ETHICS

BETWEEN LAW AND PUBLIC POLICY

The European Group on Ethics in Science and New Technologies

Rafael Capurro
  

 
 
 
First published in the
Journal of International Biotechnology Law (JIBL) Vol. 1, Issue 2, 2004, 62-66.



Introduction

The relation between ethics, law, and public policy has a long tradition in Western thought and practice going back to Plato’s “Nomoi” (722d) where he stresses the importance of “introductions” (‘proimia’) that should used in order to make laws more understandable and acceptable to the citizens (1). Aristotle makes a difference between individual and political virtues. Political and legal practice are supposed to rest on ethical counselling on the basis of morality (‘ethos’). Since Modernity, and particularly since Thomas Hobbes, there is not just a difference but a split between morality, law and public policy. Since Hegel through Pierce and Rorty there is a (pragmatic) search for overcoming it. Today’s mass media and particularly the internet have created new forms of mediation without eliminating the differences.

Ethics councils within the sphere of public policy have the function of reflecting on the moral and legal foundations of specific controversial issues without being itself neither a legal  nor a moral authority. Their task is reflection, not decision-making or dogmatic proclamation. They should counterbalance ethical arguments and give an opinion on matters that remain controversial and subject to revision. Today’s public policy has a need for such counsels particularly with regard to new developments in science and technology. This is the case since twenty years or so in the field of biology (bioethics) (2) but it becomes more and more obvious also with regard to the new information and communication technologies (information ethics) (3). Of course, such ethics bodies are not unproblematic not only concerning their legitimating body – in some cases it is the parliament, in other cases the executive –, but also with regard to possible controversial standpoints that may differ with present laws and/or directives. In other words, it is important that such bodies are politically independent, pluralist, and multidisciplinary and that they view themselves not just as guarantee of an established morality or of current law, but as a critical space where an open debate on legally and morally controversial issues can take place. Although they might look for consensual opinions, consensus should not be a conditio sine qua non of their proposals. It is also not their function to make public policy ‘more moral,’ but to encourage ethical reflection within the public sphere.

The European Group on Ethics in Science and New Technologies (EGE) is such an independent, pluralist and multidisciplinary body which advises the European Commission on ethical aspects of science and new technologies in connection with the preparation and implementation of Community legislation or policies.

In December 16, 1997 the European Commission set up the EGE for a three years mandate to succeed the Group of Advisers on the Ethical Implications of Biotechnology (GAEIB 1991-1997). During its first mandate the EGE (1998-2000) provided Opinions on subjects as diverse as human tissue banking, human embryo research, personal health data in the information society, doping in sport and human stem cell research. At a specific request of the President of the Commission, Romano Prodi, the Group also wrote the "Report on the Charter on Fundamental Rights" related to technological innovation. By a decision of March 26, 2001 the Commission adopted a revised mandate for the EGE with a duration of four years and amended the EGE remit.

During its second mandate (2001-2004) the EGE has published the following Opinions:

nr 16: Ethical aspects of patenting inventions involving human stem cells (07/05/2002)

nr 17: Ethical aspects of clinical research in developing countries (04/02/2003)

nr 18: Ethical aspects of genetic testing in the workplace (17/09/2003).

Opinion nr 19 on “Ethical aspects of cord blood stem cells banks” is in preparation. In its Opinion nr 20 EGE will deal with “Ethical Aspects of ICT in the Human Body.” Opinion nr 16, 17, and 19 were requested by the President of the European Commission, Romano Prodi. Opinions nr 18 and 20 are an initiative of the Group.

