Health research in FP7.
Date: 2007-09-18
Institutions: Directorate-General for Research and Innovation
Subjects: EU programme, health policy, medical research, research and development, scientific cooperation, small and medium-sized enterprises

SMEs and Health Research

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Research-based small and medium sized enterprises 
(SMEs)1  play  a  key  role  in  the  economy  of  the 
European Union (EU) in terms of growth potential, 
innovation  and  employment. 
competitiveness, 
Hundreds  of  research-intensive  SMEs  are  active 
in health-related R&D, and in recognition of their 
innovative potential, scientific strength and strategic 
importance, the EU considers their participation in 
the EU Framework Programmes a key priority.

Industrial participation is encouraged in the Health 
Theme, with special attention to research-intensive 
SMEs.

Participation to FP7 should permit  SMEs to expand 
their R&D activities.  SMEs can maximize the value 
of their expertise, learn from other key players and 
reduce risk by collaborating with other SMEs, with 
larger  industrial partners  and academics  from all 
over  Europe  and  beyond.  At  the  same  time,  the 
often pivotal technological input from SMEs, their 
business  orientation  and  dynamism  will  benefit 
the other project participants, optimising the total 
output  from  the  collaborative  projects  and  the 
exploitation of the results.

The  mobilisation  of  research-intensive  health/
biotech  SMEs  has  gained  momentum  during  the 
previous framework programme, and an even more 
prominent role is expected for SMEs in FP7. 

Participation of SMEs is encouraged in most 
research  projects  in  the  Health  Theme,  with 
several topics specially designed for SMEs being 
included throughout the programme.

The  proposed  ‘innovative  medicine  initiative’, 
the  health-related  joint  technology  initiative,  is 
expected to attract the participation of SMEs.

Why is fP7 more favorable 
to SME participation?

The FP7 rules of participation allow a funding up 
to  75%  for  research  and  development  activities 
of  SMEs,  rather  than  the  50%  of  the  previous 
framework programme; this should make it more 
attractive to SMEs to participate in FP7.

In  FP7,  a  guarantee  fund  replaces  the  ‘collective 
financial  responsibility’.  This  guarantee  fund 
would cover the financial risks of defaulting project 
participants, reducing the need for financial checks 
and bank guarantees.

The  rules  governing  intellectual  property  in  EU-
funded  projects  have  been  greatly  improved  in 
the  last  framework  programmes.  Clearer  IPR 
rules are designed with more attention to the 
special needs of SMEs.

Dedicated  and  experienced  local  support  is 
available through the network of national contact 
points  (NCPs)  and  through  SME-go-Health, 
an  EU-funded  project  specifically  supporting 
the participation of SMEs and SME groupings in 
Health-oriented projects.

FP7 has a broader approach to health research 
than FP6, covering also new areas, such as medical 
technologies and public health…

FP7  is  a  7  years  programme,  with  long  term 
continuity of structure, rules and procedures.

Contact

DG Research
Health Directorate
Rue du Champ de Mars 21
B-1049 Brussels
Tel:  +32 2 2962965
Fax: +32 2 2995888
More information: http://ec.europa.eu/research/fp7/home_en.html

LEGAL NOTICE
Neither  the  European  Commission  nor  any  person  acting  on  behalf  of  the  Commission  is  responsible  for  the  use  which  might  be  made  of  the  following 
information.
The views expressed in this publication are the sole responsibility of the author and do not necessarily reflect the views of the European Commission.
A great deal of additional information on the European Union is available on the Internet. It can be accessed through the Europa server (http://ec.europa.eu).
Luxembourg: Office for Official Publications of the European Communities, 2007
ISBN 978-92-79-06099-1
© European Communities, 2007
Reproduction is authorised provided the source is acknowledged.
Printed in Belgium
PRINTED ON WHITE CHLORINE-FREE PAPER

Health 
Research 
in fP7

1. For  the  definition  of  SMEs,  look  at:  http://ec.europa.eu/enterprise/

enterprise_policy/sme_definition/index_en.htm

PHOTOS : © DIGITALvISION, IMAGESOURCE, PHOTOALTO, PHOTODISC

ISBN 978-92-79-06099-1

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Health as a priority in fP7

On  18  December  2006,  the  Council  adopted 
decisions  establishing  the  Seventh  Framework 
Programme  of  the  European  Community  (EC)  for 
research  and  technological  development  for  the 
period 2007 to 2013, and the FP7 for nuclear research 
activities (Euratom) for 2007 to 2011.

FP7  is  made  up  of  4  main  blocks  of  activities 
forming  4  specific  programmes  plus  a  fifth  on 
nuclear research. 

The specific programme on ‘Cooperation’ supports 
all types of research activities carried out by different 
research  bodies 
transnational  cooperation 
and aims to gain or consolidate leadership in key 
scientific and technology areas. 

in 

Health  is  a  major  theme  of  the  Cooperation 
programme, with a total budget of e6 billion over 
the duration of FP7.

The  objective  of  health  research  under  FP7  is  to 
improve  the  health  of  European  citizens  and 
boost  the  competitiveness  of  health-related 
industries  and  businesses,  while  addressing 
issues  such  as  anti-microbial 
global  health 
resistance,  HIv/AIDS,  malaria,  tuberculosis  and 
emerging pandemics. 

In terms of the approach, emphasis is placed on:
• Translational 

research 
discoveries into clinical applications);

(translation  of  basic 

• Development and validation of new therapies;
• Communication of research results;
• Development  of  methods  of  health  promotion 
and  disease  prevention,  diagnostic  tools  and 
technologies, as well as sustainable and efficient 
health-care systems (child health and the health 
of the ageing population).

- Budget for the first call: e 637 million 
- Indicative budget for the second call : 
  e657 million (to be confirmed in April 2007)

Activities r 3 Pillars
• Biotechnology, generic tools and technologies for 

human health; 

• Translating research for human health;
• Optimising the delivery of health care to European 

citizens.

funding Schemes
• Large-scale Integrating project  
(min. EU contribution: e6 million;  
max. EU contribution: e 12 million);
• Small or medium scale focused research project 
(max. EU contribution: e 3 million, unless 
specified in work programme) ;

• Projects targeted at SME’s and International 
Cooperation (max. contribution: e 3 M);
• Coordination (or newtorking)actions: 

at least 3 independent MS/AS legal entities;

• Support actions: at least 1 legal entity;
• ERA NET plus (for Cancer topic). 

The funding thresholds will be applied as eligibility 
criteria and the proposals which do not respect 
these limits will be considered ineligible. 

Health 
Research 
in fP7

How to apply

Consulting the Health work 
programme
To prepare for a proposal, several documents must 
be consulted and instructions should be followed 
carefully.  The  first  step  is  to  consult  the  Health 
work programme, which can be downloaded from  
http://cordis.europa.eu/fp7/dc/index.cfm and 
http://cordis.europa.eu/fp7/cooperation/health_
en.html.  This  enables  the  applicants  to  check 
whether  the  scientific  idea  might  match  the 
scientific  topic  and  funding  scheme  open  in  the 
call.  Only  if  this  is  the  case,  should  the  other 
documents  be  downloaded  and  read  carefully. 
Furthermore, any specific conditions for the health 
theme,  specific  topics  and  as  well  as  for  the 
different funding schemes are also set out in the 
Health work programme and its annexes. 

following the guide for applicants
Provided  that  the  idea  matches  a  topic  in  the 
Health work programme and the funding scheme 
indicated  for  this  topic,  the  relevant  guide  for 
applicants  (there  is  one  guide  for  each  funding 
scheme)  needs  to  be  followed.  Special  attention 
needs  to  be  given  to  page  limits  of  the  different 
sections  of  the  proposal  as  additional  pages  will 
be disregarded during evaluation. Proposals must 
describe  planned  activities,  information  on  who 
will  carry  them  out,  and  specify  how  much  they 
will  cost.  Proposals  involving  any  ethical  issues 
will require carefully checking the guide (Annex 4, 
section 4 ‘ethical issues’).

