Ministers’ Deputies

CM Documents

CM(2009)122              14 August 2009[1]

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1066 Meeting, 23 September 2009
10 Legal questions

10.3 Steering Committee on Bioethics (CDBI)

c. Report of the launching Session of the Conference on Ethics of Biomedical Research in Countries with Emerging or Developing Economy (Madrid, 27 April 2009)

Item to be prepared by the GR-J at its meeting of 8 September 2009

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Introduction

1.             Dr Javier Arias, Deputy Director of the Carlos III Health Institute, and Mr Carlos de Sola, Head of the Health and Bioethics Department, welcomed the participants on behalf of the Spanish authorities and the Council of Europe respectively.

2.             They reminded them that, in the context of the Spanish Chairmanship of the Committee of Ministers of the Council of Europe, the Spanish authorities had taken the initiative of organising a Conference on ethics of biomedical research in countries with an emerging or developing economy, in order to ensure protection of the individual rights of persons participating in such research.

3.             The end purpose was the adoption of a Declaration agreed by the representatives of states participating as members or observers in the Council of Europe’s work on bioethics.

4.             This Declaration was expected to be adopted at the Conference due to be held at the end of 2010.

Overview of clinical research involving co-operation with countries with an emerging or developing economy

5.             Professor Carlos Alonso (Spain) gave an overview of clinical research involving co-operation with countries with an emerging or developing economy[2].

Experience in countries where research is carried out

6.             Mr Dirceu Greco (Brazil) introduced “Time to globalise ethics principles: the Brazilian experience” ².

Experience of a sponsoring body co-operating in research in countries with an emerging or developing economy

7.             Professor Jean-Claude Ameisen (France) outlined the principles governing the evaluation of research projects in countries with an emerging or developing economy and the respective roles of the sponsoring body and local institutions in this process.

Experience of countries sponsoring research in co-operation with countries with an emerging or developing economy

8.             Dr Dan Davies (USA) introduced “Conducting research in developing countries: ethical and practical challenges for government sponsors” ².

Bioethical aspects of biomedical research carried out in countries with an emerging or developing economy

9.             Ms Victoria Camps gave a summary of the ethical issues defining the general context of the debate.

Council of Europe

10.          Ms Laurence Lwoff introduced the relevant Council of Europe documents, in particular the ethical standards relating to biomedical research².

European Union

11.          Mr Lino Paula outlined the European Commission’s activities relating to ethics in biomedical research in a globalised context².

Presentation of the synopsis of the preparatory meeting of 23-24 April

12.          Professor Elmar Doppelfeld (Germany) presented the list of points identified during the preparatory meeting held on 23-24 April 2009, which had been attended by experts from different countries, including certain experts from countries with an emerging or developing economy, and representatives of the European institutions. The points mentioned in Appendix III were regarded by the experts as warranting discussion in connection with the preparation of the draft Declaration.

Methodology and work plan

13.          On the Secretariat’s behalf, Mr Carlos de Sola presented the structure and working methods envisaged for the preparation of the Conference.

14.          As defined in the initiative launched by the Spanish authorities, the purpose of the Conference was to adopt a Declaration of non-legally binding common principles. To ensure that the Declaration had the greatest possible impact at international level, consideration had been given to the possibility of having it adopted not only by the member states but also by the observer states. The latter would therefore be called upon to participate fully in the preparation and adoption of the Declaration. The Conference could be held in the second half of 2010.

15.          It was proposed to set up the following bodies to prepare the Conference:

-        The Preparatory Committee for the Conference (Conf/Prepa) would be responsible for preparing the draft Declaration to be submitted to the Conference for adoption. This committee would be composed of all the governmental delegations of the CDBI member and observer states. It was for each state to determine the composition of its delegation to the committee, which could include experts who were members of the CDBI.

It would also be desirable for Conf/Prepa and the CDBI to work in close association given that the theme of the Conference represented a further development of the principle contained in Article 29 of the Protocol on Biomedical Research.

