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Investigación Biomédica, Bienestar
   Social y el Valor Estratégico del Sistema
               Nacional de Salud

Universidad Internacional Menéndez Pelayo, 21 Agosto 2009
                                       y ,     g


Bernat Soria, MD, PhD
CABIMER (Centro Andaluz de Biología Molecular y Medicina Regenerativa)
C/ Américo Vespucio s/n, Isla de la Cartuja, 41092 Sevilla

bernat.soria@cabimer.es
bernat soria@cabimer es
bsoria@msc.es
1.- Research and the search for a
   solution of the economical crisis
1771   “Industrial Revolution




                                                            agnation
                                                                   n
1829   Steam engine and railways




                                                          Sta
1875   Steel , Engineering



1908   Oil, cars
       Oil cars, mass production



1971   Informatics, Computers and Telecommunications


            Five Technological Revolutions in 230 years
XXth century
1900




                                                                                                                                              2000
        Steel
        St l
1
                                                                                                                  Computers, Communications

                                    Oils, Cars, Mass Production

           1908-1918
           1908 1918




                                                Depression 30’sand 1rst World War
           MATURITY
                                                                                                  1960-74
                Social Crisis                                                                 MATURITY




                                                                        W
                1rst World War




                                                                                                                                                       cession
                                                                                    1943-59       Social Crisis
                                                                                                  VietNam War
                                                                                    SYNERGY




                                                                                                                                                     Rec
SYNERGY                1920-29
“Belle Epoque”         Frenzy
                       development
                                                Depre
                                                                                                                                 1987-2000’s
                                 (20´s)                                                                                          Frenzy
          1908-1920                                                                                                1971-87       development
           Birth                                                             Financing Regulations                 Birth
                                                                             “Bretton Woods/Keynes”
                                                                             Welfare /Marshall
                  Mass Production                                                                                                     90’s

                                                                                                                        Informatics
                                                                                                          1971
      1908                                 Crash                                                         Micro-
  Ford Model-T                             1929                                                        processor                                             ?
                                                                                                          Intel
Two Phases in a Wave

                       INSTALATION PERIOD                             SPREAD PERIOD


                                                                            MATURITY
                                                                            Politics

                                                     R        SINERGY
                                                            Production
                                                     E
Diffusion




                                                     S
                                                     E
                                                     A
                                                     R
                                                     C
                                  FRENZY             H
                               Finance
                BIRTH
                                            Finance “of its own accord”
                 Technology                 Biased prosperity
                                            Bubble
                       Explosion of novelty
                       Decline of the old                                                          Time
            Big-Bang                                                                   Siguiente
                                                                                       big-bang
                                                CRASH
2.- Scientific Research as a value and
its impact in society and its values
Value is defined as the degree
                     to which one’s ideas have
                     contributed to knowledge and
                     impacted the thinking of others




Evolution of science
contributes to social
               social,           Both
                                 B th society and
                                            i t  d
political and                    political, economical
economical                       and legal systems
development                      influence the
                                 development of
                                 science
Science and Society:
  towards a new alliance of values
       Research as a service to society
                   implies
                     p




Freedom for                   Communication with
     its                          citizens.
development                   Identify their needs
Science and Society: towards a new alliance of values



  A global society needs universal access to therapies
                 derived from research




Ethics: Service to         Economics:
mankind                    Decrease of innovation costs,
                           because of increase of
                           beneficiaries
Aggregated Value of Products
Productivity
P d ti it      =
                                      Costs

                   Options:   1. Decrease Costs
                              2. Increase Value= Innovation


                   However, Innovation Is Not Enough
Investigación Biomédica y Bienestar Social
   (una relación biunívoca que no siempre se cumple)
RESEARCH IN HEALTH: GUARANTEES WELFARE


   Increase in R+D+i
   I        i                  Improvement of welfare
                               I         t f    lf




