KA-AI-13-001-EN-C
ISSN 1725-5562
Ethically speaking
Ethically
speaking
A newsletter providing information on the
activities of the national ethics committees
compiled by the Secretariat of the European
Group on Ethics in Science and New
Technologies to the European Commission
Issue 17 — January 2013
Issue 17 — January 2013
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Ethically speaking
Issue 17
January 2013
Maurizio SALVI
Chief Editor
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Contents
Editorial
Maurizio Salvi, Head of the EGE Secretariat
5
General information on activities of the EU national and regional ethics committees
9
BELGIUM11
CYPRUS13
FRANCE17
GERMANY19
GREECE21
ITALY23
MALTA27
PORTUGAL31
UNITED KINGDOM
35
General information on activities of the non-EU national and regional ethics committees
37
ARGENTINA39
COPAB43
INDIA45
MEXICO47
RUSSIA51
European Commission
53
European Commission, Bureau of European Policy Advisers’ Ethics Sector
55
General information on activities of the international organisations
57
Council of Europe
59
Unesco61
World Health Organisation (WHO)
63
EGE Secretariat
67
Editorial
Maurizio Salvi, Head of the EGE Secretariat
EGE Opinion 27: An ethical framework for assessing research, production and use of energy
With the entering into force of the Lisbon Treaty, ethical considerations are integral components in the
formulation of European Union policies, including energy policy. This ethical analysis requires that
the production systems being considered are comparable. The analysis cannot only consider economic
issues, but must consider the impact, either positive or negative, that may occur during the entire life
cycle of the system and this should encompass the impact on the environment and the implications of
the use (or indeed cessation of use) of a particular energy source. An ethically sound policy design is
a challenge for the formulation of such an important policy sector that affects 10 % of the entire GDP
of the European Union as well as global geopolitical and macroeconomic considerations. This need has
been appreciated by European Union Member States (1) and, on 19 December 2011, the President of the
European Commission requested the European Group on Ethics in Science and New Technologies (2)
(EGE) to ‘contribute to the debate on a sustainable energy mix in Europe by studying the ethical impact
of research on different energy sources on human well-being’.
The EGE accepted this request and decided to:
• address the ethical issues arising from energy use within the EU energy agenda, the mix of energy,
consequences for the future, energy policy and regulation (including environmental consider­
ations), the precautionary principle and intergenerational justice;
• identify the ethical criteria on the manner in which decisions concerning research on sources of
energy are to be taken on an informed basis and the implications arising from the use of energy in
different areas;
• propose an integrated ethics framework for the purpose of addressing the ethical issues related to
the production, use, storage and distribution of energy;
• identify the ethically relevant areas of energy research.
On 16 January 2013, the group adopted its 27th opinion unanimously: ‘An ethical framework for assessing research, production and use of energy’.
This opinion was composed during an intense working agenda, listening carefully to many opinions
and evidence from a range of relevant experts (3), including President Barroso’s Chief Scientific Advisor. The EGE addressed this problem during 10 meetings (March 2012 to January 2013), one open round
table (100 participants) and a meeting with the chairs of national ethics councils of the European Union
(or equivalent bodies).
(1) On 28 June 2011 the Council reached a political agreement on a Commission proposal for a nuclear research and training
programme for 2012–13. Although the Council’s discussion has been successfully concluded, some Member States felt that
a broad discourse on ethical issues and sustainable energy mix in Europe should take place and indicated the need to have
an opinion of the EGE on this topic.
(2) The role of the EGE is to provide the Commission with high quality and independent advice on ethical aspects of science
and new technologies in connection with the preparation and implementation of Community legislation or policies.
(3) http://ec.europa.eu/bepa/european-group-ethics/welcome/activities/index_en.htm
Ethically speaking 17, January 20135
In its opinion, the EGE has adopted an integrated ethics approach to achieve an equilibrium between
four criteria — access rights, security of supply, safety and sustainability — in the light of social, envir­
onmental and economic concerns.
The EGE recommended the following.
1. Access to energy
The EU should secure and promote the right of access to sufficient energy services to European
citizens and this right should be included in the next revision of the Treaty or the Charter of Fundamental Rights.
In accordance with the millennium development goals, the EU should collaborate to ensure access
to energy within a global perspective.
Both quantitative and qualitative data on energy poverty should be collated and analysed across
Member States by the Commission. On the basis of these data the Commission should then prepare, adopt and implement an action plan to tackle energy poverty in the interests of solidarity and
the health and well-being of European citizens.
2. Safety and impact assessment
Data regarding any kind of elements that affect risk in the production and transport of energy,
health and environmental consequences of its use, and the total costs of any kind of energy production, should be available in a well-informed and transparent way so that society informs itself
in order to take decisions.
Impact assessment of any energy source through its whole life cycle should be carried out on
a comparative basis including the question of accountability.
A comparative integrated impact assessment should be required for all energy sources, particularly
new technologies. Such an assessment should also involve the participation of local communities
at the earliest possible opportunity and assess impact and risks across the entire life cycle of the
energy production, storage and use, in line with the Lisbon Treaty and the precautionary principle.
The EU should commission studies to: (1) obtain additional data on the environmental and social
impact of fracking; (2) show the impact of shale gas on the transition to renewables; and (3) provide possibilities as to how to implement appropriate institutional oversight. The group therefore
agrees that from an ethical viewpoint, if safety and environmental issues remain following these
studies, fracking should not be pursued within the EU unless these conditions are met.
3. Security of energy supply
The EU should decrease its vulnerability to imported energy sources in a sustainable and environmentally sound manner.
It should ensure a coordinated policy in the field of energy supply as well as energy mix in order to
achieve European Union security of supply targets at national and European level.
It should also develop European energy smart grids to secure and optimise energy supply by
consolidating cooperation among European Union Member States in the spirit of solidarity, and
decentralised systems to support the energy supply. Furthermore, decentralised systems such as
micro-generation of energy should be sustained when possible.
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Ethically speaking 17, January 2013
4.Sustainability
Policies should be implemented to:
• reduce emissions of carbon dioxide and other gases producing greenhouse effects in the production of energy, as stated in the Energy Roadmap 2050;
• favour the development and use of low-carbon technologies with special attention to renewables, for example by fiscal and other relevant measures.
Every effort is made to improve energy efficiency and to reduce energy waste. Particular attention
should be paid to the following implementing measures to achieve this goal:
• the establishment of smart grids;
• encourage incentives and establish normative requirements to reduce and distribute energy
production and uses in the field of transport, construction, heating, etc. (non-essential energy
uses, incentives to build energy-efficient urban renovation);
• promote actions to promote availability of renewable technologies to vulnerable groups of society.
The awareness of citizens should be enhanced (starting from an early age) to adopt new attitudes
and lifestyles for responsible uses of energy by promoting and financing educational projects and
awareness-raising initiatives (e.g. promoting sustainability in schools).
The different Member States’ strategies should be evaluated on a regular basis, particularly in
light of the policies to use ‘conventional’, low-carbon and ‘renewable’ energy sources.
5.Research
The EGE recommends that priorities for research should be identified and should include research on:
• technologies that would contribute to the development of European smart grid infrastructure
that is configured in such a way to have sufficient capability to harness the potential benefits of
low-carbon and renewable technologies in particular when decentralised energy production is
developed;
• new technologies for storage of energy where or when excess is produced in order to facilitate
the use of energies that are intermittent;
• interdisciplinary research on storage and transport of materials and residues related to energy
production and use;
• analysis on residue production of different energy sources, its reduction or elimination and
possible reuse;
• determining the most suitable technologies, regulations and infrastructures for future carbon
capture, storage and sequestration;
• energy efficiency in all areas, but particularly in urban design and architecture, transport, utilities and industrial facilities.
Research funding should be allocated to ongoing work in the area of psycho-social modelling of
individual and community behavioural interventions in the area of energy conservation in order to
support energy-efficiency initiatives in setting new standards beyond current best practice.
Comparative studies should be carried out on the implementation of the European Energy Roadmap 2050 in European Union Member States (quantitative and qualitative data), with specific
emphasis on sociocultural and geographical factors that have justified the adoption of specific
energy mix systems at local level.
Ethically speaking 17, January 20137
A comparative impact assessment of all energy sources should be undertaken, using the integrated
methodology of technological, social and political scenarios. They should include scenarios of
worst case (social, environmental), short-term and long-term prognoses, geopolitical contexts and
safety risks for workers.
Social sciences (individual responsibilities), psychology, social anthropology, sociology, ethics and
law should be studied.
Interdisciplinary research should be financed under Horizon 2020 on the ethical, legal and social
implications (thematic programme) of energy.
As regards democratic deliberation, participatory instruments and responsibility for future generations, the EGE recommends that the European Union should set incentives to implement participatory
approaches, for example in the following areas: (1) civil society ‘hearings’; (2) local and regional energy
cooperatives; (3) local initiatives to save energy; and (4) local and regional initiatives to low-carbon
urban development and community design.
The EGE also recommends that the European Union and its institutions should set up a structure called
‘Ombuds-person’ to protect the interests of future generations. Its function would not be to decide, but to
promote enlightened decisions by bringing into discussions the long-term effects of all political, socioeconomic and technological decisions.
The EGE discussed the opinion in a public open round table on 18 September 2012 (stakeholders involved
included academia, civil society representatives, NGOs, industry, etc.) and discussed this topic with the
chairs of the EU national ethics councils under the auspices of the Cypriot Council Rotation Presidency
(4 October 2012).
In order to promote transparency, all documents related to the EGE work (remit, hearings with external
experts, conferences and meetings) have been published on the EGE website (4). The same approach has
been taken for all actions on ethics under the responsibility of the Bureau of European Policy Advisors
(BEPA) Ethics Sector.
The opinion will be hand-delivered to President Barroso on 20 February 2013 and presented to relevant
experts at the symposium on ‘Benefits and limitations of nuclear fission for a low-carbon economy’,
organised by the European Commission in cooperation with the European Economic and Social Committee (EESC), which will take place in Brussels on 26 and 27 February 2013.
The group will now start its work on a new opinion, requested by President Barroso, on ethics of security
and surveillance technologies. The above opinion should be adopted by December 2013 or January 2014.
Maurizio Salvi, PhD,
Bureau of European Policy Advisors (BEPA),
Head of the EGE Secretariat,
Head of the BEPA Ethics Sector
(4)http://ec.europa.eu/bepa/european-group-ethics/welcome/activities/index_en.htm
8
Ethically speaking 17, January 2013
General information on
activities of the EU national
and regional ethics
committees
Ethically speaking 17, January 20139
10
Ethically speaking 17, January 2013
BELGIUM
The Belgian Advisory Committee on Bioethics
Event in Brussels (Auditorium 44, Passage 44, 1000 Brussels)
17 April 2013
My health, everyone’s health?
The ethical challenges of public health
The concept of health, defined as ‘a state of complete physical, mental and social well-being’ (Ottawa
Charter for Health Promotion), concerns the individual as a person, but also the individual as a member
of a social group. So it shouldn’t be surprising that the field of action of the public health concept has
been expanding in order to more globally address the behaviour of human beings within their environment. Naturally, that field of action concerns the prevention of epidemics, but also the prevention of
cardiovascular diseases, addictions, violence in the family and sexual abuse or bullying, to mention just
a few examples.
Starting from current topics such as compulsory vaccination, the fight against tobacco addiction, obesity and stress, the Belgian Advisory Committee on Bioethics will, on the occasion of its ninth biennial
conference, pose questions about the practice and the idea of public health, on the basis of the values and
standards that play a role therein. Solidarity, responsibility, autonomy, equality, integration, justice: how
are they evolving? Where do the potential conflicts lie? What will become of the double principle of solidarity and collective responsibility on which the protection of public health is based?
The subject is a wide-ranging one, since it touches upon health and, more broadly, biological life itself,
which over the past half century have become central elements in our value systems. But as usual, the
committee will — in a didactic yet lively manner — address the subject in interaction with members of
the public who, throughout the day, will have a chance to speak, after having participated in a survey
during the morning.
Please join us on 17 April 2013 to share your views and impressions.
For further information, please log on to the committee’s website at http://www.health.belgium.be/bioeth
Most recent publications
Opinion No 51 of 12 March 2012 on the publication of research results of experiments on humans.
Opinion No 52 of 12 March 2012 on the ethical aspects of certain provisions of the European and Belgian regulations on human tissues and cells used in reproductive medicine.
Opinion No 53 of 14 May 2012 on the refusal of medical treatment by a pregnant woman with impact
on the foetus.
Opinions are available in French and Dutch, on the website
http://www.health.belgium.be/bioeth
Ethically speaking 17, January 201311
Further information
Monique Bosson
Information Officer
Belgian Advisory Committee on Bioethics
Address
Rue de l’Autonomie 4
1st floor
1070 Brussels
BELGIUM
Tel.: + 32 25250907
E-mail: monique.bosson@health.fgov.be
Website: http://www.health.fgov.be/bioeth
12
Ethically speaking 17, January 2013
CYPRUS
The Cyprus National Bioethics Committee
The Cyprus National Bioethics Committee (CNBC) was established in 2001 by ‘Τhe Law providing for
the establishment and function of the National Bioethics Committee’ (Laws 2001 until 2010).
Its mandate is to monitor constantly, survey, systematically analyse and evaluate the issues and problems
associated with scientific research, advances in and applications of biotechnology, biology, medicine,
genetics and pharmaceutics, along with human intervention in biological processes and the human genotype, and to investigate their moral, deontological, social, humanistic and legal dimensions.
The CNBC is an independent body not subjected to administrative supervision by any ministry, agency,
department or service and has the powers conferred on it by the current law and any other law.
The CNBC has 13 members, including the chairperson. The members represent different professions and
disciplines, and are appointed by the Council of Ministers of the Republic of Cyprus for a 4-year term.
