Approaches to PersonalisedMedicine in Finland:Status Report

Tallinn 26.10.2015

Liisa-Maria Voipio-Pulkki MD PhDDirector of Health Care Group, CMOMinistry of Social Affairs and HealthFinland

Phases of the economic and needs pressure

Pensions on the increase

Increasing need of care

2010

Economic burden

Building phase of the welfare society

70 children and elderly per 100 persons in working age

50

60

70

80

indeksi

50

60

70

80indeksi

40 40

203020202000199019801970 2040year00

Situation in October 2015

10/29/2015Name Surname

3

Maritta Korhonen4 29.10.2015

Large reforms for Finnish healthcare are coming- what has happened since January 16th, 2015?

� New government => new outlines for the social and healthcare reform, major changes in division of public power between municipalities & state; major changes in taxing policies and social & hc funding

� Fiscal constraints, unemployment on the increase

� Refugee & migrant groups beyond all expectations

� New national social and health ICT strategy

� New outline for a national genome strategy

� Biobank activities face some practical challenges, including consent and data privacy issues

Etunimi Sukunimi5 29.10.2015

Social welfare and health care reform in the new Government Programme

� Prime Minister Juha Sipilä’s GovernmentProgramme was published in May 27th 2015

� Responsibility of all social and health services will be given to 5-19 regional authorities by 2019

� Main targets:

– reducing socioeconomic inequity

– improving cost containment

� Main tools:

– full integration of primary, secondary and tertiary health care as well as public health services with social services

– maximal digitalization of all services

� Joint strategy created and implemented by 3 ministries– Min. Employment and the Economy

– Min. Social Affairs and Health

– Min. Education and Culture

� For the first time the strategy examines the health sector from the perspective of innovation and business growth.

� Use of health data and genomic information for drug development and personalized medicine

National Health Sector Growth Strategy for Research and Innovation activities

6

More information: http://www.tem.fi/files/40138/TEMrap_16_2014_web_09062014.pdf

10/29/2015

© TEM / INNO 2008

Strategy: Finland´s goals

7

Finland´s goal is to be an internationally renowened forerunner in health sector research and innovation, investment and new business acitivities while benefiting peoples´s health, welfare and capacity to act.

This means that Finland is:

• The source and user of versatile and high quality scientific research and therefrom derivied inventions and innovations.

• A dynamic operating environment for new companies in the field and a reliable partner for the international growth of companies.

• An attractive target country for health sector investment.• A model country for consolidating a sustainable healthcare

system with innovative activities.

Building Blocks of PM in Finland

10/29/2015 Name Surname8

Y O U R T E S T B E D F O R N E X T G E N E R A T I O N R E A S E A R C H & I N N O V A T I O N

NATIONAL REGISTERS

Etunimi Sukunimi10 29.10.2015

National archive of health information

� ePrescription

– Provides medication summary and enables a fully electronic prescription – dispensing – reimbursement process

� eArchive

– Centralised active and real-time data store + legal archive

– Allows sharing of data between healthcare providers securely and with patient consent

� eAccess

– Citizens can view their own prescriptions and electronic records

� National services are accessed through local systems

– Implement same interoperability standards also in local systems (HL7 V3 CDA R2)

Etunimi Sukunimi11 29.10.2015

eDeliveries from pharmaciescompared to reimbursed prescriptions

years 2009–2015

reimbursed prescriptions

Million prescriptions

2009 2010 2011 2012 2013 2014 2015

ePrescriptions

Pharmacies31.03.2012

Public health care31.03.2013

Private health care31.12.2014 (>5000 res/v)

2014

ePrescription

for 3,64 M

persons (pop 5,4 M)

8.10.2015

Etunimi Sukunimi12 29.10.2015

Public healthcare providers

6.9.2011

Other national services

Kanta services

ePrescription service

Dispensations

Patient data repository

Health records, structured (CDA R2 L3)

Metadata

Consent and will management

Opt-ins and opt-outs

Organ donation wills

Living wills

National code server

Code lists and terminologies

Form and document structures

Pharmacies (~800)

Hospital districts (20)

Primary care org. (192)

