委员会实施决定2013/640/EU,设立欧洲先进转化医学研究基础设施作为欧洲研究基础设施集团(EATRIS ERIC)
技术法规类型:欧盟Eurlex法规 来源:tbtmap
OJ编号:OJ L 298, 8.11.2013, p. 38-49
中文标题:委员会实施决定2013/640/EU,设立欧洲先进转化医学研究基础设施作为欧洲研究基础设施集团(EATRIS ERIC)
原文标题:Commission Implementing Decision of 7 November 2013 on setting up the European Advanced Translational Research Infrastructure in Medicine as a European Research Infrastructure Consortium (EATRIS ERIC)
文件类型:二级立法 Decision|决定
法规全文:查看欧盟官方文件
HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN" L 298/38
EN
Official Journal of the European Union
8.11.2013
DECISIONS
COMMISSION IMPLEMENTING DECISION
of 7 November 2013
on setting up the European Advanced Translational Research Infrastructure in Medicine as a
European Research Infrastructure Consortium (EATRIS ERIC)
(2013/640/EU)
THE EUROPEAN COMMISSION,
HAS ADOPTED THIS DECISION:
Having regard to the Treaty on the Functioning of the European
Article 1
Union,
1. A
European
Research
Infrastructure
Consortium
for
the
Having regard to Council Regulation (EC) No 723/2009 of
European Advanced Translational Research Infrastructure in
25 June 2009 on the Community legal framework for a
Medicine named EATRIS ERIC is hereby established.
European Research Infrastructure Consortium (ERIC) ( 1 ), and in
particular point (a) of Article 6(1) thereof,
2. The statutes of EATRIS ERIC are set out in the Annex.
These Statutes shall be kept up to date and made publicly
Whereas:
available on the website of EATRIS ERIC and at its statutory
seat.
(1) The
Czech
Republic,
the
Kingdom
of
Denmark,
the
Republic of Estonia, the Italian Republic, the Kingdom
3. The essential elements of the EATRIS ERIC Statutes for
of the Netherlands and the Republic of Finland requested
which amendments shall require approval by the Commission
the Commission to set up the European Advanced Trans
in accordance with Article 11(1) of Regulation (EC)
lational Research Infrastructure in Medicine as a
No 723/2009 are provided for in Articles 1, 2, 18, 20, 21,
European Research Infrastructure Consortium (EATRIS
22, 23, 24, 25, 28 and 29.
ERIC). The Kingdom of Spain and the Republic of
France will participate initially in EATRIS ERIC as an
Article 2
Observer.
This Decision shall enter into force on the third day following
its publication in the Official Journal of the European Union.
(2) The
Kingdom
of
the
Netherlands
has
been
chosen
by
the
Czech Republic, the Kingdom of Denmark, the Republic
of Estonia, the Kingdom of Spain, the Republic of France,
the Italian Republic and the Republic of Finland as the
Done at Brussels, 7 November 2013.
Host Member State of EATRIS ERIC.
For the Commission
(3) The
measures
provided
for
in
this
Decision
are
in
accordance with the opinion of the Committee estab
The President
lished by Article 20 of Regulation (EC) No 723/2009,
José Manuel BARROSO
( 1 ) OJ L 206, 8.8.2009, p. 1.
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ANNEX
STATUTES OF EATRIS ERIC
THE MEMBERS,
while recognising the important role for the national centres and their translational research capacities as organised
through the EATRIS ERIC infrastructure;
Having the aim to improve translational biomedical research by developing a European advanced translational research
infrastructure consisting of key preclinical and clinical facilities and translational expertise necessary to support the
development of new preventive, diagnostic and therapeutic strategies of biomedical research and development for
providing people with better healthcare;
Having the aim to provide access to the European advanced translational research infrastructure with the objective to
realise a significant impact on healthcare and make a significant contribution to the advancement of the tools and
technologies that drive translational science;
Recognising and elaborating on the results of the EATRIS Preparatory Phase project, funded by the European Commission
and the progress made during the Transition Phase of EATRIS;
Deciding to request the European Commission to establish the European Advanced Translational Research Infrastructure
in Medicine European Research Infrastructure Consortium (EATRIS ERIC) — as an outcome of the Transition Phase of
EATRIS;
HAVE THEREFORE AGREED UPON THE FOLLOWING PROVISIONS:
CHAPTER I
GENERAL PROVISIONS
Article 1
Name, seat, and working language
1. There shall be a distributed European Research Infrastructure called ‘European Advanced Translational Research
Infrastructure in Medicine’, hereinafter referred to as ‘EATRIS’.
2.
The name of the European Research Infrastructure Consortium (ERIC) — European Advanced Translational Research
Infrastructure in Medicine shall be ‘EATRIS ERIC’.
3. EATRIS
ERIC
shall
have
its
statutory
seat
in
Amsterdam,
the
Netherlands.
4. The
working
language
of
EATRIS
ERIC
shall
be
English.
Article 2
Tasks and activities
1. EATRIS
ERIC
shall
advance
research
in
translational
medicine.
2. EATRIS
ERIC
shall
be
committed
to
organising
and
facilitating
the
governance
and
coordination
that
is
required
to
establish and operate the EATRIS research infrastructure.
3. The EATRIS research infrastructure shall connect leading European research institutes that dedicate part of their
research and development capacities to EATRIS ERIC sharing content, tools and knowledge related to research in trans
lational medicine and in particular on the following:
(a) biologics and advanced therapies, such as gene and cell therapies and regenerative medicine;
(b) biomarkers;
(c) small molecules;
(d) molecular imaging and tracers;
(e) vaccines.
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CHAPTER II
MEMBERS
Article 3
Membership and representation
1. EATRIS
ERIC
shall
have
at
least
three
Member
States
as
Member,
only
States
and
intergovernmental
organisations
may become Member and have voting rights.
2.
Any Member shall appoint one or two representatives in the Board of Governors. Two representatives shall together
hold one vote.
3.
The Members and their representatives are listed in Appendix 1. The States that submitted the application requesting
the setting up of EATRIS ERIC to the European Commission are hereinafter referred to as Founding Members.
Article 4
Admission of new members
1. Applicants for Membership shall submit a written application to the Chairperson of the Board of Governors
describing their financial contribution and other contributions to EATRIS ERIC tasks and activities and how they will
fulfil their obligations.
2. The admission of new Members shall be subject to the approval of the Board of Governors.
Article 5
Withdrawal of a member and termination of membership
1. No Member may withdraw within the first five years of the establishment of EATRIS ERIC unless the Membership
has been entered into for a specified shorter period.
2. After the first five years of the establishment of EATRIS ERIC a Member may withdraw provided a request is
submitted to this effect 12 months in advance. A withdrawal shall only become effective at the end of a financial year and
after the withdrawing Member has fulfilled its obligations.
3. By derogation from paragraph 1 of this Article, a Member may withdraw during the first five years if the Board of
Governors decide to raise the thresholds of the annual financial contribution as specified in points (e) and (f) of Appendix
2. Member wishing to withdraw shall request withdrawal within six months of the adoption of the proposal to raise the
annual financial contribution. The withdrawal shall become effective at the end of the financial year on the condition that
the withdrawing Member has fulfilled its obligations.
4. The Board of Governors shall have the power to terminate a Membership in the following cases:
(a) the Member is in serious breach of one or more of its obligations under these Statutes;
(b) the Member has failed to rectify such breach within a period of six months of notification thereof.
