Professional Documents
Culture Documents
MINISTRY OF HEALTH
National Medicines
Policy
july 2015
MINISTRY OF HEALTH
National Medicines
Policy
july 2015
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profit must be with the prior permission of the publisher
TABLE OF CONTENTS
NMP Task Team ...........................................................................................
Foreword ........................................................................................................
Glossary ..........................................................................................................
Acknowledgements ...................................................................................
Abbreviations ...............................................................................................
IV
V
VI
VII
VIII
19
19
21
23
25
26
27
28
29
30
31
32
33
34
35
BACKGROUND .................................................................................
SITUATION ANALYSIS ....................................................................
GUIDING PRINCIPLES AND FOCUS AREAS ..............................
OVERALL POLICY GOAL ................................................................
1
5
12
18
36
III
IV
INSTITUTION
Consulting Director
Access Global Ltd
Regional Inspector of Drugs
National Drug Authority
Technical Adviser Strategic Information
Ministry of Health Pharmacy Division
Chief of Party
Uganda Health Supply Chain Project
Deputy Director, HEPS-Uganda & representing UCAEM
Head, Capacity Building
Joint Medical Store
Principal Pharmacist
Ministry of Health Pharmacy Division
National Professional Officer - Medicines
World Health Organisation
Reproductive Health Commodity Security Coordinator
Ministry of Health Pharmacy Division
Deputy Chief of Party
Uganda Health Supply Chain Project
Ag. Assistant Commissioner Pharmacy
Ministry of Health Pharmacy Division
Head Stores and Operations
National Medical Stores
Project Manager
Medical Access Uganda Limited
Technical Adviser
Uganda Health Supply Chain Project
Secretary
Pharmaceutical Society of Uganda
Principal Pharmacist
Ministry of Health Pharmacy Division
FOREWORD
The development of this National Medicines Policy (NMP) 2015 has
been informed by the second National Health Policy (NHP) 2010, the
Health Sector Development Plan (HSDP) 2015 2020, the current state
of the pharmaceutical sector and global health discourse particularly the
post-2015 sustainable development agenda.
The NMP 2015 was developed through a highly consultative process
involving Ministry of Health (MoH), other Government ministries,
regulatory agencies, academia, professional associations, Health
Development Partners (HDP), district health departments, central
medicineswarehouses, private-not-for-profit sector (PNFP), private
sector, and civil society.
The goal of the NMP 2015 is the progressive realisation of the highest
attainable standard of health by Ugandans, by ensuring access to, and
appropriate use of good quality, affordable essential medicines and
health supplies. The NMP underscores three important principles of
quality of care, equity and efficient utilisation of available resources.
The NMP shall focus on supporting the achievement of Universal Health
Coverage; increasing funding for medicines; strengthening partnerships
and collaboration for health; and on increasing the capacity of Ministry
of Health and district health departments to undertake their respective
roles for full policy implementation.
GLOSSARY
For the purposes of this policy document the following terms will
have the meanings given in the table below.
Term
Medicine/
Pharmaceutical
product
Health Worker
Pharmacy
Professionals /
Personnel
VI
ACKNOWLEDGEMENTS
The production of this policy document was made possible by the
generous financial support of the Medicines Transparency Alliance
(META). Coalition for Health Promotion and Social Development (HEPSUganda) provided funding that kick started the process.
On behalf of the Government of Uganda, I thank the World Health
Organisation (WHO) Uganda Country Office and the Essential Medicines
Department of the WHO Geneva for providing technical support and the
consultants for the process.
I particularly want to thank all the members of the MoH Task Team for
leading the process of the development of the NMP 2015 and the Uganda
Health Supply Chain for the technical assistance provided. In a special
way I would like to recognise the commitment and dedication of Dr. Fred
Sebisubi, Joseph Mwoga, Thomas Ocwa Obua, Belinda Blick and the task
team secretariat for ensuring that the process remained on track and
that the policy document was delivered on time.
To all our partners and colleagues in the Ministry of Health, Government
ministries, regulatory agencies, academia, professional associations,
health development agencies, implementing partners and programmes,
district health departments, central medicine warehouses, privatenot-for-profit (PNFP) sector, the private sector and civil society, who
contributed to this process in one way or another, I thank you all.
Finally allow me to thank our consultants Dr. Hans Hogerzeil and Donna
Kusemererwa who accommodated all our requests and stayed with the
process to the very end.
