Council Conclusions and roadmap of 26 November 2002 for a strategy on life sciences and biotechnology
Date: 2003-02-18
Institutions: Council of the European Union
Subjects: biotechnology, governance, life sciences, research policy

18.2.2003

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Official Journal of the European Union

C 39/9

COUNCIL CONCLUSIONS AND ROADMAP

of 26 November 2002

for a strategy on life sciences and biotechnology

(2003/C 39/05)

THE COUNCIL OF THE EUROPEAN UNION,

1. RECALLS:

— the European Council's conclusions of Stockholm
recognising the important contribution that biotech-
nology can make towards achieving the target set at
the Lisbon European Council for Europe to become the
most competitive knowledge-based economy with thus
more and better jobs while ensuring that those devel-
opments occur in a manner which is healthy and safe
for consumers and the environment, and consistent
with common fundamental values and ethical prin-
ciples and in full compliance with the existing legis-
lative framework,

— the European Council's

account of

conclusions of Barcelona
the development of measures and a
calling for
to
timetable which enable Community businesses
the potential of biotechnology while taking
exploit
due
and
meeting ethical and social concerns; and recalling
that overall spending on R&D and innovation in the
Union should
aim of
approaching 3 % of GDP by 2010 and that two-thirds
of this new investment should come from the private
sector,

the precautionary principle

increased with the

be

— the Council conclusions of June 2002 requesting an
operational roadmap of measures to this end,
indi-
cating priorities,
responsibilities
and a timetable for implementation;

the various actors'

2. WELCOMES the Commission Communication on a life
sciences and biotechnology strategy and action plan that
provides a comprehensive basis for implementation of a
roadmap. AGREES with the main lines of the Commission's
analysis of strengths and weaknesses of
the European
Union biotechnology sector and of policies and actions
related hereto, as well as the identification of main areas
that need action to improve further policy coherence;

and may

protection,

industrial products

and processes
contribute

4. RECOGNISES that life sciences and biotechnology offer a
considerable potential in areas such as health care, agri-
and
culture/food,
environmental
to
sustainable development. UNDERLINES that this potential
should be continuously assessed on the basis of benefits
and
and risks
environmental consequences and ethical aspects and that
the successful development of a competitive biotechnology
sector in the European Union requires a comprehensive
and coordinated approach covering all major areas of
application of biotechnology;

anticipating health,

economic,

social

5. ACKNOWLEDGES that any effective approach which would
allow harvesting the potential of biotechnology in Europe
should engage all Member States and encompass all policy
areas and instruments available for the sector's promotion
international aspects, be balanced,
taking into account
including a continuing societal dialogue, a high-standard
regulatory framework which is science-based, and respect
diversity of views and freedom of choice;

6. ACKNOWLEDGES that

the European research and inno-
vation area will be particularly helpful in providing a struc-
turing effect and in overcoming the fragmentation of
resources and the lack of critical mass.
It will also
stimulate — on a voluntary basis — enhanced coor-
dination of
and
the private sector.
actions and greater involvement of
Research in life sciences and biotechnology may serve as
a model for integrating activities addressing ethical and
social aspects from the earliest possible stage;

research and development policies

7. ACKNOWLEDGES that a science-based, transparent, effective
and proportionate regulatory framework respecting the
precautionary principle is a major requirement for estab-
lishing societal, in particular, consumer confidence, which
should prevent unnecessary administrative burdens
in
particular on small and medium-sized enterprises and
stimulate responsible innovation;

3. UNDERLINES the necessity for adequate and appropriate
approaches, taking into account biosafety issues related
to new technologies and societal needs as well as the
aim to ensure consumer
freedom of choice and the
safety of consumers;

8. UNDERLINES that biotechnology could, to a certain degree,
contribute to sustainable progress and economic growth in
developing countries while decreasing the use of resources
and environmental degradation; however,
the biotech-
nology applications must correspond to the desires of
the countries concerned;

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9. ACKNOWLEDGES that the Cartagena Protocol on Biosafety
represents an important global legal instrument to secure
the protection of biodiversity while taking into account
human health and ACKNOWLEDGES the importance of
the Community's participation in capacity building in
third countries;

10. UNDERLINES that

a

comprehensive

strategy needs

a
continuous effort to ensure policy coherence and moni-
toring. RECOGNISES the need for a monitoring and a
regular
exchange of views and experiences between
Member States about creating framework conditions for
the biotechnology industry and the well-functioning of
markets. WELCOMES
intention to
present its regular life sciences and biotechnology report
including a report on the implementation of the following
roadmap for the strategy on life sciences and biotech-
nology, together incorporating the elements listed in the
following roadmap;

the Commission's

11.

