OMAN

PHARMACEUTICAL COUNTRY PROFILE

ii

Oman Pharmaceutical Country Profile

Published by the Ministry of Health of the Sultanate of Oman in collaboration with the World Health Organization

2011

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:

Ph. Sawsan Ahmed Jaffer Director General of Pharmaceutical Affairs & Drug Control

Ministry of Health P.O. Box 393 Muscat, Postal Code 100

Tel: (968) 24601044/24602177 Fax: (968) 24602287

E-mail: mohphar@omantel.net.om

This document was produced with the support of the World Health Organization (WHO) Oman Country Office, 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.

iii

Foreword

The 2011 Pharmaceutical Country Profile for Oman has been 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 Oman. 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 at the end of this document.

On the behalf of the Ministry of Oman, I wish to express my appreciation to all

those who contributed 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 Oman pharmaceutical sector will find this profile a useful tool to

aid their activities.

Director General of Pharmaceutical Affairs & Drug Control

Date: 17-12-2011

iv

Table of content

Foreword .............................................................................................................. iii

Table of content ................................................................................................... iv

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

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

Section 2 - Health Services ................................................................................ 5

Section 3 - Policy Issues .................................................................................... 8

Section 4 – Medicines Trade and Production ................................................. 10

Section 5 – Medicines Regulation ................................................................... 12

Section 6 - Medicines Financing ...................................................................... 19

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 ................... Error! Bookmark not defined.

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 Oman. 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/en/in

dex.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 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. The tables in the annexes also present all data collected for each of

the indicators in the original survey form. 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

2

School, Oswaldo Cruz Foundation (known as 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 Oman was Ph.

Sawsan Ahmed Jaffar.

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 web site.

This profile will be regularly updated by the Directorate General of

Pharmaceutical Affairs and Drug Control. Comments, suggestions or corrections

may be sent to:

Ph. Sawsan Ahmed Jaffar

Directorate General of Pharmaceutical Affairs and Drug Control

Sultan Qaboos Street

Al Ghoubra, Muscat

Sultanate of Oman

mohphar@omantel.net.om

3

Section 1 - Health and Demographic Data

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

1.1 Demographics and Socioeconomic Indicators

The total population of Oman in 2009 was 3,174,000 with an annual population

growth rate of 2.6%. The annual GDP growth rate is -23.5 %. The GDP per

capita was US$ 14,413 (at the current exchange ratei).3

34.5 % of the population is under 15 years of age, and 3.8 % of the population is

over 60 years of age. The urban population currently stands at 72% or the total

population. The fertility rate in Oman is 3.3 births per woman.3 The adult literacy

rate for the population over 15 years is 86.6%.4

1.2 Mortality and Causes of Death

The life expectancy at birth is 70 and 75.7 years for men and women respectively.

The infant mortality rate (i.e. children under 1 year) is 9.6/1,000 live births. For

children under the age of 5, the mortality rate is 12/1,000 live births. The

maternal mortality rate is 13.4/100,000 live births5.

The top 10 diseases causing mortality in Oman are:

Disease

1 Septicaemia

2 Cardiac dysrhythmias

3 Pneumonia

4 Acute myocardial infarction

5 Intracranial haemorrhage

6 Cerebral infraction

7 Heart failure

8 Intracranial injury

9 Slow fetal growth, fetal malnutrition & disorders related

i The exchange rate for calculation for NCU is 1 USD = 0.38 Omani rial (OMR), which is consistent with the timing of the collection of related NHA data.

4

to short gestation & LBW

10 Renal failure

The top 10 diseases causing morbidity in Oman are

Disease

1 Enteritis of presumed infectious origin

2 Acute respiratory infection

3 Abortions

4 Sickle-cell disorders

5 Diabetes mellitus

6 Asthma

7 Pneumonia

8 Hypertension & Hypertensive diseases

9 Cataract & disorders of lens

10 Gastritis and duodenitis

The adult mortality rate for both sexes between 15 and 60 years is 131 / 1,000

population, while the neonatal mortality rate is 6 / 1,000 live births. The age-

standardised mortality rate by non-communicable diseases. 6

5

Section 2 - Health Services

This section provides information regarding health expenditures and human

resources for health in Oman. 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 Oman, the total annual expenditure on health (THE) in 2008 was 485.26

million Omani Rial (OMR) (US$ 1,277.01 million)7. The total annual health

expenditure was 2.79 % of the GDP. The total annual expenditure on health per

capita was 153 OMR (US$ 153.89)8.

