OVERALL SPENDING ON HEALTH
Current per capita spending on health care
(current US$)
4Share of government vs out-of-pocket spending on health
4SPENDING ON MEDICINES
Spending on medicines as share of
total health-care cost
5Share of public and out-of-pocket spending on medicines
5COUNTRY AT A GLANCE
Population 763
(in 000s)
170.6 Life expectancy at birth (in years)2
3360.3
GDP
(per capita in current US$)
3Bhutan medical products profile 2019
100 $91 90 80 70 60 50 40 30 20 10
0 2006 2008 2010 2012 2014 2016
Current US$
20%
80%
0 10 20 30 40 50 60 70 80 90 100
2006 2008 2010 2012 2014 2016
Percentage (%)
MEDICAL AND PHARMACY WORKFORCE
3.7
Medical doctors/10 000 population
6A0.46
Pharmacists/10 000 population
6BNo
Pharmacy education accreditation
6CNo
Continuing professional development for pharmacists
6C0 20 40 60 80 100
Percentage (%)
9.7%
2005 2008 2011 2014
67%
33%
0 20 40 60 80 100
2005 2007 2009 2011 2013
share as percentage %
Medical products profile 2019 Bhutan
KEY MEDICINES POLICIES AND GUIDANCE
Key pharmaceutical
legislation
11National Medicine
Policy
12National Essential
Medicines List
13National Standard Treatment Guidelines
141. 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,ALeast developed country
status since
16Member of World Trade Organization
since
17TRIPS flexibilities
used
182 1971 No Not applicable
ACCESS TO MEDICINES
Tuberculosis treatment coverage 7,8
Diphtheria-tetanus-pertussis (DTP3) and hepatitis B3 immunization coverage
9Gaps in diagnosis and management of
hypertension and diabetes
10Levels of consumption of narcotic drugs
0 20 40 60 80 100
2008 2010 2012 2014 2016 2018
Percentage (%)
80%
0 20 40 60 80
100 98% 98%
2007 2010 2014 2017
Percentage (%)
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-DDD/million/day#
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
N ational regulatory authority: Drug Regulatory Authority of Bhutan www.dra.gov.bt Regulated products
19:
Medicines: YES Vaccines YES Medical devices: NO Traditional medicines: YES Medicine quality control laboratory
20: 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 medicines
21: 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 list
13:
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 procurement
14: 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 infrastructure
23Public sector facilities
23:
Hospitals: 31
Basic health unit (BHU)-I: 23 BHU-II: 184
Sub-Post: 28
Public sector Price control
22: NO
Health insurance reimbursement price: No health insurance scheme
Patient prices for essential medicines in public sector:
Free medicines: YES
Private sector
19Number of wholesalers: 27
Private sector Number of retail outlets
19: 54 Licensed retail pharmacies
per 10 000 population
19,B: 0.69
Number of traditional medicines outlets
14: 1 Private sector
Agency responsible for price control
19: Drug Regulatory Authority
Pricing mechanism
14: Price structure to be submitted at the time of registration of product.
Manufacturer Wholesale Retailer Mark-ups regulated: YES
Fixed or regressive
14: 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
