investigacion biomedica, bienestar social y el valor estrategico del sistema nacional de salud
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Investigación Biomédica, Bienestar Social y el Valor Estratégico del Sistema
Nacional de Salud
Universidad Internacional Menéndez Pelayo, 21 Agosto 2009
Bernat Soria, MD, PhDCABIMER (Centro Andaluz de Biología Molecular y Medicina Regenerativa)
y , g
CABIMER (Centro Andaluz de Biología Molecular y Medicina Regenerativa)C/ Américo Vespucio s/n, Isla de la Cartuja, 41092 Sevilla
bernat soria@cabimer esbernat.soria@cabimer.esbsoria@msc.es
1.- Research and the search for a solution of the economical crisis
“Industrial Revolution17711771
nnnn
Steam engine and railways 18291829
agna
tion
agna
tion
agna
tion
agna
tion
Steel , Engineering18751875
Sta
Sta
Sta
Sta
Oil cars mass production19081908 Oil, cars, mass production19081908
Informatics, Computers and Telecommunications19711971
Five Technological Revolutions in 230 yearsFive Technological Revolutions in 230 yearsFive Technological Revolutions in 230 yearsFive Technological Revolutions in 230 years
XXth centuryXXth centurySt l19
0019
00 000
000
1908 1918
Computers, CommunicationsSteel
Oils, Cars, Mass Production
11 22
1908-1918MATURITY
Social Crisis1960-74
Wor
ld W
arW
orld
War
MATURITYSocial Crisis1rst World War
1943-59
and
1rst
Wan
d 1r
st W
Social CrisisVietNam War
SYNERGY cess
ion
cess
ion
ssio
n 30
’sss
ion
30’s
SYNERGY“Belle Epoque”
1920-29Frenzy development
Rec
Rec
(20´s)1908-1920Birth
1971-87Birth
Dep
Dep
rere
Financing Regulations
development 1987-2000’sFrenzy development
Birth
Mass Production 90’s
Informatics
“Bretton Woods/Keynes”Welfare /Marshall
1908Ford Model-T
Informatics1971
Micro-processor
Intel
Crash1929 ?
Two Phases in a WaveTwo Phases in a Wave
INSTALATION PERIODINSTALATION PERIOD SPREAD PERIODSPREAD PERIOD
SINERGYSINERGYProductionProduction
MATURITYMATURITYPoliticsPolitics
R
iffus
ion
iffus
ion
ProductionProductionESE
DD
FRENZYFRENZY
ARCH
Finance “of its own accord”BIRTHBIRTHTechnologyTechnology
FRENZYFRENZYFinanceFinance
H
Biased prosperityBubble
Explosion of noveltyDecline of the old TimeTime
TechnologyTechnology
Decline of the oldBig-Bang
TimeTime
Siguientebig-bang
CRASH
2.- Scientific Research as a value and its impact in society and its valuesits impact in society and its values
Value is defined as the degree to which one’s ideas have contributed to knowledge andcontributed to knowledge and impacted the thinking of others
Evolution of science contributes to social B th i t dcontributes to social, political and economical development
Both society and political, economical and legal systems influence thedevelopment influence the development of science
Science and Society:Science and Society: towards a new alliance of values
Research as a service to society
impliesp
Freedom for its
development
Communication with citizens.
