# L_2016140EN.01002101.xml

| 27.5.2016 | EN | Official Journal of the European Union | L 140/21 |
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27.5.2016

EN

Official Journal of the European Union

L 140/21

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COMMISSION DECISION (EU) 2016/835

of 25 May 2016

on the renewal of the mandate of the European Group on Ethics in Science and New Technologies

THE EUROPEAN COMMISSION,

Having regard to the Treaty on European Union and the Treaty on the Functioning of the European Union,

Whereas:

| (1) | Article 2 of the Treaty on European Union enshrines the values on which the Union is founded and Article 6 accords the Charter of Fundamental Rights the same legal value as the Treaties and establishes that fundamental rights shall constitute general principles of Union law. |
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(1)

Article 2 of the Treaty on European Union enshrines the values on which the Union is founded and Article 6 accords the Charter of Fundamental Rights the same legal value as the Treaties and establishes that fundamental rights shall constitute general principles of Union law.

| (2) | On 20 November 1991, the European Commission decided to incorporate ethics into the decision-making process for Community research and technological development policies by setting up the Group of Advisers on the Ethical Implications of Biotechnology (‘GAEIB’). |
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(2)

On 20 November 1991, the European Commission decided to incorporate ethics into the decision-making process for Community research and technological development policies by setting up the Group of Advisers on the Ethical Implications of Biotechnology (‘GAEIB’).

| (3) | The Commission decided on 16 December 1997 to replace the GAEIB by the European Group on Ethics in Science and New Technologies (‘EGE’) extending the Group's mandate to cover all areas of the application of science and technology. The EGE's mandate was subsequently renewed, most recently by the Commission Decision 2010/1/EU (1). It is now appropriate to renew the mandate for a period of 5 years and subsequently to appoint the new members. |
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(3)

The Commission decided on 16 December 1997 to replace the GAEIB by the European Group on Ethics in Science and New Technologies (‘EGE’) extending the Group's mandate to cover all areas of the application of science and technology. The EGE's mandate was subsequently renewed, most recently by the Commission Decision 2010/1/EU (1). It is now appropriate to renew the mandate for a period of 5 years and subsequently to appoint the new members.

| (4) | The EGE is tasked with providing ethical guidance to the European Commission either at the request of the Commission or on its own initiative and upon agreement with the Commission. The Commission may draw the EGE's attention to issues considered by the European Parliament and the Council to be of major ethical importance. |
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(4)

The EGE is tasked with providing ethical guidance to the European Commission either at the request of the Commission or on its own initiative and upon agreement with the Commission. The Commission may draw the EGE's attention to issues considered by the European Parliament and the Council to be of major ethical importance.

| (5) | Rules on disclosure of information by members of the group should be laid down. |
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(5)

Rules on disclosure of information by members of the group should be laid down.

| (6) | Personal data should be processed in accordance with Regulation (EC) No 45/2001 of the European Parliament and of the Council (2). |
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(6)

Personal data should be processed in accordance with Regulation (EC) No 45/2001 of the European Parliament and of the Council (2).

| (7) | Decision 2010/1/EU should be repealed, |
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(7)

Decision 2010/1/EU should be repealed,

HAS ADOPTED THIS DECISION:

Article 1

Mandate

The mandate of the European Group on Ethics in Science and New Technologies, hereafter referred to as ‘EGE’, is renewed for a period of 5 years.

Article 2

Task

The task of the EGE shall be to advise the Commission on ethical questions relating to sciences and new technologies and the wider societal implications of advances in these fields, either at the request of the Commission or on request by its chair with the agreement of the Commission services. The Group therefore shall:

| (a) | identify, define and examine ethical questions raised by developments in science and technologies; |
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(a)

identify, define and examine ethical questions raised by developments in science and technologies;

| (b) | provide guidance in the form of analyses and recommendations that shall be oriented towards the promotion of ethical EU policymaking, with due regard to the Charter of Fundamental Rights of the European Union. |
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(b)

provide guidance in the form of analyses and recommendations that shall be oriented towards the promotion of ethical EU policymaking, with due regard to the Charter of Fundamental Rights of the European Union.

Article 3

Consultation

The Commission may consult the group on any matter in the remit referred to in Article 2. In that context, the Commission may draw the Group's attention to issues considered by the Parliament and the Council to be of major ethical importance.

Article 4

Membership — Appointment

1.   The EGE shall have up to 15 members. Members shall have competence in the remit referred to in Article 2.

2.   Members shall serve in a personal capacity. They shall advise the Commission in the public interest and independently from any outside influence. Members shall inform the Commission in due time of any conflict of interest which might undermine their independence.

3.   Members shall be appointed by the President of the Commission on the basis of a proposal from the Commissioner in charge of Research, Science and Innovation, following the submission of their candidacy to a call for expression of interest for membership of the EGE and a selection process overseen by an Identification Committee, based on the criteria set out in paragraphs 4 and 6 of this Article.