The law stipulates that at least four members must come from the humanities and social sciences; four
from medical and biological sciences; and four members must be from any other science or profession or
be distinguished for their contribution in any area of activity in science and society.
On 14 July the Council of Ministers of the Republic of Cyprus appointed new CNBC members for a term
of office until 13 July 2015.
According to the provisions of the national legislation currently in force, the CNBC is the body responsible for performing the bioethical review of all research protocols involving human subjects in Cyprus
(both biomedical and clinical research). In order to fulfil this, the CNBC has adopted with very few
changes the World Health Organisation ‘Operational guidelines for ethics committees that review biomedical research’ as the basis of the guidelines for ethics committees reviewing biomedical research
involving human subjects in Cyprus, which were enacted on 31 March 2005 (Κ.Δ.Π. 175/2005). In accordance with these guidelines and with the authority conferred on it by Law No 150 (I)/2001 the
Committee set up the following three bioethics review committees:
I. The Review Bioethics Committee for Biomedical Research on Human Beings and their Biological
Substances;
II. The Review Bioethics Committee for the Clinical Trials on Medicinal Products of Human Use; and
III.The Review Bioethics Committee for Biomedical Research on Human Being and their Biological
Substances and the Clinical Trials on Medicinal Products of Human Use.
The review bioethics committees review protocols relating to:
• biomedical research on human beings and their biological substances;
• clinical trials on medicinal products for human use; and
• research on medical devices applied to human beings.
The role of the review bioethics committees is to:
1. contribute to safeguarding the dignity, rights, safety and well-being of all actual or potential
research participants;
2. provide an independent, competent and timely review of the ethical aspects of proposed studies;
3. review research proposals before the research begins.
Ethically speaking 17, January 201313
The CNBC appoints the members of the review bioethics committees and monitors, directs, and coordinates their work, and reviews their decisions by applying the specific procedures provided for in the
operational guidelines (Κ.Δ.Π. 175/2005).
On 1 December 2011 new members were appointed in the review bioethics committees in replacement
of the members whom the term of office finished on 30 November 2011. The term of office of the new
members is from 1 December 2011 to 30 November 2013.
Current work and forthcoming opinions
• The Cyprus National Bioethics Committee in collaboration with the European Commission Directorate-General for Research and Innovation successfully organised in Nicosia, Cyprus, the 18th
National Ethics Councils Forum from 4 to 5 October 2012. Seventy participants from the European Union Member States’ national ethics councils and from associated countries participated in
the event. The main topics were information communication technology and ethics, responsible
research and innovation, and ethics and education.
• Updating the operational guidelines for conducting biomedical research in Cyprus.
Previous opinions
1. Opinion of the Cyprus National Bioethics Committee on the bioethical considerations arising from
the chemical (hereinafter referred to as medicinal) and surgical castration of people convicted for
sexual offences, issued on 6 July 2010 (available only in Greek).
2. Opinion of the Cyprus National Bioethics Committee on obtaining informed consent from minors
in the context of research protocols, issued on 25 May 2010 (available only in Greek).
3. Opinion of the Cyprus National Bioethics Committee on obtaining informed consent from adults,
issued on 1 December 2009 (available only in Greek).
4. Opinion on the establishment and use of human biobanks and registries of human biological samples for research purposes, issued on 23 June 2009 (available in Greek and in English).
5. Opinion on the use of ionising radiation in medical practice, issued on 12 May 2009 (available in
Greek and in English).
6. Opinion on palliative care for terminally ill and dying patients, issued on 1 July 2008 (available in
Greek and in English).
7. Opinion on genetically modified organisms, issued on 3 April 2008 (available in Greek and in
English).
8. Opinion on the prenuptial test for thalassaemia before the conclusion of a civil wedding, issued
on 24 March 2008 (available only in Greek).
9. Opinion on predictive health information in the conclusion of health and life insurance contracts,
issued on 22 January 2008 (available in Greek and in English).
10.Opinion on medically assisted human procreation (5 March 2007) (available only in Greek).
11.Opinion on PGD and sex selection of the in vitro procreated embryos, issued on 1 November 2006
(available only in Greek).
12.Opinion on human cloning, issued on 12 September 2006 (available only in Greek).
13.Opinion on human organ donors’ registries, issued on 19 July 2006 (available only in Greek).
14.Opinion on cord blood banking, issued on 27 April 2004 (available only in Greek).
15.Opinion on the transplantation of biological substances of human origin, issued on 14 April 2003
(available only in Greek).
16.Opinion on the use of preimplantation genetic diagnosis method, issued on 20 October 2003 (available only in Greek).
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Ethically speaking 17, January 2013
Further information
Dr Michael Voniatis
Chairman
The Cyprus National Bioethics Committee
Address
Nikou Kranidioti
Engomis Medical Centre
1st Floor
2411 Engomi
CYPRUS
Tel. +357 22809038 / 22809039
Fax +357 22353878
E-mail: cnbc@bioethics.gov.cy
Website: http://www.bioethics.gov.cy
Ethically speaking 17, January 201315
FRANCE
The National Consultative Ethics Committee for Health and Life Sciences
Legal basics and mandate
• The law of 6 August 2004 was reviewed in July 2011.
This new law gives to the French National Consultative Ethics Committee (CCNE) a very important new
mission in terms of initiating a public debate, every time there is a project of reform submitted to the
parliament in the field of its skills.
In the absence of a project, the CCNE has to organise ‘general states’ every 5 years.
• The mandate of half the committee members was renewed in April 2012.
The new composition of CCNE in April 2012 is as follows.
♦♦ President: Alain Grimfeld
Vice-President: Ali Benmakhlouf
Honorary Presidents: Didier Sicard, Jean-Pierre Changeux
♦♦ Members:
Yves Agid, Jean Claude Ameisen, Régis Aubry, Michaël Azoulay, Christiane Basset, François
Beaufils, Joëlle Belaisch-Allart, Marie-Germaine Bousser, Margaret Buckingham, Sylvie
Cazalot, Bernard Cazeau, André Comte-Sponville, Alain Cordier, Bernard Debré, Anne-Marie
Dickelé, Frédérique Dreifuss-Netter, Roger-Pol Droit, Pierre-Henri Duée, Patrick Gaudray,
André Glucksmann, Jean-Pierre Kahane, Xavier Lacroix, Claire Legras, Claude Matuchansky,
Lucien Neuwirth, Francis Puech, Alice René, Philippe Rouvillois, Michel Roux, Louis
Schweitzer, Dominique Stoppa-Lyonnet, Claude Sureau, Dominique Thouvenin, Claudine
Tiercelin, Didier Truchet, Michel Van Praët, Jean-Louis Vildé, Bertrand Weil.
♦♦ General Secretary: Marie-Hélène Mouneyrat
• By decree of 9 November 2012, Jean Claude Ameisen was appointed President and Alain
Grimfeld was appointed Honorary President.
The CCNE on the international scene
• A delegate from the CCNE was present at the Ninth Global Summit of National Bioethics Advisory Bodies which was held from 25 to 28 September 2012 in Tunis.
• A trilateral meeting was held between the German, British and French ethics committees in Berlin
on 8 November 2012.
Current work
• Three permanent working groups:
♦♦ neurosciences;
♦♦ medically assisted procreation;
♦♦ biodiversity relations between the human race and the living.
Ethically speaking 17, January 201317
• Other current working groups:
♦♦ ethical questions raised by the products of health;
♦♦ ethical questions raised by global analysis of the human genome;
♦♦ ethical questions raised by self-screening tests for HIV;
♦♦ ethical questions connected to medical-surgical techniques related to transsexualism.
More recent publications
• Opinion No 116: Ethical issues arising from functional neuroimaging.
• Opinion No 117: Use of stem cells derived from umbilical cord blood, the umbilical cord itself and
the placenta, their storage in biobanks. Ethical issues.
• 30th anniversary of the CCNE, Paris, 22 and 23 March 2013.
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Ethically speaking 17, January 2013
GERMANY
The German Ethics Council
Opinion on dementia and self-determination
In April 2012, the German Ethics Council presented its opinion on dementia and self-determination,
whose aim is to facilitate understanding of the situation of persons with dementia and which contains
recommendations for more account to be taken of the individual situation of those concerned so as to
assist the preservation of their self-determination.
Some 1.2 million people with moderate to severe dementia are currently living in Germany. In view of
the growing number of affected persons, dementia is one of the principal health-related challenges of
our time, in terms not only of health and social policy, but also of our conception of ourselves as human
beings and citizens.
Self-determination is an essential aspect of humanity’s understanding of itself and a particular focus
of all ethical discourse. Attention has hitherto centred almost exclusively on the deficiencies associated
with dementia. If human individuals are equated with their intellectual faculties, dementia will inevitably be seen as involving the destruction of their humanity. If, however, they are regarded not only as
thinking but also as feeling, emotional and social beings, it will be easier to allow for the resources that
still exist in each affected person. This approach underlies the German Ethics Council’s opinion, which
is concerned to show that people with dementia also retain elements of self-determination that should be
observed and supported.
Both research in and the practice of medicine and nursing are predominantly directed towards early
diagnosis and symptomatic relief, less attention being devoted to the long-term progress of the disorder
and the ongoing care for which it calls. At present the condition can only be delayed, but not permanently
held in check, so that persons with dementia are confronted with progressively declining autonomy and
an increasing need for help. Precisely in this situation, allowing scope for the exercise of whatever degree
of self-determination is still possible is positively demanded by the respect we owe to every individual.
It is therefore all the more important to discover and facilitate the perception and promotion of, and
respect for, the remaining self-determination of people with dementia. This calls for a posture of attentiveness that is based on the concrete needs of the affected person and reflects the approach of ‘assisted
self-determination’.
The German Ethics Council notes that the principles of attentive treatment of people with dementia
whereby their self-determination is supported for as long as possible are observed with great commitment in many families and care homes. The caring family members and professional nursing staff without whose ongoing dedication the current level of care could not be maintained deserve all possible recognition and support. However, great efforts are called for on the part of society as a whole if the care of
people with dementia is still to be guaranteed in the future. To this end, the German Ethics Council has
drawn up a total of 16 recommendations, the most important of which are outlined below.
• The German Ethics Council supports the federal government’s aim of developing a national action
plan for dementia with a view to coordinating the work of all actors involved so as to achieve
nationwide improvement of the medical, nursing and social care of people with dementia. This
will also help to strengthen the social inclusion of people with dementia and to acknowledge their
entitlement to self-determination.
• The concept of long-term care needs should be reviewed to take adequate account of the selfdetermination potential of persons with dementia and the resulting nursing tasks.
Ethically speaking 17, January 201319
• The work of caring family members requires effective support and financial recognition. Consideration should be given to seeking the help of people familiar with caring in the home environment
to nurse a person with dementia in hospital too.
• Greater financial support should be given to outpatient communal housing and residential communities for persons with dementia. These include in particular assisted-living communities close
to the homes of those concerned, offering an environment permitting self-determination in which
professional nursing staff and family members work together.
• Fundamental research in the field of dementia should be assisted mainly in the form of translational research directed towards clinical applications. The support given should also extend to
research on the aspects of clinical medicine and nursing science, psychosocial issues and accompanying ethico-legal research and research on care provision.
• To preserve and protect the self-determination potential of persons with dementia, the principles
of the UN Convention on the Rights of Persons with Disabilities, which extend equally to people
with dementia, should be consistently applied.
• The willingness of family members to undertake voluntary care should be reinforced by practical
support in the process of care and by societal recognition.
• In evaluation of the applicability of an advance directive, expressions of the will to live by a patient
who lacks decision-making capacity should be taken into account. In cases where the presence of
decision-making competence cannot be reliably ruled out, life-affirming utterances should always
take priority over statements to the contrary in an advance directive owing to the irreversibility of
abstaining from life-preserving measures.
In a dissenting position statement, council Member Volker Gerhardt expressed misgivings on two
aspects. The first concerns the irrevocable loss of personality that accompanies the increasing decline
in self-determination — a factor that must on no account be minimised. The second is the question
of a wish to commit suicide, which is particularly relevant in dementia in view of the problems of
self-determination.
The opinion can be accessed (in German) at http://www.ethikrat.org. An English and French translation
will be available in due course.
Further information
Dr Joachim Vetter
Head of Office Ulrike Florian
Press and public relations officer
Address
German Ethics Council
German Ethics Council
Jaegerstrasse 22/23
Jaegerstrasse 22/23
10117 Berlin10117 Berlin
GERMANYGERMANY
Tel. +49 3020370242 Tel. +49 3020370246
Fax +49 3020370252
Fax +49 3020370252
E-mail: vetter@ethikrat.org E-mail: florian@ethikrat.org
Website: http://www.ethikrat.org
Website: http://www.ethikrat.org
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Ethically speaking 17, January 2013
GREECE
The Hellenic National Bioethics Commission
A. Current work
Currently the commission is discussing ‘Enhancement of human characteristics: physical, mental and
cognitive’.
Please note that the full text (in PDF format) of all opinions and reports issued by the commission, in
English, can be found at the following URL: http://www.bioethics.gr/category.php?category_id=55 or
can be requested from the Secretariat, Secretariat@bioethics.gr.
B. Seminars on bio-law
The commission continues to organise the seminar series on bio-law which was first launched in
February 2010.
This initiative, which is addressed mainly at young scientists (lawyers, physicians and sociologists) aims
at inspiring participants in their work and at supporting the development of the new field of bio-law in
Greece.
The seminars are held once per month either at the premises of the commission or at the premises of
another institution or organisation of the public sector which hosts the event. The participants present
their work on a specific bioethical issue, and the presentation is followed by discussion led by a commentator. So far there have been presentations on the following subjects: ethical status of the foetus,
euthanasia, clinical trials, biobanks, patents, surrogacy, genetic data, social media, biopiracy, rights of
the mentally ill, QUALY’s, medical guidelines, etc.
