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KIRIBATI

PHARMACEUTICAL COUNTRY PROFILE

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Kiribati Pharmaceutical Country Profile

Published by the Ministry of Health and Medical Services in collaboration with the World Health Organization

August 2012

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

Nawerewere, Tarawa, Kiribati P.O. Box 268, Bikenibue,Tarawa, Kiribati

(686) 28100 Email: Ioana Taakau <[email protected]>

This document was produced with the support of the World Health Organization (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 Kiribati has been produced by

the Ministry of Health and Medical Services, 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 Kiribati. The compiled

data comes from international sources (e.g. the World Health Statistics1,2),

surveys conducted in the previous years and country level information

collected in 2011. The sources of data for each piece of information are

presented in the tables that can be found in the document and from

references at the end of the document.

On behalf of the Ministry of Health and Medical Services, I wish to express my

appreciation to the coordinator, Chief Pharmacist, Ms Ioana Taakau for her

contribution 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 Kiribati Pharmaceutical Sector will find this profile a useful

tool to aid their activities.

Name…Wiriki Tooma……

Secretary, Ministry of Health & Medical Services

Date 9/12/2013

Signature…

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Table of content

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

Section 1 - Health and Demographic Data ........................................................ 2

Section 2 - Health Services ................................................................................ 7

Section 3 - Policy Issues .................................................................................. 11

Section 4 - Medicines Trade and Production .................................................. 13

Section 5 - Medicines Regulation .................................................................... 16

Section 6 - Medicines Financing ...................................................................... 22

Section 7 - Pharmaceutical Procurement and Distribution in the Public Sector ................................................................................................................. 24

Section 8 - Selection and Rational Use of Medicines .................................... 26

Section 9 - Household Data / Access…………………………………….…..…..30

1

Introduction

This Pharmaceutical Country Profile provides data on existing socio-economic

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

outcomes relating to the pharmaceutical sector of Kiribati. 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_assessment/e

n/index.html).

During 2011, the World Health Organization supported all WHO Member

States to develop similar comprehensive pharmaceutical country profiles.

More recent information has also been included.

The information is categorized in 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

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

and representatives from 13 pilot countries.

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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 Kiribati was Ms Ioana Taakau.

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. Comments, suggestions or corrections

may be sent to:

Ms Ioana Taakau

Chief Pharmacist

Nawerewere,

Tarawa, Kiribati

P.O. Box 268,

Bikenibeu, Tarawa, Kiribati

Signature

3

Section 1 - Health and Demographic Data

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

Kiribati.

1.1 Demographics and Socioeconomic Indicators

The total population of Kiribati in 2011 was 103,466 with an annual population

growth rate of 1.6% (Kiribati Annual Report [KAR] 2011). The annual Gross

Domestic Product (GDP) growth rate is 1.5% (World Bank Data). The GDP

per capita was US$ 1,339.48 (IMF 2009) (at the current exchange ratei).

Of the total population, 36% is under 15 years of age and 5% is 60 years of

age and above (KAR 2011). The urban population currently stands at 48.3%

of the total population. The fertility rate in Kiribati is 2.7 births per woman. The

adult literacy rate for the population over 15 years is 91% (KAR 2011).

1.2 Mortality and Causes of Death

The life expectancy at birth is 70 and 80 years for men and women

respectively (KAR 2011). The infant mortality rate (i.e. children under one year)

is 38/1,000 live births. For children under the age of five, the mortality rate is

35/1,000 live births (WP CHIPS 2011, 2008 data).

i The current exchange rate for calculation is AUD 1 = USD 1.05432 on June 17th, 2011 [http://www.oanda.com/currency/converter/].

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The top 10 diseases causing mortality in Kiribati are (World Health Rankings,

Kiribati):

http://www.worldlifeexpectancy.com/country-health-profile/kiribati (2010)

Disease

1 Stroke

2 Diabetes mellitus

3 Lower respiratory conditions

4 Endocrine disorders

5 Tuberculosis

6 Diarrhoeal diseases

7 Low birth weight

8 Asthma

9 Liver disease

10 Hypertension

The top diseases causing morbidity requiring inpatient care in Kiribati are [Western Pacific Country Health Information Profiles, 2011 revision, 2008 data]

Disease 1 Diarrhoeal diseases 2 Acute respiratory infections 3 Communicable diseases 4 Eye diseases 5 Non-communicable diseases 6 Nutrition-related diseases 7 Injury and poisoning 8 Skin diseases

The adult mortality rate for both sexes between 15 and 60 years is 251/1,000

population, while the neonatal mortality rate is 12 /1,000 live births. The age-

standardised mortality rate by non-communicable diseases is 730/100,000,

245 /100,000 by cardiovascular diseases and 52/100,000 by cancer. The

mortality rate is 25/100,000 for tuberculosis and malaria is not present in

Kiribati (WHS 2008).

