Bhutan pharmaceutical profile 2017

OVERALL SPENDING ON HEALTH Total per capita spending on health care (current US$) 4 Total per capita spending medicines (current US$) 5 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 0 20 40 60 80 100 2005 2007 2009 2011 2013 Pe rc en ta ge ( % ) 9.7% COUNTRY AT A GLANCE 775 Population (in 000s)1 69.8 Life expectancy at birth (in years)2 2656 GDP (per capita in current US$)3 Bhutan pharmaceutical profile 2017 MEDICAL AND PHARMACY WORKFORCE 3.7 Medical practitioners/10 000 population6 No data Pharmacists & pharmacy technicians/10 000 population 0.3 Registered pharmacists/10 000 population6 $ 89 $ 9 0 25 50 75 100 125 2005 2008 2011 2014 cu rr en t U S $ 25% 75% 0 25 50 75 100 2005 2008 2011 2014 Pe rc en ta ge % 67% 33% 0 20 40 60 80 100 2005 2007 2009 2011 2013 sh ar e as p er ce nt ag e % Bhutan pharmaceutical profile 2017 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 Malaria and Tuberculosis treatment coverage 7,8 Diphtheria-tetanus-pertussis (DTP3) and Hepatitis B3 immunization coverage 9 Hypertension and Diabetes Mellitus treatment coverage 10 Access to palliative care: Opioid consumption in Morphine Equivalence (ME) minus Methadone No data available 80% 100% 0 25 50 75 100 125 150 2005 2007 2009 2011 2013 2015 Pe rc en ta ge ( % ) 99% 99% 0 25 50 75 100 2005 2010 2015 Pe rc en ta ge c ov er ag e (% ) Data for age group 18-69 years HIV/AIDS data insufficient 0 20 40 60 80 35.7% 6.4% 100 People with raised Blood Pressure (SBP ≥140 and/or DBP ≥90 mmHg and/or taking medication People with raised fasting blood glucose (plasma venous value ≥126 mg/dl or currently on medication for raised blood glucose) Pe rc en ta g e (% ) Morphine Equivalence minus methadone represents country capacity to deliver palliative care, because it excludes treatment for drug dependency Bhutan pharmaceutical profile 2017 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 Bhutan pharmaceutical profile 2017 References 1. United Nations, Department of Economic and Social Affairs, Population Division. World Population Prospects, the 2015 revision. New York, 2015. https://esa.un.org/unpd/wpp/ - accessed 12 May 2017. 2. World Health Organization. Global Health Observatory (GHO) data: life expectancy. Geneva. http://www.who.int/ gho/ mortality_burden_disease/life_tables/en/- accessed 12 May 2017. 3. The World Bank. World development indicators 2016. Washington DC. http://databank.worldbank.org/data/reports. aspx?source=world-development-indicators- accessed 12 May 2017. 4. World Health Organization. Global Health Expenditure Database (GHED): total health expenditure. Geneva. http:// apps.who. int/nha/database/Select/Indicators/en- accessed 12 May 2017. 5. World Health Organization. National Health Accounts, Bhutan. World Health Organization. Geneva. Internal communication, April 2017. 6. Data taken from SEAR health workforce survey April 2016. 7. World Health Organization. World malaria reports. Geneva. http://www.who.int/malaria/publications/world_ malaria_report/ en/ - accessed 12 May 2017. 8. World Health Organization. Global Health Observatory (GHO) data. Geneva. http://apps.who.int/gho/data/view. main.57060ALL?lang=en - accessed 12 May 2017. 9. World Health Organization. WHO/UNICEF estimates of national immunization coverage: Geneva. http://apps.who. int/ immunization_monitoring/globalsummary - accessed 12 May 2017. 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. http://www.who.int/chp/steps/Bhutan_2014_ STEPS_Report. pdf?ua=1–accessed 12 May 2017. 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 27 May 2017. 13. Ministry of Health, Bhutan. National list of essential medicines 2016. Thimpu. 2016. http://www.health.gov.bt/wp- content/ uploads/moh-files/2016/08/National-Essential-Medicines-List-2016.pdf - accessed 27 May 2017. 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 27 May 2017. 15. Data as reported by Drug Regulatory Authority, Bhutan, June 2017. 16. United Nations, Department of Economics and Social Affairs, Development Policy and Analysis Division. LDC list. 2016. http:// www.un.org/en/development/desa/policy/cdp/ldc/ldc_list.pdf - accessed 12 May 2017. 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 21 June 2017. 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. http://www.moea.gov.bt/ documents/files/ pub8yw8703ei.pdf - accessed 12 May 2017. 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%20 Bulletin-2016.pdf-accessed 12 May 2017. Notes: A. One Herbal and one Active Pharmaceutical Ingredient manufacturer. B. 54 pharmacies spread across the country.