Report from the Commission to the European Parliament, the Council and the European Economic and Social Committee - Life sciences and biotechnology - A strategy for Europe - Second progress report and future orientations {SEC (2004)438}
Date: 2004-04-07
Institutions: European Commission
Subjects: EU research policy, biology, biotechnology, report

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 07.04.2004 
COM(2004)250 final 

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

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

{SEC (2004)438} 

EN 

   EN 

 
 
 
  
 
 
 
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  in  implementing  this 
Strategy.  It  states  what  has  been  achieved  in  policy  development  and  on  the  ground, 
anticipates  emerging  issues  -  namely  tissue  engineering,  genetic  testing  and  animal 
biotechnology  –  and  indicates  elements  of  a  policy  response.  It  also  incorporates,  to  the 
largest possible extent, the elements listed in the roadmap within the conclusions adopted by 
the  Competitiveness  Council  of  26  November  2002.  It  is  supported  by  a  Commission  Staff 
Working  Paper  providing  further  detailed  information  and  timing  on  implementation  of  the 
action plan. 

Since last year’s report was issued, further progress has been made in the implementation 
of the Strategy …….. 

The 6th Framework Programme for Research (FP6) provides a major incentive for research in 
this area. The Commission, together with all other interested stakeholders, has continued its 
effort to bring science and society closer together and to develop an understanding of and an 
information exchange on life sciences and biotechnology. The review of the pharmaceutical 
legislation  was  adopted  early  this  year.  The  regulatory  framework  on  Genetically  Modified 
Organisms  has  been  completed  and  guidelines  on  co-existence  in  agriculture  have  been 
published.  

Member States have chosen different strategies to provide the policy underpinning of biotech 
development and have opted for different instruments to support biotechnology development. 
They have also responded effectively to the challenge of education. Most have revamped the 
life  sciences  curricula  and  added  new  courses  and  material.  Several  Member  States  have  in 
addition established relationships between academia and industry/society. 

There are also a number of actions in the Member States intended to obtain “brain-gain” by 
making the European Research Area (ERA) more attractive  for scientists in and outside the 
Union. 

…However, there is obviously still much to be done to improve the situation for European 
biotechnology.  

Public and private investments in research urgently needs to be increased. There is a need 
to  continue  to  improve  biotechnology  companies’  access  to  finance.  The  number  of 
European companies has remained stable, while the number of pharmaceutical compounds in 
clinical  trials  (a  common  measure  of  research  activity)  has  continued  to  increase.  This 
growing maturity of the industry will put much higher demands on the European system for 
financing innovation and growth than was previously the case. 

Member States still need to make progress on the implementation of measures to which they 
are already committed. One major example is intellectual property. The delays incurred in 
the  implementation  of  Directive  98/44/EC,  on  the  legal  protection  of  biotechnological 
inventions  leaves  companies  engaged  in  innovative  biotechnology  research  uncertain  as  to 
whether  they  are  fully  entitled  to  the  commercial  fruits  of  their  work.  This  is  severely 
hampering the industry's development, discouraging not only innovators themselves but also 

2 

 
 
  
 
the potential investors whose finance is so desperately needed. The slow progress in adopting 
a Community patent has also led many companies to adopt a strategy of primarily securing 
patents in the US and a few European states. Resolving these two issues will be important for 
the growth of the biotechnology industry. 

More  active  co-operation  from  all  Member  States  is  also  needed  in  the  implementation  of 
the  new  legislation  governing  GMOs.  Having  demanded—and  subsequently  committed 
themselves  to—a  more  rigorous  framework,  it  is  now  imperative  that  all  Member  States 
implement  the  basic  Directive  2001/18/EC  on  the  authorised  release  of  GMOs  into  the 
environment and the two regulations on traceability/labelling and GM/food and feed.  

The  next  stage  in  the  strategy  is  for  the  various  authorities  and  organisations  to  make 
commitments  and  to  begin  delivering  the  new  policy  measures  according  to  the 
responsibilities set out in the action plan.  

The Commission is directly responsible for some actions but it is also determined to do what 
it can to keep up the general momentum and to play a facilitating role.  

Against  the  background  of  the  renewed  political  debate  on  the  Lisbon  agenda  of  task  to 
revamp Europe’s competitive position, there is an acknowledged need to step up the measures 
to  meet  the  Lisbon  commitments.  The  Biotechnology  Strategy  includes  many  subjects  and 
stakeholders and the Union has to ensure that the coherence of its efforts is maintained. This 
calls  for  a  greater  coordination  and  cooperation  between  Member  States  and  the 
Commission,  with  the  aim  of  improving  Europe’s  competitiveness.  Consequently,  the 
Commission  proposes  to  reinforce  the  role  of  the  existing  Biotechnology  network  with 
Member States. 

3 

 
 
  
 
TABLE OF CONTENTS 

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

1. 

2. 

3. 

INTRODUCTION ........................................................................................................ 5 

REACTION TO THE COMMISSION’S FIRST PROGRESS REPORT .................... 5 

OVERVIEW OF POLICY DEVELOPMENTS AND PRIORITIES FOR ACTIONS.. 6 

3.1. 

HARVESTING THE POTENTIAL..................................................................................... 6 

k 

k 

k 

k 

k 

Competitiveness of European biotechnology sector and related industries................. 7 

Research and Technological Developments .............................................................. 10 

Funding research in Europe ....................................................................................... 11 

Human resources in R&D: Researchers..................................................................... 13 

Future Research Policy initiatives.............................................................................. 14 

3.2. 

GOVERNING LIFE SCIENCES AND BIOTECHNOLOGY ................................................. 14 

k 

k 

Social scrutiny and dialogue ...................................................................................... 14 

Confidence in science-based regulatory oversight..................................................... 17 

3.3. 

EUROPE IN THE WORLD-RESPONDING TO GLOBAL CHALLENGES ............................ 20 

k 

k 

A European Agenda for international collaboration .................................................. 20 

Europe’s responsibilities towards the developing world ........................................... 21 

3.4. 

NEWLY EMERGING ISSUES ........................................................................................ 23 

4. 

OVERALL CONCLUSIONS ..................................................................................... 25 

4 

 
 
  
 
1. 

INTRODUCTION 

In  January  2002,  the  Commission  adopted  a  Strategy  for  Europe  on  Life  Sciences  and 
Biotechnology.1 This sets out a comprehensive roadmap up to 2010 and puts the sector at the 
forefront  of  those  frontier  technologies  which  should  move  the  European  Union  towards  its 
long-term strategic goal established by the Lisbon European Council in March 2000. 

This  strategy  set  by  the  Commission  consisted  of  two  parts  –  policy  orientations  and  a  30 
point plan to transform policy into action. It sets out what was needed from the Commission 
and  the  other  European  Institutions,  while  also  recommending  actions  for  other  public  and 
private stakeholders. 

The  Commission  intends  to  report  regularly  on  the  progress  made.  On  5  March  2003,  the 
Commission  adopted  its  first  progress  report2,  highlighting  the  progress  made  but  also 
pointing out delays in some areas. It invited Member States to provide the necessary impetus 
to carry the strategy forward. 

This Communication is the second such response. It states what has been achieved in policy 
development and on  the  ground,  and  anticipates emerging issues. It  also  incorporates  to the 
largest possible extent the elements listed in the roadmap within the conclusions adopted by 
the Competitiveness Council of 26 November 2002.  

As last year, this report is supported by a Commission Staff Working Paper providing further 
detailed information and timing on the implementation of the action plan. 

2. 

REACTION TO THE COMMISSION’S FIRST PROGRESS REPORT 

While highlighting the progress made in the implementation of the Strategy, the Commission 
pointed out in its first progress report that the picture was more mixed in some areas and was 
already  giving  cause  for  concern.  This  was  down  to  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.  The  Commission  concluded  by  calling  on  Member 
States to develop a clearer and more consistent policy on biotechnology to avoid the risk of 
reducing the impact, effectiveness and coherence of the EU’s strategy in this field.  

In its opinion of 16 July 2003, the European Economic and Social Committee shared the 
Commission’s  views,  noting  with  a  degree  of  pessimism  that  the  Member  States  have  not 
taken sufficient steps to swiftly achieve the goals laid down in the conclusions adopted by the 
Competitiveness  Council  on  26 November  2002.  It  asked  the  Commission  to  include  a 
detailed analysis of achievements, failings and delays with respect to the approved plan in the 
next annual report. 