The Member shall be invited by the Board of Governors to present its position on the proposed decision of termination
before any decision may be adopted.
5. Members that withdraw or have their Membership terminated shall neither have right to restitution or
reimbursement of any contributions made, nor the right to lay any claim to the assets of EATRIS ERIC.
Article 6
Rights and obligations of Members
1. Rights
of
Members
shall
include:
(a) the right to attend and vote at the Board of Governors;
(b) the right to participate in the development of strategies, policies and decision-making procedures concerning EATRIS
ERIC;
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(c) the right of its research community to participate in EATRIS ERIC events;
(d) the right of its research community to have access to and to receive support from EATRIS ERIC.
2. Each
Member
shall:
(a) pay an annual financial contribution as decided by the Board of Governors;
(b) empower its representatives with the full authority to vote by single vote on all issues raised during a meeting of the
Board of Governors;
(c) create a national centre or infrastructure consortium for the purpose of fulfilling the obligations arising from these
Statutes;
(d) appoint one National Director to represent it on the Board of National Directors;
(e) provide the necessary technical infrastructure to make access possible;
(f) promote the uptake of EATRIS ERIC services among researchers in its own country and gather user feedback and
requirements;
(g) support centres in its own country that wish to join the national infrastructure of a Member State participating in the
EATRIS ERIC infrastructure.
3. Contributions other than the annual financial contribution may be made by Members individually or jointly in
cooperation with other Members, Observers or third parties. Such contributions, in cash or in kind, shall be subject to
approval by the Board of Governors.
4. EATRIS ERIC shall enter into an agreement with the national centres in order to establish the terms and conditions
under which the national centres may join the EATRIS ERIC infrastructure and commit to the tasks and activities set out
in Article 2. The National Director shall use its best efforts to coordinate the interaction of its national centres with the
EATRIS ERIC.
CHAPTER III
OBSERVERS
Article 7
Observer status
1. States
and
intergovernmental
organisations
which
are
willing
to
contribute
to
EATRIS
ERIC
but
are
not
yet
in
a
position to join as Members may apply for Observer status.
2. Observers
shall
be
admitted
for
a
maximum
of
three
years,
unless
another
term
is
decided
by
the
Board
of
Governors.
3. Applications for Observer status shall be made in writing to the Chairperson of the Board of Governors and shall
set out how the applicant intends to contribute to EATRIS ERIC tasks and activities.
4. The admission of Observers shall be subject to the approval of the Board of Governors.
Article 8
Withdrawal of an observer and termination of observer status
1.
Observers may withdraw at the end of a financial year provided they have submitted a request thereto six months in
advance.
2. Financial and other obligations must be fulfilled before a withdrawal by an Observer can take effect.
3. The Board of Governors shall have the power to terminate the Observer status of an Observer in the following
cases:
(a) the Observer is in serious breach of one or more of its obligations under these Statutes;
(b) the Observer has failed to rectify such breach within a period of six months of notification thereof.
The Observer shall be invited by the Board of Governors to present its position on the proposed decision of termination
before any decision may be adopted.
4. Observers that withdraw or have their Observer status terminated shall have neither the right to restitution or
reimbursement of any contribution made, nor the right to lay any claim to the assets of EATRIS ERIC.
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Article 9
Rights and obligations of an Observer
1. Rights
of
Observers
shall
include:
(a) the right to attend the meeting of the Board of Governors without a right to vote;
(b) the right of their research community to participate in EATRIS ERIC events;
(c) the right of their research community to access EATRIS ERIC infrastructure and to receive support from EATRIS
ERIC.
2. Each
Observer
shall:
(a) appoint one or two representatives in the Board of Governors;
(b) pay the annual financial contribution as decided by the Board of Governors;
(c) set out its contribution to the EATRIS ERIC tasks and activities set out in Article 2.
3. Contributions other than the annual financial contribution to EATRIS ERIC may be provided by Observers indi
vidually or jointly in cooperation with other Members, Observers or third parties. Such contributions, in cash or in kind,
shall be approved by the Board of Governors.
4. An Observer shall empower its representative(s) to fulfil the obligations referred to in points (b) and (c) of
Article 9(2).
5. EATRIS ERIC shall enter into an Observer Agreement with the Observer in order to establish the terms and
conditions under which the obligations are to be fulfilled or the contribution is to be made.
CHAPTER IV
GOVERNANCE OF EATRIS ERIC
Article 10
Governance and management
The governance structure of EATRIS ERIC shall comprise the following bodies:
(a) the Board of Governors;
(b) the Executive Board.
Article 11
Board of Governors
1. The
Board
of
Governors
shall
be
the
highest
and
ultimate
governing
body
of
EATRIS
ERIC
with
full
decision-
making power. The Board of Governors shall meet at least once a year and shall be responsible in accordance with the
provisions of these Statutes for the overall direction and supervision of EATRIS ERIC.
2. Member
States
shall
jointly
hold
the
majority
of
the
votes.
3. The Board of Governors shall elect amongst its members a Chairperson and a deputy for a two-year term. The
Chairperson and deputy may be re-elected. Unless decided otherwise, the Chairperson shall chair all meetings of the Board
of Governors and shall be assisted by the deputy.
4.
The Board of Governors shall use their best efforts to achieve consensus on all decisions. Failing consensus, a simple
majority of the votes cast shall suffice to pass a decision, except for decisions referred to in paragraphs 5, 6 and 7.
5. The Board of Governors shall decide with a majority of at least two-thirds of the votes of the Members on
decisions to:
(a) adopt or change the strategies for the development of EATRIS ERIC;
(b) appoint, suspend or dismiss the Finance Director and the Scientific Director after consultation with the Board of
National Directors;
(c) establish Subsidiary Bodies in addition to the Permanent Bodies;
(d) adopt or change Standing Orders which describe the mandate and specify the activities of the Executive Board and of
the Subsidiary Bodies;
(e) adopt and amend the annual work programme and the annual budget.
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6. Decisions of the Board of Governors to terminate a Membership or Observer status shall require a majority of at
least three quarters of the votes of the Members.
7. A
Member
whose
Membership
termination
is
to
be
decided
upon
shall
have
no
vote
in
that
decision.
8.
The Board of Governors shall decide with unanimity of the Members, not counting any abstentions, on decisions to:
(a) amend the statutes, except for Appendix 1;
(b) wind up EATRIS ERIC.
Unless otherwise agreed, Members shall be informed of the exact wording of amendments to the Statutes and to
Appendix 2 at least three months before those amendments are put to vote.
9. The Board of Governors shall meet and decide validly only if a quorum of two thirds of all the Members of EATRIS
ERIC are present or represented.
10. The Board of Governors shall adopt Rules of Procedure for implementing the provisions of the Statutes.
Article 12
Executive Board
1. The Executive Board shall be responsible for the implementation of EATRIS ERIC and for supporting the Board of
Governors. The Executive Board shall be accountable solely to the Board of Governors.
2. The Executive Board shall perform its duties as determined by the Board of Governors and shall prepare its own
internal procedures of organisation, meetings and the way the Finance and Scientific Director shall work together in the
Rules of Procedure, to be submitted for approval by the Board of Governors.
3. The Executive Board shall consist of the Finance Director and the Scientific Director.
4. The Finance Director shall be the legal representative of EATRIS ERIC, shall represent EATRIS ERIC in any litigation
and shall be responsible for the (day-to-day) operational management of EATRIS ERIC.
