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CROATIAN PHARMACEUTICAL SECTOR

CROATIAN PHARMACEUTICAL SECTOR. Prof.dr. Igor Francetić Division of Clinical Pharmacology Department of Internal Medicine, UHC Zagreb, Croatia. Formulation of National Drug Policy (NDP) Strategy and activity aimed at NDP Monitoring of effects.

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CROATIAN PHARMACEUTICAL SECTOR

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  1. CROATIAN PHARMACEUTICAL SECTOR Prof.dr. Igor Francetić Division of Clinical Pharmacology Department of Internal Medicine, UHC Zagreb, Croatia

  2. Formulation of National Drug Policy (NDP) Strategy and activity aimed at NDP Monitoring of effects

  3. National drug policy defined in 2002; never implemented (dead document) Strategies and activities Never defined and undertaken Observing results and missing positive effects of NDP

  4. Key components of National Drug Policy

  5. Present situation on pharmaceutical sector • Increasing gap between resources and needs • The debt of Croatian Health Insurance company increases around € 10-15 mil/month for drugs only • Drug expenditure increases at yearly rate of 18%Drug expenditure (in Croatia - outpatient and hospital) € 420 mil/year

  6. Prescription drugs in Croatia

  7. Prescription drugs + hospital expenditure in Croatia

  8. Drug expenditure per capita

  9. Central European countries (2003)

  10. Legislation in Croatia • New Drug Law (29.7.2003) • Partially in compliance with EU directives • Bylaw on clinical studies and Good Clinical Practice (GCP) (4.11.2003.)

  11. Documents from EU • EU Directive 2001/83/EC (28.11.2001.) • EU Directive 2001/20/EC (1.5.2001.) • Notice to applicants

  12. Disparities with EU Directives • Central ethical committee • Adverse drug reactions • Legal entity

  13. Drug Agency in Croatia Since 1.1.2004. • Practically still in run-in period • Competence vague • Drug registration and pharmaceutical inspection in Ministry of health

  14. Croatian Health Insurance Company • Reimbursement list (standstill) • Drug Committee (dismissed 7.2.2003.) • Monthly debt  10-15 mil €

  15. Prescription drugs in Croatia

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