Communication from the Commission to the European Parliament, to the Council and to the European Economic and Social Committee - Life Sciences and Biotechnology - A strategy for Europe progress report and future orientations [SEC (2003) 248]
Date: 2003-03-05
Institutions: European Commission
Subjects: EU action, EU research policy, bio-ethics, biotechnology, genetically modified organism, intellectual property, life sciences, report, research budget

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 5.3.2003
COM(2003) 96 final

COMMUNICATION FROM THE COMMISSION
TO THE EUROPEAN PARLIAMENT, TO THE COUNCIL
AND TO THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE

LIFE SCIENCES AND BIOTECHNOLOGY –A STRATEGY FOR EUROPE
PROGRESS REPORT AND FUTURE ORIENTATIONS

{ SEC (2003) 248 }

EXECUTIVE SUMMARY

In  January  2002,  the  Commission  adopted  a  Strategy  for  Europe  on  Life  Sciences  and
Biotechnology, consisting of two parts –policy orientations and a 30 point plan to transform
policy into action.

The Commission intends to report regularly on the progress made. This report is the first such
response.  It  sets out what has been  achieved in policy  development  and  on  the  ground,  and
anticipates  emerging  issues.  Where  further  action  is  needed,  this  report  contains  future
orientations, makes appropriate recommendations or announces new initiatives.

This Communication highlights a number of core issues which are fundamental to the success
of the Action Plan. It is supported by a Commission Staff Working Paper which sets out both
short and medium term actions to bring these about, as well as a more precise timetable  for
delivery by the Commission.

With this Communication, the Commission is  responding to the request  from the  Barcelona
European Council to report on progress in advance of the 2003 Spring European Council.

The Commission strategy on Life sciences and Biotechnology has been regarded as a major
initiative and as an achievement ……

The  European  Institutions  have  supported  the  integrated  approach  proposed  by  the
Commission  as  the  way  to  work  towards  the  Lisbon  objective  of  promoting  this  high-
technology  area  because  of  its  potential  to  create  growth  and  new  jobs  and  benefit  a  wide
range of sectors, while at the same time contributing to our broader goals, such as sustainable
development.  On  26  November,  the  Competitiveness  Council  adopted  conclusions,  which
included  a  roadmap  for  Member  States  (and  the  Commission)  identifying  priority  actions,
responsibility  and  timetable  for  implementation.  Together  with  the  action  plan  these
conclusions  have  established  a  sound  framework  for  developing  biotechnology  policy
Europe-wide  on  a  collaborative  basis.  On  21  November,  the  European  Parliament  gave  a
strongly  positive  signal  in  support  of  the  development  of  biotechnology  in  Europe  when  it
adopted, by a large majority, a resolution endorsing the Commission's biotechnology strategy.

Member  States  and  the  regions,  academia  and  the  private  sectors  are  already  identifying
measures  and  contributing  to  its  implementation  in  many  areas.  This  strategy  presents  an
integrated  policy  in  this  area  at  European  Union  level,  covering  both  the  promotion  of
biotechnology development and the responsible governance of this process.

In line with the timetable set out in the Action Plan, the Commission has moved forward on a
wide  range  of  specific  actions  within  its  own  jurisdiction  and  has  supported  various
independent actions undertaken by the regions, academia and industrial organisations alike. In
some  Member  States  a  number  of  measures  are  already  in  place  which  tie  in  with  the
Biotechnology Strategy. Although the implementation of the strategy is still at an early stage,
a certain amount of progress has been made. A notable achievement has been the adoption of
the 6th Framework Programme for Research & Technological Development (FP6), which will
continue to underpin basic scientific research and help to build a European research system.
Considerable progress has been made on the regulatory framework for GMOs.

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……but progress in some crucial areas needs to accelerate

In some areas, including areas which might seriously risk impeding the long-term success of
biotechnology  in  the  Union,  and  might  also  have  global  repercussions,  the  picture  is  more
mixed  and  is  already  giving  cause  for  concern.  These  are  the  need  for  more  research  and
financial  resources,  the  need  to  complete  the  system  of  Intellectual  Property  protection  and
the delay in the areas of GMOs. These shortcomings have direct consequences in a number of
areas, namely in innovation, competitiveness and research in European biotechnology, and in
trade.

European  biotechnology  lags  behind  the  US  in  terms  of  patents  and  collaborative  R&D
projects  and  this  principal  competitor  of  ours  has  a  dominant  lead  in  innovative  activities,
while  a rapid decline  in  GMO  field  research  has been  reported in the EU  over  the  last  four
years. This raises the risk of failing to meet the objective of the Lisbon process in the area of
life sciences and biotechnology. Decisive action is now needed in a number of areas identified
in this report.

Like any scientific progress, the  rapid advances in life sciences create  high  expectations for
curing diseases and improving quality of life while at the same time raising concern as to their
ethical  and  social  consequences.  Public  authorities  at  large  have  to  take  into  consideration
concerns about the conditions under which fundamental choices are made in this field. For its
part, the Commission is committed to ensuring that the ethical, legal, social and wider cultural
aspects,  as  well  as  the  different  underlying  ways  of  thinking,  are  taken  into  account  at  the
earliest  possible  stage  in  Community  –funded  research.  In  particular,  the  issues  of  human
cloning and human embryonic stem cell research have provoked intense public and political
debate.  Ethical  and  social  debate  must  continue  to  be  a  natural  part  of  the  research  and
development process involving society as much as possible.

Finally,  there  is  a  need  for  a  joint  effort  to  broaden  understanding  on  biotechnology  at
international level. To this end, a multilateral consultative forum, in which a broad-spectrum
dialogue on biotechnology can be engaged, will be considered.

There  continues  to  be  a  need  for  commitments  and  actions  from  all  private  and  public
stakeholders involved in the Strategy

With the Strategy,  the Commission  committed  itself  to  improving  the  coherence  of  policies
and  actions  in  order  to  encourage  an  integrated  approach  towards  all  applications  of  life
sciences  and  biotechnology.  The  Commission  is  ready  to  continue  to  deliver  on  these
commitments.

But the  Commission  is  only  one  of  several  stakeholders  in  the  field.  Many  of  the  proposed
actions are substantially or wholly within the scope of Member States or private stakeholders.
The  strategy  can  only  be  successful  if  it  is  accompanied  by  additional  activities  in  the
individual  Member  States,  by  their  setting  and  implementing,  for  example,  national
biotechnology strategies. The Commission, for its part, is ready to continue to play its role of
facilitator  and  contribute  to  work  undertaken  by  others  with  the  specific  task  of  ensuring  a
coherent European framework.

A  clear  and  consistent  policy  within  the  Member  States  on  biotechnology  is  crucial.
Experience  has  shown  that  divergent  and  uncoordinated  actions  seriously  risk  reducing  the
impact,  effectiveness  and  coherence  of  the  EU  strategy  in  this  field.  Attention  should  be
drawn  to  the  apparent  inconsistency  of,  on  the  one  hand,  the  conclusions  of  the  Lisbon,

3

Stockholm,  Barcelona  and  Seville  Summits  setting  the  objective  of  becoming  a  leading
knowledge-based  economy,  promoting  the  full  potential  of  biotechnology  and  calling  for
more  competitiveness  in  Europe’s  biotech  sector.  On  the  other  hand,  there  has  not  always
been  the  same  clear  signal  when  these  statements  are  translated  into  binding  rules  and
commitments.