4.   When proposing the composition of the EGE, the Identification Committee shall aim at ensuring, as far as possible, a high level of expertise and pluralism, a geographical balance, as well as a balanced representation of relevant know-how and areas of interest, taking into account the specific tasks of the EGE, the type of expertise required and the response to the call for expression of interest. The EGE shall be independent, pluralist and multidisciplinary.

Formula

6.   The following factors and criteria will be taken into account for the selection of candidates for membership of the Group:

| (a) | The composition of the group shall ensure that independent advice of the highest quality can be provided, combining wisdom and foresight. The credibility of the group shall be built on the balance of qualities amongst the women and men who make it up, and they shall collectively reflect the breadth of perspectives across Europe. Gender balance shall be strictly taken into account, and due consideration accorded to age balance and geographical distribution. |
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(a)

The composition of the group shall ensure that independent advice of the highest quality can be provided, combining wisdom and foresight. The credibility of the group shall be built on the balance of qualities amongst the women and men who make it up, and they shall collectively reflect the breadth of perspectives across Europe. Gender balance shall be strictly taken into account, and due consideration accorded to age balance and geographical distribution.

| (b) | The Members of the group shall be internationally recognised experts, with a track record of excellence and experience at the European and global level. |
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(b)

The Members of the group shall be internationally recognised experts, with a track record of excellence and experience at the European and global level.

| (c) | The Members shall reflect the broad cross-disciplinary scope of the group's mandate, embracing philosophy and ethics; natural and social sciences; and the law. However, they shall not perceive themselves as representatives of a particular discipline, worldview, or line of research; they shall have a broad vision which collectively reflects an understanding of important ongoing and emerging developments, including inter-, trans-, and multi-disciplinary perspectives, and the need for ethical advice at the European level. |
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(c)

The Members shall reflect the broad cross-disciplinary scope of the group's mandate, embracing philosophy and ethics; natural and social sciences; and the law. However, they shall not perceive themselves as representatives of a particular discipline, worldview, or line of research; they shall have a broad vision which collectively reflects an understanding of important ongoing and emerging developments, including inter-, trans-, and multi-disciplinary perspectives, and the need for ethical advice at the European level.

| (d) | Beyond their proven reputation, the membership shall collectively bring experience in providing ethical advice to policymakers, acquired across a broad range of Member States, and at European and international levels. |
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(d)

Beyond their proven reputation, the membership shall collectively bring experience in providing ethical advice to policymakers, acquired across a broad range of Member States, and at European and international levels.

| (e) | The group shall include members with experience in bodies such as advisory councils and committees, government advisors, national ethics councils, universities and research institutes. It may be valuable to the group to include members who have gained experience in more than one country and members from outside the European Union. |
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(e)

The group shall include members with experience in bodies such as advisory councils and committees, government advisors, national ethics councils, universities and research institutes. It may be valuable to the group to include members who have gained experience in more than one country and members from outside the European Union.

7.   The selection of the EGE members will be made on the basis of an open call for expression of interest, specifying the modalities for submitting a complete application. The Commission shall publish the call on the Europa website. A link from the Register of Commission expert groups and other similar entities (‘the register of expert groups’) to the Europa website will also be ensured.

8.   Nominations may be submitted, provided the nominee follows the modalities for submitting a complete application.

9.   The list of EGE members shall be published by the Commission in the Register of expert groups.

10.   Suitable candidates who are not appointed pursuant to paragraph 2 of this Article, shall be placed on a reserve list. The President of the Commission may appoint members from the reserve list.

11.   Where a member is no longer capable of contributing effectively to the work of the EGE, or resigns or does not comply with the conditions set out in Article 339 of the Treaty on the Functioning of the European Union, the President of the Commission may appoint a replacement member from the reserve list, for the remaining duration of the original member's term of office.

Article 5

Operation

1.   The Directorate-General for Research and Innovation, acting in close cooperation with the EGE's chairperson, shall be responsible for coordinating and organising the work of the EGE and for providing its Secretariat.

2.   The EGE shall elect a chairperson and a deputy-chairperson from among its members for the duration of their term by a simple majority.

3.   Members of the EGE, as well as invited experts, shall comply with the obligations of professional secrecy laid down by the Treaties and their implementing rules, as well as with the Commission's rules on security regarding the protection of EU classified information, laid down in Commission Decisions (EU, Euratom) 2015/443 (3) and (EU, Euratom) 2015/444 (4). Should they fail to respect these obligations, the Commission may take all appropriate measures.

4.   The EGE Work Programme, including such ethical analyses suggested on the own initiative of the EGE, shall be agreed by the Commission. Each request for an ethical analysis shall include the parameters of the requested analysis. The Commission shall, when seeking the advice of the EGE, set a time limit within which such advice shall be given.

