country profile-sudan pharmacy

SUDAN

PHARMACEUTICAL COUNTRY PROFILE

ii

Copyright 2010. All rights reserved.

This report is a property of the Government of Sudan. Copyright and other intellectual property laws protect this material. Reproduction or retransmission of the material, in whole or in part, in any manner, without the prior written consent of the copyright holder, is a violation of copyright law.

This report can be used as information source. This can be saved or printed a single copy for personal use only and not to reproduce any major extract or the entire document. Anything extracted from this report including selected passage, table diagram should acknowledge this report and the Government of Sudan.

iii

Acknowledgement The World Health Organization would like to thanks the FMOH, General

Directorate of Pharmacy, Central Medical Supply, the National Medicine and

Poison Boards, Sudan Medical Council and Ministry of Labor; and to express

appreciation to:

Dr. Thon Mangok.K Lukabyt; Assistant Undersecretary for Pharmacy/MOH

Dr. Gamal Khalafalla Mohamed Ali; Secretary General of National Medicine

and Poison Boards

Dr. Mohamed Elamin; General Director of Central Medical Supply

For their assistance and support for this work.

The WHO would also like to send thanks to

Dr. Amel Elamin Mohamed Elnour; National health information centre FMOH,

Dr. Wijdan Khalid Elfil; National Medicines and Poison Board

Dr. Mohamed Awad Abdalaziz Musnad; National Health Insurance

Dr. Abualbishr Osman Adam Alsharif; National Health Insurance

Dr. Nawal ElHadi; Central Medical Supply

Dr. Gadah Omar Babiker Shouna; Sudan Medical Council

Dr. Sara AbdelKareem; General Directorate of Pharmacy

For their support to provide the information needed for the country profile

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Foreword

This 2010 Pharmaceutical Country Profile for Sudan has been produced by the

Ministry of Health with support of the World Health Organization.

This document contains information on structures, process and outcomes of the

pharmaceutical sector in Sudan. Some of the data comes from global sources

(e.g. the World Health Statistics) or from surveys conducted in the previous

years, while other pieces of information have been collected at country level in

2010. 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 Sudan, I wish to express my appreciation

towards Dr. Nahid Salih Khalid and Dr Siham Abdoun from the World Health

Organization for their contribution to the data collection and to the

development of this profile.

It is my hope that partners, researchers and all those that are interested in the

pharmaceutical sector of Sudan will find this profile a useful tool in their

activities.

Name: H.E. Dr Abdalla Teia Juma Hammad

Federal Minister of Health

Date: December 2010

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Table of contents

Acknowledgement __________________________________________________ iii Foreword ___________________________________________________________iv Table of contents ____________________________________________________ v Introduction ________________________________________________________ 1 Section 1 - Health and Demographic Data________________________________ 3 Section 2 - Health Services ____________________________________________ 5 Section 3 - Policy Issues_______________________________________________ 9 Section 4 - Regulation _______________________________________________ 11 Section 5 - Medicines Financing _______________________________________ 15 Section 6 - Pharmaceutical procurement and distribution in the public sector 19 Section 7 - Selection and rational use of medicines ______________________ 20 References_________________________________________________________ 22 ANNEX ___________________________________________________________ 25 Section 1 Health and Demographic data ________________________________ 27 Section 2 Health Services ____________________________________________ 30 Section 3 Policy issues _______________________________________________ 34 Section 4 Regulation ________________________________________________ 38 Section 5 Medicines Financing ________________________________________ 49 Section 6 Pharm.procurement and distribution __________________________ 54 Section 7 Selection and rational use ___________________________________ 58

1

Introduction

This Pharmaceutical Country Profile provides data on structures, processes and

outcomes of the pharmaceutical sector of Sudan. The aim is to put together

existing information and to make all relevant information on the

pharmaceuticals sector available to the public in a user-friendly format. In

2010, country profiles similar to this one have been developed for 13 pilot

countries. During 2011, the World Health Organization plans to support all WHO

Member States to develop similar country profiles.

The information is categorized in 8 sections, namely: (1) Health and

Demographic data, (2) Health Services, (3) Policy Issues, (4) Regulation, (5)

Medicines Financing, (6) Supply of Pharmaceuticals, (7) Rational Use of

Medicines, and (8) Household Surveys. The indicators have been divided into

two categories, namely "core" (most important) and "supplementary" (useful if

available). The narrative profile is based only on the core indicators; while the

tables in the annexes present all indicators. For each piece of information, we

have tried to indicate the year and source of the data; these are used to build

the references in the profile and are also indicated in the tables. If key

national documents are available on-line, links are provided to the source

documents so that the user 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 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 the 13 pilot countries. Data collection in the pilot

countries was conducted using a user-friendly electronic questionnaire that

included a comprehensive glossary. Countries were requested not to conduct

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

to provide information available at the central level. To facilitate the work of

national counterparts, the questionnaires were pre-filled using all data

available at WHO HQ before being sent out to countries. A coordinator was

nominated for each of the 13 pilot countries. The coordinator for Sudan was

Mrs Nahid Idris Salih Khalid.

The completed questionnaires were then used to produce the country profiles.

In order to do this in a structured and efficient manner, a text template was

developed. Member states took part in the development of the profile and,

once the final product 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 web site of WHO.

This profile will be regularly updated by country teams. If you have any

suggestions on corrections to make please send them to Mrs Nahid Idris Salih

Khalid, [email protected], Khartoum, Osman Digna Street.

3

Section 1 - Health and Demographic Data

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

1.1 Demographics and Socioeconomic Indicators

The total population of Sudan in 2008 was 39,154,490[1] [2] with an annual

population growth rate of 2.1%. The annual GDP growth rate is 8.3% [3]. The

GNI per capita is US$ 1,511 [4].

1.2 Mortality and Causes of Death

The life expectancy at birth for men is 57 years and for women is 58 years [5].

The infant mortality rate is 81/1,000 live births. For children under the age of

5, the mortality rate is 112/1,000 live births. The maternal mortality rate is

1107/100,000 live births [6].

The 10 leading causes of mortality in hospitals in Sudan are:

1) Malaria

2) Pneumonia

3) Septicaemia

4) Other Heart Diseases

5) Malignant Neoplasm

6) Disorders of the Circulatory System

7) Heart failure

8) Acute renal failure

9) Diabetes mellitus

10) Malnutrition

4

The 10 leading causes of admission to hospital in Sudan are:

1) Malaria

2) Delivery case/Child birth

3) Pneumonia

4) Caes. Delivery

5) Obstetrics & gynaecology

6) Diarrhoea & Enteric Gastritis

7) Asthma

8) Cutaneous Abscess

9) Diabetes Mellitus

10) Abortion [4]

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Section 2 - Health Services

This section provides information regarding health expenditures and human

resources in Sudan. 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 and Pharmaceutical Expenditures

In Sudan, the total annual expenditure on health (THE) in 2010 was SDG (Sudan

Pounds) 7,886.5 million (US$ 3,755.5 million). The total health expenditure is

6.2% of the GDP. The total annual expenditure on health per capita is SDG 257

(US$ 122) [2].

The government annual expenditure1 on health accounts for 27.8% of the total

expenditure on health, with a total per capita public expenditure on health of

SDG 71 (US$ 33.9).The government annual expenditure on health represents 9

% of the total government budget [2]. From the total population 30 % is

covered by a public health service or public health insurance or social

insurance, or other sickness funds [7].

The total pharmaceutical expenditure (TPE) in Sudan in 2010 was SDG 2,833

million (US$ 1,349 million). The total pharmaceutical expenditure per capita

was SDG 72.3 (US$ 34.45). The pharmaceutical expenditure accounts for 2.2%

of the GDP and makes up 36 % of the total health expenditure (Figure 1).

