European Group on Ethics in Science and New Technologieschange has been remarkable once again, in...

European Group on Ethics in Science and

New Technologies

2011-2016

Research and Innovation

General Activity Report

European Group on Ethics in Science and New Technologies General Activity Report 2011-2016

European CommissionDirectorate-General for Research and InnovationUnit RTD.DDG1.02 — Scientific Advice Mechanism

Contact Jim Dratwa, Head of the EGE OfficeE-mail [email protected] [email protected]

European CommissionB-1049 Brussels

Printed by OP in Luxembourg.

Manuscript completed in July 2018.

Neither the European Commission nor any person acting on behalf of the Commission is responsible for the use which might be made of the following information.

The contents of this report are the sole responsibility of the European Group on Ethics in Science and New Technologies (EGE). Although staff of the Commission services participated in the preparation of the statement, the views expressed in this statement reflect the collective opinion of the EGE, and may not in any circumstances be regarded as stating an official position of the European Commission.

More information on the European Union is available on the internet (http://europa.eu).

Luxembourg: Publications Office of the European Union, 2018

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EUROPEAN COMMISSION

Directorate-General for Research and Innovation2018

GENERAL ACTIVITY REPORT 2011 – 2016

European Group on Ethics in Science and New Technologies

Brussels, 9 July 2018

On the activities of the

European Group on Ethics in Science and New Technologies 3

Table of Contents

Foreword by Commissioner Moedas ............................................................ 4

Introduction by the Chair ........................................................................... 6

Chapter 1: The evolving role of ethics in the european union ................... 13

1.1. The EU Post-Lisbon as an emerging union of values ............................ 14

1.2. Challenges in the application of ethics: A European landscape in transformation .............................................................................. 15

Chapter 2: The work of the EGE, 2011 - 2016 ........................................... 19

2.1. EGE Opinions and statements ........................................................... 19

2.2. Engaging stakeholders .................................................................... 34

2.3. Building global partnerships ............................................................. 37

2.4. Impacting EU policy ........................................................................ 39

Chapter 3: A forward look at ethics in the EU ........................................... 43

3.1. Emerging issues and future challenges: reflections by members of the EGE ........................................................................................ 44

3.2. The 10 Priorities of President Juncker ................................................ 76

4 European Group on Ethics in Science and New Technologies

Foreword by Carlos Moedas,

Commissioner for Research, Science and Innovation

The European Union is first and foremost a project for peace, solidarity and

justice. We can take pride in the fact that Europe is, and always has been, a

community of values. These principles are inscribed in our laws and our

treaties. Yet, we can never take our common values for granted and in

today's world, we need to be increasingly vigilant to protect those ideals

and principles we hold dear. Europe has been through a period of multiple

crises – economic, environmental, geopolitical and humanitarian. At the

same time, science and technology are fundamentally altering our lives:

from the way we work, travel and engage with one another, to the very

way our economies and societies are organised. Some developments are

not without controversy, and spark intense debates. Others concern

technologies that have been with us for decades but which are now moving

into new forms and functionalities, the consequences of which we are only

just beginning to understand.

Such advances bring profound questions about the kind of future we are

creating for ourselves and our children. They can also generate

uncertainties in a period where fear and insecurity is provoking populist

backlashes against deeply held values and against notions of science and

progress. If these trends tell us anything, it is that science cannot operate

in a vacuum, and innovation cannot proceed if isolated from the wider

cultural, ethical, and societal context.

That is why the European Group on Ethics (EGE) has such an important role

to play for the European Commission. The Group provides a unique forum

for deliberation and reflection, to carefully and thoughtfully weigh the

consequences and ethical dimensions of the choices we as policymakers

make, by action or inaction. Its advice transcends disciplinary boundaries; it

focuses on emerging urgencies as well as long term trajectories; and it

considers not only the national and European contexts of the ethical

questions placed before it, but also the global nature of contemporary

ethical dilemmas. It promotes the enormous potential of science and

technology to develop solutions to current challenges, and addresses the


ever closer intermeshing between technological advancement and broad societal and political developments.

Consequently, the EGE between 2011 and 2016 engaged with the headline issues that have affected Europe during the last years: energy and climate change, questions of national security and the role of state surveillance, the transition to a digital world and how we adjust to the transformative impact that information and communication technologies are having on our lives, to name but a few. Its advice has not only been of great benefit within the European Commission, but has influenced ethical, scientific and policy considerations far beyond Europe's borders. Indeed, the international dimension of the EGE's work is a key pillar of the EU's broader efforts to be a standard setter of ethical norms and values globally.

I would like to sincerely thank the Chair and the former members of the EGE for their valuable efforts over the past five years. Their work has reflected not only their steadfast dedication to the role and goals of ethics but also their commitment to the European Union as a project of peace, solidarity and justice.

The EGE has cemented its reputation as an important focus for ethical debate at EU level. Its Opinions have become a widely recognised source of independent insight and the Group's approach, rooted in inter-disciplinarity and external engagement, has allowed the EGE to successfully draw upon dialogue and collaboration, bringing together multiple perspectives. I urge the new Group to continue the excellent work in casting a critical and illuminating gaze on the major societal questions of our time and look forward to working with its members for the years to come.

Carlos Moedas


Introduction by the Chair

Introduction

In the report of the previous mandate (2005 – 2010) of the Group its chair,

Prof. Göran Hermerén, wrote that significant advances had taken place in

science and new technologies in the preceding four years. The pace of

change has been remarkable once again, in all areas of science and

medicine.

The ability to handle enormous quantities of data easily and in real time and

to correlate and analyse multiple date sets is new, and challenges our

concepts of personal data and privacy. The development of algorithms that

enable such analysis places new ethical challenges in the hands of those not

used to having to address these sorts of issues. Much of what we have

thought about concerns the protection of personal data and the manner in

which concepts of privacy may have changed. The need to think about

changes in society and its organisation and therefore justice and solidarity

in new ways has surprised us.

Advances in biotechnologies provide precision in modifying cells and genetic

information in situ, and enable rapid and affordable analysis of genetic data

previously unattainable. The pace of change seems to be accelerating, and

concepts which had been almost taken for granted in the late 20th century

are once again challenged as science and technology provide new and

exciting changes to the way we live our lives. Advances in medicine bring

new possibilities of precision medicine and therefore new ethical challenges.

It is said that less than half of medical therapies currently in use are

experimentally verified, yet there is an increase in science based medicine

and practitioners are using tests that were unforeseeable only a short time

ago. The implications of such changes are not yet fully appreciated;

assumptions about clinical trials, for example, may need a fundamental

rethink as the variation in response to clinical treatment impacts on the

interpretation of such data.

Advances in genetic science mean that data about individuals is not

restricted to that individual; anonymisation of data has become

problematic. The ubiquity of portable or wearable electronics has changed

the concept of privacy for individuals in ways unthinkable only a few years

ago, to the extent that many believe that ‘privacy is dead’, and the

globalisation of data about each of us has ethical dimensions which are

basic to our understanding of identity and identification.


What also surprised the new Group that began its work five years ago, was

the change in that which we were being asked to look at. At the beginning

of the mandate, we asked the Commission Directorates General to provide

us with suggestions for topics which we might examine. To our surprise, we

were being asked to examine the ethical issues in a vast range of areas,

way beyond that which had formed the basis for the previous work of the

EGE. Ideas included the impact of new information technologies on

freedom of expression, security and surveillance, particularly in relation to

research projects, responsible research and innovation, human

enhancement, the ethical issues involved in information and communication

technologies, geoengineering, children in research – whether medical or

social research, research integrity, including deceit in research, and dual

use.

It was only in the latter half of the 20th Century that bioethics became an

important tool for assuring the well-being of individuals in society. In 2011,

the US Presidential Commission for the Study of Bioethical issues produced

a report on STD experiments in Guatemala which showed how far our

appreciation of ethical issues had come. The Chair of that Commission

stated that 'In addition, we must look to and learn from the past so that we

can assure the public that scientific and medical research today is

conducted in an ethical manner. Research with human subjects is a sacred

trust. Without public confidence, participation will decline, and critical

research will be stopped. It is imperative that we get this right.' During the

mandate of the EGE, the World Medical Association celebrated 60 years of

the Declaration of Helsinki, first adopted in 1964. The need for clinicians to

adopt and apply ethically acceptable practices has never been as clear as it

is today, or as difficult.

The range of topics that the Group was thought to have the expertise and

willingness to examine, therefore, was exciting, challenging and daunting.

Expertise

The Group has expertise in science (primarily the medical and biological

sciences), law, ethics, theology and philosophy, and had to think about the

implications of looking in depth at topics for which little experience was

available.

We come from a variety of backgrounds, not only disciplinary, and have had

to respond to each other and interact as we learn about new technologies.


As noted by Prof. Hermerén, dialogue between the members of the Group is

critical, and does provide new insights. The wide variety of topics, most of

which in this mandate were outside the initial expertise of the Group

required a broad range of information and data to be provided. We needed,

and received information from experts within and without the European

Commission. The requirement to hold open meetings – Round Tables –

enabled us to identify problems that we had not necessarily met before.

Independence and Integrity

We have had the opportunity to spend a significant amount of time

discussing controversial issues, new to us often. We have a responsibility to

the Commission to be completely independent, not allied to any particular

faction within the European Union, even those responsible for policy

determination.

The independence of the Group required that we devised our own working

methods and that we finalised our Opinions before they could be seen by

the European Commission. The Group normally responds to requests to

provide Opinions from the President of the Commission, but has the right

(and responsibility) to decide what is included in its Opinions including

identifying a scope which may be broader or narrower than that asked for,

and even deciding on producing Opinions or statements on its own

initiative.

We are aware that on occasion we may provide advice on issues which are

already policy or law within the Union or in Member States; but it remains

important that we consider carefully the manner in which an ethical

overview might result in policy or legal considerations. If the law already

exists, that is a good thing. If policy mirrors that which we ask for, our

approach reinforces that which has been decided. If, on the other hand, the

changes to law and policy that we recommend are contrary to current policy

or law, it enables a careful examination of the measures in place.

During this mandate, the President of the Commission specifically asked us

to look at ethics in relation to a number of topics, interpreted by the Group

to be:

Ethics of information and communication technologies;

An ethical framework for assessing research, production and use of

energy;

Ethics of security and surveillance technologies; and

The ethical implications of new health technologies and citizen

participation


From whence we started

The bases for the work of the EGE have been the treaties on the European

Union, including the Charter of Fundamental Rights (noting the derogation

for Poland and the United Kingdom). It is in Article 2 of the consolidated

treaty that much of our work is founded:

'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. These values are common to

the Member States in a society in which pluralism, non-discrimination,

tolerance, justice, solidarity and equality between women and men prevail.'

In addition, Article 6 is fundamental to our approach to ethical issues when

examining the topics which the President of the Commission has chosen to

ask us to examine;

Article 6(1): The Union recognises the rights, freedoms and principles set

out in the Charter of Fundamental Rights of the European Union of 7

December 2000, as adapted at Strasbourg, on 12 December 2007, which

shall have the same legal value as the Treaties.

Article 6(3): Fundamental rights, as guaranteed by the European

Convention for the Protection of Human Rights and Fundamental Freedoms

and as they result from the constitutional traditions common to the Member

States, shall constitute general principles of the Union's law.

The future

Science is not going to stand still and technology will provide new avenues

for the utilisation of science for good, or otherwise. The EU has the

responsibility, set out so clearly in its Treaties, to consider the impact of

policies on pluralism, non-discrimination, tolerance, justice, solidarity and

equality. The EGE must continue, and challenge those responsible for

devising policy at Commission and Member States level where the policy

decisions fail to address these fundamental issues. It is for the European

Court of Justice to interpret the treaties, but we can, and should think

forward, as new technologies emerge, about the implications for the

ordinary person in our pluralistic society.

There are many issues that need clear policy that can be influenced by the

careful examination by a Group with the mandate we have had. The


independence of our Group enables the Council, Parliament and

Commission to choose not to implement our suggestions, but forces an

examination of the principles on which policy making is based.

When thinking about new science and new applications, it has become

obvious that scientific integrity is a crucial element in assuring the reliability

of the scientific knowledge upon which law and policy should be based. The

speed of change of scientific advances can never be matched by change in

policy and law. Law, therefore, will always lag behind the technology as it is

introduced. It is known that forward planning is difficult – prediction of the

changes has been shown often to be wrong. We can only base our

recommendations to the European Union on the basis of the principles

which we have enunciated as the basis of our society. As this article is

being written, it has been reported that Russia has banned all uses of foods

and food ingredients that have been genetically modified. Most of the

scientific evidence would suggest that this is wrong – EFSA has reviewed

the science for almost all that which is on the market, and concluded that

modified food is safe both for the environment and for human health on a

scientific basis. An ethical consideration of the implications of humans

modifying that which is around them is not necessarily the same as that

scientific consensus.

It is now possible to sequence the genome of an individual rapidly and

precisely. Interpreting the vast range of information is less advanced, but

this will rapidly increase and change much of the way in which the

biosciences and medicine are likely to operate. The increase in precision

when editing genes has profound ethical implications for modifying the

genes of all animals, including humans.

There are many who believe that the current intellectual property (IP)

regime in the area of biotechnology is fraught and faces many challenges.

The courts and patent offices are being careful in identifying that which is

patentable, questioning originality, prior art, utility and even the breadth of

patents in biotechnology. There have been court challenges in relation to

disclosure of information allowing those skilled in the art to reproduce the

claimed ‘effects’ (e.g. The Canadian Supreme Court looking at Teva Canada

Limited v. Pfizer Canada Inc., et al). The US Supreme court recently ruled

on the non-patentability of a process for personalised medicine ‘patented’

by Prometheus laboratories (Mayo Collaborative Services, DBA Mayo

Medical Laboratories, et al. V. Prometheus Laboratories, Inc.). The patents

for BRCA1 and BRCA2 held by Myriad laboratories has been challenged in

the U.S. Supreme Court. The CJEU has considered patents arising from the

use of human embryonic stem cells. Indeed, there is an expert group


deciding on whether the Biotechnology Patent Directive needs change – and

which specifically has excluded any analysis of ethical issues in their

deliberations. The patenting of living systems is rightly receiving careful

consideration in the courts, and remains challenging to those involved in

the science and law in the area. The importance of ensuring innovation,

ensuring adequate funding for developments in modern technology is

crucial for the future, but IP law should not impede innovation and new

developments, and full disclosure is needed to ensure that further

development in these new sciences can proceed without patent wars.

Therefore a need for ethical oversight remains important, and we are

excited that the Commission has decided that a new mandate will provide

for continuation of our role.

Thanks

It has been a fruitful and exciting five years, and I wish to thank all the

members of the Group and the secretariat for their commitment and hard

work that has enabled us to produce Opinions of a high calibre that are

useful to the Commission even where they do not agree with our

conclusions. We are not paid, and the amount of time taken for the work of

the EGE is considerable. At times it has been difficult – unsurprising for a

group with such varying backgrounds and ideas. I have learned a great

deal, and made many friends.

Thank you,

Julian Kinderlerer


Chapter 1

The evolving role of ethics in the European Union

Ethics refers, in broad terms, to the philosophical analysis and assessment

of practices according to fundamental rights and values.1 Determining a

'Europeanised' or European-wide ethics is not a straightforward task, given

the Union's diversity and in view of the restricted competences of the EU

institutions.2 Yet the bare bones of an ethical framework are established by

the values laid down in the Treaties which form the 'normative pillars' upon

which European policies are built. This framework is by no means static, but

has progressively developed over time together with the evolution of the

European project itself, its mission and expanding policy reach.

The EGE 2011 – 2016 took up activities at the dawn of a new era in the

EU's development as a Union of values. The Treaty of Lisbon had entered

into force the preceding year, bringing several key constitutional changes

with important implications for ethical policymaking. Lisbon enshrined the

notion of an EU of rights and values in its foundational Article 2 TEU. It

simultaneously elevated the EU Charter of Fundamental Rights to a legally

binding bill of rights and brought further key changes in the shape of

extended democratic accountability and a wider scrutiny by the Court of

Justice.

The EGE's activity report of 2010 welcomed this watershed in EU history,

noting that: 'The Lisbon Treaty establishes for the first time a community

based on fundamental rights and values.'3 Five years on, what bearing have

these institutional changes had on European policymaking? Has the vision

of a Europe of values been realised? How has the evolving institutional,

political and societal landscape shaped the development of ethics and their

application in the European context?