C. A new educational initiative
Since January 2013, the commission organises an integrated educational programme of seminars aiming
at an introduction to bioethical topics. The programme, which will last up to June, consists of 12 2-hour
meetings that can be attended by undergraduate and postgraduate students as well as graduates of higher
academic institutions. The number of participants will be limited to 15 (prioritised in order of submission of the application, for which some proof of experience on the topic will be required). A certificate of
participation will be issued to those who attended the programme. Registration is free.
D. Communicative tools
Since October 2008 the commission’s newsletter Bio-ethica has proved to be a most valuable tool for
communication of the commission with the general public. The newsletter includes announcements,
news and events of the commission, international news related to bioethics, book reviews and information on local and international bioethics meetings or conferences and is sent to an extensive list of recipients in Greece, at the end of every month.
E. ‘Bioethics goes to school’
On 22 November 2011, the commission launched an educational initiative welcoming for the first time
in its premises 15 high-school students, in order to inform them about bioethical issues, especially about
stem cells and cloning. An enthusiastic dialogue was triggered between the students and the representatives of the commission.
Ethically speaking 17, January 201321
The ‘Bioethics goes to school’ activity continues successfully with a total of six interested schools participating so far.
For more information:
http://www.bioethics.gr/document.php?category_id=97&document_id=1317
F. Past and future conferences organised under the auspices of the commission
• 11 June 2012: Conference on ‘Genetic tests — bioethical dilemmas’. This was organised by the
Hellenic Association of Medical Geneticists under the auspices of the commission and took place
at the history museum of the University of Athens.
• 11 December 2012: Conference on ‘Genetics in the service of health — genetic tests, prenatal
diagnosis, in vitro fertilisation — contemporary challenges and dilemmas’. This was organised by
the Institute of Biomedical Science Golden Helix under the auspices of the commission and hosted
by the Eugenides Foundation.
G. Participation in meetings
• The commission regularly participates — upon invitation of scientific institutions, universities or
other academic institutes — at meetings/conferences/workshops held in Greece.
• The commission participated — upon invitation — at the 18th national ethics councils (NECs)
forum in Nicosia organised under the auspices of the EU’s Cypriot Presidency by the Cyprus
National Bioethics Committee (3 and 4 October 2012). The commission was represented by Professor Theocharis Patargias, Member.
Further information
Mrs Marianna Dracopoulou
Head of Secretariat
Address
47, Evelpidon str.
113 62 Athens
GREECE
Tel. +30 2108847700
Fax +30 2108847701
E-mail: Secretariat@bioethics.gr
Website: http://www.bioethics.gr
22
Ethically speaking 17, January 2013
ITALY
Update on the National Bioethics Committee’s activities in 2012
Opinions
• Bioethical aspects of aesthetic and reconstructive surgery (21 June 2012)
The opinion emphasises the unacceptability of disproportionate intervention, as it is excessively
invasive or unnecessarily risky in relation to the possible benefits required by the patient. Intervention on minors and those lacking the capacity to consent may be done in their exclusive and
objective interest in terms of health. The committee believes that there should be adequate social
information and education regarding the risks and benefits of aesthetic surgery and it calls for
greater rigour in the formation and professionalism of plastic surgeons. As regards reconstructive
surgery, the National Bioethics Committee (NBC) believes that these operations, although not
essential for the survival of the patient and despite still being therapeutically experimental, are
nevertheless ethically justifiable, subject to careful assessment of the risks and benefits, in relation
to general considerations of the quality-of-life improvement of the patient. The NBC encourages
public awareness campaigns for the donation of external organs and tissues, as normally takes
place for the donation of internal ones.
• Conscious objection and bioethics (12 July 2012)
On the legal side, the new frontiers of bioethics increasingly pose new challenges to the constitutional, democratic and pluralist state to avoid imposing obligations contrary to consciously exploiting those who exercise a profession or at least protect conscious objection when inviolable human
rights are at stake without stifling the principle of legality. Therefore, legally sustainable conscious
objections should not restrict or make more difficult the exercise of rights conferred by law nor
weaken the bonds of solidarity deriving from common membership to the social body. Several
recommendations are derived from these conclusions: in the protection of conscious objection
which ensues from its being constitutionally founded, it is necessary to take adequate measures to
ensure the provision of services, taking care not to discriminate either objectors or non-objectors,
and therefore the organisation of tasks and recruitment that can balance, on the basis of available
data, objectors or non-objectors.
• On the communication of the national health system to patients on the costs of health services
(28 September 2012)
In response to a question addressed by the Minister of Health, the NBC examines the various
issues that justify direct communication to the patient (transparency by the state/regions, the
assumption of responsibility by citizens) and the opposing arguments (the possible attribution of
guilt to the patient and the introduction of an economic logic in healthcare).
The NBC, albeit the diversity of positions within it, expressed itself unanimously on the modalities
of communication (possible for some members, required for others). The NBC recommends the
communication be given by an ad hoc document, with appropriate modalities and not included in
the medical record in order to avoid discriminations and forms of attribution of guilt to the patient
while safeguarding the privacy of personal data concerning health. The committee underlines the
need for this communication to be included in a context of global education of society, in order to
grasp the relationship between individual health and social health in order to underline the close
link between individual and social health.
Ethically speaking 17, January 201323
• Food animal production and animal welfare (28 September 2012)
The NBC, in the context of the recognition of the primacy of human life and health, favours bioculture ethics which makes it possible to eliminate a concept of the animal exclusively as a means
of satisfaction of human needs and interests. This position is based on the advanced indicators of
animal welfare that allow a scientifically satisfactory definition of ethologically and physiologically appropriate breeding conditions. On such basis, the committee recommends the promotion
of an enterprise and food-chain culture aimed at a solid appreciation of the value of human responsibility towards animal welfare, suggesting the adoption of a labelling system which would allow
consumers to identify these products. The committee recommends the highlighting of the central
role of the veterinary surgeon in assessing the animals’ living conditions and in recognising the
parameters of their well-being.
• Clinical trials in adult or minor patients who are unable to give informed consent in emergency
situations (28 October 2012)
The committee, stressing the central need to protect the subject’s rights, safeguard and well-being,
in case the patient is unable to express valid informed consent and in the absence of a legal representative, justifies the licitness of trials in emergency situations on certain conditions: the approval
of a protocol based on solid experimental evidence adopted by an independent national ethics
committee established ad hoc and composed by doctors and nurses expert in the sector, jurists,
forensic scientists, patients’ rights representatives and bioethicists; the verification of a possible
previous opposing will expressed by the patient; the request for a differed consent by the patient
or his/her legal representative; and the publication of the trial results in order to avoid useless
duplications.
Motions
• Motion to complete the ratification procedure of the Oviedo convention (24 February 2012)
Since the ratification instrument, Act No 145/2001, has not yet been registered, the NBC underlines the need to conclude the ratification process and to examine all the issues related to the
completion of the ratification from a bioethical perspective, including an indication of potential
conditions and modifications of the domestic law and regulations.
• Declaration on the document ‘Proposal for a regulation of the European Parliament and of the
Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/
EC’ (17 July 2012)
The declaration highlights certain elements which are approved and others which cause concern
in ethical terms. The need for simplification and centralisation of administrative procedures, the
search for ways to reduce excessive bureaucratisation, in order on the one hand to ensure the interests of the patient, avoiding unnecessary delays, and on the other to ensure European competitiveness internationally, are appreciated in principle. However, the NBC points out that the carrying
out of the indicated procedures in a very short time could compromise patient protection. The
committee criticises the lack of an explicit reference to ethics committees as assessment bodies for
clinical experimentation evaluation.
Working groups
Body donation to research; bioethical issues in the treatment of mental disabilities; military bioethics and
enhancement; neuroscience and enhancement; ethics committees; synthetic biology.
24
Ethically speaking 17, January 2013
Events
• National bioethics conference for schools: ‘Good to eat’ bioethics, nutrition and food safety
(11 and 12 October 2012, Salerno, Italy)
The conference was held over 2 days: the first day of the conference was dedicated to food,
stressing the importance of educating pupils; the second day was dedicated to food security with
the participation of veterinarians from the Ministry of Health, the European Food Safety Authority
(EFSA), the region and the local health department of Salerno.
• International conference on the role and functions of bioethical committees (23 November 2012,
Rome, Italy)
The conference was held with the participation of the President of the EGE, Prof. Julian Kinderlerer; the President of the International Bioethics Committee of Unesco, Prof. Stefano Semplici;
the President of the Nuffield Council on Bioethics (United Kingdom), Prof. Jonathan Montgomery;
Member of the Comité Consultatif National d’Ethique pour les sciences de la vie et de la santé,
Prof. Patrick Gaudray; and the Vice-Chair of the Deutscher Ethikrat, Prof. Peter Dabrock. The
initiative aimed to promote dialogue between members representing different European bioethics
committees on the functions and roles of bioethics committees at national and international level.
Further information
Prof. Laura Palazzani
Vice-President of the Italian Bioethics Committee
Full Professor of Philosophy of Law at Lumsa University (Italy)
Dr Marina Bonfili
Member of the Scientific Secretariat of the Italian Committee for Bioethics
Address
Comitato Nazionale per la Bioetica
via della Mercede 96
00197 Rome RM
ITALY
Tel. +39 0667794601
Fax +39 0667794686
E-mail: cnbbioetica@palazzochigi.it; palazzani@lumsa.it; mbonfili@palazzochigi.it
Website: http://www.governo.it/BIOETICA
Ethically speaking 17, January 201325
MALTA
IVF law
After 20 years of unregulated in vitro fertilisation (IVF) practice and 9 years of political debate, Malta
finally has a law regulating IVF practice. The Bioethics Consultative Committee (BCC) played a significant part in reaching the social consensus necessary for the passage of this act which needed to be in
line with the social value norms held by Maltese society. The law does not only regulate IVF procedures,
but also touches on other bioethical issues such as embryo testing, gamete donation, cloning, hybrid and
chimera use, germ line gene therapy and stem cell use. The title of the act was inspired from the German
law and termed the Embryo Protection Act.
The act strives to allow IVF to treat infertility for married couples and those in stable relationships and
will make the treatment available free of charge at state hospitals. It became active on 1 January 2013.
One interesting feature about the act is that it will not allow the freezing of human embryos as a regular part of the IVF procedure except in very rare life-threatening contingent situations which would be
a threat to the embryo’s life itself. One such condition is the death or illness of the mother after fertilisation has already taken place. Instead of embryo freezing, a new technique called oocyte vitrification will
become the norm used with no more than three oocytes fertilised and transferred in difficult cases, but
with a preferable option of one or two according to circumstances for both artificial insemination and
IVF. Oocyte vitrification techniques have recently been shown to be equally effective as embryo freezing
techniques in obtaining pregnancy rates. This avoids the high embryo destruction rates associated with
embryo freezing, a rate which runs into hundreds of thousands in all centres which use this technique.
Maltese society holds dear the principal that a human being occurs after the oocyte has been fertilised
by the sperm and that this human being ought to be protected. All parties in parliament subscribe to this
principle. Human embryology gives scientific credence to this position and rendering the sacrifice of
human lives in order to solve the fertility problems of infertile couples would be deemed consequentialist
at the least and a gross disrespect to human life at its most fragile moment. This act shows that science
and ethics can indeed move hand in hand! Information on the act may be obtained from http://www.gov.
mt by clicking on the parliament link and downloading the published Act XXI of 2012.
Below is a history of the contribution to the national debate by the BCC, prepared by the BCC secretary,
Ms Maryanne Ciappara.
Medically assisted procreation — the contribution of the BCC
The following is a list of the major events.
1992
‘Reproductive technology: ethical and legal considerations’, report of the subcommittee,
National Bioethics Committee, 1992.
The document was extensively discussed at two separate seminars held at the Department
of Health.
2000
‘Ethical considerations relating to human reproductive technology’, report of the Bioethics
Consultative Committee, 2000.
This document was discussed at the symposium on reproductive technology.
2004
The BCC started revising the document of 2000, however this had to be interrupted in order
to participate in a prolonged consultation process with a Select Parliamentary Committee on
Social Affairs.
Ethically speaking 17, January 201327
2004–5
Members of the BCC were invited to make verbal or written submissions on various aspects
of medically assisted procreation before the Select Parliamentary Committee on Social
Affairs between 2004 and 2005 which was to advise parliament in the drafting of the
legislation on medically assisted procreation. Proceedings of the meetings were published in
a detailed report on medically assisted procreation by the House of Representatives in 2005.
2005
Conference on ‘Bioethics and the family’ in collaboration with the Family Commission
organised in April 2005. Prof. Agostino was the guest speaker, who expanded on the Italian
law on reproductive technology.
2005
The BCC responded to questions from the Minister of Foreign Affairs, Hon. Dr Tonio Borg,
on a number of issues related to medically assisted procreation.
2009
A draft bill on embryo protection was sent to the BCC by Hon. Dr Joseph Cassar, Parliamentary Secretary for Health, for an opinion. The BCC discussed in depth the draft bill. It
agreed that IVF should be offered to heterosexual couples, no gamete donation should be
accepted and counselling should be given for prospective parents, and it called for the setting
up of an independent regulatory authority. There was no consensus on the number of eggs
to be fertilised.
The draft bill with the amendments, accompanied by a detailed letter explaining the clauses on
which there was no consensus, and concerns of the BCC were sent to Hon. Minister John Dalli,
then Minister for Social Policy, and Hon. Dr Cassar, Parliamentary Secretary for Health.
The draft bill with the amendments together with the concerns of the BCC were send to the
Minister of Justice, Hon. Dr Carmelo Mifsud Bonnici, and were later discussed with the
minister during a meeting held for this purpose.
