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

20715Population (in 000s)1

74.9Life expectancy at birth (in years)2

3926GDP (per capita in current US$)3

Sri Lanka pharmaceutical profile 2017

MEDICAL AND PHARMACY WORKFORCE

7.4Medical practitioners/10 000 population6

0.6Pharmacists & pharmacy technicians/10 000 population6

0.7Registered pharmacists/10 000 population6

$ 28

$ 127

0

15

30

45

60

75

90

105

120

135

2005 2008 2011 2014

Cur

rent

US

$

26.5%

0

20

40

60

80

100

2005 2008 2011 2014

Perc

enta

ge (%

)

42%

58%

0

20

40

60

80

100

2005 2008 2011 2014

Perc

enta

ge (%

)

No data available

Sri Lanka pharmaceutical profile 2017

KEY MEDICINES POLICIES AND GUIDANCE

Key Pharmaceutical Legislation13

National Medicine Policy13

National Essential Medicines List14

National Standard Treatment Guidelines13

1. Cosmetics, Devices and Drugs Act (CDDA) No. 27 of 1980 with several amendments from 1985.

2. National Medicines Regulatory Authority Act, 2015

National Medicine Policy 2005

National List of Essential Medicines-2014

Specialist colleges and Sri Lanka Medical Association specific

guidelines exist.

INTELLECTUAL PROPERTY RELATED POLICIES & PRODUCTION

Number of Local pharmaceutical

manufacturers13,A

Least Developed country

status15

Member of World Trade Organization

since16

TRIPS flexibilities

used17

12 No 1995 Not applicable

ACCESS TO MEDICINES

HIV/AIDS, Tuberculosis and Malaria treatment coverage 7,8,9

Diphtheria-tetanus-pertussis (DTP3) and Hepatitis B3 immunization coverage 10

Hypertension and Diabetes Mellitus treatment coverage 11

Access to palliative care: Opioid consumption in Morphine Equivalence (ME) minus Methadone12

Results for 18-69 years age group

99% 99%

0

20

40

60

80

100

120

2005 2010 2015

Perc

enta

ge (%

)

19%

100%

69%

0

20

40

60

80

100

2005 2007 2009 2011 2013 2015

Perc

enta

ge (%

)

0.8787

0

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

1

1999 2004 2009 2014

mili

gram

per

per

son

26.10%

7.40%

0

5

10

15

20

25

30

% of respondents (both sexes)currently taking blood pressuredrugs prescribed by doctor orhealth worker, among thosediagnosed with hypertension

% of respondents (both sexes)currently taking insulin and oral

diabetes medication, amongthose previously diagnosed with

diabetes

Perc

enta

ge (%

)

Morphine Equivalence minus methadone represents country capacity to deliver palliative care, because it excludes treatment for drug dependency

Sri Lanka pharmaceutical profile 2017

Market Authorization/

Licensing/Quality Assurance

Medicine

Patient

MedicineSelection

Medicine Procurement

Pricing and Reimbursement

Distribution

National Regulatory Authority18: National Medicines Regulatory Authority (NMRA) http://nmra.gov.lk/Regulated products: Medicines18: YES Vaccines18: YES Medical Devices18: YES Traditional Medicines19: YES

Medicine Quality Control Laboratory20: National Drug Quality Assurance Laboratory.ISO 17025 certified18: NO WHO prequalified13: NO

Number of Registered Medicines13: 8095 allopathic and 960 traditional medicines

Agency responsible for selection13: Medical Supplies Division, Ministry of Health, Nutrition and Indigenous Medicine

Number of products on essential medicines list:By active ingredient13: 361 By dosage form13: >400

Traditional medicines products included in essential medicines list13: None

Medicines availability is indicated by health facility level13: YES

Number of Products in National Formulary13: Not available

Public SectorAgency responsible for Public Procurement13: State Pharmaceutical Corporation

Procurement done at Central20 State20 Facility13,B

Commonly used procurement methods21: Worldwide tenders

Public SectorAgency responsible for distribution13: Medical Supplies Division

Public Sector Facilities24:Hospitals: 622Central dispensaries/Primary care units: 475

Public Sector Price Control13: YESMechanism21: Tenders are scheduled according to ascending prices and evaluated technicallyHealth insurance reimbursement Price113,C: No public health insurance for majority of populationPatient prices for essential medicines in public sector: Free Medicines21: YES

Private Sector

Number of wholesalers21: 790

Private Sector

Number of Retail Outlets13: 3297

Licensed retail pharmacies

per 10 000 population13: 1.6

Number of Traditional Medicines outlets: Not available

Private Sector Agency responsible for Price Control22: Ministry of Trade and Industry with Sri Lanka Manufacturers Association and Sri Lankan Standards Institute.