Morries Seru
Ag Ass. Commissioner Pharmacy
Ministry of Health
VII
ABBREVIATIONS
AMU
ARV/ART
CS (O)
EAC
EMHS
EMHSLU
GMP
HF
HIV
HDP/HIP
HSDP
JMS
LMIS
MAUL
M & E
META
MoH
NDA
NMRA
NDQCL
NGO
NHP
VIII
NMP
NMS
PD
PFP
PHC
PNFP
SDP
TB
CM
UCG
UGX
US
UHC
UHMG
WHO
IX
BACKGROUND
The National Drug Policy of Uganda was first published in
1993. It was updated in 2002 to include new strategies to guide
implementation and reflect legislative changes. The changes in the
access to medicines landscape over the past decade have prompted
Ministry of Health to revise the policy in 2015.
Context
The goal of the NHP 2010 is to attain a good standard of health for all
people in Uganda in order to promote healthy and productive lives.
The priority areas are: strengthening health systems in line with
decentralisation; reconceptualising and organising supervision and
monitoring of health systems at all levels; establishing a functional
integration within the public and private sectors; and addressing
the human resource crisis.
The goal of the HSDP 2015 is to accelerate movement towards
Universal Health Coverage (UHC), with essential health and related
services needed for promotion of a healthy and productive life. The
sector hopes to achieve this through provision of equitable, safe
and sustainable health services, addressing the key determinants
of health through strengthening inter-sectoral collaboration and
partnerships, ensuring financial risk protection of households, and
enhancing the regional and global competitiveness of the health
sector.
Rationale
Access to health care is a fundamental human right, spelt out in the
Universal Declaration of Human Rights (UDHR) and recognised
worldwide. However, without access to essential medicines the
right to health cannot be fulfilled. WHO estimates that boosting
economic growth and social development and scaling up existing
interventions to fight disease could save over 10 million lives by
2015. Most of these interventions depend on essential medicines.
According to WHO, access to medical products and technologies
is one of the six building blocks of a health system, in addition to
health work force, information systems, financing, service delivery,
and leadership/ governance. Medicines, health supplies and
vaccines are often the second largest expenditure in public health
budgets.
A study of 2,580 rural households in Uganda concluded that generally,
poor people consider physical proximity, presence of skilled staff
and medicines availability as the three key determinants when
choosing a health care provider.5 Sadly out of pocket expenditure
on health in Uganda remains disproportionately high with the bulk
of this expenditure going to medicines.
5 Konde-Lule, J. et al. 2010. Private and Public health care in rural areas of
Uganda. BMC Int Health, Nov 24; 10:29
Development process
MoH developed a concept note and terms of reference which
were approved by the Medicines Procurement and Management
(MPM) technical working group. Technical assistance was sought
from WHO to guide the process; they also provided consultants.
The Pharmacy Division, together with key partners, formed a Task
Team to oversee the policy development process and guide the
consultants. In order to ensure broad ownership of the policy, a
highly consultative process involving a diversity of stakeholders
was used. Individual stakeholder consultations, consultative
meetings and workshops and a five day stakeholder retreat
were conducted. Stakeholders had the opportunity to review the
performance of the pharmaceutical sector under the old policy and
to propose revisions. The new NMP provides a basis for the further
development of the pharmaceutical sector taking into account the
vision of the health sector and the national development agenda.
SITUATION ANALYSIS
UGANDAS HEALTH SITUATION
Uganda has a population of 34.9 million people (2014) and, with an
average annual growth rate of 3.03%; it is projected to reach 42.4
million people by 2020. Communicable diseases such as HIV/AIDS,
malaria, lower respiratory infections, meningitis and tuberculosis
cause the highest numbers of life years lost in Uganda. However,
non-communicable diseases (NCDs) are increasingly becoming a
major burden. Life lost due to these conditions is rising significantly,
with diabetes, self-harm, interpersonal violence and road injuries
increasing at least twofold since 1990.
