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TRANSCRIPT
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
iv
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
v
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
2
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]
5
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.
6
FIGURE 1: Share of Total Pharmaceutical Expenditure as percentage of the Total Health
Expenditure.
36.00%
64.00%
TPE
Other
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]
7
FIGURE 2: The density of the Health Workforce 2009 in Sudan (all sectors).
0 2 4 6 8 10
Pharmacists
Physicians
Nursing and
midwifery personnel
/10,000 population
FIGURE 3: Distribution Pharmaceutical Personnel Sudan 2009.
Pharmacists
Pharmceutical techniciansand assistants
8
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].
10
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].
11
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].
12
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].
13
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].
14
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].
15
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.
16
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].
17
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.
18
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].
19
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].
20
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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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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2010.
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2010.
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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
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06-2010.
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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.
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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
Siham Abdoun
00249912999100
Amel Elamin Mohamed
0024121196775
Wijdan Khalid Elfil
00249912923859
Nawal Elhadi Elnur
00249912308355
Sara Abd Alkarim
00249912972069
Dr. Mohamed Awad Abdalaziz Musnad
00249912325864
Dr. Abualbishr Osman Adam Alsharif
0912255453
Gadah Omar Babiker Shouna
00249912234271
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)
58 2006 World Health Statistics
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)
112 2006 EMRO/Annual report of the Regional Director, 2008
Maternal mortality ratio (/100,000 live births)
1107 2006 EMRO/Annual report of the Regional Director, 2008
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
2009 Annual Health Statistical Report 2009/FMOH
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)
314 2007 World Health Statistics
Neonatal mortality rate (/1,000 live births)
41 2006 EMRO/Annual report of the Regional Director, 2008
Age-standardized mortality rate by non-communicable diseases ( /100,000 population)
986 2004 World Health Statistics
Age-standardized mortality rate by cardiovascular diseases (/100,000 population)
543 2004 World Health Statistics
Age-standardized mortality rate by cancer ( /100,000 population)
125 2004 World Health Statistics
Mortality rate for tuberculosis (/100,000 population)
19 2008 WHO/TB Data
Mortality rate for Malaria (/100,000 population)
85 2006 World Health Statistics
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
2006 Annual Health
Statistical Report 2008/FMOH
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)
1042.1 2008 Annual Health Statistical Report 2008/FMOH
General government annual expenditure on health (millions NCU)
2188.3 2008 Annual Health Statistical Report 2008/FMOH
Government annual expenditure on health as percentage of total government budget (% of total government budget)
9 2008 Annual Health Statistical Report 2008/FMOH
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
2008 Annual Health
Statistical Report 2008/FMOH
31
Annual per capita government expenditure on health (NCU)
71 2008 Annual Health Statistical Report 2008/FMOH
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)
136.7 2007 Pharmaceutical Statistical Report
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)
1.57 2007 Pharmaceutical Statistical Report
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)
268 2007 Pharmaceutical Statistical Report
Total private expenditure on pharmaceuticals (millions NCU)
595.5 2007 Pharmaceutical Statistical Report
Annual growth rate of total pharmaceuticals market value (%)
52 2007 Pharmaceutical Statistical Report
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
2,488 2009 FIP Global Pharmacy Workforce Report 2009
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
5890 2009 Annual Health Statistical Report 2009/FMOH
Total number of licensed pharmacies
2,306 2009 FIP Global Pharmacy Workforce Report 2009
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)?
Yes 2004 Sudan Medical Council Act
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 (%)
20.6 2007 Pharmaceutical Statistical Report
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)
2010 National Medicines and Poisons Board
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
Yes 2009 Medicines and Poisons Act
Legal provisions require paying a fee for Medicines Market Authorization (registration) applications
Yes 2009 Medicines and Poisons Act
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
Yes 2009 Medicines and Poisons Act and Regulations
Certificate for Pharmaceutical Products in accordance with the WHO Certification scheme is required as part of the marketing authorization application
Yes 2009 Medicines and Poisons Act and Regulations
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
Yes 2009 Medicines and Poisons Act and Regulations
Registration fee - the amount per application for pharmaceutical product containing New Chemical Entity,NCE (US$)
600 2010 National Medicines and Poisons Board
Registration fee - the Amount per application for a multisource pharmaceutical product (US$)
600 2010 National Medicines and Poisons Board
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
Yes 2009 Medicines and Poisons Act and Regulations
Does the Regulatory Authority have inspectors?
Yes 2010 National Medicines and Poisons Board
Legal provisions exist permitting inspectors to inspect premises where pharmaceutical activities are performed
Yes 2009 Medicines and Poisons Act and Regulations
Legal provisions exist requiring inspection to be performed
Yes 2009 Medicines and Poisons Act and Regulations
Inspection is a pre-requisite for licensing of facilities
Yes 2009 Medicines and Poisons Act and Regulations
Inspection requirements are the same for public and private facilities
Yes 2009 Medicines and Poisons Act and Regulations
4.04 Import Control
Core Questions
Legal provisions exist requiring authorization to import medicines
Yes 2009 Medicines and Poisons Act and Regulations
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
Yes 2009 Medicines and Poisons Act and Regulations
Legal provisions exist allowing inspection of imported
Yes 2009 Medicines and Poisons Act
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 *
Yes 2009 Medicines and Poisons Act and Regulations
Legal provisions exist requiring manufacturers to comply with Good manufacturing Practices (GMP)
Yes 2009 Medicines and Poisons Act and Regulations
GMP requirements are published by the government. If yes, please provide reference or URL below *
No
Legal provisions exist requiring importers to be licensed
Yes 2009 Medicines and Poisons Act and Regulations
Legal provisions exist requiring wholesalers and distributors to be licensed
Yes 2009 Medicines and Poisons Act and Regulations
National Good Distribution Practice requirements are published by the government
Yes 2009 National Medicines and Poisons Board
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
Yes 2009 Medicines and Poisons Act and Regulations
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
Yes 2009 Medicines and Poisons Act and Regulations
Does a laboratory exist in the country for Quality Control testing?