-        The Consultation and Drafting Group (Conf/RED), responsible for submitting proposals to Conf/Prepa, including, if appropriate, alternative proposals, concerning the entire content of the draft Declaration.  This group would be composed of some ten delegates elected from among the governmental delegations to Conf/Prepa.  The European Commission and the World Health Organisation could be represented on it. The group or its chair could decide to invite other delegates or experts to all or part of a meeting.

-        Select groups of experts (Conf/Exp) appointed by Conf/RED to consider a specific field and make proposals to it, including, if appropriate, alternative proposals, concerning the content of the draft Declaration in that field.

Election of the Consultation and Drafting Group

16.          The Consultation and Drafting Group (Conf/RED) was elected by consensus with the following membership:

- Dr Ingrid Callies (France)

- Prof. Elmar Doppelfeld (Germany)

- Prof. Eugenius Gefenas (Lithuania)

- Prof. Knut Ruyters (Norway)

- Prof. Boris Yudin (Russian Federation)

- Prof. Joze Trontelj (Slovenia)

- Prof. Javier Arias (Spain): Chair

- Dr Imogen Evans (United Kingdom)

- Ms Dafna Feinholz (Mexico)

- Dr Jerry Menikoff (USA)

17.          The European Commission and the World Health Organisation could send representatives to this body.

Secretariat of the Conference

18.          It was agreed that the Conference secretariat would be centralised at the Council of Europe. The Secretariat of the CDBI would work in co-ordination with the Spanish authorities.

Appendix I

Programme

09:30    Opening, Dr Javier Arias, Deputy Director of the Institute of Health Carlos III-ISCIII-, Spain. ; M. Carlos de Sola, Head of Health and Bioethics Department, Council of Europe

10:00    Session 1: Biomedical research in countries with emerging or developing economy

            Chairs: Mrs. Isabelle Erny, France, Chair of the Steering Committee on Bioethics (CDBI) and Prof. Carlos Romeo, CDBI member, Spain.

10:00    Overview of clinical research involving cooperation with countries with emerging or developing economy. Dr Carlos Alonso. Spain.

10:15    Practice of countries where research is carried out. Mr Dirceu Greco. Brazil.

10:30    Practice of a body, sponsoring research. Prof. Jean-Claude Ameisen. France.

10:45    Practice of a country, sponsoring research. Dr F. Daniel Davis. USA.

11:00    Bioethical issues concerning biomedical research carried out in countries with emerging or developing economy. Mrs Victoria Camps. Spain.

11:15    Coffee break

12:00    Session 2: Legal aspects and training in ethics on biomedical research carried out in countries with emerging or developing economy 

Chairs: Prof. Jean-Claude Ameisen, France, Chairman of the Ethics Committee of France, National Institute of Medical Research (INSERM); and Prof. Dr Elmar Doppelfeld, Germany, Chairman of the Union of Ethics Committees of Germany.

12:00    View point of the Council of Europe. Mrs Laurence Lwoff.

12:15    View point of the European Union (DG Research). Mr Lino Paula.

12:30    Session 3: Introducing the Conference

            Chairs: Dr. Javier Arias, Deputy Director ISCIII, Spain and Mrs. Dafna Feinholz Klip, Universidad Nacional Autónoma de México (UNAM), Mexico.

12:30    The objectives of the Conference. Dr Javier Arias, Deputy Director ISCIII. Spain.

12:45    Presentation of the outcomes of a preparatory meeting on 23-24 April. Prof. Dr Elmar Doppelfeld. Germany.

13:00    Working methods and work schedule. Mr Carlos de Sola. Council of Europe.

13:15    Election of the Organizing Committee for the Conference

13:30    Closing of the meeting. Dr Javier Arias.

