Baseline assessment of the Pharmaceutical situation in ... · WHO/EMP/MPC/2011.2 Baseline assessment of the Pharmaceutical situation in Southern African Development Community countries

Baseline assessment of the

Pharmaceutical situation in Southern African

Development Community countries

Fact Book 2009

WHO/EMP/MPC/2011.2

Baseline assessment of the

Pharmaceutical situation in Southern African

Development Community countries

Fact Book 2009

© World Health Organization 2011 All rights reserved. Publications of the World Health Organization can be obtained from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: [email protected]). Requests for permission to reproduce or translate WHO publications – whether for sale or for noncommercial distribution – should be addressed to WHO Press, at the above address (fax: +41 22 791 4806; e-mail: [email protected]). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use. The named authors alone are responsible for the views expressed in this publication.

Baseline assessment of the pharmaceutical situation in Southern African Development Community countries. WHO/EMP/MPC/2011.2

iii

Table of contents Acknowledgements......................................................................................................................v Acronyms………………………………………………………………………………………vii Executive summary................................................................................................................... ix 1. Background ...........................................................................................................................1 2. Methodology..........................................................................................................................3 3. Demography and economy...................................................................................................5

3.1 Introduction ......................................................................................................................5 3.2 Population and economy in SADC countries ...................................................................5

4. Health services ......................................................................................................................7

4.1 Introduction ......................................................................................................................7 4.2 Health expenditure ...........................................................................................................7 4.3 Human resources for the pharmaceutical sector...............................................................9 4.4 Health facilities ..............................................................................................................10

5. Medicines policy and regulatory framework ...................................................................13

5.1 Policy framework ...........................................................................................................14 5.2 Regulatory framework ...................................................................................................14

6. Financing for medicines .....................................................................................................19 7. Intellectual property rights and access to medicines .......................................................23 8. Procurment and supply......................................................................................................25

8.1 Structures and processes for procurement......................................................................25 8.2 Local production for pharmaceuticals............................................................................29

9. Selection and rational use ..................................................................................................31 10. Household data ...................................................................................................................39

iv

Annexes: Country data on selected key indicators Annex 1 Pharmaceutical personnel per 10,000 population........................................................................45 Annex 2 NMP updated within 5 years.......................................................................................................46 Annex 3 Presence of medicines regulatory authority ................................................................................47 Annex 4 Legal provisions for marketing authorization .............................................................................48 Annex 5 Legal provisions to inspect pharmaceutical premises and collect samples .................................49 Annex 6 ADRs are monitored ...................................................................................................................50 Annex 7 Legal provisions to combat counterfeits .....................................................................................51 Annex 8 Public per capita expenditure on medicines (US$) .....................................................................52 Annex 9 HIV/AIDS medicines distributed free of charge in public health facilities ................................53 Annex 10 Medicines distributed free of charge for pregnant women in public health facilities .................54 Annex 11 Maximum retail price in the private sector is regulated ..............................................................55 Annex 12 Provisions for compulsory licensing are included in the national patent law .............................56 Annex 13 Existence of EML updated within the past 5 years .....................................................................57 Annex 14 Existence of STGs updated within the past 5 years ....................................................................58 Annex 15 Generic substitution is allowed in the public sector....................................................................59 Annex 16 Generic substitution is allowed in the private sector...................................................................60

Acknowledgements

v

Acknowledgements This report has been developed by the WHO Essential Medicines and Pharmaceutical Policies Department (EMP) in Geneva. Hans V. Hogerzeil, Director EMP, provided leadership and guidance in the development of this report. Gilles Forte, EMP, coordinated and supervised the overall process of indicator development and data collection, and the production and editing of this report. Richard Laing, EMP, supervised the process of indicator development. Abayneh Desta supervised the development of this fact book. Enrico Cinnella, EMP, developed the indicators, analysed the data and prepared this report. The Questionnaire was reviewed and comments were provided by the following EMP staff: Alain Prat, Helen Moller, Kathleen Holloway and by Jean-Marie Trapsida and Abayneh Desta, WHO Regional Office for Africa. Jean-Marie Trapsida and Abayneh T. Desta coordinated data collection from the WHO Regional Office for Africa with WHO Country Offices. Data collection at country level was coordinated by: Munzala Ngola (Angola), John Botsang (Botswana), Gaston Tona Lutete (Democratic Republic of Congo), Masoko Ntsekhe (Lesotho), Nivo Hanitra Rasoanaivo (Madagascar), A. F. Chufulumira (Malawi), S. Jankee (Mauritius), Tania Vuyeya Sitoie (Mozambique), Marreli Fourie (Namibia), Lucile de Comarmond (Seychelles), Thembisile Shabangu (South Africa), Brenda Dlamini (Swaziland), Rose Shija (United Republic of Tanzania), Mildred Mulenga (Zambia) and Ropafadzai Hove (Zimbabwe). The data collected have been verified and endorsed by officers from the Ministry of Health of each country: Boaventura Moura (Angola), John Botsang (Botswana), Lokadi Otete Opheta (Democratic Republic of Congo), Masoko Ntsekhe (Lesotho), Lafy Roger Razafindrakoto (Madagascar), A. F. Chafulumira (Malawi), S. Jankee (Mauritius), Tania Vuyeya Sitoie (Mozambique), Norbert Foster (Namibia), Lucile de Comarmond (Seychelles), H. Zeeman (South Africa), Nelsiwe Sicklosana (Swaziland), Margaret Evelyn Mhando (United Republic of Tanzania), Gardner Syakanta (Zambia) and D. Dhlakama (Zimbabwe). The following people have reviewed the document: Paul Spivey (WHO consultant), Emma Back (DFID consultant), Steve Burton, Anna Guthrie and Saul Walker (UK Department for International Development, DFID), Abayneh T. Desta and Joseph Mthetwa (Southern African Development Community). This document has been produced with the financial assistance of the Department for International Development (DFID), UK. The views expressed herein are those of the authors and can therefore in no way be taken to reflect the official opinion of the Department for International Development (DFID), UK.

Baseline assessment of the pharmaceutical situation in Southern African Development Community countries

vi

Acronyms

vii

Acronyms ADR Adverse Drug Reaction

ARI Acute Respiratory Infection

DFID Department for International Development (UK)

DTC Drug and Therapeutics Committee

EML Essential Medicines List

EMP Essential Medicines and Pharmaceutical Policies (WHO Department)

