To ensure improved access, quality and use of medical products and technologies.

SEA/SPPDM-Meet.2/2.3 Page 391 Strategic Objective 11: To ensure improved access, quality and use of medical products and technologies REGIONAL PLANNING BRIEF 1. Major work of WHO for this SO in the region (RO and countries) during 2008-2009: The four areas of work were Policy, Access, Quality and Safety, and Rational Use. The RERs focuses on the first, second and fourth. However there were activities in the third too that were done outside the RERs. Policies for medicines • The major policy work in Essential Medicines in SEAR was in National Medicinal Drug Policies in a few countries and revision and updating the National Essential Medicines Lists in many more countries. The updating and revision were contributed to, by a regional workshop in 2007. Access to medicines • There were 2 major areas in Access – the first was contribution to the InterGovernmental Working Group on Intellectual Property, Innovation and Public Health. This has the potential to address drug development and delivery for the major diseases in the region that are not addressed by the pharmaceutical companies. It is a very long-term effort and should be seen as a “seeding”. The other work was in the area of Medicines Prices, where the focus was on Medicines Prices where it was a beginning to convince the Ministry of Health that Medicines Prices is a part of their responsibilities as it affects Access. Regulation of medicines • In Regulation, support was provided to improving Regulation in the countries and the Regional Activity was a side-meeting at the International Conference of Drug Regulatory Authorities. Rational use of medicines • In Rational Use, the focus was on providing information – projects that empowered the consumers through medicines information were done. These included those on patient formularies, courses on Drugs and Therapeutics Committees and using the 2008 WHO Model Formulary. Blood safety • The Blood Safety area also focused on policy, access, quality and safety of blood and blood products as well as their rational use. Major work in this area has been on assisting countries in developing their respective National Blood Policy which can be translated into nationally coordinated blood transfusion services. During 2010-2011, efforts will be made to further strengthen the national blood services as well as assisting other countries in developing their National Blood Policy. • WHO, in collaboration with International Federation of Red Cross & Red Crescent Societies, International Society for Blood Transfusion and International Federation of Blood Donors has been promoting voluntary non-remunerated blood donations especially through World Blood Donor Day which is being celebrated in all countries in SEA/SPPDM-Meet.2/2.3 Page 392 the Region on 14 June. These activities will be continued in the next biennium to improve the percentage of blood that is collected from voluntary non-remunerated blood donors. 2. Scope of work and major results planned for 2010-2011 Medicines • The scope of the work remains broadly the same as in the previous biennium though there is a greater focus on procurement and supply chain management. • The major results expected are better access to Essential Medicines through the previous year’s activities and in addition through Procurement and Supply chain management. Blood safety • The scope of work remains broadly same as in the previous biennium with focus on strengthening nationally coordinated blood transfusion services and promoting voluntary blood donation as the principal areas. • The major expected results are availability of greater quantity of safe blood to those who need it to save their lives or mitigate the disease. 3. Regional Expected Results (RERs) with indicators, baselines and targets (attached): 4. Budget information for the Strategic Objective for Country Offices (CO) and the Regional Office (RO) (in USD thousands) PB 2008-2009* PB 2010-2011 Country offices Regional Office SO Component Planned Resources Planned Resources CO RO Formulation and monitoring of policies regarding essential medicines and blood safety 2,503 1,012 570 469 Quality and safety of essential medicines, traditional medicines, vaccines and injection practices 3,516 1,948 1,291 955 Better use of Essential Medicines through provision of evidence- based, unbiased drug information 1,984 727 870 686 TOTAL 8,003 3,687 2,731 2,110 7,552 2,000 * Resources as of May 15, 2009 SEA/SPPDM-Meet.2/2.3 Page 393 South-East Asia Regional Expected Results for Regional PB 2010-2011 Strategic Objective 11: To ensure improved access, quality and use of medical products and technologies Organization-wide Expected Result Regional Expected Results Indicator Baseline Target Number of countries with national blood policy 7 9 1. National blood policy formulated and health technologies and blood transfusion services strengthened in Member States. Number of countries adopting WHO tools for health technologies 0 4 1. Formulation and monitoring of comprehensive national policies on access, quality and use of essential medical products and technologies advocated and supported. 2. Improved access to Essential Medicines based on implementation of National Medicinal Drug Policies and National Essential Medicines Lists Number of countries that have price regulation/monitorin g as part of routine activities 2 5 1. Increased availability of Essential Medicines through improvement of Regulation, Procurement and Supply Chain management in the Public and Private sector Number of countries that have evaluated their Drug Evaluation Systems OR Supply systems 3 6 2. International norms, standards and guidelines for the quality, safety, efficacy and cost-effective use of medical products and technologies developed and their national and/or regional implementation advocated and supported. 