1 General Report on the Activities of the European Group on Ethics in Science and New Technologies to the

European Commission 2005 – 2010. Available at: http://ec.europa.eu/archives/bepa/european-group-ethics/publications/opinions/index_en.htm 2 See the contribution of Herman Nys and Siobhan O'Sullivan in Chapter 3.1. of this report for a further

reflection on these questions. 3 General Report on the Activities of the European Group on Ethics in Science and New Technologies to the

European Commission 2005 – 2010. Available at: http://ec.europa.eu/archives/bepa/european-group-

ethics/publications/opinions/index_en.htm

http://ec.europa.eu/archives/bepa/european-group-ethics/publications/opinions/index_en.htm





1.1. The EU Post-Lisbon as an emerging union of values

At the institutional level, there are clear indications that rights and values

feature more and more prominently in the constitutional self-understanding

of the European Union. Indeed, the EU's legislative bodies have been active

in advancing a new era of rights protection across the spectrum of EU

activity. The European Commission has woven the Charter into its

policymaking practice,4 while the Court of Justice has been actively making

good on the Charter's protections. For instance, the court concretised the

Charter's promise of a right to privacy by creating a European 'Right to be

forgotten' and annulling the Data Retention Directive.5 The European

Parliament has also put forward a wide range of initiatives enshrined in its

Resolutions on the situation of fundamental rights in the EU aimed at

strengthening current EU mechanisms and better ensuring the respect of

the Union’s general principles.

All has not been plain sailing, the institutional integration of rights and

values into the EU's architecture has by no means been smooth during the

last years: the planned accession to the European Convention on Human

Rights has encountered headwinds; important areas of protection, such as

social rights, have seen slower progress; and policy challenges arising

during the past decade have left broad sections of our societies more

exposed (see 1.2. below).

Nevertheless, 'fundamental rights' and the foundational principles of human

dignity, equality, justice etc. from which they are derived have gained

increased currency within the EU's institutional architecture. As the

President iterates in his 'Political Guidelines for the Next European

Commission' released in July 2014:

'Our European Union is more than a big common market. It is also a Union

of shared values... I intend to make use of the prerogatives of the

Commission to uphold, within our field of competence, our shared values,

the rule of law and fundamental rights, while taking due account of the

diversity of constitutional and cultural traditions of the 28 Member States'.6

The task of embedding of ethics and values in the work programme of the

Commission under president Juncker is examined in more detail in

4 See for instance the European Commission's Annual reports on the implementation of the Charter of

Fundamental Rights 5 C-293/12 & C-594/12, Digital Rights Ireland, April 2014, Court of Justice of the European Union 6 A New Start for Europe: My Agenda for Growth, Fairness and Democratic Change – Political Guidelines for

the next European Commission, Jean-Claude Juncker, Candidate for President of the European Commission,

15 July 2014: https://ec.europa.eu/priorities/sites/beta-political/files/juncker-political-guidelines_en.pdf

https://ec.europa.eu/priorities/sites/beta-political/files/juncker-political-guidelines_en.pdf


Chapter 3.2. through examining the ten policy areas that he has designated

as political priorities for his term at the helm of the European Commission.

1.2. Challenges in the application of ethics: A European

landscape in transformation

While the EU has been progressively embedding the language and practice

of ethics into its policymaking, in parallel the European Union has witnessed

the emergence of a series of economic, societal and political developments

which raise the stakes around the place of rights and values within the

Union. This set of trends have provided the contextual backdrop that has

shaped the development of ethics and their application in Europe over the

past five years. They have also impacted the focus and reflections of the

EGE and many of these transformative shifts emerge as recurring themes in

the Group's Opinions. These trends include, but are not limited to, the

following:

Financial crisis and economic recession: The legacy of the 2008

banking crisis and the subsequent economic recession has had

ethical ripple effects across the EU. Since the crisis, economic and

social divergences in the EU have been widening and the poverty

rate and the unemployment rate, especially youth unemployment,

have increased. Government reforms in response to the crisis

brought about by fiscal austerity requirements have impacted the

evolutionary dynamics of the European Social Model. The difficult

decisions required by an increasingly squeezed state sector have

raised a series of ethical dilemmas, and placed principles of

solidarity, equality and social justice under increased pressure.

New nationalisms and the growth of populism: The economic

crisis has also formed the backdrop to a re-emergence of nationalist

parties across the continent and a distinct rise in populist rhetoric,

blending xenophobic and Eurosceptic tones. Beyond rhetoric, there is

a risk that such movements could dismantle the infrastructure that

protects EU's citizens. In certain Member States, attacks on the

concept of human rights are already playing out and fundamental

pillars of the rule of law (freedom of the Courts, of the media) have

been tested, posing a direct challenge to the foundational principles

of the European Union. Signs of nationalism and populism are not

fleeting trends but rather a reflection of a deep-rooted

disillusionment with politics, scepticism toward the representative


value of European democracy, and insecurities regarding national

identities and the durability of European social models.

Changing demographics and social cohesion: The European

Union is facing unprecedented demographic changes linked to an

ageing population, low birth rates, changing family structures and

migration. As the structures of our societies undergo radical

transformations, the question of how to maintain social cohesion and

solidarity –between generations, between communities and between

individual citizens – comes increasingly to the fore, as does the issue

of how technologies interact with dynamics of social cohesion. The

EGE's Opinion 26 on the Ethical Implications of Information and

Communication Technologies explores the ways in which digital

technologies can both facilitate social inclusion and participation as

well as exacerbate the isolation of certain vulnerable or marginalised

groups. It also highlights the ways in which notions of privacy and of

identity are re-framed by ICTs in ways that force us to re-consider

the contemporary understandings of such concepts. Classic ethical

values and principles are also being considered anew in light of the

increasingly multicultural constitution of the European Union.

Maintaining the universality of European values is a task that is both

enriched and challenged by the cultural pluralism that characterises

contemporary European societies.

Global instabilities: Even as global growth, interdependence and

technological progress have enabled ever more people to escape

poverty and lead freer lives, recent years have seen a rise of global

instability as regional orders unravel, global powers collide and

states fragment. The European Union has witnessed the direct

consequences of this deterioration in its external security

environment in the shape of terrorist attacks both within and beyond

its borders and in the dramatic rise in the displacement of persons

which has seen the number of people exiled from their homes to

seek safety elsewhere double in the last decade. The EGE's Opinion

28 on Security and Surveillance Technologies examined the

application of new technologies in the security domain and their

ethical implications. It urged caution in the way in which tools of

surveillance are applied to certain population groups and their

potential to compromise principles of non-discrimination and justice.

Our use of technologies in response to threats real or imagined is

reflective of the kind of societies we wish to live in, and the

meanings we give to notions of 'security' and 'freedom'. Similarly,


how we use technology to address the arrival of large numbers of

people at our borders is revealing if science has been directed

primarily towards erecting technological walls, frontiers and barriers

rather than for finding lasting, solidarity-based solutions.

Environmental changes: The growing severity of threats to our

environment, such as climate change, and related challenges of food

and water security, have in the last years become increasingly stark.

Their geopolitical repercussions are also now coming to the fore as

their role as multipliers for environmentally driven conflicts, political

instability, extreme poverty, energy security, and migration have

become a reality. Despite the EU's leading role in international

climate change diplomacy to spearheading the circular economy,

the political will to change course and to put into action the means to

do so has been slow to materialise. The EGE in its Opinion 27 put

forward an ethical framework for energy, while underlining that the

prospects for people to live dignified, healthy and productive lives in

harmony with nature requires a fundamental shift in technology,

energy, economics, finance and ultimately in society as a whole.

The privatisation of science and innovation: Shifts have been

detected in the steering of science and research during the past

decade as a result of wider social and political forces. Observers

have noted a trend towards a privatisation of science, and an ever

closer linking of science and innovation to the imperative for

economic competitiveness. The need to boost the Knowledge

Economy has become a dominant frame in science, technology, and

innovation (STI) policy, and it has been argued that reductionist

kinds of science focused on yielding intellectual property are heavily

shaping research in domains such as agriculture and health. This

tendency is addressed and explored in the EGE Opinion 29 on New

Health Technologies and Citizen Participation, which notes the

central role that market interests play in driving technology-based

participatory approaches to healthcare. Market-based approaches to

science and innovation ultimately influence the relative roles of

public and private R&D performers and funding sources and may

affect the space for alternative approaches to develop, for instance,

those focused on fostering social cohesion (e.g. initiatives directing

innovation toward human needs, empowering women, and activating

communities to actively solve their own problems and demand

accountability from the public sector).

http://steps-centre.org/wp-content/uploads/Innovation-Democracy.pdf

http://announcementsfiles.cohred.org/gfhr_pub/assoc/s14789e/s14789e.pdf


The challenges of the 21st century are vast - wide in range, global in scale,

and complex in nature. It is against this backdrop of fragmentation,

uncertainty and crisis that the place of ethics appears critical. Critical

because the position of ethics is being challenged and questioned in new

ways, just as the search for common ethical values and their application is

increasingly needed to adequately respond to the transformations before

us.

In an EU context, tackling the socio-economic, environmental and political

challenges described above requires an intricate interplay between

solidarity and responsibility; collective ambition and unity in diversity;

interdependence and cooperation; short-term action and long-term

perspectives. It requires a wide-ranging debate about the kind of Union we

want to create, the improvements we wish to see in our societies and how

to bring them about. Ethical values and principles have an essential role to

play in anchoring and guiding such a dialogue. During the past five years

the EGE has provided a conduit for such conversations to play out at the

European level and the Group will continue to strive to offer the guidance to

support the European Union to shape its ethical identity and vision.


Chapter 2

The Work of the EGE, 2011 - 2016

2.1. EGE Opinions and statements

During its 2011 – 2016 mandate, the EGE adopted four extended Opinions

on the topics of information and communication technologies; on energy;

on security and surveillance and on new health technologies and citizen

participation. In addition, three statements were produced by the EGE on

clinical trials, on research integrity, and on human germline modification.

EGE Opinions are initiated on the basis of a formal request from the

Commission President. Their findings and recommendations are the product

of intense series of working meetings which take place over a duration of

several months to a year. In addition to the rigorous scientific background

research, ethical analysis and debate undertaken amongst the members of

the Group, a broad range of external expertise is drawn upon during the

preparation of EGE advice, via the organisation of expert hearings and open

public Round Tables. These encompass the participation of a broad cross-

section of European stakeholders, including the scientific community,

industry representatives, policymakers, European Institutions

representatives, NGOs, and civil society organisations (see Section 2.2.).


The Opinions of the EGE: 2010 - 2016

Opinion 29

Ethical Implications of New Health

Technologies and Citizen Participation

Recent years have witnessed a wave of

innovation in health technologies driven by new

medical breakthroughs, novel scientific

approaches and the rise of digital health

technologies. Pioneering methods of drug

development and disease diagnosis, the rise of

'big health data', and new means of providing

networked care have led to predictions that

European health systems are on the cusp of

transformation. While much of the promise held in

these technological innovations remains to be fully realised, the rise of new

health technologies are accompanied by a profound set of shifts in the way

individuals – whether as patients, citizens or consumers – engage with

matters of health.

From the consumer who orders a genetic testing kit online to the patient

receiving genetically customised medication; from the diabetic monitoring

her blood sugar level with a smartphone, to rare disease patients who

mobilise online communities of sufferers to run a DIY clinical trials;

individuals and collectives are participating in new and unprecedented ways

in the conduct of health research, health policy, and health practice.

The Opinion 29 explores the transformations that citizens' participation in

health and medicine induces across different domains together with the

resulting ethical implications. Trends and implications of citizen involvement

are examined in light of new technologies that have been developed and

that are emerging in the domain of health, as well as wider cultural, societal

and political shifts, which are transforming the context in which health and

healthcare are perceived, organised and delivered.

It does not attempt to give an exhaustive account of health technologies,

rather it scrutinises citizen participation via a selection of case studies of

scientific and technological innovation, chosen because they embody a

broader set of shifts in health and medicine. These shifts include, first,

evolving understandings of health and illness and associated changing

perceptions of the self and the body; second, changing notions of what it

means to be a patient in a modern health context; and third, the


increasingly diverse roles performed by citizens/individuals and patients in

the production of knowledge and innovation on health.

The Opinion begins by examining the

principal health technologies which are

most central to the shifts outlined

above, including data intensive

medicine, omics, personalised medicine

as well as so-called 'remote' forms of

medicine such as e-health, m-health,

telemedicine and online health

resources. It then traces the emergence

of the phenomenon of citizen science

and citizen participation with specific

regard to healthcare and medical research. It critically analyses the diverse

meanings and functions of these terms before outlining recent examples of

citizen participation in the domain of health.

The Opinion continues by setting out the ethical implications of the

paradigm shift (or set of shifts) identified initially. In unpacking both the

promise and potential challenges associated with citizen participation in

health, five sets of considerations are identified:

first, the implications of new health technologies and new modes of

involvement on perceptions of the 'self', of personhood and of the body

in a medical context;

second, the implications of potential transformations in the patient-

physician relationship;

third, the implications of citizen involvement in the research endeavour

and the tensions between empowerment, engagement and exploitation;

fourth, the implications of new health technologies and citizen

involvement on societal understandings, principles and structures

governing health;

and fifth, implications for notions of solidarity and justice.

The Opinion also examines the adequacy of current governance

arrangements, and identifies new questions and gaps presented by the

nexus between new health technologies and new practices of citizens'

participation. It undertakes, first, an examination of the legal landscape

pertaining to participation charting the rights and protections enshrined in

international human rights treaties and jurisprudence which establish the

entitlements of citizens to participate in, and enjoy the results of, science

and technology. It then identifies potential gaps in the regulatory


framework in relation to new health technologies and the suitability of

existing oversight mechanisms to cover new practices of knowledge

generation and innovation engaging the individual.

Finally, the Opinion puts forward a set of 20 recommendations, addressed

to EU and national level policymakers, industry and other stakeholders,

which aim to maximise the benefits and minimise the harms associated with

new health technologies and citizen participation in health policy, research

and practice.

Based on its findings, the EGE's recommendations fall into two categories:

Recommendations regarding general considerations: changing the way

we think about health and about citizen involvement (reflecting on key

notions, establishing conceptual clarity, and promoting awareness

raising and education);

Regulatory recommendations targeting the gaps in the governance of

citizen involvement and new health technologies (including digitial

health products, data, provision of care, participation, and solidarity

and justice).

On October 2015, the EGE debated the findings and recommendations of

Opinion 29 with Commissioners Carlos Moedas, responsible for Research,

Science and Innovation, and Vytenis Andriukaitis, responsible for Health

and Food Safety, on the occasion of a working lunch which also saw the

official handover of the Opinion to both Commissioners.

Photo 1 - The EGE delivers Opinion on the Ethical implications of New Health Technologies and Citizen Participation to Commissioners Moedas and Andriukaitis


Opinion 28

Ethics of Security and Surveillance

Technologies (2014)

The EGE Opinion on the Ethics of Security

and Surveillance Technologies examines

trends in the development of new security

and surveillance technologies. It explores the

ethical implications brought by these trends,

and advances a set of 16 concrete

recommendations for the attention of the EU,

Member States, and a range of public and

private stakeholders.

The Opinion aims to provide a reference point for the European Commission

regarding the ethics of security and surveillance measures in an era where

rapid advances in telecommunications and computing have enabled the

data of billions of citizens around the globe to be tracked and scrutinised on

an unprecedented scale.

Against the backdrop of the disclosures by former NSA contractor Edward

Snowden in June 2013, the EGE calls for a renewed public debate on the

limits to be placed on security and surveillance technologies, and offers

reflection on the far-reaching impact of surveillance on trust, privacy, and

civil liberties.

Assessing the governance of security and surveillance, the EGE finds a

diverse regulatory framework, in which domains such as

telecommunications need to better keep pace with the technological

transformation in surveillance capacities. While the European Union can

genuinely pride itself with some of the strongest privacy protection

worldwide, the national security exception can constitute a form of

loophole.

Security and freedom: do we need both? And can we enjoy both without

the pursuit of one jeopardising the other? These are two central questions

addressed by the Opinion. The Opinion challenges the notion that 'security'

and 'freedom' can be traded against one another. While a balance must be

struck between competing values when they come into conflict, certain core

principles, such as human dignity, cannot be bartered with. The Opinion

calls for a more nuanced approach, in which the proportionality and

effectiveness of security and surveillance technologies are subject to

rigorous assessment, and in which rights are prioritised rather than traded.