Submitting a proposal
Proposals must be submitted electronically using a 
special web based service (EPSS) before a strictly 
enforced  deadline.  Further  information  for  elec-
tronic proposal submission will be made available 
under http://cordis.europa.eu/fp7/epss_en.html.

Proposal evaluation
A  proposal  will  have  to  pass  several  steps 
succesfully to be retained for funding. Only eligible 
proposals wil go to scientific evaluation. 

Eligibility criteria
A  proposal  will  only  be  considered  eligible  if  it 
meets all of the following conditions :
• it  is  received  by  the  Commission  before  the 

deadline given in the call text ;

• It  involves  at  least  the  minimum  number  of 
participants  for  the  distinct  funding  scheme  as 
given in the call text;

• It is complete (both the requested administrative 
forms (A part) and scientific proposal description 
(B part) are present);

• The content of the proposal is clearly related to 
the  topic(s)  and  the  right  funding  scheme  has 
been used, including any special conditions, set 
out  in  those  parts  of  the  relevant  Health  work 
programme.

Evaluation Criteria
The  evaluation  criteria  for  ‘Cooperation’  specific 
programme are:
• Scientific and or/technological excellence;
• The quality and efficiency of the implementation 

and management. 

• The  potential  impact  though  the  development, 

dissemination and use of project results.

Evaluation process
The  evaluation  process  is  a  peer  review  and  will 
be carried out by a panel of external independent 
experts (each proposal will be reviewed by at lest 
3 experts). Following the evaluation applicants will 
be informed of the outcome. Applicants of highly 
ranked proposals may be invited by the Commission 
to negotiate a grant agreement providing for an EU 
financial  contribution,  depending  on  the  budget 
available.

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Biotechnology, generic tools and 
technologies for human health

The  activity  ‘Biotechnology,  generic  tools  and  technologies  for  human  health’  aim  to  expand  and  validate  the 
necessary tools and technologies that will make possible the production of new knowledge and its transition into practical 
applications in the area of health and medicine. 

This activity is divided into four main areas: ‘High- throughput research’, ‘Detection, diagnosis and monitoring’, ‘Predicting 
suitability, safety and efﬁ cacy of therapies’; ‘Innovative therapeutic approaches and interventions’.

The First call closed on 19 April 2007. The peer-review evaluation and negotiation of proposals is taking place in 2007. 
The results will be published at http://cordis.europa.eu/fp7/cooperation/health_en.html. Projects selected for funding 
are expected to start by early 2008.

High- throughput research

The main objective is to catalyse progress in developing new research tools for modern biology including fundamental genomics 
that will enhance signiﬁ cantly data generation and improve data and specimen (biobanks), standardisation, acquisition and analysis. 
The focus will be on new technologies for: sequencing; gene expression; genotyping and phenotyping; structural and functional 
genomics; bioinformatics and systems biology.

Topics for Second call – Deadline 18 September 2007
(cid:129) SME- driven collaborative research projects for developing tools and technologies for high-throughout research
Funding scheme: Collaborative projects (small or medium-scale focused research projects targeted to SME’s)

CONTACT
Patrik Kolar – Genomics and Systems Biology Unit – Tel: +32 (0)2 29-85161– patrik.kolar@ec.europa.eu
Jacques Remacle – Genomics and Systems Biology Unit – Tel: +32 (0)2 29-63045 – jacques.remacle@ec.europa.eu
Christina Kyriakopoulou – Genomics and Systems Biology Unit – Tel: +32 (0)2 29-59890 – christina.kyriakopoulou@ec.europa.eu
Christian Desaintes – Genomics and Systems Biology Unit – Tel: +32 (0)2 29-58273 – christian.desaintes@ec.europa.eu

HEALTH RESEARCH IN FP7

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Detection, diagnosis and monitoring

The  aim  is  to  develop  visualisation,  imaging,  detection  and 
analytical tools and technologies for biomedical research, for 
prediction,  diagnosis,  monitoring  and  prognosis  of  diseases, 
and for support and guidance of therapeutic interventions. The 
focus will be on a multidisciplinary approach integrating areas 
such as: molecular and cellular biology, physiology, genetics, 
physics, chemistry, biomedical engineering, nanotechnologies, 
microsystems, devices and information technologies. 

Topics for Second call – Deadline 18 September 2007
(cid:129) Standardisation and improvement of pre-analytical 

procedures for in vitro diagnostics

Funding scheme: Collaborative projects 
(large scale integrating projects)
(cid:129) High throughput molecular diagnostics in individual patients 
for genetic diseases with heterogeneous clinical presentation

Funding scheme: Collaborative projects 
(small or medium-scale focused research projects)

CONTACT
Jean-Luc Sanne
Health Biotechnology Unit
Tel: +32 (0)2 29-92589 – jean-luc.sanne@ec.europa.eu

Innovative therapeutic approaches and interventions

The  objectives  of  the  area  ‘Innovative  therapeutic  approaches  and  interventions’  are  to  research, 
consolidate and ensure further developments in advanced therapies and technologies with broad potential 
application. The focus will be on gene and cell therapy, regenerative medicine, transplantation, immunotherapy 
and vaccines.

Topics for Second call – Deadline 18 September 2007
GENE THERAPY
(cid:129) Development of emerging gene therapy tools and technologies for clinical applications 
Funding scheme: Collaborative projects (large scale integrating projects)
(cid:129) Gene therapy tools targeting the central nervous system 
Funding scheme: Collaborative projects (small or medium-scale focused research projects)

REGENERATIVE MEDICINE
(cid:129) Stem cell lines for cell-based therapies
Funding scheme: Collaborative projects (one or more large scale integrating projects)
(cid:129) Development of stem cell culture conditions
Funding scheme: Collaborative projects (small or medium-scale focused research projects)
(cid:129) Stem cells for kidney regeneration
Funding scheme: Collaborative projects (small or medium-scale focused research projects)
(cid:129) Adding value to EU stem cell therapy research: scientiﬁ c communication and future perspectives
Funding scheme: Coordination and Support action

CONTACT
Charles Kessler 
Health Biotechnology Unit 
Tel:  +32 (0)2 29-56112 – charles.kessler@ec.europa.eu

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Translating research 
for human health
Integrating biological data and processes: 
Large Scale Gathering and Systems Biology

The  activity  ‘Translating  research  for  human  health’  aims  at  increasing  knowledge  of  biological  processes  and 
mechanisms  involved  in  normal  health  and  in  speciﬁ c  disease  situations,  to  transpose  this  knowledge  into  clinical 
applications including disease control and treatment, and to ensure that clinical (including epidemiological) data guide 
further research.

The areas covered by this activity are: ‘Integrating biological data and processes: large-scale data gathering, systems 
biology’, ‘Research on the brain and related diseases, human development and ageing’, ‘Translational research in major 
infectious diseases: to confront major threats to public health’; ‘Translational research in other major diseases’.

The First call closed on 19 April 2007. The peer-review evaluation and negotiation of proposals is taking place in 2007. 
The results will be published at http://cordis.europa.eu/fp7/cooperation/health_en.html. Projects selected for funding 
are expected to start by early 2008.

Systems Biology

The focus of systems biology will be on multidisciplinary research that will integrate a wide variety of biological data and develop 
and apply system approaches to understand model biological processes in all relevant organisms and at all levels of organization.