5.   EGE Opinions shall include a set of recommendations. They shall be based on an overview of the state of the art of the sciences and technologies concerned and a thorough analysis of the ethical issues at stake. Relevant services of the Commission shall be informed of the recommendations produced by the EGE.

6.   The EGE shall operate in a collegial way, seeking consensus among its members. The EGE shall adopt its Rules of Procedure on the basis of the standard Rules of Procedure for expert groups with the agreement of the Commission's representative. The working procedures shall seek to ensure that all members take an active role in the activities of the group.

7.   The meetings of the EGE shall normally be held on Commission premises according to the modalities and the calendar fixed by the Commission. The EGE should meet at least six times during a 12-month period involving around 12 working days a year. Further meetings may be organised when necessary, in agreement with the Commission's representative.

For the purpose of the preparation of EGE analyses and within the limits of the available resources, the Commission's representative may:

| — | Invite experts and representatives of relevant NGOs or representative organisations when appropriate for an exchange of views on an ad hoc basis. The Commission may also enlist external experts to participate in the work of the EGE on an ad hoc and temporary basis should it be deemed necessary to cover the wide spectrum of ethical questions related to advances in science and new technologies. |
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Invite experts and representatives of relevant NGOs or representative organisations when appropriate for an exchange of views on an ad hoc basis. The Commission may also enlist external experts to participate in the work of the EGE on an ad hoc and temporary basis should it be deemed necessary to cover the wide spectrum of ethical questions related to advances in science and new technologies.

| — | Initiate studies in order to collect all necessary scientific and technical information. |
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Initiate studies in order to collect all necessary scientific and technical information.

| — | Allow for working groups to be set up to consider specific issues. |
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Allow for working groups to be set up to consider specific issues.

| — | Establish close links with representatives of the various ethics bodies in the Member States and in third countries. |
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Establish close links with representatives of the various ethics bodies in the Member States and in third countries.

Moreover, the Commission shall organise a public round table in order to promote dialogue and improve transparency for each Opinion that the EGE produces. The EGE shall establish close links with Commission departments concerned by issues the Group is working on.

8.   The Group shall endeavour to reach consensus. However, where an Opinion is not adopted unanimously, it shall include any dissenting point of view (as a ‘minority opinion’) together with the name(s) of the dissenting Member(s). The Opinion shall be transmitted to the President of the Commission or to a representative designated by the President. Each Opinion shall be forthwith published and transmitted to the European Parliament and to the Council of the European Union after its adoption.

9.   If operational circumstances require that advice on a particular subject be given more quickly than the adoption of an Opinion would allow, short Statements or other forms of analyses can be produced, to be followed if necessary by a fuller analysis in the form of an Opinion, while ensuring that transparency is respected as for any other Opinion. Statements will be published and made available on the EGE website. As part of its Work Programme, in agreement with the Commission's representative, the EGE may update an Opinion if it deems it necessary.

10.   The EGE's discussions shall be confidential. In agreement with the Commission's representative, the EGE may, by a simple majority of its members, decide to open its deliberations to the public.

11.   All relevant documents related to the activities of the EGE (such as agendas, minutes, Opinions and participants' submissions) shall be made available either in the Register of expert groups or via a link from the Register to a dedicated website. Exceptions to publication are possible where disclosure of a document is deemed to undermine the protection of a public or private interest as defined in Article 4 of Regulation (EC) No 1049/2001 of the European Parliament and of the Council (5).

12.   A report on the activities of the EGE shall be produced under the responsibility of the chairperson before the end of its mandate. The report shall be published and transmitted according to the modalities set out in paragraph 11.

Article 6

Meeting expenses

1.   Participants in the activities of the EGE shall not be remunerated for the services they render.

2.   Travel and subsistence expenses for the meetings of the EGE shall be reimbursed by the Commission in accordance with the provisions in force.

3.   Those expenses shall be reimbursed within the limits of the available appropriations allocated under the annual procedure for the allocation of resources.

Article 7

Final provisions

The present decision will be published in the Official Journal of the European Union and shall enter into force on the day following that of its publication in the Official Journal of the European Union. Decision 2010/1/EU is hereby repealed.

Official Journal of the European Union

Official Journal of the European Union

Done at Brussels, 25 May 2016.

For the Commission

The President

Jean-Claude JUNCKER

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(1)  Commission Decision 2010/1/EU of 23 December 2009 on the renewal of the mandate of the European Group on Ethics in Science and New Technologies (OJ L 1, 5.1.2010, p. 8).

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(2)  Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1).

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(3)  Commission Decision (EU, Euratom) 2015/443 of 13 March 2015 on Security in the Commission (OJ L 72, 17.3.2015, p. 41).

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(4)  Commission Decision (EU, Euratom) 2015/444 of 13 March 2015 on the security rules for protecting EU classified information (OJ L 72, 17.3.2015, p. 53).

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(5)  Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43).

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