Pricing mechanism: Manufacturer23,D Wholesale23 Retailer23,E

Mark-ups regulated23: NO

Pharmaceutical system flowchart

Sri Lanka 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. Sri Lankan National Health Accounts 2013. Colombo, 2013. Internal communication, April 2017.

6. Data taken from SEAR health workforce survey April 2016.

7. United Nations Programme on HIV/AIDS. Estimates of coverage of people receiving ART. http://aidsinfo.unaids.org -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. World malaria reports. Geneva. http://www.who.int/malaria/publications/world_ malaria_report/en/ -accessed 12 May 2017.

10. World Health Organization. WHO/UNICEF estimates of national immunization coverage. Geneva. http://apps.who. int/immunization_monitoring/globalsummary -accessed 12 May 2017.

11. World Health Organization, Regional Office for South-East Asia. Non-Communicable Diseases Risk Factory Survey Sri Lanka, 2015. New Delhi, 2015. http://www.who.int/chp/steps/STEPS-report-2015-Sri-Lanka.pdf?ua=1 -accessed 12 May 2017.

12. 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.

13. World Health Organization, Regional Office for South-East Asia. Medicines in health care delivery- Sri Lanka. WHO Regional Office for South East Asia, India. 2015. http://www.searo.who.int/entity/medicines/sri_lanka_mar_2016. pdf?ua=1 - accessed 12 May 2017.

14. National Medicines Regulatory Authority, Sri Lanka. Sri Lanka: NMRA. http://nmra.gov.lk/index.php?option=com_ content&view=article&id=89&Itemid=89&lang=en -accessed 12 May 2017.

15. United Nations, Department of Economics and Social Affairs, Development Policy and Analysis Division. LDC list. 2016. https://www.un.org/development/desa/dpad/least-developed-country-category/ldcs-at-a-glance.html -accessed 12 May 2017.

16. World Trade Organization. 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.

17. 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.

18. National Medicines Regulatory Authority. Sri Lanka. Sri Lanka: NMRA. http://nmra.gov.lk/-accessed 4 June 2017.

19. Data taken from SEAR workshop on Traditional Medicines in 2015, Pyongyang.

20. Ministry of Health, Nutrition & Indigenous Medicine, Sri Lanka. Sri Lanka. http://www.health.gov.lk/moh_final/ english/ -accessed 4 June 2017.

21. National Medicines Regulatory Authority, Sri Lanka, Sri Lanka: NMRA. http://nmra.gov.lk/images/stories/new/pdf/ manualpart11.pdf -accessed 4 June 2017.

22. Democratic and Socialist Republic of Sri Lanka. National Medicines Regulatory Act, No. 5 of 2015. Gazette of Democratic and Socialist Republic of Sri Lanka. Colombo, 2015. http://apps.who.int/medicinedocs/documents/ s21877en/s21877en.pdf -accessed 4 June 2017.

23. As reported by National Medicine Regulatory Authority, Sri Lanka, June 2017.

24. Ministry of Health, Nutrition & Indigenous Medicine, Sri Lanka. Annual Health Bulletin 2014. Colombo, 2016. http:// www.health.gov.lk/moh_final/english/public/elfinder/files/publications/AHB/AHB2014.pdf -accessed 12 May 2017.

Notes:

A. 12 locally owned, allopathic manufacturers (1 government; 11 private-sector)

B. Teaching hospitals and some base hospitals are also allowed to do local purchase.

C. Insurance scheme for all government workers exist.

D. Maximum retail price is being introduced.

E. Price set by manufacturers.