see, the proposed norm establishes provisions that discriminate against the majority of the country's adult population on grounds of religion or certain beliefs. As you can imagine, the inclusion of such a norm in the final text of the law will create extremely serious legal problems for the exercise of professional activities in the transplantation sphere and certainly will not help to raise the level of trust in the work of transplant doctors, which is extremely low in modern Russian society.
Firstly, this norm obliges citizens to agree to become donors under threat of non-provision of adequate medical care in situations where there is a real and present danger to their life and health. In such a situation, it is hardly possible to apply the principles of organ donation set out in article 5 of the draft law in question, particularly the principle of voluntary donation, and there is clearly a clash of individual norms within the same potential regulatory act.
Secondly, the draft law disregards not only the fundamental provisions of the Convention on Human Rights and Biomedicine and Federal Law no. 323 of 21 November 2011 but also the Russian Federation Constitution, in which Article 19 paragraph 2 states that: "The State guarantees equality of rights and freedoms regardless of sex, race, nationality, language, origin, material and official status, place of residence, attitude to religion, convictions, membership of public associations or of other circumstances".
Thirdly, the fundamental legislative act governing relations in the sphere of health protection - the Federal Law "On the bases of public health protection in the Russian Federation" - directly establishes in Article 3 paragraph 2 the precedence of the legal provisions contained in it, emphasising that "health protection standards contained in other federal laws or legal and regulatory acts of the Russian Federation or laws and other legal and regulatory acts of constituent entities of the Russian Federation must not contradict the norms set out in the present Federal Law". On that basis, the provisions of the draft law on organ donation generate clashes of law including with the aforementioned legislative fact.
Fourthly, in violating the constitutional rights of citizens, the draft law also contradicts criminal legislation by disregarding the prohibitions set out in a number of norms of the Criminal Code of the Russian Federation.
By refusing to place a person who expresses the living wish not to be an organ donor when deceased on the organ transplant waiting list, a doctor is effectively refusing the right to life to an individual whose life is danger. Invoking the provision of the law on transplantation (if it is retained and approved as part of the law) has no legal sense since, where there is a conflict between criminal law norms and provisions of another branch of law, criminal laws take precedence. Moreover, failure to provide medical assistance in such a case must be categorised as non-fulfilment of professional duties without justified reason. In contemporary judicial and investigative practice, justified reason includes lack of suitable medical qualification or training, but refusing assistance on grounds of a patient's beliefs can in no circumstances be deemed justified. The question then arises as to how such actions are to be classified from the viewpoint of the Criminal Code of the Russian Federation.
Article 124 of the Criminal Code provides for criminal liability for failure to provide aid to a sick person if, as a result of negligence, this results in harm to the person's health or death. In this case, failure to act on the part of medical staff relates to an individual whose condition is life-threatening. It is obvious to the doctor, as a professional, that failure to provide timely assistance to a patient by transplanting a donor organ can have only one result, namely the death of the patient. So it is hardly possible to speak of negligence. In the light of the content of Article 25 paragraph 2 of the Criminal Code, the conduct of that member of medical staff is characterised by criminal intent: by refusing to put an individual requiring an organ transplant on the waiting list, they would fully realise that their actions will place the patient's life at real risk, they would foresee the inevitability of this happening and wish this to happen. However, intentionally causing the death of another person through failure to act is considered as homicide under criminal law. Obviously, we cannot really talk of a doctor intentionally causing the death of a patient. But the characteristics of individual provisions of the draft law in question are such that the doctor is placed before a choice between fulfilling the requirements of the law governing relations in the sphere of organ transplantation and carrying out actions prohibited by criminal law, in other words a crime. In addition to these problems, there is clearly a corruptive element in this norm since, if such restrictions exist, patients themselves, and their families, will quite obviously do everything they can to save their life.
The legal provision in question also violates other norms of criminal law. In addition to a violation of the person, a member of medical staff acting within the framework of Article 56 paragraph 2 of the draft law would also be in breach of Article 136 of the Criminal Code, which provides for liability for discrimination, namely violation of human and civil rights, freedoms and legitimate interests based on gender, race, ethnicity, language, origin, property or official status, place of residence, attitude to religion, convictions or affiliation with public associations or any social groups, committed by a person through the use of their official position.
This is not the only provision of the draft law that has not been thought through. Another key issue relates to willing consent. In article 37 paragraph 3 it is stated that a live donor shall give informed willing consent to the carrying out of a living-related transplant on the basis of the full/exhaustive information, provided to them in a form understandable to them by the doctor or the medical organisation involved, on their state of health founded on a medical examination and the aims, method and possible consequences, including of a life-threatening nature, of medical intervention for the purpose of removing the donor organ for transplantation. It would appear that the necessary conditions characterising the institution of willing informed consent have been taken into account. However, already in article 38 paragraph 1 of the draft law listing the rights of the living donor, it is stated that they are entitled to receive full information from the medical organisation regarding possible complications/consequences potentially affecting their health in connection with the medical intervention. It may be concluded, therefore, that the content and scope of information provided by the member of medical staff to the living donor is corrected by the medical organisation itself and depends on what questions are asked by the donor. The draft law incorporates the right of the donor, a person with no medical knowledge, to ask questions on the potential outcomes of their decision for their health but makes no reference to the obligation of the doctor, a person with professional knowledge, to reveal to what adverse health effects the donor is exposed by providing a donor organ. Where willing informed consent is concerned, there are two sides: on the one side there is the patient who is entitled to receive detailed and objective information on the adverse consequences of the medical actions carried out, and on the other side there is the member of medical staff who has an obligation to provide full information in this respect. And that algorithm must be reflected directly in the law.
In most cases the removal of an organ from a living donor causes serious harm to their health. Consent to such an action is defined in criminal law as consent given by a victim and rules out any criminal nature of the action. If there is no obligation for the member of medical staff to provide the donor with exhaustive information unless the latter asks questions, then the donor will be giving consent to an operation to remove an organ from their body that can certainly be described as willing but far from always being informed, with all the criminal law consequences this entails.
It is noteworthy that the provision on willing informed consent is repeated like a mantra in medical practice. There is not a single procedure that would take place without such a document being signed, whether in private or in state medical establishments that would take place. However, the ways in which it is worded is puzzling and in any case does not rule out the potential application of criminal law, as there is no reference to the scale of potential adverse effects and the nature and complexity of the medical procedure. In stomatology clinics for example, where a patient might go with toothache or perhaps require major surgery, the scale and severity of potential consequences differ substantially. A stomatology patient gives consent to the violation of their corporal integrity and the causing of pain but they are hardly willing to part with their life. That is why the sentences in the document referring to that the fact that the patient has been warned of the adverse effects, including a fatal outcome, compels a law enforcer to recall the provisions of Article 109 of the Criminal Code providing for liability for causing death by negligence, since the individual (doctor) foresaw the possibility of the patient's death but expected to prevent these consequences without sufficient reason.
To sum up, I would point out that the numerous shortcomings in the draft law giving rise to problems of legal application (the ones I have referred to are far from being the only ones) are linked first and foremost to the fact that this regulatory act was drawn up mainly by doctors specialising in transplantation and, by all appearances, criminologists were not involved, although joint work on the draft law would have avoided numerous inconsistencies with regard to criminal law. Obviously, work on draft legislation governing an individual segment of the medical sphere requires the input of both experts in that subject and law specialists. However, the latter do not possess specialist medical knowledge and, if we are to achieve high-quality normative material, they must undergo training of a kind that enables them to handle the medical issues at a certain level.
At the junction of biomedicine and law: new methods of professional training in the programmes of the Council of Europe
Training for legal professionals in the field of human rights and freedoms has become one of the priority thrusts of the Council of Europe's work in recent years. An anniversary was celebrated in Russia in 2016: 20 years of membership of this unique pan-European organisation. In this connection it would be appropriate to look back over the changes that our activities have undergone in this sphere during that time.
In the early stages the Council of Europe's work mainly involved transmitting and disseminating new legal material. The European Convention for the protection of human rights and fundamental freedoms[2] (hereinafter - the Convention) and the case-law of the European Court of Human Rights (hereinafter – the ECHR) introduced a whole host of new legal approaches into Russia and many other countries. As demonstrated by the judgments of domestic courts, including the Supreme Court and the Constitutional Court of the Russian Federation, many of these approaches have now become an inalienable part of Russia's legal system. Similar changes have taken place in other European countries.
The Council of Europe's approaches and methods in the area of professional training have gradually changed. The Organisation's focus is now not so much on the dissemination of new information as the perfecting of methodology with the aim of training highly qualified law specialists in the implementation of constitutional and international guarantees of fundamental rights and freedoms. This work is built on the insight yielded by the cutting-edge experience of the 47 member States and aimed, in view of the Council of Europe's specific legal characteristics, primarily at law specialists (judges, prosecutors, investigators, lawyers).