At its core, the Opinion contends that an ethical foundation for the use of

security and surveillance technologies requires a broader understanding of

the security concept, encompassing the human and societal dimensions of

security. Security is not simply protection from physical harm, but a means

to enable individual and collective flourishing. The Opinion highlights the

adverse consequences at stake when security becomes an end in its own

right, noting that excessive surveillance in the pursuit of security erodes

trust, social cohesion, solidarity and intellectual freedom.

Based on its findings, the Opinion advances 16 recommendations,

addressing a wide number of key issues:

Recommendations to improve the application and oversight of

technologies with a security function (judicial oversight; a common

European understanding of national security; and an EU regulatory

framework governing the use of drones);

Recommendations targeting the use of surveillance technologies

(including the call for an EU code of conduct for big data analytics;

greater transparency in the use of algorithms; and closer scrutiny of EU

border surveillance systems);

Recommendations regarding measures designed to re-build trust and

improve citizens' control over the management of their data and

privacy (including improved data protection enforcement, protection for

whistleblowers and measures to improve education and awareness

among the public and practitioners).

Photo 2 - Exchange of views with J. M. Barroso, the former President of the EC


Opinion 28 was presented to Mr José Manuel Barroso, the former President

of the European Commission at a handover ceremony on May 2014.

Photo 3 - Prof. Julian Kinderlerer, the President of the EGE, delivers Opinion on the Ethics of Security and Surveillance Technologies to Mr J. M. Barroso, the former President of the EC.


Opinion 27

An ethical framework for assessing

research, production and use of energy

(2013)

Fossil fuels are the energy source that shaped

19th and 20th century and enabled industrial

output. Burning coal, oil and gas has proved

highly damaging to our environment. Carbon

dioxide emissions, greenhouse effect gases,

and fumes and unburned particles all

contribute to the disruption in the balance of

our planet's climate and impact on human and

animal health. Global energy consumption is set

to triple by the end of the century, even where

there may be a reduction in use by individuals in Europe. Worse, supplies of

fossil fuels are being depleted and the consequences of their exploitation

without measures to reduce the residues and gases that impact on the

environment are serious. New or improved low-carbon technologies (in

particular renewables) for energy production are vital if EU's objectives for

2020 and 2050 as regards the fight against climate change, security of

energy supply and competitiveness of European companies are to be

fulfilled. How will we meet increasing energy demands while protecting our

environment and maintaining our civilisation?

With the entry into force of the Lisbon Treaty, ethical considerations are

integral components in the formulation of European Union policies, including

energy policy. This ethical analysis requires that the production systems

being considered should be comparable. The analysis cannot only consider

economic issues, but must consider the impact, either positive or negative,

that may occur during the entire lifecycle of the system and this should

encompass the impact on the environment and the implications of the use

(or indeed cessation of use) of a particular energy source. An ethically

sound policy design is a challenge for the formulation of such an important

policy sector that affects 10% of the entire GDP of the European Union as

well as well as global geopolitical and macroeconomic considerations.

Within this context, on June 2011 the Council reached a political agreement

on a Commission proposal for a nuclear research and training programme

for 2012-2013. Although the Council's discussion were successfully

concluded, some Member States felt that a broad discourse on ethical

issues and sustainable energy mix in Europe should take place and


indicated the need of having an Opinion of the EGE on this topic. The

former President of the European Commission, José Manuel Barroso,

therefore requested the EGE to 'contribute to the debate on a sustainable

energy mix in Europe by studying the ethical impact of research on different

energy sources on human well-being' on December 19, 2011.

The EGE accepted the request from the President and decided to:

Address the ethical issues arising from energy use

within the EU energy agenda, mix of energy,

consequences for the future, energy policy and

regulation (including environmental

considerations), precautionary principle and

intergenerational justice;

Identify the ethical criteria on the manner in which

decisions concerning research on sources of

energy are to be taken on an informed basis and

the implications arising from the use of energy in

different areas;

Propose an integrated ethics framework for the purpose of addressing

the ethical issues related to the production, use, storage and

distribution of energy;

Identify the ethically relevant areas of energy research.

On January 2013, the Group adopted its 27th Opinion unanimously: 'An

ethical framework for assessing research, production, and use of Energy'.

In its Opinion, the EGE adopts an integrated ethics approach to achieve an

equilibrium between four criteria - access rights, security of supply, safety,

and sustainability - in the light of social, environmental and economic

concerns.

Based on its findings, the Opinion advances several recommendations,

addressing a wide number of key issues:

Recommendations to ensure and promote the right of access to energy

to European citizens;

Recommendations regarding the safety and impact assessment of any

energy source and production;

Recommendations to secure energy supply at a National and European

level;

Recommendations to enhance energy sustainability;


Recommendations on the priorities for research that should be

identified;

Recommendations on democratic deliberation, participatory instruments

and responsibility for future generations.

The Opinion was delivered to President Barroso on February 2013, and

presented to relevant experts at the symposium on 'Benefits and

Limitations of Nuclear Fission for a Low Carbon Economy', organised by the

European Commission in cooperation with the European Economic and

Social Committee (EESC), which took place in Brussels on 26-27 February

2013. It was also presented to Mr Günther Oettinger, European

Commissioner for Energy.

Photo 4 - Prof. Julian Kinderlerer, the President of the EGE, presents Opinion on the Ethical Framework For Assessing Research, Production And Use Of Energy to Commissioner Oettinger


Opinion 26

Ethics of information and communication

technologies (2012)

In May 2010, the European Commission

adopted the Digital Agenda for Europe (DAE),

aiming to promote innovative uses of

Information Communication Technologies (ICT)

while respecting citizens' rights and EU

fundamental values. This was one of the seven

flagship initiatives foreseen in the Europe 2020

strategy for smart, sustainable and inclusive

growth.

In order to promote a responsible, socially inclusive and ethically sound

implementation of this strategy, Mr José Manuel Barroso, the former

President of the European Commission, requested the EGE to issue an

Opinion on the ethical implications of ICT.

The Opinion resulted from an intense

series of meetings with external experts

and relevant stakeholders (including

industry, civil society, NGO, academia and

the Chairpersons of the EU 27 National

Ethics Councils). The Opinion addresses

governance aspects (ethical, legal, social

and political aspects) related to the

following sectors of the EU Digital Agenda:

Social networks; E-Government; E-

Commerce; Corporate Social

responsibility; Digital divide; E-Skills; E-

Advertising; Cybercrime; Net Neutrality;

Internet of Things; E-Health; EU

Regulatory Frameworks for Personal Data Protection; Data Mining and Data

Profiling; Protection of Vulnerable Groups; Political Participation;

Environmental Impact and Use of Raw Materials, etc.

In the Opinion the EGE recognises the potential of the DAE for the European

Union, and stresses the need to promote a responsible, inclusive and

socially sustainable implementation of this important policy sector. The

Group therefore advocates the need to promote DAE actions in accordance

with the European Union fundamental values.


Based on its findings, the Opinion advances several recommendations,

calling for the following specific actions to be undertaken at the EU level:

To secure and promote the right of access to the Internet;

To provide means to foster responsibility amongst those using ICT,

whether individual users or those providing services (with additional

safeguards for children and adolescents);

Personal data in ICT to be processed on the basis of the explicit consent

of the person concerned (including withdrawal provisions) or other

legitimate basis;

The need for keeping Internet as a communication domain where

freedom of expression is protected from censorship within the

framework of the Charter of Fundamental Rights;

To ensure that social media networks protect the data submitted by

users in a responsible manner;

To encourage companies to take privacy into consideration when

applying their Corporate Social Responsibility measures– also using the

technological solutions such as Privacy impact assessment, Privacy

enhancing technology and piracy by design;

Individuals to be explicitly informed by businesses, State bodies or

research bodies that their information may be mined for specific

purposes;

The establishment of transparent informed consent procedures for the

collection of ICT users' data and clear definition of responsibilities of

relevant actors involved in the use of such data.

Former President J. M. Barroso and Commissioner Kroes welcomed the

Opinion and its support for actions by the European Commission to

implement the Digital Agenda for Europe in a responsible way. They

indicated that the Commission will now take inspiration from the proposed

recommendations to further foster societal and ethical consideration in the

construction of the European digital society.


Statements of the EGE: 2010 – 2016

Statement on Gene Editing (2016)

Human germline modification technologies are rapidly developing and have

elicited increasing concerns and international debate, coming under

significant pressure in 2015. The announcement in April 2015 of genome

editing of non-viable human embryos using CRISPR-Cas9 demonstrated

that human germline gene modification has moved out of the realm of the

theoretical, and clinical applications are becoming feasible. Given the

inextricably linked ethical, scientific and regulatory issues pertaining to

germline and somatic cell gene modification, the EGE unpacks the

assumptions and scrutinises the tensions at the heart of these

developments in its 2016 Statement on Gene Editing.

The EGE highlights that techniques such as CRISPR-

Cas9 are already challenging the international

regulatory landscape for the modification of human

cells. The EGE notes that the question whether

germline genome editing technology research should

be suspended warrants careful consideration, given

the profound potential consequences of this research

for humanity. It has been suggested that research

with a clinical application, as distinct from basic

research, should be subject to a moratorium. The

EGE calls for caution as regards whether such a

clear-cut distinction can be made between basic and

translational research. Likewise, the blurring of the lines between clinical

applications in pursuit of therapeutic or enhancement goals (albeit the

ethical issues pertaining to each may be different), must be considered. The

EGE considers that deliberation regarding the acceptability and desirability

of gene editing will require inclusive debate which extends to civil society

where diverse perspectives and those with different expertise and values

can be heard, as this cannot be left to select countries, social groups or

disciplines alone.


Statement on the formulation of a code of conduct for research

integrity for projects funded by the European Commission (2015)

Research Integrity is a prerequisite for research excellence, as there can be

no socially relevant scientific progress or innovation without a responsible

conduct of research. For this reason, the European Commission has placed

the respect of ethical principles as a key priority through Horizon 2020,

having reinforced the legal basis and the related set of procedures in

comparison with the previous Framework Programmes. Within this context,

a draft research integrity code of conduct for projects funded by the

European Commission was formulated, the EGE being requested by DG

Research & Innovation to provide input.

The 2015 EGE Statement on Research Integrity provides a set of

considerations that should be integral to any code of good scientific

practices. These include a set of specific measures to safeguard academic

freedom, the need to explicitly describe what are considered to be proper

research procedures, and the need for proper procedures to assess

indications of scientific misconduct, including protection of whistle-blowers.

During the Luxembourg Presidency of the Council of the EU in 2015, the

President of the EGE, Prof. Julian Kinderlerer, presented the EGE's position

on research integrity in the margins of the informal meeting of Ministers for

Competitiveness held in Luxembourg on 21 July 2015. This meeting laid the

grounds for the adoption of the Council conclusions on this topic on

December 2015, where Member States agreed that research at a EU and

Member State level should be founded on the principles listed in the

'European Code of Conduct for Research Integrity', these being: honesty;

reliability; objectivity; impartiality and independence; open communication;

duty of care; fairness; and, responsibility for future science generations.


Statement on the Proposal for a Regulation of the European

Parliament and the Council on Clinical Trials on Medicinal Products

for Human Use, and repealing Directive 2001/20/EC (COM 2012) 369

(2013)

The European Commission launched a

proposal for a Regulation on Clinical

Trials on Medicinal Products for Human

Use on the 17 July 2012. The purpose of

the proposal aimed ’at achieving an

internal market as regards clinical trials

and medicinal products’.

The EGE appreciated the objective of the

Commission to harmonise and fast-track the clinical trial process with a

view to bringing new medicines to the market. However, in its Statement

on Clinical Trials, the EGE raises some concerns regarding the draft

regulation, namely concerning:

1. the marginalisation of research ethics committees;

2. the nomination process for the reporting Member State (MS);

3. the narrow grounds upon which another MS can disagree with the

reporting MS;

4. the unrealistic timelines for review and authorisation

The EGE underlined its support for a harmonisation of clinical trial

evaluation first and foremost in the interests of patients accessing effective

innovative medicines in a timely manner, and also to enhance the European

Union competitive performance in the clinical trial arena. However, it

emphasised that marginalising the role of research ethics evaluation

achieves neither of those objectives. In view of these comments, the EGE

recommended the EU Institutions to:

Explicitly provide for research ethics committee evaluation of proposals

in the interests of protecting the rights of research participants;

Give consideration to how best to avoid any type of ethics shopping,

which may weaken the legitimacy of the evaluation e.g. by rotating the

reporting MS function;

Consider expanding the grounds upon which a MS disagree with the

Reporting MS in the interests of building consensus and respecting

ethical subsidiarity;

Set realistic timelines which should serve to expedite the process while

allowing a robust consideration of the issues.


2.2. Engaging stakeholders

Providing rich ethical expertise with a European perspective requires a

broad dialogue with a range of different actors. Consequently the EGE has,

with the support of the European Commission, established a strategy of

transparency and inclusiveness, enacting a number of channels by which to

engage external stakeholders in its reflections and activities.

Transparency

Transparency is written into the EGE's legal mandate and underpins all

aspects of the Group's functioning from member selection, and meetings to

publication of outputs. The 15 members of the EGE were appointed by the

President of the European Commission following an open call for applicants

published on the internet. The Group's legal mandate and rules of

procedure are publicised on the EGE website, as are all meeting agendas

and the names of all experts invited to participate in hearings.

The EGE website has become an important tool for disseminating EGE

activities and publications. All publications are made available for download

free of charge and the presentations, proceedings and videos of key events

such as the Open Public Round Tables and the European Commission's

International Dialogue on Bioethics are available online. Contact details of

the Secretariat are available for any enquiries.

Expert hearings

Expert hearings provide

an important channel

for the EGE to draw

upon external expertise

during the development

of Opinions. For each of

the Opinions produced

under the EGE's 2011 –

2016 mandate, leading experts (academics, practitioners, civil society with

specialist expertise etc.) were invited to participate in hearings during EGE

plenary meetings. These constituted sessions of approximately two hours,

comprising a presentation to the group followed by in-depth debate with the

members. In selecting the experts to participate in hearings, careful

attention was paid to ensuring a proper balance between diverse

disciplinary approaches and perspectives.


Open Round Tables

The EC Decision (2010/1/EU) which forms the basis of the EGE's legal

mandate provides for the organisation of public Round Tables. These events

have subsequently become a key means of garnering a broad-based input

during the development of EGE Opinions. One roundtable is organised per

Opinion and the event aims at stimulating debate on the topic of the

Opinion under preparation, exploring the issue from a range of

perspectives, and identifying gaps and outstanding questions.

Four public Round Tables were organised during the period 2011 – 2016. All

were open to the public, free of charge and saw a participation of more than

100 participants comprising a broad cross-section of European

stakeholders, including the scientific community, industry representatives,

policymakers, European Institutions representatives, NGOs, and civil society

organisations.

Panels of speakers aimed to reflect this broad

cross-section of stakeholder groups and

ample time slots were allocated to debate,

giving participants the opportunity to engage

directly with members of the Group, and to

highlight issues they felt merited special

attention. To maximise participation in the

discussion, an open invitation was sent to

relevant stakeholders (EU and beyond) and published on the EGE website,

and the Round Tables were web-streamed via the EGE website. In addition,

Round Tables were accompanied by a consultation process whereby written

comments were solicited from interested parties, compiled and distributed

to the members of the EGE.


Relations with National Ethics Councils

The EGE consulted and debated the topics covered by its Opinions with the

representatives of the EU-28 National Ethics Councils (NEC). Meetings of

the NEC Forum provided a suitable platform for these exchanges. NEC

Forum membership comprises the chairpersons and secretaries and is

hosted by the NEC of the country that holds the EU Council rotating

Presidency. Five were held in the period 2011 - 2016 by Hungary and

Poland (Joint meeting in 2011), Denmark (2012), Cyprus (2012), Ireland

(2013), and Italy (2014). At each meeting, the EGE participates in a joint-

session with the NEC Forum and bi-lateral meetings with the NEC of the

country holding the EU Council rotating Presidency.

Relations with international organisations

The European Commission – through the Secretariat of the EGE –

represents the EU in the international fora with a formal role in the

international ethics governance framework, such as the UN Inter-Agency

Committee on Bioethics and the International Bioethics Committee as well

as the Council of Europe, the OECD, and the UN-system international

organisations. The Commission participates regularly in meetings of the

relevant committees, cooperates in drafting international documents, and

keeps counterparts informed and updated with the developments, priorities

and activities, including those of the EGE.