            Concepts NOT always linked
Health Indicators

                                  USA            SPAIN
                               1986    2005    1986    2005
Life expectancy Females        78,2    80,4    79,9    83,7
                Males          71,2    75,2    73,4    77,0
Infant
I f t mortality
         t lit                 10,4
                               10 4     6,9
                                        69      9,2
                                                92      3,8
                                                        38
Deaths/1.000 live births
Potential years of life lost
          y                    6.471   4.965   4.968   3.201
All causes <year/100.000
Causes of mortality            261,1   144,6   104,9   77,9
(ischaemic h t di
(i h    i heart diseases
males deaths/100.000)
HEALTH STATUS
                         LIFE EXPECTANCY AT BIRTH




Source: Health at a Glance 2007: OECD Indicators
SPAIN NHS: AN EFFICIENT SYSTEM

                Expenditure              Perinatal
                  (aprox)/               Mortality
               inhabitant
               i h bit t per
                    year:

    SPAIN      2.000 $              4,9 x 1000
               (1.300 €)


    USA        6.000
               6 000 $              6,7
                                    6 7 x 1000
               (4.500 €)


                       OECD Health Data 2008.
RESEARCH IN HEALTH: GUARANTEES WELFARE


        Increase in R+D+i       Improvement of welfare

Concepts NOT always linked

               USA             NEEDS HEALTH STRUCTURE
World N. 1 in R+D+i          WHICH TRANSFORMS KNOWLEDGE
                                       WELFARE
Lacks a good health system

Bad health indicators         THE NATIONAL HEALTH SYSTEM
3.- Strategic Value of the
National Health System
SPANISH NATIONAL HEALTH SYSTEM


SPANISH CONSTITUTION, 1978


      General Health Act 1986

                     NATIONAL HEALTH SYSTEM
                 • Universal Coverage (including immigrants)
                 • Financed through taxes
                                 g
                 • “Federal-like” system (17 autonomous regions)
                 • Extensive portfolio of services
UNIVERSAL COVERAGE


SOCIAL SECURITY                          NATIONAL HEALTH
                        Coverage
 SYSTEM (UNTIL                          SYSTEM (SINCE 1986)
     1986)


  Insured population
                                            All citizens
                                             covered

                                             (Includes
Restricted to active                        immigrants)
employees and their
  p y
      families


  1986                                             2006
                        Primary
   First                                             13.091
  Primary              Healthcare                   Primary
 Healthcare                                        Healthcare
Centres built                                       Centres
SPANISH NATIONAL HEALTH SYSTEM

• I. Among the best in the world
•     - Ranked 4th among the 19 most developed countries
•       Health Affairs ( Health Affairs 27: 58-71 (2008);)
•     -R k d
       Ranked           6th among 191 countries
                                          ti
•       British Medical Journal (Evans DB & cols. Comparative efficiency of national health
     systems: cross national econometric analysis. BMJ. 2001 Aug 11;323(7308):307-10)

•     - Ranked 7th among 191 countries
•       WHO (World Health Report 2000. Health Systems. Improving performance )

• II. Number one in the world in organ transplantation
FIRST IN THE WORLD IN CADAVERIC ORGAN DONATION. SPAIN, EU-27 AND USA
                                                     ,
COUNTRIES                                     SPAIN            EU-27            USA
Population
(million inhabitants)                          45.2            492.3            303.9
Cadaveric Organ Donor                         1,550            8,293            8,089
(Rate –pmp-)                                  (34.4)           (16.9)           (26.6)
SPANISH NATIONAL HEALTH SYSTEM


STRATEGIC VALUE (I)

1. Warrants the state of health of the country's workforce
2. Since healthcare is covered, citizens may take on other
   economical risks (buying houses etc.)
                             houses, etc )
3. Provides of direct high-quality employment that cannot
                      high-
   be delocalised




   Labour Force Survey: 5.85 % of total employment
     (
     (1,119,200 employees, women > men)
                     y                   )
SPANISH NATIONAL HEALTH SYSTEM



STRATEGIC VALUE (II)

4. Direct source of wealth generation with a Return on Investment Factor
    (Drag Factor) = 40%


    2006 Expenditure €82,064 million → Return €32,825 million



5. Niche for the traditional business fabric's diversification :
    Biotechnology, Pharmacy Industry, Services and Tourist Industry (our
    first industry: 60 million visitors/year)
4.- Spanish NHS: an efficient system
HEALTH EXPENDITURE




