KENYA FINAL trans · Measuring Transparency to Improve Good Governance in the Public Pharmaceutical...

WHO/AFR/EDM/EDP/12.04

Measuring Transparency to Improve Good Governance in the Public Pharmaceutical Sector

KENYA

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Measuring Transparency to Improve Good Governance in the Public Pharmaceutical Sector ‐‐ KENYA

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CONTENTS

ABBREVIATIONS ................................................................................................................................................................ V

KENYA GGM ASSESSMENT TEAM ............................................................................................................................. VI

FOREWORD ........................................................................................................................................................................ VII

EXECUTIVE SUMMARY .................................................................................................................................................... IX

BACKGROUND ...................................................................................................................................................................... ix

METHODOLOGY .................................................................................................................................................................... ix

RESULTS ................................................................................................................................................................................ ix

GENERAL RECOMMENDATIONS ........................................................................................................................................... xi

SPECIFIC RECOMMENDATIONS ............................................................................................................................................ xi

1. INTRODUCTION ..................................................................................................................................................... 1

1.1. BACKGROUND .......................................................................................................................................................... 1

1.2. OVERVIEW OF THE PHARMACEUTICAL SECTOR IN KENYA ................................................................................... 1

1.2.1. Country socio‐economic and health profile ................................................................................................. 1

1.2.2. Pharmaceutical sector profile ....................................................................................................................... 2

1.3. OBJECTIVES ............................................................................................................................................................... 3

2. METHODOLOGY .................................................................................................................................................... 4

2.1. STUDY PERIOD AND AREA ....................................................................................................................................... 4

2.2. NATIONAL ASSESSORS ............................................................................................................................................. 4

2.3. SELECTION OF KEY INFORMANTS ........................................................................................................................... 4

2.4. DATA COLLECTION .................................................................................................................................................. 5

2.5. DATA SCORING AND ANALYSIS .............................................................................................................................. 6

3. RESULTS .................................................................................................................................................................... 6

3.1. REGISTRATION OF MEDICINES ................................................................................................................................. 8

3.2. LICENSING OF PHARMACEUTICAL ESTABLISHMENTS ........................................................................................ 12

3.3. INSPECTION AND MARKET CONTROL OF MEDICINES .......................................................................................... 16

3.4. MEDICINES PROMOTION CONTROL ..................................................................................................................... 19

3.5. CONTROL OF CLINICAL TRIALS ............................................................................................................................ 24

3.6. SELECTION OF MEDICINES .................................................................................................................................... 28

3.7. PROCUREMENT OF MEDICINES ............................................................................................................................. 31

3.8. DISTRIBUTION OF MEDICINES ............................................................................................................................... 35


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4. DISCUSSION ......................................................................................................................................................... 40

4.1. REGISTRATION OF MEDICINES .............................................................................................................................. 40

4.2. LICENSING OF PHARMACEUTICAL ESTABLISHMENTS ......................................................................................... 40

4.3. INSPECTION AND MARKET CONTROL OF MEDICINES .......................................................................................... 41

4.4. MEDICINES PROMOTION CONTROL ..................................................................................................................... 41

4.5. CONTROL OF CLINICAL TRIALS ............................................................................................................................ 42

4.6. SELECTION OF MEDICINES .................................................................................................................................... 43

4.7. PROCUREMENT OF MEDICINES ............................................................................................................................. 43

4.8. DISTRIBUTION OF MEDICINES ............................................................................................................................... 44

5. CONCLUSIONS ..................................................................................................................................................... 45

6. RECOMMENDATIONS ...................................................................................................................................... 48

6.1. GENERAL RECOMMENDATIONS .......................................................................................................................... 48

6.2. SPECIFIC RECOMMENDATIONS ............................................................................................................................ 48

6.2.1. Registration of medicines .......................................................................................................................... 48

6.2.2. Licensing of pharmaceutical establishments ............................................................................................ 48

6.2.3. Inspection and market control of medicines ............................................................................................. 49

6.2.4. Medicines promotion control .................................................................................................................... 49

6.2.5. Control of clinical trials ............................................................................................................................ 50

6.2.6. Selection of medicines ............................................................................................................................... 50

6.2.7. Procurement of medicines ......................................................................................................................... 51

6.2.8. Distribution of medicines ......................................................................................................................... 51

7. GLOSSARY ............................................................................................................................................................. 52

8. REFERENCES ......................................................................................................................................................... 54

9. ANNEXES ................................................................................................................................................................ 55

ANNEX 1: SCORE SHEETS ............................................................................................................................................... 56

ANNEX 2: LIST OF DOCUMENTARY EVIDENCE OBTAINED ............................................................................. 65

ANNEX 3: ORGANIZATIONAL STRUCTURE OF THE PHARMACY AND POISONS BOARD .................. 66


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ABBREVIATIONS

AIDS Acquired Immunodeficiency Syndrome

CCT Committee for Clinical Trials

CDR Committee for Drug Registration

CMS Central Medical Stores

COI Conflict of Interest

EML Essential Medicines List

ERC Ethics and Research Committee

GCP Good Clinical Practices

GDP Good Distribution Practices

GGM Good Governance for Medicines

GMP Good Manufacturing Practices

HIV Human Immunodeficiency Virus

IEC Independent Ethics Committee

INN International Nonproprietary Name

KEMRI Kenya Medical Research Institute

KEMSA Kenya Medical Supplies Agency

KI Key Informant

KNDP Kenya National Drug Policy (1994)

KNH Kenyatta National Hospital

KNPP Kenya National Pharmaceutical Policy (2007)

MDGs Millennium Development Goals

MEDS Mission for Essential Drugs and Supplies

MoH Ministry of Health

MOMS Ministry of Medical Services

MRA Medicines Regulatory Authority

NCST National Council of Science and Technology

NGO Nongovernmental Organization

NHSSP National Health Sector Strategic Plan

NMTC National Medicines and Therapeutics Committee

NQCL National Quality Control Laboratory for Drugs and Medical Devices

PPB Pharmacy and Poisons Board

PPOA Public Procurement and Oversight Authority

QA Quality Assurance

SOP Standard Operating Procedure

TB Tuberculosis

TOR Terms of Reference

UoN University of Nairobi

WHO World Health Organization


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KENYA GGM ASSESSMENT TEAM

COORDINATORS

Fred Siyoi Deputy Chief Pharmacist/Deputy Registrar, MOMS

Njeri Mucheru Deputy Chief Pharmacist, Division of Pharmaceutical Policy, MOMS

Regina Mbindyo National Medicines Adviser, World Health Organization, Kenya

NATIONAL ASSESSORS

Grace N. Thoithi Dean, School of Pharmacy, University of Nairobi

James Mwenda Customer Services Manager, Mission for Essential Drugs & Supplies (MEDS)


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FOREWORD

This report is a national assessment of transparency and potential vulnerability to corruption and

unethical practices in eight key pharmaceutical system functions in Kenya, namely: medicines

registration, licensing, inspection, promotion, clinical trials, selection, procurement and distribution.

It was conducted using an assessment tool and model framework developed by the World Health

Organization, which focuses on structures and mechanisms to prevent unethical practices in decision‐

making in the public pharmaceutical sector.

Kenya is in the process of implementing its development blueprint ‐ Vision 2030 – which is anchored

on economic, social and political pillars, some key aspects being governance reforms as well as

public sector reforms. In this regard, the Government continues to intensify efforts to bring about an

attitudinal change in public service that values transparency and accountability to the citizens of

Kenya. Health sector reform is in progress under the National Health Sector Strategic Plan (NHSSP

II) and mechanisms for health sector governance and coordination are actively being strengthened.

To guide the much‐needed reforms in the pharmaceutical sector, the Government has developed the

Kenya National Pharmaceutical Policy (KNPP) which enshrines ‘good governance’ as one of its core

principles. The Pharmaceutical Strategy will provide a framework for coordinated planning,

monitoring and evaluation.

Promoting good governance in the pharmaceutical sector requires a long‐term strategy through

which best practices and evidence‐based decision‐making are actively assimilated into

pharmaceutical systems. To achieve significant impact, efforts to address corruption must include the

application of two basic strategies: i) discipline‐based strategy – establishing comprehensive laws

and regulations with adequate sanctions for non‐compliance; and ii) values‐based strategy – building

institutional integrity through the promotion of moral values and ethical principles. This assessment

is therefore timely, and the findings and recommendations will inform strategies for entrenching

transparency and best practices in all aspects of pharmaceutical services.

I wish to gratefully acknowledge the efforts of the national assessors and coordinators who were

involved in all technical aspects of this assessment; and to the key informants who readily provided

the information analysed in this report. In addition, we acknowledge the technical support from

WHO, which enabled the necessary training of national assessors, adaptation of the tools and

development of the assessment report.

It is my sincere hope this report promotes awareness among health stakeholders and the general

public on the basic components necessary for promoting good governance in the management of the

national pharmaceutical system. I urge all stakeholders to participate in defining and supporting

strategies for sustaining good governance in the pharmaceutical system.

____________________________

Dr Francis Kimani

Director of Medical Services


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EXECUTIVE SUMMARY

Background

A study was undertaken in Kenya to collect the perceptions of pharmaceutical policy‐makers and

other stakeholders on the transparency and vulnerability to corruption in the pharmaceutical sector.

It covered procedures and structures for medicines registration, licensing of pharmaceutical

establishments, medicines inspection and market control, medicines promotion control, control of

clinical trials, medicines selection, procurement and distribution. The findings will be used in the

development of a national good governance for medicines (GGM) framework and in the

implementation of a national GGM programme.

Methodology

Two trained national assessors carried out the study between May and July 2008 using a

standardized World Health Organization (WHO) assessment tool. A total of 113 key informants (KIs)

were interviewed. Interviewees were from the Medicines Regulatory Authority (MRA) (Pharmacy

and Poisons Board (PPB)), Government procurement and distribution department, other

Government ministries, universities, community pharmacies, the private pharmaceutical industry,

national and international nongovernmental organizations (NGOs), media and legal institutions. The

quantitative indicators used were scored and a rating system was used to represent the degrees of

vulnerability to corruption.

Results

Registration of medicines: The average final score for registration was 4.36, indicating moderate

vulnerability to corruption. The requirements for applicants are fairly well documented, including a

standard application form for submission of applications for registration, guidelines on how to

submit the application and a list of registered medicines. There is a committee which meets regularly

to assess applications, and applicants who have their applications rejected by the committee can

make formal appeals to the PPB. However, there are no written guidelines on selection criteria for

members of this committee, on the committee’s composition and terms of reference, procedures on

how to assess applications, how and where medicines registration officers meet with applicants and

on conflict of interest (COI) with regard to registration activities.

Licensing of pharmaceutical establishments: The average final score for licensing was 5.21,

indicating moderate vulnerability to corruption. There is provision in the law for licensing of

pharmaceutical establishments and the MRA has a unit and a committee for licensing activities.

There are written procedures on how to submit applications for licensing and how to assess

applications. Although a pre‐licensing inspection report is required before issuing a licence, post‐

licensing inspection of establishments is not regular. There is a list of licensed pharmaceutical

establishments, but it is neither comprehensive nor up‐to‐date. There are no written guidelines on

selection criteria for members of the committee for licensing or on its composition and terms of

reference. There is no independent appeals system for applicants who have their applications for

licensing rejected.


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Inspection and market control of medicines: Inspection and market control of medicines is very

vulnerable to corruption, having an average final score of 3.95. There is comprehensive provision in

the medicines legislation covering inspection of pharmaceutical establishments and written standard

operating procedures (SOPs) for conducting inspections. There are written guidelines for Good

Manufacturing Practices (GMP) and also for Good Distribution Practices (GDP) for pharmaceutical

products in Kenya, but these guidelines do not classify non‐compliance with GMP or GDP. No

written criteria for selection and recruitment of inspectors and no guidelines on COI exist. Written

procedures to prevent regulatory capture between inspectors and the manufacturing and

distributing companies inspected are also non‐existent.

Drug promotion control: The average final score for licensing was 4.53, indicating moderate

vulnerability to corruption. There is provision within the pharmacy legislation covering promotion

and advertising of medicines, with clear penalties for anyone who breaches the law. Pre‐approval of

promotional material is required and there is a promotions service that vets medicines promotion

advertisements, but monitoring and enforcing the provisions on this promotion are very weak. SOPs

for the service for medicines promotion are being developed. However, there are no written

guidelines on selection criteria for members of the promotion service unit, nor on the composition

and terms of reference of the committee. There are no written procedures to report unethical

promotional practices and none for COI.

Control of clinical trials: The average final score for control of clinical trials was 6.25 which indicates

marginal vulnerability to corruption. There is provision for the regulation of clinical trials in the

Science and Technology Act. The PPB has a committee which is responsible for reviewing

applications and it also has requirements for the manufacture, importation, exportation and use of

investigational products. There are guidelines on the submission of applications to the PPB to

conduct clinical trials and to the various institutional ethics and research committees. There is no

system for inspection of clinical trials and no written guidelines on selection criteria for members of

the PPB and Ethics and Research Committees (ERCs) nor on COI. There are no national guidelines on

principles of Good Clinical Practice and none for the establishment of an independent ethics

committee.

Selection of medicines: Selection of medicines had the lowest average final score of 2.95, showing that

this function is very vulnerable to corruption. The essential medicines list (EML) is in line with WHO

procedures, but it was last updated in 2002. There are no written criteria for the selection process for

including or deleting medicines from the national EML. A National Medicines and Therapeutics

Committee (NMTC) was constituted in 2007, but it is not yet operational. There are clear criteria for

the selection of NMTC members, and terms of reference describing the role and responsibilities of

the NMTC have been developed, but most stakeholders are not aware of their existence. There are no

written guidelines on COI and the NMTC has no SOPs for their decision‐making.

Procurement of medicines: The average final score for procurement of medicines was 7.01, which

indicates marginal vulnerability to corruption. Transparent and explicit procedures for procurement

exist and are heavily informed by the Public Procurement and Disposal Act. A description of the

internal procedures to be followed by procurement staff when processing bids is available to the

staff. The Procurement Office monitors supplier performance for compliance with the contract terms

and it is also audited on a regular basis. There is a Tender Committee whose functions are clearly

separated from the functions of the Procurement Office. There is a formal appeals process for


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applicants who have their bids rejected. There are no written guidelines on COI with regard to the

procurement of medicines.

Distribution of medicines: Distribution of medicines had the highest of all scores, 7.82, indicating

marginal vulnerability to corruption. All procured commodities are delivered from the suppliers

directly to the central warehouses where they are verified. Most medicines carry a Government

identification inscription on both the primary and secondary packaging. A “master map” showing

the location of medicines does not exist, but products are arranged taking into account their expiry

dates. A security management system, procedure for requesting medicines, SOPs for stock

management, computerized and manual information systems, a monitoring and evaluation system,

and a communication system between distributions points are all in place. The warehouses are

subject to regular internal and external auditing. Sanctions to be imposed on individuals for theft or

corrupt practices are set out in the Public Procurement Act.

General recommendations

1. Create a formal appeals system in each function.

2. Improve communication between all players in the pharmaceutical sector: the Ministry, the

PPB and the pharmaceutical industry.

3. Regularly update and publicize all documents and improve data management systems to

provide instant information.

4. Build the human resource capacity in each of the functions.

5. Institutionalize the declaration of COI for all activities.

Specific recommendations

Registration: The development of guidelines for the selection of committees and decision‐making

processes, control of the number of registered products, pre‐registration analysis of all medicines and

sharing of information between drug registration, inspection and importation departments within

the PPB should be embarked on.

Licensing: A review of the Food and Chemical Substances Act (Cap 254), enforcement of annual

renewal of licences, and guidelines for selection and the decision‐making processes of the licensing

committees are required.

Inspection and market control: There is a need to develop documents for selecting and guiding the

decisions of committee members and inspectors, to have regular schedules of inspections, to enforce

the law, and to improve information sharing between the drug registration, pharmacovigilance and

inspection departments within the PPB.

Drug promotion control: The law should be enforced and amended to include control of

complementary medicines’ promotion. Guidelines and SOPs should be strengthened and public

awareness on the regulation of promotion of medicines should be created.


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Control of clinical trials: There is a need to review legislation and enforce it, to develop all the

necessary documents, increase the capacity of reviewers, establish an inspection system and improve

interaction between researchers, the National Council of Science and Technology (NCST), ERCs, the

Ministry of Medical Services and the PPB.

Selection: The selection process should be publicized, the NMTC should be operationalized and

documentation on the selection process should be developed.

Procurement: Procurement of all medicines should be done centrally by the Kenya Medical Supply

Agency (KEMSA), the procurement function should be independent and the Public Procurement and

Oversight Authority (PPOA) should be operationalized.

Distribution: A performance monitoring system for the supply chain should be set up, GDP enforced

and regional depots strengthened.


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1. INTRODUCTION

1.1. Background

Medicines complement other types of health‐care services in reducing morbidity and

mortality rates and enhancing the quality of life. Therefore, access to health‐care and

essential medicines is increasingly being viewed as a fundamental human right1. The ability

of medicines to save lives, reduce suffering and improve health depends on their being of

good quality, safe, available, affordable and properly used. In many countries these

conditions are far from being met and it is estimated that today almost two billion people

(one third of the global population) do 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 regular access. Furthermore, one third of countries have either no regulatory authority or

only limited capacity to regulate the medicines market. Unreliable supply systems persist,

and irrational use of medicines is a major problem worldwide2.

Poverty, market failures and Government failures, among others, contribute to these urgent

challenges in the pharmaceutical sector. The latter often results, at least in part, from a lack

of transparency in the pharmaceutical system, which is one of the possible reasons for the

medicines gap described above. Lack of transparency in the pharmaceutical system is

increasingly becoming an issue of concern because bad practices can waste resources, which

in turn reduces the availability of essential medicines and so threatens the well‐being of

populations.

1.2. Overview of the pharmaceutical sector in Kenya

1.2.1. Country socio-economic and health profile

Kenya’s population stands at about 34 million people (2005 census), 56% of which lives

below the poverty line and depends on less than US$ 1 per day. Substantial resource inputs

to the health sector by the Government and development partners have resulted in specific

gains and various improvements, however, some key health indicators have been on the

decline and a significant number of Kenyans cannot reliably access the medicines they need3.

Malaria, HIV/AIDS, tuberculosis (TB), diarrhoea and respiratory diseases are the main

threats to health. An estimated 1.5 million Kenyans are living with HIV/AIDS. Malaria is the

main contributor to morbidity and mortality in Kenya, causing 34,000 deaths annually in

children below 5 years of age. Medicines, medical devices and diagnostics to manage these

and other diseases are expensive, and present great challenges for access, monitoring and

regulation. This has put a significant demand on the health system in general and

specifically on the pharmaceutical sector.