2.3. Building global partnerships

Under the 2011 – 2016 mandate of the EGE, relations with Ethics Councils

across the globe have been stepped up as part of a concerted strategy to

promote ethical discussion in international policymaking and to advance

peace, democracy and human rights worldwide. The on-going endeavour to

strengthen global cooperation on ethics is key to placing the European

Union at the forefront of developing the norms and principles underpinning

developments in science and technology.

The European Commission's International Dialogue on Bioethics

In 2009, the Commission decided to establish the International Dialogue on

Bioethics and Ethics of Science and New Technologies (IDB). The IDB aimed

to cluster Chairs of National Ethics Councils or equivalent bodies from

different regions of the world to allow a better exchange of information and

communication between them. Under the 2011 – 2016 mandate of the EGE

this annual conference organised by the EGE Secretariat has developed into

an important platform of mutual learning and ethical debate. Four IDBs

were organised during the course of the mandate (in 2011, 2012, 2013 and

2014) bringing together the Chairs of non-European (and Multi-National)

Ethics Councils from across all continents. Videos of the event proceedings,

and event reports and presentations were made available to the public on

the EGE website.


Bi-regional dialogues

As part of its strategy to forge international cooperation on ethics in science

and technologies, the Commission laid the groundwork in 2014 for new and

emerging bi-regional dialogues. These dialogues aim to consolidate and

deepen targeted collaboration with key global partners and emerging

regional players within the international ethics framework and comprised:

the African Union - EU dialogue, on the occasion of the IDB conference in

Brussels in October 2014; the Latin America - EU dialogue, on the occasion

of the Global Summit and the World Congress of Bioethics in Mexico in June

2014; the US-EU dialogue on the occasion of the NEC-EGE Forum in Rome

held under the auspices of the Italian Presidency in November 2014.


2.4. Impacting EU policy

Providing policy guidance to the European Commission

Collaborative links have been forged with representatives of the European

Commission services across a range of relevant 'Directorates-General'

(DGs). Their input has been sought during the selection of Opinion topics

and during the elaboration of EGE Opinions, in order to ensure that the

EGE's policy advice responds to the needs of Commission policymakers and

takes into account the compelling ethical issues confronting the Commission

on a daily basis.

These collaborative networks have also provided a key means to

disseminate the EGE's findings and policy recommendations upon the

publication of EGE Opinions and statements and have led to fruitful

cooperation and take-up of EGE advice within the institution. One

illustrative example is provided by the cooperation with the DG for Research

and Innovation on Commission programming for energy research funding.

Following the delivery in 2013 of Opinion 27 on an Ethical Framework for

Assessing Research, Production and Use of Energy to Mr Günther Oettinger,

then Commissioner for Energy, the Commissioner asked his Cabinet and DG

RTD to bring forward proposals for concrete actions to implement the

recommendations of the EGE Opinion. This led DG Research and Innovation

to actively take up the recommendations on energy research in its

programming for research funding.

Similarly, Opinion 28 on the Ethical Implications on Security and

Surveillance Technologies provided an important reference point for the

European Commission in promoting a responsible use of security and

surveillance technologies and was distributed widely among the relevant

Directorates-General such as Home Affairs, Justice and GROW among

others. The Opinion provided a springboard for continuing inter-service

cooperation in the context of the European Commission's follow-up to its

2014 communication on civil drones,7 in particular the ethical, societal and

privacy implications. Furthermore, the EGE's recommendations on border

surveillance technologies, and on the EU-US data protection agreements

such as Safe Harbour, have taken on renewed pertinence in the wake of

7 Communication from the Commission to the European Parliament and the Council A new era for aviation -

Opening the aviation market to the civil use of remotely piloted aircraft systems in a safe and sustainable

manner http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52014DC0207&from=EN

http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52014DC0207&from=EN


developments following the Opinion's adoption and continue to be a source

of reflection and debate.

2014 saw cross-service collaboration on Open Science, which drew on the

on-going reflections of the EGE towards its Opinion 29 on New Health

Technologies and Citizen Participation. A joint background paper on

Fundamental Rights and Ethics in the context of Open Science was

produced in collaboration with DG Justice with a view to having a cross-

service input into the public consultation by DG Communications Networks,

Content & Technology and DG Research and Innovation.8

In addition to the policy steer provided by its Opinions, the European

Commission also calls upon the guidance of the EGE as a result of

emerging, shorter-term policy needs. By way of example, when the

Commission was required to respond to the European Citizens Initiative

'One of Us' on human stem cell research, the EU Commission's response in

its communication drew heavily on Recommendations on the ethical review

of hESC FP7 research projects (Opinion 22) and stipulated that should

alternatives to hESCs with the same potential as embryo-derived stem cells

be found in the future, the Commission will revert to the EGE for an

Opinion.9

The EGE's work has also fed into the development of the European

Commission legislation at the inter-institutional level. Such was the case

during the tri-lateral negotiations between the Commission, the European

Parliament and the Council on the Commission's 2012 proposal for a

Regulation on Clinical Trials on Medicinal Products for Human Use. The

EGE's statement on the EU Commission's draft proposal provided a key

contribution to the wide-ranging debates around this draft legislation that

ultimately resulted in an improved text, subsequently adopted in 2014, with

stronger measures covering access to the results of clinical trials, the role of

ethics bodies and measures to protect trial participants.10

8 Final report of public consultation on Science 2.0 / open science https://ec.europa.eu/digital-

agenda/en/news/final-report-science-20-public-consultation 9 Communication from the Commission on the European Citizens' Initiative 'One of us'

http://ec.europa.eu/research/eci/one-of-us_en.pdf 10 Regulation (EU) No 536/2014 of the European Parliament and the Council of 16 April 2014 on clinical trials

on medicinal products for human use, and repealing Directive 2001/20/EC.

https://ec.europa.eu/digital-agenda/en/news/final-report-science-20-public-consultation

https://ec.europa.eu/digital-agenda/en/news/final-report-science-20-public-consultation

http://ec.europa.eu/research/eci/one-of-us_en.pdf


Inter-Service Group on Ethics and EU Policies

The Inter-Service Group on Ethics and EU Policies provides a platform

through which the activities of the EGE intersect with the wider work of the

European Commission. This Group, set up to rationalise and coordinate the

European Commission's actions in the fields of ethics and EU policies, brings

together representatives from departments across the European

Commission to exchange information on policy files with an ethical

dimension. Topics discussed by the Group during the period 2011 – 2016

have included responsible research and innovation, ICT governance, the

Transatlantic Trade and Investment Partnership (TTIP), drone technology,

and the inter-institutional debate on energy mix. The meetings also aim to

coordinate EC actions with relevant international organisations (UN

Agencies, Council of Europe) and provide a bridge to the activities and

outputs of the EGE.

Ten meetings of the Inter-Service Group on Ethics and EU policies were

held during the period 2011 – 2016. The last meeting of the EGE under its

2011 – 2016 mandate brought together EGE members with representatives

of the Inter-Service Group to reflect upon the evolving role of ethics in the

EU institutional landscape and how to best optimise the value of the EGE for

the European Commission.

Relations with the European Parliament and Council

The European Parliament is an important conduit of ethical guidance and

interlocutor for the EGE. The EGE enjoys a close working relationship with

the Science and Technology Options Assessment Panel (STOA) and

representatives are regularly invited to participate in EGE events. Similarly,

members of the EGE have been invited to hearings in the European

Parliament. For example, in 2015 Professor Pere Puigdomenech presented

the EGE's position and recommendations at the joint public hearing held by

the ENVI and AGRI Committees of the European Parliament on issues

related to the cloning of animals for food production. Close contacts with

the European Parliament were also engaged during the preparation of the

EGE Opinion on Security and Surveillance, in particular with the LIBE

Committee and its chair, Claude Moraes, MEP, against the backdrop of the

Committee's special inquiry on the mass surveillance of citizens.

The work of the EGE has also been drawn upon at the level of the Council.

With research integrity constituting a priority of the Luxembourg Presidency

of the Council of the EU in 2015, the Chair of the EGE, Prof. Julian

Kinderlerer, presented the EGE's position on research integrity at the

margins of the informal meeting of Ministers for Competitiveness held in


Luxembourg on 21 July 2015. This, together with the EGE statement on

Research Integrity, prepared at the request of the European Commission's

DG for Research and Innovation, formed a contribution towards the

adoption of the Council conclusions on Research Integrity on December

2015.11

Similarly, in 2011, the EGE was called upon following delicate negotiations

in the Council concerning energy research. On 28 June 2011 the Council

reached a political agreement on a Commission proposal for a nuclear

research and training programme for 2012–13. Although the Council’s

discussion has been successfully concluded, some Member States felt that a

broad discourse on ethical issues and sustainable energy mix in Europe

should take place and indicated the need of having an Opinion EGE on this

topic. Consequently, the President of the European Commission requested

the EGE to ‘contribute to the debate on a sustainable energy mix in Europe

by studying the ethical impact of research on different energy sources on

human well-being.’ The EGE delivered its Opinion 27 on an ethical

framework for assessing research, production and use of energy,

considering issues such as security of supply, storage of energy where

necessary due to the nature of electricity generation particularly where

intermittent sources are utilised, competition for water and food in the case

of biofuels, waste treatment and/or storage and pollution.

11 Council conclusions on Research integrity, adopted by the Council at its 3431st meeting held on 1

December 2015.


Chapter 3

A Forward Look at Ethics in the EU

The focus and reflections of the EGE are steered by the emerging ethical

dilemmas that form the backdrop to their work, as Chapter 1 and 2 of this

report have shown. This chapter presents a forward look at ethics in the EU

for the years to come and a taste of those key issues which may come to

define the activities of the next Group.

Section 3.1. explores a set of emerging issues identified by members

serving during the EGE's 2011 – 2016 mandate in which they individually or

collectively develop a viewpoint which is their own.

Section 3.2. situates emerging ethical issues in relation to the European

Commission's work programme for the coming years, presenting an

overview of President Jean-Claude Juncker's 10 political priorities and

pinpointing those dimensions of each priority that may generate ethical

questions or challenges in the years ahead.


3.1. Emerging issues and future challenges: reflections by

members of the EGE

Ethics and education in Europe, by Marie-Jo Thiel

Senators S. Sutour and JL Lorrain published in October 2013, an

information report on behalf of the French Senate Committee on European

Affairs on 'Ethics: A European problem'12. They recalled the ethical

foundations of the Council of Europe and the European Union, incorporating

this 'requirement' of ethics within their institutional frameworks, mainly in

biomedicine. While ethics is not an EU competence and the subsidiarity

principle should apply, the 'European ethical framework nevertheless

emerged pragmatically in some areas' as biomedicine, research, corporate

social responsibility, the animal welfare... And because the ethical approach

can 'become a major asset in the development of contemporary society,'

the report recommended among others to 'promote a more participatory

democratic debate, based on citizen information and training. School,

university, ethics committees, have a role in the acquisition of a critical

thinking and in the dissemination of a culture of debate and a discourse

ethics. '

But which education in ethics? For whom? By which teachers? Supported by

which research? In which places, structures, training programs? With which

requirements? Which kind of ethics? Which anthropology of ethics13? Which

methodologies? Each Member State tries to face both a no man’s land (no

real official recognition of ethics) and an anarchical development of

initiatives opening the door to any abuse. The interdisciplinary aspect is

seen as a necessity but is at the same time at the core of this complexity.

The Sutour-Lorrain report was based on hearings and an observation that

had been made by a symposium14: ethics is more and more a real but very

little part of academic courses not only for health professionals but also in

management schools, in the curricula of science, etc.. Providing a set of

practical references and values in this context (disconnected from any

fundamental reflection because there is no time foreseen in the curricula for

this) is certainly a good start. Nevertheless if there is not somewhere in the

university a strong research and a high quality education of an

12 Simon Sutour et Jean-Louis Lorrain (†), sénateurs, Rapport d´information fait au nom de la commission des affaires européennes sur la prise en compte des questions éthiques à l’échelon européen, N°27,

enregistré à la Présidence du Sénat le 10 octobre 2013. 13 See Raymond Massé, Anthropologie de la morale et de l’éthique. Les presses universitaires de Laval,

2015. 14 Edwige Rude-Antoine et Marc Piévic (dir.), Un état des lieux de la recherche et de l’enseignement en

éthique. Coll. « Fondation Ostad Elahi », Paris, Ed. L’Harmattan, 2014.


interdisciplinary ethics, such a sketchy initiation may become harmful, a

'magical setting' that functions as an ethical stamp and gives the

impression of having resolved the difficult and complex issues that our

societies have to face.

Moreover, ethics suffers from the idea that it can be practiced instinctively,

without any learning, just by appealing to 'common sense'. To break this

deadlock and avoid the development of ethics 'at a discount', the European

Union needs to encourage high quality training in interdisciplinary ethics,

based on education and worthy academic research. Interdisciplinary, means

ethics is not just philosophical (only ethical theories) but is open to different

fields of reality to make the actors capable of situation analysis, based on

the contributions of the humanities, on medical, legal, economic, and

political inputs, in a changing and fundamentally plural world. But this

interdisciplinary ethics then faces the difficulty to exist autonomously within

the university, it is reduced in its means and its scale. Because the

interaction of different ethical fields is so decisive to be connected with

reality and at the same time to be innovative and efficient, the Sutour-

Lorrain report recommended to recognise interdisciplinary ethics for itself,

to organize a coherent education sector, guarantee of quality for research

and diplomas in the field of ethics.

The report of the EU SATORI project about the ethical assessment of

research and innovation,15 has come to similar general conclusions that

'ethics assessment of research and innovation in the European Union faces

many challenges: it currently lacks unity, recognized approaches,

professional standards and proper recognition in some sectors of society.

Stakeholders such as universities, research institutes, corporations and

government organizations have flagged the importance of ethics

assessment and developing different initiatives and mechanisms to address

ethical issues. The rapid expansion of ethics assessment has not, however,

been accompanied by significant efforts to harmonize approaches in

different fields and organizations, to raise standards, and to introduce

quality assurance. Questions remain about the feasibility of transferring

ethics principles and practices from fields with well-developed ethics

assessment skills to other fields. While there are certainly specific aspects

that can be usefully transferred, some areas such as the social sciences and

humanities are faced with the challenge of and largely unknown, contexts.'

15 Ethical Assessment of Research and Innovation: A Comparative Analysis of Practices and Institutions in the EU and selected other countries (June 2015): http://satoriproject.eu/media/D1.1_Ethical-assessment-

of-RI_a-comparative-analysis.pdf

http://satoriproject.eu/media/D1.1_Ethical-assessment-of-RI_a-comparative-analysis.pdf

http://satoriproject.eu/media/D1.1_Ethical-assessment-of-RI_a-comparative-analysis.pdf


The European Commission/EGE should engage a deep reflection about

Ethics and Education in the EU, taking up both new and old issues and

challenges. E.g. how can education set a framework of values? What is

responsibility? It should implement the role of education to establish

responsibility and to shape individuals to become citizens of the polis. There

are many organizations engaged in some form of ethics training. But who

knows what exists, what is likely to exist? What structure(s) can we /

should we put in place so that ethics may not be a vague request or a

cosmetic dusting, but benefits from research and a training of excellence,

providing the basis for an ethical culture for the whole of society and its

activities (which are now experiencing radical changes). What is ethics,

interdisciplinary ethics? Ethics, for what and for whom? Any statutory

recognition? Is there a 'European' ethics? What is an ethics’ group? Etc.

The EU has the responsibility, set out so clearly in its treaties, to construct

Europe according to the ethical and juridical values, to construct a strong

Europe based on the human dignity of each of its members, on pluralism

and non-discrimination, tolerance and justice, solidarity and equality,

safety and prosperity. Ethical issues must not be feared, they are not

simple wrongs and rights of moral dicta, and because they are not,

education is so fundamental in order to learn at all levels (with specific

inputs in specific areas), that the prime ethical obligation is to carefully and

deliberately weigh the consequences and ethical dimensions of the choices

we make individually and collectively, by action or inaction. As European

citizens are more and more aware about participation challenges and willing

to be involved, Member States must all the more foster ethical discussion,

education and research, but in a creative way, without fearing the classical

boundaries of the disciplines. The European Union must be more

democratic, 'creating Europeans' (Alfred Grosser), enriched by their values.