           2006

                   82 billion euros
                      billi
  PUBLIC HEALTH                               PRIVATE HEALTH
   EXPENDITURE                                 EXPENDITURE

 58,5 billion euros                           23,5 billion euros


    6.0 % of GDP                                 2.4% of GDP                   - Spain: €1,800/inhab. per
                                                                               year ($2,500)
                                                                               - USA: $
                                                                                      $6,000/inhab. per year
                           8.4% of GDP

Source: Ministry of Health and Consumer Affairs. Public Health Expenditure Statistics, 2006
BOTH PUBLIC AND PRIVATE HEALTHCARE CARE CO-EXIST
                                        CO EXIST

                                       _
                                       ∼   23,000 M€

                                FREE

        PRIVATE HEALTH CARE       or

               - Hospital     CONCERTED/CONTRACT
               - Service
               - Diagnosis

            +
        PUBLIC HEALTH CARE
                                  _    PUBLIC
                                  ∼ 60,000 M €
SPANISH NATIONAL HEALTH SYSTEM




           EXTENSIVE BENEFITS

Public Health
Primary Health Care
Specialised Health Care
Socio-sanitary Care
Emergency
Pharmacy
Orthoprosthethic devices
      p
Nutritional complements
Transport (ambulances)
SPANISH NATIONAL HEALTH SYSTEM




                 EXTENSIVE BENEFITS
           PRIMARY HEALTH CARE
General benefits           Specific benefits
   Family Doctor              Women healthcare
   Paediatrics                Children healthcare
   Nursing Care               Emergencies
                              Elderly
                              Dental healthcare (in
                              process-50%)
SPANISH NATIONAL HEALTH SYSTEM




     EXTENSIVE BENEFITS

 SPECIALISED HEALTH CARE
    - Hospitalisation
    -“Day hospital”
    - Outpatient Care
    - Emergencies
    - Mental Health and Psychiatric Care
    - Transplants
SPANISH NATIONAL HEALTH SYSTEM




1 million consultations /day



                             13.091   PC Centres                  325   Hospitals
                             38.913 GPs                      112.000    Beds
                             27.000 Nurses                    82.000    Physicians
                          300 million consultations/year     111.000    Nurses
                                                           70 million   Consultations/year
                                                            4 million   Discharges/year
OVERALL SATISFACTION ON THE
     WAY THE PUBLIC HEALTH
   SERVICE WORKS (SCALE 1-10)
                          10)

                        10

                         9

                         8

                         7
                                               6.1                 6.3
                                                                    6,3
                             6.0               6,1
             rcentage




                             6,0
                         6

                         5
           Per




                         4

                         3

                         2

                         1
                             2003             2005                 2007
                                               Year




Source: Ministry of Health and Consumer Affairs. Health System Barometer
PERCEPTION OF CITIZEN.
                   USER SATISFACTION
     SATISFACTION WITH THE HEALTHCARE SYSTEM, SPAIN


                                       4.4 4,4   0.9
                                                 0,9



              25.025


                                                                                             Well:          50.5%
                                                                               50.5
                                                                              50,5           Fairly well:   19.2%

                                                                                                            69.7%

                          19,2
                         19.2
                Works well though needs changes        Works fairly well
                Needs fundamental changes              It's so bad it needs to be redone completely
                Don't k
                D 't know / no reply
                                  l



                                             Year 2007
Source: Ministry of Health and Consumer Affairs Health System Barometer
                                        Affairs.
5.- Quality & Innovation
      • Health care strategies
      • e Health
        e-Health
      • Key indicators
Back to the future:
 Quality and Innnovation Strategies


5 GOALS.12 STRATEGIES
    189 PROJECTS

                   HEALTH STRATEGIES


                  CLINICAL EXCELLENCE


                         e-HEALTH


                KNOWLEDGE MANAGEMENT
6.-
6 Fighting the Crisis

  a) Innovation

      • Organ donation & transplantation
      • Stem Cell therapies
      • eHealth

  b) Creating Structures that convert knowledge in
  wealth and welfare
Spain up to 2004