Opinion nr 16 addresses the ethical implications of human stem cell research and its uses. It makes recommendations to set up a strict public control by centralised authorities, on human embryo research where it is allowed, to take measures to prevent commercialisation of human embryos or cadaveric foetal tissue, and to ensure the respect of ethical principles through the control of public authorities, concerning import of human stem cells, where allowed. The Group addresses the ethical dilemma that arises from the fact that patents can encourage scientific progress but they can also impair access to health care due to the need of a licence to use them and to the fees that will have to be paid to the patent holder. The Group is well aware that all procedures involving directly or indirectly the human embryo are controversial. Considering the risk of instrumentalisation and commercialisation of the embryo, the Group calls for a cautious approach, excluding the patentability of the process of creation of a human embryo by cloning of stem cells. According to the Group only human stem cell lines which have been modified by an inventive process to get new characteristics for specific industrial application are patentable. The Group stresses the urgent need to engage a public debate on that issue. It also calls for the creation of an EU Registry of unmodified human stem cell lines. The Group insists on the necessity to avoid the granting of too broad patents on stem cell lines that would impair further research and development. It also finds that the recourse to compulsory licence should be encouraged when the access to diagnosis and treatment is blocked by misuse of patent rights. One of the members of the Group hold a dissident opinion with the argument that human embryonic stem cells and embryonic stem cell lines should be excluded from patentability because it is not possible to get them without destroying an embryo.

Opinion nr 17 deals with ethical aspects of clinical research in developing countries. The 6th Framework Programme (2002-2006) opens the possibility for developing countries to get EU funding in all research areas. This should make possible to join efforts in order to combat poverty-linked diseases such as AIDS, malaria and tuberculosis. It is in this context that the European Commission requested the EGE to submit an opinion. Clinical trials in developing countries give rise to ethical questions specifically linked to socio-economic inequalities and poverty but also to cultural diversity. The EGE stresses that the huge economic inequalities are the cause for most of the problems raised in this opinion. The implementation of EU research programmes in developing countries should be based on solidarity, in line with the Charter of Fundamental Rights. The general approach is that the fundamental ethical rules applied to clinical trials in industrialised countries, including the ones concerning the use of placebos, are to be applicable everywhere. The Group insists that the scientific and ethical evaluation of research protocol should involve local committees, or local independent experts.

Opinion nr 18 raises not only ethical issues related to genetic testing with particular reference to genetic screening but also to the principle of justice and non-discrimination in access to work. This issue has a particular European dimension since workers can freely cross borderlines within the EU. According to the Group, only the present health status of the employees should be considered in the employment context with regard to genetic screening. Moreover, the use of genetic screening in the context of medical examination, as well as the disclosure of the results of previous genetic tests, are seen “in general” as non ethically acceptable. Medical examination can fulfil the legitimate duties and right of employers concerning the protection of health and the assessment of ability. The Group states the conditions under which genetic testing could be considered.

Remit of the EGE

1. Purpose: The European Group on Ethics in Science and New Technologies, hereafter the “Group”, shall act within the scope of the following remit.

2. Remit and request for opinions: The task of the Group shall be to advise the Commission on all ethical questions relating to sciences and new technologies, either at the request of the Commission or on its own initiative. The Parliament and the Council may draw the Commission's attention to questions which they consider of major ethical importance. The Commission shall, when seeking the opinion of the Group, set a time limit within which such opinion shall be given. 

3. Composition: The Group shall have twelve members appointed for their expertise and personal qualities. It shall be independent, pluralist and multidisciplinary. 

4. Appointment: The members of the Group shall be appointed by the Commission. 

5. Term of office: Each member of the Group shall be appointed for a term of four years. This term shall be renewable once. A member who resigns before completion of the term of office shall be replaced for the remainder of the term in accordance with the procedure laid down in Point 4. 

6. Reimbursement of expenses: Travel and subsistence expenses for the Group’s meetings shall be covered by the Commission in accordance with the relevant administrative rules. 

7. Chair: The Group shall elect a chairperson and a vice-chairperson from among its members for the duration of the term of office. 

8. Secretariat: The Secretariat-General of the Commission, acting in close cooperation with the Group’s chairperson, shall be responsible for organising the work of the Group and its secretariat. 

9. Working methods: The Group’s regular working meetings shall not be open to the public. For the purposes of preparing its Opinions and within the limits of the available resources for this action, the Group:

- may invite experts either from a Member State of the Union or from outside to take part in its proceedings on a given topic on the agenda.  