2. National Guidelines on promoting the appropriate use of Herbal Medicine/Traditional Medicine in PHC developed. Number of publications of National Guidelines on regulation, production and use of Herbal/Traditional Medicines for PHC 6 9 SEA/SPPDM-Meet.2/2.3 Page 394 Organization-wide Expected Result Regional Expected Results Indicator Baseline Target 3. Availability of vaccines and biologicals of assured quality through norms and standards, strengthened national regulatory authorities, effective management of vaccines and safe injection practices. Number of countries that have a national regulatory authority able to carry out regulatory functions. 2 10 3. Evidence-based policy guidance on promoting scientifically sound and cost-effective use of medical products and technologies by health workers and consumers developed and supported within the Secretariat and regional and national programmes. 1. Better use of Essential Medicines through provision of evidence-based, unbiased drug information through formularies, treatment guidelines and drug information centers. Number of countries that have published General National Formularies or in Specific areas (Paediatrics) 3 6 SEA/SPPDM-Meet.2/2.3 Page 395 395 Country Planning Brief: Bangladesh (SO-11) 1. Major work of WHO for this SO in country during 2008-2009: Essential Medicines • Lessons learned from UNICEF GMP inspection documented and disseminated. Guidelines & SOPs testing drug samples by Drug Testing Laboratory is being prepared. Updated ADR manual used in organizing orientation of focal point for reporting ADRs. • Updated Essential Drug List disseminated and promoted for use in the production and supply systems. • National Committee for promoting rational use of medicine established and contributing to the orientation of practitioners on rational use of drugs and on cost-effective use of traditional medicines by AMC practitioners. Blood Safety • Strategies and guidelines for voluntary blood donation developed. • 15 electro-medical technicians were trained in India. • Tool kits for monitoring and quality assurance for safe blood transfusion developed and a database of blood bank and donors Developed. Vaccine quality and safety • Draft guidelines for Fast track licensing developed, the procedures to be set up in 2009. Support is needed from SEARO for a TIP to provide technical assistance during licensing of first selected traditional vaccines through fast track mechanism. • AEFI surveillance guidelines are in place but to be updated in 2009. Refresher training of the field staff on AEFI surveillance will be completed in 2009 together with the training on Hib vaccine introduction 2. Scope of work and major results planned for 2010-2011 (by SO component): Essential Medicines • Strengthened NRA institutional setting & technical capacity for drug testing & promoting partnership for ensuring quality of production and rational use of allopathic & traditional medicines Blood Safety • Develop an integrated system for collection of blood from voluntary, non-remunerated blood donors with screening and reduction of unnecessary blood transfusion. Vaccine quality and safety • Quality of vaccines is assured by functional NRA and NCL, strengthened AEFI surveillance and effective management of vaccines by National EPI SEA/SPPDM-Meet.2/2.3 Page 396 396 3. How the scope and results are related to the Country Cooperation Strategy: All components • BAN CCS Strategic Action 6.3: Enhance national capacity to ensure access to quality essential medicines, vaccines and medical technologies 4. Budget information for the Strategic Objective (in USD thousands) PB 2008-2009 PB 2010-2011 SO Component AC VC planned VC actual* AC VC Formulation and monitoring of policies regarding essential medicines and blood safety 106 17 0 232 121 Quality and safety of essential medicines, technologies, traditional medicines, vaccines and injection practices 191 22 0 0 196 Better use of essential medicines and medical technologies through provision of evidence- based, unbiased information 36 30 0 TOTAL 333 69 0 232 317 * Available as of 15 May 2009 5. Possible VC funding through new or continuing projects: All components • At this stage, there is no identified source. 6. Staff requirements for 2010-2011 (short and long-term): Vaccine quality and safety • National professional – NOB – LTS for vaccine quality and safety SEA/SPPDM-Meet.2/2.3 Page 397 397 Country Planning Brief: Bhutan (SO-11) 1. Major work of WHO for this SO in country during 2008-2009: • Capacity building in the area of Product Evaluation and Registration of medicinal products. Established Drug Information Center for providing drug information for the consumers and healthcare professionals. • Quality system in the national blood transfusion service. • Curriculum for drungtsho and menpa revised. Conducted in service training for faculty members on teaching methodology and research skills. • Health workers of JDWNRH, Mongar Regional and Paro Hospitals were trained on health care waste management and infection control. Standard treatment guideline printed. 2. Scope of work and major results planned for 2010-2011. To provide policy and technical support in: • Strengthening DEDTC (EDP) program. • Promoting and enhancing the Drug Regulatory Authority of Bhutan. • Strengthening the laboratory, blood safety systems and services. 