Private healthcare providers (4000)

Patient summary management

Diagnoses

Lab

Radiology

Procedures

Vaccinations

Physical findingse

pS

OS

NC

P

Swedish epSOS NCP

Risks Medication

Other NCPs not yet connected

Healthcare and social care organizations register

Radiology DICOM studies

IHE

X

DS

IHE

X

DS

-I

Pharmacies register

PrescriptionsRenewals

Logs

Logs

Health and care plan

Patient data management service

Certification services Health care professionals register

Pharmaceutical database

Health records, legacy (CDA R2 L1)

Health care professionals

My KantapagesCitizens (> 5 000 000)

Web services for HCPs

Kan

tam

ess

agin

g la

yer

Aged 18 and

older

Main standards

• HL7 V3: CDA R2 Level 3 and Medical Records

• IHE IT-I Profiles • W3C XML DSig• WS Addressing, WS-I• TLS, X.509

Personal Health and Social Record

APPS

mHealth

OwnCare

SelfCare

Etunimi Sukunimi13 29.10.2015

All visits

Different visitors

8.10.2

015

20112010 20142012 2013

Monthly visits and different visitors in My Kanta service

2015

Etunimi Sukunimi14 29.10.2015

Patients can check how their personal information is used

� Patients can check the use and release of their personal healthinformation.

� Through the eAccess portal, patients can monitor whichorganisations access or process their personal information and to which organisations the information is released.

� Patients can also request the register authority to detail whohave accessed and processed the data.

Y O U R T E S T B E D F O R N E X T G E N E R A T I O N R E A S E A R C H & I N N O V A T I O N

Regulation by

national authorities

• professionality, quality

standards

KEY DRIVERTHE BIOBANK ACT OF 2013 WITH THREE IMPORTANT PRINCIPLES

Protection of

donors’ rights

• informed consent;

optout procedure for

retrospective samples

• privacy protection

and sample

pseudoymization

• donors right to know

the usage of samples

Promotion of

research and R&D

• broad consent

• permission to link biobank

specimens with information

from hospital databases and

national registries

• all raw data resulting from

the biobank material will

return to the biobank for

future biobank research

purposes

KSSHP

• Background: biobank law 2013, BBMRI_ERIC agreement by the state of Finland

• Health Growth Strategy

• 2014:

• Terveyden ja Hyvinvoinnin Laitos THL (THL Biopankki)

• TYKS ERVA ja Turun yliopisto (Auria Biopankki)

• HYKS ERVA ja Helsingin yliopisto/FIMM (HAMC Biopankki)

• Laaja alueelinen biopankki

• Projektien biopankit HUB ja FHRB

• Latest additions:

• Pohjois-Savon SHP ja Itä-Suomen yliopisto

• Pohjois-Pohjanmaan SHP ja Oulun yliopisto

• Pirkanman SHP ja Tampereen yliopisto

• Keski-Suomen SHP ja Jyväskylän yliopisto

BBMRI.fi

Clinical data

Genomic medicine in the

service of better health and

health care

Official launch date:

June 11th, 2015

By the year 2020, genomic data will be effectively used in healthcare and in the

promotion of health and wellbeing

to achieve population health benefits

Why do we need a genomics strategy?

� To take full advantage of the potential benefits of the genomics era

� Fostering research and innovation policies

� Mainstreaming genomic technologies in the Finnish health system

� Ensuring equitable access to and rational use of the technologies

19

Y O U R T E S T B E D F O R N E X T G E N E R A T I O N R E A S E A R C H & I N N O V A T I O N

EARLY SETTLEMENT • 2000-10 000 years ago

• South and Coast

LATE SETTLEMENT• 16th century

• multiple bottle necks

EXPANSION • 18th century – population 250 000

• Today – population 5.4 million

EARLY

SETTLEMENT

LATE

SETTLEMENT

10/29/201521

By the year 2020, genomic data will be effectively used in healthcare and in the promotion of health and wellbeing

� Ethical principles and legal framework are available for the application of genomics