The public expenditure on pharmaceuticals per capita in 2007 was SDG 3.5

(US$1.57). The total private expenditure on pharmaceuticals in 2007 was SDG

595.5 million (US$ 268 million). The annual growth rate of the total

pharmaceuticals market value is 52 % [8].

1 By government expenditure it is meant all expenditure from public sources, like central government, local government, insurance funds and parastatal companies. This follows the definition used by the WHO National Health Accounts.

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FIGURE 1: Share of Total Pharmaceutical Expenditure as percentage of the Total Health

Expenditure.

36.00%

64.00%

TPEOther

Source: Federal Ministry of Health, Sudan, 2010 [2].

2.2 Health Personnel

The health workforce is described in the table below, and in figures 2 and 3. In

Sudan, there is no strategic plan for pharmaceutical human resource

development in place.

Licensed pharmacists 1.53/10,000

Pharmacists in the public sector 0.39/10,000

Pharmaceutical technicians and

assistants (all sectors)

0.64/10,000 [7]

Physicians (all sectors) 2.8/10,000

Nursing and midwifery personnel (all

sectors)

8.4/10,000 [4]

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FIGURE 2: The density of the Health Workforce 2009 in Sudan (all sectors).

0 2 4 6 8 10

Pharmacists

Physicians

Nursing andmidwifery personnel

/10,000 population

FIGURE 3: Distribution Pharmaceutical Personnel Sudan 2009.

Pharmacists

Pharmceutical techniciansand assistants

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2.3 Health Infrastructure

The health centre and hospital statistics are described in the table below.

Hospitals 0.1/10,000

Hospital beds 7.4/10,000

Primary health care units and centres 1.5/10,000[4]

Licensed pharmacies 0.59/10,000 [7]

9

Section 3 - Policy Issues

This section addresses the main structure of the pharmaceutical policy in Sudan.

Information about the capacity for manufacturing medicines and regulations

regarding patents is also provided.

3.1 Policy Framework

In Sudan, a National Health Policy (NHP) exists. It was updated in 2007 [9] [10].

An official National Medicines Policy (NMP) document exists in Sudan. It was

updated in 2005.

The NMP covers:

Selection of essential medicines

Medicines pricing

Procurement

Distribution and regulation

Pharmacovigilance

Rational use of medicines

Human resource development

Research

Monitoring and evaluation

Traditional medicine [11].

There are official written guidelines on medicines donations [12]. The

pharmaceutical policy implementation is being regularly monitored/assessed.

The General Directorate of Pharmacy is responsible for this activity [13].

There is a National Good Governance Policy in Sudan, both a multisectoral one

and one specifically for the pharmaceutical sector and the Ministry of Labor

and Human Resources Development is responsible for this policy [14] [15].

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

pharmaceutical affairs [15]. There is a formal code of conduct for public

officials. The Sudan Medical Council is by law responsible for establishing ethics

for all medical practices [16]. There is a whistle-blowing mechanism allowing

individuals to raise a concern about wrongdoing occurring in the

pharmaceutical sector of Sudan. The Sudan Medical Council is responsible for

receiving, handling and judging of all consumers complaints [15].

3.2 Intellectual Property Laws and Medicines

Sudan is not a member of the World Trade Organization; therefore information

on patenting laws is not applicable or available [17].

3.3 Manufacturing

There are 19 licensed pharmaceutical manufacturers in Sudan. Sudan does not

have the capacity for the Research & Development for discovering new active

substances and the production of pharmaceutical starting materials. On the

other hand, there is capacity for production of formulations from

pharmaceutical starting materials and for repackaging of finished dosage forms

[18]. In 2008 the percentage of market share by value of goods produced by

domestic manufacturers was 20.6 % [8].

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Section 4 - Regulation

This section covers a broad range of pharmaceutical regulatory policy,

institutions and practices in Sudan.

4.1 Regulatory Framework

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

of the medicines regulatory authority (MRA). The MRA is a semi-autonomous

agency [19]. The MRA has its own website; the URL address is

http://www.nmpb.gov.sd. The MRA is not involved in

harmonization/collaboration initiatives [18]. An assessment of the medicines

regulatory system has been conducted in the last five year. This was done in

2006 before the separation of the MRA from the FMOH; a tool developed by

WHO was used for the evaluation [20].

4.2 Marketing Authorization

In Sudan, legal provisions require a marketing authorization (registration) for

all pharmaceutical products on the market [19]. Explicit and publicly available

criteria exist for assessing applications for marketing authorization of

pharmaceutical products [21]. In 2009, the number of pharmaceutical products

registered in Sudan is 3,702 [22]. There are no legal provisions requiring the

MRA to make the list of registered pharmaceutical products publicly available.

However, the list is available on the National Medicines and Poisons Board

website: htp://www.nmpb.gov.sd [18]. Medicines are 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 applications [19].

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4.3 Regulatory Inspection

In Sudan, legal provisions exist allowing for appointment of government

pharmaceutical inspectors [19]. The Regulatory Authority has its own inspectors

[18]. Legal provisions exist permitting them to inspect premises where

pharmaceutical activities are performed. By law, inspections have to be

performed and are a pre-requisite for licensing facilities. The inspection

requirements are the same for public and private facilities [19].

4.4 Import Control

Legal provisions exist requiring authorization to import medicines. There are

laws allowing the sampling of imported products for testing. There are legal

provisions exist requiring importation of medicines through authorized ports of

entry. Legislations exist to allow for inspection of imported pharmaceutical

products at the authorized port of entry [19].

4.5 Licensing

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

provisions exist requiring manufacturers to comply with Good Manufacturing

Practices (GMP), but these are not published by the government.

Legal provisions exist requiring importers, wholesalers and distributers to be

licensed. Good Distributing Practices have been published by the government

[18] [19]. Legal provisions exist requiring pharmacists to be registered. Legal

provisions exists requiring private and public pharmacies to be licensed.

National Good Pharmacy Practice Guidelines are published by the Medical

Council [15] [19].

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4.6 Market Control and Quality Control

A laboratory exists in Sudan for Quality Control testing. Samples are collected

by government inspectors for post-marketing surveillance testing.

In the past 2 years, 7536 samples were taken for Quality Control testing and

816 (10.8 %) of them failed to meet the quality standards. The results of the

quality control testing are not publicly available. Only recalled medicines are

published on the MRA website [17] [18].

4.7 Medicines Advertising and Promotion

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

all medicines. The National Medicines and Poisons Board is responsible for

regulating promotion and/or advertising of medicines. Legal provisions prohibit

direct advertising of all medicines to the public. Legal provisions require a pre-

approval for medicines advertisements and promotional materials. Guidelines

and regulations 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 [19].

4.8 Clinical Trials

In Sudan, legal provisions exist requiring authorization for conducting Clinical

Trials by the MRA. Laws require the agreement by an ethics committee or

institutional review board of the Clinical Trials to be performed. Registration of

the clinical trials into international/national/regional registry is not required

by law [19].

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4.9 Controlled Medicines

Sudan is signatory to the:

- Single Convention on Narcotic Drugs, 1961

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

- Convention on Psychotropic Substances 1971

- United Nations Convention against the Illicit Traffic in Narcotic Drugs and

Psychotropic Substances, 1988 [23].

Laws exist for the control of narcotic and psychotropic medicines and

substances, and precursors [17] , [18] by the ministry of Interior and national

medicines and poisons board. The annual consumption of Morphine is 0.029

mg/capita [24].

4.10 Pharmacovigilance

In Sudan, there are no legal provisions in the Medicines and Poisons 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. The

national medicines and poisons board emphasize the importance of

pharmacovigilance activity 11] a national pharmacovigilance centre linked to

the MRA exists in Sudan. It has 1 full-time staff member and has published at

least one analysis report in the previous two years, but it does not publish an

ADR bulletin regularly.

An official standardized form for reporting ADRs is used in Sudan [25] and a

national ADR database exists. In the past 2 years, 50 ADR reports were sent to

the WHO database in Uppsala. ADRs are monitored in at least one public health

program [18].