GDP Gross National Product

GMP Good Manufacturing Practices

GNI Gross National Income

HAI Health Action International

HIV/AIDS Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome

MeTA Medicines Transparency Alliance

NMP National Medicines Policy

PPP Purchasing Power Parity

STGs Standard Treatment Guidelines

SADAP South Africa Drug Action Programme

SADC Southern African Development Community

TRIPS Trade-Related Aspects of Intellectual Property Rights

UK United Kingdom of Great Britain and Northern Ireland

WHO World Health Organization

WTO World Trade Organization


viii

Executive summary

ix

Executive summary The World Health Organization (WHO) is committed to supporting the Southern African Development Community (SADC) Secretariat in the implementation of the SADC Pharmaceutical Business Plan. As part of this support, a baseline assessment of the pharmaceutical situation in 15 SADC member states (Angola, Botswana, Democratic Republic of the Congo, Lesotho, Madagascar, Malawi, Mauritius, Mozambique, Namibia, Seychelles, South Africa, Swaziland, United Republic of Tanzania, Zambia and Zimbabwe) was conducted during the summer of 2009. The aim of this Fact Book is to disseminate some of the data collected through the baseline survey. Only preliminary analysis of the data has been conducted and neither recommendations nor conclusions have been made. The complete data set can be made available for further use upon request. Demography and economy The population in SADC member countries range from less than 100 000 to over 60 million. Economic and socioeconomic differences are illustrated by the fact that five countries have a Gross National Income (GNI) per capita over US$ 5 000, against a median figure of US$ 1 000. Economic growth figures vary from plus 21% to minus 5%. Health services The national annual per capita expenditure on health varies from US$ 10 to US$ 400. On average, public sector expenditure on health accounts for 60% of the total national expenditure on health. Only three countries devote 15% or more of their national budget to health as pledged by the Abuja Declaration of 20011. Pharmacists, pharmacy technicians and trained assistants pharmaceutical personnel are scarce in most countries. Medicines policy and regulatory framework Eighty per cent of SADC countries have a National Medicines Policy, although some need updating. Eleven countries have a Drug Regulatory Authority and issue marketing authorizations for pharmaceuticals. Of the 101 domestic manufacturers in SADC countries, 40% are based in one country; four countries have capacity for research and development of new pharmaceutical active substances. Financing for medicines The total expenditure on medicines is 12.5% (median) of total health expenditure in SADC countries and average annual public sector per capita medicines expenditure is US$ 10. Most countries provide medicines free of charge for targeted health problems and vulnerable groups including children and pregnant women. Regulation of medicine prices is not common, over 80% of the countries levy duties on imported raw materials and 40% taxes on medicines.

1 Abuja Declaration on HIV/AIDS, Tuberculosis and Other Related Infectious Diseases. African Summit on

HIV/AIDS, Tuberculosis and Other Related Infectious Diseases. Abuja, Nigeria, 24-27 April 2001.


x

Intellectual property rights and access to medicines Fourteen out of 15 SADC countries are members of the World Trade Organization (WTO) and 57% of countries have modified their legislation to comply with the TRIPS Agreement. Pharmaceutical procurement and supply The majority of countries have a procurement policy and give priority to domestic suppliers, while no country gives preferences to suppliers from other SADC countries. Most countries use tender boards, prequalification and quality assurance procedures. The most common procurement method is international competitive tender. Selection and rational use Twelve countries have updated their Essential Medicines Lists (EMLs) and Standard Treatment Guidelines (STGs) within the past five years. Prescribing by generic name in the public sector is compulsory in 12 countries out of 15. Regulation to set up Drug and Therapeutics Committees (DTCs) has been established in 67% of countries. Data on prescribing patterns at facility level are available for only seven countries. Household data According to the Word Health Survey conducted in 2002-3, on average, around 80% of patients had all prescribed medicines available, but great variations were observed between countries. As regards to reasons for patients not taking all prescribed medicines, affordability seems to be a considerable problem in some countries. In other countries where medicines are provided free of charge at public health-care facilities, the problem seems to be related more to lack of availability.

Background

1

1. Background

The Southern African region has been the focus of the global HIV/AIDS pandemic and has very high rates of mortality from TB and malaria. Mortality among women and children is also unacceptably high1. The disease burden in the SADC region is undermining efforts to eradicate poverty, which is the overarching priority for the regional integration agenda2. One of the obstacles affecting the response to the heavy disease burden is limited access to medicines and related commodities for prevention and treatment. While some countries have relatively good access to medicines and diagnostics, others are struggling to deliver good quality products to patients in sufficient quantities. Lack of access to essential medicines and related commodities has resulted in many unnecessary deaths in the region2. There are a number of factors that contribute to limited access to medicines and related commodities. These include inadequate public financing, weak procurement and supply management, insufficient qualified personnel, inadequate infrastructure, weak regulatory and quality assurance mechanisms and unaffordable prices3. WHO encourages countries to establish a strong legal and policy basis for the regulation and provision of medicines. The importance of human resources for health for the efficient functioning of a health-care system was stressed in the 2006 World Health Report4. The increasing demand for quality medicines and commodities in the region was one reason for the establishment of a pharmaceutical task force at the SADC Secretariat in August 2003. Its mandate is to plan, coordinate and harmonize regional policies and strategies in order to improve access to affordable pharmaceuticals. Consistent with this mandate, with the support of WHO, a Regional Pharmaceutical Business Plan was developed in 2007. The demand for medicines has also led to the prioritization of regional production of pharmaceuticals under the SADC Industrial Development Strategy. WHO and DFID both have a long history of commitment to improving access to medicines. In Southern Africa, DFID supported the South Africa Drug Action Programme (SADAP; 1996 – 2005) that was implemented by the South African Department of Health and WHO. Both WHO and DFID contributed to the development of the SADC Pharmaceutical Business Plan as part of the DFID/WHO/HAI Regional Collaboration for Action on Essential Medicines in Africa. WHO is committed to supporting the SADC Secretariat in the implementation of the SADC Pharmaceutical Business Plan, with overall objectives of ensuring the availability of essential medicines, including African traditional medicines, and contributing toward the reduction of the heavy disease burden in the countries. Within this collaboration, WHO has supported each of the SADC countries to collect and analyse data about the pharmaceutical situation during 2009. This information provides a useful baseline for embarking on the implementation of the 1 World health statistics 2010. Geneva, World Health Organization, 2010. 2 2008 SADC Consultative Conference and Summit Conference on Poverty and Development "Regional economic

Integration: a strategy for poverty eradication towards sustainable development". 18-20 April, 2008 Mauritius. Published by SADC Secretariat. Gaborone, 2008.

3 SADC Pharmaceutical business plan 2007-2013. SADC Secretariat, 27th June 2007. 4 The world health report 2006: Working together for health. Geneva, World Health Organization, 2006.


2

Pharmaceutical Business Plan. It can be used to identify areas in each country that need strengthening and support; to compare results between countries, fostering a sharing of experiences and enabling identification of common sectoral strategies; and to measure, over time, the impact of the support provided through the SADC Secretariat, WHO and other partners.

Methodology

3

2. Methodology WHO has developed a set of tools to assess the pharmaceutical situation in WHO Member States. They have been tested and used in several countries, and modified and improved according to the inputs received from users. The tools are divided into three levels and organized into a package. Level I is a questionnaire on the structures and processes of a country pharmaceutical situation and measures the situation at the level of national governments. It reveals whether key policies and structures (such as National Medicines Policies, Essential Medicines Lists etc.) are in place. The Level I Questionnaire is distributed every four years to all Member States and the latest round, in 2007, collected information from 156 countries. Level II is a practical and cost-efficient survey tool used by Ministries of Health to assess the outcomes of their policies and interventions in health facilities and in the community. It assesses the availability, rational use and many other aspects of medicines by sampling a number of public and private facilities. In addition to the facility survey, outcomes are also measured at household level using a sample of about 1000 households for each country. Level III is a series of more detailed survey tools to assess specific aspects of the pharmaceutical sector, such as medicines prices, procurement and supply systems, human resources or traditional medicines. For the purposes of the baseline assessment of the pharmaceutical situation in SADC countries, a revised questionnaire on pharmaceutical policies and structures was developed, based on previous tools elaborated by WHO and by other partners, such as the Medicines Transparency Alliance (MeTA). To facilitate the work at country level, country-specific data, available from global sources (e.g. WHO's Statistical System) and from within the Essential Medicines Department of WHO, were pre-filled in the questionnaire. These included data from the 2007 Level I Survey and also from country-specific assessments, such as the Level II facility survey6 and the WHO/HAI pricing surveys7. The partially pre-filled questionnaires were sent to the 15 SADC countries8 for public officials to review and amend the filled data and, where possible, complete the missing data fields. WHO Country Offices have overseen and facilitated the process and collected information from key agencies (Department of Pharmaceuticals, Central Medical Store, etc.). National consultants were recruited when necessary to assist with this process. The names of respondents to each section were registered in case follow-up was needed; the source of data was also included in the questionnaire as a guarantee of the quality of the information. A senior official in each

6 WHO Operational package for assessing, monitoring and evaluating country pharmaceutical situations. Guide for

coordinators and data collectors. Geneva, World Health Organization, 2007. 7 Measuring medicine prices, availability, affordability and price components, 2nd ed.. Geneva, World Health

Organization and Health Action International, 2008. 8 Angola, Botswana, Democratic Republic of the Congo, Lesotho, Madagascar, Malawi, Mauritius, Mozambique,

Namibia, Seychelles, South Africa, Swaziland, United Republic of Tanzania, Zambia and Zimbabwe.