Health services in Uganda are provided by both public and private
sectors. The private sector comprises of the PNFP, private-forprofit (PFP), and the traditional and complementary medicine
practitioners (TCMPs). Ministry of Health is responsible for setting
the policy and strategic direction while the local governments are
responsible for service delivery under Ugandas decentralised
health care delivery model. In 2013, Uganda had 4,478 health
facilities, of which 65% were public, 20% PNFP and 14% PFP. 6
Health services in Uganda are financed by Government, private
sources and development partners. Only 11.6% of Government
expenditure is spent on health which is far short of its commitment
under the Abuja Declaration in which African governments pledged
to spend at least 15% of their budgets on health. This means that
considerable health expenditure (about 36%) is out-of-pocket,
putting the poor and vulnerable at risk of catastrophic health
expenditure7. A national health insurance scheme has been under
discussion for over a decade however it is not yet in place.
Medicines Financing
Medicines Pricing
Medicines Use
Pharmaceutical Manufacturing
The domestic manufacturing industry is still growing. Some
incentives for local manufacturers are in place such as reduced
import tariffs on pharmaceutical equipment and a 15% preferential
rate in public procurement. However, it appears that the latter
incentive has not yet been fully effected.
Human Resources
11
3) Quality of Care
In line with the aspirations of the health sector, the policy aims
to ensure that quality of care is emphasised in all applicable
areas of policy implementation. Investments in quality of care
will increase effectiveness of service delivery and improve
patient safety.
Focus Areas
14
7. Strengthening
Authority:
the
National
Medicines
Regulatory
8. Governance:
15
17
18
Regulation
and
Quality
Policy Objectives
1. To provide a comprehensive regulatory and legislative
framework that enables protection of health and ensures
availability of safe and efficacious pharmaceutical products
for the Uganda population.
19
Strategies
1. Harmonise, amend/enact and enforce the legislation required
to enable the effective regulation of pharmaceutical products,
personnel, premises and practices.
2. Develop, update and enforce regulations on pharmaceutical
products, personnel, premises and practices both in the public
and in the private sector.
20
INVENTORY MANAGEMENT
Policy Objectives
1. To strengthen inventory management systems at all levels in
order to maintain optimal stock levels throughout the supply
chain.
2. To ensure that all medicines are appropriately, costeffectively,
safely and securely stored, distributed and accounted for at all
levels of the health system.
3. To safely dispose of expired or otherwise unwanted
medicines.
Justification
23
Strategies
1. Establish and implement a system of tax incentives or subsidies
for domestic manufacturers of essential medicines.
2. Encourage national and international procurement agencies
to procure domestically produced essential medicines of good
quality and competitive price.
24
Medicines Use
Policy objective
To ensure that end-users receive maximum therapeutic benefits
from medicines through their scientifically sound and cost-effective
use by prescribers, dispensers and consumers.
Justification
26
Medicines Financing
Policy Objective
To ensure the financing of adequate quantities of essential
medicines for the people of Uganda, with equitable provisions for
the poor and vulnerable, as well as cost-effective use of available
resources.
Justification
27
Medicines Pricing
Policy Objective
To ensure medicines are affordable to the individual and to the
community.
Justification
Both the PNFP and the PFP providers play an essential role
in delivering health care and pharmaceutical services to the
population, especially in the rural areas. The PFP sector also plays a
crucial role in the local manufacture, importation and distribution
of medicines country wide. Effective engagement of the private
sector is an important prerequisite for the achievement of national
health goals.
Strategies
30
Community Engagement
Policy Objective
To harness the synergies and opportunities in the community to
maximise the implementation of the NMP.
Justification
31
32
33
Justification
34
NAME
Lubyayi Lawrence
Prof Paul Waako
Denis Okidi
Philip Apira .O
ORGANISATION
MoH/PD
Dusileine UN
UHSC
UHMG
6.
7.
UPMB
USAID
8.
Gladys Tugume
USAID-SUSTAIN
10.
14
18.
19.
20.
22.
24.
25.
26.
John Obicho
Lawrence Were
Amuha Monica
Benson Obonyo
Nakade Shamin
Turyamureeba Colina
Pamela Achii
Arnold Kabbale
Agenorwot Anna F
STAR-SW
MoH-UNFPA
MoH
MSH/UHSC
IDI
KCCA
MoH
MoH
IFRAD
27.
28.
29.
30
PB-MoH
UHSC
MoH
MoH
31.
32.
33.
34.
35.
Lubega Abdukarim
Anguyo Patrick
Stella Nanyonga
Rogers Sekabira
PACE
KCCA
Naguru Hospital
Baylor Uganda
36
C. QCIL
TITLE
M&E specialist
dean
Tech. Advisor
Head of Business
DCO/SCM
Clinical Services
Supply Chain
Systems Adv.