2009–10 A parliamentary committee was set up to discuss legislation on assisted procreation. The
committee was asked specially to discuss three issues, these were: the eligibility of couples
to treatment, the freezing of embryos and the donation of gametes. These issues were left
open in the report of the Social Affairs Committee, 2005. Members of the BCC were invited
to make written submissions on these issues. The Parliamentary Committee on Medically
Assisted Procreation presented its report in October 2010.
The BCC, after discussing the report, issued a press release, amplifying its opinion. It
objected to the freezing of embryos and noted that not enough importance was given to technological developments which would allow the vitrification of oocytes.
2011
The BCC continued its trust in the vitrification of oocytes as an alternative to the freezing
of embryos.
A presentation on the vitrification of oocytes was made by the Chairman of the BCC at
a conference on medically assisted procreation.
2011
The case for the vitrification of oocytes was made at the meeting of the Social Affairs Committee. The Social Affairs Committee had reconvened with the objective of evaluating the
vitrification of oocytes as an alternative to the freezing of embryos following public objections by the lobby group, Professionals Against Embryo Freezing (PAEF).
The report of the Social Affairs Committee was presented to parliament.
2011
28
A conference on medically assisted procreation and freezing techniques was organised in
May 2011. Guest speakers were Dr Eleonora Porcu, Assisted Reproduction Unit attached to
the School of Medicine at the University of Bologna, and Dr Helen Watt, Senior Research
Fellow at the Anscombe Bioethics Centre, Oxford.
Ethically speaking 17, January 2013
2012
Issues relating to medically assisted procreations were discussed at a meeting with Hon. Dr
Chris Said, Minister for Justice. The BCC continued its discussions and representations on
medically assisted procreation.
2012
The Embryo Protection Bill was published in mid-summer and was open for consultation.
Submissions on the bill were made by members of the BCC. The issues raised included the
Embryo Protection Authority, and the number of embryos to be transferred to the uterus. It
was noted that apart from some details surrounding these two issues, the bill included all the
principles that the BCC had submitted to the authorities in the amended draft bill in 2009.
These issues were later consensually resolved.
2012
The Embryo Protection Act, Act XXI of 2012, was passed through parliament on
26 November.
Dr Michael Asciak MD, M.Phil, PhD
Chairman
Ethically speaking 17, January 201329
PORTUGAL
The National Council of Ethics for the Life Sciences
Name: Conselho Nacional de Ética para as Ciências da Vida (CNECV) (National Council of Ethics for
the Life Sciences).
Year of establishment: the CNECV was set up in 1990 pursuant to Law No 14/90 of 9 June as an independent consultative body. Having entered its fourth term of office (2009–14), the CNECV currently
functions adjunct to the Portuguese parliament — Law No 24/2009 of 29 May.
Remit of the CNECV: to analyse and give opinions regarding the ethical problems which arise from
scientific progress in the fields of biology, medicine or general healthcare and the life sciences. The
council has been involved in publicly debating current ethical themes and organising and participating
in national and international events. The CNECV strives to fulfill its responsibilities and to stimulate the
bioethics debate at all levels of society.
Recent opinions
64/CNECV/2012 — Opinion on a decision model for financing the cost of medicines: The request
made by His Excellency the Minister of Health concerned the drafting of an opinion on the ethical basis
for the funding of three groups of drugs, namely retroviral drugs for HIV+ patients, oncologic drugs and
biological drugs in patients with rheumatoid arthritis. The request for an opinion stated clearly that the
measures in question fall into the need for the sustainability of the National Health Service (NHS) and
points out that ensuring access to healthcare for all citizens is essential.
Among other considerations, the CNECV stated that there is an ethical foundation for the NHS to promote measures to contain the costs of medicines. Such measures should be based on a transparent and
participative decision model in order to ensure the most equitable and balanced distribution of existing
resources. In this sense, the principle of accountability for reasonableness implies the involvement of
civil society and health professionals in the decision-making process, and all should make the respective
declaration of conflict of interest, to which there is public access.
Furthermore, in decisions on cost rationalisation, it should be made clear that the fundamental choices are
between ‘the cheapest of the best’ (drugs of proven effectiveness) and not about ‘the best of the cheapest’.
The CNECV considered it urgent to identify situations of inequality in access to medicines by different
groups of patients, in order to try to prevent ethically unacceptable situations.
The council also recommended that, as part of their ethics training, training content on this issue must be
introduced in the core curriculum required at pre- and post-graduate level in the health courses, allowing
professionals to make fairer and more responsible decisions.
Moreover, models of accountability of expenditure on health should be developed and applied, allowing
in a clear manner for everyone to know the criteria used.
In drugs subsidised by the NHS, the CNECV underlined the urgency to re-evaluate current spending in
terms of cost-opportunity and cost-effectiveness, with possible substitutions, disinvestments or suspensions. Indeed, the debate cannot be limited to containment of additional costs, but to make better use of
existing resources and to fight waste and inefficiency in health.
In any case, the CNECV considers that it is essential to not undermine the trust connection and therapeutic alliance between patients and health professionals.
Ethically speaking 17, January 201331
The CNECV paid particular attention to reflection on this theme in its seminar ‘Ethical grounds in health
priorities,’ held on 29 November 2011 at the Calouste Gulbenkian Foundation, Lisbon (CNECV, 2012).
65/CNECV/2012 — Opinion on the quality and safety legal framework for the donation, procurement, testing, processing, preservation, storage, distribution and application of organs of human
origin: At the request of the Deputy Secretary of State to the Minister of Health, the CNECV issued an
opinion on the draft bill for the establishment of ‘standards to ensure the quality and safety of organs of
human origin intended for transplantation to the human body, in order to ensure a high level of human
health protection’, thus transposing into national law Directive 2010/53/EU of the European Parliament
and of the Council of 7 July 2010 on standards of quality and safety of organs intended for transplantation.
It is apparent that the extensive therapeutic use of organs for transplantation requires that the quality and
safety of these organs is ensured so as to minimise any risk of disease transmission. Thus, the need to
ensure that the organs of human origin intended for transplantation meet the quality and safety criteria
common to all the Member States is justified, in an effort to standardise that reflects at the outset the
reality of this ever-increasing exchange of organs, tissues and cells of human origin at international level.
The ethical framework in this matter is based on the fundamental values of respect for the autonomy and
integrity of the individual, including the need for consent, even if presumed in accordance with already
established terms, and also on values of solidarity and altruism.
In turn, the safety and quality of the transplant procedure are also ethical benchmarks to take into
account. Such values are reflected in the importance of maximising the success of the technique with
minimal risk to the health of both the donor and the recipient. Recognising, however, that the risks associated with the procedures cannot be completely eliminated, the assessment of risks and their impact
must be ensured in casu, along with an accurate and detailed record of all relevant information. This
includes the need for following up living donors and recipients, monitoring and managing adverse reactions and acting accordingly, both nationally and in the cases of organ exchange with third countries.
The CNECV considered of relevant ethical value to promote coherent and uniform legislation that guarantees the quality of the acts of transplantation, as well as safeguarding the health and integrity of both
donors and recipients. In this regard, the proposed draft bill did not raise substantial ethical objections,
since there remain the fundamental aspects of respect for autonomy and integrity, information and consent, gratuitousness and beneficence.
However, the manner of coordinating the competencies of the competent authorities must still be defined
clearly, in order to avoid situations of overlapping or cooperation failures that result in loss to the citizens.
In the special case of donors that are minors or adult donors who are disabled, the special restrictions on
admissibility of the donation or procurement should find reinforcement.
Also, the system for recording and safeguarding the confidentiality of donor and recipient identification
should be subject to detailed regulations, clarifying the permissions and the degree of access to data by
the different professionals and entities involved, as well as defining the specific mechanisms to guarantee
data safety.
66/CNECV/2012 — Opinion on draft Bills No 266/2012 and No 323/2012 on clinical research and
clinical trials: The importance and significance of the search for biological knowledge and truth and the
extraordinary contribution that scientific advances have provided to human life is universally recognised,
both in its quantitative parameter and in its quality, as are the social and economic benefits that such
research brings. All these gains would not, by themselves, justify resorting to human beings for experiments, whose risk can be estimated or calculated, but never fully anticipated. In addition to a classical
utilitarian criterion — clinical research results as a very appreciable good to a large number of people —
one must use other criteria of ethical reasoning.
32
Ethically speaking 17, January 2013
In this regard, and bearing in mind that the progress achieved by the clinical studies and trials cannot be
achieved solely by other means, the lawfulness of those studies and trials is established, based on values
of solidarity and altruism to achieve enormous benefits for the health of patients, for individual members
of the community or for the community as a whole, through the voluntary and conscious participation of
a few in such studies and trials.
Consequently, it is essential that the scientific activity is accomplished within a legal framework that
guarantees its appropriateness, quality and relevance, and above all protects the human rights of the
participants — physical and psychological integrity, as well as the dignity of the participants, must be
guaranteed, not to mention the supreme good that is life.
At the same time, the authorities should recognise that the community must be informed in a transparent
way on aspects of the research related, among other factors, to risks, benefits or results, which may be
both positive and negative.
Having found no global ethical objections the CNECV understood, however, that the draft bills in question
should be corrected and improved, taking into account various aspects, among which a better definition of
‘adverse event’, which in fact is confused with ‘adverse reaction’; the need to clarify the somewhat ambiguous definition of ‘researcher’, and to determine with more precision the professional and scientific qualifications of the main researcher; the requirements regarding ‘clinical study participants’; and the ‘declaration
of conflicts of interest’ on the part of the sponsors or health professionals involved in clinical trials.
The CNECV also recommended that placebo-controlled studies must be limited to situations where there
are no alternatives, favouring the trial as opposed to known therapies and recognised as effective, the
only way to ascertain the true therapeutic innovation that the new drug brings.
As for the proposed establishment of a national network of health ethics committees, the council found
it ethically necessary and urgent to tackle this issue in the context of a possible revision of Decree-Law
No 97/95 of 10 May, which regulates the health ethics committees in Portugal.
The above opinions have been fully translated into English and are already available on the council’s
website — http://www.cnecv.pt/pareceres.php English version.
Update on recent activity
• First joint meeting CNECV/health care committees — Lisbon, 14 June 2012.
• Third joint meeting on bioethics CNECV/Spanish Bioethics Committee (CBE) — Porto,
1 October 2012.
Upcoming conference: ‘Bioethics and religions’ — Lisbon, 7 December 2012
This seminar is a joint organisation with the Luso-American Development Foundation (FLAD). It aims
to provide a unique opportunity for a plural debate on ethical issues regarding the dialectic relation
between bioethics and several of the most representative monotheistic religions, bringing together the
scientific community, the media and the general public.
Current work and forthcoming opinions
The CNECV is currently preparing new opinions on the following topics.
• ‘Ethical aspects of umbilical cord blood banks’: a joint discussion with the CBE on the benefits
and harms of umbilical cord blood banking, having in mind the current legal framework in both
countries, as well as the ongoing debate on private vs public blood cord banks.
• ‘The regulation of genetic testing’: at the request of the Deputy Secretary of State to the Minister
of Health, the CNECV is drafting an opinion regarding the draft bill that establishes the principles
Ethically speaking 17, January 201333
inherent to genetic testing, as well as the rules presiding to the protection of genetic data in terms
of access, security, confidentiality and privacy. The proposed draft bill aims at regulating a section
of Law No 12/2005 of 26 January on personal genetic data and health information.
• ‘Ethics in public health’: this reflection aspires to highlighting the ethical questions which arise out
of public health choices, in the context of the multiple philosophical perspectives therein. It also
aims at proposing a model for analysis which will serve as a reference for ethical deliberation in
public health.
• ‘Ethics and the use of potable water’: according to the WHO, approximately 1 billion people worldwide have no access to potable water. This has a tendency to increase, which brings to the forefront of the ethical reflection the value of potable water. Clean water is a non-renewable resource.
Access to clean water is thus regarded as a fundamental human right. The CNECV will debate the
necessity of ensuring high-quality drinkable water, its importance in healthcare and the equality
in the access for all to such a precious natural resource.
Further information
Miguel Oliveira da Silva
President
mos@cnecv.pt
Michel Renaud
Vice-President
mrenaud@cnecv.pt
Cíntia Águas
Executive Secretary
caguas@cnecv.pt
Address
National Council of Ethics for the Life Sciences
Avenida D. Carlos I, n.º 146 – 2º Esq.
1200-651 Lisbon
PORTUGAL
Tel. +351 213910884
Fax +351 213917509
E-mail: geral@cnecv.pt
Website: http://www.cnecv.pt
34
Ethically speaking 17, January 2013
UNITED KINGDOM
The Nuffield Council on Bioethics
The Nuffield Council on Bioethics is an independent body that examines and reports on ethical issues in
biology and medicine. Its role is to provide independent advice to policymakers and to stimulate debate
in bioethics. The council was established by the Nuffield Foundation in 1991, and since 1994 it has been
funded jointly by the foundation, the Wellcome Trust and the Medical Research Council.
Novel techniques for the prevention of mitochondrial DNA disorders: an ethical review
The Council published its report, ‘Novel techniques for the prevention of mitochondrial DNA disorders:
ethical issues’, in June 2012. This report considers the ethical issues raised by IVF techniques being
developed to prevent through the donation of mitochondria the transmission of mitochondrial DNA disorders that can cause severely debilitating symptoms and premature death. The report is intended to
promote and support further debate on the ethical suitability and legality of these techniques and it concluded that:
• provided that the techniques are proved to be sufficiently safe and effective, and an appropriate
level of information and support is offered, it would be ethical for families to use these techniques
as treatment;
• subject to appropriate oversight, it is ethical to continue to research these techniques, in order that
they can be considered for treatment use. The wider policy debate could benefit from a fuller discussion of the ethics of other possible future germline therapies for genetic disorders.