Topics for Second call – Deadline 18 September 2007
• Multidisciplinary fundamental genomics and molecular biology approaches to study basic biological processes relevant to 

health and diseases

Funding scheme: Collaborative projects (small or medium-scale focused research projects)
• Coordination and Support actions in large-scale data gathering and systems biology:

- international activities in large scale data gathering for functional genomics
- preparing for the future challenges of systems biology

Funding scheme: Coordination and Support action

Topics for Speciﬁ c International Cooperation Action (SICA) – Deadline 18 September 2007
• Traditional Chinese medicine in post-genomic era
Funding scheme: Coordination and Support action

CONTACT
Patrik Kolar – Genomics and Systems Biology Unit – Tel: +32 (0)2 29-85161 –  patrik.kolar@ec.europa.eu
Jacques Remacle – Genomics and Systems Biology Unit – Tel: +32 (0)2 29-63045 – jacques.remacle@ec.europa.eu
Christina Kyriakopoulou – Genomics and Systems Biology Unit – Tel: +32 (0)2 29-59890 – christina.kyriakopoulou@ec.europa.eu
Christian Desaintes – Genomics and Systems Biology Unit – Tel: +32 (0)2 29-58273 – christian.desaintes@ec.europa.eu

HEALTH RESEARCH IN FP7

‘This picture is provided  Tuomas 
Tammela, Molecular/Cancer Biology 
Laboratory, University of Helsinki’

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Research on the brain and related diseases,
human development and ageing

Brain and brain related diseases

The objectives are to better understand the integrated structure and dynamics of the brain, and to study brain diseases 
including relevant age related illness (e.g. dementia, Parkinson’s disease) and search new therapies. The focus will 
be to gain a global understanding of the brain by exploring brain functions, from molecules to cognition including 
neuroinformatics,  and  brain  dysfunction,  from  synaptic  impairment  to  neurodegeneration.  Research  will  address 
neurological and psychiatric diseases and disorders, including regenerative and restorative therapeutic approaches. 

Topics for Second call – Deadline 18 September 2007
• Restorative approaches for therapy of neurodegenerative diseases
Funding scheme: Collaborative Project (small or medium-scale focused research projects with maximum 
contribution of €6.000.000/project)
• From mood disorders to experimental models
Funding scheme: Collaborative project (large scale integrating projects)
• Neuronal mechanisms of vision and related diseases
Funding scheme: Collaborative Project (small or medium-scale focused research projects)

Topics for Speciﬁ c International Cooperation Action (SICA) – Deadline 18 September 2007
• Childhood and adolescent mental disorders
Target Regions:  Eastern Europe and Central Asia and Western Balkans
Funding scheme: Collaborative Project (small or medium-scale focused research projects)

CONTACT
Patrizia Tosetti – Medical and Public Health Research
Tel: +32 (0)2 29-84990 – patrizia.tosetti@ec.europa.eu

Alfredo Cesario – Medical and Public Health Research 
Tel: +32 (0)2 29-63372 – alfredo.cesario@ec.europa.eu

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Translating research 
for human health 
Major Infectious diseases

The activity: ‘Translational research in major infectious diseases: to confront major threats to public health’ is 
divided into four main areas of research: ‘Anti-microbial drug resistance including fungal pathogens’; ‘HIV/AIDS, malaria 
and tuberculosis’; ‘Potentially new and re-emerging epidemics’ and ‘Neglected infectious diseases’.

The First call closed on 19 April 2007. The peer-review evaluation and negotiation of proposals is taking place in 2007. 
The results will be published at http://cordis.europa.eu/fp7/cooperation/health_en.html. Projects selected for funding 
are expected to start by early 2008.

Anti-microbial drug resistance including 
fungal pathogens

The strategic objective of ‘anti-microbial drug resistance’ is to 
confront  the  increasing  emergence  and  spread  of  microbial 
drug resistant pathogens in Europe and the rest of the world 
at  broad  fronts  and  in  a  multidisciplinary  approach  through 
the development of effective infection prevention and control 
strategies.

HIV/AIDS, malaria and tuberculosis

Under the area ‘HIV/AIDS, malaria and tuberculosis’ research 
will focus on developing new therapies, diagnostic tools, and 
preventive tools such as vaccines and chemicals barriers such 
as  HIV  microbicides.  Research  efforts  will  confront  the  three 
diseases at global level, but will also address speciﬁ c European 
aspects of the three diseases as hepatitis co-infection. Preclinical 
and early clinical research activities will be emphasised. 

Topics for Second call – Deadline 18 September 2007
(cid:129) Novel targets for drugs against Gram negative bacteria
Funding scheme: Collaborative Projects 
(small or medium-scale focused research projects with 
maximum contribution of €6.000.000/project)
(cid:129) Host-pathogen interactions in infections by Streptococcus 

pneumoniae

Funding scheme: Collaborative Projects 
(small or medium-scale focused research projects)
(cid:129) An integrated platform for development and clinical 

evaluation of point-of-care diagnostic devices for microbial 
detection, antibiotic susceptibility determination and 
biomarkers

Funding scheme: Collaborative Projects 
(large scale Integrating projects)
(cid:129) Molecular epidemiology to control nosocomial and 

community spreading of highly virulent multi-drug resistant 
strains of bacterial pathogens.

Funding scheme: Collaborative Projects 
(small or medium-scale focused research projects)
(cid:129) Health and economic cost of antimicrobial resistance
Funding scheme: Coordination and Support action
(cid:129) Conference on genetic and biochemical tools for post- 
genomic physiological analysis of Staphylococcus, in 
particular MRSA

Funding scheme: Coordination and Support action

CONTACT
Anna Lönnroth – Infectious Diseases Unit
Tel: +32 (0)2 29-94210 – anna.lonnroth@ec.europa.eu

Cornelius Schmaltz – Infectious Diseases Unit
Tel: +32 (0)2 29-58984 – cornelius.schmaltz@ec.europa.eu

HEALTH RESEARCH IN FP7

Topics for Second call – Deadline 18 September 2007
(cid:129) Network on HIV and anti HIV drug resistance
Funding scheme: Collaborative projects (large-scale Integrating 
projects)
(cid:129) HIV and hepatitis co-infection
Funding scheme: Coordination and Support action
(cid:129) Blocking the transmission of malaria: the mosquito vector 

target

Funding scheme: Collaborative Projects (small or medium-scale 
focused research projects)
(cid:129) European network for study and clinical management of TB 

drug resistance

Funding scheme: Collaborative projects (large-scale Integrating 
projects)
(cid:129) Support platform for the development of PRD vaccines
Funding scheme: Coordination and Support action

Topics for Speciﬁ c International Cooperation Action 
(SICA) – Deadline 18 September 2007
(cid:129) Highly innovative research in HIV/AIDS, malaria and 
tuberculosis between Indian and European partners

Funding scheme: Collaborative Projects (small or medium-scale 
focused research projects)
(cid:129) Coordination of European research activities with global 

initiatives, including Public-Private Partnerships
Funding scheme: Coordination and Support action
(cid:129) Next Generation of researchers for HIV/AIDS, malaria, 

tuberculosis and neglected infectious diseases
Funding scheme: Coordination and Support action

CONTACT
Manuel Romaris – Infectious Diseases Unit
Tel: +32 (0)2 29-98733 – manuel.romaris@ec.europa.eu

Hannu Laang – Infectious Diseases Unit
Tel: +32 (0)2 29-69602 – hannu.laang@ec.europa.eu

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Potentially new and re-emerging epidemics
The area related to ‘Potentially new and re-emerging epidemics’ 
intends  to  confront  emerging  pathogens  with  pandemic 
potential including zoonoses (e.g. SARS and highly pathogenic 
inﬂ uenza).  Call  topics  aim  to  cover  the  full’  value  chain’  of 
health research: from innovative basic research to early stage 
clinical  trials  of  new  prevention,  diagnostic  and  therapeutic 
measures all the way to implementation research supporting 
effective public health responses. 

Topics for Second call – Deadline 18 September 2007
(cid:129) Strengthening  research on prediction, identiﬁ cation, 

modelling and surveillance of newly emerging infectious 
diseases in humans

Funding scheme: Collaborative projects 
(large-scale integrating projects)
(cid:129) Deﬁ nition of research needs and priorities in Europe in 

the area of Emerging Infectious Epidemics

Funding scheme: Coordination and Support action

CONTACT
Cornelius Schmaltz – Infectious Diseases Unit
Tel: +32 (0)2 29-58984 – cornelius.schmaltz@ec.europa.eu

Anna Lönnroth – Infectious Diseases Unit
Tel: +32 (0)2 29-94210 – anna.lonnroth@ec.europa.eu

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Neglected infectious diseases

Under  the  area  ‘Neglected  infectious  diseases’,  research 
will  focus  on  an  integrated  approach  for  the  development 
of  preventive,  therapeutic  and  control  tools  for  neglected 
infectious  diseases:  diseases  caused  by  Trypanosomatidae 
species  and  a  wider  range  of  vector-borne  diseases,  as  well 
as  other  neglected  infectious  diseases,  including  childhood 
infections.