In recent times we have observed a tendency to broaden the target audience to take in representatives of other professions. In particular, medical staff are keen to gain practical knowledge of the multitude of legal issues relating to bioethics (protection of human rights in the field of biology and medicine), such as the obtaining of a patient's informed consent to certain medical acts, the protection of medical secrecy and other medical information, legal issues linked to the beginning and end of life, legal guarantees during the conducting of research etc. For that reason, there is a constantly growing demand for corresponding training programmes from higher education institutions and further training centres for medical staff and biologists.
If we are to briefly describe the Council of Europe's current approach to training and further training for highly qualified specialists in all its 47 member States, including Russia, we must focus on two distinguishing features. Firstly, the training courses are founded on the integration and continual interaction of international and domestic law sources. The Council of Europe's conventions and other sources of law are put forward not as an external component but as legal material forming an organic relationship with domestic legal sources. Secondly, the Council of Europe's programmes are increasingly focusing on transversal topics at the junction of law and other disciplines. This is a logical choice given that fundamental rights and freedoms are to be implemented in all spheres of our life, bioethics being a prime example.
So why is it so important to ensure the interaction of international and domestic law sources in the legal training process?
The main reason is that, regardless of the possible approaches to the relationship between domestic and international law and the concept adhered to by any given State, it is quite clear that, in the modern world, international and domestic law have an increasingly strong influence on each other. We might refer to this trend as the integration of law sources in different dimensions — international, domestic and sectoral.
As proof of this we could put forward the judicial practice of virtually any European State. One of the prime movers in the European integration process has been the aforementioned Convention, which, to quote a well-known expression, lives above all in the decisions of member States' courts. This assertion applies to a certain extent to other Council of Europe treaties too, for example the Convention on Human Rights and Biomedicine[3]. The experience accumulated within the framework of the latter Convention is ever more frequently used by both doctors and law specialists in their day-to-day tasks on an entirely practical level.
In this way, international and domestic law are not only influencing but also enriching each other. More than that, international law is ever more deeply penetrating the fabric of domestic law and merging with it in practice through the work of the courts, both domestic and international.
In parallel with this trend there is a growing need for transversal specialists. So, to master medicine-related law and its effective application in practice, standard legal training is not enough; specialist knowledge in the field of medicine is required. Medical specialists in turn need knowledge in the field of law, for example to prevent possible rights violations in their practices. They are the ones in the front-line of relations with patients, patients' families and colleagues. Law specialists enter the process at a later point, as a rule when a problem has already arisen.
In other words, we have growing and interconnected trends which might be summed up as the integration and interaction of law sources in different dimensions - international, domestic and sectoral. And yet, in most cases, higher education and further vocational training programmes in the form that has existed up to now in many countries, including Russia, do not make provision for courses involving the integrated study of international and domestic law sources. In addition, students more often than not acquire knowledge purely within the framework of their speciality.
As a result, the training process does not reflect the realities of integration and substantially lags behind them. That does not mean that the corresponding material is not taught at all in universities or further training institutions. The problem is more to do with how it is presented: usually in the form of isolated or special courses with no links whatsoever to other disciplines and domestic law realities.
So students take international law courses after completing the study cycle on domestic law. Even if we take into account the fact that medical faculties offer courses in "Legal science" and "Fundamentals of medicine-related law" and law departments generally offer a "Forensic medicine" course, these courses tend to provide more of an overview rather than practical know-how. As a result, students regard the information acquired as an external component and do not develop the capability to creatively make practical use of knowledge of international law in conjunction with domestic law or knowledge of medicine in conjunction with legal knowledge. At best, the information passed on to students enables them to broaden their horizons but does not give them the skills they need to handle concrete practical tasks.
Meanwhile, when higher education graduates start work in courts, lawyers' offices, hospitals or laboratories, they are required, from day one, to find solutions to purely practical issues. As they do so, the solutions generally fall into categories not of domestic and foreign, or legal and medical, but effective and ineffective solutions.
Knowledge of foreign and international experience is handy for resolving day-to-day tasks. Best practices in international law are mostly unique and practically oriented products of comparative law, based on the best national samples. Of course, resorting to best practices does not mean robotically copying given legal or scientific approaches, but an inability to exploit ready-made positive experience results in an unjustified waste of time and resources.
The Council of Europe has done a great deal to change the situation for the better. Its efforts have above all targeted the inclusion of judicial practice in applying the Convention in national university courses, including the study of constitutional law and criminal and civil procedure. The corresponding Recommendation[4] made by the Council of Europe's Committee of Ministers in 2004 remains as topical as ever. Further work is planned within the framework of this document in the near future to take account of the latest practices, and I hope that Russian educational institutions will participate in that process, on the one hand as a recipient of best practices and on the other hand as a source of positive experience of its own. The main task of the Council of Europe is to support and exploit the cutting-edge achievements of its member States based on integration, mutual consolidation of different sources and a transversal approach.
In practice, the problems of segregation of international and domestic law sources and lack of in-depth interdisciplinary skills are more often than not resolved when students are fresh out of university and undergo professional training and further training. This leads me to another important point, namely that higher education does not end with universities – it is only just beginning at that point. The modernisation of the educational process is hardly conceivable unless we rethink the interaction between basic training and subsequent further training.
The lack of a practical slant in university education may be overcome by including practical training sessions in the course scheme which have been devised in institutions running professional training for judges, lawyers and medical staff. In addition, we will have to consider to what extent universities are capable of going beyond the framework of basic training and becoming involved in in-service training for practitioners.
This question is already on the Council of Europe's agenda. Our HELP programme[5], which is gaining momentum in Russia too, is an outstanding example of the new integrated approach to training based on an entire corpus of international and national sources. Within it, the legal stances of the ECHR are taught not as an external component wedged into a domestic legal system but as a source of law that must be perceived as part of a close, organic interaction with domestic legal sources, including the case-law of constitutional and supreme courts. We note that, in practice, the legal stances of national supreme courts and the ECHR frequently reinforce each other. Under the programme a number of next-generation courses have already been created, in the Russian language and adapted to Russian legal realities, covering topics such as the submission and assessment of evidence in criminal proceedings, human rights and asylum, criteria of admissibility for applications to the European Court or family law.
An important innovative feature of the HELP programme is the methodology involving distance learning by computer which, while unable to replace intramural study, supplements it superbly, reaching a bigger audience. It should be borne in mind that HELP is the only pan-European programme in the sphere of legal training, promoting cutting-edge experience in all the Council of Europe's 47 member States and operating on the basis of a constant exchange of information between partner institutions in the field of training for legal professionals in all those countries.
One of the recent initiatives proposed within the framework of this programme entails the devising of a new training course on the protection of human rights in the field of biomedicine. This course will be aimed at a mixed audience of law specialists, including court and prosecutor's office staff, and medical staff. A working group for the preparation of this course will comprise experts from eastern, western, northern and southern Europe, including Russian specialists. The basic course programme will then be adapted to the national legislation and legal realities of each interested State. The aims of the course include not only gaining more in-depth knowledge in the area of human rights and biomedicine but also fostering dialogue between law specialists and medical practitioners. This course is a clear illustration of the transversal nature of the programmes proposed by the Council of Europe.
In conclusion, it is worth mentioning that, already today, many universities and professional training centres are taking the path towards the creation of integrated practical courses, including interdisciplinary ones, organically combining international and domestic law sources and geared as far as possible to the most acute issues facing the legal professions in each country.
The job of the Council of Europe is to support those processes, providing all interested countries with a pan-European platform for exchanging cutting-edge experience in order to create modern, effective and sought-after training courses based on the wealth of legal material created in Europe throughout post-war history. In the course of 20 years of Council of Europe membership, Russia has become part of the pan-European legal sphere, which has accumulated colossal experience in effectively resolving complex issues. We must make more active use of that knowledge and these best practices in producing training material and also find suitable academic platforms for delivering that material to its final destination, namely practitioners not only in the legal profession but in other fields too.
SESSION 2 – HUMAN RIGHTS AND ORGAN DONATION – ETHICAL AND LEGAL PERSPECTIVES
European Human Rights Legal Instruments. Additional Protocol to the Oviedo Convention concerning Transplantation of Organs and Tissues of Human Origin
Summary
The “Additional Protocol to the Convention on Human Rights and Biomedicine concerning Transplantation of Organs and Tissues of Human Origin” was adopted by the Council of Europe in 2002. The main object of this document was to provide an additional protection to the dignity and identity of everyone and guarantee, without discrimination, respect for his or her integrity and other rights and fundamental freedoms with regard to transplantation of organs and tissues of human origin. This Protocol applied to the transplantation of organs and tissues of human origin carried out for therapeutic purposes, including cells and haematopoietic stem cells. In addition of highlight the importance of free informed consent, the document also addresses several important issues, including, among others, evaluation of risks for the donor, protection of persons not able to consent, and the prohibition of organ and tissue trafficking or financial gain.