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Section 5 - Medicines Financing

In this section, information is provided on the structure of user fees for

medicines and on the existence of public programmes providing free medicines.

Policies and regulations in place that affect the prices of medicines (e.g. price

control and taxes) are presented.

5.1 Medicines Coverage and Exemptions

A public programme in Sudan exists providing free medicines to children under

the age of 5. Reproductive health is supported by the UNFPA [26].

Public programmes exist providing free medicines for:

- Malaria

- Tuberculosis

- Sexually transmitted diseases

- HIV/AIDS

- Vaccines for children (Expanded Programme of Immunization).

The government also provides free medicines for treating emergency cases for

the first 24 hours; blood transfusions; renal dialyses and transplantations; and

anti cancer medicines. The Global Fund supports the medicines for Malaria, HIV

and TB. Global Alliance for Vaccines and Immunization supports the provision

of EPI vaccines [17] [27] [28].

There is a public health service, public health insurance, social insurance or

other sickness fund provides at least partial medicines coverage. It provides

coverage for medicines that are on the Essential Medicines List (EML) for

inpatients and outpatients [29]. The coverage is not full as the Health

Insurance has its own list of medicines and this does not necessarily includes all

medicines in the EML. Private health insurance schemes provide medicines

coverage. They are required to provide at least partial coverage for medicines

that are on the EML.

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5.2 Patients Fees and Copayments

In the health system of Sudan, at the point of delivery, there are

copayments/fee requirements for both consultations and medicines. 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. In the

Health Insurance Scheme, patients pay only 25% of the cost of the prescription,

but the prescribed medicines should be part of the health insurance list [13]

[17].

5.3 Pricing Regulation for the Private Sector (not including the non-profit

voluntary sector)

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

These provisions are aimed at the level of manufacturers, wholesalers and

retailers. These are based on comparisons between generics and registered

originators, and prices in other countries.

The government does not run an active national medicines price monitoring

system for retail prices. Regulations do not exist mandating that retail

medicine price information should be publicly accessible [19].

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5.4 Prices, Availability and Affordability of Key Medicines

In 2006, WHO/HAI Pricing surveys were conducted in Sudan. The table below

contains the results of the average of the Khartoum, Kordofan, Gadarif and

Nothern State [30].

In public sector, availability of generic medicines was 51.7%. The private sector

had higher availability (77% for generics).

Prices of medicines have been compared to international reference prices2 and

expressed as a ratio of the international price (e.g. a price ratio of 2 would

mean that the price is two times the international reference price). Since

prices have been collected for a basket of medicines, the median price ratio

has been selected to represent the situation in the country.

As for patient prices, the Median Price Ratio in the public sector was 3.4 for

originators and 4.4 for generics, while the private sector had slightly higher

prices (11.5 for originators and 4.7 for generics).

Affordability of medicines is measured in terms of number of days of wage

necessary to purchase treatment for a condition. The wage is the one of the

lowest paid government worker. In the public sector of Sudan, it would take

0.275 days of wage to purchase treatment with co-trimoxazole for a child

respiratory infection using generic medicines. In the private sector, medicines

are slightly less affordable as it would take 0.3 days of wage to purchase

treatment using generic medicines and 1.4 days using originators.

2 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.

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5.5 Price Components and Affordability

In 2008, a survey on medicines price components was conducted by WHO/EMRO.

The median cumulative percentage mark-up between MSP/CIF price and final

medicine price for a basket of key medicines was 66.7% in the private sector

[31].

5.6 Duties and Taxes on Pharmaceuticals (Market)

There are duties on imported raw materials, imported finished products and

there is a value-added tax on medical consumables (VAT15%) [17].

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Section 6 - 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 Sudan.

6.1 Public Sector Procurement

The public sector procurement in Sudan is centralized and decentralized. There

is a Central Medical supplies public corporation and then there are Revolving

Drug Funds (RDF) projects at state level and regional stores.

The public sector procurement is centralized under the responsibility of a

procurement agency which is a semi-autonomous agency.

The public sector tender bids are publicly available and public sector awards

are publicly available [24]. Procurements are based on prequalification of

suppliers. Manufacturers must have been inspected and registered by the

national MRA before starting procurement of awarded items. The dossier for

each item should comply with tender technical conditions [32].

6.2 Public Sector Distribution

The government supply system department in Sudan has a Central Medical

Store at a National Level [24]. There are national guidelines on Good

Distribution Practices (GDP). There is no licensing authority that issues GDP

licenses. In Sudan distributors are also wholesalers. There is a national

guideline for them and a list of licensed distributors/wholesalers (Guideline for

Good Distribution and Transportation) [18] [33].

6.3 Private Sector Distribution

Legal provisions exist for licensing wholesalers, but not for distributors in the

private sector of Sudan. A list of GDP certified wholesalers or distributors in

the private sector does not exist [24] [33].

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Section 7 - Selection and rational use of medicines

This section presents the structures and policies that are in place in Sudan for

selection of essential medicines and promotion of rational drug use.

7.1 National Structures

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

have not been produced nor endorsed by the MoH in Sudan [34]. A National

Essential Medicines List (EML) exists and it is publicly available. There are 565

medicines on the EML that was lastly updated in 2007. There is a written

process for selecting medicines on the EML. [13] [17] [35].

There is no public or independently funded national medicines information

centre providing information on medicines to prescribers, dispensers and

consumers. No public education campaign on rational medicine use topics has

been conducted in the last two years. No survey on rational use of medicines

has been conducted in the previous two years. There is no national programme

or committee, involving government, civil society, and professional bodies to

monitor and promote rational use of medicines [17]. Similarly, there is no

written National Strategy to contain antimicrobial resistance [34].

7.2 Prescribing

In Sudan, there are legal provisions to govern the licensing and prescribing

practices of prescribers. Legal provisions exist to restrict dispensing by

prescribers, which is only allowed where there are no dispensaries [15]. There

are no regulations requiring hospitals to organize/develop Drug and

Therapeutics Committees (DTCs) [22].

The core medical training curriculum does not include components on the

concept of EML, use of STGs, pharmacovigilance and problem-based

pharmacotherapy.

21

The core nursing training curriculum does not include components on the

concept of EML, use of STGs and pharmacovigilance.

The core paramedical staff training curriculum does not include components on

the concept of EML, use of STGs and pharmacovigilance.

Mandatory continuing education that includes pharmaceutical issues is not

required for doctors, nurses and paramedical staff [15] [17].

Prescribing by INN name is obligatory in the public sector [19]. The average

number of medicines prescribed per patient contact in public health facilities is

2.3. Seventy three percent of medicines prescribed to outpatient in public

health care facilities are from the EML, but only 43.5% are prescribed by INN

name. Sixty five percent of patients treated in public health facilities receive

antibiotics and 28.6% receive injections. 84.4% of prescribed drugs are

dispensed to patients in the same facilities and 61.1% of dispensed drugs are

adequately labelled [13].

7.3 Dispensing

Legal provisions in Sudan exist to govern dispensing practices of pharmaceutical

personnel [19]. The core pharmacist training curriculum does not include

components on the concept of EML, use of STGs, drug information, clinical

pharmacy and medicines supply management. Yet, some universities include

some of these components.

Mandatory continuing education that includes pharmaceutical issues is not

required for pharmacists.

Substitution of generic equivalents at the point of dispensing in public and

private sector facilities is allowed [15]. Antibiotics and injectable medicines

are sold over-the-counter without a prescription [17].

22

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http://www.cbs.gov.sd/Tiedadat/Tiedadat%205th%20E.htm, accessed on 08-

06-2010.

[2] Federal Ministry of Health, 2010.

