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DH-BIO/INF (2014) 6 REV

DH-BIO/INF(2014)7

bilingual
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COMMITTEE ON BIOETHICS
COMITE DE BIOETHIQUE
(DH-BIO)





Developments in the field of bioethics
in member states and other states
Dveloppements dans le domaine de la biothique
dans les Etats membres et les autres Etats

Developments in the field of bioethics in international organisations
Dveloppements dans le domaine de la biothique
dans les organisations internationales














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This document contains contributions in their original language. / Ce document contient les contributions dans
leur langue dorigine.
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TABLE OF CONTENTS
TABLE DES MATIERES


BELGIUM/BELGIQUE ............................................................................................................................. 3
DENMARK/DANEMARK ......................................................................................................................... 3
FINLAND/FINLANDE .............................................................................................................................. 4
GERMANY/ALLEMAGNE ....................................................................................................................... 4
GREECE/GRECE .................................................................................................................................... 5
ITALY/ITALIE ........................................................................................................................................... 7
SAN MARINO/SAN MARIN ..................................................................................................................... 8


BELGIUM / BELGIQUE

La loi du 28 mai 2002 relative leuthanasie a t modifie par une loi du 28 fvrier 2014 en
vue dtendre leuthanasie aux mineurs (M.B. 12.03.2014, p. 21053).

Dsormais, un mineur dot de la capacit de discernement qui se trouve dans une situation
mdicale sans issue de souffrance physique constante et insupportable qui ne peut tre
apaise et qui entraine un dcs brve chance, et qui rsulte dune affection
accidentelle ou pathologique grave et incurable, peut demander une euthanasie.
Contrairement ce qui est prvu pour une personne majeure, le lgislateur ne permets pas
au mineur de demander une euthanasie pour une souffrance psychique, ni pour un dcs
qui nest pas prvu brve chance.

Concernant les modalits, un pdopsychiatre ou un psychologue doit sassurer de la
capacit de discernement du mineur. Les reprsentants lgaux du mineur (ex. parents ou
tuteur) doivent quant eux marquer leur accord sur la demande du patient mineur.

Prcisons que cette extension de leuthanasie aux mineurs ne concerne pas la rdaction
dune dclaration anticipe relative leuthanasie. Cette dernire permet une personne de
consigner par crit, pour le cas o elle ne pourrait plus manifester sa volont lavenir (ex.
coma), sa volont quun mdecin pratique une euthanasie si les conditions lgales sont
remplies. Pour rdiger une telle dclaration, il faut toujours tre majeur ou mineur mancip.

DENMARK / DANEMARK

In the beginning of 2014 Danish Council of Ethics published a statement regarding the use of
antibiotics. The statement aims to qualify the public debate on how to deal with the threat
from rapidly growing resistance to antibiotics. The statement can be read on this webpage:

http://www.etiskraad.dk/Udgivelser/~/media/bibliotek/udtalelser/2014/DCE-statement-on-the-
use-of-antibiotics-2014.pdf

In December 2013 the Danish Council of Ethics has published a report regarding
International trade in human eggs, surrogacy and organs. In the report the Danish Council
of Ethics looks at the ethical dilemmas associated with medical tourism, which involves
Danes buying human body parts in other countries. The three cases, trade in human eggs,
surrogacy and organs, have been selected because they differ in respect of some ethically
significant parameters in terms of what might be called injury, including loss of function, to
the person providing them. The statement can be read on this webpage:

http://www.etiskraad.dk/Udgivelser/~/media/bibliotek/rapporter/2013/International-trade-in-
human-eggs-surrogacy-and-organs.pdf

Furthermore it can be mentioned that the Danish Government this spring is planning to
introduce bills regarding the possibility for transgender people to carry out a legal sex
change without castration/sex change operation. If the bills are passed the legal sex
changes can be carried out by sending an application to Ministry of Economic Affairs and
the Interior and if the applicant after a six months reflection period upholds the application,
the person will receive a new social security number and be registered with the chosen sex
in the Danish Civil Registration System.

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FINLAND / FINLANDE

Government Bill on the new Self-determination Act:

The bill includes a proposal to enact a new law on strengthening the right of self-
determination of social welfare clients and patients and on conditions for use of limitation
measures (Self-determination Act). The proposed act would provide for strengthening the
right of self-determination in social and health care services as well as for the conditions for
use of limitation measures in connection with health care. The proposed act would also
contain provisions on supervision and legal safeguards relating to the use of limitation
measures.

