Source: EURLEX
Language: en
Format: md

*|*

# 52014DC0355

**COMMUNICATION FROM THE COMMISSION on the European Citizens' Initiative "One of us" /\* COM/2014/0355 final  \*/**

  

1.            INTRODUCTION

The European Citizens'
Initiative, introduced by the Lisbon Treaty to encourage a greater democratic
involvement of citizens in European affairs[1],
allows one million citizens of the European Union (EU), coming from at least
seven Member States, to call on the European Commission to propose legislation
on matters of EU competence. Complete information on this new legal instrument
and on all initiatives launched to date can be found in the Official Register
on the European Citizens' Initiative[2].

"One of Us"
is the second European Citizens' Initiative to have met the requirements set
out in the Regulation of the European Parliament and the Council on the
citizens' Initiative. It was officially submitted to the Commission
by its organisers on 28 February 2014, having received the support of more than
1.7 million citizens with thresholds reached in 18 Member States.

In line with the
provisions of the Regulation on the citizens' Initiative, the Commission has
three months within which to present its response in a Communication setting
out "its legal and political conclusions on the Initiative, the action it
intends to take, if any, and its reasons for taking or not taking that
action"[3].

The Commission
received the organisers on 9 April 2014; on 10 April, the organisers were given
the opportunity to present their Initiative at a public hearing organised by
the Commission and European Parliament at the European Parliament. Annex I
provides further information on the procedural aspects of the citizens' Initiative.

The subject matter
of the "One of Us" Initiative concerns the "juridical
protection of the dignity, the right to life and of the integrity of every
human being from conception in the areas of EU competence in which such
protection is of particular importance"[4].

Under the main
objectives the organisers state that "the human embryo deserves respect
to its dignity and integrity. This is enounced by the European Court of Justice
in the Brüstle case, which defines the human embryo as the beginning of the
development of the human being. To ensure consistency in areas of its
competence where the life of the human embryo is at stake, the EU should establish
a ban and end the financing of activities which presuppose the destruction of
human embryos, in particular in the areas of research, development aid and
public health".

The Annex requests
three legislative amendments:

–
The Financial Regulation[5]: Principle of
consistency: No budget allocation will be made for the funding of activities
that destroys human embryos, or that presumes their destruction;

–
Research funding – The Horizon 2020 Regulation[6]: Ethical principles: The following fields of research shall not be
financed: […] Research activities that destroy human
embryos, including those aimed at obtaining stem cells, and research involving
the use of human embryonic stem cells in subsequent steps to obtain them;

–
Development cooperation
- Development Cooperation Instrument (DCI) Regulation[7]: Scope: The
assistance of the Union, on the basis of this Regulation, shall not be used to
fund abortion, directly or indirectly, through the funding of organizations
that encourage or promote abortion. No reference is made in this Regulation to
reproductive and sexual health, health care, rights, services, supplies,
education and information at the International Conference on Population and on
Development, its principles and Program of Action, the Cairo Agenda and the
Millennium Development Goals, in particular MDG n. 5 about health and maternal
mortality, can be interpreted as providing a legal basis for using EU funds to
finance directly or indirectly abortion;

The Initiative must
be considered in accordance with EU Treaty rules, including notably the principles
of conferral, proportionality and subsidiarity.

2.         State of Play

2.1. Human Dignity
in EU Legislation

The Treaty on European Union (TEU) explicitly enshrines human
dignity, the right to life, and the right to the integrity of the person. According
to Article 2 TEU, "the Union is founded on the values of respect for human
dignity, freedom, democracy, equality, the rule of law and respect for human
rights, including the rights of persons belonging to minorities".
According to Article 21 TEU, “the Union’s action on the international scene
shall be guided by the principles which have inspired its own creation,
development and enlargement, and which it seeks to advance in the wider world:
democracy, the rule of law, the universality and indivisibility of human rights
and fundamental freedoms, respect for human dignity, the principles of equality
and solidarity, and respect for the principles of the United Nations Charter
and international law”.

The Charter of
Fundamental Rights of the European Union, which constitutes an integral part of
the EU Treaties and which is binding upon the EU institutions, protects in its
first three articles, respectively, human dignity, the right to life, and the
right to the integrity of the person.

All EU legislation
and all EU expenditure must comply with the Treaties and the Charter, and must
therefore respect human dignity, the right to life, and the right to the
integrity of the person. This therefore also applies to EU legislation and
expenditure on human embryonic stem cell research and development cooperation.

It should be noted
that the so-called Brüstle judgement of the European Court of Justice (Case
C-34/10, Brüstle v Greenpeace), which was referred to by the organisers in
their objectives, stated that “the purpose of the [Biotech] Directive is not to
regulate the use of human embryos in the context of scientific research. It is
limited to the patentability of biotechnological inventions”.[8] It did not deal with
the question of whether such research can be carried out and whether it can be
funded.

2.2. Human Embryonic Stem Cell Research

2.2.1. Stem Cell Research

Human embryonic stem cell (hESC) research has
the potential to contribute to the next generation of healthcare by offering treatments
or possible cures for untreatable and/or life-threatening diseases, such as
Parkinson's, diabetes, stroke, heart disease and blindness. For instance, 1.2 million
European citizens are estimated to be suffering from Parkinson's disease today[9].

Embryonic stem cells are unique because they
can form any of the cells of the body and scientists use this feature to make
new cells that can be transplanted into patients to replace damaged or diseased
tissue. In addition, studies of embryonic stem cells
enable biologists[10]
to understand how our tissues develop and maintain themselves, and stem cells
are also used to screen new drugs to
decrease their risk of toxicity and to advance pharmaceutical research. Embryonic stem cells are cell lines capable of producing an infinite
number of identical cells which can be frozen, stored and shipped to other laboratories
for further culture and experimentation. Researchers therefore almost always use
cell lines that already exist rather than creating new ones using spare blastocysts[11]
left over from fertility treatment which are donated for research following explicit,
written, informed consent. Clinical trials of
treatments based on human embryonic stem cells are ongoing, covering diseases
such as spinal cord injury, heart failure and various forms of blindness, and are
being carried out in US, France, South Korea and UK.[12]

Tissue-specific or adult stem cells have
also been identified; they are found in certain tissues of the body and are
valuable for therapy in some, but not all cases. Induced pluripotent stem cells
(iPSC), are adult, specialised cells that have been genetically reprogrammed.
The researcher who discovered this technique, building on prior knowledge
obtained from research on embryonic stem cells, was awarded the 2012 Nobel Prize.
Induced pluripotent stem cells have many similar properties to embryonic stem
cells and research continues to make progress; however, these cells cannot yet
be produced to clinical standard or be treated as natural cells. One clinical
trial is beginning in Japan using induced pluripotent
stem cells[13].

The discovery and ongoing development of
iPSC has been reliant on hESC research, and embryonic stems cells remain
important for the development of iPSC research – the knowledge derived from
both is complimentary. Given the promise of
stem cell therapies for many diseases and the fast pace of movement in research
on them, many areas of research may be pursued simultaneously to find the best
cell source for a particular medical application.[14]

2.2.2. Competences and activities of
Member States in this area

Human embryonic stem cell research in
Europe is subject to national laws and regulations which vary from country to
country. These range from countries which permit the establishment of human
embryonic stem cell lines to those which do not permit this step but allow the
importation of embryonic stem cell lines, those which prohibit any form of
research on human embryonic stem cells, and those that have no specific
legislation on the matter. Currently, human embryonic stem cell research is
permitted, subject to controls and conditions in 18 Member States, whilst 3
prohibit it and the rest have no specific legislation.[15]

2.2.3. Competences and activities at
Union level in this area

Treaty Provisions on Research

Article 182 of the Treaty on the Functioning of the European Union
(TFEU) provides the legal basis for EU research programmes: “A multiannual
framework programme, setting out all the activities of the Union, shall be
adopted by the European Parliament and the Council, acting in accordance with
the ordinary legislative procedure after consulting the Economic and Social
Committee”.