The report received significant media coverage at the time of launch and subsequently when the United
Kingdom’s Human Fertilisation and Embryology Authority (HFEA) launched a public consultation on
the issue in September 2012.
Emerging biotechnologies: technology, choice and the public good
Biotechnologies play an important role in many areas fundamental to our well-being and way of life,
including medicine, industry and agriculture. The potential of emerging biotechnologies seems enormous,
yet the form and directions they take are not a given, nor are the benefits self-evident. In practice, only
a fraction of the technologies that are possible can actually ever be fully realised, as particular developments take place, others are foreclosed. How can our society make ethical choices about such technologies?
In December 2012, the Council published a report, ‘Emerging biotechnologies: technology, choice and
the public good’, which identifies and examines common features among emerging biotechnologies and
the particular challenges they pose. It develops an ethical approach for responding to these challenges,
and makes recommendations that can help guide improved practice in policymaking, in research and in
regulation to maximise the socially beneficial and democratically accountable governance of emerging
biotechnologies.
Donor conception: ethical aspects of information disclosure
Parents of people conceived using donor eggs or sperm may or may not choose to tell them about their
genetic origins. Is this a private family matter, or are there wider public interests at stake? What kind of
information might donor-conceived people and their parents need about their genetic origin? What interests do donors have in receiving information? This project considers the ethical issues that arise around
the disclosure of information in connection with donor-conceived people, and will publish its findings in
spring 2013.
Ethically speaking 17, January 201335
Novel neurotechnologies: intervening in the brain
This project is exploring the ethical, social and legal issues arising from novel neurotechnologies such
as deep brain stimulation, brain–computer interfaces (BCI) and neuron replacement therapy. The working party has been informed by a public consultation, followed by a series of fact finding meetings with
experts, researchers and regulators in the field. A report is expected to be published in summer 2013.
Strategic plan
Following the completion of a wide ranging strategic review in 2011/12, the council has published a strategic plan for the period 2012–16. The plan sets out a number of objectives for the council’s work and
outlines specific ways in which we will address our key priorities over the coming years, including:
• diversity of input, ensuring that as wide a range of people as possible are able to contribute to our
work;
• ensuring a wide reach so that both the policy impact and promotion of public debate is maximised;
• making sure our processes and decision-making are transparent, enabling stakeholders to see how
we operate and how people can interact with the council;
• evaluation of the quality, reach and impact of our work.
Future projects
The council has decided to establish a new work theme to examine the ethical issues raised by sharing
and linking health and biological data; this will begin in early 2013. Later in 2013 the council will start
a project on the ethical issues raised by children taking part in medical research.
Outreach and educational activities
The council has set up a new blog where the chair, council members and others will write stories and
comment on contemporary bioethics issues including, but not limited to, those covered in the council’s
current and previous projects.
In September the council opened its film competition Box office bioethics for a second year. The competition aims to inspire young people to make short films about contemporary bioethics issues.
The council is continuing its work to support bioethics education through the development and promotion of resources for teachers and students. A set of teaching materials based on the report ‘Human bodies: donation for medicine and research’ is currently being developed for launch in early 2013.
Further information
Hugh Whittall
Director, Nuffield Council on Bioethics
Address
The Nuffield Council on Bioethics
28 Bedford Square
London WC1B 3JS
UNITED KINGDOM
Tel. +44 2076819619 E-mail: bioethics@nuffieldbioethics.org
Website: http://www.nuffieldbioethics.org
36
Ethically speaking 17, January 2013
General information on
activities of the non-EU
national and regional
ethics committees
Ethically speaking 17, January 201337
ARGENTINA
Comité Nacional de Ética en la Ciencia y la Tecnología de la República Argentina
Large research and medical databases in clinical and research multi-centres trials
I. Introduction and objectives
Given that the nature of this intervention is necessarily brief, I will show: (a) the main lines of the Argentine legal system related to the ethical aspects of this issue, (b) a case that shows the weakness of the
effectiveness of these rules, and (c) special concern of the National Committee of Ethics for public access
to knowledge.
II. Basic rules
(1) Law 25.326 — personal data protection law (October 2000)
This law describes the data on health as sensitive data and, as such, it is protected. The specific rule —
Section Two — says that sensitive data means personal data revealing racial and ethnic origin, political
opinions, religious, philosophical or moral beliefs, labour union membership and information concerning
health conditions or sexual life.
Because of this characteristic, other rules state:
‘UNIT 8.- Public or private health institutions, as well as medical science professionals are entitled to
collect and treat personal data related to the physical or mental health of patients who make use of their
services or who are or may have been in their care, in pursuance of the principles of professional secret.’
‘SECTION 12.- 1.- The transfer of any type of personal information to countries or international or supranational entities which do not provide adequate levels of protection, is prohibited. 2.- The prohibition shall not
apply in the following circumstances: a) international judicial cooperation; b) exchange of medical information, when so required for the treatment of the party affected, or in case of an epidemiological survey … ’.
(2) Law 3301 of the City of Buenos Aires about the protection of human subjects in health
research (2010)
This law contains provisions relating to both aspects: the privacy of the individual subject and free
access to public information.
Section 5. 15) Protection of the subject privacy: the privacy and data protection must be safeguarded
according to Law 25.326. The privacy of the subjects and the confidentiality of information will be
respected, ensuring non-use of information obtained to the detriment of individuals and/or communities. The researcher is obliged to implement methods for the anonymity of the subjects and that enable
personal data to be dissociated from the functional scientific data for research. Any collection, use and
transfer of any data not specifically set forth in the instruments of free and informed consent and in the
research protocol are prohibited.
Section 5. 23) Information of public access: activities and broadcast programmes on clinical research
should be promoted and a database of public access to information on the researches undertaken in
the city will be developed. The database will be published online and will provide relevant data of the
protocol such as: objective, phase, responsible, place, drug used or its code, in case of need to preserve
confidentiality. The enforcement authority will seek to coordinate and/or unify this database with existing databases at the national, provincial and international levels.
Ethically speaking 17, January 201339
(3) Guidelines for research on human beings approved by Resolution 1480/2011 of the Ministry of
Health of Argentina on 13 September 2011 (5)
These guidelines have been carefully prepared during 2011. The main items related to the topic under
study say that the information obtained from human health research should be recorded and filed so as to
allow adequate interpretation and verification. When the result of an investigation is published, it should:
(a) maintain the accuracy of the data and of their interpretation, and (b) declare the sources of finance,
labour relations and other potential conflicts of interest. Articles that do not meet the ethical standards
should not be accepted for publication (6).
Publication of the study results: researchers are obliged to disclose information that is of public interest by any appropriate means available and provided that the confidentiality of participants is respected
and that the interpretations or inferences are not presented as if they were proven true or in a way that
promotes or appears to promote special interests, for example that it has been proven that a product is
effective. The publication of the research results, both positive and negative, is strongly recommended
to facilitate transparency and to avoid the repetition of studies already completed and the submission of
new participants to unnecessary risk.
(4) A national project
The Chamber of Deputies passed a new bill on 23 May 2012 stating that all national scientific institutions
must provide open access (OA) archives of their research, allowing the public (not only scientists and
professionals, but also the general public) full access to journal articles, dissertation theses and technical
reports, as well as data obtained by publicly funded projects, but excluding confidential data.
(5) A jurisprudential case that shows non-compliance with rules
The National Administration of Drugs, Foods and Medical Devices (Anmat) authorised the firm GlaxoSmithKline to conduct a ‘Clinical otitis media and pneumonia study’ (Compas), phase III, randomised,
controlled and multi-centre study to demonstrate the effectiveness of the pneumococcal vaccine for the
prevention of acquired pneumonia and acute otitis media.
Anmat conducted several inspections at the research authorised centre; in a province some irregularities emerged, most linked to the lack of information of mothers and children, who were all vulnerable
persons.
Anmat fined the laboratory 400 000 Argentine pesos (about 80 000 US dollars), which it did not agree to
pay. It went to court, but the judge upheld the decision (7).
Subsequently, on 3 January 2012, Anmat reported that: (a) the sanctions were linked to irregularities
in the provision of informed consent, (b) that none of the deaths (12 children) that occurred during
the study were linked to the vaccine administration, and (c) that the vaccine is authorised/licensed in
over 80 countries.
III.Special concern of the national committee of ethics for public access to knowledge
In 2006, the National Committee of Ethics issued a recommendation entitled ‘Protecting the public
domain: access to and use of scientific data and information’ (8). The general conclusion states that:
‘There is an urgent need to rethink the meaning and role of the public domain in general, and of scientific
(5) http://leg.msal.gov.ar/index2.htm
(6) A8. Data management and results, pages 15 and 16.
(7) J. Penal Económico No 2, 28/12/2011, GlaxoSmithKline Argentina s/infracción ley 16.463, Doctrina Judicial, 18/4/2012,
No 16, page 65.
(8) http://www.cecte.gov.ar/recomendaciones-e-informes/
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Ethically speaking 17, January 2013
data and information, in particular. The public domain should not only be a matter of concern for the scientific community, as the limitations to the access to knowledge and products derived from there affect
the society at large. The fundamental challenge is to prevent the further erosion of the public domain and
to ensure that the use of scientific information is not artificially limited by new protectionist measures.’
IV. Provisional conclusions
There is no opposition to conducting multi-centre clinical trials of transnational companies, provided
that the local authority has the ability to distinguish between those that truly seek to develop innovative
medicines, from those that aim to produce mass-market medicines that only favour the company.
On the other hand, the public domain should not only be a matter of concern for the scientific community, as the limitations to the access to knowledge and products derived from there affect society at large.
Further information
Mrs Aída Kemelmajer de Carlucci
Member
Address
Comité Nacional de Ética en la Ciencia y la Tecnología de la República Argentina
Ecuador 873 4to Piso CP 1214 Ciudad Autónoma de Buenos Aires
ARGENTINA
Tel. +54 1148918796
E-mail: cecte@mincyt.gov.ar
Website: http://www.mincyt.gov.ar/ministerio/estructura/unid_asesoras/cecte/index.php
Ethically speaking 17, January 201341
COPAB
Advancing ethics and bioethics in Africa
Prof. Pierre Effa, President a.i. of the COPAB
Introductory note
Invited to participate in the fifth Conference of Ministers of Member States of the African Union for Science and Technology (AMCOST V) in Brazzaville, Congo from 12 to 15 November 2012, the President a.i.
of the Pan-African Congress for Ethics and Bioethics (COPAB) seized the opportunity offered to him to
present the status of COPAB proposals in the implementation of Resolution No AHG/Res.254 (XXXII) on
bioethics and development of Africa that was adopted by the 32nd Summit of Heads of State and Government of the Organisation of African Unity (OAU)/African Union (AU) in July 1996 in Yaounde.
After the fourth International Dialogue of Bioethics in Copenhagen: implementation of privileged
partnership for the protection of life in Africa
The results of the representation of the African Union by COPAB from the contribution of the President
a.i. of the COPAB at the Fourth Conference of the International Dialogue of Bioethics (IDB) in Copenhagen on 19 June 2012 have reinforced the concern for COPAB to contribute to the implementation of
the resolutions of the EU–Africa summit in Lisbon in December 2007. Thus, in the context of the fourth
bipartite summit in 2013 in Brussels, COPAB suggests the establishment of a privileged partnership on
ethics and bioethics for the protection of life in Africa, in the framework of the implementation of the
joint African–European Union strategy (JAES).
Workshop of African platforms on ethics: implementation of the African Task Force on Ethics
and Bioethics
The COPAB interim executive committee also found the meeting of the AMCOST V in Brazzaville
the appropriate forum to raise this august institution to mobilise the organisation and the success of the
regional workshop for implementation of African platforms on ethics. These platforms are a collection of
skills and abilities without borders, in consultation and dialogue to discuss, such as the African palaver,
issues of bioethics (bioethics forum), health, including the implementation of the declaration of Abuja and
the strategic plan of the African Union in the fight against AIDS (health stakeholder forum (COPAS)) and
basic and universal human values including governance and the fight against corruption (ethics forum).
African platforms on ethics will be the place where the COPAB discusses international partnerships for
the African certification system for ethical evaluation for member countries of the African Union.
Implementation of the consolidated plan of action on science, technology and innovation of the
African Union
The AMCOST V in Brazzaville adopted the consolidated plan of action (CPA) on science, technology
and innovation for the whole African continent for 2013 to 2023.
Finally, the COPAB is in charge of implementation of the ethics programme of the CPA on science, technology and innovation of the African Union as adopted by AMCOST V in Brazzaville for 2013 to 2023.
Programming the third session of the health actors’ forum (COPAS)
It will meet the members of the pan-African movement for ethics and bioethics concerned with health
platforms, including the implementation of the Abuja declaration and the strategic plan of the African
Union in the fight against AIDS. It will involve the Ministries of Health of the member countries of the
Ethically speaking 17, January 201343
African Union and major health institutions on the continent. The theme focuses on ‘improving the quality of care in all health sectors in Africa.’
Community education programme in bioethics in Africa
The COPAB began to implement its community education programme in bioethics in 2012, and envisages strengthening it in 2013 and later. Indeed, the establishment of an ‘integrated ethics sphere of the
entire African continent’ as the implementation of the resolution of the OAU/AU, and the creation and
functioning of a Global Ethics Committee with the General-Secretariat of the United Nations organisation pledged to promote peace, justice and sustainable harmonious development, constitutes the major
challenge of the COPAB. The strategy to achieve this is also the use of the African palaver and community education.
The goal of the COPAB is to make ethics and bioethics concepts easily brewed in and through communities, in both rural and urban areas in Africa.