Appendix II

List of participants

Andorra/Andorre – Monsieur Pere PASTOR VILANOVA, Juge, Batllia d'Andorra

Armenia/Arménie – Mr Igor MADOYAN, Phd, President of National Center on Bioethics, Yerevan

Austria/Autriche – Mag. Ivonne GRÖSSL, Richterin, Bundesministerium für Justiz, Wien

Dr Doris WOLFSLEHNER, Head of the division “Bioethics” at the Federal Chancellery, Wien

Azerbaijan/Azerbaïdjan – Dr Gulsum GURBANOVA, Int. Relations Deptt, Ministry of Health, Baku

Belgium/Belgique – Mme Godelieve LEUNENS, Federal Public service for Health, Brussels

Bosnia and Herzegovina/Bosnie-Herzégovine – apologised/excusée

Bulgaria/Bulgarie – Ms Sylvia TOMOVA, Ministry of Health, Legal Directorate, Chief Legal Advisor, Sofia

Croatia/Croatie - Ms Ana BOROVECKI, “Andrija Stampar” School of Public Health, Zagreb

Cyprus/Chypre – Ms Rena PETRIDOU-VRAHIMI, Chair of the National Bioethics Committee, Nicosia

Czech Republic/République Tchèque– Prof. Pavel MARTASEK, 1st School of Medicine, Charles University, Prague

Denmark/Danemark – apologised/excusé

Estonia/Estonie – Prof. Hele EVERAUS, Head of the Clinic, Haematology and Oncology Clinic, Tartu Finland/Finlande – Dr Terhi HERMANSON, Ministry of Social Affairs and Public Health, Helsinki

Mr Jaakko HALTTUNEN, Legal Department / Unit for Human Rights Courts and Conventions, Helsinki

France - M. André ALBERT, Ministère de la Justice, Direction des Affaires Civiles et du Sceau, Paris

Mme Marie-Gabrielle MERLOZ, Ministère des Affaires Etrangères, Direction des Affaires Juridiques, Paris

Mme Isabelle ERNY, Ministère de la Santé, Division droit, éthique et appui juridique, Paris

Dr Jacques MONTAGUT, Directeur de l'IFREARES, Toulouse

Georgia/Géorgie – apologised/excusé

Germany/Allemagne – Ms Eva SCHEWIOR, Referat, Bioethik; Bundesministerium der Justiz, Berlin

Prof. Elmar DOPPELFELD, Président de l’Union des Comités d’Ethique, Köln

Dr Ingo HÄRTEL, German Federal Ministry of Health - Head of Interministerial Working Group on Regulatory Questions in Biomedicine and Bioethics, Berlin

Ms Ingrid KLEIN, Federal Ministry of Education and Research, Berlin

Greece/Grèce – Ms Stamatia GARANIS, Legal Adviser, National School of Public Health, Athens

Hungary/Hongrie - Dr Dorottya MOGYOROSI, Office of the Parliamentary Commissioner for Future Generations, Budapest

Iceland/Islande – Ms Gudridur THORSTEINSDOTTIR, Director, Legal Affairs Dept., Health Ministry, Reykjavik     

Ireland/Irlande – Ms Sarah FARRELL, Legal Adviser to Department of Health and Children, Dublin

Italy/Italie – Prof. Adriano BOMPIANI, Université catholique Polyclinique "A. Gemelli", Roma              

Latvia/Lettonie – Ms Laima RUDZE, Head of International Services Dept., Compulsory Health Insurance State Agency of Latvia, Riga

Liechtenstein – apologised/excusé

Lithuania/Lituanie – Dr Eugenijus GEFENAS, Chairman of Lithuanian Bioethics Committee, Vilnius

Luxembourg – M. Jean-Paul HARPES, membre du Comité National d'Ethique de la Recherche, Luxembourg

Malta - Ms Mary Anne CIAPPARA, Hon. Secretary, Bioethics Consultative Committee, Valleta

Moldova – Dr Mihail GAVRILIUC, Ministry of Health, Chisinau

Monaco – apologised/excusé

Montenegro/Monténégro – Dr Omer ADZOVIC, Medical Centre of Montenegro, Podgorica

Nina NILOVIC

Netherlands/Pays-Bas – Ms Lisette GELDOF VAN DOORN, Ministry of Health, Welfare and Sport, Directorate Public Health, Section Ethics, Den Haag