Full text
The 1997 Council of Europe “Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine” (Convention on Human Rights and Biomedicine or “Oviedo Convention”) provided a legally binding common framework for the protection of human rights with regard to the applications of biomedicine. The Convention compiled a sort of commonly agreed fundamental principles applicable to all areas of biology and medicine, including transplantation of organs and tissues. The text also foresaw that those principles could be developed and expanded in the form of future additional protocols addressing specific fields of biomedicine.
In particular, in November 2001, it was adopted by the Committee of Ministers the “Additional Protocol Concerning Transplantation of Organs and Tissues of Human Origin”, also a legally binding document, focusing in protection of human rights and dignity in the transplantation of organs and tissues for therapeutic purposes.
While the Oviedo Convention had already laid down fundamental principles for the protection of living donors (Articles 19 and 20) and, particularly, against any financial gain or comparable advantage derived from the human body or body parts (Article 21), the Additional Protocol amplified the principles embodied in the Convention, expanding them to cover all aspects of the transplantation process, including the obtaining and distribution of organs/tissues and the involved technical and medical practices. In addition of organs and tissues, the provisions of the Protocol would also be applicable to cells, although there are some exceptions, out of the scope, affecting reproductive cells, as well as biological material of embryonic/foetal origin, and blood/blood components. The guiding principle of the protocol is to encourage donation while ensuring a high level of protection of fundamental rights of donors and recipients.
The Protocol introduces a key element of transparency and equity: the need for a well-structured transplantation system that allocated all available organs according to an official waiting list (Article 3). The nature or organisation of the system is not defined in this Protocol; it rests with individual States to decide whether to use local, regional, national or international organisations to guarantee the existence of such a system. Transplant candidates are to be allocated to the waiting list according to medical criteria and the persons or bodies responsible for the allocation decision must be designated within this framework.
In this framework, transplantation system and, particularly, all professionals involved must also guarantee the highest standards of safety and quality during removal and preservation, to minimise the risk of damage to the graft and to maximise its viability. This requirement also means, where appropriate, ensuring transport is available to minimise delays.
Another important responsibility for the transplantation system is to contribute to the safety of potential recipients by guaranteeing the traceability of all organs, tissues or cells obtained for transplantation. This requirement should not be incompatible with the need to protect confidentiality and personal data for both donors and recipients.
The ultimate aim of this crucial requirement of a transplantation system, with high ethical standards, is to facilitate the optimal use of organs available while reducing inequities in organ distribution as well as the risk of trafficking.
An important focus of protection for the Protocol is the living donor. Applicable provisions imply stringent requirements for removal of organs from living donors. It “may be carried out solely for the therapeutic benefit of the recipient and where there is no suitable organ or tissue available from a deceased person and no other alternative therapeutic method of comparable effectiveness” (Article 9). For the consideration of therapeutic alternatives of comparable effectiveness, it is necessary to take into account that, according to the Explanatory Report of the Additional Protocol, dialysis treatment is not considered to provide results in terms of the patient’s quality of life comparable to those obtained by a kidney transplant. The suitability of organs available from deceased persons is also an aspect to be decided on a case-by-case basis. As it will be discussed later, for a particular recipient, live donation may be the preferred option if the results of a living donor transplantation are expected to be significantly better than those expected utilising a graft removed from a deceased person.
Another requirement for living donation is the existence of close personal relationship between the donor and the intended recipient (Article 10). The exact nature of the relationship is a matter for national law to determine, and may depend on cultural or other local factors. In the absence of such a relationship, living donation can still be performed, but only by under the conditions defined by law, and requiring the approval of an appropriate independent body. The referred body, for example an ethics committee, must be provided for by law and is responsible for ensuring that the other required conditions have been met. This way it should guarantee the rights of the donor, paying special attention to ruling out any kind of coercion or undue incentive for the donor to decide giving his/her organs or tissues. These provisions are thus an important safeguard against potential organ trafficking or the use of inducements.
In any case, the removal may not be carried out if there is a serious risk to the donor, and that includes psychological risk (Article 11). An example of psychological harm is if the donor develops an undue sense of ownership towards the recipient or the recipient feels unduly obligated to the donor.
Before living donation it is also required a free, informed, specific consent, in written form or before official body (Articles 12 and 13). Information to the donor must include the right to have access to independent advice about potential risks, and that he or she may freely withdraw consent at any time. To further protect the health of the living donor, the Protocol specifies that appropriate medical follow-up must be offered to donors after the transplantation process.
As a general rule, removal of organs or tissues from persons not able to consent is explicitly prohibited by the Protocol (Article 14). However, exceptionally, and under the protective conditions prescribed by law, the removal of regenerative tissue from a person who does not have the capacity to consent may be authorised provided strict additional conditions are met. Here, exceptions are justified by the fact that regenerative tissue, in particular bone marrow, can only be transplanted between genetically compatible persons, often brothers and sisters, and that cell removal usually implies minimal risk and minimal burden for the donor.
Regarding donation from a deceased donor, the Protocol dictates that no organ or tissue can be removed from the body of a deceased person unless that person has been certified dead in accordance with the law. In addition, to provide protection against any conflict of interests, death must be certified by doctors not involved in the transplantation process.
A second important provision for donation from a deceased donor is the respect for the person’s previous wishes. Accordingly, the removal shall not be carried out if the deceased person had objected to it. However, if the deceased person’s wishes are at all in doubt, it must be possible to rely on national law for guidance as to the appropriate procedure. In several States the law permits that if there is not explicit or implicit objection to donation, then removal can be carried out. In any case, it is important that the law clarifies whether organ or tissue retrieval can take place if a deceased person’s wishes are not known and cannot be ascertained from relatives or friends.
Although a dead body is not legally regarded as a person, it nonetheless should be treated with respect, and the Protocol instructs in this regard, also including the provision that the body should be restored as far as possible to its original appearance.
Another important requirement of the Protocol is for States to take all appropriate measures to promote the donation of organs and tissues (Article 19). The "appropriate" measures are not defined, but they might include the provision of information to health professionals and to the public (Article 8), the already mentioned need to set up a transplant system (Article 3), and to have recognised means of giving consent or authorization (Article 17).
Several measures to protect the recipient are also specified in the Protocol. The relevant provisions include the need for appropriate information (Article 5), quality and traceability requirements to both improve success of transplantation and minimize the risks of disease transmission (Article 6), and appropriate medical follow-up after transplantation (Article 7).
One basic requirement of the Convention: “Human body and its parts shall not, as such, give rise to financial gain” (Article 21), is replicated in the Protocol, also in Article 21. Under this provision, organs and tissues should not be bought or sold or give rise to direct financial gain for the person from whom they have been removed for a third party. Nor should the person from whom they have been removed, or a third party, gain any other advantage whatsoever comparable to a financial gain such as benefits in kind or promotion for example. However, Article 21 states that certain payments that a donor may receive are not to be treated as financial gain within the meaning of this article. For example, in the case of the donor it allows for compensation for loss of earnings and other justifiable expenses. Also, some medical or technical services performed as part of the transplant process may legitimately give rise to reasonable remuneration. Additionally, donors can receive compensation for undue damage resulting from the removal. By undue damage is meant any harm whose occurrence is not a normal consequence of a transplant procedure.
Recognizing the serious risk that organ trafficking poses for donors, recipient and society, and as a way to reinforce the already mentioned provisions contained in Article 21, the Protocol additionally contains an explicit prohibition of organ and tissue trafficking (Article 22), as well as the need that States provide for appropriate sanctions to deter organ and tissue trafficking or any attempt at commercial trade in organs or tissues (Article 26).
In order to keep the Additional Protocol alive and in pace with the developments in this field of medicine, embodied in the Protocol itself is an instruction for a periodic re-examination of the document (Article 29). To accomplish that requirement, a prolonged re-examination process took place several years later under the responsibility of the DH-BIO. The re-examination was resolved in 2012, with one main conclusion: developments in the field concerned did not warrant amendments to the Protocol. It was however agreement on the need to complement the Explanatory Report to further clarify some issues that generated some debate. The most relevant of them concerned the living donation, in particular the requirement as to the availability of organs and the requirement that they be of suitable quality. The significant disparity between the growing number of people awaiting transplantation and the number of available organs, as well as the change in the quality of organs removed from deceased persons, may result in that live donation may be the preferred therapeutic option for a given recipient. Therefore, transplantation of organs removed from deceased persons and transplantation of organs removed from living donors, provided the conditions for ensuring protection of living donors are met, are not to be opposed and rather fulfil a therapeutic need.
