Prof. Juozas Galdikas Lthuania - BioAsia 2013

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  • 1. INNOVATION AND REGULATION IN HEALTH CARE Prof. Juozas Galdikas, Director State Healthcare Accreditation Agency, LithuaniaHyderabad,28-30 January, 2013
  • 2. 2
  • 3. Lithuania in figures (1)1009 – first mentioned in written annals in Germany1236 – Kingdom of Lithuania1387 – Lithuania was converted to Christianity1579 – Vilnius University was founded1918 – Lithuania is proclaimed an Independent Republic1940 – 1990 – Lithuania was occupied by Soviet Union1990 – Lithuania’s independence was restored1991 – Member of UN – Member of WHO1992 – Member of CoE2004 – Member of EU – Member of NATO 3
  • 4. Lithuania in figures (2)The Capital – VilniusThe supreme legistative body is SEIMAS (the Parliament)Teritory – 65,300 sq. kmPopulation – 3,0 mln. (urban – 2,6 mln.)Ethnic composition – 84 % Lithuanian – 6 % Russian – 6 % Polish – 4 % OthersGDP (PPP)/cap. – 18,000 USDHealth exp./cap. – 800 USDGovernment H. Exp. – 73 % of all H. Exp. 4
  • 5. Health in figures (1)Health is a major concern of state – 91%Life expectancy – 74Population over 64 – 16 %Number of deaths – 963 /100.000Main causes of death – CSD – 60 %Infant mortality – 4 /1.000 LBSuicide – 31 /100.000 5
  • 6. Health in figures (2)HCP – 2200Privat HCP – 1860Privat GP – 184 (of 2000)Pharmacies – 1550 (4200 pop./ph.)Hospital bads – 700/100.000Bad occupancy – 280 daysLength of stay in hosp. – 12 days 6
  • 7. Health systemCompulsory health insurance – 1997Budget of CHIF – 1,6 billion USDMain principles – solidarity – money follow by the patient owned – equityContracts with HCP – annualyAverage doctor’s salary – 1545 USDAverage nurse salary – 920 USDAllocations 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 Lithuania1976 – Graduated secondary school1983 – Graduated VU Medical faculty1983 – 1996 – research-vascular surgery at the Clinic forCardiovascular Surgery of VU1987 – M.D. degree1993 – Habilitation dr. degree1996 – Professor of medicine1996 – 2000 – Member of the Parliament (Seimas)1996 – 1998 – Member of the 8’th Government of Lithuania, Ministerof Health2001 – 2006 – Deputy director of VASPVT2006 – 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 EUregulations) 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 influence13
  • 14. MAIN QUESTION14
  • 15. Safety of MD & M – REG by EU Safety of MD & M – REG by MS Quality of health procedures – REG by MS15
  • 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 HP16
  • 17. RESPONSIBILITY OF REGULATION - EU - MS - HC providers - Distributors - Producers RESPONSIBILITY OF REGISTRATION - EU - MS - HC providers17
  • 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 care18
  • 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 MD20
  • 21. REGULATION (PRODUCERS)- Purchasing- Instructing & training of HC Sp. & HC Techn.- Service of MD- Development of MD & M- New MD & M21
  • 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 MD23
  • 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 technologies24
  • 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 people25
  • 26. Thank you for attention www.vaspvt.gov.lt E-mail: juozas.galdikas@vaspvt.gov.lt