The public health‐care system remains the major provider of health services, accounting for

58% of health facilities, 52% of hospital beds and 70% of health personnel. The private for‐

profit sector and the private not‐for‐profit providers complement the public sector health

services3.


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Public financing of the health sector through the Exchequer is about US$ 6.2 per capita, or

5% of Gross Domestic Product4, which falls below the WHO recommended level of US$ 34

per capita5 and far short of the Government’s commitment to spend 15% of the national

budget on health, as agreed in the Abuja Declarations (2001 and 2006)6. This under‐funding

has reduced the sector’s ability to ensure an adequate level of service provision to the

population, and has led to significant out‐of‐pocket payments, thus contributing to inequity

in access to health care for poor and disadvantaged groups. These factors put Kenya at risk

of not achieving the Millennium Development Goals (MDGs). Kenya’s Health Policy

Framework (1994)7 outlines health sector reforms, among them strengthening the policy role

of the central Ministry of Health (MoH); decentralization and capacity strengthening of

provincial and district levels; reorientation, retraining and redeployment of health human

resources; and adoption and implementation of the Kenya National Drug Policy (1994)8 as

the guide for legislative reforms, staff development and management improvements in

pharmaceutical services3.

1.2.2. Pharmaceutical sector profile

The growth of the Kenyan population from about 27 million in 1994 when the KNDP was

adopted to about 34 million (2005), coupled with the ongoing burden of HIV, TB and

malaria have created a lot of pressure on the health system. Although the number of public

and private health facilities has also increased, the health system remains overburdened,

and the pharmaceutical sector has experienced the same challenges affecting the health

sector generally. Public sector pharmaceutical services are provided by the MoH through the

Department of Pharmacy, headed by the Chief Pharmacist who is also the Registrar of the

MRA, PPB. The Government has established the Kenya Medicines Supply Agency (KEMSA)

for pharmaceutical supply and the National Quality Control Laboratory (NQCL) for analysis

of medicines. However, the current MoH structure and the dual roles of some MoH officers

are not conducive to effective pharmaceutical sub‐sector management and do not facilitate

effective delivery of services.

The ratio of pharmaceutical personnel (pharmacists and pharmaceutical technologists) to the

population is insufficient, with approximately 1 to 10,000 (Table 1)3. Moreover, these

personnel are inequitably distributed across the country, with the majority concentrated in

the private sector and in urban areas, and there are notable skills gaps in key areas, such as

management, procurement and supply. As a result, the quality of pharmaceutical services is

compromised.

The Government and its bilateral partners contribute significantly to health sector

strengthening and financing but currently this is insufficient to ensure equitable access to

essential medicines for all Kenyans. Factors such as national debt, inflation, economic

growth, unpredictable donor support and lack of required budget‐planning information

make concrete budget projections difficult. This contributes to major gaps in funding and

consequently, access to medicines and resources for the pharmaceutical sector and

medicines supply remain grossly inadequate.


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Table 1: Key indicators for the pharmaceutical sector in Kenya

Indicator Value (Year)

Public sector medicines expenditure (US$) 16 million (2002/3)

Public sector per capita medicines expenditure (US$) 0.51 (2002/3)

Percentage of MoH recurrent budget spent on medicines & other medical supplies 11.3% (2006/2007)

Pharmaceutical sub-sector value (US$) 130 million (2004)

Number of registered pharmaceutical manufacturers 35 (2006)

Number of registered pharmacies (including 208 wholesalers) 1153 (2006)

Number of registered pharmacists 1895 (2006)

Number of enrolled pharmaceutical technologists 1436 (2006)

Ratio of pharmaceutical personnel/population (per 1000) 0.08 (2006)

Source: The Kenya National Pharmaceutical Policy3

There has been enormous development of the local pharmaceutical market over the last

decade, with more than 10,000 products currently marketed in Kenya. A vibrant

pharmaceutical manufacturing industry has been established with great potential and

opportunities to serve the region. Trade liberalization and a challenging local manufacturing

environment must be addressed to ensure the effectiveness and sustainability of this vital

resource.

Kenya has a public pharmaceutical sector with most of the basic structures that are required

to offer and regulate pharmaceutical services. However, in view of limited financial

resources to support an ever increasing population, inadequate pharmaceutical personnel

and the challenges of a high disease burden, it is essential to create an effective framework

for good practices in the pharmaceutical sector.

1.3. Objectives

This study aims to collect the perceptions of pharmaceutical policy‐makers and other

stakeholders on the transparency of the pharmaceutical sector. Stakeholders include the

private pharmaceutical sector, academia, national and international NGOs, as well as

international governmental organizations.

The specific objective of the study was to assess the level of transparency and vulnerability

to corruption in the procedures and structures of the following eight functions of the

pharmaceutical sector in Kenya:

1. Registration of medicines

2. Licensing of pharmaceutical establishments

3. Inspection and market control of medicines

4. Medicines promotion control

5. Control of clinical trials

6. Selection of medicines

7. Procurement of medicines

8. Distribution of medicines


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The findings of the study will be used in the development of a national good governance for

medicines (GGM) framework and in the implementation of a national GGM programme.

2. METHODOLOGY

2.1. Study period and area

The study was carried out between May and July 2008. Most of the KIs interviewed were

from Kenya’s capital city, Nairobi, where the regulators and policy‐makers are and where

most of the activities take place. However, to corroborate the information obtained, some

KIs from other parts of the country were interviewed, especially with respect to

procurement and distribution of medicines.

2.2. National assessors

The two national assessors who carried out the study were trained for three days on the

GGM programme and on how to conduct the study. The training took place in Lusaka,

Zambia, on 8‐10 April 2008. The assessors co‐opted one co‐assessor to help in data collection,

whom they trained on the use of the assessment tools.

2.3. Selection of key informants

For each of the eight pharmaceutical functions studied, 13‐15 KIs were interviewed to give a

total of 114 informants. Their selection was carefully made based on knowledge and level of

involvement in the pharmaceutical sector. The KIs were a mix of senior‐, middle‐ and junior‐

level pharmaceutical sector personnel and they represented various institutions, such as the

MRA, the Government procurement and distribution departments, Government ministries,

universities, private community pharmacies (chemists), the private pharmaceutical industry,

and national and international NGOs. In addition, some KIs from other sectors, such as

finance, media and legal (lawyers) were also interviewed.

Table 2 shows the distribution of KIs for each of the pharmaceutical functions studied

among the different sectors.


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Table 2: Affiliation of key informants interviewed for each pharmaceutical function

Registration Licensing Inspection Promotion Clinical trials

Selection Procurement Distribution

Government

PPB Dirs - 1 - 2 - 1 - -

PPB Depts 7 1 5 2 1 - - -

MoH 1 - 1 - 1 7 a 2 1

NQCL - - 3 - - - 2 -

KEMSA - - - - - - 4 6

Hospital - - - - - 5 3 2

Private

Chemist 1 3 1 2 - - - -

Industry 2 2 - 6 2 - 1 1

Consultant - - 1 - 1 - - -

NGO (Int) - - - 1 - - 1 1

NGO - - 2 1 - - 1 2

Other

Academia 3 b 6 c 1 1 8d 2 - -

Lawyer - - - - 1 - - -

Media - - - - 1 - - -

KEMRI - - 1 - - - - -

Total 14 13 15 15 15 15 14 13

a: Three people were from MoH Pharmacy Department, two were from the MoH Malaria Division and two from the HIV/AIDS Division. b: All were members of the PPB Committee on Drug Registration. c: Four of these people own chemists. d: Four were researchers in clinical trials, three were members of an institutional ethics and research committee, while one was a member of the PPB committee for clinical trials. Int: International. KEMRI: Kenya Medical Research Institute. KEMSA: Kenya Medical Supplies Agency. MoH: Ministry of Health. NGO: Nongovernmental Organization. NQCL: National Quality Control Laboratory. PPB Dirs: Pharmacy and Poisons Board of Directors. PPB Dept: Pharmacy and Poisons Technical Departments.

2.4. Data collection

To collect information, the national assessors used a set of structured questionnaires that

were developed by WHO’s GGM programme for assessment of each of the eight

pharmaceutical functions. KIs were interviewed at a place of their choice, which in most

cases was in their offices. The assessors assured the KIs of the confidentiality of the

information given. Four methods were used to determine the level of transparency. Only

Methods 1 and 2 were used to score the vulnerability to corruption for each function.

Method 3 allowed the perception of the KI to be compared with the existing procedures and

structures, while Method 4 questions were open‐ended to capture additional information.

To validate and support the information obtained through the questionnaires, the assessors

collected supporting documents from the informants (Annex 2).


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2.5. Data scoring and analysis

Only answers to Method 1 and Method 2 questions were included in the scores. For both

Method 1 and 2 questions, each indicator required a “yes” or “no” response from the KIs,

determining the presence or absence of the existing practice at the Department of Health.

For Method 1, which required a binary answer (yes/no, a “yes” answer was given a value of

“1”, only if there was evidence of a supporting document. A “no” answer was given a value

of “0” irrespective of whether a supporting document was available or not. Method 2

questions had a series of sub‐criteria questions. Each criteria was answered by (yes/no/don’t

know); a “yes” answer was given a value of “1” and a “no” answer was given a value of “0”.

All the “don’t know” answers were considered invalid and were not scored. The overall

score for the question was obtained by dividing the total “yes” answers by the total of valid

answers (yes and no). Each question was scored between 0 and 1. A value of “1” represented

low vulnerability to corruption, while the value of “0” represented high vulnerability to

corruption.

Using Microsoft Excel, the sum of scores for all indicators for each function was then

divided by the number of indicators, and multiplied by 10 to give the final score for each

function on a scale of zero to 10. The 10‐point rating system represented the degrees of

vulnerability to corruption shown in Table 3.

Table 3: Scale of vulnerability to corruption for pharmaceutical functions

3. RESULTS

The overall final scores for each function of the assessment are summarized in Table 4.

Selection of medicines was found to be very vulnerable to corruption, while control of

clinical trials, procurement and distribution were only marginally vulnerable. The functions

that were moderately vulnerable were registration of medicines, licensing of pharmaceutical

establishments, inspection and market control, and promotion of medicines.

0.0 – 2.0 2.1 – 4.0 4.1 – 6.0 6.1 – 8.0 8.1 – 10.0

Extremely vulnerable

Very vulnerable

Moderately vulnerable

Marginally vulnerable

Minimally vulnerable


‐‐ 7 ‐‐

Table 4: Vulnerability scale scores in the eight pharmaceutical functions

Registration Licensing Inspection Promotion Clinical trials

Selection Procurement Distribution

Indicator 1 0.71 1.00 0.87 1.00 0.69 0.93 0.97 0.67

Indicator 2 0.70 1.00 0.74 0.48 0.33 M3 0.93 M3

Indicator 3 0.75 0.58 0.39 0.53 0.63 0.00 0.64 0.94

Indicator 4 0.33 0.27 0.40 0.77 0.81 0.45 1.00 0.91

Indicator 5 0.96 0.77 0.00 0.10 0.93 0.53 0.95 0.54

Indicator 6 0.00 0.78 0.00 0.73 0.77 M3 M3 0.90

Indicator 7 1.00 0.00 0.57 0.48 0.71 0.22 0.69 0.92

Indicator 8 0.00 0.00 0.58 0.00 0.27 0.00 0.00 0.52

Indicator 9 0.00 0.31 0.00 0.44 0.57 0.22 M3 0.77

Indicator10 0.00 0.69 M3 0.00 0.79 0.00 0.36 0.67

Indicator11 M3 M3 M3 M3 0.55 M4 0.69 0.97

Indicator12 0.00 0.33 M4 M3 0.45 M4 0.65 1.00

Indicator13 0.79 M3 M4 M3 M3 - 0.83 0.58

Indicator14 M3 M4 - M3 M3 - M3 1.00

Indicator15 M3 M4 - M4 M3 - M4 0.58

Indicator16 M4 - - M4 M4 - M4 0.67

Indicator17 M4 - - - M4 - - 0.88

Indicator18 - - - - - - - M3

Indicator19 - - - - - - - M4

Indicator20 - - - - - - - M4

Total* 5.24 5.73 3.56 4.53 7.50 2.36 7.71 12.51

Final Score** 4.36 5.21 3.95 4.53 6.25 2.95 7.01 7.82

Vulner-ability Moderate Moderate

Very vulnerable

Moderate Marginal Very vul-nerable Marginal Marginal

The scores given are an average of scores for all KIs for that indicator in a function. *Total: sum of all average scores for Method 1 and Method 2 only indicators in a function. ** Final score: Total divided by number of indicators and multiplied by10. M3: Method 3. M4: Method 4.


‐‐ 8 ‐‐

3.1. Registration of medicines

The Registration Department of the PPB has guidelines for applicants on how to submit an

application for registration of medicinal products, an application form for submission of

applications for registration of medicines and an up‐to‐date list of all registered

pharmaceutical products. There is a Committee for Drug Registration (CDR) that assesses

applications for registration of medicines, but no written evidence of procedures for

assessing applications was found. Appeals can be made to the PPB by applicants who have

their applications rejected.

Indicator I.1: Up-to-date list of all registered pharmaceutical products

Ten of the 14 KIs said there was an up‐to‐date list of pharmaceutical products. Two

Government and two private KIs answered this question in the negative because their

perception was that the list is not up‐to date.

Indicator I.2: Minimum level of information on list of registered pharmaceutical products

The majority of the KIs said that the list includes the name of the product (100% of the KIs),

date of registration (100%), name of the manufacturer (92.9%), country of manufacture

(71.4%) and validity of registration (57.1%). However, fewer of them said that the list

included packaging and identifying marks (28.6%), date of registration (42.9%) and

conditions for registration, such as prescription only or over‐the‐counter (50.0%).

Indicator I.3: Procedures on how to submit applications for registration of medicines

Thirteen of the 14 KIs indicated that there were written procedures on how to submit

applications for registration of medicines. The procedures are written, publicly accessible

and they describe the process to follow in submitting an application. In addition, they

mention the fees to be paid, the data to be submitted and the criteria for registration. All 13

KIs said the procedures make no mention of the time frame for processing. The KI who

indicated that there were no procedures for submitting applications was from the private

sector.

Indicator I.4: Procedures for assessing applications for registration

Five KIs (three CDR members, one from the PPB and one from the private sector) said there

were no procedures for evaluators to assess applications for registration of medicines. Three

(one from the MoH and two from the private sector) did not know if the procedures existed.

One of the KIs (PPB) said only a checklist, and not procedures, existed while five

respondents (all from the PPB) said the procedures existed. These five KIs all said the

procedures were written, described the process to follow in assessing submissions and that

they provided guidance on report writing. However, only one of the five KIs said that the

procedures were publicly accessible and that they mentioned the time frame for processing

the applications.


‐‐ 9 ‐‐

Indicator I.5: Application form for registration of medicinal products

All KIs agreed that there is a standard application form publicly available for the submission

of applications for registration of medicinal products. More than 95% of them said that the

form is publicly accessible and available at a Government office, that it required descriptions

of the product (brand name and international nonproprietary name (INN)), composition per

unit dose, a summary of the method of manufacture, specifications for the active ingredients

and excipients, a summary of product characteristics (such as pharmacological action,

therapeutic classification, indications, contraindications), packaging materials, inserts and

labelling.

Indicator I.6: Guidelines on how and where medicines registration officers meet with applicants

All KIs responded that there were no guidelines setting limits on how and where medicines

registration officers meet with applicants.

Indicator I.7: Committee for assessing applications for registration of medicines

All respondents indicated that there was a functioning formal committee responsible for

assessing applications for registration of pharmaceutical products.

Indicator I.8: Criteria for selecting the members of the committee

Only two KIs, both from the PPB, said that there were written criteria for selecting the

members of two of the registration committees. However there was no written evidence of

such criteria.

Indicator I.9: Composition and terms of reference of the committee

Only one KI, who was from the PPB, said that there was a written and publicly accessible

document that describes the composition and terms of reference of the committee. There

was no evidence of such a document.

Indicator I.10: Guidelines on conflicts of interest with regard to registration activities

There were no written guidelines on COI and no COI declaration form with regard to

registration activities.

Indicator I.11: Systematic, objective selection of Registration Committee members (see also I.8)

As shown in Table 5 below, one KI strongly agreed, four agreed and another four disagreed

with the statement “the members of the Registration Committee are systemically and

objectively selected based on the written criteria in force in Kenya”. Four respondents said

the question was not applicable and one did not know.


‐‐ 10 ‐‐

Table 5: Perception of key informants on the selection criteria of Registration Committee members

Sector Strongly disagree

Disagree Undecided Agree Strongly agree

NA DK Total

Government 0 2 0 3 1 1 1 8

Private 0 1 0 0 0 2 0 3

Academia 1 0 1 0 1 0 3

Total 0 4 0 4 1 4 1 14

DK: Don’t know, NA: Not applicable

Indicator I.12: Guidelines for the Committee's decision-making process

Three KIs, one from the PPB and two from academia, said there were clear and

comprehensive guidelines for the Committee’s decision‐making process, but there was no

evidence of such documents.

Indicator I.13: Formal appeals system for rejected applications

The majority (78.6%) of the respondents said that there was a formal appeals system for

applicants who had their registration applications rejected and that this involved appealing

to the PPB when the Committee for Drug Registration rejected their applications.

Indicator I.14: Influence of gifts on the final decisions of officials of medicines registration

Table 6 shows that three (23.1%) KIs strongly agreed, two (15.4%) agreed, four (30.8%)

disagreed and 15.4% strongly disagreed with the statement “Gifts and other benefits given

to the officials in charge of medicines registration have no influence at all on their final

decisions”. Two of the respondents were undecided.

Table 6: Perception of key informants on the influence of gifts on the decisions of officials



NA DK Total

Government 1 1 2 2 2 0 0 8

Private 1 2 0 0 0 0 0 3

Academia 0 1 0 0 1 0 1 3

Total 2 4 2 2 3 0 1 14


Indicator I.15: Frequency of meetings and minutes of the Registration Committee

Ten (71.4%) of the KIs strongly agreed and the remaining four just agreed with the statement

“the Registration Committee meets on a regular basis and keeps minutes of its meetings”.


‐‐ 11 ‐‐

Indicator I.16: Unethical behaviour in the registration system

Below is a list of what the KIs gave as their perceptions of unethical behaviour common in

the registration area in Kenya:

a. Frequent change of authorized importers and/or agents

b. Substandard drugs: Presence of counterfeit and unregistered medicines in the market

c. Many products are registered without undergoing analysis

d. Data submitted: Incomplete stability protocols and data; plagiarism of data from

innovator products by applicants of generic products; and infringement of patent

rights by some applicants using similar names/presentation of their products as

existing products

e. Influence of registration officers: Officers are influenced by applicants by being given

dinners and gifts, there is lobbying by applicants to have registration of their

products fast‐tracked; some products are registered without going through

evaluation; and some registration officers have obvious vested interest in registration

of certain products

f. Disappearance of registration dossiers from the secretariat

g. In some cases the PPB overrules expert decisions of the Registration Committee

without any good explanation.