Given the broad range of protection conferred by the Protocol, it could be concluded that this document continues to be a valid general framework, a reference, for the protection of recipients and donors, both living and deceased, during the process of transplantation of organs, tissues or cells.
Overview of European Court of Human Rights case-law in the sphere of organ transplants
The Council of Europe's judicial body, the European Court of Human Rights (hereinafter – the European Court), is the mechanism for protecting the rights guaranteed under the European Convention for the protection of human rights and fundamental freedoms[6] (hereinafter – the Convention). The Convention has been ratified by 47 European States, including the Russian Federation, which came under the jurisdiction of the European Court as of the date of ratification (5 May 1998 in the case of the Russian Federation). Despite the fact that the Convention was devised and entered into force in 1953, over 70 years ago, it remains a living document. Its interpretation and application in the context of the rapidly changing circumstances of the contemporary world is handled by the European Court, including where issues of bioethics, medicine and organ transplants are concerned.
Examples of how the European Court has responded to the demands of the modern age, requiring decisions on a set of complex interwoven legal, ethical and medical questions, include:
— Lambert and Others v. France[7], examined by the Grand Chamber of the European Court in 2015 and relating to the possibility of discontinuing life-sustaining treatment and switching off the life-support system of a patient who had been in a chronic neuro-vegetative state for over seven years;
— Parrillo v. Italy[8],also examined by the Grand Chamber of the European Court in 2015, which concerns the ban imposed by the Italian authorities on the donation of non-implanted human embryos for laboratory research;
— Hristozov and Others v. Bulgaria[9], ruled on by the European Court in 2012 and concerning the refusal of the Bulgarian authorities to allow the use of an experimental and unauthorised medicine (MBVax Coley Fluid) on patients in the terminal stages of cancer.
This list could go on, but the main aim of the present contribution is to analyse the case-law of the European Court of Human Rights on organ transplants. To date, the European Court has passed final judgment on very few such cases - two in fact, both against Latvia. These are the cases of Petrova v. Latvia[10], judged in June 2014, and Elberte v. Latvia[11], judged in April 2015. The storylines of these cases are very similar: close relatives of both applicants were involved in car accidents and taken to hospital; after they had been pronounced dead and their ID documents checked for the absence of a stamp indicating a refusal to donate organs, organs were removed from their bodies (kidneys and spleen in the first case, the outer layer of the meninges, a piece of tissue measuring 10 by 10 cm in the second case). The relatives of the deceased were not informed of the organ removal and found out several months later when criminal cases were lodged in connection with the road traffic accidents.
Under the Latvian legislation applicable at the time of organ removal from both donors, any living person with legal capacity was entitled to give written notification of their consent or refusal to be an organ donor after their death to an institution specially created for such purposes or have that consent or refusal recorded in their national identity card. This information was also entered in the corresponding state register. Organs could not be used if the individual concerned had expressed refusal in their lifetime. If such information was not registered, organ removal was permitted if no close relatives (restricted in this case to parents, children, spouses and germane brothers/sisters) objected.
Following these events, which prompted two joined cases (and as a response to what had happened), Latvian legislation was amended to more clearly define the concept of "consent", including "consent of close relatives". Under the new legislation the removal of organs is allowed only in cases where there is no written refusal to donate from the persons concerned in the state register and if their close relatives do not provide written notification to the medical establishment of their refusal of a transplantation procedure prior to the beginning of the procedure. The removal of organs from a dead child is allowed only where there is written consent to that procedure from one of their relatives or guardians.
In both cases, the European Court was required to examine the complaint submitted by the applicants on the basis of Article 8 of the Convention, guaranteeing respect for private and family life. The State and the applicants had differing interpretations of the concept of consent. In particular, the applicants disputed the possibility of removing organs for the purpose of donation without direct prior consent of the donor himself or a close relative (in this case the applicant). The Latvian Government, in turn, insisted that the system of presumed consent was operative in Latvia at the time of the organ removals, meaning that an individual had to take active steps in their lifetime to express their refusal of the removal of their organs.
The European Court considered that the essence of the dispute was the clarity of national legislation and the manner in which domestic legal standards governed the issue of removal of donor organs. Proceeding on the basis of the standard usually adopted by the Court when assessing cases brought under Article 8 of the Convention, any intervention of state authorities in private and family life (in this case in the form of taking a decision to remove organs) must be conducted in line with the standards of domestic law, which must also fulfil a number of criteria, including a detailed, clear and precise indication of the grounds for such intervention and the provision of adequate legal protection against arbitrariness in the taking of such important decisions.
The fundamental issue focused on by the European Court in both cases was whether there was provision for a mechanism enabling close relatives of the donor to express their consent to or refusal of organ removal and, if so, what kind of mechanism this was.
Concluding that the applicants' rights guaranteed by Article 8 of the Convention had been violated, the European Court laid emphasis on the following aspects:
— close relatives had not been given prior notification by the authorities that it had been decided to remove organs despite the fact that several days had elapsed between the patient arriving in hospital and their being pronounced dead;
— the domestic law standards establishing the necessity of consent were formulated in such a way that different national bodies considering the applicants' complaint interpreted those standards in a completely contradictory manner: the police and the prosecutor's office, for example, considered that the failure to inform relatives of organ removal had not violated the requirements of domestic legislation, whereas the Ministry of Health found, on the contrary, that domestic legislation required close relatives to be informed. On that basis, the European Court concluded that Latvian legislation had not determined with the requisite clarity the scope of national authorities' obligations to request permission from close relatives to remove organs from their deceased family member;
— neither the legislation nor practical application established in detail how the system of presumed consent to organ donation, emphasised by the Latvian authorities, was to function, particularly in cases where relatives had not been informed (as was the case with the applicants) that they had certain rights and it was not explained to them how they could avail themselves of those rights if they wished to object to the potential removal of organs from their close relative;
— within the national system there was no adequate protection from possible abuses for close relatives. Although Latvian law prohibited the removal of organs in the event of direct refusal by close relatives, it did not require the relatives to be informed of their rights, including the necessity of giving direct and written refusal of organ removal.
Accordingly, the European Court found a violation of Article 8 of the Convention in both cases and established serious failings in domestic legislation with regard to the procedure for obtaining consent from a dead person's close relatives to removal of that person's organs. It is noteworthy in particular that the Court's criticism was directed at the quality of the legislation, the impossibility of clearly foreseeing the consequences of its application and the lack of a mechanism to ensure that the discretion afforded to state authorities and medical establishments by the system of presumed consent to organ donation was not subject to abuse.
It must furthermore be pointed out that the European Court stopped short of addressing the long-standing dispute arising from different international documents concerning the choice between presumed and requested consent or imposing a particular system (presumed consent or presumed refusal) on the State. Its criticism related solely to the form in which the question of consent was regulated in Latvian law only insofar as the Convention makes demands in terms of the quality of legislation under which a State interferes with one of the rights enshrined in the Convention. Moreover, the European Court judgments in both cases referred to the necessity of introducing special guarantees and precautionary measures which, regardless of the system for expressing consent chosen by the State in the light of its cultural, legal, social or other traditions, must ensure a balance between the discretionary power of the State and the protection of close relatives' rights.
SESSION 3 - PROTECTING HUMAN RIGHTS THROUGH GOOD PRACTICES IN ORGAN DONATION AND TRANSPLANTATION SYSTEMS
Organ donation and transplantation systems in Europe –
current situation and prospects
Organ transplantation has evolved to the treatment of choice for many patients with end-stage organ failure over the past decades. The Newsletter Transplant published in 2015[12] shows that in 2014 European Union 31.890 transplants from more than 10.000 deceased donors were performed in 28 countries with more than 510 million inhabitants. While the total number of transplants is impressive the report also shows that there is a huge variety of donation and transplant rates between countries in Europe: the total number of patients transplanted per million population is highest in Austria (92,6 pmp), Spain (90,2 pmp) and Norway (89,2 pmp) while in other counties transplant programs still need to be established or are in its infancy. Both the Council of Europe and the European Union are actively supporting with different programs and initiatives organ donation and transplant activities in the European countries.
Incidence of end-stage organ failure
The European Renal Association – European Dialysis and Transplant Association (ERA-EDTA) collects population-based dialysis and kidney transplantation data in its registry since 1964. Complete individual patient data is available from 17, aggregated patient data from an additional 16 European countries. These data show that there is a huge variability in the prevalence of chronic kidney disease (CKD) ranging from 3 to 17 % across Europe, and the incidence of CKD varies between 27 pmp in Montenegro to 216 pmp in Greece according to the 2013 ERA-EDTA registry report.