Identify their needsdevelopment 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 mankind
Economics:Decrease of innovation costs, because of increase of beneficiaries
Aggregated Value of ProductsP d ti it
CostsProductivity =
Options: 1. Decrease Costs2. Increase Value= Innovation
However, Innovation Is Not Enough
Investigación Biomédica y Bienestar SocialInvestigación Biomédica y Bienestar Social
(una relación biunívoca que no siempre se cumple)
RESEARCH IN HEALTH: GUARANTEES WELFARERESEARCH IN HEALTH: GUARANTEES WELFARE
I i R+D+i I t f lfIncrease in R+D+i Improvement of welfare
Concepts NOT always linked
Health IndicatorsHealth Indicators
USA SPAIN1986 2005 1986 2005
Life expectancy FemalesMales
78,271,2
80,475,2
79,973,4
83,777,0
I f t t lit 10 4 6 9 9 2 3 8Infant mortalityDeaths/1.000 live births
10,4 6,9 9,2 3,8
Potential years of life lost 6.471 4.965 4.968 3.201yAll causes <year/100.000Causes of mortality(i h i h t di
261,1 144,6 104,9 77,9(ischaemic heart diseases males deaths/100.000)
HEALTH STATUS LIFE EXPECTANCY AT BIRTH
Source: Health at a Glance 2007: OECD Indicators
SPAIN NHS: AN EFFICIENT SYSTEMSPAIN NHS: AN EFFICIENT SYSTEM
Expenditure (aprox)/
i h bit t
Perinatal Mortality
inhabitant per year:
SPAIN 2.000 $ 4,9 x 1000SPAIN(1.300 €)
USA 6 000 $ 6 7 1000USA 6.000 $(4.500 €)
6,7 x 1000
OECD Health Data 2008.
RESEARCH IN HEALTH: GUARANTEES WELFARERESEARCH IN HEALTH: GUARANTEES WELFARE
Increase in R+D+i Improvement of welfare
Concepts NOT always linked
USAUSA NEEDS HEALTH STRUCTURE World N. 1 in R+D+i
Lacks a good health system
WHICH TRANSFORMS KNOWLEDGE WELFARE
Bad health indicators THE NATIONAL HEALTH SYSTEM
3.- Strategic Value of the National Health SystemNational Health System
SPANISH NATIONAL HEALTH SYSTEM
SPANISH CONSTITUTION, 1978SPANISH CONSTITUTION, 1978
General Health ActGeneral Health Act 19861986
NATIONAL HEALTH SYSTEMNATIONAL HEALTH SYSTEM
• Universal Coverage (including immigrants)
• Financed through taxesg
• “Federal-like” system (17 autonomous regions)
• Extensive portfolio of services
UNIVERSAL COVERAGEUNIVERSAL COVERAGE
SOCIAL SECURITY SOCIAL SECURITY SYSTEM (UNTIL SYSTEM (UNTIL
1986)1986)
NATIONAL HEALTH NATIONAL HEALTH SYSTEM (SINCE 1986)SYSTEM (SINCE 1986)CoverageCoverage
All citizens covered
Insured population
covered
Restricted to active employees and their
(Includes immigrants)
1986 2006
p yfamilies
1986 2006Primary
HealthcareFirst Primary
13.091 PrimaryPrimary
Healthcare Centres built
Primary Healthcare
Centres
SPANISH NATIONAL HEALTH SYSTEMSPANISH NATIONAL HEALTH SYSTEM
•• I. Among the best in the worldI. 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 6th 191 t i• - Ranked 6th among 191 countries• 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 transplantationII. Number one in the world in organ transplantationFIRST IN THE WORLD IN CADAVERIC ORGAN DONATION. SPAIN, EU-27 AND USA,
COUNTRIESPopulation (million inhabitants)
SPAIN
45.2
EU-27
492.3
USA
303.9
Cadaveric Organ Donor(Rate –pmp-)
1,550(34.4)
8,293(16.9)
8,089(26.6)
SPANISH NATIONAL HEALTH SYSTEMSPANISH NATIONAL HEALTH SYSTEM
STRATEGIC VALUE (I)STRATEGIC VALUE (I)
1.1. Warrants the state of health of the country's workforce Warrants the state of health of the country's workforce 2.2. Since healthcare is covered, citizens may take on other Since healthcare is covered, citizens may take on other