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Further information:

(Source Kiribati MH&MS 2012. Country Health Information Profile)

The Republic of Kiribati includes three island groups – Gilbert, Phoenix and Line – and comprises 32 atolls and one elevated coral island with a total land area of 811 square kilometres dispersed over five million square kilometres of ocean making it the most dispersed among the Pacific island Countries. The wide dispersal of small population groups and the infrequency of transportation servicing them that poses significant challenges to the timely provision of health services. The low-‐lying atolls of Kiribati make the country very vulnerable to climate change and rises in sea-‐level. It is estimated (World Bank Regional Economic Report 2000) that, without appropriate adaptation measures, 25%-‐54% of the land in areas of South Tarawa and 55%-‐80% in North Tarawa will be inundated by 2050.

The natural environment in urban areas is under pressure due to groundwater depletion, marine-‐life and sea-‐water contamination from human and solid waste, over-‐fishing of the reefs and lagoons, ad hoc construction of seawalls, coastal erosion and illegal beach mining. The country is also facing considerable socioeconomic difficulties due to the ad hoc management of urban growth.

With the current growth rate, the population of Kiribati will double by 2025; however with steady migration to the capital, the population of South Tarawa will double by 2015 causing stress on the environment, schools and labour markets. (WHO&MHMS 2012).

Environmental factors are increasing the risk of communicable diseases in Kiribati. High-‐density housing and overcrowding in urban areas, such as South Tarawa, is facilitating the transmission of infectious diseases. TB incidence in Kiribati has now surpassed that of other Pacific island countries, and most reported cases are found in the urban settlement of Betio in South Tarawa. Other health indicators suggest that the health status of people living in South Tarawa is now worse than that of people living in the outer islands.

Inadequate water supplies, unsafe drinking-‐water, variable standards of personal hygiene, poor food handling and storage, and poor sanitation are all contributing to the high number of cases of diarrhoeal, respiratory, eye and skin infections. Diarrhoeal diseases and respiratory infections are major causes of mortality among children.

There is a high prevalence of STI, with a surveillance study in 2004 showing that approximately 15% of pregnant women were infected. HIV was first confirmed in Kiribati in 1991, and the number of people infected continues to rise. At the end of 2010, Kiribati had a cumulative total of 54 HIV cases, of whom 24 were known to have died (follow-‐up is a problem). Since 2006, nine people living with HIV have been enrolled in a care and treatment program. Three have since died.

Data suggest that the prevalence of non-‐communicable diseases is increasing. Around 70% of males between the ages of 30 and 54 are regular smokers, compared with less than 50% of the adult female population, while 32% of young males aged 15-‐19 smoke (2005 census).

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Further Information (continued)

Economic development and modernization has increased reliance on imported, processed food, such as rice and noodles, and on motorized transport. Such changes, together with a strong tradition of feasting, have led to overnutrition (overweight and obesity among women >80%) and reduced activity in adults, increasing the risk of noncommunicable disease. Results from the 2004-‐2005 STEPs survey showed approximately 22% of the adult population had diabetes (second highest worldwide), and disease of the circulatory system is now the second leading cause of mortality.

The Ministry of Health receives significant technical and financial support from development partners.

WHO provides funding and technical support for: epidemic alert and response; HIV care and treatment; health promotion, including tobacco control; environmental health; essential health technologies and medicines; health information; and health system development. The United Nations Population Fund (UNFPA) supports reproductive health activities and the United Nations Children’s Fund (UNICEF) supports the expanded programme on immunization (EPI), nutrition and infant feeding, and implementation of the integrated management of childhood illness (IMCI) strategy. The Secretariat for the Pacific Community (SPC) supports the control of tuberculosis, HIV/STIs, noncommunicable diseases, disease surveillance and pandemic preparedness. Considerable support is also provided by the Australian Agency for International Development, the New Zealand Agency for International Development, through its High Commission, and the governments of Cuba and Taiwan (China).

A large outer island project, funded by the European Union, is refurbishing outer island health facilities, providing in-‐country training courses from the Fiji School of Medicine and developing primary health care capacity in the outer islands.

The Ministry of Health and Medical Service’s Strategic Plan (2012-‐2015) builds on previous plans and has six Objectives:

1. Increase access to and use of high quality, comprehensive family planning services, particularly for vulnerable populations including women whose health and wellbeing will be at risk if they become pregnant

2. Improve maternal, newborn and child health

3. Prevent the introduction and spread of communicable diseases, strengthen existing control programmes and ensure Kiribati is prepared for any future outbreaks

4. Strengthen initiatives to reduce the prevalence of risk factors for NCDs, and consequently reduce morbidity, disability and mortality from NCDs

5. Address gaps in health service delivery and strengthen the pillars of the health system

6. Improve access to high quality and appropriate health care services for victims of gender based violence, and services that specifically address the needs of youth

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Section 2 - Health Services

This section provides information regarding health expenditures and human

resources for health in Kiribati. 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 Kiribati, the total health expenditure (THE) in 2009 was AU$ 20.00 million

(US$ 15.63 million). The THE was 12.03% of the GDP, equivalent to

AU$ 206.19 (US$ 161.13) per capita (NHA data).