These EU research programmes are adopted without prejudice to Member
State activities in the field of research. The reason is that according to primary
EU law – the Lisbon Treaty, research is a parallel competence. According to
Article 4(3) TFEU, "in the areas of research, technological development
and space, the Union shall have competence to carry out activities, in
particular to define and implement programmes; however, the exercise of that
competence shall not result in Member States being prevented from exercising
theirs”.

Horizon 2020 – The
EU Research and Innovation Programme

Horizon 2020 is the EU
Research and Innovation programme with nearly €80 billion of funding available
over the next seven years (2014 - 2020). To develop this new programme, the
Commission launched a wide-ranging
consultation involving all key stakeholders, and took into account discussions
with the European Parliament and Council, as well as lessons learnt from
previous programmes. The Commission also took into account the recommendations
of the European Group on Ethics[16]
and the findings of a Eurobarometer survey, in which a randomised sample of
citizens from across Europe were asked their views on a range of topics
including embryonic stem cell research. The majority approved of embryonic stem
cell research.[17]
The Commission, taking into account all aspects of support for research
including the added value of support at EU level, ethical considerations and
the potential health benefits of all types of stem cell research, presented its
proposal in November 2011.

In the democratic process that led to
agreement by Council and Parliament on Horizon 2020 in December 2013, the
Commission, Council and Parliament also took into account all aspects of
support for research. The outcome of Horizon 2020 discussions by elected
representatives is that EU support for health research is foreseen and human
embryonic stem cell research is possible, restricted to research subsequent to
the establishment of stem cell lines.

It was agreed that EU level human embryonic
stem cell research projects add value to Member State activities in this area
in compliance with the principle of subsidiarity.[18] In the field of
research, the EU adds value to Member States' activities by supporting
cross-border collaborative research where a critical mass of complementary
knowledge and financial resources is required for breakthroughs. This is
particularly the case in human embryonic stem cell research, where bringing a
new stem cell therapy to the clinic requires many scientific disciplines and
many different skills and resources. Cross-border collaborative research
projects also help increase coordination and reduce duplicative and therefore
unnecessary production and use of stem cell lines.

It was also agreed that human embryonic
stem cell research holds potential for valuable breakthroughs in health
research and that the checks and balances proposed, identical to those agreed
in FP7, provide appropriate safeguards to ensure compliance with the strict
rules in place.

The Horizon 2020 Framework Governing Human
Embryonic Stem Cell Research

Horizon 2020 support for human embryonic
stem cell research is strictly governed by both general and specific
provisions. As under the last framework programme for research (FP7), Horizon
2020 contains specific provisions governing direct financial support for human
embryonic stem cell research. These are set out in Article 19 of the Horizon
2020 Regulation (ANNEX II) and the accompanying Commission Statement (ANNEX III),
which was requested during the inter-institutional negotiations on the agreement
between the Council of the European Union and the European Parliament, and
which was presented by the Commission at the time of the adoption of the
legislative act. The Statement is an integral part of the Horizon 2020
legislative package and serves to interpret the practical implementation of
legislative provisions, given the diversity of views on this area of research
and the different legal situation and practices in Member States. The Horizon
2020 package, including the provisions on human embryonic stem cell research
were subject to the ordinary legislative process and adopted in a democratic
manner, in full compliance with the Treaty provisions, through clear majorities
by both co-legislators – the European Parliament adopted the Regulation at its
plenary session on 21 November 2013[19]
and the Council of the European Union at its meeting on 3 December 2013.[20]

The strict ethical framework within which
Horizon 2020 operates mirrors exactly the provisions carefully agreed for FP7 (ANNEXES
IV and V). As mentioned in the Horizon 2020 Commission Statement, the
Commission proposed the continuation of the FP7 ethics framework because “[the
Commission] has developed, based on experience, a responsible approach for an
area of science which holds much promise and that has proven to work
satisfactorily in the context of a research programme in which researchers
participate from many countries with very diverse regulatory situations”. The
framework is based on the recommendations of the European Group on Ethics in
Science and New Technologies[21]
and consists of the 'triple lock' system:

First and foremost, national legislation
is respected – EU projects must follow the laws of the country in which
research is carried out.
In addition, all projects must be
scientifically validated by peer review and must undergo rigorous ethical
review.
Finally, EU funds may not be used for
derivation of new stem cell lines, or for research that destroys embryos -
including for the procurement of stem cells.

The Horizon 2020 programme takes a societal challenge-based approach,
addressing major concerns shared by citizens in
Europe and elsewhere. In the field of health, this includes for example research
on cancer, diabetes, Alzheimer’s disease, and Parkinson’s disease. In
implementing its research programmes, the Commission does not publish calls for
research proposals specifically on human embryonic stem cell research. Rather,
it is for scientists to propose, in a bottom-up way, the best possible
approaches for a particular study. EU research also allows for projects that
may include a comparison of different cell types, including human embryonic
stem cells and induced pluripotent stem cells, keeping all avenues of research
open in the light of scientific advances. The European registry[22] of human embryonic
stem cell lines, supported by the European Commission, facilitates the
monitoring of existing human embryonic stem cells in Europe and beyond,
improves their availability to scientists and helps avoiding the unnecessary
establishment of new stem cell lines.

Article 19(3) of the Horizon 2020 Regulation states that "the
following fields of research shall not be financed: research activity aiming at
human cloning for reproductive purposes; research activity intended to modify
the genetic heritage of human beings which could make such changes heritable;
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". The Article foresees that these fields of
research may be reviewed within the context of the interim evaluation of
Horizon 2020, in the light of scientific advances.

Article 19(4) states that "research on human stem cells, both
adult and embryonic, may be financed, depending both on the contents of the
scientific proposal and the legal framework of the Member States involved. No
funding shall be granted for research activities that are prohibited in all the
Member States. No activity shall be funded in a Member State where such
activity is forbidden".

The evaluation, granting and funding of EU research
project proposals involving human embryonic stem cells is strictly legislated. Compliance
with the rules set out in Article 19 of the Regulation and in the Statement is
assessed through a number of ex-ante and ex-post monitoring checks.

Horizon
2020 Ex-ante and Ex-post Checks on Human Embryonic Stem Cell Research

Each proposal involving human
embryonic stem cells is scientifically evaluated by independent international
peer review. This evaluation examines the necessity of using such stem cells to
achieve the scientific objectives. Each proposal must also undergo a rigorous
ethical review[23],
which takes into account the principles reflected in the EU Charter of
Fundamental Rights and relevant international conventions[24], and is undertaken
by Commission appointed independent experts; any requirements specified by these
reviewers become contractual obligations for the project participants.

Each proposal that has passed both the
scientific evaluation and ethics review stages is then decided upon by the
Commission and subjected to a specific Member State approval procedure at the
level of the individual project to ensure it follows the laws of the country in
which research is carried out. The Programme Committee,
composed of representatives from all Member States and observers from countries
associated to the Framework Programme, operates under the examination procedure for the approval of the funding of these projects. Only then are contracts, that include clear
ethics provisions and reporting requirements, concluded.

In addition to the monitoring of the
projects during implementation, the Commission will carry out ethics check on
selected projects assisted by independent external experts to verify that the
research is carried out according to the requirements put forward by the ethics
review. In an ethics audit of 6 projects funded under FP7 that involved the use
of human embryonic stem cells, the panel of independent external experts was
satisfied that all ethics and regulatory requirements were fulfilled and that
the projects were in compliance with the terms of their contract and the
provisions of the FP7 legislative text. In a case where a project should be found
to contravene the accepted ethical principles and the terms of conducting
research using human embryonic stem cells, all provisions are in place to stop
the project and impose appropriate penalties. No instances of non-compliance
have been detected with respect to FP7 projects involving human embryonic stem
cells.

