Proposal for a Council recommendation on measures to combat neurodegenerative diseases, in particular Alzheimer's, through joint programming of research activities {SEC(2009) 1039}
Date: 2009-07-22
Institutions: European Commission
Subjects: EU action, EU programme, disease of the nervous system, disease prevention, harmonisation of standards, health care, health care system, health costs, health policy, medical research

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 22.7.2009 
COM(2009) 379 final 

Proposal for a 

COUNCIL RECOMMENDATION 

on measures to combat neurodegenerative diseases, in particular Alzheimer's, through 
joint programming of research activities 

{SEC(2009) 1039}

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EXPLANATORY MEMORANDUM 

EXECUTIVE SUMMARY 

The Commission is proposing more strategic cooperation among EU Member States (MS) in 
research and development (R&D) in view of addressing large societal challenges. One way to 
do so is a new ‘Joint Programming’ approach. Joint Programming (JP) involves MS engaging 
voluntarily on a variable-geometry basis in defining, developing and implementing strategic 
research  agendas.  Neurodegenerative  diseases  (ND),  and  in  particular  Alzheimer’s  disease 
(AD), have been proposed as a pilot project. 

Around  7.3  million  people  are  reckoned  today  to  suffer  from  AD  and  related  disorders  in 
Europe,  a  figure  that  is  expected  to  double  by  2020.  AD  is  expected  to  place  a  heavy  and 
growing burden on health-care systems, including informal care and long-term care facilities, 
in  Europe.  In  an  ageing  society,  research  on  ND  mobilises  significant  financial  and  human 
resources, both in the EU and at the level of the EU Framework Programme for research and 
technological development (RTD). 

In  spite  of  this,  there  is  at  present  no  effective  treatment  able  to  slow  down  or  stop  the 
deterioration  of  brain  function.  Early  diagnosis  is  close  to  impossible,  and  because  it  often 
occurs  too  late,  treatment  to  mitigate  the  effects  of  the  illness  remains  limited.  If  we  are  to 
succeed  in  combating  ND  in  general  and  AD  in  particular,  a  focused  research  effort 
addressing prevention, diagnosis and treatment is essential. Coordinating research in Europe 
would bring added value, better results and lead to more accurate diagnostic tools and more 
effective forms of treatment. 

In  September  and  December  2008,  the  Council  adopted  conclusions  recommending  that  a 
common  European  initiative  be  launched  in  this  field  through  a  JP  approach.  It  invited  the 
Commission  to  submit  a  proposal  for  a  Council  Recommendation  with  a  view  to  this  pilot 
initiative being launched in 2009. 

As a consequence, this Recommendation invites the MS to work towards a common vision of 
how  research  cooperation  and  coordination  at  European  level  can  help  us  to  understand, 
detect,  prevent  and  combat  ND,  especially  AD,  and  develop  a  Strategic  Research  Agenda 
(SRA)  establishing  medium  to  long-term  research  needs  and  objectives,  including  an 
implementation  plan  establishing  priorities,  milestones  and  timelines.  This  might  include 
exchanging information on national programmes, research activities and health care systems; 
identifying  areas  which  would  benefit  from  coordination,  joint  calls  or  the  pooling  of 
resources; facilitating transdisciplinary and cross-sectoral mobility and training; and exploring 
the joint exploitation of research infrastructures and the networking of research centres.  

The  Recommendation  also  invites  MS  to  cooperate  with  the  Commission  with  a  view  to 
exploring  possible  Commission  initiatives,  using  the  facilities  provided  by  the  existing 
instruments, to assist MS in developing and implementing the common research agenda or to 
promote JP in this area. 

1. 

TOWARDS JOINT PROGRAMMING  

Until recently, the main tools for promoting cooperation in science and technology in Europe 
were transnational collaborative research projects and networks. 

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In 2008 the Commission proposed a new approach called Joint Programming for large-scale 
joint public research initiatives at European level1. JP grew out of the revised Lisbon strategy 
and  is  the  process  by  which  MS  engage  voluntarily  and  on  a  variable-geometry  basis  in 
defining, developing and implementing common SRA based on a common vision of how to 
address major societal challenges that no MS is capable of resolving alone. 