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

national health accounts (NHA) was 355.28 millions OMR (US$ 934.95). That is

73.21 % of the total expenditure on health, with a total annual per capita public

expenditure on health of 112 OMR (US$ 295). The government annual

expenditure on health represents 4.7 % of the total government budget. Private

health expenditure covers the remaining 26.79 % of the total health expenditure.

2.2 Health Personnel and Infrastructure

The health workforce is described in the table below and in Figure 3. There are

1,251(3.94 /10,000) licensed pharmacists, of which 321 (1.01 /10,000) work in

the public sector. There are 1,533 (4.83 /10,000) pharmaceutical technicians

and assistants (in all sectors). There are approximately 1.2 more pharmacy

technicians as pharmacists.

ii 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.

6

There are 5,862 (18.47 /10,000) physicians and 12,865 (40.53 /10,000) nursing

and midwifery personnel in Oman. The ratio of doctors to pharmacists is 4.69

and the ratio of doctors to nurses and midwifery personnel is 0.46.9

Table 1: Human resources for health in Oman9

Human Resource

Licensed pharmacists (all sectors) 1,251 (3.94 /10,000)

Pharmacists in the public sector 321 (1.01 /10,000)

Pharmaceutical technicians and assistants (all

sectors)

1,533 (4.83 /10,000)

Physicians (all sectors) 5,862 (18.47 /10,000)

Nursing and midwifery personnel (all sectors) 12,865 (40.53 /10,000)

Figure 3: The density of the Health Workforce 2010 in Oman (all sectors)

MOH, Annual Health Report (2010)

The health workforce is described in the table below and in Table 2. There are

62 hospitals and 17.7 /10,000 hospital beds in Oman. There are 221 primary

health care units and centres and 400 licensed pharmacies.9

0 5 10 15 20 25 30 35 40 45

Pharmacists

Pharmaceutical technicians and assistants

Physicians

Nursing and midwifery personnel

/10,000 population

7

Table 2: Health centre and hospital statistics (MOH, Annual Health Report 2010)9

Infrastructure

Hospitals 62

Hospital beds 17.7 /10,000

Primary health care units and centres 221

Licensed pharmacies 400

8

Section 3 - Policy Issues

This section addresses the main characteristics of the pharmaceutical policy in

Oman. 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 Oman, a National Health Policy (NHP) exists. It was updated in 2000. A

national health policy implementation plan exists.10

An official National Medicines Policy document exists in Oman11. It was updated

in 2000. A NMP implementation plan also exists which was most recently

updated in year 2005. Policies addressing pharmaceuticals exist, as detailed in

the Table 3. Pharmaceutical policy implementation is regularly

monitored/assessed by the Directorate General of Pharmaceutical Affairs & Drug

Control.

The Directorate General of Pharmaceutical Affairs & Drug Control, under the

Office of Undersecretary of Health Affairs, develops and implements national

drug policy. Directorate of Rational drug use, Directorate of Treatment abroad

and Directorate of Private Health establishment also follow Undersecretary of

health affairs.

9

Table 3: The NMP covers11

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 No

Monitoring and evaluation Yes

Traditional Medicine Yes

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 a national good governance policy in Oman. This Good Governance

policy relates solely to the pharmaceutical sector. The Directorate General of

Pharmaceutical Affairs & Drug Control is responsible for implementing this policy.

A policy is in place to manage and sanction conflict of interest issues in

pharmaceutical affairs. There is no associated formal code of conduct for public

officials. The country is now working on an updated code of conduct. A whistle-

blowing mechanism that allows individuals to raise concerns about wrongdoing

occurring in the pharmaceutical sector of Oman, exists (via direct communication

with the Directorate General of Pharmaceutical Affairs & Drug Control).

10

Section 4 – Medicines Trade and Production

4.1 Intellectual Property Laws and Medicines

Oman is a member of the World Trade Organization12. Legal provisions granting

patents to manufacturers exist. These cover pharmaceuticals.