The Commission strictly respected the
commitment and monitoring of these principles in the previous framework
programmes and regularly informed the
Programme Committee of the overall progress of the implementation of the
programme. It will follow the same monitoring and verification process
for Horizon 2020. Under the FP7 Health
programme (2007-2013), the EU funded 27 collaborative research projects
involving the use of human embryonic stem cells; the more recent of these also
include work on induced pluripotent stem cells. European Research Council
grants (10) and Marie Skłodowska-Curie actions (24) have also involved human
embryonic stem cell research[25].
No new human embryonic stem cell lines have been created with the support of funds
from EU research projects.

The Commission is open and transparent about
promoting responsible research and provides information about it to citizens
and scientists. In addition to reporting the project details on the
Commission's CORDIS site, projects are encouraged to set up their own websites,
and the Commission supports the EuroStemCell website[26] which provides
reliable, independent information and road-tested educational resources on stem
cells and their impact on society.

2.3. Development cooperation

2.3.1 Maternal and Child Health in developing countries

287,000 women were
still dying from pregnancy or childbirth-related complications around the world
in 2010. Almost all of these deaths (99%) occur in developing countries and
disproportionately affect those populations that are poor and most vulnerable.

Approaches to protect
the health of the mother also protect the health of their babies. For example,
the rate of pre-term births, which is the leading cause of newborn deaths, can
be effectively addressed by improving access to family planning and good
quality care for women, particularly adolescents. Therefore, skilled care
before, during, and after childbirth is necessary to save the lives of both
mothers and babies and requires access to comprehensive health services that
integrate sexual, reproductive, maternal, newborn and child health services
across the continuum of care.

One of the causes of maternal mortality is
unsafe abortions, accounting for about 13% of all maternal mortality, resulting
in 47,000 deaths each year, almost exclusively in developing countries. According to the World Health Organisation (WHO), the most
effective intervention to reduce unintended pregnancies and induced abortion is
improving access to family planning services and the effectiveness of
contraceptive use[27]. The number of abortions could therefore be
reduced. In almost all countries of the world[28],
the law permits abortion to save the woman’s life, and in the majority of
countries, abortion is allowed to preserve the physical and/or mental health of
the woman.

2.3.2 Competence
and activities of the EU Member States

The development
cooperation of the EU Member States in the area of maternal and child health is
guided by the Millennium Development Goals (MDGs) and the ‘International
Conference on Population and Development’ Programme of Action.

‘International
Conference on Population and Development’ Programme of Action

At the International
Conference on Population and Development (ICPD) held in Cairo in 1994, 179
countries - including all 28 EU Member States - adopted a programme of action
defining equality and the empowerment of women as a global priority, from the
perspective of universal human rights but also as an essential step towards
poverty eradication[29].

A woman’s ability to
access reproductive health and to have her reproductive rights recognised is a
cornerstone of her empowerment and contributes to sustainable development. The
programme calls for actions to provide universal access to family planning and
sexual and reproductive health services and reproductive rights. Amongst others,
the programme identifies unsafe abortions as a major public health concern and
asks for prevention of unwanted pregnancies to receive the highest priority. In
no case should abortion be promoted as a method of family planning. Abortion
care needs to take place in the legal context of each country. The ICPD
underlines that where it is not against the law, abortion should be safe.

Every five years
since 1994, countries have reconvened to reconfirm these commitments and review
progress on the Programme of Action. The benchmarks added at the first such
review conference of the ICPD  in 1999 went on to inform the eight Millennium
Development Goals.

Millennium
Development Goals

In 2000, the Heads
of State and Government of 189 countries - including all 28 EU Member States -
adopted in the UN General Assembly, the Millennium Declaration with a set of eight
Millennium Development Goals that included ambitious targets for the reduction
of maternal and child mortality by 2015. MDG 4 aims to reduce the mortality
rate among under-five children by two thirds. MDG 5 aims to reduce maternal
mortality by three quarters between 1990 and 2015 and achieve universal access
to reproductive health.

The Millennium
Development Goals have since become the benchmark for global development
policy. They have led to an unprecedented focus on human well-being, human
development and human poverty in the international community. The UN is
currently coordinating a structured process to define a development framework
beyond 2015 when the current MDGs expire.

2.3.3 Competence
and activities carried out at Union level

Treaty Provisions
on Development Cooperation

The main objective
of the EU development cooperation policy is to reduce and then eradicate
poverty[30],
in full respect of human dignity. This comes out strongly in the EU’s
commitment to the MDGs to reduce extreme poverty and hunger, improve wellbeing
of people by reducing maternal and child mortality, combat HIV/AIDS, malaria
and other diseases. The new EU development policy, the Agenda for Change,[31] reiterates the
human-centred approach by setting human rights (democracy and rule of law) and
inclusive, sustainable growth for human development as important goals of
development aid.

EU development
cooperation measures are adopted without prejudice to Member States' activities
in the field of development cooperation. According to Article 4(4) TFEU,
development cooperation is a parallel competence: “in the areas of development
cooperation and humanitarian aid, the Union shall have competence to carry out
activities and conduct a common policy; however, the exercise of that
competence shall not result in Member States being prevented from exercising
theirs”.

Articles 208-211
TFEU provide the legal basis for EU development cooperation measures.  Article
208(2) TFEU determines that both "[T]he Union and the Member States shall
comply with the commitments and objectives they have approved in the context of
the United Nations and other competent international organisations".

The added value of
action at Union level is based on the EU’s global field presence, its
wide-ranging expertise, its supranational nature, its role as facilitator of
coordination, and the potential to realise economies of scale. The “European
Consensus”[32] adopted by the Member States, the European Commission, the Parliament
and the Council in 2005 identifies shared values, goals, principles and
commitments for the implementation of development programmes at Member State
and Union level: reducing poverty, respect for human rights, democracy,
fundamental freedoms and the rule of law, good governance, gender equality,
solidarity, social justice and effective multilateral action.

Main EU financing
instruments for development cooperation

The main EU
financing instruments for development cooperation are the European Development
Fund (EDF)[33]
and the Development Cooperation Instrument (DCI)[34]. The EDF supports co-operation
with countries in Africa, the Caribbean and the Pacific and focuses on
economic, social and human development, and regional cooperation and
integration. It is managed by the Commission  with EU Member States
contributing to it directly.

The DCI on the other
hand, provides bilateral support to developing countries which are not covered
by the EDF and thematic support to all partner countries on priority themes
such as human rights, democracy and good governance, inclusive and sustainable
growth.

The 11th EDF
for 2014-2020 will have a budget of EUR 30.5 billion. The DCI will receive an
allocation of EUR 19.7 billion from the EU budget for the period 2014-2020.

Before proposing these new financing
instruments for 2014-2020 and in addition to the impact assessment and the
internal review of different evaluations, audit and mid-term review reports,
the Commission held between 26 November 2010 and 31 January 2011 a public
consultation on future funding for EU external action. This process was based
on a public online questionnaire accompanied by a background paper 'What
funding for EU external action after 2013?'[35]
The Commission presented a legisltative proposal in
December 2011, taking into account all aspects of development policy including
the added value of support at EU level to developing countries in accordance
with the principles of the European Consensus on Development (2005) and the
"Agenda for Change".

The DCI Regulation
was adopted on 11 March 2014 in accordance with article 209 TFEU: “The European
Parliament and the Council, acting in accordance with the ordinary legislative
procedure, shall adopt the measures necessary for the implementation of
development cooperation policy, which may relate to multiannual cooperation
programmes with developing countries or programmes with a thematic approach.” The
democratic process showed that clear majorities in both the European Parliament
and the Council (the European Parliament adopted the Regulation at its plenary
session on 6 December 2013 and the Council of the European Union at its meeting
on 11 March 2014) supported the policy priorities and objectives for
development policy including cooperation on the priority themes as proposed by
the Commission.