Mainstreaming ICT, by Peter Dabrock

There is nothing in the modern world that is not profoundly shaped by ICT.

Each form of communication, as long as it does not take place face-to-face,

could not be experienced without the achievements of ICT. ‘Shaped’ in this

case has to be understood as follows: ICT does not only act as a canal that

allows the water that flows through it to remain unaffected by itself. In fact,

ICT will shape and transform communication and will let it become a

different one as it were without this medium. McLuhan’s statement ‘The

medium is the message’ is still lacking complexity in order to get to the

heart of what the challenge of ICT really means. If the medium was only

the message, one could easily identify its influence. The function of the

medium and the content would have solely been laterally interchanged and

could be easily disconnected. In many ICT-communications, ICT seemingly

remains the serving medium, whilst it actually refashions the content in

such a sustainable way that one can in fact no longer speak of a just

mediating character of technology. The fact that technology has always

challenged and transformed the self-conception of humans is not a new

phenomenon but has accompanied human history and could almost be

named as an expression of human nature itself. But with ICT, especially in

its cutting edge variants: Big-Data-driven, equipped with ubiquitous sensor

features, we do not only experience a kind of technology, which subliminally

transforms every aspect of the human nature. The various intransparencies

of the present trends require highest attention. Such an alertness is needed

as the pace of ICT developments, especially in the mentioned cutting edge

variants, is largely promoted and impacted by only a few companies, to an

extent rarely found in economic history. All three features (Big Data,

ubiquitous tracking sensors, mono- and oligopolies) are already challenging

for themselves, but are strengthened by their intertwining.

Big Data not only through the enormous data accumulation, but also

through data pervasion, driven by algorithms. A development that to the

individual affected but also to the actors using the collected data

(authorities, companies) figures prediction as reality, correlation as

causality and stratification as individuality. The algorithms and their results

are often inscrutable – even for the designers themselves – and cause

patterns of recognitions, which are taken at their face value leading to the

affected parties finding themselves with the burden of proof to demonstrate

that the ascribed attributes were inaccurate.

These ambiguities are enhanced by the ubiquity of the sensors intertwined

with Big Data technology. These sensors do not only cover all kind of things

(internet of things) but become more and more intensively deployed in a


body-related way (internet of body). By this feature of cutting edge ICT, the

aforementioned Big Data-effects may be reached in real time.

After all, applications in the field of ICT require such a high investment that

only a handful of companies – mostly located in the United States – are

capable of coping with the financial expenditures. As a result this will

however directly and indirectly lead to mono- and oligopolies. It does not

surprise that – even if the Safe Harbor Agreement will be replaced with a

new contract – problems of commercial law will emerge if European

standards of data protection will have to be effectively complied with.

Considering that health data and personalised data from research projects

belong to the category of particularly sensitive datasets, but are at the

same time de facto increasingly difficult to effectively protect (since

anonymisation becomes more and more difficult under the above-

mentioned conditions) it can be seen which enormous challenges the

development of ICT poses for applying the so called set of European values

(dignity, autonomy, privacy, justice, solidarity, security), but concretely

also for self-determined life-styles of individuals, the designing of a living

democracy under the rule of law, the framing of European economy, but

also for the trust-building in science and technology development. Against

this background, analysing all of this, creating and implementing strategies

of responsible research and innovation is and will become more and more

an extremely important and difficult task.


Converging technologies: challenges to ethics, by Laura Palazzani

The expression 'converging technologies' refers to the combination of four

scientific sectors: nanosciences and nanotechnologies, biotechnologies

applied to living systems in the biomedical field and genetic engineering,

information and communication technologies, cognitive sciences and

neurosciences (generally indicated with the acronym NBIC). The innovation

of converging technologies is not given by the sum of the results in the

different scientific sectors, but from the systems interaction and synergic

integration at the confluence of different methodologies. The deep

innovation and unprecedented transformation is identified with the interface

between the biological and the informational level, both levels at the

intersection of nano, neuro and cogno.

The continuous, rapid, dynamic progress both in scientific knowledge and in

technological applications makes it difficult to provide an updated

description of emerging converging technologies: each attempt to update is

inevitably incomplete, and needs to be constantly revised. It is possible to

identify major trends of this new techno-scientific advancement in the

process of ‘biologisation of information’ and ‘informatisation of biology’.

The first trend 'from biology to technology' identifies with the progressive

technological and informational transformation of the body and its parts:

bioengeeniring of biological living complex systems, genes, cells, tissues,

organs, brain; ‘neuro-engineering’ with nano-neuro-implants; interactions

between neurosciences and artificial intelligence, informatics and robotics;

brain/computer interfaces, wearable sensors and computers, reverse

engineering the brain, artificial life. The second trend from 'technology to

biology' coincides with the interconnection of informatics and cognitive

processes, with the creation of machines similar to living beings, able to

self-repair, think and act intelligently: the so called ‘living technology’,

‘living artefacts’, bio-inspired or socio-inspired artefacts, social robots.

The increasingly exponential acceleration of techno-scientific progress in the

convergence of nano-bio-info-cogno, sets an ethical challenge not just in

number, scope, depth of issues but also in the very form the ethical

reflection takes. Ethics should be dynamic and integrated, in the ongoing

process of techno-science since the beginning of the research project,

during the process, until the application at every stage in a case-by-case

methodology.

Convergence of technologies requires ‘convergent ethics’. Not only in the

sense of finding common minimum values in a pluralistic society, but also in


elaborating a synthetic view dealing jointly with the different levels of

analysis (nano-ethics; biotechnology ethics; ICT ethics; cognitive sciences

ethics). Ethics should also be integrated with social sciences, that deal with

the societal impact of new technologies.

There is a preliminary ethical distinction to be made between the

technologies on human beings (intervention on the body and on the mind),

the technologies involved in the interaction between human bodies/minds

and artefacts, and the technologies producing artefacts with the

robotisation of the body/life and artificialisation of intelligence.

The technologies intervening on the human body/mind give rise to many

emerging ethical challenges: the definition of health and illness, the

distinction between cure/care of the patients and enhancement of capacities

(physical, psychological, emotional, social) of the healthy subjects,

increasing in a quantitative sense and/or bettering-improving in a

qualitative sense performances. Medical and non medical purposes

challenge the ‘traditional’ values, such as respect of human dignity,

integrity and identity. Technologies producing artefacts (interaction

between bio and techno-info-digital, cognitive and behavioural sciences,

robo-ethics) trigger anthropological dilemmas involving the interpretation of

human nature facing the new possibility of hybridization and artificialisation

of man (disembodiment, functionalism).

The ethical distinction between invasive/non invasive technologies, possible

non serious or serious damage, immediate and long-term effects, reversible

or irreversible damage, require a deep reflection on security/efficacy, and

the right to be informed.

Besides concerns about the protection of integrity, security and efficacy of

technologies, there is also the question of access, strictly linked to the

distribution of scarce resources. Emerging technologies are challenging and

require a re-framing in the elaboration and application of the criterion of

distributive justice, as it deals with technologies ‘beyond’ therapy and

healthcare, with blurring boundaries between medical/non medical

applications, with complex, uncertain and likely to reach an unpredictable

benefit/risk balance with regard to individuals and society. There is the

possibility that, leaving the regulation of distribution to the free market,

only wealthy people could afford access to expensive technologies, further

increasing the already existing natural and social inequalities.

The technological divide (nano-divide, biotechnological divide, digital divide,

cognitive divide) outlines a possible scenario of inequalities. The risk is one


of discrimination, stigmatisation and marginalisation of those having no

access to technologies, that live under disadvantaged conditions and

emerging technological vulnerabilities. A delicate problem concerns the

distribution and allocation of resources to the field of enhancement that

may be at the expense of those who need to be cured and cared for. This

right is fundamental for the dignity of the human being (not to be

discriminated in access) and for freedom of choice (access to technologies

is the requirement for choice to use or not to use it).

Having ‘in principle’ access to technologies (technologies being actually

available to everyone, or at least widely available), there should be a right

to know, to be informed/educated or a right to technological literacy. This

means a right to be motivated to a critical awareness in the use of

technologies of the benefits/risks on the individual and social level. In this

sense, equity of access to emerging technologies requires a duty of

adequate information/education and transparent communication and

dissemination of scientific novelties.

The conditions to use emerging technologies in an appropriate way is the

right to be correctly informed on risks/benefits: information is necessary in

order to protect the right to safety (physical, mental, emotional integrity)

and to privacy (and confidentiality). The risk of a gap between

technologically educated and uneducated (according to age, ability,

technological literacy). Specific challenges arise with reference to minors,

the elderly, the disabled and the incompetent.

Having ‘in principle’ access to technologies and critical information on their

use is relevant for recognising the right not to use technologies, to dissent

to the use of technologies, the right to refuse the use of technologies when

personal identity and interpersonal relationship, safety and privacy are at

stake.

The ethical challenge to protect vulnerable individuals comes to the fore

whenever they might access technologies and are adequately informed, but

feel an undue pressure to use them, as a hidden form of exploitation,

reducing freedom of choice and autonomy. The right not to use

technologies with uncertain risks, that may be serious and irreversible; the

right to achieve, with personal effort, results; the right to behave according

to normal standard of performances; the right to resist pressure to accept

enhancing technologies, and to avoid social expectations.

Social pressure to the use of these emerging technologies becomes direct

or indirect coercion that threatens the right to avoid and abstain. An


extrinsic indirect hidden coercion impoverishes the authenticity of the

person and reduces freedom annulling it in homologation to exterior

standard expectations of excellence. There is the risk that the spread of the

use of enhancing technologies may heighten the tendency to compete

rather than to cooperate, to tolerate imperfection, to accept others and

nature as given.

It should also be considered that improvement is always possible and

intrinsic to all human beings: every function, physical, mental, emotional,

can be improved in a more lasting manner through instruction, education

and continuous training, a rich social life and interpersonal relationships,

ranging from studying, learning, continuous stimulation of interests, to

healthy lifestyles (nutrition, physical activity). It is a path that clearly

requires a lot of time, but (perhaps) it is respectful of the opportunities for

growth and development of personal and relational identity as well as of

self-esteem and the feeling of self-fulfilment. A ‘right to achievement’ or

realization of individual potentialities through personal and active effort,

development or flourishing of natural capacities, accepting human limits. It

is a path that clearly requires a lot of time, strong effort and effective

determination, but it is respectful of the opportunities for growth and

development of personal and relational identity. Medicalisation of everyday

life is a quicker and ‘easier’ solution (a ‘technological shortcut’) to

difficulties, but with possible negative consequences both on health and on

psychological status.

The complexity of techno-scientific knowledge necessarily entails an

informed, inclusive and active democratic participation of citizens: this will

be made possible by fostering a public debate during the regulatory

process. This is the emerging perspective coming to the fore to shape an

innovative ʽgovernanceʼ model for technologies under conditions of

uncertainty.

There are new challenges to regulations, that could draw inspiration from

the representation of reality, based on reliable empirical data, and the

imaginary anticipation of possible scenarios that can be envisaged,

weighing pros and cons, as well as evaluating alternative options, at the

scientific, ethical and social levels, while analysing the decision in the

context of a transparent, wise and precautionary approach.

We should be aware of the fact that inasmuch as the seriousness and

irreversibility of the risk/harm likely to be caused to man and humankind is

tainted with uncertainty, personal and social responsibilities should be

clearly defined. Regulations should be focused on adjusting the instruments


needed to protect human health to the specificity of different technologies,

in order to safeguard personal freedom and justice, in a spectrum ranging

from restrictive to permissive regulatory forms.

Regulatory issues arise at National and International levels, harmonizing

rules across different countries. Although the problems are diverse

throughout the variegated social and cultural contexts, all technologically

advanced countries are seeking to devise regulatory frameworks for recent

enhancement technologies.

The transnational and intercultural biojuridical dialogue has been launched

and is progressively developing the perception of the need to formulate an

imperative, effective and global answer, especially in a number of

particularly timely bioethical areas, which put the identity of man, the

human species and life on earth at stake.


Changing European Societies: Ageing, Demographic Change,

Migration and Multiculturalism, by Paula Martinho da Silva and

Emmanuel Agius

Europe’s demographic situation is characterised by low fertility, an

increasing life expectancy, and overall by a projected shrinking of its

populations in the decades to come. Compared to other world regions

Europe faces rapid demographic ageing. Moreover, with the phenomena of

migration from regions such as the Middle East and North Africa, Europe is

facing suddenly one of the most important and drastic changes of its

history:

Europeans are living longer than ever before, they are having fewer

children16;

Europe is becoming increasingly diverse as a result of migration from

other regions of the world, such as Africa as well as the current

intensive migration from the Middle East.

These two trends raise a set of issues that must be analysed deeply and

require a review of European and national policies in order to turn the

challenges into opportunities.

Two immediate consequences of these trends relates to the sustainability of

public finances in the EU Member States including the following:

the social security system (the impact of longevity on public

pensions);

the public health care system.

These two challenges will continue to exert a considerable amount of

pressure on how to maintain a sound balance between future public

expenditure and tax revenues17.

These challenges may be considered even more complex in the context of

the European health care systems keeping in mind the never-ending

emergence of new health technologies. As mentioned in the introduction of

16 By 2060, there will be just 2 workers for every person aged 65 or over - half today's figure. Despite

immigration, the population of about half of EU countries is expected to shrink. Overall EU population will

grow only slightly before peaking in 2050,

http://ec.europa.eu/economy_finance/structural_reforms/ageing/demography/index_en.htm

The EU population is projected to increase in size slightly by 2060, but with a much older age profile than today.

The EU population is projected to increase by 5% from 507 million in 2013 to a peak of 526 million in 2050,

before declining slowly to 523 million in 2060. http://ec.europa.eu/economy_finance/graphs/2015-05-

18_ageing_report_en.htm 17 As mentioned by the Working Group on Ageing Populations and Sustainability,

http://europa.eu/epc/working_groups/ageing_en.htm

http://ec.europa.eu/economy_finance/structural_reforms/ageing/demography/index_en.htm

http://ec.europa.eu/economy_finance/graphs/2015-05-18_ageing_report_en.htm

http://ec.europa.eu/economy_finance/graphs/2015-05-18_ageing_report_en.htm

http://europa.eu/epc/working_groups/ageing_en.htm


EGE Opinion 29 'Recent years have witnessed a wave of innovation in

health technologies driven by new medical breakthroughs, novel scientific

approaches and the rise of digital health technologies. Pioneering methods

of drug development and disease diagnosis, the rise of 'big health data',

and new means of providing networked care have led to predictions that

European health systems are on the cusp of transformation.'

Decisions regarding the access to all citizens to the current and future

innovative health treatments (that may save lives, predict severe diseases

in advance, and guarantee stronger efficacy than traditional medicine),

which are in most cases extremely expensive or having access to

personalised medicine possible, must be faced now and in the future. For

this reason new policies, prioritisation and good practices must be urgently

adopted both at a national and EU levels.

At the same time, while much of the promises envisaged by these

technological innovations remain to be fully realised, the emergence of new

health technologies is accompanied by a profound set of paradigm shifts in

the way individuals – whether as patients, citizens or consumers – engage

with matters of health. 18

With successive waves of migration movements, multiculturalism continued

to consolidate pluralism in Europe. Such multiculturalism is not only

characterised by diversity of European citizens, but also with citizens whose

values differ both in meaning and interpretation from the core values that

have traditionally shaped the European continent. To refer to one example,

a greater effort is now needed for healthcare professionals to respect

patients’ autonomy in a cultural context which manifests a plurality of

meaning and interpretation on the implementation of this ethical principle.

In order to change these challenges into opportunities, Member States are

invited to encourage innovation and technology, to increase investment in

'human capital' and to treat migrants in particular as a major asset. The

success of the EU 2020 Strategy will depend largely on the EU’s ability to

face up to the major demographic transformations of the coming decade

and its capability to use the strong potential of the two fastest growing

population segments: older people and immigrants and to further increase

female employment rates.

18 EGE Opinion 29 on the Ethical Implications of New Health Technologies and Citizen Participation, 2015.


Through implementing family-friendly policies, providing better

opportunities for education and lifelong learning, encouraging active ageing,

combating age discrimination and optimising human well-being, the EU's

citizens will be able to realise their full potential.


Governance of ethical questions in the future - Why and how, by

Linda Nielsen

From bioethics to biolaw – this has been the trend since a number of years.