- may initiate studies in order to collect all necessary scientific and technical information 

- may set up working groups to consider specific issues 

- may organize public Round Tables in order to promote dialogue and improve transparency 

- may establish closer links with representatives of the various ethics bodies which exist in the European Union and in the applicant countries.

10. Opinions: Every opinion shall be published immediately after its adoption. Where an opinion is not adopted unanimously, it shall include any dissenting point of view. 

11. Rules of Procedure: The Group shall adopt its Rules of Procedure. 

12. Activity report: A report on the Group’s activities shall be produced under the responsibility of the chairperson before the end of its term of office. The report shall be published. 

13. Replacement of previous text: This text describing the remit of the European Group on Ethics in Science and New Technologies shall replace the remit annexed to the Communication to the Commission of 12 December 1997 on the establishment of the European Group on Ethics in Science and New Technologies (SEC(97)2404)

Members and Secretariat

By a decision of April 2, 2001 the Commission proceeded to the nomination of the twelve members. They are appointed for their competence and personal qualities. They come from different countries and are experts in disciplines such as biology and genetics, medicine, informatics, law, philosophy or theology.

Following the resignation of Mrs Noelle Lenoir (France) and Mr Spiros Simitis (Germany), the Commission has nominated two new members: Mrs Catherine Labrusse-Riou (France) and Mr Nikos C. Alivizatos (Greece) for September 2002.
Prof. Göran HERMERÉN (Sweden), President, Philosopher, Professor of Medical Ethics, Faculty of Medicine, Lund University

Prof. Linda NIELSEN (Denmark), Vice-President, Professor of Law, Rector of the University of Copenhagen.

Prof. Nicos C. ALIVIZATOS (Greece), Professor of Constitutional Law, University of Athens.


Prof. Rafael CAPURRO (Germany), Professor of Information Management and Information Ethics at Fachhochschule Stuttgart, Hochschule der Medien, University of Applied Sciences


Prof. Inez DE BEAUFORT (The Netherlands), Professor of Health Care Ethics at the Medical Faculty of the Erasmus University, Rotterdam.


Prof. Yvon ENGLERT (Belgium), Head of Fertility Clinic, Free University of Brussels (ULB), Professor of Medical Ethics and Deontology, ULB


Prof. Catherine LABRUSSE-RIOU (France), Centre de recherche en droit privé, Université de Paris.

Dr. Anne McLAREN (United Kingdom), Geneticist, Research Associate at Wellcome CRC Institute, Cambridg


Prof. Pere PUIGDOMÈNECH ROSELL (Spain), Research Professor at the Department for Molecular Genetics, Director of Institut de Biologia Molecular de Barcelona, CSIC


Prof. Stefano RODOTA (Italy), Professor of Civil Law, University of Rome, Chairman of the Italian Data Protection Authority, Chairman of the European Group of the Data Protection Authorities.


Prof. Günter VIRT (Austria), Professor of Theology, Institute of Moral Theology, Catholic University of Vienna.


Prof. Peter WHITTAKER (Ireland), Biologist, Professor of Biology, Institute of Environment, Philosophy and Public Policy, University of Lancaster, Furness College


Secretariat of the EGE
 

The Secretariat is an integral part of the Group of Policy Advisers. Secretary of the EGE is Ms Christiane Bardoux., European Commission,  200 rue de la Loi (Brey 10/128), B-1049 Brussels.

EGE-Newsletter "Ethically Speaking": providing information on the activities of the National Ethics Committees. 


Activities 2001-2004 

2001

The Group under the revised mandate held its first meeting on 29 May in Brussels. In his welcome message President Prodi requested the Group to give two opinions: 

- an Opinion (nr 16) on the ethical aspects of patents resulting from research into stem cells, 
- an Opinion (nr 17) on the ethical aspects of clinical research in developing countries.  