At  the  Competitiveness  Council  of  22  September  2003,  EU  Ministers  welcomed  the  first 
progress  report  on  the  implementation  of  the  European  Biotechnology  Strategy  and  agreed 
with the broad lines of its analysis and adopted a set of conclusions. 

1 
2 

COM(2002)27 final. 
COM(2003)96 final. It was supported by Commission Staff Working Paper SEC(2003)248 

5 

 
 
  
 
                                                 
The Council 

–  stressed  the  need  for  “significant  efforts  to  be  made  to  move  from  the 
conceptual and planning stage to the implementation of the Strategy and of 
the roadmap contained in the Council conclusions of 26 November 2002 in 
order to contribute effectively to the achievement of the EU competitiveness 
objectives set by the Lisbon European Council, 

–  encouraged  Member  States  and  the  Commission  to  step  up  their  co-
operation and to regularly exchange information on progress made in order 
to  advance  in  the  priority  areas  for  future  action  already  identified  and,  in 
particular,  to  improve  conditions  for  access  to  finance  for  biotechnology 
companies  and 
the  general  regulatory 
framework. 

to  complete  and 

implement 

The  European  Convention  on  Life  Sciences  and  Biotechnology  organised  by  the  Italian 
Presidency  on  21-22  November  2003  further  stressed  the  need  for  greater  cooperation 
amongst various parties and for better co-ordination to be achieved in the national policies of 
Member States. 

Priorities for future actions 

Commission and Member States 

►  to  increase  their  co-operation  and  exchange  of  information  in  order  to  enhance  coherence  and 
disseminate best practices. To this end, reinforcement of the existing Biotechnology network with 
Member States should be considered. 

3. 

OVERVIEW OF POLICY DEVELOPMENTS AND PRIORITIES FOR ACTIONS 

3.1. 

Harvesting the potential 

Competitiveness of European biotechnology sector and related industries 

The  biotechnology  industry  world-wide  has  continued  to  develop,  although  at  a  slower  rate 
than  previously  due  mainly  to  the  lower  confidence  of  investors  in  high-technology  sectors 
since  2000.  However,  there  seems  to  have  been  some  recovery  in  biotechnology  in  2003, 
particularly in the US but increasingly also in Europe.  

The number of European companies has remained stable, while the number of pharmaceutical 
compounds  in  clinical  trials  (a  common  measure  of  research  activity)  has  continued  to 
increase.  This  growing  maturity  of  the  industry  will  put  much  higher  demands  on  the 
European system for financing innovation and growth than was previously the case. The slow 
progress in adopting a Community patent has also led many companies – specifically SMEs- 
to  adopt  a  strategy  of  primarily  securing  patents  in  the  US  and  a  few  European  states. 
Resolving  these  two  issues  will  be  important  for  the  growth  and  competitiveness  of  the 
biotechnology industry. 

As highlighted in a recent letter of Prime Minister Tony Blair, President Jacques Chirac and 
Federal Chancellor Gerhard Schröder in anticipation to the 2004 Spring Council, life sciences 
and  biotechnology  are  amongst  the  key  growth  technologies  for  a  more  innovative  and 

6 

 
 
  
 
competitive Europe. Critical to the success of the innovation process is the ability of business 
to transform research initiatives into commercially viable processes and products. 

It is well known that Europe has more biotechnology companies than the US. It is also often 
repeated  that  the  US  industry  employs  far  more  people  and  has  a  much  higher  turnover.  A 
more careful analysis highlights some interesting aspects of this seeming paradox.  

The  innovative  and  economic  performance  of  small  European  biotechnology  companies  is 
comparable to their US counterparts. There does not seem to be any fundamental limitations 
on  European  companies  at  that  level.  Interestingly  enough,  neither  does  there  seem  to  be 
much  difference  in  the  performance  of  medium-size  companies.  Europe  does  however  have 
far fewer of those companies compared to the US. Undoubtedly, this can partly be ascribed to 
Europe’s  younger  industry,  but  there  are  clear  indications  that  difficult  access  to  later-stage 
finance and the absence of liquid stock markets for technology shares have contributed.  

As noted in the Strategy, there is a strong potential for the use of biotechnology in industrial 
processes  and  new  materials.  This  so  called  “white  biotechnology”  may  well  represent  a 
significant  portion  of  the  whole  biotechnology  industry  in  the  coming  years,  but  is  also  a 
sector  where  European  companies  hold  a  strong  position.  One  of  the  main  challenges  to 
European  policy-makers  will  be  to  put  the  conditions  in  place  to  ensure  that  bio-based 
solutions become mainstream options for industrial development. 

Member States have chosen different strategies to provide the policy underpinning of biotech 
development.  In  Finland  a  ministerial  working  group  coordinates  the  work  while  in  other 
Member States the task is done by individual ministries or through government agencies.  

In similar fashion, Member States have chosen different instruments to support biotechnology 
development.  Some  have  introduced  fiscal  benefits  or  deferred  social  security  payments 
(France,  Italy),  some  are  encouraging  inward  investment  (Ireland,  Spain),  yet  others  stress 
technology  transfer  (Italy).  There  is  no  single  measure  that  is  universally  applicable,  but 
continuing exchanges of views and collaboration will help to policymakers to choose the mix 
of measures that is most beneficial given the local circumstances. 

Member  States  have  also  responded  effectively  to  the  challenge  of  education.  Most  have 
revamped  the  life  sciences  curricula  and  added  new  courses  and  material.  Several  Member 
states have in addition established relationships between academia and industry/society. It is 
likely that there is much to be learned from an exchange of experiences. 

There are also a number of actions in the Member States intended to obtain “brain-gain” by 
making the European Research Area more attractive for scientists in and outside the Union. 
Tax treatment and better conditions for leading edge research are being introduced in Austria, 
Denmark, Germany, Italy and other Member States. 

The Competitiveness in Biotechnology Advisory Group 

In  accordance  with  Action  10b  of  the  Strategy,  in  2003  the  Commission  appointed  a 
Competitiveness in Biotechnology Advisory Group with Industry and Academia (CBAG). 
It gathers representatives from all the various industry segments and from companies at every 
stage  of  company  development  together  with  entrepreneurial  academics  and  has  the  role  of 
issuing recommendations to the Commission and contributing to this annual report. In its first 
report, the group chose to concentrate on the issues of access to finance and regulation.  

7 

 
 
  
 
The Group highlighted that entrepreneurial biotechnology companies are faced with the same 
pressures  as  other  innovative  companies,  except  that  for  biotech  companies  these  pressures 
are  often  more  acute.  It  identified  three  main  areas  that  require  attention  to  boost  the 
financial environment for biotech companies, namely 

(cid:190)  protecting intellectual property rights, 

(cid:190)  boosting finance, liquidity and capital markets in Europe, and  

(cid:190)  research funding through public/private partnerships. 

The  Group  stressed  that,  for  fast  and  effective  improvements,  the  entrepreneurial 
biotechnology community expects policy changes mainly at national level rather than at EU 
level.  Therefore,  many  of  its  recommended  actions  target  Member  States  rather  than  the 
Commission. 

The full text of the Group’s report can be found in the Commission staff working paper. 

Intellectual property protection 

The  CBAG  calls  for  a  speedy  and  full  implementation  and  application  of  adopted 
Community legislation and criticises the delays in some Member States in transposing already 
agreed  legislation,  in  particular  the  Biotechnology  Patent  Directive.  The  Group  recommends 
enhanced  communication  between  regulatory  authorities  and  between  such  authorities 
and applicants. 

After  receiving  the  opinion  of  the  European  Parliament,  the  Commission  proposal  for  a 
Regulation on the Community Patent3 is being discussed in the Council, where, on 3 March 
2003, a common political approach was agreed on a number of issues. This approach provides 
useful guidance for the finalisation of the regulation. 

To  date,  only  seven  Member  States4  have  transposed  Directive  98/44/EC5  on  the  legal 
protection  of  biotechnological  inventions  into  their  national  legal  systems  while  the  other 
Member States are currently at varying stages of progress. On 9 July 2003, the Commission 
referred  the  other  eight  Member  States  to  the  European  Court  of  Justice  for  their  failure  to 
transpose  the  Directive  into  their  national  legislation.  The  lack  of  transposition  of  the 
Directive  leaves  companies  engaged  in  innovative  biotechnology  research  uncertain  as  to 
whether  they  are  fully  entitled  to  the  commercial  fruits  of  their  work.  This  is  severely 
hampering the industry's development, discouraging not only innovators themselves but also 
the potential investors whose finance is so desperately needed. 