The general government health expenditure (GGHE) in 2009 as reflected in

the National Health Accounts (NHA) was AU$ 17.00 million (US$ 13.28

million). That is 8.7% of the THE, with a public health expenditure of

AU$ 175.26 (85%). The GGHE 2009 represents 16.5% of the total

government budget according to the KAR 2011.

There is no national public health insurance, social insurance, other sickness

fund or private health insurance.

Total pharmaceutical expenditure (TPE) in 2010 was AU$ 1.3 million (US$ 1.0

million), which makes AU$ 12.60 (US$9.0) per capita. The total

pharmaceutical expenditure makes up 17% of the THE (Figure 1.)

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Figure 1: Share of Total Pharmaceutical Expenditure as percentage of the Total Health Expenditure 2010. The THE in 2009 was AU$ 20.00 million ($US 15.63 million)

Source: MHMS Health Service Delivery Profile 2012

The Government is the sole provider of health services in Kiribati except for

one Mormon Clinic.

Health care services are provided free of charge to all Kiribati residents so

there is minimal out-of-pocket expenditure for health. All non-I-Kiribati tourists

and travellers, and foreign seamen are charged for any medical services

provided. There are also charges to patients admitted to the private ward in

the hospital. Any non-I-Kiribati involved with the Government of Kiribati or with

missionaries also receive free health care services.

The New Zealand Aid program provides funding for medical referrals to New

Zealand. In 2010 a total of $US 630,000 was spent on referral of 57 patients.

All health care is government financed but the government gets financial

assistance from relevant donor programs including the Global Fund.

2.2 Health Personnel and Infrastructure

The health workforce is described in Table 1 and in Figure 2. There are five

(0.5/10,000) licensed pharmacists, of which all work in the public sector.

There are three (0.3/10,000) pharmacy technicians and assistants (in all

sectors). There are fewer pharmacy technicians than pharmacists.

TPE 17%

THE 83%

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There are 20 (2.06 /10,000) physicians and 276 (26.8 /10,000) nursing and

midwifery personnel in Kiribati. The ratio of doctors to pharmacists is 4:1 and

the ratio of doctors to nurses and midwifery personnel is 1:10.

Table 1: Human resources for health in Kiribati

Human Resource

Licensed pharmacists (all sectors) 5 (0.5 /10,000)

Pharmacists in the public sector 5 (0.5 /10,000)

Pharmacy technicians and assistants (all sectors) 3 (0.3/10,000)

Physicians (all sectors) 20 (2.06/10,000)

Nursing and midwifery personnel (all sectors) 276 (26.8 /10,000) Figure 2: The density of the Health Workforce 2009 in Kiribati /10,000 population (all sectors)

(Western Pacific CHIPs 2010)

In Kiribati, there is no strategic plan for pharmaceutical human resource

development in place.

The health facilities are described in Table 2 below. There are four hospitals

and a total of 140 hospital beds in Kiribati. There are 102 primary health care

units and centres (including dispensaries) and no private retail pharmacies.

0 5 10 15 20 25 30

Nurses/midwives

Doctors

Pharmacists

Pharm.Assistants

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Table 2: Health centre and hospital statistics (WHO, KMHMS 2102 Health Service Delivery Profile)

Infrastructure

Hospitals 4

Hospital beds 140

Primary health care units and centres 102

Licensed pharmacies 0

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

sector is AU$ 12,000. The total number of pharmacists who graduated (as a

first degree) in the past two years is two. There are no Pharmacy schools in

Kiribati. Pharmacy study is undertaken in Australia, Fiji or New Zealand.

Further information and key findings:

Human resources are a major weak spot in the health care system. The workforce is very sensitive to ‘brain drain’ to countries such as Australia and New Zealand.

In health facilities, pharmacy related work is done by nurses. Primary health centres are run by Medical Assistants (MA) -‐ nurses who undergo extra training. Their formal training does not cover medicines management sufficiently so it is important that on-‐the-‐job training and supervision are provided to strengthen knowledge of rational use of medicines (according to existing Standard Treatment Guidelines), maintenance of records and correct ordering to ensure a reliable supply of medicines. More pharmacists are needed to do the training.

The introduction of the Cuban Medical Program in 2008 was a result of an agreement between the Government of Kiribati and the Government of Cuba to assist Kiribati with its shortages in medical specialists. There are also I-‐Kiribati students studying medicine in Taiwan.

Key recommendations:

• Collaboration between the health sector and Secondary Schools should be strengthened to try to develop programmes that could encourage more students to embark on health sector careers.