Intellectual Property Rights are managed and enforced by Ministry of Commerce

& Industry, http://www.mocioman.gov.om/.

National Legislation has been modified to implement the TRIPS Agreement and

contains TRIPS-specific flexibilities and safeguards, presented in Table 4. Oman

is not eligible for the transitional period to 2016.

Table 4: TRIPS flexibilities and safeguards are present in the national law

Flexibility and safeguards Included

Compulsory licensing provisions that can be applied for reasons of

public health

Yes

Bolar exceptionsiii Yes

Parallel importing provisions No

There are legal provisions for data exclusivity for pharmaceuticals, patent term

extension and linkage between patent status and marketing authorization.13

iii Many countries use this provision of the TRIPS Agreement to advance science and technology.

They allow researchers to use a patented invention for research, in order to understand the invention more fully. In addition, some countries allow manufacturers of generic drugs to use the patented invention to obtain marketing approval (for example from public health authorities) without the patent owner’s permission and before the patent protection expires. The generic producers can then market their versions as soon as the patent expires. This provision is sometimes called the “regulatory exception” or “Bolar” provision. Article 30 This has been upheld as conforming with the TRIPS Agreement in a WTO dispute ruling. In its report adopted on 7 April 2000, a WTO dispute settlement panel said Canadian law conforms with the TRIPS Agreement in allowing manufacturers to do this. (The case was titled “Canada - Patent Protection for Pharmaceutical Products”) [In: WTO OMC Fact sheet: TRIPS and pharmaceutical patents, can be found on line at: http://www.wto.org/english/tratop_e/trips_e/tripsfactsheet_pharma_2006_e.pdf]

11

4.2 Manufacturing

There are 4 licensed pharmaceutical manufacturers in Oman. Manufacturing

capabilities are presented in Table 5 below.

Table 5: Oman manufacturing capabilities14

Manufacturing capabilities

Research and Development for discovering new active substances No

Production of pharmaceutical starting materials (APIs) Yes

The production of formulations from pharmaceutical starting material Yes

The repackaging of finished dosage forms Yes

12

Section 5 – Medicines Regulation

This section details the pharmaceutical regulatory framework, resources,

governing institutions and practices in Oman.

5.1 Regulatory Framework

In Oman, there are legal provisions establishing the powers and responsibilities

of the Medicines Regulatory Authority (MRA).

The MRA (Directorate General of Pharmaceutical Affairs & Drug Control) is part

of the Ministry of Health with a number of functions outlined in Table 6. The MRA

has its own website, for which the URL address is

http://www.moh.gov.om/nv_menu.php?fNm=pharma/regulation.htm.

Table 6: Functions of the national MRA14

Function

Marketing authorisation / registration Yes

Inspection Yes

Import control Yes

Licensing Yes

Market control Yes

Quality control Yes

Medicines advertising and promotion No

Clinical trials control No

Pharmacovigilance Yes

As of 2011, there were 67 permanent staff working for the MRA. The MRA

receives external technical assistance (short term consultants in collaboration

with WHO via JPRM) to support its activities. The MRA is involved in

harmonization/collaboration initiatives. An assessment of the medicines

regulatory system has not been conducted in the last five year. Funding for the

13

MRA is provided through the regular government budget. The Regulatory

Authority does not retain revenues derived from regulatory activities. This body

does not utilize a computerized information management system to store and

retrieve information on processes that include registrations, inspection etc14.

(Comment: The computer system is under process and will be implemented

soon.)

5.2 Marketing Authorization (Registration)

In Oman, legal provisions require marketing authorization (registration) for all

pharmaceutical products on the market, however exceptions/waivers for

registration do exist15. Mutual recognitions mechanisms are in place (through

GCC Central Gulf Registration16. Explicit and publicly available criteria do not

exist for assessing applications for marketing authorization of pharmaceutical

products. In 2011, there were 3,957 pharmaceutical products registered in Oman.

There are not 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 INN (International Non-proprietary Names) or Brand

name + INN. Legal provisions require a fee to be paid for Medicines Market

Authorization (registration) based on applications17.