4

country was requested to confirm the accuracy of the information and to provide permission for immediate publication on the SADC and WHO web sites. The aim of this fact book is to present summary of the data collected through the baseline assessment and not to draw conclusions or to make recommendations. Therefore, only preliminary analysis has been conducted on some of the data provided by SADC countries and, for the selected indicators, the results of this analysis are presented in this report. The report is divided into eight sections, one for each of the eight topic areas of the questionnaire:

• Health and demographic data • Health services • Medicines policy and regulatory framework • Financing for medicines • Intellectual property rights and access to medicines • Procurement and supply • Selection and rational use • Household data

For each section, the data are presented in table format, showing the number and percentage of SADC countries that have a particular structure in place or, in the case of numeric variables, the median value as well as the minimum and maximum values. In addition, graphs are provided for some of the indicators presented in the tables. Some countries did not reply to some of the questions. When the non-response rate for an indicator is above 30%, an asterisk (*) is placed beside the question. The median is used for an average, in preference to the mean average, in order to eliminate the influence of extreme values caused by the diverse country situations. For a list of key selected indicators data on each country completed of year and source is provided in the annexes. These indicators presented in the annexes are highlighted in grey in the report. Besides the development of this summary report, the data collected through the baseline assessment have also been used to develop a Pharmaceutical Profile for each of the responding countries. These profiles can be accessed on-line through the WHO Medicines web site at http://www.who.int/medicines/areas/coordination/coordination_assessment/en/index.html. This fact book presents information on only a number of indicators collected through the baseline survey. Anyone wishing to receive an electronic copy of the complete dataset can contact the Department of Essential Medicines and Pharmaceutical Policies, World Health Organization, 1211 Geneva 27, Switzerland, Fax +41 22 791 4167, E-mail: [email protected].

Demography and economy

5

3. Demography and economy 3.1 Introduction This section provides basic information on health, economy and population in the SADC countries. Key demographic data are presented, such as total population, composition of the population, literacy rate, life expectancy and mortality. In addition to this, economic information is presented, such as the GNI per capita and Gross Domestic Product (GDP) growth. The data demonstrates the diversity within SADC with a country population ranging from 87 000 (Seychelles) to over 60 million (Democratic Republic of Congo). The Seychelles is an upper-middle-income country with the mortality profile of a developed country, while several other SADC countries have GNIs per capita of less than US$ 1 000 and very high rates of maternal and child mortality; in these latter countries more than half the population lives on less than US$ 1 a day, while the median figure across SADC is 52%. The total GDP of SADC countries is over US$ 500 billion, almost 70% of which is represented by South Africa. The rate of economic growth varies from over 20% (Angola) down to a negative growth rate (Zimbabwe and South Africa). 3.2 Demographic and economic indicators in SADC countries

Table 3.1 Population Median MAX MIN

Population (,000) 65,800 87

% of population < 15 years 40% 50% 23%

% of population > 60 years 5% 11% 4%

% of urban population 36% 60% 18%

Population growth 2% 2.9% 0.5%

Fertility rate 3.6 6.5 1.9


6

Table 3.2 Economy

Median MAX MIN

GDP US$ billions 362.8 0.7

GDP growth 6% 21.1% 5.3%

GNI per capita, US $ current exchange rate 1 030 8 960 140

Population living < PPP int. US$ 1 a day 52% 82% 21%

Income share held by lowest 20%* 6% 10% 1%

PPP= Purchasing Power Parity. * More than 30% of countries did not respond to this question

Table 3.3 Life expectancy and mortality

Median MAX MIN

Life expectancy at birth both sexes 50 73 33

Adult mortality rate (15 to 60 years) per 1000 514 725 157

Maternal mortality ratio per 100,000 live births 549 1 400 15

Neonatal mortality rate per 1000 32 54 9

Infant mortality rate per 1000 70 116 13

Under 5 mortality rate per 1000 91 170 15

Health services

7

4. Health services 4.1 Introduction

This section presents data about health expenditure in SADC countries, the number of personnel working in the pharmaceutical sector and the number of health facilities available. Information on health expenditure was mainly gathered through the National Health Accounts available on the WHO web site9, but some countries have updated information using their own accounting systems. Again the diversity of SADC countries is demonstrated.

Only a few countries are living up to the commitment of the Abuja Declaration of 2001 that requires governments to devote 15% of their total budget to health spending10. The share of public health expenditure in the total health expenditure is 60% on average in the responding SADC countries.

The annual per capita expenditure on health varies from over US$ 400 in Seychelles and South Africa to around US$ 10 in Democratic Republic of Congo and Madagascar. The median figure of US$ 32 is low, considering that, in 2001, the Commission on Macroeconomics and Health considered a per capita expenditure of US$ 34 as "very modest"11.

The number of pharmaceutical personnel per 10 000 population varies from over seven in Seychelles to 0.3 in Lesotho and Malawi. The low number of pharmaceutical personnel found in some SADC countries has implications for the functioning of the health system and for the health of the population. The data reveal national variations in the proportion of pharmacists to technician/assistant levels and also in the number of licensed pharmacies.

4.2 Health expenditure

Table 4.1 Health expenditure Median Max Min

Total annual exp on health (US$) 34 525 679 297 36 523 312

Expenditure on health as % of GDP 6.9% 12.9% 2.6%

Government annual expenditure on health (US$) 13 028 733 666 27 495 375

Expenditure on health as % of government budget 11.3% 18.0% 3.6%

Expenditure on health per capita (US$) 32 565 9

Government expenditure as % of total expenditure 62.8% 86.8% 10.8%

Private expenditure as % of total health expenditure 37.2% 89.2% 13.2%

9 http://www.who.int/nha/en/ 10 Abuja Declaration on HIV/AIDS, Tuberculosis and Other Related Infectious Diseases. African Summit on

HIV/AIDS, Tuberculosis and Other Related Infectious Diseases. Abuja, Nigeria, 24-27 April 2001. 11 Macroeconomics and health: Investing in health for economic development. Report of the Commission on

Macroeconomics and Health. Geneva, World Health Organization, 2001.