3. How the scope and results are related to the Country Cooperation Strategy: Strategic Priority #03 • Contribute to the strengthening of the Health System • Norms and standards and quality assurance for basic health care scaled-up towards universal coverage 4. Budget information for the Strategic Objective (in USD thousands) PB 2008-2009 PB 2010-2011 SO Component AC VC planned VC actual* AC VC Formulation and monitoring of policies regarding essential medicines and blood safety 68 68 0 Quality and safety of essential medicines, technologies, traditional medicines, vaccines and injection practices 88 159 0 Better use of essential medicines and medical technologies through provision of evidence- based, unbiased information 36 30 0 TOTAL 192 257 0 157 250 * Available as of 15 May 2009 SEA/SPPDM-Meet.2/2.3 Page 398 398 5. Possible VC funding through new or continuing projects: None 6. Staff requirements for 2010-2011 (short and long-term): None SEA/SPPDM-Meet.2/2.3 Page 399 399 Country Planning Brief: DPR Korea (SO-11) 1. Major work of WHO for this SO in country during 2008-2009: Blood and Clinical Technologies • QA system for blood product established in alignment of National blood safety program • The level of supervision by NRL over the clinical labs in peripheries committed to be at standard by upgrading of facilities in NCRL. Essential Health Technology • Local capacity for adopting safety measures against radioactive harms in clinical settings built up Essential Drugs and Medicine • Rational use of the traditional medicine and complimentary alternative medicine enhanced. • National Essential Medicine list, national formulary, guidelines updated as well as better access for population to essential medicines • Support for local production of GMP compliant medicines Vaccine Quality and Safety • Technical assistance to develop National Regulatory Authority for drug and vaccine quality solicited • Capacity building for NRA establishment including development of guidelines • Plan for NRA development to be initiated Herbal and Traditional Medicine • Promotion of rationale use of traditional/herbal medicine • Development and printing of Koryo medicine guidelines including approach to cases, treatment and essential drugs used in Koryo Medicine • Integration of Koryo medicine practices and approached in Household Doctors training package • Designation application for Academy of Koryo Medicine as WHOCC initiated. 2. Scope of work and major results planned for 2010-2011 (by SO component): Blood and Clinical Technologies • Routine QA reporting system established for timely identification of issues from and remedial actions for QC practices at peripheries and the facilities of blood centers upgraded to meet the requirement of QA • Increased in voluntary non remunerated blood donors in the country • Local capacity built up to enable indigenous production of lab reagent (partly related with QA requirement) and wider range of blood component products for safe blood transfusion service • Improved level of role/performance of NCRL in order to fulfill its mandate of supervising and guiding lab practices in clinical settings as per global GLP standard SEA/SPPDM-Meet.2/2.3 Page 400 400 Essential health technologies • Local capacity developed for ensuring radioactive harm reduction at clinical settings where outdated radiological diagnostic devices are in use and strategic plan developed for radiological safety program. Essential Drugs & Medicine • Therapeutically sound use of traditional medicine through capacity building, documentation and research, dissemination and institutional strengthening promoted • National regulatory authorities for effective management and supervision of quality drug and vaccine production strengthened. • National capacities to meet GMP standards enhanced • Improved access to essential drugs and medicines and capacities for rational use of the drugs and medicines strengthened. Vaccine Quality and Safety • Establishment of National Regulatory authority and National reference laboratory • Human resource development per the NRA plan for effective and efficient functioning of the NRA/NRL Herbal and Traditional Medicine • Promotion of Koryo medicine practices including developing, printing and dissemination of guidelines, protocols and IEC materials • Documentation of Koryo medicine practices including development of text and reference books • Capacity building including research to generate evidence and documentation • Advocacy for rationale use of Koryo medicine drugs especially in PHC 3. How the scope and results are related to the Country Cooperation Strategy: • Strategic Priority No. 1 (CCS 2009-2013): Strengthening the health system to further develop capacity for policy, planning, and improve service delivery. SEA/SPPDM-Meet.2/2.3 Page 401 401 4. Budget information for the Strategic Objective (in USD thousands) PB 2008-2009 PB 2010-2011 SO Component AC VC planned VC actual* AC VC Formulation and monitoring of policies regarding essential medicines and blood safety 168 498 0 Quality and safety of essential medicines, technologies, traditional medicines, vaccines and injection practices 109 0 0 Better use of essential medicines and medical technologies through provision of evidence- based, unbiased information 127 486 0 TOTAL 404 984 0 500 600 * Available as of 15 May 2009 * Funds were made available for BCT areas but are shown in SO5 per existing business rule. 5. Possible VC funding through new or continuing projects: • Blood and Clinical technologies: RoK, CERF, SIDA, Global Fund • Essential Drugs and Medicine: AusAid, Global Fund 6. Staff requirements for 2010-2011 (short and long-term): • National Professional Officer • Medical Officer - (shared responsibilities) • Need based Short Term consultancies SEA/SPPDM-Meet.2/2.3 Page 402 402 Country Planning Brief: India (SO-11) 1. Major work of WHO in country during 2008-2009: • Functional capacity of national drug regulatory authority strengthened. • Updating of National Essential Medicines list and development of STGs for promoting rational use of drugs supported. • Trade and health work strengthened with setting up WTO cell in MoHFW. • Development of pharmacovigilance system for ASU drugs supported. • AYUSH treatment guidelines/protocols and databases developed. • Good Collection Practices for Indian medicinal plants developed. • Capacity building of institutions & human resources supported. 