economical risks (buying houses etc )economical risks (buying houses etc )economical risks (buying houses, etc.)economical risks (buying houses, etc.)3.3. Provides of direct highProvides of direct high--quality employment that cannot quality employment that cannot
be delocalisedbe delocalised
Labour Force Survey: 5.85 % of total employment Labour Force Survey: 5.85 % of total employment (1,119,200 employees, women > men)(1,119,200 employees, women > men)( y )( y )
SPANISH NATIONAL HEALTH SYSTEMSPANISH NATIONAL HEALTH SYSTEMSPANISH NATIONAL HEALTH SYSTEMSPANISH NATIONAL HEALTH SYSTEM
STRATEGIC VALUE (II)STRATEGIC VALUE (II)
4. Direct source of wealth generation with a Return on Investment Factor 4. Direct source of wealth generation with a Return on Investment Factor (Drag Factor) = 40%(Drag Factor) = 40%
2006 Expenditure 2006 Expenditure €€82,064 million → Return 82,064 million → Return €€32,825 million32,825 million
5. Niche for the traditional business fabric's diversification : 5. Niche for the traditional business fabric's diversification : Biotechnology, Pharmacy Industry, Services and Tourist Industry (our Biotechnology, Pharmacy Industry, Services and Tourist Industry (our first industry: 60 million visitors/year)first industry: 60 million visitors/year)first industry: 60 million visitors/year)first industry: 60 million visitors/year)
4.- Spanish NHS: an efficient system
HEALTH EXPENDITUREHEALTH EXPENDITURE
82 billi
2006
82 billion euros
PUBLIC HEALTH EXPENDITURE
PRIVATE HEALTH EXPENDITUREEXPENDITURE 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)
$8.4% of GDP
Source: Ministry of Health and Consumer Affairs. Public Health Expenditure Statistics, 2006
- USA: $6,000/inhab. per year
BOTH PUBLIC AND PRIVATE HEALTHCARE CARE CO-EXISTBOTH PUBLIC AND PRIVATE HEALTHCARE CARE CO EXIST
23,000 M€_∼
PRIVATE HEALTH CARE or
FREE
PRIVATE HEALTH CARECONCERTED/CONTRACT- Hospital
- Service- Diagnosis
+- Diagnosis
PUBLIC HEALTH CAREPUBLIC_∼ 60,000 M €PUBLIC
SPANISH NATIONAL HEALTH SYSTEMSPANISH NATIONAL HEALTH SYSTEM
EXTENSIVE BENEFITSEXTENSIVE BENEFITS
Public HealthPrimary Health CareSpecialised Health CareSocio-sanitary CareEmergencyEmergencyPharmacyOrthoprosthethic devicespNutritional complementsTransport (ambulances)
SPANISH NATIONAL HEALTH SYSTEMSPANISH NATIONAL HEALTH SYSTEM
EXTENSIVE BENEFITSEXTENSIVE BENEFITS
PRIMARY HEALTH CAREPRIMARY HEALTH CAREGeneral benefitsGeneral benefits Specific benefitsSpecific benefits
Family DoctorPaediatrics
Women healthcareChildren healthcare
Nursing Care EmergenciesElderlyDental healthcare (in process-50%)
SPANISH NATIONAL HEALTH SYSTEMSPANISH NATIONAL HEALTH SYSTEM
EXTENSIVE BENEFITSEXTENSIVE BENEFITS
SPECIALISED HEALTH CARESPECIALISED HEALTH CARE- Hospitalisation
-“Day hospital”
- Outpatient Care
- Emergencies
- Mental Health and Psychiatric Care
-- Transplants
SPANISH NATIONAL HEALTH SYSTEMSPANISH NATIONAL HEALTH SYSTEM
1 million consultations /day
13.091 PC Centres38.913 GPs27.000 Nurses
300 million consultations/year
325 Hospitals112.000 Beds
82.000 Physicians111.000 Nurses300 million consultations/year 111.000 Nurses
70 million Consultations/year4 million Discharges/year
OVERALL OVERALL SATISFACTION ON THE SATISFACTION ON THE WAY THE PUBLIC HEALTH WAY THE PUBLIC HEALTH
SERVICE WORKS (SCALE SERVICE WORKS (SCALE 11--1010))
8
9
10
6,0 6,1 6,3
5
6
7
rcen
tage 6.0 6.1 6.3
3
4
5
Per
1
2
2003 2005 2007
YYear
Source: Ministry of Health and Consumer Affairs. Health System Barometer
PERCEPTION OF CITIZEN.PERCEPTION OF CITIZEN.