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TABLE OF CONTENTS

Executive Summary ................................................................................................................... 2

1. Introduction ............................................................................................................................ 6

2. Reactions to the Commission’s Strategy................................................................................ 6

Council and the European Council .............................................................................. 7

European Parliament, European Economic and Social Committee and Committee of
the Regions................................................................................................................... 7

3.

Overview of policy developments and priorities for urgent actions ............................ 8

a) European Research................................................................................................... 8

b) Science and Society ................................................................................................. 9

c) Competitiveness, innovation and intellectual property.......................................... 12

Fragmentation and access to finance.......................................................................... 12

Intellectual property protection .................................................................................. 14

d) Genetically Modified Organisms (GMOs) ............................................................ 15

Regulatory framework and public perception............................................................ 15

e) International issues................................................................................................. 19

4.

Overall conclusions.................................................................................................... 22

5

1. INTRODUCTION

In  January  2002,  the  Commission  adopted  a  Strategy  for  Europe  on  Life  Sciences  and
Biotechnology.1  This  was  in  response  to  the  importance  attached  to  life  sciences  by  the
European Council. It proposes a comprehensive roadmap up to 2010 and puts the sector at the
forefront of those frontier technologies which are helping to take the European Union towards
its  long-term  strategic  goal  established  by  the  Lisbon  European  Council  in  March  2000  of
becoming  “the  most  competitive  and  dynamic,  knowledge-based  economy  in  the  world,
capable of sustainable growth with more and better jobs…” within a decade.

This  strategy  set  by  the  Commission  consisted  of  two  parts  –  policy  orientations  and  a  30
point plan to transform policy into action. It set out what was needed  from the Commission
and  the  other  European  Institutions,  but  also  recommended  actions  for  other  public  and
private  stakeholders.  The  strategy  therefore  provides  a  framework  and  a  reference  both  for
action undertaken by the many stakeholders concerned within their own responsibilities and
for co-operation between these stakeholders.

The Barcelona European Council examined the Action Plan and asked the  Commission  and
the Council to develop measures and a timetable to enable Community business to exploit the
potential of biotechnology while taking account of the precautionary principle and addressing
ethical and social concerns. It also asked the Commission to report on progress in advance of
the 2003 Spring European Council.

The Commission intends to report regularly on the progress made. This report is the first such
response.  It  states  what  has  been  achieved  in  policy  development  and  on  the  ground,  and
anticipates  emerging  issues.  Its  purpose  is  not  to  repeat  the  comprehensive  outline  for  the
future  course  of  action  provided  by  the  action  plan.  Many  measures  in  line  with  the  action
plan  are  already  been  developed  or  implemented  across  the  EU.  However,  where  there  is  a
specific  need  for  fresh  political  impetus  in  some  priority  areas,  this  report  contains
orientations for the future and appropriate recommendations or announces new initiatives.

This Communication highlights a number of core issues which are fundamental to the success
of the Action Plan. It is supported by a Commission Staff Working Paper which sets out both
short and medium-term actions to bring these about, as well as a more precise timetable for
delivery  by  the  Commission.  In  the  current  early  phase  of  implementation,  this  first  report
focuses on action  undertaken  by  the Commission and  only  provides  occasional  reference  to
other stakeholder activities.

2. REACTIONS TO THE COMMISSION’S STRATEGY

The  Strategy  on  Life  Sciences  and  Biotechnology  has  been  generally  welcomed.  Member
States and the Regions, academia and the private sectors are already identifying measures and
contributing to its implementation in many areas. It presents an integrated policy in this area
at  European  Union  level,  covering  both  the  promotion  of  biotechnology  development  and
responsible governance of this process. It has proven possible to arbitrate between competing
interests and between different sectors to establish a common, albeit evolving approach.

1

COM(2002) 27 Final.

6

                                                
The strategy has been taken as a sign that the Community has begun to regain leadership in
this sensitive area; an  area  which  affects an  increasing  number  of  Community  policies.  The
strategy, and the way in which it has been developed, provides a good example of European
governance in practice.

A short overview of the political response of the European Institutions is provided below.

Council and the European Council

In March 2002, the Barcelona European Council stressed the importance of frontier technologies as
a key factor for future growth. It welcomed the Commission’s strategic  vision on  Life Sciences and
Biotechnology as a basis for the future framework. It asked Council and the Commission to develop
detailed measures to implement the approach and to report on progress in good time before the 2003
European Council.

In  Seville,  the  European  Council  added  a  request  to  the  Council  to  implement  the  biotechnology
strategy proposed by the Commission.

The  Council  responded  in  November  2002,  with  the  adoption  of  conclusions  within  the
Competitiveness Council, which welcomed the Commission’s Strategy and included a roadmap for
Member  States  (and  the  Commission)  identifying  priority  actions,  responsibility  and  timetable  for
implementation.

These conclusions have established a sound framework for developing biotechnology policy
Europe-wide on a collaborative basis.

However,  some  Member  States  have  not  yet  been  able  to  transform  the  aims  of  those
conclusions into action in areas which are vital to the development of biotechnology and life
sciences,  notably  because  of  delays  in  transposing  legislation  concerning  biotechnology
patents  and  in  progressing  with  the  authorisation  of  new  Genetically  Modified  Organisms
(GMOs). There has also been only slow progress on the Community Patent proposal.

European  Parliament,  European  Economic  and  Social  Committee  and  Committee  of  the

Regions

The European Economic and Social Committee adopted its report on 24 September, welcoming the
Commission  strategy  and  considering  the  Action  Plan  to  be  well-constructed,  precise,  dynamic  and
pro-active.

On  21  November,  the  European  Parliament  gave  a  strong  positive  signal  in  support  of  the
development of biotechnology in Europe when it adopted by a large majority a resolution endorsing
the  Commission's  biotechnology  strategy.  Parliament  took  the  opportunity  to  debate  all  aspects  of
biotechnology in a single text and thus supported a clear and coherent concept of the importance of
life sciences. Parliament highlighted in particular the need for a Community Patent and for a progress
in the authorisation of new GMOs in order to stimulate innovation in this sector.

The Committee of the Regions did not take a position on the Commission's biotechnology strategy.

These  responses  show  that  the  European  Institutions  support  the  integrated  approach  as  the
way to move towards the Lisbon objective of promoting this high-technology area, realising
its potential to create growth and new jobs and benefit a wide range of sectors, while at the
same time contributing to our broader goals, such as sustainable development.

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3.

OVERVIEW OF POLICY DEVELOPMENTS AND PRIORITIES FOR URGENT ACTIONS

In line with the timetable set out in the Action Plan, the Commission has moved forward on a
wide  range  of  specific  actions  within  its  own  jurisdiction  and  has  supported  various
independent  actions  undertaken  by  the  regions,  academia  and  industry  organisations  (See
supporting Commission Staff Working Paper for a  detailed state of implementation of those
actions, including a more specific timetable for their delivery2).

In  some  Member  States  a  number  of  measures  are  already  in  place  which  tie  in  with  the
Biotechnology Strategy.

Although implementation of the strategy is still at an early stage, a certain amount of progress
has been made.

However, in some areas, including areas which seriously risk impeding the long-term success
of biotechnology  in the Union,  and  may  also  have global repercussions, the  picture  is  more
mixed  and  is  already  giving  cause  for  concern.  These  are  the  need  for  more  research  and
financial resources, the need to complete the system of Intellectual Property protection and to
further progress in the areas of GMOs.