2. Scope of work and major results planned for 2010-2011 • Strengthening of drug regulatory mechanism. • Development of national standards and guidelines for medical products and technologies. • Promoting the use of Essential Medicines List and Standard Treatment Guidelines. • Development of reference materials and guidelines/manuals for promoting evidence- based, safe and rational use of AYUSH treatment modalities. • Development of specific capacities in AYUSH institutions and research councils. 3. How the scope and results are related to the Country Cooperation Strategy (CCS) • The proposed work plan and expected results are focused towards promoting accessibility, quality control and appropriate use of medical products & technologies including traditional medicine (AYUSH) as outlined in the CCS. SEA/SPPDM-Meet.2/2.3 Page 403 403 4. Budget information for the Strategic Objective (in USD thousands) PB 2008-2009 PB 2010-2011 SO Component AC VC planned VC actual* AC VC Formulation and monitoring of policies regarding essential medicines and blood safety 249 25 37 350 200 Quality and safety of essential medicines, technologies, traditional medicines, vaccines and injection practices 498 515 303 390 300 Better use of essential medicines and medical technologies through provision of evidence- based, unbiased information 159 195 0 250 700 TOTAL 906 735 340 990 1,200 * Available as of 15 May 2009 5. Possible VC funding through new or continuing projects: 6. Staff requirements for 2010-2011 (short and long-term): • National Professional Officer – Health systems development (shared) • National Professional Officer – Traditional medicine SEA/SPPDM-Meet.2/2.3 Page 404 404 Country Planning Brief: Indonesia (SO-11) 1. Major work of WHO for this SO in country during 2008-2009: Supporting national essential drugs programme • development of technical guidelines to ensure the implementation of quality assurance scheme of medicine and consumable medical devices • strengthening capacities to move the program of rational use of medicine in hospitals as well as in the community • dissemination of updated national EML 2008 and STG for Health Centers • support to develop strategic planning on traditional medicine policy and health supplement (in Indonesia health supplement is differ from herbal medicine) Strengthening safe injection practices • Ensure quality vaccines are used and safe injection practiced • Strengthening Adverse effects following immunization (AEFI) and support National Regulatory Authority (NRA) to support safe injection practices • Capacity building of the national and provincial AEFI committees and conducting safe injection assessment. Blood safety 2. Scope of work and major results planned for 2010-2011 (by SO component): Supporting national essential drugs programme • Support promotion and use of appropriate standards and protocol along with improved management of essential drugs and equipments. • Strengthened capacity of National Drug Regulatory Agency in QSE control of medicine and medical devices including counterfeit and pharmacovigilance system. • Strengthened medicine procurement and supply system for improved availability, accessibility, affordability of essential medicine and equipment in public sector. • Managerial tools updated and continued promotional activities for rational use of medicine, education, community empowerment. • Advocating GGM, a WHO initiative program for maintaining transparency of pharmaceutical system in Indonesia • Facilitated national QC laboratory entering WHO Prequalification program for ATM medicines. • Strengthened capacity on traditional medicine policy formulation and its implementation. • Continued activities of previous Biennium (2008-2009) on developing guidelines and initiate follow up action for implementation. Strengthening safe injection practices • Support NRA and practice of safe injection and sharp waste management SEA/SPPDM-Meet.2/2.3 Page 405 405 • Safe injection practices promoted and effective vaccine store management (EVSM) practiced nationally. Blood safety • The blood safety programme in Indonesia has been weak and a cause of major concern. There was no Blood Transfusion Council, no national blood policy, no FDA regulatory authority for blood safety, and 20% of districts do not have a blood bank. With advocacy efforts spear-headed by the WR, a proposed national blood systems was designed with significant WHO expertise. Hon Minister of Health expressed commitment to the national blood transfusion system proposed. 