For its part, the Commission has considered two questions identified in 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 provided for 
by Article 16(c) of Directive 98/44/EC6, namely the scope of patents relating to sequences or 
part-sequences of genes isolated from the human body, and the patentability of human stem 
cells and cell lines obtained from them. 

3 
4 
5 
6 

COM(2000)412. 
Denmark, Finland, Ireland, United Kingdom, Greece, Spain and Portugal. 
OJ L 213, 30.7.1998, p.13. 
COM(2002)545 final, 7.10.2002. 

8 

 
 
  
 
                                                 
These  two  topics  have  been  studied  and  analysed  by  a  group  of  independent  experts.  The 
Commission is drafting the second report provided for in Article 16© of the directive, taking 
into account the comments made by the experts. 

Priorities for future actions 

Council 

►  to resolve the remaining difficulties following the political agreement of 3 March 2003, and to adopt 

the Community Patent Regulation in 2004, 

►  to  take  a  decision  in  good  time  on  the  creation  of  the  centralised  Community  patent  court,  for 

which the Commission has presented a proposal7 to the Council in December 2003, 

►  to  agree  on  changes  to  the  European  Patent  Convention  in  order  to  allow  the  European  Patent 

Office to grant Community Patents. 

Member States 

►  to fully and swiftly transpose and implement Directive 98/44/EC. 

Access to finance 

The  biotechnology  industry,  with  its  long  development  times  and  high  costs,  is  uniquely 
dependent on effective access to finance. 

The  CBAG  stresses  that lack  of  capital  and  the  fragmentation  of the  European  securities 
markets  is  impeding  the  industry’s  development  and  recommends  swift  harmonisation  of 
securities  regulations,  to  enable  multiple  listings  and  mergers  of  markets.  The  Group  agrees 
with  the  conclusions  of  the  Biotechnology  and  Finance  Forum  as  mentioned  below  and 
recommends  the  establishment  of  funds  to  cover  the  gap  between  traditional  venture 
capital (VC) financing and the IPO stage. 

In general, the financial community has retained confidence in the industry, but in 2002-2003 
the overall retrenchment of risk capital and the arrival of a large number of companies at the 
point  where  they  need  new  financing  to  continue  their  expansion  combined  to  threaten  a 
substantial segment of the industry.  

This problem first surfaced in countries, such as Germany, where the success of the BioRegio 
programme  in  the  nineties  had  led  to  a  large  number  of  companies  at  the  same  stage  of 
development, but other Member States where the industry has made a significant start shortly 
face  the  same problem. It should be noted that the present  problem is a  consequence  of  the 
large-scale success in developing an industry, not of failure  

The Commission’s advisory Biotechnology and Finance Forum, reporting early in 2003 on 
the  issue,  identified  a  number  of  problems  and  several  Member  States  and  the  European 
financial institutions have worked to find appropriate solutions.  

Germany and the European Investment Fund (EIF) have created a common fund to tackle this 
acute  situation,  while  other  Member  States,  such  as  France  have  acted  by  reviewing  their 
fiscal and social contributions policies. In October 2003 the European Investment Bank (EIB) 
decided  to  commit  half  a  billion  €  for  the  EIF  to  invest  in  funds  in  high-technology 

7 

COM(2003)827 and 828 

9 

 
 
  
 
                                                 
companies.  This  measure  can  be  expected  largely  to  benefit  biotechnology  companies.  The 
EIF  investment  rules  have  also  been  changed  to  allow  investments  in  later  stage 
entrepreneurial companies. This provision is of great importance given the long development 
times of most biotech products. 

The biotechnology industry will always be characterised by the creation and disappearance of 
entrepreneurial  companies,  but  it  may  be  hoped  that  the  recent  measures  will  help  to  retain 
companies with good products and good management that would otherwise find the situation 
impossible.  This  is  of  vital importance  to  the  consolidation  and  development  of  an  industry 
with a critical mass also composed of medium-size companies. 

Networking Europe’s biotechnology 

Fragmentation  is  still  a  crucial  issue  for  Europe’s  biotechnology  stakeholders.  There  is  still 
too  little  cross-national  collaboration  between  researchers  and  companies,  and  too  little 
awareness  of  developments  in  other  European  countries.  There  are  many  regional 
biotechnology  clusters,  although  co-operation  between  them  is  under-developed;  this  is  a 
particular problem considering that many of them lack critical mass. 

In consequence, networking is vital for the effective further development of biotechnology in 
Europe. The Commission is supporting the creation of an external European Biotechnology 
Web  Portal,  with  the  aim  to  successfully  link  up  companies,  the  academic  world  and 
interested lay people. The portal will be available in 2004. 

The informal network with Member States officials on competitiveness issues, established 
in  accordance  with  action  10a  of  the  Strategy,  is  operating  successfully  and  has  now  been 
expanded  to  the  accession  countries.  This  network  will  play  an  important  role  in  the 
benchmarking  of  European  Biotechnology  Policies  that  has  just  been  launched  and  has 
already made a constructive contribution to the previously mentioned finance issue. 

Priorities for future actions 

Commission and Member States 

►  to develop, in 2004-2005, a benchmarking programme as a tool for policymakers to develop the 
right mix of policies, given their Member State’s circumstances, and to repeat the benchmarking at 
intervals to provide a basis for an exchange of best practices and fine-tuning of policies. 

Research and Technological Developments 

In its report to the Spring European Council8, the Commission indicated that the Union is still 
far from achieving the objectives set at the Lisbon European Council. An analysis of progress 
has highlighted the lack of investment in knowledge sectors, namely research, innovation, 
education  and  training.  High  priority  should  now  be  given  to  improving  the  framework 
conditions and public support for research investment and ensuring consistency and synergy 
in Europe through the open method of co-ordination.  

This  requires  a  determined  and  co-ordinated  efforts  by  all  interested  parties  -  EU  Member 
States and public  and  private sector stakeholders - to implement the Investing in Research 
action plan9 setting out initiatives to give Europe a stronger public research base and to make 

8 
9 

COM(2004)29 final, Delivering Lisbon: Reforms for the enlarged Union 
COM(2003)226 final, Investing in research : an action plan for Europe 

10 

 
 
  
 
                                                 
it much more attractive to private investment in research and innovation. Key actions include 
setting  up  European  technology  platforms,  strengthening  links  between  industry  and  public 
research,  redirecting  public  spending  towards  research  and  innovation,  making  research 
careers more attractive and developing better fiscal incentives for research. 

Priorities for future actions 

Member States, public and private sector stakeholders 

►  to implement the action plan “Investing in Research”. 

Funding research in Europe 

For  its  part,  the  Commission  has  enhanced  its  support  for  Life  Sciences  and  Biotechnology 
research under the 6th Framework Programme for Research (FP6). Implementation of this 
Programme has in fact increased the Commission’s financial contribution to research in this 
area by some 20% compared with the 5th Framework Programme for Research. As a result of 
the first call for proposals more than €810 million was allocated to actions in the 2 thematic 
priorities  “Life  sciences,  genomics  and  biotechnology  for  health”  and  “Food  Quality  and 
Safety”, mobilising more than 2700 laboratories, including about 400 SMEs. 

Disciplines  are  converging  and  life  sciences  and  biotechnology  are  now  permeating  many 
areas  of  research  including  nanotechnology,  informatics,  social  sciences  and  engineering. 
Therefore,  other  thematic  priorities  such  as  Nanotechnology,  Sustainable  Development, 
Citizen  and  Governance  as  well  as  research  in  ethics  under  Science  and  Society,  will 
contribute to generating progress in life sciences and biotechnology. 

Funding has been concentrated on a few selected priorities and the new funding instruments 
(Network of Excellence and Integrated Projects) provide top researchers with a critical mass 
of resources and skills to be at the leading edge of science and technological developments. 
The new instruments foster linkage between basic scientists and clinicians, between academia 
and industry, between disciplines (physicists, geneticists, computer scientists, etc.), involving 
both the natural sciences and experts in ethics and social sciences, and between the scientific 
communities  and  consumer  and  patient  organisations,  etc.  The  goal  of  stimulating  these 
interactions  is  not  unique  to  Europe,  but  the  European  experience  may  benefit  the 
international scientific community and serve as a model for other nations.  

As a result of the first call for proposals, about 10% of the budget (approximately €80m) will 
be  allocated  to  SMEs.  In  addition,  52  Specific  SME  activities  (Co-operative  Research, 
Collective  Research)  and  research  and  innovation  activities  (Economic  and  Technological 
Intelligence  actions)  will  be  implemented  to  help  a  large  community  of  SME’s  develop 
innovation in healthcare, food quality and safety, agriculture and aquaculture. 