• Consideration of suitable career structure including incentives is suggested to retain staff and regularly update skills by a continuing education and refresher training program.

• Consideration should be given to development of a strategic plan for pharmaceutical workforce development.

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Section 3 - Policy Issues

This section addresses the main characteristics of the pharmaceutical policy

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

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

The Ministry of Health and Medical Services (MH&MS) works within a

framework of policies and service delivery guidelines. The associated

MH&MS Strategic Plan was updated in 2011 to extend the period to 2012 -

2015 (see additional information at the end of this section).

An official National Medicines Policy document exists. It was updated in 2011

but has not been endorsed or launched. An NMP implementation plan does

not exist. Policies addressing pharmaceuticals are detailed in Table 3.

Pharmaceutical policy implementation is not regularly monitored/assessed.

Table 3: The (draft) NMP covers

Aspect of policy Covered

Selection of essential medicines Yes

Medicines financing Yes

Medicines pricing No

Medicines Procurement Yes

Medicines Distribution Yes

Medicines Regulation Yes

Pharmacovigilance No

Rational use of medicines Yes

Human Resource Development Yes

Research No

Monitoring and evaluation Yes

Traditional Medicine No

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A policy relating to clinical laboratories does not exist. Access to essential

medicines/technologies as part of the fulfillment of the right to health, is

recognized in the constitution or national legislation. There are official written

guidelines on medicines donations.

There is no national good governance policy.

There is no policy in place to manage and sanction conflict of interest issues

in pharmaceutical affairs, while there is a formal code of conduct for public

officials. A whistle-blowing mechanism that allows individuals to raise

concerns about wrong-doing occurring in the pharmaceutical sector of Kiribati

does not exist.

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The strategic objectives for the MH&MS Strategic Plan for the period 2012–2015 are:

1. Increase access to and use of high quality, comprehensive family planning services, particularly for vulnerable populations including women whose health and wellbeing will be at risk if they become pregnant

2. Improve maternal, newborn and child health

3. Prevent the introduction and spread of communicable diseases, strengthen existing control programmes and ensure Kiribati is prepared for any future outbreaks

4. Strengthen initiatives to reduce the prevalence of risk factors for noncommunicable diseases (NCDs), and consequently reduce morbidity, disability and mortality from NCDs

5. Address gaps in health service delivery and strengthen the pillars of the health system

6. Improve access to high quality and appropriate health care services for victims of gender based violence, and services that specifically address the needs of youth

Other important strategies and legislation include:

• Kiribati Development Plan (2008-‐2011). Major issues for health include maternal and child health; tuberculosis; NCDs, HIV and AIDS, STIs and hepatitis; medical supplies and facilities and population growth

• Kiribati National Development Strategies (NDS) (2008-‐2011). The Plan is strongly aligned with the MDGs, and includes health as one of its six priority areas

• National Population Policy (2005). Establishes the clear target to stabilise the population by 2025

• Medical Services Act (1996). The objective is to control the registration and discipline of all health professionals (except traditional healers)

• National HIV and STI Strategic Plan (2005-‐2008). Contains three priority areas: treatment, care and support; prevention; and coordination of the national multi-‐sectoral response.


A Strategic Plan for implementation of the National Medicines Policy (2010) should be developed. Short -‐ medium – and long-‐term activities should be identified that will address the components of the NMP. Expected outcomes of those activities should be described in the Plan along with the persons responsible for implementation together with expected indicators of achievement.

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Section 4 - Medicines Trade and Production

4.1 Intellectual Property Laws and Medicines

Kiribati is not a member of the World Trade Organization. However, legal

provisions granting patents to manufacturers exist and they cover

pharmaceuticals, laboratory supplies, medical supplies, medical equipment.

Intellectual Property Rights are managed and enforced by Industrial Property,

Ministry of Commerce, Industry and Tourism, P.O. Box 510, Betio, Tarawa,

Kiribati.

Currently Kiribati refers to Registration of UK Patents Ordinance.

National Legislation has not been modified to implement the Trade- Related

Aspects of Intellectual Property Rights (TRIPS) Agreement and to contain

TRIPS-specific flexibilities and safeguards. Kiribati is eligible for the

transitional period to 2016.

The country is not engaged in capacity-strengthening initiatives to manage

and apply Intellectual Property Rights in order to contribute to innovation and

promote public health.

4.2 Manufacturing

There are no licensed pharmaceutical manufacturers in Kiribati.

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It is recommended that Trade-‐Related Aspects of Intellectual Property Rights (TRIPS) compliant, health sensitive Laws be developed to enable access to affordable medicines that are needed to address the health problems of Kiribati.

• The Government should take advantage of all the flexibilities and safeguards within the TRIPS Agreement for the promotion of public health and ensuring access to pharmaceuticals.