These  shortcomings  have  direct  consequences  in  a  number  of  areas,  namely  in  innovation,
competitiveness  and  research  in  European  biotechnology,  and  in  relations  with  our
international trading partners, including developing countries.

This raises the  risk  of  failing  to  meet  the  objective of the  Lisbon process  in the  area of  life
sciences and biotechnology.

In  the  recent  letter  of  Federal  Chancellor  Gerhard  Schröeder,  President  Jacques  Chirac  and
Prime  Minister  Tony  Blair  in  anticipation  to  the  2003  Spring  Council,  the  potential  of
biotechnology  in  improving  European  industrial  competitiveness  and  ensure  employment
opportunities  was  recognised,  while  stressing  the  need  to  develop  all  aspects  of  European
business as a key role in the success of the Lisbon Strategy.

a)

European Research

Research is the engine that drives the development of biotechnology. Greater, better and more
coherent  research  investments  through  the  establishment  of  a  true  European  Research  Area
are a prerequisite if Europe wants to succeed in the life sciences.

The  European  research  in  general,  but  also  in  life  sciences  and  biotechnology  still  suffers
from  insufficient  resources  and  from  fragmentation.  National  and  regional  research
programmes are insufficiently geared up to each other and cross-border co-operation between
universities and industry is not yet widespread.

The  establishments  of  a  European  Research  Area  will  be  helped  by  the  Union’s  Sixth
Framework  Programme  for  Research  &  Technological  Development  (FP6)3.  The  latters’
adoption  by  the  Council  and  the  European  Parliament  in  June  2002,  six  months  before  its
entry into force, is the most visible and prominent achievement in the year since the launch of
the  strategy.  .  It  marks  a  decisive  step  towards  involving  Europe’s  research  and  scientific

2

3

SEC(2003) 248
Decision No 1513/2002/EC (OJ L232, 29.8.2002, p.1).

8

                                                
networks  in  the  fulfilment  of  the  Lisbon  agenda  of  economic,  social  and  environmental
renewal.

The Sixth Framework Programme for Research & Technological Development (FP6)

The FP6 is the Union’s principal instrument for its researchpolicy.  With  an  overall  budget  of  €17.5
billion  covering  the  four-year  period  2003-2006,  it  represents  approximately  5%  of  total  public
research  spending  in  Europe.  The  funding  modalities  have  been  revamped  so  as  to  enable  the
mobilisation of a critical mass of expertise and resources around ambitious scientific objectives and to
have  a  better  structuring  impact  on  the  research  landscape  in  Europe.  Universities,  companies  and
research centres will work together in integrated projects and will establish networks of excellence on
topics that present a European dimension. Biotechnology research is catered for in most of the FP6’s 7
thematic priorities, including biotechnology for health; nanotechnologies; food quality and safety and
sustainable development. Specific  attention  will  be  given  to  the  participation  of  small  and  medium-
sized  companies.  Additional  support  will  be  provided  for  international  scientific  co-operation,
research infrastructures and mobility and training of researchers.

At the heart of FP6 is the creationof a true European Research Area, an internal market where
researchers,  knowledge  and  technologies  freely  circulate.  It  aims  to  promote  scientific
excellence,  improve  competitiveness  and  innovation  through  greater  co-operation  among
researchers  and  increase  co-ordinationamog  those  that  invest  in  research,  including  national
research programmes.

FP6  will  help  to  address  some  of  the  outstanding  problems  hampering  the  development  of
biotechnology  in  Europe,  such  as  insufficient  mobility,  ‘brain-drain’  or  our  researchers,
fragmentation of research efforts and lagging transformation of research results into products
and services. This European public research effort will complement and spur the investments
made by entrepreneurial biotechnology companies, totalling€7.5 billion in researchin 2001.

Investment in research

Investment in knowledge creation is a precondition for Europe to achieve the goal set by the
European Council at Lisbon of becoming “the most competitive knowledge-based economy in
the world”. However, current level of investment in R&D is insufficient to achieve this goal.
The European Union invests 1.9 % of GDP in R&D compared with 2.7% invested by US and
3% by Japan. In 2000, the gap between US and EU investment in R&D reached €124 billion.
It has doubled at constant prices since 1994. More than 80% of this R&D gap is due to lower
funding by the EU business sector.

At  the  March  2002  Barcelona  European  Council,  the  EU  agreed  that  overall  spending  on
R&D in the Union should be increased with the aim of approaching by 2010 3% of GDP, of
which  two-third  should  come  from  the  private  sector.  On  11  September  2002,  the
Commission  Communication  “More  Research  for  Europe  -  Towards  3%  of  GDP”  was
adopted.  With  this  Communication  the  Commission  has  engaged  a  debate  with  all
stakeholders  on  the  ways  and  means  of  achieving  the  ambitious  goal  set  in  Barcelona.  It
intends to come forward in spring 2003 with an action plan.

The  Commission  calls  for  coherent  mobilisation  of  a  wide  range  of  policies  in  order  to
establish framework conditions that are more conducive to private investment in R&D, and to
ensure a more effective use of public R&D financing mechanisms.

9

Priorities for future actions

The  life  sciences  and  biotech  industry  has  and  will  continue  to  have  its  roots  in  public
research.  Actions  agreed  at  European  level  must  be  matched  by  a  solid  nationally  funded
research  effort  that  delivers  results  at  national  and  local  levels,  and  that  allows  for
unhampered  cross-border  co-operation  between  the  best  researchers  from  public  and
private sectors in dedicated fields.

b)

Science and Society

Like any scientific progress, the rapid advances in life sciences have created high expectations
for curing diseases and improving quality of life but have at the same time raised concerns as
to  their  ethical  and  social  consequences.  Public  authorities  at  large  have  to  take  on  board
concerns about the conditions under which fundamental choices are made in this field.

For its part, the Commission is committed to ensuring that the ethical, legal, social and wider
cultural aspects, as well as the different underlying ways of thinking, are taken into account at
the earliest possible stage in Community–funded research.

Fostering informed public dialogue

As in the past, the Commission will, in the implementation of FP6 and in other action, ensure
that ethical and social debate continues to be a natural part of the research and development
process, involving society as much as possible.

In order to encourage scientists managing their projects in such an inclusive way and dialogue
with the public, the Commission calls for initiatives  that integrate discussion platforms as  a
strategic  element  of  the  work.  Large  research  clusters  like  one  on  the  safety  assessment  of
GMOs or another on probiotics have designed new ways of conducting research, with NGOs
participating as partners in the projects.

Through  the  FP6,  the  Commission  supports  measures  to  help  researchers  become
communicators and debaters, caring for the conditions in which all parties in society can be
involved  and  embarking  in  new  ways  of  collective  learning.  One  concrete  example  is  the
“Science-Generation”  project,  which  creates  partnerships  between  local  communities,  the
media and scientists in France, Italy and Sweden.

In  addition  and  for  the  first  time,  the  FP6  now  includes  a  Science  and  Society  programme
which  supports  comparative,  foresight  and  technology  impact  research  linked  to  ethical
questions emerging in new fields of science and their applications.

Recently,  two  issues  have  provoked  intense  public  and  political  debate:  human  cloning  and
human embryonic stem cell research.

