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FIJI

PHARMACEUTICAL COUNTRY PROFILE

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Fiji Pharmaceutical Country Profile Published by Ministry of Health in collaboration with the World Health

Organization

June 2013

Any part of this document may be freely reviewed, quoted, reproduced, or translated in full or in part, provided that the source is acknowledged. It may not

be sold, or used in conjunction with commercial purposes or for profit.

Users of this Profile are encouraged to send any comments or queries to the following address:

The Chief Pharmacist

Fiji Pharmaceutical & Biomedical Services Centre Lot 1, Jerusalem Road, Box 106, Suva

Republic of Fiji

Phone: 3388000 Fax: 3388003

Apolosi Vosanibola <[email protected]>

This document was produced with the support of the WHO Representative Office in the South Pacific, and all reasonable precautions have been taken to verify the information contained

herein. The published material does not imply the expression of any opinion whatsoever on the part of the World Health Organization, and is being distributed without any warranty of any kind – either expressed or implied. The responsibility for interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising

from its use.

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Foreword The 2011 Pharmaceutical Country Profile for Fiji was produced by the

Ministry of Health, in collaboration with the World Health Organization.

This document contains information on existing socio-economic and

health-related conditions, resources; as well as on regulatory structures,

processes and outcomes relating to the pharmaceutical sector in Fiji. The

compiled data comes from international sources (e.g. the World Health

Statistics), surveys conducted in the previous years and country level

information collected in 2011. More recent information is also included. The

sources of data for each piece of information are presented in the

references that can be found at the end of this document.

On behalf of the Ministry of Health, Fiji, I wish to express my appreciation

to Ms Lkhagvadorj Vanchinsuren from the World Health Organization and

Ms Muniamma Gounder and Ms Vinita Prasad from Fiji Pharmaceutical

and Biomedical Services Centre and Dr Sheetalpreet Singh from Ministry

of Health for their contributions to the process of data collection and the

development of this profile.

It is my hope that partners, researchers, policy-makers and all those who

are interested in the Fiji pharmaceutical sector will find this profile a useful

tool to aid their activities.

Name…Apolosi Tamani Vosanibola Function in the Ministry of Health: Chief Pharmacist Date…11/12/2013

Signature…

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Table of content

Introduction ............................................................................................................ 1

Section 1 - Health and Demographic Data ........................................................ 3

Section 2 - Health Services ................................................................................ 6

Section 3 - Policy Issues .................................................................................. 10

Section 4 - Medicines Trade and Production .................................................. 12

Section 5 - Medicines Regulation .................................................................... 14

Section 6 - Medicines Financing ...................................................................... 23

Section 7 - Pharmaceutical Procurement and Distribution in the Public Sector ................................................................................................... 27

Section 8 - Selection and Rational Use of Medicines .................................... 30

Section 9 - Household Data/Access…………………… ………………………...34

1

Introduction

This Pharmaceutical Country Profile provides data on socio-economic and

health-related conditions, resources, regulatory structures, processes and

outcomes relating to the pharmaceutical sector of Fiji. The aim of this

document is to compile all relevant, existing information on the

pharmaceutical sector and make it available to the public in a user-friendly

format. In 2010, the country profiles project was piloted in 13 countries

(http://www.who.int/medicines/areas/coordination/coordination_assessmen

t/en/index.html).

During 2011, the World Health Organization has supported all WHO

Member States to develop similar comprehensive pharmaceutical country

profiles.

The information is categorized in nine (9) sections, namely: (1) Health and

Demographic data, (2) Health Services, (3) Policy Issues, (4) Medicines

Trade and Production (5) Medicines Regulation, (6) Medicines Financing,

(7) Pharmaceutical Procurement and Distribution, (8) Selection and

Rational Use, and (9) Household data/Access. The indicators have been

divided into two categories, namely "core" (most important) and

"supplementary" (useful if available). This narrative profile is based on data

derived from both the core and supplementary indicators. For each piece

of information, the year and source of the data are indicated; these have

been used to build the references in the profile and are also indicated in

the tables. If key national documents are available on-line, links have been

provided to the source documents so that users can easily access these

documents.

The selection of indicators for the profiles has involved all technical units

working in the Essential Medicines Department of the World Health

Organization (WHO), as well as experts from WHO Regional and Country

Offices, Harvard Medical School, Oswaldo Cruz Foundation (known as

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Fiocruz), University of Utrecht, the Austrian Federal Institute for Health

Care and representatives from 13 pilot countries.

Data collection in all 193 member states has been conducted using a user-

friendly electronic questionnaire that included a comprehensive instruction

manual and glossary. Countries were requested not to conduct any

additional surveys, but only to enter the results from previous surveys and

to provide centrally available information. To facilitate the work of national

counterparts, the questionnaires were pre-filled at WHO HQ using all

publicly-available data and before being sent out to each country by the

WHO Regional Office. A coordinator was nominated for each of the

member states. The coordinator for Fiji was Ms Vinita Prasad.

The completed questionnaires were then used to generate individual

country profiles. In order to do this in a structured and efficient manner, a

text template was developed. Experts from member states took part in the

development of the profile and, once the final document was ready, an

officer from the Ministry of Health certified the quality of the information and

gave formal permission to publish the profile on the WHO website.

This profile will be regularly updated by Fiji Pharmaceuticals and

Biomedical Services Centre Chief Pharmacist. Comments, suggestions or

corrections may be sent to:

The Chief Pharmacist Fiji Pharmaceutical & Biomedical Services Centre Lot 1, Jerusalem Road, Box 106, Suva Republic of Fiji: Apolosi Vosanibola [email protected]

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Section 1 - Health and Demographic Data

This section gives an overview of the demographics and health status of

Fiji.

1.1 Demographics and Socioeconomic Indicators

The total population of Fiji in 2009 was 849,000 with an annual population

growth rate of 0.6%. The annual Gross Domestic Product (GDP) growth

rate is -2.50%. The GDP per capita was US$ 3,574.12 (at the current

exchange ratei).

Of the total population, 31% is under 15 years of age and 8% is over 60

years of age. The urban population currently stands at 53% of the total

population. The fertility rate in Fiji is 2.7 births per woman. 40% of the

population is living with less than $1 per day. The adult literacy rate for the

population over 15 years is 94.4%ii,.

