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EC policy on hESC: Ethics and Bioethics. BEPA European Commission. EU Directives having relevance to ethics in research include: Charter of Fundamental Rights of The European Union Directive 95/46 on the protection of personal data Directive 2001/20/EC on good clinical practice

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Bepa european commission

EC policy on hESC: Ethics

and Bioethics

BEPA

European Commission


Bepa european commission

EU Directives having relevance to ethics in research include:

Charter of Fundamental Rights of The European Union

Directive 95/46 on the protection of personal data

Directive 2001/20/EC on good clinical practice

Directive 2001/83/EC on medicinal products for human use and Directive 2003/63/EC amending Directive 2001/83/EC

Directive 86/609/EEC on the protection of animals used fore experimental and other scientific purposes

Protocol on Protection and welfare of animals (Protocol to the Amsterdam Treaty)

Directive 90/219/EEC on the contained use of genetically modified micro-organisms.

Council Directive 98/81/EC amending Directive 90/219/EEC on the contained use of genetically modified micro-organisms

Directive 2000/54/EC on the protection of workers from risks related to exposure to biological agents at work

European Parliament resolution on human cloning

Directive 96/9 on the legal protection of databases,

And others…

Relevant EU Legislation


Bepa european commission

These include:

The Helsinki Declaration

The Convention of the Council of Europe on Human Rights and Biomedicine signed in Oviedo on 4 April 1997 and its Additional Protocols,

The UN Convention on the Rights of the Child,

The Universal Declaration on the human genome and human rights adopted by UNESCO,

The Universal Declaration on Bioethics and Human Rights (UNESCO, October 2005)

UN Biological and Toxin Weapons Convention (BTWC),

International Treaty on Plant Genetic Resources for Food and Agriculture,

Relevant World Health Organisation (WHO) resolutions

International Regulations


To summarise

Regulation of ethical issues remains the responsibility of individual Member States, reflecting the ethical pluralism and the principle of subsidiarity that characterises the European Union.

A common set of basic European values does however exist at the EU level as embodied in the Charter of Fundamental Rights

to summarise…


Bepa european commission1

European Group on Ethics in Science

and New Technologies (EGE)

BEPA

European Commission


European group on ethics in science and new technologies ege

The EGE is an independent, pluralist and multidisciplinary body which advises the European Commission on ethical aspects of science and new technologies in connection with the preparation and implementation of Community legislation or policies

http://europa.eu.int/comm/european_group_ethics/index_en.htm

European Group on Ethics in Science and New Technologies (EGE)


European group on ethics in science and new technologies ege1

European Group on Ethics in Science and New Technologies (EGE)

Göran Hermerén, Linda Nielsen, Rafael Capurro,  Inez de Beaufort,

Pere Puigdomenèch Rosell and Günter Virt, (from the former EGE)

new  members: Emmanuel Agius, Diana Bánáti,  Anne Cambon-Thomsen

Jozef Glaza, Hille Haker, Julian Kinderlerer, Krzysztof Marczewski

Paula Martinho da Silva.


Opinions gaeib 1991 1997

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

n° 2Products derived from human blood or human plasma (12/03/1993)

n° 3 Ethical questions arising from the Commission proposal for a Council directive for legal protection of biotechnological inventions (30/09/1993)

n° 4 The ethical implications of gene therapy (13/12/1994)

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

n° 6Ethical aspects of prenatal diagnosis (20/02/1996)

n° 7 Ethical aspects of genetic modification of animals (21/05/1996)

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

n° 9Ethical aspects of cloning techniques (28/05/1997)

n° 10 Ethical aspects of the 5th Research Framework Program (11/12/1997)

OPINIONS GAEIB 1991-1997


Opinions ege 1998 2005

n° 11 Ethical aspects of human tissue banking (21/07/1998)

n° 12 Ethical aspects of research involving the use of human embryo in the context of the 5th framework program (23/11/1998)

n° 13 Ethical issues of healthcare in the information society (30/07/1999)

n° 14 Ethical aspects arising from doping in sport (14/11/1999)