Human reproductive cloning

Recent speculation on the possibility of human reproductive cloning has reignited the debate
on  its  acceptability  from  an  ethical  as  well  as  a  scientific  point  of  view.  A  number  of
initiatives on this issue have been taken, both at national and at international level. A Franco-
German initiative on a world convention banning the reproductive  cloning  of human  beings

10

has  been  announced  and  is  being  discussed  in  the  United  Nations.  Japan  has  recently
indicated  its  wish  to  join  other  countries  in  drawing  up  a  world  treaty  prohibiting  human
reproductive cloning.

The  European  Parliament  has  adopted  a  number  of  resolutions  on  the  cloning  of  human
embryos  and  the  ethical  and  legal  problems  of  genetic  engineering.4  An  EP  own-initiative
report on the ethical, legal, economic and social implications of human genetics was rejected
in plenary.5

Human reproductive cloning is prohibited by Article 3 of the Charter of Fundamental Rights
of the European Union6. The European Group on Ethics in Sciences and New Technologies
(EGE) has also spoken out against such procedure.7 Accordingly, the European Community’s
Sixth  Framework  Programme  has  excluded  from  funding  any  research  that  involves  human
reproductive cloning.

The  Commission  reaffirms  its  full  support  for  a  worldwide  ban  on  human  reproductive
cloning.

Human embryonic stem cell research

The issue of human embryonic stem cell research was highlighted in the process of adopting
FP6  and  its  implementing  measures.8  In  particular,  the  final  discussions  in  the  Council  and
Parliament on the specific programme “Integrating and Strengthening the European Research
Area (ERA)” implementing FP6 focused on this specific issue.

Council position on research on stem cells

In the Council meeting of 30th September 2002, the Council and the Commission agreed that detailed
implementing  provisions  concerning  research  activities  involving  the  use  of  human  embryos  and
human  embryonic  stem  cells  which  may  be  funded  under  the  FP6  have  to  be  established  by  31
December  2003.Furthermore,  in  that  occasion,  the  Commission  stated  that,  during  that  period  and
pending  the  establishment  of  detailed  implementation  provisions,  it  will  not  propose  to  fund  such,
with the exception of banked or isolated human embryonic stem cells in culture.

The  Commission  is  constantly  monitoring  scientific  advances  and  needs  as  well  as  the
evolution  of  international  and  national  legislation,  regulations  and  ethical  rules  regarding
these issues. In so doing, it takes into account the opinions of the European Group of Advisers

4

5

6

7

8

EP  Resolution  of  16  March  1989  on  the  ethical  and  legal  problems  of  genetic  engineering,  EP
Resolution  of  28  October  1993  on  the  cloning  of  the  human  embryo,  EP  resolution  B4-0209  of  12
March 1997, EP resolution B4-0050/98 of 15 January 1998 and EP resolution B5-0710 of 7 September
2000 on the cloning of human beings.
Report  on  the  ethical,  legal,  economic  and  social  implications  of  human  genetics  –  A5-0391/2001,
voted and rejected in plenary on 29.11.2001.
OJ C 364, 18.12.2000, p.1.
“Ethical  Aspects of Cloning Techniques” Opinion No 9 of 28 May 1997. Information concerning the
EGE can be found at the following site: http://europa.eu.int/comm/european_group_ethics
Council Decision 2002/834/EC (OJ L 294, 29.10.2002, p.1), Council Decision 2002/835/EC (OJ L 294,
29.10.2002,  p.44),  Council  Decision  2002/836/EC  (OJ  L  294,  29.10.2002,  p.60),  Council  Decision
2002/837/Euratom  (OJ  L  294,  29.10.2002,  p.74),  Council  Decision  2002/838/Euratom  (OJ  L  294,
29.10.2002, p.86).

11

                                                
on the Ethical Implications of Biotechnology (1991-1997) and the opinions of the European
Group on Ethics in Science and New Technologies (as from 1998).9

Priorities for future actions

In  accordance  with  the  Council  declaration  on  the  specific  programme  “Integrating  and
strengthening the European Research Area”, the Commission will

(cid:1)
in  Spring  2003,  present  a  report  on  human  embryonic  stem  cell  research  to  the
European Parliament and to the Council which will form the basis for discussion at an inter-
institutional seminar on bioethics, and is expected to contribute to a Europe-wide discussion
on the ethical issues of modern biotechnology, particularly on human embryonic stem cells;

(cid:1)
submit  a  proposal,  based  on  Article  166(4)  of  the  Treaty,  establishing  further
guidelines on the principles for deciding on possible Community funding of research projects
involving in particular the use of human embryonic stem cells.

c)

Competitiveness, innovation and intellectual property

There  have  been  encouraging  signs  of  dynamism:  a  wave  of  entry  of  new  dedicated
biotechnology  firms  entering  the  market  in  a  number  of  European  countries.  The  European
biotech  industry  is  a  late  starter  and  still  at  an  early  stage  in  terms  of  size  of  companies,
revenues and product pipeline. There is now an urgent need for further industry development
and  consolidation.  Biotechnology  is  a  global,  highly  capital-intensive  and  knowledge-based
industry. Its development will thus depend on progress in overcoming the three fundamental
issues of fragmentation, access to finance and intellectual property protection.

Fragmentation and access to finance

The fragmentation that characterises research is also reflected in European industry. This is
partly  due  to  general  regulatory,  entrepreneurial,  fiscal  and  financial  factors,  but  more
specifically also to the traditionally national nature of research spilling over to the companies
created out of that research. There is little co-operation across Member States and it has been
shown that European companies are more likely to enter into research collaboration with US
companies  than  with  Europeans  counterparts.  In  addition,  the  interface  between  the  public
research system and industry is insufficiently developed.

Innovation and competitiveness in European Biotechnology

A study10 shows that European biotechnology lags behind the US in terms of patents and collaborative
R&D projects and that this principal competitor of ours has a dominant lead in innovative activities.

Underpinning  public  basic  scientific  research  and  the  ongoing  establishment  of  a  European
Research Area offers the most effective means of counteracting this fragmentation.

It  is  a  fact  that  none  of  the  biotechnology  clusters  in  Europe  at  present  are  as  dynamic  in
developing companies and products as the leading US biotechnology clusters in New England

9

10

Opinion  No  15  of  14  November  2000  on  the  ethical  aspects  of  human  stem  cell  research  and  use;
Opinion  No  16  of  7  May  2002  on  the  ethical  aspects  of  patenting  inventions  involving  human  stem
cells.
This study provides details on the competitiveness of the European biotechnology industry. Innovation
and competitiveness in European Biotechnology, Enterprise Papers No 7, 2002, European Commission.

12

                                                
and California. A forthcoming innovation scoreboard study of biotechnology  shows that the
top  performers  of  the  EU  are  competitive  with  the  US  but  that  many  have  not  reached  a
critical mass. In the time since the Commission issued the Communication on Biotechnology
strategy there have been an increasing number of initiatives and meetings involving regions,
clusters,  companies  and  research  institutions.  Europe’s  regions  are  developing  a  network
based  on  an  open  membership  structure  and  co-operation  between  interested  parties  on
specific issues. There have also been a number of other promising initiatives from the private
and academic  sectors  and  NGOs  to  promote  dialogue  between  stakeholders  and  the  general
public. The Commission welcomes this type of activity and above all its bottom-up approach,
which should ensure that activities correspond to the priorities of the participants. Following a
recently  concluded  evaluation  of  proposals,  a  European  biotechnology  web  hub  will  be
established  in  2003  with  Commission  support,  the  aim  being  to  provide  a  central  linkup
function between the stakeholders in the biotechnology community.