Former ethical questions have been transformed into regulation of different

kinds. In some areas hard law, comprising bans etc., have been introduced

and implemented, but more and more soft law in a number of forms have

found their way into the ethical domain. Procedures, ethical councils of

different kinds, sunset clauses and other kinds of regulatory tools have

been part of this 'soft law' trend.

There are, however, many problems and challenges attached to the

transformation from bioethics to biolaw and to the EU´s role in this

transformation. Some of these are addressed below:

1. Timely regulation – how can this be ensured?

Biolaw is playing catch-up with science. While technology moves fast,

regulation tends to move slowly – and sometimes too late to have an

impact. It is therefore important that governance bodies are informed on

new technologies and have relevant and flexible tools to deal with the new

challenges. In this respect ethics councils play a crucial role, both at EU

level and in the Member States. To secure timely regulation it is important

to ensure that these ethics councils deal both with ethical challenges as well

as governance tools.

2. Individualisation versus societal interests – how should this be

balanced?

Biolaw reflects a balance between individual and common, societal

interests. The trend seems to be individualisation. It is, of course,

extremely important to protect individuals, but other trends make it

necessary to secure societal values as well. One example is the upcoming

'Me medicine' to supplement 'We medicine' and many others can be found.

The need to protect the next generations, the values and the environment,

makes a balance necessary between individual rights and societal needs.

Biolaw should always reflect a balance, which has taken both aspects into

consideration. And it should always be inclusive in the sense that public

participation and debate is essential – this is not a 'quick fix', but dependant

on how the content of the debate contributes to securing a balanced

governance solution.


3. Global governance – what should the EU´s role be?

The ethical challenges very often call for global solutions – just as global

justice makes it paramount to include global, social responsibility. This

represents a major challenge, as experience has documented the difficulties

in achieving global agreements on ethical questions - based on differences

in cultures, governance traditions etc. It is important that EU and the

Member States acknowledge these challenges, and include global aspects in

their biolaw – considerations and supplement the EU and Member State

regulation with global, social responsibility and bilateral agreements. In this

respect the EU has a special potential to participate in global policy

activities and initiate bilateral efforts.

4. Implementation and control – how can this be expanded?

Governance only works, if it is being followed. The efforts to introduce

biolaw should be followed by efforts to secure implementation and control.

Tools may be monitoring and reporting on these themes, but this area

needs more emphasis and research, as flexible problem-solving and new

forms of governance, implementation and control are needed. In this

context it would probably be fruitful to include anthropologists,

psychologists etc. with the aim of providing new tools, taking culture,

behaviourial research etc. into account.

Bioethics and biolaw need to go hand in hand. As stressed by Henk Ten

Have (in the UNESCO book Global Bioethics: What for?)': 'Bioethics needs

bayonets'. Bioethics thus needs biolaw. But as also stressed by Henk Ten

Have: 'Laws are made of paper, bayonets are made of steel'. 'Talking is

good, but acting is better'. Biolaw thus needs monitoring, implementation

and enforcement. But as bayonets should not be used without legitimacy, I

would supplement by saying: 'Bio-ethics needs bayonets and bio-

governance'.


Ethical implications of altered role and position of physicians in

healthcare and medical research, by Andrzej Górski

The good physician treats the disease, the great physician treats the patient

who has the disease (Sir William Osler).

In recent years there has been a wave of innovation in health technologies

primarily caused by digitalisation of health services, the rise of the

phenomenon of big data and a shift towards economic factors as an

important measure of efficiency in providing healthcare. In particular,

progress and wide introduction of telemedicine have altered patient-

physician interactions while online sources of health information supplement

and sometimes replace medical advice. What is more, we are entering an

era of patient – centeredness, where they are no longer passengers, but

instead are 'co-pilots'; such patient engagement should be the blockbuster

drug of the century19 (in biomedical research, medical product

development, regulatory decision making and health delivery).

In our Opinion 29 we 'set out to explore new trends of participation in

health by patients, citizens and consumers' and have pointed out that 'the

nature of this change is as yet not clear'. In fact, although the

developments resulting from these changes may be beneficial to patients,

there are also risks (the emergence of 'self-patients' and possible

substitution of the physicians). Is the physician already – or perhaps he will

be in the near future – an endangered species? Will his role and position

decline and – if so – is such a phenomenon really beneficial or perhaps

detrimental to the patient? What should be the response of the medical

world to these phenomena – passive or active and, if so, how should

doctors react?

Digitalisation of medicine translates into increased demands for doctors to

become savvy in digital technology. Approx. 30% of doctors use email to

communicate with patients and some 20% of them use text messages, but

many are concerned about privacy and security.20 Doctors' virtual

consultations with patients will double by 2020, but the status of medical

liability and insurance coverage is uncertain. Thus, as recently pointed out,

as the practice of telemedicine continues to grow so do the legal risks

associated with virtual care.21 What is more, data on the true value of many

19 Anderson M., McCleary KK. From passengers to co-pilots: patient roles expand. Science

Trans Med 2015,291, 291fs25. 20 Potarazu S. The changing role of the doctor. Medpage Today 3 April, 2013. 21 Gallegos A. Telemedicine poses novel legal risks for doctors. www.chestphysicians.org,

6 Oct 2015.

http://www.chestphysicians.org/


technologies is still controversial, for example robotic surgery22 and their

introduction poses tough ethical dilemmas such as which of them should be

reimbursed in a time when many highly efficacious and sometimes life-

saving medicines are not reimbursed. Also, the advent of telemedicine

requires alterations of at least some ethical codes of doctors: for example,

the code of Polish doctors stipulates that a physician may undertake

treatment solely after examining a patient while remote examination should

be exceptional (art.9).

There appears to be a consecutive wave of technology challenges that

doctors have been exposed to in the past years. In 1988 it was noted that

the advent of technology results in physician not feeling different from the

plumber or the butcher – mainly because the fees were no longer paid in

guineas. In other words, the former gentleman of the profession has then

become a manual worker.23 Today in some hospital systems non-physicians

provide almost a third of primary-care services and care for patients who

are just as complicated as those seen by physicians – the quality of their

services is suggested to be equivalent.24 Even if this is true – does the

'quality' translate into improving patients’ health and wellbeing?

'The great physicians differ from the good physicians because they

understand the entire story. Only when we understand the complete story

do we make consistent diagnoses. Each patient represents a story (their

diseases, their new problems, their social situation and their beliefs… we

must develop excellent communication skills and gather the history in

appropriate depth… perform targeted physician examination based on the

historical clues… order the correct diagnostic tests and interpret them in the

context of the history and physical exam – then we should construct the

patient story that includes making the correct diagnosis which must

describe the patient context – who is the patient? What are the patient’s

goals? How might the patient’s personal situation impact our treatment

options?'25 Those words have been articulated only eight years ago!

There are clear ethical challenges to medical ethics emerging from those

significant alterations in a doctors' role in healthcare and medical research.

Let’s consider, for example, the dilemma of compliance, or rather non-

compliance. Despite all the best intention and efforts on the part of doctors

the management of diseases may not be achievable if the patients are non-

22 Beck M. Robotic surgery brings higher costs, more complications, study shows. The Wall Street Journal, 7

Oct, 2014. 23 Fraser I. The changing role of the physician. The Ulster Med J 1988,57,200-4. 24 Gounder C. The case for changing how doctors work. The New Yorker, 1 Oct, 2013. 25 Centor RM. To be a great physician, you must understand the whole story. MedGenMed 2007,9,59.


compliant with all the serious and detrimental effects of non-compliance.

This dilemma has been of a great clinical and ethical concern due to the

widespread nature of non-compliance with therapy: it is estimated that the

compliance rate of long-term medication is between 40% and 50% (for

short-term between 70% and 80%, while the compliance with lifestyle

changes is 20%-30%). Patients who had poor compliance eventually drop

out of treatment completely. Non-compliance causes an increased financial

burden for society (excess urgent visits, hospitalisations and higher

treatment costs with up to 70% of related hospital admissions in the USA)

estimated at the level of $100 to $289 billion each year in the USA alone26.

Interestingly, several studies have shown that patients with lower

educational qualifications have better compliance, while misconceptions or

erroneous beliefs held by patients contribute to poor compliance.27

As stated,28 according to the Oxford dictionary, compliance is defined as

'the practice of obeying rules or requests made by people in authority'. If

patients were 'co-pilots' how would this new share of responsibilities

translate into compliance? Will the physicians remain 'people in authority'

and – if we agree that this authority should be shared between the

physicians and patients – who is primarily responsible for patients

treatment, its results and legal consequences of applying therapy that is not

in accord with Evidence Based Medicine (EBM)?

EBM has become central to the practice of medicine and, according to the

British Medical Journal. EBM is 'the conscientious, explicit and judicious use

of current best evidence in making decisions about the care of individual

patients integrating individual clinical expertise with the best available

external clinical evidence from systematic research.'29 This gold standard of

healthcare has recently been the subject of criticism for ignoring patient

values, preferences, and circumstances, in contrast to Shared Decision

Making (SDM) where both clinician and patient jointly participate in health

decisions after discussing the options, the benefits and harms, and

considering the patient values, preferences and circumstances. Therefore,

some experts believe that 'without SDM, EBM can turn into 'evidence

tyranny'.30 However, some surveys indicate that patients may be

misguided by their own sources of information which reflects a key insight:

26 www.forbes.com 27 Jin J, Sklar GE, Oh VM, Li L.SC. Factors affecting therapeutic compliance: a review from the patient’s perspective. Ther Clin Ris Manag 2008,4,269-86. 28 Ibid. 29 Sackett DL, Gray JAM, Haynes RB, Richardson WS. Evidence Based Medicine: what it is and what it isn’t.

Br Med J 1996,312,71. 30 Hoffmann TC, Montori VM, Del Mar CP. The connection between Evidence_based Medicine and Shared

Decision Making. JAMA 2014,312,1295-6.

http://www.forbes.com/


the challenges intrinsic to incorporating patient preferences are the same as

those involved in incorporating experts views into guidelines. Guidelines

must not replace clinicians’ compassionate and mindful engagement of the

patient in making decisions together.31

Therefore, changes in existing curricula of medical schools and

postgraduate teaching programs are necessary to teach medical students

and practicing physicians so as to include SDM skill training and other

educational elements related to the currently ongoing and forthcoming

changes in working style and position of physicians.

31 Montori VM, Brito JP, Mured MH. The optimal practice of Evidence-Based Medicine: incorporating patient

preferences in practice guidelines. JAMA 2013,310,2503-4; Hohman R, Shea M, Kozak M. Regulatory

decision-making meets the real world. Science Trans Med 2015,7,313fs46 (11 Nov 2015).


Genes, technology and ethics, by Ritva Halila

During the last years scientists have developed techniques with which one

can edit genetic code more easily, rapidly and safely than ever before. The

development has been astonishingly rapid: The code of DNA was discovered

in 1953, but rapid development of technologies started in 1970s and has

only accelerated since. In the 1980s, genes and their inborn errors could be

detected already, but methods were slow and expensive. The knowledge

could be used for prenatal diagnostics, but risks for miscarriages were

significant, and the only cure was late abortion. Since then in vitro

fertilization techniques spread to clinical practice during the 1980s, and

genetic errors have been able to be diagnosed before the implantation of an

embryo. This technique has been mainly used to detect single gene

mutations in families with risks of inherited diseases, but it can also be used

for other purposes, such as detecting savior siblings for organ and blood

stem cell transplantations, selecting the sex of future children, or selecting

embryos for other reasons. Rapid developments in human genome analysis

and computer processing capacity has made personal genome analyses

feasible just by sending a sample from mouth to a laboratory, and obtaining

the risk profiles of many common diseases, such as diabetes, heart

diseases and mental disorders, via internet. Many countries have set legal

restrictions to these methods, but globalization also in the health market

seems to make evaluations and judgments problematic: if you are not

allowed to do one thing in your country, why you wouldn´t go abroad to do

it?

And now incorrect genes can even be modified. Some scientists have used

new technologies for editing genomes of human embryos.32 Are we entering

an era of a brave new world?

The same discussion rose some years ago, when scientists used nuclear

transfer techniques to human embryos.33 The first news was shown to be

misinformation, but after years of research, it seems that nuclear transfer

would be possible in human eggs and embryos to produce stable pluripotent

cell lines. The nuclear transfer technique was first introduced to clone

animals such as Dolly, the first cloned sheep. Since then the same

technique has been used to clone some other mammals. All the cloned

animals are the results of hundreds of attempts, and researchers have

reported very high failure rates, genetic errors, later developmental

32 Chinese scientists genetically modify human embryos http://www.nature.com/news/chinese-scientists-

genetically-modify-human-embryos-1.17378 33 Human Embryonic Stem Cells Derived by Somatic Cell Nuclear Transfer

http://www.cell.com/abstract/S0092-8674(13)00571-0

http://www.nature.com/news/chinese-scientists-genetically-modify-human-embryos-1.17378

http://www.nature.com/news/chinese-scientists-genetically-modify-human-embryos-1.17378

http://www.cell.com/abstract/S0092-8674(13)00571-0


problems and problems with the health of the animal. These are too risky

for human experiments. Dolly did not live a long life, and cloning has not

become a popular technique in animal breeding. It has shown to be a very

expensive, difficult and error-sensitive method, and speculation about

cloning humans have quietly disappeared.

Still research on producing personalized pluripotent stem cells using

somatic cell nuclear transfer with embryos, and possibly in the future using

induced pluripotent stem cells (IPSC) is going on. This technique has

potentials to cure diseases without rejection problems. Up to now the

technique has shown to be difficult, slow and very expensive, and so it

probably does not become a general medicament for humankind.

All these have been achievable because of the rapid technological

development of medicine. In vitro fertilization techniques have produced so

called surplus embryos that are not needed for fertility treatments. These

have been a center of vigorous discussion. Many people, researchers as well

as gamete donors think that they could be used for research instead of just

pouring them down the sink.

The new gene editing technique was first used in plants but soon the

technique spread into other species, animals, and humans. Their use is far

from safe although it is much safer, easier and also less expensive than

previous techniques. Some researchers have also studied this technique in

human eggs and embryos. Still there are pitfalls, low efficiency rates,

possibilities of errors as well as possibilities to correct inborn mistakes in

our genes.

Although problems in mistakes, errors, inefficiencies and high prices can be

solved, still there is a question of ethical and moral limits. If genetic

engineering would be an easy and possible method, what would be

indications to use them for changes that may affect the generations after

us? Do the changes that we consider important help us to eradicate or even

alleviate suffering of our species in a way that cannot be done with other

methods with which our descendants can keep their integrity untouched.

What would be their values, what do they think are worthwhile, and what

would be their solutions to the problems of their society? And how would

they judge our decision?


The role of scientists in ethical advice related to science and new

technologies, by Pere Puigdomenech

New scientific knowledge, as well as new technologies, often generates

discussions about the way society will apply or accept them. In some cases

new developments may be seen as a threat to established ideas, habits or

economic interests. In addition, new risks may appear or may be perceived

and they have to be balanced with the benefits that new technologies

provide. Public institutions may consider new regulatory approaches and

therefore they may seek advice before taking decisions or initiating

legislative action. In this context it may seem obvious that an essential

component of the advice would be to get information on the scientific

knowledge related to the specific question examined but this is not always

the case. Here it will be argued that to have the best possible scientific

information is always necessary.

To have the best possible scientific information may not be easy. This may

be the case for different reasons: it may happen that to have conclusive

scientific results on a particular question is difficult and diverging opinions

exist. At any moment in the history of science a number of paradigms are

accepted by the scientific community and they have to be communicated to

society, however by its own nature, scientific activity is based on systematic

doubt and any scientist has to be prepared to revise his own ideas if new

observations or better interpretations are provided. If questions that are

essentially new are to be analysed, uncertainties appear, contrasting

opinions may be presented and the advice requested may seem imperfect.

There are solutions to these dilemmas.

One solution is to establish systems of consultation that undergo an

exhaustive analysis of the data that are available on the question by

scientists having different perspectives. Maybe the best example at this

moment is the work of the International Panel on Climate Change. It

involves hundreds of scientists from all over the world that examine the

validity and the conclusions of all data and all publications available on the

changes that are being observed in the atmosphere and their causes as well

as prediction of future scenarios. They produce opinions in which they try to

transmit the degree of certainty that the conclusions have. Another solution

is to ask for new data if those available seem incomplete. This is what is

normally done when the approval of a specific product, for instance in

medicine, requires a scientific opinion that needs scientific data of sufficient

quality.