In  order  to  improve  the  access  to  biological  resources  and  large-scale  high  technology 
facilities  essential  for  both  the  research  and  commercial  development  of  biotechnology, 
actions  on  access  to  research  infrastructures  are  supported  under  the  specific  programme 
"Structuring the European Research Area" (2002-2006) (EU contribution of €48.7m). 

Amongst  the  numerous  areas  holding  much  potential  in  the  area  of  Life  Sciences  and 
Biotechnology, the following are being promoted: 

11 

 
 
  
 
(cid:190)  Genomics research 

The  BioSapiens  Network  of  Excellence  brings  together  24  bioinformatics  centres  in  14 
countries  throughout  Europe.  Bio  Sapiens  aims  to  address  the  current  fragmentation  of 
the  “European  Virtual  Institute  for  Genome 
European  bioinformatics  by  creating 
Annotation”10. The Institute will establish a permanent European School of Bioinformatics. 

(cid:190)  Biotechnology for health 

As one of the measures geared towards the European Research Area (ERA), the Commission 
has  called  together  the  Forum  of  Genomes  Programme  Managers  to  help  find  synergies 
between national research activities in the field of genomes research in Europe. 

CO-ORDINATION OF GENOMES RESEARCH ACROSS EUROPE ( COGENE) 

COGENE11  aims  to  promote  the  development  of  synergies  between  national  genome  research 
programmes  related  to  human  health  in  Europe.  It  acts  on  behalf  of  the  Forum  of  Genomes 
Programme Managers with representatives from 25 European countries. At the moment COGENE is 
mapping major national research funding sources and the most important infrastructures for genomes 
research within the COGENE forum member countries. COGENE workshops, which brought together 
industry,  have  yielded 
research  managers  from  national  funding  agencies,  academia  and 
recommendations for further actions to co-ordinate research in strategically important fields, such as 
pharmacogenomics and population genomics. 

(cid:190)  Plant genomics and biotechnology 

Although progress on GMO’s has been made in recent years and new non-GM technologies 
(e.g.  marker-assisted  breeding  and  high-throughput  identification  of  mutations  in  genes  of 
interest)  are  being  developed  and  applied,  it  will  take  a  joint  effort  on  the  part  of  all 
stakeholders to regain ground in plant science and strengthen the competitive position of EU 
research and industry in the world. 

The Integrated Project “New strategies to improve grain legumes for food and feed”, involving 
52 participants from 18 countries, will mobilise and integrate European scientific research on 
grain  legumes  (e.g.  peas,  lupins,  lentils,  chick  peas)  in  particular  it  will  contribute  to  the 
sequencing  of  the  genome  of  the  model  legume  M.  truncatula  and  generate  extensive 
functional  genomics  tools  for  M.  truncatula  as  well  as  for  grain  legumes  of  economic 
importance for Europe. In yet another step towards creating a true European Research Area, 
the Commission is also supporting an ERA-NET on Plant Genomics12 aimed at coordinating 
the national research programmes in this area of ten EU member states and Norway. 

This  ERA-NET  is  expected  to  be  an  important  part  of  a  future  European  technology 
platform on plant genomics and biotechnology, which is currently being set up. The aim of 
this  platform  is  to  develop  an  EU-wide  strategy  to  re-build  and  strengthen  the  S&T  base  in 
plant  genomics  and  biotechnology,  taking  into  account  the  needs  of  the  different  industrial 
sectors  (food,  chemicals,  pharmaceuticals  etc.).  The  platform  will  involve  key  stakeholders 
from research, biotech, - food and feed- industry, farmers, regulators and consumers. Based 

10 

11 
12 

‘Annotation’ is the process by which features of the genes or proteins stored in a database are extracted 
from other sources, defined and interpreted. 
http://www.cogene.net 
http://www.cordis.lu/coordination/era-net.htm 

12 

 
 
  
 
 
                                                 
on a common vision for the development of plant genomics and biotechnology in Europe, one 
of the key objectives of this platform will be to formulate a strategic research agenda for 
2005-2010  defining,  for  both  medium  and  long-term  targets,  priorities,  and  building  up  the 
necessary public-private-partnership, including the mechanism to mobilise private and public 
investments which will be required for the implementation of the research and development 
strategies. 

Priorities for future actions 

Commission 

►  to launch the European technology platform on plant genomics and biotechnology in Spring 2004. 

Industrial biotechnology 

The  potential  of  industrial  biotechnology  in  terms  of  competitiveness,  growth  and 
environmental  sustainability  has  been  reflected  in  a  series  of  OECD  reports13.  Despite  the 
funding  of  this  area  under  the  various  EC  Framework  Programmes  and  strategic  research 
programmes  in  a  number  of  Member  States,  large  scale  practical  applications  of  industrial 
biotechnology in Europe seem to be limited, while in the US and in Japan a strategic research 
agenda for the development of industrial biotechnology has been formulated. 

The importance of industrial biotech for sustainable development has been highlighted in the 
recent Commission Communication on “Environmental Technology Action Plan”14. 

Priorities for future actions 

Commission 

►  to  launch  a  series  of  roundtables  in  Spring  2004  bringing  together  stakeholders  from  research, 
industry,  NGOs,  regulators  and  representatives  from  Member  States  with  the  aim  to  prepare  by 
mid 2004 a vision paper for European industrial biotechnology. 

Human resources in R&D: Researchers 

Human  resources  are  vital  to  R&D.  The  need  to  take  action  has  been  acknowledged.  The 
Commission  has  taken  a  proactive  role,  from  promoting  and  financing  several  initiatives  to 
attempting to streamline legislations, in an attempt to improve the researchers’ environment 
and  to  make  the  European  Research  Area  more  attractive  to  scientists  in  and  outside  the 
Union. As part of the implementation of the Mobility Strategy for the European Research 
Area15,  the  Commission  has  launched  several  initiatives,  in  close  cooperation  with  the 
Member States, including the “The Researcher’s Mobility Portal”16, which provides web-
based national and Community information on a European scale, specific job and fellowship 
opportunities  for  researchers,  and  the  European  network  of  mobility  centres(  ERA-
MORE)  which  will  provide  researchers  and  their  families  with  customised  assistance  in  all 
matters relating to their working and daily lives when undertaking a mobility experience. 

13 

14 

15 
16 

E.g.  "Biotechnology  for  Clean  Industrial  Products  and  Processes:  Towards  Industrial  Sustainability", 
1999; and "The Application of Biotechnology to Industrial Sustainability", 2001; OECD, Paris. 
COM(2004)38  final  “Stimulating  Technologies  for  Sustainable  Development:  An  Environmental 
Technologies Action Plan for the European Union.( http:\\europa.eu.int/comm/environment/etap)  
(COM(2001)331 final of 20.06.2001) 
http://www.europa.eu.int/eracareers 

13 

 
 
  
 
                                                 
The  budget  for  the  Structuring  Activity  “Human  resources  and  mobility”  under  the  6th 
Framework  Programme  for  Research  has  been  almost  doubled  from  the  5th  Framework 
Programme  value17.  Research  training  opportunities  in  Europe  for  researchers  have  been 
reinforced. Specific grants providing return opportunities for those European researchers who 
have spend long periods outside Europe as well as International Marie Curie Fellowships 
and Marie Curie Excellence Grants and Chairs to attract world-class researchers to Europe 
have  been  introduced.  As  a  result  of  the  first  calls  for  proposals  €47  million  (13%  of  the 
budget) has been allocated to “Human resources and mobility”/”Marie Curie” actions in Life 
Sciences and Biotechnology. 

In  its  Communication “Researchers  in  the  European  Research  Area:  one  profession, 
multiple careers”18, the Commission addresses for the first time at European level the issue 
of the researcher profession and researchers’ careers. 

A proposal for a Directive on the  entry and stay of third country researchers within  the  EU 
and an associated action plan was adopted by the Commission on 16 March 200419. 

The Commission is launching a series of initiatives, which will be implemented in the course 
of 2004, in order to open a structured dialogue between the different stakeholders. 

Priorities for future actions 

Commission 

►  to  propose  Recommendations  on  a  “European  Researcher’s  Charter”,  a  framework  for  the 
career management of human resources in R&D, based on voluntary regulation, as well as on a 
“code of conduct for the recruitment of researchers” to improve recruitment methods, and to 
launch studies to assess and benchmark the multiple career paths of researchers. 