     Restrictions to Research Freedom

              Legal restrictions
              Religious, ethical,
              Religious ethical cultural
              Lack of budget
                  Rare diseases
                  Orphan drugs
Legislation in force before 2007: insufficient for the development of
research

                •Medicament Act (1990)
                •Code of Medical Ethics and Deontology OMC (1999)
                •Guarantees and Rational Use of Medicaments Act (2006)
                 Guarantees
                •Patient Autonomy Act (2002)
                •Assisted Reproduction Techniques Acts (35/1998 and
                14/2006)
                •Donation and Use of E b
                 D     ti    dU     f Embryos and Human Foetuses or
                                                 dH       F t
                their Cells
                •RD 1301/2006 on Quality and Safety Regulations for
                Donation, Obtention, Evaluation, Processing, Preservation,
                Storage and Distribution of Human Cells and Tissues
                •Several Acts on Organ and Tissue Donation, Extraction
                and Transplant, and Regenerative Medicine (Act 30/1979,
                RD 426/1980 RD 411/1996 RD 2070/1999 RD 174/2004
                    426/1980,    411/1996,    2070/1999,
ACT 14/2007 ON BIOMEDICAL RESEARCH

  Legal framework regulating biomedical research in Spain

              Use of human embryonic cells and tissues
              Invasive procedures
              Genetic testing
              Biological samples and biobanks
REGULATES:
               Requirements for donation and use of human embryos and
             foetuses for research
               Authorizes nuclear transfer
hESC        Nuclear
                     N l        Number f
                                N b of      Orphan Drugs
                                              and Rare
        Research     Transfer    Projects     Diseases




2004   Forbidden   Forbidden        0            2



2008   Allowed     Allowed         65           36
RESEARCH
    •stem cell research
    •orphan drugs
        h d
    •others
NEED FOR THE INTRODUCTION OF ADVANCED THERAPIES



                             •Genetic and oncological diseases
                              Genetic
  -Gene Therapy              •Neurodegenerative diseases
                                 •Parkinson’s, ALS
  -Cellular Therapy
   Cellular                      •Alzheimer’s, Friedrich s Ataxia
                                  Alzheimer s, Friedrich’s
    Somatic cells:           •Autoimmune diseases
    Embryonic cells or           •Multiple sclerosis
  Reprogrammed cells (IPS)       •Diabetes
                             •Spinal injuries
  -Tissue Engineering        •Burns
                             •Bone reconstruction
STEPS UNDERTAKEN


1. 2008,
1 - 2008 DG for Advanced Therapies and Transplants


2.- Legal regulations

     Assisted H man Reproduction Act 2006
              Human Reprod ction Act,
     Biomedical Research Act, 2007
STEPS UNDERTAKEN




   3.- Non-regulatory actions
             g      y

   - Training
   - E l ti
     Evaluation, A th i ti and R i t
                 Authorization d Registry
   - Support Office for Independent Research
   - Creation of the Advanced Therapies European Forum
   - Development of productive infrastructures (white rooms)


  4.-Financing
Seville (Spain)
        ( p )
Cartuja 93- Scientific and Technological Park
Muchas gracias
Investigacion Biomedica, Bienestar Social y el Valor estrategico del Sistema Nacional de Salud

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Investigacion Biomedica, Bienestar Social y el Valor estrategico del Sistema Nacional de Salud

