Communication from the Commission to the Council, the European Parliament, the European Economic and Social Committee and the Committee of the Regions on the mid term review of the Strategy on Life Sciences and Biotechnology {SEC(2007) 441}
Date: 2007-04-10
Institutions: European Commission
Subjects: EU research policy, agricultural production, biotechnology, competitiveness, innovation, life sciences, public awareness campaign, public health, report

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 10.4.2007 
COM(2007) 175 final 

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

on the mid term review of the Strategy on Life Sciences and Biotechnology 

{SEC(2007) 441} 

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1. 

PREPARING THE EU FOR 2010 

Life  sciences  and  biotechnology1  is  a  fast-evolving  area  with  direct  or  potential 
significance  for  European  businesses  and  European  policymakers.  It  plays  an 
increasing  and  accepted  role  in  the  health  sector,  with  the  development  of  new 
techniques for treatments and disease prevention. The industrial landscape in Europe 
is steadily being transformed by the use of life sciences and biotechnology by a large 
number of industries, resulting in a wide range of products already on the market2.  

The "bio-economy" therefore has the potential to contribute to key EU policy goals 
and  help  address  new  challenges  in  relation  to  health,  energy  supplies,  global 
warming  or  an  ageing  population.  The  knowledge  and  skills  available  in  Europe 
leaves  it  well  placed  to  exploit  this  potential  both  within  Europe  and  on  a  global 
scale, including in its relations with developing countries. 

Biotechnology is an important means to promote growth, jobs and competitiveness in 
the  EU.  The  use  of  biotechnology  is  however  not  without  controversy  and  the 
enhanced use of biotechnology needs to be accompanied by a broad societal debate 
about  the  potential  risks  and  benefits  of  biotechnology  including  its  ethical 
dimension. 

The European Council and the European Parliament have recognised the importance 
of  life  sciences  and  biotechnology,  and  the  Commission  has  put  forward  an  action 
plan  to  address  the  challenges  and  opportunities  involved.  This  Strategy  on  Life 
Sciences  and  Biotechnology3,  adopted  by  the  Commission  in  2002,  proposed  a  30 
point  action  plan  involving  the  Commission,  the  other  European  Institutions  and 
other stakeholders. It runs until 2010. 

The  scope  of  the  Strategy  –  the  first  of  its  kind  at  EU  level  –  was  originally  very 
broad,  to  cover  all  possible  relevant  policy  issues  and  facilitate  the  uptake  of  the 
technology  in  a  wide  range  of  different  sectors.  Action  was  proposed  under  four 
headings:  harvesting  the  potential  (research,  access  to  capital  etc),  promoting 
governance  (social  dialogue,  ethical  scrutiny  etc),  answering  global  challenges 
(encourage  scientific  cooperation  with  developing  countries  etc)  and  ensuring 
coherence between the full range of policies concerned. 

The implementation of the Strategy is now at its mid point. It is time to evaluate the 
progress achieved since 2002 and update the Strategy, to reflect new analysis of how 

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According  to  the  latest  OECD  definition,  biotechnology  is  defined  as  "the  application  of  science  and 
technology  to  living  organisms  as  well  as  parts,  products  and  models  thereof,  to  alter  living  or  non-
living  materials 
services". 
http://stats.oecd.org/glossary/index.htm 
Such as, for example, vaccines against Hepatitis B, fruit juice concentrates or car bumpers made out of 
bioplastic 
COM(2002)27 of 23/01/2002 

knowledge, 

production 

goods 

and 

the 

for 

of 

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this fast-moving sector could contribute to EU policies4. This is the purpose of this 
Communication and the annexed Staff Working Paper. 

The original design of the Strategy followed a holistic approach still relevant today. 
Life sciences and biotechnology cannot be seen in a vacuum. Other policies have a 
direct impact on their development, such as the innovation policy recently set out by 
the Commission and given political support at the informal meeting of Heads of State 
and Government at Lahti in October 20065.  

The mid term review puts life sciences and biotechnology in this broader context, but 
also  refocuses  the  Action  Plan  on  sector  specific  issues  and  prioritises  actions  in 
those areas where the potential benefits of biotechnology can be maximised. 

