Bhutan medical products profile 2019

OVERALL SPENDING ON HEALTH Current per capita spending on health care (current US$) 4 Share of government vs out-of-pocket spending on health 4 SPENDING ON MEDICINES Spending on medicines as share of total health-care cost 5 Share of public and out-of-pocket spending on medicines 5 COUNTRY AT A GLANCE 763 Population (in 000s)1 70.6 Life expectancy at birth (in years)2 3360.3 GDP (per capita in current US$)3 Bhutan medical products profile 2019 $91 100 90 80 70 60 50 40 30 20 10 0 2006 2008 2010 2012 2014 2016 C u rr en t U S$ 20% 80% 0 10 20 30 40 50 60 70 80 90 100 2006 2008 2010 2012 2014 2016 Pe rc en ta ge ( % ) MEDICAL AND PHARMACY WORKFORCE 3.7 Medical doctors/10 000 population6A 0.46 Pharmacists/10 000 population6B No Pharmacy education accreditation6C No Continuing professional development for pharmacists6C 0 20 40 60 80 100 Pe rc en ta ge ( % ) 9.7% 2005 2008 2011 2014 67% 33% 0 20 40 60 80 100 2005 2007 2009 2011 2013 sh ar e as p er ce nt ag e % Medical products profile 2019 Bhutan KEY MEDICINES POLICIES AND GUIDANCE Key pharmaceutical legislation11 National Medicine Policy12 National Essential Medicines List13 National Standard Treatment Guidelines14 1. Medicines Act of the Kingdom of Bhutan, 2003; 2. Bhutan Medicines Rules and Regulations, 2012; 3. Blood and Blood Products Regulation, 2016 National Medicine Policy 2007 National List of Essential Medicines-2016 National Standard Treatment Guidelines 2014, distributed to all district facilities INTELLECTUAL PROPERTY RELATED POLICIES & PRODUCTION Number of local pharmaceutical manufacturers 15,A Least developed country status since16 Member of World Trade Organization since 17 TRIPS flexibilities used 18 2 1971 No Not applicable ACCESS TO MEDICINES Tuberculosis treatment coverage 7,8 Diphtheria-tetanus-pertussis (DTP3) and hepatitis B3 immunization coverage 9 Gaps in diagnosis and management of hypertension and diabetes10 Levels of consumption of narcotic drugs 0 20 40 60 80 100 2008 2010 2012 2014 2016 2018 Pe rc en ta ge ( % ) 80% 0 20 40 60 80 100 98% 98% 2007 2010 2014 2017 Pe rc en ta g e (% ) HIV/AIDS data insufficient 0% 20% 40% 60% 80% 100% Male Female Male Female Hypertension Diabetes Treated and controlled Treated but uncontrolled Diagnosed but untreated Undiagnosed 0 300 600 900 1200 1500 1800 2008 2010 2012 2014 2016 S- D D D /m ill io n/ da y# Total Methadone Total methadone* Morphine #S-DDD; Statistical defined daily dose/million/day; *Total minus methadone shows usage mainly for palliative care, because it excludes methadone treatment for drug dependency. Data from STEPwise approach to surveillance (STEPS) or equivalent population surveys Medical products profile 2019 Bhutan Market Authorization/ Licensing/Quality Assurance Patient Medicine Medicine Selection Medicine Procurement Pricing and Reimbursement Distribution National regulatory authority: Drug Regulatory Authority of Bhutan www.dra.gov.bt Regulated products19: Medicines: YES Vaccines YES Medical devices: NO Traditional medicines: YES Medicine quality control laboratory20: Drug testing Laboratory, Royal Centre for Disease Control, Ministry of Health, Bhutan and other testing laboratory outside Bhutan based on contract service agreement. ISO 17025 certified: NO WHO prequalified: NO Number of registered medicines21: allopathic-1450 & traditional medicinal products-77 Agency responsible for selection: Essential Medicines & Technology Division, Department of Medical Services, Ministry of Health Number of products on essential medicines list13: By active ingredient: 332 By dosage form: 429 Traditional medicines products included in essential medicines list: YES Medicines availability is indicated by health facility level: YES Number of products in national formulary : 429 Public sector Agency responsible for public procurement14: Medical Supplies Procurement Division under Department of Medical Supplies and Health Infrastructure (DMSHI), Ministry of Health Procurement done at Central State Facility Commonly used procurement methods: International tendering Public sector Agency responsible for distribution: Medical stores and distribution division under department of medical supplies & health infrastructure23 Public sector facilities23: Hospitals: 31 Basic health unit (BHU)-I: 23 BHU-II: 184 Sub-Post: 28 Public sector Price control22 : NO Health insurance reimbursement price: No health insurance scheme Patient prices for essential medicines in public sector: Free medicines: YES Private sector19 Number of wholesalers: 27 Private sector Number of retail outlets19: 54 Licensed retail pharmacies per 10 000 population19,B: 0.69 Number of traditional medicines outlets14: 1 Private sector Agency responsible for price control19: Drug Regulatory Authority Pricing mechanism14: Price structure to be submitted at the time of registration of product. Manufacturer Wholesale Retailer Mark-ups regulated: YES Fixed or regressive14: Fixed Maximum Retail Price (MRP), which is the same MRP as in India Pharmaceutical system flowchart Medical products profile 2019 Bhutan References 1. United Nations, Department of Economic and Social Affairs, Population Division. World Population Prospects 2019. https://population.un.org/wpp/Download/Standard/Population/- accessed 28th June 2019. 