Topics for Speciﬁ c International Cooperation Action 
(SICA) – Deadline 18 September 2007
(cid:129) Development of new tools to control infections due to 

parasites of the Trypanosomatidae family.

(cid:129) Development of a Leishmania vaccine
(cid:129) Bio prospecting for drug leads
Funding scheme: Collaborative Projects (small or medium-
scale focused research projects)

CONTACT
Ole Olesen – Infectious Diseases Unit
Tel +32 (0)2 29-53999 – ole.olesen@ec.europa.eu
Andreas Holtel – Infectious Diseases Unit
Tel +32 (0)2 29-53716 – andreas.holtel@ec.europa.eu

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Translational research 
in other major diseases:
Cancer, Cardiovascular disease, Diabetes and 
obesity, Rare diseases, Other chronic diseases

The First call closed on 19 April 2007. The peer-review evaluation and negotiation of proposals is taking place in 2007. 
The results will be published at http://cordis.europa.eu/fp7/cooperation/health_en.html. Projects selected for funding 
are expected to start by early 2008.

Cancer

Cardiovascular disease

The  focus  will  be  on  disease  aetiology,  new  medicines 
and  therapies,  identifying  and  validating  drug  targets  and 
biological markers that aid in the prevention, early diagnosis 
and treatment; and assessing the effectiveness of preventive, 
prognostic,  diagnostic  and  therapeutic  interventions.  The 
activities  funded  in  this  area  will  further  understanding  of 
the  basic  mechanisms  underlying  cancer  and  therefore  help 
translate  into  clinical  setting.  It  is  expected  that  projects  will 
successfully exploit this knowledge to develop novel drugs and 
new treatment strategies.

Topics for ERA NET – Deadline 31 July 2007
(cid:129) ERA_NET on optimisation of the use of cancer registries 

for cancer research purposes

Funding scheme: Coordination and Support action

Topics for Second call – Deadline 18 September 2007
(cid:129) Innovative combination clinical trials for multimodal cancer 

therapy

(cid:129) Role of inﬂ ammation in tumour initiation and progression
(cid:129) Epidemiology of gene-environment interactions involved in 

carcinogenesis

(cid:129) Translating the hypoxic tumour microenvironment
Funding scheme: Collaborative projects 
(large scale integrating projects)

Topics for Speciﬁ c International Cooperation Action 
(SICA) –
Deadline 18 September 2007
(cid:129) Studying cancer aetiology in Latin America
Funding scheme: Collaborative Projects 
(small or medium-scale focused research projects)

CONTACT
Medical and Public Health Research Unit
Maria Vidal-Ragout – Tel: +32 (0)2 29-65789
maria-jose.vidal-ragout@ec.europa.eu
Jan Van de Loo – Tel: +32 (0)2 29-87492
jan-willem.van-de-loo@ec.europa.eu
Elengo Manoussaki – Tel: +32 (09)2 29-95915
elengo.manoussaki@ec.europa.eu
Olaf Kelm – Tel: +32 (0)2 29-86459
olaf.kelm@ec.europa.eu

HEALTH RESEARCH IN FP7

The  focus  will  be  on  diagnosis,  prevention,  treatment  and 
monitoring  of  heart  and  blood  vessel  diseases  using  broad 
multidisciplinary approaches. 

Topics for Second call – Deadline 18 September 2007
(cid:129) Congenital pathologies affecting the heart
(cid:129) Cell therapies for the treatment of heart ischemia
(cid:129) Organ imaging in CVD
(cid:129) Integrating pharmacogenomic approaches into the 

treatment of CVD 

Funding scheme: Collaborative Projects 
(small or medium-scale focused research)

CONTACT
Virginija Dambrauskaite – Medical and Public Health Research
Tel: +32 (0)2 29-21208 – virginija.dambrauskaite@ec.europa.eu

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Other chronic diseases

The  focus  will  be  on  non-lethal  diseases  with  a  high  impact 
on the quality of life at old age such as functional and sensory 
impairment and other chronic diseases (e.g. rheumatoid and 
respiratory diseases).

Topics for Second call – Deadline 18 September 2007
(cid:129) Understanding and combating age related muscle 

weakness 

Funding scheme: Collaborative projects 
(large scale integrating projects)
(cid:129) Translational research aiming for a treatment of urinary 

incontinence 

Funding scheme: Collaborative Projects (small or medium-
scale focused research projects)
(cid:129) Early processes in the pathogenesis of chronic 

inﬂ ammatory diseases

Funding scheme: Collaborative Projects 
(small or medium-scale focused research projects)

CONTACT
Stefan Wagener – Medical and public Health Research Unit
Tel: +32 (0)2 29-99717 

Diabetes and obesity 

For Diabetes, the focus will be on aetiologies of the different 
types of diabetes, and their related prevention and treatment. 
For Obesity, the focus will be on multidisciplinary approaches 
including  genetics,  life  style  and  epidemiology.  For  both, 
special attention will be given to juvenile diseases and factors 
operating in childhood.

Topics for Second call – Deadline 18 September 2007
(cid:129) Nutritional signals and the development of new diabetes/

obesity therapeutic agents

(cid:129) Markers and treatment for diabetic neuropathy 

complications

(cid:129) Gene and phenotypical differentiation of type 2 subjects 

and monogenic subjects

(cid:129) Use of beta cell imaging in diabetes mellitus
Funding scheme: Collaborative Projects 
(small or medium-scale focused research with maximum EC 
contribution of €6.000.000/project)

CONTACT
Nathalie Vercruysse – Medical and Public Health Research
Tel: +32 (0)2 29-66561 – nathalie.vercruysse@ec.europa.eu

Rare diseases

The  focus  will  be  on  Europe-wide  studies  of  natural  history, 
pathophysiology and on development of preventive, diagnostic 
and  therapeutic  interventions.  This  sector  will  include  rare 
Mendelian phenotypes of common diseases.

CONTACT
Catherine Berens – Medical and Public Health Research
Tel: +32 (0)2 29-50940 – catherine.berens@ec.europa.eu

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Optimising the delivery 
of health care to European citizens

The activity ‘Optimising the delivery of health care to European citizens’ aims at developing new research methods 
and generating the necessary scientiﬁ c basis to underpin informed policy decisions on health systems and more effective 
and efﬁ cient evidence-based strategies of health promotion, disease prevention, diagnosis and therapy. 

The  focus  of  the  activity  ‘Optimising  the  delivery  of  health  care  to  European  citizens’  will  be  on:  ‘Translating  clinical 
research  into  clinical  practice’,  ‘Quality,  efﬁ ciency  and  solidarity  of  health  systems’  and  ‘Enhanced  health  promotion 
and disease prevention’. Moreover, Horizontal Coordination and support actions and Speciﬁ c International Cooperation 
Actions have been enclosed under this activity.

Translating clinical research into clinical 
practice 
The main objective under Translating clinical research into clinical 
practice  is  to  better  understand  clinical  decision-making,  and  the 
appropriate use of behavioural and organisational interventions and 
new health therapies and technologies. Special attention will be given 
to patient safety.

Topics for Second call – Deadline 18 September 2007
(cid:129) Implementation of research into healthcare practice
Funding scheme: Collaborative Projects 
(small or medium-scale focused research projects)
(cid:129) Self medication and patient safety
Funding scheme: Collaborative Projects 
(small or medium-scale focused research projects)
(cid:129) Patient Safety Research Network
Funding scheme: Coordination action
(cid:129) Improving clinical decision making
(cid:129) Better use of medicines
(cid:129) Continuity of clinical care
(cid:129) Patient self-management of chronic disease 
Funding scheme: Collaborative Projects 
(small or medium-scale focused research projects)

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Quality, efﬁ ciency and solidarity of health care systems
The  objective  of  the  area  Quality,  efﬁ ciency  and  solidarity  of  health  care  systems  is  to  provide  a  basis  for  countries  to  learn  from  the 
experience of others, taking into account the importance of national contexts and population characteristics (ageing, mobility, migration, education, 
socioeconomic status and the changing world of work etc). Focus will be on organisational, ﬁ nancial and regulatory aspects of health systems, their 
implementation and their outcomes in terms of effectiveness, efﬁ ciency and equity. Special attention will be paid to investment issues and human 
resources, including home care strategies.