G10 Medicines and review of the pharmaceutical legislation

In  May  2002  the  High  Level  Group  on  Innovation  and  Provision  of  Medicines  (G10
Medicines)  delivered  its  report11  on  ways  to  improve  the  competitiveness  of  the  European-
based  pharmaceutical  industry  within  the  context  of  achieving  social  and  public  health
objectives.  Given 
tomorrow's
pharmaceutical  products,  the  Report  underlined  the  importance  of  the  Commission’s
biotechnology strategy and referred, in particular, to the need to complete the implementation
of the Directive on biotechnological inventions. The Commission will respond to the report’s
recommendations in the form of a Communication that is likely to be adopted in the summer
of 2003.

important  role  of  biotechnology 

in  developing 

the 

Many  important  steps  to  improve  the  innovative  capacity  of  European  pharmaceutical
industry  are  taken  on  board  in  the  ongoing  revision  of  the  Community’s  pharmaceutical
legislation as laid down in Regulation No 2309/93 and Directive 2001/83/EC. Key elements
in  the  Commission’s  efforts  to  overcome  the  current  fragmentation  of  the  markets  and  to
establish the necessary intellectual property protection are certain adaptations of the so-called
centralised procedure including increased scientific advice of the companies and harmonised
data protection periods.

The biotechnology industry is dependent on access in particular to risk capital.

Companies  will  have  to  manage  a  very  long  and  costly  research  and  development  process
before they have a marketable product or in some cases fail. Public and private investors have
to be prepared to invest with a longer perspective in high-risk companies. During the last five
years Europe has been very successful in creating new biotechnology companies, but a large
proportion  of  those  companies  are  now  facing  the  need  to  renew  their  financing  in  a  very
difficult financial market.

There  is  no  doubt  that  a  number  of  biotechnology  companies  are  going  to  disappear  in  the
consolidation process, as  some would  not be viable  even in  good market conditions.  Others
will find a future through mergers or  as divisions  of  larger  companies.  This  does not lessen
the fact that Europe runs the risk of losing not only a number of potentially viable companies
but also a generation of researchers and its resulting intellectual property. Europe risks losing
knowledge assets already acquired. It has therefore been realised that the main problem lies in
financing  more  mature  companies.  The  Commission's  advisory  Biotechnology  and  Finance
Forum estimated a potential funding gap of up to $1 billion during 2003.

11

Available on “http://pharmacos.eudra.org”

13

                                                
Priorities for future actions

There  is  some  indication  of  the  scope  and  urgency  of  the  financial  situation  in  the
entrepreneurial  biotechnology  industry.  The  Member  States,  the  Commission  and  financial
institutions  now  have  to  consider  their  response  to  ensure  that  Europe  does  not  lose  what
knowledge assets it has.

Intellectual property protection

A clear, equitable, affordable and effective patent regime applied consistently across the EU
is  crucial  if  we  are  to  exploit  fully  the  medical,  environmental  and  economic  potential  of
biotechnology in line with high ethical standards, while taking due account of public concerns
on the issue of patents granted for biotechnological innovations.

This objective involves

–  the Community Patent, and

–  the Directive on biotechnological inventions.

Patent protection in the EU is currently ensured by two systems, neither of which is based on
a Community legal instrument: the European Patent System and the national patent systems.
As  a  result,  patenting  in  Europe  is  expensive  and  fraught  with  legal  uncertainty.  A
Community  patent  of  a  unitary  nature  valid  in  all  Member  States  remains  utterly  desirable,
particularly  in  a  field  of  global  application  like  biotechnology.  With  this  in  mind,  the
Commission  has  submitted  a  proposal  for  a  Regulation  on  the  Community  Patent,12  which,
after  receiving  the  opinion  of  the  European  Parliament,  is  being  discussed  in  the  Council,
where, on 3 March 2003, a political agreement has been reached.

Directive 98/44/EC13 on the legal protection of biotechnological inventions was adopted after
a  long  and  constructive  debate  which  lasted  about  ten  years  in  both  the  Council  and  the
European Parliament. During those negotiations, it was fully recognised that biotechnological
inventions are a sector in full expansion and need a sound legal framework to allow European
businesses  to  develop  and  market  the  resulting  products  and  processes.  New  techniques  of
great  promise  for  cures,  industrial  processes  and  foodstuffs  are  becoming  established  very
rapidly, and the European legislator considered it essential not to hamper their development.

is  crucial  for  both  scientific  progress  and 

This  Directive,  which 
innovation  and
competitiveness, has been applicable since 30 July 2000. The European Patent Organisation, a
non-Community Body which grants patents having effect, among others, in the territory of the
Member States, amended its implementing regulation in 1999 in order to take account of the
provisions contained in Directive 98/44/EC.

As provided for by Article 16(c) of Directive 98/44/EC, the Commission adopted the Annual
Report of the  Commission to the  European  Parliament and the Council  on  the  development
and implications of patent law in the field of biotechnology and genetic engineering,14 the aim
being to  monitor  developments  and  prevent  any  malfunctioning  in  this  sector.  In  particular,

12

13

14

COM (2000) 412.
OJ L 213, 30.7.1998, p.13.
COM (2002) 545 Final, 7.10.2002.

14

                                                
the report highlights the key provisions of the Directive in the light of the judgement of the
Court of Justice of the European Communities of 9 October 2001.15

In  its  judgement  the  Court  dismissed  the  action  for  annulment  brought  by  the  Netherlands,
reiterating  de  jure  the  essential  principles  of  the  Directive  and  casting  new  light  on  a  number  of
specific provisions. In particular, the Court confirmed the scope of the Directive and its compatibility
with existing international agreements in the field of biotechnology.
The Court pointed out that the Directive complies with the fundamental rights relating to the respect
of human dignity and human integrity.
Finally, the Court also recalled the patentability of inventions relating to plants.

Despite the above, to date, only six Member States16 have transposed Directive 98/44/EC into
their national legal systems while the other Member States are currently at varying stages of
progress.  Reasoned  opinions,  the  second  stage  of  formal  infringement  proceedings  under
Article 226 of the EC Treaty have been sent to the Member States concerned asking them to
transpose Directive 98/44/EC into national law.

Transposition of this Directive is a legal obligation under the Treaty and is essential in order
to  avoid  any  discrepancies  between  the  legislations  of  the  Member  States.  This  situation  is
considerably  hampering  the  development  of  biotechnology  in  Europe  in  comparison  to  our
competitors.

Priorities for future actions

(cid:1)  Following the political agreement of 3 March 2003, the Commission invites the Council to
resolve  the  remaining  difficulties  and  to  adopt  the  Community  Patent  Regulation  before
the  end  of  2003.  The  Council  is  furthermore  invited  to  take  a  timely  decision  for  the
creation  of  the  centralised  court,  for  which  the  Commission  is  now  able  to  present  a
proposal to the Council in due course. Changes to the European Patent Convention will
also have to be agreed in order to allow the European Patent Office to grant Community
Patents.

(cid:1) 

In  the  light  of  the  judgement  of  the  Court,  the  Commission  strongly  calls  upon  the
Member  States  concerned  to  fully  and  swiftly  transpose  and  implement  Directive
98/44/EC.