Marketing Authorization holders are required by law to provide information about

variations to the existing Marketing Authorization. Legally, a Summary of Product

Characteristics (SPC) of the medicines that are registered is not required to be

published. However, legal provisions requiring the establishment of an expert

committee involved in the Marketing Authorization process are in place.

Possession of a Certificate for Pharmaceutical Products (that accords with the

WHO Certification scheme) is required as part of the Marketing Authorization

application. By law, potential conflict of interests for experts involved in the

assessment and decision-making for registration need not be declared.

Applicants may legally appeal MRA decisions.

14

5.3 Regulatory Inspection

In Oman, legal provisions exist allowing for appointment of government

pharmaceutical inspectors. Legal provisions exist permitting inspectors to

inspect premises where pharmaceutical activities are performed. Such

inspections are required by law and are a pre-requisite for the licensing of private

facilities. Where inspections are legal requirements, these are not the same for

public and private facilities. Inspections are carried out on a number of entities,

outlined in Table 7.

Table 7: Local entities inspected for GMP compliance15

Entity Inspection

Local manufacturers Yes

Private wholesalers Yes

Retail distributors Yes

Public pharmacies and stores Yes (TPN)

Pharmacies and dispensing points if health facilities Yes

Inspection is carried out 2 to 3 times per year for all pharmaceutical establishments in the country

(wholesalers and retailers)

5.4 Import Control

Legal provisions exist requiring authorization to import medicines. Laws exist that

allow the sampling of imported products for testing.

Legal provisions exist requiring importation of medicines through authorized ports

of entry. Regulations or laws exist to allow for inspection of imported

pharmaceutical products at authorized ports of entry.

5.5 Licensing

In Oman, legal provisions exist requiring manufacturers to be licensed

(Pharmacy Practice Law issued vide Royal Decree No. 41/1996 and Ministerial

Decision No. 74/2000 and its amendments) 18. Legal provisions exist requiring

manufacturers (both domestic and international) to comply with Good

15

Manufacturing Practices (GMP). Good Manufacturing Practices are not published

by the government.

Legal provisions exist requiring importers/wholesalers/distributers to be licensed.

Legal provisions exist requiring wholesalers and distributors to comply with Good

Distributing Practices.

Table 8: Legal provisions pertaining to licensing

Entity requiring licensing

Importers Yes

Wholesalers Yes

Distributors Yes

Good Distribution Practices are published by the government. Legal provisions

exist requiring pharmacists to be registered. Legal provisions exist requiring

private pharmacies to be licensed. National Good Pharmacy Practice Guidelines

are not published by the government. By law, a list of all licensed

pharmaceutical facilities is not required to be published.

5.6 Market Control and Quality Control

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

laboratory exists in Oman for Quality Control testing. The laboratory is a

functional part of the MRA.

Existing national laboratory facilities have been accepted for collaboration with

the WHO pre-qualification Programme (the Central Quality Control Laboratory in

DGPA&DC is a member in the External Quality Assurance Assessment Scheme

by WHO). Medicines are tested for a number of reasons, summarised in Table 9.

16

Table 9: Reason for medicines testing

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 Yes

For public procurement prequalification Yes

For public program products prior to acceptance and/or distribution Yes

Samples are collected by government inspectors for undertaking post-marketing

surveillance testing.

In the past 2 years, 2,480 samples were taken for quality control testing. Of the

samples tested, 94 (or 3.8%) failed to meet the quality standards. The results are

publicly available.

5.7 Medicines Advertising and Promotion

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

prescription medicines. The Ministry of Health (Directorate General of

Pharmaceutical Affairs & Drug Control) is 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 do not exist for 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 Oman, legal provisions exist requiring authorization for conducting Clinical

Trials by the MRA. There are additional laws requiring the agreement by an

iv Routine sampling in pharmacy stores and health facilities

v Routine sampling in retail outlets

17

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.

Legal provisions do not exist for GMP compliance of investigational products.

Sponsor investigators are not legally required to comply with Good Clinical

Practices (GCP). Legal provisions do not permit the inspection of facilities where

clinical trials are performed.

5.9 Controlled Medicines

Oman is a signatory to a number of international conventions, detailed in Table

10.

Table 10: International Conventions to which Oman is a signatory19

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 exist for the control of narcotic and psychotropic substances, and

precursors20. The annual consumption of Morphine is 0.664273 mg/capita.