8

Figure 4.1

government expenditure on health as % of government budget

0%

4%

8%

12%

16%

20%

Angola

Botswana

DRCLesotho

Madagascar

Malawi

Mauritius

Mozambique

Namibia

Seychelles

South Afric

a

Swaziland

United Republic

ofTanzaniaZambia

Zimbabwe

Figure 4.2

Abuja commitment of 15% of budget

Government expenditure as % of total expenditure on health

0%

20%

40%

60%

80%

100%

Angola

Botswana

DRC

Lesotho

MadagascarMalawi

Mauritius

MozambiqueNamibia

Seychelles

South Africa

Swaziland

United Republic ofTanzaniaZambia

Zimbabwe

Median 62.8%

Health services

9

Pharmaceutical personnel per 10 000 of the population

0

1

2

3

4

5

6

7

8

Angola

Botswana

DRC

Lesotho

Madagascar

Malawi

Mozambique

Namibia

Seychelles

South Africa

Swaziland

United Republic ofTanzania

Zambia

Zimbabwe

Median 0.7

4.3 Human resources for the pharmaceutical sector

Table 4.2 Human resources for the pharmaceutical sector

Median Max Min

Total number of pharmaceutical personnel 803 20 162 61

Total number of pharmacists 247 11 833 3

Total number of technicians and assistants 385 3 409 37

Newly registered pharmacists 19 142 0

Number of pharmaceutical personnel per 10 000 pop 0.7 7.6 0.3

Figure 4.3


10

Figure 4.4

Composition of the pharmaceutical workforce

0%10%20%30%40%50%60%70%80%90%

100%

Angola

Botswan

aDRC

Malawi

Mozam

bique

Namibi

a

Seych

elles

South

Africa

Swazila

nd

United

Rep

ublic

ofTan

zania

Zambia

Zimba

bwe

technicians &assistants

pharmacists

4.3 Health facilities

Table 4.3 Health Facilities (Public and private sector)

Median Max Min

Hospitals 48 639 6

Hospital beds per 10,000 pop 13 39 3

Primary health-care units and facilities 1 462 6 705 16

Licensed pharmacies 168 1 036 3

Licensed pharmacies per 10,000 pop 0.03 0.18 0.00

Health services

11

Hospital beds for 10,000 population

048

121620242832364044

Angola

Botswan

aDRC

Leso

tho

Madag

asca

r

Malawi

Mauriti

us

Mozam

bique

Namibi

a

Seych

elles

South

Africa

Swazila

nd

United

Rep

ublic

ofTan

zania

Zambia

Zimba

bwe

Licensed pharmacies

0

200

400

600

800

1,000

1,200

Angola

Botswan

a

Madag

asca

r

Malawi

Mauriti

us

Mozam

bique

Namibi

a

Seych

elles

Swazila

nd

United

Rep

ublic

ofTan

zania

Zambia

Zimba

bwe

no. o

f lic

ense

d ph

arm

acie

s

0.00

0.02

0.04

0.06

0.08

0.10

0.12

0.14

0.16

0.18

0.20

licen

sed

phar

mac

ies

per

10 0

00 p

op

no. oflicensedpharmacies

Licensedpharmaciesper 10,000pop

Figure 4.5

Figure 4.6

Median

13


12

Medicines policy and regulatory framework

13

5. Medicines policy and regulatory framework WHO recommends that countries formulate and implement a National Medicines Policy (NMP) as a “commitment to a goal and a guide for action”. A NMP needs to be updated regularly as new challenges arise (e.g. HIV/AIDS; international trade agreements). Laws and regulations create a legal basis for ensuring the quality of public and private pharmaceutical activities. Twelve out of 15 countries have an official National Medicines Policy, but only five of them have updated it within the last five years. Ten out of 12 countries with a NMP also have an implementation plan. Eleven out of 15 countries have a formal Drug Regulatory Authority and about half of them collect registration fees. Eleven out of 15 countries have provision for marketing authorization of pharmaceuticals. The median average registration fee for branded medicines is about US$ 600 though South Africa has a fee of US$ 30 000. The fee for generic products drops by 50% in South Africa but there is only a minor difference between fees for branded and generic medicines in other countries. The number of medicines registered varies widely from country to country, starting from 1,407 in Mozambique reaching a maximum of 12 000 in South Africa. Most of the countries have legal provisions to inspect pharmaceutical premises and over 70% of the countries test medicine samples for post-marketing surveillance. Adverse drug reactions (ADRs) are monitored in over 85% of the countries and 69% of the countries report them to the WHO Collaborating Centre in Uppsala.


14

5.1 Policy framework

Table 5.1 National Medicines Policies in SADC countries

Yes/Respondents %

Official National Medicines Policy document exists 12/15 80.0%

-If no, draft NMP document exists 3/15 20%

NMP updated within the last 5 years 5/15 33.3%

National Medicines Policy Implementation Plan exists 10/15 66.7%

Traditional Medicines Policy exists 4/14 28.6%

5.2 Regulatory framework

Table 5.2 Drug Regulatory Authorities in SADC countries

Yes/

Respondents % Median MAX MIN

Formal Regulatory Authority 11/15 73.3%

Number of staff * - - 17 143 3

Authority financed from government budget 11/13 84.6%

Authority financed through fees 7/13 53.8%

Regulatory Authority involved in harmonization initiatives 13/15 86.7%

* More than 30% of countries did not respond to this question


15

Number of regulatory staff

0

20

40

60

80

100

120

140

160

Angola

Botswan

a

Madag

asca

r

Malawi

Mozam

bique

Namibi

a

Seych

elles

Tanza

nia

Figure 5.1


Table 5.3 Registration

Yes/

Respondents % Median Max Min

Legal provision for marketing authorization 11/15 73.3%

Number of medicines registered* - - 3 382 12 083 1,407

List of registered products publicly available 10/12 83.3%

Fee for originator or branded medicines (US$)* - - 610 30 000 150

Fee for generic medicines (US$)* - - 510 15 000 136

Length of time for registration (months)* - - 9 24 3

Median

17


16

Number of medicines registered

3,5642,400

4,486

12,083

2,148

4,7133,200

1,451

5,000

1,407

0

2,000

4,000

6,000

8,000

10,000

12,000

14,000

Botswan

a

Madag

asca

r

Malawi

Mauriti

us

Mozam

bique

Namibi

a

South

Africa

United

Rep

ublic

ofTan

zania

Zambia

Zimba

bwe

Figure 5.2

Table 5.4 Quality control

Yes/Respondents %

Legal provisions to inspect pharmaceutical premises and collect samples 13/15 86.7%

Legal provisions to combat counterfeits 8/13 53.3%

Samples tested for post-marketing surveillance 11/15 73.3%

ADRs are monitored 13/15 86.7%

ADRs are reported to the WHO Collaborating Centre, Uppsala 9/13 69.2%

Median 3,382


17

Figure 5.3

Table 5.5 Promotion of medicines

Yes/Respondents %

Legal provisions to regulate promotion 10/15 66.7%

Direct advertising of prescription medicines to consumers is forbidden 11/15 73.3%

Regulatory preapproval is required 8/14 57.1%

Guidelines on promotion exist 7/15 46.7%

Code of conduct for doctors exists 2/11 18.2%

Quality control

0%20%40%60%80%

100%

Legal provisions to inspect premises and collect samples

Legal provisions to combat

counterfeits

Samples tested for post- marketing

surveillance

ADRs are monitored


18

Promotion and advertising

0%

20%

40%

60%

80%

Lega

l prov

isions

to re

gulat

e prom

otion

No adv

ertisin

g of p

rescri

ption

med

icine

s to t

he pu

blic

Regula

tory p

reapp

roval

is req

uired

Guideli

nes o

n prom

otion

exist

s

Code o

f con

duct

for do

ctors

exist

s

Figure 5.4

Financing for medicines

19

6. Financing for medicines Public expenditure per capita on pharmaceuticals in many SADC countries remains extremely low with a median figure of less than US$ 10 per capita. Five countries have a per capita expenditure on medicines of less than US$ 3. Low levels of funding are a major obstacle to providing access to medicines. On average, expenditure on medicines accounts for almost 20% of public expenditure on health. Most SADC countries provide medicines free of charge for key treatments like HIV/AIDS, TB and, less often, malaria, but user fees continue to be applied for other essential medicines in some countries. More than 80% of the countries have duties on imported raw materials, while only 40% have duties on imported finished products. Forty percent of the countries impose value-added tax (VAT) or other taxes on medicines. Regulation of medicines prices is an important strategy since the price of medicines can be a major obstacle to ensure affordability and access to medicines. Only 20-25% of the countries regulate the manufacturer's selling price and the maximum wholesale mark-up. The maximum retail mark-up is regulated by almost 50% of the countries, but only 25% of the countries regulate maximum retail price. Twenty-five percent of the countries conduct active monitoring of retail prices and of these countries, only two make the information on medicines prices publicly available.