Topics for Second call – Deadline 18 September 2007
(cid:129) Evaluation of disease management programmes
(cid:129) Health systems and long term care of the elderly
(cid:129) Mobility of health professionals
(cid:129) Health care human resource planning in nursing
(cid:129) Clinician working time and patient safety
(cid:129) Health outcome measures and population ageing
(cid:129) Trends of population health 
(cid:129) European system of Diagnosis-related group (DRG)
Funding scheme: Collaborative Projects (small or medium-scale focused research projects)

HEALTH RESEARCH IN FP7

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Enhanced health promotion and disease 
prevention

The  area  Enhanced  health  promotion  and  disease  prevention 
research  aims  to  develop  evidence  for  effective  public  health 
interventions addressing wider determinants of health (such as stress, 
diet or environmental and behavioural factors) at both the individual 
and community level.

Topics for Second call – Deadline 18 September 2007
(cid:129) Promoting healthy behaviour in children and adolescents
(cid:129) Interventions addressing the gradient of health inequalities
(cid:129) Public health interventions addressing the abuse of alcohol
(cid:129) Evaluation of suicide prevention strategies across and within 

European countries

(cid:129) Improve vaccination coverage
Funding scheme: Collaborative Projects 
(small or medium-scale focused research projects)

Horizontal Coordination and support actions

Topics for Second call – Deadline 18 September 2007
(cid:129) Disease networks of centres of reference
(cid:129) Effectiveness of health investments
(cid:129) Patient mobility and access to information
(cid:129) Brokering research into policy
(cid:129) A road-map for ageing research
(cid:129) Health services research conference
(cid:129) Mental health Research Conference
(cid:129) Public Health Intervention research conference 

Speciﬁ c international cooperation actions for health systems research

The objective of speciﬁ c international cooperation actions for health systems research is to support research in order to provide a 
scientiﬁ c  base  for  International  Cooperation  Partner  Countries  to  improve  their  health  service  delivery,  including  aspects  of  accessibility, 
effectiveness, efﬁ ciency and quality of care and user-friendliness. It also covers public health concepts and interventions beyond health services 
through  cross-sectorial  and  multi-disciplinary  research  approaches.  Global  initiatives  such  as  the  Millennium  Development  Goals  (MDGs) 
should be taken into account.

Topics for SICA – Deadline 18 September 2007
(cid:129) Epidemiological investigations into long-term trends of population health as a consequence of socio-economic transitions, including 

lifestyle induced health problems 
Target Regions:  Mediterranean Partner Countries, Russia, Eastern Europe and Central Asia

(cid:129) Universal and equitable access to health care and health ﬁ nancing

Target Regions:  Africa, Caribbean, Paciﬁ c (ACP), Mediterranean Partner Countries, Asia & Latin America

(cid:129) Health care intervention research – optimising hospital care

Target Region:  Western Balkans

(cid:129) Health care intervention research – improving pre-natal & maternal care 

Target Regions:  ACP & Mediterranean Partner Countries

Funding scheme: Collaborative Projects (small or medium-scale focused research projects)
(cid:129) Health care intervention research – improving pre-natal & maternal care 

Target Regions:  ACP & Mediterranean Partner Countries

Funding scheme: Collaborative Projects (small or medium-scale focused research projects)

Other Public Health related topic 
(under Responding to EU Policy needs)

Topics for Second call – Deadline 18 September 2007
(cid:129) Effectiveness of ﬁ scal policies for tobacco control in Europe
Funding scheme: Collaborative Projects
(small or medium-scale focused research project)

FOR MORE INFORMATION
http://cordis.europa.eu/fp7/dc/index cfm?fuseaction= 
UserSite. CooperationDetailsCallPage&call_id=63 

CONTACT
Kevin McCarthy – Public Health Research
Tel: +32 (0)2 29-53938 – kevin.mccarthy@ec.europa.eu

Jan Paehler – jan.paehler@ec.europa.eu
Gesa Hansen – gesa.hansen@ec.europa.eu
Véronique Bernard – veronique.bernard@ec.europa.eu
Oyvind Hope – oyvind.hope@ec.europa.eu

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Other actions across the health theme 

Under the activity ‘Other actions across the health theme’, two areas will be covered: ‘Coordination and support 
actions across the theme’ and ‘Responding to EU policy needs’. 

Coordination and support actions across the theme
Topics for Speciﬁ c International Cooperation Action (SICA) 
– Deadline 18 September 2007
(cid:129) Promotion and facilitation of international cooperation in areas relevant to 

the objectives of this Theme

CONTACT
Aziza Haas – Horizontal aspects and coordination Unit
Tel: +32 (0)2 29-85744 – aziza.haas@ec.europa.eu 

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Responding to EU Policy needs

Pediatric medical products
Topics for Second call – Deadline 18 September 2007
(cid:129) Adapting off-patent medicines to the speciﬁ c needs of paediatric 

populations

Funding scheme: Collaborative Projects 
(small or medium-scale focused research with 
maximum EC contribution of €6.000.000/project)

Drug Safety research
(cid:129) Relative safety of non steroidal anti-inﬂ ammatory drugs (NSAIDs)
Funding scheme: Collaborative Projects 
(small or medium-scale focused research projects)

Living and working conditions 
(cid:129) Research to assess the economic dimension of occupational 

health and safety

Funding scheme: Coordination and support actions 

Health Statistics
(cid:129) Health statistics and rare events
Funding scheme: Collaborative Projects 
(small or medium-scale research projects)

Framework Condition on Tobacco Control
Topics for Second call – Deadline 18 September 2007
(cid:129) Effectiveness of ﬁ scal policies for tobacco control in Europe

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Calls for tender

In addition, some horizontal objectives may be taken forward through public procurement procedures 
(calls  for  tenders  or  existing  framework  contracts).  These  will  help  the  Commission  prepare  new 
initiatives in a targeted manner that will complement the more “bottom” up approach offered by calls 
for proposals. 

Areas that may be covered
(cid:129) Communication/dissemination actions related to EU RTD activities in Health
(cid:129) Ex post evaluation and impact assessment of EU RTD funding in Health

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Opportunities for SMEs 
in Health Research

Research-intensive  SMEs  are  the  main  economic  drivers 
of  healthcare,  biotechnology  and  medical 
technologies. 
Recognising their innovative potential,  EU-supported research 
actively seeks SME participation. 

Inclusion  of  high  tech  SMEs  in  the  health  and  biotechnology 
sectors  has  gained  momentum  during  FP6  and  an  even  more 
prominent role is therefore expected for SMEs in FP7.  In addition, 
SMEs  providing  a  service,  e.g.  management  or  intellectual 
property expertise, are also eligible to participate.

FP7
Out  of  the  €6  billion  dedicated  to  the  Health  Theme  in  the 
Seventh Framework Programme (2007-2013), the share going 
to SMEs is expected to be at least 15%, or €900 million.

A priority of the Health Theme is the inclusion of ‘high-tech’ 
SMEs in most projects throughout the work-programme. 

However,  SME  inputs  in  research  and  innovation  are 
particularly  encouraged  in  certain  speciﬁ c  topics1  for 
Collaborative  Projects  (small  or  medium-scale  focused 
research projects) targeted to SMEs. The expected results of 
these projects should clearly be of interest and potential beneﬁ t 
to SME(s). The relevant consortia should have at least 40% of the 
requested EC contribution going to SMEs (those projects should 
not necessarily be co-ordinated by the participating SME(s)).

1. In the Second call see topics HEALTH-2007-1.1-4 and HEALTH-2007-
2.4.3-6 (HTTP://cordis.europa.eu/fp7/cooperation/health_en.htlm)

FP7 IS MORE FAVORABLE TO SME 
PARTICIPATION

FP7 has a broader approach to health research than FP6, 
covering also new areas, such as medical technologies and 
public health… Furthermore, it is a 7 year programme, with 
long term continuity of structure, rules and procedures.