3. How the scope and results are related to the Country Cooperation Strategy: The broad scope and planned results are inline with CCS 2007-2011 Indonesia as stated in section 6: strategic agenda, strategic direction # 1 which emphasized on “improving management of essential medicine and equipment”. Taking consideration of this strategic action, following sub-strategies has been taken into account, • Improving managing essential medicine and equipment supply in decentralization environment • Dissemination of essential medicine concept and EBM approach in medicine selection • promoting the use of appropriate standards and protocols • (including STG, national EML, hospital formulary) and Community • empowerment on rational use of medicine • ensuring quality safety efficacy, availability, affordability of essential medicines, herbal medicine, consumable medical devices Strengthening safe injection practices • Prevention and control of communicable diseases is one of the six high priority areas identified by the CCS. Technical support and to advocate safe injection practice and sharps waste management will further strengthen the country immunization programme. SEA/SPPDM-Meet.2/2.3 Page 406 406 4. Budget information for the Strategic Objective (in USD thousands) PB 2008-2009 PB 2010-2011 SO Component AC VC planned VC actual* AC VC Formulation and monitoring of policies regarding essential medicines and blood safety 20 780 120 Quality and safety of essential medicines, technologies, traditional medicines, vaccines and injection practices 69 658 125 Better use of essential medicines and medical technologies through provision of evidence- based, unbiased information 41 223 0 TOTAL 130 1,661 245 151 547 * Available as of 15 May 2009 5. Possible VC funding through new or continuing projects: Possible VC funding sources: Global Fund for ATM, other donors (through WHO SEARO and WHO HQ) • Staff requirements for 2010-2011 (short and long-term): (This should include the number of short and long-term staff needed to complete the 2010-2011, not necessarily the existing staff.) • NPO for EDM as long term staff, and short term consultants as required. Strengthening safe injection practices • Funding through WHO SEARO and WHO HQ 6. Staff requirements for 2010-2011 (short and long-term): Strengthening safe injection practices • The activities under SO 11 will be implemented by staff covered under SO 1 and with assistance from WHO SEARO and WHO HQ. SEA/SPPDM-Meet.2/2.3 Page 407 407 Country Planning Brief: Maldives (SO-11) 1. Major work of WHO for this SO in country during 2008-2009: Essential health technologies: • Support provided for the accreditation of Hithadhoo Regional Hospital and IGMH • Laboratory staff trained in quality management and quality assurance • Nationals trained in blood donor recruitment and retention programme • Advocacy meetings held to promote voluntary blood donation Essential medicines: • Nationals trained in Heavy Metal Analysis of Cosmetics and Herbal Drugs • Pharmacy inspectors trained to inspect entry points and drug outlets • Situation analysis of the use of traditional/alternative to be completed by end of 2009 • National Essential Medicine List has been updated Immunization and vaccine development: • Nationals to be trained in immunisation safety and sharp waste management 2. Scope of work and major results planned for 2010-2011 (by SO component): Essential health technologies: • Accreditation (Management and technical) of Central and Regional Hospitals and clinical and health Laboratories • Review/update and implement the National Blood Policy with special emphasis on quality assurance • Enhance capacity of National Health Laboratories and peripheral laboratories • Voluntary blood donation promoted Essential medicines: • To enhance national capacity to address implications of trade related agreements (intellectual property rights and access to medicines; GATTs etc) • Strengthen capacity of Maldives Food and Drug Authority and National Health Laboratory to ensure that all medicines authorized imported, distributed and sold in the Maldives are effective, safe and of good quality and available at affordable cost • Develop National guidelines / regulation for the use of traditional / alternative medicines and establish a mechanism to regulate these products • Develop policy guidance on scientifically sound and cost-effective use of medical products and technologies • Review/update and publish National Essential Medicine List • Establish a system to regulate and monitor medical devices imported and used in Maldives SEA/SPPDM-Meet.2/2.3 Page 408 408 • Compose a Medicine Act and revise/review the current medicine regulation Immunization and vaccine development: • Enhance capacity to ensure immunization safety, vaccine management and sharp waste management 3. How the scope and results are related to the Country Cooperation Strategy: Priority areas: 1 – Strengthening health systems 6 – Food safety 4. Budget information for the Strategic Objective (in USD thousands) PB 2008-2009 PB 2010-2011 SO Component AC VC planned VC actual* AC VC Formulation and monitoring of policies regarding essential medicines and blood safety 38 25 0 Quality and safety of essential medicines, technologies, traditional medicines, vaccines and injection practices 22 60 0 Better use of essential medicines and medical technologies through provision of evidence- based, unbiased information 11 15 0 TOTAL 71 100 0 65 100 * Available as of 15 May 2009 5. Possible VC funding through new or continuing projects: None 6. Staff requirements for 2010-2011 (short and long-term): None SEA/SPPDM-Meet.2/2.3 Page 409 409 Country Planning Brief: Myanmar (SO-11) 1. Major work of WHO for this SO in country during 2008-2009: Essential Medicines and other drugs • Sustained availability of essential medicines and equipment at PHC level supported through capacity building of health personnel (OWER3) • Information on use and availability of essential medicines strengthened and essential drugs list updated and distributed (OWER3) Herbal/Traditional Medicines • Providing technical support to national programme on traditional medicine, through capacity building traditional medicine practitioners and for quality assurance of traditional medicine preparations (OWER2) Vaccine quality and safety • Support to National regulatory authority for maintaining quality control /quality assurance of vaccines to be used in national EPI (OWER2) Health Technology • Improved security of medical supplies enhanced at Central Medical Store Department through capacity building of staff and upgrading of warehouse (OWER 2) • Institutional capacity enhanced to strengthen pharmaceutical administration and technical skills to assessing the quality of drugs, cosmetics and medical devices.