5. The Scientific Director of EATRIS ERIC shall be responsible for the strategic scientific development and all oper
ational scientific matters of EATRIS ERIC.
6. The Directors of the Executive Board may serve for a term of up to five years to be decided by the Board of
Governors. After the initial term the Board of Governors shall decide on any extension. The procedures for the selection
and appointment of Directors shall be laid down in Rules of Procedure adopted by the Board of Governors.
Article 13
EATRIS ERIC coordination and support office
1. EATRIS ERIC Coordination and Support Office shall be the central management and daily operations office of
EATRIS ERIC and shall assist the Board of Governors. It shall be managed and its staff shall be recruited by the Finance
Director in consultation with the Scientific Director.
2. The EATRIS Coordination and Support Office shall be accommodated at the premises of EATRIS ERIC located at its
statutory seat.
CHAPTER V
SUBSIDIARY BODIES
Article 14
Subsidiary bodies
1. EATRIS
ERIC
shall
have
the
following
Subsidiary
Bodies:
(a) the Board of National Directors;
(b) the Scientific Advisory Board.
2. The Board of Governors may establish other Subsidiary Bodies if deemed necessary for the functioning of EATRIS
ERIC.
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Article 15
Board of National Directors
1. The Board of National Directors shall oversee the coordination of the implementation of the strategies approved by
the Board of Governors. The Board of National Directors shall be responsible for all national scientific activities related to
EATRIS ERIC and shall maintain coherence and consistency across EATRIS ERIC and collaboration between the Members.
2. The Board of National Directors shall consist of the National Directors appointed by the Members.
3. The members of the Board of National Directors shall elect amongst its members a Chairperson and a deputy for a
two-year term with the possibility of re-election in conformity with the procedures laid down in Rules of Procedure.
4. The Board of National Directors shall propose the Rules of Procedure and adopt them after approval by the Board
of Governors for their internal operational procedures.
5. The Board of National Directors shall perform the activities as determined by the Board of Governors in Standing
Orders.
6. The Board of National Directors shall select the members of the Scientific Advisory Board subject to approval by the
Board of Governors.
Article 16
Scientific Advisory Board
1. The
Scientific
Advisory
Board
shall
consist
of
independent
and
internationally
recognised
scientists
involved
in
biomedical translational research acting on their personal title and strategic experience.
2. The Scientific Advisory Board shall offer advice on request to the Board of Governors and may be consulted by the
Executive Board and the Board of National Directors on all scientifically and technologically relevant matters including
questions regarding the EATRIS ERIC research agenda, scientific strategies, ethical issues and the annual work programme.
CHAPTER VI
FINANCE AND REPORTING
Article 17
Budgetary principles and accounts
1. The financial year of EATRIS ERIC shall begin on 1 January and shall end on 31 December of each year.
2. EATRIS
ERIC
funds
may
be
used
solely
for
purposes
as
laid
down
in
these
Statutes.
3. All items of revenue and expenditure of EATRIS ERIC shall be included in estimates to be drawn up for each
financial year and shall be recorded in the annual budget.
4. The
accounts
of
EATRIS
ERIC
shall
be
accompanied
by
an
audited
report
on
the
budgetary
and
financial
management of the financial year. EATRIS ERIC shall produce an annual activity report, describing, in particular, the
scientific, operational and financial aspects of its activities. The report shall be approved by the Board of Governors and
transmitted to the European Commission and relevant public authorities within six months of the end of the
corresponding financial year. This report shall be made publicly available in full or in part.
5.
EATRIS ERIC shall be subject to the requirements of the applicable law and regulations as regards preparation, filing,
auditing and publication of accounts.
6. EATRIS ERIC shall ensure that all appropriations shall be used in accordance with the principles of sound financial
management.
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Article 18
Liability
1. EATRIS
ERIC
shall
be
liable
for
its
debts.
2. The Members’ financial liability towards ERIC’s debts shall be limited to each individual Member’s annual financial
contribution.
3. EATRIS ERIC shall take appropriate insurance to cover the risks of liability specific to the construction and
operation of EATRIS ERIC.
CHAPTER VII
POLICIES
Article 19
Agreements with third parties
In cases where EATRIS ERIC deems it beneficial, it can enter into agreements with third parties.
Article 20
Intellectual property rights policy
1.
The term intellectual property shall mean intellectual property as defined in Article 2 of the Convention Establishing
the World Intellectual Property Organization signed on 14 July 1967.
2. The Board of National Directors shall provide for common principles and policies for Intellectual Property as laid
down in Rules of Procedure. Those common principles and policies shall be approved by the Board of Governors.
3. The Board of National Directors may recommend agreements with the national centres and infrastructure consortia
within the EATRIS research infrastructure in order to ensure that these entities as well as third parties have access to the
scientific knowledge of the EATRIS research infrastructure.
Article 21
Access policy
1. EATRIS ERIC shall ensure as a general rule open access to services and infrastructures supporting and promoting
excellence in translational research as well as a culture of ‘best practices’ through training activities.
2. EATRIS ERIC shall provide guidance for users of EATRIS infrastructure to best ensure that research which has been
undertaken using the resources of the EATRIS infrastructure recognises and respects compliance with any property,
personal privacy, ethical and data owner’s protection rights as well as secrecy and confidentiality obligations as
defined in Rules of Procedure, further ensuring that users comply with access terms and conditions, security arrangements
for the internal storage and handling of (bio) materials and handling of information of research institutions participating
in EATRIS infrastructure.
3. The criteria and procedures that provide or restrict access to EATRIS ERIC infrastructure data and tools shall be
defined in Rules of Procedure and decided by the Board of Governors after advice from the Board of National Directors
and the Scientific Advisory Board.
Article 22
Scientific evaluation policy
1. EATRIS ERIC shall provide access to its translational infrastructure to projects that have the most potential for
making a significant impact on health care or a significant contribution to the advancement of the tools and technologies
that drive translational science.
2. The
scientific
evaluation
process
of
projects
requesting
access
to
the
EATRIS
ERIC
infrastructure
shall
consider
scientific merit, unmet medical need, eligibility and translational potential, and shall be based on transparency, fairness
and impartiality. That process shall be approved by the Board of Governors and laid down in Rules of Procedure.
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3. The scientific evaluation of projects within the EATRIS ERIC infrastructure shall consider scientific merit, unmet
medical need and translational potential based on transparency, fairness and impartiality and shall be further elaborated
by the Board of Governors and laid down in Rules of Procedure.
Article 23
Dissemination policy
1. EATRIS ERIC shall take all appropriate action to promote the infrastructure and its use in research and education.
2. EATRIS ERIC shall promote the dissemination and sharing of results obtained by national and international research
activities.
3. Without prejudice to any property rights EATRIS ERIC shall request its users to make their research results publicly
available and to make results available through EATRIS ERIC.
4. The dissemination policy shall identify the various target groups, and EATRIS ERIC shall use several channels to
reach the target audiences, such as web portals, newsletters, workshops, presence at conferences, articles in journals and
daily newspapers.
Article 24
Employment policy
EATRIS ERIC shall endeavour to select the best candidate on a non-discriminatory basis, regardless of background,
nationality, religion or gender, reflecting contributions made by the Members.
Article 25
Procurement policy
1. EATRIS ERIC shall treat procurement candidates and tenderers equally and without discrimination, regardless of
whether or not they are based within the European Union. The EATRIS ERIC procurement policy shall respect the
principles of transparency, non-discrimination and competition. The Board of Governors shall adopt Rules of Procedure
establishing detailed rules on procurement procedures and criteria.