2. 

MODERN  LIFE  SCIENCES  AND  BIOTECHNOLOGY  APPLICATIONS  AND  THEIR 
CONTRIBUTION TO EU POLICIES 

2.1. 

The contribution to EU policies 

Life sciences and biotechnology have grown to be central to certain sectors of the EU 
economy:  in  healthcare  and  pharmaceuticals,  but  also  in  the  fields  of  industrial 
processing and primary production/agro-food. Overall, modern biotechnology relates 
to  the  generation  of  about  1.56%  EU  gross  value  added  (GVA,  2002  values),  to 
which  could  be  added  positive  impacts  of  biotechnology  such  as  a  healthier 
population. The recent adoption of an ambitious energy policy for Europe is likely to 
stimulate the contribution of biotechnology to another sector, alternative energy. 

In March 2007, the European Council agreed a binding minimum level for biofuels of 10% 
of vehicle fuel by 2020. Biofuels are seen as beneficial in that they are renewable, reducing 
greenhouse gas emissions and boosting the EU’s energy security. 

The  production  process  of  bioethanol  relies  largely  on  biotechnology  (through  the  use  of 
enzyme  or  micro-organisms,  to  make  ethanol  out  of  biomass,  whether  crops,  wood  or 
biowastes). It is estimated that the development of biofuels could create a significant number 
of new jobs throughout the EU and open new markets for agricultural products.  

Secondly, life sciences and biotechnology make a significant contribution to core EU 
policy  goals  such  as  health,  economic  growth,  job  creation,  the  ageing  society  and 
sustainable development. Again, there are differences between the three main sectors 
(health,  industrial  production  and  processes,  primary  production/agro-food),  which 
justify separate analysis. 

4 

5 

The  current  mid  term  review  exercise  has  had  the  chance  to  benefit  from  a  so  far  unique  source  of 
information on biotechnology in the EU, the "Bio4EU" study, which presents an exhaustive picture of 
possible applications, with concrete examples, and assesses their impact on an economical, social and 
environmental point of view, including comparative data on the situation in third countries. This study 
has  been  finalised 
in  April  2007.  All  figures  are  from  BIO4EU,  otherwise  specified  - 
http://bio4eu.jrc.es/index.html 
Commission Communication "Putting knowledge into practice: A broad based innovation strategy for 
the EU”, COM(2006) 502 final, 13.9.2006 

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The  European  dedicated  biotechnology  industry  directly  employs  96.500  people,  mostly  in 
SMEs, but employment in industries using biotechnology products is many times higher. The 
industry  is  highly  research-intensive  with  44%  of  employees  (42.500)  involved  in  research 
and development functions6. 

Biotechnology  products  and  processes  are  used  in  numerous  other  industries  (e.g. 
chemicals,  textile,  paper  etc)  both  in  terms  of  novel  products  and  improved  production 
methods. 

Thirdly, whilst current statistics show relatively modest figures for the biotechnology 
industry  in  the  European  Union,  it  also  appears  that  those  may  be  underestimated 
since  they  mainly  count  as  "biotech  companies"  only  those  which  are  exclusively 
dedicated  to  this  activity,  thus  excluding  large  industrial  groups  which  use 
biotechnology  to  bring  added  value  to  their  core  business  (such  as  chemicals  or 
pharmaceuticals).  

According  to  the  latest  statistics,  in  2004,  Europe  had  2163  dedicated  biotech  companies, 
which spent in total €7.6 billion in R&D. Th e typical European company might be 6-10 years 
of age and rather small, averaging around 28 employees, and spending an average of €3.3 
million on R&D activities7. The share of the European Union in biotechnology patents filed 
at  the  EPO  in  2002-2004  was  34,8%,  as  compared  to  41,1%  for  the  USA.  Despite  many 
successful European start-ups, it is not yet a sizeable and sustainable industry. 

2.2. 

