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View the PDF Document REPUBLIC OF KENYA Sessional Paper on NATIONAL PHARMACEUTICAL POLICY Reforming the pharmaceutical sector to ensure equitable access to Essential Medicines and essential health technologies for all Kenyans MINISTRY OF MEDICAL SERVICES & MINISTRY OF PUBLIC HEALTH AND SANITATION June 2010 CONTENTS ABBREVIATIONS ................................................................................................................... 4 PREAMBLE .............................................................................................................................. 6 1 INTRODUCTION .............................................................................................................. 7 1.1 THE PROBLEM ............................................................................................................................... 7 1.2 POLICY PRINCIPLES ........................................................................................................................ 7 1.3 VISION, GOAL, OBJECTIVES AND STRUCTURE OF THE POLICY ......................................................... 8 1.3.1 Vision of the Policy ........................................................................................................................ 8 1.3.2 Policy Goal .................................................................................................................................... 8 1.3.3 Policy Objectives ........................................................................................................................... 9 1.3.4 Structure of the Pharmaceutical Policy.......................................................................................... 9 1.3.5 Review of the Pharmaceutical Policy ............................................................................................. 10 2 BACKGROUND AND CONTEXT .................................................................................. 10 2.1 COUNTRY BACKGROUND ............................................................................................................ 10 2.2 PHARMACEUTICAL SECTOR AND NATIONAL DEVELOPMENT ........................................................ 10 2.2.1 Pharmaceutical Sector Structure and Overview ............................................................................ 10 2.3 POLITICAL, ECONOMIC SOCIAL AND REGIONAL CONTEXT ............................................................ 11 2.3.1 Political Context ............................................................................................................................ 11 2.3.2 Economic Context ......................................................................................................................... 11 2.3.3 Social and Demographic Context ................................................................................................... 11 2.3.4 Regional and International Context ............................................................................................... 12 2.4 NATIONAL HEALTHCARE CONTEXT .............................................................................................. 12 2.4.1 Health Policy Framework .............................................................................................................. 12 2.4.2 Healthcare Governance Structures ................................................................................................ 13 2.4.3 Health Services Structure .............................................................................................................. 13 2.4.4 Healthcare Financing ..................................................................................................................... 14 2.4.5 Health Profile ................................................................................................................................ 14 2.5 ENSURING ACCESS TO ESSENTIAL MEDICINES .............................................................................. 15 2.5.1 Framework for Ensuring Access to Essential Medicines ................................................................. 15 2.5.2 Performance of the Sector on Access to Essential Medicines ........................................................ 16 2.6 RATIONALE FOR THIS NATIONAL PHARMACEUTICAL POLICY ........................................................ 18 2.6.1 Performance of the Past National Drug Policy ............................................................................... 18 2.6.2 Constraints .................................................................................................................................... 19 2.6.3 Emerging and Continuing Challenges ............................................................................................ 19 2.7 FOCUS OF THIS POLICY ................................................................................................................ 20 2.7.1 Health Considerations ................................................................................................................... 20 2.7.2 Development Considerations ........................................................................................................ 21 2.8 CRITICAL PHARMACEUTICAL SECTOR ISSUES ............................................................................... 21 3 THE PHARMACEUTICAL POLICY FRAMEWORK .................................................. 22 3.1 REVAMPING PHARMACEUTICAL SECTOR GOVERNANCE AND POLICY DIRECTION ......................... 22 3.1.1 Overall Policy Direction, Sector Governance and Coordination ..................................................... 22 3.1.2 Management of Public Pharmaceutical Services ........................................................................... 22 3.1.3 Enhancing Partnerships and Coordination on Pharmaceuticals ..................................................... 22 2 3.2 STRENGTHENING PHARMACEUTICAL SECTOR REGULATION ......................................................... 24 3.3 EXPANDING AVAILABILITY OF ESSENTIAL MEDICINES .................................................................. 27 3.3.1 Public Sector Procurement and Supply .......................................................................................... 27 3.3.2 Procurement and Supply System of the Faith‐Based Health Services ............................................ 28 3.3.3 Private Sector Supply System ........................................................................................................ 28 3.4 EXPANDING LOCAL PHARMACEUTICAL PRODUCTION .................................................................. 31 3.5 IMPROVING AFFORDABILITY OF ESSENTIAL MEDICINES ............................................................... 33 3.5.1 Overview of Medicine Prices and Affordability in Kenya ............................................................... 33 3.5.2 Medicine Pricing Approaches in Kenya .......................................................................................... 34 3.5.3 Regulation and Rationalization of Medicine Prices for Affordability .............................................. 35 3.5.4 Promoting Use of Generics ............................................................................................................ 36 3.6 PROMOTING APPROPRIATE MEDICINES USE ................................................................................ 37 3.6.1 Medicines Selection and Rationalization of Therapeutics .............................................................. 37 3.6.2 Appropriate Medicines Information and Promotion ...................................................................... 38 3.6.3 Prescribing and Dispensing ............................................................................................................ 40 3.6.4 Traditional Medicines .................................................................................................................... 41 3.7 PHARMACEUTICAL RESEARCH AND DEVELOPMENT ..................................................................... 42 3.8 INFORMATION AND COMMUNICATION TECHNOLOGY (ICT) ......................................................... 44 3.9 HUMAN RESOURCES FOR THE PHARMACEUTICAL SECTOR ........................................................... 45 3.9.1 Pharmaceutical Personnel and Training ........................................................................................ 45 3.9.2 Pharmaceutical Human Resource Development ........................................................................... 45 3.9.3 Pharmaceutical Human Resource Utilization ................................................................................. 45 3.10 PROMOTING ACCESS AND SAFEGUARDING PUBLIC HEALTH IN PHARMACEUTICAL TRADE ...... 48 3.10.1 Pharmaceuticals in Trade and Economic Policies ........................................................................... 48 3.10.2 Enhancing Regional and International Cooperation ...................................................................... 49 3.11 ENHANCING ACCESS TO VETERINARY MEDICINES ................................................................... 50 3.11.1 Structure of Veterinary Pharmaceutical Services ........................................................................ 51 3.11.2 Regulation of Veterinary Pharmaceutical Products ....................................................................... 51 3.12 FINANCING FOR ESSENTIAL PHARMACEUTICALS AND SERVICES .............................................. 52 3.12.1 Overall Health Care Financing ......................................................................................................
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