It may also happen that scientific opinions reach conclusions that are not

comfortable for those in power or that scientific knowledge is not

considered necessary to take a specific political decision because there are

other factors that are seen as more important. If we consider the same

example of climate change, there are countries where the conclusions of

the scientific analysis on this question are considered by a number of

political or social groups as irrelevant or as the fabrication of groups of

interested scientists. Another example of this type of case is the use of

genetically modified organisms. The question is the object of analysis by

dedicated scientific committees that are asked to evaluate the risks related

to these organisms. It has also been the object of hundreds of publications

in international journals and the subject of research of a number of

European research projects. Although experience has shown that for the

moment the use of these organisms, essentially plants in agriculture, has

resulted in no problem to human or animal health or to the environment,

this conclusion has been disputed by a number of social and political groups

and the question is still the object of complex and difficult decisions at

European level.

One of the problems that may exist in scientific advice is the existence of

conflicts of interest that some of those consulted may have and that is

considered a case of misconduct for scientists acting to evaluate or to give

advice in different situations. The solution to this question is usually

transparency about any interests that may exist. The most normal cases

are economic or institutional interests that are to be declared in many

instances. However, it may be argued that political or even ideological

interests could be considered not only for scientists but also for other

agents that may influence opinions or decisions about new applications of

technological developments.

Ethics Committees are often asked to produce opinions on the ethical

concerns raised by some scientific or technological development. When such

a concern arises, those responsible to propose the social or regulatory

framework for the new development may either ask advice to a specific

group of experts or they may consult an established consultative

committee. In the first case members may include scientists with direct

knowledge of the question. In the second case, as is the case for the EGE,

no specialists on each one of the questions debated are present. In such a

case an exhaustive analysis of the situation may not be necessary but it is

essential to try to base the conclusions on state-of-the-art science. The

tradition of the EGE, for example, has been to request information either to

the European Commission services or to external experts, and generally to

both. In this way the Group may acquire sufficient information to develop


its own debate and to provide the advice required. In this setting the

presence of scientists in the debate is essential. To interpret the results, to

put forward the reasons why some conclusions are drawn, to examine what

is the probability that certain results may find an application or to have a

critical appraisal of the latest results, expertise on scientific practices is

needed. In this context to include a significant proportion of scientists in

groups such as the EGE is crucial.

In general terms, it may seem obvious a priori that those having the

responsibility to take decisions on new technological developments may

seek the best possible scientific information on a given question. This is not

always the case, because scientific opinions may appear to be in conflict

with political views or with the opinions of some vocal social groups, and

indeed, there are cases when politics must not strictly follow the opinion of

scientists. Other social values, including ethical considerations, may prevail

in the political debate. Nevertheless, experience shows that, unless clear

reasons exist, it is in general an indicator of quality when political decisions

are based on a thorough scientific analysis or when well-founded ethical

advice is followed or at least considered.


European citizenship, human rights and ethics in the European

Union, by Herman Nys and Siobhan O’ Sullivan

In 1993 the Treaty of Maastricht which introduced the citizenship of the

European Union entered into force. Citizenship traditionally has been based

on political rights in public life. The idea of European citizenship has a much

broader sense and includes a more direct and active participation of the

citizen into debate and public life.34 Citizenship is a status that empowers its

holder. It guarantees protections and rights, and promises equal treatment

within society. Union citizenship as a form of transnational or inter-state

citizenship offers its holder rights of residence and a degree of equal

treatment in other EU Member States, allowing them to access and become

part of the host society. This conception of European citizenship has to a

large extent been achieved and represents a significant accomplishment for

the European Union. Envisaging EU citizenship, as sharing a common

identity, a common responsibility, built on a foundation of common shared

values is a more contested notion.35 In 1995, the Charter of European

identity was established and is based on 'unity in diversity and common

values for all citizens'36. The issue of whether a consensus exists around

common values amongst European citizens and if this plays an integral role

in the rationale for a political association is still an open question. In this

regard it is interesting to note the findings of the 2012 Eurobarometer

survey37, which found that a slim majority of Europeans (49% versus 42%

who disagreed) feel that Member States are closely related in terms of

shared values. Those values identified as common amongst EU Member

States included peace, democracy, human rights, rule of law, respect for

other cultures and solidarity.

The EU has developed from an economic vehicle promoting the idea of the

'market citizen' to a political Union also safeguarding fundamental rights.

Prior to the adoption of the Charter of Fundamental Human Rights in 2000

and its entering into legal force in 2009, protection of human rights within

the EU had developed in a rather incremental fashion, largely through the

case law of the European Court of Justice. The Charter was innovative in

that it enshrined social rights alongside economic and political rights. The

34 Citizens' rights and new technologies: a European challenge, Report of the European Group on Ethics in

Science and New Technologies on the Charter on Fundamental Rights related to technological innovation as

requested by President Prodi on February 3, 2000, Brussels, May 23, 2000 (EGE website), 27. 35 Víctor Pérez-Díaz The Public Sphere and a European Civil Society (1998), p235; Jeffrey Alexander (ed.)

Real Civil Societies (London: Sage, 1998) 36 Charter of European Identity, ’Towards a European Identity’:

http://www.eurit.it/eurplace/diba/citta/cartaci.htm, accessed 1st December 2015. 37 Standard Eurobarometer 77 Values of Europeans – Spring 2012

http://ec.europa.eu/public_opinion/archives/eb/eb77/eb77_value_en.pdf, accessed 1st December 2015

http://ec.europa.eu/public_opinion/archives/eb/eb77/eb77_value_en.pdf


Charter now operates as the primary source of human rights within the EU

and is regularly referenced by the European Court of Justice. The Court’s

case law on non-discrimination and free movement holds that a person’s

status (whether her name, nationality, race, sex, marital status or sexual

orientation) is so intimately related to her capacity and self-determination

that it cannot be stripped or altered upon movement to another Member

State. For example, Member States that do not (yet) recognize same sex

marriages have to recognize the marital status of a gay couple that married

in Belgium, regardless of their nationality and must attribute the same

rights to that status as it does for traditional marriage.38

It seems that there is no area of national law anymore that is protected

from the pressures exerted by EU law. The EU has gone beyond the

confines of a Common Market, encompassing a much greater range of

activities, most recently in the areas of security and justice. This growth in

EU competence has seen an extension in the jurisdiction of the European

Court of Justice to criminal matters and immigration. Indeed it could be

argued that EU law serves to overcome limits on permissible behaviour

imposed by Member States on their own citizens. According to De Witte, the

free movement provisions in this sense operate as a 'type of trampoline

that allows citizens to escape the normative limitations imposed by their

own Member States and more fully pursue their individual aspirations'.39

What does this mean for the relation between EU law and ethics? The Court

usually argues that the free movement provisions themselves are 'blind to

moral or ethical judgments'. In fact a consistent criticism of the Court has

been its penchant to equate fundamental market freedoms with

fundamental rights40. To some extent this is understandable as economic

integration and not fundamental rights were the foundation stone of the

EEC. Whether this is a sustainable position is highly questionable. This

'ethics-blindness' or 'neutrality' of the EU came to the surface in a recent

publication of Frischhut.41 He came to the conclusion that none of the three

main EU institutions (Commission, Parliament and Council) themselves have

explicitly incorporated ethics and morality into their Rules of Procedure and

that the same is true for the Court of Justice.42 He also demonstrated that

38 This has not yet been decided by the Court but follows implicitly from its case law, see F. De Witte, ’Sex,

Drugs & EU law: the recognition of moral and ethical diversity in EU law’, Common Market Law Review,

2013, 1576, note 142. 39 Idem, 1556. 40 Douglas-Scott S. The European Union and Human Rights after the Treaty of Lisbon. Human Rights Review

2001:11(4):645-682. 41 M. Frischhut, 'EU: short for 'Ethical Union'? The role of ethics in European Union Law', Zeitschrift für

ausländisches öffentliches Recht und Völkerrecht, 2015/3, 531-577. 42 Idem, 539.


ethics is often used to serve as a national protection shield of non-

interference by EU law. One noteworthy example of such a protection shield

can be found in Horizon 2020 that attributes ethics to the national level as

participants have to 'comply with national legislation, regulations and

ethical rules in the countries where the action will be carried out'.43

One can refer to other recent examples of what De Witte calls 'the politics

of diversity and the argument from self-determination' (by the Member

States in this context).44 One of them is patient mobility, regulated by

Directive 2011/24 on patient rights and cross-border care. Health care is a

broad concept and some Member States feared the application of the

Directive to sensitive issues such as euthanasia, DNA-testing of IVF. At a

very early stage of the legislative procedure, the European Parliament

proposed amendments making clear that 'no provisions of this Directive

should be interpreted as to undermine the fundamental ethical choices of

Member States' (emphasis added).45

The question remains as to whether this principle of non-interference has to

be interpreted in a narrow sense, as it required 'fundamental' ethical

choices.46 Another recent example can be found in the Regulation on clinical

trials.47 Article 31, § 1, g (ii) allows under very strict conditions a clinical

trial on an incapacitated person that has no direct benefit to her but some

benefit for the population represented by the incapacitated subject

concerned when the clinical trial relates directly to the life-threatening or

debilitating medical condition from which the subject suffers and such a trial

will pose only minimal risk to, and will impose minimal burden on, the

incapacitated subject concerned in comparison with the standard treatment

of the incapacitated subject's condition. According to article 31, § 2 of the

Regulation however more stringent national rules prohibiting the conduct of

those clinical trials on incapacitated subjects, where there are no scientific

grounds to expect that participation in the clinical trial will produce a direct

benefit to the subject outweighing the risks and burdens involved remain

valid. It is very exceptional that an EU Regulation that, unlike an EU

Directive, becomes immediately enforceable as law in all Member States

simultaneously contains such a provision offering protection against

interference by EU law.

43 Idem, 547. 44 F. De Witte, 1546 45 See Recital 7 of Directive 2011/24. 46 M. Frischhut, 548. 47 Regulation (EU) No 536/2014 of The European Parliament and of The Council of 16 April 2014 on clinical

trials on medicinal products for human use, and repealing Directive 2001/20/EC. This Regulation will

become applicable on 1 January 2018.


This is not a plea to 'Europeanise' the ethical choices and to replace the

assessment of such choices by national citizens through an assessment by

European citizens. But the ambiguity that results from the 'ethics-blindness'

of the Court in free movement judgments on the one hand and the

protective shield against interference by EU law threatens to reduce ethics

to a mere substitute for the subsidiarity principle. A greater emphasis on

ethics is essential to Europe.48Perhaps the time has come to reflect on an

inclusive European citizenship, founded on multiple identities where

differences in language, ethnicity and culture are embraced, while at the

same time forging a consensus which goes beyond economic integration

and recognizes fundamental rights as goods in and of themselves. European

citizenship can be anchored in common values but the challenge we face in

these difficult times is to guard against constructing a European identity

where fundamental rights are eroded through a discourse dominated by

economic and security concerns.

48 Citizens rights and new technologies: a European challenge, Report of the European Group on Ethics in

Science and New Technologies on the Charter on Fundamental Rights related to technological innovation,

Brussels, May 23, 2000 (EGE website), 3


Intergenerational Governance of Science and Technology: An

‘Ombudsperson’ for Future Generations, by Prof. Emmanuel Agius

It is a known fact that science and technology have had a greater impact on

humankind and the environment in general than any other single factor in

the history of the world. Indeed, science and the integration of technology

into society have significantly influenced our way of life. Technology has

had both positive and negative effects on humankind thus far and with the

emergence of new scientific and technological innovations, it is evident that

they would have an even more pronounced effect on future generations. We

all know that science and technology can make the world a more

comfortable and convenient place to live, or a place where human beings

suffer because of the accumulation of their adverse impact on people’s

lives. It is reasonable to assume that as science and technology continue to

accelerate, we can expect dramatic changes in the years and decades

ahead.

While science and technology can make the world an easier, more

comfortable place to live in generations yet to be born, decisions on

scientific and technological research which lack foresight by the current

generation can bequeath immense risks and burdens to posterity. For this

reason, the good governance of science and emerging technologies requires

to take seriously into account not only ‘space’ but also ‘time’ when impact

assessments are carried out. Science and technology can have immense

benefits or devastating effects not only on those living now, but also

generations yet to be born. The ethical and regulatory challenges of today’s

emerging technologies need to move beyond the myopic vision of global

concern to safeguard the interests of the intergenerational community of

humankind which includes the far-distant unborn generations. Good global

and intergenerational governance is needed to reshape societal

relationships.

Transparency and participation are the hallmarks of good governance.

These ethical principles demand that future generations should not be

excluded from participation in today’s scientific and technological decisions

which might have far-reaching impacts on the quality of their lives.

Ultimately, how the present generation approaches the regulation of

emerging technologies will inevitably have wide implications - not only for

those living now, but also for not yet born generations whose dignity,

inclusiveness and equality cannot be discounted simply because of their

temporal distance.


The EGE has already recommended in Opinion 27 on the Ethical Framework

for Assessing Research, Production and Use of Energy that the 'European

Union and its institutions should set up an ‘ombudsperson’ structure to

protect the interests of future generations; the function of this office would

not be to decide, but to promote enlightened decisions by bringing into

discussions the long-term effects of all political, socioeconomic and

technological decisions.'

Now time is ripe enough for intergeneration equity to be reflected in EU

legislative and policymaking process in science and technology. The

interests of future generations cannot be ignored in the current decision-

making process. For this reason the EU needs to set up the necessary

structures to safeguard the interest of generations yet to be born. Both

spatial and temporal dimensions of the consequences of human decisions

play a crucial role in the ethics of emerging technologies. The current

generation has the moral obligation to give up some of its interests in the

application of science and technology for the benefit of posterity whose

interests are presented by an ‘ombudsperson’. The role of the

‘ombudsperson’ is not to decide on behalf of those not yet born but to plead

to European fora to take more seriously into account the precautionary

principle in order to leave as many options as possible for the future. That

would be a great achievement for generations yet to be born!


Challenges facing institutional consideration of matters relating to

ethics in the EU, by Prof. Günter Virt

Ethics became an independent philosophical discipline as a result of the

works of Aristotle at a time when the society in which he lived was in crisis.

The moral crisis at the root of the social crisis called for systematic thinking

on morality, or ‘ethics’. Throughout history the urgent need for ethical

reflection has always become more profound in times of crisis.

The following developments and changes have taken place since I was

appointed to the EGE in 2001:

The EGE's areas of interest have broadened from its initial

consideration of biotechnology to other technological developments

which present society with difficult decisions and major organisational

problems: to ICT, energy supply, safety technologies and new, health-

related technologies as a whole.

It has become established practice for a rapporteur to be appointed

from each of the areas of empirical science, jurisprudence and ethics.

The experts appointed were not always those proposed by us.

In order to extend the impact of our recommendations, many of which

have been of a very general nature, it would be beneficial to republish

them and to assess the extent to which account has in the past been

taken of those recommendations of relevance to current discussions

(e.g. meat from cloned animals for human consumption) or of

particular urgency (e.g. the appointment of an ombudsman

representing the interests of future generations). The challenge of

achieving consensus has prevented many targeted recommendations

from being proposed. Those recommendations should not, however, go

unreported.

The EGE has in many cases been quick to address the big issues for the

future. It has a proven track record in the field of prospective ethics, due in

part to the thematic agenda it has set itself. Robot technology and

technical developments in ‘artificial intelligence’ will present particularly

important technological challenges to the EU. Recent studies (C.B. Frey and

M. Osborne, The Future of Employment) suggest that over 50 % of people

currently employed, including professionals, will be replaced by the new

technologies in the foreseeable future. Major changes in the labour market

will greatly exacerbate the problems of unemployment that we are already

facing. Future economies will be characterised by high levels of

innovativeness and productivity as a result of the autonomous provision of

technical services, without the need for any human intervention. It is

therefore essential that suitable strategies are adopted for the workplace to

be successfully transformed. New approaches will have to be taken in order


to usefully employ people of working age outside of conventional gainful

employment. It is also high time to prepare the next generations for the

challenges ahead and to set our educational targets accordingly. All training

will have to focus on teaching people how to be creative and on enabling

them to find their own niches of meaningful employment and, above all, to

work in the public interest. Training for its own sake will no longer be

sufficient. Training courses should as soon as possible add the element of

time spent working for the common good to the conventional division of

working time and leisure time. This would also have a beneficial effect in

terms of the extra years which many elderly people are going to live.