On June 11-12, 2001 the Group participates at the conference: "Ethics and Biomedical Research" (Umea, Sweden), organised by the Swedish Presidency.

In preparation of the Opinion nr 16 the Group organised on November 20,  in Brussels, a round-table debate on the ethical aspects of patenting inventions involving human stem cells in order to discuss the topic with scientific experts, lawyers, philosophers, as well as representatives from the European Parliament, international organisations, representatives of patients, industry, religions, and other interested parties.

2002

Under the Spanish Presidency, on April 18-19, the Group held in Barcelona a working meeting and met Members of the Spanish Parliament and of Spanish working groups on bioethics. The Group also took part in the Platform "European African partnership on clinical trials programme for poverty related diseases."

Within the preparatory work on its next opinion nr 17, the Group organised on October 1, 2002 in Brussels a round-table debate on “The ethical aspects of clinical research in developing countries” with representatives of the European Parliament, international organisations, representatives of patients, industry, religions, and other interested parties.

Under the Danish Presidency, on October 24-25,  the Group held a working meeting in Copenhagen and met twelve members of the Danish Consumer Agency and of the National Ethics Committee. The Group also had a debate with researchers within the area of developing countries and took part in the conference on “Future Food on Bioethics,” organised by the Danish Consumer Agency and hosted by the Danish Government.

2003

The Group edited on 4th February  the opinion nr 17 on “the ethical aspects of clinical research in developing countries”.

The Group presented on 20th February a statement on “Advertising genetic tests via the Internet”.

Under the Greek Presidency, on May 26th and 27th, the Group held a working meeting in Athens and met the Greek Minister of Health, Dr. C. Stefanis.   The Group also organized a debate with the Members of the Greek Bioethics Committee (GBC), chaired by Prof. George Koumantos, in order to prepare its last Opinion nr 18 on "the ethical aspects of Genetic testing in the workplace".

The Group adopted on 28 July the opinion nr 18 on “the ethical aspects of genetic testing in the workplace”.

Under the Italian Presidency, on October 20th-22nd, the Group held a working meeting in Rome and met members of the National Bioethics Committee (NBC), chaired by Prof. Francesco D'Agostino. The main theme of the exchange with members of the NBC was on genetic testing on the net. The EGE was then received by the President of the Italian Republic, Mr Carlo Azeglio Ciampi. The Group also met the organisers of the website "Storia e memoria", representatives of Parliament who presented projects of law concerning cord blood banks, and  Prof. Salvatore Mancuso, Director of the Department of Gynecology at the Catholic University in Rome where the biggest umbilical cord cell bank is located.

The Group is currently preparing  the opinion nr 19 on "the Ethical aspects of umbilical cord blood private banking". Indeed, the development of private banks as well as their publicity on the web raises concerns and it is at the request of the Commission that the EGE will submit this opinion. This opinion should be ready in the beginning of 2004.

In parallel, the Group is also looking at the ethical aspects attached to information and communication technologies and is as well envisaging to give an opinion on the ethical aspects linked to nanotechnologies.


Opinions, Statements, and Publications

OPINIONS

The Opinions are available at the EGE website:
europa.eu.int/comm/european_group_ethics


GAEIB 1993-1997

nr 1: The ethical implications of the use of performance-enhancers in agriculture and fisheries (12/03/1993)

nr 2: Products derived from human blood or human plasma (12/03/1993)

nr 3: Opinion on ethical questions arising from the Commission proposal for a Council directive for legal protection of biotechnological inventions (30/09/1993)

nr 4: The ethical implications of gene therapy (13/12/1994)

nr 5: Ethical aspects of the labelling of the food derived from modern biotechnology (05/05/1995)

nr 6: Ethical aspects of prenatal diagnosis (20/02/1996)

nr 7: Ethical aspects of genetic modification of animals (21/05/1996)

nr 8: Ethical aspects of patenting inventions involving elements of human origin (25/09/1996)

nr 9: Ethical aspects of cloning techniques (28/05/1997)

nr 10: Ethical aspects of the 5th Research Framework Programme (11/12/1997)