Priorities for EU
development funding in the health sector, including sexual and reproductive health and rights

The DCI Regulation recalls
in its article 2 that the fight against poverty in line with the MDGs remains
the primary objective of development cooperation. This includes the promotion
of the full and effective implementation of the ICPD Programme of Action, as
indicated in Annexes I and II of the Regulation.[36]

Under the DCI
Regulation, priorities for EU funding are reflected in geographic and thematic
Multiannual Indicative Programmes (MIP) which are subject to a strategic
dialogue with the European Parliament. During the strategic dialogue held in
the first quarter of 2014, the Parliament requested better attention to be given
to women’s rights and gender equality in the MIPs. These changes are being
integrated into the MIPs as a result of the strategic dialogue.

Priorities of EU
funding are also determined jointly with the governments of the partner
countries. In the area of health, EU funding is therefore
focused on strengthening partner countries' health systems so that they can
provide universal access to a comprehensive package of quality health services.
EU action is based on national healthcare plans defined by public authorities
of recipient countries. So long as these health systems comply with human
rights and international requirements, it is the sovereign right of each of our
partner countries to decide on the range of services and how they are offered to
their citizens. The EU's role is to support these countries' efforts to develop
effective systems for health service provision throughout the continuum of care.

EU funding may support building and rehabilitating health care
facilities, training of health personnel, providing equipment, essential
medicines and supplies as well as providing technical assistance and policy
advice to governments in support of national health strategies. The preferred
mode for such funding is through the regular budget of partner countries to
improve country ownership and sustainability of programmes. This aid modality,
called "budget support", focuses on supporting sector policies and
reforms to improve governance and service delivery to populations, leading to
concrete and measurable results through the conduct of a policy dialogue with
the government and the definition of indicators to be reached. During the
period 2002-2010 the EU has committed EUR 5 billion to support the public budgets
of partner countries, and an additional EUR 1.3 billion specifically to the
health budgets or government programmes of partner countries. [37] An important other
channel of EU funding is through UN agencies active in the health sector and
Global Health Initiatives such as the Global Fund to fight AIDS, Tuberculosis
and Malaria, and the GAVI Alliance. During the period 2002-2010 the EU has
committed EUR 1 billion to these beneficiaries.

EU funding can also be used to finance civil society organisations,
particularly where access to basic health services needs to be improved for
marginalised and hard-to-reach populations, especially in contexts of emergency
or conflict, i.e. in situations where governments are unable or unwilling to
take effective action on their own. Most of the funding to civil society organisations
is however targeted at developing their advocacy capacity and strengthening their
role to contribute to policy-making, monitor reforms
and hold governments to account.  During the period
2002-2010 the EU has committed EUR 1.3 billion to civil society organisations
working in the health sector.

Of the  EUR 3.2
billion of development funds that the EU spent in the 5-year period 2008-2012 on
the health sector in partner countries, EUR 1.5 billion
were spent on maternal, new-born, and child-health calculated by a methodology
agreed by the G8. Specifically, EUR 87 million went to reproductive health
care, EUR 17 million to family planning, and EUR 95 million to controlling
sexually transmitted diseases. Contributions to the Global Fund to fight AIDS, Tuberculosis and Malaria account for another
EUR 503 million.

Alignment on the ICPD programme of action and the MDGs

EU development
funding is closely aligned with the objectives and international commitments
agreed in the ICPD programme of action and the MDGs. Even though the Union was
not a signatory of these landmark international agreements when they were
adopted, their objectives and commitments were subsequently integrated in the EU
law setting out the Union's policy on development cooperation, with clear
references included in the European Consensus on Development, the Council Conclusions on the EU role in Global
Health[38],
the Council Conclusions on the Overarching Post 2015 Agenda[39],
as well as the 2007-2013 and 2014-2020 DCI Regulations.

The European
Parliament adopted several resolutions[40]
in support of the MDGs and the ICPD in which it asked “for the EU to strongly
defend the right to the highest attainable standard of health, including sexual
and reproductive health and rights and the integration of HIV/AIDS, inter alia
in the provision of voluntary family planning, safe abortion and
contraceptives”[41].

In full alignment
with ICPD principles, EU development assistance does not promote abortion as a method
of family planning. Rather it aims to reduce recourse to abortion through
expanded and improved family-planning services; give priority to the prevention
of unwanted pregnancies and eliminate the need for abortion. EU funding focuses
on meeting the needs of vulnerable and disadvantaged women, adolescents, single
women, refugees and displaced women, women living with HIV, and  rape victims.

Controls on the
use of EU development funds

The EU contractual
terms[42]
are strict to ensure that all interventions funded by EU development assistance
respect the legislation of the countries where they take place. All EU grant
recipients and their staff must comply with human rights. The use of EU funds
for their intended purposes is ensured through various control activities, and
checks and balances along the project cycle management.

The Commission
monitors the performance of projects and programmes through independent
assessments carried out by external experts using internationally accepted
criteria. In 2013 this system of Results Oriented Monitoring reviewed more than
1,600 ongoing and closed projects and programmes (including budget support
operations) across all sectors of EU support.[43]
64 of these projects and programmes concerned the health sector, and 22 concerned
the sector of population policies/programmes and reproductive health. 81% of
the projects monitored in these two sectors were rated ‘very good’ or ‘good’
(compared to 75% on average for projects across all sectors of EU cooperation).
For those projects were major difficulties are identified, a specific follow-up
is ensured by the Commission. This ‘on-the-spot’
independent monitoring is complementary to the own internal monitoring carried
out by Commission staff.

In addition to
evaluations at project or programme level, strategic evaluations made by
independent external experts provide important feedback on impact and results
achieved. This was the case in 2012 with the evaluation of the European
Commission support to the health sector, which found that it was coherent with
the EU development policy and well-focused on poverty reduction[44]. EU support was found
to have made significant contributions to health service quality improvements
and strengthened institutional and procedural systems related to transparency
and accountability in the countries in which it has implemented programmes.

The European Court
of Auditors annually reviews the management of the EU’s development aid. In its
recent report on the EDF, the Court states that EU Delegations had a good
overview of the operational implementation of projects, chiefly through
monitoring visits.[45]

Results from all
evaluations and audits were taken into account in the definition of the new
financial instruments for the 2014-2020 financial framework, including the
DCI.

In complement to
monitoring and evaluations, financial audits and verifications provide
assurance on the legality and regularity of external aid operations. Recipients
of EU aid that have made false declarations, committed substantial errors,
irregularities or fraud will have their grants suspended and may be excluded
from further EU financing and be subject to financial penalties.

3.         ASSESSMENT
OF THE EUROPEAN CITIZENS’ INITIATIVE REQUESTS

3.1. General observations

As referred to in the introduction of this
Communication, the objective of the European Citizens’ Initiative "One of
Us" is that the EU establish a ban and end the financing of activities
that presuppose the destruction of human embryos, in particular in the areas of
research, development aid and public health to respect human dignity and
integrity. To this end, the financial regulation, the regulation for the
research framework programme Horizon 2020 and the regulation establishing a
financing instrument for development cooperation should be modified as
appropriate.

The Commission has carefully examined this
request.

As regards the request to stop EU financing
of these activities and modify the Financial Regulation, it should be noted
that according to Article 87 of the Financial Regulation, all EU expenditure
must be in compliance with the EU Treaties and the Charter of Fundamental
Rights. The EU Financial Regulation therefore already ensures that all EU
expenditure, including in the areas of research, development cooperation and public
health, must respect human dignity, the right to life, and the right to the
integrity of the person. Moreover, the purpose of the Financial Regulation is to
provide financial rules in general terms and not for a specific field of EU
policy, in particular for establishing and implementing the EU budget.

3.2. Human embryonic stem cell research

The European Commission has carefully
analysed the request of the European citizen's Initiative to introduce legislation that would ban any EU financing of "research activities that destroy human
embryos, including those aimed at obtaining stem cells, and research involving
the use of human embryonic stem cells in subsequent steps to obtain them".