The objective of the new act is to strengthen the right of self-determination of clients and
patients and to reduce the use of limitation measures in social and health care. Even in
situations where the use of limitation measures would be allowed as the last-resort means to
provide social and health care in accordance with the law, the measures should always be
dimensioned correctly and the mildest possible method should be chosen.

It is proposed that the provisions on limitation measures under the Self-determination Act
should not be applied to the treatment against a persons will under the Act on Social Work
with Substance Abusers, the treatment and examinations against a persons will under the
Mental Health Act and the combating of communicable diseases under the Communicable
Diseases Act. These provisions would neither be applied to child welfare, except for the
provisions on a persons right of access to a home or other place of residence in order to find
out the persons state of health or need for social welfare.

The service provider should promote the implementation of the right of self-determination in
the context of the services provided to a client or patient. The new Self-determination Act
would also include provisions on assessment of the clients or patients ability of self-
determination and on planning regarding the individual right of self-determination. At the
latest when a clients or patients ability of self-determination has been determined to be
reduced in the way referred to in the act, an individual plan should be drawn up for the client
or patient and appended to the plan in accordance with the Act on the Status and Rights of
Social Welfare Clients or the Act on the Status and Rights of Patients.

The Self-determination Act would lay down provisions on the general conditions for use of
limitation measures, such as requirements for necessity and proportionality and respect for
human dignity. The act would also contain provisions on particular conditions to be imposed
on each measure. The new act would also contain provisions on the procedure to be
observed in making a decision or other solution regarding a limitation measure.

In connection with enactment of the Self-determination Act new provisions would also be
added to the Act on the Status and Rights of Social Welfare Clients and the Act on the Status
and Rights of Patients regarding provision of support in decision-making.

The purpose is that the proposed acts enter into force on 1 November 2014.

GERMANY / ALLEMAGNE

The German delegation would like to inform you, that the English version of the opinion of
the German Ethics Council on "The future of genetic testing - from research to clinical
applications" now can be found under the following link: http://www.ethikrat.org/files/opinion-
the-future-of-genetic-diagnosis.pdf

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GREECE / GRECE

I. Hellenic National Bioethics Commission
www.bioethics.gr

Opinions -Recommendations - Reports
The Hellenic National Bioethics Commission has recently issued:
a Recommendation on the issue of Do-Not-Resuscitate Orders: o study the issue,
the Commission held relevant hearings with members of the scientific community
an Opinion on the Management and Burial of Embryos Less Than 180 Days of
Gestation, Human Body Parts and Cadaveric Preparations
an Opinion on the Control of Non-Invasive Clinical Trials for Drugs
an Opinion and a Report on Human Enhancement: effect on cognitive and mental
state. According to this Report "Many psychiatric, neurodegenerative and
neurodevelopmental disorders coexist with abnormalities in normal cognitive and
mental functions. Autism, intellectual disability, attention deficit disorder,
schizophrenia, depression but also neurodegenerative diseases, such as Alzheimer's,
Parkinson's and Huntington's chorea, are associated with impairment of cognitive
functions. Aging of the brain also leads to similar effects. The continuous and rapid
scientific developments make it possible, to some extent, to intervene in the
development of these diseases and delay their symptoms, mainly through
pharmaceutical substances that aim to enhance cognitive functions. Therefore, the
moral issue raised here, is whether these pharmaceutical substances could be used
in healthy people in order to enhance their cognitive and mental characteristics". To
study the issue, the Commission held relevant hearings with members of the
scientific community
a Recommendation on Participation of midwifes in artificial termination of pregnancy
a Recommendation on the issue of Control on Medically Assisted Reproduction:
although in Greece there is an exemplary legal framework (Act 3089/02 and Act
3305/2005, this has not been completely enacted. This gap has led to the inactivation
for a long time of the National Authority of Medically Assisted Reproduction and
consequently to illegal practices including trafficking of women, commercialization of
ova donation, use of illicit drugs etc. The Recommendation recommended the urgent
reactivation of the National Authority which indeed took place recently.