1.2 Mortality and Causes of Death

The life expectancy at birth is 66 and 73 years for men and women

respectively. The Ministry of Health, Annual Report 2009 reported infant

mortality rate (i.e. children under 1 year) is 15/1,000 live births. For children

under the age of 5, the mortality rate is 18/1,000 live births. The maternal

mortality rate is 31.7 /100,000 live births.

i The current exchange rate for calculation is FJD 1 = USD 0.56640 on June 2nd, 2011 [http://www.oanda.com/currency/converter/] ii Adult literacy rate should be interpreted with caution as it refers to estimates for 2005 from UNESCO Institute for Statistics (2003), based on outdated census or survey information

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The top 10 diseases causing mortality in Fiji are [Ministry of Health, Annual Report 2009] Disease Total %

1 Diseases of the circulatory system 2595 40.52

2 Endocrine, nutritional and metabolic diseases 1153 18.00

3 Neoplasms 652 10.18

4 Certain infectious and parasitic diseases 397 6.20

5 Diseases of the respiratory system 357 5.57

6 Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified

312 4.87

7 Injury, poisoning and certain other consequences of external causes

310 4.84

8 Diseases of the digestive system 156 2.44

9 Diseases of the genitourinary system 152 2.37

10 Certain conditions originating in the perinatal period

150 2.34

The top 10 diseases causing morbidity in Fiji are [Ministry of Health, Annual Report 2009] Disease %

1 Pregnancy, Childbirth & Puerperium complications 27.8

2 Factors Influencing Health Status & Contact with Health Services 17.3

3 External Causes of Morbidity & Mortality 11.8

4 Endocrine, Nutritional & Metabolic Diseases 7.2

5 Injury, Poisoning & Certain Consequences External Causes 5.9

6 Diseases of the Circulatory System 4.9

7 Certain Infectious & Parasitic Diseases 4.7

8 Diseases of the Digestive System 3.4

9 Diseases of the Genitourinary System 2.8

10 Diseases of the Skin & Subcutaneous Tissue 2.7

The World Health Statistics 2009 reported the adult mortality rate for both

sexes between 15 and 60 years at 212/1,000 population, with the neonatal

mortality rate at 9/1,000 live births. The age-standardised mortality rate by

non-communicable diseases - 752/100,000, 440/100,000 followed by

cardiovascular diseases and 81/100,000 by cancer. The mortality rate

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reported for HIV-related disease is 2.1/100,000 and 2.0/100,000 for

tuberculosis. There is no malaria in Fiji.

Further information:

Fiji is faced with the double burden of disease from both communicable and non-‐communicable diseases. The rising trend of non-‐communicable diseases (NCDs) is a major public health issue for Fiji to the extent that it is now termed an ‘epidemic’ largely attributable to a fundamental shift in lifestyle which includes increased consumption of energy dense food and more sedentary lifestyle. 82% of deaths in Fiji are due to NCDs. According to the NCD STEPS Survey of 2002, the prevalence of Diabetes is about 16% of which half were not aware of their diabetic status. The prevalence has increased 4-‐fold in the past 2 decades. i.e. from 4% in 1985 to 16% in 2002.

About 900 cases of Ischaemic Heart Disease are admitted to Fiji hospitals per year representing up to 3% of annual admissions. According to the NCD STEPS Survey, the prevalence of hypertension was about 19% in 2002 of which 63% were previously unaware. Moreover a third of all deaths were due to circulatory diseases.

By international standards, the prevalence of HIV-‐related disease is low (being less than 0.1%) However, the cumulative incidence is rising rapidly and there were 333 confirmed cases in December 2009 compared to 4 in 1989 The reported cases are mainly among 30-‐39 and 40-‐49 age groups. Malaria is not a health issue in Fiji, and the incidence of tuberculosis (TB) and prevalence of TB has declined over the years.

In terms of meeting Fiji’s Millennium Development Goals and targets, the progress has been incremental. While there has been a decline in the incidence of some of the communicable diseases such as tuberculosis and filariasis over the past 20 years, the rise in incidence of leptospirosis and typhoid fever in recent years and outbreaks of Dengue Fever every 5 to 8 years are cause for concern. Some of the key challenges in addressing these include: staff shortages, insufficient monitoring of pregnancy related illness, cost of health services to allow poor to take advantage of available health facilities and the need to strengthen health systems through improving investment in technical infrastructures.

The Ministry of Health receives financial and technical assistance to achieve its goals from various donor agencies, NGOs, UN agencies including WHO, UNFPA, UNICEF; the Global Fund; Australian Agency for International Development (AusAID) through Fiji Health Sector Support Programme (FHSSP); Japanese International Cooperation Agency ((JICA), and civil society and institutions such as the Fiji National University.

Some of the projects for Health Information Systems include development of Health Information Policy (which has been drafted, and is pending endorsement from the National Health Executive Committee) from which the National Health Information Strategic Plan will be drawn. In addition, the Patient Information System (PATIS) is presently being upgraded to include additional features of a Laboratory Information System.

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Section 2 - Health Services

This section provides information regarding health expenditures and

human resources for health in Fiji. The contribution of the public and

private sector to overall health expenditure is shown and the specific

information on pharmaceutical expenditure is also presented. Data on

human resources for health and for the pharmaceutical sector is provided

as well.

2.1 Health Expenditures

In Fiji, the total health expenditure (THE) in 2008 was FJ$ 205.8 million

(US$ 105 million). The total health expenditure was 3.46% of the GDP,

equivalent to FJ$ 242.40 (US$ 123.67) per capita (Review of

Pharmaceutical Financing and Expenditure in Selected PICs, 2005; Fiji

Health Accounts, 2008).

The general governmentiii health expenditure (GGHE) in 2008, as reflected

in the National Health Accounts (NHA) (National Health Accounts (NHA)

Country Information, 2009) was FJ$ 143.16 (US$ 87.8). That is, 69.56% of

THE, with a total public health expenditure of FJ$ 168.62 (US$ 103.42)

per capita. Private health expenditure covers the remaining 30.44% of THE.

The GGHE represents 7.7% of the total government budget.

Of the total population, 29.43% is covered by a private health insurance.

Total pharmaceutical expenditure (TPE) in Fiji in 2005 was FJ$ 19.19

million (US$ 10.66 million), which is a per capita pharmaceutical

expenditure of FJ$ 22.60 (US$ 12.56). TPE accounts for 0.35% of the

GDP and makes up 9.32% of THE (Figure 1.).

iii According to the NHA definition, by "government expenditure" it is meant all expenditure from public sources, like central government, local government, public insurance funds and parastatal companies.

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Figure 1: Share of Total Pharmaceutical Expenditure (2005) as percentage of the Total Health Expenditure (2008). The THE in 2008 was FJ$ 205.8 million (US$ 105 million)

[Review of Pharmaceutical Financing and Expenditure in Selected PICs, 2005; Fiji Health

Accounts, 2008]

A 2005 study showed public expenditure on pharmaceuticals representing

53.31% of the total expenditure on pharmaceuticals (Figure 2). There has

not been a more recent study of public versus private expenditure on

pharmaceuticals.