This programme will probably revive the minds of ancient practices in the collective memory, that have
enabled Africa to perpetuate the concept of the millennium ankh, that is to say the promotion of ‘social,
spiritual and cosmic integrity of human being’ as defined by the Egyptologist Theophile Obenga, to the
triumph of the forces of life over the forces of death (cf. historian and philosopher Engelbert Mveng).
The COPAB targets or partners in this community education programme in bioethics are organisations
of the lifeblood of the African nation in general, to the attention of their basic communities, and in particular those especially involved in implementation of bioethics activities, such as the medical profession
as a whole.
The strategy used is to highlight bioethics, ethical, anthropological and professional lessons from the
basic texts of these organisations, in light of the customs of communities eclectically identified as proper
to protect, preserve, promote and to value life.
In practice, it is to make a ‘coaching of communities’ in the reactivation of the spirit of their own customs and traditions with the characteristics of the protection and enhancement of life. So the subsequent
establishment of the ethics committees and awareness of these communities in the understanding and
application of bioethics laws and their adherence to programmes of biomedical research or health would
find a fertile ground for integration or mastering the modern principles of bioethics that the international
community has developed to promote international research, while ensuring respect for the dignity of
the human.
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Ethically speaking 17, January 2013
INDIA
The Indian Council of Medical Research
The Central Ethics Committee on Human Research (CECHR)
Year of establishment: 1996
Remit of the NEC: The Central Ethics Committee on Human Research (CECHR) is the national ethics
committee, with its secretariat at the Indian Council of Medical Research (ICMR), Headquarters Office,
New Delhi, India. It is a referral body for the Ministry of Health and Family Welfare as well as other
ministries under the government of India on bioethics. Its activities include giving opinions on bioethics
issues at national level, formulating ethical guidelines for biomedical research involving human subjects
and other activities related to bioethics.
Composition of the NEC:
1. Dr P. N. Tandon, New Delhi, Neurosurgeon and President, National Brain Research Centre, Manesar — Chairman
2. Dr Ranjit Roy Chaudhury, Former Professor of Pharmacology, PGIMER, Chandigarh
3. Dr S. D. Seth, Advisor, Clinical Trial Registry of India, New Delhi
4. Dr N. R. Madhav Menon, Director, National Law Academy, Bhopal
5. Dr B. N. Dhawan, Former Director, Central Drug Research Institute, Luknow
6. Dr Vinod K. Paul, Pediatrician, All India Institute of Medical Sciences, New Delhi
7. Dr Thomas Kalam, Theologist and Director, St. John’s Medical College, Bangalore
8. Dr Sunil K. Pandya, Neurosurgeon, Jaslok Hospital and Research Centre, Mumbai
9. Dr P. S. S. Rao, Biostatistician, Bangalore
10.Dr S. S. Agarwal, Human Geneticist, Lucknow
11.Dr Sandip Basu, Immunologist, Former Director, National Institute of Immunology, New Delhi
12.Dr C. A. K. Yesudian, Social Scientist, Tata Institute of Social Sciences, Mumbai
13.Dr V. I. Mathan, Clinical Epidemiologist, Vellore
14.Dr G. Padmanabhan, Basic Scientist and Former Director, Indian Institute of Sciences, Bangalore
15.Dr Mira Shiva M.D.
Coordinator, Initiative for Health Equity & Society
Director, Diverse Women for Diversity, New Delhi
16.Dr Vasantha Muthuswamy, Ethics Expert and Former Scientist G, Indian Council of Medical
Research, New Delhi
17.
Lt. Gen. D. Raghunath, Sir Dorabji Tata Centre for Research in Tropical Diseases
Innovation Centre, Indian Institute of Science Campus, Bangalore
18.Dr Vijay Kumar, Scientist F — Member Secretary
Indian Council of Medical Research
Ethically speaking 17, January 201345
List of the last three NEC’s opinions
1. Opinion on bridging studies on the H1N1 vaccine.
2. Updated ICMR guidelines for safety assessment of food derived from genetically engineered
plants (2008).
3. Revision of guidelines for stem cell research and therapy.
List of the future topics covered by NEC’s opinions
1. Ethical guidelines for conducting research on mental illness or cognitive impairment and research
involving mentally ill or cognitively impaired individuals.
2. Guidelines for compensation to participants for research-related injury in India.
3. The biomedical and health research regulation bill.
Further information
Chairperson and Secretariat
Dr P. N. Tandon
Chairman
Central Ethics Committee on Human Research (CECHR)
Indian Council of Medical Research
New Delhi -110029
INDIA
Contact details
Dr Vijay Kumar
Scientist F and Member Secretary, CECHR
Indian Council of Medical Research
AIIMS Campus, Ansari Nagar
New Delhi -110029
INDIA
Telefax +91 1126589791
E-mail: kumarv@icmr.org.in; vijayprabhakar@yahoo.com
46
Ethically speaking 17, January 2013
MEXICO
The National Bioethics Commission of Mexico
Manuel H. Ruiz de Chávez, MD, MSC, FRCP
The following text presents the most relevant actions in 10 main areas undertaken by the National Bioethics Commission during the 2009–12 period, which will allow a thorough evaluation of its journey and
also to envision what needs to be done in the future, while identifying new challenges and perspectives
that will guide the institutional chores for both the short and the long term towards its central mission: to
promote the bioethics culture in Mexico.
1. An institution with a 20-year continuous evolution
The National Bioethics Commission (Conbioética), since its creation in 1992 until its constitution as
a deconcentrated agency of the Secretariat of Health, with technical and operational autonomy (2005),
has been working non-stop, with the mission of promoting a bioethical culture in Mexico with a plural
and inclusive scope and a secular outlook, based on the respect for human rights and the protection of
living beings and the environment.
In 2012 we celebrated the first 20 years of the national commission, and for this 20th anniversary many
activities took place: the inauguration of the new seat; the signature of collaboration agreements with the
National Autonomous University of Mexico (UNAM) and the National Council for Science and Technology (CONACyT); the first exhibition of the former chairmans of Conbioética; the issue of a commemorative postal stamp; a bioethics book expo; the edition of a commemorative lottery ticket from the National
Lottery; and the exhibition ‘Bioethics and social responsibility’. Also during these events, the seventh
national meeting of statal bioethics commissions took place, and we also celebrated the 10th anniversary
of the international award Manuel Velasco Suárez for excellency in bioethics, a joint effort between
the Pan-American Health and Education Foundation (PAHEF), the Pan-American Health Organisation
(PAHO) and Conbioética as part of the Secretariat of Health.
2. Conbioética is now projected from a new seat
Since January 2012, Conbioética has been designated to a new seat, which has encouraged its job, especially since the Centre of Bioethical Knowledge (Cecobe) has been strengthened by these new modern
facilities. The proposal for the new building has taken into account bioethical criteria in its design, like
easy access to people with disabilities according to federal regulations and environmentally friendly use
of energy, among others, so that Mexico, as many other countries in the world, has an adequate space to
work on bioethics. This will be completed with a seminar unit that will be used for the development of
human resources and academic and diffusion activities.
3. Conbioética: national reference
Conbioética is a reference of actions made in Mexico in the bioethical field, as a normative and consulting multidisciplinary organism, and also because of it governing nature in bioethics in the country,
which is why it has been trusted with the task of formulating and expressing technical opinions and
pronouncements regarding legislation and public policies in bioethics from the executive, legislative and
judicial branches, either federal or local.
Conbioética has been encouraging the proper integration of the bioethics infrastructure throughout the
country, which is led by the statal bioethics commissions, collective organisms that promote the foundations and the application of the existing regulations in bioethics and also foster public debate around
Ethically speaking 17, January 201347
bioethical issues in the local scene, especially regarding healthcare, medical research and the protection
of the environment.
4. Conbioética: international reference, Mexico, world host in 2014
Mexico, through Conbioética, has been designated as host of the 10th Global Summit of National Bio­
ethics Commissions, which is sponsored by the World Health Organisation, and the 12th World Congress
of Bioethics of the International Bioethics Association. Both events are to take place in 2014.
These events are of the utmost relevance in their type and are trendsetters in the development of bio­
ethics in the international context, which is why 2014 will be the Year of Bioethics in Mexico.
The commission enjoys enough prestige and international recognition, which is why it will be able to
communicate with consulting organisms from different countries, especially in the American region,
as a result of the meeting hosted by Conbioética during 2011, which summoned the representatives of
consulting bodies of 10 countries of the American region. Also, during the ninth meeting of national
committees on research ethics, which took place in Carthage, Tunisia, in 2012, Conbioética presided
the international working group of research ethics. The commission is constantly collaborating with
the main international organisations and institutions on bioethics as well, such as: the Ethics and Health
Division, WHO/PAHO; Global Summit of National Bioethics Advisory Bodies, WHO; Committee on
Bioethics (DH-BIO), Council of Europe; International Bioethics Committees Unesco and its Ethics Division; Latin American and Caribbean Federation of Bioethics Institutions (FELAIBE); European Commission’s International Dialogue on Bioethics (BEPA); Nuffield Council on Bioethics, United Kingdom;
and the International Association of Bioethics (IAB).
5. Conbioética: an institution with scientific and technologic development recognition nationwide
In 2011, Conbioética became a part of the National Registry of Scientific and Technological Institutions
and Enterprises (RENIECyT), which helps to identify the institutions that carry out activities related
to research, and scientific and technological development in Mexico. This registration allows the participation in federal incentive and support programmes in order to undertake new tasks and projects.
As a result of this, Conbioética has received a donation in order to strengthen the Centre of Bioethical
Knowledge, with the establishment of a virtual library and a telebioethics system.
6. Mandatory research ethics and clinical bioethics committees
Conbioética supported the reformation of the General Health Act, in order to establish as mandatory
the existence of clinical bioethics committees and research ethics committees in every healthcare and
research institution in Mexico, which must observe the guidelines and criteria established by the commission. Therefore, Conbioética issued these regulations regarding the registration and integration of
these committees, which have been published through an agreement from the Secretary of Health,
strengthening its normative function.
7. Bioethics: closer to society
The National Bioethics Commission, and generally the institutions that form the national bioethics infrastructure in the country, are an important support for the protection of human rights and dignity, because
of their leading role in the decisions and management of bioethical issues, especially those immersed in the
context of healthcare and research, both from the individual and collective point of view. Its performance
has influence on the improvement of life quality, which results in direct benefits for the whole population.
8. Creation and scope of the Centre of Bioethical Knowledge
The Centre of Bioethical Knowledge (Cecobe) started to operate as part of the main activities of Conbioética. Its function is to collaborate in order to increase the impact on the promotion of bioethics
48
Ethically speaking 17, January 2013
culture specifically through two synergic actions: the searching, gathering and updating of specialised
information in the field of bioethics (physical and virtual library), and the development of a dissemination programme regarding the main topics of this discipline, and of course of the advances and perspectives of the commission.
The library offers free information services to the general population and also students, specialists,
academics and researchers in bioethics, through printed and digital publications, and diverse databases
which are completely avant-garde nationwide and worldwide. With this, Cecobe pretends to become one
of the most complete and specialised information centres in the field of bioethics. As for the dissemination strategies, we can mention many books, pamphlets, posters and publications of many sorts, as well
as the development of a social communication and education programme about the main topics in bio­
ethics through different communication media. Until today, Cecobe has formalised numerous collaboration and exchange agreements with several libraries and information centres, which increases its possibilities to offer services of the utmost quality.
9. Strategic agreements and alliances
During 2012, the commission formalised collaboration agreements with UNAM and CONACyT. These
agreements are meant to establish the foundations and mechanisms of the collaboration between the
institutions involved, and therefore carry out specific actions that may contribute to the improvement,
development and encouragement of the academic activities, research and dissemination of bioethics,
and also to begin designing mechanisms to strengthen bioethics and ethics in science, technology and
research.
Additionally, the commission has managed to formally establish other alliances with institutions such as
the general hospital of Mexico (Dr Eduardo Liceaga), the National Academia of Medicine of Mexico, and
the Council for Ethics and Transparency of the Pharmaceutical Industry (Cetifarma), in order to engage
joint activities regarding bioethics. It also maintains a close relationship with its peers worldwide, such as
the Comité Consultatif National d’Éthique pour les Sciences de la Vie et de la Santé of France; the Commission de l’éthique en science et en technologie (CEST), from Quebec, Canada; and of course Unesco
in order to address the different issues that bioethics care for, and to strengthen the development of this
discipline not only in Mexico, but all over the world, participating in their forums and working groups.
10. Strengthening of the national commission as a decentralised organism of the Secretariat of
Health
The commission is a national institution, with a plural, inclusive and secular scope, and technical and
operational autonomy. It is directed by a council, which is integrated by a president and six members who
are designated carefully in order to preserve a balance of different professions, gender and perspectives,
with wide recognition in their field of knowledge. Their essential tasks include analysing and discussing
bioethical issues for public debate and expressing their opinions, and also being familiar with different
points of view.
During the past few years, the consolidation of the legal framework of Conbioética has consolidated its
leading and normative roles and performance as a consulting organism for the establishment of public
policies, especially in the field of public health, regarding bioethics. Additionally, Conbioética participates actively in the National Health Council and the staff meetings of the Secretary of Health.
Epilogue
Without being exhaustive, this report constitutes a summary of the universe of current and potential
activities that are a part of our new vision and our new challenges in order to have a sound performance and impact towards reaching the main goal of Conbioética: to promote bioethical culture in our
country.
