WHO/AFR/EDM/EDP/12.03
Measuring Transparency to Improve Good Governance in the Public Pharmaceutical Sector
ZAMBIA
Ray Handema Chipupu Kandeke Albert Lupuma Loyce Lishimpi Caroline Yeta
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© World Health Organization. Regional Office for Africa, 2012
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Contents
Abbreviations ..................................................................................................................................v
Acknowledgements ....................................................................................................................... vii
Executive summary ......................................................................................................................... ix
1. Introduction ........................................................................................................................... 1
1.1 Background ................................................................................................................. 1
1.2 Assessment objectives ................................................................................................. 2
1.3 Methodology ............................................................................................................... 2
1.4 Assumptions and limitations ....................................................................................... 4
2. General information on Zambia .............................................................................................. 4
3. Health services in Zambia ....................................................................................................... 5
4. Pharmaceutical sector in Zambia ............................................................................................ 6
5. Assessment findings ............................................................................................................... 8
5.1 Drug registration ......................................................................................................... 8
5.2 Control of drug promotion ......................................................................................... 12
5.3 Inspection .................................................................................................................. 17
5.4 Drug selection ........................................................................................................... 20
5.5 Procurement ............................................................................................................. 23
5.6 Distribution ............................................................................................................... 28
6. General findings and analysis................................................................................................. 32
7. Conclusions ........................................................................................................................... 34
Bibliography ................................................................................................................................. 35
Annex 1. Ministry of Health Functional Organizational Structure ............................................. 37
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Abbreviations
ACC Anti‐Corruption Commission
AIDS Acquired Immunodeficiency Syndrome
ART Antiretroviral therapy
ARV Antiretroviral
CHAZ Churches Health Association of Zambia
COI Conflict of Interest
DEC Drug Enforcement Commission
EPI Expanded Programme on Immunization
GDP Gross Domestic Product
GF Global Fund
GGM Good Governance for Medicines
GRZ Government of the Republic of Zambia
HIV Human Immunodeficiency Virus
HMIS Health Management Information System
ICB International Competitive Bidding
KI Key Informant
LIB Limited International Bidding
M&E Monitoring and Evaluation
LMIS Logistics Management Information System
MISA Media Institute of Southern Africa
MOFNP Ministry of Finance and National Planning
MOH Ministry of Health
MSH Management Sciences for Health
MSL Medical Stores Limited
MTC Ministerial Tender Committee
MeTA Medicines Transparency Alliance
NCB National Competitive Bidding
NDP National Drug Policy
NEML National Essential Medicines List
NGO Nongovernmental Organization
NISIR National Institute for Scientific and Industrial Research
NSTC National Science and Technology Council
PEPFAR President’s Emergency Plan for AIDS Relief
PHO Provincial Health Office
PRA Pharmaceutical Regulatory Authority
PTC Pharmacy and Therapeutics Committees
PTWG Procurement Technical Working Group
SOPs Standard Operating Procedures
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SSPs Standard Storage Procedures
STGs Standard Treatment Guidelines
TB Tuberculosis
TIZ Transparency International Zambia
UNDP United Nations Development Programme
USAID United States Agency for International Development
WHO World Health Organization
ZDHS Zambia Demographic Health Survey
ZNF Zambia National Formulary
ZNTB Zambia National Tender Board
ZPPA Zambia Public Procurement Authority
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Acknowledgements
The World Health Organization (WHO) and the Government of the Republic of Zambia,
through the Ministry of Health, wish to thank the National Assessors, Ray Handema,
Chipupu Kandeke, the Government Officials, Albert Lupupa, Caroline Yeta, as well as the
WHO Essential Medicines National Professional Officer, Loyce Lishimpi, who tirelessly
conducted the assessment and produced the results of the study.
The contributions and support of the following people is also acknowledged: Dr Peter Mwaba,
Permanent Secretary, Ministry of Health (MOH); Dr Velepi Mtonga, former Permanent
Secretary, MOH; Dr Simon Miti, former Permanent Secretary, MOH; Dr Olusegun Babaniyi,
WHO Country Representative for Zambia; Dr Magda Robalo Correia e Silva, former WHO
Country Representative for Zambia, Dr Victor Mukonka, Director, Public Health and Research,
MOH; Dr Gardner Syakantu, Director, Clinical Care and Diagnostic Services, MOH; Ms Esnat
Mwape, Director General, Pharmaceutical Regulatory Authority; and Mr Davy Nanduba,
Deputy Director, Pharmaceutical Services, MOH.
This document has been produced with the financial assistance of the European Union and
the German Government through BMZ . The views expressed herein are those of the authors
and can therefore in no way be taken to reflect the official opinion of the European Union or
the German Government (BMZ).
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Executive summary
The Good Governance for Medicines (GGM) assessment was undertaken to measure the
extent of vulnerability to corruption in Zambia’s pharmaceutical sector, using a WHO
standardized assessment tool. The assessment focused on the following six essential
regulatory and supply functions: medicine registration, promotion, inspection, selection,
procurement and distribution.
In 2004, the World Health Organization (WHO) introduced the GGM programme in an
attempt to curb corruption in the pharmaceutical sector. The programme’s goal is to reduce
corruption in pharmaceutical sector systems through the application of transparent,
accountable, administrative procedures and the promotion of ethical practices among health
professionals. The programme focuses on improving pharmaceutical systems through the
consistent application of two complementary strategies: discipline‐ and values-based strategies.
The six pharmaceutical functions listed above were assessed between 15th October and 3rd
December 2007. On 17th and 18th July 2008, a national stakeholders’ workshop discussed the
findings of the assessment and adopted the assessment report with amendments and
recommendations. The assessment revealed that registration, inspection, procurement and
distribution were marginally vulnerable, while promotion and selection were moderately
vulnerable to corruption (see table below). Areas of concern included, among others, conflict
of interest (COI) not being declared. Overall there is a marginal degree of vulnerability (score
6.92) in the governance of the medicines system in Zambia, which could become worse if
certain issues are not addressed. (The scoring system used in the assessment is explained in
Section 1.3.2).
Registration Promotion Inspection Selection Procurement Distribution
Final score 6.95 5.12 8.03 5.19 6.68 9.55 Degree of vulnerability Marginal Moderate Marginal Moderate Marginal Marginal
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Measuring Transparency to Improve Good Governance in the Public Pharmaceutical Sector ZAMBIA
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1. Introduction
1.1 Background
Health systems cannot function without pharmaceuticals. By complementing other types of
health‐care services, pharmaceuticals can reduce morbidity and mortality rates and enhance
quality of life. Access to health care and essential medicines is therefore increasingly viewed
as a fundamental human right. It is also important that pharmaceuticals are accessible, of
proven quality and safety and that they are properly used to save lives, reduce suffering and
improve health.
Many countries are unable to achieve such standards. It is estimated that today, one third of
the world’s population does not have regular access to essential medicines. In some of the
lowest‐income countries in Africa and Asia, more than half of the population has no
properly functioning medicine authorities to regulate the medicines market, including
registration of medicines, inspection of pharmaceutical establishments and control of drug
promotion. Unreliable supply systems persist, and irrational use of medicines is a major
problem worldwide (WHO, September 2007).
There are a number of factors that contribute to these challenges in the pharmaceutical
sector including poverty, and market and government failures. The latter often result, at
least in part, from a lack of transparency in the pharmaceutical system – which is one of the
possible reasons for the medicine gap described above. Lack of transparency in the sector is
increasingly becoming an issue of concern because bad practices can waste resources, which
in turn reduces the availability of essential medicines and threatens the well‐being of
populations.
Experts estimate that 10–25% of the funds spent globally on public procurement of
medicines are lost through corruption (WHO, September 2007). Thus, millions of people,
especially in the poorest countries, are being robbed of their health as life‐saving resources
for essential medicines and for the recruitment of medical professionals are siphoned off.
The World Bank has also identified corruption as the single greatest obstacle to economic
and social development.
In an attempt to curb corruption, WHO initiated the GGM programme in 2004. The
programme’s goal is to reduce corruption in pharmaceutical sector systems through the
application of transparent, accountable, administrative procedures and the promotion of
ethical practices among health professionals. Good governance is essential in the public
pharmaceutical sector because of the three‐fold impact that corruption and fraud have on:
Health – loss of government capacity to provide access to quality‐assured essential
medicines. There are more unsafe medical products on the market due to counterfeiting
and/or bribery of officials.
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Economy – low‐income countries are hardest hit. Pharmaceutical expenditure may represent
up to 50% of national health‐care costs, so corruption losses are extremely detrimental.
Image and trust – abuse and lack of transparency reduce the credibility of public institutions and erode public/donor confidence in governments.
Moreover, corruption within the public sector undermines the efforts of the donor
community in providing vital aid for global public health, such as that from the Global Fund
to Fight AIDS, Tuberculosis and Malaria (GFTAM), the Bill & Melinda Gates Foundation
and the President’s Emergency Plan for AIDS Relief (PEPFAR). Successful implementation
of such funds ultimately depends on good governance.
1.2 Assessment objectives
The objective of the assessment was to provide a general but comprehensive picture of the
level of transparency and potential vulnerability to corruption in the procedures followed
and structure of the following six pharmaceutical functions in the public sector: Registration, Promotion, Inspection, Selection, Procurement and Distribution. Recommendations from
the assessment will lead to the development of a national GGM programme aimed at
increasing transparency and accountability in the pharmaceutical sector.