Better funding

FP7 ‘rules of participation’ allows funding of up to 75% for 
research and development activities of SMEs, rather than the 
50%  of  the  previous  framework  programme.    Management 
and training activities are funded up to 100%.

Better protection of intellectual property 

The  rules  governing  intellectual  property  in  EU-funded 
projects  have  been  greatly  improved  in  the  last  framework 
programmes. Clearer IPR rules are designed with more 
attention to the special needs of SMEs.

Reduced need for ﬁ nancial checks and bank 
guarantees

In  FP7,  a  guarantee  fund  replaces  the  ‘collective  ﬁ nancial 
responsibility’. This fund is set up to cover the ﬁ nancial risks 
of defaulting project participants.

More information on 7th Framework Programme

http://cordis.europa.eu/fr/home.html 
http://ec.europa.eu/research/fp7

HEALTH RESEARCH IN FP7

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SME participation in FP6: € 350 million

In the Sixth Framework Programme (2002-2006), the Thematic 
Priority  1  ‘life  sciences,  genomics  and  biotechnology  for 
Health’ encouraged SMEs to participate in all activity areas 
and projects, with several topics of special interest for SMEs 
being  included  throughout  the  programme.  Furthermore,  a 
very successful ‘SME-call’ (the FP6-2005-LIFESCIHEALTH-7 
call) was published at the end of the programme. This call was 
particularly aimed at establishing projects with high number 
of  research-intensive  SMEs;    from  a  total  budget  of  € 200 
million, more than 40% was  allocated to about 270 SMEs.

Overall, of the € 2.39 billion of the total FP6 available budget 
for ‘health’, some € 350 million are for SMEs. 

During  FP6,  research  intensive  SMEs  in  the  health  and 
biotech sector gained a pivotal role as key players and driving 
forces  in  the  research  activities  of  several  small  and  large 
EU-funded projects. The scientiﬁ c involvement ranged from 
activities such as identiﬁ cation of biomarkers, elucidation of 
candidate genes and their role, providing microRNA discovery 
and validation platforms or bioinformatics and transcriptomic 
analysis,  developing  photonic  and  electro-optics,  designing 
microchip  or  magnetic  phase  platforms,  etc.  Specialised 
SMEs  with  expertise  in  intellectual  property  management, 
technology transfer, project management or training activities 
also participated actively in some EU-funded projects. 

SME Deﬁ nition

(cid:129) less than 250 employees 
(cid:129) annual turnover less or equal to 50 million € 
and balance sheet less or equal to 43 million €  
(cid:129) the company has to be ‘independent’ 

For more details see

http://ec.europa.eu/enterprise/enterprise_policy/
sme_deﬁ nition/index_en.htm

WHERE TO GET HELP TO PREPARE 
A PROPOSAL

Dedicated  local  support  is  available  through  SME-go-
Health,  an  EU-funded  project,  speciﬁ cally  supporting  the 
participation  of  SMEs  and  SME  groupings  in  Health-oriented 
projects. They provide several services, including a matchmaking 
database for proposals preparation. 

Contact them at
http://www.smesgohealth.org/ 

The network of National Contact Points in the Member States 
and Associated States, provides guidance, practical information 
and assistance on all aspects of participation in the Framework 
Programmes. 

Contact your NCP at 
http://cordis.europa.eu/fp7/ncp_en.html 

The SME Contact Ofﬁ cer in the Health Directorate is 
Ludovica Seraﬁ ni, e-mail: ludovica.seraﬁ ni@ec.europa.eu

Other Support Services

New support services designed for the industrial and scientiﬁ c 
community  in  Health  will  be  funded  through  appropriate 
Coordination  and  Support  Actions  during  FP7  as  needed.  As 
example, in the ﬁ rst call were published the topics HEALTH-2007-
4.1-2 Promoting participation of high-technology research 
intensive SMEs, operating in the biomedical engineering 
and other medical technology sectors relevant to Health 
Theme, and HEALTH-2007-4.1-3 Assessment and valorisation 
of  project  outcome  for  high-technology  and  research 
intensive  SME  participating  to  Framework  Programmes 
of Research in the healthcare sector to support SMEs and 
Innovation. 

A  number  of  other  support  services  related  to  innovation  are  
available: 
http://cordis.europa.eu/fp7/get-support_en.html 

In  addition  to  FP7,  other  forms  of  support  for  innovation  will 
be  funded  though  other  EU  institutions,  in  particular  the 
Competitiveness  and  Innovation  Framework  Programme  (CIP) 
ﬁ nanced by DG Enterprise.  
(http://cordis.europa.eu/innovation/en/policy/cip.htm)  

The European Medicine Agency (EMEA) has established an ‘SME 
Ofﬁ ce’, which is dedicated to addressing the particular needs of 
smaller companies 
(http://www.emea.eu.int/SME/SMEoverview.htm)

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(cid:36)(cid:80)(cid:78)(cid:78)(cid:86)(cid:79)(cid:74)(cid:85)(cid:90)(cid:1)(cid:83)(cid:70)(cid:84)(cid:70)(cid:66)(cid:83)(cid:68)(cid:73)

International Cooperation

International cooperation is an integral part of the Health Theme and project consortia in all areas are encouraged to 
include organisations from third countries, especially from the International Cooperation Partner Countries (ICPC) and 
from countries with Scientiﬁ c and Technological cooperation agreements with the EU according to the participation rules. 
Funding can be provided to participants from the ICPCs, whereas funding for organisations from industrialised third 
countries may be provided on a case by case basis if considered essential for carrying out the project.  

International  cooperation  will  be  implemented 
via two mechanisms:

1. Opening  of  all  activities  of  the  Theme  to  international 
is  particularly 
cooperation.  Third  country  participation 
emphasised  (enhanced  international  participation)  in  the 
areas addressing global health problems: Anti-microbial drug 
resistance, HIV/AIDS, malaria and tuberculosis, and emerging 
epidemics, as well as in certain individual topics in the other 
areas of the Theme, as indicated in the text.

2. Speciﬁ c International Cooperation Actions (SICA) which aim 
to  generate,  share  and  use  knowledge  through  research 
partnerships  with  third  countries  in  the  areas  identiﬁ ed 
through bi-regional dialogues with third countries/regions and 
international fora, on the basis of mutual interest and mutual 
beneﬁ t. Research areas may include: health policy research, 
health  systems  and  health  care  service  research,  neglected 
infectious diseases and emerging unforeseen policy needs in 
those regions, as well as other topics of strategic importance. 
Collaborative  projects  must  involve  at  least  two  participants 
from  two  different  Member  States  or  Associated  countries 
and at least two partners from two different ICPCs.

The  European  interest  in  opening  the  themes  to  international 
partners can be seen in the context of globalisation and the need 
to remain competitive by collaborating widely, while at the same 
time aiding sustainable development in lower income countries 
and  strengthening  ties  to  third  countries  in  general,  including 
industrialised  countries.  In  this  way  the  inclusion  of  a  third 
country partner in a project can be regarded as enhancing the 
European added value of the joint effort. Any such participation 
has though to be carefully weighted with regard to the beneﬁ ts to 
the projects and the European research community. Furthermore 
the  participation  has  to  be  balanced  and  well  justiﬁ ed  in  the 
proposal. 

For the calls corresponding to the ﬁ rst Work Programme of the 
Health  Theme,  the  SICA  topics  are  mainly  to  be  found  in  the 
second call. For these ﬁ rst two calls an amount of 64 million Euro 
has been earmarked for SICA projects. This is expected to rise 
in the later years. For international collaboration in other topics 
there is no such speciﬁ ed budget. 