Indicator I.17: Actions to improve the medicines registration process

Below is a list of suggestions by KIs on how to improve the medicines registration process:

a. Make the PPB autonomous.

b. Establish a clear appeals system for applicants whose applications for medicines

registration have been rejected.

c. Limit the number of generics that can be registered for any molecule. Fewer generics

would result in more effective pharmacovigilance, control of counterfeit medicines

and facilitate education of the public on rational use of medicines.

d. Improve documentation for medicines registration, including: SOPs for the drug

registration process; time frames for assessment; methods of arbitration when any

two members of the Registration Committee disagree; updated list of rejected and

approved medicines; and declaration of COI for registration activities.

e. Improve the capacity for internal evaluation of generics by using the PPB secretariat

pharmacists, leaving the CDR experts to evaluate only innovator products.

f. Improve interaction and sharing of information between: drug registration, GMP

and importation departments; Registration Committees and applicants; and the PPB

and the Registration Committees.

g. Put in place effective and comprehensive post‐ marketing surveillance to ensure the

quality of subsequent batches of registered products; enforce the withdrawal of all

rejected and unregistered products in the market; and strengthen surveillance at

ports of entry.

h. Draw up a Memorandum of Understanding between the PPB and the NQCL to

ensure that all medicines are analysed before registration, and specify the time

within which analysis should be completed, among other things.


‐‐ 12 ‐‐

i. Create data management systems to provide instant information to clients and make

available information/literature/internet searches for evaluators as they are meeting.

j. Harmonize: the three Drug Registration Committees (human, veterinary and

complementary medicines), and regional guidelines on medicines registration.

3.2. Licensing of pharmaceutical establishments

The Inspectorate Department of the PPB is responsible for licensing pharmaceutical

establishments. There are two formal committees that assess applications for licensing of a

pharmaceutical establishment at the PPB, one assesses applications for licence renewals (PPB

Management Committee) and the other assesses applications for new licences (PPB Practice

Committee). The guidelines for submission of applications for licensing were published in

June 2006. The process is also clearly spelt out in the service charter, which is publicly

available and covers administrative criteria to be met by applicants, and description of the

requirements to be met in terms of premises, facilities and personnel. Application fee

structure and the time frame for processing applications are also indicated. A list of

establishments (2007) exists, but it mainly includes the names of wholesalers and

manufacturers.

Indicator II.1: Requirement for a licence in order to operate a pharmaceutical establishment in Kenya

All 13 KIs indicated that it was a legal requirement to have a licence in order to operate a

pharmaceutical establishment in Kenya.

Indicator II.2: Issuance of pharmaceutical establishment licences at the medicines regulatory authority

All 13 indicated that there is a unit for issuing pharmaceutical establishment licences at the

PPB. The unit is established under the Inspectorate Department of the PPB.

Indicator II.3: Procedures for submission of applications for licensing

Ten (76.9%) of the KIs indicated that there were written procedures for submission of

applications for licensing. Three KIs, two from the private sector and one from academia,

were unaware of the existence of these procedures, which were published in 2006. Indeed,

most KIs who do not work at the PPB were not very knowledgeable about the contents of

the guidelines and the PPB service charter.

Indicator II.4: Guidelines for assessing applications for a licence

Eight (61.5%) of the KIs indicated that there were no written guidelines for assessing

applications for a licence. Only three (two from the MRA and one from academia) were

aware of the written guidelines. Two from the private sector did not know whether

guidelines existed or not. The procedure for processing of applications is published in the

guidelines.


‐‐ 13 ‐‐

Indicator II.5: Submission of a pre-licensing inspection report

Ten of the KIs indicated that submission of a pre‐licensing inspection report is required for

making decisions on whether to issue a licence or not. Three from the private sector said it

was not a requirement. One KI from the private sector indicated that sometimes you can get

provisional licence from the PPB or District Pharmacist.

Indicator II.6: Committee that assesses applications for licensing of pharmaceutical establishments

Seven KIs (53.8%) indicated that there was a functioning formal committee that assesses

applications for licensing of a pharmaceutical establishment. Two, both from the private

sector, said that no such committee existed, while four others did not know if it existed or

not.

Indicator II.7: Criteria for selecting members of the committee

Only two KIs (15.4%) out of 13 indicated that criteria for selecting members of the

committees that assess licences existed. The KI from the PPB said criteria exist, but they are

not publicly available. No evidence was offered. The other KI from academia thought that

the criteria existed. Four KIs (30.8%) said that no such criteria existed and another four did

not know whether there were any criteria or not.

Indicator II.8: Composition and terms of reference of the committee

Five KIs indicated that there was no written document that describes the composition and

terms of reference of the committee and the other eight KIs (61.5%) did not know whether

the document existed or not.

Indicator II.9: Post-licensing inspection of licensed pharmaceutical establishments

Only four of the KIs indicated that post‐licensing inspection of licensed pharmaceutical

establishments is carried out at least every two years for all licensed establishments. Two of

the four were from the PPB, one from academia and the other one from the private sector.

All the other nine KIs (69.2%) disagreed and said that post‐licensing inspection of licensed

pharmaceutical establishments is erratic and done on an ad hoc basis. The reason given is

inadequate financial and human resources capacity.

Indicator II.10: List of all licensed pharmaceutical establishments available in the country

Eleven (84.6%) KIs indicated that there is an up‐to‐date list of all licensed pharmaceutical

establishments available in Kenya. One from academia said that no such list existed, while

one from the private sector did not know whether it existed or not. A list of licensed

pharmaceutical establishments (2007) was obtained, however, it mainly listed names of

wholesalers and manufacturers, and was incomplete on retail pharmacies.


‐‐ 14 ‐‐

Indicator II.11: Opinion about the process of licensing of pharmaceutical establishments

Seven (53.8%) of the KIs disagreed or strongly disagreed with the statement “the licensing of

pharmaceutical establishments is systematically carried out according to policies and

procedures”, two were undecided and four either agreed or strongly agreed with the

statement (Table 7).

Table 7: Perception of key informants on the process of licensing of pharmaceutical establishments



NA DK Total

Government 0 0 0 0 2 0 0 2

Private 1 2 2 1 0 0 0 6

Academic 2 2 0 1 0 0 0 5

Total 3 4 2 2 2 0 0 13


Indicator II.12: Appeals system for applicants who have their applications for licensing rejected

Six (46.2%) KIs, including two from the PPB, said there was no independent appeals system

for applicants who have their applications for licensing rejected. Four did not know whether

it existed or not, while three (23.1%) said it exists but is not independent. An independent

appeals system for applicants who have their applications for licensing rejected does not

exist. However, the guidelines indicate that in the case of an unsuccessful application, the

applicant will be given further opportunity to revise and comply.

Indicator II.13: Operations and meetings of the committee that assesses applications for licensing

Mixed responses were received from the KIs to the statement “The formal committee that

assesses applications for licensing of pharmaceutical establishments is fully operational and

meets on a regular basisʺ. Two were undecided, three did not know, while four disagreed or

strongly disagreed with the statement. The two KIs from the PPB strongly agreed and two

other KIs from academia just agreed with the statement (Table 8).

Table 8: Perception of key informants on how operational the committee that assesses applications for licensing of pharmaceutical establishments is



NA DK Total

Government 0 0 0 0 2 0 0 2

Private 1 1 1 0 0 0 3 6

Academic 1 1 1 2 0 0 0 5

Total 2 2 2 2 2 0 3 13



‐‐ 15 ‐‐

Indicator II.14: Unethical behaviour in the licensing of pharmaceutical establishments

Below is a list of what the KIs perceived as the unethical practices that commonly occur in

the process of licensing pharmaceutical establishments in Kenya:

a. Subjectivity of the licensing officers: There is subjectivity in licensing so that the outcome depends on which officer handled it; there is bribery; some establishments

are licensed without full compliance with the basic requirements or without pre‐

licensing inspection; and there is manipulation of the pre‐licensing report.

b. Licensing of unqualified persons: There is licensing of unqualified people to operate pharmacies and manufacturing establishments; medical doctors and other

non‐pharmacists being allowed to operate a pharmacy within their clinics without a

pharmacist; and some pharmacists sell their licences to businessmen to operate

pharmaceutical establishments without the pharmacist being in charge.

c. Unethical behaviour: Unfriendly inspectors intimidate applicants in order to obtain

bribes; and lethargy within the PPB secretariat causes unnecessary delays in

licensing.

d. Unethical licensing: Some establishments are licensed for both retail and wholesale

business thus undercutting those that are licensed for retail business only; and there

is licensing of retail pharmacies situated too close to one another, hence promoting

unethical competition.

Indicator II.15: Actions that should be taken to improve the licensing process

The following are suggestions from KIs on how to improve licensing of pharmaceutical

establishments in Kenya:

a. Autonomy: Make the PPB autonomous from the MoH and establish an independent

licensing unit with a clear mandate, terms of reference and performance indicators.

b. Develop new documents and improve existing documentation for licensing, and make them easily accessible: These should include a checklist for inspectors;

guidelines for the composition, selection criteria and terms of reference for licensing

committees; and guidelines on COI with regard to licensing activities.

c. Improve the human resource capacity to carry out regular inspections and improve

on the ethical standards of inspectors.

d. Law enforcement: Carry out audits of licensed and unlicensed establishments; close

all the unlicensed ones; adhere to licensing guidelines; enforce annual renewal of

licences; enforce regular (biannual) inspection of establishments; encourage self‐

inspection of establishments; and have regular rotation of inspectors.

e. Application process: Establish on‐line application for licensing; shorten the time

taken to process and approve applications for licensing; and decentralize licensing to

provinces and districts.

f. Database: Establish an up‐to‐date database of all the licensed establishments.

g. Establish a well defined appeals system for applicants whose applications are

rejected.


‐‐ 16 ‐‐

3.3. Inspection and market control of medicines

There is a comprehensive provision in the Pharmacy and Poisons Act (Cap. 244)9 covering

inspection of pharmaceutical establishments. There are written guidelines for GMP and also

for GDP for pharmaceutical products in Kenya. There are written SOPs for inspectors on

how to conduct inspections.

Indicator III.1: Legislation/regulation covering inspection of pharmaceutical establishments

Thirteen of the 15 KIs said there was provision in the medicines legislation that covered

inspection of pharmaceutical establishments. Two respondents, one from an NGO and the

other from the private sector, said that there was no provision.

Indicator III.2: Minimum level of information on inspection

All 13 respondents who said that there is provision for inspection of pharmaceutical

establishments in the legislation thought that the provision is comprehensive and that it

provides power to inspectors to enter, at any reasonable time, any place where medicines

are being produced, packaged, stored, distributed or tested. Many (92.3%) said that the

provision provides the PPB with the power to inspect, and 69.2% said the provision defines

the inspector’s duties and responsibilities. Another 76.9% said that the provision is available

to companies being inspected and that, although inspectors do not have identification

documents, they are provided with special identification tags or badges.

Indicator III.3: Guidelines classifying non-compliance with good manufacturing practices

Five KIs said that there were no written guidelines classifying non‐compliance with GMP

that describe the types of deficiencies and the corresponding measures to be taken by the

PPB. Nine KIs said that such guidelines existed in writing. Out of these nine, six (66.6%) said

that the guidelines define corresponding measures to be taken in case of non‐compliance

and that they were easily accessible to all stakeholders, while five (55.5%) said the guidelines

provide classification of GMP deficiencies. A minority of them (33.3%) said that the

guidelines provide an appeals mechanism for companies, but no one was aware of an

appeals system independent of the body making the original decision. Results from one KI

were invalid (too many “don’t knows”).

Indicator III.4: Guidelines classifying non-compliance with good distribution practices

Five KIs said that there were no written guidelines classifying non‐compliance with GDP

that describe the types of deficiencies and the corresponding measures to be taken by the

PPB and two did not know. Eight KIs said that such guidelines existed in writing. Out of

these eight, 87.5% said that they were easily accessible to all stakeholders, while 62.5% said

that the guidelines define corresponding measures to be taken in case of non‐compliance.

Four of them said the guidelines provide classification of GMP deficiencies. Three of them

(37.5%) said that the guidelines provide an appeals mechanism for companies and 12.5%

were not aware of an appeals system that is independent of the body making the original

decision.


‐‐ 17 ‐‐

Indicator III.5: Procedures and mechanisms to prevent regulatory capture

Eleven KIs responded that there were no written procedures to prevent regulatory capture

between inspectors and the manufacturers or distributors, and one KI did not know.

Although three respondents said that such procedures exist, there was no evidence of

written procedures. However, some KIs (four from Government and one from the private

sector) added that although there were no written procedures, regulatory capture is

prevented as a matter of practice.

Indicator III.6: Guidelines on conflict of interest

All KIs responded that there were no written guidelines on COI with regard to inspection

activities. Some respondents said that the WHO guidelines on COI are followed, but that

they had not been domesticated.

Indicator III.7: Internal review of inspection findings

Eight KIs said that inspection findings and conclusions are subject to an internal review, one

answered that he did not know whether they are or not and six said there was no internal

review of inspection.

Indicator III.8: Standard operating procedures for conducting inspections

The majority (12) of the KIs thought that there were SOPs for inspectors on how to conduct

inspections, but three of them (NGO, government and private sector) said there were no

SOPs. All of the 12 KIs said there was an inspection checklist, but only seven said that there

were procedures detailing requirements for pre‐inspection activities. Eight respondents said

that there were procedures detailing requirements for post‐inspection activities, a

scheduling system identifying companies due for inspection within a set time frame and that

there was a format and content specified for inspection reports.

Indicator III.9: Criteria for the selection and recruitment of inspectors

Only three KIs, who were all from the Government, said that there were written criteria for

the selection and recruitment of inspectors. One responded that he did not know and 11 said

there were no criteria.

Indicator III.10: Influence of personal gain on the integrity of inspectors

Table 9 shows that the majority (11) of the respondents either strongly disagreed (40.0%) or

disagreed (33.3%) with the statement “The integrity of inspectors is in no way influenced by

personal gain, such as bribes, gifts, material or any other benefits”, while two agreed and

one strongly agreed. Those who either strongly disagreed or disagreed came from

Government (seven), private sector (2), academia (1) and an NGO (1). One respondent was

undecided.


‐‐ 18 ‐‐

Table 9: Perception of key informants on the influence of personal gain on the integrity of inspectors



NA DK Total

Government 4 3 0 2 1 0 0 10

Private 1 1 0 0 0 0 0 2

Academia 0 1 0 0 0 0 0 1

NGO 1 0 1 0 0 0 0 2

Total 6 5 1 2 1 0 0 15


Indicator III.11: The use of guidelines and procedures in inspection activities

While about half of the respondents either strongly disagreed (3) or disagreed (5) with the

statement “Inspection activities are systematically carried out in accordance with the

guidelines and procedures to prevent bias”, the other half either strongly agreed (4) or

agreed (3) with the statement (Table 10).

Table 10: Perception of key informants on the influence of gifts on officials’ decisions



NA DK Total

Government 2 2 0 2 4 0 0 10

Private 0 2 0 0 0 0 0 2

Academia 1 0 0 0 0 0 0 1

NGO 0 1 0 1 0 0 0 2

Total 3 5 0 3 4 0 0 15


Indicator III.12: Types of unethical behaviour common in the inspection area

Below is a list of what the KIs perceived as the unethical practices common in the inspection

function in Kenya:

a. Unethical behaviour of the inspection officers: Inspectors are influenced by personal gain, either monetary or elevation of status; there is subjectivity of

inspectors who benefit from sponsored trips by proprietors of establishments;

inspectors do not introduce and identify themselves properly; and inspectors do not

help the companies to improve on their weak areas.

b. Unethical behaviour of proprietors: Proprietors of establishments try to bribe

inspectors; there is stocking of unregistered drugs; pharmacists play the role of

clinicians; during inspections the inspectees try to block inspectors from entering

some areas of the establishment; and some establishments fund inspectors’ travel on

trips.

c. Regulatory processes: There is regulatory capture because there is no rotation of inspectors; reports of inspectors are sometimes not acted on by the PPB; there is slow

feedback to establishments about the inspection report; and those inspected do not

have sufficient knowledge of the powers of the inspectors.


‐‐ 19 ‐‐

d. Law enforcement: There are no regular inspections and when they are carried out,

there are few sanctions for non‐compliance; inspection guidelines are poor and so

enforcement is left to the discretion of the inspectors; and there are fake inspectors in

the country who harass owners of establishments.

Indicator III.13: Actions to improve the inspection area

The following were the actions suggested by the KIs to improve the inspection function in

Kenya:

a. There were contradictory suggestions on the organizational structure as follows: that

the PPB should be overhauled; the inspectorate should be made independent of the

PPB; the inspectorate should be under the MoH and not the PPB; the inspectorate in

the MoH and that in the PPB should be merged.

b. Documentation: Develop new and improve existing documentation for inspection,

especially guidelines and checklists.

c. Increase the capacity of inspection personnel in numbers and by training; and instil

ethical behaviour in inspectors.

d. Motivation and remuneration of inspectors: Remunerate inspectors well to decrease

the temptation to take bribes and give them confidence, by the PPB acting on their

reports.

e. Improve communication and interaction between the drug registration,

pharmacovigilance and inspection departments of the PPB; encourage benchmarking

for current Good Manufacturing Practices (cGMP) among pharmaceutical

establishments; work closely with the establishments to train personnel, discourage

bribes and show them the benefit of inspections.

f. Law enforcement: Revise the law regulating medicines, increase penalties for

offences and give clear power to the inspectorate; ensure that only registered

establishments are operating; have inspectors at all ports of entry for medicines.

g. Inspection procedures: Rotate inspectors to prevent capture; use ad hoc committees

to help the regular inspectors; have regular schedules of inspections and also have

impromptu inspections; encourage self‐inspection of establishments; introduce pre‐

shipping inspection of all imported drugs and seal to prevent counterfeiting and

changing drugs; report back to those inspected within two weeks.

3.4. Medicines promotion control

Advertising of medicines is governed by the laws of Kenya Cap 244, which mention the

following areas: advertisement to professionals, advertisement to the public, qualification

and training of medical representatives, restrictions on and monitoring of free samples, and

packaging, labelling and package inserts, plus penalties for breaching the law. At the PPB

there is a Promotions Committee that vets medicines promotion advertisements.

Indicator IV.1: Provision in the medicines legislation/regulations covering drug promotion and advertising

All 15 KIs said that there is a provision within the pharmacy legislation covering promotion

and advertising of medicines.