Future Research Policy Initiatives 

The  Commission  is  now  starting  to  reflect  on  the  design  of  the  next  European  Research 
Framework Programme. A vision for future research activities is vital in order to maintain and 
increase  momentum  towards  an  effective  knowledge-based  economy  and  society.  Taking 
current  initiatives  as  a  basis  and  identifying  the  needs  and  expectations  of  the  scientific 
community, policy-decision-makers and society, an orientation document will be presented to 
initiate a debate engaging all stakeholders. 

Priorities for future actions 

Commission 

►  to present a Communication regarding future research policy initiatives in May 2004. 

►  to prepare a revision of the Community framework on state aid for R&D. 

17 
18 
19 

Human capital web site: http://www.europa.eu.int/comm/research/fp6/mariecurie-actions/home_en.html 
COM(2003)436 of 18.07.2003 
COM(2004)178 final 

14 

 
 
  
 
                                                 
3.2. 

Governing life sciences and biotechnology 

Social scrutiny and dialogue 

Uncertainties  about  social  acceptance  of  biotechnology  have  continued  to  weaken  the  EU’s 
capacity  for  innovation.  With  the  exception  of  medical  applications,  public  expectation  of 
biotechnology,  with  particular  reference  to  agricultural  applications,  remains  moderate. 
Therefore, the Commission, together with all interest stakeholders, has continued its efforts to 
bring science and society closer together and to develop an understanding of and information 
exchange on life sciences and biotechnology. However, it is imperative that industry should 
openly  explain  and  document  the  benefit  and  potential  of  this  technology  in  all  its  fields  of 
application,  and  the  initiatives  to  a  broader  dialogue  by  the  industry  and  by  the  European 
Federation of Biotechnology are to be welcomed. 

As envisaged in Action 13(a) of the Strategy, the Commission organised the first stakeholder 
conference  entitled  “Risk  perception:  Science,  Public  Debate  and  Policy  making”  in 
December  2003.  The  objective  of  the  conference  was  to  explore  the  effect  of  human 
perception  on  risk  assessment  and  risk  analysis  and  its  significance  and  implications  in 
promoting key scientific paradigms underlying regulatory oversight and governance. 

The  emergence  of  “Technology  Platforms”  is  expected  to  add  a  new  dimension  of 
dynamism  to  societal  dialogue  by  bringing  together  all  interested  stakeholders  -  research 
organisations,  industry,  regulators,  user  groups,  etc.  –  around  key  technologies,  in  order  to 
devise and implement a common strategy for the development, deployment and use of these 
technologies in Europe. 

The  importance  of  research  communication,  openness  and  researchers  contact  with  society 
has  been  recognised  and  Member  States  as  well  as  the  Commission  have  taken  actions  to 
identify measures and tools to improve communication. Within FP6 research communication 
to the general public is an integral part of the research projects.  

Priorities for future actions 

Commission and Member States 

►  to  engage  in  exchange  of  experience  in  order  to  establish  a  more  comprehensive  strategy  for 

communicating research. 

We  can  not  neglect  that  at  the  same  time  as  research  in  Life  Science  and  Biotechnology  is 
demonstrating  its  vast  potential  for  improving  quality  of  life,  weapons  engineered  to  attack 
humans, animals or plants is becoming an increasing concern. 

It  is  clear  that  a  central  component  of  the  debate  is  to  raise  the  awareness  of  the  global 
scientific community also about this dual-use “tension” and the responsibility to mitigate any 
possible risks associated with research in Life Science and Biotechnology. As a first initiative 
to stimulate an international dialogue, the Commission organised a conference 3-4 February 
2004 on the “Ethical implications of scientific research on bioweapons and prevention of bio 
terrorism”.  The  participants  appeared  to  agree  that  concerning  the  restriction  of  release  of 
scientific  results,  the  benefits  of  releasing  scientific  information  outweighs  the  risk  of  its 
misuse. 

15 

 
 
  
 
Developing  life  sciences  and  biotechnology  in  harmony  with  ethical  values  and  societal 
goals 

The immediate responsibility of the Commission is to ensure public trust and confidence in its 
research  projects.  The  application  of  the  ethical  review  system  in  the  FP6  has  been  made 
more  consistent  and  systematic  for  research  project  involving  human  beings,  human  tissue, 
private or personal data, genetic information and/or animals. A reporting system has improved 
the governance and transparency of such EC funded research. It also acts as a mean for raising 
the awareness of research regarding ethical issues. 

Several specific actions have been undertaken in the context of implementation of the Science 
and Society action plan20. In particular, a Forum of the Presidents of the National Ethics 
Councils  has  been  established,  allowing  for  an  exchange  of  positions  and  views  about 
important  topics  of  bioethics  and  ethics  in  research  in  Europe.  A  directory  of  local  ethics 
committees has been collected in the 33 countries of ERA. 

Priorities for future actions 

Commission 

►  to  establish  a  documentation  and  information  system  on  ethics  in  research  in  2005.  The 
system  will  be  based  on  a  FP5  project  and  a  feasibility  study  launched  in  February  2004.  It  will 
provide information on the different legislation, debates and important literature in ERA 

The  European  Group  on  Life  Sciences  (EGLS)  has  been  continuing  its  activities  towards 
facilitating  broad  communication  and  societal  dialogue  on  life  sciences  and  biotechnology. 
An  Encounter  -  Modern  Biology  and  Visions  of  Humanity  -  gathering  scientists,  humanists 
and scholars from the arts to reflect on the reciprocal impact of life sciences, our cultures and 
societies, took place on 22-23 March 2004.  

In accordance with the statements to the minutes of the Council of 30 September 2003 on the 
specific programme “Integrating and strengthening the European Research Area” and in order 
to  contribute  to  the  current  debate  within  the  context  of  deciding  on  the  funding  of  human 
embryonic  stem  cell  research  under  the  FP6,  the  following  steps  were  taken  by  the 
Commission: 

20 

COM(2001)714 final 

16 

 
 
  
 
                                                 
–  a report on human embryonic stem cell research was published on 3 April 

2003 (SEC(2003) 441); 

–  an inter-institutional seminar was organised on 24 April 2003 on the same 

subject; 

–  procedural  modalities  for  research  activities  involving  banked  or 
isolated  human  embryonic  stem  cells  in  culture  to  be  funded  under  FP6 
were  adopted  by  the  Commission  on  11  November  2003  (  C(2003)  2952). 
These  modalities  clarify  the  procedure  which  the  Commission  will  follow 
when  evaluating  selecting  and  supporting  research  projects  involving  such 
research activities; 

–  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 within the framework of FP6, was submitted to the Institutions in July 
2003.  Although  supported  by  the  European  Parliament,  these  guidelines 
were not adopted by the Council. 

Confidence in science-based regulatory oversight 

Review of the pharmaceutical legislation 

The review of the pharmaceutical legislation was adopted on 11 March 2004. There are three 
elements  of  particular 
the  development  of  stronger  entrepreneurial 
biotechnology,  namely  a  series  of  provisions  to  develop  and  reinforce  the  system  of  giving 
scientific advice through the creation of expert panels and permanent working groups in the 
EMEA, the introduction of a fast-track marketing authorisation procedure for products with a 
major public health interest for European patients, and a conditional marketing authorisation.  

importance  for 

In  parallel,  the  G10  process,  launched  in  2001,  has  already  passed  some  significant 
milestones. Following the Council Conclusions on the Communication21, the G10 process has 
now entered its implementation phase. 

Most of the Recommendations will be implemented through existing EU programmes such as 
the Pharmaceutical Review, the FP6 and the Public Health Programme. However, it will be 
supplemented  by  specific  exercises  to  take  forward  recommendations  on  benchmarking, 
patient  information,  pricing  and  relative  effectiveness.  To  make  progress  in  these  areas  will 
require  both  the  Commission  and  Member  States  to  take  joint  action  building  on  the 
consensus developed through the G10 process. 

Genetically Modified Organisms (GMOs) legislation 

On 28 January 2004, the Commission held an orientation debate on GMOs and related issues 
to take stock of the progress made in recent years in building a comprehensive EU regulatory 
framework on GMOs, in close dialogue with Member States and all stakeholders22. 