• The implications of international trade and other treaties should be studied so as to safeguard the national interest concerning public health and ensure access to pharmaceuticals. In particular, any potential Free Trade Agreement will be examined in detail to ensure that flexibilities available under the TRIPS agreement are not affected.

• The Ministry of Health and Medical Service should collaborate with other Ministries and other relevant agencies in the area of Intellectual Property Rights in developing a legal framework that enhances access to essential medicines including grant of compulsory licensing and parallel importation and Government Use. Public health and access to pharmaceuticals must remain in the forefront while undertaking and signing any bilateral or international treaties or agreements.

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Section 5 - Medicines Regulation

This section details the pharmaceutical regulatory framework, resources,

governing institutions and practices in Kiribati.

5.1 Regulatory Framework

There is no medicines legislation at present. Medicines legislation was drafted

in 2004 but it is still work in progress. Without medicines legislation in place,

there is insufficient regulatory control of medicines-related activities (Allen and

Clarke 2009). The NMP will be finalized and endorsed, then legislation will be

updated.

In Kiribati, there are no legal provisions establishing the powers and

responsibilities of a Medicines Regulatory Authority (MRA) but elements of an

MRA exist in the Pharmacy Department within the Ministry of Health and

Medical Services (MHMS).

Table 4: Elements of an MRA in the Pharmacy Department within the MHMS

Function

Marketing authorisation / registration No

Inspection Yes

Import control Yes

Licensing Yes

Market control N/A

Quality control Yes

Medicines advertising and promotion Yes

Clinical trials control No

Pharmacovigilance Yes

(The NDTC is involved in initiatives such as development of Standard

Treatment Guidelines and guiding the use of medicines in Kiribati.)

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5.2 Marketing Authorization (Registration)

In Kiribati, there are no national legal provisions requiring marketing

authorization (registration) for all pharmaceutical products on the market so

information from the prequalification programme managed by WHO is used

for product registration.

Possession of a Certificate for Pharmaceutical Products that accords with the

WHO Certification Scheme on the Quality of Pharmaceutical Products Moving

in International Commerce is required. By law, potential conflict of interests for

experts involved in the assessment and decision-making need not be

declared.

5.3 Regulatory Inspection In Kiribati, legal provisions allowing for appointment of government

pharmaceutical inspectors do not exist. However, staff of the Pharmacy

Department may inspect premises where pharmaceutical activities are

performed and where medical products are sold over-the-counter in retail

stores and super-markets.

5.4 Import Control

Legal provisions requiring authorization to import medicines do not exist. The

Pharmacy Department is the sole importer of medicines for the public health

programs. However donor organisations (eg Global Fund) and specific

disease focussed programs assist with provision of medicines supplies in

collaboration with the Ministry of Health.

In addition general importers import medicines that can be sold over- the-

counter in retail stores. Laws do not exist that allow the sampling of imported

products for testing and legal provisions do not exist requiring importation of

medicines through authorized ports of entry. Regulations or laws that allow for

inspection of imported pharmaceutical products at authorized ports of entry do

not exist. However the procurement process ensures quality of imported

pharmaceutical products for the national health sector.

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5.5 Licensing

There are no pharmaceutical manufacturers in Kiribati and there are no legal

provisions requiring manufacturers (domestic and/or international) to comply

with Good Manufacturing Practices (GMP). Good Manufacturing Practices are

not published by the government.

Legal provisions do not exist requiring importers/wholesalers/distributors to be

licensed. General importers/wholesalers/distributors without licenses import

pharmaceutical products allowed for over-the-counter sale in retail outlets.

Legal provisions requiring wholesalers and distributors to comply with Good

Distribution Practices do not exist. However, Good Distribution Practices are

published by the government.

Legal provisions requiring pharmacists to be registered do not exist and there

are currently no private pharmacies. National Good Pharmacy Practice

Guidelines are not published by the government.

5.6 Market Control and Quality Control

In Kiribati, legal provisions do not exist for controlling the pharmaceutical

market. Although there are no private pharmacies, over-the-counter medicinal

products are sold in retail stores.

There is no Medicines Quality Control Laboratory. Quality control testing is

contracted elsewhere in collaboration with other Pacific island Countries.

These services include the Therapeutic Goods Administration Laboratories

(TGAL), Australia and other WHO prequalified laboratories in the region.

Medicines are tested for a number of reasons, summarised in Table 5.

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Table 5: Reason for medicines testing

Medicines tested:

For quality monitoring in the public sectoriii Yes

For quality monitoring in the private sector No

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

Quality testing has not been done in the last two years..

Some suppliers (for example Fiji Pharmaceuticals and Biomedical Services

Centre) do quality control testing and they report results of testing if

pharmaceuticals tested failed to meet standards.