1.3 Methodology
A WHO transparency tool was used in this study. The tool provides quantitative and
qualitative information on vulnerability to corruption in the six functions listed above.
Quantitative data collected were used to measure the level of transparency in the six
functions. Qualitative data were used to quantify vulnerability to corruption and
perceptions of relevant key informants (KIs) in the public and private sectors.
1.3.1 Data collection method
Face to face interviews with KIs were held between 15 November and 3 December 2007. The
KIs were drawn from the Government (Ministry of Health (MOH)), the Pharmaceutical
Regulatory Authority (PRA), second‐ and third‐level hospitals, district health offices and
tertiary hospitals); and private, media and nongovernmental organizations (NGOs). See
Table 1 for details. For each of the six functions in the tool there were 15 indicators. Verbal
responses given to these indicators during discussions were entered on to the assessment
tool. Information on structural indicators was validated by comparing evidence gathered
from the KIs’ responses with existing information obtained from relevant documents.
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Table 1: Affiliation of the key informants interviewed
Area/ Function
Total Indicators
Number of KIs
Government Official
Private Sector
NGO International Organization
Media
Registration 12 9 3 3 2 1 0
Promotion 8 12 6 3 1 1 1
Inspection 8 11 6 1 2 1 1
Selection 8 11 7 1 2 1 0
Procurement 11 15 7 3 3 2 0
Distribution 12 11 5 1 4 1 0
Total 59 69 34 12 14 7 2
1.3.2 Data analysis and scoring
Scoring was done for each indicator and a final score was given using a formula that was
provided. To determine the level of transparency, data analysis and interpretation were
done using four methods. However, only answers from methods 1 and 2 were counted in
the final score during this assessment.
Method 1: This method required a “yes” or “no” answer. A “yes” was given a value of 1 and
a “no” was given a value of 0. A value of 1 represented low vulnerability to corruption
depending on the availability of supporting documents. A value of 0 represented high
vulnerability to corruption. The final score ranging from 0 to 1 was entered on the
spreadsheet. The total score for each indicator was calculated from the total number of KIs
interviewed.
Method 2: This method involved questions with a series of sub‐criteria; each criterion had
three possible answers to choose from: “yes”/”no”/”don’t know”; then the total “yes”
answers were counted and divided by the total number of valid answers. “Don’t know”
answers were subtracted from the total number of responses to obtain the valid answers.
Each question was scored between 1 and 0. The average rating was calculated for each
section, then results were converted on a zero to ten (0–10) scale.
All individual scores for methods 1 and 2 were entered in an Excel spreadsheet template and
used to calculate the final score for each section. Interpretation of results was according to
degrees of vulnerability to corruption, as indicated in Table 2 below.
Table 2: Interpretation of assessment results
0.0 – 2.0 2.1 – 4.0 4.1 – 6.0 6.1– 8.0 8.1 – 10 Extremely vulnerable
Very vulnerable
Moderately vulnerable
Marginally vulnerable
Minimally vulnerable
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Method 3: This method was used for subjective questions that probed the KIs’ perceptions,
so revealing their valuable insights into the transparency level of each of the assessed
functions. This method was used as cross‐triangulation to support (or not) the data collected
with methods 1 and 2. Responses to these questions were put in table formats followed by
comments.
Method 4: In this method, open questions were used, giving KIs the opportunity to provide
additional input as well as their independent opinions on the issue in question. In this way
qualitative information confirming method 1 and 2 findings was provided.
1.4 Assumptions and limitations
During the assessment it was assumed that the selected KIs were knowledgeable,
experienced and involved in the area for which they had been selected for interview. It was
also assumed that the KIs would provide honest answers to the questions put to them and
that they would be able to back up their responses with evidence/documents. Time was
obviously a limitation, as KIs had to take time out from their normal daily work.
2. General information on Zambia
Zambia is a land‐locked country with an estimated population of 11.2 million in 2005
(Zambia Demographic Health Survey (ZDHS). It is bordered by Angola, Botswana, the
Democratic Republic of the Congo, Malawi, Mozambique, Namibia, the United Republic of
Tanzania and Zimbabwe. It has an area of 752 614 square kilometres, only 12% of which is
used for agriculture. The country is divided into 9 provinces and 73 districts. The official
language is English but 72 local languages are spoken.
Zambia has a tropical climate and vegetation, with three distinct seasons: the cool dry winter
from May to August, a hot dry season during September and October and a warm wet
season from November to April. Average temperatures are relatively warm, between 20–24
degrees Celsius, and annual rainfall is over 900 millimetres.
When Zambia gained its independence from Britain in 1964 it was the developing world’s
largest copper producing country, with a strong economy that has continued to be
predominantly dependent on copper and to a lesser extent agriculture. Declining copper
prices in the 1980s and 1990s and prolonged drought damaged the economy severely. The
real growth rate of per capita Gross Domestic Product (GDP) was estimated at 4.6% in 2004,
and public debt was 127.5% of annual GDP, with per capita US$ 350.
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3. Health services in Zambia
The health sector has been implementing major reforms since 1992, with the emphasis on the
achievement of the sector’s vision. The vision is to ensure “equity of access to assured quality
and affordable healthcare services, as close to the family as possible”. This is to be achieved through
the “establishment of a strong, responsive and reliable health sector which is founded on the
principles of strong leadership, equity of access, affordability, cost‐effectiveness, decentralization,
partnerships and accountability”.
The infant mortality rate was estimated at 88 per 1000 live births. Life expectancy was
estimated to have plummeted from 50 years at independence to 37 years by 2000. This is
among the lowest in the world, and is primarily the result of underlying poverty combined
with HIV/AIDS, which had an estimated prevalence rate of 16.5% (Central Statistics Office
2002; CIA 2005; Gaynor 2005; UNDP 2004).
Over the past five years, the overall performance of the health sector has shown some
improvement as reflected in the trends of basic delivery indicators, such as health centre
outpatient per capita attendance, first antenatal coverage, and fully immunized children
under the age of five years.
Even though some major achievements have been reported in various programme areas, the
sector has continued to operate under significant pressure. This is largely due to challenges
relating to the high burden of disease, inadequate funding, critical shortages of qualified
health workers, erratic supply of drugs and medical supplies, as well as problematic
infrastructure development and maintenance.
In 2008, the top 10 main causes of morbidity and mortality in Zambia were malaria,
respiratory infections (non‐pneumonia), diarrhoea (non‐blood), trauma (accidents, injuries,
wounds and burns), eye infections, skin infections, respiratory infections (pneumonia), ear,
nose and throat infections, intestinal worms and anaemia.
Malaria is endemic in Zambia and remains the leading cause of morbidity and mortality in
the country. HIV/AIDS has continued to be a major epidemic with significant impact on
morbidity and mortality levels. However, the malaria incidence is reported to have reduced
from 358 cases per 1000 population in 2007 to 252 cases in 2008 (MOH, Health Management
Information System (HMIS) 2008). The prevalence of HIV in the adult population has also
reduced from 16.1% in 2002 to 14.2% in 2007 (ZDHS 2007).
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The main providers of health‐care services in Zambia include: public health facilities under
the MOH; facilities in the Ministry of Defence; clinics in the Ministry of Home Affairs; mine
hospitals; mission hospitals and clinics coordinated by the Churches Health Association of
Zambia (CHAZ); private pharmacies, hospitals and clinics; NGOs; and traditional health
practitioners. Management and control of all public health facilities and services is under the
MOH, through the Provincial Health Offices (PHOs).
The public health sector in Zambia is sub‐divided into three broad categories, namely, the
core health service delivery facilities (health post, heath centre, district hospital, general
hospital central and specialized hospitals), training institutions and statutory boards.
4. Pharmaceutical sector in Zambia
The pharmaceutical sector in Zambia is regulated by the Pharmaceutical Act No. 14 of 2004,
which establishes the PRA. The PRA is responsible for registration and regulation of
pharmacies, registration and regulation of medicines, herbal medicines and allied
substances intended for human use and for animal use, regulation and control of the
manufacture, importation, exportation, possession, storage, distribution, supply, promotion,
sale and use of medicines, herbal medicines and allied substances. However, the Act does
not regulate the practice of pharmacy professionals. Pharmaceutical staff is registered under
another piece of legislation, the Health Professions Act of 2009.
Registration of pharmaceutical products for use on the Zambian market is carried out by the
PRA through the Directorate of Product Registration. The Directorate further submits
evaluation reports to the Medicines Committee for consideration before inclusion of
products on the register. The formation of a Medicines Committee is provided for under
Section 9 of the Pharmaceutical Act No. 14 of 2004. Forecasting and quantification of
medicines is done by the MOH’s Directorate of Clinical Care and Diagnostics Services,
Pharmacy Unit, in liaison with cooperating partners. The Unit is also responsible for
capacity building in pharmaceutical management in public sector health institutions.
The procurement of medicines for Government health institutions is done by the
Procurement and Supplies Unit of the MOH. There has been restructuring at the MOH,
which has also included the Procurement and Supplies Unit. The Head of Procurement
reports directly to the Permanent Secretary. Under him are three Chief Procurement Officers
one of whom is a pharmacist specifically for procurement of medicines and other medical
products. Under the Chief Procurement Officer are two Senior Purchasing and Supplies
Officers, and again one of the two is a pharmacist.