‐‐ 20 ‐‐

Indicator IV.2: Forms of promotion explicitly mentioned in the provisions on drug promotion

All 15 indicated that the provisions on promotion of medicines mention the following areas:

advertisement to professionals, advertisement to the public, qualification and training of

medical representatives, restrictions on and monitoring of free samples, and packaging,

labelling and package inserts. However, there is no mention of symposia and scientific

meetings, post‐marketing scientific studies, speaker’s fees and consultancies, promotion of

exported drugs, and restrictions and limits on gifts and gimmicks.

Indicator IV.3: Pre-approval of promotional and advertising materials

Eleven KIs (73.3%) indicated that pre‐approval of promotional and advertising materials is

mandatory in Kenya and must include a summary of key product characteristics, such as

dosage form, company name, major indications for use, brand name and generic name,

medicine interactions and adverse/side‐effects profile. Information about the price of the

medicine is not mandatory for approval of the advertising material. Four KIs (26.7%) said

that pre‐approval of promotional materials is not officially required. Three of these were

from the private sector and one from a local NGO who had previously worked with a

multinational drug firm, however. He said that all materials targeted for clinicians did not

require pre‐approvals.

Indicator IV.4: Enforcement mechanism on promotion and advertisement of medicines

Ten KIs (66.7%) indicated that the provisions foresee an enforcement mechanism on

promotion of medicines and sanctions were clearly stated. Three said there were no

provisions, while two did not know. The provisions enforcement is spelt out in subsection

36‐40 of Chapter 244 of Laws of Kenya, which gives sanctions and indicates the type of

penalties for any person or pharmaceutical companies breaching the law.

Indicator IV.5: Complaints procedure to report unethical promotional practices

Eight (53.3%) of KIs indicated that there is no formal complaints procedure to report

unethical promotional practices, five (33.3%) said they did not know and two said it existed.

There are no written procedures, no evidence that any complaints procedure is used or

results of complaints published. Reporting is usually done informally.

Indicator IV.6: Monitoring and enforcing the provisions on drug promotion

Eight KIs indicated that there was a committee responsible for monitoring and enforcing the

provisions on drug promotion. Four of the KIs said they did not know, while three (20.0%)

indicated that such a committee did not exist. At the PPB there is a committee that vets

medicines promotion advertisements, but there is no Government service or committee

responsible for monitoring and enforcing the provisions on drug promotion.


‐‐ 21 ‐‐

Indicator IV.7: Criteria for selecting members of service/Committee for Monitoring and Enforcing Provisions on Medicines Promotion

Three KIs indicated that there were no clear criteria for selecting members of the committee,

while five said that criteria existed. Seven (46.7%) indicated that they did not know of any

clear criteria for selecting members of the Committee for Monitoring and Enforcing

Provisions on Medicines Promotion. No criteria are available in writing and neither are there

specifications for the professional qualifications, technical skills or work experience

necessary. Selection of people involved in control of medicines promotion is done by the

Registrar of the PPB.

Indicator IV.8: Composition and terms of reference of the service/committee

Only one KI from the PPB indicated that there was a written document that describes the

composition and terms of reference of the service/committee. He described the document as

a memo from the head of the PPB. Five KIs said that no written document was available.

Nine (60.0%) did not know.

Indicator IV.9: Standard operating procedures guiding the services responsible for pre-approving or monitoring drug promotion and advertising

All the KIs indicated that there were no written SOPs guiding the services responsible for

pre‐approving or monitoring drug promotion and advertising. The KIs from the PPB

indicated that the SOPs were being developed.

Indicator IV.10: Guidelines on conflicts of interest with regard to medicine promotion activities

All KIs indicated that there were no written guidelines on COI with regard to the control of

medicine promotion activities.

Indicator IV.11: How legal provisions on drug promotion have been developed

Ten of the KIs disagreed or strongly disagreed with the statement: “The legal provisions on

drug promotion have been developed in broad consultation with all interested parties”.

Four agreed or strongly agreed (two from the MRA and two from the private sector), while

one did not know (Table 11).

Table 11: Perception of key informants on how legal provisions on drug promotion have been developed



NA DK Total

Government 0 1 0 1 1 0 0 3

Private 2 3 0 2 0 0 1 8

Academic 1 2 0 0 0 0 0 3

NGO 0 1 0 0 0 0 0 1

Total 3 7 0 3 1 0 1 15



‐‐ 22 ‐‐

Indicator IV.12: Pre-approval of promotional and advertising materials before they are made public

Ten KIs disagreed or strongly disagreed with the statement: “Pre‐approval of promotional

and advertising materials is systematically obtained before they are made public”. One was

undecided, and four agreed or strongly agreed (Table 12).

Table 12: Perception of key informants on the requirement for pre-approval of promotional and advertising materials



NA DK Total

Government 0 1 0 1 1 0 0 3

Private 2 5 0 0 1 0 0 8

Academic 0 1 1 1 0 0 0 3

NGO 0 1 0 0 0 0 0 1

Total 2 8 1 2 2 0 0 15


Indicator IV.13: Civil society/nongovernmental organizations’ influence on improving the control of drug promotion

Table 13 shows that nine KIs disagreed or strongly disagreed with the statement: “Civil

society/nongovernmental organizations have a great influence on improving the control of

drug promotion in Kenya”. One was undecided and five agreed or strongly agreed with the

statement.

Table 13: Perception of key informants on the role of civil society organizations/NGOs in improving control of medicines promotion in Kenya



NA DK Total

Government 2 0 0 1 0 0 0 3

Private 4 2 0 0 2 0 0 8

Academic 0 1 0 2 0 0 0 3

NGO 0 0 1 0 0 0 0 1

Total 6 3 1 3 2 0 0 15


Indicator IV.14: Application of sanctions when there is a breach in medicines promotion activities

Ten KIs disagreed or strongly disagreed with the statement “Sanctions foreseen in the

provisions on medicine promotion are systematically applied when there is a breach”. Two

were undecided, another two agreed and one did not know (Table 14).


‐‐ 23 ‐‐

Table 14: Perception of KIs on application of sanctions when there is a breach in medicines promotion



NA DK Total

Government 0 2 0 1 1 0 0 4

Private 4 3 1 0 0 0 0 8

Academic 0 0 1 0 0 0 1 2

NGO 0 1 0 0 0 0 0 1

Total 4 6 2 1 1 0 1 15


Indicator IV.15: Types of unethical behaviours common in the medicines promotion area

The following were cited by KIs as the perceived unethical practices common in the

medicines promotion area in Kenya:

a. Pharmaceutical firms induce doctors to prescribe certain products through giving incentives, such as free samples, cash, gifts, sponsoring of tours, holidays and

workshops.

b. Unethical promotion: Promoters make biased and false claims without warning

about side‐effects and interactions; and promotion meant for health practitioners

only are directed to the general public through radio advertisements and talk shows.

c. Regulation: Sometimes unregistered medicines are approved for promotion; and

there is inadequate monitoring of promotion.

d. Law enforcement: Legislation and regulation of promotion is weak; and

interventions to address unethical behaviours often occur too late.

Indicator IV.16: Actions to improve the drug promotion process

The following were the actions suggested by the KIs to improve the promotion area in

Kenya:

a. Legislation: Amend the law to include control of herbal and complementary

medicines.

b. Regulation: Promote only registered products; vet all promotional materials;

emphasize the use of INN names in medicines promotion; constitute a promotions

control committee that includes non‐medical practitioners, such as civil society

groups and consumer organizations.

c. Documentation: Develop and strengthen guidelines and SOPs for the control of medicines promotion.

d. Education and awareness: Introduce a unit in the pharmacy education curriculum

on drug promotion; institute mass media campaigns to educate the public on the

dangers of unethical medicines promotion; ensure medical representatives are well

trained and ethical in medicines promotion.

e. Law enforcement: Introduce strict penalties for unethical behaviour and empower

the PPB to penalize offenders; set up an inspectorate to police the promotion of

medicines in the country.


‐‐ 24 ‐‐

3.5. Control of clinical trials

There is legal provision for the regulation of clinical trials in Kenya, which is provided in the

Laws of Kenya, the Science and Technology Act10 of 1979. This Act established the creation

of the National Council of Science and Technology (NCST), which has mandated the major

hospitals and institutions doing research to have institutional ethics and research

committees (ERCs). The institutions with ERCs are Kenyatta National Hospital/University of

Nairobi (KNH/UoN), Kenya Medical Resarch Institute (KEMRI), Moi Teaching and Referral

Hospital and the Aga Khan University Hospital. There are written and publicly available

guidelines on the submission of applications to the PPB to conduct clinical trials and there is

also a documented procedure for submission of applications to the various institutional

ERCs. The PPB also has requirements for the manufacture, importation, exportation and use

of investigational products. The PPB has a formal review committee which is responsible for

reviewing applications. According to the service charter of the PPB11, the evaluation of the

application and subsequent approval or rejection must be completed within two months.

Indicator V.1: Legal provision requiring regulation of clinical trials

Nine of the 15 KIs said there was provision for regulation of clinical trials in the legislation,

two did not know and four said that it did not exist.

Indicator V.2: National guidelines on principles of Good Clinical Practice

There are no national guidelines on principles of Good Clinical Practice. Ten KIs were aware

of the non‐existence of national guidelines, but five were not.

Indicator V.3: Guidelines on submission of applications to the Pharmacy and Poisons Board

Four KIs said that there were no written guidelines and one KI did not know. The KIs who

were not aware of these guidelines were from the MoH and from the Ethics and Research

Committees (ERCs). The other 10 KIs were aware of the existence of the guidelines and they

were mainly from the PPB, private pharmaceutical companies and researchers conducting

clinical trials. They said that the guidelines included the trials’ objective and purpose (90.0%

of the 10 KIs), trial design (100%), criteria for inclusion and exclusion of trial subjects

(90.0%), the means of obtaining informed consent (80.0%) and the time frame for assessing

applications (70.0%). Although the time frame for assessing applications is not in the

guidelines, it is in the service charter for the PPB.

Indicator V.4: Procedure for submission of clinical trial applications to an Independent Ethics Review Committee

There is no Independent Ethics Review Committee in Kenya and review of clinical trial

applications is only done by the institutional ERCs. Only one KI responded that the

procedure for submission of clinical trial applications to an Independent Ethics Committee

does not exist. The other 14 said that it existed, but in fact they were referring to procedures

of the ERCs, which exist in writing. In reference to the procedure for submission of

applications to the ERCs, 85.7% of KIs said that the following details were required:

acceptability of the investigator for the proposed trial; suitability of the proposal; means by

which subjects are recruited; completeness of information and provision for compensation


‐‐ 25 ‐‐

or treatment in case of death or loss or injury to the subject. Seven of the 14 KIs indicated

that the form of payment or remuneration from the sponsor should be included in the

application.

Indicator V.5: Requirement for the manufacture, importation, exportation and use of investigational products

One KI said there were no requirements for regulation of investigational products and one

KI did not know. The other twelve KIs were all aware of the requirements.

Indicator V.6: Committee for reviewing clinical trials applications and results

The Pharmacy and Poisons Board reviews clinical trials applications through the Committee

for Clinical Trials (CCT). This Committee has been in existence for less than two years and

has so far been evaluating applications but not the results of the clinical trials. Only 10 KIs

were aware of the existence of this Committee, three said it did not exist and two did not

know.

Indicator V.7: Mechanisms to ensure reviewers have expertise

Although there were no written guidelines, 11 KIs were confident that there are working

mechanisms to ensure that those involved in the review of applications and clinical trial

results have sufficient and current expertise in all the required areas. The KIs also believed

that the guidelines covered reviewers’ technical qualification (100% of the 11 KIs), their

experience in research and clinical investigation (100%), declaration of COI (90.1%) and the

time frame for serving as a committee member (81.8%).

Indicator V.8: Established and operational clinical trials inspection system

There is no established and operational clinical trials inspection system in Kenya. The PPB

Committee for Clinical Trials has not yet started inspection. Different ERCs also occasionally

carry out inspections, but these are rare and often prompted by adverse effects reports.

Eleven KIs were aware that there is no inspection system, but four said that an inspection

system existed.

Indicator V.9: Establishment of an Independent Ethics Committee

The national guidelines that cover clinical trials do not require the establishment of an

Independent Ethics Committee, but they recommend independence in the review of clinical

trial applications. Eight KIs said that the national guidelines require the establishment of an

Independent Ethics Committee; six said there is no requirement and one did not know.

Indicator V.10: Time frame for assessing clinical trial applications

Eleven KIs said that there is a time frame for the Review Committee to assess clinical trial

applications; three said there is no time frame and one did not know.

Indicator V.11: Guidelines on conflict of interest

Six KIs said there were written guidelines on COI, three said there were none and five did

not know. Those KIs who said there were no guidelines were from the PPB and the CCT,


‐‐ 26 ‐‐

while the ‘Don’t know’ responses were mainly from researchers. The respondents who said

‘yes’ were mostly members of ERCs and they said the guidelines were in the form of SOPs.

Indicator V.12: List of all approved and rejected clinical trial applications

In Kenya, each ERC keeps a list of all approved and rejected clinical trials that it has

assessed. There is no published national list giving all clinical trials in the country. Eight KIs

said there was a list of all approved, amended and rejected clinical trials applications, six

said there was not and one KI did not know. Seven out of the eight said that the list was not

publicly available.

Indicator V.13: Selection criteria for Independent Ethics Committee

Half of the KIs strongly agreed (4) or agreed (3) with the statement “The Independent Ethics

Committee members are systematically selected based on the written selection criteria” and

only about a third of the KIs either strongly disagreed or disagreed (Table 15). Since there is

no IEC in Kenya, the KIs were referring to the ERCs.

Table 15: Perception of KIs on the selection criteria for independent ethics committee



NA DK Total

Government 0 0 0 0 0 1 1 2

Private 0 2 0 1 0 0 0 3

Academia 1 1 0 1 3 0 1 7

Media 0 0 0 1 0 0 0 1

Lawyer 0 0 0 0 1 0 0 1

Total 1 3 0 3 4 1 2 14


Indicator V.14: Selection criteria for the Pharmacy and Poisons Board Review Committee members

Table 16 shows that the majority of the KIs, including all the ones from the private sector,

did not agree with the statement “The Pharmacy and Poisons Board Review Committee

members are selected systematically based on the written selection criteria”. Three KIs

agreed with the statement and two strongly agreed.

Table16: Perception of KIs on the selection criteria for PPB Review Committee members



NA DK Total

Government 1 0 0 0 0 0 1 2

Private 0 3 0 0 0 0 0 3

Academia 3 1 0 1 2 0 1 8

Media 0 0 0 1 0 0 0 1

Lawyer 0 0 0 1 0 0 0 1

Total 4 4 0 3 2 0 2 15



‐‐ 27 ‐‐

Indicator V.15: The Pharmacy and Poisons Board ensures that clinical trials are conducted according to regulation

The number of KIs who agreed with the statement “The PPB is ensuring that clinical trials in

Kenya are done in accordance with the regulation and GCP principles” was almost the same

as that of those who disagreed. As in the previous indicator, all the KIs from the private

sector disagreed (Table 17).

Table 17: Perception of KIs on whether the PPB is ensuring clinical trials are conducted according to regulations



NA DK Total

Government 0 0 0 0 1 0 1 2

Private 0 3 0 0 0 0 0 3

Academia 2 0 0 2 3 0 1 8

Media 1 0 0 0 0 0 0 1

Lawyer 0 0 0 1 0 0 0 1

Total 3 3 0 3 4 0 2 15


Indicator V.16: Types of unethical behaviour common in the clinical trials area

The following were cited by KIs as the perceived unethical practices common in the clinical

trials function in Kenya:

a. Researchers: Some researchers carry out clinical trials without approval; researchers

export biological samples without approval; studies are done without the informed

consent of the subjects, or informed consent is obtained without giving the subject

full information, such as that of adverse effects or by giving therapeutic

misconceptions of the trial; researchers use of vulnerable groups (orphans, other

children) in clinical trials; researchers delay in reporting or non‐reporting of adverse

effects; data are falsified by researchers, especially to please sponsors; there is non‐

adherence to the protocol by researchers i.e. they carry out activities that are not

declared in the protocol; there is inducement of subjects to participate in the trial by

being paid under the guise of ‘travel allowance’ or ‘compensation for time’;

sometimes subjects’ confidentiality is breached; proposals rejected by one ERC are

taken to a different one and approved without cross consultation; there is failure to

identify situations that require the subject to re‐consent e.g. where dosages are

changed.

b. Promoters: Promoters do not declare all known information about the study or the

investigational product e.g. adverse effects; some investigational products are used

without being approved by the PPB; sometimes investigational products are put in

the custody of unauthorized persons; results are disseminated in international fora

rather than national fora and so it takes a long time for local interested parties to

discover the findings; there is poor compensation for subjects who fall ill during the

trial.


‐‐ 28 ‐‐

c. Regulators: Some studies have been stopped without sound scientific basis;

sometimes there is no independence of review; there is no mechanism to ensure that

applications rejected by one ERC are not approved by another; there is hardly any

inspection of on‐going trials.

d. Ethics and research committees: Sometimes the committee approving the studies is

made up of members who are researchers in the clinical trial being evaluated; the

relationship between applicants and the ERCs is not cordial and is often hostile

towards applicants; the term of office of ERC members is not defined.

Indicator V.17: Actions to improve the clinical trials area

KIs gave the following suggestions for improving clinical trial activities in Kenya

a. Legislation: Review legislation regulating clinical trials as a stand alone law on clinical trials instead of the current law which clusters clinical trials under biomedical

research; include new types of clinical trials such as those on genetic products in the

law; and specify penalties for errant researchers and promoters in the law.

b. Regulation: Enforce coordination and regulation of clinical trials at national level and involve NCST, MoH and the PPB; set up an independent ethics committee;

establish an inspectorate for clinical trials; ensure all investigational products are

registered; publish a list of all clinical trials applications and their status; expedite the

review process to make it shorter; enforce disciplinary measures for errant

researchers.

c. Documentation: Put in place well established processes and publicize them. These

include documents for recruitment, applications, reporting and COI.

d. Education and capacity building: Give technical support and capacity building for the PPB and train staff through other regulatory bodies like the U.S. Food and Drug

Administration; source expertise for review of applications beyond Kenya; educate

and sensitize regulators, subjects, ERC members and researchers through

workshops; strengthen data safety and monitoring boards.

3.6. Selection of medicines

There is a National Essential Medicines List which is in line with WHO procedures, but it

was last updated in 2002. A National Medicines and Therapeutics Committee (NMTC) was

constituted in 2007 with the mandate of selection of medicines, but it is not yet operational.

There are clear criteria for the selection of members of the NMTC and terms of reference that

describe the role and responsibilities of the NMTC that have been developed over the last

year, but they are not yet in use.

