1. INNOVATION AND REGULATION
IN HEALTH CARE
Prof. Juozas Galdikas, Director
State Healthcare Accreditation Agency, Lithuania
Hyderabad,
28-30 January, 2013

2. 2

3. Lithuania in figures (1)
1009 – first mentioned in written annals in Germany
1236 – Kingdom of Lithuania
1387 – Lithuania was converted to Christianity
1579 – Vilnius University was founded
1918 – Lithuania is proclaimed an Independent Republic
1940 – 1990 – Lithuania was occupied by Soviet Union
1990 – Lithuania’s independence was restored
1991 – Member of UN
– Member of WHO
1992 – Member of CoE
2004 – Member of EU
– Member of NATO
3

4. Lithuania in figures (2)
The Capital – Vilnius
The supreme legistative body is SEIMAS (the Parliament)
Teritory – 65,300 sq. km
Population – 3,0 mln. (urban – 2,6 mln.)
Ethnic composition – 84 % Lithuanian
– 6 % Russian
– 6 % Polish
– 4 % Others
GDP (PPP)/cap. – 18,000 USD
Health exp./cap. – 800 USD
Government H. Exp. – 73 % of all H. Exp.
4

5. Health in figures (1)
Health is a major concern of state – 91%
Life expectancy – 74
Population over 64 – 16 %
Number of deaths – 963 /100.000
Main causes of death – CSD – 60 %
Infant mortality – 4 /1.000 LB
Suicide – 31 /100.000
5

6. Health in figures (2)
HCP – 2200
Privat HCP – 1860
Privat GP – 184 (of 2000)
Pharmacies – 1550 (4200 pop./ph.)
Hospital bads – 700/100.000
Bad occupancy – 280 days
Length of stay in hosp. – 12 days
6

7. Health system
Compulsory health insurance – 1997
Budget of CHIF – 1,6 billion USD
Main principles – solidarity
– money follow by the patient owned
– equity
Contracts with HCP – annualy
Average doctor’s salary – 1545 USD
Average nurse salary – 920 USD
Allocations of CHIF – 51% – in patient care
15 % – MD&D
5 % – PHC
3 % – Rheabilitation
16 % – Outpatien spec. services
10 % – others.
7

8. Figures about J.G.
1958 – Born in Lithuania
1976 – Graduated secondary school
1983 – Graduated VU Medical faculty
1983 – 1996 – research-vascular surgery at the Clinic for
Cardiovascular Surgery of VU
1987 – M.D. degree
1993 – Habilitation dr. degree
1996 – Professor of medicine
1996 – 2000 – Member of the Parliament (Seimas)
1996 – 1998 – Member of the 8’th Government of Lithuania, Minister
of Health
2001 – 2006 – Deputy director of VASPVT
2006 – now – Director of VASPVT
8

9. MAIN RESPONSIBILITIES OF VASPVT (1)
1. Licensing of the health care organizations (mandatory)
2. Licensing of the health professionals (mandatory)
3. Accreditation of health care organizations (voluntary)
4. Competent authority for medical devices (due to EU
regulations)
9

10. MAIN RESPONSIBILITIES OF VASPVT (2)
5. Regulation and management of medical devices (national level)
6. Health technologies assessment:
- Organization of health technologies assessment
(national level)
- Providing of Health technologies assessment
(related to medical devices)
7. Supervision and control of quality of health procedures
(national level)
8. Supervision of patients rights (national level)
10

11. EXPERIENCE OF VASPVT
MED DEV regulation (since 1998)
MED DEV registration (since 2000)
HTA (EunetHTA – 2010, EUnetHTA JA – 2010-2012)
MED DEV management (since 2010)
11

12. Challenges
Doubled expenditures for HC – 2020
Ageing of population
More than 0,5 mln. types of MD in EU (EUDAMED)
Deaths from chronic disease will increase by 17 % – 2015
12

13. Trends
Minimal invasive procedures
IVD tests
Request for screening
Personalized Medicine
HC at home
IT power and influence
13

14. MAIN QUESTION
14

15. Safety of MD & M – REG by EU
Safety of MD & M – REG by MS
Quality of health procedures – REG by MS
15

16. AIM OF REGULATION
- Safety
- Improvement of quality in HP
- New HT
- Improvement of efficacy of HP
- Improvement of efficiency of HP
- Economy of resources
AIM OF REIMBURSEMENT
- Accessibility of safety HP
- Improvement of efficacy HP
- Improvement of efficiency of HP
- Improvement of quality of HP
16

17. RESPONSIBILITY OF REGULATION
- EU
- MS
- HC providers
- Distributors
- Producers
RESPONSIBILITY OF REGISTRATION
- EU
- MS
- HC providers
17

18. REGULATION (MS)
- Fixed allocations for MD & M
- Control of usage of MD & M
- Control of efficacy of MD & M
- Control of procurement of Exp. MD & M
- Control of new HT
- Shortening of bed-days in hospitals
- Change of hospital care to ambulatory care
18

19. REGULATION (HCP)
- Fixed allocations for MD & M
- Control of usage of MD & M
- Control of efficacy of MD & M
- Shortening of bed-days in hospitals
- Change of hospital care to ambulatory care
19

20. REGULATION (DISTRIBUTORS)
- Purchasing
- Instructing & training of HC Sp. & HC Techn.
- Service of MD
20

21. REGULATION (PRODUCERS)
- Purchasing
- Instructing & training of HC Sp. & HC Techn.
- Service of MD
- Development of MD & M
- New MD & M
21

22. REGISTRATION
- EU regulations
- EU directives
- International projects (registries)
- MS (national, regional registries)
- HCP (information systems for better management)
22

23. HTA in practice
- Reliable MD
- Reliable specialist
- Efficient usage of MD
23

24. Role of Public authorities
- Innovative technology as long term investment
- Should translate faster innovation from research to
market
- Should support IT innovations
- Reimbursement system should support implementation
of innovative technologies
24

25. Reengineering – reevaluation of HTA
- Prioritizing of HTA
- Strengthening relations between HCP (dif. level)
- Motivate HC specialists for saving allocations
- Show for public that we are working for people
25

26. Thank you for attention
www.vaspvt.gov.lt
E-mail: juozas.galdikas@vaspvt.gov.lt