Different factors have been identified that are associated with a higher incidence of renal replacement therapy (RRT) like ageing of the general population and higher prevalence of diabetes mellitus and hypertension and limited success of prevention of end-stage renal disease (ESRD) or halting the progression of CKD. Next to these more medical factors, organizational or infrastructural factors play an important role: According to a report by FJ Caskey published in Nephrology, Dialysis, Transplantation (NDT) in 2011[13], a higher percentage of the GDP per capita rate spend on health care and a higher dialysis facility reimbursement relative to the GDP lead into a higher incidence of RRT.
The ERA-EDTA registry report also shows a huge variability of the type of dialysis being used. While in some countries like Denmark more than one-third of the patients on dialysis are treated with peritoneal dialysis, in other countries this cost effective therapy which results in a high quality of life for the patients, is almost not used at all.
Access to the organ transplant list
The number of registrations on the waiting list for organ transplantation varies substantially between the European countries. One would expect that the variation in registrations on the waiting list for kidney transplantation is due to the differences in the incidence of ESRD described above. But in fact when combining world wide data published by the United States renal data system (USRDS) with data from the Council of Europe in the Newsletter Transplant, it becomes evident that there is no correlation between the incidence of ESRD in a country and the number of registrations on the waiting list.
Figure1: Incidence of end-stage renal disease vs. number of kidney transplants in different countries worldwide (data form USRDS 2011) 
On the other hand the following figure based on 2011 data in the Newsletter Transplant of CoE make clear that there is a close correlation between the number of kidney transplants performed in a country and the number of registrations on the waiting list. With other words, the more kidney transplants are performed in a country the more patients are registered on the waiting list.
Figure 2: Registrations on the waiting list for kidney transplantation vs number of transplants in different European countries (data from Council of Europe, Newsletter Transplant)
In countries with less active transplant programs, fewer patients are registered on the waiting list, probably due the fact that doctors get more restrictive with waiting-listing patients if only few donor organs are available.
Therefore the number of patients that die on the waiting list while waiting for a suitable organ transplant is most probably. This is just showing the tip of the iceberg of the number of patients that could benefit from a transplant, because only a fraction of the patients that actually could benefit from a transplant are put on the waiting list in countries with small transplant programs. This aspect has to be taken into account when estimating the benefits that could be achieved by extending and improving transplant programs within all European countries.
Donation rates – influencing factors
As described in the introduction organ donation rates both for deceased and living donors vary substantially from one country to another. Often these differences are attributed to effects of the legal system regarding consent to donation. Two main types of consent to donation from deceased donors are distinguished in national legislation: presumed consent (‘opting out’) and explicit consent (‘opting-in’). While in a presumed consent system no explicit consent is required in order to become a potential donor, in an explicit consent system the donor himself needs to explicitly consent to organ removal after death.
In practice the differences are less pronounced as one would expect from this definition: In opting-out countries, relatives are typically asked whether the deceased person had objected to organ donation during life time. In opting-in countries the deceased’s next-of-kin are approached to find out whether the deceased person had or would have had consented to organ donation. Still data form the different European countries show that on average donation figures are higher in countries with an opting-out than with an opting-in consent system. It is not known whether these statistical differences are in fact due to the differences in legislation or if the consent system of a country just reflects the public attitude towards donation. With other words it is possible that an opt-in-system just reflects reservation of the population towards organ donation in this country. Recently legislation in Wales was changed from an opt-in to an opt-out system while it kept unchanged in the other parts of the UK. It will be interesting to see, whether and to what extend this change in legislation has an impact on donation rates in Wales (compared to the rest of the UK) in the near future.
Rafael Matesanz, the director of the Spanish organ procurement organization Organización Nacional de Trasplantes (ONT), repeatedly stressed that from his point of view the enormous success of the Spanish organ donation and transplant system is not mainly due to legal system but rather to the organizational structure of organ donation in Spain. One key element for a successful organ donation system is the active involvement of all potential donor hospitals in a country. The establishment of in-house donor coordinators has shown to be an especially effective way of achieving this goal and both the European Committee on Organ Transplantation (CD-P-TO) CD-P-TO and the European Union have been supporting this approach for all European countries over the past years.
The critical pathway for deceased organ donation
In 2010 the Third World Health Organization (WHO) Global Consultation on Organ Donation and Transplantation: Striving to Achieve Self-Sufficiency took place in Madrid, Spain. The participants agreed that all countries should regard organ donation and transplantation as part of their nation’s responsibility to meet the health needs of its population. To support deceased donation activities around the world, it was suggested to use a common systematic approach to the process of organ donation. For this purpose, critical pathways both for donation after brain death and for donation after cardiac death were developed, covering all steps from donor identification via donor referral to organ procurement and transplantation[14].
While donation after brain death (DBD) has been stable or even decreased in most European countries, donation after circulatory death has increased substantially in many countries over the past years. The number of countries in Europe using organs from donors after circulatory death (DCD) has increased over the past years. In some European countries DCD is legally not allowed because determination of death based on neurological criteria is the prerequisite for organ donation.
The critical pathways for organ donation have proven to be an important tool for countries to analyze and improve their deceased organ donation system independent of the type of donors used and regardless of the level of development of the health care system and the experience on deceased organ donation. To this end it is especially helpful that the critical pathways also depict possible obstacles to organ donation encountered in the system and thereby provide very practical help for improving deceased organ donation.
Table 1: Critical pathways for organ donation
|
Donation after brain death |
Donation after circulatory death (DCD) |
|
|
Possible donor |
A patient with a devastating brain injury or lesion or a patient with circulatory failure and |
|
|
Potential donor |
A person whose clinical condition is suspected to fulfill brain death criteria |
or
|
|
Eligible donor |
A medically suitable person who has been declared dead based on: |
|
|
Neurologic criteria as stipulated by the law of the relevant jurisdiction |
Irreversible absence of circulatory and respiratory functions as stipulated by the law of the relevant jurisdiction, within a time frame that enables organ recovery |
|
|
Actual donor |
A consented eligible donor:
or
|
|
|
Utilized donor |
An actual donor from whom at least one organ was transplanted |
|
Organ allocation – basic principles
Organ allocation aims at finding a suitable organ for each patient on the waiting list in time. According to the “transplant window”-concept transplantation should not take place “too early” because in an early stage of beginning organ failure the risk of transplantation might be larger than the potential benefits and the patient might be better off with medical therapy or other surgical options. On the other hand, if organ failure has progressed over a long time and the potential recipient has developed comorbidities and general deterioration of his or her health status, it could be “too late” for transplantation.
Figure 3: The “transplant window” concept
In Europe different organ allocation systems are in place in different countries to achieve the above mentioned general goal. The following formal aspects characterize an ideal allocation system:
- Objective: independent of subjective factor (procurement organization, transplant centers etc.)
- Reliable: with the same donor information and the same waiting list information an identical match list is generated
- Transparent: every step in the allocation process is documented and can be explained
The allocation rules should have a solid ethical foundation and should be built on evidence-based medical criteria. Typically, the development of new allocation rules follows a stepwise approach. As a first step the general allocation principles to be used for a specific organ are agreed upon (i.e. urgency of the transplantation, outcome of transplantation, equity…). Then it is important to select the corresponding allocation factors: The risk of dying on the waiting list within one year without a transplant could be used to measure urgency, the risk of dying within one year after transplantation to measure the outcome of transplantation. Next it is important to select the clinical indicators that allow to calculate these allocation factors. For patients on the waiting list awaiting heart transplantation the ejection fraction of the heart, the extent of medical therapy and the need for inotropic support etc. could be used as indicators of urgency for example. This last step can be achieved best based on the analysis of data available in a transplant registry. Continuous monitoring of the allocation rules and their impact on the patients on the waiting list and transplant results is essential to allow future improvement of allocation. This is another reason for establishing and using a transplant registry that should be in place in all countries with an active transplant program. In order to support developing and improving allocation rules, to address also the specific situation of patients with rare diseases and to be able to predict the impact of certain donor factors, it would be ideal to combine data from the different national registries in a larger multinational transplant registry.