Indicator VI.1: National Essential Drugs List

The Government has an officially adopted national essential medicines list that is publicly

available and all the KIs affirmed this. The list was last reviewed in 2002. However, some of

the KIs said that this list is not widely disseminated because there is no system for

distribution and only small quantities are published.


‐‐ 29 ‐‐

Indicator VI.2: Consultation during the development of the National Essential Drugs List

The number of KIs who agreed with the statement “The national essential medicines list has

been developed in consultation with all interested parties and using an evidence‐based

approach” was almost the same as that of those who disagreed (Table 18). Most of those

who disagreed were the older professionals who have been working in the MoH and were

involved in the last review of the EDL. Some emphasized that major stakeholders were not

consulted in the development of the EML, while others said the approach used was not

evidence based.

Table 18: Perception of key informants on the extent of consultations with interested parties in the development of the National Essential Drugs List



NA DK Total

Government 1 6 0 5 0 0 1 13

Academia 0 0 0 1 0 1 0 2

Total 1 6 0 6 0 1 1 15


Indicator VI.3: Guidelines for selection of medicines in the essential medicines list

There are no written guidelines for the selection process for including or deleting medicines

from the national EML. Eleven KIs said there were no guidelines, but four said that there

were guidelines. Since no evidence was available, the score for this indicator was therefore

zero.

Indicator VI.4: Essential medicines list and WHO procedures

Eleven KIs said that the EML was in line with WHO procedures, three said ‘No’ and one did

not know. The majority said that the EML was published but not easily accessible (63.6% of

the 11 KIs), not widely disseminated to relevant health professionals (90.9) and had not been

revised in the last five years (72.7%). The KIs said that theEML gives drugs by their generic

names (100%), is listed by levels of health care (72.7%) and is linked to national standard

treatment guidelines (90.9%).

Indicator VI.5: Committee for selection of the national essential medicines list

The National Medicines and Therapeutics Committee is responsible for the selection of the

EML. Eight KIs said that this committee exists but four said there is no such committee.

IndicatorVI.6: Influences on the committee for the selection of the national essential medicines list

Five KIs agreed or strongly agreed with the statement “The committee responsible for the

selection of the national EML is operating free from external influence”, four disagreed and

five said that the question is ‘not applicable because the committee does not exist’. One KI

responded “Don’t know” (Table 19).


‐‐ 30 ‐‐

Table 19: Perception of KIs on the extent to which the committee responsible for selection is operating free from external influence



NA DK Total

Government 1 2 0 3 1 5 1 13

Academia 1 0 0 1 0 0 0 2

Total 2 2 0 4 1 5 1 15


Indicator VI.7: Selection criteria for the members of the Selection Committee

Clear written criteria for the selection of members of the Selection Committee have been

developed since 2007. The criteria define the professional requirements of members, and

membership includes experts from different fields, the criteria have a requirement for

declaration of COI for members, and they also require membership for a limited time.

However, 10 KIs said that these criteria do not exist. On the other hand, five KIs (two from

hospital, two from the MoH and one from academia) were aware of the existence of these

criteria.

Indicator VI.8: Guidelines on conflict of interest with regard to selection of essential medicines

All KIs said that there were no written guidelines on COI with regard to the selection of

essential medicines in Kenya.

Indicator VI.9: Terms of reference for the Selection Committee

There are written terms of reference (TORs) that describe the role and responsibilities of the

Selection Committee. However, the TORs are not publicly available and they do not describe

the rules for decision‐making. Only five of the 15 KIs were aware of the existence of these

TORs.

Indicator VI.10: SOPs for the committee’s decision-making process

All KIs said that there were no SOPs for the Selection Committee’s decision‐making process.

Indicator VI.11: Types of unethical behaviour common in the selection area

KIs cited the following as their perceived types of unethical behaviour in the selection of

medicines:

a. Influencing selection: Lobbying of influential persons by pharmaceutical companies

to have their drugs included in lists; selection officials are influenced by sponsoring

them on trips; some companies are also provided with information about selection

that puts them at an advantage over their competitors during tendering; some

selection officials have a bias towards selection of medicines from certain companies;

sometimes specifications are skewed to favour certain companies e.g. specifying the

salt form of a medicine.

b. Documentation: The EML is not up‐to‐date and the speed of updating it is very

slow; guidelines are not clear; there are no COI guidelines.


‐‐ 31 ‐‐

c. Selection process: The annual selection is based on institutional prescribing and practices, more than on the EML, which is not frequently updated; there is confusion

between medicines recommended in the EML and those in the treatment guidelines,

which are often more up‐to‐date; decisions are sometimes made by incompetent

people, leading to irrational decisions; there is lack of objectivity in selection, e.g.

inclusion of too many antimalarial drugs in the list or inclusion of expensive and

rarely used medicines; and selection is influenced by the cost of medicines.

d. There is inappropriate representation in Selection Committees.

e. Higher authorities sometimes overrule the expert opinion given.

f. There is leniency in disciplining errant selection officials.

Indicator VI.12: Actions to improve the selection area

The following suggestions were made by KIs to improve medicines selection in Kenya:

a. Selection Committee: Operationalize the NMTC and decrease the number of MoH

officials in this Committee; speed up the Committee’s work; give it support at the

highest level (minister, permanent secretary, director of medical services); and

introduce rotation and time limits for members.

b. Documentation: develop clear guidelines for the Committee’s work; develop

regional lists to address different disease patterns; and set up a national drug

formulary.

c. Selection process: Carry out a survey to establish which drugs would cater for the

bulk (90%) of health needs; involve wide consultation in the selection process and

include all stakeholders; increase transparency of the procurement process; provide

enough time for the selection and procurement process.

d. Awareness: Publicize the selection process and educate both the public and professionals on selection.

e. Set up a coordination committee to implement decisions.

f. Increase budgetary allocation for selection.

g. Ensure that only prequalified drugs are in the market.

3.7. Procurement of medicines

Public sector procurement of medicines is done by Kenya Medical Supplies Agency

(KEMSA). Procedures for procurement exist and are heavily informed by the newly

published Public Procurement and Disposal Act12. This document is publicly available and

requires: the use of generic names; the advertisement of tenders; that contract specifications

be publicly available to all bidders; that criteria for adjudication of tenders be included as

part of the tender package and all bidders informed in advance; and that the information on

the tender process and results be made public. The Procurement Office monitors supplier

performance during every tender for compliance with the contract terms; the monitoring

system tracks supplier’s lead‐time, delivery status, shelf life and packaging of products.

Product quality is also tracked, and suppliers with poor performance are barred from future

tenders.


‐‐ 32 ‐‐

Indicator VII.1: Procedures for procurement of pharmaceutical products

All of the 14 KIs indicated that Government uses explicit procedures for procurement of

pharmaceutical products.

Indicator VII.2: Guidance for Procurement Office staff on the type of procurement method to be used for different types of products

Thirteen (92.8%) KIs indicated that a written in‐house guideline existed and is used to guide

the procurement staff on the method to use for different types of products. One KI from the

MoH indicated that no guidelines existed.

Indicator VII.3: Quantification method to determine the amounts to be purchased

Nine (64.3%) of the KIs indicated that procurement was done with an objective

quantification method to determine the quantity of pharmaceuticals to be purchased, but

five (35.7%) said it did not.

Indicator VII.4: Appeals process for applicants who have their bids rejected

Twelve (85.7%) of the KIs said that there was a formal appeals process for applicants who

have their bids rejected and it was clearly defined in the Procurement Act. Two KIs did not

know about the appeals system.

Indicator VII.5: Separation of key functions of the Procurement Office and those of the Tender Committee

All 14 KIs indicated that a Tender Committee was formally established, was responsible for

suppliers’ selection for all tenders and for contract decisions and that the functions of the

Procurement Office and those of the Tender Committee were clearly separated.

Indicator VII.6: Decisions of the Tender Committee

Ten (71.4%) of KIs agreed or strongly agreed with the statement that “Decisions of the

Tender Committee are always taken into account in the procurement process” as shown in

Table 20.

Table 20: Perception of KIs regarding the extent to which decisions of the Tender Committee are taken into account in the procurement process



NA DK Total

Government 0 2 0 3 5 0 1 11

Private 0 0 0 0 2 0 0 2

Academic 0 1 0 0 0 0 0 1

Total 0 3 0 3 7 0 1 14


Indicator VII.7: Criteria for Tender Committee membership

Thirteen KIs indicated that the criteria for Tender Committee membership are written and

publicly available. One did not know.


‐‐ 33 ‐‐

Indicator VII.8: Guidelines on conflicts of interest

The law requires members to declare COI. However, 11 (78.6%) of the KIs said they did not

know of any written guidelines on COI with regard to the procurement process. Three

(21.4%) indicated that written guidelines were in place. Forms for members to sign do not

exist and rules on acceptance of gifts are generally covered in the law. The law requires

members to declare COI but there was no evidence of enforcement of this.

Indicator VII.9: Criteria for selection of members of the Tender Committee

Ten KIs agreed with the statement “The members of the Tender Committee are systemically

selected based on specific criteria” (Table 21).

Table 21: Perception of KIs about selection of members of the Tender Committee



NA DK Total

Government 0 1 1 3 5 0 1 11

Private 0 0 0 1 1 0 0 2

Academic 1 0 0 0 0 0 0 1

Total 1 1 1 4 6 0 1 14


Indicator VII.10: Computerized management information system to report product problems

Seven of the 14 KIs indicated that there was no computerized management information

system used to report product problems in procurement. Four (28.6%) indicted that the

system existed and two did not know. Responses from MoH were mixed with some saying

that the system existed and others saying it did not. The KIs from central medical stores

(KEMSA) procurement department indicated that the management information system is

computerized and it includes product records, and monitors supplier performance and

tracks the status for each order. It does not, however, record quality assurance information

for the products purchased, nor client performance nor does the system track quantities

actually purchased compared with the original estimates made.

Indicator VII.11: Standard operating procedures for routine inspection of consignments

Thirteen KIs indicated that SOPs for routine inspection existed and that each shipment of

medicines should be physically inspected. One KI from the private sector did not know

whether SOPs existed or not. The procedures in place involve checking adherence to

contract specifications. Samples are sent to an in‐house quality control laboratory. Random

sampling is done for regular suppliers and systematic sampling for new ones. All

documents (inspection reports and laboratory testing results) are archived in the

Procurement Office. Only one KI from MoH headquarters was unaware of the existence of

the SOPs.


‐‐ 34 ‐‐

Indicator VII.12: Post-tender system to monitor and report on suppliers' performance

Four KIs (three from MoH and one from the private sector) indicated that they did not know

if there was a post‐tender system to monitor and report on suppliersʹ performance to the

Tender Committee, eight (57.1%) KIs gave an affirmative response and 2 KIs said that no

system existed. The Procurement Office monitors supplier performance during every tender

for compliance with the contract terms. The monitoring system tracks suppliers’ lead‐time,

delivery status, shelf life and packaging of products. Product quality is also tracked, and

suppliers with poor performance are barred from future tenders.

Indicator VII.13: Audits for the Procurement Office

Twelve KIs indicated that the Procurement Office undergoes internal audit and external

auditing by the Government’s Auditor General at least once a year, and results are made

available publicly. Two KIs said they did not know. The annual audit gives a report on the

operating costs of the Procurement Office, pharmaceutical products tendered, quantities of

the products procured and the contracts awarded.

Indicator VII.14: KIs’ opinion about transparency of the procurement system

Nine (64.3%) disagreed or strongly disagreed with the statement “The procurement system

in Kenya is operating in a totally transparent manner”. Two were undecided and three

agreed or strongly agreed (Table 22).

Table 22: Perception of KIs on transparency of procurement system in Kenya



NA DK Total

Government 1 7 1 1 1 0 0 11

Private 0 0 1 1 0 0 0 2

Intern Org 1 0 0 0 0 0 0 1

Total 2 7 2 2 1 0 0 14

DK: Don’t know. NA: Not applicable

Indicator VII.15: Types of unethical behaviour common in the procurement system

KIs cited the following as their perception of unethical behaviour in the procurement

function in Kenya:

a. Influencing the process: Procurement officers skew specifications to favour certain

suppliers and/or products; there is bid rigging or insider trading; there is interference

and/or lobbying by senior Government officials and politicians; collusion between

procurement staff and selected bidders; gifts and monetary inducements; and

bribery.

b. Bidders: Existence of fictitious companies where one person or group bids through

many different firms; there is fraud, double invoicing or alteration of quantities to be

paid twice; and inflation of medicines prices.


‐‐ 35 ‐‐

Indicator VII.16: Actions to improve the public procurement process

The following actions were proposed by KIs to improve the systems and processes of public

sector procurement in Kenya:

a. Autonomy: Make the procurement function independent to avoid political

interference and avoid corruption; ensure that procurement of both pharmaceuticals

and non‐pharmaceuticals is centrally done from the central medical stores (KEMSA).

b. Procurement process: Review procurement operations in line with the law and

ensure strict follow up; avoid procurement from middlemen where it is possible to

get the commodities from the manufacturers or appointed agents; ensure accurate

and reliable quantification; strengthen supervision of the procurement function; and

ensure accurate and reliable quantification.

c. Capacity building: Train procurement staff and build capacity to apply and adhere

to procurement laws.

d. Quality control: Require that all bidders supply samples for prior analysis;

emphasize quality over price to reduce dumping of substandard products in the

country.

e. Audit: Strengthen and operationalize the Public Procurement and Oversight

Authority (PPOA); strengthen procurement audit.

f. Enforce principles of good governance, a system that works starting from the tender

committee membership.

3.8. Distribution of medicines

Distribution of pharmaceuticals is done by KEMSA. Both quality assurance staff and

warehouse staff are involved in receiving and verifying medicines received from suppliers.

Partial consignments are usually accompanied by a delivery note. Products are arranged

taking into account their expiry and there is a security management system. SOPs for stock

management exist at each level of the distribution system. There are inventory records and

procedures in the warehouses at the various levels of the distribution system. The KEMSA

warehouses are subjected to both internal and external auditing by the national audit office

and other independent auditors at regular intervals. Both computerized and manual

systems exist and provide information on medicines that have left the warehouse to go to

health facilities. An elaborate procedure for requesting medicines, a communication system

between distributions points and a monitoring and evaluation programme all exist.

Sanctions to be imposed on individuals for theft or corrupt practices are as spelt out in the

Public Procurement Act.

Indicator VIII.1: Systems to expedite port clearing

Four (30.8%) KIs indicated that a system is in place to expedite port clearing. Five (38.5%)

said the indicator was not applicable since goods are delivered directly to the warehouse

and there is no need for port clearing. Two KIs from NGOs said a system is in place to

expedite port clearing. Two other KIs did not know. All medicines are delivered at the

central medical stores and hence the MoH procurement agency is not involved with clearing

from the port. The question was thus not applicable to KIs from KEMSA.


‐‐ 36 ‐‐

Indicator VIII.2: Opinion about transparency of port clearing process

Table 23 shows that three KIs agree with the statement that the “Port clearing process is

done smoothly and there is no need for bribery or gift‐giving to expedite the process”. Four

disagreed. Five KIs said the question on port clearing was not applicable to their

procurement process. Indeed, the question was not applicable to the MoH distribution

system.

Table 23: Perception of key informants on transparency of port clearing in Kenya



NA DK Total

Government 1 1 0 2 0 5 1 10

Private 0 0 0 1 0 0 0 1

NGO 0 2 0 0 0 0 0 2

Total 1 3 0 3 0 5 1 13


Indicator VIII.3: Inspection system to verify that the medicines delivered match those shipped

All the KIs indicated that an inspection system exists to verify that the medicines delivered

from the port or directly from a supplier match those that were shipped from the supplier.

The receiving staff verifies the medicines received against the delivery note and copy of

purchase order issued to supplier. Both quality assurance staff and warehouse staff are

involved in receiving and verifying medicines received from suppliers. Partial consignments

are accompanied by a delivery note.

Indicator VIII.4: Coding system used to identify Government medicines

Ten KIs (76.9%) indicated that Government medicines carry the inscription “GOK

(Government of Kenya)/MoH: NOT FOR SALE” on both primary and secondary packaging.

Two from the NGOs did not know, while one from the private sector indicated that a coding

system does not exist. The KIs from MoH/KEMSA said that there are plans to print the code

on the tablets/capsules.

Indicator VIII.5: Shelving of products in warehouses or store rooms

Eleven (84.6%) KIs indicated that there is systematic and orderly shelving of products in

warehouses. Two (15%) indicated that there is no systematic and orderly shelving.

Medicines in warehouses are organized systematically according to dosage forms, such as

tablets and capsules, injections, syrups and suspensions, creams and ointments. Overall

arrangement is based on therapeutic action. A master map showing the location of

medicines does not exist. However products are arranged taking into account the expiry

dates to ensure FEFO (“first expiry, first out”).

Indicator VIII.6: Security management system to oversee storage and distribution

All the KIs indicated that there is a security management system in place to oversee storage

and distribution. Indeed, a security management system is in place and consists of


‐‐ 37 ‐‐

monitoring of entry and exit to and from warehouses as well as searches by security

personnel of those leaving the warehouse. There is limited access to unauthorized persons

and there are locks with controlled key distribution. Controlled substances such as narcotics

are separated and secured. However, alarm system for security is yet to be installed at the

central medical stores. Panic buttons are currently in use.

Indicator VIII.7: Standard operating procedures for stock management

Twelve KIs indicated that there are SOPs for stock management at each level of the

distribution system. Only one KI from a district hospital indicated that there are no SOPs in

place. SOPs for stock management exist at each level of the distribution system, but the

extent to which they are followed has not been determined.

Indicator VIII.8: Inventory management system

All the KIs indicated that there is an inventory management system at each level of the

distribution system. There are inventory records and procedures in the warehouses at the

various levels of the distribution system. The inventory management system is however

inefficient and does not provide information on the following elements: the average working

stock; the amount of safety stock; the frequency of reordering; the quantity of reordering and

the average inventory. Only the expiry date and lead time are readily available from the

system. They also indicated that a system exists, but it is not regularly updated.

Indicator VIII.9: Reconciliation of stock records with physical counts

Ten KIs indicated that stock records are reconciled with physical counts at least every three

months by internal staff. Three (23.1%) said reconciliation is not done. The practice is such

that the warehouse staff carries out weekly cycle counts, monthly and annual stock counts

and reconciles the stock records with physical counts.

Indicator VIII.10: Independent audits of warehouses

Nine (69.2%) KIs indicated that there are independent audits of warehouses by external

inspectors or auditors, in particular the Government’s Auditor General every year. Four,

two from MoH and two from NGOs, did not think that independent audits are carried out.