Healthcare biotechnology  

This is the main area of activity of the dedicated biotech industry and includes many 
applications  with  considerable  economic  and  public  health  significance.  Modern 
the 
biotechnology  applications 
pharmaceutical sector GVA (2002 values) and about 0.04% of the EU25 GVA, but 
indirect  effects  would  add  to  these  figures.  Biotech-based  products  are  mainly  for 
therapeutic  use  (i.e.  biopharmaceutical8),  but  also  diagnostics  and  preventives  (i.e. 
vaccines9). 

represent  some  5%  of 

in  human  health 

Biotechnology  is  also  a  processing  technology  used  when  the  end  product  is  not 
biological but chemical, and as a result is widely used in the pharmaceutical sector. 
In the context of current challenges such as the consequences of an ageing population 
or  the  fight  against  possible  pandemics  (e.g.  avian  flu),  life  sciences  and 
biotechnology  appear  to  be  of  key  importance.  This  includes  the  responsible  and 
effective use of genomics (including genetic testing) for the benefit of human health. 

Many  promising  applications  are  in  the  pipeline,  including  so-called  "advanced 
therapies",  involving  tissue  engineering,  gene  and  cell-based  therapies,  and 
"nanomedicine"10.  Some  raise  high  expectations  and  at  the  same  time  significant 
controversy, such as the use of embryonic stem cells. 

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Biotechnology in Europe: 2006 Comparative study, Critical I, 2006. 
Critical I, 2006. 
Biopharmaceuticals represented 9% of the EU pharmaceutical market per value (€
Recombinant vaccines represent about 20% of all available vaccines. 
Application of nanotechnology in treatment and disease diagnosis and monitoring 

 11 billion) in 2005.  

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Human  insulin  was  the  first  true  biotechnology  based  product  and  gradually  replaced  the 
insulin  extracted  from  cattle  and  pigs.  It  is  currently  the  most  available  form  of  insulin 
worldwide,  accounting  for  70%  of  the  worldwide  insulin  market.  Aside  from  drugs, 
biotechnology  has  also  enabled  the  development  of  tests  for  diagnosis  of  acute 
cardiovascular disease in emergency clinics, for the detection of hereditary diseases (genetic 
testing) or infectious diseases such as HIV/AIDS. 

Actions which could support the development of the health biotechnology industry, 
in  particular  helping  SMEs  and  increasing  research  should  be  considered  to  be  a 
particular priority for the European Union. This would take account of the full range 
of economic, ethical and other considerations. 

2.3. 

Industrial biotechnology  

Industrial biotechnology is already used for a broad range of products and processes, 
often unknown to the general public. Industrial biotechnology is gaining momentum 
due  to  increasing  environmental  and  energy  supply  concerns,  since  it  represents  an 
alternative  to  chemical  processes  and  fossil  fuels  and  promises  economic  and 
environmental  benefits.  Industrial  biotechnology  contributes  to  about  0.46%  of  the 
GVA  of  the  manufacturing  sector  and  about  0.08%  of  the  EU  GVA  (without  food 
processing and chemicals), reflecting its limited use so far. 

The  change  from  the  chemical  to  the  biotechnological  method  for  the  production  of  a 
widespread category of antibiotics11 showed a reduction of the use of electricity of 37%, of 
solvents of almost 100% and a reduction in wastewater by 90%. There are other industrial 
applications,  such  as  biodegradable  plastics  and  packaging,  which  could  bring  similar 
benefits. 

The development of biotechnology processes and their uptake by the industry are not 
optimal.  Aside  from  underfunding,  which  is  regularly  highlighted  by  the  industry, 
technology  transfer  appears  to  be  insufficient.  In  combination  with  EU  policies  on 
innovation,  this  should  be  as  a  priority  for  the  Strategy,  with  support  actions  for 
research and the uptake of new technologies. 

2.4. 

Primary production and agro-food biotechnology  

There are many modern biotechnology applications in primary production and agro-
food,  which  are  less  visible,  but  have  sizable  economic,  environmental  and  public 
health  significance.  Modern  biotechnology  is  mainly  used  in  the  input  sectors,  i.e. 
breeding,  diagnostics,  fine  chemicals  (feed  additives)  and  enzyme  production. 
Overall,  modern  biotechnology  is  used  for  1.31-1.57  %  of  GVA  generated  by  the 
primary production and agro-food sector. 