(OWER2) • Enhancing production of high quality biologicals for anti snake venom from Myanmar Pharmaceuticals Factory to meet the partial requirements of the country (OWER 2) Blood Safety (OWER1) • Support the National Health Laboratory and the National Blood Bank in strengthening blood safety policies and building capacity of laboratory technicians involved in blood banking technology (OWER1) • Support to the completion and approval of the National Blood Policy (OWER1) 2. Scope of work and major results planned for 2010-2011 (by SO component): Essential Medicines and other drugs • Formulation and monitoring of comprehensive national policies on access, quality and use of essential medical products and technologies advocated and supported (OWER 3). Herbal/Traditional Medicines • To further strengthen the traditional medicine programme through capacity building, quality assurance and research studies on traditional medicine formulation and herbal plants (OWER2) SEA/SPPDM-Meet.2/2.3 Page 410 410 Vaccine quality and safety • To continue technical and funding support to NRA for quality assurance of traditional as well as new vaccines use in the country(OWER2) Health Technology • Support and advocate the promotion of International norms standards and guidelines for the quality safely, efficacy and cost- effective use of medical products and technologies by health workers and consumers (OWER2) • Improved security and management of medical supplies enhanced (OWER 3) • Enhancing production of high quality biologicals for anti snake venom from Myanmar Pharmaceuticals Factory to meet the partial requirements of the country (OWER 2) Blood Safety • Nationally coordinated blood transfusion services strengthened (OWER 1) 3. How the scope and results are related to the Country Cooperation Strategy: • As a priority in the CCS, improvement of the health system performance must include support for ensuring the quality safety, efficacy and cost- effective use of medical products and technologies delivered through a correctly managed logistics system • Support to the traditional medicine programme will improve health care services of which it is an integral part. • One of the priorities in the CCS, improved health conditions for children can be assured in part through assuring standard quality of vaccine used in EPI. • Adequate blood banking services are essential for the control of transmission of blood borne infections including HIV and hepatitis viruses. In this regard it contributes to the control of communicable diseases which is one of the priorities of the CCS. SEA/SPPDM-Meet.2/2.3 Page 411 411 4. Budget information for the Strategic Objective by component (in USD thousands) PB 2008-2009 PB 2010-2011 SO Component AC VC planned VC actual* AC VC Formulation and monitoring of policies regarding essential medicines and blood safety 40 43 22 26 446 Quality and safety of essential medicines, technologies, traditional medicines, vaccines and injection practices 279 76 0 172 97 Better use of essential medicines and medical technologies through provision of evidence- based, unbiased information 197 27 0 166 57 TOTAL 516 146 22 364 600 * Available as of 15 May 2009 5. Possible VC funding through new or continuing projects: • Not yet possible to estimate contributions through WHO 6. Staff requirements for 2010-2011 (short and long-term): • Special Service Agreement – Essential medicines • Other staff requirements covered under other SOs SEA/SPPDM-Meet.2/2.3 Page 412 412 Country Planning Brief: Nepal (SO-11) 1. Major work of WHO for this SO in country during 2008-2009: • National standard and guideline have been revised, developed and implemented for the quality, safety, efficacy and cost effective use of medical products and technologies including traditional medicine. • Quality assurance system to ensure the quality care has been supported through implementation of National standards and rational use of medicines has been promoted. • Logistic and operational support for NEQAS blood blank networking has been done. • Regional blood banks will be assessed and equipments will be procured. 2. Scope of work and major results planned for 2010-2011 (by SO component): • To support assessment of current national policies for implementation and monitoring on access, quality and use of essential medical products and technologies including traditional medicine • To provide technical support for policies and other initiatives ensuring quality and safety of blood and blood products • To provide assistance for the development and implementation of national standards and guidelines in improving quality, safety, efficacy and cost-effective use of medical products and technologies • To provide assistance in implementation of policies and strategies on traditional medicines. • To support implementation of strategies on rational use of medical products and technologies by various stakeholders • Assessment of blood transfusion services, development of SOPs and capacity building on Blood transfusion services. • Support on monitoring of waste management in blood transfusion services and establishment of blood data management in line with HMIS. • Support on quality assurance in laboratory practices of blood transfusion services 