International cooperation in organ transplantation could benefit the patients on the waiting list well beyond setting up a common transplant registry. It could help prevent organ loss in case there is no suitable recipient for a specific donor organ in the donor country. Especially for donor organs from children or from donors with rare blood groups or other specific donor characteristics it is sometimes difficult to find a recipient in a donor country with a short waiting list. At the same time international cooperation can help to address the needs of special patient groups: For highly immunized patients on the kidney waiting list it is often extremely challenging to find a suitable donor organ. And in case of acute organ failure like acute liver failure after an intoxication it is essential to find a suitable donor organ within a few hours, something that can only be achieved with a sufficient large donor pool. International cooperation could also help to improve the outcome of organ transplantation by achieving optimal matching between donor and recipient. Several such international cooperation like SAT (South Transplant Alliance), ScandiaTransplant and Eurotransplant are established in Europe.
Council of Europe - European Committee on Organ Transplantation
The Council of Europe contributes with its European Committee on Organ Transplantation (CD-P-TO) actively to the implementation of high standards for the protection of public health and for the promotion of human rights and dignity. It promotes the non-commercialization of organ donation, the fight against organ trafficking, and the development of ethical, quality and safety standards in the field of organ, tissue and cell transplantation.
The mission of the CD-P-TO is to:
• examine questions related to the transplantation of organs, tissues and cells and provide guidelines on ethical, quality and safety standards and their implementation;
• monitor practices in Europe and assess risks linked to procurement, storage and transplantation of organs, tissues and cells;
• assist member states in improving their organ donation and transplantation services, whilst promoting the principle of voluntary non-remunerated donation;
• examine the organizational structures concerning organ transplantation with a view to addressing the causes of organ shortage;
• develop links between organ exchange organizations and experts throughout Europe and ensure the transfer of knowledge and expertise;
• contribute to raising the awareness of the general public on organ, tissue and cell donation for transplantation.
There is a broad spectrum of activities of the CD-P-TO in the area of organ transplantation, several of them will be presented:
• Conventions, Recommendations and Resolutions to cover the ethical, social, scientific and training aspects of organ donation and transplantation, thereby promoting continuous improvements in ethical, organizational and regulatory frameworks. Important aims are among others guaranteeing non-commercialization of organ donation and fighting against organ trafficking;
• Guide to the quality and safety of organs for transplantation: provides professionals with a useful overview of the most recent advancements at every step of these complex organ donation and transplantation processes and helps them at a practical level by elaborating comprehensive quality, safety and ethical reference standards;
• European Day for Organ Donation and Transplantation, contributes to raising the awareness of the public on organ shortage and encourages donation for transplantation based on the principle of voluntary non-remunerated donations. It is hosted every year in a different country with the support of local governmental organizations or others;
• Newsletter Transplant: annual collection of international figures on organ donation and transplantation.
Data from the Newsletter Transplant show huge differences in donation and transplant activities among the different Council of Europe member countries. In some countries the number of donors is below 5 donors per million population (pmp), at the same time donation figures are well above 30 pmp in Croatia and Spain. While in all countries organ donation after brain death (DBD) is established since many years, the number of countries with organ donation after circulatory death (DCD) is slowly increasing and has helped in these countries to substantially support transplant activities. The average DBD donor age has increased steadily over the past years and donor acceptance criteria have broadened. As consequence the number of extended criteria organ donors (ECD) has risen substantially making careful donor characterization and optimal matching between donor and recipient especially important.
CD-P-TO is working on a common strategy to safely increase living donation programs throughout Europe with a special focus on the health and safety of the living donor including sociological and psychological aspects of living donation. Over the past years an increase of more than 10% in living donor transplant activities could be achieved in the EU countries, an important contribution to the effort to achieve self-sufficiency in organ donation and transplantation in Europe.
System of human organ transplantation in the Russian Federation
In the Russian Federation, organ transplantation is available using organs from deceased and living related donors.
Powers relating to the organisation of transplant care, including organ donation, are vested in the Ministry of Health of the Russian Federation and the sub-federal executive authorities in charge of health care. Oversight is performed by the Federal Service for the Supervision of Health Care. Federal Law No. 323-FZ of 21 November 2011 “On the fundamentals of public health protection in the Russian Federation” (Chapter 3). Responsibility for the development of transplant care lies with specialist units/departments of the Ministry of Health and the sub-federal executive authorities in charge of health care and their chief non-staff transplant surgeons (see Table 1).
Transplant care is funded through the compulsory medical insurance fund and the federal and regional budgets. The medical care provided to the recipient is paid for through the compulsory medical insurance fund, while the donation stage and immunosuppressive drugs for organ transplant recipients are financed through the budget. Federal Law No. 323-FZ “On the fundamentals of public health protection in the Russian Federation” (Chapter 11).
Table 1. Distribution of powers relating to the management of organ transplantation.
|
Federal level |
State body, organisation, official |
Functions (powers) |
||||
|
Statutory regulation |
Management |
Funding |
Oversight |
Methodological support |
||
|
RF Ministry of Health |
+ |
+ |
+ |
+ |
+ |
|
|
Federal compulsory medical insurance fund |
+ |
+ |
||||
|
Federal Service for the Supervision of Health Care |
+ |
+ |
||||
|
Russian Transplant Society |
+ |
|||||
|
Chief non-staff transplant surgeon, RF Ministry of Health |
+ |
|||||
|
Regional level |
Sub-federal executive authority in charge of health care |
+ |
+ |
+ |
+ |
+ |
|
Regional compulsory medical insurance fund |
+ |
+ |
||||
|
Regional office of the Federal Service for the Supervision of Health Care |
+ |
|||||
|
Chief non-staff transplant surgeon |
+ |
|||||
Under Russian law, organ donations and transplants may be performed only in state-run health care organisations. In order to operate and before they can be included in the list of organisations engaged in organ transplants, which is approved by the Russian Ministry of Health and the Russian Academy of Sciences, organisations must obtain the appropriate licences. RF Law No. 4180-I of 22 December 1992 “On the transplantation of human organs and/or tissues” (Article 4). Russian Ministry of Health and the Russian Academy of Sciences Order No. 307n/4 of 4 June 2015 “Approving the list of health care institutions engaged in the recovery, purveyance and transplantation of human organs and/or tissues”.
Transplant surgery is included in the programme of state guarantees for the provision of free medical care. Transplant care in Russia is organised and provided by health care organisations in the form of an annual state target set by the Russian Ministry of Health. RF Government Decree No. 1273 of 28 November 2014 “On the Programme of State Guarantees for the Provision of Free Public Medical Care for 2015 and for the Planning Period 2016-2017.”
Organ transplant care is provided by specialists who have undergone additional training in organ donation and transplantation. Transplantology is not a separate discipline in Russia. The biggest facility for training specialists in organ donation and transplantation is based at the Shumakov Federal Scientific Centre for Transplantation and Artificial Organs in Moscow.
The provision of organ transplant care is based on an official Procedure, standards and clinical recommendations/protocols. The Procedure regulates the various stages in the provision of organ transplant care, the structure and functions of the health care organisations and units which provide such care and the requirements in terms of equipment and staffing. RF Ministry of Health Order No. 567n of 30 October 2012 “Approving the Procedure for the provision of surgical care (transplantation of human organs and/or tissues)”.
The standards are medico-economic in nature and contain patient models and a range of medical services, including a list of medicines and medical devices, with details of the frequency with which they may be prescribed and how many times. 27 standards have been drawn up covering all types of organ transplants, for deceased and living related donors. Non-standard medical procedures, medicines and/or medical devices may be carried out/prescribed but only if there are valid reasons for doing so and if the medical board of the health care organisation concerned approves.
Based on proven clinical experience, the clinical recommendations/protocols set out the procedures to be followed by doctors in the diagnosis, treatment, rehabilitation and preventive care of patients with a particular diagnosis. Under the auspices of the Russian Transplant Society, 15 national clinical recommendations have been drawn up and approved, covering all types of organ transplants, whether from living related donors or deceased donors.
When certifying the death of a potential donor, reference is made to the RF Ministry of Health-approved instructions for declaring death on the basis of a diagnosis of brain death and on the criteria and procedure for determining the time of death and for terminating resuscitation attempts. RF Ministry of Health Order No. 908n of 25 December 2014 “On the procedure for diagnosing brain death”. RF Ministry of Health Order No. 73 of 4 March 2003 “Approving the Instruction on determining the criteria and procedure for determining time of death and terminating resuscitation attempts”.
In accordance with international principles and domestic law, it is prohibited for transplant surgeons to be involved in diagnosing the death of a potential donor.
In health care organisations, waiting lists for organ transplants from cadavers are administered in accordance with the requirements laid down in the Procedure. In some parts of the country, regional waiting lists have been drawn up pursuant to regulatory instruments issued by the sub-federal executive authorities in charge of health care. A legislative framework is currently being developed for the purpose of introducing a single federal waiting list for cadaveric organ transplants. Draft federal law “On human organ donation and transplantation”.