Ethically speaking 17, January 201349
Further information
Manuel H. Ruiz de Chávez, MD, MSC, FRCP
Chair of the Board
Address
National Bioethics Commission of Mexico
Calz. Arenal 134
Col. El Arenal Tepepan
Deleg. Tlalpan
14610 México, D.F.
MEXICO
Tel. +52 5556301046
+52 5554879964
E-mail: manuelruizdechavez@gmail.com; manuel.ruizdechavez@salud.gob.mx
Website: http://www.conbioetica-mexico.salud.gob.mx
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Ethically speaking 17, January 2013
RUSSIA
Russia under new healthcare legislation
V. Vlassov, MD, President, Society for Evidence-Based Medicine
In the last 3 years, Russia has introduced new legislation spanning the whole field of healthcare, with
new laws on healthcare, on the marketing of drugs and on mandatory healthcare insurance. Cementing
a number of post-Soviet reforms, these laws have incorporated new initiatives introduced since 2000.
The Russian healthcare law has inherited the Soviet-era Physician’s Oath, which it enshrines in Article 71.
It retains some of the substance of the modified versions of the Hippocratic Oath popular in western
universities, but not the style. From the first post-Soviet healthcare law (1993), the new law has kept the
declaration of access to healthcare as a human right and the basic principle of informed consent to medical
intervention. Unfortunately, this principle is not adhered to rigorously. With regard to the treatment of
patients with severe conditions, the law deprives them of the right to withhold consent to treatment, in the
way it forbids euthanasia (Article 45). The law describes the euthanasia very inclusively, as ‘hastening the
death of a patient at his request by any action or inaction or means, including stopping artificial means of
supporting the life of a patient.’
Aspects of healthcare for the dying are not well developed in Russian legislation. Brain death is described
in the law (Article 66), but the vegetative state (the death of the brain stem) is not recognised. There is
some progress: the new legislation refers to the possibility to abstain from cardiorespiratory resuscitation. Unfortunately, even this progress is doubtful, because neither consent to these procedures nor the
concept of the living will is recognised by Russian lawmakers.
All these omissions and misinterpretations were discussed by medical professionals before the draft law was
sent to the Duma (Russian parliament). But, because of a specific misunderstanding of state power as a possibility to ignore public views and scientific evidence, these proposals and criticisms were mostly ignored.
In the law on the marketing of drugs, the Russian government designed and lawmakers voted for a specific model of drug approval. In this model, clinical trials are part of the drug registration procedure. To
receive permission to begin a trial, the sponsor needs first to apply for a marketing authorisation. Then
permission for the trial will be given as part of the registration process. The only body which may give
permission for a drug trial is the national Ministry of Health, which manages drug registration. The only
entity which may apply for permission for a trial is the sponsor, i.e. the drug’s owner. This is probably the
only legislation in the world that allows only the drug owner to test the drug. The process is further centralised by giving the power to check the ethics of trial protocols to only one ethics committee — in the
national Ministry of Health. Rather frivolously, Russian lawmakers inserted a rule in the drug marketing law that only drugs tested in trials in Russia may receive a marketing authorisation. By design, this
requirement is bound to increase the number of trials in Russia. Naturally, this requirement is leading to
delays in marketing authorisation for drugs not yet tested in Russia.
National centralisation is also the main theme of the new law on mandatory healthcare insurance. Under
the new law, all Russian citizens are insured not by medical insurance companies, but by a national (federal) mandatory insurance fund. The medical insurance companies act only as fund transfer agents. The
declared intention of the legislators was to make it simpler for Russian citizens to obtain access to healthcare anywhere in the country. Unfortunately it does not work, as is clear now, after 2 years under the
new legislation. The main problem of Russian healthcare continues to be underfunding and the mismatch
between the generous promise of the Constitution and the limited funding. In these conditions, access to
healthcare is limited not by law but by available resources.
Ethically speaking 17, January 201351
European Commission
Ethically speaking 17, January 201353
European Commission, Bureau of European
Policy Advisers’ Ethics Sector
On 22 March 2011, the President of the European Commission requested the European Group on Ethics in Science and New Technologies (EGE) to issue an opinion on the ethical implications of information communication technology (ICT). Following the last Competiveness Council on the Euratom
programme, the Commission also asked the EGE to contribute to the debate on a sustainable energy mix
in Europe by issuing an opinion on the ethical impact of research on different energy sources on human
well-being. The EGE is an independent advisory body with a status defined in several EC legal documents (e.g. Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal
protection of biotechnological inventions).
Actions undertaken to implement the above Commission goals included (in chronological order) the
following.
On 15 and 16 January 2013, the EGE held its monthly meeting in Brussels. On 16 January, the group
adopted its Opinion No 27: An ethical framework for assessing research, production and use of
energy. The opinion has been transmitted to President Barroso and will be presented at the European Commission Symposium on Nuclear Fission Research for a Low-Carbon Economy, taking place
on 26 and 27 February 2013 in Brussels. In its opinion, the EGE proposed an ‘integrated ethics approach’
for the research, production and use of energy in the EU seeking for an ‘equilibrium’ between four criteria — access rights, security of supply, safety and sustainability — in the light of social, environmental
and economic concerns.
On 11 and 12 December 2012, the EGE held its 22nd meeting in Brussels. The group worked on the
finalisation of Opinion No 27.
On 20 and 21 November 2012, the EGE held its monthly meeting in Brussels aimed to complete
the opinion on the ethics of the energy mix. During this session, the EGE also adopted its position
on the proposal for a regulation of the European Parliament and the Council on clinical trials.
On 19 November 2012, the EGE held its rapporteurs’ meeting in Brussels. Discussions centered around
the finalisation of the EGE opinion on the ethics of energy mix in Europe.
On 4 and 5 October 2012, the EGE together with the EU national ethics councils (NECs) forum, gathering the chairs of the EU-27 NECs, met in Nicosia, Cyprus. The joint event was organised by the Bureau
of European Policy Advisers (BEPA) and the Directorate-General for Research and Innovation (RTD),
in collaboration with the Cypriot Council Rotation Presidency. The meeting touched upon: the Horizon 2020 programme, the function of NEC forums as dialogue platforms on science within the EU, the
adopted EGE Opinion No 26 on ethics and ICT as well as the forthcoming EGE Opinion 27 on ethics
of the energy mix in Europe. In the afternoon of 4 and 5 October, the EGE held its working meeting in
parallel to the NEC forum meeting.
On 3 October 2012, the EGE met the Cyprus National Bioethics Committee in Nicosia for a bilateral
meeting. The afternoon session comprised an EGE working group meeting.
On 18 September 2012, the EGE Secretariat organised an open round table on ethical aspects of the
energy mix in Europe (100 participants). The round table was aimed at promoting a transparent dialogue between relevant stakeholders. Among participants, the EGE Secretariat welcomed members of the
scientific community, industry, civil society, policymakers, media and the general public.
Ethically speaking 17, January 201355
On 19 September 2012, the EGE Secretariat held its 17th meeting in Brussels. On 16 and 17 July 2012,
the EGE Secretariat organised a rapporteurs’ meeting in Rome, Italy. On 18 to 20 June 2012, under the
auspices of the Danish Council Rotation Presidency, the EGE, the Danish National Ethics Committee, the International Dialogue on Bioethics (clustering the chairs of G20 NECs and the forum of the
EU-27 NECs) met in a 3-day event which took place in Copenhagen.
On 18 June, the EGE had its working meeting on its approaching opinion on ethics of the energy mix.
The members worked on the structure of the current opinion.
On 19 June, the fourth meeting of the European Commission International Dialogue on Bioethics
(IDB) took place; an event organised by the European Commission under the auspice of the Danish
Rotation Council Presidency. Invited participants included members of the EGE, the chairs of 15 nonEU NECs, and the chairs of the EU-27 NECs and Croatia, Norway, Serbia and Switzerland (46 countries). The non-European countries represented this year included: Argentina, Canada, China, Egypt,
India, Indonesia, Japan, Mexico, the Philippines, Russia, South Africa and COPAB (Pan-African Bioethics Congress). Representatives of the bioethics sector within Unesco, the WHO and the Council on
Health Research for Development (Cohred) also made a speech. The topic discussed this year was ‘The
governance of large research and medical databases in clinical and research multi-centre trials’, as
proposed by the Chief Scientific Adviser, Prof. Anne Glover.
On 20 June 2012, the EGE and the Danish NEC organised a bilateral meeting, focusing on the previous
Danish opinions on climate change and food security and the Danish debate on renewable energy.
On 15 and 16 May, the EGE held its 14th meeting in Brussels. The 16th ISG meeting took place
on 31 May, topics addressed include ICT governance, Horizon 2020, revision of the clinical trials directive (9), the European Strategy and Policy Analysis System (ESPAS), the inter-institutional debate on
energy mix, etc. Fifteen Commission services confirmed their participation and their attendance to the
meeting (Secretariat-General; DG Communication; Bureau of European Policy Advisers; DG Enterprise and Industry; DG Competition; DG Energy; DG Environment; DG Research and Innovation; Joint
Research Centre; DG Communications Networks, Content and Technology; DG Maritime Affairs and
Fisheries; DG Education and Culture; DG Health and Consumers; DG Home Affairs; DG Justice; DG
Trade; Research Executive Agency; and European External Action Service). On 17 and 18 April, the
EGE held its 13th meeting in Brussels.
On 20 and 21 March, the EGE started working on its new opinion on ethics of energy requested by
President Barroso on 19 December 2011. The opinion will contribute to the debate on a sustainable
energy mix in Europe by studying the ethical impact of research on different energy sources on human
well-being. The EGE also had a meeting with Vice-President Neelie Kroes in order to discuss the content of its Opinion No 26: Ethics of Information and communication technologies. Vice-President
Kroes welcomed the EGE opinion and underlined that the Commission will now take inspiration from
the proposed recommendations to further foster societal and ethical considerations in the construction
of the European digital society. On 21 and 22 February, the EGE adopted its Opinion 26: Ethics of
information and communication technologies.
On 18 and 19 January, the EGE held its 10th meeting in Brussels. The group worked on the completion
of the opinion.
(9) Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws,
regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in
the conduct of clinical trials on medicinal products for human use.
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Ethically speaking 17, January 2013
General information
on activities of the
international organisations
Ethically speaking 17, January 201357
Council of Europe
Decision-making process regarding medical treatment in end-of-life situations
The Committee on Bioethics (DH-BIO) (10) has been continuing its work on the decision-making process
regarding medical treatment in end-of-life situations following the symposium held on this theme at the
end of 2010. On the basis of the symposium’s conclusions, a drafting group was entrusted with the task
of preparing a preliminary draft guide on the decision-making process regarding medical treatment in
end-of-life situations. This guide aims to facilitate the implementation of the principles laid down in the
Convention on Human Rights and Biomedicine including the principle set out in its Article 9 concerning
previously expressed wishes.
The preliminary draft guide was examined by the DH-BIO at its December plenary meeting, which
agreed to make it public for consultation as a working document in February 2013. The purpose of this
consultation is to elicit comments from the different fields concerned which will be taken into account
when finalising the guide. The consultation is foreseen until the end of April 2013.
Predictivity, genetic testing and insurance
The public consultation on a document on predictivity, genetic testing and insurance was completed in
May 2012 and the replies have been published on the website (http://www.coe.int/bioethics). An analysis
of these replies was examined by the Committee on Bioethics at its second plenary meeting in December 2012. On the basis of a number of points identified in this analysis, the Secretariat, in consultation
with experts having participated in the previous working party, was entrusted with the task of preparing proposals with a view to the possible preparation of a non-binding legal instrument on predictivity,
genetic testing and insurance.
Symposium on biobanks and research on biological materials of human origin
(19 and 20 June 2012)
A symposium on biobanks, organised by the Committee on Bioethics, was held on 19 and 20 June 2012 in
Strasbourg, with the objective of providing a basis for the re-examination of Council of Europe Recommendation (2006) 4 on research on biological materials of human origin. In the light of the presentations and discussion at the symposium, the drafting group on biobanks identified possible issues for the
re-examination of the instrument regarding consent and information; governance; ethics review; data
protection; access and trans-border flow; and some additional issues. At its December meeting, the DHBIO exchanged views on these issues and entrusted the drafting group to prepare proposals for the reexamination of the recommendation to be discussed at its meeting in May 2013.
New additional protocol on the protection of the dignity and fundamental rights of persons with
mental disorders
The Committee on Bioethics will begin its work on the preparation of an additional protocol to the
Oviedo convention on the protection of the dignity and fundamental rights of persons with mental
disorders with regard to involuntary treatment and placement. The first meeting of the drafting group
entrusted with the task of preparing proposals is foreseen for the end of March 2013.
(10) On 1 January 2012, following the reorganisation of intergovernmental bodies at the Council of Europe, the Committee
on Bioethics (DH-BIO) has taken over the responsibilities of the Steering Committee on Bioethics (CDBI) for the tasks
assigned by the Convention on Human Rights and Biomedicine as well as for the intergovernmental work on the protection
of human rights in the field of biomedicine. The reorganisation results also in creating a closer link between the DH-BIO
and the Steering Committee for Human Rights (CDDH).
Ethically speaking 17, January 201359
Prenatal sex selection
Following the response of the Committee of Ministers to Parliamentary Assembly Recommendation 1979 (2011), the Committee on Bioethics was entrusted with the task of conducting a comparative
study on prenatal sex selection and considering, where appropriate, the preparation of guidelines and
good practices in the context of Article 14 of the Oviedo convention. As a first step, the DH-BIO prepared a questionnaire which was addressed to its delegations in order to gather information for an initial
overview of the situation in the Member States.
Genetic tests for health purposes
In order to facilitate the implementation of Article 20 of the additional protocol concerning genetic testing for health purposes, the Council of Europe has produced a brochure for the general public on genetic
testing with the support of the European Society of Human Genetics and EuroGentest. It provides general objective information on genetic tests, including their nature and the potential implications of their
results. The brochure is available online (http://www.coe.int/bioethics) and is currently being translated
into some 20 European languages.