Biotech-based  diagnostics  and  veterinary  products,  mainly  vaccines,  play  a  role  in 
controlling  and  monitoring  some  of  the  most  important  animal  diseases,  zoonoses 
and food safety concerns. 

The  development  of  biotechnological  methods  for  surveillance  of  Bovine  spongiform 
encephalopathy  in  the  EU  have  allowed  for  many  more  samples  to  be  tested,  enabling  the 

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Cephalosporin 

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level  of  surveillance  required  by  Community  legislation  to  be  met  and  contributing  to  the 
protection  of  consumers  and  the  resumption  of  trade.  Biotech-based  diagnostics  are  also 
used for the early detection of salmonella. 

Aside  from  these  applications,  biotechnology  is  also  used  to  select,  or  improve, 
specific  traits  of  an  organism.  The  best  known  examples  are  genetically  modified 
plants.  About  a  dozen  products  have  been  recently  approved  under  the  EU  legal 
framework, which requires stringent risk assessment procedures, and some forty are 
in the pipeline, including some for cultivation. GM technology is likely to have in the 
future more application in the field of industrial processes. For example, sectors such 
as the production of biofuels or paper will have an interest in higher yielding plants. 

There  is  a  strong  need  for  an  assessment  of  the  benefits  and  risks  of  the  use  of 
genetically  modified  organisms  (GMOs)  in  all  sectors,  taking  into  account  their 
environmental and health effects as well as their acceptance in EU society. However, 
the approval of GMOs should continue to be based on a case by case risk analysis. In 
certain cases, risk management measures to prevent contamination of the food/feed 
chain by products which are specifically designed for industrial uses (e.g. when crops 
are  used  for  example  for  the  production  of  pharmaceutical  substances)  should  be 
further developed. 

3. 

THE DIVERSIFIED SCOPE OF MODERN BIOTECHNOLOGY AND PUBLIC PERCEPTIONS 

Governance was a key issue in the original design of the Strategy. Recent experience 
with  the  implementation  of  sectoral  legislation  has  confirmed  that  the  uptake  of 
biotechnology depends on the development of specific applications as well as relying 
on public support. Overall all fields of biotechnology generally enjoy a high level of 
public  support  with  the  exception  of  GM  food,  where  public  opinion  is  more 
ambivalent, and the implementation of the legislation in this field has proved to  be 
difficult. 

Eurobarometer 200512 shows that optimism about biotechnology has increased since 1999, 
after a period of decline (52% say it will improve their life) and an overall support for many 
biotech  applications  (such  as  gene  therapy,  biofuel  or,  bioplastics).  It  also  shows  that 
knowledge about biotechnology and genetics, although improving, remains limited. 

However, 58% of the respondents oppose GM food while 42% do not. The Eurobarometer 
confirmed  also  that  there  were  major  differences  in  acceptance  levels  between  Member 
States. It should be noted that 50% or more say they would buy GM food if it were healthier, 
if it were to contain less pesticide residues, or if were to be more environmentally friendly. 

Despite the fact that the EU has an entirely new science-based legal framework, one 
of  the  most  stringent  in  the  world,  negative  public  perceptions  of  GM  food  has  an 
influence  on  the  positions  taken  by  Member  States  when  faced  with  case-by-case 
decisions  about  whether  to  place  a  product  on  the  market.  In  all  recent  cases  there 

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http://www.ec.europa.eu/research/press/2006/pdf/pr1906_eb_64_3_final_report-may2006_en.pdf 

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has  been  no  consensus.  The  issue  of  EU  decision  taking  on  GMOs  was  also  the 
subject of a report by a World Trade Organisation Panel at the end of 200613. 

The  implementation  and  enforcement  problems  which  have  been  encountered  are 
partly  due  to  the  fact  that  the  applicable  legal  framework  is  recent:  the 
implementation of transition provisions between the "old" and the "new" legislation 
has  led  to  reluctance  by  some  Member  States.  Although  GMOs  represent  only  a 
small part of biotechnology, public perception often sees this as the main application. 
The gap between public perception and the agreed legal framework on GMOs has to 
be addressed. 