Yes 2009 Medicines and Poisons Act and Regulations
If not, does the regulatory authority contract services elsewhere?
Samples are collected by government inspectors for undertaking post-marketing surveillance testing
Yes 2009 Medicines and Poisons Act and Regulations
How many Quality Control samples were taken for testing in the past two years?
7536 2009 National Medicines and Poisons Board
What is the total number of samples tested in the previous two years that failed to meet quality standards?
816 2009 National Medicines and Poisons Board
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
Yes 2009 Medicines and Poisons Act and Regulations
Legal provisions require a pre-approval for medicines advertisements and promotional materials
Yes 2009 Medicines and Poisons Act and Regulations
Guidelines/Regulations exist for advertising and promotion of non-prescription medicines
Yes 2009 Medicines and Poisons Act and Regulations
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
Yes 2009 Medicines and Poisons Act and Regulations
Legal provisions exist requiring the agreement by an ethics committee/ institutional review board of the Clinical Trials to be performed
Yes 2009 Medicines and Poisons Act and Regulations
Legal provisions exist requiring registration of the clinical trials into international/national/regional registry
Yes 2009 Medicines and Poisons Act and Regulations
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
Yes 2009 International Narcotics Control Board
Convention on Psychotropic Substances 1971
Yes 2009 International Narcotics Control Board
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
Yes 2008 National Medicines and Poisons Board
If a national pharmacovigilance centre exists in your country, how many staff does it employ full-time
1 2010 National Medicines and Poisons Board
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 *
Yes 2008 National Medicines and Poisons Board
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 *
Yes 2008 National Medicines and Poisons Board
47
A national Adverse Drug Reactions database exists in your country.
Yes 2008 National Medicines and Poisons Board
Are ADR reports set to the WHO database in Uppsala?
Yes 2008 National Medicines and Poisons Board
If yes, number of reports sent in the past two years
50 (Is the number of reports during the last 2 years)
2008 National Medicines and Poisons Board
ADRs are monitored in at least one public health program (for example TB, HIV, AIDS)?
Yes 2008 National Medicines and Poisons Board
Supplementary Questions
How many ADR reports are in the database?
160 2010 National Medicines and Poisons Board
Feedback is provided to reporters
Yes 2010 National Medicines and Poisons Board
The ADR database is computerized
Yes 2008 National Medicines and Poisons Board
Medications errors (MEs) are reported.
Yes 2009 National Medicines and Poisons Board
How many MEs are there in the ADRs database?
3 2009 National Medicines and Poisons Board
There is a risk management plan presented as part of product dossier submitted for Marketing Authorization?
Yes 2010 National Medicines and Poisons Board
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?
1 2009 National Medicines and Poisons Board
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
Yes 2007 WHO Level I
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
Yes 2007 WHO Level I
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
Yes 2009 Medicines and Poisons Act
If yes, are the provisions aimed Yes 2009 Medicines and
51
at Manufacturers Poisons Act
If yes, are the provisions aimed at Wholesalers
Yes 2009 Medicines and Poisons Act
If yes, are the provisions aimed at Retailers
Yes 2009 Medicines and Poisons Act
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)
Yes 2007 WHO Level I
There are duties on imported finished products
Yes 2007 WHO Level I
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
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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
Yes 2003 CMS Quality Manual
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)
Yes 2008 National Medicines and Poisons Board
There is a licensing authority that issues GDP licenses
No (Distributors are the whole salers. There is national guideline for licensing wholesalers)
2010 National Medicines and Poisons Board
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)
2010 National Medicines and Poisons Board
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
Yes 2003 CMS Quality Manual
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.
Yes 2007 WHO Level I
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 *
Yes 2004 Sudan Medical Council Act
Legal provisions exist to restrict dispensing by prescribers, if yes please attach document or provide URL below *
Yes 2004 Sudan Medical Council Act
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)
2.3 2007 Pharmaceutical sector assessment report
% 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)
43.5 2007 Pharmaceutical sector assessment report
% of patients in outpatient public health care facilities receiving antibiotics (mean)
65 2007 Pharmaceutical sector assessment report
% of patients in outpatient public health care facilities receiving injections (mean)
28.6 2007 Pharmaceutical sector assessment report
% of prescribed drugs dispensed to patients (mean)
84.4 2007 Pharmaceutical sector assessment report
% 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 (%)
48 2007 Pharmaceutical sector assessment report
63
7.03 Dispensing
Core Questions
Legal provisions exist to govern dispensing practices of pharmaceutical personnel
Yes 2009 Medicines and Poisons Act
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
Yes 2007 WHO Level I
Injectable medicines are sold over-the-counter without a prescription
Yes 2007 WHO Level I
Supplementary Questions
A professional association code of conduct exists governing professional behaviour of pharmacists
Yes 1979 Medical Ethics and Medico Moral Problem
Are the following categories of staff prescribing prescription-only medicines at primary care level in the public sector?
2007 WHO Level I
Doctors Yes
64
Nurses Yes
Pharmacists Yes
Comments The code of conduct is included in the Medical Ethics and Medico Moral problems.