INVITES the Commission to coordinate, with the active
contribution of Member States,
the implementation of
the road map including:

sector

related

industries,

— monitoring the competitiveness of the European Union
biotechnology
in
and
particular the European Union framework conditions,
entrepreneurship and functioning of markets, the legal
framework, access to and dissemination of knowledge
and technological counselling, research and innovation,
access to capital, including venture capital, and public-
private
and ethical
concerns,

societal dialogue

cooperation,

— monitoring and driving the implementation of

the
following roadmap for the strategy on life sciences
and biotechnology,
social,
health, environmental, safety and ethical aspects,

taking into account

its

— working for cross-sectoral coordination within fields of

relevance to biotechnology.

Based on a yearly report from the Commission the Council
once a year should hold an in depth discussion, beginning
in 2003, on the implementation of the following roadmap
for the strategy on life sciences and biotechnology;

I. STRENGTHENING THE VALUE CREATION CHAIN

A. Human resources

Member States should keep under review and assess,
before mid-2003, future requirements in specific skills
in the European Union for
technicians,
engineers and managers within the various life science
specialities.

scientists,

Member States and the Commission should

— cooperate in identifying tools, such as education
modules or curriculum elements, and compare best
practices to fill those needs, particularly relating to:

— initial

life

education:
secondary school
education
resources,
interest, reduction of drop-out rate,

education at
level, university and technical
science

strengthening

science

— continuous professional development and lifelong
learning related to biotechnology, as well as
management and legal skills needed by entrepre-
neurial companies,

— mobility, attraction and retention of researchers,

— collaborate with academia and industry to establish
and disseminate best practices to match workforce
with available positions, and improve mobility.

These measures should be operational by 2004.

Member States and the Commission call upon industry
and academia to assist in developing tools and contribute
within their own areas of
staff
exchanges and in-house training and ‘research academy’
partnerships. The Commission is invited to monitor this
process and report to the Council before the end of
2004.

competence,

e.g.

B. From knowledge to market

Research

12. CALLS UPON THE COMMISSION, THE MEMBER STATES AND
THE PRIVATE SECTOR AS WELL AS OTHER STAKEHOLDERS,
within their respective competencies and responsibilities,
to engage in defining and implementing measures in a
cooperative way within the framework of the following
roadmap for the implementation of the strategy on life
sciences and biotechnology which sets out priorities
within an indicative timetable.

The Council invites the Member States and the private
sector to increase or continue to increase the research
resources allocated to life sciences and biotechnology,
and improve the efficiency and effectiveness of national
research by working to implement the European research
area in those aspects of science, technology and engin-
eering which specifically underpin and support biotech-
nology developments.

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Member states should make the best use of the areas
which have been identified under the Sixth Framework
Programme (2003-2006)
the European
Union life sciences and biotechnology industries so as
in a coordinated
to enhance their competitiveness
manner, while taking into account views on ethical
standards and social, health and safety concerns.

to benefit of

Intellectual property

recognises the vital

the
importance of
The Council
proposed Community patent
for a dynamic biotech-
nology sector and will — in line with the Barcelona
conclusions of 2002 — resolve the outstanding issues
as soon as possible and invites Member States to:

— continue the transposition of Directive 98/44/EC of
the European Parliament and of the Council of 6 July
1998 on the legal protection of biotechnology
inventions (1) taking into account
the Commission
report on the development and implications of
patent law in the field of biotechnology and genetic
engineering. The status of transposition and practical
experience in application should be reported every
year to the Council — beginning in 2003,

sharing experience and exploring best practices.
Results will be reported before the end of 2004.