Figure 2: Share of Total Pharmaceutical Expenditure by sector (2005)

[Review of Pharmaceutical Financing and Expenditure in Selected PICs, 2005]

9%

91%

TPE Other

47%53%

Public sector Private sector

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Fiji National Health Accounts, 2008 showed total private expenditure on

pharmaceuticals to be FJ$ 8.96 million (US$ 4.97 million). There is no

government social security expenditure expenditure on health. Premiums

for private prepaid health plans are 15.04% of total private health

expenditure.

2.2 Health Personnel and Infrastructure

The health workforce (2009) is described in Table 1 below. There are 40

(0.47/10,000) licensed pharmacists. There are 380 (4.48/10,000)

physicians and 1,660 (19.55 /10,000) nursing and midwifery personnel in

Fiji. The ratio of doctors to nurses and midwifery personnel is 0.23.

Table 1: Human resources for health in Fiji (2009)

Human Resource Licensed pharmacists (all sectors) 40 (0.47 /10,000)

Physicians (all sectors) 380 (4.48 /10,000)

Nursing and midwifery personnel (all sectors) 1,660 (19.55 /10,000)

The health infrastructure is described in Table 2 below. There are 1,783

hospital beds (21 per 10,000 population) and 76 primary health care units

and centres in Fiji. Nursing stations (96) based in communities refer to the

primary health care units and centres. Table 2: Health infrastructure

Infrastructure Hospital beds 1,783 (21 /10,000)

Primary health care units and centres 76

Nursing stations 96

The annual starting salary for a newly registered pharmacist in the public

sector is US$ 8,000. The total number of pharmacists who graduated (as a

first degree) in the past 2 years is 37 as yet. Accreditation requirements for

pharmacy schools are in place. The pharmacy curriculum is regularly

reviewed.

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The Ministry of Health (MOH) will undertake an assessment of the role, functions and level of expertise of the existing personnel connected with different aspects of the pharmaceutical sector. An attempt will be made to identify the needs over the next 5-‐10 years and accordingly MOH will initiate discussions with relevant academic and professional institutions and organizations as to how best such needs can be met.

Strategic planning for the expansion and maintenance of the services needed to implement the National Medicinal Products Policy (NMPP) has been undertaken. This planning will enable Human Resources needs to be identified so that strategies can be developed through collaboration between the Fiji Pharmaceutical and Biomedical Services Centre (FPBSC) and the Fiji National University for the selection and training of future staff required by NMPP. Continuing education will be developed as part of ongoing accreditation. Sufficient financial resources will be ensured to support the Human Resources needed to implement the components of this NMPP.

The FPBSC will develop an interim plan to provide adequate training for implementing components of NMPP as well as technical expertise in the distribution and dispensing of medicines and other medical stores tasks until such time as the required number of trained staff is available.

In addition, the FPBSC will strive to improve the career prospects of all pharmaceutical personnel in the public sector and will encourage and support opportunities for upgrading and refresher courses and continuing professional development for existing personnel, in order to secure their positions and develop a good human resources team.

A suitable career structure including incentives will be designed to retain such staff and their skills will be regularly improved and updated by a continuing education and refresher training program.

Ancillary and support personnel will be provided with basic and periodic training to ensure satisfactory performance of support duties. They may be supplied with additional on-‐the-‐job training for permanent positions within the system.

Further education and training of dispensing personnel in the private sector as appropriate under this NMPP may be provided collaboratively through the Professional Associations.

The Ministry of Health will explore the issue of partnerships with other organizations; and technical cooperation for exchange programs involving qualified personnel from other countries whose services can be utilised for a period of time to address unmet training and service delivery needs.

National Medicinal Products Policy 2012 and Draft Pharmaceutical Sector Strategic Plan for implementing the Fiji National Medicinal Products Policy 2013-‐2018

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Section 3 - Policy Issues

This section addresses the main characteristics of the pharmaceutical

policy in Fiji. The many components of a national pharmaceutical policy are

taken from the WHO publication “How to develop and implement national

drug policy” (http://apps.who.int/medicinedocs/en/d/Js2283e/). Information

about the capacity for manufacturing medicines and the legal provisions

governing patents is also provided.

3.1 Policy Framework

In Fiji, a National Health Policy (NHP) does not exist. However, a Strategic

Plan for 2011-2015 exists. It documents the policy priorities the Ministry of

Health has set regarding its strategic direction for health care in Fiji for the

relevant 5 years.

A revised official National Medicinal Products Policy (NMPP) document

exists in Fiji, as detailed in Table 3 and a Strategic Implementation Plan

has been drafted. Pharmaceutical policy implementation will continue to be

regularly monitored and assessed.

Table 3: The NMPP (The National Medicinal Products Policy of the Republic of Fiji, 2012) covers Aspect of policy Covered Selection of essential medicines Yes

Medicines financing Yes

Medicines pricing Yes

Medicines Procurement Yes

Medicines Distribution Yes

Medicines Regulation Yes

Pharmacovigilance Yes

Rational use of medicines Yes

Human Resource Development Yes

Research Yes

Monitoring and evaluation Yes

Traditional Medicine Yes

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There are official written guidelines on medicines donations. There is a

formal code of conduct for public officials.


The National Strategic Plan for Health has been developed in concert with the Government’s national strategic policy document: the 2009 – 2014 Roadmap for Democracy and Sustainable Socio‐Economic Development. The two overall strategic objectives for health in the Roadmap are as follows:

• Communities are serviced by adequate primary and preventive health services thereby protecting, promoting and supporting their well being.

• Communities have access to effective, efficient and quality clinical health care and rehabilitation services.

The pricing of medicines is controlled under a separate legislation which is the Counter Inflation Act. This is reviewed on a regular basis by Ministry of Trade & Commerce. The regulation of medicines in general is covered under the Pharmacy and Poisons Act, Cap 115 but the Regulations will be updated during 2013.

The Pharmacy Profession Decree and the Medicinal Products Decree were approved in 2011 and the National Medicinal Products Policy, 2012 is approved by the Cabinet Decision, No.201 on 5 June 2012.

The first National Pharmaceutical Sector Strategic Plan for the period 2013-‐2018 has been drafted (May 2013). The Plan provides direction for implementation of activities that will fulfill the objectives of the National Medicinal Products Policy of Fiji Islands and the development of the pharmaceutical sector (public and private). It provides guidance to donors interested in supporting the sector development in Fiji for the period 2013-‐2018. The planning process, for the preparation of this strategy, was overseen by the Ministry of Health and undertaken by the Fiji Pharmaceutical and Biomedical Services Centre with participation from all components of the Pharmaceutical Sector and all relevant stakeholders. The Plan recommends activities to be undertaken to achieve the aims of the NMPP and provides the timing requirements, means of verification of activities undertaken, monitoring and evaluation criteria and reporting mechanisms.