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Ethically speaking 17, January 2013
Unesco
1. Work of the International Bioethics Committee of Unesco and the Intergovernmental Bioethics
Committee
Through its advisory bodies in the field of bioethics, Unesco continues to offer a unique platform for
reflection and debate based on its interdisciplinary, multicultural and pluralist approach. The International Bioethics Committee (IBC) and the Intergovernmental Bioethics Committee (IGBC) build on the
universal values enshrined in the Universal Declaration on Bioethics and Human Rights to ensure that
progress in science and new technologies serve all human beings, in particular those who are the most
vulnerable.
The Unesco headquarters in Paris was the venue, from 10 to 14 September 2012, of the 19th session of
the IBC, as well as the joint session of the IBC and the IGBC, and the special session of the IGBC to elect
its bureau. The events attracted approximately 110 participants from 47 different countries, gathering
representatives of Member States as well as representatives of international organisations, NGOs and
other external partners.
The IBC discussed the draft report on traditional medicine and its ethical implications, and opened up the
deliberation to include the voices and opinions of Unesco’s sectors of culture and natural sciences, as well
as the WHO, various international NGOs and other external partners. Based on the input received on the
draft, a working group set up by the IBC on this topic will revise and finalise the document before the 20th
session of the IBC in 2013, scheduled to take place in June (the exact dates and location are being finalised).
The IBC also prepared a preliminary document on the principle of non-discrimination and non-stigmatisation, as set forth in Article 11 of the Universal Declaration on Bioethics and Human Rights. This topic
will serve as a ‘conceptual umbrella’ under which the IBC will reflect upon and transversally analyse
issues such as access to drugs, biobanks, HIV/AIDS, nanotechnologies, neuroscience and organ, tissues
and cell transplantation, and trafficking.
The seventh session of the IGBC, which is comprised of 36 Member States whose representatives meet
at least once every 2 years to examine the advice and recommendations of the IBC, will be convened in
Paris during the summer of 2013 (the exact dates and location are being finalised).
2. The assisting bioethics committees project
Although the bioethics committees have assumed an indispensable role in addressing bioethical challenges in various countries, they are mostly absent from the picture in the developing countries, contributing to a serious handicap of these societies to confront important ethical questions that put at risk millions
of vulnerable persons. Member States of Unesco have recognised the significance of supporting such
committees by dedicating a separate article to this issue in Unesco’s Universal Declaration on Bioethics
and Human Rights (2005), which calls for the establishment and support of independent, multidisciplinary
and pluralist ethics committees at the appropriate level. As a response, the bioethics programme designed
the assisting bioethics committees (ABC) project to offer Member States a comprehensive capacity-building assistance for a period of 3 years. After graduating from ABC, the newly established committees will
have undertaken three separate training modules, established a working partnership with a long-standing
committee and developed independent internal capacity to carry on its important mandate.
The project is characterised by its depth of engagement with the participating Member States — it makes
a concerted effort to holistically develop capacities of the committees in order to make sure that they can
stand on their feet independently and address the bioethical challenges, both substantively and procedurally, after being weaned off the project.
Ethically speaking 17, January 201361
In 2012, the ABC programme made significant progress on building capacities for managing bioethical
dilemmas, primarily by conducting trainings with a special focus on Africa. The trainings for the newly
established national bioethics committees were held in Chad, Côte d’Ivoire, Gabon, Ghana, Guinea,
Malawi and Togo. Moreover, Oman and Malaysia have recently set up their national bioethics committees and will soon commence their collaboration with Unesco. Argentina is currently negotiating with
Unesco to join the ABC project.
3. The ethics education programme
Unesco’s ethics education programme (EEP), much like the ABC activity, stems from the Universal Declaration on Bioethics and Human Rights, the Article 23 of which requests to ‘foster bioethics education
and training at all levels as well as to encourage information and knowledge dissemination programmes
about bioethics’. The EEP is designed to respond to the request of Member States for Unesco to initiate
and support teaching ethics in all relevant scientific and professional modules of education.
In recent times, ethics has become an important part of the higher education curricula in various disciplines — not only in medical sciences but also in law, social sciences, public policy, philosophy and
others. In order to gain a clear picture of the state of the art in ethics teaching around the world, Unesco
is mapping existing ethics teaching programmes in its Member States. To date, 235 ethics teaching programmes have been identified and entered into the global ethics observatory of Unesco (GEObs) for easy
public access. Teachers interested in launching or strengthening ethics teaching programmes in their
institutions can consult the database to find suggestions and ideas from the existing programmes.
The bioethics core curriculum is yet another tool created by Unesco in order to promote bioethics education around the world. The core curriculum, which was developed by a special group of experts from
diverse cultural backgrounds, is based on the declaration and is designed to introduce the bioethical principles of the declaration to university students. It therefore does not impose a particular model or specific
view of bioethics, but articulates ethical principles that are shared by scientific experts, policymakers and
health professionals from various countries with different cultural, historical and religious backgrounds.
In order to ensure a flexible application of this tool, the curriculum invites teachers and students to
expand its contents and approaches based on the local context. The curriculum has already been successfully integrated into university programmes in many countries around the world.
While practical educational tools, such as the GEObs database and the bioethics core curriculum are
helpful, the quality of ethics education also depends on the substantive and pedagogic competencies of
the teachers. In other words, an effective ethics teacher should be knowledgeable about how to teach,
as well as what to teach to the students. The ethics teacher training courses (ETTC) project, designed
to target the young generation of experts and educators who are engaged in teaching ethics at various
academic faculties and institutions around the world, complements the practical ethics teaching tools
developed by Unesco by focusing on the methodology and pedagogy behind ethics education.
In the past, the ethics teacher training courses have been held in Bucharest, Romania (2006); Egerton
University Njoro Campus, Kenya (2007); Bratislava, Slovakia (2007); Riyadh, Saudi Arabia (2007);
Minsk, Belarus (2008); Dubrovnik, Croatia (2010, 2011); and Belgrade, Serbia (2011).
In 2012, Unesco organised four ETTC sessions in Baku, Azerbaijan; Dubrovnik, Croatia; Vilnius, Lithuania; and Windhoek, Namibia, to train close to 70 ethics teachers from a wide variety of countries (Azerbaijan, Belarus, Canada, Croatia, Egypt, Kenya, Latvia, Lithuania, Mexico, Namibia, Nigeria, Portugal,
Russia, Saudi Arabia, Serbia, South Africa and Tanzania). The bioethics core curriculum of Unesco was
a central focus of the trainings, with an aim to promote it as an education tool and to facilitate its broad
dissemination around the world.
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Ethically speaking 17, January 2013
World Health Organisation (WHO)
Public health ethics
a. Ethics of tuberculosis prevention, care and control
After the publication of the WHO guidance on ethics of tuberculosis (TB) (http://whqlibdoc.who.int/
publications/2010/9789241500531_eng.pdf) at the end of 2010, a series of implementation activities have
been organised at regional and country level. Over 400 Ministries of Health officials, public health specialists and TB doctors have participated in these events, including in Azerbaijan, Benin, China, Greece,
Guatemala, Malaysia and the Netherlands. The document is available in the six official WHO languages.
b.Cholera
There has been an ongoing debate over the utility and feasibility of establishing a stockpile of cholera vaccines for use in cholera epidemics. A number of ethical issues need to be taken into account in
the decision-making processes and the management of a potential stockpile. Since the supply would, at
least at the start, not meet the demand, the fair distribution and equitable access to this vital but scarce
resource poses a number of ethical questions which have been addressed in several international consultations over the last months.
c. Ethics in public health crises in disasters
Following the recommendations of an expert meeting, a virtual working group has been constituted to
develop a training course on ethical issues to address in public health crises and disasters. The WHO
sponsored a session on ethics in public health crises and disasters at the World Congress in Bioethics in
Rotterdam, 27 June 2012.
d.HIV/AIDS
The use of antiretrovirals (ARVs) for treatment and for prevention of HIV is a dynamic and rapidly
evolving field. Important new evidence has emerged demonstrating the benefit of earlier initiation of
ARV for the HIV-positive individual to prevent onward transmission to their HIV-negative partner and
oral as well as topical ARV pre-exposure prophylaxis (PrEP) for the HIV-negative individual to prevent
HIV acquisition. The fact that ARVs cannot only be used for treatment, but also for prevention, poses
ethical dilemmas in terms of priority setting and fair allocation of resources. These ethical questions are
being addressed in a joint WHO/UNAIDS project. An international consultation on the ethics of PrEP
and early initiation of ARVs for prevention was held in Geneva on 10 and 11 October 2012, in order to
help countries with their decision-making processes.
Research ethics
a. International clinical trial registry platform
Following the resolution adopted by the World Health Assembly in 2005, the International Clinical Trial
Registry Platform (ICTRP) was established to promote transparency in health research activities. In
March 2012, the EU Clinical Trials Register (EU-CTR) became a data provider to the ICTRP search portal. The ICTRP database now contains more than 200 000 records of clinical trials and collects data from
data providers globally (more information is available on http://www.who.int/ictrp/en/index.html). The
standards adopted by the WHO primary registries contribute to harmonising procedures and to ensuring
the quality of data collection.
Ethically speaking 17, January 201363
b. H5N1 and dual-use research
H5N1 avian influenza is an infectious disease of birds that can be spread to people, but is difficult to
transmit from person to person. Researchers have recently succeeded in creating H5N1 viruses that
are more transmissible in mammals than those that occur naturally. This has raised concerns about
the risks and safety of such research and the WHO was asked to convene a technical consultation
on 16 and 17 February 2012. The participants at this meeting reached consensus on two urgent issues
related to the newly created H5N1 influenza viruses: extending the temporary moratorium on research
with new laboratory-modified H5N1 viruses and recognition that research on the naturally occurring
H5N1 influenza virus must continue in order to protect public health. An international consultation is
being planned to take place in Geneva on 26 to 28 February 2013, in order to review the status quo and
show the way forward in this area.
c. Standards for research ethics committees
Following the publication of the ‘Standards and operational guidance for the ethics review of healthrelated research with human participants’ (http://www.who.int/ethics/publications/en), the ethics and
health unit is developing a set of indicators that should be used for the oversight of the research ethics
committees at country level.
d. Online course on research ethics
The WHO is currently developing an online research ethics course for its staff members. Once it is tested
and made available to all WHO staff, open access will be considered.
e. Pan-African Clinical Trial Alliance
The ethics and health team works in close collaboration with the WHO vaccine department on the oversight of clinical trials in Africa. This project aims to strengthen ethics review systems, improve the
coordination between research ethics committees and national regulatory authorities and promote the
registration of all clinical trials.
Global partnership
a. Global network of WHO collaborating centres for bioethics
The fourth meeting of the global network of the WHO’s collaborating centres for bioethics was hosted
by Columbia University, in New York, on 14 and 15 June 2012, to agree on a joint work plan in the area
of public health ethics, clinical ethics and research ethics. Further collaborating centres, in particular in
lower-middle-income countries (LMICs) are to be designated in the near future.
b. Ninth Global Summit of National Ethics Committees
The Global Summit of National Ethics Committees (NECs) is an initiative taken by NECs, since 1996.
The Ethics and Health Unit serves as the permanent Secretariat of the summit, as such it provides technical support to working groups of NECs established to address priority ethical issues and works in close
collaboration with the local organisers. A database of NECs was developed to provide access to opinions published by NECs (see http://apps.who.int/ethics/nationalcommittees); this tool should facilitate
exchange between NECs on issues of common interest.
The Ninth Global Summit of National Ethics Committees was hosted by the Tunisian Ministry of Health
and the Tunisian NEC in Carthage, Tunisia on 26 to 28 September 2012. Thirty-eight countries were
represented with a total of more than 100 participants including observers and representatives from
Unesco, the Council of Europe, and the WHO headquarters and regional offices. Before the summit, four
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Ethically speaking 17, January 2013
background papers were developed by groups of NECs from all around the world on the following issues,
identified during the previous summit:
• biobanks;
• research ethics committees;
• infectious diseases (TB, HIV, malaria);
• organ, tissue and cell transplantation.
These topics were discussed during the summit as well as other emerging topics and ongoing activities
in the different NECs.
The 10th summit will take place in Mexico in June 2014.
c. Collaboration with NGOs
• The WHO is part of the review process of the Council of International Organisations of Medical
Sciences (CIOMS) guidelines on biomedical research.
• The WHO is part of a working group on the use of placebos in biomedical research established by
the World Medical Association (WMA) for the update of the Declaration of Helsinki on ethical
principles for medical research involving human subjects.
Ethically speaking 17, January 201365
EGE Secretariat
Ethically speaking 17, January 201367
Secretariat
Address
European Commission
Berl 8/362
1049 Brussels
BELGIUM
Fax +32 229-94565
E-mail: BEPA-ETHICS-GROUP@ec.europa.eu
Maurizio SALVI
MBA, MBS, PhD, D. Biotech.
European Commission
Head BEPA Ethics Sector
Head of the EGE Secretariat
General Secretary EC IBD
Berl 8/359
1049 Brussels
BELGIUM
E-mail: maurizio.salvi@ec.europa.eu
Kim Hoang Le
European Commission
EGE Secretariat
Berl 8/362
1049 Brussels
BELGIUM
Tel. +32 229-99228
E-mail: Kim-hoang.le@ec.europa.eu
Adriana Sorina Oltean
European Commission
EGE Secretariat
Berl 8/362
1049 Brussels
BELGIUM
Tel. +32 229-93016
E-mail: adriana-sorina.oltean@ec.europa.eu
Website: http://ec.europa.eu/european_group_ethics/index_en.htm
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Ethically speaking 17, January 2013
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KA-AI-13-001-EN-C
ISSN 1725-5562
Ethically speaking
Ethically
speaking
A newsletter providing information on the
activities of the national ethics committees
compiled by the Secretariat of the European
Group on Ethics in Science and New
Technologies to the European Commission
Issue 17 — January 2013
Issue 17 — January 2013