Ms Marlies VOS, Ministry of Health, Welfare and Sport, Section Ethics, Den Haag

Norway/Norvège - Ms Anne FORUS, Norwegian Directorate for Health, Oslo

Ms Kari STEIG, Juridical adviser, Norwegian Directorate for Health and Social Affairs, Oslo

Poland/Pologne – Dr Jerzy UMIASTOWSKI, Chairman of the Medical Ethics Committee of the Polish Medical Board, Gdansk

Portugal - Victor Manuel Da SILVEIRA

Romania/Roumanie – Prof. Dr. Vasile ASTARASTOAE Institutul de Medicina Legala, Iasi

Ms Beatrice Gabriela IOAN, President of the Bioethics Commission of the Romanian College of Physicians, Iasi

Mr Gheorghe BORCEAN, Vice-President of the Romanian College of Physicians, Caransebes

Russia/Russie - Mr Boris YUDIN, Director, Institute of Human Studies, Russian Academy of Sciences, Moscow

San Marino/Saint-Marin - Mr Mauro FIORINI, Borgo Maggiore

Serbia/Serbie - Prof. Dr. Zvonko MAGIC, Head of Department for Clinical and Experimental Molecular Genetics and Genetic Engineering, Belgrade

Marija SKERLJ

Slovakia/Slovaquie – apologised/excusé

Slovenia/Slovénie – Prof. Joze V. TRONTELJ, Chair, National Medical Ethics Committee, Ljubljana 

Spain/Espagne – Prof. Carlos ALONSO BEDATE, Centro de Biologica Molecular, Université autonome, Madrid,

Prof. Carlos M. ROMEO–CASABONA, Head, Inter-University Chair in Law and the Human Genome, Bilbao

Dr Javier ARIAS, Associate Professor of Surgery, Instituto de Salud Carlos III,  Madrid

Sweden/Suède – apologised/excusée

Switzerland/Suisse – Ms Dolores KRAPF, Division de Droit, Office Fédéral de la Santé Publique, Berne

"The Former Yugoslav Republic of Macedonia"/"l'ex-République yougoslave de Macédoine" –

Mr Burim MAKSUTI, Sector for European integration, Ministry of Health, Skopje

Mr Zoram STOJANOVSKI

Turkey/Turquie – Prof. Ergun ÖZSUNAY, Istanbul Culture University, Faculty of Law

Ukraine - Prof. Zoreslava SHKIRYAK-NYZHNYK, Vice-president of Bioethics Committee of Academy of Medical Sciences, Institute of Paediatrics, Obstetrics and Gynaecology, Kyiv

United Kingdom/Royaume-Uni – Dr Mark BALE, Head of Genetics Branch; Scientific Development & Bioethics Division, Department of Health, London

Mr Peter JONES, Department of Health, London

CDDH – Dr Dubravka SIMONOVIC, Ministry of Foreign Affairs, Head of Human Rights Section, Zagreb

CDSP - Dr Vlasta MOČNIK DRNOVŠEK, European Affairs and International Cooperation Service, Ministry of Health, Ljubljana

PARLIAMENTARY ASSEMBLY/ASSEMBLÉE PARLEMENTAIRE – apologised/excusée

EUROPEAN COMMUNITY/COMMUNAUTE EUROPEENNE – Dr Maurizio SALVI, European Bureau of Policy Advisors (BEPA), European Commission, Bruxelles         

Mr Lino PAULA, Science, Governance and Ethics Unit, Directorate-General for Research, Brussels

Canada – Mr Glenn Rivard, Department of Justice Canada, Health Canada Legal Services, Ottawa

Holy See/Saint-Siège– Dott.ssa Monica Lopez BARAHONA, c/o Nonciature Apostolique en Espagne, Madrid

Japan/Japon  – apologised/excusé

Mexico/Mexique – Ms Dafna FEINHOLZ, Directrice Exécutive de la Commission Nationale de Bioétique du Secrétariat de la Santé, México

USA/Etats-Unis d'Amérique – Dr F. Daniel DAVIS Ph. D., Executive Director, President's Council on Bioethics, Washington, D.C.