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

n° 16 Ethical aspects of patenting inventions involving human stem cells 07/05/2002)

n° 17 Ethical aspects of clinical research in developing countries (04/02/2003)

n° 18 Ethical aspects of genetic testing in the workplace (28/07/2003)

n°19Ethical aspects of umbilical cord blood banking (16/03/2004)

n°20Ethical aspects of ICT implants in the human body (16/3/ 2005)

OPINIONSEGE 1998-2005


Relations with national ethics committees

- Bilateral meetings during each Presidency

- EGE Newsletter “Ethically Speaking” providing

information on the activities of the national ethics

committees

- Ad hoc participation of National Committees to

round tables and hearings

- Links between websites

- Contacts with ethics committees of new EU and future Member States

- Contacts with relevant bodies such as International organisations (Council of Europe, UN Agencies etc.)

Relations with national ethics committees


Bepa european commission2

EC Activities on Ethics and Science

and Bioethics

BEPA

European Commission


Ethics types of activities

3 types of activities in the field of bioethics:

Promotion offundamental rights, in the preparation and implementation of Community legislation or policies, including emerging legislation. In particular the Commission is also ensuring through the ethical review that EU-funded research proposals that do involve issues of major significance on bioethics (e.g. use of human biological material, involvement of vulnerable people in research activities –children, aged peoples etc., use of non-human primates etc.) are ethically sound.

Funding ofresearch on ethical, legal and social issuesraised by developments in science and technology, through the Community Research Framework Programmes (FPs). 

Promoting Pan European and International dialogueon ethics.

Ethics: Types of activities…


The approach chosen

Embedding ethics in EU policies and Facilitating dialogue

Research Programmeand activities, EGE Opinions

The approach chosen…

Horizontal approach

Vertical approach


The instruments

The instruments

Research Projects and

conferences

Deepening ELSA

and

promoting debates

Monitoring EU

projects

Ethical review

Participatory Process

Contributing to

EU and International

Decision making


Ethics and science european commission

Ethical review of EU Funded Research

Ethics and Science

European Commission


Budgets of the eu framework programmes

The Future: FP7 (2007-2013)

Budgets of the EU Framework Programmes

*

* Including 2,75 Billion for Euratom for 2007-2011


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The Ethical review, FP6

  • FP Article 3:

"All the research activities carried out

under the Framework Programme 2002-2006

must be carried out in compliance with

fundamental ethical principles.”

  • Rules for participation:

“A proposal which contravenes fundamental

ethical principles….…shall not be selected.

Such a proposal may be excluded from the

evaluation and selection procedures at any time.”


Number of fp6 research proposals undergoing ethical reviews

Number of FP6 Research Proposals undergoing Ethical Reviews


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FP6 Proposals undergoing Ethical Reviews11% of all funded FP6 projects have undergone an ethical review

Breakdown of projects having undergone ethical review, by research area


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Ethical Review in Context – Balance in the Fields of Expertise

45 % of female experts

Balance in fields of expertise: experts from different disciplines such as law, sociology, philosophy and ethics, psychology, IT, medicine, molecular biology, veterinary science


Geographical balance

Geographical Balance

  • Geographical Balance: Experts mainly from the EU Member States, Candidate countries but also from developing countries and emerging economies


Legal basis for ethical reviews in fp7

■Seventh Framework Programme (Decision N° 1982/2006/EC), Article 6 (1§):

Rules for Participation, Article 10:

Legal Basis for Ethical Reviews in FP7 –

« All the research activities carried out under the Seventh Framework Programme shall be carried out in compliance with fundamental ethical principles. »

« A proposal […] which contravenes fundamental ethical principles […] shall not be selected . Such a proposal may be excluded from the evaluation and selection procedures at any time. »


Legal basis for ethical reviews in fp 7

■Areas excluded from funding under FP 7, Art. 6 (2§):

Legal Basis for Ethical Reviews in FP 7 –

A)Research activity aiming at human cloning for reproductive purposes

B)Research activity intended to modify the genetic heritage of human beings which could make such changes heritable (Research related to cancer treatment of the gonads can be financed)

C)Research activities intended to create human embryos solely for the purpose of research or for the purpose of stem cell procurement, including by means of somatic cell nuclear transfer

Research activities that destroy embryos including the procurement of stem cells


Sc research funded at eu level

SC research funded at EU level

FP5 (1998-2002)▪ 50 projects with at least one component of SC research/ EC contribution  € 86 million▪over 95% of projects only involved somatic SC.▪2 projects also involved hESC.