In September 2008, the Council recognised the challenges posed by ND in the context of an 
ageing European population and the need to understand, detect, prevent and combat the basic 
mechanisms  which  trigger  these  diseases,  particularly  AD.  The  Council  conclusions 
recommended that a European initiative be launched, bringing together MS, the Commission 
and other stakeholders with a view to reducing ND, particularly AD2.  

In  December  2008,  the  Council  adopted  conclusions  recognising  the  necessity  of  a  pilot  JP 
initiative  on  ND,  especially  AD,  and  inviting  the  Commission  to  submit  a  proposal  for  a 
Council recommendation to prepare for this pilot initiative as soon as possible in 20093. 

Working through an informal working group set up under the French Presidency, MS started 
discussing how best to develop a pilot JP initiative on ND and AD. These discussions led to a 
Declaration of Intent in December 2008, agreed by ten MS and one country associated with 
the 7th Framework Programme (FP7). 

The Declaration underlines these countries’ willingness to take on the challenge, setting the 
basis  for  a  shared  vision  in  this  field,  outlining  the  research  fields  where  Europe  could  add 
value,  and  describing  a  preliminary  management  structure.  Following  a  presentation  to  the 
High Level Group on JP (GPC), representatives from 20 countries are currently involved in 
formulating the terms of reference for a management structure for this pilot initiative. 

A case for Joint Programming 

During the French Presidency in 2008, ND and AD in particular, were identified by MS as an 
area where social demand is high and where a common initiative, using JP, would offer major 
added value compared with the current, fragmented efforts in the European Research Area.  

There is a real and urgent need to pool and coordinate the efforts of European fundamental, 
clinical and social researchers in this field. Given that most research on ND is still at the pre-
clinical  phase,  publicly  funded  research  will  be  instrumental  in  any  breakthrough  in  such 
areas as research on biomarkers, the development of new criteria and methods for prevention 
and  diagnosis,  and  the  testing  of  new  therapeutics  in  large-scale  clinical  trials.  These  will 
increase  Europe’s  chances  of  understanding,  detecting,  preventing  and  combating  the  basic 
mechanisms  that  trigger  ND,  and  particularly  AD,  and  of  providing  better  care  for  people 
suffering  from  these  diseases.  In  turn,  this  would  mitigate  the  financial  burden  caused  by 
having such a large population of sufferers. 

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COM(2008) 468. 
http://register.consilium.europa.eu/pdf/en/08/st13/st13668.en08.pdf 
http://register.consilium.europa.eu/pdf/en/08/st16/st16775.en08.pdf 

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2. 

COMBATING  NEURODEGENERATIVE  DISEASES, 
ALZHEIMER'S 

IN  PARTICULAR 

A major issue for public health in Europe 

ND  are  hereditary  or  sporadic  conditions  which  are  characterised  by  progressive  nervous 
system dysfunction, often associated with atrophy of the affected central or peripheral nervous 
system  structures.  They  are  a  heterogeneous  group  of  age-associated,  chronic  illnesses  of 
varying aetiologies. 

AD is the most prevalent ND, accounting for around 50 -70 % of all dementias, followed by 
Parkinson's  disease4.  In  2006,  7.3  million  Europeans  across  the  27  Member  States  were 
suffering  from  dementias5..  Alzheimer's  is  the  fourth  most  common  cause  of  burden  of 
disease in high-income countries. 

With the rise in life expectancy in Europe this number will increase dramatically, and current 
forecasts speak in terms of a doubling of the number of affected persons every twenty years in 
EU-276. 

Indeed, the population of Europe is ageing, with persons aged over 80 constituting the fastest 
growing cohort in most European countries. 70% of diagnosed AD patients are aged 75 and 
over. Dementia is therefore expected to be one of the main challenges for healthcare systems, 
including informal care and long-term care facilities, in the coming decades.  

AD  and  related  disorders  are  terminal  conditions,  but  people  can  live  and  progressively 
deteriorate  for  7–12  years  after  initial  diagnosis.  The  disorder  manifests  with  a  progressive 
decline  in  multiple  areas  of  function,  including  memory,  reasoning,  communication  and  the 
skills needed to carry out daily activities.  