2. The Executive Board shall be responsible for all EATRIS ERIC procurement. All tenders shall be published on the
EATRIS ERIC website and in the Members’ and Observers’ territories. For procurement amounts higher than
EUR 200 000 EATRIS ERIC shall follow the principles of Directive 2004/18/EC of the European Parliament and of
the Council of 31 March 2004 concerning the coordination of procedures for the award of public works contracts, public
supply contracts and public service contracts ( 1 ). The decision to award procurement shall be published and include a full
justification.
Article 26
Tax exemption
1. Tax
exemptions
based
on
Articles
143(1)(g)
and
151(1)(b)
of
Council
Directive
2006/112/EC
( 2 ) and in accordance
with Articles 50 and 51 of Council Implementing Regulation (EU) No 282/2011 ( 3 ) shall be limited to the value added
tax for such goods and services which are for official use by EATRIS ERIC, exceed the value of EUR 250, and are wholly
paid for and procured by EATRIS ERIC. Procurement by individual Members shall not benefit from these exemptions.
Without prejudice to paragraphs 2 and 3 no further limits shall apply.
2. Tax
exemptions
shall
apply
to
non-economic
activities,
not
to
economic
activities.
3. Tax
exemptions
shall
be
applied
to
goods
and
services
for
the
scientific,
technical
and
administrative
operations
undertaken by EATRIS ERIC in line with its principal tasks. This shall also include expenses for conferences, workshops
and meetings directly linked to the official activities of EATRIS ERIC. However travel and accommodation expenses shall
not be covered by tax exemptions.
( 1 ) OJ L 134, 30.4.2004, p. 114.
( 2 ) OJ L 347, 11.12.2006, p. 1.
( 3 ) OJ L 77, 23.3.2011, p. 1.
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Article 27
Data policy
The Executive Board shall submit to the Board of Governors for approval Rules of Procedure for data policy in relation to
users of EATRIS ERIC infrastructure, the national centres and third parties such as universities, research institutes and
industry, with due respect for existing licences.
CHAPTER VIII
DURATION, WINDING UP, DISPUTES, SET UP PROVISIONS
Article 28
Duration
The duration of EATRIS ERIC shall be indefinite.
Article 29
Winding up
1. The winding up of EATRIS ERIC shall be decided by the Board of Governors.
2. The European Commission shall be notified within 10 calendar days of the decision to wind up EATRIS ERIC.
3. Assets remaining after payment of EATRIS ERIC debts shall be apportioned among the Members in proportion to
their accumulated annual contribution to EATRIS ERIC.
4. The European Commission shall be notified within 10 calendar days of the closure of the winding up procedure.
Article 30
Language and availability of the Statutes
1. These Statutes shall be kept up to date and made publicly available on the website of the ERIC and at its statutory
seat.
2.
These Statutes shall be deemed authentic in all official language versions of the Members listed in Appendix 1. These
Statutes shall also be deemed authentic in the official language versions of the Members States not listed in Appendix 1.
No language version shall prevail.
3. When
language
versions
are
not
provided
for
through
the
Official
Journal
in
case
of
amendments
to
these
Statutes
that do not require a Commission Decision, they shall be provided by EATRIS ERIC Coordination and Support Office.
Article 31
Set-up provisions
1. A constitutional meeting of the Board of Governors shall be called by the host country as soon as possible but no
later than within 45 calendar days after the entry into force of the decision of the European Commission setting up
EATRIS ERIC. Without prejudice to paragraph 2 no decisions shall be taken by the Board of Governors before at least five
Members have joined EATRIS ERIC.
2. The host country shall notify the Founding Members of any specific urgent legal action that needs to be taken on
behalf of EATRIS ERIC before the constitutional meeting is held. Unless a Founding Member objects within five working
days of being notified, the legal action shall be carried out by a person duly authorised by the host state.
3. As of the establishment of EATRIS ERIC, its bodies shall act in accordance with the Standing Orders and Rules of
Procedure as approved by the EATRIS Governing Board during the EATRIS Transition Phase.
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Appendix 1
List of members, observers, and the entities representing them
Members Representing
entity
Czech Republic Ministry
of
Education,
Youth
and
Sports
(MEYS)
Kingdom of Denmark Danish
Agency
for
Science,
Technology
and
Innovation
(DASTI)
Republic of Estonia
Ministry of Education and Research of the Republic of
Estonia (MER EE)
Italian Republic Istituto
Superiore
di
Sanità
(ISS)
Kingdom of the Netherlands ZonMW
Republic of Finland Ministry
of
Education
and
Culture
(OKM)
Observers Representing
entity
Kingdom of Spain Instituto
de
Salud
‘Carlos
III’
(ISCIII)
French Republic Commissariat
à
l’Energie
Atomique
et
aux
Energies
Alternatives (CEA)
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Appendix 2
Annual financial contribution
Financial Commitment for the first five years
For the initial five-year period after the establishment of EATRIS ERIC the principles for the financial commitment shall
be as follows:
(a) initial commitment for Founding Members is five years (no initial commitment for Observers);
(b) Founding Members can sign up for less than five years subject to a 25 % increase in the annual contribution; the
excess shall be refunded if the Member completes the five years;
(c) the initial financial contribution for EATRIS ERIC year one is based on the agreed five-year budget excluding any
uncertain income source (e.g. the income from user fees) and a minimum of five Founding Members;
(d) the Netherlands will pay an additional hosting contribution of EUR 500 000 in 2013, 2014 and 2015. After 2015
the Netherlands will pay an additional hosting contribution of EUR 50 000;
(e) no Founding Member that has made a five-year commitment will pay more than EUR 140
000 per year (maximum
threshold);
(f) the
minimum
membership
contribution
will
not
be
lower
than
EUR
50
000 per
year
regardless
of
the
number
of
Members and regardless of any income generated by EATRIS ERIC (minimum threshold);
(g) the financial contribution for EATRIS ERIC year two is based on the agreed five-year budget minus the net result
from income in EATRIS ERIC year one. The financial contribution for EATRIS ERIC year three is based on the agreed
five-year budget minus the net result from income in EATRIS ERIC year two etc.;
(h) a new Member starts at the financial contribution level it would have paid as a Founding Member in EATRIS ERIC
year one plus 25 %. After accession year one it pays the financial contribution set for EATRIS ERIC year two plus
25 % etc. If the new Member completes a five-year term, the excess is refunded;
(i) Founding Observers with institutes not participating in all activities of EATRIS and not providing services pay 25 %
of the annual financial contribution of what they would have paid as Founding Members; a Founding Observer with
institutes participating in all activities of EATRIS including providing services shall pay the same annual financial
contribution as a Founding Member;
(j) a Founding Observer that pays 25 % of the annual financial contribution and that becomes a Member starts at the
same level of financial contribution it would have paid as a Founding Member in EATRIS ERIC year one. After
accession year one it pays the financial contribution set for EATRIS ERIC year two etc. If it completes a five-year
term, the Observer financial contribution shall be refunded;
(k) a new Observer starts at 25 % of the financial contribution it would have paid as a Founding Member in EATRIS
ERIC year one. In year two of its accession it pays 25 % of what it would have paid in EATRIS ERIC year two etc.;
(l) if a new Observer becomes a Member it pays the financial contribution it would have paid as a Founding Member in
EATRIS ERIC year one; after accession year one it pays the financial contribution set for EATRIS ERIC year two etc.;
if the new Member completes a five-year term, the Observer financial contribution shall be refunded;
(m) if new Members or Observers join or if an Observer becomes a Member the financial contribution for that year is
recalculated for all Members and Observers;
(n) in all cases mentioned in points (a) to (m), the 25 % extra financial contribution shall be held in reserve.