C. Networking and clusters

access

financed biotechnology portal
free

The Council welcomes the Commission support for the
creation of a self
for
to information on
Europe, providing
available networking Internet platforms. In addition, the
Commission, as it has indicated, should further develop
its own website in order to provide a broad entry
platform into the Commission's work on biotechnology
giving all relevant actors easy access to information. This
portal and the entry platform should be operational
before the end of 2003.

representatives

learning and develop best
In order to create mutual
practices,
from biotechnology clusters
are encouraged to exchange experiences yearly. The
Commission is invited to report yearly to the Council
on best practices related to biotechnology clusters.

— discuss, in close cooperation with academia, national
plans for increasing awareness of the strategic uses of
intellectual property in a responsible manner.

Member States, regions and the Commission should take
initiatives to stimulate interregional cooperation between
biotechnology companies and institutions — including
biotechnology clusters and centres of excellence.

Technology transfer

Member States and the Commission should in 2003
establish an inventory of best practices
the
promotion of
and subsequent
technology
transfer
support of
the dissemination through networks and
pilot projects.

for

Finance

insti-
Member States,
tutions should consider how to improve the financial
framework for biotechnologies, and in particular:

the Commission and financial

the

European

— use the results of
and

the collaboration between the
Commission
Investment
Bank/Fund to improve innovation finance including
venture capital availability in their own innovation
policies and increase investments in this area, e.g.
through EIB/EIF instruments supporting late stage
investments or consolidation funds,

— intensify work on a cross-national basis, e.g. by
structures,

networks

between

building

existing

The Commission is invited to monitor the process and
the development of clusters and cooperation between
clusters and report yearly to the Council beginning in
2003.

D. A proactive role for public authorities

Member States and the Commission should prepare and
a benchmarking
implement on a voluntary basis
programme in 2003, highly focussed on areas of
special relevance, to assist the development of biotech-
nology policy through identification and exchange of
best practices. Such a programme may for example
include measurement of the extent of commercial devel-
opment of biotechnology: the resource base (human and
financial), public policies (national and sub-national) to
promote the development of commercial biotechnology
(e.g. technology transfer and SME support), regulatory
factors including transparency and other (national and
sub-national) factors affecting the business climate for
commercial
the
precautionary principle.

biotechnology,

and

use

the

of

(1) OJ L 213, 30.7.1998, p. 13.

The programme should make full use of already existing
measures and involve all interested stakeholders.

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States
The Member
continuously monitor
economic,
health, environmental, ethical and safety factors.

and the Commission should
social,
and assess

II. RESPONSIBLE GOVERNANCE

A. Participation of society

Societal scrutiny and dialogue

and

structured

joins the Commission's commitment

The Council
to
support an open and transparent as well as compre-
hensive,
and
stakeholders,
information
notably through a broadly-based stakeholders forum
starting at the latest in 2003 as well as other targeted
measures, as indicated in the Commission Science and
Society Action Plan.

exchange,

including

focussed

dialogue

all

Member States, the Commission, academia, industry and
civil society should take part in a continuous dialogue on
issues of societal concern, by encouraging discussion-
forums at the appropriate levels, starting at the latest
in 2003.

awareness of

the promotion of

Member States and the Commission should initiate and
support
scientific
paradigms underlying regulatory oversight, as well as
an open and transparent public dialogue on biotech-
nology between all stakeholders,
focussing on tech-
nological developments and potential benefits and risk.
Balanced and informed debates should take place in each
Member State starting at the latest before the end of
2003.

Member States and the Commission will
take into
account the output emerging from the abovementioned
initiatives.