Key recommendations:

Implementation of the first National Pharmaceutical Sector Strategic Plan (May 2013) is a priority. It should be endorsed and launched promptly.

The FPBSC management team will prioritise activities and monitor and evaluate the implementation of strategic plan, and include a midterm review in 2015. This team is an integral part of the Ministry of Health's monitoring and evaluation framework. At the end of the time-‐frame the implementation plan will be re-‐evaluated and extended as needed for achievement of the aims.

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Section 4 - Medicines Trade and Production 4.1 Intellectual Property Laws and Medicines

Fiji is a member of the World Trade Organization. Legal provisions granting

patents to manufacturers exist. These cover pharmaceuticals, laboratory

supplies, medical supplies and medical equipment.

Intellectual Property Rights are managed and enforced by the Office of the

Attorney General, http://www.ag.gov.fj/.

National Legislation has not yet been modified to implement the WTO’s

Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement

and does not contain TRIPS-specific flexibilities and safeguards. There are

no legal provisions yet for data exclusivity for pharmaceuticals or linkage

between patent status and marketing authorization. However the TRIPS

safeguards are enshrined in the National Medicinal Products Policy 2012.

Fiji is not eligible for the transitional period to 2016.

4.2 Manufacturing

There is one licensed pharmaceutical manufacturer in Fiji. Manufacturing

capabilities are presented in Table 4 below. This manufacturer is a foreign-

owned company. It produces only for export, so the share of the local

market is zero.

Table 4: Fiji manufacturing capabilities

Manufacturing capabilities

Research and Development for discovering new active substances No

Production of pharmaceutical starting materials (APIs) No

The production of formulations from pharmaceutical starting material Yes

The repackaging of finished dosage forms Yes

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Further information and key findings:

• The Patent Bill is pending with Ministry of Justice. The Ministry of Health has

made its submissions already on including TRIPS flexibilities in the Patent Law. • The Ministry of Health is working with the sole manufacturer “Douglas

Pharmaceuticals” on options to support local demand of pharmaceuticals. • Licensing procedures in compliance with the National Medicinal Products

Policy 2012 component associated with local manufacture will ensure Good Manufacturing Practice and adherence to export and national distribution policy.

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Section 5 - Medicines Regulation

This section details the pharmaceutical regulatory framework, resources,

governing institutions and practices in Fiji.

5.1 Regulatory Framework

In Fiji, there are legal provisions establishing the powers and

responsibilities of the Medicines Regulatory Authority (MRA). The MRA is a

part of the Fiji Pharmaceuticals and Biomedical Services Centre, Ministry

of Health with a number of functions outlined in Table 5.

Table 5: Functions of the national MRA

Function Marketing authorisation / registration Yes

Inspection Yes

Import control Yes

Licensing Yes

Market control Yes

Quality control Yes

Medicines advertising and promotion Yes

Clinical trials control Yes


Other No

The MRA is involved in harmonization/collaboration initiatives. An

assessment of the medicines regulatory system had been conducted in

2006. Funding for the MRA is provided through the regular government

budget. The Medicines Regulatory Authority has not retained revenues

derived from regulatory activities. However, the Medicines Registration

Unit within the MRA has the option of imposing fees for investigation,

registration and licensing.

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5.2 Marketing Authorization (Registration) In Fiji, there are now legal provisions that require marketing authorization

(registration) for all pharmaceutical products on the market. Other

regulatory functions (e.g. inspection) are also being undertaken by Fiji

Pharmaceutical and Biomedical Services Centre FPBSC). Since FPBSC is

the only importer for the public sector, they know what is imported in the

public sector. When importing for the public sector, FPBSC relies on

assessments done by other regulatory agencies because the capacity

does not exist for assessing applications for marketing authorization of

pharmaceutical products. Possession of a Certificate for Pharmaceutical

Products (that accords with the WHO Certification scheme) is required as

part of the Marketing Authorization application. The Medicinal Products

Decree 2011 provides legal provisions requiring the MRA to make the list

of registered pharmaceutical products publicly available and update it

regularly. Medicines are always registered by their International Non-

proprietary Names (INN) or Brand name + INN.

Legal provisions requiring the establishment of an expert committee

involved in the Marketing Authorization process are not in place.

5.3 Regulatory Inspection In Fiji, legal provisions permitting inspectors to inspect premises where

pharmaceutical activities are performed exist. Such inspections are

required by law and are a pre-requisite for the licensing of private, but not

public, facilities. Where inspections are legal requirements, these are the

same for public and private facilities. Inspections are carried out on a

number of entities, outlined in Table 6.

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Table 6: Local entities inspected for GMP compliance

Entity Inspection Frequency

Local manufacturers Yes Quarterly

Private wholesalers Yes Quarterly

Retail distributors Yes Quarterly

Public pharmacies and stores Yes Quarterly

Pharmacies and dispensing points if health facilities Yes Quarterly

5.4 Import Control

Legal provisions requiring authorization to import medicines exist. Laws do

not exist that allow the sampling of imported products for testing. Legal

provisions requiring importation of medicines through authorized ports of

entry exist and Regulations or Laws to allow for inspection of imported

pharmaceutical products at authorized ports of entry also exist.

5.5 Licensing

In Fiji, legal provisions requiring manufacturers to be licensed exist. Legal

provisions requiring manufacturers (both domestic and international) to

comply with Good Manufacturing Practices (GMP) also exist. Good

Manufacturing Practices are not published by the government but

international standards such as those accepted by the Therapeutic Goods

Administration (TGA), Australia are used as a reference point.

Legal provisions requiring importers, wholesalers and distributors to be

licensed exist. Legal provisions requiring wholesalers and distributors to

comply with Good Distribution Practices are included in the National

Medicinal Products Decree (2011) and are enshrined in the National

Medicinal Products Policy 2012.

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Table 7: Legal provisions pertaining to licensing

Entity requiring licensing Importers Yes

Wholesalers Yes

Distributors Yes

Legal provisions requiring pharmacists to be registered exist. Legal

provisions requiring private and public pharmacies to be licensed also exist.

National Good Pharmacy Practice Guidelines are published by the

government. By law, a list of all licensed pharmaceutical facilities is

required to be published.

5.6 Market Control and Quality Control

In Fiji, legal provisions for controlling the pharmaceutical market exist. A

Quality Control Laboratory does not exist in Fiji. The regulatory authority

contracts services elsewhere. Samples are sent to TGA Laboratories,

Australia.