3.2. The 10 Priorities of President Juncker

Ahead of his appointment as the next President of the European

Commission, Jean-Claude Juncker set out the political agenda for his five-

year term (2014-19) at the head of the institution. He presented a set of

‘political guidelines’ focusing on ten policy areas in which he said that the

European Union could make a difference, and underlined the importance of

achieving concrete results in each area. President Juncker referred to these

political guidelines as being ‘somewhat akin to a political contract… to mark

the beginning of a new mandate and to prioritise the work of the new

Commission’.

The following presents an overview of these ten priorities, examining each

issue area from an ethical perspective and pinpointing those dimensions

that may be a source of ethical questions or challenges in the years to

come.


Priority 1 – New boost for jobs, growth and investment

In the wake of economic recession, top priority has been given by President

Juncker to strengthening the EU's competitiveness and to stimulating

investment for the purpose of job creation. This includes the flagship

initiative of a European Fund for Strategic Investments (EFSI), which uses

public money to guarantee and stimulate private investment.

The use of EU public funding to steer investment provokes a deeper set of

questions over the prioritisation of projects selected and the objectives

driving allocations of public money. The Commission has underscored the

importance of 'sustainable growth' under EFSI, prioritising investment in

education, research, renewable energy and healthcare and towards projects

that can help get the younger generation back to work. In doing so, it

recognises that competitiveness and growth are not ends alone, but should

'bring benefit to the wider society' and intersect with broader questions

concerning the resilience of our economies, societies and infrastructure

which require in-depth reflection beyond the immediate needs of short-

medium term policymaking.

Another key dimension of the Commission's efforts to boost growth and

investment is to streamline the regulatory climate for businesses, by

reducing overly prescriptive, detailed and burdensome regulations. In

cutting red tape, a careful balance must be struck between reducing cost

and inefficiency on the one hand, while imposing safeguards and standards

necessary to achieve public interest objectives. Ethical debates over where

to draw this line have already arisen in relation to laws covering

environmental standards and maternity leave. The EGE can offer valuable

guidance as the Commission grapples with the value judgements embedded

in deregulation processes.


Priority 2 – A Connected Digital Single Market

The priority to establish a connected digital single market touches on many

issue areas already explored by the EGE in previous Opinions including the

importance of common EU data protection rules, regulatory changes

brought by the growing use of digital technologies, and the drive to boost

digital skills and learning across society, among others. In its Opinion on

the ethical implications of Information and Communication Technologies in

particular, the EGE lays much of the groundwork for defining an ethical

framework for a European connected digital single market.

However, in the rapidly evolving environment of digital technologies, new

issue areas are coming to the fore, requiring renewed ethical reflection:

how should the EU deal for instance with new technological phenomena

such as block chain which promise to revolutionalise transactions in a digital

economy with important consequences for trust and security?

The Commission 'wants everyone to have better access to digital goods and

services, to reliable high-speed infrastructure and to get the most out of the

digital economy'. Establishing a connected digital single market asks us to

consider what kind of digital environment we wish to foster in Europe.

Should open internet and net neutrality form our guiding approach as a

means to ensure the full resources of the internet are easily accessible to all

individuals and companies? Should internet services be considered a public

good and treated in a similar way as other public utilities? Such questions

take us beyond regulatory detail to touch upon fundamental issues of

transparency, justice, equality and the building of an inclusive society.


Priority 3 – A Resilient Energy Union with a Forward-Looking Climate

Change Policy

Following the geopolitical events that reminded the European Union of its

high dependence on fuel and gas imports, the European Commission has

launched plans for a new resilient European Energy Union. EU's energy

policy aims both to be more 'secure, sustainable and reliable', and to fight

against global warming in an effort to preserve the climate for future

generations.

The United Nations Climate Change Conference in Paris 2015 illustrated that

it is possible to link today's policies and climate-neutrality to achieve a

global impact. While these negotiations represent a crucial step, concerted

actions will be needed to reach the objectives that Europe has set itself for

2020, 2030 and 2050 as regards the fight against climate change, security

of energy supply and competitiveness of European companies. This priority

speaks to fundamental questions about how we interact with our

environment, how to fairly and effectively address the world's increasing

energy demands and how to support the wellbeing of future generations.

The EGE's Opinion 27 on an ethical framework for assessing research,

production and use of energy (2013) addresses these questions and its

integrated ethics approach to achieving access, security of supply, safety,

and sustainability in the light of social, environmental and economic

concerns can continue to be a touchstone for the Commission's energy

policy. An ethically sound policy design is a challenge for the formulation of

such an important policy sector that not only affects 10% of the entire GDP

of the European Union, but that also entails global geopolitical and

macroeconomic considerations.


Priority 4 – A deeper and Fairer Internal Market with a Strengthened

Industrial Base

In an increasing globalised world, building on the strength of the European

Union's internal market while fully exploiting its potential has been a key

priority for Commission President Jean-Claude Juncker. To this end, the

fields of taxation, finance, goods and services are touched upon, seeking to

create the launch pad for companies and industry to thrive in the global

economy. This priority seeks to establish stricter controls on banks through

new supervisory and resolution rules; create a capital markets union to

make the European Union a more attractive place to invest; combat tax

evasion and tax fraud for a 'fairer' internal market; and promote labour

mobility for greater economic opportunity.

The reinforcement of rules against money laundering, ensuring that all

companies active in the European Union pay their share of taxes, or the

recognised necessity to intensify the fight against tax fraud and evasion,

acknowledges the need for greater solidarity and fairness in our internal

market. Is the European Union on the road towards a greater Union of

justice where business ethics is at the forefront? In doing so, not only would

the creation of growth and jobs be boosted, but it would also enhance 'fair,

growth-friendly and transparent taxation', intersecting with broader ethical

questions related to solidarity, justice and fairness.

Another crucial dimension of the Commission's efforts relates to its support

for labour mobility, seeking to facilitate cross-border activities while

enhancing European integration. Ethical debates on the possible abuse of

workers have been raised, particularly in relation to social dumping,

employment conditions, mismatching of skills, or the coordination of social

security systems. The EGE can provide valuable guidance on the above-

mentioned embedded tensions in an attempt to defend one of the key

pillars of EU's internal market.


Priority 5 – A Deeper and Fairer Economic and Monetary Union

To tackle the global economic crisis, the EU and its Member States took

bold and unprecedented measures that were not always easy, especially for

citizens, and that sometimes did not take their social consequences

sufficiently into account. The future prospect is to draw on the lessons

learned for an improved economic governance and pursue the completion of

the Economic and Monetary Union (EMU) based on the ‘Five Presidents’

Report’ under the lead of President Juncker.

The European Union is confronted with a crisis of solidarity which is a crisis

of the European project itself, epitomized most poignantly by the Greek

trials and tribulations and by the refugee crisis.

As President Juncker reflected in his State of the Union address on 9

September 2015, with regard to the state of the European Union in general

and, in particular, to the refugee crisis and the situation in Greece, 'There is

not enough Europe in this Union. And there is not enough Union in this

Union.'

This key Commission priority recognises that 'The Eu's social dimension' can

never be put to one side. It calls upon 'social fairness' and also sets out a

clear and concrete vision: 'The social effects of structural reforms need to

be discussed in public, and the fight against poverty must be a priority.'

Not only is it particularly rich with explicit and purposeful ethical, societal

and fundamental rights orientations for action, it also throws open a wide

array of ethical issues. Among those questions are the following issues: the

evolving role and vocation of the welfare state; the measuring of poverty

and of inequality; the sustainability of public finances.

At the heart of those future-oriented questions are matters of justice,

dignity and solidarity; dimensions which continue to shape the European

project itself as well as its place in the world.


Priority 6 – A reasonable and balanced free trade agreement with the US

In trade policy, the Commission committed to negotiate a new, overarching

trade agreement with the United States known as the Transatlantic Trade

and Investment Partnership (TTIP). Since then, the world has seen

significant political shifts and a rise in protectionist sentiment that has

placed EU-US negotiations on hold. These developments have shone

renewed light on the challenge of ensuring that global trade is both free and

fair.

TTIP, and subsequently CETA, the EU-Canada trade agreement, has

generated a significant level of debate among the public and civil society,

concerned that the agreement may erode Europe's high regulatory

standards in health, safety and the environment and make privatisation of

public services more difficult to reverse. In setting out this priority,

President Juncker commits the Commission to safeguard Euroepan norms

and standards: 'I will not sacrifice Europe's safety, health, social and data

protection standards or our cultural diversity on the altar of free trade.'

As the EU advances its trade strategy, including a negotiating agenda with

partners such as Japan, Mexico and South Africa, it will need to take into

account divergences between its regulatory regime and those of third

countries which often reflect very different values and approaches to key

ethical dilemmas in the field of science and technology. Contentious issue,

including those addressed by the EGE in the past such as GMOs, cloning for

food production, and data protection, can re-surface in new guises during

the course of trade negotiations in the years to come.

Wider ethical questions are also likely to gain prominence under this priority

area. Recent debate has raised questions of trust and the importance of

information and transparency when negotiating international agreements.

Also important is the need to work with developing countries within the

world trading system in a way that re-balances global disparities in wealth,

as well as making values such as sustainability, fairness and wellbeing part

and parcel of trade agreements.


Priority 7 – An Area of Justice and Fundamental Rights Based on Mutual

Trust

The Commission re-states its objective to pursue a common area of justice

and protection in full respect of fundamental rights and the rule of law. This

commitment 'to uphold… our shared values, the rule of law and

fundamental rights', is taking on a new significance during the course of

this Commission's mandate.

With a series of terrorist attacks striking at the heart of the constitutive

principles of European societies, the Commission has launched a new EU

Agenda on Security, mobilising the EU and its Member States on a range of

counter-terror measures. Behind this agenda is a set of far reaching and

profound questions: how to combat terrorism while preventing the

stigmatization of certain communities? What flaws of social inclusion are

exposed by the attraction of radical Islam to young Europeans? How to

secure European societies without trading the very values we seek to

protect?

In affirming that 'the Commission will not lose sight of those values' in its

efforts to fight terrorism and other forms of organised crime, it

acknowledges the extremely thorny ethical dimensions of this priority area.

The EGE's Opinion on Security and Surveillance Technologies will continue

to resonate as the above questions play out in key Commission policy files

under the Justice and Fundamental Rights portfolio: putting the Security

Agenda into action, e.g. by reinforcing data sharing systems; strengthening

EU anti-discrimination legislation; and upholding the rights of EU citizens in

the transferral of personal data between the EU and the US, via the

conclusion of the EU-US data protection umbrella agreement.

In parallel, new challenges are emerging which are shaping the context of

Commission policymaking in the justice domain. The rise of populism in the

EU, increase in hate speech and anti-semitism, and tendencies towards

autocratic governance among certain Member States, are serving to

underscore the importance of strong ethical guidance, and a value-based

leadership if the European Union is to remain a standard bearer in

advancing individual freedoms in the years to come.


Priority 8 – Towards a new policy on migration

The arrival of hundreds of thousands of people seeking refuge in Europe is

shining a spotlight on the structural limitations of the EU's migration policy.

It also exposes significant gaps in European solidarity. Advancing a new

policy on migration has consequently become one of the most pressing

political priorities of this Commission and is taking shape in new measures

to complete a common asylum policy, develop a renewed policy on legal

migration, and strengthen border controls.

In his political guidelines of 15 July 2014, President Juncker emphasises the

deep ethical dimension that underpins the Commission's policy action on

migration: 'This is first of all a humanitarian imperative. I am convinced

that we must work closely together in a spirit of solidarity.'

What form this solidarity should take will remain an enduring question in an

era where geopolitical instabilities have led to a paradigm shift in the scale

of global displacement. Discussions of 'burden sharing' between Member

States are only one dimension of this debate: how to establish a genuine

solidarity with third countries, one that places humanitarian objectives and

development goals above short term migration management needs? How to

lay the ground for a stronger solidarity with the very people seeking safety,

stability, and a new home in Europe? And what potential tensions might

arise between new technological means of controlling borders and an

ethical, rights-based European migration policy? The increasing use of

science and technology in pursuit of managing migration cannot take place

without consideration of its potentially profound impacts upon human

dignity.


Priority 9 – A Stronger Global Actor

Effective and united EU external action in the face of global challenges has

become all the more paramount in the wake of recent geopolitical

instabilities and following renewed questioning of the multilateral system

and global governance institutions.

This priority encompasses a spectrum of ethically sensitive policy areas

from crisis management and peace building in the Middle East, to work

towards the global sustainable development goals. It covers humanitarian

aid and protection for those fleeing conflict in Syria, to a deeper embedding

of European security and defence cooperation.

It integrates the strong recognition that while the Union needs to step up its

efforts when pooling together its external action 'toolbox', it is equally

important to remain unified in the common understanding and defence of

its European ideals. Fostering diplomatic relations and advancing

international cooperation on policy objectives such as migration, climate

change, and trade need to be pursued without compromising the EU's

position as a normative power, a standard bearer for European values, such

as democracy, human rights, equality and solidarity. When striking strategic

partnerships, finding the right balance between sometimes competing

objectives (e.g. development and migration management goals) can open

complex ethical dilemmas.

Similarly, in an era where science and technology are playing an

increasingly important role in defence policy and the defence industry,

previous and future work of the EGE may provide a useful reference point

for the Commission in tackling questions such as cyber-security, the

military use of drones and the research and funding of automation and AI in

warfare.


Priority 10 – A Union of Democratic change

The European Union is a project of peace, of solidarity and of justice. The

European community is a community of values and these principles are

inscribed in our laws and our Treaties. Yet, we can never take our common

values for granted and, in today’s world, we need to be increasingly vigilant

to protect those ideals and principles we hold dear.

In what Europe –indeed in what world– do we want to live together? How to

shape this vision together and to make good on the promise it holds?

The Better Regulation Package and Agenda will improve the quality of new

laws and opens the door to greater public consultation. Indeed the place of

the citizens in the European edifice is the crux of the matter. This pertains

to transparency (of the policy process, including with regard to contacts

with stakeholders and lobbyists), to representation (with the important role

of the European Parliament and of the national Parliaments), to the values

of solidarity, dignity and justice at the heart of the European project, and

indeed to forms of involvement of all citizens in the polis, in the common

political life. The matter is not restrained to political institutions. Questions

of legitimacy face the making of sciences and technologies as well as the

making of policies. The European project itself is faced with this challenge.

Some of the answers reside in a reinforced interinstitutional dialogue,

including a new partnership with the European Parliament and with the

national Parliaments. Others lie in a reinforced dialogue with the people of

Europe, bridging the gap between the European project and the European

citizens. Indeed another set of answers stems from a reinvigoration of our

attention to democracy.

As indicated in the Political Guidelines, socio-technological changes are

intrinsically linked to democratic advances and predicaments. Undeniably,

biotechnologies as well as the safety of the food we eat and of the

environment in which we live are important examples of these matters of

concern which call upon more than technical answers as they raise deep

societal, ethical questions.

___


The EGE Office

European Commission

Email: [email protected]

Jim DRATWA

European Commission

Head of the EGE Office

Secretary-General of the IDB

E-mail: [email protected]

Joanna PARKIN

European Commission

Policy Officer

EGE Office

E-mail: [email protected]

Laura CUESTA

European Commission

Policy Assistant

EGE Office


Kim HOANG LE

European Commission

Administrative Assistant

EGE Office


With thanks to former members of the EGE team, including: Maurizio Salvi,

Adriana Oltean, Maja Prelog. Additional thanks to newly-joined colleagues

Aylin Avcioglu and Rasida El Haouzi.

mailto:[email protected]





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Societal, ethical considerations gain more and more prominence on the European political agenda, in pace with technological transformations. The European Group on Ethics in Science and New Technologies (EGE) is an independent body appointed by the President of the European Commission to provides advice on all aspects of Commission policies and legislation where ethical, societal and fundamental rights dimensions intersect with the development of science and new technologies.

During its 2011-2016 mandate, the EGE adopted four extended Opinions: on information and communication technologies; on energy; on security and surveillance; and on new health technologies and citizen participation. In addition, three statements were produced by the EGE: on clinical trials; on research integrity; and on gene editing.

This report describes the main activities of the group in the course of its 2011-2016 mandate, the context of increasing demand for a broadened ethical expertise, the variety of domains and stakeholders engaged in the development of these ethical frameworks, as well as a set of forward-looking perspectives.

Research and Innovation policy

European Group on Ethics in Science and New Technologieschange has been remarkable once again, in...

Documents

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