Table 6.1 Public expenditure on medicines

Median Max Min

Total public expenditure on medicines (US$)

23,639,585 51,686,261 1,691,670

Public per capita expenditure on medicines (US$)

9.4 34.5 0.1


20

Figure 6.1

Expenditure per capita on medicines (US$)

5.4

27.5

9.4

2.6

11.1

0.9

36.2

2.42.7

9.5

34.7

1.4

10.1

0.1

34.5

2.3

9.5

2.0

0

5

10

15

20

25

30

35

40

Botswan

a

Leso

tho

Madag

asca

r

Malawi

Mauriti

us

Mozam

bique

Namibi

a

Seych

elles

Swazila

nd

United

Rep

ublic

ofTan

zania

Zambia

totalpublic

Table 6.2 Provision of medicines free of charge at public health facilities

Yes/Respondents %

Existence of National Health Insurance or Social Health Insurance 6/14 42.9%

National Health Insurance or Social Health Insurance covers medicines* 5/5 100.0%

Free medicines for HIV/AIDS 15/15 100.0%

Free medicines for tuberculosis 15/15 100.0%

Free medicines for malaria 11/14 78.6%

Free medicines for children below 5 years of age 13/15 86.7%

Free medicines for pregnant women 14/15 93.3%

Free medicines for those who cannot afford them 14/15 93.3%


Financing for medicines

21

Free medicines at public health facilities

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Free medicines forHIV/AIDS

Free medicines forTB

Free medicines formalaria

Free medicines forchildren below 5

Free medicines forpregnant women

Free medicines forthose who cannot

afford them

Figure 6.2

Table 6.3 Regulation and price control in the private sector

Yes/Respondents %

Manufacturers' selling price is regulated 3/14 21.4%

Maximum wholesale mark-up 4/15 26.7%

Maximum retail mark-up 7/15 46.7%

Maximum retail price 4/15 26.7%

Active national monitoring of retail prices 4/15 26.7%

Information on retail prices of medicines is made publicly available

2/14 14.3%


22

Table 6.4 Duties and taxes on pharmaceuticals

Yes/Respondents %

Duty on imported raw materials 12/14 85.7%

Duty on imported finished products 6/15 40.0%

VAT or other taxes on medicines 6/15 40.0%

Intellectual property rights and access to medicines

23

7. Intellectual property rights and access

to medicines

The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) requires WTO members to provide minimum standards of intellectual property protection, including patent protection. There are TRIPS-compliant mechanisms that can be used to enable access to lower-priced medicines, which are necessary to address public health concerns. Almost all SADC countries are members of WTO. Over 50% have modified their legislation to take account of the TRIPS Agreement and public health safeguards and other measures that promote generic competition and 60% of countries use the TRIPS flexibilities including compulsory licensing (9 countries), parallel importing provisions (7 countries) and Bolar provision (4 countries). Table 7.1 Patents

Yes/Respondents %

Country member of WTO 14/15 93.3%

Patents granted by national offices 10/15 66.7%

Legislation modified to incorporate the TRIPS Agreement and flexibilities

8/14 57.1%

TRIPS flexibilities in place: - -

-Compulsory licensing 9/15 60.0%

-Government use 8/14 57.1%

-Parallel importing 7/15 46.7%

-Bolar provision 4/13 30.8%


24

TRIPS flexibilities incorporated in legislation

0%

20%40%60%

80%

100%

Compusorylicensing

Government use Parallel importing Bolar exception

Figure 7.1

Procurement and supply

25

8. Procurement and supply This section addresses the procurement of medicines and briefly highlights the main features of procurement systems in SADC countries. The majority of countries have a written public sector procurement policy; almost all countries (93%) have a procurement board and a process in place to ensure the quality of procured products. The most commonly used procurement method is international competitive tender and 13 of the 14 responding countries have a tender board committee as well as a process to ensure the quality of products procured. Prequalification of suppliers is carried out in 80% of the countries.

All responding countries have provisions giving priority to domestic suppliers (importers and wholesalers) but no country gives priority to suppliers from other SADC countries. Out of the 50 most procured products in Zambia, the great majority are provided by suppliers from India (76%) and China (16%). In Malawi, suppliers from India account for the greatest share of public sector procurement, but suppliers from SADC countries (38%) and national suppliers (10%) also have considerable importance.

All countries have software tools available for the management of distribution in the public sector but less than half of the countries have national guidelines for good distribution of pharmaceuticals.

The procurement methods used vary considerably between different countries in the SADC region.

Only a minority of countries have capacity for research and development, and production of pharmaceutical starting materials (4 and 2 respectively).

The country with the highest number of domestic manufacturers in the community is South Africa with 40% of the manufacturers in the SADC region (42 manufacturers).

8.1 Structures and processes for pharmaceutical procurement and supply systems

Table 8.1 Procurement

Yes/Respondents %

Presence of written public sector procurement policy 11/14 78.6%

Preference to domestic manufacturers 12/12 100.0%

Preference to SADC manufacturers from another country 0/14 0.0%

General procurement rules for the public sector also apply to pharmaceuticals 12/14 85.7%


26

Human resources for procurement

0

10

20

30

40

50

60

70

Botswan

aDRC

Madag

asca

r

Leso

tho

Malawi

Mauriti

us

Mozambiq

ue

Namibi

a

Seych

elles

Swazila

nd

United

Repu

blic ofT

anza

nia

Zambia

Zimba

bwe

working full-time inprocurement

working full-time inquality control

Figure 8.1

Table 8.2 Procurement capacity for pharmaceuticals

Yes/ Respondents

% Median MAX MIN

Tender Board 13/14 92.9%

Functioning process to ensure quality 13/14 92.9%

Prequalification of suppliers is carried out 11/14 78.6%

Capacity building strategy 9/13 69.2%

Number of people working on public procurement - - 11 65 3

Number of people working on quality assurance - - 4 15 1


27

Procurement methods used (% of procurement value)

0%10%20%30%40%50%60%70%80%90%

100%

DRC

Madag

asca

r

Malawi

Mauriti

us

Mozam

bique

Namibi

a

Seych

elles

South

Africa

Swazila

nd

United

Rep

ublic

ofTan

zania

Zambia

direct purchasingnegotiationint. comp. tend.nat. comp. tend.