As described above, the legislation on the
current EU research programme contains detailed provisions governing EU support
for human embryonic stem cell research. These provisions were only recently
(December 2013) agreed by the EU co-legislator, i.e. the European Parliament
and the Council, through the ordinary legislative procedure, in full accordance
with Article 182 TFEU. The provisions for funding under Horizon 2020 were
agreed taking into account all aspects, including ethical considerations, EU
added value and potential health benefits of all types of stem cell research.

The Horizon 2020 provisions on human
embryonic stem cell research are carefully calibrated and together constitute a
“triple lock” system involving:

First and foremost, national legislation
is respected – EU projects must follow the laws of the country in which
research is carried out.
In addition, all projects must be
scientifically validated by peer review and must undergo rigorous ethical
review.
Finally, EU funds may not be used for
derivation of new stem cell lines, or for research that destroys embryos -
including for the procurement of stem cells.

They include a set of explicit exclusions and
conditionalities, a number of rigorous ex-ante checks (scientific review,
ethics review), additional layers of decision-making at the level of the
individual project involving the Member States, contractual obligations,
detailed reporting requirements, and ex-post audits (Please refer to ANNEXES II
and III for full texts of Article 19 and the Commission Statement). System-level
audits have demonstrated that the system put in place is well-designed and
complied with in accordance with the highest ethical standards. In addition,
the Commission does not solicit explicitly research proposals involving human
embryonic stem cells.

The Commission considers that the Horizon
2020 provisions on human embryonic stem cell research are in full accordance
with the EU Treaties and the Charter of Fundamental Rights of the European
Union.[46]
It also considers that these provisions already address a number of important
requests of the organisers notably that the EU does not fund the destruction of
human embryos and that appropriate controls are put in place. The Commission
considers, however, that it cannot meet the request of the organisers that the
EU does not fund research subsequent to the establishment of human embryonic
stem cell lines. The reason is that the Commission formulated its proposal taking
into account ethical considerations, potential health benefits, and the added
value of support at EU level, for all types of stem cell research. This
proposal was adopted by the co-legislator, i.e. the European Parliament and the
Council, based on an agreement democratically reached during the
inter-institutional negotiations.

3.3. Development cooperation

The European
Commission has carefully analysed the request of the Citizens' Initiative to
introduce legislation that would ban any potential EU funding of activities
that destroy human embryos or presume their destruction, i.e. specifically any
direct or indirect financing of abortion through development aid.

The underlying
objective of the Citizens' initiative is a reduction in the number of abortions
undertaken in developing countries.

In
developing partner countries where the EU supports the health sector, it provides
assistance to the health-care systems, either
supporting integrated service provision that includes sexual, reproductive,
maternal, newborn and child health services across the continuum of care, or
providing budget support to assist countries to improve national health service
delivery. By definition, that assistance will contribute directly or indirectly
to the entire spectrum of health services offered by partner countries, which
may or may not include abortion-related services to save the mother’s life.
This comprehensive EU support contributes substantively to a reduction in the
number of abortions because it increases access to safe and quality services,
including good-quality family planning, a broad range of contraceptive methods,
emergency contraception and comprehensive sexual education.

While
the objective of EU development cooperation is universal and equitable access
to good quality care for all citizens, the EU fully respects the sovereign
decisions of partner countries as to which health services will be provided and
how they are packaged as long as they are in line with agreed human rights
principles. Therefore the Commission does not favour earmarking aid for certain
services only, because it  would
make the comprehensive and effective  support of a country's health strategy more
difficult.

The
Commission considers that the EU must live up to its international commitment
to the achievement of MDG 5. Despite impressive gains in contraceptive use, a
substantial number of mothers still die every year as a result of abortions
that are performed without the necessary skills or in an environment lacking
minimal medical standards. According to the WHO, maternal deaths and illness
can be dramatically reduced by improving the safety of such health services.

The
Commission applies stringent rules and any funding is and shall always be in
full respect of the EU regulatory framework and the relevant national
legislation. Once funding is granted, comprehensive and transparent oversight
mechanisms are put in place. The oversight is effective, and the Commission is
committed to the continued application of contractual and monitoring safeguards
and to do so in a fully transparent manner.

Finally,
while the UN has started the process of defining a new development agenda
beyond 2015, the EU is currently working to ensure that the main principles and
commitments of ICPD Programme of Action and the MDGs are incorporated in the
post-2015 framework. The robust international consensus on the scope and
definition of sexual and reproductive health and rights codified in the ICPD
Programme of Action in 1994 has just been reconfirmed in its April 2014 review[47] that will serve as the basis for the September
2014 United Nations General Assembly Special Session on ICPD. The principles agreed at the ICPD continue to shape global
development cooperation and are strongly supported by the EU and its Member
States.

4.           Conclusions

In
reply to the European Citizens' Initiative "One of Us", the Commission
concludes as follows:

4.1 General

EU
primary legislation explicitly enshrines human dignity, the right to life, and
the right to the integrity of the person. The EU Financial Regulation states
that all EU expenditure should comply with EU primary legislation. Therefore
the Commission does not see a need to propose changes to the Financial
Regulation.

4.2 Human embryonic stem cell research

The
Horizon 2020 provisions on human embryonic stem cell research have only recently
been decided by the EU co-legislator (in December 2013). They involve a
carefully calibrated set of exclusions and conditionalities, rigorous ex-ante
checks, case-by-case decision-making involving the Member States, contractual
obligations, reporting requirements, and ex-post audits. These provisions
explicitly exclude from EU funding the destruction of blastocysts for research
purposes and fully respect national legislation on human embryonic stem cell
research. System-level audits have demonstrated that the system in place is
well-designed and complied with in accordance with the highest ethical
standards. The Commission underlines that research proposals involving human
embryonic stem cells are not explicitly solicited.

The Commission considers that the Horizon
2020 provisions on human embryonic stem cell research are in full accordance
with the EU Treaties and the Charter of Fundamental Rights of the European
Union.[48]
It also considers that these provisions already address a number of important
requests of the organisers notably that the EU does not fund the destruction of
human embryos and that appropriate controls are put in place. The Commission
considers, however, that the request of the organisers that the EU does not
fund research subsequent to the establishment of human embryonic stem cell
lines cannot be met. The reason is that the Commission formulated its proposal taking
into account ethical considerations, potential health benefits, and the added
value of support at EU level, for all types of stem cell research. This
proposal was adopted by the co-legislator, i.e. the European Parliament and the
Council, based on an agreement democratically reached during the
inter-institutional negotiations.

The
Commission will continue to strictly apply the 'triple lock' system and respect
the monitoring and verification rules already observed in FP7 and as outlined
in Article 19 of the Horizon 2020 Regulation and associated Commission
Statement (Please refer to ANNEXES II and III for full
texts of Article 19 and the Commission Statement). This
will be done in a fully transparent manner.

Article
19 of the Horizon 2020 Regulation states in its fifth paragraph that the list
of fields of research that shall not be financed included in its third
paragraph may be reviewed within the context of the Horizon 2020 interim
evaluation to be carried out by 31 December 2017. The decision to undertake
this specific review will depend on the development of the scientific areas and
technologies concerned.

With
respect to future EU support for health research, the Commission will carefully
follow scientific advances in research, notably in the field of induced
pluripotent stem cell research, which have many similar properties to embryonic
stem cells but cannot yet be produced to full clinical standard or be treated
as natural cells, and provide support as appropriate.

The
Commission agrees with Opinion 22 of the European Group on Ethics and New
Technologies that “should alternatives to hESCs with the same potential as
embryo-derived stem cells be found in the future, the implications of such
developments for both scientific and ethical aspects of the hESC-based research
projects ought to be taken into account as soon as possible”[49]. This means that once
fully equivalent alternatives to hESCs are available, the Commission will
explore their full deployment and potential and will revert to the European
Group on Ethics and New Technologies for an Opinion in the light of results of
hESC research and of scientific advances in alternatives to hESC.