2. World Health Organization. Global Health Observatory (GHO) data: life expectancy. Geneva. http://apps.who.int/ gho/data/view.main.SDG2016LEXv?lang=en - accessed 10th May 2019. 3. The World Bank. World development indicators 2016. Washington DC. http://databank.worldbank.org/data/reports. aspx?source=world-development-indicators- accessed on 10th May 2019. 4. World Health Organization. Global Health Expenditure Database (GHED): total health expenditure. Geneva. http:// apps.who.int/nha/database/Select/Indicators/en- accessed on 10th may 2019. 5. World Health Organization. National Health Accounts, Bhutan. World Health Organization. Geneva. Internal communication, April 2017. 6. A. Global Health Observatory data repository. Health Workforce. Medical Doctors. http://apps.who.int/gho/data/ view.main.HWFMEDv - accessed on 28th June 2019. B. Global Health Observatory data repository. Health Workforce. Pharmaceutical personnel. http://apps.who.int/ gho/data/view.main.HWFPHAv - accessed on 28th June 2019. C. Decade for health workforce strengthening in the South-East Asia Region 2015–2024. Second review of progress, 2018. 1-52. https://apps.who.int/iris/bitstream/handle/10665/274310/9789290226574-eng. pdf?sequence=1&isAllowed=y - accessed on 28th June 2019 7. World Health Organization. World malaria reports. Geneva. https://www.who.int/malaria/publications/world- malaria-report-2018/en/- accessed on 10th May 2019. 8. World Health Organization. Global Health Observatory (GHO) data. Geneva. http://apps.who.int/gho/data/view.main. UHCTBTREATMENTv- accessed on 10th May 2019- effect coverage/ % coverage data ? 9. WHO vaccine-preventable diseases: monitoring system. 2018 global summary. http://apps.who.int/immunization_ monitoring/globalsummary- accessed on 10th May 2019. 10. World Health Organization, Regional Office for South-East Asia. National survey for NCD risk factors and mental health using WHO STEPS approach in Bhutan 2014. New Delhi, 2015. https://apps.who.int/iris/bitstream/ handle/10665/204659/9789290225003.pdf?sequence=5&isAllowed=y- accessed on 10th May 2019. 11. Drug Regulatory Authority, Bhutan. Bhutan: DRA. http://dra.gov.bt/dra-guidelines-and-regulations/ - accessed 27 May 2017. 12. World Health Organization, Regional Office for South-East Asia. National medicine Policies for SEA Region. New Delhi. http://www.searo.who.int/entity/medicines/national_medicines_policy/en/ - accessed 10th May 2019. 13. Ministry of Health, Bhutan. National list of essential medicines 2018. http://www.health.gov.bt/wp-content/ uploads/afd-files/2019/02/National-Essential-Medicines-List-2018.pdf - indicator to be upodate to 2018. 14. World Health Organization, Regional Office for South-East Asia. Medicines in health care delivery- Bhutan. New Delhi, 2015. http://www.searo.who.int/entity/medicines/bhutan_situational_analysis_oct15.pdf?ua=1-accessed 10th May 2019. 15. Data as reported by Drug Regulatory Authority, Bhutan, June 2019. 16. United Nations, Department of Economics and Social Affairs, Development Policy and Analysis Division. LDC list. 2016. https://www.un.org/development/desa/dpad/wp-content/uploads/sites/45/publication/ldc_list.pdf- accessed 10th May 2019. 17. World Trade Organization (WTO). Members and Observers. World Trade Organization. Geneva. 2016. https://www. wto.org/english/thewto_e/whatis_e/tif_e/org6_e.htm - accessed on 10th May 2019. 18. World Intellectual Property Organization. Statistical Country profiles. World Intellectual Property Organization. Geneva. http://www.wipo.int/ipstats/en/statistics/country_profile/ –accessed 21 June 2017. 19. Drug Regulatory Authority, Bhutan. Bhutan: DRA. http://dra.gov.bt/ - accessed 27 May 2017. 20. Ministry of Health, Bhutan, Department of Public Health. Royal Centre for Disease Control. http://www.rcdc.gov.bt/ web/laboratory-service/ - accessed 12 May 2017. 21. Drug Regulatory Authority, Bhutan. Bhutan: DRA. https://docs.google.com/spreadsheets/d/19VlUmo4ZeFdixpP2HvM pvQRBXfzSV2L55GKL4Lzw8oA/edit#gid=0 – accessed 27 May 2017. 22. IDRG consultancy. Detailed feasibility report on hospital Supplies. Bhutan, 2009. https://www.moea.gov.bt/wp- content/uploads/2017/10/HOSPITAL-PART-1.pdf -accesed on 10th May 2019. 23. Ministry of Health, Bhutan. Health management and information system, policy and planning division: Annual Health Bulletin - 2016. Thimpu, 2016. http://www.health.gov.bt/wp-content/uploads/ftps/annual-health-bulletins/ Annual%20Health%20Bulletin-2017.pdf - accessed on 10th May 2019. 24. International Narcotics Control Board. Narcotic Drugs-Technical Report. http://www.incb.org/incb/en/narcotic-drugs/ Technical_Reports/narcotic_drugs_reports.html - accessed on 23rd May 2019. Notes: A. One Herbal and one Active Pharmaceutical Ingredient manufacturer. B. 54 pharmacies spread across the country. Medical products profile 2019 Bhutan