Deputy Chief of
Party
RHCSC
STO
Advisor
P.H.C
H/Asst
QPPU
Pharmacist
Programmes
Manager
Registrar
STO
Pharmacist
Deputy Registrar
AHPC
Business manager/
Chair
Pharmacist
DTCS
Senior Pharmacist
Pharm. Coordinator
36.
37.
38.
39
40.
41.
42.
43.
Ahimbisibwe E
Paul Okware
Myers Lugemwa
Sseguya Simon
Richard Odoi Adome
Musuba B.F
Comfort Ssenyanwe
Murungi A. Marion
MoH
NMS
MoH
Mulago hospital
Makerere Univ
OP/cab. secretariat
PSU
IDI
44.
45.
46.
47.
48.
49.
50.
51.
56.
57.
58.
60.
Yiff Grusz
Brian Arinitwe
Grace Kabaniha
Joyce Tamale
John Kamili
Dr. Bagambe V
Amony M.Nancy
Nakagiri Emilly
Saudah A Kigande
Mateeba .Tim
Olivia Kiconco
Dr. Michael Oketcho
61.
62.
63.
64.
65.
66.
Lutoti Stephen
Dr. Nambatya G.K
Asiimwe Anthony
Aryeija Oren
Sr. Josephine Oyela
Mr.Opio Martin
67.
68.
69.
70.
71.
72.
73.
74.
Dr.Opio Jimmy
Nanziri Ruth
Muthoka .E.N
Dr. Olaro Charles
Kaggwa David
Dr. Wamasebu Gideon
Prof. P.Waako
Namboira Catherine
CHAI
HMU
WHO
UHMG
Cipla QCIL
MoH/FCO
SCMS
MoH
Alive med
MoH
MoH-RPF
Uganda Heart
Institute
MoH
NCRI-MoH
Buliisa
Kabale
Gulu
Kitovu hospital
Masaka
Moyo
Buikwe
Tororo
Fortportal
Wakiso
Manafa
Mbale
Arua
PHE
HOSAO
D/PM
Principal pharmacist
PPS
HC member
Pharmacy Logistics
Specialist
CD
As. Director
NOP.HEC
Managing director
FA manager
Q/A manager
SPA
RPMT
Lab Tech
RH
P. Officer RH
Surgeon
Research Officer
Director of research
DTLS
DMMS
Pharmacist
Medical supp
physician
DHO
MMS
Pharmacist
pharmacist
DHO
Dean
MMS
37
75.
76
77
78
Namulindwa Noeline
Samuel Mutyaba
Obua Thomas
Onen Solomon
Kitgum
MoH
MoH
NDA
79
80
Brenda Kasya
Walimbwa Aliyi
MoH
MoH
81
82
83
Bamwoze Paul
Albert Kalangwa
Dorothy Namuganga
MoH
Access Global
Star-EC
84
85
86
87
88
89
90
91
92
93
94
95
96
97
98
99
100
101
102
Nabattu Nulu
Okiror Adakuru
Nakagiri Emily
Mildred Kabayaga
William Mutabazi
Namweseza Zam
Mr. Oteba Martin
Rashid Settala
Talibita Moses
Kalidi Rajab
Dr. Ebong
MoH
CPHL-MoH
NCRI-MoH
PSU
MoH
Kabale district
KCCA
St. Marys Hospital
Lacor
UoMB
Rene Industries
MoH
UPMB
Baylor Uganda
APDL
MSH/UHSC
Medical Officer
UNHCO
MUK
MoH
38
MMS
Data manager
Sen Pharmacist
Regional Inspector
of Drugs
Drugs Officer
Senior Health
Planner
IT officer
Consultant
Medical Logistics
Officer
M&E Specialist
Tech. Advisor
Research Officer
Pharmacist
ACUS QA
SCO
Lab Tech
Pharmacist
M&E
Pharmacist
Pharmacist
Supply chain Officer
Pharmacist
Pharmacist
DCoP
Legal Officer
Lecturer
MINISTRY OF HEALTH
Plot 6 Lourdel Rd, Nakasero
P.O. Box 7272 Kampala, Uganda
Tel: 256-414-340874 /231563 /9
Fax: 256-41-4231584
Email: info@health.go.ug
Web: www.health.go.ug
40