The KEMSA warehouses are subject to both internal and external auditing by the national

audit office and other independent auditors at regular intervals. Annual audits are

mandatory and audit records are documented.

Indicator VIII.11: System to track the movement of pharmaceuticals from a warehouse to a health facility

Twelve of the 13 KIs indicated that there is a system in place to track the movement of

pharmaceuticals from a warehouse to health facilities. One KI from MoH did not know if a

system exists. Both computerized and manual systems exist and provide information on

medicines that have left the warehouse to health facilities, including: type of medicines that

have left the warehouse; quantity of medicines that have left the warehouse; the person who

verified the amounts; and the intended recipients of the medicines. The date when the

medicines arrived at the designated health facility is determined from the receipt stamp on

the delivery notes.


‐‐ 38 ‐‐

Indicator VIII.12: Procedure for requesting medicines

All the KIs indicated that the health facilities have an appropriate procedure for requesting

medicines. An elaborate procedure for requesting medicines exists and involves filling of

requisition forms with name of medicine, dosage form, strength and quantity required. The

requisition is then checked by the responsible person, dated and signed and then forwarded

to the central medical stores.

Indicator VIII.13: Guidelines on transportation and delivery of medicines from and to warehouses

Four KIs indicated that there are no appropriately written guidelines on transportation and

delivery of medicines from and to warehouses. The other nine KIs explained that the

guidelines on transportation of medicines are provided in the service level agreement and

provide guidance on measures to take in case of adverse weather conditions, theft during

transportation, and how to protect against this. Measures to prevent swapping of

consignment during transportation are in place. The person responsible for transportation is

required to sign a receipt for the consignment.

Indicator VIII.14: Communication system between distribution points

All the KIs indicated that there is a well‐functioning communication system between

distribution points., which includes a manual/document exchange system between

distribution points at all levels and also telephone contact between all levels of the

distribution points. A computerized network system does not exist, but communication is

enhanced by regional and field liaison officers who make regular visits to the facilities.

Indicator VIII.15: Monitoring and evaluation of the performance of the medicine distribution system

Ten KIs indicated that a programme exists for monitoring and evaluating the performance

of the medicine distribution system. Two KIs from NGOs and one from MoH said that no

system exists. A programme exists for monitoring and evaluation of the performance of the

medicine distribution system, but the reports are not publicly available. Monitoring and

evaluation is done by the MoH, external auditors and through customer satisfaction surveys.

Indicator VIII.16: Sanctions for theft or other corrupt practices associated with distribution

Ten KIs indicated that sanctions are imposed on individuals or agencies/companies for theft

or other corrupt practices associated with distribution. Three (23.1%) thought otherwise.

However, there was no evidence that any individuals have been sanctioned for corrupt

behaviour. Sanctions to be imposed on individuals for theft or corrupt practices are as spelt

out in the Public Procurement Act. Procedures foreseeing the application of sanctions for

corrupt behaviour exist and include the type of sanctions to be applied depending on the

nature and gravity of the act of corruption. However there is no evidence of any individuals

sanctioned for corrupt behaviour.


‐‐ 39 ‐‐

Indicator VIII.17: Procedures for disposal of expired/spoilt medicines

All the KIs indicated that medical stores/health facilities have appropriate procedures for

disposal of expired/spoilt medicines. A mechanism to notify the PPB about expired/spoilt

medicines exists. Disposal is supervised by a committee referred to as “a board of survey”.

Minutes concerning disposal are taken and names of disposed medicines entered in an

official form (Form FO58).

Indicator VIII.18: Leakages in the medicine distribution system in Kenya

Ten (77%) of the KIs disagreed or strongly disagreed with the statement “There are very

rarely leakages in the medicine distribution system in Kenya”, while three (23%) agreed or

strongly agreed (Table 24). Most leakages were reported to occur at the health facility level.

Table 24: Perception of KIs about the extent of leakages in medicine distribution system



NA DK Total

Government 2 5 0 2 1 0 0 10

Private 1 0 0 0 0 0 0 1

NGO 1 1 0 0 0 0 0 2

Total 4 6 0 2 1 0 0 13


Indicator VIII.19: Unethical behaviour in public sector medicines distribution

The following were the two perceived types of unethical behaviour cited by KIs:

a. Pilferage at level of end user facilities.

b. Bribery by transporters to influence bids during contract awards.

Indicator VIII.20: Actions to improve public sector distribution

KIs gave the following suggestions to improve the systems and processes of public sector

medicine distribution in Kenya:

a. Capacity building: Train staff, equip the warehouses and provide proper storage

facilities.

b. Autonomy: Make KEMSA semi‐autonomous with a revolving fund and/or provide

seed money for commercialization.

c. Computerization: Link KEMSA with health facilities to facilitate online ordering.

d. Distribution processes: Implement a “pull” system of distribution; institute

measures to allow for “Just‐in‐time” procurement and distribution; set up a

performance monitoring system for the supply chain; enforce good distribution

practices; and ensure proper quantification of consumption from facility level to

national level.

e. Strengthen regional depots.


‐‐ 40 ‐‐

4. DISCUSSION

4.1. Registration of medicines

The average final score for registration was 4.36 indicating moderate vulnerability to

corruption. The requirements for those applying are fairly well documented. The guidelines

for applicants on how to submit an application for registration of medicinal products are

comprehensive, clearly written and on the web site. There is a standard application form

publicly available for submission of applications, which can be found at the PPB secretariat

and on the web site. In addition, there is an up‐to‐date list of all registered pharmaceutical

products, which provides sufficient information.

There is a functioning formal committee that is responsible for assessing applications for

registration of medicines. The committee meets at least once a week and keeps minutes of its

meetings. However, there are no written criteria for selecting members of this committee,

and there is no document that describes the composition and terms of reference of the

committee. There are no written procedures for assessors on how to assess applications

submitted for registration of medicines and there are no written guidelines for the

committee’s decision‐making process. Also, there are no written guidelines describing how

and where medicines registration officers should meet with applicants, and none on COI

with regard to registration activities. It is assumed that officers with COI will declare them.

Applicants who have their applications rejected by the committee make formal appeals to

the PPB.

The most cited complaints by KIs were the presence of too many generics; and too many

counterfeit/substandard medicines and unregistered medicines in the market. Many also

thought that the registration process is not free from influence.

4.2. Licensing of pharmaceutical establishments

The average final score for licensing was 5.21 indicating moderate vulnerability to

corruption. There is a low level of awareness in the area of licensing in Kenya because

procedures and guidelines are not widely disseminated. The unit responsible for licensing is

established under the Inspectorate Department of the PPB. The guidelines for licensing were

published in June 2006. The process is also clearly spelt out in the service charter, which is

publicly available and covers administrative criteria to be met by applicants; and a

description of the requirements to be met in terms of premises, facilities and personnel. The

application fee structure is also indicated in the guidelines. A time frame for processing

applications is given. There are two formal committees that assess applications for licensing

of a pharmaceutical establishment at the PPB ‐ one assesses applications for licence renewals

(PPB Management Committee) and the other assesses applications for new licences (Practice

Committee). Post‐licensing inspection of licensed pharmaceutical establishments is erratic

and done on an ad hoc basis. The reason given is lack of adequate financial and human

resource capacity. In essence it is supposed to be done annually.

There was no evidence of an up‐to‐date list of all licensed pharmaceutical establishments

available in Kenya. A 2007 list exists, but mainly has the names of wholesalers and

manufacturers. The list available on the PPB web site is not updated. There is no ‘validity


‐‐ 41 ‐‐

date’ on the licences issued for the establishments. Once a licence is given, it is assumed to

be on‐going.

There is no independent appeals system for applicants who have their applications for

licensing rejected. However, the guidelines indicate that in the case of an unsuccessful

application, the applicant will be given further opportunity to revise the application and re‐

apply.

The most commonly mentioned unethical behaviour was the subjectivity of the licensing

officers, which was attributed to them being influenced by licensees through various means,

including bribes. Unqualified persons have also been allowed to operate pharmaceutical

establishments and inspectors can be hostile and unethical.

4.3. Inspection and market control of medicines

Inspection and market control of medicines had an average final score of 3.95, which

indicates that the function is very vulnerable to corruption. There is a comprehensive

provision in the medicines legislation covering inspection of pharmaceutical establishments.

There are written guidelines for GMP and also for GDP for pharmaceutical products in

Kenya. However, these guidelines do not classify non‐compliance with GMP or GDP, nor do

they describe types of deficiencies and measures to be taken by the PPB. There are written

SOPs for inspectors on how to conduct inspection and the inspection findings and

conclusions are subject to an internal review. There are, however, no written criteria for

selection and recruitment of inspectors, and there are no written guidelines on COI with

regard to inspection activities. No written procedures exist to prevent regulatory capture

between inspectors and the manufacturing and distributing companies inspected.

KIs frequently indicated that inspectors are unethical and that their decisions are influenced

by personal gain. Proprietors of establishments also try to bribe inspectors, and there is poor

enforcement of the law by the PPB.

4.4. Medicines promotion control

The average final score for medicines promotion control was 4.53 indicating moderate

vulnerability to corruption. Advertising and promotion of medicines is governed by the

Laws of Kenya Cap 244 subsections 36‐409. The provisions mention the following areas:

advertisement to professionals, advertisement to public, qualification and training of

medical representatives, restrictions on and monitoring of free samples, and packaging,

labelling and package inserts. However, it is silent on symposia and scientific meetings,

post‐marketing scientific studies, speaker’s fees and consultancies, promotion of exported

drugs, and restrictions and limits on gifts and gimmicks. The provisions on enforcement

spelt out in subsection 36‐40 of Cap 244 of the Laws of Kenya include sanctions and indicate

the type of penalties to be imposed on any person or pharmaceutical company for breaching

the law.

At management level there is a promotions committee that vets medicines promotion

advertisements. It is done within a department in the PPB, not through a committee per se.

There is thus no Government service or committee responsible for monitoring and enforcing

the provisions on drug promotion.


‐‐ 42 ‐‐

The unethical behaviour in the promotion area involves influencing doctors to prescribe

certain products through giving incentives, companies making biased and false claims,

approval of promotion for non‐registered medicines, weak regulation of promotions and

late interventions to address unethical behaviours.

4.5. Control of clinical trials

The average final score for control of clinical trials was 6.25, which indicates marginal

vulnerability to corruption. There is legal provision for the regulation of clinical trials in

Kenya which is provided in the Laws of Kenya, the Science and Technology10 Act of 1979.

The documentation for guidelines for control of clinical trials is fairly comprehensive. There

are written and publicly available guidelines on the submission of applications to the PPB to

conduct clinical trials and there is also a documented procedure for submission of

applications to the various institutional ethics and research committees. The PPB also has

requirements for the manufacture, importation, exportation and use of investigational

products.

The PPB has a formal Review Committee which is responsible for reviewing applications.

This Committee was constituted in 2007 and has not yet started reviewing clinical trials

results, although this is within its mandate. There is no established and operational system

for inspection of clinical trials. However, the study Data Monitoring Safety and Committees

monitor the studies and the ERCs have been trying to inspect trials that they have approved.

However, due to limited capacity, this is not comprehensive. According to the service

charter of the PPB, the evaluation of the application and subsequent approval or rejection

must be completed within two months. There are no written guidelines on COI with regard

to clinical trials activities.

Although the PPB selects assessors who have the expertise in the required areas, there is no

documented mechanism to ensure that those involved in the review of applications have

sufficient and current expertise in all the required areas.

There are no national guidelines on principles of GCP and researchers generally apply the

International Conference on Harmonisation of Technical Requirements for Registration of

Pharmaceuticals for Human Use (ICH) guidelines on GCP. The national guidelines from the

National Council of Science and Technology13 recommend that review of clinical trials

should have independence. However, there is no requirement, and no guidelines for the

establishment of an Independent Ethics Committee, and currently there is none in the

country.

In the area of clinical trials, most of the unethical behaviours cited revolved around the

activities of researchers. Anomalies included carrying out trials without approval; exporting

biological samples without approval; doing studies without informed consent; not reporting

adverse effects and falsification of data. Some promoters do not declare all known

information about the study and some investigational products are used without being

approved by the PPB. The regulators do not ensure the independence of reviews nor do they

clear declarations of COI and there is no inspection of on‐going trials.


‐‐ 43 ‐‐

4.6. Selection of medicines

Selection of medicines had the lowest average final score of 2.95 and this shows that this

function is very vulnerable to corruption. The essential medicines list is in line with WHO

procedures, but it was last updated in 2002. There are no written criteria for the selection

process for including or deleting medicines from the national list.

In the past, the EML has been drawn up by ad hoc committees of experts. A National

Medicines and Therapeutics Committee (NMTC) was constituted in 2007 with the mandate

of selection of medicines, but it is not yet operational. There are clear criteria for the selection

of members of the NMTC and terms of reference that describe the role and responsibilities of

the NMTC, which have been developed over the last year but most stakeholders are not

aware of their existence. There are no written guidelines on COI with regard to selection of

essential medicines and the NMTC has no SOPs for their decision making.

The unethical behaviour in the selection area consists mainly of pharmaceutical companies

influencing officers to have their drugs included in lists, a selection process that is not

evidence‐based, and inappropriate representation in Selection Committees.

4.7. Procurement of medicines

The average final score for procurement of medicines was 7.01 which indicates marginal

vulnerability to corruption. Public sector procurement of medicines is done by Kenya

Medical Supplies Agency (KEMSA). Procedures for procurement exist and are heavily

informed by the newly published Public Procurement and Disposal Act12. This document is

publicly available and requires: the use of generic names; the advertisement of tenders; that

contract specification be publicly available to all bidders; that the criteria for adjudication of

tenders be included as part of the tender package and all bidders informed in advance; and

that the information on the tender process and results be made public. Tender Committee

membership is defined by the Public Procurement Act, which requires professionals with

specific skills. The law requires members to declare COI, it is however silent on how often

the membership is required to change and does not include representation from client

facilities. A description of the internal process to be followed by the procurement staff on

how to process the bids is available to the staff. However interference with decisions of the

Tender Committee by interested parties cannot be ruled out.

The Procurement Office monitors supplier performance during every tender for compliance

with the contract terms, the monitoring system tracks supplier’s lead‐time, delivery status,

shelf life, and the packaging of products. Product quality is also tracked, and suppliers with

poor performance are barred from future tenders.

The most common unethical behaviour in procurement is pharmaceutical companies

lobbying senior Government officials and politicians for procurement of certain products,

using gifts and bribery. Companies that are bidding also indulge in malpractices such as

double invoicing and inflating medicine prices.


‐‐ 44 ‐‐

4.8. Distribution of medicines

Distribution of medicines had the highest of all scores, 7.82, indicating marginal

vulnerability to corruption. Distribution of pharmaceuticals is done by Kenya Medical

Supplies Agency (KEMSA), which is the central medical stores for the MoH. Most medicines

carry the inscription “GOK (Government of Kenya)/MoH: NOT FOR SALE” on both

primary and secondary packaging. There are plans to print the code on the tablets/capsules

as well. All commodities procured are delivered directly to KEMSA warehouses from the

suppliers. The receiving staff verify the medicines received against the delivery note and a

copy of the purchase order is issued to the supplier. Both quality assurance staff and

warehouse staff are involved in receiving and verifying medicines from suppliers. Partial

consignments are usually accompanied by a delivery note.

A master map showing the location of medicines does not exist. However, products are

arranged taking into account the expiry dates to ensure FEFO (“first expiry, first out”). A

security management system is in place and consists of monitoring warehouse entries and

exits as well as searches of those leaving the warehouse by security personnel. There is

limited access to unauthorized persons and locks with controlled key distribution.

Controlled substances such as narcotics are separated and secured. However, a security

alarm system is yet to be installed at the central medical stores. Panic buttons are currently

in use.

SOPs for stock management exist at each level of the distribution system but the extent to

which they are followed has not been determined. There are inventory records and

procedures in the warehouses at the various levels of the distribution system. The inventory

management system is however inadequate and does not provide information on the

following elements: the average working stock; the amount of safety stock; the frequency of

reordering; the quantity of reordering and the average inventory. Only the expiry date and

lead time are readily available from the system.

The KEMSA warehouses are subjected to both internal and external auditing by the national

audit office and other independent auditors at regular intervals. Audit reports are on file.

Annual audits are mandatory.

Both computerized and manual systems exist and provide information on medicines that

have left the warehouse to health facilities including: type of medicines that have left the

warehouse; quantity of medicines that have left the warehouse; the person who verified the

amounts and the intended recipients of the medicines. The date when the medicines arrived

at the designated health facility is determined from the receipt stamp on the delivery notes.

An elaborate procedure for requesting medicines exists and involves filling in requisition

forms with the name of the medicine, dosage form, strength and quantity required. The

requisition is checked by the responsible person, dated and signed and then forwarded to

the central medical stores. A pull system is used for bi‐monthly deliveries to hospitals and a

push system for rural health facilities which receive supplies on a quarterly basis.

There is a communication system between distributions points, which includes a

manual/document exchange system between distribution points at all levels and telephone


‐‐ 45 ‐‐

contact also between all levels of the distribution points. A networked computerized system

does not exist but communication is enhanced by regional and field liaison officers who

make regular visits to the facilities. A programme exists for monitoring and evaluating the

performance of the medicine distribution system but the reports are not publicly available.

Monitoring and evaluation is done by the MoH, external auditors and through customer

satisfaction surveys.

Sanctions to be imposed on individuals for theft or corrupt practices are as spelt out in the

Public Procurement Act. Procedures foreseeing the application of sanctions for corrupt

behaviour exist and include the type of sanctions to be applied depending on the nature and

gravity of the act of corruption. However, there is no evidence of any individuals being

sanctioned for corrupt behaviour.

5. CONCLUSIONS

Registration of medicines: The average final score for registration was 4.36 indicating

moderate vulnerability to corruption. The requirements for applicants are fairly well

documented. They include a standard application form for submission of applications for

registration of medicines, guidelines on how to submit the application and a list of

registered medicines available. There is a committee which meets regularly to assess

applications for registration of medicines, and applicants who have their applications

rejected by the committee can make formal appeals to the PPB. However, there are no

written guidelines on selection criteria for members of this committee, on the composition

and terms of reference of the committee, procedures on how to assess applications, how and

where medicines registration officers meet with applicants and on COI with regard to

registration activities. To improve transparency, procedures used by registration officers and

committee members at the PPB should all be documented and implemented, the number of

registered medicines in the market should be reduced, all medicines should be analysed

before registration, and interaction between various departments of the PPB should be

enhanced.