5.10 Pharmacovigilance

In Oman, there are legal provisions in the Medicines Act that provide for

pharmacovigilance activities as part of the MRA mandate. Legal provisions 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 (ADR) exist in Oman. A national pharmacovigilance

centre linked to the MRA exists.

18

The Pharmacovigilance centre has 2 full-time staff members.

The centre has published an analysis report in the previous two years and it

regularly publishes an ADR bulletin. An official standardized form for reporting

ADRs is used in Oman. Information pertaining to ADRs is stored in a national

ADR database. The ADR database currently comprises 4,905 ADR reports, of

which 1,896 have been submitted in the past 2 years. These reports are also

sent to the WHO collaborating centre in Uppsala.

There is no national ADR or 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 Oman. A clear communication strategy for

routine communication and crises communication does not exist.

19

Section 6 - Medicines Financing

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

Oman, 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 Oman, concessions are made for certain groups to receive medicines free of

charge (see Table 12). Furthermore, the public health system or social health

insurance schemes provide medicines free of charge for particular conditions

(see Table 13).

Table 12: 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

Comment: All Omani nationals and expatriates working in the government sector

receive medicines free of charge from government health facilities.

Table 13: Medications provided publicly, at no cost

Conditions Covered

All diseases in the EML Yes

Any non-communicable diseases Yes

Malaria Yes

Tuberculosis Yes

20

Sexually transmitted diseases Yes

HIV/AIDS Yes

Expanded Program on Immunization (EPI) vaccines for children Yes

Private health insurance schemes are not mandatorily required to provide

medicines coverage. They are not mandatorily required to provide at least partial

coverage for medicines that are on the EML.

6.2 Patients Fees and Co-payments

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

delivery. Furthermore, there are no copayments or fee requirements imposed for

medicines. . Medicines are free for the nationals as well as expatriate

government sector employees. 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.15

6.3 Pricing Regulation for the Private Sectorvi

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

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

Originator shall be priced taking into consideration of the following:

(1) Price of drug in country of origin

(2) Price of drug in GCC countries

(3) Price of other drug from same pharmacological group

(4) Price of drug in official references (BNF)

Generic shall be priced taking into consideration of the following:

(1) Price of drug in country of origin

(2) Price of drug in GCC countries

(3) Number of similars registered in the country

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

21

The government runs an active national medicines price monitoring system for

retail prices. Regulations exist mandating that retail medicine price information

should be publicly accessible.

The medicine price list is available in all retail private pharmacies and it is also

available on the MOH website. The retail pharmacies are required to show the

price list to the consumers on their request.

6.4 Prices, Availability and Affordability of Key Medicines

In 2007, a WHO/HAI pricing survey was conducted in Oman21. Table 13

provides specific details regarding availability, pricing and affordability in the

country.

Availability

Public sector availability of originator medicines was 15.6 %, while availability of

the Lowest priced generic (LPG) medicines was 70.2 %. Availability in the private

sector was 49.4 % for originator and 55.3 % for generics.

Pricing

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

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

been compared to international reference pricesvii and 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 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.

vii

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 (http://erc.msh.org/mainpage.cfm?file=1.0.htm&module=DMP&language=English). For more information on the methodology WHO/HAI pricing survey, you can download a free copy of the manual at http://apps.who.int/medicinedocs/documents/s14868e/s14868e.pdf.

22

Public procurement prices for generics were slightly lower than their international

reference prices. The public sector is procuring originator brands at more than 5

times higher than their international reference prices: the Median Price Ratio for

originators was 5.80 and for generics 0.95. As for patient prices, the Median

Price Ratio in the public sector was 5.8 for originators and 0.95 for generics,

while the private sector had higher prices (22.44 for originators and 7.39 for

generics).

Affordability

Affordability of medicines is measured in terms of the number of days’ of wages

necessary to purchase a particular treatment for a specific condition. The wage

considered is that paid to the lowest paid government worker in Oman.

Comment: Since the government supplies medicines for Omani patients for free,

affordability was measured only if medicine was purchased from the private

sector.

Specific data collected for the survey underlying this profile examined the number

of days’ wages required to purchase treatment with co-trimoxazole for a child

respiratory infection. The purchase of generic medication necessitated 0.6 days’

wages for private patients.