  • 1. Investigación Biomédica, Bienestar Social y el Valor Estratégico del Sistema Nacional de Salud Universidad Internacional Menéndez Pelayo, 21 Agosto 2009 y , g Bernat Soria, MD, PhD CABIMER (Centro Andaluz de Biología Molecular y Medicina Regenerativa) C/ Américo Vespucio s/n, Isla de la Cartuja, 41092 Sevilla bernat.soria@cabimer.es bernat soria@cabimer es bsoria@msc.es
  • 2. 1.- Research and the search for a solution of the economical crisis
  • 3. 1771 “Industrial Revolution agnation n 1829 Steam engine and railways Sta 1875 Steel , Engineering 1908 Oil, cars Oil cars, mass production 1971 Informatics, Computers and Telecommunications Five Technological Revolutions in 230 years
  • 4. XXth century 1900 2000 Steel St l 1 Computers, Communications Oils, Cars, Mass Production 1908-1918 1908 1918 Depression 30’sand 1rst World War MATURITY 1960-74 Social Crisis MATURITY W 1rst World War cession 1943-59 Social Crisis VietNam War SYNERGY Rec SYNERGY 1920-29 “Belle Epoque” Frenzy development Depre 1987-2000’s (20´s) Frenzy 1908-1920 1971-87 development Birth Financing Regulations Birth “Bretton Woods/Keynes” Welfare /Marshall Mass Production 90’s Informatics 1971 1908 Crash Micro- Ford Model-T 1929 processor ? Intel
  • 5. Two Phases in a Wave INSTALATION PERIOD SPREAD PERIOD MATURITY Politics R SINERGY Production E Diffusion S E A R C FRENZY H Finance BIRTH Finance “of its own accord” Technology Biased prosperity Bubble Explosion of novelty Decline of the old Time Big-Bang Siguiente big-bang CRASH
  • 6. 2.- Scientific Research as a value and its impact in society and its values
  • 7. Value is defined as the degree to which one’s ideas have contributed to knowledge and impacted the thinking of others Evolution of science contributes to social social, Both B th society and i t d political and political, economical economical and legal systems development influence the development of science
  • 8. Science and Society: towards a new alliance of values Research as a service to society implies p Freedom for Communication with its citizens. development Identify their needs
  • 9. Science and Society: towards a new alliance of values A global society needs universal access to therapies derived from research Ethics: Service to Economics: mankind Decrease of innovation costs, because of increase of beneficiaries
  • 10. Aggregated Value of Products Productivity P d ti it = Costs Options: 1. Decrease Costs 2. Increase Value= Innovation However, Innovation Is Not Enough
  • 11. Investigación Biomédica y Bienestar Social (una relación biunívoca que no siempre se cumple)
  • 12. RESEARCH IN HEALTH: GUARANTEES WELFARE Increase in R+D+i I i Improvement of welfare I t f lf Concepts NOT always linked
  • 13. Health Indicators USA SPAIN 1986 2005 1986 2005 Life expectancy Females 78,2 80,4 79,9 83,7 Males 71,2 75,2 73,4 77,0 Infant I f t mortality t lit 10,4 10 4 6,9 69 9,2 92 3,8 38 Deaths/1.000 live births Potential years of life lost y 6.471 4.965 4.968 3.201 All causes <year/100.000 Causes of mortality 261,1 144,6 104,9 77,9 (ischaemic h t di (i h i heart diseases males deaths/100.000)
  • 14. HEALTH STATUS LIFE EXPECTANCY AT BIRTH Source: Health at a Glance 2007: OECD Indicators
  • 15. SPAIN NHS: AN EFFICIENT SYSTEM Expenditure Perinatal (aprox)/ Mortality inhabitant i h bit t per year: SPAIN 2.000 $ 4,9 x 1000 (1.300 €) USA 6.000 6 000 $ 6,7 6 7 x 1000 (4.500 €) OECD Health Data 2008.
  • 16. RESEARCH IN HEALTH: GUARANTEES WELFARE Increase in R+D+i Improvement of welfare Concepts NOT always linked USA NEEDS HEALTH STRUCTURE World N. 1 in R+D+i WHICH TRANSFORMS KNOWLEDGE WELFARE Lacks a good health system Bad health indicators THE NATIONAL HEALTH SYSTEM