3. How the scope and results are related to the Country Cooperation Strategy: • To support revision, development and implementation of National Standard and Guideline for the quality, safety, efficacy and cost effective use of medical products and technologies. • To support the development of systems that integrates essential drug supplies into the essential health care services. • To support the strengthening of Quality Assurance system and promotion of rational use of medicines. • The work to be completed in the prospective work-plan is in accord with strategic approaches that stratify over WHO strategy of strengthening the health. At present blood transfusion services is provided by the Nepal Red Cross Society. • Support for the on-going process of health services decentralization from enhancing capacity of district. • Support equity in health and increased access to services through partnerships, key stakeholders coordination and integrated policy approach. SEA/SPPDM-Meet.2/2.3 Page 413 413 4. Budget information for the Strategic Objective (in USD thousands) PB 2008-2009 PB 2010-2011 SO Component AC VC planned VC actual* AC VC Formulation and monitoring of policies regarding essential medicines and blood safety 27 0 0 Quality and safety of essential medicines, technologies, traditional medicines, vaccines and injection practices 146 135 0 Better use of essential medicines and medical technologies through provision of evidence- based, unbiased information 21 16 0 TOTAL 194 151 0 196 150 * Available as of 15 May 2009 5. Possible VC funding through new or continuing projects: Nepal Red Cross Society (in the area of blood safety) 6. Staff requirements for 2010-2011 (short and long-term): None SEA/SPPDM-Meet.2/2.3 Page 414 414 Country Planning Brief: Sri Lanka (SO-11) 1. Major work of WHO for this SO in country during 2008-2009: Essential Medicines: • Draft Act prepared for the implementation of the National Medicinal Drug Policy based on the Essential medicines concept to improve access to medicines. . • List of Essential Medicines updated in support of rational use of medicines • Guidelines and other tools developed for rational use and cost-effective use of medicines and medical devices. • Technical support provided to strengthened drug regulatory, drug quality assurance and drug supply systems. Blood safety: • National Blood Policy developed to improve access to safe blood. • Blood Transfusion Service staff trained on new techniques in blood group serology • A National External Quality Assessment Scheme established for transfusion transmissible infections and blood group serology Medical technologies • Capacity building of laboratory personnel in central and provincial levels. 2. Scope of work and major results planned for 2010-2011 (by SO component): • Major activities will focus on formulation and implementation of national policies and guidelines to improve access and cost-effective use of medical products and technologies 3. How the scope and results are related to the Country Cooperation Strategy: • Implementation of the National Medicinal Drug Policy has been included under the CCS strategic area Health System. However, Essential Medical Products and Technologies is relevant to all 6 priority areas of the CCS. SEA/SPPDM-Meet.2/2.3 Page 415 415 4. Budget information for the Strategic Objective (in USD thousands) PB 2008-2009 PB 2010-2011 SO Component AC VC planned VC actual* AC VC Formulation and monitoring of policies regarding essential medicines and blood safety 86 134 0 123 150 Quality and safety of essential medicines, technologies, traditional medicines, vaccines and injection practices 36 143 0 7 23 Better use of essential medicines and medical technologies through provision of evidence- based, unbiased information 39 143 0 10 75 TOTAL 161 420 0 140 248 * Available as of 15 May 2009 5. Possible VC funding through new or continuing projects: GAVI funding 6. Staff requirements for 2010-2011 (short and long-term): Short-term staff - 01 (VC funds) SEA/SPPDM-Meet.2/2.3 Page 416 416 Country Planning Brief: Thailand (SO-11) 1. Major work of WHO for this SO in country during 2008-2009 National Drug Policy and Policy on Medical Equipment • The situation analysis towards the roadmap to tackle counterfeit medicine issues • Strengthening the drug re-evaluation system in Thailand • Development of Medical Device Code System for Medical Devices Management in Government Healthcare Sector • Development of the national protocol for appropriate adoption of new vaccines(s) (e.g. HPV vaccine) for prevention and control of cervical cancer in Thailand • Development Patient’s registration system for Implantable Medical Device: A Pilot project for electronic registration upon the new Medical Device Act 2008 Appropriate use of Traditional Medicine • Development of "Guideline on Efficacy and Safety Evaluation of Medicinal Plants and Herbal Medicine" • Development of "Guideline on the appropriate use of medicinal plants in the primary health care for the public" Vaccine Development • Dengue Candidate Viruses: Master Seed Lot Preparation in Vero cell Development of essential health technology based on evidence-based criteria. • The role of health technology assessment evidence in decision making: the case of Human Papilloma Virus vaccination policy in Thailand 2. Scope of work and major results planned for 2010-2011 • National Drug Policy and Policy on Medical Equipment. • Implications of Intellectual property rights on access to medicines. • Appropriate use of Traditional Medicine. • Vaccine Development. • Safe injection practices and waste management promoted • Development of essential health technology based on evidence-based criteria. 