AD is a devastating disorder for the patients themselves. Also, a very heavy burden is placed 
on  the  shoulders  of  the  patients’  relatives.  Family  carers  are  often  old  and  frail  themselves, 
with  high  levels  of  depression  and  physical  illness,  and  a  diminished  quality  of  life.  As  a 
consequence,  AD  is  extremely  costly  for  society  as  a  whole:  according  to  the  Dementia  in 
Europe Yearbook (2008), the total direct and informal care costs of AD and other dementias 
in 2005 amounted to €130 billion for EU-27, 56  % of costs were for informal care7. 

A substantial research effort is needed  

The  causes  of  AD  and  related  disorders  are  not  well  understood,  but  they  all  result  in 
structural and chemical changes in the brain, leading to the death of brain tissue.  

There is currently no treatment for AD which is able to slow or stop the deterioration of brain 
cells8.  Available  therapies  are  still  very  limited  and  mostly  treat  the  symptoms  rather  than 

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M. Flint Beal, Anthony E. Lang, Albert C. Ludolph. Neurodegenerative diseases: neurobiology, 
pathogenesis and therapeutics, Cambridge University Press 2005. 
http://ec.europa.eu/health/ph_information/dissemination/echi/docs/dementia2_en.pdf 
Alzheimer’s disease: Scientific, medical and societal implications, Synthesis and recommendations, 
INSERM, 2007. 
Alzheimer Europe (2008) Dementia in Europe Yearbook 2008. 
2009 Alzheimer’s disease facts and figures, US Alzheimer’s Association, 
http://www.alz.org/national/documents/report_alzfactsfigures2009.pdf 

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being  curative.  Indeed,  although  our  understanding  of  the  mechanisms  of  the  disease  has 
greatly improved over the past few years, we are far from seeing the full picture, and there is 
no  immediate  prospect  of  finding  therapies  that  might  slow  or  halt  the  progression  of  the 
illness. 

Furthermore, diagnosis is usually made at too late a stage to make best use of the treatments 
currently  available.  While  some  genetic,  behavioural,  cardiovascular,  and  nutritional  risk 
factors have been observed, long-term prevention studies have yet to be conducted to see if 
the  incidence  of  AD  can  be  reduced.  Furthermore,  the  possible  link  between  environmental 
stressors and ND including AD has to be investigated in depth. 

The  main  cause  for  concern,  according  to  the  available  epidemiological  data,  is  that  AD 
remains  under-diagnosed  in  the  EU9.  Currently  only  about  one-third  of  people  with  the 
disease receive a formal diagnosis at any time in their illness. When diagnoses are made, it is 
often too late for sufferers to make choices. The battle against ND and AD in particular will 
therefore not be won until we mobilise the research effort, covering the whole spectrum from 
prevention  and  diagnosis  to  treatment.  Priorities  for  future  research  should  include: 
prevention;  biomarkers,  including  genetic  susceptibility; 
imaging  technologies;  early 
diagnostic methods using a multidisciplinary approach; standardisation of diagnostic criteria 
and  diagnostic  instruments;  large  databases  that  could  be  used  for  population  studies; 
treatment  strategies  and  clinical  trials  of  new  chemicals,  biologicals,  vaccines  or  novel 
technologies. 

A field of growing priority for research funding in Europe  

Current action in the Member States 

AD  and  related  disorders  present  a  common  challenge  to  all  MS,  as  percentage  figures  for 
dementia  prevalence  are  roughly  similar  from  country  to  country.  They  also  pose  particular 
challenges  to  the  way  health  care  is  provided  nowadays.  Often,  the  services  offered  are  not 
adapted to current needs, and there is also a lack of capacity, continuity and knowledge. 

Given the expected increase in ND, and particularly AD, for healthcare systems in Europe in 
the  medium  and  long  term,  most  European  countries  have  started  recognising  the  need  for 
specific  comprehensive  strategies  for  tackling  AD  and  related  disorders.  In  many  countries, 
AD is becoming one of the emerging research priorities.  