The sources of funding for procurement of medicines are the Government and cooperating
partners. For 2007‐2008, the MOH embarked on Framework Contracts with pharmaceutical
suppliers to improve (without interruptions) the supply of medicines and other
pharmaceuticals.
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In its procurement operations the MOH is guided by the procedures for public procurement
laid down by the Zambia Public Procurement Authority (ZPPA). All procurements above
the authorized thresholds (US$ 1000 000 for MOH) are channelled through other
procurement methods as per Zambia National Tender Board guidelines. The procurement
methods recommended by ZPPA include: International Competitive Bidding (ICB), Limited
International Bidding (LIB) and National Competitive Bidding (NCB).
Procurement of pharmaceuticals and related supplies is one of the key roles of the MOH
Procurement and Supplies Unit. The pharmaceuticals and other medical supplies procured
for the public sector are directly delivered to Medical Stores Limited (MSL), which is the
central/national store, by respective suppliers. MSL receives the goods on behalf of the MOH
ensuring that the items meet quality standards and all other contract specifications. MSL
then issues the Goods Acceptance Certificate, a document used by the MOH to initiate
payments. The MSL informs the MOH in writing of any rejects/under‐ or over‐supplies.
The storage and distribution of pharmaceuticals and other medical supplies to district health
offices and hospitals is done by the national MSL, and district management teams in turn
distribute to health centres and clinics within their districts. The MSL is a parastatal
company owned by the Ministry of Finance and the MOH. Currently the management of the
MSL is contracted to Crown Agents.
CHAZ is involved in medicines supply management as a complementary service (about 20–
30%) to the Government supply system. Through a revolving drug fund CHAZ sells
essential medicines to member institutions and other not‐for‐profit organizations, including
Government health institutions. In addition, with support from cooperating partners, CHAZ
runs an antiretroviral therapy (ART) programme that includes procurement, storage and
distribution.
The private pharmaceutical sector consists of local manufacturers, wholesalers and retailers.
These are concentrated mainly along the rail system lines, in urban areas (Lusaka,
Copperbelt and, to a small extent, Livingstone). The Government is the main buyer of
medicines and allied products. Local manufacturing capacity is very small and so medicines
are imported, mainly from India.
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5. Assessment findings
5.1 Drug registration
The registration of pharmaceuticals and allied products in Zambia is the responsibility of the
PRA. The total number of KIs interviewed about the drug registration function and their
institutions is shown in the table below:
Area/
Function Total
Indicators Number of KIs
Government Official
Private Sector
NGO International Organization
Media
Registration 12 9 3 3 2 1 0
Indicator I.1:
Is there an up-to-date list of all registered pharmaceutical products available in the country?
Of the 9 KIs interviewed, 7 (78%) said “yes” to the existence of an up‐to‐date list of all
registered pharmaceutical products in Zambia and 2 (22%) said “no” because they had never
seen it, nor did they know where it was kept if it did exist. However, no evidence was
provided by any of the 7 KIs who said that there was such a list. The PRA does maintain a
record of all registered products but this record is not readily available to the public except
on request. The PRA is in the process of establishing computerized software (WHO SIAMED
software) to facilitate the production of a register of licensed medicines in Zambia, which
will be published.
Indicator I.2:
If such a list exists, does it provide a minimum level of information?
The assessors were not provided with any evidence of an up‐to‐date list of all registered
pharmaceutical products in Zambia by any of the 7 KIs who said that such a list existed. The
most probable reason could be that these KIs’ responses were based on what they knew
about its existence and what it contained.
Indicator I.3:
Are there written procedures for applicants on how to submit an application for registration of medicinal products?
Of the 9 KIs interviewed, 8 (89%) said that there are written procedures on how applicants
should submit an application for registration of medicinal products. Only 1 (11%) KI said
that no procedures are available. Again no evidence of such procedures was found. There
was, however, great concern regarding the time taken to process an application, with 67% of
the KIs interviewed stating that the process took too long or was slow.
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Indicator I.4:
Are there written procedures for assessors on how to assess applications submitted for registration of medicinal products?
This was a rather tricky question in that the information sought is for people who are in the
system, i.e. those responsible for assessing submitted applications. Five (55%) of the KIs
interviewed said that these procedures existed in writing, although they could not provide
any evidence. The other four (45%) replied honestly that they did not know, a reflection of
the fact that these procedures are not readily available to the public.
Indicator I.5:
Is there a standard application form publicly available for submission of applications for registration of medicinal products?
This is a form that must be readily available for anyone wishing to apply for registration of a
medicinal product. Of the KIs interviewed 78% said the form existed and was publicly
available. However, one KI from a private pharmaceutical company, who claimed to be a
regular applicant, said that this was not the case, a response which gained credibility given
the failure of the 78% to provide evidence that the form existed. Another KI, also from the
private sector, said that he did not know. At the time of the assessment the PRA was
working on procedures for registration of medicinal products.
Indicator I.6:
Are there written guidelines setting limits on how and where medicines registration officers meet with applicants?
44% of the KIs interviewed said that there were no such guidelines but that these were to be
included in the code of conduct that was being developed for staff members. 22% of the KIs
said that they did not know, while 33% said these guidelines existed but they could not
provide evidence.
Indicator I.7:
Is there a functioning formal committee involved in the assessment of the applications for registration of pharmaceutical products?
The Pharmaceutical Act No. 14 of 2004, Sub‐section 1, provides for the establishment of such
a committee. 67% of the KIs interviewed were aware of the existence of a committee, 22%
did not know, while 11% responded “no” to this question. Evidence was provided in the
form of a copy of the Pharmaceutical Act No. 14 of 2004.
Indicator I.8:
Are there clear written criteria for selecting the members of the committee?
The Pharmaceutical Act No. 14 of 2004, Sub‐section 1, gives powers to the Pharmaceutical
Regulatory Authority Board to constitute the Medicines Committee and it stipulates the
composition of its members. The members nominate their Chairperson and the Vice‐chair.
Of the KIs interviewed, 55% said “yes”, clear written criteria existed, 11% said “no” and 33%
said “don’t know”.
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Indicator I.9:
Is there a written document that describes the composition and terms of reference of the committee?
In the same way that it sets out the composition of the Pharmaceutical Regulatory Authority
Board, Pharmaceutical Act No. 14 of 2004 also describes the composition of this committee
and its terms of reference. Of the 9 responding KIs, 44% said “yes” while another 45% said
they did not know and 11% said “no”. The high percentage of those who said they did not
know is a reflection of not having a copy of the Pharmaceutical Act No. 14, 2004, as they all
said it was only available at Pharmaceutical Headquarters in Lusaka. The Pharmaceutical
Act is available at the Government Printers for a fee.
Indicator I.10:
Are there written guidelines on conflicts of interest with regard to registration activities?
The Pharmaceutical Act. No. 14 of 2004 does not mention conflicts of interest (COIs) in the
way committee members are supposed to conduct themselves. Fifty‐six per cent of the KIs
interviewed said they did not know the answer to this question, 22% said “no”, and 22%
said “yes”. A copy of COI guidelines was not provided as evidence. However, the PRA
informed the assessors that guidelines on COI are being developed.
Indicator I.11:
To what extent do you agree with the following statement: "The members of the Registration Committee are systematically and objectively selected based on the written criteria in force in your country"? (see question I.8)
Strongly disagree Disagree Undecided Agree Strongly agree NA DK 0 1 1 1 1 2 3
Comments: The responses shown above indicate that the method and criteria of selecting
members of the Registration Committee are not well known. There is therefore a need to
strengthen this area. The Pharmaceutical Act provides basic guidelines on how to select
members and on the committee’s terms of reference. There is a need to develop
comprehensive guidelines and terms of reference to manage this process effectively.
Indicator I.12:
Are there clear and comprehensive guidelines for the Committee's decision-making process?
This was a tricky question that could be adequately answered only by people who are in the
system of assessing submitted applications. However, Sub‐section 3 of Part V (37) of the
Pharmaceutical Act No.14 of 2004 states the conditions that an application must meet before
a product licence can be granted. Of the KIs interviewed, 56% said they did not know
whether the guidelines for the committee’s decision‐making process were clear and
comprehensive, but 45% of interviewees said that they were, although they did not provide
any written evidence.
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Indicator I.13:
Is there a formal appeals system for applicants who have their drug applications rejected?
The majority of the respondents (89%) said that a formal appeals system for applicants who
have their drug applications rejected exists and only 11% said it did not. Sub‐section 1 of
Part V (39) of the Pharmaceutical Act No. 14 of 2004 does provide for an appeals system
through the MOH.
Indicator I.14:
To what extent do you agree with the following statement: "Gifts and other benefits given to the officials in charge of medicines registration have no influence at all on their final decisions"?
Strongly disagree Disagree Undecided Agree Strongly agree NA DK 1 4 0 3 0 0 1
Comments: Most KIs (5 out of 9) disagreed with this statement, which is in line with the
responses to question I.15 where the giving of gifts and other benefits were highlighted as
the common forms of unethical behaviour in the registration system. The indication is that
these gifts might have an influence and there is therefore a need for stiff punitive measures
to be taken against culprits.
Indicator I.15:
In your opinion, what types of unethical behaviour are common in the registration system in your country? These can include bribery, material gifts, favouritism (family, friends), conflict of interest (e.g. investments in pharmaceutical companies), etc.