In
the meantime, the Commission will continue to provide support for the European
Registry for human embryonic stem cell lines to facilitate the monitoring of
existing hESCs in Europe and to help optimise their use by avoiding unnecessary
derivations of new hESC lines.

4.3 Development cooperation

The Commission
concludes that the EU currently has the necessary legal framework to
effectively manage EU development funding in a way that helps minimise the
number of abortions performed in developing countries.   While the Citizens'
Initiative does not directly challenge the core objectives and commitments of
the MDGs and the ICPD programme of action, the Commission considers that a
funding ban would constrain the Union’s ability to deliver on the objectives
set out in the MDGs, particularly on maternal health, and the ICPD, which were
recently reconfirmed at both international and EU levels.

The UN has started the process of defining
a new development agenda beyond 2015, and the EU is currently working to ensure
that the main principles and commitments of ICPD Programme of Action and the
MDGs are incorporated in the post-2015 framework. The robust international
consensus on the scope and definition of sexual and reproductive health and
rights codified in the ICPD Programme of Action in 1994 has just been reconfirmed
in its April 2014 review[50] that will inform the September 2014 United
Nations General Assembly Special Session on ICPD. The
principles agreed at the ICPD continue to shape global development cooperation
and are strongly supported by the EU and its Member States. The Commission will
strive to inform stakeholders and civil society through an international conference
in 2015 promoting a better understanding of the new international instruments
with a view to improving the effectiveness of development and humanitarian aid
policy and cooperation.

The Commission will continue to improve its
monitoring and oversight systems, and regularly report on progress to the
European Court of Auditors. For example, the Commission is developing tools and
guidance to strengthen monitoring systems and assess the quality of audit
reports. The Commission is also delivering on better reporting of operational
results of EU funded development programmes. Such reporting systems will inform
management practices, lead to more accountability, transparency and visibility
of EU aid, and ultimately enhance the impact of EU Development objectives as set
out in the Agenda for Change.[51]

A mid-term review of the DCI is due to take
place no later than end 2017. The mid-term review will analyse the evidence
from evaluations, both thematic and programmatic, and feed the strategic
dialogue with the co-legislators. Thus, the Commission's approach is based
on a full democratic and transparent review that is ongoing and permanent.

In accordance with article 10(2) of the ECI
regulation, the present Communication will be notified to the organisers of the
Initiative as well as to the European Parliament and the Council and it will be
made public.

[1]  REGULATION (EU) No 211/2011 of the European Parliament and of the
Council on the citizens' initiative,, OJ L 65, 11.3.2011, p. 1

[2]  Official Register can be consulted online under: http://ec.europa.eu/citizens-initiative/public/welcome

[3]  In line with the provisions of article 10 (1) of the Regulation on
the citizens' initiative

[4]  http://ec.europa.eu/citizens-initiative/public/initiatives/ongoing/details/2012/000005

[5]  REGULATION (EU, Euratom) No 966/2012 of the European Parliament
and of the Council of 25 October 2012 on the financial rules applicable to the
general budget of the Union and repealing Council Regulation (EC, Euratom) No
1605/2002, OJ L 298, 26.10.2012, p. 1; COMMISSION DELEGATED REGULATION (EU) No
1268/2012 of 29 October 2012 on the rules of application of Regulation (EU,
Euratom) No 966/2012 of the European Parliament and of the Council on the
financial rules applicable to the general budget of the Union? OJ L 362,
31.12.2012, p. 1

[6]  REGULATION (EU) No 1291/2013 of the European Parliament and of the
Council of 11 December 2013 establishing Horizon 2020 - the Framework Programme
for Research and Innovation (2014-2020) and repealing Decision No 1982/2006/EC,
OJ L 347, 20.12.2013, p. 104.

[7]  REGULATION (EU) No 233/2014 of the European Parliament and of the
Council of 11 March 2014 establishing a financing instrument for development
cooperation for the period 2014-2020, OJ L 77, 13.03.2014, p. 44

[8] Paragraph 40 of the Judgment of the Court of Justice of the
European Union (Grand Chamber), 18 October 2011, Reports of Cases 2011 I-09821

[9] http://www.epda.eu.com/en/#

[10] http://workshops.biologists.com/workshop\_sept\_2014.html

[11] A blastocyst is the structure consisting of about a hundred cells
formed at about five or six days after fertilisation and not yet implanted in
the uterus.

[12] www.clinicaltrials.gov; http://www.advancedcell.com

[13] http://apps.who.int/trialsearch/

[14] With respect to this issue, 2012 Nobel Prize winner Yamanaka
stated: "Embryonic stem cells are still important
for the development of iPS cell research. Findings
from research on embryonic stem cells, such as methods to create various types
of cells, have been applied to iPS cell research.
That's why iPS cell research has evolved so rapidly. In addition, embryonic
stem cells are used as control [comparison] materials when researchers conduct
experiments on iPS cells and analyze their quality" (http://articles.latimes.com/2010/nov/27/science/la-sci-yamanaka-20101127).

[15] ESF Science Policy Briefing 38, http://www.esf.org/publications/science-policy-briefings.html

[16] Recommendations on the ethical review of hESC FP7 research projects
(Opinion 22) European Group on Ethics in Science and New Technologies (EGE) 20
June 2007.
http://ec.europa.eu/bepa/european-group-ethics/docs/publications/opinion\_22\_final\_follow\_up\_en.pdf
The EGE is an independent, pluralist and multidisciplinary
body advising the European Commission on ethics in science and new technologies
in connection with Community legislation or policies.

[17] http://ec.europa.eu/public\_opinion/archives/ebs/ebs\_341\_en.pdf

[18] According to Article 5 TEU, “under the principle of subsidiarity,
in areas which do not fall within its exclusive competence, the Union shall act
only if and in so far as the objectives of the proposed action cannot be
sufficiently achieved by the Member States, either at central level or at regional
and local level, but can rather, by reason of the scale or effects of the
proposed action, be better achieved at Union level”.

[19] 533 in favour, 29 against, 22 abstentions.

[20] 2 abstentions.

[21] http://ec.europa.eu/bepa/european-group-ethics/docs/publications/opinion\_22\_final\_follow\_up\_en.pdf

[22]www.hescreg.eu hESCreg was created to offer the research community, legislators,
regulators and the general public at large an in-depth overview on the current
status of human pluripotent stem cell (hPSC) research in Europe.

[23]Based on opinion 22 of the European Group on Ethics in Science and
New Technologies. http://ec.europa.eu/bepa/european-group-ethics/docs/publications/opinion\_22\_final\_follow\_up\_en.pdf

[24] Convention of the Council of Europe on Human Rights and Biomedicine
signed in Oviedo on 4 April 1997 and its additional protocols and the Universal
Declaration on the Human Genome and the Human Rights adopted by UNESCO.