Several  countries  have  adopted  or  are  in  the  process  of  adopting  national  plans.  In  2008, 
France made ND, and AD in particular, a priority, and adopted a €1.6 billion national plan in 
this  field10.  England  launched  in  2008  a  National  Dementia  Strategy,  Lifelong  Health  and 
Well Being Initiative11, backed by £150 million over the first two years, as well as its 2008 
Medical  Research  Council  Strategic  Review  of  Neurodegeneration12  and,  also  in  2008, 
Scotland  launched  the  Dementia  as  National  Priority  initiative13.  Norway  adopted  the 

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Moise, P., Schwarzinger, M., Um M-Y (2004) Dementia Care in 9 OECD Countries: A comparative 
analysis, OECD Health Working Papers No 13, OECD, Paris. 
Alzheimer Plan 2008-2012, http://www.plan-alzheimer.gouv.fr/ 
Living well with dementia: a National Dementia Strategy, UK Department of Health, 2008 
http://www.dh.gov.uk/en/SocialCare/Deliveringadultsocialcare/Olderpeople/NationalDementiaStrategy/
DH_083355 
http://www.mrc.ac.uk/Utilities/Documentrecord/index.htm?d=MRC004898 
http://www.scotland.gov.uk/Topics/Health/health/mental-health/servicespolicy/DFMH/dementia 

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Dementia National Plan 201514 with five main strategies for meeting future care challenges. 
Early diagnosis of ND including AD was defined in 2008 as one of the six priority areas of 
the  German  Federal  Ministry  of  Education  and  Research  (BMBF)15.  In  addition,  a  German 
Helmholtz Centre for Neurodegenerative Diseases (DZNE) has been established in Bonn with 
an annual budget of €50 million.  

In  Sweden,  the  Swedish  Brain  Power  Network  was  launched  in  2005  as  a  national 
collaborative effort between six founders in the  sum  of  SEK  100  million  over  five  years.  It 
seeks to improve early diagnosis, treatment and care of patients affected by ND16. In Ireland, 
almost €100 million are being devoted to  age-related disease and care research17. 

The  Netherlands18  and  Italy  have  funded  large  cohort  studies  in  the  field  for  years, 
establishing  an  important  collection  of  research  data.  Italy  has  made  Alzheimer's  a  research 
priority  for  its  Ministry  of  Health19.  Spain  has  established  several  consolidated  national 
networks addressing biomedical research on ND and mental health20. 

Current action at European Union level 

Research on ND, and particularly AD, has also benefited from growing attention at European 
level.  In  the  6th  RTD  Framework  Programme  (FP6)  €136  million  were  allocated  to  28 
collaborative  research  projects  in  this  area.  Of  this,  €40  million  specifically  tackled  a 
translational approach to the study of AD21.  

FP6  has  also  provided  a  means  of  addressing  fragmentation  and  coordination  of  national 
research  activities  on  ND,  including  AD,  through  the  ERA-NET  projects  ERA-AGE22  and 
NEURON23.  The  latter,  involving  12  MS,  issued  a  first  joint  call  for  proposals  in  2008.  12 
projects are being supported, with funding of €10 million 24. 

Efforts  in  this  area  have  been  strengthened  as  part  of  the  Health  Theme  within  FP7  (2007-
2013) with special reference to brain research and ‘Optimising the delivery of health care to 
European  citizens’.  Currently,  one-third  of  the  available  funds  for  brain  research  for  2008-
2009 have been allocated to neurodegeneration research. 24 collaborative research projects in 
the sum of €94 million are being supported in  this field, of which €24 million are for AD and 
related  disorders.  A  further  €8  million  are  de dicated  to  collaborative  research  focusing  on 
various aspects of the organisation, provision and quality of long-term care of the elderly in 
Europe.  

The  White  Paper  ‘Together  for  Health:  A  Strategic  Approach  for  the  EU  2008-2013’25, 
developing the EU Health Strategy, also identifies better understanding of ND, such as AD, as 

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http://www.regjeringen.no/upload/HOD/Dokumenter%20KTA/DementiaPlan2015.pdf 
http://www.bmbf.de/en/10849.php 
http://www.swedishbrainpower.se/eng/about_us.htm 
http://www.hrb.ie/, http://www.tcd.ie/Neuroscience 
http://www.minocw.nl/english/index.html 
http://www.ministerosalute.it 
http://www.isciii.es/htdocs/index.jsp 
ftp://ftp.cordis.europa.eu/pub/lifescihealth/docs/major_catalogue_complet.pdf 
http://era-age.group.shef.ac.uk 
http://www.neuron-eranet.eu 
http://www.neuron-eranet.eu/_media/newsLetter_January09.pdf 
COM(2007) 630 - http://ec.europa.eu/health/ph_overview/strategy/health_strategy_en.htm 

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an important need to be addressed in the context of demographic ageing. EU action has been 
launched under the Public Health Programme (2003-2008) in the field of information on AD 
and related disorders. 