4. 

THE IMPLEMENTATION OF THE STRATEGY FOR THE 2002-2006 PERIOD 

The  annexed  Commission  Staff  Working  Paper  contains  a  detailed  report  on  the 
implementation  of  the  Action  Plan.  It  has  been  elaborated  on  the  basis  of 
contributions from Commission services, Member State authorities and stakeholders. 
It  is  complemented  by  a  summary  chart  of  the  main  achievements  in  the 
implementation of the 30 actions.  

The main conclusions of this review exercise are that: 

–  The  Strategy  has  been  successful  and  is  still  relevant.  The  list  of  achievements, 
such  as  research  activities  and  regional  integration  of  clusters,  clearly  highlights 
the  role  that  the  Strategy  has  played  in  terms  of  integrating  the  "biotech 
dimension" in other policy areas, as well as inspiring national biotech plans. The 
strong  support  enjoyed  by  the  Strategy  from  stakeholders  is  evidence  of  its 
success; 

–  A  small  number  of  actions  have  already  been  completed.  This  mainly  relates  to 
the  adoption  of  the  new  legal  framework  on  GMOs,  which  has  been  very 
significantly revised since 2002; 

–  A few other actions have become obsolete, mainly because of lack of interest by 
the  audience  they  targeted  (e.g.  Action  aiming  at  creating  networks  of 
biotechnology company managers); 

–  There  is  a  strong  case  to  continue  a  majority  of  the  actions,  ensuring  coherence 
with  other  horizontal  initiatives  (e.g.  education,  IPR…)  and  in  accordance  with 
the  EU's 
to  Multilateral 
Environmental Agreements); 

international  commitments 

(e.g.  contribution 

–  Some  actions  need  to  be  refocused  and  given  a  special  priority,  given  their 

importance and biotechnology-specific character. 

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European  Communities  —  Measures  Affecting  the  Approval  and  Marketing  of  Biotech  Products  - 
http://www.wto.org/english/tratop_e/dispu_e/meet_21nov06_e.htm 

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5. 

WAY FORWARD FOR THE CONTINUATION OF THE STRATEGY  

The original design of the Strategy was consciously wide in scope, to give an initial 
mapping  of  the  situation  and  to  identify  the  full  range  of  linked  policy  areas.  With 
this phase complete, the mid term review offers an opportunity to refocus in order to 
maximise  the  impact  of  the  Strategy.  This  implies  pursuing  actions  which  are  still 
relevant  according  to  their  original  design,  reinforcing  synergies  with  other 
horizontal  policies  and  reviewing  priorities  which  are  specific  to  the  sector  of 
biotechnologies. The result will be to improve the output of the Strategy to 2010. 

These  biotech-specific  priorities  can  be  regrouped  under  five  main  interdependent 
themes: 

(1) 

(2) 

(3) 

for 

Promote  research  and  market  development 
life  sciences  and 
biotechnology applications and the Knowledge Based Bio-Economy (KBBE). 
Research  remains  a  precondition  for  the  development  of  biotechnology  and 
the Action Plan needs to be adapted to the new FP7. Europe's basic biotech 
research  is  advanced  but  Europe  does  not  excel  in  turning  research  into 
commercial  applications.  The  Action  Plan  should  be  refocused  in  order  to 
foster market development for bio-based products and improve the uptake of 
new technologies; 

Foster  competitiveness,  knowledge  transfer  and  innovation  from  the  science 
base  to  industry.  Europe's  dedicated  biotech  companies  are  mostly  SMEs 
with  limited  resources  whose  growth  and  economic  sustainability  are  held 
back  by  three  main  constraints:  Europe's  fragmented  patent  system,  the 
insufficient  supply  of  risk  capital  and  shortcomings  in  the  cooperation 
between  science  and  business.  The  Commission  has  identified  the  lack  of  a 
clear  and  coherent  legal  framework  for  IPR  protection  as  an  obstacle  to 
innovation in Europe14, and will propose concrete steps toward a modern and 
affordable  framework.  In  addition  to  this,  refocusing  the  Action  Plan  can 
contribute 
to 
competitiveness specific to the biotech sector. 