Medicines are tested for a number of reasons, summarised in Table 8.

Table 8: Reason for medicines testing13

Medicines tested:

For quality monitoring in the public sectoriv Yes

For quality monitoring in the private sectorv Yes

When there are complaints or problem reports Yes

For product registration No

For public procurement prequalification No

For public program products prior to acceptance and/or distribution No

Samples are collected by government inspectors for undertaking post-

marketing surveillance testing. In 2008-2010, eight samples were taken for

iv Routine sampling in pharmacy stores and health facilities v Routine sampling in retail outlets

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quality control testing. Of the samples tested, one (or 12.5%) failed to

meet the quality standards. The results are not publicly available.

5.7 Medicines Advertising and Promotion

In Fiji, legal provisions to control the promotion and/or advertising of

prescription medicines exist. The Pharmacy and Poisons Board has been

responsible for regulating promotion and/or advertising of medicines. Legal

provisions prohibit direct advertising of prescription medicines to the public

and pre-approval for medicines advertisements and promotional materials

is required. Guidelines and Regulations for advertising and promotion of

non-prescription medicines exist. Control of advertising and promotion of

medicines by marketing authorization holders is covered in the National

Medicinal Products Policy 2012.

5.8 Clinical Trials

In Fiji, legal provisions exist requiring authorization for conducting Clinical

Trials. Applications for conducting clinical trials are dealt by the ethics

committee.vi

Legal provisions exist for GMP compliance of investigational products.

Sponsor investigators are legally required to comply with Good Clinical

Practices (GCP). National GCP regulations are not published by the

Government but International Standards are adhered tovii. Legal provisions

permit the inspection of facilities where clinical trials are performed.

vi Conduct of Clinical Trials is covered in the National Medicinal Products Policy 2012 and in the National Medicinal Products Decree 2011. vii Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines for Biomedical Research Involving Human Subjects

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5.9 Controlled Medicines

Fiji is a signatory to a number of international conventions, detailed in

Table 9.

Table 9: International Conventions to which Fiji is a signatory

Convention Signatory

Single Convention on Narcotic Drugs, 1961 Yes

1972 Protocol amending the Single Convention on Narcotic Drugs, 1961 Yes

Convention on Psychotropic Substances 1971 Yes

United Nations Convention against the Illicit Traffic in Narcotic Drugs and Psychotropic Substances, 1988

Yes

Laws for the control of narcotic and psychotropic substances and

precursors exist. The annual consumption of Morphine is 0.4988 mg/capita.

Figures regarding the annual consumption of certain controlled substances

in the country are outlined in Table 9S below.

Table 9S: Annual consumption of selected controlled substances in Fiji18

Controlled substance Annual

consumption (mg/capita)

Morphine 0.4988viii

Fentanyl 0.202536viii

Pethidine 3.090588viii

Oxycodone N/A

Hydrocodone N/A

Phenobarbital 37.64706ix

Methadone 0.008824ix

N/A: data not available

5.10 Pharmacovigilance In Fiji, there are no legal provisions in the Medicines Act that provide for

pharmacovigilance activities as part of the MRA mandate. x Legal

viii 2009 data ix 2010 data

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provisions exist requiring the Marketing Authorization holder to

continuously monitor the safety of their products and report to the MRA.

Laws regarding the monitoring of Adverse Drug Reactions (ADRs) do not

exist in Fiji. A National Pharmacovigilance Centre linked to the MRA exists

and has one full-time staff member. The centre has not published an

analysis report in the previous two years and it does not publish an ADR

bulletin.

An official standardized form for reporting ADRs is used in Fiji. Feedback is

provided to reporters. Information pertaining to ADRs is not stored in a

national ADR database.

There is a national ADR and pharmacovigilance advisory committee able

to provide technical assistance or causality assessment, risk assessment,

risk management, case investigation and, where necessary, crisis

management including crisis communication in Fiji. A clear communication

strategy for routine communication and crises communication exists.

A number of steps are being considered in order to enhance the

pharmacovigilance system. This includes increasing human resource

capacityxi.

Medication errors (MEs) are reported. A risk management plan is not

presented as part of the product dossier submitted for Marketing

Authorization.

Table 10, below shows who has reported ADRs in the past two years -

there was not a single regulatory decision based on local

pharmacovigilance. There are no training courses in pharmacovigilance yet.

x Expanded Pharmacovigilance activities are covered in the National Medicinal Products Policy 2012 and in the Draft Pharmaceutical Sector Strategic Plan for implementing the Fiji National Medicinal Products Policy 2013-2018. Available from FPBSC. xi See Box – Further Information - in Section 2.

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Table 10: Reporting of ADRs

Reporting by: Doctors Yes

Nurses No

Pharmacists Yes

Consumers No

Pharmaceutical Companies No

Others No


The MRA is also responsible for regulating the Licensing and Registration of Pharmacies and Wholesalers. The need for registration of medicinal products has been stated in the Medicinal Products Decree 2011 and the National Medicinal Products Policy 2012. These documents require that medicinal products meet standards for safety, efficacy, and quality and that they are produced in accordance with good manufacturing practice. Thus, the Medicines Registration Unit within the MRA is developing a registration system to comply with the law. The registration system will verify the quality, safety, efficacy and production in accordance with good manufacturing practice of medicinal products. This assurance will protect the public from exposure to substandard medicinal products and the associated negative health and economic impact. The system will ensure all medicinal products meet quality standards, and that they continue to do so in the future. Only registered medicinal products will be imported into Fiji. The Pharmacovigilance aspects are monitored by the Essential Medicines Management Section of the Fiji Pharmaceutical & Biomedical Services Centre. The Ministry of Justice monitors controlled substance/medicines as per the Illicit Drugs Control Act, 2004.

Further developments

The Ministry of Health has completed the review of the current legislation with assistance from WHO. The Regulatory framework is redefined and outlines of the functions of different regulatory bodies are covered in the Medicinal Products Decree, the Pharmacy Professions Decree, the National Medicinal Products Policy and strategic implementation plans have been drafted. Directions for the Ministry of Health are covered in the above documents and implementation plans developed in the following areas:

• Ministry of Health will further strengthen Market Control through more thorough inspections/investigation.

• Inspectorate capacity improvement in terms of Human Resources/Capacity Building

• Ministry of Health collaboration with Police/Customs concerning imports; and especially pertaining to controlled medicines / chemicals.

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The policy documents and recommendations relating to this section that are in place for the next years are:

• The Pharmacy Profession Decree 2011 • The Medicinal Products Decree 2011 • The National Medicinal Products Policy of the Republic of Fiji, 2012. • Draft Pharmaceutical Sector Strategic Plan for implementing the Fiji National

Medicinal Products Policy 2013-‐2018. Available from FPBSC.