In descending order the unethical behaviours common in the registration system in Zambia
are: bribery (67%), material gifts (56%), COI (56%) and favouritism (33%).
Indicator I.16:
If you were in a position of highest authority, what would be the first action that you would take to improve the registration process in your country?
Indicators 1.1 to 1.14 sought to increase understanding of how current registration of
products is conducted and identify weaknesses that would make the system vulnerable to
corruption. However, indicator 1.16 enabled interviewed KIs to put across their ideas on
how they think or feel that they could make the system better if they were the ones in
control. Below is a list of responses.
The quality of services offered by the public institutions
In order to improve the quality of services offered to the public, the KIs interviewed said they
would do the following:
Streamline registration procedures at directorate level
Strengthen the Medicines Committee and make it fully functional
Improve on time limits, i.e. reduce the period of registration
Have access to a laboratory to verify the information provided
Employ sufficient qualified registration officers
Review the current registration process with the assistance of qualified professionals
Form a permanent committee to deal only with registration of products
Develop registration guidelines.
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Transparency in the services offered by public institutions In order to improve the transparency in the services offered to the public, the KIs interviewed
said they would do the following:
Make the Medicines Committee operational
Include stakeholders such as chemists and other health professionals
Establish a web site
Circulate a list of registered products periodically
Request sufficient funding to pay assessors
Implement and enforce all aspects of the Pharmaceutical Act No.14 of 2004
Hold regular meetings with the PRA and stakeholders to discuss fees.
Strengths of the registration system in Zambia
The strengths in the registration of products include:
There is a list of registered pharmaceutical and allied products and information on the
registration process. However, it is only readily available at the PRA
A standard application form for registration is in place
A statutory instrument for product registration requirements is in place
The Pharmaceutical Act guides the composition of the Registration Committee
An appeals system is provided for in the Pharmaceutical Act.
Weaknesses of the registration system in Zambia
The list of registered pharmaceutical products is not available for most stakeholders
There is no system for submitting an application for registration of products
There are no rules on acceptance of gifts but these will be included in the staff code of
conduct, currently being developed
Gifts and other benefits appear to have an influence on final medicines registration decisions
(56% of respondents agreed)
The public has limited knowledge of how the PRA operates.
Recommendations
Complete, publish and disseminate the register for licensed medicines to all stakeholders
PRA to finalize the web site and put the register on the web site PRA to reduce the lead time for the registration process.
5.2 Control of drug promotion
Control of medicines promotion and advertisement in Zambia is the responsibility of the
PRA. The total number of KIs interviewed about drug promotion and their institutions is
shown in the table below.
Area/ Function
Total Indicators
Number of KIs
Government Official
Private Sector
NGO International Organization
Media
Promotion 8 12 6 3 1 1 1
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Indicator II.1:
Is there a provision in the medicines legislation/regulations covering drug promotion and advertising?
Of the 12 KIs interviewed, 92% said that there was a provision in the medicines
legislation/regulations covering drug promotion and advertising but no evidence was
provided. Part V, Section 43, Sub‐sections 1, 2 and 3 of the Pharmaceutical Act No.14 of 2004
provide regulations covering drug promotion and advertising. The failure to provide
evidence could be attributed to difficulties in accessing the Pharmaceutical Act.
Indicator II.2:
Do the provisions on drug promotion and advertising include explicit mention of the following areas?
Advertising to professionals and to the public
Qualification and training of medical representatives
Restrictions on monitoring of free samples
Symposia and scientific meetings
Post‐marketing scientific studies
Speakers’ fees and consultancies
Packaging, labelling and package inserts
Promotion of exported drugs
Restrictions and limits on gifts and gimmicks.
Although the Pharmaceutical Act covers promotion and advertising, details such as the ones
in the questionnaire are among the regulations which are still under development.
Nevertheless, 58% of the respondents said promotion forms do mention them, probably
based on what they know or think should be there. 33%, composed of respondents from the
Government (PRA and MOH), could not give further information, indicating that these
issues are in the regulations still being developed. “Do not know” was the response of 8% of
the KIs.
Indicator II.3:
Is pre-approval of promotional and advertising materials officially required?
Of the 12 KIs interviewed, 75% were aware that pre‐approval of promotional and
advertising materials was officially required while 25% said it was not a requirement. Part V,
Section 43, Sub‐section 1 of the Pharmaceutical Act No. 14 of 2004 states that “a person shall
not advertise medicines unless the advertisement conforms to the information submitted to
obtain a licence under this Part.” Hence by law pre‐approval of promotional and advertising
materials is officially required.
Indicator II.4:
Do the provisions foresee an enforcement mechanism on promotion and advertisement of medicines?
Of the 12 KIs interviewed, 84% were aware of the provision stating what punitive measures
are to be taken against would‐be contraveners of Sub‐sections 1 or 2 of Part V, Section 43 of
the Pharmaceutical Act No. 14 of 2004 as contained in Sub‐section 4 of the same Act. This
leaves 2 (16%) respondents who said “no” (1 = 8%) and “don’t know” (1 = 8%).
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Indicator II.5:
Is there a formal complaints procedure to report unethical promotional practices?
Two (17%) respondents said they did not know if there was a formal complaints procedure
for reporting unethical promotional practices while 75 % said there was no formal procedure.
One respondent from the private sector said that the procedure existed, while the
Government KIs said these procedures are still being developed.
Indicator II.6:
Is there a service or committee responsible for monitoring and enforcing the provisions on medicine promotion?
67% of the KIs interviewed view the Medicines Committee to be responsible for monitoring
and enforcing provisions on drug promotion but 25% said they did not know whether such
a committee existed for this function. One respondent said that it did not. The
Pharmaceutical Act Section 9 mandates the Medicines Committee to monitor advertisements
and promotion of medicines, herbal medicines and allied substances. However, Section 9 is
not yet operational.
Indicator II.7:
Are there written and publicly available Standard Operating Procedures guiding the services responsible for pre-approving or monitoring drug promotion and advertising?
58% of the respondents said there were no Standard Operating Procedures (SOPs), 17% said
they did not know but 25% said that SOPs existed, however they could produce no evidence.
In fact SOPs are currently being developed.
Indicator II.8:
Are there written guidelines on conflicts of interest with regard to control of medicine promotion activities?
On COI guidelines, 58% denied their existence while 34% said they did not know. General
guidelines from the Zambia National Tender Board (ZNTB) are being used, and it is
assumed that the one respondent from the private sector who said that guidelines were
available could have been referring to these ZNTB ones.
Indicator II.9:
To what extent do you agree with the following statement: "The legal provisions on drug promotion have been developed in broad consultation with all interested parties"?
The number of KI responses for each of the alternative responses is given and this reveals
how vulnerable the operations in the pharmaceutical system in Zambia might be.
Strongly disagree Disagree Undecided Agree Strongly agree NA DK
1 4 0 6 1 0 0
Comments: The number of respondents agreeing with the statement is higher, i.e. 7 out of 12.
There is, however, a need to do more to improve these provisions.
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Indicator II.10:
To what extent do you agree with the following statement: "Civil society/nongovernmental organizations have a great influence on improving the control of drug promotion in Zambia”?
Strongly disagree Disagree Undecided Agree Strongly agree NA DK 0 3 0 8 1 0 0
Comments: There definitely seems to be a general consensus that civil society/NGOs have a
great influence on improving control of drug promotion in Zambia. They must therefore be
thoroughly and regularly consulted on matters of drug promotion in order to bring about
positive results.
Indicator II.11:
To what extent do you agree with the following statement: "The provisions on drug promotion are well respected in Zambia"?
Strongly disagree Disagree Undecided Agree Strongly agree NA DK 3 6 0 1 1 0 1
Comments: The responses here are the opposite of II.10 above, so amplifying the last
sentence of that comment. The Pharmaceutical Act states that it is an offence to contravene
Section 43 of the Act. The results suggest the need to put in place measures to facilitate
enforcement of this provision.
Indicator II.12:
In your opinion, what types of unethical behaviour are common in the drug promotion area in your country? These can include bribery, material gifts, favouritism (family, friends), conflict of interest (e.g. investments in pharmaceutical companies), etc.
Involving health professionals and health institutions in general The question had a poor response with 75% of the respondents feeling that this was not an
issue because little attention was being paid to it or because there were few medicines
promotion activities to address in Zambia. However 25% of the respondents felt unethical
behaviour involves the following in decreasing order of importance: COI, material gifts,
bribery and favouritism.
Involving regulatory office staff and committee members responsible for controlling drug promotion Similarly, responses were even lower here as 84% of respondents either said that it was not
applicable or not an issue in Zambia. However two respondents ranked them in the same
way as COI, bribery and material gifts.
Indicator II.13:
If you were in a position of highest authority, what would be the first action that you would take to improve the drug promotion process in your country?
Indicator II.13 enabled interviewed KIs to put across their ideas on how they think or feel
they could make the system better if they were to be put in a position of highest authority.
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The following is a pooled list of things that they said they would do:
The quality of services offered by public institutions
Update the guidelines and improve on legislation
Improve staffing levels at PRA
Make guidelines and SOPs readily available through the media and professional associations
Recognize the need for a drug information service
Intensify post‐marketing activities
Involve key stakeholders
Support provisions of the Pharmaceutical Act
Enforce the law on promotion Transparency in the services offered by public institutions
Give autonomy to PRA and reduce outside influence
Broaden the spectrum of stakeholders’ membership of committee including non‐health
workers
Involve external auditors to review the services
Strengthen the Medicines Committee
Establish a web site for the promotion of medicines
Develop a media programme to educate the public
Make Board decisions available to stakeholders in writing
Hold regular fora to discuss promotional activities followed by production of bulletin
Sensitize the public on functions of the PRA
Establish a system for getting pre‐approval.