[3] Country data, Sudan. Washington, the World Bank, 2008. Available at:

http://data.worldbank.org/country/sudan

[4] Annual health statistical report. Khartoum, National Ministry of Health;

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[5] World Health Statistics. Geneva, World Health Organization, 2007. Available

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2010.

[6] Annual report of the regional director. Cairo, World Health Organization;

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.pdf, 08-06-2010.

[7] FIP global pharmacy workforce report. The Hague, Federation

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2010.

[8] Annual pharmaceutical statistical report. Sudan, MOH, 2006-2007.

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Available at: http://www.fmoh.gov.sd/English/Health-

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2010.

[10] National policy for private (for profit) health sector. Khartoum, National

Ministry of Health; Health policy department, 2009.

[11] National medicines policy. 2005.

23

[12] Guidelines for good medicines donation. Place, National Medicines and

Poisons Board, 2008. Available at:

http://www.nmpb.gov.sd/Guidelins/Good%20Medicine%20Donation..pdf, 08-

06-2010.

[13] Pharmaceutical sector assessment report North Sudan. Khartoum, Federal

Ministry of Health (WHO/EMRO), 2007. Available at: (Arabic version only)

[14] Public service national legal provisions, 2007. Available at: (Arabic version

only).

[15] Sudan Medical Council (SMC) act, 2004. Available at: (Arabic version only)

[16] Medical Ethics and Medico Moral problems, 1979. Available at: (Arabic

version only)

[17] Country pharmaceutical situations. Fact book on WHO Level I indicators

2007. Geneva, World Health Organization, 2007.

[18] National Medicines and Poisons Board (NMPB). Khartoum, 2010. Available

at: http://www.nmpb.gov.sd, 08-06-2010.

[19] Medicines and Poisons Act, 2009. Available at:

http://www.nmpb.gov.sd/Regulations/The%20medicines%20and%20poisns%20ac

t%202009_.pdf, 08-06-2010 (Arabic version only).

[20] Federal Board of Pharmacy and Poisons (MRA) assessment report, World

Health Organization, 2006.

21] Standard registration dossier document (drug master file). Sudan, Federal

board of pharmacy and poisons, Year 2010. Available at:

http://www.nmpb.gov.sd/Publication/volume-1.pdf, 08-06-2010.

[22] List of Registered medicines (Sudan Medicines Index). Khartoum, National

Medicines & Poisons Board, 2009. Available at:

http://www.nmpb.gov.sd/DisplaySearch2.php, 08-06-2010.

[23] Report of the International Narcotics Control. Vienna, International

Narcotics Control Board, 2009. Available at: www.incb.org, 08-06-2010.

[24] Central medical store. Khartoum, Central Medical Supplies Public

Corporation, 2005. Available at: http://www.cmssudan.org/, 08-06-2010.

24

[25] Adverse drug reaction reporting form. Khartoum, Federal Pharmacy and

Poisons Board; Pharmacovigilance Department, 2008. Available at:

http://www.nmpb.gov.sd/Pharmacovigilance/Form-1.pdf, 08-06-2010.

[26] Improving reproductive health. United Nations Population Fund, 2010

Available at: http://www.unfpa.org/rh/index.htm, 08-06-2010.

[27] Global EPI Program, Sudan, Federal Ministry of Health

[28] Grant portfolio Sudan. Geneva, the Global Fund to AIDS, Tuberculosis and

Malaria, 2010. Available at:

http://portfolio.theglobalfund.org/Country/Index/SUD?lang=en, 09-06-2010.

[29] List of medicines served by public health insurance, 2007. Available at:

(English versiononly)

[30] HAI Pricing survey Sudan, average of Khartoum State, Kordofan State,

Gadarif State and the Northern State. PLACE, WHO/Health Action International,

2006.

[31] Medicines prices, availability, affordability and price components report.

WHO Pricing components. Cairo, World Health Organization. Regional Office for

the Eastern Mediterranean, 2008. Available at:

http://www.emro.who.int/dsaf/dsa964.pdf, 08-06-2010.

[32] Central medical store tender. Khartoum, Central Medical Supplies Public

Corporation, 2008. Available at:

http://www.cmssudan.org/tender2008_2010/conditions.doc, 08-06-2010.

[33] Guidelines for good distribution and transportation. Sudan, National

Medicines and Poisons Board, 2008. Available at:

http://www.nmpb.gov.sd/Guidelins/Good%20Distribution%20And%20Transporta

tion%20Practice%20Of%20Medicinal%20Products.pdf, 08-06-2010.

[34] General Directorate of Pharmacy. Sudan

[35] National list of essential medicines. Khartoum, General Directorate of

Pharmacy; FMoH, 2007. Available at:

http://www.who.int/selection_medicines/country_lists/sdn_eml_2007.pdf, 08-

06-2010.

25

Sudan Pharmaceutical Country Profile

ANNEX

Survey Data

26

Respondents to the questionnaire:

Nahid Idris Salih Khalid (coordinator)

00249912167165

[email protected]

Siham Abdoun

[email protected]

00249912999100

Amel Elamin Mohamed

0024121196775

[email protected]

Wijdan Khalid Elfil

00249912923859

[email protected]

Nawal Elhadi Elnur

00249912308355

[email protected]

Sara Abd Alkarim

00249912972069

[email protected]

Dr. Mohamed Awad Abdalaziz Musnad

00249912325864

[email protected]

Dr. Abualbishr Osman Adam Alsharif

0912255453

[email protected]

Gadah Omar Babiker Shouna

00249912234271

[email protected]

27

Section 1 Health and Demographic data

1.01 Demographic and Socioeconomic Indicators Core Questions Population, total (,000) 39,154.39 2008 National Health

Accounts Population growth rate (Annual %)

2.1 2008 World Bank

GDP growth (Annual %) 8.3 2008 World Bank GNI per capita (US$ current exchange rate)

1,511 2008 FMOH

Supplementary questions Population < 15 years (% of total population)

45 2008 Sudan Census

Population > 60 years (% of total population)

5.1 2008 Sudan Census

Urban population (% of total population)

38.27 2007 Annual Health Statistical Report 2008/FMOH

Fertility rate, total (Births per woman)

4.3 2007 World Health Statistics

Population living with less than $1/day (international PPP) (%)

50 2008 Status of MDG_Sudan/UNDP

Adult literacy rate, 15+ years

(% of total population) 60.9 2007 World Health

Statistics

28

1.02 Mortality and Causes of Death Core questions Life expectancy at birth for men (Years)

57 2006 World Health Statistics

Life expectancy at birth for women (Years)


Infant mortality rate, between birth and age 1 (/1,000 live births)

81 2006 EMRO/Annual report of the Regional Director, 2008

Under 5 mortality rate (/1,000 live births)


Maternal mortality ratio (/100,000 live births)


Please provide a list of top 10 diseases causing mortality

Malaria Pneumonia Septicaemia Other Heart Diseases Malignant Neoplasm Disorders of the Circulatory System Heart failure Acute renal failure Diabetes mellitus Malnutrition

2009 Annual Health Statistical Report 2009/FMOH

Please provide a list of top 10 diseases causing morbidity

Malaria S.S. Delivery Pneumonia Delivery Case Obstetrics & gynaecology Asthma Cutaneous Abscess Abortion Diabetes Mellitus Diarrhoea & Enteric Gastritis


Comments

These diseases apply to the adult mortality/morbidity

29

Supplementary questions Adult mortality rate for both sexes between 15 and 60 years (/1,000 population)


Neonatal mortality rate (/1,000 live births)


Age-standardized mortality rate by non-communicable diseases ( /100,000 population)


Age-standardized mortality rate by cardiovascular diseases (/100,000 population)


Age-standardized mortality rate by cancer ( /100,000 population)


Mortality rate for tuberculosis (/100,000 population)

19 2008 WHO/TB Data

Mortality rate for Malaria (/100,000 population)


Comments

No data has been calculated before for HIV/AIDS.

