Strategies for Working with Countries – Regional and Sub-Regional Perspective and Experiences Essential Drugs and Medicines Policy WHO South-East Asia Region Krisantha Weerasuriya, Regional Adviser Technical Briefing Seminar, Geneva, October 2007 World Health Organization

WHO Medicines Strategy 2004 – 2007: 4 objectives, 7 components, 44 expected outcomes OBJECTIVES Policy Access Quality and safety Rational use COMPONENTS 1.Implementation and monitoring of medicines policies 2.Traditional and complementary medicine 3.Fair financing and affordability 4.Medicines supply systems 5.Norms and standards 6.Regulations and quality assurance systems 7.Rational use by health professionals and consumers

HTP TCM PSM Other WHO Clusters Coordinated efforts between HQ Departments Regional & Country Offices Coordinated efforts between HQ Departments Regional & Country Offices Primary interaction Secondary interaction AFRO AMRO EMRO EURO SEARO WPRO Country Offices NPO

Headquarters: Strategy and policy making Planning & monitoring Partnerships and Collaboration Resource Mobilisation Provide specific technical & policy support Support in HR development & training Roles and responsibilities for supporting implementation of WHO Medicine Strategy Roles and responsibilities for supporting implementation of WHO Medicine Strategy Strategy, policy guidance, support and collaborations Regional Offices: Oversee country operations Planning and monitoring of country support Technical, policy and management support to countries Human resources development & training Partnerships and collaborations at regional level Country Offices: Assess needs and identify priorities for technical support Plan & implement WHO work Provide technical and policy support to countries Assist in coordination Partnerships & collaborations in countries Feedback and report Ministries of Health: Identify needs & priorities Plan, implement and monitor action Coordinate with other Ministries and national bilateral and multilateral agencies and CSO's. Planning, implementation, monitoring

Brief Description of South-East Asia Region  Eleven countries  Bangladesh, Bhutan, DPRK, India, Indonesia Maldives, Myanmar, Nepal, Sri Lanka, Thailand & Timor-Leste (11)  Enormous variation in medicines situation Self sufficient  ---  Totally dependent on imports  One common feature – all developing countries  Country needs and regional cooperation form basis of activities

What is the framework for cooperation? (Common for all Regions)  Country Budget & Workplan  Decided at the beginning of the biennium after consultation between countries, Regional Office (RO) & HQ.  Based on WHO Medicines Strategy  Additional funds may become available depending on particular initiatives  Workplan – mixture of activities (workshops), specific supplies, and training (in-country and outside)  WHO is NOT a funding agency – does not fund routine service activities

How does specific collaboration come about ?  Country driven – they have a specific issue – Good Manufacturing Practices – how can we develop our guidelines ? Registration of Medical Devices – how can it be done, what is the experience of the other countries?  Country driven – emergency – Tsunami - donations  WHO Initiative – as part of WHA Resolution or Regional Committee Resolution. Bulk Procurement scheme for the Region  Both WHO and Country concerns (Avian influenza)

Examples of collaboration  Drug Donations – Tsunami India & Thailand – no donations please Sri Lanka – posted what was needed (but included non-emergency medicines) Indonesia – all donations accepted Studies on donations done with WHO assistance in Sri Lanka and Indonesia Country driven – emergency – Tsunami - donations  Intellectual Property Rights and Pharmaceutical Patents (Regional Collaboration based on Inter Governmental Working Group on Public Health, Innovation & Intellectual Property. Indian Patent Legislation, Thailand Compulsory Licensing, Indonesia “Govt” use.  National Essential Medicines Lists – Regional Workshop – 30 th Anniversary – WHO Initiative with country participation

Examples of collaboration  Counterfeits – Global Initiative – Biregional (SEARO-WPRO) Activity – learning from each other Developing common definitions Developing common methods Sharing information Understanding how to tackle the problems  Controlled Substances (not taken up by countries) – use of opioids in pain relief in terminal illness  Pharmacovigilance – Uppsala Center, encouraging countries to be part of global scheme  Specific country activities – evaluation of the DRA as joint activity –HQ/RO/Country – Situation analysis and suggestions for improvement  Developing norms – adopt WHO ones but where necessary adapt

Summary  Country cooperation based on WHO Medicines Strategy  Regular workplans based on country needs  Initiatives outside the workplans are accommodated when necessary  WHO support - Technical assistance and not funding  Continuing long term work + “ when needed ” assistance