[25] Full project details may be found on CORDIS http://cordis.europa.eu/

[26] http://www.eurostemcell.org/

[27] WHO (2012): Safe abortion: technical and policy guidance for health
systems; p.87, 90

[28]Only six countries prohibit abortions under all circumstances. Source:
United Nations; World Abortion Policies 2013; www.unpopulation.org

[29] UNFPA (1995): International Conference on Population and
Development - ICPD - Programme of Action A/CONF.171/13/Rev.1

[30] Art. 208, TFEU

[31] Council Conclusions, 14 May 2012: Increasing the Impact of EU
Development Policy: an Agenda for Change

[32] Joint statement by the Council and the representatives of the
governments of the Member States meeting within the Council, the European Parliament
and the Commission on European Union Development Policy: ‘The European
Consensus’ (OJ 2006/C 46/01), OJ C 46, 24.02.2006, p. 1

[33] COUNCIL REGULATION (EC) No 617/2007 of 14 May 2007 on the
implementation of the 10th European Development Fund under the ACP-EC Partnership
Agreement, OJ L 152, 13.06.2007, p. 1

[34] REGULATION (EU) No 233/2014

[35] http://ec.europa.eu/europeaid/how/public-consultations/5240\_en.htm

[36] REGULATION (EU) No 233/2014

[37] http://ec.europa.eu/europeaid/how/evaluation/evaluation\_reports/2012/1308\_docs\_en.htm, Annex II

[38] Council Conclusions on the EU role in global health, 10 May 2010

[39] Council conclusions on the Overarching Post 2015 Agenda, 25 June
2013

[40] European Parliament Resolutions of 23.10.2012 (2012/2002(INI)); of
12.03.2013 (2012/2222(INI); of 11.12.2013 (2013/2057(INL))

[41] European Parliament Resolution of 13.06.2013 on the Millennium
Development Goals – defining the post-2015 framework (2012/2289(INI)

[42] PRAG 2014: Procurement and Grants for European Union external
actions. see chapters 2.3.3; 2.3.4; 2.4.14; and annex e3h2;  http://ec.europa.eu/europeaid/prag

[43] European Commission: Annual Report 2014 on the European Union’s
development and external assistance policies and their implementation in 2013
(to be published on:  http://ec.europa.eu/europeaid/multimedia/publications/index\_en.htm
)

[44] http://ec.europa.eu/europeaid/how/evaluation/evaluation\_reports/2012/1308\_docs\_en.htm

[45] European Court of Auditors (2013): Annual Report on the activities
funded by the 8th, 9th and 10th European
Development Funds; (2013/C 331/02)

[46] Horizon 2020 Regulation, Article 19, paragraph 1: “All the research
and innovation activities carried out under Horizon 2020 shall comply with
ethical principles and relevant national, Union and international legislation,
including the Charter of Fundamental Rights of the European Union and the
European Convention on Human Rights and its Supplementary Protocols”.

[47] http://www.un.org/en/development/desa/population/commission/sessions/2014/index.shtml

[48] Horizon 2020 Regulation, Article 19, paragraph 1: “All the research
and innovation activities carried out under Horizon 2020 shall comply with
ethical principles and relevant national, Union and international legislation,
including the Charter of Fundamental Rights of the European Union and the
European Convention on Human Rights and its Supplementary Protocols”.

[49] Recommendations on the ethical review of hESC FP7 research projects
- Opinion No 22 - 20 June 2007, p. 41.

[50] http://www.un.org/en/development/desa/population/commission/sessions/2014/index.shtml

[51] Commission Staff Working Document “Paving the way for an EU
Development and Cooperation Results Framework”, 10.12.2013,  SWD(2013) 530

ANNEX I: Procedural
aspects of the ONE OF US citizens' initiative

In accordance with Article 4(2) of
Regulation (EU) No 211/2011 the present Initiative was registered on 11/05/2012
and published in the Commission's online register.

The members of the Citizens' committee
registered with the Commission are residents of the following Member States: France,
Italy, the United Kingdom, Hungary, Poland, Spain, and Germany.

The Initiative was registered in Italian.
Then the organisers provided translations of the title, subject-matter, and
objectives of the Initiative in all official EU languages.

In accordance with the Regulation on the Citizens'
Initiative, the forms used by citizens to give their support to the Initiative
contained the title, subject-matter and objectives of
the Initiative. The link to the Commission's online register was also available
on the forms, allowing citizens who wished so to find more detailed information
on the Initiative, as provided by the organisers in a draft legal act as part of
their registration request. The organisers provided translations of this draft
legal act in 19 official EU languages. This draft legal act may not have been
consulted by all citizens who supported the Initiative.

The formal 12-month collection period for
the Initiative ended on 11 May 2013. However, the Commission has accepted
statements in support of the Initiative up until 1 November 2013, due to
the difficulties that most organisers experienced as regards the setting-up of
their online collection systems during the start-up phase of the European Citizens'
Initiative[1].
After the verification of the collected statements of support by the relevant
competent Member States' authorities, the organisers submitted their Initiative
to the Commission on 28 February 2014, together with certificates issued by the
28 Member States' competent authorities and information on their sources of
funding and support, in accordance with Article 9 of the Regulation.

The number of valid statements of support
indicated in the certificates and information provided by the Member States'
competent authorities are reflected in the table below. These figures take into
account the additional collection period until 1 November 2013.

Member State || Number of signatories || Threshold to be counted among the minimum number of seven Member States

Belgium || 5 478 || 16 500

Bulgaria || 906 || 13 500

Czech Republic || 11 468 || 16 500

Denmark || 7 563 || 9 750

Germany || 137 874 || 74 250

Estonia || 2 417 || 4 500

Ireland || 6 679 || 9 000

Greece || 52 977 || 16 500

Spain || 144 827 || 40 500

France || 83 503 || 55 500

Croatia || 12 778 || 9 000

Italy || 623 947 || 54 750

Cyprus || 6 407 || 4 500

Latvia || 9 132 || 6 750

Lithuania || 11 646 || 9 000

Luxembourg || 5 469 || 4 500

Hungary || 45 933 || 16 500

Malta || 23 017 || 4 500

Netherlands || 27 271 || 19 500

Austria || 24 973 || 14 250

Poland || 235 964 || 38 250

Portugal || 65 564 || 16 500

Romania || 110 405 || 24 750

Slovenia || 3 481 || 6 000

Slovakia || 31 951 || 9 750

Finland || 1 230 || 9 750

Sweden || 2 468 || 15 000

United Kingdom || 26 298 || 54 750

Total || 1 721 626 || Threshold reached in 18 Member States

In accordance with Article 10 of the Regulation, the Commission:

- published on 28 February 2014 the relevant information
in the register at:

http://ec.europa.eu/citizens-initiative/public/initiatives/finalised/details/2012/000005

- received the organisers on 9 April 2014.

On 10 April 2014, in accordance with Article 11 of the
Regulation, organisers were given the opportunity to present their Initiative
in a public hearing organised at the European Parliament.

During the meeting at the Commission, the Commission was
represented by Commissioner Geoghegan-Quinn and senior officials from DG DEVCO
and other services concerned.

Both Commissioner Geoghegan-Quinn and Commissioner Piebalgs represented the Commission at the public hearing.

ANNEX II:
Horizon 2020 Regulation – Article 19[2]

Article 19

Ethical principles

1. All the research and
innovation activities carried out under Horizon 2020 shall comply with ethical
principles and relevant national, Union and international legislation,
including the Charter of Fundamental Rights of the European Union and the
European Convention on Human Rights and its Supplementary Protocols.

Particular attention shall be
paid to the principle of proportionality, the right to privacy, the right to
the protection of personal data, the right to the physical and mental integrity
of a person, the right to non-discrimination and the need to ensure high levels
of human health protection.

2. Research and innovation
activities carried out under Horizon 2020 shall have an exclusive focus on
civil applications.

3. The following fields of
research shall not be financed:

(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 ( 1 );

(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.

4. Research on human stem cells,
both adult and embryonic, may be financed, depending both on the contents of
the scientific proposal and the legal framework of the Member States involved.
No funding shall be granted for research activities that are prohibited in all
the Member States. No activity shall be funded in a Member State where such
activity is forbidden.

5.
The fields of research set out in paragraph 3 of this Article may be reviewed
within the context of the interim evaluation set out in Article 32(3) in the
light of scientific advances.

ANNEX III: Horizon 2020 – Commission Statement[3]

Declarations of the Commission (Framework Programme)

2013/C 373/02

STATEMENT BY THE
COMMISSION

For the Horizon 2020
Framework Programme, the European Commission proposes to continue with the same
ethical framework for deciding on the EU funding of human embryonic stem cell
research as in the 7th Framework Programme.

The European Commission
proposes the continuation of this ethics framework because it has developed,
based on experience, a responsible approach for an area of science which holds
much promise and that has proven to work satisfactorily in the context of a
research programme in which researchers participate from many countries with
very diverse regulatory situations.