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List of Speciﬁ c International Cooperation Actions (SICA)

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Second call

Topics  

HEALTH-2007-2.1.2-7: Traditional Chinese Medicine in post-genomic era
(Coordination or Support Action) 

HEALTH-2007-2.2.1-10:  Childhood and adolescent mental disorders 
(small or medium-scale focused research projects) 

HEALTH-2007-2.3.2-12: Highly innovative research in HIV/AIDS, malaria 
and tuberculosibetween Indian and European partners  
(small or medium-scale focused research projects) 

HEALTH-2007-2.3.2-13: Coordination of European research activities with
global initiatives, including Public-Private Partnerships  
(Coordination or Support Action) 

HEALTH-2007-2.3.2-14: Next generation of researchers for HIV/AIDS, malaria, 
tuberculosis and neglected infectious diseases  
(Coordination or Support Action) 

HEALTH-2007-2.4.1-14: Studying cancer aetiology in Latin America 
(small or medium-scale focused research projects) 

HEALTH-2007-2.3.4-1: Development of new tools to control infectious due 
to parasites of the Trypanosomatidae family  
(small or medium-scale focused research projects) 

HEALTH-2007-2.3.4-2: Development of a Leishmania vaccine 
(small or medium-scale focused research projects) 

HEALTH-2007-2.3.4-3: Bioprospecting for drug leads 
(small or medium-scale focused research projects) 

HEALTH-2007-3.5-1: Epidemiological investigations into long-term trends 
of population health as consequence of socio-economic transitions,  
induced health problems  
(small or medium-scale focused research projects) 

HEALTH-2007-3.5-2: Universal and equitable access to health care and  
health ﬁ nancing (Small or medium-scale focused research projects) 

HEALTH-2007-3.5-3: Health care intervention research – optimising hospital care 
(small or medium-scale focused research projects)  

HEALTH-2007-3.5-4: Health care intervention research – improving pre-natal 
and maternal care (small or medium-scale focused research projects)   

HEALTH-2007-4.1-8: Promotion and facilitation of international cooperation 
in areas relevant to the objectives of this Theme (Coordination or Support Action) 

Contact
Indridi Benediktsson – Horizontal aspects and Coordination Unit
Tel: +32 (0)2 29-93137 – indridi.benediktsson@ec.europa.eu

Targeted Country/Region 

China

EECA and
Western Balkans

India

ICPC

ICPC

Latin America

ICPC

ICPC

ICPC

MPC, Russia including life-style 
and EECA

MPC, ACP, Asia
and Latin America

Western Balkans

ACP and MPC

ICPC

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(cid:36)(cid:48)(cid:46)(cid:46)(cid:42)(cid:52)(cid:52)(cid:42)(cid:48)(cid:47)

(cid:36)(cid:80)(cid:78)(cid:78)(cid:86)(cid:79)(cid:74)(cid:85)(cid:90)(cid:1)(cid:83)(cid:70)(cid:84)(cid:70)(cid:66)(cid:83)(cid:68)(cid:73)

Ethics Issues 
in Health Research

Ethics is central to scientiﬁ c integrity, honesty and clarity of science. It is considered essential by the European Commission 
in the research activities that it funds or carries out itself. This means that in any proposal submitted to the 7th Framework 
programme,  ethics  issues  must  be  identiﬁ ed  and  addressed.  Proposals  that  pose  ethics  concerns  will  be  ﬂ agged. 
If some aspects are incomplete, clariﬁ cation may be sought, but this will cause delays in the application process.  

Considering ethics issues from the concept stage of a proposal enhances the quality of research. Applicants should take 
time to consider the beneﬁ t/burden balance of each work package; consider the impact of the research, not only in terms 
of scientiﬁ c advancement, but also in terms of human dignity and social and cultural impact; consider elements such 
as the ethics and social impact of the research and whether there is a balance between the objectives and the means.

Ethics Reviews in Practice
All proposals submitted to the European Commission for funding 
are evaluated by  a panel of independent experts on the basis of 
3 criteria:
(cid:129) Scientiﬁ c and Technological excellence;
(cid:129) Implementation and Management;
(cid:129) Potential Impact.

The independent experts will also detect proposals raising Ethics 
issues and recommend Ethics Review.

Ethics review and the reviewers

Ethics review aims to prevent Community funding being used for 
research activities that contravene fundamental rights. 

(cid:129) Reviewers are selected on the basis of their expertise.
(cid:129) Reviewers must ﬁ rst register online on CORDIS.
(cid:129) Reviewers have a wide range of skills. They include doctors, 

biologists and clinicians, ethicists, lawyers.

(cid:129)  Gender balance is promoted.
(cid:129) Reviewers come from the European Union and other countries.

Every proposal gets a report outlining the views of the reviewers.
No marks are given, but if the proposal is unclear on ethics issues,
clariﬁ cation may be asked for.

Ethics review is automatic if a proposal includes:
(cid:129) interventions on human beings;
(cid:129) the use of human embryonic stem cells (hESC); and/or
(cid:129) the use of non-human primates.

Ethics Review may be necessary if the proposal is ﬂ agged by the 
scientiﬁ c expert as raising speciﬁ c ethics issues.

Main Ethics Issues that MUST be addressed
(cid:129) Informed consent
(cid:129) Human embryonic stem cells
(cid:129) Privacy and data protection
(cid:129) Use of human biological samples and data
(cid:129) Research on animals
(cid:129) Research in developing countries
(cid:129) Dual use

Areas excluded from funding
1. Research activity aiming at human cloning for reproductive purposes.

2. Research activity intended to modify the genetic heritage of human 
beings which could make such changes heritable (Research related 
to cancer treatment of the gonads can be ﬁ nanced).

3. Research activities intended to create human embryos solely for the 
purpose of research or for the purpose of stem cell procurement, 
including by means of somatic cell nuclear transfer.

Major Changes from FP6 to FP7
(cid:129) The Ethic Review will be carried out on the proposal as it is 

submitted.

(cid:129) No additional information will be requested at Ethical Review.
(cid:129) Drafts of Information Sheet and Consent Form have to be 

submitted.

(cid:129) No need to submit copies of legislation.

Take Home Message:
GET IT RIGHT FIRST TIME!
Identify and contact the ethics expert in your organisation now!

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Informed Consent  

When is it needed?
(cid:129) When children are involved
(cid:129) Healthy volunteers
(cid:129) Human genetic material
(cid:129) Human biological samples
(cid:129) Human data collection

What must be in a Consent form?

Human Embryonic 
Stem Cell Research (hESC)

Each proposal using hESC is assessed by at least two independent 
ethics reviews: one in the country where the research is carried 
out and one at the EU level. No system in the world offers a higher 
guarantee regarding the respect of fundamental ethics principles. 

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When involving the use of hESC in their research project, 
researchers should take into account and specify:

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(cid:129) A statement that this is a research project.
(cid:129) The purpose of the research, the duration, procedures to be used 

and identiﬁ cation of any experimental procedure.

(cid:129) A description of the foreseen risks and beneﬁ ts to be included.
(cid:129) A statement describing the extent to which conﬁ dentiality of 

records identifying the subject will be maintained.

(cid:129)   A disclosure of any alternative procedures that might be 

beneﬁ cial.

(cid:129) For research involving more than minimal risk, an explanation as 
to whether there are any treatments or compensation if injury 
occurs and if so what they consist of or where further information 
can be obtained.

(cid:129) Identity the contact person for answers to questions about the 
research and research subject’s rights, and whom to contact in 
the event of injury to the subject.

(cid:129) A statement that participation is voluntary, withdrawal from the 
research can be undertaken at any time without loss of beneﬁ ts 
which the subject is otherwise entitled to.

How to deal with informed consent in practice?

Ensure that: 

(cid:129) it is understood. Explain how you check the critical part of the 

process;

(cid:129) it excludes vulnerable persons, prisoners, mentally impaired persons, 
severely-injured patients, very young children, but avoid lost oppor-
tunities for these persons. The framework should guarantee their 
participation (notion of surrogate legal/ therapeutic representative);

(cid:129) you address the fact that people rarely recall what they have 

agreed upon when signing an informed consent form.

Privacy and data protection
Privacy problems exist wherever uniquely identiﬁ able data relating 
to a person is collected or stored, in digital form or otherwise. 
Improper disclosure control can be the root cause for privacy 
issues. 

Data affected by privacy issues
(cid:129) Health Information
(cid:129) Financial and Genetic information
(cid:129) Criminal justice
(cid:129) Location information
(cid:129) Data privacy/sharing data while protecting identiﬁ able 

information

How to address Data protection and Privacy?
(cid:129) Describe the procedures for informed consent conﬁ dentiality.
(cid:129) Inform consent for duration and limited purposes.
(cid:129) Code or anonymise banked biomaterial, security for storage and 

handling and make sure it is lawfully processed.