Strengths of the promotion process in Zambia
There is a provision covering drug promotion and advertising in the Pharmaceutical Act of
2004
There is a Medicines Committee responsible for monitoring and enforcing the provisions on
drug promotion
The legal provisions on drug promotion were developed in broad consultation with all
interested parties (58% agreed)
There appear to be a great influence from civil society/non‐governmental organizations on
improving the control of medicine promotion (75%).
Weaknesses of the promotion process in Zambia
Detailed regulations are not in place but are being developed
There is no formal procedure for reporting unethical promotional practices but these are
being developed
There are no SOPs that guide pre‐approvals or monitoring of drug promotion and
advertising (being developed)
There are no guidelines on COI with regard to control of medicines promotion and
advertising
The provisions on drug promotion appear not to be respected (75% agreed)
In general material gifts and COI appear to be the common unethical behaviours involving
health professionals and health institutions.
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Recommendation
PRA should enforce the provisions on drug promotion.
5.3 Inspection
Inspection of medicines is the responsibility of the PRA. The total number of KIs
interviewed for drug inspection and their institution is shown in the table below:
Area/
Function Total
Indicators Number of KIs
Government Official
Private Sector
NGO International Organization
Media
Inspections 8 11 6 1 2 1 1
Indicator III.1:
Is there a provision in the medicines legislation/regulation covering inspection of medicines manufacturers and distributors?
All 11 (100%) KIs were aware that medicines legislation/regulation governing inspection of
medicines manufacturers and distributors existed. This is covered under Part X of the
Pharmaceutical Act No. 14 of 2004.
Indicator III.2:
Is the provision on inspection comprehensive enough?
Again all (100%) the respondents responded positively, saying the provisions were
comprehensive enough. Inspectors are given the authority to enter any premises that store,
manufacture, distribute and dispense medicines.
Indicator III.3:
Are there written guidelines on classification of Good Manufacturing Practices (GMP) or Good Distribution Practices (GDP) non-compliance that describes the types of deficiencies and the corresponding measures to be taken by the MRA?
82% respondents admitted that the guidelines in question are there but they could not
provide any evidence. However, two (18%) said they did not know if such guidelines
existed.
Indicator III.4:
Are there written procedures/mechanisms to prevent regulatory capture between inspectors and the manufacturers or distributors that he/she inspects?
Written procedures to prevent regulatory capture between inspectors and the manufacturers
or distributors that he/she inspects are not there and this was supported by the fact that the
55% who said they were there could not produce them and 27% said they did not know
while 18% said no. The 55% seemed to have responded based on what they know are the
rules.
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Indicator III.5:
Are there written guidelines on conflicts of interest with regard to inspection activities?
Written guidelines on COI are not there as evidenced by 55% and 36% who said “no” or “do
not know” respectively. The one respondent (9%) who said “yes” also admitted to never
having seen written guidelines.
Indicator III.6:
Are inspection findings and conclusions subject to an internal review?
The explanation given by 73% respondents who said “yes” is that once data on inspection
have been collected, they are reported and discussed by the PRA officials. This shows some
levels of credibility because if the findings are seen to be questionable, the regulatory
authority can demand another inspection or investigation. This also protects those who are
inspected from unjustifiable victimization by inspectors who may want to settle some old
scores. However 9% of the respondents said “no” and 18% said they did not know whether
inspection findings and conclusions were subject to an internal review.
Indicator III.7:
Are there written Standard Operating Procedures for inspectors on how to conduct inspections?
Although no evidence was produced, all (100%) respondents confidently affirmed that they
were written SOPs on how to conduct inspections, asking how inspections could be
conducted if there were no written procedures.
Indicator III.8:
Are there written criteria for the selection and recruitment of inspectors?
The respondents (100%) agreed that criteria for selection and recruitment of inspectors exist
and available through the advertisements, short listing and interviewing processes.
Indicator III.9:
To what extent do you agree with the following statement: "The integrity of inspectors is not at all influenced by personal gains, such as bribes, gifts, material or other benefits, etc."?
Strongly disagree Disagree Undecided Agree Strongly agree NA DK 3 2 1 4 1 0 0
Comments: The number of those agreeing with the statement and those not agreeing is the
same, i.e. 5 out of 11. The fact that there are currently very few inspectors who are over
worked makes them vulnerable. The response here also agrees with the responses in
question III.10 where gifts and other benefits have been highlighted as the common forms of
unethical behaviour in the inspection system. This indicates that these gifts might have an
influence. There is an urgent need to improve on the staffing in this field.
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Indicator III.10:
In your opinion, what types of unethical behaviour are common in the inspection area in your country? These can include bribery, material gifts, favouritism (family, friends), conflicts of interest (e.g. investments in pharmaceutical companies), etc.
Unethical behaviour in the inspection area was identified to be present by 9 (82%) of the
respondents. There was also a view that these unethical behaviour cases go unnoticed
because there seems to be no control system in place, inspectors are left to operate on their
own conscious. Such a level of trustworthy would be very good and desirable if it could be
attained. On the other hand, two (18%) of the respondents said they did not know if there
were unethical behaviour issues amongst the inspectors.
Indicator III.11:
If you were in a position of highest authority, what would be the first action that you would take to improve the inspection process in your country?
Indicator III.11 enabled interviewed KIs to put across their ideas on how they think or feel
they could improve the inspection process in Zambia if they were to be put in a position of
highest authority. The following is a pooled list of things that they said they would do: The quality of inspection services offered by public institutions
Define job description clearly to the inspectors
Proper orientation of new members of staff
Give tips on the “dos” and “don’ts”
Employ qualified pharmacists as full time inspectors
Have the SOPs in place
Improve the conditions of service for inspectors
Procure enough transport
Train inspectors in public relations
Decentralize inspections
Put in place security cover for inspectors.
Transparency in the inspection services offered by public institutions
Document inspection reports properly
Recruit adequate numbers of inspectors
Rotate the inspectors in their duty stations
Start publishing newsletters with activity details of inspections
Encourage working with Government security wings, such as the police
Use independent inspectors
Develop inspection guidelines.
Strengths of the inspection system in Zambia
There is a comprehensive provision covering legislation/regulation of medicines
manufacturers and distributors in the Pharmaceutical Act
Standards for pharmaceutical practice are in place
Advertisements for positions for inspectors are detailed and include all necessary
qualifications and experience.
Weaknesses of the inspection system in Zambia
There are few inspectors to cover the whole country
Lack of adequate transport.
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Recommendations
PRA should decentralize the inspection system PRA should establish inspections offices at all ports of entry.
5.4 Drug selection
Selection of medicines to be included on the National Essential Medicines List is done by the
National Formulary Committee. The total number of KIs interviewed about drug selection
and their institutions is shown in the table below:
Area/
Function Total
Indicators Number of KIs
Government Official
Private Sector
NGO International Organization
Media
Selection 8 11 7 1 2 1 0
Indicator IV.1:
Does the Government have an officially adopted national essential medicines list (EML) publicly available?
All the respondents were not aware of the existence of the Zambia Essential Medicines List
(ZEML) published in 2004. There is a need to disseminate and distribute the ZEML widely.
Indicator IV.2:
To what extent do you agree with the following statement: "The national essential medicines list has been developed in consultation with, and considering the opinion of, all interested parties and using an evidence-based approach"?
Strongly disagree Disagree Undecided Agree Strongly agree NA DK 0 7 0 2 2 0 0
Comments: Those disagreeing are more and this calls for a review on how this is being done.
Indicator IV.3:
Are there clearly written and transparent rules/criteria for the selection process for including or deleting medicines from the national EML?
Of the11 KIs interviewed, 3 (27%) said the rules are there but failed to provide evidence.
Two (18%) said they did not know while 6 (55%) said no. There are no written rules/criteria
for the selection process for including or deleting medicines from the national EML as no
evidence was provided.
Indicator IV.4:
Is the EML in line with WHO procedures?
There were 8 (73%) of the respondents who agreed that the EML is in line with WHO
procedures and 3 (27%) said no it wasn’t. What was noted at that time is that the 2004 EML
was not available in all the places visited and the 2005 ‐2008 ZNF was also not available to
places visited out of Lusaka at the time. People were still using the 2000 ‐ 2004 ZNF.
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Indicator IV.5:
Is there a committee responsible for the selection of the national EML?
The National Drug Policy of 1999 provides for the existence of the Zambia National
Formulary Committee whose functions include the selection of medicines to be included in
the EML and 73% of the respondents were aware of this. 2 (18%) of the respondents said
such a committee does not exist while 1 (9%) did not know. Selection of essential medicines
is the responsibility of the district/hospital Pharmacy and Therapeutics Committee(s) and
the National Formulary Committee whose secretariat is the Pharmacy Unit under the MOH,
as provided for in the National Drug Policy.
Indicator IV.6:
To what extent do you agree with the following statement: "The committee responsible for the selection of the national EML is operating free from external influence"?