  • 17. 3.- Strategic Value of the National Health System
  • 18. SPANISH NATIONAL HEALTH SYSTEM SPANISH CONSTITUTION, 1978 General Health Act 1986 NATIONAL HEALTH SYSTEM • Universal Coverage (including immigrants) • Financed through taxes g • “Federal-like” system (17 autonomous regions) • Extensive portfolio of services
  • 19. UNIVERSAL COVERAGE SOCIAL SECURITY NATIONAL HEALTH Coverage SYSTEM (UNTIL SYSTEM (SINCE 1986) 1986) Insured population All citizens covered (Includes Restricted to active immigrants) employees and their p y families 1986 2006 Primary First 13.091 Primary Healthcare Primary Healthcare Healthcare Centres built Centres
  • 20. SPANISH NATIONAL HEALTH SYSTEM • I. Among the best in the world • - Ranked 4th among the 19 most developed countries • Health Affairs ( Health Affairs 27: 58-71 (2008);) • -R k d Ranked 6th among 191 countries ti • British Medical Journal (Evans DB & cols. Comparative efficiency of national health systems: cross national econometric analysis. BMJ. 2001 Aug 11;323(7308):307-10) • - Ranked 7th among 191 countries • WHO (World Health Report 2000. Health Systems. Improving performance ) • II. Number one in the world in organ transplantation FIRST IN THE WORLD IN CADAVERIC ORGAN DONATION. SPAIN, EU-27 AND USA , COUNTRIES SPAIN EU-27 USA Population (million inhabitants) 45.2 492.3 303.9 Cadaveric Organ Donor 1,550 8,293 8,089 (Rate –pmp-) (34.4) (16.9) (26.6)
  • 21. SPANISH NATIONAL HEALTH SYSTEM STRATEGIC VALUE (I) 1. Warrants the state of health of the country's workforce 2. Since healthcare is covered, citizens may take on other economical risks (buying houses etc.) houses, etc ) 3. Provides of direct high-quality employment that cannot high- be delocalised Labour Force Survey: 5.85 % of total employment ( (1,119,200 employees, women > men) y )
  • 22. SPANISH NATIONAL HEALTH SYSTEM STRATEGIC VALUE (II) 4. Direct source of wealth generation with a Return on Investment Factor (Drag Factor) = 40% 2006 Expenditure €82,064 million → Return €32,825 million 5. Niche for the traditional business fabric's diversification : Biotechnology, Pharmacy Industry, Services and Tourist Industry (our first industry: 60 million visitors/year)
  • 23. 4.- Spanish NHS: an efficient system
  • 24. HEALTH EXPENDITURE 2006 82 billion euros billi PUBLIC HEALTH PRIVATE HEALTH EXPENDITURE EXPENDITURE 58,5 billion euros 23,5 billion euros 6.0 % of GDP 2.4% of GDP - Spain: €1,800/inhab. per year ($2,500) - USA: $ $6,000/inhab. per year 8.4% of GDP Source: Ministry of Health and Consumer Affairs. Public Health Expenditure Statistics, 2006
  • 25. BOTH PUBLIC AND PRIVATE HEALTHCARE CARE CO-EXIST CO EXIST _ ∼ 23,000 M€ FREE PRIVATE HEALTH CARE or - Hospital CONCERTED/CONTRACT - Service - Diagnosis + PUBLIC HEALTH CARE _ PUBLIC ∼ 60,000 M €
  • 26. SPANISH NATIONAL HEALTH SYSTEM EXTENSIVE BENEFITS Public Health Primary Health Care Specialised Health Care Socio-sanitary Care Emergency Pharmacy Orthoprosthethic devices p Nutritional complements Transport (ambulances)
  • 27. SPANISH NATIONAL HEALTH SYSTEM EXTENSIVE BENEFITS PRIMARY HEALTH CARE General benefits Specific benefits Family Doctor Women healthcare Paediatrics Children healthcare Nursing Care Emergencies Elderly Dental healthcare (in process-50%)
  • 28. SPANISH NATIONAL HEALTH SYSTEM EXTENSIVE BENEFITS SPECIALISED HEALTH CARE - Hospitalisation -“Day hospital” - Outpatient Care - Emergencies - Mental Health and Psychiatric Care - Transplants
  • 29. SPANISH NATIONAL HEALTH SYSTEM 1 million consultations /day 13.091 PC Centres 325 Hospitals 38.913 GPs 112.000 Beds 27.000 Nurses 82.000 Physicians 300 million consultations/year 111.000 Nurses 70 million Consultations/year 4 million Discharges/year