� Genomics research is integrated into healthcare

� Healthcare workforce have the knowledge and skill to apply genomic information

� Informatics infrastructure is in place for effective application of genomics

� Genomic information is widely used in healthcare to meet the needs of individuals and the population

� People understand and are able to make effective use of genomic information to improve their own health

� In genomics, Finland is an attractive research and innovation environment for collaboration and investment

Y O U R T E S T B E D F O R N E X T G E N E R A T I O N R E A S E A R C H & I N N O V A T I O N

THE 200K

Genome wide genotype data

73 000

Genome or exome sequences

>26 000

NATIONAL

BIOBANKExtensive health,

phenotype,

metabolomic data

Population cohorts

Disease specific

collections

200 000 individuals

4% of the population

REFERENCE DATABASE

POPULATION SPECIFIC CHIP/GENOTYPING

IMPUTATION

SISU-PROJECT

SEQUENCING INITIATIVE SUOMI (FINLAND)

DNA and RNA Analyses

Clinical

measurements & imaging

Functional imaging

Microbiome

Lifestyle data

Family history

Metabolomics

Reference database

Dream BigNational

health registries

Y O U R T E S T B E D F O R N E X T G E N E R A T I O N R E A S E A R C H & I N N O V A T I O N

DIGITAL HEALTH HUB:

A NATIONAL OPERATOR FOR HEALTH AND WELLBEING DATA

DIGITAL

HEALTH HUB

2017

NATIONAL

PHR

NATIONAL

GENOME

DATABASE

NATIONAL

PATIENT DATA

ARCHIVE (KANTA)

OPEN AND

OTHER DATA

SOURCES

DATA SOURCES:

SERVICE

PROVIDERSHEALTHCARE MEDICAL

RESEARCH

OTHER

RESEARCH

DATA USERS:

“One-stop-service”

National Operator

National Operator for Health and Well-being Informationcombined with new legislation on the secondary use of sensitive health data and other sensivite personal information 2015-

25

Data Creation

“My Kanta” / personal

online service for

medical details

EHR database

Bio-

banks

Integrated and analysed data

Standard interfaces

Customized interfaces

Ecosystem and Partner Network

• Public Research Institutes

• Private Research Institutes

• Pharmaceutical Industry

• Healthcare

Information Enrichment and Increased Customer Value

Revenue Stream

Utilization of Information

KanTa

Genome

-database

Other data sources

Value Added Services

Data anonymization

Individual

Benefit

1 3Data Gathering and

Refining

2

Individual

• Individual

Analytic services

End-user applications

Services containing anonymized data

Etc.

Audit Trail and Securing Information Reliability

• National Centres of Expertise

4

Sitra • 28.9.2015

What next?

10/29/2015Name Surname

26

Individualized systems medicine (ISM)

System medicine approach:- Data integration- Repeated sampling- Feedback to clinic- Learning system

Pemovska et al. Cancer Discovery, on-line Sep 20, 2013

Active Client: New role in client-oriented

service process modelling

29.10.201528

Visits Episode Visit Visit Visits

Active role of the client Health gain

Primary care Special care Home care

Service plans and good practices maximice effectivity/

indicators for quality and effectivity

Functional capacity of the client, Social networks and Culture

Patient dataPatient data

Business opportunities in digital health

Environmental

data

Environmental

data

Health dataHealth dataLifestyle data Lifestyle data

Genetic dataGenetic data

Early detection of diseases

Wellbeing services

Health promotionHealth promotionSelf-monitoring and careSelf-monitoring and care

Diagnostics industry

Personalised healthcare

Personalised healthcare

Pharma industry

Social media Game industry

Software industry

BioIT industry

Big data

Biobanks

Remote care

Clinical decision support

Population health management

Global digital health market EUR 47 bn in 2018

Sensors

DM 1381236

Y O U R T E S T B E D F O R N E X T G E N E R A T I O N R E A S E A R C H & I N N O V A T I O N

Ministero della Salute

Rogowski et al, Nature Reviews in Genetics, 2009

Regulatory nightmare or protection of patient privacy and safety?

29.10.2015

Thank you!

liisa-maria.voipio-pulkki@stm.fitel +358 50 3310314