3. How the scope and results are related to the Country Cooperation Strategy: • The scope and results stated in 2. respond to the CCS 2008-2011 (Thailand): • ‘(4) Strengthening capacity for monitoring and evaluating, and for health system development • (7) Strengthening the development of human resources for health through existing networks within and outside the country’ SEA/SPPDM-Meet.2/2.3 Page 417 417 4. Budget information for the strategic objective PB 2008-2009 PB 2010-2011 SO Component AC VC planned VC actual* AC VC Formulation and monitoring of policies regarding essential medicines and blood safety 18 20 0 20 20 Quality and safety of essential medicines, technologies, traditional medicines, vaccines and injection practices 62 248 20 50 200 Better use of essential medicines and medical technologies through provision of evidence- based, unbiased information 30 80 0 30 50 TOTAL 110 348 20 100 270 * Available as of 15 May 2009 5. Possible VC funding through new or continuing projects. 6. Staff requirements for 2010-2011 None. SEA/SPPDM-Meet.2/2.3 Page 418 418 Country Planning Brief: Timor Leste (SO-11) 1. Major work of WHO for this SO in country during 2008-2009: Essential Medicines and other drugs: • The formulation of Standard Treatment Guidelines is under process with close collaboration with the pharmacy department of the Ministry of Health and the Central Pharmacy (SAMES). Health technology • A major purchase of laboratory equipment and supplies has been completed and technical assistance to the National laboratory for training has been provided. • Measles-Rubella laboratory training was conducted in National Health Laboratory in April 2008 and Measles-Rubella laboratory network is established. The staffs trained are competent to carry out Measles-Rubella testing in the country with close collaboration with the Surveillance unit in the Ministry of Health. • Japanese Encephalitis laboratory training was held in National Health Laboratory in November 2008. The staffs training are competent to conduct Japanese Encephalitis testing in the country with close collaboration with Surveillance unit and Communicable Diseases Control Department in the Ministry of Health. • Laboratory equipments such as biosafety cabinets, freezers, etc., consumables and diagnostic kits have been continuously supported to the National Health Laboratory and the Hospitals’ Laboratory throughout the country to facilitate laboratory testing. • Two Laboratory staff were orientated and trained for sample collection for suspected avian flu cases. • Two laboratory staffs were sent for IATA training in Darwin-Australia to facilitate the transportation of laboratory specimen to reference laboratories. • One laboratory staff was sent for morphology training in New-Zealand for better diagnosing of blood disorder. • The internal quality assurance was set up in the national health laboratory with continue support to improve the external quality control & quality assurance in all department. • Continue to support to improve the good laboratory practice (GLP) in the National Laboratory by updating the Standard Operating Procedures (SOPs) and guidelines and log books and rearrangement of the Storage. • Malaria External competency assessment was carried out in October 2008 with collaboration with the Asian Collaboration Training Network (ACT) for Malaria, the National Health laboratory and the Ministry of Health. 12 laboratory technicians throughout the countries were assessed for malaria microscopy. • Malaria microscopy refresher training was conducted in December 2008 with collaboration with the National Health laboratory and the Malaria unit of the Ministry of Health. Around 25 newly graduated Laboratory Technician were retrained SEA/SPPDM-Meet.2/2.3 Page 419 419 Blood Safety • Laboratory equipments and supplies of blood grouping kits and diagnostic kits have been continuously supported to the National Blood Transfusions Services throughout the country. • Promotional activities to communities and government and staff of development partners during the World Blood Bank Day on 15th June 2008. 2. Scope of work and major results planned for 2010-2011 (by SO component): • Quality assurance in the National Laboratory, Central Blood Bank, Pharmacy and district and sub-district laboratory network strengthened. • Procurement and management f drugs, vaccines and supplies by MoH and SAMES (Central Pharmacy) strengthened 3. How the scope and results are related to the Country Cooperation Strategy: • In the TLS CCS, Medical Products and technologies are included in Strategy Priority 1 (Health Policy and System) in the “Other Focus on Health System Issues” which includes Essential Medicines and drug supply and management and Strategy Priority 2 (Disease Prevention and Control under “Other Focus” which also include Health Laboratories. 4. Budget information for the Strategic Objective (in USD thousands) PB 2008-2009 PB 2010-2011 SO Component AC VC planned VC actual* AC VC Formulation and monitoring of policies regarding essential medicines and blood safety 13 60 0 30 175 Quality and safety of essential medicines, technologies, traditional medicines, vaccines and injection practices 0 0 0 20 150 Better use of essential medicines and medical technologies through provision of evidence- based, unbiased information 30 12 0 0 0 TOTAL 43 72 0 50 325 * Available as of 15 May 2009 5. Possible VC funding through new or continuing projects: • Funding will be received through the GFATM and GAVI (shared USD 200,000 per year for 5 year period: used for SO1, SO 10 and SO11). 6. Staff requirements for 2010-2011 (short and long-term): • Non-core staff: One 24 person month National Officer for Laboratory support.