(cid:129) Check for accuracy, and security Check for data transferred 

abroad unprotected.

Dual use
Dual use is a term used to refer to technology which can be used 
for both peaceful and military aims.

Double Standards
The issues at stake when conducting research in Third Countries are 
linked with applying the same criteria to other cultures. This implies 
that you take into account the wide disparities in health systems, the 
burden of disease, the level of literacy and the scientiﬁ c and ethics 
infrastructures.

(cid:129)  if it does not destroy embryos (including to procure stem cells);
(cid:129)  if the consortium has taken into account the legislation, 

regulations, ethics rules and/or codes of conduct in place in the 
countries where the research using the hESC will take place, 
including the procedures for obtaining informed consent;

(cid:129)  the source of the hESC;
(cid:129)  the protection of personal data (genetic data and privacy);
(cid:129)  the nature of ﬁ nancial inducements, if any; 
(cid:129)  positive opinion from a Committee constituted by Member States 

representatives;

(cid:129)  approval of the relevant national or local ethics committee prior to 

the start of the research activities.

Elements for a good approach

(cid:129)  Foresee Ethics Responsibility at the level of Work-Package 

Leadership.

(cid:129)  Include a ﬂ owchart of the Ethics review process within the 

partnership.

(cid:129)   Include an appropriate periodic report on ethics.
(cid:129)  Ethics consideration is reﬂ ected in the structure of the proposal. 
(cid:129)  Include an Ethics Standing Committee or at least a periodic 

monitoring for ethics.

(cid:129)  Include a Work Package on Ethics (if relevant). 
(cid:129)  Speciﬁ cally include: Insurance of participants, Conﬂ ict of interest, 

Incidental ﬁ ndings.

(cid:129)  The content of the Ethics part of the proposal should reﬂ ects that 

the issue was thought of thoroughly.

(cid:129)  Address possible ethics issues, even if to justify that they are not 

applicable, give justiﬁ cation.

(cid:129)  Justify the choice of animals, estimate the numbers.
(cid:129)  Take into account data, data transfer, banks, collecting samples, 

future clinical trials.

Research on Animals
(cid:129) Address the question of animal by 
explaining your choices of species.

(cid:129) Make a detailed and convincing 
explanation for the application of 
the 3Rs: Reduction, Replacement, 
Reﬁ nement.

(cid:129) Justify species and give an estimate 
of numbers of animals you will use.
(cid:129) Refer humane end points and pain 

suffering.

(cid:129) Check for alternatives. 

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FOR MORE INFORMATION
(cid:129) Guide for Applicants and Ethics Review guidance: 

http://cordis.europa.eu/fp7/dc/index.cfm

(cid:129) Experts’ registration: https://cordis.europa.eu/emmfp7/
(cid:129) Ethics Review: http://cordis.europa.eu/fp7/ethics_en.html
(cid:129) Research on Animals: 

http://www.nc3rs.org.uk/category.asp?catID=3
http://www.vet.uu.nl/nca/links/databases_of_3r_models

CONTACT
Joana Namorado
Unit F1, Horizontal aspects 
and coordination 
Tel: +32 (0)2 29-85466
Joana.namorado@ec.europa.eu

Disclaimer: this leaﬂ et provides only a general overview. Applicants must refer to the “Guide for Applicants” and websites mentioned above.  

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(cid:36)(cid:80)(cid:78)(cid:78)(cid:86)(cid:79)(cid:74)(cid:85)(cid:90)(cid:1)(cid:83)(cid:70)(cid:84)(cid:70)(cid:66)(cid:83)(cid:68)(cid:73)

Innovative Medicines 
Initiative

Under  the  7th  Framework  Programme  (FP7),  Joint  Technology  Initiatives  (JTIs)  have  been  introduced  to  realise 
Public-Private Partnerships in research at European level.

The  Innovative  Medicines  Initiative  (IMI)  is  proposed  to  be  establish  as  one  of  these  Joint  Technology  Initiatives, 
forming a Public-Private Partnership between the pharmaceutical industry represented by the European Federation of 
pharmaceutical Industries and Associations (EFPIA) and the European Commission.

The  Innovative  Medicines  Initiative  proposal  is  based  on  the  principle  of  co-ﬁ nancing  between  the  EC  and  the 
pharmaceutical  industry.  The  total  budget  of  the  Innovative  Medicines  Initiative  will  be  2  billion  €.  The  European 
Commission will contribute with 1 billion € with a matching contribution of EFPIA and its member companies.

IMI to be funded equally by
Pharma industry and European Commission

2 Billion EURO

at least 
equal to EC 
contribution

1 Billion
EURO

Research performed by industry 
funded by own resources

Research performed by academics 
and SME’s funded by EC

The Innovative Medicines Initiative will support pre-competitive pharmaceutical research to tackle bottlenecks in the 
drug development process.1 The main research objectives of the Innovative Medicines Initiative will be development and 
validation of new and better techniques and methods to predict safety and efﬁ cacy of new medicines. A key feature of the 
Initiative is that research results will be compiled and made available to beneﬁ t the entire European pharmaceutical sector.

1. Based on the Strategic Research Agenda 2006.  www.imi-europe.org/Publications.aspx?viewCategory=Researchx20Agenda

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IMI Focus Research Areas

SAFETY

KNOWLEDGE 
MANAGEMENT

EDUCATION &
TRAINING

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Source: EFPIA

EFFICACY

The research activities, to be supported under the Innovative Medicines Initiative, will be open to all research actors. Any 
legal entity will be eligible to participate in projects, the only condition being that the research is performed in Member 
states and countries associated in FP7. Innovative Medicines Initiative activities are expected to be carried out by multi-
stakeholder  research  consortia  comprising  e.g.  pharmaceutical  companies,  SMEs,  public  institutions  following  open 
calls for proposals and a peer review process. Academics, SMEs, patient organisations etc. are eligible for Community 
support. Companies not considered as a SMEs shall be carry their own costs for participating in the projects. The ﬁ rst 
call is foreseen to be launched at the beginning of 2008 (pending on Council and Parliament).2

2. All information is based on the Commissions «Proposal for a Council Regulation setting up the Innovative Medicines Initiative Joint Undertaking, 15 May 2007. The Council will decide on 

the Commissions proposal and the Parliament is requested to give an opinion.

Overall Policy Objective

The  overall  goal  of  the  Innovative  Medicines  Initiative  (IMI)  is  to  re-invigorate  the  European  bio-
pharmaceutical sector and to make Europe more attractive for private R&D investment in this sector. In 
the long term, IMI is also expected to provide faster access to better medicines for European citizens.

Innovative Medicines Initiative - Commissions proposal
ec.europa.eu/research/health/imi/docs/com2007_0241en01_en.pdf

Budget
The  total  budget  of  the  Innovative  Medicines  Initiative  will  be  2  billion  €.  EC  contribution  to  the 
Innovative Medicines Initiative is € 1 billion for the period of the 7th Framework Programme. 

Structure
The executive bodies will be the Board, the Scientiﬁ c Committee and the Executive Ofﬁ ce. The Innovative 
Medicines  Initiative  involves  two  additional  groups:  a  Member  States  Group  and  a  Stakeholders’ 
Forum (researchers from academia, SMEs, industry, clinicians, regulators, patients, etc.).

Participation
Any legal entity can participate provided the research is done in Member States or in the countries 
associated with FP7.

More Information
ec.europa.eu/research/health/imi/index_en.html
www.imi-europe.org

CONTACT
Commission Contacts: Irene NORSTEDT – Deputy Head of Unit, Biotechnology for Health, 
Directorate for Health Research – European Commission – Tel: +32 (0)2 29-69527
Irene.Norstedt@ec.europa.eu

EFPIA Contacts: Mark REILLY – European Federation of Pharmaceutical Industries and 
Associations – (EFPIA), Brussels, Belgium – Tel: +32 (0)2 62-62564 – markreilly@efpia.org

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