SATISFACTION WITH THE HEALTHCARE SYSTEM, SPAIN
USER SATISFACTIONUSER SATISFACTION
4,4 0,94.4 0.9
2525.0
Well: 50.5%
50,550.5 Fairly well: 19.2%
69.7%
19,2
Works well though needs changes Works fairly wellNeeds fundamental changes It's so bad it needs to be redone completelyD 't k / l
19.2
Source: Ministry of Health and Consumer Affairs Health System Barometer
Year 2007
Don't know / no reply
Source: Ministry of Health and Consumer Affairs. Health System Barometer
5.- Quality & Innovation• Health care strategies• e Health• e-Health• Key indicators
Back to the future: Quality and Innnovation Strategies
5 GOALS.12 STRATEGIES189 PROJECTS
HEALTH STRATEGIES
CLINICAL EXCELLENCE
e-HEALTH
KNOWLEDGE MANAGEMENTKNOWLEDGE MANAGEMENT
6 Fighting the Crisis6.- Fighting the Crisis
a) Innovationa) 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 restrictionsReligious ethical culturalReligious, ethical, culturalLack of budget
Rare diseasesOrphan drugsOrphan 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 and Rational Use of Medicaments Act (2006)•Patient Autonomy Act (2002)•Assisted Reproduction Techniques Acts (35/1998 and 14/2006)D ti d U f E b d H F t•Donation and Use of Embryos and Human Foetuses or
their Cells•RD 1301/2006 on Quality and Safety Regulations for Donation, Obtention, Evaluation, Processing, Preservation,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 174/2004RD 426/1980, RD 411/1996, RD 2070/1999, RD 174/2004
ACT 14/2007 ON BIOMEDICAL RESEARCHACT 14/2007 ON BIOMEDICAL RESEARCH
Legal framework regulating biomedical research in Spain
Use of human embryonic cells and tissues Invasive proceduresInvasive proceduresGenetic testingBiological samples and biobanksREGULATES:Requirements for donation and use of human embryos and
foetuses for research Authorizes nuclear transfer
hESC N l N b f Orphan DrugshESC Research
Nuclear Transfer
Number of Projects
Orphan Drugs and Rare Diseases
2004 Forbidden Forbidden 0 2
2008 Allowed Allowed 65 36
RESEARCH•stem cell research
h d•orphan drugs•others
NEED FOR THE INTRODUCTION OF ADVANCED THERAPIES
•Genetic and oncological diseasesGenetic and oncological diseases •Neurodegenerative diseases
•Parkinson’s, ALS•Alzheimer’s, Friedrich’s Ataxia
-Gene Therapy
Cellular Therapy Alzheimer s, Friedrich s Ataxia•Autoimmune diseases
•Multiple sclerosis•Diabetes
-Cellular TherapySomatic cells:Embryonic cells or
Reprogrammed cells (IPS)
•Spinal injuries•Burns•Bone reconstruction
-Tissue Engineering
STEPS UNDERTAKEN
1 - 2008 DG for Advanced Therapies and Transplants1. 2008, DG for Advanced Therapies and Transplants
2.- Legal regulations
Assisted H man Reprod ction Act 2006Assisted Human Reproduction Act, 2006Biomedical Research Act, 2007
STEPS UNDERTAKEN
3.- Non-regulatory actionsg y
- TrainingE l ti A th i ti d R i t- Evaluation, Authorization and Registry
- Support Office for Independent Research- Creation of the Advanced Therapies European Forum- 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 graciasMuchas gracias
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