23

Table 14: Availability, Pricing and Affordability of medicines in Oman21

Public

procurement Public

patient Private

patient

Availability

Mean (%) Originator 15.6 49.4

Lowest priced generic (LPG) 70.2 55.3

Median (%) Originator

Lowest priced generic (LPG) 96.7 70.3

Price

Mean Price

Ratio

Originator 5.8 5.8 22.44

Lowest priced generic (LPG) 0.95 0.95 7.39

Affordability

Number of

days’ wages

Originator

Lowest priced generic (LPG) 0.6

6.5 Price Components and Affordability

The last medicines price survey was conducted in 2004. Medicines are tax free in

Oman. Medicines retail prices are unified across the country and are fixed by the

Ministry of Health as an additional 55% added to the approved Cost Insurance

and Freight (CIF) prices for imported medicines and 34% for locally

manufactured medicines. The wholesaler mark-up is 20.9% and pharmacist

mark-up is 28.2%.

6.6 Duties and Taxes on Pharmaceuticals (Market)

Oman does not impose duties on imported active pharmaceutical ingredients

(APIs) or duties on imported finished products. Value-added tax or other taxes

are not imposed on finished pharmaceutical products. Provisions for tax

exceptions or waivers for pharmaceuticals and health products are not in place.

24

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 Oman.

7.1 Public Sector Procurement

Public sector procurement in Oman is centralized. The public sector procurement

is centralized under the responsibility of a procurement agency which is a part of

the MoH / a government agency that procures all public goods.

Public sector request for tender documents and public sector tender awards are

publicly available. Legal provisions exist that give priority to locally produced

goods in public procurement.

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

clearly separated. A process exists to ensure the quality of products that are

publicly procured.

7.2 Public Sector Distribution

The government supply system department in Oman has a Central Medical Store

at National Level for the Ministry of Health known as Directorate General of

Medical Supplies22. There are 2 government regional warehouses in the

secondary tier of the public sector distribution for the Ministry of Health. There

are national guidelines on Good Distribution Practices (GDP). A licensing

authority that issues GDP licenses exists for the private sector. The licensing

authority does not accredit public distribution facilities. A list of GDP certified

wholesalers or distributors does not exist in the public sector in the public sector.

The percentage availability of key medicines at the Central Medical Store (CMS)

is 80 %.

25

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 exists in the private

sector.

26

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 in Oman.

8.1 National Structures

A National Essential Medicines List (EML) exists (for the government sector).

The EML was lastly updated in 2011 and is not publicly available.

There are currently 650 medicines on the EML. Selection of medicines for the

EML is undertaken through a written process. A mechanism aligning the EML

with the Standard Treatment Guidelines (STGs) is in place.

National Standard Treatment Guidelines (STGs) for the most common illnesses

are produced/endorsed by the MoH in Oman. Specific STGs cover primary care.

Of the public health facilities, 94 % have a copy of the STGs.

There is public or independently funded national medicines information centre

providing information on medicines to prescribers, dispensers and consumers15.

A survey on rational use of medicines has not been conducted in the previous

two years. There is a 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 200715.

A national medicines formulary does exist. A funded national intersectoral task

force to coordinate the promotion of the appropriate use of antimicrobials and

prevention of the spread of infection exists. A national reference laboratory or

other institution has responsibility for coordinating epidemiological surveillance of

antimicrobial resistance.

27

8.2 Prescribing

Legal provisions exist to govern the licensing and prescribing practices of

prescribers. Furthermore, legal provisions restricting dispensing by prescribers

exist15.

There are regulations requiring hospitals to organize/develop Drug and

Therapeutics Committees (DTCs)15.Where there are requirements for DTCs,

more than half of referral / general / regions / provinces have one.

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

components detailed in Table 16.

Table 16: Core aspects of the medical training curriculum

Curriculum Covered

The concept of EML Yes

Use of STGs Yes

Pharmacovigilance Yes

Problem based pharmacotherapy Yes

Mandatory continuing education that includes pharmaceutical issues is not

required for doctors / nurses / paramedical staff.