For each patient/recipient, the health care organisations duly maintain medical records of both outpatients and in-patients. In the case of a deceased organ donation, a certificate of removal is drawn up, together with a passport for the organ being donated.
All medical interventions involving a recipient and living related donor required the informed voluntary consent of the patient or their legal representative. Ethics committees in Russia do not deal with issues relating to organ donation and transplants. In clinically and/or ethically complex cases, the decision is taken by the health care organisation’s medical board. RF Ministry of Health and Social Development Order No. 502n of 5 May 2012 “Approving the procedure governing the setting-up and operation of medical boards in health care organisations”.
Deceased organ donations operate on a presumption of consent. The removal of organs from deceased donors is carried out with the permission of the health care organisation’s chief physician and a forensic expert. RF Law No. 4180-I of 22 December 1992 “On the transplantation of human organs and/or tissues” (Articles 8 and 10).
The state system for tracking donor organs, donors and recipients is still at the development stage. Under the auspices of the Russian Transplant Society, however, a transplant register has been kept since 2008, and every year data are transferred from this to international registers.
According to this register, in 2015 there were 43 organ transplant centres operating in the Russian Federation. Renal transplants were performed in 36 of these centres, liver transplants in 17, heart transplants in 10, pancreas transplants in 3 and lung transplants in 3. Of these 43 transplant centres, 18 are federal institutions, including 3 facilities run by the Federal Agency for Scientific Organisations and 3 state medical universities. The remaining 25 centres come under the authority of subjects [constituent entities] of the Russian Federation.
The transplant centres operating in the Russian Federation are located in 24 RF subjects with a population of 85.6 million people. Of these, 10 centres are based in or around Moscow, while 6 are in or around St Petersburg.
61 RF subjects with a population of 60.8 million do not have any transplant centres operating within their territory, despite the existing need for organ transplants in these regions, which also offer untapped potential for organ donation.
In 2015, 1,485 organ transplants were carried out in total, which equates to 10.1 per million population (see Table 2).
Table 2. Number of donors and organ transplants in the Russian Federation in 2015.
|
Number (absolute) |
Per million population* |
|
|
Organ donation |
||
|
Total organ donors |
757 |
|
|
Deceased donors |
434 |
3.0 |
|
Living (related) donors |
323 |
|
|
Organ transplantation |
||
|
Total organ transplants Incl. transplants to minors |
1,485 163 |
10.1 |
|
Kidney Of which deceased donor transplants Of which living donor transplants Incl. transplants to minors |
945 755 190 65 |
6.5 |
|
Liver Of which deceased donor transplants Of which living donor transplants Incl. transplants to minors |
325 192 133 92 |
2.2 |
|
Heart Incl. transplants to minors |
179 6 |
1.2 |
|
Pancreas |
12 |
0.1 |
|
Lungs |
24 |
0.2 |
|
Heart and lungs |
0 |
|
|
Small intestine |
0 |
|
*Population of RF in 2015: 146.4 million
(http://www.gks.ru/free_doc/new_site/population/demo/Popul2015.xls)
The number of actual donors in 2015 was 434 or 3.0 per million population. In 2015, Moscow and the surrounding region accounted for 186 actual donors or 42.9% of the total figure. Overall, 251 multi-organ retrieval procedures were performed in 2015 and the percentage of multi-organ retrieval was 57.5%. The Moscow and Moscow region programmes accounted for 133 of all multi-organ donors, or 53.0%. The average number of organs retrieved from a single donor was 2.7; the rate of use of donated kidneys was 87%.
Fig. 1 shows the number of deceased organ donors in the Russian Federation from 2006 to 2015.
Fig 1. Number of deceased organ donors in the Russian Federation from 2006 to 2015
In 2015, out of the 31,500 or so patients receiving dialysis (according to the Russian Dialysis Society), 4,167 or 13% were on the waiting list for a deceased donor kidney. In total, 945 renal transplants (6.5 per million population) were carried out in 2015. The number of cadaver kidney transplants in 2015 was 755 (5.2 per million population) while the number of living related kidney transplants was 190. The 9 renal transplant centres located in and around Moscow together accounted for 487 renal transplants, i.e. 51.5% of all renal transplants carried out nationwide.
Fig. 2 shows the number of renal transplants performed in the Russian Federation from 2006 to 2015.
Fig. 2. Number of renal transplants performed in the Russian Federation from 2006 to 2015
In total, 1,179 heart transplants were performed in 2015 (1.2 per million population). In six of these cases, the recipients were children or adolescents. The Shumakov Federal Scientific Centre for Transplantation and Artificial Organs in Moscow accounted for 103 heart transplants, i.e. 57.5% of the national total. The Shumakov Centre’s successful heart transplant programme was a determining factor in the general upward trend in the number of heart transplants carried out nationwide between 2009 and 2015. Lung transplants were performed in 3 transplant centres in 2015 and numbered 24 in total.
A total of 325 liver transplants were carried out in 2015 (2.2 per million population). Four transplant centres situated in Moscow accounted for 221 of these procedures, or 68.0%.
12 pancreas transplants were carried out in 2015. Of these, 11 were performed simultaneously with a kidney transplantation.
Fig. 3 shows the number of extra-renal organ transplants performed in the Russian Federation from 2006 to 2015.
Fig. 3. Number of extra-renal organ transplants performed in the Russian Federation from 2006 to 2015
The Russian Federation continues to offer a congenial environment and potential for the further development of transplant services and an increase in organ donation and transplant activity.
SESSION 4 - ADDRESSING TRAFFICKING IN HUMAN ORGANS
Ph.D. in legal sciences, lecturer, honoured lawyer of the Russian Federation, head scientific associate at the Academy of the Prosecutor General's Office of the Russian Federation
Fight against organ and tissue trafficking. Russian practice
1. The fight against trafficking in human organs is a most complex, specific and extremely covert sphere of action against transnational organised crime. Its salient features include the substantial demand for and high prices of trafficked organs, the colossal incomes of organised crime structures, the high tech-oriented and finely tuned organisation of criminal business, the corporate solidarity of those involved and the sophisticated means used to conceal criminal activity.
2. Improvements to the legal regulation of action against trafficking in human organs at international level must be based on unified, commonly adopted and agreed international strategies, the main ones, in our view, being:
- recognition of the vital necessity of all Council of Europe member States swiftly ratifying the Council of Europe Convention against trafficking in human organs, which entered into force on 25 March 2015;
- the legal definition of trafficking in human organs as a sector of trafficking in human beings (in respect of disposing of a human being as an item of property);
- clear agreement on medical and legal criteria for distinguishing and classifying human biological materials (organs, tissues, cells) with regard to their illegal removal, trade and exploitation for commercial purposes;
- the definition of the human being and especially the child as the beneficiary of singular legal protection from criminal violations in the capacity of a single, entire biological system (rational biological entity);
- the inadmissibility of removing human organs without donor consent;
- the need to take account of the latest advances in transplantation and forecasts of their adverse side-effects in terms of the state, structure and developmental trends of organised crime business in this sphere;
- the organisation of suitable scientific and practical research work in this sphere with a view to establishing the state and structure of and trends in demand and proposals regarding the illegal sale of human organs, tissues or cells and identifying ways, channels and means for their implementation;
- monitoring of the migration situation in Council of Europe States, identification of new threats to the well-being of refugees and other categories of displaced persons at high risk of victimisation (heavily socially dependent) and likely to be the first victims of organised crime gangs seeking to illegally remove and traffic human organs, tissues or cells for massive criminal profits;
- a real assessment of the market mechanisms used by people traffickers to stimulate/exploit demand and offers relating to human organs/tissue/cells in order to make huge profits from such criminal dealings;
- future criminalisation at national level of all means of removing and trafficking in human organs, tissues or cells.
- more effective international cooperation between the competent state authorities, including the health protection and medical authorities, non-governmental organisations, civil society institutions and the public in preventing, identifying, suppressing and exposing trafficking in human organs, tissues or cells.
3. One major factor in optimising the fight against trafficking in human organs is the stepping up of close cooperation in terms of organisation, law standards, information and methods between law enforcement agencies, health authorities, civil society institutions and the public in combating the new challenges and threats linked to the practice of illegally removing, trafficking and exploiting human organs, tissues or cells for commercial purposes.
4. One gage of more effectively preventing, identifying, suppressing and exposing crimes linked to trafficking in human beings, including trafficking in human organs, tissues or cells, must be the specialisation of preliminary investigation, investigation and prosecution authority staff in this line of law enforcement activity. This proposal is dictated by the exceptionally specific nature of the organisation, tactics and methods of the fight against crimes linked to trafficking in human beings and especially criminal infringements in the area of biomedicine.