Strongly disagree Disagree Undecided Agree Strongly agree NA DK 0 5 2 1 1 0 2
Comments: There are more KIs disagreeing or Undecided and Do not know indicating that
the selection of the national essential medicines list is not operating free from external
influence. Factors that prevent this from happening need to be identified and addressed.
Indicator IV.7:
Are there clear criteria for the selection of members of the Selection Committee?
The 3 (27%) respondents who said “yes” to the question felt that the Permanent Secretary
(PS) at the MOH decides who should be a member. There were also 3 (27%) who said that
there are no criteria but almost half (46%) were not aware of the existence of the criteria.
Indicator IV.8:
Are there written guidelines on conflicts of interest (COI) with regard to selection of essential medicines?
There are no guidelines on COI with regard to selection of essential medicines: 73%
respondents said no and 27% said they did not know. Even though these are not available
publicly, one respondent who sits on the Selection Committee said that the Chairperson of
the Selection Committee always places great emphasis on COI at their meetings.
Indicator IV.9:
Are there clear and publicly available Standard Operating Procedures (SOPs) that describe the role and responsibilities of the Selection Committee?
One KI who sits on the Selection Committee confirmed that there are no SOP that describe
the role and responsibilities of the Selection Committee confirming the response of the 6
(55%) of those who said no. On the other hand, 2 (18%) said they did not know while 3 (27%)
said the SOPs exist though they could not produce them.
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Indicator IV.10:
Are the rules for decision-making clear and transparent in the SOPs?
Since the SOPs did not exist (Indicator IV.9) the rules for decision making were hence not
there. However the responses were as follows: 4 (36%) no; 4 (36%) I don’t know and 3 (28%)
yes.
Indicator IV.11:
In your opinion, what types of unethical behaviour are common in the selection process in your country? These can include bribery, material gifts, favouritism (family, friends), conflicts of interest (e.g. investments in pharmaceutical companies), pressure on consultants by companies, etc.
The views and perceptions of the respondents were that all the unethical behavior cited
above happen. Other observations were that some people are allowed to be members of the
selection committee whilst they are still practicing medicine or are working for
manufacturing companies.
Indicator IV.12:
If you were in a position of highest authority, what would be the first action that you would take to improve drug selection?
Indicator IV.12 enabled interviewed KIs to put across their ideas on how they think they
would act first to improve drug selection process in Zambia if they were to be put in a
position of highest authority. The following is a pooled list of things that they said they
would do:
The quality of the services offered by public institutions
Ensure that guidelines and SOPs are in place
Build human resource capacity
Closely link to WHO recommendations
Monitor and evaluate the effectiveness of selected medicines
Provide operational funds
Ensure all selected medicines are registered with PRA
Distribute the guidelines to stakeholders
Include practitioners on the medicines selection committee.
Transparency in the services offered by public institutions
Give autonomy to medicines selection committee in decision making
Publicize the committee decisions through media, bulletins, etc.
Justify the process with evidence
Reorganize the committee
Audit the selection processes
Regularly meet stakeholders
Use open tenders
Avail selection process to stakeholders
Strengths of the selection system in Zambia
The National Essential Medicines List (NEML) is available in the Standard Treatment
Guidelines, Essential Medicines List and Essential Laboratory Supplies List for Zambia, First
Edition, 2004.
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The rules/criteria for the selection process are in place
At hospital and district levels the guidelines for selection of medicines are in place.
Weaknesses of the selection system in Zambia
Most of the places visited outside Lusaka were still using 2000 – 2004 National Formulary
Places visited did not have the Zambia Essential Medicines List
It appears that the committee responsible for the selection of essential medicines is not
operating free from external influence (46% agreed)
The SOPs describing the role and responsibilities of the selection committee are not in place
Medical specialists who act as consultants for pharmaceutical companies are allowed to be
members of the selection committee
The NEML appear not to have been developed with broad consultation with interested
parties (64% agreed to this).
Recommendations
MOH should distribute the NEML/ZNF to all stake holders MOH should develop/review the selection criteria and TOR for the
medicines selection committee members MOH should develop/review the selection criteria for the selection of
medicines for inclusion in the EML.
5.5 Procurement
Unlike in other countries procurement, storage and distribution functions are done by
National Medical Stores, the situation is different in Zambia. The Ministry of Health
(Procurement and Supplies Unit) is responsible for procurement of pharmaceuticals up to a
certain threshold. Procurements above U$1 000 000.00 are referred to the National Tender
Committee. The total number of KIs interviewed for the drug procurement and their
institutions is shown in the table below.
Area/
Function Total
Indicators Number of KIs
Government Official
Private Sector
NGO International Organization
Media
Procurement 11 15 7 3 3 2 0
Indicator V.1:
Does the Government use transparent and explicit procedures for procurement of pharmaceutical products?
The Zambia National Tender Board procedures of 1997 are used for procurement of
pharmaceutical products in Zambia and 12 out of 15 KIs interviewed alluded to this fact.
However, 2 (13%) of them said they did not know and only 1 (7%) said the Government
does not use any explicit procedures. The procurement methods recommended by ZNTB
include: International Competitive Bidding (ICB); Limited International Bidding (LIB) and;
National Competitive Bidding (NCB).
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Indicator V.2:
Is there written guidance for procurement office staff on the type of procurement method to be used for different types of products?
Of the 15 respondents, 8 (53%) were aware of their existence while 3 (20%) said written
guidance is not there and 4 (27%) did not know. The recommended ZNTB procurement
methods listed in Indicator V.1 above also apply here.
Indicator V.3:
Is procurement done with an objective quantification method to determine the quantity of pharmaceuticals to be purchased?
This had a100% affirmative response. The respondents said that particular attention is paid
to this aspect, and the World Bank Technical Note in Sub‐section 4.2.1 of Section 4.2 that
recommends the methodology of quantification was referred to by the Government KIs
interviewed. The MOH is responsible for national quantification.
Indicator V.4:
Is there a formal appeals process for applicants who have their bids rejected?
Of the 15 respondents, 7 (47%) said they did not know of any appeals process, 3 (20%) said
“no” but 5 (33%) answered “yes” it was there. The formal appeals process, according to
Government KIs interviewed, is through an arbitration process via the ZNTB and is part of
procurement guidelines. However one respondent felt that even though the appeals process
exists it is not fully used. This might be due to the lack of knowledge of the stakeholders.
Indicator V.5:
Is there a Tender Committee? If so are the key functions of the Procurement Office and those of the Tender Committee clearly separated?
All (100%) the respondents agreed that there was a Tender Committee at the MOH that is
mandated to handle procurement of up to US$1 000 000. Procurement above this amount is
handled by another committee, “The Ministerial Tender Committee.” There is a
Procurement Technical Working Group (PTWG) which oversees the operations of the MOH
Tender Committee. The PTWG is composed of members from senior management (MOH)
and cooperating partners.
Indicator V.6:
Are there specific criteria for Tender Committee membership?
The breakdown of responses was as follows: 9 out 15 (60%) said “yes” and 6 (40%) said they
“did not know”. Evidence of the specific criteria for Tender Committee membership
indicated in Indicator V.5 above was not provided. However, the explanation given by some
senior Government KIs interviewed is that membership is by virtue of office held at the
MOH or in politics (ministerial level). Members are the Permanent Secretary (MOH) who is
the Chairperson, Directors, and the Head of the Procurement and Supplies Unit who acts as
Secretary to the MOH Tender Committee. The composition of the Committee is all in‐house
and tenure of office is indefinite for as long as the person holds that office at the MOH.
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Because of the criteria used to choose who should be a member, some respondents raised
serious concerns, such as that the composition of the Committee was inadequate
professionally and that pharmacists in health institutions were not consulted at all during
the procurement process.
Indicator V.7:
Are there written guidelines on conflicts of interest with regard to the procurement process?
There are no guidelines on conflicts of interest (COI) with regard to the procurement process.
What are being used are general guidelines from the Zambia National Tender Board.
However, responses from the 15 respondents were as follows: 6 (40%) said no, 6 (40%) did
not know and 3 (20%) said yes. Those who said yes when asked to provide evidence said
they were referring to the Zambia National Tender Board guidelines. However during the
process of Tender Committee meetings, the chair person would call upon anyone with a
vested interest to declare it.
Indicator V.8:
To what extent do you agree with the following statement: "The members of the Tender Committee are systematically selected based on specific criteria”? (see question V.6)
Strongly disagree Disagree Undecided Agree Strongly agree NA DK 2 4 1 4 1 0 3
Comments: Six (40%) strongly disagreed/disagreed, 5 (33%) strongly agreed/agreed, 1 (7%)
was undecided and 3 (20%) said that they did not know. The comment from those who
strongly disagreed/disagreed was that there is a need to be more transparent on the selection
of members for this Committee to reconcile the divergent perceptions exhibited in the
responses above. Please refer to indicator V.6 above for more detailed information.
Indicator V.9:
Is there a computerized management information system used to report product problems in procurement?
The majority of the respondents (9 or 60%) said there was no computerized management
information system that is used to report product problems in procurement and 3 (20 %)
said they did not know. The system is said to be under development. Only 3 (20%) said the
system was there. One Government respondent informed the assessors that orders are
resource‐based and not based on estimate comparisons.
Indicator V.10:
Are there Standard Operating Procedures (SOPs) for routine inspection of consignments?