* More than 30% of countries did not respond to this question Figure 8.2

Table 8.3 Procurement methods used

Median MAX MIN

National competitive tenders 7.0% 100.0% 0.0%

International competitive tenders 79% 100.0% 0.0%

Negotiation* 0.0% 75.0% 0.0%

Direct purchasing* 4.0% 31.0% 0.0%


28

Location of suppliers of 50 most procured products- Zambia

India76%

China16%

Local4%

SADC4%

Figures 8.3 a) and b) a) b)

Location of suppliers of 50 most procured products- Malawi

SADC38%

Local10%

India52%


29

Number of domestic manufacturers

0 0

22

0 14 2 1 1 0

42

1

7 6

14

0

5

10

15

20

25

30

35

40

45

Angola

Botswan

aDRC

Leso

tho

Madag

asca

r

Malawi

Mauriti

us

Mozam

bique

Namibi

a

Seych

elles

South

Africa

Swazila

nd

United

Rep

ublic

ofTan

zania

Zambia

Zimba

bwe

8.2 Local production for pharmaceuticals

Table 8.3 Local Production

Yes/ Respondents

% Median Max Min

Legal provisions for licensing of domestic manufacturers 11/15 73.3%

Good Manufacturing Practices (GMP) guidelines are available 10/15 66.7%

Number of domestic manufacturers /15 - 42 0

Number of GMP compliant manufacturers /14 - 0 39 0

Capacity for Research and Development 4/15 26.7%

Capacity for production of pharmaceutical starting materials 2/15 13.3%

Capacity for production of formulations from pharmaceutical starting material 11/15 73.3%

Capacity for repackaging of finished dosage forms 8/15 53.3%

Figure 8.4


30

Selection and rational use

31

9. Selection and rational use Some policies, strategies and interventions which WHO has found to be of value are used as criteria to assess the rational use of medicines. These include the development and dissemination of national standard treatment guidelines, lists of essential medicines and the establishments of structures promoting rational use such as hospital Drug and Therapeutics Committees.

Twelve countries out of 15 have updated Essential Medicines List as well as updated Standard Treatment Guidelines. The number of medicines in the National EMLs range from 600 in Madagascar and Namibia to around 200 in Lesotho and Malawi, with an average of 430.

Nurses and midwives are legally allowed to prescribe in around 50% of the countries, while a small minority of countries allow pharmacists and community health workers to prescribe. Antibiotics and some other potent or specialised medicines are usually listed as prescription-only medicines, however in a number of countries antibiotics seem to be sold over-the-counter despite national laws forbidding this practice.

Two-thirds of the countries have regulations requiring hospitals to set up Drug and Therapeutic Committees and 50% of countries have provisions to make continuing education for doctors compulsory. There is an information centre for prescribers in less than 50% of countries. Prescribing by generic name is compulsory in the public sector of over 80% of SADC countries.

Half of the countries submitted information on prescribing indicators. The percentage of patients prescribed antibiotics range from 70% in Malawi to 24% in Seychelles; injections are given to 16% of patients; in Malawi and in Seychelles 87% of children with diarrhoea are treated with oral rehydration salts, but the percentage is only 41% in Angola.

Table 9.1 Selection of medicine, formularies and standard treatment guidelines

Yes/ Respondents % Median MAX MIN

Existence of EML updated over the last 5 years 12/15 80.0%

Number of medicines in EML* - - 433 600 180

Committee for selection of EML 14/15 93.3%

Explicit criteria for selection of medicines 9/11 81.8%

Existence of STGs updated over the last 5 years 13/15 86.7%

Existence of National Formulary updated over the last 5 years

5/15 33.3%

Existence of STGs for children updated over the last 5 years

8/14 57.1%



32

Essential Medicines List and Standard Treatment Guidelines

0%

20%

40%

60%

80%

100%

Existence of updated EML Updated STGs Updated formulary Updated STGs for children

Figure 9.1

Figure 9.2

Number of medicines in Essential Medicines List

500

216180

400 415

600

497

404

556

450

0

100

200

300

400

500

600

700

Botswana

Lesotho

Madagascar

Malawi

Mauritius

Mozambique

Namibia

Seychelles

Swaziland

Zambia


33

Health workers allowed to prescribe

0%10%20%30%40%50%60%70%80%90%

100%

Nurses legally allowedto prescribe

Midwives legallyallowed to prescribe

Community healthworkers legally allowed

to prescribe

Pharmacists legallyallowed to prescribe

Table 9.2 Legislation and policies on prescribing

Yes/Respondents %

Nurses legally allowed to prescribe 7/12 58.3%

Midwives legally allowed to prescribe 6/12 50.0%

Community health workers legally allowed to prescribe 2/12 16.7%

Pharmacists legally allowed to prescribe 1a/12 8.3%

Prescribers are legally allowed to dispense 8/13 61.5%

Regulation requiring DTCs to be set up 10/15 66.7%

Compulsory continuing education for doctors 7/14 50.0%

Medicine information centre for prescribers 7/15 46.7%

Prescribing by generic name compulsory in public sector 12/15 80.0%

Prescribing by generic name compulsory in private sector 4/15 26.7%

Figure 9.3

a The country is Namibia. Pharmacists are only allowed to prescribe certain medicines (Namibian Schedule 1 list).


34

Policies to promote rational prescribing

0%10%20%30%40%50%60%70%80%90%

100%

Regulation requiring DTCsto be set up

Compulsory continuingeducation for doctors

Information centre forprescribers

Prescribing by genericname compulsory in public

sector

Figure 9.4

Table 9.3 Rational prescribing indicatorsa

Median MAX MIN Respondents

Number of medicines prescribed per patient* 3.0 4.0 1.8 9

% of patients prescribed antibiotics* 49.9% 70.0% 24.0% 9

% of patients given injections* 14.0% 32.6% 4.6% 7

Diarrhea in children treated with oral rehydration salts (%)*

82.0% 100.0% 41.2% 7

Non-pneumonia acute respiratory infections treated with antibiotics (%)* 71.0% 90.0% 49.0% 6


a These data come from surveys conducted at national level. The sources of information for each country

are indicated in the Pharmaceutical Country Profiles at http://www.who.int/medicines/areas/coordination/coordination_assessment/en/index.html.


35

Average number of medicines prescribed per visit

0

0.5

1

1.5

2

2.5

3

3.5

4

4.5

Angola

Botswan

aDRC

Leso

tho

Malawi

Namibi

a

Seych

elles

United

Rep

ublic

of Tan

zania

Zambia

Use of antibiotics and injections

0%

10%

20%

30%

40%

50%

60%

70%

80%

Angola Botswana DRC Lesotho Malawi Namibia Seychelles UnitedRepublic ofTanzania

Zambia

% of patientsgivenantibiotics

% of patientsgiveninjections

Figure 9.5

Figure 9.6


36

Policies to promote rational dispensing

0%

20%

40%

60%

80%

100%

Pharmacistcurriculum

covering EML

Mandatorycontinuing

education for pharmacists

Publicinformationcentre for

prescribers

Genericsubstitutionpermitted in

publicpharmacies

Genericsubstitutionpermitted in

privatepharmacies

Figure 9.7

Adherence to STGs

0%10%20%30%40%50%60%70%80%90%

100%

Angola

Botswan

aDRC

Leso

tho

Malawi

Seych

elles

United

Rep

ublic

of Tan

zania

Zambia

diarrohea inchildrentreated withORS (%)