framework  conditions 

to  addressing 

relating 

some 

Encourage informed societal debates on the benefits and risk of life sciences 
and  biotechnology.  The  uptake  of  biotechnology  is  also  conditional  on  its 
societal and market acceptance. Ethical concerns are also more prevalent than 
in  other  forefront  technologies.  There  is  a  clear  prerequisite  for  actions 
aiming at associating the public and stakeholders as closely as possible to the 
decision  making  process,  taking  into  account  the  benefits  and  risks  of  life 
sciences and biotechnology, on the basis of harmonised data and statistics, as 
well as ethical considerations. 

(4) 

Ensure  a  sustainable  contribution  of  modern  biotechnology  to  agriculture. 
Biotechnology  in  the  field  of  primary  production  and  agro/food  has  a  huge 
potential  for  development,  in  particular  the  replacement  of  chemical 
processes  and  fossil  fuels.  Nonetheless,  some  of  the  technologies  involved 

14 

Commission  Communication  ""An  innovation-friendly  modern  Europe",  COM(2006)  589  final, 
12.10.2006 

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need  close  scrutiny.  The  legal  framework  on  GMOs  takes  into  account 
possible  long-term  effects  on  the  environment  and  health,  the  safety  of  the 
food chain and respects other modes of agricultural production. Nonetheless, 
in  certain  cases  risk  management  measures  for  products  which  are 
specifically designed for industrial uses should be further developed. 

(5) 

the 

implementation  of 

Improve 
impact  on 
the 
competitiveness.  The  EU  has  probably  the  most  developed,  and  sometimes 
most  stringent,  legal  framework  on  life  sciences  and  biotechnology. 
Nonetheless,  stringent  rules  should  not  hinder  competitiveness  and 
innovation.  

legislation  and 

its 

The  way  the  Commission  intends  to  refocus  its  implementation  of  the  Strategy  in 
light  of  the  above  five  priority  themes  is  detailed  in  the  attached  "Refocused  Life 
Sciences and Biotechnology Action Plan". 

6. 

CONCLUSIONS 

The potential of biotechnology to support EU policies is real and has been proven by 
numerous  practical  examples.  Consequently,  there  is  a  strong  need  to  continue 
promoting  the  development  of  life  sciences  and  biotechnology  in  the  EU,  in 
particular  by  increasing  research  and  promoting  competitiveness.  The  main  EU 
instrument for this is the Strategy.  

Whilst the technology is promising, there is also a call for a reasoned use of some of 
its  applications,  in  particular  in  the  agro-food  area,  as  well  as  for  closer  public 
scrutiny and forward looking regulatory control.  

With biotechnology evolving at a rapid pace, there is an absolute necessity for policy 
makers  to  maintain  a  flexible  forward  looking  approach  in  order  to  anticipate 
developments  and  adapt  to  new  challenges.  Recent  examples  include  the  potential 
use  of  cloned  animals  or  of  their  offspring  in  the  agro/food  sector,  or  the  use  of 
genetically modified chicken for the production of pharmaceutical substances in their 
eggs.  

The original broad scope of the Strategy has offered a full picture; now a refocusing 
would  ensure  effective  implementation,  with  more  precise  goals  and  enhanced 
coherence with other policies. 

For these reasons, the Commission will: 

–  Continue  the  implementation  of  the  action  plan  up  to  2010,  while  putting  a 

specific emphasis on a focused set of biotech specific priority actions; 

–  Include biotechnology in the implementation of innovation strategies;  

–  In cooperation with Member States and stakeholders, improve the implementation 

of the Strategy. 

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Refocused Life Sciences and Biotechnology Action Plan 

(1) 

Promote  research  and  market  development  for  life  sciences  and  biotechnology 
applications and the KBBE. – Refocused action 315: 

–  Generate new knowledge under FP7. 

–  In  cooperation  with  industry,  Member  States  and  other  funding  bodies,  mobilise 
public and private research funding and reinforce the coordination of research. 