Standard Operating Procedures for routine inspection of consignments are there and are
available at the Medical Stores Limited which is responsible for the distribution of medical
products. This was supported by 13 (87%) respondents. Products that fail an inspection are
sent back and a replacement is requested. The discrepancy reports are sent to the suppliers
for action. The MOH which processes the tenders and procures is not involved in the
inspection of procured consignments but receives a report from MSL which it uses to
Measuring Transparency to Improve Good Governance in the Public Pharmaceutical Sector ZAMBIA
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confirm and processing of payments. Within the supply chain systems, receiving committees
conduct inspection using stores procedures manual when goods are received.
Indicator V.11:
Is there an efficient post-tender system in place to monitor and report on suppliers' performance to the Tender Committee?
Seven (47%) of the respondents agreed that an efficient post‐tender system for monitoring
and reporting on supplier’s performance to the Tender Committee is in place. It was further
explained that this monitoring of the supplier’s performance is not scheduled but is done
whenever the need arises. Identified suppliers with poor performance are denied further
invitations on the same product(s) but are not blacklisted. However 6 (40%) of the
respondents did not know while only 2 (13%) said there was no system.
Indicator V.12:
Does the procurement office undergo regular audits?
The ZNTB requirement is that a procurement office undergoes regular audits and 8 (53%) of
the respondents were aware of this. However 7 (47%) of them did not know probably
because they do not work in procurement offices.
Indicator V.13:
To what extent do you agree with the following statement: "The procurement system in Zambia is operating in a totally transparent manner"?
Strongly disagree Disagree Undecided Agree Strongly agree NA DK 1 5 3 5 1 0 0
Comments: Six (40%) strongly disagreed/disagreed, 6 (40%) strongly agreed/agreed, and 3
(20%) were undecided. The comment from those who strongly disagreed/disagreed was that
there is a need to be more transparent in the procurement system.
Indicator V.14:
In your opinion, what types of unethical behaviour are common in the procurement system in Zambia? These can include bribery, material gifts, favouritism (family, friends), conflict of interest (e.g. investments in pharmaceutical companies), etc.
The procurement system in Zambia experiences some forms of unethical behaviour. Out of
15 KIs interviewed, 4 said all the given examples of unethical behaviour exist. The other
responses were: 1 for bribery, material gifts and favouritism; 1 for bribery and favouritism; 2
for bribery only; 2 for favouritism only; 1 for COI only. There were, however, 4 respondents
who said unethical behaviour in the procurement system in Zambia does not exist.
Indicator V.15:
If you were in a position of highest authority, what would be the first action that you would take to improve the systems and processes of procurement?
The KIs interviewed expressed their ideas on what they thought their first actions would be
to improve procurement systems and processes in Zambia if they were to be put in a
Measuring Transparency to Improve Good Governance in the Public Pharmaceutical Sector ZAMBIA
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position of highest authority. Below are pooled lists of things that they said they would do
to achieve improvements:
The quality of procurement services
Employ well trained staff in the procurement unit
Retain trained staff by motivating them
Improve on the supervision of the procurement staff
Identify and fill‐in the gaps in the current procedures
Strengthen and increase sites where quality control mini‐lab kits are used
Support local manufacturers by procuring locally;
Improve on funding
Reduce on tender lead time
Follow tender procedures when procuring items.
Transparency in procurement services
Improve record keeping
Develop a computerized system for procurement
Secure bid documents in a strong room to avoid leaking of information to unauthorized
persons
Have regular independent audits
Institute regular transfers to avoid building up of relationships
Have a clear separation of duties between the Tender Committee, the National Tender Board
and the Procurement Department
Publicize the winners of tenders
Include critical stakeholders, such as pharmacists, on the Tender Committee
Establish a specialized Tender Sub‐committee at national level
Put in place procurement guidelines.
Strengths of the procurement system in Zambia
The MOH uses Zambia National Tender Board (ZNTB) Guidelines of 1997
There is a Ministerial Tender Committee (MTC) mandated to purchase goods amounting up
to US$ 1000 000.00 above which the National Tender Board takes over
Provisions for appeal for applicants who have their bids rejected are in the procurement
regulations
Procurement office undergoes regular audits from the Auditor General’s Office as required
by law. ZNTB also inspects the Procurement Unit
There are SOPs for routine inspection of consignments.
Weaknesses of the procurement system in Zambia
There are no MOH specific guidelines on COI. However, the Ministry uses ZNTB guidelines
There is no formal system for monitoring supplier performance by the procurement unit. This
function has been delegated to MSL
It appears that the Tender Committee members are not systematically selected based on
specific criteria (40% agreed). Membership is by virtue of position; for example, the
Permanent Secretary (PS) is the Chairperson
There is no computerized management information system used to report product problems
in procurement
The issue of the procurement system operating in a totally transparent manner could not be
resolved in this assessment (40% for: 40% against with 20% undecided). However, the
common unethical behaviours in the procurement system appear to be favouritism, bribery
and COI.
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Recommendations
MOH should develop guidelines and a database to monitor supplier performance.
MOH should engage an independent Procurement Audit every two years. MOH should establish a strong room for storing procurement documents
for security purposes
5.6 Distribution
The distribution of Government health products is the responsibility of MSL. At the moment
the management of MSL has been contracted out to Crown Agents. The total number of KIs
interviewed for the drug distribution function and their institutions is shown in the table
below:
Area/
Function Total
Indicators Number of KIs
Government Official
Private Sector
NGO International Organization
Media
Distribution 12 11 5 1 4 1 0
Indicator VI.1:
Is there a system in place that can expedite port clearing?
Of the 11 KIs interviewed, 6 (55%) were aware of a system that can expedite port clearing
while 1 (9%) was not and 4 (36%) did not know. Zambia is land‐locked and therefore relies
on the international ports of entry in border towns and airports where pharmaceutical
products enter the country. Clearing is done by officers from the Zambia Revenue Authority
who are stationed at the ports of entry and PRA officers who are stationed at Lusaka
International Airport only.
Indicator VI.2:
To what extent do you agree with the following statement: "port clearing is done smoothly and there is no need for bribery or gift-giving to expedite the process"?
Strongly disagree Disagree Undecided Agree Strongly agree NA DK 0 1 0 4 2 1 3
Comments: This seems to be working well so far.
Indicator VI.3:
Is there an inspection system to verify that the medicines delivered from the port or directly from a supplier match those that were shipped from the supplier?
“Yes” there is, testified 10 (91%) of the respondents although 1 (9%) out of the 11 did not
know. Verification is carried out by comparing the tender document with what has been
received. Verification is done by the Director, Pharmaceutical Standards, at the MSL.
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Indicator VI.4:
Is there a coding system used to identify Government medicines?
Eight (73%) of the respondents were aware of the coding system used to identify
Government of the Republic of Zambia (GRZ) medicines, but 1 (9%) said “no” and 2 (18%)
did not know. The medicines are identified through batch numbers and MOH or GRZ labels.
However, this does not apply to all medicines because some are procured under
internal/external influence or are procured locally.
Indicator VI.5:
Is there a systematic and orderly shelving of products in warehouses or storerooms?
All the respondents agreed that there is a systematic and orderly shelving of products in
warehouses or storerooms. There are Standard Storage Procedures (SSP) but what could be a
problem is the level of adherence.
Indicator VI.6:
Is there a security management system in place to oversee storage and distribution?
There is a security management system in place to oversee storage and distribution (100%
affirmative response). When goods are entering or leaving the warehouse, there is a
watchman/guard and a dispatch clerk recording what is coming in or going out. The main
security systems in use are grill doors, burglary bars and security staff.
Indicator VI.7:
Is there an inventory management system that is used in the warehouse at each level of the distribution system?
The fact that logistics and management systems are in place was affirmed by 10 (91%) of the
respondents while 1 (9%) said that systems are non‐existent.
Indicator VI.8:
Are stock records reconciled with physical counts at least every 3 months by internal staff?
Stock records are reconciled by internal staff with physical counts at least every 3 months
and at times monthly if necessary. There was a 100% affirmative response to this question.
Indicator VI.9:
Are there independent audits of warehouses by external inspectors or auditors?
The external auditors are from the Auditor General’s Office. These audits are done once per
year under normal circumstances. Donors also send their own auditors whenever the need
arises. The accountant signs on the stock control card as evidence/report of warehouse audit.
Ten (91%) of the respondents positively affirmed, however 1 (09%) did not.
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Indicator VI.10:
Is there a system (computerized or manual, historical or current) in place to track the movement of pharmaceuticals from a warehouse to a health facility?
There was a 100% response that there is a system in place to track the movement of
pharmaceuticals from a warehouse to a health facility, and that this system is both manual
and computerized.
Indicator VI.11:
Is there a well-functioning communication system between distribution points?
There was a 100% response that there is a well‐functioning communication system between
distribution points, which includes manual, telephones (landline and cell phones) and faxes.
Indicator VI.12:
Does a programme exist for monitoring and evaluating the performance of the medicine distribution system?
Six (55%) of the respondents agreed that an M&E programme exists, 3 (27%) said “no” it
does not exist while 2 (18%) said they did not know. There is an M&E programme but its
emphasis is on medicines for vertical programmes, such as ART and TB medicines.
Respondents noted that information identifying weaknesses and making recommendations
publicly available is not shared or communicated back to distribution sites. Reports are
produced and mainly reach senior management officials for decision‐making. Some
stakeholders can access reports on request.
Indicator VI.13:
Are sanctions imposed on individuals or agencies/companies for theft or other corrupt practices associated with distribution?