5.7 Medicines Advertising and Promotion In Kiribati, legal provisions exist to control the promotion and/or advertising of

prescription medicines. The MHMS is responsible for regulating promotion

and/or advertising of medicines. There are no legal provisions to prohibit

direct advertising of prescription medicines to the public and there are no legal

provisions for pre-approval for medicines advertisements and promotional

materials. In addition, there are no guidelines or regulations covering

advertising and promotion of non-prescription medicines. There is no national

code of conduct concerning advertising and promotion of medicines by

marketing authorization holders.

5.8 Clinical Trials

In Kiribati, legal provisions do not exist requiring authorization for conducting

clinical trials. There are no additional laws requiring the agreement by an

ethics committee or institutional review board of the clinical trials to be

performed. Clinical trials are not required to be entered into an

international/national/regional registry, by law.

iii Routine sampling in pharmacy stores and health facilities

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5.9 Controlled Medicines

Kiribati is a signatory to the UN Convention on Psychotropic Substances,

1971, detailed in Table 6.

Table 6: International Conventions to which Kiribati is a signatory

Convention Signatory

Single Convention on Narcotic Drugs, 1961 No

1972 Protocol amending the Single Convention on Narcotic Drugs,

1961

No

Convention on Psychotropic Substances 1971 Yes

United Nations Convention against the Illicit Traffic in Narcotic Drugs

and Psychotropic Substances, 1988

No

5.10 Pharmacovigilance In Kiribati, there are no legal provisions that provide for pharmacovigilance

activities as part of an MRA mandate. Legal provisions also do not 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 and there is no national

pharmacovigilance centre.

Reports for ADRs have been included in the Poisons Report Recording

System (computerised), however no health worker has reported a case.

ADRs are monitored in at least one public health program (e.g. tuberculosis,

HIV related disease).

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With no revised Medicines Legislation many of the issues in this section cannot be addressed.

The National Medicines Policy does address the issues in the section and legislation should support the Policy.

The revision of the National Medicines Policy has involved all stake-‐holders so there should be ownership of implementation of the NMP. The NMP also specifies that legislation and the NMP must support each other. Therefore appropriate content of the NMP must be ensured and supporting Legislation must be submitted to be passed by Parliament as soon as possible.


The NMP should be checked to ensure it does address all the necessary issues and it should be promptly adjusted if necessary and re-‐launched as a priority.

The NMP recognises that legislation must be in place to support the policy so legislation much be updated and submitted to Parliament as an urgent priority.

A Strategic Plan for implementation of the National Medicines Policy (2010) should be developed as articulated after Section 3. That will identify short-‐ medium-‐ and long-‐term activities that will address the outstanding issues in this section. Expected outcomes of those activities should be described in the Strategic Plan along with the persons responsible for implementation and timelines together with expected indicators of achievement.

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Section 6 - Medicines Financing

In this section, information is provided on the medicines financing mechanism

in Kiribati, 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 Kiribati, medicines are provided free to all citizens including groups

described in Table 7. There is no social health insurance scheme.

Table 7: 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 8: Medications provided publicly, at no cost

Conditions Covered

All conditions covered by medicines in the EML Yes

Any non-communicable diseases Yes

Malaria (not present) -

Tuberculosis Yes Sexually transmitted diseases Yes HIV related disease Yes Expanded Program on Immunization (EPI) vaccines for children Yes

6.2 Patients Fees and Co-payments

There are no co-payments or fee requirements for consultations at the point of

delivery and no co-payments or fee requirements imposed for medicines.

There is no revenue from fees or from the sale of medicines used to pay the

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salaries or supplement the income of public health personnel in the same

facility.

6.3 Pricing Regulation for the Private Sectoriv

In Kiribati there are no legal or regulatory provisions affecting pricing of

medicines. There is no retail sector so there was no WHO /HAI pricing survey

conducted.

6.4 Prices, Availability and Affordability of Key Medicines

According to Pharmacy procurement data, public procurement prices were in

line with international reference prices. Generics are procured routinely.

Affordability As medicines are all available free to Kiribati citizens, affordability is not an

issue.

6.6 Duties and Taxes on Pharmaceuticals (Market)

There are tax waivers on health products so no import tax is imposed on

pharmaceutical products in Kiribati.


There has been some discussion among health personnel about charging patients minimal flat fees for medicines to encourage better care of medicines and to deter unnecessary requests for repeats. However the idea is repeatedly rejected.


Capacity to report and deal with adverse medicine reactions and medication errors should be developed with the assistance of the National Medicines and Therapeutics Committee.

iv This section does not include information pertaining to the non-profit voluntary sector

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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 Kiribati.

7.1 Public Sector Procurement

The public sector procurement in Kiribati is centralised under the responsibility

of Pharmacy Department, Ministry of Health and Medical Services.