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DECISIONS
COMMISSION IMPLEMENTING DECISION
of 7 November 2013
on setting up the European Advanced Translational Research Infrastructure in Medicine as a
European Research Infrastructure Consortium (EATRIS ERIC)
(2013/640/EU)
THE EUROPEAN COMMISSION,
HAS ADOPTED THIS DECISION:
Having regard to the Treaty on the Functioning of the European
Article 1
Union,
1. A
European
Research
Infrastructure
Consortium
for
the
Having regard to Council Regulation (EC) No 723/2009 of
European Advanced Translational Research Infrastructure in
25 June 2009 on the Community legal framework for a
Medicine named EATRIS ERIC is hereby established.
European Research Infrastructure Consortium (ERIC) ( 1 ), and in
particular point (a) of Article 6(1) thereof,
2. The statutes of EATRIS ERIC are set out in the Annex.
These Statutes shall be kept up to date and made publicly
Whereas:
available on the website of EATRIS ERIC and at its statutory
seat.
(1) The
Czech
Republic,
the
Kingdom
of
Denmark,
the
Republic of Estonia, the Italian Republic, the Kingdom
3. The essential elements of the EATRIS ERIC Statutes for
of the Netherlands and the Republic of Finland requested
which amendments shall require approval by the Commission
the Commission to set up the European Advanced Trans
in accordance with Article 11(1) of Regulation (EC)
lational Research Infrastructure in Medicine as a
No 723/2009 are provided for in Articles 1, 2, 18, 20, 21,
European Research Infrastructure Consortium (EATRIS
22, 23, 24, 25, 28 and 29.
ERIC). The Kingdom of Spain and the Republic of
France will participate initially in EATRIS ERIC as an
Article 2
Observer.
This Decision shall enter into force on the third day following
its publication in the Official Journal of the European Union.
(2) The
Kingdom
of
the
Netherlands
has
been
chosen
by
the
Czech Republic, the Kingdom of Denmark, the Republic
of Estonia, the Kingdom of Spain, the Republic of France,
the Italian Republic and the Republic of Finland as the
Done at Brussels, 7 November 2013.
Host Member State of EATRIS ERIC.
For the Commission
(3) The
measures
provided
for
in
this
Decision
are
in
accordance with the opinion of the Committee estab
The President
lished by Article 20 of Regulation (EC) No 723/2009,
José Manuel BARROSO
( 1 ) OJ L 206, 8.8.2009, p. 1.
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ANNEX
STATUTES OF EATRIS ERIC
THE MEMBERS,
while recognising the important role for the national centres and their translational research capacities as organised
through the EATRIS ERIC infrastructure;
Having the aim to improve translational biomedical research by developing a European advanced translational research
infrastructure consisting of key preclinical and clinical facilities and translational expertise necessary to support the
development of new preventive, diagnostic and therapeutic strategies of biomedical research and development for
providing people with better healthcare;
Having the aim to provide access to the European advanced translational research infrastructure with the objective to
realise a significant impact on healthcare and make a significant contribution to the advancement of the tools and
technologies that drive translational science;
Recognising and elaborating on the results of the EATRIS Preparatory Phase project, funded by the European Commission
and the progress made during the Transition Phase of EATRIS;
Deciding to request the European Commission to establish the European Advanced Translational Research Infrastructure
in Medicine European Research Infrastructure Consortium (EATRIS ERIC) — as an outcome of the Transition Phase of
EATRIS;
HAVE THEREFORE AGREED UPON THE FOLLOWING PROVISIONS:
CHAPTER I
GENERAL PROVISIONS
Article 1
Name, seat, and working language
1. There shall be a distributed European Research Infrastructure called ‘European Advanced Translational Research
Infrastructure in Medicine’, hereinafter referred to as ‘EATRIS’.
2.
The name of the European Research Infrastructure Consortium (ERIC) — European Advanced Translational Research
Infrastructure in Medicine shall be ‘EATRIS ERIC’.
3. EATRIS
ERIC
shall
have
its
statutory
seat
in
Amsterdam,
the
Netherlands.
4. The
working
language
of
EATRIS
ERIC
shall
be
English.
Article 2
Tasks and activities
1. EATRIS
ERIC
shall
advance
research
in
translational
medicine.
2. EATRIS
ERIC
shall
be
committed
to
organising
and
facilitating
the
governance
and
coordination
that
is
required
to
establish and operate the EATRIS research infrastructure.
3. The EATRIS research infrastructure shall connect leading European research institutes that dedicate part of their
research and development capacities to EATRIS ERIC sharing content, tools and knowledge related to research in trans
lational medicine and in particular on the following:
(a) biologics and advanced therapies, such as gene and cell therapies and regenerative medicine;
(b) biomarkers;
(c) small molecules;
(d) molecular imaging and tracers;
(e) vaccines.
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CHAPTER II
MEMBERS
Article 3
Membership and representation
1. EATRIS
ERIC
shall
have
at
least
three
Member
States
as
Member,
only
States
and
intergovernmental
organisations
may become Member and have voting rights.
2.
Any Member shall appoint one or two representatives in the Board of Governors. Two representatives shall together
hold one vote.
3.
The Members and their representatives are listed in Appendix 1. The States that submitted the application requesting
the setting up of EATRIS ERIC to the European Commission are hereinafter referred to as Founding Members.
Article 4
Admission of new members
1. Applicants for Membership shall submit a written application to the Chairperson of the Board of Governors
describing their financial contribution and other contributions to EATRIS ERIC tasks and activities and how they will
fulfil their obligations.
2. The admission of new Members shall be subject to the approval of the Board of Governors.
Article 5
Withdrawal of a member and termination of membership
1. No Member may withdraw within the first five years of the establishment of EATRIS ERIC unless the Membership
has been entered into for a specified shorter period.
2. After the first five years of the establishment of EATRIS ERIC a Member may withdraw provided a request is
submitted to this effect 12 months in advance. A withdrawal shall only become effective at the end of a financial year and
after the withdrawing Member has fulfilled its obligations.
3. By derogation from paragraph 1 of this Article, a Member may withdraw during the first five years if the Board of
Governors decide to raise the thresholds of the annual financial contribution as specified in points (e) and (f) of Appendix
2. Member wishing to withdraw shall request withdrawal within six months of the adoption of the proposal to raise the
annual financial contribution. The withdrawal shall become effective at the end of the financial year on the condition that
the withdrawing Member has fulfilled its obligations.
4. The Board of Governors shall have the power to terminate a Membership in the following cases:
(a) the Member is in serious breach of one or more of its obligations under these Statutes;
(b) the Member has failed to rectify such breach within a period of six months of notification thereof.
The Member shall be invited by the Board of Governors to present its position on the proposed decision of termination
before any decision may be adopted.
5. Members that withdraw or have their Membership terminated shall neither have right to restitution or
reimbursement of any contributions made, nor the right to lay any claim to the assets of EATRIS ERIC.
Article 6
Rights and obligations of Members
1. Rights
of
Members
shall
include:
(a) the right to attend and vote at the Board of Governors;
(b) the right to participate in the development of strategies, policies and decision-making procedures concerning EATRIS
ERIC;
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(c) the right of its research community to participate in EATRIS ERIC events;
(d) the right of its research community to have access to and to receive support from EATRIS ERIC.