21 

Communication  from  the  Commission  to  the  Council,  the  European  Parliament,  the  Economic  and 
Social  Committee  and  the  Committee  of  the  Regions  ‘A  stronger  European-based  Pharmaceutical 
Industry for the Benefit of the Patient – A Call for Action COM(2003)383 final 

17 

 
 
  
 
                                                 
Regulatory Framework on GMOs 

–  Directive  2001/18/EC23,  which  provides  for  a  more  complete  authorisation  procedure  for 

GMOs, has been fully applicable since 17 October 2002;  

– 

the  two  new  Regulations  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, have been adopted by the Council and EP 
and will be fully applicable by April 200424; Regulation (EC) No 1829/2003 covers GMOs 
for food and feed use as well as food and feed containing, consisting of, or produced from 
GMOs. The Regulation is based on the “one door-one key” principle. Thus, it is possible to 
file a single application for obtaining both the  authorisation for the deliberate release of a 
GMO  into  the  environment,  under  the  criteria  laid  down  in  Directive 2001/18/EC  and the 
authorisation  for  use  of  this  GMO  in  food  and/or  feed  under  the  criteria  laid  down  in 
Regulation  1829/2003.  This  authorisation,  valid  throughout  the  Community,  is  granted 
subject  to  a  single  risk  assessment  process  under  the  responsibility  of  the  European  Food 
Safety Authority and a single risk management process involving the Commission and the 
Member States through a regulatory committee procedure. 

The Regulation extends the labelling provisions to all genetically modified food and feed 
irrespective of the detectability of DNA and protein. The applicability of this requirement 
is  ensured  through  the  provisions  laid  down  in  Regulation  1830/2003  on  traceability  and 
labelling. In order to ensure the feasibility and practicability of the Regulation, provisions 
regarding  derogation  for  adventitious  or  technically  unavoidable  presence  of  GMOs  in 
food/feed have been foreseen. 

–  a  number  of  implementing  measures  and  guidelines  for  the  above  legislation  have  been 
adopted or  are  in  preparation  with  a  view  to  completing and  ensuring full  applicability  of 
the new regulatory framework by April 2004; 

–  Regulation (EC) No 1946/2003 on transboundary movements of GMOs was adopted on 
15 July 2003 by the Council and the EP and is applicable as of 25 November 2003 25. This 
Regulation complements the above regulatory framework on GMOs, in particular as regards 
exports,  and  aligns  it  with  the  provisions  of  the  Cartagena  Protocol  on  Biosafety,  which 
entered into force on 11 September 2003. 

On  that  occasion,  the  Commission  reconfirmed  its  approach  on  GMO  authorisation 
procedures and agreed on a number of actions in the short term. 

The Commission now expects more active co-operation from all Member States in ensuring 
correct  implementation  of  the  new  legislation  governing  GMOs,  which  they  themselves 
demanded—and subsequently committed themselves to. 

Regrettably, 
their 
implementation measures for Directive 2001/18/EC26. These are currently being assessed by 

to  date  only  seven  Member  States  have  fully  communicated 

22 

23 
24 

25 

26 

Communication to the Commission available at: 
http://www.europa.eu.int/rapid/start/cgi/guesten.ksh?p_action.gettxt=gt&doc=IP/04/118|0|RAPID&lg=
EN&display= 
OJ L 106, 17.4.2001, p.1. 
Regulation (EC) No 1829/2003 of the EP and of the Council of 22.9.2003 on genetically modified food 
and  feed  (OJ  L  268,  18.10.2003,  p.1;  Regulation  (EC)  No  1830/2003  concerning  the  traceability  and 
labelling  of  genetically  modified  organisms  and  the  traceability  of  food  and  feed  products  produced 
from genetically modified organisms and amending Directive 2001/18/EC (OJ L 268, 18.10.2003, p.24) 
Regulation  (EC)  No  1946/2003  of  the  European  Parliament  and  of  the  Council  on  the  transboundary 
movement of GMOs (OJ L 287, 5.11.2003, p.1). 
UK, Denmark, Sweden, Portugal, Italy, Spain and Ireland. 

18 

 
 
  
 
                                                                                                                                                         
the Commission for their conformity. The Commission has referred the eight Member States 
that have still not adopted national transposition measures to the European Court of Justice. 

Priorities for future actions 

Member States 

►  to fully and swiftly transpose and implement Directive 2001/18/EC, 

►  to withdraw national measures invoked under the novel food regulations and under environmental 

legislation and to lift the relevant restrictions. 

Commission 

►  to complete the adoption of implementing measures and guidelines, 

►  to adopt labelling thresholds for the adventitious or technically unavoidable presence of authorised 
GM  seeds  in  seeds  of  non-GM  varieties  under  Article  21(2)  of  Directive  2001/18/EC.  Similar 
thresholds will then be adopted under the Seeds Directives. 

Co-existence of GM crops with conventional and organic crops 

The  cultivation  of  GM  crops  may  have  implications  for  the  organisation  of  agricultural 
production. Co-existence refers to the ability of farmers to make a practical choice between 
conventional,  organic  and  GM  crop  production  in  compliance  with  the  legal  obligations  for 
labelling and purity standards. 

At its meeting on 5 March 2003, the Commission agreed that it should be up to the Member 
States  to  develop  and  implement  management  measures  concerning  co-existence,  in 
accordance with the subsidiarity principle. The Round Table hosted by the Commission on 
24  April  2003  to  examine  the  latest  research  results  on  the  co-existence  of  GM  and 
non-GM crops concluded that any approach needs to take account of the diversity in regional 
conditions, which argues against a unified Community approach towards co-existence. 

In  the  light  of  the  above,  on  23  July  2003,  the  Commission  adopted  a  Recommendation 
setting  out  guidelines  for  the  development  of  national  strategies  and  best  practices  to 
ensure the co-existence27 of GMOs with conventional and organic farming.  

The guidelines provide a list of general principles and elements for the development of national 
strategies and best practices as well as an indicative catalogue of measures that can be used to 
reduce  or  avoid  the  accidental  mixture  of  GM  and  non-GM  crops.  The  basic  principle 
underlying the guidelines is that no form of agriculture, be it GM, conventional or organic, 
should  be  excluded  in  the  EU  in  the  future.  Measures  for  co-existence  should  be  efficient, 
cost-effective and proportionate and should not go beyond what is necessary to ensure that the 
adventitious presence of GMOs stays below the tolerance thresholds. 

The  subsidiarity  approach  was  endorsed  by  the  Council  and  the  European  Parliament  last 
July, when a new Article specifically authorising Member States to take appropriate measures 
to  avoid  “the  unintended  presence  of  GMOs  in  other  products”  was  introduced  in  the 
environmental legislation (i.e. Article 26(a) of Directive 2001/18/EC on the deliberate release 
into the environment of GMOs). This Article also establishes that the role of the Commission 
is to gather and co-ordinate information and observe developments regarding co-existence in 

27 

Commission Recommendation 2003/556/EC on co-existence. 

19 

 
 
  
 
                                                 
the  Member  States.  In  the  Recommendation  itself,  the  Commission  committed  itself  to 
coordinating  the  exchange  of  information  on  measures,  experiences  and  best  practices 
supplied by the Member States. 

Many Member States are now seeking clarification as to what sort of co-existence measures 
would be legally acceptable.  

The  Commission  recommendation  on  co-existence  was  discussed  in  the  Council  of 
Agricultural  Ministers  of  29  September  2003,  where  Member  States  and  acceding  countries 
were  split  between  supporting  the  subsidiarity  approach  and  requesting  that  rules  on  co-
existence be established at Community level.  

Furthermore, on 18 December 2003, the EP plenary adopted an own-initiative report calling 
for uniform and binding rules on co-existence to be established at Community level, including 
Community-wide  liability  rules  and  insurance  in  respect  of  possible  economic  damage  in 
connection with co-existence. 

Several Member States have been considering their policies on co-existence. Following public 
debate, science  review  and  studies on the costs and benefits  of GM crops. National debates 
were organised, amongst other initiatives, in the UK28 and Denmark. National co-existence 
strategies are in advanced stage of adoption by Denmark and Germany.  

While  a  number  of  draft  “co-existence”  measures  have  already  been  notified  to  the 
Commission,  the  Commission  is  also  aware  of  non-notified  co-existence  measures,  taken  at 
national,  regional  or  local  level,  which  might  contradict  Community  legislation  and  could 
prompt infringement procedures. 

Priorities for future actions 

Member States 

►  to ensure an exchange of information on successful approaches and best practices and to notify 

national or regional measures on co-existence to the Commission. 

Commission 

►  to  enhance  its  co-ordination  role  as  defined  in  Directive  2001/18/EC,  in  order  to  smooth  any 

potential problems linked to the development of co-existence strategies by Member States, 

►  to report to the Council and the European Parliament, using information from the Member States, 
on  the  experience  gained  in  the  Member  States  concerning  the  implementation  of  measures  to 
address co-existence, including, where appropriate, an evaluation and assessment of all possible 
and necessary steps to be taken. 

