Pharmaceutical procurement and supply

Pharmaceutical procurement and
supply systems within national
pharmaceutical policies: regulations,
roles, responsibilities and challenges
Cécile Macé
EMP/PAU
Workshop on Strenghtening Logistic Management Information
Systems , Ouagadougou, 6 May 2014
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RBM Workshop 6-8 May 2014
National Pharmaceutical Policy
Common framework to solve problems in
pharmaceuticals within which the activities of the
pharmaceutical sector can be coordinated
A commitment to a goal and a guide for action
The Goal: To ensure equitable access to qualityassured, safe and efficacious essential medicines
and health products and to promote rational use.
To achieve this goal one of the component of the
policy will describe the policy options chosen for the
national supply system
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RBM Workshop, 6-8 May 2014
Pharmaceutical system
National Policy
R&D
API Manufacturers
FP Manufacturers
National Medicines
Regulatory Authority
Public sector
Private sector
Medicines authorized for use
National procurement
agency/department
Distributors/Wholesalers
Quality Control laboratory
Supply chain
CMS, RS, DS, HF
Pharmaceutical inspection
Supply chain
HF, Private Pharmacies
Pharmacovigilance
Patients
Patients
Public supply chain
Manufacturer
Manufacturer
Manufacturer
National Procurement Agency/Department
Regional stores
District stores
Teaching
Hospital
Regional
Hospital
District
Hospital
PATIENTS
Health
Centre
Private supply chain
Private wholesalers/distributors
Pharmacies
Private health
facilities
(Clinics…)
PATIENTS
Non-profit private
health facilities
National Procurement and Supply System
 The structure, regulatory framework, norms and standards,
roles and responsibilities for the Procurement and Supply
System should be defined at national level and should be
described in a document
 This document should be validated at national level and
implemented (e.g: procurement strategy, regulation…)
 Based on the structure of the national procurement and
supply system, this document or an annex should describe
the data to be collected at each level, where the data
should be used for further decisions and clarify
responsibilities
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RBM Workshop 6-8 May 2014
Roles and responsibilities
for public sector
 National Regulatory Authority: to guarantee the quality, efficacy and
safety of products procured, to license the pharmaceutical
establishments, to inspect the establishments and facilities, to monitor
the quality of medicines and health products within the distribution chain
 National Procurement Agency: to procure, stock and supply medicines
until a certain level in the national system (often regional), to keep track
of quantities dispatched – in some countries functions done by two
separate entities (national procurement department and central medical
store)
 Ministry of Health: management of districts and health facilities including
distribution, stock and order management at peripheral level,
responsible for providing tools and capacity building on drug
management (existing tools available in many countries)
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RBM Workshop 6-8 May 2014
Norms and Standards
 Should be agreed at national level based on existing
WHO Guidelines (Operational principles for good
procurement practices, MQAS, GDP, GSP, Guidelines
for medicine donations…)
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RBM Workshop 6-8 May 2014
Role of Partners in PSM systems
 Alignment with national policies and plans
– Paris Declaration
 Support the development of national
systems and the reinforcement of
capacities
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RBM Workshop 6-8 May 2014
In reality…
 Results of the studies on Mapping and in depth
assessment of medicines supply systems carried out in
17 countries and ongoing in 2 countries:
http://www.who.int/medicines/areas/coordination/partnersc
oordination/en/index.html
 To document "Who does what, how and with which funds",
to compare the situation with existing policies, legislation and
regulation, norms and standards, best pharmaceutical
practices and to use evidence for strengthening PSM