Tender documents are not publicly available. A process exists to ensure the

quality of products that are publicly procured. Procurement is based on the

prequalification of suppliers and use of the WHO Certification Scheme on the

Quality of Pharmaceutical Products Moving in International Commerce or by

use of information from countries with stringent regulatory systems such as

Australia and New Zealand. The key functions of the procurement unit and

those of the tender committee are clearly separated.

The tender methods employed in public sector procurement include

international competitive tenders, restricted tenders and direct purchasing in

some cases.

7.2 Public Sector Distribution

The government supply system department (Pharmacy Department) in Kiribati

has a Central Medical Store (CMS) at National Level, based at the Tunguru

Central Referral Hospital, that supplies the outer islands as well as the major

part of Tarawa. A secondary tier of the public sector pharmacy distribution is

based at the eastern end of Tarawa in Betio hospital pharmacy. It is a

distribution point for the Betio wards and Betio clinics. There are no national

guidelines on Good Distribution Practices (GDP).

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A number of processes are in place at the CMS as detailed in Table 9.

Table 9: Processes employed by the Central Medical Store

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%. The average

stock-out duration at the CMS is 10 days. Routine procedures to track the

expiry dates of medicines at the CMS exists.

7.3 Private Sector Distribution

There is no private sector distribution.


There are some SOPs covering activities in the CMS. However, a Strategic Plan for the Implementation of National Medicines Policy to cover all aspects of medicines supply management including procurement and distribution, would articulate activities to be undertaken as well as development of other SOPs or manuals that would strengthen the system.


• The NMP should be checked and adjusted if necessary to cover the necessary aspects of the procurement and supply system.

• A Strategic Plan for Implementation of the the NMP should be developed as a priority to guide activities to strengthen the procurement and supply system.

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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 medicines use in Kiribati.

8.1 National Structures

A National Essential Medicines List (EML) exists.

The EML was lastly updated in 2013 and is not yet publicly available.

There are currently 340 medicines on the EML. Selection of medicines for the

EML is undertaken through a written process by the National Medicines and

Therapeutics Committee. For areas where Standard Treatment Guidelines

exist, a mechanism aligning the EML with the Standard Treatment Guidelines

is in place. There is no conflict of interest declaration required from committee

members,

National Standard Treatment Guidelines (STGs) including guidelines for use

of Antibiotics exist (updated 2012 with the assistance of the Pharmacy

Department) and are endorsed by the Ministry of Health. They include special

management of paediatric conditions. Further STGs for treatment of non-

communicable diseases are being developed.

The EML and the Antibiotic Guidelines are distributed to all health facilities.

There is no publicly funded national medicines information centre providing

information on medicines to prescribers, dispensers and consumers. However,

public education campaigns on rational medicine use topics, and including

antibiotic use, have been conducted by the Pharmacy Department in the last

two years and a Medicines Education Committee was set up in 2012.

Brochures and posters for education on antibiotics were produced.

Assessment of antibiotic use undertaken in 2012 identified the five outer

islands with the greatest antimicrobial use for the population, and plans were

made for targeted education initiatives on those islands.

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A written National Strategy for Containing Antimicrobial Resistance does not

yet exist. There is no national reference laboratory or other institution with

responsibility for coordinating epidemiological surveillance of antimicrobial

resistance.

A national medicines formulary does not exist.

8.2 Prescribing

Legal provisions exist to govern the licensing and prescribing practices of

prescribers (Kiribati Medical Services Act No.14. 1996). Prescribing in health

facilities is restricted to the medicines supplied according to the levels of

different facilities as identified in the EML.

The Central Referral Hospital (Tungaru) is required to have a Medicines and

Therapeutics Committee (MTC) that oversees medicines use throughout

Kiribati.

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

components detailed in Table 10.

Table 10: Core aspects of the training curriculum for doctors and nurses

Curriculum Covered

The concept of EML Yes

Use of STGs Yes

Pharmacovigilance No

Problem based pharmacotherapy No

There is no mandatory continuing education that includes pharmaceutical

issues required for paramedical staff. However, the Pharmacy Department,

with the assistance of an Australian volunteer pharmacist, has undertaken

continuing education and training on medicines management including

dispensing practices, reproductive health needs and specialised handling of

injectables for all paramedical staff throughout Kiribati (including outer islands),

Guidelines and manuals have been produced to assist staff in medicines

management.

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Prescribing by INN is obligatory in the public sector. The average number of

medicines per patient is not known. Of the medicines prescribed in the

outpatient public health care facilities, 100% are on the national EML and all

are prescribed by INN. Information is not available concerning the number of

the patients treated in the outpatient public health care facilities, with

antibiotics and injections. There are record logs in each facility for each

patient, but information is not centralised making it difficult to collate. Of

prescribed drugs, 100% are dispensed to patients. There has been no survey

to assess the number of medicines adequately labelled.

A professional association code of conduct which governs the professional

behaviour of doctors does exist as does a professional association code of

conduct governing the professional behaviour of nurses (Medical Services Act

1996). A professional association code of conduct which governs the

professional behaviour of pharmacists does not exist.

