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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: [email protected]
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.
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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
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.
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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.
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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).
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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]
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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.
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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)