strategies, coordination and capacity building
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RBM Workshop 6-8 May 2014
Results of mapping of supply systems
 National Procurement systems exist and in most of the countries the
distribution of pharmaceutical products (public and private) is well
defined and functional
 Partners are bringing important additional financial resources
necessary to support purchase of pharmaceutical products (an
average of 17 financial partners per country)
 Countries are having a national quality assurance policy in place
 Some partners are providing technical support to reinforce national
capacities (but not always well coordinated)
 Some partners are providing logistic support to improve distribution
and geographical availability of some specific products
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RBM Workshop 6-8 May 2014
Ministère de la Santé
Du Burkina
Systèmes d'approvisionnement des produits pharmaceutiques au BURKINA FASO, Sept 2010
MEG
ACT
ARVs
TB
ARVs
Ped
IO
REACTIFS
Autres
Antipaludique
VACCINS
Contraceptifs
Dispositifs
Médicaux
Etat
Fonds commun
Bailleurs
bilatéraux
Bailleurs
multilatéraux
ONG/Privé
Sources
de
Financement
Fonds
Mondial
ETAT
DAF/MS
CAMEG (Population)
R6
(SP/CNLSIST)
Structure
d'approvisionnement
M
S
F
CAMEG
1er point
de stockage
MSF
CAMEG
DGPML
DLM
MSF
CAMEG Agences régionales
2ème point
de stockage
O
M
S
Fournisseurs
privés
PNT central
PLAN
BURKINA
OMS GDF
PEV
central
DRS
G
D
F
U
N
I
C
E
F
G
A
V
I
UNICEF
UNICEF
Burkina
U
N
I
T
A
I
D
P
R
O
M
A
C
O
U
S
A
I
D
Structures privées
CHU
CHR
CM/CMA
CSPS
CHU
PATIENT
CHR
ONG/Association
F
N
U
A
P
CHAI GFA Deliver FNUAP
CNTS
DSF central
CRTS
Dépôts district
Dépôts district (DRD)
3ème point
de stockage
Structure
dispensatrice
PADS :
BM, Fonds Mondial R8
Bill et Melinda Gates
Pays-bas, AFD, ASDI
FNUAP, Etat
CHR
CHU
CMA
République de RDC
Ministère de la santé
Systèmes d'approvisionnement des produits pharmaceutiques en RDC Mai 2009
MEDICAMENTS
ESSENTIELS
PALUDISME
Y compris CTA
ARVs
TB
REACTIFS
sécurité
du sang
(+ test HIV)
ARVs
Ped
IO
VACCINS
Préservatifs
Dispositifs
Médicaux
Contraceptifs
Etat
Bailleurs
bilatéraux
Bailleurs
multilatéraux
ONG/Privé
Sources
de
Financement
Structure
d'approvisionnement
1er point
de stockage
2ème point
de stockage
CDR
(15)
CDR HGR
(7)
A
S
R
A
M
E
S
FONDS
MONDIAL
O
M
S
BCAF CDR
PMURR ASRAMES PNUD PNMLS OMS PARSS
Kin.
(15)
CDR (15)
BCZS
CC
CDR
(ue)
PNT
B
D
O
M
U
E
C
F
PNTS UNICEF CLINTON BDOM
Dépôt Dépôt
CDR CDR ASRAMES AGETRAF OMS
kin. PNTS
PNT
(ctb) (ue)
PEV
PNT ONGs Dépôts AEP PNTS
Prov. Pnud BCP
Prov.
3ème point
de stockage
Structure
dispensatrice
BM
C
L
I
N
T
O
N
U
N
I
C
E
F
UNICEF
PEV
Prov.
CDR
(15)
C
T
B
PSA
MDM FD
BDOM PSA
HGR
G
A
V
I
MDM
BDOM
U
S
A
I
D
F
N
U
A
P
ASF
PNT
UNC
ASF
FOSA
IMA
F
E
G
M
S
F
Grossistes
privés
(GP)
FNUAP FEG
UNC
ECC
ONG
CSDT
FNUAP
ASF
Prov.
BCZS
MSF GP
MSF
GP
FNUAP
Prov.
GP
GP
Antennes PEV
FOSA
BCZS
PATIENT
HGR
CSDT
CC
Mobi.
CHU CHS OP
République du Mali
Ministère de la santé
Systèmes d'approvisionnement des produits pharmaceutiques au MALI. Janvier 2008
MEDICAMENTS
ESSENTIELS
PALUDISME
Y compris CTA
ARVs
TB
ARVs
Ped
IO
REACTIFS
sécurité du sang
(+ test HIV)
MII
VACCINS
Préservatifs
Maladies
tropicales
négligées
Contraceptifs
Dispositifs
Médicaux
Etat
Bailleurs
bilatéraux
Bailleurs
multilatéraux
ONG/Privé
FONDS
MONDIAL
PPM
ETAT
Sources
de
Financement
Structure
d'approvisionnement
1er point
de stockage
2ème point
de stockage
3ème point
de stockage
Structure
dispensatrice
DAF
PPM
DRS
CS Ref
PNLT
GDF
OMS
OMS
CS Ref
O
M
S
CLINTON
UNICEF
U
N
I
T
A
I
D
UNICEF
DNS
Malaria
No More
USA
P
F
I
Z
E
R
DIFLUCAN
ITI
U
E
BIOMALI
JSI
E
S
T
H
E
R
Site
PPM
CAG
PH
DV CS Ref
DV CSCOM
G
A
V
I
K
F
W
U
S
A
I
D
PSI
USAI
D
PSI
CAG
I
P
P
F
F
N
U
A
P
M
S
D
S
C
I
IPPF FNUAP MECTIZAN SCI
DPM
Grossistes
privés /
Population
Grossistes
privés
Grossistes privés
Grossistes privés
Grossistes
privés
DRC
CS Ref
CSCO
M
U
N
I
C
E
F
Magasin régional
PPM
DRS
PNLT
DRS
G
D
F
Site prise en charge
PATIENT
Site de dépistage
AMPPF
OFFICINES DNS/Vacc
Republic of Ghana
Medicines supply systems in GHANA 2007
Category
of
Products
ESSENTIAL
MEDICINES
ARVs
MALARIA
TB
OI
REAGENT
Blood safety
(+ test HIV)
ARVs
Ped
color code
VACCINES
CONDOMS
Contraceptives
