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

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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