2. Each
Member
shall:
(a) pay an annual financial contribution as decided by the Board of Governors;
(b) empower its representatives with the full authority to vote by single vote on all issues raised during a meeting of the
Board of Governors;
(c) create a national centre or infrastructure consortium for the purpose of fulfilling the obligations arising from these
Statutes;
(d) appoint one National Director to represent it on the Board of National Directors;
(e) provide the necessary technical infrastructure to make access possible;
(f) promote the uptake of EATRIS ERIC services among researchers in its own country and gather user feedback and
requirements;
(g) support centres in its own country that wish to join the national infrastructure of a Member State participating in the
EATRIS ERIC infrastructure.
3. Contributions other than the annual financial contribution may be made by Members individually or jointly in
cooperation with other Members, Observers or third parties. Such contributions, in cash or in kind, shall be subject to
approval by the Board of Governors.
4. EATRIS ERIC shall enter into an agreement with the national centres in order to establish the terms and conditions
under which the national centres may join the EATRIS ERIC infrastructure and commit to the tasks and activities set out
in Article 2. The National Director shall use its best efforts to coordinate the interaction of its national centres with the
EATRIS ERIC.
CHAPTER III
OBSERVERS
Article 7
Observer status
1. States
and
intergovernmental
organisations
which
are
willing
to
contribute
to
EATRIS
ERIC
but
are
not
yet
in
a
position to join as Members may apply for Observer status.
2. Observers
shall
be
admitted
for
a
maximum
of
three
years,
unless
another
term
is
decided
by
the
Board
of
Governors.
3. Applications for Observer status shall be made in writing to the Chairperson of the Board of Governors and shall
set out how the applicant intends to contribute to EATRIS ERIC tasks and activities.
4. The admission of Observers shall be subject to the approval of the Board of Governors.
Article 8
Withdrawal of an observer and termination of observer status
1.
Observers may withdraw at the end of a financial year provided they have submitted a request thereto six months in
advance.
2. Financial and other obligations must be fulfilled before a withdrawal by an Observer can take effect.
3. The Board of Governors shall have the power to terminate the Observer status of an Observer in the following
cases:
(a) the Observer is in serious breach of one or more of its obligations under these Statutes;
(b) the Observer has failed to rectify such breach within a period of six months of notification thereof.
The Observer shall be invited by the Board of Governors to present its position on the proposed decision of termination
before any decision may be adopted.
4. Observers that withdraw or have their Observer status terminated shall have neither the right to restitution or
reimbursement of any contribution made, nor the right to lay any claim to the assets of EATRIS ERIC.
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Article 9
Rights and obligations of an Observer
1. Rights
of
Observers
shall
include:
(a) the right to attend the meeting of the Board of Governors without a right to vote;
(b) the right of their research community to participate in EATRIS ERIC events;
(c) the right of their research community to access EATRIS ERIC infrastructure and to receive support from EATRIS
ERIC.
2. Each
Observer
shall:
(a) appoint one or two representatives in the Board of Governors;
(b) pay the annual financial contribution as decided by the Board of Governors;
(c) set out its contribution to the EATRIS ERIC tasks and activities set out in Article 2.
3. Contributions other than the annual financial contribution to EATRIS ERIC may be provided by Observers indi
vidually or jointly in cooperation with other Members, Observers or third parties. Such contributions, in cash or in kind,
shall be approved by the Board of Governors.
4. An Observer shall empower its representative(s) to fulfil the obligations referred to in points (b) and (c) of
Article 9(2).
5. EATRIS ERIC shall enter into an Observer Agreement with the Observer in order to establish the terms and
conditions under which the obligations are to be fulfilled or the contribution is to be made.
CHAPTER IV
GOVERNANCE OF EATRIS ERIC
Article 10
Governance and management
The governance structure of EATRIS ERIC shall comprise the following bodies:
(a) the Board of Governors;
(b) the Executive Board.
Article 11
Board of Governors
1. The
Board
of
Governors
shall
be
the
highest
and
ultimate
governing
body
of
EATRIS
ERIC
with
full
decision-
making power. The Board of Governors shall meet at least once a year and shall be responsible in accordance with the
provisions of these Statutes for the overall direction and supervision of EATRIS ERIC.
2. Member
States
shall
jointly
hold
the
majority
of
the
votes.
3. The Board of Governors shall elect amongst its members a Chairperson and a deputy for a two-year term. The
Chairperson and deputy may be re-elected. Unless decided otherwise, the Chairperson shall chair all meetings of the Board
of Governors and shall be assisted by the deputy.
4.
The Board of Governors shall use their best efforts to achieve consensus on all decisions. Failing consensus, a simple
majority of the votes cast shall suffice to pass a decision, except for decisions referred to in paragraphs 5, 6 and 7.
5. The Board of Governors shall decide with a majority of at least two-thirds of the votes of the Members on
decisions to:
(a) adopt or change the strategies for the development of EATRIS ERIC;
(b) appoint, suspend or dismiss the Finance Director and the Scientific Director after consultation with the Board of
National Directors;
(c) establish Subsidiary Bodies in addition to the Permanent Bodies;
(d) adopt or change Standing Orders which describe the mandate and specify the activities of the Executive Board and of
the Subsidiary Bodies;
(e) adopt and amend the annual work programme and the annual budget.
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6. Decisions of the Board of Governors to terminate a Membership or Observer status shall require a majority of at
least three quarters of the votes of the Members.
7. A
Member
whose
Membership
termination
is
to
be
decided
upon
shall
have
no
vote
in
that
decision.
8.
The Board of Governors shall decide with unanimity of the Members, not counting any abstentions, on decisions to:
(a) amend the statutes, except for Appendix 1;
(b) wind up EATRIS ERIC.
Unless otherwise agreed, Members shall be informed of the exact wording of amendments to the Statutes and to
Appendix 2 at least three months before those amendments are put to vote.
9. The Board of Governors shall meet and decide validly only if a quorum of two thirds of all the Members of EATRIS
ERIC are present or represented.
10. The Board of Governors shall adopt Rules of Procedure for implementing the provisions of the Statutes.
Article 12
Executive Board
1. The Executive Board shall be responsible for the implementation of EATRIS ERIC and for supporting the Board of
Governors. The Executive Board shall be accountable solely to the Board of Governors.
2. The Executive Board shall perform its duties as determined by the Board of Governors and shall prepare its own
internal procedures of organisation, meetings and the way the Finance and Scientific Director shall work together in the
Rules of Procedure, to be submitted for approval by the Board of Governors.
3. The Executive Board shall consist of the Finance Director and the Scientific Director.
4. The Finance Director shall be the legal representative of EATRIS ERIC, shall represent EATRIS ERIC in any litigation
and shall be responsible for the (day-to-day) operational management of EATRIS ERIC.
5. The Scientific Director of EATRIS ERIC shall be responsible for the strategic scientific development and all oper
ational scientific matters of EATRIS ERIC.
6. The Directors of the Executive Board may serve for a term of up to five years to be decided by the Board of
Governors. After the initial term the Board of Governors shall decide on any extension. The procedures for the selection
and appointment of Directors shall be laid down in Rules of Procedure adopted by the Board of Governors.
Article 13
EATRIS ERIC coordination and support office
1. EATRIS ERIC Coordination and Support Office shall be the central management and daily operations office of
EATRIS ERIC and shall assist the Board of Governors. It shall be managed and its staff shall be recruited by the Finance
Director in consultation with the Scientific Director.