UNESCO – apologised/excusée

OECD/OCDE – apologised/excusée

World Health Organisation/Organisation Mondiale de la Santé (WHO/OMS) – apologised/excusée

International Commission on Civil Status/Commission Internationale de l'Etat Civil (CIEC) – apologised/excusée

Spain/Espagne – Ms Maria Concepcion MARTIN ; Ms Cecila MARTIN

Australia/Australie – apologised/excusé

Israel/Israël – Dr Ilana SCHMIDT-HOPFELD, Dept. of Science Teaching, Weizmann Institute of Science, Rehovot

European Science Foundation/Fondation Européenne de la Science (ESF) – apologised/excusée

KEK – Church and Society Commission of the Conference of European Churches/Commission Eglise et Société de la Conférence des Eglises Européennes – Pasteur Richard FISCHER, Secrétaire Exécutif, Strasbourg

SECRETARIAT

Directorate General III Social Cohesion / Direction Générale III Cohésion Sociale

Health and Bioethics Department / Service de la Santé et de la Bioéthique

Mr Carlos de SOLA, Head of Health and Bioethics Department / Chef du Service de la Santé et de la Bioéthique,

Mme Laurence LWOFF, Head of Bioethics Division, Secretary of the CDBI / Chef de la Division de la Bioéthique, Secrétaire du CDBI

Mlle Ayşegül ELVERİŞ, Secretary of the Group of Specialists on Predictivity, Genetic Testing and Insurance / Secrétaire du Groupe de Spécialistes sur la prédictivité, les tests génetiques et l’assurance,

Mlle Tatiana WINTER, Assistant / Assistante

INTERPRETERS / INTERPRETES

M. Robert SZYMANSKI

Mme Jolyn JEELOF-WUHRMANN 

Mme Isabelle MEUNIER 

M. Claude LORD 

Appendix III

Summary of the preparatory meeting of 23-24 April 2009

of the Launching Session of the Conference on Ethics of Biomedical Research in

Countries with Emerging or Developing Economy

The following are suggestions from the preparatory meeting as to the main issues that could be contemplated in the preparation of the Declaration:

● The Declaration would take as a basis the provision of Article 29 of the Additional Protocol to the Convention on Human Rights and Biomedicine concerning Biomedical Research[3] .

● The Declaration would elaborate on this provision and be applicable to research projects within the scope of the Additional Protocol.  However, the relevance of a number of principles contained in the Protocol for other types of research involving humans could be acknowledged.

● The Declaration would recall the responsibility of States to take appropriate measures to ensure protection of the individual rights of persons participating in research. It could aim at identifying those measures in the context of research undertaken in a country with emerging or developing economy by researchers or sponsors within their jurisdiction.

● The application of the ethical principles contained in universally adopted instruments in particular the UNESCO Declaration on bioethics and human rights and stated in the Additional Protocol would need to be considered in the light of the local circumstances, taking particular account of relevant cultural and socio economic aspects.

Among the issues identified as being particularly relevant for the research concerned, the following points have been particularly discussed at the preparatory meeting:

v  Justification of the research, including reasons to carry out research in the country concerned

v  Cooperation/partnership with the country concerned for carrying out the research

v  Review of the research project in all countries concerned

v  Independence and multidisciplinarity of research ethics committees (REC)

v  Safety of research participants

v  Standards of care, including provision of treatment

v  Issues of control group and placebo

v  Appropriate prior information and free and informed consent

v  Potential benefits and foreseeable risks for research participants or the community or group

v  Compensation for damage

v  Monitoring of research project

v  Public access to research results (e.g. publication)

v  Measures to ensure that ethical standards are effectively applied (e.g. criteria for authorisation for putting product, such as drug, on the market)

v  Access to treatment and other benefits after research