Licensing of pharmaceutical establishments: The average final score for licensing was 5.21

indicating moderate vulnerability to corruption. There is provision in the law for licensing of

pharmaceutical establishments, and the Medicines Regulatory Authority has a unit and a

committee for licensing activities. There are written procedures on how to submit

applications for licensing and to assess applications. Although a pre‐licensing inspection

report is required before issuing of a licence, post‐licensing inspection of establishments is

erratic and done on an ad hoc basis. There is a list of licensed pharmaceutical

establishments, but it is neither comprehensive nor up‐to‐date. There are no written

guidelines on selection criteria for members of this committee, or on its composition and

terms of reference. No independent appeals system for applicants who have their

applications for licensing rejected exists. In order to reduce the level of vulnerability of the

licensing function, the Food and Chemical Substances Act should be reviewed. The PPB

should build capacity to carry out regular inspection of all establishments and close down

all unlicensed ones. Procedures used by the licensing unit at the PPB should all be

documented and implemented, and a well defined appeals system should be put in place.


‐‐ 46 ‐‐

Inspection and market control of medicines: Inspection and market control of medicines had

an average final score of 3.95, which indicates that the function is very vulnerable to

corruption. There is a comprehensive provision in the medicines legislation covering

inspection of pharmaceutical establishments and written SOPs for conducting inspections.

There are written guidelines for GMP and also for GDP for pharmaceutical products in

Kenya, but these guidelines do not classify non‐compliance with GMP or GDP. There are,

however, no written criteria for the selection and recruitment of inspectors and there are no

written guidelines on COI with regard to inspection activities. No written procedures exist

to prevent regulatory capture between inspectors and the manufacturing and distributing

companies inspected. Procedures used by the inspection unit of the PPB should all be

documented and implemented, the capacity of the inspectorate should be increased to

enable regular inspections and the law should be enforced for errant establishments. The

interaction and sharing of information between the drug registration, pharmacovigilance

and inspection departments within the PPB should be strengthened.

Drug promotion control: The average final score for medicines promotion was 4.53

indicating moderate vulnerability to corruption. There is a provision within the pharmacy

legislation covering promotion and advertising of medicines with clear penalties for any

person who breaches the law. Pre‐approval of promotional material is required. There is a

promotions service that vets medicines promotion advertisements, but monitoring and

enforcing the provisions on drug promotion are very weak. SOPs for the service for

medicines promotion are being developed. However, there are no written guidelines on

selection criteria for members of the promotion service unit, the composition and terms of

reference of the committee and on COI with regard to promotion activities. There is no

written procedure to report unethical promotional practices. To decrease vulnerability to

corruption, the law should be amended to include control of promotion of herbal and

complimentary medicines, and strict penalties for unethical behaviour. Comprehensive

guidelines for control of medicines promotion should be developed and used to vet all

promotional materials. The PPB should create awareness in the public about the process of

regulation of promotion materials.

Control of clinical trials: The average final score for control of clinical trials was 6.25 which

indicates marginal vulnerability to corruption. There is legal provision for the regulation of

clinical trials in the Science and Technology Act. There are guidelines on the submission of

applications to the PPB to conduct clinical trials and to the various institutional ethics and

research committees. The PPB has a committee which is responsible for reviewing

applications. It also has requirements for the manufacture, importation, exportation and use

of investigational products. There is no system for inspection of clinical trials and no written

guidelines on selection criteria for members of the PPB and ERC committees and on COI

with regard to control of trials. There are no national guidelines on principles of GCP and

none for the establishment of an Independent Ethics Committee. Transparency can be

enhanced by review of the law, building capacity of the ERCs and PPB clinical trials

committees, developing guidelines for all the committees’ decision‐making process,

establishing an independent clinical trials’ inspection system and making a list of all

approved and rejected clinical trial applications. An Independent Ethics Committee should

be created and interaction between researchers, NCST, ERCs, MoH and the PPB needs to be

encouraged.


‐‐ 47 ‐‐

Selection of medicines: Selection of medicines had the lowest average final score of 2.95,

showing that this function is very vulnerable to corruption. The essential medicines list is in

line with WHO procedures, but it was last updated in 2002. There are no written criteria for

the selection process for including or deleting medicines from the national EML. An NMTC

was constituted in 2007, but it is not yet operational. There are clear criteria for the selection

of members of the NMTC and terms of reference that describe the role and responsibilities of

the NMTC, which were developed over the previous year, but most stakeholders are not

aware of their existence. There are no written guidelines on COI with regard to selection of

essential medicines and the NMTC has no SOPs for their decision making. Operationalizing

the NMTC, implementing the use of existing documents and publicizing the selection

process will improve the selection function. An evidence‐based survey to establish which

medicines would cater for the bulk of health needs should be carried out.

Procurement of medicines: The average final score for procurement of medicines was 7.01,

which indicates marginal vulnerability to corruption. Transparent and explicit procedures

for procurement exist and are heavily informed by the Public Procurement and Disposal

Act. A description of the internal process to be followed by the procurement staff on how to

process the bids is available to the staff. The Procurement Office monitors supplier

performance during every tender for compliance with the contract terms and it is also

audited on a regular basis. Product quality is also tracked, and suppliers with poor

performance are barred from future tenders. There is a Tender Committee whose functions

are clearly separated from the functions of the Procurement Office. However interference

with decisions of the Tender Committee by interested parties cannot be ruled out. There is a

formal appeals process for applicants who have their bids rejected. There are no written

guidelines on COI with regard to procurement of medicines. To enhance transparency,

procurement should be independent of political interference and operations should adhere

to the law. Procurement staff should get regular training, audit should be strengthened and

the Public Procurement and Oversight Authority should be operationalized.

Distribution of medicines: Distribution of medicines had the highest of all scores, 7.82,

indicating marginal vulnerability to corruption. All procured commodities are delivered

from the suppliers directly to the central warehouses where they are verified. Most

medicines carry a Government identification inscription on both primary and secondary

packaging. A master map showing the location of medicines does not exist, but products are

arranged taking into account their expiry dates. A security management system, procedure

for requesting medicines, SOPs for stock management, computerized and manual

information systems, a monitoring and evaluation system, and a communication system

between distributions points are all in place. The warehouses are subject to regular internal

and external auditing. Sanctions to be imposed on individuals for theft or corrupt practices

are as spelt out in the Public Procurement Act. However, there is no evidence of any

individuals being sanctioned for corrupt behaviour. To strengthen procurement, KEMSA

should be made semi‐autonomous and be linked with health facilities to facilitate online

ordering based on proper quantification and GDP. There is a need to strengthen regional

depots and staff capacity building, and to construct and equip warehouses. A performance

monitoring system should be set up.


‐‐ 48 ‐‐

6. RECOMMENDATIONS

6.1. General recommendations

1. Create a formal appeals system in each function

2. Improve communication between all players in the pharmaceutical sector:

MoH, PPB and the pharmaceutical industry

3. Improve data management systems to provide instant information and

regularly update and publicize all documents

4. Build the human resource capacity in each of the sectors

5. Institutionalize declaration of COI for each of the functions.

6.2. Specific recommendations

6.2.1. Registration of medicines

a. Develop the following documents and implement their use, review them

regularly and widely disseminate them:

guidelines setting limits on how and where medicines registration

officers meet with applicants

criteria for selecting the members of the Registration Committee

guidelines on the composition and terms of reference of the Registration

Committee

guidelines for the Committeeʹs decision‐making process

b. Reduce the number of registered products in the market through:

limiting the number of generics registerable for any molecule

enforcing the withdrawal of all rejected and unregistered products in

the market

c. Improve interaction and sharing of information between the drug registration,

inspection and importation departments within the PPB

d. Ensure that all medicines are analysed before registration and strengthen

market surveillance.

6.2.2. Licensing of pharmaceutical establishments

a. Review of the Food and Chemical Substances Act (Cap 254). Public Health

Officers use this Act to issue Food and Drugs Certificates to shopkeepers. This

has been misused as a legal instrument for opening illegal drug outlets

b. Develop licensing guidelines and make them easily and publicly available

c. The PPB should establish an on‐line system for application for licensing,

shorten the time taken to process and approve applications, and decentralize

licensing to provinces and districts

d. De‐link the PPB from the MoH to enhance its independence as a national

medicines regulator


‐‐ 49 ‐‐

e. The PPB should carry out an audit of licensed and unlicensed establishments,

maintain an up‐to‐date database and close all the unlicensed establishments

f. The PPB should improve human resource capacity to carry out regular

inspections and enforce annual renewal of licences. Enforce adherence to

licensing guidelines, regular rotation of inspectors and regular inspections of

establishments

g. Establish guidelines for the composition and selection criteria for the Licensing

Committee and develop TORs for the Practice Committee.

6.2.3. Inspection and market control of medicines

a. Develop the following documents and implement their use, review them


procedures to prevent regulatory capture between inspectors and the

manufacturers or distributors

SOPs for conducting inspections

criteria for the selection and recruitment of inspectors

guidelines on COI with regard to inspection activities

guidelines for the internal review of inspection findings

b. Increase the capacity of the inspectorate:

in personnel numbers, and have inspectors at all ports of entry

by training

c. Enforce the law with regard to inspection activities:

by acting on the findings of inspectors, including closing down non‐

conforming establishments

disciplining unethical inspectors

d. Have regular schedules of inspections and also have impromptu inspections

e. Improve interaction and sharing of information between drug registration,

pharmacovigilance and inspection departments within the PPB.

6.2.4. Medicines promotion control

To improve medicines promotion, the following recommendations should be

considered:

a. The PPB and MoH should explore strategies to create public awareness of the

process of regulation of promotion materials by instituting mass media

campaigns to educate the public on the dangers of unethical medicines

promotion

b. The law should be amended to include control of herbal and complementary

medicines, and also introduce strict penalties for unethical behaviour and

empower the PPB to penalize the offenders. All promotional materials should

be vetted to ensure that only registered products are promoted


‐‐ 50 ‐‐

c. Set up an inspectorate to police promotion of medicines in the country and

ensure medical representatives are well trained and ethical in medicines

promotion

d. Constitute a promotions control committee that includes non‐medical

practitioners such as civil society groups and consumer organizations

e. Develop and strengthen guidelines and SOPs for control of medicines

promotion.

6.2.5. Control of clinical trials

a. Review legislation regulating clinical trials as a stand alone law on clinical

trials instead of the current law which clusters clinical trials under biomedical

research

b. Develop the following documents and implement their use, review them


national guidelines on principles of Good Clinical Practice

guidelines on composition and criteria for selecting the members of the

PPB clinical trials committee and the ethics and research committees

guidelines on COI with regard to clinical trials activities

guidelines for the committeeʹs decision‐making process

a list of all approved and rejected clinical trial applications in the

country.

c. Establish:

an operational clinical trials inspection system

an Independent Ethics Committee.

d. Increase the capacity of ERCs and PPB Clinical Trials Committee:

by training them to attain international standards

to expedite the review process to make it shorter

supplement the capacity by sourcing for review expertise beyond

Kenya.

e. Enforce the law with regard to inspection activities:

by ensuring all investigational products are registered

by disciplining errant researchers and sponsors.

f. Improve interaction and sharing of information between researchers, NSCT,

ERCs, MoH and the PPB.

6.2.6. Selection of medicines

a. Operationalize the NMTC

give support at the highest level

implement and publicize the guidelines that have been developed on

the criteria for selection of members, and terms of reference that

describe the role and responsibilities of the NMTC members


‐‐ 51 ‐‐

b. Develop the following documents and implement their use, review them


guidelines for the selection process for including or deleting medicines

from the national EML

guidelines for the Committeeʹs decision‐making process.

c. Do a survey to establish which drugs would cater for the bulk (90%) of health

needs. This would require data from practice. The survey should also establish

the quality, safety and efficacy of drugs

d. Publicize the selection process and involve all stakeholders.

6.2.7. Procurement of medicines

a. Ensure that procurement of both pharmaceuticals and non‐pharmaceuticals is

done centrally from KEMSA to ensure proper controls for the process and cut

out unnecessary bureaucratic procedures

b. Make the procurement function independent to avoid political interference

c. Review procurement operations in line with the law and ensure strict follow

up

d. Train procurement staff and build capacity to apply and adhere to

procurement laws

e. Strengthen and operationalize the Public Procurement and Oversight

Authority (PPOA). This will facilitate the enforcement of principles of good

governance

f. Strengthen procurement audit.

6.2.8. Distribution of medicines

a. Invest more in capacity building through staff training, equipping the

warehouses and provision of proper storage facilities

b. Make KEMSA semi‐autonomous with a revolving fund or through provision of

seed money for commercialization

c. Link CMS with health facilities to facilitate online communication

d. Set up a performance monitoring system for the supply chain and enforce GDP

e. Ensure proper quantification of consumption from facility level to national

level

f. Strengthen regional depots for faster and more cost effective service delivery.


‐‐ 52 ‐‐

7. GLOSSARY

Auditing: Official examination of an organization or institutionʹs accounts to make sure

money has been spent correctly.

Bribery: Bribery is the act of offering someone money or other valuables, in order to

persuade him/her to do something for you. By definition bribery is corruption.

Conflict of interest: Conflict of interest means that the expert or his/her partner, or the

administrative unit with which the expert has an employment relationship, has a financial or

other interest that could unduly influence the expert’s position with respect to the subject‐

matter being considered.

Corruption: Behaviour on the part of officials in the public and private sectors, in which

they improperly and unlawfully enrich themselves and/or those close to them, or induce

others to do so, by misusing the position in which they are placed.

Easily accessible document: A document which is obtainable effortlessly when needed,

without delays or any bureaucratic obstacle.

Essential medicines: Medicines that satisfy the priority health‐care needs of the population.

They are selected with due regard to public health relevance, evidence on efficacy and

safety, and comparative cost‐effectiveness. Essential medicines are intended to be available

within the context of functioning health systems at all times in adequate amounts, in the

appropriate dosage forms, with assured quality and adequate information, and at a price the

individual and the community can afford.

Generic medicine: A pharmaceutical product usually intended to be interchangeable with

the innovator brand product, manufactured without a licence from the innovator

manufacturer and marketed after the expiry of patent or other exclusivity rights. Generic

medicines are marketed either under a nonproprietary name (INN), or occasionally another

approved name, rather than under a proprietary or brand name.

Governance: The traditions and institutions by which authority in a country is exercised for

the common good. In WHOʹs Good Governance for Medicines programme, good

governance refers to the formulation and implementation of appropriate policies and

procedures that ensure the effective, efficient and ethical management of pharmaceutical

systems, in particular medicine regulatory systems and medicine supply systems, in a

manner that is transparent, accountable, follows the rule of law and minimizes corruption.

Inspection: Entry by staff of the regulatory authority into premises where medicines are

manufactured stored and distributed to ensure that processes are carried out in accordance

with norms and standards, as well as the national legislation/regulation.

International Nonproprietary Name (INN): A common generic name selected by

designated experts, using procedures and guiding principles adopted by the WHO World

Health Assembly, for the unambiguous identification of a new pharmaceutical substance.

This name is often identical to the generic name.


‐‐ 53 ‐‐

Licensing: Authorization by an official body to an individual, an institution or a company to

carry out a certain activity or business operation.

Marketing authorization: An official document issued by the competent medicine

regulatory authority for the purpose of the marketing or free distribution of a product after

evaluation for safety, efficacy and quality.

Medicine: Any dosage form containing a substance approved for the prevention and

treatment of disease. The term ʺmedicineʺ is increasingly used to distinguish it from a

medicine as a substance that is misused.

Medicine Regulatory Authority (MRA): A national agency which is established by

legislation to administer the full spectrum of medicine regulatory functions.

Pharmaceutical sector: Refers to the various actors (government, nongovernmental

organizations, private‐for‐profit organizations, private not‐for–profit organizations etc.)

engaged in activities such as the research, manufacture, import, export, distribution and sale

of medicines.

Pharmaceutical system: Refers to the relationship/interactions between the various actors of

the pharmaceutical sector and the way decisions are made in particular in the government.

Promotion: All informational and persuasive activities by manufacturers and distributors,

the effect of which is to induce the prescription, supply, purchase and/or use of medicinal

products.

Publicly available document: A document which is found openly, widely, with no

restrictions and usually in more than one media (i.e. soft copy; website; hard copies; at a

Governmental office, documentation centre or in a national gazette).

Registration: Any statutory system of approval required at national level as a pre‐condition

for introducing a pharmaceutical product on the market.

State capture: The phenomenon in which outside interests (often the private sector, mafia

networks, etc.) are able to bend state laws, policies and regulations to their (mainly financial)

benefit through corrupt transactions with public officers and politicians.

Transparency: Transparency means clearness, honesty and openness. Transparency is the

principle that those affected by administrative decisions should be informed, and the duty of

civil servants, managers and trustees is to act visibly, predictably and understandably.


‐‐ 54 ‐‐

8. REFERENCES

1. Hogerzeil HV. Access to Essential Medicines as a Human Right. Essential Medicines

Monitor, 2003; 33:26‐27. (http://apps.who.int/medicinedocs/pdf/s4941e/s4941e.pdf

http://apps.who.int/medicinedocs/en/d/Js5416e/)

2. WHO Medicines Strategy 2004 ‐ 2007: Countries at the Core. Geneva, World Health

Organization, 2004 (http://apps.who.int/medicinedocs/en/d/Js5416e/)

3. Kenya National Pharmaceutical Policy, 2007.

4. Ministry of Health National Health Accounts, 2003.

5. WHO Statistical Information System (WHOSIS), February 2007.

6. The Abuja Declarations 2001 and 2006, Abuja, Nigeria.

(http://www.rbm.who.int/docs/Abuja_declaration.pdf)

7. Kenya Health Policy Framework. Nairobi, Ministry of Health, 1994.

8. Kenya National Drug Policy. Nairobi, Ministry of Health, 1994.

9. Laws of Kenya, The Pharmacy and Poisons Act, Chapter 244.

10. Laws of Kenya, The Science and Technology Act, 1979

11. Pharmacy and Poisons Board; Customer Service Charter, 2008.

12. Kenya Gazette. The Public Procurement and Disposal Regulations, 2006 – Legal notice

No. 174.

13. Guidelines for Ethical Conduct of Biomedical Research Involving Human Subjects in

Kenya. NCST No. 45. 2005. National Council of Science and Technology, Nairobi, Kenya.


‐‐ 55 ‐‐

9. ANNEXES


‐‐ 56 ‐‐

Annex 1: Score sheets

Key to score sheets 1-8

* Profession:

G = Government or public official

P = Private sector (national or international)

N = Nongovernmental organization (national or international)

IO = International governmental organization

M = Media

O = Other

** The average for each question is calculated only on valid responses and all DK and NA answers are discarded *** score = total average/number of indicators x 10

M ethod 3

SD = Strongly disagree

DI = Disagree Note:

Method 3 and Method 4 questions (M3, M4) are not part of the quantitative aspect of the assessment because they are not expressed with numbers/quantities. They are the base for the qualitative part of the assessment. For this reason M3 and M4 questions are not calculated in the totals and/or averages present in this consolidation table.