(cid:1)  For  its  part,  the  Commission  will  consider  the  following  two  questions  identified  in  the

report:

a) the scope of patents relating to sequences or part-sequences of genes isolated from the

human body;

b) the patentability of human stem cells and cell lines obtained from them.

These  two  topics  will  be  studied  and  analysed  by  a  group  of  independent  experts
(specialising in the fields of economics, law and natural sciences). This group will also help
the Commission to identify priority topics to be covered in future reports.

15

16

Case C-377/98.
Denmark, Finland, Ireland, United Kingdom, Greece and Spain.

15

                                                
d)

Genetically Modified Organisms (GMOs)

Regulatory framework and public perception

The regulatory framework in place since 1990 on the deliberate release into the environment
of  GMOs  (Directive  90/220/EEC)  and  since  1997  on  novel  food  and  novel  food  ingredient
(Regulation (EC) No 258/97) have already provided for a high level of protection for human
and the environment.

Considerable progress has been made in further advancing in the regulatory framework  for
GMOs, namely:

–  Directive 2001/18/EC17, which provides for a more complete authorisation procedure for GMOs,
has  been  fully  applicable  since  17  October  2002.  This  Directive  improves  legislation  on  the
deliberate  release  of  GMOs  into  the  environment,  providing  a  solid  base  for  transparent  and
responsible management of the use of GMOs. Furthermore, implementing measures18 needed for
the  applicability  of  that  Directive  at  that  date,  including  guidance  notes  on  risk  assessment  and
monitoring, are also in place;

– 

the reaching of political agreement in the Council on first readings in the European Parliament of
the  two  Commission  proposals  on  genetically  modified  organisms  (GMOs),  establishing  a
comprehensive  Community  system  to  trace  and  label  GMOs  and  to  regulate  the  placing  on  the
market and labelling of GM food and feed;19,20

–  steps  forward  in  the  implementation  of  the  Cartagena  Protocol,  which
guarantees all signatory countries the freedom to carry out a risk assessment prior
to accepting import of a new GMO. On 17 October 2002, political agreement was
reached  in  the  Environmental  Council  on  the  Commission  proposal  for
transposing the Cartagena Protocol into EU legislation, which will govern exports
of GMOs. 21

Furthermore, the European Network of GMO Laboratories (ENGL) was set up to contribute
more effectively to the uniform enforcement of legislation across the Community through the
harmonisation  and  standardisation  of  means  and  methods  of  sampling,  detection,
identification and quantification of GMOs or derived products in a wide variety of matrices,
covering seed, grains, food, feed and environmental samples.

17

18

19

20

21

OJ L 106, 17.4.2001, p.1.
Council Decision 2002/813/EC establishing the Summary Notification Information Format Part B(OJ,
L  280,  10.8.2002,  p.62),  Council  Decision  2002/812/EC  establishing  the  Summary  Notification
Information  Format  Part  C  (OJ  L  280,  10.8.2002,  p.37),  Commission  Decision  2002/623/EC
establishing  guidance  notes  supplementing  Annex  II  to  Directive  2001/18/EC  (OJ  L  200,  30.7.2002,
p.22),  Council  Decision  2002/811/EC  establishing  the  guidance  notes  supplementing  Annex  VII  to
Directive 2001/18/EC (OJ L 280, 10.8.2002, p.27).
Proposal for a  Regulation  of  the  European  Parliament  and  of  the  Council  concerning  traceability  and
labelling of genetically modified organisms and traceability of food and feed products produced from
genetically modified organisms. (COM (2001) 182 Final).
Proposal for a Regulation of the European Parliament and of the Council on genetically modified food
and feed. (COM (2001) 425 Final).
Proposal  for  a  Regulation  of  the  European  Parliament  and  of  the  Council  on  the  transboundary
movement of GMOs (COM (2002) 85 Final).

16

                                                
The ENGL set out to act as a scientific and technical European Union network of excellence within
the context of EU GMO regulation.

The  network  was  inaugurated  in  Brussels  on  4th  December  2002  and  currently
consists of 44 EU enforcement laboratories, plus Norway and a number of observers
such  as  Accession  Countries.  The  GMO  laboratory  of  the  Commission’s  Joint
Research  Centre  (JRC)  will  co-ordinate  ENGL's  activities.  It  will  act  as  the  EU
reference laboratory for GMO food and feed legislation.

The EU regulatory framework on GMOs and GM food and feed is one of the most thorough
and transparent regulatory framework on GMOs in the world. It aims to provide a high level
protection of human health and the environment, legal certainty for operators, address public
concerns, including ethical concerns, facilitate consumers’ choice,and thereby fosters further
public  confidence  on  the  use  of  GMOs.The  Commission  considers  that  it  has  met  its
commitments  to  create  the  conditions  for  making  the  GMO  authorisation  procedure
operational  and  it  is  ready  to  play  its  role  in  managing  the  new  procedure.  Member  States
should  equally  assume  their  responsibilities  in  order  to  ensure  that  progress  is  made  on
authorisations.  However,  in  spite  of  the  improvements  in  the  regulatory  framework,  public
and political concerns with GMOs continue. Whilst medical applications involving the use of
GMOs  have  continued  to  make  progress,  this  is  not  the  case  for  the  use  of  GMOs
inagriculture, where so far there are no obvious perceived benefits for consumers.

Since October 1998, progress in the authorisation of new GMOs have been limited. However,
food products produced from GMOs have been placed on the market in the Community under
the  Novel  Foods  Regulation,22  on  the  basis  of  their  ‘substantial  equivalency’  to  the
conventional products.

The deadline for transposition of Directive 2001/18/EC was 17th October 2002. To date only
Denmark  and  Sweden  have  fully  communicated  its  implementation  measures  for  this
Directive.  The  Commission  had  already  addressed  Letters  of  Formal  Notice  to  13  Member
States for non-communication of transposition measures and is considering sending one to the
UK for partial communications of transposition measures.

The most recent in the series of Eurobarometer surveys on what the European public thinks
about  biotechnology  indicates  that,  although  there  may  be  a  softening  of  attitudes  towards
biotechnology in general, GM foods are still seen as having no benefits and to carrying risks.

Whilst  public  authorithies  are  responsible  for  providing  a  clear  and  predictable  legal
framework  for  the  approval  of  GMOs  and  derived  products,  it  is  primarily  for  the  biotech
industry to openly explain and document the benefits of the use of GMOs.

The  lack  of  progress  on  the  authorisations  of  new  GMOs  is  having  a  direct  impact  on
research activities on GMOs and GMO field trials in Europe.

22

Regulation  (EC)  No  258/97  of  the  European  Parliament  and  of  the  Council  of  27  January  1997
concerning novel foods and novel foods ingredients (OJ L 43, 14.2.1997, p.1)

17

                                                
Impact on research activities and development in GMOs

A survey among private companies and research institutes active in the field of GMOs was conducted
in order to get an overview of basic and applied research activities on GMOs in Europe.23 The survey
reveals  that  39%  of  the  respondents  have  cancelled  R&D  projects  on  Genetically  Modified
Organisms  (GMOs)  over  the  last  four  years  giving  as  the  main  reasons  the  unclear  regulatory
framework and uncertain market situation. The tendency to cancel R&D projects is low for the public
sector  (23 %  of  respondents  have  cancelled  projects)  and  higher  in  the  private  sector  (61 %  of
respondents having cancelled projects).