Activities: Bioethics goes to schools
The Commission organizes educational activities for schools (Secondary Schools and High
Schools) related to bioethics

Educational Seminars
The Hellenic National Bioethics Commission for the second consecutive year, organizes
educational seminars, which cover a wide range of critical issues including human
reproduction, applications of genetics, clinical studies, euthanasia, cloning and
nanotechnology.
The seminars are addressed to undergraduate and graduate students, doctors, biologist,
lawyers, educators, health professionals, social scientists, journalists, and those who are
simply interested in the ethical and social consequences of the scientific progress. Prominent
guest scientists present a lecture every two weeks, followed by an open discussion. The
program will run from January to June 2014.
Events
Life, Society and Nature before the challenges of Biosciences, discussion-event
(27-01-2014)
Direct-to-consumer genetic tests, Meeting (17-01-2014)
Medical Liability and Bioethics II, Conference (14-03-2014)

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Current activities
Accreditation of genetic laboratories/centers
Weekly meetings with patients associations

II. Legislation /Policy
Convention on Rights of Persons with Disabilities.
Greece ratified the Convention with Act 4074/2012. Relevant discussions had already started
in the legal circles in order to achieve clarification, the National Federation of Persons with
Disabilities has established a collaboration with the Centre of European Constitutional Law,
the aim of which will be the further investigation of compatibility of Greek legislation with the
UN Convention and the possibility of restructuring of certain Greek policies and laws under
the prism of the Conventions provisions.

National Action Plan on Human Rights
Under the auspice of the Ministry of Justice took place the finalization of the National Plan on
Human Rights. The official launching of the document however, met with severe criticism
from various NGOs as well as from the Greek Society for Human Rights. The criticism mainly
focused on the insufficient reference to issues of domestic violence, mental health, trafficking
of human beings and racism.

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ITALY / ITALIE

Opinions issued by the Italian National Committees for Bioethics

I. Year 2014
Pediatric Biobanks
Lifestyles and protection of health
Concerning bioethical issues raised by the Law August 6th, 2013, n, 96 Criteria in
the view of a Governmental decree for the fulfillment of the directive 2010/63/UE of
the European Parliament and of the Council of September 22, 2010
Year 2013
Health within the walls"
Conjoined twins and separation surgery: bioethical aspects
Mental disability in developing age and autism
Intensive care unit "open" to family visits
Illegal trafficking of human organs from living donors
Donation of the corpse for scientific research
Neuroscience and pharmacological cognitive enhancement: bioethical aspects
Human rights, medical ethics and enhancement technologies in military contexts
Abstracts and complete texts, translated in English, available on the website
http://www.governo.it/bioetica/eng/motion.html

Normative framework

On heterologous fertilization
Recent judgment delivered by Italys Constitutional Court (the publication of its reference
number is underway) modifying Article 4 of Law 40/2004, whereby lifting the ban on
heterologous fertilization.
Cross-border healthcare: Legislative Decree approval
December 4
th
2013 The Italian Council of Ministers, upon the proposal of the Minister of
Health and of the Minister of European Affairs, approved the final draft of a Legislative
Decree implementing Directive 2011/24/EU of the European Parliament and of the
Council of 9 March 2011 on the application of the patients rights in cross-border
healthcare.
Decree-Law 36/2014 clinical trials of off-label use of drugs
Decree-Law No. 36 of March 20, 2014, Urgent Provisions governing the use of narcotic
drugs and psychotropic substances, prevention, treatment and rehabilitation related to
drug abuse problems, referred to in the Decree of the President of the Italian Republic
No. 309 of October 9, 1990, and concerning the use of less expensive drugs for the
National Health Service was published in the Official Gazette No. 67 of March 21, 2014.
Surrogacy abroad The Court of Brescia condemns an Italian couple for alteration of civil
status
Contrary to the Decisions issued, in the last months, by the Courts of Milan and Trieste,
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the Court of Brescia ruled that any act intended to declare the newborn as the child of a
woman different from the one who actually gave birth to the baby constitutes an offence
of alteration of civil status, also in the event of a formation of the birth certificate abroad
and eventual registration in Italy.

SAN MARINO / SAN MARIN

Public debate:
On December 2013 was held in San Marino a public panel discussion entitled: The
respect for human rights and the promotion of inclusion, organized by the Minister
of Health and Social Security, by the Minister of Education and Culture, by Institute for
Social Security, in collaboration with the National Bioethics Committee of Republic of
San Marino.
The UN Convention on the Rights of Persons with Disabilities (2006) marked a reversal
cultural approach to persons with disabilities, no longer based on different beliefs and
conventions that govern individual countries, but on the universal recognition of the
human rights: it is a switch from a policy of assistance to a policy of inclusion and
mainstreaming.
The Republic of San Marino was among the first States that have ratified this historical
international document in February 2008 and, in the context of the promotion and
application of the UN Convention, has taken steps to undertake a number of initiatives in
this respect, since document "The bioethical approach to persons with disabilities",
approved by the National Bioethics Committee of Republic of San Marino, on February
25, 2013.
The seminar of December 2013 is placed in this groove, with the aim of illustrating the
impact to citizens in the bioethical, cultural, social and political system that involves the
promotion of inclusion.
On April 2014 was held in San Marino a three-day Conference entitled: Pain and
nursing care. Detect, prevent, treat and manage pain (http://www.assdolore.org/).
The Conference has received the patronage of the National Bioethics Committee of
Republic of San Marino, because the treatment of pain takes on a high bioethics value,
especially in decision-making process regarding medical treatment in end-of-life
situations, also in the light of what is stated in the draft Guide of DH-BIO.
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TABLE OF CONTENTS
TABLE DES MATIERES