EGE 1998-2000

nr 11: Ethical aspects of human tissue banking (21/07/1998)

nr 12: Ethical aspects of research involving the use of human embryo in the context of the 5th framework programme (23/11/1998)

nr 13: Ethical issues of healthcare in the information society (30/07/1999)

nr 14: Ethical aspects arising from doping in sport (14/11/1999)

nr 15: Ethical aspects of human stem cell research and use (14/11/2000)

Report: 23/05/2000 Citizens Rights and New Technologies: A European Challenge. Report on the Charter on fundamental rights related to technological innovation requested by the President of the Commission, Romano Prodi.


EGE 2001-2004

nr 16: Ethical aspects of patenting inventions involving human stem cells (07/05/2002)

nr 17: Ethical aspects of clinical research in developing countries (04/02/2003)

nr 18: Ethical aspects of genetic texting in the workplance (17/09/2003)

nr 19: Ethical aspects of cord blood stem cells banks (in prep.)


STATEMENTS

Statement nr 1: On Advertising Genetic Tests via the Internet (24/2/2003)


PUBLICATIONS

Paper version, free of charge, available upon request.

General Report on the activities of the EGE 1998-2000

Genetic testing in the workplace. Round Table Debate, Brussels, 6 March 2000.

Opinion nr 15: "Ethical aspects of human stem cell research and uses," accompanying document including the text of the Opinion in French, English and German as well as relevant texts of the European Institutions, National Ethics Committees and experts on scientific, ethical or legal issues. Revised edition, September 2002.

Opinion nr 16: "Ethical aspects of patenting inventions involving human stem cells" (The text of the opinion is also available in German)

"A history of patenting life in the United States with comparative attention to Canada and Europe," by Prof. Kevles. This study has been carried out at the request of the EGE for the preparation of the opinion nr 16.


"Study on the patenting of inventions related to human stem cells" by Prof. Van Overwalle. This study has been carried out at the request of the EGE for the preparation of the opinion nr 16.

"National regulations in the European Union regarding research on human embryos" by Brigitte Gratton-

"The ethical aspects of biomedical research in developing countries," Proceedings of the Round Table Debate held in Brussels on October 1, 2002.

Opinion nr 17: “Ethical aspects of clinical research in developing countries” (The text of the opinion is also available in German.

Opinion nr 18: “Ethical aspects of genetic testing in the workplace” (The text of the opinion is also available in German)


References

(1) See my „Ethik in Europa zwischen Forschung und Politik“ in: Wissenschaftszentrum Nordrhein-Westfalen ed. Jahrbuch 2002/2003, 200-211.

(2) The first opinion of the French ethics committee (Comité Consultatif National d’Ethique/CCNE: http://www.ccne-ethique.fr/) dates from 22.5.1984: “Opinion on sampling of dead human embryonic and fetal tissue for therapeutic, diagnostic, and scientific purposes.” Most European and non-European national and international ethics committees have been created in the nineties. UNESCO’s International Bioethics Committee (IBC) was created in 1993. The Steering Committee on Bioethics of the Council of Europe dates from 1992. US President George W. Bush created The President’s Council on Bioethics on the basis of the Executive Order 13237 from November 28, 2001 (http://www.bioethics.gov/). Most ethics committees are in fact committees on bioethics. See the web site of the European Group on Ethics in Science and New Technologies (EGE) of the European Commission

(3) The EGE is the first international body to address ethical issues in such a broad context. With regard to information ethics see International Center for Information Ethics (ICIE): http://icie.zkm.de


Last update: January 16,  2012



 

Copyright © 2005 by Rafael Capurro, all rights reserved. This text may be used and shared in accordance with the fair-use provisions of U.S. and international copyright law, and it may be archived and redistributed in electronic form, provided that the author is notified and no fee is charged for access. Archiving, redistribution, or republication of this text on other terms, in any medium, requires the consent of the author.

 

 
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