30

Section 2 Health Services

2.01 Health Expenditures Core Questions Total annual expenditure on health (millions US$ average exchange rate)

3755.5 2010 FMOH

Total annual expenditure on health (millions NCU)

7886.5 2010 FMOH

Total health expenditure as % of Gross Domestic Product

6.2 2008 Calculated from Annual Health Statistical Report 2008/FMOH

Total annual expenditure on health per capita (US$ average exchange rate)

122


Total annual expenditure on health per capita (NCU)

257 2006 Annual Health Statistical Report 2008/FMOH

General government annual expenditure on health (millions US$ average exchange rate)


General government annual expenditure on health (millions NCU)


Government annual expenditure on health as percentage of total government budget (% of total government budget)


Government annual expenditure on health as % of total expenditure on health (% of total expenditure on health)

27.8 2008 NHA

Annual per capita government expenditure on health (US$ average exchange rate)

33.9


31

Annual per capita government expenditure on health (NCU)


Private health expenditure as % of total health expenditure (% of total expenditure on health)

68.5 2008 NHA

Population covered by a public health service or public health insurance or social insurance, or other sickness funds (% of total population)

30 2009 FIP Global Pharmacy Workforce Report

Total pharmaceutical expenditure (millions US$ current exchange rate)

1,349 2010 FMOH

Total pharmaceutical expenditure (millions NCU)

2,832. 9 2010 FMOH

Total pharmaceutical expenditure per capita (US$ current exchange rate)

34.45 2010 FMOH

Total pharmaceutical expenditure per capita (NCU)

72.3 2010 FMOH

Pharmaceutical expenditure as a % of GDP (% of GDP)

2.2 % 2010 FMOH

Pharmaceutical expenditure as a % of Health Expenditure (% of total health expenditure)

35.98 %

2010 FMOH

Total public expenditure on pharmaceuticals (millions US$ current exchange rate)

61.5 2007 Pharmaceutical Statistical Report

Total public expenditure on pharmaceuticals (millions NCU)


Share of public expenditure on pharmaceuticals as percentage of total expenditure on pharmaceuticals (%)

19 2007 Pharmaceutical Statistical Report

Total public expenditure on pharmaceuticals per capita (US$ current exchange rate)


Total public expenditure on pharmaceuticals per capita

3.5 2007 Pharmaceutical Statistical

32

(NCU) Report Total private expenditure on pharmaceuticals (million US$ current exchange rate)


Total private expenditure on pharmaceuticals (millions NCU)


Annual growth rate of total pharmaceuticals market value (%)


Comments Public pharmaceutical expenditure includes CMS procurement of both free and cost recovery items. Private pharmaceutical expenditure includes all types of medical supplies.

Supplementary Questions Social security expenditure as % of government expenditure on health (% of government expenditure on health)

11 2008 NHA

Private out-of-pocket expenditure as % of private health expenditure (% of private expenditure on health)

97.5 2008 NHA

Premiums for private prepaid health plans as % of total private health expenditure (% of private expenditure on health)

0 2008 NHA

33

2.02 Health Personnel and Infrastructure Core Questions Total number of pharmacists licensed/registered to practice in your country

5,980 2009 FIP Global Pharmacy Workforce Report 2009

Total number of pharmacists working in the public sector

1,542 2009 Calculated from FIP Global Pharmacy Workforce Report 2009

Total number of pharmaceutical technicians and assistants


A strategic plan for pharmaceutical human resource development is in place in your country?

No

Total number of physicians 11129 2009 Annual Health Statistical Report 2009/FMOH

Total number of nursing and midwifery personnel

32,948 2009 Annual Health Statistical Report 2009/FMOH

Total number of hospitals 407 2009 Annual Health Statistical Report 2009/FMOH

Total number of hospitals bed 29103 2009 Annual Health Statistical Report 2009/FMOH

Total number of primary health care units and centres


Total number of licensed pharmacies


Comments Physicians include housemen and university staff. Nursing and midwifery personnel include midwives, nutrition officers and health visitors.

Supplementary Questions Starting annual salary for a newly registered pharmacist in the public sector - NCU

7,200 2007 Public Service National Legal Provisions

Are there accreditation requirements for pharmacy schools?

Yes 2007 Sudan Medical Council (SMC) Act

Is the Pharmacy Curriculum regularly reviewed?

No

34

Section 3 Policy issues 3.01 Policy Framework Core Questions National Health Policy exists. If yes, please write year of the most recent document in the "year" field and attach document or provide URL below*

Yes 2007 1- National Health Policy (NHP) 2- National Health Policy for Private Health Sector (NHP) 2009

National Medicines Policy official document exists. If yes, please write the year of the most recent document in the "year" field and attach document or provide URL below*

Yes 2005 National Medicines Policy

Group of policies addressing pharmaceuticals exist. Please attach document or provide URL below *

No

National Medicines Policy covers the following components:

Selection of Essential Medicines

Yes

Medicines Financing Yes Medicines Pricing Yes Medicines Procurement Yes Medicines Distribution Yes Medicines Regulation Yes Pharmacovigilance Yes Rational Use of Medicines Yes Human Resource Development

Yes

Research Yes Monitoring and Evaluation Yes Traditional Medicine Yes National medicines policy Unknown

35

implementation plan exists. If yes, please write year of the most recent document in the "year" field and attach document or provide URL below* There are official written guidelines on medicines donations. Please attach document or provide URL below *

Yes 2008 Guidelines for Good Medicines

Is pharmaceutical policy implementation being regularly monitored/assessed?

Yes 2007 Pharmaceutical sector assessment report

Who is responsible for pharmaceutical policy monitoring?

General Directorate of Pharmacy/FMOH

Is there a national good governance policy?

Yes 2007 Public service national legal provisions

Multisectoral Yes

2007 Public service national legal provisions

For the pharmaceutical sector Yes

2004

Sudan Medical Council Act

Which agencies are responsible?

Ministry of Labour and Human Resources Development

A policy is in place to manage and sanction conflict of interest issues in pharmaceutical affairs. Please attach document or provide URL below *

Yes 2004 Sudan Medical Council Act

There is a formal code of conduct for public officials. Please attach document or provide URL below *

Yes 1979 Medical Ethics and Medico Moral Problems

Is there a whistle-blowing mechanism allowing individuals to raise a concern about wrongdoing occurring in the pharmaceutical sector of your country (ombudsman)?


36

Please describe: By law The Sudan Medical Council is responsible for receiving, handling and judging of all consumers complains.

Comments There are multi sectoral legal provisions covering issues related to good governance. The Sudan Medical Council is by law responsible for establishing ethics for all medical provisions

3.02 Intellectual Property Laws and Medicines Core Questions Country is a member of the World Trade Organization

No 2007 WHO Level I

Legal provisions provide for granting of Patents on pharmaceuticals

Unknown

National Legislation has been modified to implement the TRIPS Agreement

Unknown

Current laws contain (TRIPS) flexibilities and safeguards

Unknown

Country is eligible for the transitional period to 2016

Unknown

Which of the following (TRIPS) flexibilities and safeguards are present in the national law?

Compulsory licensing provisions that can be applied for reasons of public health

Unknown

Bolar exception Unknown Are parallel importing provisions present in the national law?

Unknown

The country is engaged in initiatives to strengthen capacity to manage and apply intellectual property rights to contribute to innovation and promote public health

Unknown

Are there legal provisions for data exclusivity for pharmaceuticals

Unknown

Legal provisions exist for patent extension

Unknown

37

Legal provisions exist for linkage between patent status and marketing authorization

Unknown

3.03 Manufacturing Core Questions Number of licensed pharmaceutical manufacturers in the country

19 2010 National Medicines and Poisons Board (NMPB)

Country has manufacturing capacity for:

2010 National Medicines and Poisons Board

R&D to discover new active substances

No

Production of pharmaceutical starting materials (APIs)

No (manufacturing capacity is mainly for non sterile medicines)

Production of formulations from pharmaceutical starting material

Yes

Repackaging of finished dosage forms

Yes

Percentage of market share by value produced by domestic manufacturers (%)


Supplementary Questions Number of multinational pharmaceutical companies manufacturing medicines locally

0

38

Section 4 Regulation

4.01 Regulatory Framework Core Questions Are there legal provisions establishing the powers and responsibilities of the medicines regulatory authority?