The EuroCoDe (European Collaboration on Dementia)26 Project (2006-2008), supported by 
the Public Health Programme (2003-2008) and coordinated by Alzheimer Europe, is aimed at: 
(i)  devising  new  consensual  prevalence  rates  for  dementia;  (ii)  developing  guidelines  on 
diagnosis,  treatment  and  non-pharmacological  interventions;  (iii)  establishing  prevention 
strategies; (iv) analysing the socio-economic costs of AD and making an inventory of social 
support systems. 

As part of EuroCoDe, Alzheimer Europe has published the Dementia in Europe Yearbooks 
2006, 2007, and 200827, which provide a comprehensive overview of the present situation of 
AD and other dementias in the European Union. 

The  European  Pact  on  Mental  Health  and  Well-Being,  adopted  in  2008,  focuses  on  four 
priority themes: prevention of suicide and depression, mental health in youth and education, 
mental health in workplace settings, and mental health in older people28. 

The EU also supports the EADC (European Alzheimer's Disease Consortium)29, a network of 
European  centres  of  excellence  working  in  the  field  of  AD.  The  centres  increase  basic 
scientific  understanding  of,  and  develop  ways  of  preventing,  slowing,  or  ameliorating  the 
primary and secondary symptoms of AD by facilitating trans-European research. 

Following  the  priorities  set  out  in  the  EU  Health  Strategy  and  the  Council  conclusions  on 
public health strategies to combat ND associated with ageing, and in particular AD, adopted 
in December 2008 by the Ministers of Health, a Commission Communication on a European 
Initiative  on  Alzheimer's  Disease  and  other  Dementias  is  scheduled  to  be  adopted  in  July 
2009. The Communication will state that these diseases constitute a priority for action in view 
of the ageing of the European population, and will take account of how the increase in these 
diseases might impact on the financial sustainability of health and social protection systems.  

The benefits of better coordination  

Reducing  the  burden  of  ND,  in  particular  AD,  is  a  major  societal  challenge  for  Europe,  as 
16 % of the population is aged 65 and older, a share which is expected to double in the next 25 
years,  should  current  European  population  trends  continue  and  no  prevention  methods 
emerge. 

Brain research is subject of a significant research effort both in the MS and at European level. 
In 2005, the total spending on brain research in Europe was some €4.1  billion. Of this, €855 
million  came  from  the  public  sector,  with  the  EU  Framework  Programme  contributing  €94 
million and €105 million specifically to research on ND.  

However,  the  picture  of  support  for  ND  research  in  Europe  is  complex,  mostly  due  to  the 
variety  of  financing  systems,  research  policies  and  organisational  structures  across  MS,  and 

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http://ec.europa.eu/health/ph_projects/2005/action1/action1_2005_10_en.htm 
http://ec.europa.eu/health/ph_information/reporting/docs/2008_dementiayearbook_en.pdf 
http://ec.europa.eu/health/ph_determinants/life_style/mental/docs/pact_en.pdf 
http://eadc.alzheimer-europe.org/introduction.html 

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the  wide  variation  in  spending  on  ND  research  by  different  organisations  and  countries. 
Coordination  of  national  research  efforts  in  this  field  at  European  level  leaves  much  to  be 
desired. Key elements accountable for this situation include: 

–  The  barriers  between  disciplines  and  fields  of  research,  and  the  compartmentalisation  of 
research  activities.  The  knowledge  needed  to  advance  our  understanding  of  the  problem 
and  the  potential  solutions  spans  not  only  a  broad  and  diverse  range  of  disciplines  and 
stakeholders, but also the various European countries. 

–  A  major  weakness  is  the  lack  of  linkages  between  basic,  clinical  and  public  health,  and 
social research, which means that only some of the existing or acquired basic knowledge 
feeds into current clinical practice and care organisation and delivery. 

–  The  way  these  activities  are  run,  mainly  in  a  national  context,  reinforcing  fragmentation 
and limiting the sharing of current best practices throughout the EU as regards diagnosis, 
treatment and prevention.  