5. One priority strategy for improving the work of law enforcement agencies in this area of international cooperation is the prediction of negative factors/processes linked to the further development of transplantation and other biomedical advances. Above all, this must involve predicting the most probable means and mechanisms deployed to illegally exploit these advances by those engaged in trafficking in human organs/tissues/cells, with a view to devising ways of preventing or minimising/eliminating the conditions allowing this to happen, and to heightening transparency and public and state supervision of the lawfulness of decisions, actions and procedures adopted and implemented in this area.
6. Identification, analysis and assessment of applicable criminal law standards of specific States where defined measures are already being taken to combat negative tendencies appearing as side-effects of the rapid development of biomedicine are important requisites for further improving the legal regulation of the fight against trafficking in human organs, tissues or cells. The standards laid down in the criminal codes of a number of member countries of the Commonwealth of Independent States are instructive in this respect.
Article 136 of the Criminal Code of the Republic of Azerbaijan, for example, provides for liability for illegal artificial fertilisation and implantation of an embryo and for medical sterilisation of an individual.
Article 129 of the Criminal Code of the Republic of Kazakhstan criminalises human cloning or the use of human embryos for commercial, military or industrial purposes as well as the exportation of reproductive cells or human embryos from the Republic of Kazakhstan for such purposes.
Similar measures are provided for in the criminal legislation of the Republic of Moldova. In particular, Article 144 of the Criminal Code of the Republic of Moldova provides for liability for the creation of a human being via cloning, while Article 161 of the Code prohibits artificial fertilisation or implantation of an embryo without the patient's consent.
Prohibitions of the illegal removal of organs and tissues from a deceased donor/corpse are also noteworthy and can be found in Article 348 of the Criminal Code of the Republic of Belarus and Article 315 of the Criminal Code of the Republic of Kazakhstan.
So we can see that the negative side-effects of the rapid development of biomedicine in the current context poses new and complex problems for the medical profession, lawyers and other specialists, as well as the law enforcement agencies. If we are to find a comprehensive solution, we must on the one hand take account of the irreversibility of what is generally positive scientific progress and on the other hand construct a failsafe barrier against law-breakers who, for their own mercenary ends and interests, are prepared to disregard the prohibitions imposed by law with regard to the inadmissibility of trading in human organs, tissues or cells.
CLOSING SESSION
Philippe Boillat
Concluding Remarks
Dear Vice-Minister,
Ladies and Gentleman,
· This conference is coming to its end and I wish to thank the Ministry of Health, in particular Ms Gabbasova assisted by Ms Anastasia Koylyu for their work and very constructive and fruitful cooperation in the organisation of this event.
· I wish to share with you some final observations on what was together a celebration, an achievement and a starting point.
A celebration
· A celebration of what was a highly important milestone in the European history, i.e. the accession of Russia to the Council of Europe, anchoring the pan European dimension of the Council of Europe and creating a common legal space for the whole continent.
· The active role taken by Russia over these 20 years in sponsoring and promoting legal instruments has been duly recalled today. But also illustrated by its action in the biomedical field where Russian contribution was and remains of great relevance and importance.
An achievement
· The protection of Human Rights in the biomedical field was at the centre of this conference. The Council of Europe has been pursuing this work since early 80’s in bioethics when it launched its first pioneering initiatives in this area;
· Bioethical issues arise in numerous fields and the related rights are often referred to as a new generation of human rights.
· This is a field where ethics, law and science, in particular, are closely related. This was perfectly illustrated by the case of organ donation and transplantation.
· The situations encountered are not only sensitive but often very complex. Human lives are at stake. Related human rights challenges need to be addressed for the benefit and respect of human beings; we also need to build trust in the system in place.
· In this context, we have seen the central role of the free and informed consent of the person from whom the organ is to be removed, including after his or her death. Where presumed consent regime is in place for organ removal on deceased persons, all necessary measures have to be taken to ascertain that this person has not objected when alive. This may be done by approaching relatives to know whether the person concerned has expressed any objection when alive. It is also important to keep up to date a centralised register to record such objections. This centralised register should be properly consulted by medical professionals.
· In my opening address, I referred to the necessary synergy between protection of human rights and promotion of medical and scientific progress. The presentations and debates today confirmed the importance of such synergies to be created.
· The Oviedo Convention and its additional protocol aim at providing the necessary legal framework for the protection of fundamental rights in the field of organ donation and transplantation.
· Promoting organ donation and transplantation is a necessity. But protecting fundamental rights of donors and recipients is a legal requirement and the only way to fight organ trafficking.
· The conference also illustrated the relevance of those issues for both legal and health professionals. They need to better understand the implications of biomedical practices in their respective areas of competence and the importance of full respect of the legal principles to ensure appropriate safeguards for the sake of better protection.
· This conference made it possible not only to reaffirm the fundamental principles and values that should guide our actions, but also to raise awareness on the multidisciplinary cooperation required to ensure their implementation in practice.
A starting point
· Cooperation and continuous dialogue are indeed essential to ensure the protection of human rights. Bioethical issues are societal issues which need to be debated by all those concerned. That is all citizens and not only legal or medical specialists.
· Experience and expertise have to be shared - not only within a country but also between different countries. Cooperation activities among the Council of Europe Member States have already made it possible to build up a substantial set of instruments and tools to facilitate the implementation of established standards at international level.
· In this context, education and training is essential. Professional training on bioethics requires an innovative multidisciplinary approach; training activities should be directed to both for legal and health professionals. A new course on bioethics is planned to be prepared in the context of the pan-European HELP programme of the Council of Europe. We are particularly pleased to see strong support expressed by the Russian authorities for this project and the interest by various academic institutions of Russia for devising and implementing such a new course. The participation of Russian experts in this project would be an asset.
· Stronger international cooperation is required for effective fight against trafficking in human organs. Russia’s commitment in this field has already been expressed through the recent signature of the Convention against trafficking in human organs. We know that ratification is forthcoming.
· The organisation of this conference also confirms the interest and importance placed by the Russian Federation in the general protection of human rights in the biomedical field. We are looking forward to the further development of cooperation with the relevant Russian authorities in this field; the Conference may thus be seen as a starting point for new joint activities.
· We will celebrate next year the 20th anniversary of the Convention on Human Rights and Biomedicine and we would welcome a new State Party joining this Convention in the near future.
· I thank all the speakers, moderators and participants, without forgetting the interpreters, for this intense but very fruitful day.
[1] During this coffee break a press point will be given by Ms Veronica I. Skvortsova, Minister of Health of the Russian Federation, Mr Daniel Tarschys, former Secretary General of the Council of Europe and Mr Philippe Boillat, Director General, Directorate General of Human Rights and the Rule of Law (DGI), Council of Europe
[2] Convention for the protection of human rights and fundamental freedoms (concluded in Rome on 4 November 1950) // Compendium of Legislation of the Russian Federation. 2001. no. 2. Art. 163.
[3] Convention for the protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine (ETS no. 164) (concluded in Oviedo on 4 April 1997). Russia is not a signatory.
[4] Recommendation Rec(2004)4 of the Committee of Ministers of the Council of Europe to member states on the European Convention on Human Rights in university education and professional training (adopted by the Committee of Ministers on 12 May 2004 at its 114th session) // http://www.coe.int/t/dgi/hr-natimplement/Source/Rec(2004)4_en.pdf
[5] HELP — Human Rights Education for Legal Professionals
[6] Convention for the protection of human rights and fundamental freedoms (concluded in Rome on 4 November 1950) // Compendium of Legislation of the Russian Federation. 2001. no. 2. Art. 163
[7] Case of Lambert and Others v. France. Application no. 46043/14. Judgment of 5 June 2015 // http://hudoc.echr.coe.int
[8] Case of Parrillo v. Italy. Application no. 46470/11. Judgment of 27 August 2015 // http://hudoc.echr.coe.int
[9] Case of Hristozov and Others v. Bulgaria. Applications no. 47039/11, no. 358/12. Judgment of 13 November 2012 // http://hudoc.echr.coe.int
[10] Case of Petrova v. Latvia. Application no. 4605/05. Judgment of 24 June 2014 // http://hudoc.echr.coe.int
[11] Case of Elberte v. Latvia. Application no. 61243/08. Judgment of 13 April 2015 // http://hudoc.echr.coe.int
[12] https://www.edqm.eu/sites/default/files/newsletter_transplant_2015.pdf
[13] „Global variation in renal replacment therapy for end-stage renal disease“; Caskey FJ et al.; NDT 2011; 26: 2604-10,
[14] „The critical pathway for deceased donation: reportable uniformity in the approach to deceased donation.” B. Dominguez-Gil et al.; Transplant International 2011; 24: 373-378