Implementation according to the Pharmaceutical Sector Strategic Plan (May 2013) concerning all regulatory aspects outlined in this section is a priority.

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Section 6 - Medicines Financing

In this section, information is provided on the medicines financing

mechanism in Fiji, including the medicines coverage through public and

private health insurance, use of user charges for medicines and the

existence of public programmes providing free medicines. Policies and

regulations affecting the pricing and availability of medicines (e.g. price

control and taxes) are also discussed.

6.1 Medicines Coverage and Exemptions

In Fiji, concessions are made for certain groups to receive medicines free

of charge (see Table 11). Furthermore, the public health system or social

health insurance schemes provide medicines free of charge for particular

conditions (see Table 12).

Table 11: Population groups provided with medicines free of charge

Patient group Covered Patients who cannot afford them Yes

Children under 5 Yes

Pregnant women Yes

Elderly persons Yes

Table 12: Medications provided publicly, at no cost14

Conditions Covered All conditions covered by medicines in the EML Varies (see above)

Any non-communicable diseases Varies (see above)

Malaria Yes

Tuberculosis Yes

Sexually transmitted diseases Yes

HIV-related disease Yes

Expanded Program on Immunization (EPI) vaccines for children

Yes

Other No

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6.2 Patients Fees and Co-payments

Co-payments or fee requirements for consultations are levied at the point

of delivery. However, there are no co-payments or fee requirements

imposed for medicines in the public sector. Revenue from fees or from the

sale of medicines is not used to pay the salaries or supplement the income

of public health personnel in the same facility.

6.3 Pricing Regulation for the Private Sectorxii

In Fiji, there are legal or regulatory provisions affecting pricing of medicines.

These provisions are aimed at the level of wholesalers and retailers.

6.4 Prices, Availability and Affordability of Key Medicines

In 2004, a WHO/HAI pricing survey was conducted in Fijixiii . Table 13

provides specific details regarding availability, pricing and affordability in

the country.

Availability

Availability in the private sector was 75% for the lowest priced generic

(LPG).

Pricing

The Median Price Ratio is used to indicate how prices of medicines in Fiji

relate to those on the international market. That is, prices of medicines

have been compared to international reference pricesxiv and are expressed

as a ratio of the national price to the international price. For example, a

price ratio of 2 would mean that the price is twice that of the international

xii This section does not include information pertaining to the non-profit voluntary sector xiii For more information on the methodology WHO/HAI pricing survey, you can download a free copy of the manual at http://www.haiweb.org/medicineprices/manual/documents.html xiv The International reference price is the median of prices offered by international suppliers (both for profit and not profit) as report by MHS International Price Indicator Guide (see Key References).

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reference price. Since prices have been collected for a predefined basket

of medicines, the Median Price Ratio has been selected to reflect the

situation in the country.

Patient prices in the private sector were above international reference

prices: Median Price Ratio for originators was 9.21 and for generics 2.73.

Table 13: Availability, Pricing and Affordability of medicines in Fiji

Public procurement

Public patient

Private patient

Availability

Mean (%) Originator N/A N/A

Lowest priced generic (LPG) N/A N/A

Median (%) Originator N/A N/A

Lowest priced generic (LPG) N/A 75

Price

Mean Price

Ratio

Originator N/A N/A 9.21

Lowest priced generic (LPG) N/A N/A 2.73

Affordability

Number of

days’ wages

Originator N/A N/A

Lowest priced generic (LPG) N/A N/A

N/A: data not available

6.5 Price Components and Affordability

No survey on medicine price components has been conducted in the past

five years.

6.6 Duties and Taxes on Pharmaceuticals (Market)

Fiji imposes duties on imported active pharmaceutical ingredients (APIs)

and duties on imported finished products are also imposed.

26


Currently the Ministry of Health provides medicines free of charge and is covering more than 70% of the population.

The coverage has improved over the last 10 years, whilst the Private sector has grown slowly and caters for around 30% of the population.

Patients with chronic renal failure, are not adequately covered as they’re responsible for organising their own dialysis treatment.

The Ministry of Health, is currently looking at various financing options and has so far completed a Project for setting up National Health Accounts.


It is recommended that the Ministry’s National Strategic Plan for Health, 2011-‐2015, is implemented. In the Plan, Government has recognised the need to strengthen healthcare services and through the Peoples Charter has made a commitment to have an annual increase to the health budget by 0.5% for the next 5 – 7 years to see it arrive to at least 5% of GDP; a figure that many observers say would make a huge impact on the delivery of healthcare services in Fiji.

• There has also been a focus on cost recovery strategies and a new schedule of fees for diagnostic and dental services; and inpatient hospital charges for paying patients are now in force. However, it needs to be pointed out that all revenue collected from this exercise goes to General Consolidated Account.

• The establishment of a Health Care Financing Unit is part of the Ministry’s strategic efforts to ensure it is able to identify gaps in the system and how to address them and also find out ways to have cost effective programmes.

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Section 7 - Pharmaceutical Procurement and Distribution in the Public Sector

This section provides a short overview on the procurement and distribution

of pharmaceuticals in the public sector of Fiji.

7.1 Public Sector Procurement

Public sector procurement in Fiji is both centralized and decentralized. The

public sector procurement is centralized under the responsibility of a

procurement agency (Fiji Pharmaceuticals and Biomedical Services Centre)

which is a part of the Ministry of Health. Procurement is based on the

prequalification of suppliers.

There is a written public sector procurement policy. This policy was

approved in 1995. Legal provisions that give priority to locally produced

goods in public procurement do not exist.

The key functions of the procurement unit and those of the tender

committee are clearly separated. A process to ensure the quality of

products that are publicly procured exists. The quality assurance process

includes the pre-qualification of products and suppliers. Explicit criteria and

procedures for pre-qualification of suppliers exist and a list of pre-qualified

suppliers and products is available.

The tender methods employed in public sector procurement include

national competitive tenders and international competitive tenders.

A list of samples tested during the procurement process and the results of

quality testing are available.

7.2 Public Sector Distribution

The government supply system department (Fiji Pharmaceuticals and

Biomedical Services Centre) in Fiji has a Central Medical Store (CMS) at

National Level. There is one public warehouse in the secondary tier of the

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public sector distribution which is based at a Divisional Hospital. There are

no national guidelines on Good Distribution Practices (GDP)xv. A licensing

authority that issues GDP licenses does not exist, however, GDP is

addressed in the National Medicinal Products Policy 2012.

A number of processes are in place at the CMS as detailed in Table 14.