Thus, despite the high volume of financial resources, and the substantial range of initiatives 
on the part of individual MS, current efforts are not seeing the advantages of a coherent and 
coordinated approach. 

Approaches at a macro level are the way to bridge the gaps in our understanding and action. A 
few  examples  include  pinpointing  best  practice  in  the  early  diagnosis  of  AD  and  related 
disorders,  and  the  use  of  existing  interventions,  which  could  best  be  achieved  by  sharing 
knowledge  and  efforts.  Coordinated  databases  with  genomic  information,  banks  of  samples 
and tissues will of course be essential to this drive. 

Developing  and  validating  new  prevention  methods  and  therapies,  and  assessing  the 
effectiveness  of  current  ones,  will  require  large-scale  clinical  studies  whose  natural 
environment would be cross-border collaboration, given the very large number of patients of 
(more or less) different genetic backgrounds needed if meaningful results are to be obtained. 

Similarly,  the  launching  and  integration  of  large-scale  population  cohorts,  databases  and 
registries  will  be  needed  if  we  are  to  fully understand  the  role  and  contribution  of  genetics, 
nutrition, behaviour and other risk factors in the development of these diseases, and the place 
for  prevention  strategies.  Understanding  European  diversity  related  to  these  risk  factors  and 
putting it to use could help us gain a competitive edge when it comes to a better understanding 
of the disease. 

Standardisation of diagnostic criteria and assessment tools throughout MS will be essential if 
best practices and optimal clinical care are to be delivered across Europe. 

By enabling a critical mass of skills, knowledge and financial resources to be pooled, and by 
facilitating interdisciplinarity, joint action would get us closer to dealing with the medical and 
social challenges posed by these diseases. 

A dedicated JP action in this politically and socially highly challenging area would capitalise 
on the existing structures and programmes, while avoiding unnecessary duplication of work, 
effort  and  resources,  to  the  benefit  of  all  European  citizens.  It  would  also  help  the  EU  to 
develop a coherent approach in international cooperation with third countries of a comparable 
demographic  profile  and  facing  the  same  issues,  in  particular  those  countries  associated  to 

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FP7,  building  on  such  initiatives  as  the  European  Alzheimer’s  Disease  Neuroimaging 
Initiative supported by the US National Institute of Health30.  

The  Recommendation  also  invites  MS  to  cooperate  with  the  Commission  with  a  view  to 
exploring possible  Commission  initiatives to assist  MS in developing  and  implementing  the 
common research agenda. 

The Commission may take any other initiatives to promote JP in this area, such as providing 
"ad-hoc" and complementary measures to support such a pilot JP initiative. These measures 
could include the support to the management structure and the establishment of the SRA, the 
provision of  data and information  and  analysis on the state of art in this field in MS and at 
European level and annual reporting on the progress of this initiative. Commission may also 
look  into  possible  forms  of  consultation  and  cooperation  on  this  subject  with  scientifically 
advanced groupings at international level.  

3. 

LEGAL ELEMENTS OF THE PROPOSAL  

Summary of the proposed action 

The  proposal  invites  the  MS  to  adopt  a  common  approach  at  European  level  through  JP  in 
research on ND, in particular AD. 

JP  will  require  the  interested  MS  to  work  together  to  define  a  common  vision  of  research 
needs and opportunities in this field and, on this basis, develop a SRA establishing priorities, 
milestones and timelines, including an implementation plan outlining the actions, instruments 
and resources needed to implement the SRA and realise the joint vision. For these purposes, a 
management structure has to be set up, and MS are asked to define its mandate. The proposal 
also  invites  MS  to  cooperate  with  the  Commission  with  a  view  to  exploring  possible 
Commission  initiatives  to  assist  MS  in  developing  and  implementing  the  SRA.  The 
Commission may take any other initiatives to promote JP in this area. 

Legal basis 

Article 165 EC Treaty provides the legal basis. 