  • 30. OVERALL SATISFACTION ON THE WAY THE PUBLIC HEALTH SERVICE WORKS (SCALE 1-10) 10) 10 9 8 7 6.1 6.3 6,3 6.0 6,1 rcentage 6,0 6 5 Per 4 3 2 1 2003 2005 2007 Year Source: Ministry of Health and Consumer Affairs. Health System Barometer
  • 31. PERCEPTION OF CITIZEN. USER SATISFACTION SATISFACTION WITH THE HEALTHCARE SYSTEM, SPAIN 4.4 4,4 0.9 0,9 25.025 Well: 50.5% 50.5 50,5 Fairly well: 19.2% 69.7% 19,2 19.2 Works well though needs changes Works fairly well Needs fundamental changes It's so bad it needs to be redone completely Don't k D 't know / no reply l Year 2007 Source: Ministry of Health and Consumer Affairs Health System Barometer Affairs.
  • 32. 5.- Quality & Innovation • Health care strategies • e Health e-Health • Key indicators
  • 33. Back to the future: Quality and Innnovation Strategies 5 GOALS.12 STRATEGIES 189 PROJECTS HEALTH STRATEGIES CLINICAL EXCELLENCE e-HEALTH KNOWLEDGE MANAGEMENT
  • 34. 6.- 6 Fighting the Crisis a) Innovation • Organ donation & transplantation • Stem Cell therapies • eHealth b) Creating Structures that convert knowledge in wealth and welfare
  • 35. Spain up to 2004 Restrictions to Research Freedom Legal restrictions Religious, ethical, Religious ethical cultural Lack of budget Rare diseases Orphan drugs
  • 36. Legislation in force before 2007: insufficient for the development of research •Medicament Act (1990) •Code of Medical Ethics and Deontology OMC (1999) •Guarantees and Rational Use of Medicaments Act (2006) Guarantees •Patient Autonomy Act (2002) •Assisted Reproduction Techniques Acts (35/1998 and 14/2006) •Donation and Use of E b D ti dU f Embryos and Human Foetuses or dH F t their Cells •RD 1301/2006 on Quality and Safety Regulations for Donation, Obtention, Evaluation, Processing, Preservation, Storage and Distribution of Human Cells and Tissues •Several Acts on Organ and Tissue Donation, Extraction and Transplant, and Regenerative Medicine (Act 30/1979, RD 426/1980 RD 411/1996 RD 2070/1999 RD 174/2004 426/1980, 411/1996, 2070/1999,
  • 37. ACT 14/2007 ON BIOMEDICAL RESEARCH Legal framework regulating biomedical research in Spain Use of human embryonic cells and tissues Invasive procedures Genetic testing Biological samples and biobanks REGULATES: Requirements for donation and use of human embryos and foetuses for research Authorizes nuclear transfer
  • 38. hESC Nuclear N l Number f N b of Orphan Drugs and Rare Research Transfer Projects Diseases 2004 Forbidden Forbidden 0 2 2008 Allowed Allowed 65 36
  • 39. RESEARCH •stem cell research •orphan drugs h d •others
  • 40. NEED FOR THE INTRODUCTION OF ADVANCED THERAPIES •Genetic and oncological diseases Genetic -Gene Therapy •Neurodegenerative diseases •Parkinson’s, ALS -Cellular Therapy Cellular •Alzheimer’s, Friedrich s Ataxia Alzheimer s, Friedrich’s Somatic cells: •Autoimmune diseases Embryonic cells or •Multiple sclerosis Reprogrammed cells (IPS) •Diabetes •Spinal injuries -Tissue Engineering •Burns •Bone reconstruction
  • 41. STEPS UNDERTAKEN 1. 2008, 1 - 2008 DG for Advanced Therapies and Transplants 2.- Legal regulations Assisted H man Reproduction Act 2006 Human Reprod ction Act, Biomedical Research Act, 2007
  • 42. STEPS UNDERTAKEN 3.- Non-regulatory actions g y - Training - E l ti Evaluation, A th i ti and R i t Authorization d Registry - Support Office for Independent Research - Creation of the Advanced Therapies European Forum - Development of productive infrastructures (white rooms) 4.-Financing
  • 43. Seville (Spain) ( p ) Cartuja 93- Scientific and Technological Park