UD = Undecided

AG = Agree

SA = Strongly agree

DK = Do not know

NA = Not applicable


‐‐ 57 ‐‐

Score Sheet 1

Country name: Period assessment carried out:

Registration

Kenya

June-July 2008

Method

KI 1 KI 2 KI 3 KI 4 KI 5 KI 6 KI 7 KI 8 KI 9 KI 10 KI 11 KI 12 KI 13 KI 14 KI 15 Total Average per question**

Profession* --- G G G G G G O O O P G G P P

Indicator I.1 M1 1 1 1 0 1 1 1 1 1 0 1 0 1 0 10 0.71

Indicator I.2 M2 1 0.5 0.63 0.63 0.88 0.88 0.63 1 DK 0.8 0.5 0.38 0.86 0.38 9.07 0.70

Indicator I.3 M2 0.86 0.86 0.86 0.86 0.86 0.86 0.86 0.71 1 0.86 0.86 0.19 0.86 0 10.5 0.75

Indicator I.4 M2 0.67 0.67 0.67 0.17 0.67 0.83 0 0 0 DK 0 DK DK 0 3.68 0.33

Indicator I.5 M2 1 1 0.88 0.88 1 1 1 1 1 1 1 0.86 1 0.75 13.37 0.96

Indicator I.6 M1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0.00

Indicator I.7 M1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 14 1.00

Indicator I.8 M2 0 0 0 0 0 0 0 0 0 DK 0 DK DK DK 0 0.00

Indicator I.9 M2 0 0 0 0 0 0 0 0 0 DK 0 DK DK 0 0 0.00

Indicator I.10 M2 0 0 0 0 0 0 0 0 0 DK DK DK DK 0 0 0.00

Indicator I.11 M3 DK NA AG DI AG SA AG NA DI NA AG DI NA DI

Indicator I.12 M2 0 0 - 0 0 0 0 0 0 DK 0 DK DK 0 0 0.00

Indicator I.13 M1 1 0 1 1 1 1 1 1 1 0 1 1 1 0 11 0.79

Indicator I.14 M3 UD SA SA AG AG UD DI DK SA DI DI SD SD DI

Indicator I.15 M3 SA SA SA SA SA SA SA SA SA AG SA AG AG AG

Indicator I.16 M4 see text in narrative report

Indicator I.17 M4 see text in narrative report

Total 5.24

***Final score Registration 4.36


‐‐ 58 ‐‐

Score Sheet 2


Licensing

Kenya

June-July 2008

Method


Profession* --- G P O G P P P P P P P P O

Indicator II.1 M1 1 1 1 1 1 1 1 1 1 1 1 1 1 13 1.00

Indicator II.2 M1 1 1 1 1 1 1 1 1 1 1 1 1 1 13 1.00

Indicator II.3 M2 0.83 0 1 1 0.67 0.67 0 0.83 0 0.33 0.83 0.8 0.6 7.56 0.58

Indicator II.4 M1 1 0 1 1 0 0 0 DK 0 0 0 DK 0 3 0.27

Indicator II.5 M2 1 0 1 1 1 1 1 1 1 1 0 0 1 10 0.77

Indicator II.6 M2 1 0 1 1 1 1 1 DK 0 DK DK DK 1 7 0.78

Indicator II.7 M2 0 NA 0 0 0 0 DK NA DK DK DK NA 0 0 0.00

Indicator II.8 M2 0 NA DK 0 0 0 DK NA DK DK DK NA 0 0 0.00

Indicator II.9 M1 1 0 0 1 0 0 1 0 0 1 0 0 0 4 0.31

Indicator II.10 M2 0.6 0.4 0 1 0.8 1 1 1 DK 0.8 0.4 0.75 0.5 8.25 0.69

Indicator II.11 M3 SA D SD SA D A SD UN SD AG D UN D

Indicator II.12 M1 1 0 0 0 1 0 1 0 0 DK DK DK DK 3 0.33

Indicator II.13 M3 SA SD SD SA D A UN UN D DK DK DK A

Indicator II.14 M4 see text in narrative report

Indicator II.15 M4 see text in narrative report

Total 5.73

***Final score Licensing 5.21


‐‐ 59 ‐‐

Score Sheet 3


Inspection

Kenya

June-July 2008

Method


Profession* --- G G G G G N G G N G O G G P P

Indicator III.1 M1 1 1 1 1 1 0 1 1 1 1 1 1 1 1 0 13 0.87

Indicator III.2 M2 1 1 1 1 0.6 0 0.8 0.8 0.75 0.8 0.8 0.6 1 1 0 11.15 0.74

Indicator III.3 M2 0.5 0.6 0.67 0.83 - 0.33 0.67 0.83 0 0 0 0 0.25 0.83 0 5.51 0.39

Indicator III.4 M2 0.5 0.5 0 0.83 DK 0.33 DK 0.83 0 0 0 0.6 0.8 0.83 0 5.22 0.40

Indicator III.5 M2 0 0 0 0 0 0 0 0 0 0 0 0 DK 0 0 0 0.00

Indicator III.6 M2 0 0 0 0 0 0 0 0 0 0 DK 0 0 0 0 0 0.00

Indicator III.7 M1 1 1 1 1 0 DK 0 0 1 1 0 1 0 1 0 8 0.57

Indicator III.8 M2 0.4 1 1 1 0.2 1 0.5 1 0 0.6 1 0 0.2 0.8 0 8.7 0.58

Indicator III.9 M2 0 0 DK 0 0 0 0 0 0 0 0 0 0 0 0 0 0.00

Indicator III.10 M3 SD SD AG AG SA SD SD DI UD DI DI DI SD SD DI

Indicator III.11 M3 SD SA SA SA SA DI SD AG AG DI SD AG DI DI DI

Indicator III.12 M4 see text in narrative report

Indicator III.13 M4 see text in narrative report

Total 3.56

***Final score Inspection 3.95


‐‐ 60 ‐‐

Score Sheet 4


Promotion

Kenya

June-July 2008

Method


Profession* --- O G G P P P P P P P O O G P N

Indicator IV.1 M1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 15 1.00

Indicator IV.2 M2 0.1 0.67 0.3 0.4 0.7 0.7 0.67 0.7 0.3 0.63 0.4 0.43 0.5 0.3 0.4 7.2 0.48

Indicator IV.3 M2 0.5 0.88 0.88 0.5 0 1 0 0 0.5 0.88 0.88 0.67 0.88 0.38 0 7.95 0.53

Indicator IV.4 M1 DK 1 1 1 1 1 DK 1 1 1 1 0 1 0 0 10 0.77

Indicator IV.5 M2 DK 0 0.75 0 DK DK DK 0 0 DK 0.25 0 0 0 0 1 0.10

Indicator IV.6 M1 DK 1 1 DK 1 1 DK 0 0 1 DK 0 1 1 1 8 0.73

Indicator IV.7 M2 NA 0.8 0.6 NA DK DK DK DK 0 0.8 0.67 0 0 DK 1 3.87 0.48

Indicator IV.8 M2 NA 0 0 NA DK DK DK DK 0 DK 0 0 0 DK DK 0 0.00

Indicator IV.9 M2 DK 0 1 DK DK DK DK DK 0 0 0 0 1 1 1 4 0.44

Indicator IV.10 M2 DK 0 0 0 DK 0 DK DK 0 0 0 0 0 0 0 0 0.00

Indicator IV.11 M3 DI AG SA SD AG SD DK DI DI DI DI SD DI AG DI

Indicator IV.12 M3 UN AG DI DI DI SD SD DI DI SA AG DI SA DI DI

Indicator IV.13 M3 AG AG SD DI DI SA SD SD SD SA AG DI SD SD UN

Indicator IV.14 M3 UN AG DI DI SD SD SD DI SD UN SA DK DI DI DI

Indicator IV.15 M4 see text in narrative report

Indicator IV.16 M4 see text in narrative report

Total 4.53

***Final score Promotion 4.53


‐‐ 61 ‐‐

Score Sheet 5


Clinical trials

Kenya June-July 2008

Method KI 1 KI 2 KI 3 KI 4 KI 5 KI 6 KI 7 KI 8 KI 9 KI 10 KI 11 KI 12 KI 13 KI 14 KI 15 Total Average per question**

ACA

CTC

Profession* --- G O P O G O M O O O P O O P P

Indicator V.1 M1 1 1 0 DK 0 1 1 1 1 DK 1 1 1 0 0 9 0.69

Indicator V.2 M1 0 0 0 0 1 1 1 0 0 0 0 1 0 1 0 5 0.33

Indicator V.3 M2 0.8 1 0 0.4 0 0 1 1 1 0 1 DK 1 1 0.6 8.8 0.63

Indicator V.4 M2 1 1 0 0.83 0 1 0.83 1 0.83 1 0.83 1 0.83 1 1 12.15 0.81

Indicator V.5 M1 1 1 0 1 DK 1 1 1 1 1 1 1 1 1 1 13 0.93

Indicator V.6 M1 1 1 0 1 1 0 DK 1 1 1 0 DK 1 1 1 10 0.77

Indicator V.7 M2 1 1 0 DK 0.5 0 1 0.75 1 1 0 0.75 1 1 1 10 0.71

Indicator V.8 M1 0 0 0 0 1 1 0 0 0 0 0 1 1 0 0 4 0.27

Indicator V.9 M2 1 1 0 1 0 1 0 1 1 0 0 DK 0 1 1 8 0.57

Indicator V.10 M1 1 1 1 1 0 1 1 DK 1 1 0 1 1 0 1 11 0.79

Indicator V.11 M2 0 DK 0 1 DK 1 - DK DK DK 0 0.8 1 0.17 1 4.97 0.55

Indicator V.12 M2 0.75 0 0 0.75 0 0.75 0 0.75 0.75 DK 0 1 0.75 0.75 0 6.25 0.45

Indicator V.13 M3 DK SA DI DK NA SA AG SD DK SA AG AG - SA DI

Indicator V.14 M3 AG AG DK DK DK DK DK SD DK SA DK DK DK AG DI

Indicator V.15 M3 SA SA DI SD DK DK SD SA AG SA DI SD AG AG DI

Indicator V.16 M4 see text in narrative report

Indicator V.17 M4 see text in narrative report

Total 7.50

***Final score Clinical trials 6.25


‐‐ 62 ‐‐

Score Sheet 6

Method


Profession* --- G G G G G G G G G G G G O O O

Indicator VI.1 M1 1 1 1 1 1 1 1 1 1 1 1 1 1 0 1 14 0.93

Indicator VI.2 M3 DI DI DI DI AG DK AG DI AG AG DI AG AG NA SD

Indicator VI.3 M2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0.00

Indicator VI.4 M2 0 0.67 0.5 0.5 0.83 0.5 0 DK 0.5 0.4 0.17 0.5 1 0 0.67 6.24 0.45

Indicator VI.5 M1 0 0 0 0 1 0 1 1 0 1 1 1 1 1 0 8 0.53

Indicator VI.6 M3 NA NA NA NA AG DK AG NA SA AG DI DI AG SD AG

Indicator VI.7 M2 0 0.71 0 1 0 0 0 0 0 0.5 0.43 0 0 0.714 0 3.354 0.22

Indicator VI.8 M2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0.00

Indicator VI.9 M2 0.33 0.33 0 0.67 0 0 0 0 0 1 1 0 0 0 0 3.33 0.22

Indicator VI.10 M2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0.00

Indicator VI.11 M4 see text in narrative report 0

Indicator VI.12 M4 see text in narrative report

Total 2.36

***Final score Selection 2.95


‐‐ 63 ‐‐

Score Sheet 7


Procurement

Kenya

June-July 2008

Method

KI 1 KI 2 KI 3 KI 4 KI 5 KI 6 KI 7 KI 8 KI 9

KI 10 KI 11 KI 12 KI 13 KI 14 KI 15 Total Average per question**

Profession* --- G G P G G G G P G G G G IO G

Indicator VII.1 M2 1 1 0.89 1 1 1 1 0.75 1 1 1 1 1 1 13.64 0.97

Indicator VII.2 M1 1 1 1 0 1 1 1 1 1 1 1 1 1 1 13 0.93

Indicator VII.3 M1 0 1 1 0 1 1 1 0 0 0 1 1 1 1 9 0.64

Indicator VII.4 M1 1 1 1 DK 1 1 1 DK 1 1 1 1 1 1 12 1.00

Indicator VII.5 M2 1 1 1 1 1 0.33 1 1 1 1 1 1 1 1 13.33 0.95

Indicator VII.6 M3 AG SA SA DK DI SA AG SA SA DI SA AG DI SA

Indicator VII.7 M2 0.57 0.87 0.71 0.67 0.71 0.71 0.71 0.4 0.8 DK 0.71 0.57 1 0.57 9 0.69

Indicator VII.8 M2 0 0 0 DK 0 DK DK DK DK 0 0 DK DK 0 0 0.00

Indicator VII.9 M3 AG SA AG AG AG SA UN SA SA DK SA DI SD SA

Indicator VII.10 M2 0 0.57 1 DK 0 0 DK 0 0 1 0 1 0 0.71 4.28 0.36

Indicator VII.11 M2 1 0.5 1 0 0.5 1 0.5 DK 0.5 1 0.75 1 0.25 1 9 0.69

Indicator VII.12 M2 0.67 0.83 0.83 DK 1 DK 0.67 DK 0 DK 0.5 1 0 1 6.5 0.65

Indicator VII.13 M2 0.5 0.88 0.75 0.88 1 0.86 0.83 DK 1 DK 0.57 1 0.63 1 9.9 0.83

Indicator VII.14 M3 DI DI UD UD DI DI DI AG DI SD AG DI SD SA

Indicator VII.15 M4 see text in narrative report

Indicator VII.16 M4 see text in narrative report

Total 7.71

***Final score Procurement 7.01


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Score Sheet 8 Country name: Period assessment carried out: Distribution

Kenya June-July 2008

Method KI 1 KI 2 KI 3 KI 4 KI 5 KI 6 KI 7 KI 8 KI 9 KI 10 KI 11 KI 12 KI 13 KI 14 KI 15 Total Average/question**

G = Government or public official

G G G G G G G G N N G G P

Indicator VIII.1 M1 0 DK DK DK DK DK 1 1 1 1 DK DK 0 4 0.67

Indicator VIII.2 M3 AG NA NA NA DI NA SD AG DI DI NA DK AG

Indicator VIII.3 M2 1 1 0.75 1 1 1 1 0.75 1 1 1 0.75 1 12.25 0.94

Indicator VIII.4 M1 1 1 1 1 1 1 1 1 DK DK 1 1 0 10 0.91

Indicator VIII.5 M2 0.67 0.67 0.67 0.33 0 1 0.67 0 0.67 0.33 0.67 0.67 0.67 7.02 0.54

Indicator VIII.6 M2 0.83 1 1 0.83 1 0.83 1 0.83 0.83 1 0.83 0.67 1 11.65 0.90

Indicator VIII.7 M1 1 1 1 1 1 1 1 1 1 1 1 0 1 12 0.92

Indicator VIII.8 M2 0.71 0.43 0.43 0.43 0.57 1 0.14 0.57 0.14 1 0.29 0.14 0.86 6.71 0.52

Indicator VIII.9 M1 1 1 1 1 0 1 1 0 1 0 1 1 1 10 0.77

Indicator VIII.10 M2 1 1 0 1 0.67 1 1 0 0 0 1 1 1 8.67 0.67

Indicator VIII.11 M2 1 1 1 1 1 1 1 1 0.83 0.83 1 DK 1 11.66 0.97

Indicator VIII.12 M2 1 1 1 1 1 1 1 1 1 1 1 1 1 13 1.00

Indicator VIII.13 M2 0.75 1 0 1 DK 1 0.75 0 0 0 1 1 0.5 7 0.58

Indicator VIII.14 M1 1 1 1 1 1 1 1 1 1 1 1 1 1 13 1.00

Indicator VIII.15 M2 0.86 0.71 0.71 0.86 0.57 1 0.71 0 0 0 0.86 0.71 0.57 7.56 0.58

Indicator VIII.16 M2 0.33 1 1 0.67 1 1 1 1 0 0 1 0 0.67 8.67 0.67

Indicator VIII.17 M2 1 1 1 1 1 1 0.75 0.75 0.67 0.75 1 1 0.5 11.42 0.88

Indicator VIII.18 M3 DI AG DI SA DI DI SD AG SD DI SD DI SD

Indicator VIII.19

Indicator VIII.20 M4 see text in narrative report

Total 12.51

***Final score Distribution 7.82


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Annex 2: List of Documentary Evidence Obtained

a. Registration

Checklist for new applications for medicine registration

Requirements for all new manufacturers applying for new drug applications

Guidelines for parallel importation of medicines in Kenya

Guidelines for National Pharmacovigilance system in Kenya

Guidelines for applicants on how to submit an application for registration of

medicinal products

Application form for submission of applications for registration of medicines

List of all registered pharmaceutical products.

b. Licensing

Guidelines for Registration (Licensing) of premises and issuance of wholesale

dealer’s licence

List of licensed pharmaceutical establishments in Kenya (2007). (Not

comprehensive).

c. Inspection

Guidelines for Good Wholesaling and Retail Practice for Pharmaceuticals

Guidelines for Good Manufacturing Practices for medicines in Kenya

Guidelines for product recall and withdrawal

Standard operating procedures for inspectors on how to conduct inspections.

d. Promotion

Code of promotional practices for pharmaceutical representatives in Kenya.

e. Clinical trials

Checklist for submitting documents to the (PPB) committee on clinical trials

Guidelines on the submission of applications to the PPB to conduct clinical

trials

Form for submitting applications to KNH/UoN ERC

Guidelines for protocol development

Forms for reporting adverse effects

Guidelines on the process of protocol review

Standard operating procedures for KNH/UoN ERC.

f. Selection

Kenya Essential Drugs List (KEDL), Third Edition (August 2003)

Criteria for selection of essential medicines (Draft)

Criteria for selection of members of the National Medicines and Therapeutics

Committee (Draft)

Terms of reference for the National Medicines and Therapeutics Committee

(Draft).

g. Procurement

h. Distribution


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Annex 3: Organizational Structure of the Pharmacy and Poisons Board

HEADMEDICINE

INFORMATION

HEADDRUG

REGISTRATION

HEADPHARMACO-VIGILANCE

HEADPHARMACEUTICAL

INSPECTORATE

LEGALOFFICE

HEADGMP

INSPECTORATE

IMPORT &EXPORT

DEPARTMENT

HEADTRAINING &ASSESSMENTDEPARTMENT

SITUATION ORGANIZATION STRUCTURE

MINISTER OF HEALTH

BOARD OF DIRECTORS

REGISTRAR

DEPUTY REGISTRAR

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