2. The EATRIS Coordination and Support Office shall be accommodated at the premises of EATRIS ERIC located at its
statutory seat.
CHAPTER V
SUBSIDIARY BODIES
Article 14
Subsidiary bodies
1. EATRIS
ERIC
shall
have
the
following
Subsidiary
Bodies:
(a) the Board of National Directors;
(b) the Scientific Advisory Board.
2. The Board of Governors may establish other Subsidiary Bodies if deemed necessary for the functioning of EATRIS
ERIC.
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Article 15
Board of National Directors
1. The Board of National Directors shall oversee the coordination of the implementation of the strategies approved by
the Board of Governors. The Board of National Directors shall be responsible for all national scientific activities related to
EATRIS ERIC and shall maintain coherence and consistency across EATRIS ERIC and collaboration between the Members.
2. The Board of National Directors shall consist of the National Directors appointed by the Members.
3. The members of the Board of National Directors shall elect amongst its members a Chairperson and a deputy for a
two-year term with the possibility of re-election in conformity with the procedures laid down in Rules of Procedure.
4. The Board of National Directors shall propose the Rules of Procedure and adopt them after approval by the Board
of Governors for their internal operational procedures.
5. The Board of National Directors shall perform the activities as determined by the Board of Governors in Standing
Orders.
6. The Board of National Directors shall select the members of the Scientific Advisory Board subject to approval by the
Board of Governors.
Article 16
Scientific Advisory Board
1. The
Scientific
Advisory
Board
shall
consist
of
independent
and
internationally
recognised
scientists
involved
in
biomedical translational research acting on their personal title and strategic experience.
2. The Scientific Advisory Board shall offer advice on request to the Board of Governors and may be consulted by the
Executive Board and the Board of National Directors on all scientifically and technologically relevant matters including
questions regarding the EATRIS ERIC research agenda, scientific strategies, ethical issues and the annual work programme.
CHAPTER VI
FINANCE AND REPORTING
Article 17
Budgetary principles and accounts
1. The financial year of EATRIS ERIC shall begin on 1 January and shall end on 31 December of each year.
2. EATRIS
ERIC
funds
may
be
used
solely
for
purposes
as
laid
down
in
these
Statutes.
3. All items of revenue and expenditure of EATRIS ERIC shall be included in estimates to be drawn up for each
financial year and shall be recorded in the annual budget.
4. The
accounts
of
EATRIS
ERIC
shall
be
accompanied
by
an
audited
report
on
the
budgetary
and
financial
management of the financial year. EATRIS ERIC shall produce an annual activity report, describing, in particular, the
scientific, operational and financial aspects of its activities. The report shall be approved by the Board of Governors and
transmitted to the European Commission and relevant public authorities within six months of the end of the
corresponding financial year. This report shall be made publicly available in full or in part.
5.
EATRIS ERIC shall be subject to the requirements of the applicable law and regulations as regards preparation, filing,
auditing and publication of accounts.
6. EATRIS ERIC shall ensure that all appropriations shall be used in accordance with the principles of sound financial
management.
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Article 18
Liability
1. EATRIS
ERIC
shall
be
liable
for
its
debts.
2. The Members’ financial liability towards ERIC’s debts shall be limited to each individual Member’s annual financial
contribution.
3. EATRIS ERIC shall take appropriate insurance to cover the risks of liability specific to the construction and
operation of EATRIS ERIC.
CHAPTER VII
POLICIES
Article 19
Agreements with third parties
In cases where EATRIS ERIC deems it beneficial, it can enter into agreements with third parties.
Article 20
Intellectual property rights policy
1.
The term intellectual property shall mean intellectual property as defined in Article 2 of the Convention Establishing
the World Intellectual Property Organization signed on 14 July 1967.
2. The Board of National Directors shall provide for common principles and policies for Intellectual Property as laid
down in Rules of Procedure. Those common principles and policies shall be approved by the Board of Governors.
3. The Board of National Directors may recommend agreements with the national centres and infrastructure consortia
within the EATRIS research infrastructure in order to ensure that these entities as well as third parties have access to the
scientific knowledge of the EATRIS research infrastructure.
Article 21
Access policy
1. EATRIS ERIC shall ensure as a general rule open access to services and infrastructures supporting and promoting
excellence in translational research as well as a culture of ‘best practices’ through training activities.
2. EATRIS ERIC shall provide guidance for users of EATRIS infrastructure to best ensure that research which has been
undertaken using the resources of the EATRIS infrastructure recognises and respects compliance with any property,
personal privacy, ethical and data owner’s protection rights as well as secrecy and confidentiality obligations as
defined in Rules of Procedure, further ensuring that users comply with access terms and conditions, security arrangements
for the internal storage and handling of (bio) materials and handling of information of research institutions participating
in EATRIS infrastructure.
3. The criteria and procedures that provide or restrict access to EATRIS ERIC infrastructure data and tools shall be
defined in Rules of Procedure and decided by the Board of Governors after advice from the Board of National Directors
and the Scientific Advisory Board.
Article 22
Scientific evaluation policy
1. EATRIS ERIC shall provide access to its translational infrastructure to projects that have the most potential for
making a significant impact on health care or a significant contribution to the advancement of the tools and technologies
that drive translational science.
2. The
scientific
evaluation
process
of
projects
requesting
access
to
the
EATRIS
ERIC
infrastructure
shall
consider
scientific merit, unmet medical need, eligibility and translational potential, and shall be based on transparency, fairness
and impartiality. That process shall be approved by the Board of Governors and laid down in Rules of Procedure.
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3. The scientific evaluation of projects within the EATRIS ERIC infrastructure shall consider scientific merit, unmet
medical need and translational potential based on transparency, fairness and impartiality and shall be further elaborated
by the Board of Governors and laid down in Rules of Procedure.
Article 23
Dissemination policy
1. EATRIS ERIC shall take all appropriate action to promote the infrastructure and its use in research and education.
2. EATRIS ERIC shall promote the dissemination and sharing of results obtained by national and international research
activities.
3. Without prejudice to any property rights EATRIS ERIC shall request its users to make their research results publicly
available and to make results available through EATRIS ERIC.
4. The dissemination policy shall identify the various target groups, and EATRIS ERIC shall use several channels to
reach the target audiences, such as web portals, newsletters, workshops, presence at conferences, articles in journals and
daily newspapers.
Article 24
Employment policy
EATRIS ERIC shall endeavour to select the best candidate on a non-discriminatory basis, regardless of background,
nationality, religion or gender, reflecting contributions made by the Members.
Article 25
Procurement policy
1. EATRIS ERIC shall treat procurement candidates and tenderers equally and without discrimination, regardless of
whether or not they are based within the European Union. The EATRIS ERIC procurement policy shall respect the
principles of transparency, non-discrimination and competition. The Board of Governors shall adopt Rules of Procedure
establishing detailed rules on procurement procedures and criteria.
2. The Executive Board shall be responsible for all EATRIS ERIC procurement. All tenders shall be published on the
EATRIS ERIC website and in the Members’ and Observers’ territories. For procurement amounts higher than
EUR 200 000 EATRIS ERIC shall follow the principles of Directive 2004/18/EC of the European Parliament and of
the Council of 31 March 2004 concerning the coordination of procedures for the award of public works contracts, public
supply contracts and public service contracts ( 1 ). The decision to award procurement shall be published and include a full
justification.