1. || The decision on the Horizon 2020 Framework Programme explicitly excludes three fields of research from Community funding: — || research activities aiming at human cloning for reproductive purposes;

— || research activities intended to modify the genetic heritage of human beings which could make such changes heritable;

— || 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.

2. || No activity will be funded that is forbidden in all Member States. No activity will be funded in a Member State where such activity is forbidden.

3. || The decision on Horizon 2020 and the provisions for the ethics framework governing the Community funding of human embryonic stem cell research entail in no way a value judgment on the regulatory or ethics framework governing such research in Member States.

4. || In calling for proposals, the European Commission does not explicitly solicit the use of human embryonic stem cells. The use of human stem cells, be they adult or embryonic, if any, depends on the judgment of the scientists in view of the objectives they want to achieve. In practice, by far the largest part of Community funds for stem cell research is devoted to the use of adult stem cells. There is no reason why this would substantially change in Horizon 2020.

5. || Each project proposing to use human embryonic stem cells must successfully pass a scientific evaluation during which the necessity of using such stem cells to achieve the scientific objectives is assessed by independent scientific experts.

6. || Proposals which successfully pass the scientific evaluation are then subject to a stringent ethics review organised by the European Commission. In this ethics review, account is taken of principles reflected in the EU Charter of Fundamental Rights and relevant international conventions such as the Convention of the Council of Europe on Human Rights and Biomedicine signed in Oviedo on 4 April 1997 and its additional protocols and the Universal Declaration on the Human Genome and the Human Rights adopted by UNESCO. The ethics review also serves to check that the proposals respect the rules of the countries where the research will be carried out.

7. || In particular cases, an ethics check may be carried out during the lifetime of the project.

8. || Each project proposing to use human embryonic stem cells must seek the approval of the relevant national or local ethics committee prior to the start of the project. All national rules and procedures must be respected, including on such issues as parental consent, absence of financial inducement, etc. Checks will be made on whether the project includes references to licensing and control measures to be taken by the competent authorities of the Member State where the research will be carried out.

9. || A proposal that successfully passes the scientific evaluation, the national or local ethics reviews and the European ethics review will be presented for approval, on a case by case basis, to the Member States, meeting as a committee acting in accordance with the examination procedure. No project involving the use of human embryonic stem cells will be funded that does not obtain approval from the Member States.

10. || The European Commission will continue to work to make the results from Community funded stem cell research widely accessible to all researchers, for the ultimate benefit of patients in all countries.

11. || The European Commission will support actions and initiatives that contribute to a coordination and rationalisation of HESC research within a responsible ethical approach. In particular, the Commission will continue to support a European registry of human embryonic stem cell lines. Support for such a registry will allow a monitoring of existing human embryonic stem cells in Europe, will contribute to maximise their use by scientists and may help to avoid unnecessary derivations of new stem cell lines.

12. || The European Commission will continue with the current practice and will not submit to the committee acting in accordance with the examination procedure 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.

ANNEX IV: FP7
Decision – Article 6[4]

Article 6

Ethical principles

1.
All the research activities carried out under the Seventh Framework Programme
shall be carried out in compliance with fundamental ethical principles.

2.
The following fields of research shall not be financed under this Framework
Programme:

—
research activity aiming at human cloning for reproductive purposes,

—
research activity intended to modify the genetic heritage of human beings which
could make such changes heritable (2),

—
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.

3.
Research on human stem cells, both adult and embryonic, may be financed,
depending both on the contents of the scientific proposal and the legal
framework of the Member State(s) involved.

Any
application for financing for research on human embryonic stem cells shall
include, as appropriate, details of licensing and control measures that will be
taken by the competent authorities of the Member States as well as details of
the ethical approval(s) that will be provided.

As
regards the derivation of human embryonic stem cells, institutions,
organisations and researchers shall be subject to strict licensing and control
in accordance with the legal framework of the Member State(s) involved.

4.
The fields of research set out above shall be reviewed for the second phase of
this programme (2010-2013) in the light of scientific advances.

ANNEX V: FP7 – Commission Statement[5]

Re Article 6

For the 7th Framework
Programme, the European Commission proposes to continue with the same ethical
framework for deciding on the EU funding of human embryonic stem cell research
as in the 6th Framework Programme.

The European
Commission proposes the continuation of this ethical framework because it has
developed, based on experience, a responsible approach for an area of science
which holds much promise and that has proven to work satisfactorily in the
context of a research programme in which researchers participate from many
countries with very diverse regulatory situations.

(1)  The decision on the 7th Framework Programme explicitly excludes three fields of research from Community funding: — || research activities aiming at human cloning for reproductive purposes;

— || research activities intended to modify the genetic heritage of human beings which could make such changes heritable;

— || 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.

(2)  No activity will be funded that is forbidden in all Member States. No activity will be funded in a Member State where such activity is forbidden.

(3)  The decision on FP7 and the provisions for the ethical framework governing the Community funding of human embryonic stem cell research entail in no way a value judgement on the regulatory or ethical framework governing such research in Member States.

(4)  In calling for proposals, the European Commission does not explicitly solicit the use of human embryonic stem cells. The use of human stem cells, be they adult or embryonic, if any, depends on the judgement of the scientists in view of the objectives they want to achieve. In practice, by far the largest part of Community funds for stem cell research is devoted to the use of adult stem cells. There is no reason why this would substantially change in FP7.

(5)  Each project proposing to use human embryonic stem cells must successfully pass a scientific evaluation during which the necessity of using such stem cells to achieve the scientific objectives is assessed by independent scientific experts.

(6)  Proposals which successfully pass the scientific evaluation are then subject to a stringent ethical review organised by the European Commission. In this ethical review, account is taken of principles reflected in the EU Charter of Fundamental Rights and relevant international conventions such as the Convention of the Council of Europe on Human Rights and Biomedicine signed in Oviedo on 4 April 1997 and its additional protocols and the Universal Declaration on the Human Genome and the Human Rights adopted by UNESCO. The ethical review also serves to check that the proposals respect the rules of the countries where the research will be carried out.

(7)  In particular cases, an ethical review may be carried out during the lifetime of the project.

(8)  Each project proposing to use human embryonic stem cells must seek the approval of the relevant national or local ethics committee prior to the start of the project. All national rules and procedures must be respected, including on such issues as parental consent, absence of financial inducement, etc. Checks will be made on whether the project includes references to licensing and control measures to be taken by the competent authorities of the Member State where the research will be carried out.

(9)  A proposal that successfully passes the scientific evaluation, the national or local ethical reviews and the European ethical review will be presented for approval, on a case by case basis, to the Member States, meeting as a Regulatory Committee. No project involving the use of human embryonic stem cells will be funded that does not obtain approval from the Member States.

(10)  The European Commission will continue to work to make the results from Community funded stem cell research widely accessible to all researchers, for the ultimate benefit of patients in all countries.

(11)  The European Commission will support actions and initiatives that contribute to a coordination and rationalisation of HESC research within a responsible ethical approach. In particular, the Commission will support a European registry of human embryonic stem cell lines. Support for such a registry will allow a monitoring of existing human embryonic stem cells in Europe, will contribute to maximise their use by scientists and may help to avoid unnecessary derivations of new stem cell lines.

(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.

[1]  press release 18/07/2012: http://ec.europa.eu/commission\_2010-2014/sefcovic/headlines/press-releases/2012/07/2012\_07\_18\_eci\_en.htm

[2] REGULATION (EU) No 1291/2013 of the European Parliament and of the
Council of 11 December 2013 establishing Horizon 2020 - the Framework Programme
for Research and Innovation (2014-2020) and repealing Decision No 1982/2006/EC.

[3] Official Journal of the European Union, C 373/1220.12.2013.

[4] DECISION No 1982/2006/EC of the European Parliament and of the
Council of 18 December 2006 concerning the Seventh Framework Programme of the
European Community for research, technological development and demonstration
activities (2007-2013).

[5] Official Journal of the European Union, L 412/42, 30.12.2006.

[Top](#document1)