Table 14: Processes employed by the Central Medical Store13

Process

Forecasting of order quantities Yes

Requisition/Stock orders Yes

Preparation of picking/packing slips Yes

Reports of stock on hand Yes

Reports of outstanding order lines Yes

Expiry dates management Yes

Batch tracking Yes

Reports of products out of stock Yes

The percentage availability of key medicines at the CMS is 95% (2009).

The average stock-out duration at the CMS is 15 to 45 days. Routine

procedures to track the expiry dates of medicines at the CMS exist. The

Public CMS is not GDP certified by a licensing authority or ISO certified.

The second tier public warehouse is also not GDP certified by a licensing

authority or ISO certified.

7.3 Private Sector Distribution

Legal provisions exist for licensing wholesalers and distributors in the

private sector. A list of GDP certified wholesalers and distributors exist in

the private sector.

xv Good Distribution Practices are covered in the National Medicinal Products Policy 2012 and the Strategic Plan for Implementation of that policy includes relevant activities to achieve Good Distribution Practices.

29


A tour to assess inventory management, dispensing and prescribing practices was undertaken on Vanua Levu by staff of the FPBSC in November 2008. Targets for further education were identified and training modules and Standard Operating Procedures were developed.

Supervision and monitoring supported by the Global Fund are undertaken regularly to check whether key medicines are available at health centres and whether stock management has improved.

In addition, there has been a thorough review of Procurement & Distribution processes with assistance from AusAID (FHSIP).

Standard Operating Procedures for the warehouse activities were reviewed with assistance from WHO, and Ausaid has provided support in terms of capacity building for warehouse activities.

The Medicinal Products Decree 2011 and the National Medicinal Products Policy 2012 further define the parameters of an efficient and cost–effective procurement system.

• The Pharmaceutical Sector Strategic Plan for implementing the Fiji National Medicinal Products Policy 2013-‐2018 identifies activities that will strengthen all aspects of the procurement and supply management cycle

• Capacity building of current staff has been identified as a major area of need.


The activities associated with the Procurement and Distributions domains in the Pharmaceutical Sector Strategic Plan for implementing the Fiji National Medicinal Products Policy 2013-‐2018 should be implemented as a priority. Implementation of those activities will address all aspects of the Procurement and Supply Management cycle including:

• Human resources needs and capacity • Forecasting & Quantification of needs • Cost effective procurement • Data management for forecasting and quantification for national procurement

for the public sector • Contracting, monitoring of order delivery and supplier performance • Evaluation of efficiency • Procurement in emergency situations • Appropriate transport, logistics, stock management and storage • Quality assurance processes for medicines in circulation • Distribution by private wholesalers

30

Section 8 - Selection and Rational Use of Medicines This section outlines the structures and policies governing the selection of

essential medicines and promotion of rational drug use in Fiji.

8.1 National Structures

A National Essential Medicines List (EML) exists. The EML (Fiji Essential

Drug Formulary) was updated in 2006 and is publicly available. There are

currently 444 medicines on the EML. Selection of medicines for the EML is

undertaken by a written process by specialist committees recognised by

the National Medicines and Therapeutics Committee (NMTC), Ministry of

Health. A mechanism aligning the EML with the Standard Treatment

Guidelines is in place.

National Standard Treatment Guidelines (STGs) for most common

illnesses are produced/endorsed by the NMTC. Specific STGs cover

secondary care (updated in 2010) and paediatric conditions (updated in

2007).

There is a public or independently funded national medicines information

centre providing information on medicines to prescribers, dispensers and

consumers. Public education campaigns on rational medicine use topics

have not been conducted in the last two years. A survey on rational use of

medicines has been conducted in the previous two years. There has been

no national programme or committee, involving government, civil society

and professional bodies, to monitor and promote rational use of medicines.

A written National Strategy for Containing Antimicrobial Resistance exists,

and was last updated in 2007.

Fiji’s EML includes formulations specifically for children. Criteria for the

selection of medicines in the EML are explicitly documented. A formal

committee or other equivalent structure for the selection of products on the

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EML exists. Conflict of interest declarations are not required from members

of the national EML committee.xvi

A funded national inter-sectoral task force to coordinate the promotion of

the appropriate use of antimicrobials and prevention of the spread of

infection does not exist. A national reference laboratory or other institution

has responsibility for coordinating epidemiological surveillance of

antimicrobial resistance.

8.2 Prescribing

Legal provisions to govern the licensing and prescribing practices of

prescribers exist. Furthermore, legal provisions restricting dispensing by

prescribers exist. Prescribers in the private sector sometimes dispense

medicines. There are regulations requiring hospitals to organize or develop

Drug and Therapeutics Committees (DTCs). All divisional hospitals have

DTCs.

The training curriculum for doctors and nurses is made up of a number of

core components detailed in Table 15.

Table 15: Core aspects of the medical training curriculum

Curriculum Covered The concept of EML Yes

Use of STGs Yes


Problem based pharmacotherapy Yes

Mandatory continuing education that includes pharmaceutical issues is

required for doctors and paramedical staff, but not for nurses. Prescribing

by INN is obligatory in the public and private sector.

xvi The Pharmaceutical Sector Strategic Plan for implementing the Fiji National Medicinal Products Policy 2013-2018 provides for the development of Terms of Reference for the NDTC that will include a Conflict of Interest Clause.

32

8.3 Dispensing

The basic pharmacist training curriculum at the Fiji National University

includes a spectrum of components as outlined in Table 16.

Table 16: Core aspects of the pharmacist training curriculum

Curriculum Covered The concept of EML Yes

Use of STGs Yes

Drug information Yes

Clinical pharmacology Yes

Medicines supply management Yes

Mandatory continuing education that includes rational use of medicines is

required for pharmacists.

Substitution of generic equivalents at the point of dispensing is allowed in

public and private sector facilities. Sometimes, antibiotics are sold over-

the-counter without a prescription. Sometimes, injectable medicines are

sold over-the-counter without a prescription.

A professional association code of conduct which governs the professional

behaviour of pharmacists exists. In practice, nurses (only specialised

Nurse Practitioners) do sometimes prescribe prescription-only medicines at

the primary care level in the public sector (even though this may be

contrary to regulations).

33


Standard Treatment Guidelines (STGs) are regularly updated. They are being advocated and distributed to promote rational use of medicines. All medicines on STGs are available and supplied free of charge by the Ministry of Health.

STGs are being developed with technical and financial assistance from Therapeutic Guidelines Limited, Australia, and WHO.