Article 26
Tax exemption
1. Tax
exemptions
based
on
Articles
143(1)(g)
and
151(1)(b)
of
Council
Directive
2006/112/EC
( 2 ) and in accordance
with Articles 50 and 51 of Council Implementing Regulation (EU) No 282/2011 ( 3 ) shall be limited to the value added
tax for such goods and services which are for official use by EATRIS ERIC, exceed the value of EUR 250, and are wholly
paid for and procured by EATRIS ERIC. Procurement by individual Members shall not benefit from these exemptions.
Without prejudice to paragraphs 2 and 3 no further limits shall apply.
2. Tax
exemptions
shall
apply
to
non-economic
activities,
not
to
economic
activities.
3. Tax
exemptions
shall
be
applied
to
goods
and
services
for
the
scientific,
technical
and
administrative
operations
undertaken by EATRIS ERIC in line with its principal tasks. This shall also include expenses for conferences, workshops
and meetings directly linked to the official activities of EATRIS ERIC. However travel and accommodation expenses shall
not be covered by tax exemptions.
( 1 ) OJ L 134, 30.4.2004, p. 114.
( 2 ) OJ L 347, 11.12.2006, p. 1.
( 3 ) OJ L 77, 23.3.2011, p. 1.
EN
8.11.2013 Official
Journal
of
the
European
Union L
298/47
Article 27
Data policy
The Executive Board shall submit to the Board of Governors for approval Rules of Procedure for data policy in relation to
users of EATRIS ERIC infrastructure, the national centres and third parties such as universities, research institutes and
industry, with due respect for existing licences.
CHAPTER VIII
DURATION, WINDING UP, DISPUTES, SET UP PROVISIONS
Article 28
Duration
The duration of EATRIS ERIC shall be indefinite.
Article 29
Winding up
1. The winding up of EATRIS ERIC shall be decided by the Board of Governors.
2. The European Commission shall be notified within 10 calendar days of the decision to wind up EATRIS ERIC.
3. Assets remaining after payment of EATRIS ERIC debts shall be apportioned among the Members in proportion to
their accumulated annual contribution to EATRIS ERIC.
4. The European Commission shall be notified within 10 calendar days of the closure of the winding up procedure.
Article 30
Language and availability of the Statutes
1. These Statutes shall be kept up to date and made publicly available on the website of the ERIC and at its statutory
seat.
2.
These Statutes shall be deemed authentic in all official language versions of the Members listed in Appendix 1. These
Statutes shall also be deemed authentic in the official language versions of the Members States not listed in Appendix 1.
No language version shall prevail.
3. When
language
versions
are
not
provided
for
through
the
Official
Journal
in
case
of
amendments
to
these
Statutes
that do not require a Commission Decision, they shall be provided by EATRIS ERIC Coordination and Support Office.
Article 31
Set-up provisions
1. A constitutional meeting of the Board of Governors shall be called by the host country as soon as possible but no
later than within 45 calendar days after the entry into force of the decision of the European Commission setting up
EATRIS ERIC. Without prejudice to paragraph 2 no decisions shall be taken by the Board of Governors before at least five
Members have joined EATRIS ERIC.
2. The host country shall notify the Founding Members of any specific urgent legal action that needs to be taken on
behalf of EATRIS ERIC before the constitutional meeting is held. Unless a Founding Member objects within five working
days of being notified, the legal action shall be carried out by a person duly authorised by the host state.
3. As of the establishment of EATRIS ERIC, its bodies shall act in accordance with the Standing Orders and Rules of
Procedure as approved by the EATRIS Governing Board during the EATRIS Transition Phase.
L 298/48
EN
Official Journal of the European Union
8.11.2013
Appendix 1
List of members, observers, and the entities representing them
Members Representing
entity
Czech Republic Ministry
of
Education,
Youth
and
Sports
(MEYS)
Kingdom of Denmark Danish
Agency
for
Science,
Technology
and
Innovation
(DASTI)
Republic of Estonia
Ministry of Education and Research of the Republic of
Estonia (MER EE)
Italian Republic Istituto
Superiore
di
Sanità
(ISS)
Kingdom of the Netherlands ZonMW
Republic of Finland Ministry
of
Education
and
Culture
(OKM)
Observers Representing
entity
Kingdom of Spain Instituto
de
Salud
‘Carlos
III’
(ISCIII)
French Republic Commissariat
à
l’Energie
Atomique
et
aux
Energies
Alternatives (CEA)
EN
8.11.2013 Official
Journal
of
the
European
Union L
298/49
Appendix 2
Annual financial contribution
Financial Commitment for the first five years
For the initial five-year period after the establishment of EATRIS ERIC the principles for the financial commitment shall
be as follows:
(a) initial commitment for Founding Members is five years (no initial commitment for Observers);
(b) Founding Members can sign up for less than five years subject to a 25 % increase in the annual contribution; the
excess shall be refunded if the Member completes the five years;
(c) the initial financial contribution for EATRIS ERIC year one is based on the agreed five-year budget excluding any
uncertain income source (e.g. the income from user fees) and a minimum of five Founding Members;
(d) the Netherlands will pay an additional hosting contribution of EUR 500 000 in 2013, 2014 and 2015. After 2015
the Netherlands will pay an additional hosting contribution of EUR 50 000;
(e) no Founding Member that has made a five-year commitment will pay more than EUR 140
000 per year (maximum
threshold);
(f) the
minimum
membership
contribution
will
not
be
lower
than
EUR
50
000 per
year
regardless
of
the
number
of
Members and regardless of any income generated by EATRIS ERIC (minimum threshold);
(g) the financial contribution for EATRIS ERIC year two is based on the agreed five-year budget minus the net result
from income in EATRIS ERIC year one. The financial contribution for EATRIS ERIC year three is based on the agreed
five-year budget minus the net result from income in EATRIS ERIC year two etc.;
(h) a new Member starts at the financial contribution level it would have paid as a Founding Member in EATRIS ERIC
year one plus 25 %. After accession year one it pays the financial contribution set for EATRIS ERIC year two plus
25 % etc. If the new Member completes a five-year term, the excess is refunded;
(i) Founding Observers with institutes not participating in all activities of EATRIS and not providing services pay 25 %
of the annual financial contribution of what they would have paid as Founding Members; a Founding Observer with
institutes participating in all activities of EATRIS including providing services shall pay the same annual financial
contribution as a Founding Member;
(j) a Founding Observer that pays 25 % of the annual financial contribution and that becomes a Member starts at the
same level of financial contribution it would have paid as a Founding Member in EATRIS ERIC year one. After
accession year one it pays the financial contribution set for EATRIS ERIC year two etc. If it completes a five-year
term, the Observer financial contribution shall be refunded;
(k) a new Observer starts at 25 % of the financial contribution it would have paid as a Founding Member in EATRIS
ERIC year one. In year two of its accession it pays 25 % of what it would have paid in EATRIS ERIC year two etc.;
(l) if a new Observer becomes a Member it pays the financial contribution it would have paid as a Founding Member in
EATRIS ERIC year one; after accession year one it pays the financial contribution set for EATRIS ERIC year two etc.;
if the new Member completes a five-year term, the Observer financial contribution shall be refunded;
(m) if new Members or Observers join or if an Observer becomes a Member the financial contribution for that year is
recalculated for all Members and Observers;
(n) in all cases mentioned in points (a) to (m), the 25 % extra financial contribution shall be held in reserve.
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