FP6 (2002-2006)▪ 100 projects with at least one component of SC research / EC contribution  € 500 million▪ about 80% of projects only involved somatic SC.▪18 projects also involved hESC.


Sc research funded at eu level1

SC research funded at EU level

 hESC from less 5% of the total SC projects in FP6 to ~ 17% in FP6

 In line with the evolution of the research in this sector (more developments / more legislations in place)


Bepa european commission

SC research funded at EU level

104 FP6 projects involving stem cells

UNDERSTANDING

Fundamental knowledge relevant to human health

DEVELOPING

Tools for new therapies and medicines

BUILDING

Tissue engineering

MODELLING

Mathematical & biology models,alternatives to animals testing

REPAIRING

Pre-clinical & clinical studies for diseases

and impairements

TREATING

Improvement of standard hematopoeitic

SC transplantation

INTEGRATING

Ethics, legal, societal aspects, training


Bepa european commission

SC research funded at EU level

FP6 projects: type of cells/tissues/organs

Nervous system & annexes

Skin/oth. epithelium tissues

Bone/oth. connective tissues

Heart & vasculature

Digestive & urogenital tracts

Blood & immune system

Cancer

Heritable & Rare Diseases

Basic or horizontal issues

http://europa.eu.int/comm/research/stemcells


Bepa european commission

SC research funded at EU level

Changes between FP5 &FP6

Change in size

significant increase of SC research funded at EU level (~ X 6)

  • Change in nature

  • FP6 large projects (25 partners /  €10 million /i.e.  €400 000 per partner/4 years) help to:

    • Comparison of SC from different origins (adult/fœtal/embryonic)

    • Translational research

 Stem cell research is a field where collaborative research is of clear EU added value


Bepa european commission

SC research funded at EU level

Analysis of the participants who are involved in hESC research funded under FP6

  • 10 are from EU:

  • FI – IT – SE- UK – DE- NL – DK – CZ – FR - BE

  • this in fact represents 10 out of the 11 EU Member States who are active in this research (just ES is missing)

  • 2 are from Associated States:

  • CH - IL


Bepa european commission

hESC legislation

FI, DK, FR, LV, EE, SI, EL, ES, HU, NL, CZ, CH

AT,PL,LU LT,SK,MTCYIE,PT* LU

BE, SE, UK, Israel

IT§

DE

European Picture

Broader research on hESC

No research

on hESC

Brazil

Canada

Japan,Taiwan

USA non-federal

funds, Australia

China, India Singapore,South Korea

USA federal funds

* law expected

§ law prohibiting procurement

but no law on existing hESC


Bepa european commission

hESC EU policy

Citizens’ Opinion

Extracted from Eurobarometer surveys on biotechnology published in June 2006

(ref. Eurobarometer 64.3)

 59 % of the European citizens are supportive provided it is regulated


Bepa european commission

hESC EU policy

  • EU has no legal competency to regulate in this sector of ethics

  • The Commission has the responsibility to implement the EU research programs evenwhere some areas of research raise important ethical issues.

  • Respect of national rules is a fundamental principle  no research forbidden in a Member State supported by EU funds there


Bepa european commission

hESCEU policy

  • same ethical framework in FP7 (2006-2013) than

    in FP6 with a revision for 2010-2013.

  • Ciment of the overall FP7 agreement: statements by the Commission as regards article 6 of FP7 (ethical principles)

  • engagement of the Commission to respect the step by step procedure it established for this research in FP6 and which gave 100% success. In particular,

  • (12) The European Commission will continue with the current practice and will not submit to the Regulatory Committee proposals for projects which include research activities which destroy human embryos, including for the procurement of stem cells. The exclusion of funding of this step of research will not prevent Community funding of subsequent steps involving human embryonic stem cells.