MEDICAL
SUPPLIES
Government
Bilateral Donor
Multilateral
Donor
NGO/ Private
Source
Of Funds
Procurement
Agent/Body
GOVERNMENT
WB
PROCUREMENT UNIT
MOH
(CROWN AGENTS)
GLOBAL
FUND
UNICEF
GAVI
UNFPA
WHO
GLOBAL
FUND
UNICEF
UNFPA
Point of first
warehousing
CENTRAL MEDICAL STORE
Point of 2nd
warehousing
Point of 3th
warehousing
REGIONAL MEDICAL STORE/ EPI
USAID
REGIONAL MEDICAL STORE
DISTRICT MEDICAL STORE (SERVICE DELIVERY POINTS
PATIENT
DESIGNATED TREATMENT
CENTER
USAID
GOVT
Of
JAPAN
GOVT
Of
JAPAN
Challenges
 Very complex procurement and supply systems in countries with many
technical and financial partners involved, lack of harmonization and alignment
 Responsibilities and tasks of each actor not clearly defined and not always in
compliance with their mandate
 Lack or ineffective national coordination mechanism particularly in
quantification and procurement between MoH, NPA, National Programs and
Partners
 Multitude of procurement agencies in countries with specific procurement
procedure not in accordance with the national policy to use National
Procurement Agency/Department
 Lack of coordination of technical assistance and lack of technical assistance
for strengthening the national system
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RBM Workshop 6-8 May 2014
Challenges
 High risk of stock-outs and overstocks due to the
complexity of the system
 High risk of financial loss and waste
 High risk of obtaining unreliable logistic data for
quantification due to the fragmentation of the system and
the lack of a clearly defined LMIS (existence of parallel
systems with non-harmonised data to be recorded and
various tools)
 Lack of computerization and use of new technology
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RBM Workshop 6-8 May 2014
Medicines supply systems in country: proposed model and strategy
ESSENTIAL
MEDICINES
ARVs
MALARIA
TB
OI
Medicines for
Noncommunicable
&
Mental
Health
Medicines for
Neglected T.
Diseases
ARVs
Ped
REAGENT
Blood safety
(+ HIV test)
HSS/EMP
VACCINES
CONDOMS
Contraceptives
MEDICAL
DEVICES
GOVERNMENT
Put in place a National Coordination mechanism
BILATERAL
DONOR
MULTILATERAL
DONOR
NGO/PRIVATE
Source
of
Funds
E
T
A
T
C
E
N
T
R
A
L
E
F
M
C
L
I
N
T
O
N
C
D
P
T
F
E
B
I
P
Simplify,Fharmonize Dand
A
R
U
N
I
align
C
E
F
C
O
L
U
M
B
I
A
C
I
C
technical
R
B
M
C
D
C
C
T
P
and financial
D
M
A
S
M
F
procedures
I
E
N
G
T
Z
G
A
V
I
G
D
F
U
S
A
I
D
P
S
I
F
N
U
A
P
Private
wholesalers
Basket funds : Supply driven financing
or Demand driven financing
Strengthen
and use
existing
system
Procurement
agent/body
CENTRAL MEDICAL STORES
Private
wholesalers
Point of 1er
warehousing
CENTRAL MEDICAL STORES
Private
wholesalers
Point of 2nd
warehousing
REGIONAL STORES
Point of 3th
warehousing
Point of
dispensation
Measure the results :
access to quality Medicines
DISTRICT STORES
District hospital
Primary health
centre
Regional
hospital
PATIENT
Teaching
hospital
Private clinic
Pharmacy
Proposed solutions and Role of WHO
 Support the establishment of a coordination mechanism between the
MoH, National Programs, key actors of the pharmaceutical system and
partners to support the MoH in the establishment/development of the
national PSM system (including LMIS and tools) and to clarify
responsibilities and for the coordination of funding, technical assistance,
capacity building and training.
 Encourage technical and financial partners to respect their
commitment on the alignment to national systems and to contribute
to the development and reinforcement of national systems
 Improve dissemination of WHO norms and standards, good
practices and of best practices in countries in the
development/improvement of their national PSM system
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RBM Workshop 6-8 May 2014
Proposed solutions and Role of WHO
 Support the mobilization of resources for PSM
activities (including development of national LMIS)
 Support countries to prioritize investments for
strengthening national PSM systems and to take the
best benefit of support given by partners in a coordinated
way
 Support countries to monitor and evaluate PSM
system performance and take corrective action
accordingly
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RBM Workshop 6-8 May 2014