–  Through  a  public-private  partnership  between  European  Commission  and  the 
European  Federation  of  Pharmaceutical  Industries  Associations  (EFPIA), 
implement the Joint Technology Initiative on Innovative Medicine under FP7. 

–  In  cooperation  with  industry,  Member  States  and  other  funding  bodies,  engage 
schemes  to  finance/promote  the  establishment  of  multi-functional  pilot  plants  to 
demonstrate  the  potential  of  bio-based  applications  and  facilitate  their  market 
penetration, subject to a proportionate impact assessment and in accordance with 
EC rules in the field of competition and internal market. 

–  Explore  in  cooperation  with  stakeholders  lead  market  initiatives  in  the  areas  of 
eco-efficient bio-based products, subject to a proportionate impact assessment and 
in accordance with EC rules in the field of competition and internal market. 

(2) 

Foster  competitiveness,  knowledge  transfer  and  innovation  from  the  science  base  to 
industry. Refocused actions 5, 6 and 9: 

–  In  cooperation  with  Member  States,  develop  best  practices  in  the  responsible 

licensing of genetic inventions. 

–  In  cooperation  with  Member  States,  promote  knowledge  transfer  by  improving 
links between research organisations and industry and incentives to innovation. 

–  Monitor  the  implementation  of  Directive  98/44/EC  on  the  legal  protection  of 
biotechnological inventions and explore ways of facilitating the patenting system 
for SMEs. 

–  Encourage Member States to consider specific rules and/or incentives for Young 

Innovative Companies. 

–  Promote the use of EIF/EIB instruments and the Competitiveness and Innovation 
Framework  Programme  to  facilitate  access  to  finance  for  biotechnology 
companies. 

–  In  cooperation  with  the  EIB,  implement  Risk–Sharing  Finance  Facilities  co-

funded by FP7 and the EIB. 

–  Support  for  the  development  and  the  integration  of  clusters  and  of  regional 

networks. 

15 

Action numbers in brackets refer to the original Action Plan 

EN 

10 

   EN 

 
                                                 
(3) 

Encourage societal debates on the benefits and risk of life sciences and biotechnology. 
Refocused actions 13, 14 and 16: 

–  Stimulate the possible establishment of an institutionalised interface with different 

stakeholders on benefits and risk of life sciences and biotechnology. 

–  Set up proposals on how to improve the cooperation with all relevant stakeholders 

to ensure input in the Commission's activities. 

–  In  cooperation  with  Eurostat,  Industry,  Member  States  and  OECD,  set  up  a 
proposal  for  the  establishment  of  international  quantitative  impact  indicators 
(including social and economic) and structured collection of data. 

–  Adapt the action to the new FP7, and produce guidance for EC funded activities to 

address ethical issues.  

–  Anticipate the possible ethical and socio-economic impact of emerging scientific 

issues. 

(4) 

Ensure a sustainable contribution of modern biotechnology to agriculture. Refocused 
actions 17 and 23: 

–  Assess  notified  national  and  regional  measures  on  co-existence  and  study 

applicable national civil liability systems. 

–  Re-evaluate by 2008 the possible need for further guidance on co-existence at EU 

level. 

–  In cooperation with Member States, support  research and  develop  guidelines for 
crop-specific  co-existence  measures  and  exchange  information  on  best  practices 
among Member States. 

–  Adopt crop-specific labelling thresholds for seeds. 

–  Conduct  studies  and  support  related  research  activities  on  potential  positive  and 

negative long term effects of commercially available GMOs. 

–  Explore  benefits  and  risks  of  GM  crops  used  for  industrial  transformation  or 

molecular farming. 

(5) 

Improve  the  implementation  of  the  legislation  and  its  impact  on  competitiveness. 
Refocused action 29: 

–  Reinforce 

the  existing  networks  with  Member  States 
the  Strategy  and  address 

to  monitor 
regulatory  obstacles 

the 
to 

implementation  of 
competitiveness. 

–  Pursue  foresight  activities  and  the  evaluation  of  the  regulatory  coverage  on 

emerging issues. 

–  Improve  policy  coordination,  including  on  cross  cutting  issues,  with  a  particular 

focus on newly emerging issues. 

EN 

11 

   EN