Nine (82%) of the respondents said “yes”, 1 (9%) said “no”, and 1 (9%) “did not know”.
Some people who have been involved in theft or other corrupt practices have been
suspended or lost their jobs.
Indicator VI.14:
To what extent do you agree with the following statement: “There are very rarely leakages in the medicine distribution system in your country”.
Strongly disagree Disagree Undecided Agree Strongly agree NA DK 4 4 1 2 0 0 0
Comments: There is strong disagreement (8 out of 11 or 73%) with this statement, indicating
the need for a review of the operations system.
Indicator VI.15:
If you were in a position of highest authority, what would be the first action that you would take to improve the systems and processes of public sector medicine distribution in Zambia?
The KIs interviewed expressed their ideas on the first actions they thought that they would
take to improve the systems and processes of public sector medicine distribution in Zambia
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if they were put in a position of highest authority. Below are pooled lists of what that they
said that they would do to achieve improvements.
The quality of services offered by public institutions
Employ and retain trained staff to handle medicines distributions
Have more than one distributor, i.e. no monopoly
Decentralize distribution
Create a pharmaceutical directorate at national level to handle distribution
Strengthen operations systems at ports of entry
Introduce laboratories to monitor the quality of drugs being distributed
Introduce regional warehouses.
Transparency in services offered by public institutions
Integrate distribution systems for vertical programmes with the MOH system
Introduce more collaboration with facilities, i.e. Provincial Health Directors
Publicize monitoring and evaluation results
Employ and retain trained staff to handle medicines distribution
Introduce a stakeholders committee
Introduce a Logistics Management Information System (LMIS) for all pharmaceutical
products.
Strengths of the distribution system in Zambia
There is a system in place that expedites port clearing and is done smoothly with no need for
bribery or gift‐giving (55% agreed)
There is a system that verifies delivered medicines
There is a security management system in place that oversees storage and distribution of
medicines
There is an inventory management system used in the warehouse at each level of the
distribution system
Stock records are reconciled with physical counts at least once a month
There are independent audits of warehouses
At national level there is a computerized system, while at lower levels a manual system is
used to track the movement of pharmaceuticals from a warehouse to a health facility.
Weaknesses of the distribution system in Zambia
Information on monitoring and evaluation is not shared with distribution sites
Currently M&E concentrates on vertical programmes, such as those using ARVs and TB
medicines
It appears that there are leakages in the medicines distribution system (73% agreed).
Recommendations
MOH should improve the tracking system throughout the supply chain MOH should improve the storage facilities at all levels MOH should strengthen the LMIS for medicines MOH should strengthen the inventory system at all levels of service
delivery.
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6. General findings and analysis
The summary of overall scores for each function is provided in Table 3.
Table 3: Summary of overall scores for each function
Registration Promotion Inspection Selection Procurement Distribution
Indicator II.1 0.67 0.92 1.00 1.00 0.82 0.86
Indicator II.2 0.72 0.57 0.95 -- 0.73 --
Indicator II.3 0.81 0.72 0.91 0.41 1.00 1.00
Indicator II.4 0.75 0.91 0.45 0.73 0.63 0.89
Indicator II.5 0.88 0.16 0.26 0.80 0.93 1.00
Indicator II.6 0.43 0.55 0.89 -- 0.52 0.84
Indicator II.7 0.86 0.48 0.96 0.31 0.28 0.82
Indicator II.8 0.64 0.31 1.00 -- -- -- -- 1
Indicator II.9 0.70 -- -- 0.43 0.32 0.97
Indicator II.10 0.32 -- -- 0.46 0.66 1.00
Indicator II.11 -- -- -- -- 0.75 0.68
Indicator II.12 0.69 -- -- -- 0.71 0.57
Indicator II.13 0.89 -- -- -- -- 0.92
Indicator II.14 -- -- -- -- -- --
Indicator II.15 -- -- -- -- -- --
Total 8.34 4.61 6.43 4.15 7.35 10.55
Final Score 6.95 5.12 8.03 5.19 6.68 9.55 Degree vulnerability
Marginally vulnerable
Moderately vulnerable
Marginally vulnerable
Moderately vulnerable
Marginally vulnerable
Marginally vulnerable
The greatest strength of the pharmaceutical system in Zambia is in distribution. There are
systems for inventory management and distribution and there was evidence of SOPs at the
MSL. There were confirmed reports of dismissal of staff involved in pilferage of medicines.
The main weakness was that leakages were common. The need for adequate numbers of
trained pharmaceutical staff to manage the distribution system was also emphasized.
Decentralizing and integrating vertical programmes’ distribution systems into the MOH
system would facilitate effective implementation of the LMIS and supervision.
Selection and promotion received the lowest scores in the assessment. Many KIs were not
aware of how members of the National Formulary Committee were selected. There was a
general belief that some members of the Committee were influenced by pharmaceutical
companies, as they acted as consultants for companies.
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An important issue raised was that monitoring and evaluation (M&E) of the effectiveness
of selected medicines require urgent attention. This process would be facilitated by adoption
of the ZNDP recommendation that the PTCs and the ZNF Committee select medicines for
inclusion in the EML. To manage such a process a structure linking the PTCs and the ZNF
Committee should be established including a secretariat with full‐time staff. Current practice
does not support the evidence‐based, bottom‐up approach recommended for making
decisions on inclusion or deletion of medicines on the EML. Equally systematic collection
and dissemination of information about medicines is not supported, with a number of
weaknesses identified suggesting inadequate consultation in the present system.
Although current regulations have provisions on control of drug promotion, many KIs
believed that very little was being done in this area. At the time of the assessment
regulations on drug promotion were still being developed by the PRA.
Also a number of regulations and guidelines related to registration and inspections were still
being developed by the PRA.
Although some KIs indicated that COI forms existed, copies were not made available to the
assessors except at the PRA.
From the results it can be deduced that the legal requirements on advertisement and
promotion of medicines is not understood by the general public. It is important to educate
the public to facilitate adherence. Dissemination of information removes many doubts and
ultimately builds patient confidence in the system.
The issue of inspectors’ integrity could not be resolved in this assessment (45%:45%).
However, unethical behaviour, such as bribery and material gifts, was apparent from
responses. The observation that there are few inspectors to cover the whole country is
important. The negative effects of a weak inspectorate system permeate many unethical
practices, such as importation/manufacture of counterfeit and/or substandard medicines.
The problem is even worse in a land‐locked country like Zambia with its many border
towns. It is important for the Government to strengthen the inspectorate unit to protect the
public and reduce wastage of resources.
Despite the fact that the assessment results indicate marginal vulnerability, the number of
respondents indicating that the level of all forms of unethical behaviour is high suggests that
there is a problem that needs to be addressed. The respondents suggested that the
Government look into the need for adequate numbers and appropriately qualified staff to
manage the procurement system and improve supervision. Tender procedures should be
strictly followed. Regular independent audits should be strengthened as they may help
diagnose a problem at an early stage. Equally the maintenance and security of records play
an important role in managing the procurement system effectively and efficiently.
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7. Conclusions
This assessment has shown that there is some level of vulnerability to corruption in the
medicines supply system (6.92). The vulnerability level starting with the highest is:
promotion (5.13), selection (5.19), procurement (6.68), registration (6.95), inspections (8.03)
and distribution (9.57).
Although procurement is rated 6.68 (marginally vulnerable) in this study, most people’s
perception during the stakeholders’ meeting was that procurement is more susceptible to
corruption than is indicated by the assessment result.
On registration the stakeholders indicated that there was an elaborate process for
registration in place. However the group felt that there was need for the highest level of
professionalism, transparency, integrity, efficiency, courtesy, fairness and a need for the
code of conduct.
On inspection, the group recognized that there was need for a well‐qualified team of
inspectors and it was critical to have moral values of fairness, justice and truthfulness.
On selection, the group agreed that selection was based on the standard treatment
guidelines as it was through this that an essential medicines list is drawn. This means that
selection of medicines is based on the prevalence of diseases.
On distribution the findings were consistent with the group observations.
The stakeholders recommended that whistleblowers need to be protected since they provide
vital information.
In order for the pharmaceutical sector to function effectively and efficiently there is a need to
ensure that adequate qualified staff are employed. Furthermore, sufficient transport and
financial resources should be made available.
General recommendations MOH to implement the GGM programme MOH to develop a national GGM framework MOH to constitute a national multi-stakeholder M&E committee on GGM that
will develop a monitoring and evaluation framework.
Measuring Transparency to Improve Good Governance in the Public Pharmaceutical Sector ZAMBIA
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Measuring Transparency to Improve Good Governance in the Public Pharmaceutical Sector ZAMBIA
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Measuring Transparency to Improve Good Governance in the Public Pharmaceutical Sector ZAMBIA
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Annex 1. Ministry of Health Functional Organizational Structure
Provincial Medical Offices
Directorate of Technical
Support Services
Directorate of Clinical
Care
Director Clinical Care &
Diagnostic Service MDS/1
Regulatory Body
MINISTER
Deputy Minister
Permanent Secretary
Directorate of Policy & Planning
Directorate of Human
Resources & Administration
Directorate of Public
Health and Research
Principal Pharmacist Pharmaceutical Care &
Rational Drug Use MDS/3
Principal Pharmacist Logistics Management
& Administration MDS/3
Deputy Director Pharmaceutical Service MDS/2