Specific procedural modalities for research involving hesc

Specific Procedural Modalities for research involving hESC

  • Scientific Evaluation:

    Independent experts assess the necessity of using hESC for achieving the objectives set forth in the proposal.

All proposals for funding involving the use of hESC and/or fœtal issues will be automatically submitted to an ethical review panel.


Procedural modalities for hesc

Once the scientific evaluators confirm the necessity of using hESC in the research proposal, the ethical review panel assesses:

That the proposal does not include research activities which destroys embryos including for the procurement of stem cells;

Whether the consortium has taken into account the legislation, regulations, ethical rules and/or codes of conduct in place in the country(ies) where the research using hESC is to take place, including the procedures for obtaining informed consent*

The source of the hESC;

The measures taken to protect personal data, including genetic data, and privacy;

The nature of financial inducements, if any

* Cf. Directive 2004/23/EC

Procedural Modalities for hESC


Procedural modalities for hesc1

In addition, when research proposals involve the use of hESC, the following procedures are required:

 A positive opinion from a Regulatory Committee constituted by Member States’ representatives is required .

 Participants in research projects must seek the approval of the relevant national or local ethics committees prior to the start of the research activities (General Clause in the contract!)

Procedural Modalities for hESC


Procedural modalities hesc

Procedural Modalities hESC

In conclusion, each research proposal involving the use of hESC, which is supported within FP7, is assessed by at least two independent ethical reviews: one in the country itself where the research will be carried out) and one at the EU level.*

No System in the world offers a higher guarantee regarding the respect of fundamental ethical principles.

*If the research raising ethical issues is performed in more than one country (i.e. n countries), it implies that more than two ethical reviews will be performed (i.e. in fact n+1 ethical reviews)


Bepa european commission

Proposal

Submission and evaluation in FP7

Eligibility

Individual

evaluation

Security

Scrutiny

(if needed)

Consensus

Thresholds

Applicants informed of results

of expert evaluation*

Panel review

with hearing

(optional)

Ethical

Review

(if needed)

Commission ranking

  • invitation to submit second-stage

  • proposal, when applicable

Negotiation

Commission rejection

decision

Consultation of programme committee

(if required)

Applicants informed of

Commission decision

Commission funding

and/or rejection decision


Bepa european commission

hESC EU Policy

  • Creation of a EuropeanhESC registry:

  • to gather the information on all the European lines

  • in order to maximise the use of existing ones

  • to disseminate the information to all the scientific

  • community

  • to favour the comparability of results

Consortium with a representative from all EU Member States where this research is performed plus Turkey, Israël and Switzerland

 will start in Feb. 2007


Why the ec why ethics some responses to extrapolate

?

Why the EC?Why Ethics?Some Responsesto extrapolate…


Bepa european commission

Europe is a Community of values, based on respect for subsidiarity while promoting shared ethics values.

The integration and respect of human rights and ethics is an integral component of hESC governance in the EU

Open debate, mutual respect, tolerance are axes on which the EU is focusing efforts, actions and initiatives.


Personal contact

Maurizio SALVI, PhD,

Bureau of European Policy Advisors. (BEPA),

Head of the EGE Secretariat,

Chair EC Inter-service Platform on Ethics and EU Policies

European Commission, Rue de la Loi 200, BERL 8/146;

B-1049 Bruxelles, Belgium;

Tel.: 0032-2-2991179,  Fax: +32(0)2 299 45 65

E-Mail [email protected]

Information available:

EGE Secretariat e-mail: [email protected]

BEPA homepage: http://ec.europa.eu/dgs/policy_advisers/index_en.htm

EGE homepage: http://europa.eu.int/comm/european_group_ethics/index_en.htm

FP7 calls: http://cordis.europa.eu/fp7/dc/index.cfm

Research on ethics: http://ec.europa.eu/research/science-society/page_en.cfm?id=3120

Conferences on ethics: http://ec.europa.eu/research/science-society/page_en.cfm?id=3131

Ethical review: http://ec.europa.eu/research/science-society/page_en.cfm?id=3115

Personal Contact:


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