Yes 2009 Medicines and Poisons Act 2009

Part of MOH No Semi autonomous agency Yes The MRA has its own website Yes 2008 National

Medicines and Poisons Board

- If yes, please provide MRA Web site address (URL)

www.nmpb.gov.sd

The MRA is involved in harmonization/ collaboration initiatives

Yes

An assessment of the medicines regulatory system has been conducted in the last five years.

Yes 2006 MRA assessment report

Comments Assessment using WHO tools conducted in 2006 before the separation of the MRA from FMOH

Supplementary Questions Formal code of conduct exists for staff involved in medicines regulation

Yes 2009 By laws of NMPB conduct of work

Medicines Regulatory Authority gets funds from regular budget of the government.

Yes 2010 National Medicines and Poisons Board

Medicines Regulatory Authority is funded from fees for services provided.

No 2010 National Medicines and Poisons Board

Medicines Regulatory Authority receives funds/support from other sources

Yes 2010 WHO

- If yes, please specify WHO, EC & GF

39

Revenues derived from regulatory activities are kept with the regulatory authority

No National Medicines and Poisons Board

The Regulatory Authority is using a computerized information management system to store and retrieve information on registration, inspections, etc.

Yes (national software used for registration)


4.02 Marketing Authorization (Registration) Core Questions Legal provisions require a marketing authorization (registration) for all pharmaceutical products on the market

Yes 2009 Medicines and Poisons Act

Explicit and publicly available criteria exist for assessing applications for marketing authorization of pharmaceutical products

Yes 2009 Regulation of Pharmaceutical Products Regulations

Number of pharmaceutical products registered in your country

3,702 2009 List of registered medicines (Sudan Medicines Index

Legal provisions require the MRA to make publicly available the registered pharmaceutical with defined periodicity

Yes National Medicines and Poisons Board

- If yes, please provide updated list or URL *

www.nmpb.gov.sd

Medicines are registered by their INN (International Non-proprietary Names) or Brand name + INN


Legal provisions require paying a fee for Medicines Market Authorization (registration) applications


40

Comments List of registered medicines is regulary updated on website

Supplementary Questions Legal provisions require marketing authorization holders to provide information about variations to the existing marketing authorization

Yes 2009 Medicines and Poisons Act and Regulations

Legal provisions require to publish the Summary Product Characteristics (SPCs) of the medicines registered

No

Legal provisions require the establishment of an expert committee involved in the marketing authorization process


Certificate for Pharmaceutical Products in accordance with the WHO Certification scheme is required as part of the marketing authorization application


Legal provision require declaration of potential conflict of interests for the experts involved in the assessment and decision-making for registration

Yes 2009 By-laws of NMPB conduct of work.

Legal provisions allow applicants to appeal against MRAs decisions


Registration fee - the amount per application for pharmaceutical product containing New Chemical Entity,NCE (US$)

600 2010 National Medicines and Poisons Board

Registration fee - the Amount per application for a multisource pharmaceutical product (US$)


Time limit for the assessment of a marketing authorization

12 (it is 9 months for positive list)

2010 National Medicines and

41

application (Months) Poisons Board 4.03 Regulatory Inspection Core Questions Legal provisions exist allowing for appointment of government pharmaceutical inspectors


Does the Regulatory Authority have inspectors?


Legal provisions exist permitting inspectors to inspect premises where pharmaceutical activities are performed


Legal provisions exist requiring inspection to be performed


Inspection is a pre-requisite for licensing of facilities


Inspection requirements are the same for public and private facilities


4.04 Import Control Core Questions Legal provisions exist requiring authorization to import medicines


Legal provisions exist allowing the sampling of imported products for testing

No 2009 Medicines and Poisons Act and Regulations

Legal provisions exist requiring importation of medicines through authorized ports of entry


Legal provisions exist allowing inspection of imported


42

pharmaceutical products at the authorized port of entry

and Regulations

4.05 Licensing Core Questions Legal provisions exist requiring manufacturers to be licensed If yes please provide documents below. Please attach document or provide URL below *


Legal provisions exist requiring manufacturers to comply with Good manufacturing Practices (GMP)


GMP requirements are published by the government. If yes, please provide reference or URL below *

No

Legal provisions exist requiring importers to be licensed


Legal provisions exist requiring wholesalers and distributors to be licensed


National Good Distribution Practice requirements are published by the government


Legal provisions exist requiring pharmacists to be registered

Yes 2009 Sudan Medical Council Law

Legal provisions exists requiring private pharmacies to be licensed

Yes 2009 Sudan Medical Council Law

Legal provision exist requiring public pharmacies to be licensed


National Good Pharmacy Practice Guidelines are published by the government

Yes (medical council is publishing some regulation for pharmacy practice)

2004 Sudan Medical Council Law

Comments Only public pharmacies outside health facilities (belong to public institutes).

43

Supplementary Questions Legal provisions require the publication of different categories of all pharmaceutical facilities licensed

Yes

4.06 Market Control and Quality Control Core Questions Legal Provisions for controlling the pharmaceutical market exist


Does a laboratory exist in the country for Quality Control testing?


If not, does the regulatory authority contract services elsewhere?

Samples are collected by government inspectors for undertaking post-marketing surveillance testing


How many Quality Control samples were taken for testing in the past two years?


What is the total number of samples tested in the previous two years that failed to meet quality standards?


Results of quality testing in past two years are publicly available

No

Comments Only recalled medicines are published in the MRA website 4.07 Medicines Advertising and Promotion Core Questions Legal provisions exist to control the promotion and/or advertising of prescription medicines

Yes 2009 Medicines and Poisons Ac and Regulations

Who is responsible for regulating, promotion and/or

National Medicines and Poisons Board

44

advertising of medicines? Please describe: Legal provisions prohibit direct advertising of prescription medicines to the public


Legal provisions require a pre-approval for medicines advertisements and promotional materials


Guidelines/Regulations exist for advertising and promotion of non-prescription medicines


A national code of conduct exists concerning advertising and promotion of medicines by marketing authorization holders and is publicly available

No

Comments Medicines and poisons act and Regulations is prohibiting advertisement of all to the public

4.08 Clinical trials Core Questions Legal provisions exist requiring authorization for conducting Clinical Trials by the MRA


Legal provisions exist requiring the agreement by an ethics committee/ institutional review board of the Clinical Trials to be performed


Legal provisions exist requiring registration of the clinical trials into international/national/regional registry


Supplementary Questions Legal provisions exist for GMP compliance of investigational products

No

Legal provisions require No

45

sponsor, investigator to comply with Good Clinical Practices (GCP) National GCP regulations are published by the Government.

