Maldives 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 COUNTRY AT A GLANCE 364 Population (in 000s)1 78.5 Life expectancy at birth (in years)2 8396 GDP (per capita in current US$)3 Maldives pharmaceutical profile 2017 MEDICAL AND PHARMACY WORKFORCE 25.8 Medical practitioners/10 000 population6 5.3 Pharmacists & pharmacy technicians/10 000 population6 5.5 Registered pharmacists/10 000 population6 $101 $ 1 165 0 150 300 450 600 750 900 1050 1200 2005 2008 2011 2014 C ur re nt U S$ 18% 82% 0 10 20 30 40 50 60 70 80 90 100 2005 2008 2011 2014 Pe rc en ta ge (% ) Pe rc en ta ge ( % ) 9.7% 0 20 40 60 80 100 2005 2008 2011 2014 48% 52% 0 20 40 60 80 100 2005 2008 2011 2014 sh ar e as p er ce nt ag e (% ) Maldives pharmaceutical profile 2017 KEY MEDICINES POLICIES AND GUIDANCE Key Pharmaceutical Legislation11 National Medicine Policy12,A National Essential Medicines List11 National Standard Treatment Guidelines13 1. Medicines Act – 1994 2. Medicine Regulation (R-46) in force since, 2015 National Medicine Policy – 2007 Essential Medicines List – 2016 Individual disease guidelines exist INTELLECTUAL PROPERTY RELATED POLICIES & PRODUCTION Number of Local pharmaceutical manufacturers13 Least Developed country14 Member of World Trade Organization since15 TRIPS flexibilities used16 0 No 1995 Not applicable ACCESS TO MEDICINES Tuberculosis treatment coverage 7 Diphtheria-tetanus-pertussis (DTP3) and Hepatitis B3 immunization coverage 8 Hypertension treatment coverage 9 Access to palliative care: Opioid consumption in Morphine Equivalence (ME) minus Methadone 10 *Data for Diabetes Mellitus treatment insufficient to analyse Data for age group 15-64 years HIV/AIDS data insufficient for analysis 80% 0 10 20 30 40 50 60 70 80 90 100 2005 2010 2015 Pe rc en ta ge (% ) 99% 99% 0 20 40 60 80 100 2005 2010 2015 Pe rc en ta ge (% ) 0.32 0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1 1999 2004 2009 2014 m g pe r pe rs on Pe rc en ta g e (% ) 16.6% 0 20 40 60 80 100 % of respondents (both sexes) currently taking blood pressure drugs prescribed by doctor or health worker, among those diagnosed with hypertension Morphine Equivalence minus methadone represents country capacity to deliver palliative care, because it excludes treatment for drug dependency Maldives pharmaceutical profile 2017 Market Authorization/ Licensing/Quality Assurance Medicine Patient Medicine Selection Medicine Procurement Pricing and Reimbursement Distribution National Regulatory Authority17: Maldives Food and Drug Authority (MFDA) http://www.mfda.gov.mv Regulated products: Medicines13: YES Vaccines13: YES Medical devices: NA Traditional medicines13: YES Medicine Quality Control Laboratory13: National Health Laboratory. ISO 17025 certified: NA WHO prequalified13: NO Number of registered medicines18: 3818 Agency responsible for selection11: Maldives Food and Drug Authority Number of products on essential medicines list: By active ingredient13,B: 326 By dosage form13,B: 510 Traditional medicines products included in essential medicines list: NA Medicines availability is indicated by health facility level13: YES National Formulary13,C : No national formulary manual Public sector Agency responsible for public procurement11,D: State Trading Oganization (STO) Procurement done at Central13,E State Facility Commonly used procurement methods11: Purchasing directly from manufactures and from third parties for importing medicines Public sector Agency responsible for distribution13: Health Supply Unit, Administration Division Public sector facilities19: Tertiary hospital: 1 Regional hospitals: 6 Atoll hospitals: 13 Health-care centres: 132 Health aid posts: 108 Public sector Price control13: NO Health insurance reimbursement Price13: Public health insurance (Asandha Insurance system ) covers the entire population Patient prices for essential medicines in public sector: Free medicines13: NO Fixed price13: YES Private sector Number of wholesalers13: 15 Private sector Number of retail outlets20 : 197 Licensed retail pharmacies per 10 000 population13: 5.6 Number of traditional medicines outlets: Not available Private sector Agency responsible for price control13: MFDA and Ministry of Economic Affairs Pricing mechanism11,F: Under review Manufacturer Wholesale Retailer Mark-ups regulated: Under review Fixed or regressive: Under review Pharmaceutical system flowchart Maldives 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, Maldives. World Health Organization. Geneva. Internal communication, April 2017. 6. Data taken from SEAR health workforce survey April 2016. 7. World Health Organization. Global Health Observatory (GHO) data. Geneva. http://apps.who.int/gho/data/view. main.57060ALL?lang=en -accessed 12 May 2017. 8. World Health Organization. WHO/UNICEF estimates of national immunization coverage. Geneva. http://apps.who. int/ immunization_monitoring/globalsummary -accessed 12 May 2017. 9. World Health Organization, Regional Office for South-East Asia. WHO STEPS survey on risk factors for non-communicable diseases Maldives 2011. New Delhi, 2014. http://www.who.int/chp/steps/ MaldivesSTEPSReport2011.pdf?ua=1 - accessed 12 May 2017. 10. Pain & Policy Studies Group. Country Profiles: Opioid consumption in Morphine Equivalence (ME) minus Methadone. University of Wisconsin, USA. 2015. http://www.painpolicy.wisc.edu/countryprofiles -accessed 12 may 2017. 11. As reported by Ministry of Health, Republic of Maldives, June 2017. 12. Ministry of Health, Republic of Maldives. National Medicine Policy 2007. Ministry of Health, Maldives. 2007. Male. http://www. searo.who.int/entity/medicines/nmp_mav_2007_who_ok.pdf?ua=1 - accessed 4 June 2017. 13. World Health Organization, Regional Office for South-East Asia. Medicines in health care delivery- Maldives. New Delhi, 2014. http://www.searo.who.int/entity/medicines/maldives_situational_analysis_2014.pdf?ua=1 -accessed 21 May 2017. 14. 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. 15. 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. 16. 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. 17. Maldives Food and Drug Authority, Maldives. Republic of Maldives: MFDA. http://www.mfda.gov.mv -accessed 21 May 2017. 18. Ministry of Health, Republic of Maldives. Approved Drug List, April 2017. Republic of Maldives. 2017. http://health. gov.mv/ Uploads/Downloads//Publications/Publication(13).pdf -accessed 21 May 2017. 19. World Health Organization, Country Office for Maldives. WHO Country Cooperation Strategy Republic of Maldives 2013-2017. Male, 2013. http://www.searo.who.int/maldives/CCS.pdf -accessed 21 May 2017. 20. As reported in Ministry of Health, Republic of Maldives, Annual Report. Notes: A. National Medicine Policy is presently being revised. B. As per National list of Essential Medicines -2013. C. Approved list of registered drugs is available, but there is no national formulary manual. D. Currently, there is no public procurement agency. However, State Trading Organization (STO) is responsible for procuring medicines for government health facilities as per their need. E. Decentralized to State Trading Organization and private importers. F. Work in process to include pricing under medicine regulation. MFDA has worked on a costing structure for MRP in consultation with stakeholders and working on its finalization. It will address price control mechanisms at manufacturer, wholesaler and retailer level. Mark-ups will be regulated according to the costing structure.