Subsidiarity principle 

The proposal complies with the subsidiarity principle as its objectives cannot be sufficiently 
achieved at MS level and can therefore, by reason of the scale and effects of the objectives, be 
better achieved at Community level. The added value of addressing such a research issue in 
the framework of a common European effort, through JP, resides mainly in the fact that joint 
action would allow the pooling of a critical mass of skills, knowledge and financial resources, 
combining mutually complementary expertise more easily and avoiding wasteful duplication 
of  efforts.  Action  at  Community  level  would  counter  the  current  fragmentation  and 
disparities,  and  ensure  better  use  of  increasingly  scarce  resources  while  maintaining  full 
leadership of the process by the MS. Accordingly, a set of recommendations at Community 
level  will  offer  for  addressing  such  societal  challenges  in  a  more  efficient  and  coordinated 
way.  

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Proportionality principle 

The  proposal  complies  with  the  proportionality  principle  because  rather  than  replacing,  it 
complements and streamlines current action in MS on fighting ND, including AD. It leaves it 
up to the MS to decide how to put the recommendations into practice.  

On  the  other  hand,  the  magnitude  of  the  challenge  that  European  nations  have  to  face,  and 
their demographic trends, together demand so much more in the way of means and resources 
that  selected  joint  action  will  be  the  only  possible  way  to  deliver  the  results  needed  to 
preserve  social  security  systems  and  protect  the  well-being  of  large  cross-sections  of  the 
population. 

Choice of instrument 

Council Recommendation. 

4. 

BUDGETARY IMPLICATIONS OF THE PROPOSAL  

This proposal has no implications for the Community budget.

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Proposal for a 

COUNCIL RECOMMENDATION 

on measures to combat neurodegenerative diseases, in particular Alzheimer's, through 
joint programming of research activities 

THE COUNCIL OF THE EUROPEAN UNION, 

Having regard to the Treaty establishing the European Community, and in particular Article 
165 thereof, 

Having regard to the proposal from the Commission31, 

Having regard to the opinion of the European Parliament32 

Having regard to the opinion of the European Economic and Social Committee33, 

Having regard to the opinion of the Committee of the Regions34, 

Whereas: 

(1) 

(2) 

(3) 

Article  152  of  the  Treaty  provides  that  Community  action,  which  shall  complement 
national policies, shall be directed towards improving public health, preventing human 
illness and diseases, and obviating sources of danger to human health. 

The  number  of  people  suffering  from  Alzheimer's  disease  and  related  disorders  in 
Europe  is  estimated  to  be  7.3  million.  There  is  currently  no  effective  treatment  for 
Alzheimer's  disease  able  to  slow  or  stop  the  progression  of  the  illness  and  available 
therapies  remain  very  limited.  Alzheimer's  accounts  for  around  50  -70%  of  all 
dementia cases, representing one of the main causes of disabilities of the elderly. 

Those  figures  are  expected  to  rise  drastically  by  2020,  due  to  the  increased  life 
expectancy and a decreasing ratio of working to retired populations. This will lead to a 
greater  burden  on  patients,  their  families  and  caregivers  and  pose  substantial 
challenges  ahead  for  Member  States'  healthcare  systems  in  terms  of  costs  and 
organisation.  

31 
32 
33 
34 

OJ C, p 
OJ C, p 
Optional consultation, OJ C, p 
Optional consultation, OJ C, p 

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(4)  Member States have therefore recognised the need to adopt specific national plans and 
strategies for Alzheimer’s disease and related disorders in order to alleviate the burden 
on society in general and on healthcare systems.  

(5) 

(6) 

(7) 

(8) 

However,  there  is  also  a  growing  awareness  that  the  impact  of  neurodegenerative 
diseases on the population in Europe is of such a magnitude that no Member State is 
capable  of  resolving  it  alone.  Member  States  would  therefore  benefit  from 
coordinating their actions to develop a stronger, better coordinated and more effective 
response at the European level. 

On  2  December  2008,  the  Competitiveness  Council  recognised  neurodegenerative 
diseases  as  an area where Joint Programming  would  provide  a  major  added  value  to 
the current, fragmented efforts of Member States in the field of research. It therefore 
adopted  conclusions  recognising  the  need  to  launch  a  pilot  Joint  Programming 
initiative on combating those diseases, in particular Alzheimer's disease, and inviting 
the Commission to submit a proposal for a Council Recommendation.  

Joint  Programming  in  research  on  neurodegenerative  diseases  would  encourage  the 
pooling of skills, knowledge and resources, with a view to advancing research on the 
prevention, diagnosis and treatment and to alleviating the burden of neurodegenerative 
diseases on patients and society. 