Yes

Legal provisions permit inspection of facilities where clinical trials are performed

No

4.09 Controlled Medicines Core Questions The country is a signatory to conventions

Single Convention on Narcotic Drugs, 1961

Yes 2009 International Narcotics Control Board

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


Convention on Psychotropic Substances 1971


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

Yes 2009

International Narcotics Control Board

Laws for the control of narcotic and psychotropic substances, and precursors exist, If yes, please attach below *

Yes 2007 WHO Level I

Annual consumption of Morphine (mg/capita)

0.029 2009 CMS

Comments Data taken from CMS consumption data Supplementary Questions The laws and regulations for the control of narcotic and psychotropic substances, and precursors has been reviewed by a WHO International Expert or Partner Organization to assess the balance between the prevention of abuse and access for medical need

No

46

Annual consumption of Fentanyl (mg/capita)

0.065 2009 CMS

Annual consumption of Pethidine (mg/capita)

0.254 2009 CMS

Annual consumption of Oxycodone (mg/capita)

0

Annual consumption of Hydrocodone (mg/capita)

0

Annual consumption of Phenobarbital (mg/capita)

2.28 2009 CMS

Annual consumption of Methadone (mg/capita)

0

4.10 Pharmacovigilance Core Questions There are legal provision in the Medicines Act that provides for pharmacovigilance activities as part of the MRA mandate

No

Legal provisions exist requiring the Marketing Authorization holder to continuously monitor the safety of their products and report to the MRA

No

A national Pharmacovigilance centre linked to the MRA exists in your country


If a national pharmacovigilance centre exists in your country, how many staff does it employ full-time


If a national pharmacovigilance center exists in your country, an analysis report has been published in the previous two years. Please attach document or provide URL below *


If a national pharmacovigilance center exists in your country, it publishes an ADR bulletin

No

An official standardized form for reporting ADRs is used in your country. If yes, please attach document below *


47

A national Adverse Drug Reactions database exists in your country.


Are ADR reports set to the WHO database in Uppsala?


If yes, number of reports sent in the past two years

50 (Is the number of reports during the last 2 years)


ADRs are monitored in at least one public health program (for example TB, HIV, AIDS)?


Supplementary Questions How many ADR reports are in the database?


Feedback is provided to reporters


The ADR database is computerized


Medications errors (MEs) are reported.


How many MEs are there in the ADRs database?


There is a risk management plan presented as part of product dossier submitted for Marketing Authorization?


In the past two years, who has reported ADRs?

2010

National Medicines and Poisons Board

Doctors Yes

Nurses No Pharmacists Yes Consumers No Pharmaceutical Companies No Was there any regulatory No

48

decision based on local PV data in the last 2 years? Are there training courses in Pharmacovigilance?

Yes

If yes, how many people have been trained in the past two years?


49

Section 5 Medicines Financing

5.01 Medicines Coverage and Exemptions Core Questions If a public programme providing free medicines exists, medicines are available free-of-charge for:

Patients who cannot afford them No 2007 WHO Level I Children under 5 Yes 2007 WHO Level I Pregnant women No 2007 WHO Level I Elderly persons No 2007 WHO Level I Please describe/explain your yes answers for questions above

If a public programme providing some/all medicines free exists, the following types of medicines are free

All medicines for all conditions No Any non-communicable diseases

No

Malaria medicines Yes 2007 WHO Level I Tuberculosis medicines Yes 2007 WHO Level I Sexually transmitted diseases medicines


HIV/AIDS medicines Yes 2007 WHO Level I EPI vaccines Yes 2007 WHO Level I If others, please specify The government provides free medicines for: Treating

emergency cases for the first 24 hours; blood transfusion services; renal dialysis and transplantation; and many anticancer medicines.

Does a public health service, public health insurance, social insurance or other sickness fund provides at least partial medicines coverage

Yes

Does it provide coverage for medicines that are on the EML for inpatients

Yes

Does it provide coverage for medicines that are on the EML

Yes

50

for outpatients Does it provide at least partial medicines coverage for inpatients

Yes

Does it provide at least partial medicines coverage for outpatients

Yes

Please describe/explain your answers for questions above

Health insurance have their own list of medicines; but not necessary includes all medicines on EML

Do private health insurance schemes provide any medicines coverage?

Yes

If yes, is it required to provide at least partial coverage for medicines that are on the EML?

Yes

Comments There are different package of services in private health insurance, all of them provides at least partial covergae for medicines on EML

5.02 Patients Fees and Copayments Core Questions In your health system, at the point of delivery, are there any copayment/fee requirements for consultations


In your health system, at the point of delivery, are there any copayment/fee requirements for medicines

Yes 2007 Pharmaceutical sector assessment report

Is revenue from fees or from the sale of medicines used to pay the salaries or supplement the income of public health personnel in the same facility

No 2007 WHO Level I

Please describe the patient fees and copayments system

In health insurance scheme, patients pay only 25% of the cost of the prescription. The prescribed medicines should be within the health insurance list

5.03 Pricing Regulation for the Private Sector Core Questions Are there legal or regulatory provisions affecting pricing of medicines


If yes, are the provisions aimed Yes 2009 Medicines and

51

at Manufacturers Poisons Act If yes, are the provisions aimed at Wholesalers


If yes, are the provisions aimed at Retailers


Please explain the positive answers above: (explain scope of provisions i.e generics vs. originator or subsets of medicines, EML etc.

Compare the generic vs. registered originator and other registered brands and compare with prices of brand in other countries

Government runs an active national medicines price monitoring system for retail prices

No

Regulations exists mandating that retail medicine price information should be publicly accessible

No

5.04 Prices, Availability and Affordability Core Questions Please state if a medicines price survey using the WHO/HAI methodology has been conducted in the past 5 years in your country.

HAI Pricing Survey Sudan; average of Khartoum, Kordofan, Gadarif and the Northern State, 2006

Basket of key medicines Public

procurement Public patient

Private patient

Orig.

NA

NA Mean (%)

LPG

NA

NA Orig.

0

0

Availability (one or both of)

Median (%)

LPG

51.7

77.05 Price Median

Price Ratio

Orig.

NA

3.41

11.5

LPG NA

4.4

4.7 Orig.

NA

1.4 Affordability Days wages of the lowest paid govt worker for standard treatment with co-trimoxazole for a child respiratory infection

Number of days' wages LPG

0.275

0.3

52

Comments Report on pricing survey is not received from the MoH yet. 5.05 Price Components and Affordability Core Questions Please state if a survey of medicines price components has been conducted in the past 5 years in your country. If yes, please indicate the year of the survey and use the results to fill in the questions below

Yes 2008 Medicine prices, availability, affordability and price components report WHO/EMRO

Median cumulative percentage mark-up between MSP/CIF price and final medicine price for a basket of key medicines in the public sector (Median % contribution)

-

Median cumulative percentage mark-up between MSP/CIF price and final medicine price for a basket of key medicines in the private sector (Median % contribution)

66.7

Comment Report on pricing survey is not received from the MoH yet. Supplementary Questions

Median percentage contribution of MSP/CIF to final medicine price for a basket of key medicines in the private sector (Median % contribution)

60

Median manufacturer selling price (CIF) as percent of final medicine price for a basket of key medicines (%)

60

Median wholesaler selling price as percent of final medicine price for a basket of key medicines (%)

83.3

Median pharmacist mark-up or dispensing fee as percent of retail price for a basket of key

16.7

53

medicines (%) Median percentage contribution of wholesaler's mark-up to final medicine price for a basket of key medicines (in the public and private sectors) (%)

10.8

Median percentage contribution of retailer's mark-up to final medicine price for a basket of key medicines (in the public and private sectors) (%)

16.7

Comment Report on pricing survey is not received from the MoH yet. All figures in section 5.05 are calculated from the break down of price components

5.06 Duties and Taxes on Pharmaceuticals (Market) Core Questions There are duties on imported active pharmaceutical ingredients (APIs)


There are duties on imported finished products


VAT (value-added tax) or any other tax on pharmaceuticals

No

Comments VAT (15%) is added to medical consumables. Supplementary Questions Amount of duties on imported active pharmaceutical ingredients, APIs (%)

11.5 2008 Medicine prices, availability, affordability and price components report WHO/EMRO

Amount of duties on imported finished products (%)

11.5 2008 Medicine prices, availability, affordability and price components report WHO/EMRO

54

Section 6 Pharm.procurement and distribution

6.01 Public Sector Procurement Core Questions Public sector procurement is 2007 CMS Legal

Provisions Decentralized No Centralized and decentralized Yes Please describe There is central medical stores and has RDF projects at

state level and regional stores If public sector procurement is wholly or partially centralized, it is under the responsibility of a procurement agency which is:

2007 CMS Legal Provisions

Part of MoH No Semi-Autonomous Yes Autonomous No A government procurement Agency which procures all public goods

No

Public sector tenders bids documents are publicly available

Yes 2008 CMS

Public sector awards are publicly available

Yes 2008 CMS

Procurements are based on prequalification of suppliers

Yes 2008 CMS Tender Conditions

If yes, please describe how it works

The main criteria for manufacturer has to be inspected and registered by the national MRA before starting procurement of awarded items. Dossier for each item should comply to tender technical conditions.