non-pneumoniaARIs treatedwith antibiotics

Figure 9.8


37

Table 9.4 Legislation and policies on dispensing

Yes/ Respondent

%

Legal provision to govern licensing of pharmacists 15/15 100.0%

Pharmacist curriculum covering the concept of Essential Medicines 10/12 83.3%

Mandatory continuing education for pharmacists 6715 40.0%

Public medicine information centre for dispensers 6/15 40.0%

Generic substitution permitted for public dispensers 12/15 80.0%

Generic substitution permitted for private dispensers 11/15 73.3%


38

Household data

39

10. Household data WHO has developed and implemented the World Health Survey to compile comprehensive baseline information on the health of populations, on the outcomes associated with the investment in health systems and on the way health systems are currently functioning. The data have been collected at the household level in over 70 countries1. This section presents information taken from the World Health Surveys conducted in some SADC countries in 2002-03, but also, when available, information gathered through household surveys conducted by some countries with the support of the Essential Medicines and Pharmaceutical Policies Department of WHO. These household surveys on access to and use of medicines have been developed in the past few years and represent a powerful instrument to gather information on prices and availability of medicines as well as patients' practice2. The data presented here highlight the differences between countries in terms of access to medicines; in some countries access seems to be constrained by availability issues while in others affordability of medicines is the main obstacle. On average, around 80% of patients have all the medicines prescribed available, but there are great variations between countries. For example, while in Mauritius almost all patients with chronic conditions have their prescribed medicines available, in Zambia only 57% of them do so. As regards the reasons for not taking all medicines, affordability seems to be a considerable problem in Angola. In other countries where medicines are provided for free at public health care facilities (Malawi, Namibia, South Africa and Zambia) the problem seems to be more related to lack of availability.

1 More information on the World Health Survey can be found at:

http://www.who.int/healthinfo/survey/en/index.html 2 More information on household surveys and other studies on access to medicines in countries can be found at:

http://www.who.int/medicines/areas/coordination/coordination_assessment/en/index.html.


40

Source: "WHO World Health Survey 2002-2003. For Angola, the source is "Avaliação do Sector Farmacêutico de Angola, 2007".

* Poor household are those that are in the poorest 20% of the population.

Table 10.1 Access to medicines at household level (2002-2007)

Median Max Min

Adults with acute conditions taking all medicines prescribed 85.4% 100.0% 62.8%

Adults with acute conditions not taking all medicines because they cannot afford them 1.3% 18.1% 0.0%

AD

UL

T A

CU

TE

Adults with acute conditions not taking all medicines because they cannot find them 8.0% 17.0% 0.0%

Adults (from poor households)* with acute conditions taking all medicines prescribed 84.4% 100.0% 71.1%

AD

UL

T

AC

UT

E P

OO

R

Adults (from poor households)* with acute conditions not taking all medicines because they cannot afford them

0.6% 5.3% 0.0%

Adults with chronic conditions taking all medicines prescribed 90.8% 98.5% 56.8%

Adults with chronic conditions not taking all medicines because they cannot afford them 1.6% 11.4% 0.0%

AD

UL

T C

HR

ON

IC

Adults with chronic conditions not taking all medicines because they cannot find them 4.7% 31.8% 0.0%

Adults (from poor households)* with chronic conditions taking all medicines prescribed 83.0% 98.6% 68.2%

AD

UL

T

CH

RO

NIC

PO

OR

Adults (from poor households)* with chronic conditions not taking all medicines because they cannot afford them

0.0% 10.0% 0.0%

Children with acute conditions taking all medicines prescribed 88.1% 99.2% 82.0%

Children with acute conditions not taking all medicines because they cannot afford them 1.0% 5.6% 0.0%

CH

ILD

RE

N A

CU

TE

Children with acute conditions not taking all medicines because they cannot find them 8.1% 13.9% 0.0%

Children (from poor households)* with acute conditions taking all medicines prescribed 87.1% 99.5% 70.3%

CH

ILD

RE

N

AC

UT

E P

OO

R

Children (from poor households)* with acute conditions not taking all medicines because they cannot afford them

0.2% 7.0% 0.0%

Household data

41

Adults with acute conditions not taking all medicines prescribed because they cannot afford them

0.4% 0.2%2.9% 2.6% 2.4% 1.3%

18.1%

0.0%0.0%0%2%4%6%8%

10%12%14%16%18%20%

AngolaMalawi

Mauritius

Namibia

Seychelles

South Africa

SwazilandZambia

Zimbabwe

Adults with acute conditions not taking all medicines prescribed because they cannot find them

7.7% 8.2%

0.4%

8.5%7.0%

0.0%

17.0%

10.9%

0%2%4%6%8%

10%12%14%16%18%

Angola

Malawi

Mauriti

us

Namibi

a

South

Africa

Swazila

nd

Zambia

Zimba

bwe

Figure 10.1

Figure 10.2


42

Annexes: Country data on selected key indicators

43

Annexes

Country data on

selected key indicators


44


45

Annex 1 Pharmaceutical personnel per 10,000 population

Country Value Year Source

Angola 0.7 2004 WHO Global Atlas of Health Workforce

Botswana 2.3 2009 Health Manpower Establishment Register

Democratic Republic of Congo 0.5 2008 Ordre des Pharmaciens

Lesotho 0.3 2003 WHO Global Atlas of health workforce

Madagascar 3.2 2004 Global Atlas of health workforce

Malawi 0.3 2009 Pharmacy, Medicines and Poisons Board

Mauritius N.A. N.A. N.A.

Mozambique 0.82 2009 Ministério da Saúde

Namibia 2 2008 Pharmacy Council of Namibia

Seychelles 7.6 2004 Global Atlas of Health Workforce

South Africa 4.1 2009 South Africa Pharmaceutical Council

Swaziland 0.7 2007 Expert Opinion

United Republic of Tanzania 0.4 2009

Assessment of the Human Resources for the pharmaceutical sector in Tanzania, 2009

Zambia 0.6 2009 Medical Council of Zambia register

Zimbabwe 0.7 2004 Global Atlas of Health Workforce


46

Annex 2 NMP updated within 5 years

Country NMP available

Year of last update Source

Angola No Avaliação do Sector Farmacêutico de Angola, 2007

Botswana Yes 2002 National Medicines Policy

Democratic Republic of Congo Yes 2005 Politique Pharmaceutique

Nationale

Lesotho Yes 2005 National Medicines Policy

Madagascar Yes 2005 Politique Pharmaceutique Nationale

Malawi Yes 2009 National Medicines Policy

Mauritius No N.A. WHO Level I Survey

Mozambique Yes 1995 Ministério da Saúde

Namibia Yes 1998 Ministry of Health and Social Services Namibia

Seychelles No N.A. WHO Level I Survey

South Africa Yes 1996 National Medicines Policy

Swaziland Yes 2008 National Pharmaceutical Policy

United Republic of Tanzania Yes

1991 for Mainland 2008 for Zanzibar

National Pharmaceutical Policy

Zambia Yes 1999 WHO Level I

Zimbabwe Yes 1995 Ministry of Health and child welfare


47

Annex 3 Presence of medicines regulatory authority

Country Value Year Source Angola Yes 2003 WHO Level I Survey

Botswana Noa 2009 Ministry of Health

Democratic Republic of Congo Yes 2008 Ministère de la Santé

Publique

Lesotho No 2009 Ministry of Health

Madagascar Yes 2007 WHO Level I Survey

Malawi Yes 2007 WHO Level I Survey

Mauritius Yes 2007 WHO Level I Survey

Mozambique No 2007 WHO Level I Survey

Namibia Yes 2009 Ministry of Health and Social Services

Seychelles Yes 2009 Draft National Medicines Policy

South Africa Yes 2007 WHO Level I Survey

Swaziland No 2009 Ministry of Health Pharmaceutical Service Directorate

United Republic of Tanzania Yes 2007 WHO Level I


Zimbabwe Yes 2007 WHO Level I

a A drug regulatory unit has been formed within the Ministry of Health to carry out regulatory

affairs.