3.3. 

Europe in the world - responding to global challenges 

A European Agenda for international cooperation 

The Commission has continued to play an active role in developing international guidelines, 
standards  and  recommendations  in  the  relevant  sectors  and  within  established  international 
forums  such  as  UN-organisations,  OECD,  the  Council  of  Europe  Steering  Committee  on 
Bioethics. Now that the Community has become a full member of the Codex Alimentarius 

28 

Further details are available on the "GM Nation" web site - http://www.gmnation.org.uk/ 

20 

 
 
  
 
                                                 
Commission,  the  Commission  intends  to  contribute  in  full  to  the  development  of  Codex 
guidelines relating to food produced from biotechnology. 

An  important  example  of  this  commitment  is  the  Commission's  role  in  the  works  of  the 
Cartagena Protocol on Biosafety which entered into force on 11 September 2003. At the First 
Meeting  of  the  Parties  to  the  Cartagena  Protocol,  held  in  Kuala  Lumpur  (23-27  February 
2004),  a  consensus  was  reached  in  relation  to  documentation  requirements  for  the 
transboundary  movement  of  GMOs,  on  an  action  plan  to  help  developing  countries 
implementing the Protocol, on a compliance mechanism and on a fully operational internet-
based Clearing House for the international exchange of information related to GMOs.  

At the same time, it has promoted and participated in initiatives aimed at improving dialogue 
with our trade partners towards a better understanding of the issues relating to the application 
of biotechnology and its governance.  

The Commission actively participated in the UNIDO Global Biotechnology Forum, which 
took place in Chile 2-5 March 2004.  

Constructive and fruitful bilateral dialogues with Japan, which, like the EU, also launched a 
strategy for life sciences and biotechnology in 2002, have taken place within the framework 
of  the  EU-Japan  Industrial  Policy  Dialogue  and  within  the  industry-led  EU-Japan  Business 
Dialogue Round Table.  

However,  on  29  August  2003  the  long-standing  divergence  of  views  between  the  EU  and 
some of its trading partners culminated in the establishment of a WTO panel, at the request 
of the US, Canada and Argentina, to rule on the matter of GMOs.  

The  Commission  has  always  made  it  clear  that  a  WTO  challenge  is  an  inappropriate  and 
regrettable move. At a time when most countries are developing appropriate legal frameworks 
to deal with the modern techniques of genetic modification, the decision to start a WTO case 
is in stark contrast with the spirit of co-operation that should herald the global trend towards 
more comprehensive and better regulation. While it is only right and proper for states to raise 
their  legitimate  trade  concerns  through  the appropriate  channels,  the  Commission  views  the 
WTO  challenge  on  GMOs  as  an  obstacle  to  the  search  for  common,  trade-enhancing 
approaches to biotechnology. 

The Commission will continue to promote international and bilateral cooperation in the field 
of biotechnology. The Commission considers that there are important political and technical 
issues  that  need  to  be  addressed  at  international  level  and  remains  committed  to  discussing 
those issues with any parties willing to enter into a constructive dialogue. 

Europe’s responsibilities towards the developing world 

Agriculture and Genetic Resources 

The  EC  is  the  main  contributor  to  the  new  Consultative  Group  on  International 
Agricultural  Research  (CGIAR)  Challenge  Program  “Unlocking  Genetic  Diversity  in 
Crops  for  the  Resource-Poor”,  which  is  developing  a  unique  platform  involving  public, 
private and civil society partners for accessing and developing new genetic resources using 
the  programme,  an 
new  molecular 
unprecedented  array  of  genomic  and  genetic  resources,  ready  for  direct  use  in  plant 
improvement,  will  be  made  available  as  public  goods  in  the  form  of  enabling  technologies 

traditional  means.  Through 

technologies  and 

21 

 
 
  
 
and  intermediate  products  for  crop  improvement  programmes.  Tolerance  to  drought  will  be 
the first issue to be considered for proof of concept. 

Health 

In February 2003, the Commission adopted a Communication reviewing progress achieved 
under  the  Programme  for  Action  entitled  "Accelerated  action  on  HIV/AIDS, malaria and 
TB in the context of poverty reduction" and putting forward recommendations for further 
actions29. 

In terms of ‘increasing investment in research and development’, substantial resources have 
been  allocated  from  the  Research  Framework  Programmes  for  HIV/AIDS,  malaria  and  TB 
research,  including  the  establishment  of  the  new  European  and  Developing  Countries 
Clinical  Trials  Partnership  (EDCTP)  initiative  which  is  the  first  joint  programme  to  bring 
together  the  efforts  of  several  Member  States  aimed  at  developing  and  evaluating  new 
vaccines and drugs against those diseases. The EDCTP clearly constitutes a new step forward 
as it provides a unified voice to represent European research contributions in the fight against 
the  three  diseases  in  developing  countries.  Additional  direct  and  indirect  incentives  for 
research  and  development  of  specific  global  public  goods  to  fight  the  three  diseases  will 
require primary focus in the coming years. 

European and Developing Countries Clinical Trials Partnership (EDCTP) 

The  EDTCP  was  adopted  in  June  2003  and  will  be  fully  operational  during  the  first  half  of 
2004. It is an independent legal entity with its own operational procedures, including calls for 
proposals  and  appropriate  selection  of  the  clinical  trials  to  be  fully  or  partially  funded.  The 
EDCTP has a target budget of € 600 million. The Community will contribute one third of the 
budget via the 6th FP, whereas another € 200 million will be provided by Member States and 
Norway.  The  remaining  €  200  million  will  be  sought  from  private  sources,  R&D  industry, 
foundations, charities and Community development funds (e.g. EDF).  

A carefully balanced management structure ensures that developing countries are equal partners 
in strategic decisions.  

In  addition,  financial  support  for  research  projects  under  FP6  in  the  area  of  poverty-related 
diseases  (HIV/AIDS,  malaria  and  tuberculosis)  is  significantly  increased.  Support  will  be 
given to Preclinical and early clinical testing of new drugs, vaccines and microbicides for 
HIV/AIDS, malaria and  TB. Support will be given in particular to large research consortia 
that  integrate  different  disciplines  and  approaches  and  can  generate  a  critical  mass  between 
the  different  players  involved.  Active  participation  of  partners  from  endemic,  developing 
countries is specifically encouraged. The first call for proposals under FP6 resulted in funding 
projects, among others, for the development of a new TB vaccine and for preclinical testing of 
vaccines and microbicides targeting HIV. 

Finally, the Commission will also continue to support research on further neglected tropical 
diseases, such as ''sleeping sickness''. 

29 

COM(2003)93 final 

22 

 
 
  
 
                                                 
3.4. 

Newly Emerging issues 

Tissue engineering 

Tissue  engineering  is  a,  young  and  emerging  multidisciplinary  biotechnology  sector  which 
promises  to  change  medical  practice  profoundly,  regenerating  diseased  tissues  and  organs 
instead of just repairing them. However, as highlighted in a report of the Commission’s Joint 
Research Centre (JRC)30, the size of the tissue engineering market and the commercial range 
of applications is still in its infant phase, mostly because the first products (skin, cartilage and 
bone) have “conventional” alternatives firmly rooted in the market. This situation may change 
if  tissue  engineering  begins  to  produce  applications  with  life  saving  properties,  and  targets 
conditions with no conventional counterparts. Several significant scientific and technological 
challenges  still  have  to  be  met.  Meanwhile  the  regulatory  framework  applied  differs  from 
Member State to Member State. The lack of a clear and uniform regulatory framework leads 
to  legal  uncertainty  and  to  a  fragmentation  of  this  emerging  market.  This  might  in  the  long 
term undermine EU competitiveness in the sector. 

In  its  report,  the  CBAG  has  called  for  new  market  authorisation  legislation  for 
biotechnology-based healthcare applications that are not considered medicines or medical 
devices, such as human tissue engineering. 

Priorities for future actions 

Commission 

►  to prepare legislation to harmonise the authorisation procedures for marketing products/processes 
from  human  tissue  engineering,  while  guaranteeing  a  high  level  of  protection  for  patients,  to  be 
presented to Parliament and Council before summer 2004. 

Genetic testing 

Genetic  testing  is  a  most  relevant  example  of  leading-edge  research  and  development  - 
showing potential for the benefit of society - and at the same time having policy implications 
for  research,  public  health,  regulation,  fundamental  rights,  ethics  and  international 
cooperation beyond the EU.  