Supplementary Questions Is there a written public sector procurement policy?. If yes, please write the year of approval in the "year" field.

No (There is SOPs as part of the QA system at CMS)

2003 CMS Quality Manual

Are there provisions giving priority in public procurement to goods produced by local manufacturers?

No 2003 CMS Quality Manual

55

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

Yes 2003 CMS Quality Manual

A process exists to ensure the quality of products procured


If yes, the quality assurance process includes pre-qualification of products and suppliers

Yes

If yes, explicit criteria and procedures exist for pre-qualification of suppliers

Yes

If yes, a list of pre-qualified suppliers and products is publicly available

No (available only inside CMS)

List of samples tested during the procurement process and results of quality testing is available

Yes 2009 QA/CMS

Which of the following tender methods are used in public sector procurement:

2007

WHO Level I

National competitive tenders Yes International competitive tenders

Yes

Direct purchasing Yes 6.02 Public Sector Distribution Core Indicators The government supply system department has a Central Medical Store at National Level

Yes 2007 CMS Legal Provisions

There are national guidelines on Good Distribution Practices (GDP)


There is a licensing authority that issues GDP licenses

No (Distributors are the whole salers. There is national guideline for licensing wholesalers)


If a licensing authority exists, does it accredit public

No 2010 National Medicines and

56

distribution facilities? Poisons Board List of GDP certified warehouses in the public sector exists

No (there is a list of licensed wholesalers who also work as distributors)


List of GDP certified distributors in the public sector exists

No 2010 National Medicines and Poisons Board

Supplementary Questions Which of the following processes at the Central Medical Store is in place

2003 CMS Quality Manual

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 No Reports of products out of stock

Yes

Routine Procedure exists to track the expiry dates of medicines


The Public Central Medical Store is GDP certified by a licensing authority

No (No certificate called GDP but license to act as wholesaler according to medicine & poisons law and national requirements).

The Public Central Medical Store is ISO certified

Yes 2003 CMS

The second tier public warehouses are GDP certified by a licensing authority

No

The second tier public warehouses are ISO certified

No

Comments CMS acts as a procurement and supply agency by law.

57

6.03 Private Sector Distribution Core Questions Legal provisions exist for licensing wholesalers in the private sector

Yes

Legal provisions exist for licensing distributors in the private sector

No

List of GDP certified wholesalers in the private sector exists

No

List of GDP certified distributors in the private sector exists

No

58

Section 7 Selection and rational use

7.01 National Structures Core Questions National Standard Treatment Guidelines (STGs) for most common illnesses are produced/endorsed by the MoH. If yes, please insert year of last update of STGs in the "year" field and attach document or provide URL below*

No 2010 General Directorate of Pharmacy

National essential medicines list (EML) exists. If yes, please write year of last update of EML in the "year" field and attach document or provide URL below.


If yes, number of medicines on the EML

565 (Only number of generics on the list)

If yes, there is a written process for selecting medicines on the EML

Yes

If yes, the EML is publicly available

Yes

% of public health facilities with copy of EML (mean)- Survey data

0.1 2007 Pharmaceutical sector assessment report

% of public health facilities with copy of STGs (mean)- Survey data

54.8 (only for malaria) 2007 Pharmaceutical sector assessment report

A public or independently funded national medicines information centre provides information on medicines to prescribers, dispensers and consumers

No 2007 WHO Level I

Public education campaigns on rational medicine use topics

No

59

have been conducted in the previous two years A survey on rational use of medicines has been conducted in the previous two years

No

A national programme or committee (involving government, civil society, and professional bodies) exists to monitor and promote rational use of medicines

No 2007 WHO Level I

A written National Strategy exists to contain antimicrobial resistance. If yes, please write year of last update of the strategy in the "year" field and attach document or provide URL below.

No 2010 General Directorate of Pharmacy

Supplementary Questions The EML includes formulations specific for children

Yes 2007 EML 2007

There are explicit documented criteria for selection of medicines in the EML

No

There is a formal committee or other equivalent structure for the selection of products on the national EML

No 2007 WHO Level I

National medicines formulary exists

No

Is there a funded national inter-sectoral task force to coordinate the promotion of appropriate use of antimicrobials and prevention of spread of infection?

No

A national reference laboratory/or any other institution has responsibility for coordinating epidemiological surveillance of antimicrobial resistance

No 2007 WHO Level I

60

7.02 Prescribing Core Questions Legal provisions exist to govern the licensing and prescribing practices of prescribers, if yes please attach document or provide URL below *


Legal provisions exist to restrict dispensing by prescribers, if yes please attach document or provide URL below *


Regulations require hospitals to organize/develop Drug and Therapeutics Committees (DTCs)

No 2007 WHO Level I

The core medical training curriculum includes components on:

Concept of EML - Use fo STGs - Pharmacovigilance - Problem based pharmacotherapy

-

The core nursing training curriculum includes components on:

2007 WHO Level I

Concept of EML No Use of STGs No Pharmacovigilance No The core training curriculum for paramedical staff includes components on:

Concept of EML - Use of STGs - Pharmacovigilance - Mandatory continuing education that includes pharmaceutical issues is required for Doctors

No 2010 Sudan Medical Council

61

Mandatory continuing education that includes pharmaceutical issues is required for Nurses

No 2010 Sudan Medical Council

Mandatory continuing education that includes pharmaceutical issues is required for Paramedical staff

No 2007 WHO Level I

Prescribing by INN name is obligatory in:

Private sector No

Public sector Yes 2009

Medicines and Poisons Act

Average number of medicines prescribed per patient contact in public health facilities (mean)


% of medicines prescribed in outpatient public health care facilities that are in the national EML (mean)

73 2007 Pharmaceutical sector assessment report

% of medicines in outpatient public health care facilities that are prescribed by INN name (mean)


% of patients in outpatient public health care facilities receiving antibiotics (mean)


% of patients in outpatient public health care facilities receiving injections (mean)


% of prescribed drugs dispensed to patients (mean)


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

61 2007 Pharmaceutical sector assessment

Comments Dispensing by prescribers is allowed only where there are no dispensary

62

Supplementary Questions A professional association code of conduct exists governing professional behaviour of doctors

Yes 2004 Sudan Medical Council

A professional association code of conduct exists governing professional behaviour of nurses

Unknown

Diarrhoea in children treated with ORS (%)


63

7.03 Dispensing Core Questions Legal provisions exist to govern dispensing practices of pharmaceutical personnel


The basic pharmacist training curriculum includes components on:

Some universities have and some do not have

2010 Sudan Medical Council

Concept of EML No Use fo STGs No Drug Information No Clinical pharmacology No Medicines supply management No Mandatory continuing education tat includes rational use of medicines is required for pharmacists

No

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

Yes

Substitution of generic equivalents at the point of dispensing in private sector facilities is allowed

Yes

Antibiotics are sold over-the-counter without a prescription


Injectable medicines are sold over-the-counter without a prescription


Supplementary Questions A professional association code of conduct exists governing professional behaviour of pharmacists

Yes 1979 Medical Eth

country profile-sudan pharmacy

Documents

ministry of health

ministry of sudan

world health organization

government of sudan

world health statistics

pharmaceutical sector

pieces of information

piece of information