Ethics

The Council notes that the ethical acceptability of some
areas of biotechnology is related to the diversity among
Member States and is governed by national
law in
subsidiarity. An
accordance with the principle of
increased dialogue between ethical bodies
in the
European Union,
including the European Group on
Ethics in Science and New Technologies, and with the
general public should facilitate the identification of
different ethical standpoints and contribute to mutual
understanding of their basis and exploration of where
common views
is
important
to promote the understanding of ethical,
legal and social aspects in the scientific community.

and desirable.

are possible

It

research

— before the end of 2004 strengthen and focus
for
socio-
Community
support
economic and ethical
issues and dissemination of
results, including criteria for assessing the cost and
benefit of using biotechnology, in order to facilitate
future reporting and provide a good basis for societal
decisions on the application of
life sciences and
biotechnology;

into

— fund bioethics research and ensure that the ethical,
legal and social implications are taken into account at
the earliest possible stages of Community-supported
research by providing an ethical review of research
proposals received;

— to promote the dialogue between national ethical
bodies and private and public partners with a view
to examine, on a case by case basis, where it might
be possible to work towards Common approaches to
be used e.g. in decision-making processes and as a
basis for public consultation and information, taking
into account the experience obtained under the Sixth
Framework Programme.

B. Regulatory framework

Pharmaceuticals

the most

regulatory

framework

the Commission's efforts

to
The Council welcomes
for medicinal
improve
the
important
products that constitute one of
sectors of applied biotechnology, and will conclude
discussion on the proposed review of the pharmaceutical
legislation,
authorisation
procedures, conditional approval and enforced scientific
advice for applicant companies, in order to increase the
competitiveness of the pharmaceutical sector with a high
level of consumer confidence. The Commission is invited
to yearly evaluate progress made in implementation and
its impact.

accelerated

including

The recommendations made by the High-Level Group on
Innovation and Provision of Medicines,
and the
Commission's reaction to the recommendations should
provide a basis to arrive at operational conclusions to be
presented by 2003.

Genetically modified organisms (GMO) legislation

organisms (1)

genetically modified

Directive 2001/18/EC of the European Parliament and of
the Council of 12 March 2001 on the deliberate release
the
of
environment has been applicable since 17 October
2002.
Its objectives are to strengthen the regulatory
approval system and to provide a high level of health
and environmental protection, as well as to ensure indi-
vidual choice. In this context, the Council is considering
the outcome of the ongoing work concerning further
GMO related legislation.

into

In that respect, the Council welcomes the Commission's
intention to:

(1) OJ L 106, 17.4.2001, p. 1. Directive as amended by Council

Decision 2002/811/EC (OJ L 280, 18.10.2002, p. 27).

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The Council encourages the Commission, Member States
and other interested stakeholders to develop agronomic
and other options to enable the coexistence of all
different agricultural practices, considering the need to
safeguard sustainability and diversity in Europe and fully
apply the principle of freedom of choice for operators
should be
and consumers. Results
included in the Commission annual
report on the
strategy for life sciences and biotechnology based on
information coming notably from the Member States.

in this

respect

The Commission is invited to, as it has indicated, peri-
odically, beginning in 2003, publish a rolling regulatory
work programme
coherence,
to further
predictability, transparency and quality of the regulatory
framework, applying notably the principles of:

improve

— product authorisation on the basis of scientific risk

management,

— the precautionary principle,

— risk management measures also taking into account

other legitimate factors as appropriate,

— the proportionality of risk management measures,

— the transparency of procedures assessments and, as
provided for by the Aarhus Convention, public
participation,

— consumer information and choice,

— the testing and validation of control methods,

— regular reviews of legislation,

— the functioning of the approval system.

C. International/development cooperation

in order

Member States and the Commission should provide
strong European Union support
to enable
developing countries and countries with economies in
transition to assess and use the potential of biotech-
nology and to develop their own capacity for
the
adequate policy response, according to their needs and
to the local conditions. Support should include inter-
national scientific cooperation, such as the establishment
of effective research partnerships between public and
private research organisations in developing countries
and the European Union. Assistance should be based
on the express preferences of the developing partner.
this
from assistance for application purposes,
Apart
should reinforce assistance to implement the relevant
international Conventions and Agreements, for example
the International Treaty on Plant Genetic Resources for
Food and Agriculture,
the Convention on Biological
Diversity including the Cartagena Protocol on Biosafety.
By the end of 2003, the Commission should report on
results in this respect.