8.3 Dispensing

Legal provisions in Kiribati do not exist to govern dispensing practices of

pharmacy personnel. However dispensing practices are covered in formal

training for nurses who work in Primary Health Care facilities. The basic

pharmacist training curriculum includes a spectrum of components as outlined

in Table 11.

Table 11: Core aspects of the pharmacy training curriculum Curriculum Covered

The concept of EML Yes

Use of STGs Yes

Drug information Yes Clinical pharmacology Yes Medicines supply management Yes

Antibiotics and injectable medicines are not sold over-the-counter without a

prescription. There are no private pharmacies.

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In practice, personnel with less than one month of training do sometimes

prescribe prescription-only medicines at the primary care level in the public

sector (even though this may be contrary to regulations).


• Information regarding supply of medicines is collected at health facilities but it needs to be analysed to understand trends and identify targets for education

• Activities could be articulated in a Strategic Plan for Implementation of the NMP which does cover rational use of medicines and analysis of prescribing.


• The NMP should be checked and adjusted if necessary to adequately cover the necessary aspects of prescribing, dispensing, rational use of medicines, provision of medicines information and continuing education.

• Survey/s should be undertaken to gather information on the use of medicines and to identify targets for further education.

• The Strategic Plan for Implementation of NMP should include activities to strengthen rational use of medicines together with expected outcomes, a timeline and indicators of achievement.

30

Section 9 - Household data/access There have been no past household surveys in Kiribati regarding actual

access to medicines by normal and poor households.

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List of key reference documents: Allen & Clarke Policy and Regulatory Specialists Ltd. Review of licensing and regulation of health professionals in Kiribati. Manila, WHO Western Pacific Regional Office, 2009.

Guidelines for medical supplies donations to Kiribati 2011

Kiribati Antibiotic Treatment Guidelines

Kiribati Essential Medicines List

Kiribati Guide to evaluating EML addition requests

Kiribati Guidelines for Management of Drugs at the Outer Island Health Centres and Dispensaries. 2007

Kiribati Medical Services Act No. 14, 1996

Kiribati MH&MS 2012. Country Health Information Profile. WHO / KMH&MS

Kiribati MH&MS Annual Report (2011). Available at http://www.phinnetwork.org/Portals/0/Annual%20Report_Kiribati_2011_Part01.pdf

Kiribati National Medicines Policy

Kiribati Procurement Policy & Procedures 2009. Available from Pharmacy Department MH&MS.

Ministry of Commerce, Industry and Tourism, P.O. Box 510, Betio, Tarawa, Kiribati.

Ministry of Health and Medical Service’s Strategic Plan (2012-2015) Ministry of Health and Medical Services (MHMS). Kiribati National Health Accounts: Estimates for 2007 to 2009. Tarawa, Government of Kiribati, 2010.

Ministry of Health and Medical Services / WHO 2012. Kiribati Service Delivery Profile. Available at Service_delivery_profile_Kiribati.pdf

MSH. International Price Indicator Guide. Available at http://erc.msh.org/mainpage.cfm?file=1.0.htm&module=DMP&language=English

Registration of UK Patents Act. Available at http://www.ipo.gov.uk/pro-policy/policy-information/extendukip/extendukip-kiribati.htm

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

United Nations International Narcotics Control Board. Narcotic Drugs: Estimated World Requirements for 2013-Statistics for 2011 [E/INCB/2012/2] [Internet]. 2012. Available from: http://www.incb.org/incb/en/narcotic-drugs/Technical_Reports/2012/narcotic-drugs-technical-report_2012.html

Western Pacific Country Health Information Profiles 2010

WHO Collaborating Centre for Drug Statistics Methodology. ATC/DDD Index [Internet]. 2011 [cited 2011 Sep 16]. Available from: http://www.whocc.no/atc_ddd_index/

WHO Global Health Observatory Data Repository. Available at http://apps.who.int/gho/data/node.main.75?lang=en WHO National Health Accounts Kiribati http://www.who.int/nha/country/kir/en/

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World Health Organization (WHO), 2009. World Health Statistics 2009, Geneva: WHO Press. Available at: <http://www.who.int/whosis/whostat/2009/en/index.html> [Accessed 20 May 2011]

World Health Organization (WHO), 2010. World Health Statistics 2010, Geneva: WHO Press. Available at: <http://www.who.int/whosis/whostat/2010/en/index.html> [Accessed 21 July 2011]

World Health Organization (WHO). Country health information profile: Kiribati 2011. Manila, Western Pacific Region Health Databank, 2011 http://www.wpro.who.int/countries/kir/en/index.html. Available at

World Trade Organization (WTO). Website: Available at http://www.wto.org/english/thewto_e/whatis_e/tif_e/org6_e.htm

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