Furthermore, the number of notifications for GMO field trials in the EU increased rapidly from
1991  to  1998,  and  declined  sharply  thereafter  (76  %  decrease  by  end  2001).  In  2001,  the
Commission’s  Joint  Research  Centre  (JRC)  database,  which  keeps  a  register  of  EU  field  trials,
received just 61 notifications for field trials with GM plants, compared with over 250 in 1998. Such a
marked decrease in the number of GMO field trials has not taken place to this extent outside Europe
(e.g.  in  the  US).  According  to  the  study,  there  is  a  response  effect  to  the  lack  of  progress  in  new
commercial  release  of  GMOs  as  well  as  the  widespread  tendency  of  the  European  public  to  reject
GMOs.

This situation underlines the importance of a clear and predictable regulatory framework not
only  for  fostering  consumer  acceptance  and  providing  legal  certainty  for  operators  in  the
production  and  distribution  chain,  but  also  for  reversing  the  rapid  decline  in  GMO  field
research in the EU.

Priorities for future actions

Against the above background, the Commission calls upon

(cid:1) 

(cid:1) 

the  Member  States  concerned  to  fully  and  swiftly  transpose  and  implement  Directive
2001/18/EC and not to withold new authorisation on GM products which fulfil current legal
requirements, and

the European Parliament and the Council to adopt of the two Commission proposals on
the traceability and labelling of GMOs and on GM food and feed, at the earliest

in order to provide a modernised legal framework based on transparency and efficiency and
facilitating  the  freedom  of  choice  of  consumers  as  well  as  providing  legal  certainty  for
operators.

e)

International issues

Biotechnology  has  been  increasingly  adopted  in  the  world.  In  the  agriculture/food  sector,
biotechnology  has  spread  very  quickly  and  continues  to  spread.  In  2002,  up  to  58  millions
hectares  were  planted  with  GM  crops.  While  the  US  still  dominates  the  production  of  GM
food,  several  developing  countries  grew  GM  crops  or  started  to  authorise  GMOs  in
agriculture.

23

"Review of GMOs under Research and Development and in the pipeline in Europe", an ongoing study
of  the  Institute  of  Prospective  Technological  Studies  (IPTS-JRC)  and  the  European  Science  and
Technology Observatory (ESTO)".

18

                                                
Existing international forums and initiatives

Discussions  on  biotechnology  and  issues  related  to  biotechnology  take  place  today  in  a
multitude  of  international  forums.  A  number  of  international  organisations  have  direct
competence in dealing with  issues relating to biotechnology – biosafety is  addressed  by  the
Cartagena  Protocol,  biodiversity  by  the  Convention  on  Biological  Diversity  (CBD),
agriculture by the Food and Agriculture Organisation (FAO), intellectual property rights and
technology transfer by the World Intellectual Property Organisation (WIPO) and World Trade
Organisation  (WTO),  trade  by  the  WTO,  risk  analysis  of  foods  derived  from  modern
biotechnology  in  Codex  Alimentarius  under  the  World  Health  Organisation  (WHO)/FAO,
plant  protection  under  the  International  Plant  Protection  Convention  (IPPC),  and  the
development  of  consensus  documents  by  the  Organisation  for  Economic  Co-operation  and
Development (OECD).

Recently, new initiatives have been launched and other organisations have also taken up the
issue of biotechnology. The OECD organised two conferences on GM crops and feed in 2000
and  2001  with  world-wide  participation,  the  UNIDO  intends  to  organise  a  Global  Biotech
Forum  later  in  2003,  the  WHO  is  working  on  GM  food  safety,  and  the  World  Bank  has
launched  a  consultative  process  on  the  proposed  international  assessment  of  the  role  of
agricultural  science  and  technology  in  reducing  hunger,  improving  rural  livelihoods  and
stimulating environmentally sustainable economic growth.

Need for improved dialogue

The  increasing  number  of  international  initiatives  reflect  the  different  concerns  and  current
controversy  surrounding  biotechnology  and  raises  a  more  fundamental  question  relating  to
international  governance.  Each  of  the  above  organisations  plays  an  essential  role  in  their
specific  area.  However,  none  appears  to  provide  an  adequate  forum  for  promoting  an  open
and transparent dialogue between all the stakeholders concerned. Such a dialogue, on all the
issues  at  stake  in  biotechnology,  would  facilitate  mutual  understanding  of  the  concerns  and
objectives of the different countries and regions. Without it, there is a risk that the approach to
biotechnology  in  the  international  system  will  become  too  fragmented,  incoherent  and
overlapping. It is also increasingly difficult for developing countries to afford the resources to
participate in all of the on-going activities.

Improved dialogue is particularly important where regulatory requirements and the concerns
of  countries  and  regions  are  going  in  different  directions.  In  particular,  the  current
developments  in  the  EU  regulatory  framework  are  being  closely  followed  by  a  number  of
third  countries,  some  of  which  have  expressed  strong  reservations  regarding 
the
implementation of existing legislation and the design of future rules.

The economic stakeholders and interests involved in the production of GM- crops extend well
beyond  national  frontiers.  Therefore,  governing  biotechnology  innovation  means  finding  a
way of laying down common rules and principles on a global scale while still respecting the
pursuit  of  legitimate  approaches  in  different  parts  of  the  world.  This  is  proving  to  be  a
difficult  challenge.  Resorting  to  legal  challenges  or  showing  disrespect  for  the  legitimate
rights  of  governments  is  not  going  to  solve  the  public  concerns  expressed  in  different
countries, and would most likely lead to more controversy and polarisation.

The current divergence of views between the EU and some of its trading partners is adding to
the  perception  of  a  lack  of  "international  governance"  in  the  field  of  biotechnology,
particularly for agricultural biotechnology.

19

The  most  salient  example  is  the  reported  threat  from  certain  Third  Countries  of  a  WTO
challenge against the EU biotechnology legislation.

Threats of a WTO legal challenge

At the November 2002 meeting of the World Trade Organisation (WTO) Committee on Sanitary and
Phytosanitary  Agreement  (SPS),  the  US,  Canada,  Argentina  and  the  Philippines  again  raised  their
concerns  regarding  the  EU’s  continued  handling  of  the  approval  of  new  GMOs  and  on  the  WTO
compatibility of new and forthcoming European legislation, namely the Commission proposals on the
traceability and labelling of GMOs and on GM food and feed.

The  introduction  of  GMOs  in  agriculture  raises  several  issues  among  which  human  health,
environment,  the  economically  viable  co-existence  of  different  agricultural  production
systems, intellectual property rights and trade.

Many  developing  countries  have  not  yet  developed  a  policy  to  address  these  issues  and
several still lack the capacity to develop and enforce biotechnology legislation.

GM crops and developing countries

The recent food crisis in Southern Africa and the GMO- content of related food aid supplies has once
again  brought  to  the  public  attention  the  issue  of  the  introduction  of  GMOs  into  certain  developing
countries.

The  recent  controversy  has  been  sparked  by  the  US  supply  of  substantial  amounts  of  food  aid  as  a
response  to  the  serious  food  shortage  in  Southern  Africa.  US-supplied  maize  contains  grain  from
varieties which are genetically modified.

Some  countries  in  the  region24  initially  refused  to  take  the  maize  for  several  reasons,  among  which
human health concerns, environmental considerations, intellectual property rights concerns, the risk of
spread of transgenes into their own maize production, and the repercussions such a spread could have
on regional and international trade.