Activities defined in the Pharmaceutical Sector Strategic Plan, 2013-‐2018, for implementing the National Medicinal Products Policy, 2012 will address outstanding issues associated with rational use of medicines. They should be prioritized and undertaken in a timely manner. Among others, activities are defined to strengthen:

• The roles of the Medicines and Therapeutics committee • The roles of the Essential Medicines Authority including maintenance of an

updated EML • Training for rational use of medicines; prescribing and dispensing • Patient compliance and self-‐medication • Adverse medicines reaction reporting and response • Medicines Information.

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Section 9 - Household data/access

In the past 5 years, no household surveys have been undertaken to assess

the access to medicines.

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List of key reference documents: Antibiotic Guidelines, 2nd Edition, 2003/2004 (updated 2010)

Bailey M. Afffordability of medicines in Fiji, 2004. Available online: http://www.haiweb.org/medicineprices/surveys/200409FJ/survey_report.pdf

Cardiovascular Drug Guidelines, 2nd edition 2006 (updated 2011)

Cornelius, M, Decourten, M, Pryor J, Saketa, S, Waqanivalu, T, Laqeretabua, A, Chung, E 2002, ‘Fiji Non-Communicable Diseases (NCD) STEPS Survey’ WHO, pp 22-29

Costing Study of Selected Health Facilities in Fiji.pdf Available online: http://www.health.gov.fj/costing-study-of-selected-health-facilities-in-fiji.html#.Ultu3OBC-sE

Draft Pharmaceutical Sector Strategic Plan for implementing the Fiji National Medicinal Products Policy 2013-2018. Available from FPBSC.

Emergency Drug Guidelines, 2nd Edition, 2008

Fiji Essential Medicines Formulary (List), 2006 (updated)

Fiji Essential Medicines List (2012) Available online: http://www.health.gov.fj/essential-med-authority.html#.UluRa-BC-sE

Fiji Health Accounts 2007-2008, Ministry of Health. Available online: http://www.health.gov.fj/files/reports/Fiji%20NHA%20Report%202007-2008.pdf

Fiji HIV Decree http://hivaidsclearinghouse.unesco.org/search/resources/iiep_fijihivaidsdecree.pdf Fiji Ministry of Health's National Strategic Plan for Health, 2011-2015. Available online http://www.wpro.who.int/health_services/fiji_nationalhealthplan.pdf

Fiji National Health Information Policy

Fiji Public Health Act (Repealed to September 2011)

Guide to Good Manufacturing Practice for Medicinal Products. Available online http://www.tga.gov.au/industry/manuf-pics-gmp-medicines.htm

Guidelines for Medical Supplies Donations to The Republic of Fiji Islands 2007. Available from FPBSC.

Guidelines for the Management of Diabetes Mellitus, 2nd Edition, 2005

Guidelines of Drugs Commonly Used in Treating Mental Illness and Related Disorders, 1st Edition, 2010

Health Systems in Transition The Fiji Islands, Health Systems Review. Vol.1 No.1 2011. Available online: shttp://www.wpro.who.int/asia_pacific_observatory/hits/series/Fiji_Islands_Health_Systems_Review.pdf

Hospitals, Health Centres and Nursing Stations in Fiji. Available online: http://www.health.gov.fj/locate-us.html#.UluSq-BC-sF

Illicit Drugs Control Act, 2004

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International Ethical Guidelines for Biomedical Research Involving Human Subjects. Prepared by the Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO). Available online: http://www.cioms.ch/publications/layout_guide2002.pdf

Inventory Management, Dispensing and Prescribing Practices Assessment Tour Report: Vanua Levu 17/11/08 – 21/11/08. Available from FPBSC.

MDG Report 1990-2009, Fiji Islands (2008)

Ministry of Health Annual Reports 2002-2009

Ministry of Health Fiji, Official Website (2011): http://www.health.gov.fj/

Ministry of Health Strategic Plan, 2011-2015

Ministry of National Planning, MDG Report 2nd Report, 1990-2008, 2009 Report for the Fiji Islands

MSH International Price Indicator Guide. Available online: http://www.msh.org/blog/2013/07/08/new-international-drug-price-indicator-guide-now-available

National Antiretroviral Therapy Guidelines, 1st Edition, 2004

National Health Accounts (NHA) Country Information (2008), “Fiji”. Available online: http://www.who.int/nha/country/fji/en/

National Health Accounts (NHA) Country Information (2009), “Fiji”. Available online: http://www.who.int/nha/country/fji/en/

National Health Strategic Plan (2011-2015)

National Medicinal Products Policy 2012. Available from FPBSC

Office of the Attorney-General, Ministry of Justice, Box 2213, Government Buildings, Suva, Fiji. Website: http://www.ag.gov.fj/

Patents Act [Chapter 239], January 25th 1879, Laws of Fiji, Ed 1978. Available online: http://www.wipo.int/wipolex/en/text.jsp?file_id=184378

Public Hospitals and Dispensaries (Amendment) Regulations 2012.pdf (5.67 MB)

Respiratory Drug Guidelines, 1st Edition 2008

Review of Pharmaceutical Financing and Expenditure in Selected PICs (2005). Available at: http://apps.who.int/medicinedocs/en/m/abstract/Js16791e/

The Medicinal Products Decree 2011

The National Medicinal Products Policy of the Republic of Fiji, 2012.

The Pharmacy Profession Decree 2011

WHO: http://www.wpro.who.int/health_information_evidence/documents/CHIPS/en/index.html

WHO: Western Pacific Country Health Information Profiles 2010 Revision, 2006 data; World Health Statistics 2011, 2009 data

World Bank data. Available online: http://www.worldbank.org/en/country/pacificislands

World Health Organization (WHO) (2009), “World Health Statistics 2009”, WHO Press, Geneva. Available online: http://www.who.int/whosis/whostat/2009/en/index.html.

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World Health Organization (WHO) (2010), “World Health Statistics 2010”, WHO Press, Geneva. Available online: http://www.who.int/whosis/whostat/2010/en/index.html.

World Health Organization (WHO) (2011), “World Health Statistics 2011”, WHO Press, Geneva. Available online: http://www.who.int/whosis/whostat/2011/en/index.html

World Health Organization (WHO) Western Pacific Region (2010), “Country Health Information Profiles (CHIPS)”, 2010 Revision, WHO Press, Geneva. Available online: http://www.wpro.who.int/internet/files/hin/CHIPS2010.pdf

World Health Organization (WHO) Western Pacific Region, “Country Health Information Profiles (CHIPS)”, 2011 Revision, WHO Press, Geneva. Available online: http://www.wpro.who.int/health_information_evidence/documents/CHIPS2011.pdf

World Trade Organization (1996). Available online: http://www.wto.org/english/thewto_e/countries_e/fiji_e.htm

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