A  growing  number  of  laboratories  in  Europe  and  the  world  are  offering  a  wide  and  varied 
array  of  genetic  testing  and  analysis  services.  These  practices  are  becoming  increasingly 
frequent, highly variable in quality, and available across national boundaries and some genetic 
tests are becoming the subject of uncontrolled “mass marketing”, including via the Internet. In 
a  recent  statement,  the  European  Group  on  Ethics  (EGE)  warned  against  the  risks  of 
advertising genetic testing via the Internet31. 

As yet no EU Member State is self-sufficient in testing for rare diseases, and cross-border co-
operation  remains  suboptimal,  highlighting  the  need  to  encourage  a  broader  exchange  of 
information and samples though trans-national networking, which is essential for ensuring the 
development of tests as well as for accessibility to genetic testing. 

30 

31 

The  JRC  report  “Human  tissue-engineered  products.  Today’s  markets  and  future  prospects”  may  be 
downloaded at: http://www.jrc.es 
http://europa.eu.int/comm/european_group_ethics/docs/statgentest-en.pdf 

23 

 
 
  
 
                                                 
Although  genetics  specialists  and  professional  organisations  have  made  many  moves  to 
promote  quality  assessment,  genetic  testing  services  are  provided  under  widely  varying 
conditions and regulatory frameworks in different countries, including in the EU. The recent 
prospective  study  from  the  Commission’s  JRC32  identifies  shortcomings  and  measures  to 
ensure the highest quality of such services, including 

►  harmonised quality control genetic tests and the counselling that accompanies them,  

►  development of a common range of certified reference materials,  

►  better cross-border co-operation, and  

►  the establishment of a European database of genetic testing centres 

In view of the increasing international trade in genetic tests and services (60% of genetic test 
specimens are circulate across borders), and the policy issues this raises, the Commission and 
the  OECD  jointly  organised  an  EC-OECD  Colloquium  on  Genetic  Testing  Quality 
Assurance, held in Brussels on 6 October 2003. As a result of the discussions the OECD is 
now considering drafting “codes of conducts” for quality assurance of genetic testing.  

level  expert  group  “ETAN-STRATA”,  composed  of  representatives  from 
A  high 
pharmaceutical  companies,  NGOs  (in  particular  patient  organisations),  scientists  and  social 
and  legal  experts  has  been  discussing  the  ethical,  legal  and  social  implications  of  genetic 
testing for a year now. A final report including actions and recommendations to be undertaken 
will be published in April 2004. It should provide the basis for a wider  discussion on  these 
recommendations at a stakeholder conference planned for 6-7 May 2004.  

Furthermore, the Commission organised, in collaboration with the “European Association of 
Mutualities”  a  conference  on  the  impact  of  genetic  testing  on  the  heath  insurance  system 
“New genetic applications and access to healthcare” in Brussels, 24-25 March 2004. 

Following a request from the Commission, the EGE gave an opinion in July 2003 on genetic 
testing in the workplace33, recommending that legal measures should be taken at EU level to 
preserve the confidentiality of genetic data, including in the event of transborder movement of 
employees/employers,  i.e.  in  the  context  of  free  movement  of  workers  within  the  EU.  A 
proposal for a Directive on the protection of workers’ personal data in the employment 
context is currently under preparation. 

The various activities undertaken regarding genetic testing at European and international level 
have indicated the need for a co-ordinated approach to this emerging field. 

32 

33 

The  JRC report  “Towards quality  assurance  and harmonisation of  genetic  testing  services  in  the  EU” 
may be downloaded at: http://www.jrc.es 
The  EGE  opinion  “Ethical  aspects  of  genetic  testing  in  the  workplace”  may  be  downloaded  at: 
http://www.europa.eu.int/comm/european_group_ethics/index_en.htm 

24 

 
 
  
 
                                                 
Priorities for future actions 

Commission and Member States 

►  to engage in EU-wide co-ordination of efforts to ensure the highest quality of genetic testing in 

the EU and beyond EU-25, 

►  to  establish  EU-wide  networking  of  national  centres  for  exchanges  of  information  regarding 
quality  assurance  of  genetic  testing,  including  training  activities,  and  EU-wide  networking  for 
genetic testing of rare diseases. 

Animal biotechnology 

Animal biotechnology, like many other categories of biotechnology, covers a wide range of 
applications. As much as any other category, it may become economically significant but also 
controversial.  Its  technological  development  seems  to  be  approaching  the  point  where  the 
commercialisation of startling innovations is starting to attract public attention. 

The  EU’s  case-by-case  approach  to  the  deliberate  release  of  GMOs  into  the  environment 
applies to both  GM animals  and GM plants. Thus authorisation  to place any GM variety of 
animal species on the market would require a rigorous scientific assessment of possible risks 
to  the  environment  and  human  health  before  the  marketing  of  the  animal  is  authorised. 
Similarly, the marketing of food and feed products produced from such GM animals would be 
subject  to  cases  by  cases  authorisation  based  on  a  rigorous  scientific  risk  assessment.  The 
existing regulatory framework for GMOs appears to be satisfactory at EU level. 

Another emerging issue is the application of cloning technology in animals, and in particular 
the introduction of products obtained from cloned livestock into the food chain. It may raise 
ethical and social and safety concerns. 

Priorities for future actions 

Commission 

►  to launch initiatives on the potential benefits, risks and possible new policy issues associated with 

the application of animal cloning, including a prospective study. 

4. 

OVERALL CONCLUSIONS 

Since  last  year’s  report,  further  progress  has  been  made  on  implementation  of  the  Strategy 
and  roadmap  on  Life  Sciences  and  Biotechnology.  The  review  of  the  Pharmaceutical 
legislation  and  the  GMO  regulatory  framework  have  both  been  completed,  guidelines  on 
coexistence  in  agriculture  have  been  published,  and  FP6  provides  a  major  incentive  for 
research in this area. 

However, there is no doubt that there is a lot to be done to improve the situation for European 
biotechnology and its competitiveness: 

–  public and private investment in research needs urgently to be increased, 

–  biotechnology companies’ access to finance needs to be further improved. 

25 

 
 
  
 
The  next  stage  in  the  strategy  is  for  the  various  authorities  and  organisations  to  make 
commitments  and  to  begin  delivering  the  new  policy  measures  in  accordance  with  the 
responsibilities set out in the action plan.  

This  involves  not  only  the  European  Institutions;  it  also  seeks  to  include  measures  that  are 
more  the  responsibility  of  the  Member  States  and  other  public  authorities  and  the  private 
sector. The Commission is directly responsible for some actions but it is also determined to do 
what it can to keep up the general momentum and to play a facilitating role. For their part, the 
Member States are now actively working with the Commission to flesh out the details of how 
some of the actions should be implemented. However, they also still need to make progress 
on the implementation of measures to which they are already committed.  

One  major  example  is  intellectual  property,  where  delays  have  occurred  in  the 
implementation of Directive 98/44/EC, on the legal protection of biotechnological inventions. 
The  slow  progress  in  adopting  a  practical  Community  Patent  Regulation  is  also  a  source  of 
concern. 

Member States and the Commission  will also have to continue their collaboration to ensure 
that the follow up of the G10 process moves forward effectively in all its aspects. 

More  active  co-operation  from  all  Member  States  is  also  needed  in  the  implementation  of 
the  new  legislation  governing  GMOs.  Having  demanded—and  subsequently  committed 
themselves  to—a  more  rigorous  framework,  it  is  now  imperative  that  all  Member  States 
should implement the basic Directive 2001/18/EC on the authorised release of GMOs into the 
environment and the two regulations on traceability/labelling and on GM/food and feed.  

Against  the  background  of  the  renewed  political  debate  on  the  Lisbon  agenda  of  task  to 
revamp Europe’s competitive position, there is an acknowledged need to step up the measures 
to  fulfil  the  Lisbon  commitments.  The  Biotechnology  Strategy  includes  many  subjects  and 
stakeholders and the Union has to ensure that the coherence of its efforts is maintained. This 
calls  for  strengthened  coordination  and  cooperation  between  Member  States  and  the 
Commission,  with  the  aim  of  improving  Europe’s  competitiveness.  The  Commission 
suggests that on the basis of this Report, the Council discuss the state of implementation and 
what  further  measures  may  usefully  be  taken  to  achieve  these  objectives.  Against  this 
background, the Commission also proposes to reinforce the role of the existing Biotechnology 
network with Member States. 

26