The Commission considers that all countries  have the  right  to  take  the  measures  they  deem
appropriate  to  control  the  intentional  or  unintentional  dissemination  of  genetically  modified
organisms  in  their  territory.  However,  regulations  should,  as  a  general  principle,  take  into
account the current degree of scientific knowledge, be transparent and predictable, and should
not be more trade-restrictive than is necessary to fulfil their objectives, taking into account the
level of protection sought. There is a need to improve international governance in the field of
biotechnology and to ensure that different regulatory mechanisms can co-exist.

To  date,  the  EU-US  Biotechnology  Consultative  Forum,  launched  by  President  Prodi  and
President  Clinton  in  May  2000,  remains  as  a  unique  example  of  an  independent  group  of
experts representing diverse views on the two sides of the Atlantic. The Forum was a useful
exercise  in  promoting  understanding  of,  and  consensus  on  some  of  the  difficult  and
contentious issues that underlie the different points of view on biotechnology within the EU
and the US and between the respective governments. Because of the background and causes
of  the  controversies  surrounding  biotechnology  and  its  rapid  evolution,  the  Forum  made  a

24

At the beginning of October, Lesotho and Swaziland were accepting GM grain, and Malawi, Zimbabwe
and Mozambique agreed to retract their ban, provided that the GM grain was milled before distribution,
thereby  removing  the  potential  for  outcrossing  of  GM  maize  with  indigenous  crops.  Zambia  is  still
refusing the GM grain.

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number of recommendations including further work and analysis. The Commission has made
its  position  on  the  Forum’s  recommendations  public25  and  is  willing  to  continue  dialogue
towards a co-operative solution to the issues at stake.

The initiative of an international process designed to engage a broad range of stakeholders has
indeed been considered in the recent past.  In fact, at the Okinawa Summit in July 2000, the
G8 agreed “to explore, in consultation with international organisations and interested bodies
including  scientific  academies,  the  way  to  best  integrate  the  best  scientific  knowledge
available into the global process of consensus building on biotechnology and other aspects of
food  and  crop  safety”.  After  the  tragic  events  of  11September  2001,  the  G8  has  been
preoccupied with combating terrorism and, thus,  the  issue  of  food  safety  and  biotechnology
has been deferred.

On  30  and  31  January  2003,  the  Commission  organised  a  conference  in  Brussels  on  the
subject  of  biotechnology  in  agriculture  in  developing  countries.  The  conference  attracted
more  than  900  participants  from  all  over  the  world,  including  scientists,  government
representatives, NGOs, industry, media.

Priorities for future actions

It is time to give further consideration to the need for a multilateral consultative forum to
facilitate  open  and  balanced  dialogue,  including  all  stakeholders  and  to  promote  better
consistency of the agreements achieved in the different forums.

Such  a  consultative  body  should  be  capable  of  fostering  a  wide  spectrum  of  interests,
including  scientists  and  a  cross  section  of  civil  society,  the  aim  being  to  contribute  to  the
process  of  international  consensus  building  on  issues  relating  to  biotechnology  without
duplicating  on-going  work  in  established  international  forums.  Such  an  initiative  should  be
intended as an essential step towards a better global understanding of the issues relating to
the  application  of  biotechnology  and  the  differences  in  regulatory  approaches  amongst
regions and countries.

The Commission will pursue this matter further with a view to verifying the feasibility of such
a  forum  and  the  willingness  of  our  trading  partners  to  engage  in  such  a  dialogue.  The
Commission  will  also  support  an  independent  review  of  existing  scientific  knowledge
concerning agricultural biotechnology in the context of developing countries.

4.

Overall conclusions

–  The Commission strategy on Life sciences and Biotechnology has been widely regarded as

a major initiative and as an achievement.

–  With the Strategy, the Commission committed itself to improving the coherence of policies
and  actions  in  order  to  encourage  an  integrated  approach  towards  all  applications  of  life
sciences  and  biotechnology.  The  Commission  is  ready  to  continue  to  deliver  on  these
commitments.

–  Progress has been made in some areas, but others are suffering from serious delays. There
is a need for commitments and actions from all private and public stakeholders involved in
the Strategy. The Commission is only one of several stakeholders in the field. Many of the
proposed actions are substantially or wholly within the jurisdiction of the Member States

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http://europa.eu.int/comm/external_relations/us/biotech/ec_commentary.htm.

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or  private  stakeholders.  The  strategy  can  only  be  successful  if  it  is  accompanied  by
additional  activities  in  the  individual  Member  States,  by  setting  and  implementing,  for
example,  national  biotechnology  strategies.  The  Commission,  for  its  part,  is  ready  to
continue to play its role of facilitator and contribute to work undertaken by others with the
specific  task  of  ensuring  a  coherent  European  framework.  The  Council  conclusions  of
November  2002  are  a  major  contribution  to  this  framework.  A  concerted  effort  is  now
needed to continue the process of implementation.

–  A clear and consistent policy in the Member States on biotechnology is crucial. Experience
has  shown  that  divergent  and  uncoordinated  actions  seriously  risk  reducing  the  impact,
effectiveness and coherence of the EU strategy in this field. Attention should be drawn to
the apparent inconsistency of, on the one hand, the conclusions of the Lisbon, Stockholm,
Barcelona  and  Seville  Summits  setting  the  objective  of  becoming  a  leading  knowledge-
based  economy,  promoting  the  full  potential  of  biotechnology  and  calling  for  more
competitiveness in Europe’s biotech sector. On the other hand, there has not always been
the  same  clear  signal  when  these  statements  are  translated  into  binding  rules  and
commitments. In particular, the maintenance of a situation of legal uncertainty, notably the
delay  in  progress  in  the  area  of  GMOs,  and  the  non-transposition  of  EC  legislation  on
patents along with the delay in setting up a unitary Community patent, is having an impact
on  competitiveness,  research  capabilities  and  trade.  Decisive  action  in  now  needed  in  a
number of areas identified in this report.

–  The  regulatory  framework  on  GMOs,  including  the  Commission’s  proposals  on
traceability and labelling of GMOs and on GM food and feed provides for a high level of
protection  for human health  and the  environment, legal certainty for  operators, addresses
public  concerns  and  facilitates  consumers’  choice,  and  thereby  fosters  further  public
confidence on the use of GMOs. It is also important that the regulatory framework is clear
and predictable if the rapid decline in GMO field research in the EU is to be reversed.

–  Like any scientific progress, the rapid advances in life sciences create high expectations for
curing diseases and improving quality of life while at the same time raising concerns as to
their  ethical  and  social  consequences.  Public  authorities  at  large  have  to  take  on  board
concerns about the conditions under which fundamental choices are made in this field. For
its part, the European Commission is committed to ensuring that the ethical, legal, social
and wider cultural aspects, as well as the different underlying ways of thinking, are taken
into  account  at  the  earliest  possible  stage  in  Community–funded  research.  Ethical  and
social debate must continue to be a natural part of the research and development process,
involving society as much as possible.

–  Finally,  there  is  a  need  for  a  joint  effort  to  broaden  understanding  on  biotechnology  at
international  level.  To  this  end,  a  multilateral  consultative  forum,  in  which  a  broad-
spectrum dialogue on biotechnology can be engaged, will be considered.

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