Prescribing by INN name is obligatory in the public sector, but not in the private

sector. The average number of medicines prescribed per patient contact in public

health facilities is 2.5. Of the medicines prescribed in the outpatient public health

care facilities, 97.5 % are on the national EML. Of the patients treated in the

outpatient public health care facilities, 48.2 % receives antibiotics and 6.9 %

receive injections. Of medicines in public health facilities, 65.2 % are adequately

labelled.

28

Table 17: Characteristics of medicines prescribing

Curriculum %

% of medicines prescribed in outpatient public health care facilities that

are in the national EML (mean)

97.5

% of patients in outpatient public health care facilities receiving

antibiotics (mean)

48.2

% of patients in outpatient public health care facilities receiving

injections (mean)

6.9

% of medicines adequately labelled in public health facilities (mean) 65.2

A professional association code of conduct which governs the professional

behaviour of doctors exists.

8.3 Dispensing

Legal provisions in Oman exist to govern dispensing practices of pharmaceutical

personnel. The basic pharmacist training curriculum includes a spectrum of

components as outlined in Table 18.

Table 18: Core aspects of the pharmacist training curriculum

Curriculum Covered

The concept of EML Yes

Use of STGS Yes

Drug information Yes

Medicines supply management Yes

Mandatory continuing education that includes rational use of medicines is not

required for pharmacists.

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

sector facilities14. Antibiotics are not sold over-the-counter without a prescription.

Injectable medicines are not sold over-the-counter without a prescription.

29

List of key reference documents:

1 World Health Organization (WHO) (2010), “World Health Statistics 2010”, WHO Press, Geneva.

Available online: http://www.who.int/whosis/whostat/2010/en/index.html.

2 World Health Organization (WHO) (2009), “World Health Statistics 2009”, WHO Press, Geneva.

Available online: http://www.who.int/whosis/whostat/2009/en/index.html. 3 Ministry of National Economy (MONE), Sultanate of Oman (2009)

4 Data from 2008, UNESCO, Institute for Statistics, available at: stats.uis.unesco.org/, 2011-12-12

5 Ministry of Health, Sultanate of Oman (2009)

6 World Health Organization (WHO) (2011), “World Health Statistics 2011”, WHO Press, Geneva.

Available online: http://www.who.int/whosis/whostat/2011/en/index.html. 7 Oman National Health Accounts (NHA) (2008)

8 Calculated based on data provided by MONE (2009) and NHA (2008)

9 Annual Health Report (2010), Ministry of Health Oman.

10 The Seventh Five Year Plan for Health Development - 2006-2010, MOH Oman, available at:

http://www.moh.gov.om/nv_menu.php?fNm=fiveyearPlan.htm&SP=1

11 National Drug Policy (2000),MOH Oman, Available at:

http://www.moh.gov.om/pharma/ndpeng.pdf

12 World Trade Organization (2000), Member list available online:

http://www.wto.org/english/thewto_e/whatis_e/tif_e/org6_e.htm 13

Industrial Property Rights and their Enforcement for the Sultanate of Oman (Royal Decree No. 67/2008), available at: http://www.wipo.int/wipolex/en/profile.jsp?code=OM

14 Directorate General of Pharmaceutical Affairs & Drug Control (DGPA&DC),

http://www.moh.gov.om/nv_menu.php?fNm=pharma/regulation.htm 15

WHO Level 1 Survey, World Health Organization, 2007, WHO, Geneva.

16 Gulf Central Committee for Drug Registration, http://www.sgh.org.sa/register.htm

17 Information provided by MOH Oman, 2011.

18 Pharmacy Practice Law issued vide Royal Decree No. 41/1996 and Ministerial Decision No.

74/2000 and its amendments 19

United Nations Treaty collection, Status of Treaties Available online: http://treaties.un.org/pages/ParticipationStatus.aspx 20

Law of Narcotics & Psychotropic Control issued against Royal Decree No. 17/99 and its exclusive rule by Ministerial Decision No. 99/2001

21 Medicine Prices, Availability, Affordability and Price Components in Oman. Ministry of Health,

Sultanate of Oman, October 2007, report date: December 2008. Available at:

http://www.haiweb.org/medicineprices/surveys/200710OM/sdocs/survey_report.pdf, 01-11-2011.

22 Directorate General of Medical Supplies MOH (1970)