European Commission / Commission Europenne .............................................................................. 10
European Science Foundation / Fondation Europenne de la Science ............................................... 12





European Commission / Commission Europenne

In January 2013, the European Group on Ethics (EGE)
2
finalized and adopted its Opinion on
research, production and use of energy. As of February 2013, following the request of
President Barroso, the European Group on Ethics started the work for its future Opinion on
Ethics of Security and Surveillance Technologies. From February 2013 to date, the Group
met ten times and welcomed the inputs of 18 experts including also representatives of the
Commission services, the EU Data Protection Supervisor, the Information and Privacy
Commissioner of Ontario, etc. The EGE further discussed Opinion 28 on Ethics of Security
and Surveillance Technologies with the Chairs of the EU28 National Ethics Councils on 18
June 2013 in Dublin under the auspices of the Irish Presidency of the EU Council.
In the course of 2013 several meetings were held between the EGE and President Barroso.
Opinion 28 is currently undergoing finalization and is to be adopted in spring 2014.
The subject of the next Opinion will be announced in May 2014.

17 September 2013 was the date of the EC International Dialogue on Bioethics, bringing
together the Presidents of the National Ethics Councils from Member States as well as Third
Countries across all continents, the 15 EGE members and the representatives of UNESCO,
WHO and the Council of Europe, to share experiences and reflect together on the topic of
Research Security and Security Research.

18 September 2013 was the date of the public Round Table on the Ethics of Security and
Surveillance Technologies, organized in accordance with the EGE's Rules of Procedure with
the purpose of promoting dialogue and transparency, in the context of the development of
the Opinion on this subject, with the participation of members of academia, industry, think
tanks, NGOs, representatives of the European Institutions and the civil society, amounting to
over 100 participants including Professor Giorgio Agamben among the guest speakers.

We also convened two meetings of the Inter-Service Group on Ethics and EU Policies
(among the different services of the European Commission), furthering the exchange of
information and the coordination of EC actions in the field of ethics and EU policies.

The Annual Report on the Application of the EU Charter of Fundamental Rights, published by
the European Commission with regard to the implementation of fundamental rights and
freedoms enshrined in the Charter, can be found here:
http://ec.europa.eu/justice/fundamental-rights/charter/application/index_en.htm

Last but by no means least, the launch of Horizon 2020 (the new European framework
programme for research and innovation 2014-2020, including research on and with bioethics
and ethics in science and new technologies) in January 2014 constitutes another important
milestone.

To note on Clinical Trials

On 20-21 November 2012, the EGE had adopted its position on the proposal for a regulation
of the European Parliament and the Council on Clinical Trials.
The EGE position has since been appreciatively acknowledged and drawn upon in the inter-
institutional process of refinement of the Clinical Trials regulation.

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The European Group on Ethics in Science and New Technologies (EGE) is an independent advisory body with a
status defined in several EC legal documents (e.g. EC/98/44).
The current mandate of the EGE was adopted by Commission Decision on December 23, 2009 (C(2009)10353).
According to that remit, the role of the EGE is to provide the European 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.
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The developments in that regard can be found here: http://ec.europa.eu/health/human-
use/clinical-trials/
(this European Commission web-site directs to all documents and to further tools such as
http://www.europarl.europa.eu/oeil/popups/ficheprocedure.do?lang=en&reference=2012/019
2%28COD%29
enabling to follow the proposal in the different steps of the procedure).

A compromise text has been agreed between the co-legislators at the end of December 2013
(subject to technical finalisation and formal approval).
Commissioner Borg has issue a statement on the agreement on 20 December:
http://ec.europa.eu/health/files/clinicaltrials/memo-13-1190_en.pdf
Vote in EP plenary in April and the Council to pronounce itself soon after.
Publication could thus be expected for May-June and application from mid-2016.

Dates of future activities in 2014

20 May 2014 (foreseen) :
Official handing over event for the Opinion on Ethics of Security and Surveillance
Technologies to be handed over to President Barroso, Brussels.

