who/afr/edm/edp/12 · who/afr/edm/edp/12.03 ... executive summary the good governance for medicines...

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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Printed by the WHO Document Production Services, Geneva, Switzerland

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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


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"?


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


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”?


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"?


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.


— 16—

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.


— 17—

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


Government Official

Private Sector


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."?


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


Government Official

Private Sector


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"?


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.


— 21—

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"?


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.


— 23—

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


Government Official

Private Sector


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).


— 24—

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.


— 25—

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)


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


— 26—

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"?


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


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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


Government Official

Private Sector


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"?


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”.


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







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.


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Bibliography

Measuring transparency in the public pharmaceutical sector: Assessment instrument. Geneva, World Health

Organization, 2009. Document no. WHO/EMP/MAR/2009.4.

The Zambia Pharmaceutical Act No. 14 (2004).

The Zambia National Drug Policy (1999).

The Zambia Public Procurement Act (2008).

Operational principles for good pharmaceutical procurement. Interagency document. Geneva, World

Health Organization, 1999. Document no. WHO/EDM/PAR/99.5. Available at:

http://hinfo198.tempdomainname.com/gsdl2/collect/edmweb/pdf/whozip49e/whozip49e.pdf

WHO Good Governance for Medicines web site: http://www.who.int/medicines/ggm/en/index.html

WHO medicines strategy: Countries at the core 2004‐2007. Geneva, World Health Organization, 2004.

(Document no. WHO/EDM/2004.5). Available at:

http://hinfo198.tempdomainname.com/gsdl2/collect/edmweb/pdf/s5416e/s5416e.pdf

Cohen JC, Carikeo Montoya J. Using technology to fight corruption in pharmaceutical purchasing:

lessons learned from the Chilean experience. Flagship Online Journal. World Bank, 20 February 2001.

Available at: http://www.worldbank.org/wbi/healthflagship/journal/Chile.pdf


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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

who/afr/edm/edp/12 · who/afr/edm/edp/12.03 ... executive summary the good governance for medicines...

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