In  order  to  ensure  the  efficiency  of  the  joint  efforts  of  Member  States  in  fighting 
neurodegenerative diseases, Member States should develop a strategic research agenda 
based  on  a  common  approach  as  regards  the  prevention,  diagnosis  and  treatment  of 
neurodegenerative diseases. 

(9)  With a view to ensuring effective management of the different common actions to be 
taken,  Member  States  should  set  up  a  common  management  structure  mandated  to 
establish  common  conditions,  rules  and  procedures  for  cooperation  and  coordination 
and to monitor the implementation of the strategic research agenda.  

(10) 

In  order  to  achieve  the  goals  set  by  this  Recommendation,  Member  States  should 
cooperate with the Commission in exploring possible Commission initiatives to assist 
Member States in developing and implementing the strategic research agenda. 

(11)  The  Commission  should  act  as  a  facilitator  by  adopting  complementary  measures  to 
support  the  implementation  of  this  pilot  Joint  Programming  initiative  and  should 
report  regularly  to  the  Council  on  the  progress  of  this  initiative.  Furthermore,  the 
Commission  should  further  explore  how  best  to  contribute  to  the  strategic  research 
agenda and to its implementation plan via Community funding instruments, in synergy 
and  complementary  to  the  instruments  and  actions  of  the  Member  States  and  other 
stakeholders. 

HEREBY INVITES THE MEMBER STATES TO: 

1. 

2. 

EN 

Develop  a  common  vision  on  how  cooperation  and  coordination  in  the  field  of 
research  at  the  European  level  can  improve  prevention,  diagnosis  and  treatment  of 
neurodegenerative diseases, in particular Alzheimer's. 

Develop a strategic research agenda establishing medium to long term research needs 
and  objectives  in  the  area  of  neurodegenerative  diseases,  in  particular  Alzheimer's. 

12 

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The  strategic  research  agenda  should  contain  an  implementation  plan  establishing 
priorities  and  timelines  and  specifying  the  actions,  instruments  and  resources 
required for its implementation. 

2.1. 

The following actions should be undertaken as part of the implementation plan:  

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

identify  and  exchange  information  on  relevant  national  programmes  and 
research activities;  

reinforce  joint  foresight  and  technology  assessment  capacities  at  the  level  of 
basic, medical, health and social services research;  

identify  areas  or  research  activities  that  would  benefit  from  coordination  or 
joint  calls  for  proposals  or  pooling  of  resources  in  areas  such  as  the 
development  of  new  prevention  and  treatment  strategies,  new  imaging 
technologies and biomarkers; 

exchange  information  resources  and  best  practices  in  areas  such  as  the 
comparison of healthcare systems, including long term care and informal care 
settings;  

share, where appropriate, existing research infrastructures or develop new ones 
in areas such as coordinated registries, biobanks for blood samples and tissues 
or the development of animal models for the study of these diseases;  

network  centres  dedicated  to  research  on  neurodegenerative  diseases  in  areas 
such  as  clinical  trials,  standardisation  of  diagnostic  criteria  and  diagnostic 
instruments. 

3. 

4. 

Set up a common management structure in the field of neurodegenerative diseases, in 
particular Alzheimer’s disease, mandated to establish common conditions, rules and 
procedures  for  cooperation  and  coordination  and  to  monitor  the  implementation  of 
the strategic research agenda. 

Cooperate  with  the  Commission  with  a  view  to  exploring  possible  Commission 
initiatives  to  assist  Member  States  in  developing  and  implementing  the  common 
research agenda. 

HEREBY INVITES THE COMMISSION TO: 

1. 

2. 

3. 

Provide ad-hoc and complementary measures to support the pilot Joint Programming 
initiative.  Those  measures  should  include  support  to  the  management  structure  and 
the establishment of the strategic research agenda, the provision of data, information 
and  analysis  on  the  state  of  the  art  in  this  field  in  Member  States  and  at  European 
level. 

Explore  how  best  to  contribute  with  complementary  measures  to  the  strategic 
research agenda and to its implementation plan via Community funding instruments. 

Look  into  possible  forms  of  consultation  and  cooperation  on  this  subject  with 
scientifically-advanced groupings at international level. 

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Done at Brussels, […] 

For the Council 
The President 

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