48

Annex 4 Legal provisions for marketing authorization

Country Value Year Source Angola No 2003 WHO Level I Survey

Botswana Yes 1992 Drugs and Related Substances Act (DRSA)


Publique


Madagascar Yes 2007 WHO Level I

Malawi Yes 2007 WHO Level I

Mauritius Yes 2007 WHO Level I

Mozambique Yes 2009 Departamento Farmacêutico


Seychelles No 2007 WHO Level I

South Africa Yes 2007 WHO Level I

Swaziland No 2009 Ministry of Health Pharmaceutical Service Directorate





49

Annex 5 Legal provisions to inspect pharmaceutical premises and collect samples


Angola Yes 2008 National Directorate of Medicines and Equipments



Publique

Lesotho Yes 2003 WHO Level I Survey






Seychelles No 2007 WHO Level I Survey


Swaziland No 2009 Ministry of Health Pharmaceutical Services Directorate





50

Annex 6 ADRs are monitored


Angola No 2008 National Directorate of Medicines and Equipments

Botswana Yes 2008 WHO Collaborating Centre Uppsala


Publique/



Malawi No 2007 WHO Level I Survey



Namibia Yes 2008

Namibia Medicines Regulatory Council and Therapeutic Information and Pharmacovigilance Centre

Seychelles Yes 2007 WHO Level I Survey


Swaziland Yes 2009 Ministry of Health Pharmaceutical Services Directorate





51

Annex 7 Legal provisions to combat counterfeits


Angola No 2008 National Directorate of Medicines and Equipments

Botswana No 2009 Ministry of Health


Publique


Madagascar No 2007 WHO Level I






South Africa Yes 2007 WHO Level I Survey

Swaziland No 2009 Ministry of Health Pharmaceutical Services Directorate





52

Annex 8 Public per capita expenditure on medicines (US$)

Country Value Year Source Angola N.A. N.A N.A

Botswana 27.5 2008 Central Medical Store Database

Democratic Republic of Congo N.A. N.A. N.A.

Lesotho 9.4 2009 Ministry of Health. Annual Joint Report 2009

Madagascar 0.1 2008 SAF/MSPF/ Budget de l'Etat

Malawi 2.6 2009-2010 Ministry of Health Planning

Mauritius 9.5 2007 WHO/HAI Pricing Survey

Mozambique 2.1 2009 Central de Medicamentos e Artigos Médicos

Namibia 10.1 2009 Ministry of Health and Social Services

Seychelles 34.8 2008 Ministry of Health and Ministry of Finance

South Africa 135.8 2005 WHO Level I

Swaziland 11.1 2009 Ministry of Health Budget 2008/2009

United Republic of Tanzania 0.9 2008/09 Ministry of Health and

Social Welfare

Zambia 2.3 2008 Ministry of Health

Zimbabwe N.A. N.A. N.A.


53

Annex 9 HIV/AIDS medicines distributed free of charge in public health facilities


Angola Yes 2008 National Management of Public Health

Botswana Yes 1995 National Health Policy

Democratic Republic of Congo Yes 2008

Ministère de la Santé Publique/Direction des Soins de Santé Primaires

Lesotho Yes 2009 Ministry of Health







South Africa Yes 2009 National Department of Health

Swaziland Yes 2007 National Health Policy 2007

United Republic of Tanzania Yes 2007 WHO level I




54

Annex 10 Medicines distributed free of charge for pregnant women in public health facilities


Angola Yes 2008 National Management of Public Health

Botswana Yes 1995 Pregnant Women


Ministère de la Santé Publique/Direction des Soins de Santé Primaires


Madagascar Yes 2007 Semaine de la Santé de la Mère et de l’Enfant







Swaziland Yes 2007 National Health Policy 2007

United Republic of Tanzania Yes 2007 WHO level I




55

Annex 11 Maximum retail price in the private sector is regulated

Country Value Year Source Angola Yes 2008 Ministry of Finance

Botswana No 2009 Ministry of Health

Democratic Republic of Congo

No 2008 Ministère de l’Economie


Madagascar No 2008 Agence du Médicament

Malawi No 2009 Ministry of Health

Mauritius Yes 2007 WHO Level I 2007


Namibia Not legally, but country uses SA computer systems which give final consumer

price automatically

2009 Namibia Medical Aid Fund

Seychelles No 2009 Health Services Agency

South Africa No 2009 National Department of Health

Swaziland No 2009 Ministry of Health PSD

United Republic of Tanzania

No 2009 WHO Medicines Adviser

Zambia No 2009 Ministry of Health

Zimbabwe No 2008 Ministry of Health and Child Welfare


56

Annex 12 Provisions for compulsory licensing are included in the national patent law


Botswana Yes 2008 Industrial Property Bill

Democratic Republic of Congo

No 2008 Ministère du Commerce


Madagascar Yes 1995 Office Malgache de la Propriété Industrielle




Namibia No 2009 Ministry of Health and Social Services

Seychelles No 2007 WHO Level I


Swaziland Yes 2009 Medicines and Related Substance Control Bill

United Republic of Tanzania

No 2009 WHO Level I




57

Annex 13 Existence of EML updated within the past 5 years

Country EML available


Angola No N.A. National Directorate of Medicines and Equipments

Botswana Yes 2005 Botswana Essential Drug List (BEDL)

Democratic Republic of Congo Yes 2007 Liste Nationale des

Médicaments Essentiels

Lesotho Yes 2006 Lesotho Essential Medicines List

Madagascar Yes 2008 Algorithmes Traitements Standards

Malawi Yes 1998 Essential Medicines List

Mauritius Yes 2005 Essential Medicines List


Namibia Yes 2009 Ministry of Health and Social Services: Pharmaceutical Services

Seychelles Yes 2009 Essential Medicines List


Swaziland Yes 2009 Ministry of Health

United Republic of Tanzania Yes 2007 National List of

Essential Medicines

Zambia Yes 2009 National Essential Medicines List 2009

Zimbabwe Yes 2006 Essential Medicines List


58

Annex 14 Existence of STGs updated within the past 5 years

Country STGs available


Angola No N.A. National Directorate of Medicines and Equipments

Botswana Yes 2007 Botswana Treatment Guidelines


Ministère de la Santé Publique/ 5ème Direction et programmes spécialisés

Lesotho Yes 2009 Expert Opinion

Madagascar Yes 2005 Algorithmes Traitements Standards

Malawi Yes 2009 Standard Treatment Guidelines

Mauritius Yes 2005 Standard Treatment Guidelines



Seychelles Yes 2004 Expert Opinion


Swaziland Yes 2008 Ministry of Health

United Republic of Tanzania Yes

2007 for Mainland 2009 for Zanzibar

National List of Essential Medicines

Zambia Yes 2009 National Standard Treatment Guidelines 2009

Zimbabwe Yes 2006 Standard Treatment Guidelines


59

Annex 15 Generic substitution is allowed in the public sector


Botswana Yes 1992 Drugs and Related Substances Act

Democratic Republic of Congo No 2008 Ministère de la Santé

Publique









Swaziland Yes 2007 WHO Level I





60

Annex 16 Generic substitution is allowed in the private sector



Democratic Republic of Congo No 2008 Ministère de la Santé

Publique




Mauritius No 2007 WHO Level I Survey





Swaziland Yes 2007 WHO Level I




Documents

Baseline assessment of the Pharmaceutical situation in ... · WHO/EMP/MPC/2011.2 Baseline assessment of the Pharmaceutical situation in Southern African Development Community countries