21 Oct 2014 (foreseen) :
EC International Dialogue on Bioethics and Ethics of Science and New Technologies,
Brussels.

22 Oct 2014 (foreseen) :
Ethics Round Table, Brussels.

18-20 Nov 2014 (foreseen) :
Meeting bringing together the European Group on Ethics in Science and New Technologies
(EGE) and the NEC-Forum of all European Union member states National Ethics Councils,
Rome.
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European Science Foundation / Fondation Europenne de la
Science

Five smaller Scientific Review Groups (SRGs) replace the previous Standing Committees of
the European Science Foundation (ESF). For more information (activities, publications and
news) about the different SRGs, see: http://www.esf.org/hosting-experts/scientific-review-
groups.html (access to all SRGs from the left menu)

We present in this report the developments at the ESF in the Scientific Review Groups for
the:
Biomedical Sciences (SRG-MED, formerly Standing Committee for the European
Medical Research Councils EMRC)
Social Sciences (SRG-SOC, formerly Standing Committee for the Social Sciences
SCSS)
Life, Earth and Environmental Sciences (SRG-LEE, formerly Standing Committee for
the Life, Earth and Environmental Sciences LESC)


Report Human Stem Cell Research and Regenerative Medicine - Focus on European
policy and scientific contributions
As a follow-up to the ESF-EMRC 2010 Science Policy Briefing no. 38 Human Stem Cell
Research and Regenerative Medicine - A European Perspective on Scientific, Ethical and
Legal Issues, this new report was published on 6 November 2013 with the support of all DH-
BIO representatives who provided input on their national legislative frameworks on human
stem cell research regulation and legislation in Europe. It has been disseminated through
various media (e.g. editorial in The Lancet) and will be disseminated during an Exploratory
Workshop entitled Regulating Stem Cell-Based Regenerative Medicine: New Ethical
Challenges For Europe that will take place on 17-19 September 2014 in Toulouse (France).
Report available from: http://www.esf.org/publications/medical-sciences.html
Press release available from: http://www.esf.org/media-centre/ext-single-news/article/new-
report-calls-for-sustained-public-endorsement-and-funding-for-human-stem-cell-research-
978.html
More information about the Exploratory Workshop: http://www.esf.org/coordinating-
research/exploratory-workshops/biomedical-sciences-med/workshops-detail.html?ew=13038


Forward Look report Personalised Medicine for the European Citizen (iPM)
The iPM Forward Look final report was published in December 2012 and launched on
28 January 2013 in Brussels (BE). ESF is now part of a Coordinated Strategic Action
(PerMed: http://www.permed2020.eu/) funded by the European Commission that was
launched on 8 October 2013 and had its first workshop on 27-28 March 2014 in Berlin (DE).
The programme and presentations of this workshop are available from:
http://www.permed2020.eu/1408.php
ESF is also a permanent guest in the European Alliance for Personalised Medicine (EAPM:
www.euapm.eu) who supports the implementation of the Forward Look report.


Science Policy Briefing Science in Society: Caring for our futures in turbulent times
This Science Policy Briefing was released during a launch event on 24 September 2013, with
Professors Ulrike Felt (Chair of the Scientific Committee), Helga Nowotny (President of the
European Research Council) and Paul Boyle (President of Science Europe).
Report and additional information available from: http://www.esf.org/hosting-
experts/scientific-review-groups/social-sciences-soc/activities/strategic-activities/the-future-
of-science-in-society.html
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Press release available from: http://www.esf.org/media-centre/ext-single-
news/article/science-in-society-caring-for-our-futures-in-turbulent-times-967.html
A video of the launch event including brief interviews with participants is available from:
http://www.esf.org/hosting-experts/scientific-review-groups/social-sciences-
soc/activities/strategic-activities/the-future-of-science-in-society/videos.html


EUROCORES Programme Synthetic Biology: Engineering Complex Biological
Systems (EuroSYNBIO)
This EUROCORES (European Collaborative Research) programme was composed of 5
Collaborative Research Projects including SynMod (Synthetic biology to obtain novel
antibiotics and optimized production systems) which focussed on the ethical, legal and
societal impacts of the field of synthetic biology. This non-lab group investigated the
potential impact of synthetic biology on the safety of biotechnological processes and its
ethical implications for our society. These considerations are shared with the public to
institute a constructive dialogue about a potentially transformative novel technology in the
format of a video now available from: https://vimeo.com/92919018
For more information, see: www.esf.org/eurosynbio


FINAL_HumanStemC
ellResearch.pdf
ESF_SPB50_ScienceI
nSociety.pdf