Overview of Procurement and Supply

Management Policies

Meeting of WHO Prequalification Programme with European

manufacturers and EU marketing authorisation holders
Copenhagen, November 2009

Carmen Perez Casas

Pharmaceutical Management Unit
 Presentation Outline

1. Global Fund grants

2. Overview of procurement volumes by grantees
3. Quality assurance policy
4. Procurement and Supply Management Policy
5. Most frequently purchased medicines

WHO/EURO, November 2009

 The Global Fund
Making a sustainable and significant contribution
to the achievement of the Millennium Development Goals

Extract of TGF Guiding principles :

Operate as a financial instrument , not implementing agency
Make available and leverage additional financial resources
Support programs that evolve from national plans and
priorities

Performance-based funding mechanism

678 grants in 140 countries (Nov. 09)

WHO/EURO, November 2009

 Rapid scaling up of results
Global Fund Top 3 result indicators (2009)

Intervention
mid 2007 mid 2008 July 2009

HIV:
People on ARV treatment
1.1 million 1.75 m 2.3 m

TB:
People treated under DOTS
2.8 million 3,9 m 5.4 m

Malaria:
Insecticide-treated nets 30 million 59 m 88 m
distributed

Malaria treatments .. .. 74 m

WHO/EURO, November 2009

 Global Resources Distribution
Rounds 1-8, (July 2009)

Expenditure Component (July 2009) by Regions

Middle East &

Other
North Affrica East Asia &
14% 6% Pacific
Monitoring and 14%
Evaluation Eastern Europe
4% & Central Asia
Commodities,
7%
Infrastructure Products, Drugs
and Equipment 45% Latin America &
9% the Caribbean
7%
Administration
7% South Asia
Sub-Saharan 8%
Human
Resources Africa
58%
21%

Estimates from Rounds 2-8 proposals 100% = US$ 15.9 billion

100% = $8.2 billion USD % of total funds approved by the Board, including Phase 2 & RCC

WHO/EURO, November 2009

OP/140709/2
 Disease Components Distribution
Rounds 1-8, (July 2009)
Global Fund Resources by Disease Component

Malaria
29%

HIV/AIDS
57%

TB
14%
100% = US$ 15.9 billion
Percentages of total funds approved by the
Board, including Phase 2 & RCC

WHO/EURO, November 2009

OP/140709/3
 Overview of procurement of medicines by value

Data from
2006-2007

WHO/EURO, November 2009

 The Global Fund Approach for procurement

Principles and minimum standards, not detailed

procedures
Build upon existing systems
Principal Recipients responsible for all PSM
activities
Even if contracted out
Operational principles for
Good Pharmaceutical Procurement.

WHO/EURO, November 2009

Policies and Principles

Guide outlines what PRs need to do

Quality-assured products
Lowest possible price
National laws and international
agreements
Conduct procurement processes in
a transparent and competitive
manner

WHO/EURO, November 2009

 Procurement mechanisms

PRs use own purchasing system,

Or subcontract procurement agent
mandatory in case insufficient capacity exist,
most commonly used procurement agents : UNICEF, IDA, WHO PPS ...
MDR-TB treatment: mandatory Green Light Committee support
services
Voluntary Pooled Procurement and Capacity Building
Services: Launched in June 2009
Affordable Medicine Facility for malaria (AMFm): Approved in
November 2008

WHO/EURO, November 2009

QA Policy for Pharmaceutical Products

Global Fund resources may only be used

to procure medicines that have been
authorized for use by the NDRA in the
recipient country in accordance with its
standard practices for drug registration (or
other forms of authorization)

WHO/EURO, November 2009

 QA Policy for Pharmaceutical Products
For medicines prequalified by the WHO PQ, NDRAs are
encouraged to expedite the process for authorizing their use
by accepting the PQ approval letter and supporting documentation,
including WHO PQ report and the manufacturer's summary of information
relating to the quality, safety and efficacy

For medicines authorized for use by an SRA, NDRAs are

encouraged to expedite the process for authorizing their use
by accepting the executive summary of the Common Technical Document
for the Registration of Pharmaceutical Products for Human Use (CTD) or
sections of the CTD relating to the quality, safety and efficacy

and all necessary information to perform quality control testing of products

and necessary reference standards.

WHO/EURO, November 2009

 QA policy for ARVs, antiTB and antimalarials

Antiretrovirals, antituberculosis, and antimalarial

pharmaceutical products can be purchased using
Global Fund resources if they are,
prequalified by the WHO Prequalification Programme,
and/or
authorized for marketing in a country with a stringent
drug regulatory authority (SRA) (registration "for export
only" is not sufficient),
or

WHO/EURO, November 2009

 QA policy for ARVs, antiTB and antimalarials

for products marketed exclusively outside ICH region,

approved or subject to a positive opinion under one of
the following schemes:
Canada S.C. 2004, c. 23 (Bill C-9) procedure (HIV
medications),
Art. 58 of European Union Regulation (EC9 No. 726/2004) ,
US-FDA tentative approval (ARVS)
or

WHO/EURO, November 2009

 QA policy for ARVs, antiTB and antimalarials

if there are <2 products available on the market from

previous categories (WHO prequalified or registered
by a SRA),

Alternative products can accepted for purchase by the

Global Fund based on the recommendation of an
independent panel of technical experts (ERP)
independent technical body hosted by WHO

WHO/EURO, November 2009

 QA Policy for Procurement of All Other
Pharmaceuticals
All FPPs, other than ARVs, anti-TB and antimalarials,
need only to comply with the relevant quality standards
that are established by the National Drug Regulatory
Authority (NDRA) in the country of use

PRs must ensure that all FPPs are procured in

accordance with principles set forth in the Interagency
Guidelines:
A Model Quality Assurance System for Procurement
Agencies (WHO, 2006)
WHO/EURO, November 2009
 Monitoring quality product

Monitoring quality of products all along the supply chain

Systematic random quality control testing
Recipients report testing results to Global Fund

Manufacturers must provide methods used

for quality control of products not published in pharmacopoeia

WHO/EURO, November 2009

 Which medicines can be procured?

Medicines listed in WHO or national or institutional

Standard Treatment Guidelines or essential medicines
list

grant applicants or PRs to provide technical justification

for selection of unlisted products in one of the STGs

WHO/EURO, November 2009

 Which medicines are procured? Tuberculosis
WHO PQ EOI
First line medicines:
Single ingredient products
Fixed dose combinations

Second-line TB medicines :
procured through the Green Light Committee

Plus Adjunctive therapies in MDR-TB treatment:

Low volumes
Nutritional support
Corticosteroids
Medicines for management of side effects

WHO/EURO, November 2009

 GUIDELINES FOR THE PROGRAMMATIC MANAGEMENT OF DRUG-
RESISTANT TUBERCULOSIS, WHO 2006 (2008)

Metoclopramide, dimenhydrinate, prochlorperazine,

promethazine, bismuth subsalicylate
H2-blockers (ranitidine, cimetidine, famotidine, etc.), ulcer proton
pump inhibitors (omeprazole, lansoprazole, etc.)
Fluconazole, clotrimazole lozenges
Loperamide
Selective serotonin reuptake inhibitors (fluoxetine, sertraline),
tricyclic antidepressants (amitriptyline)
Lorazepam, diazepam, clonazepam
Dimenhydrinate
Haloperidol, thorazine, risperidone (benzotropine or biperiden )
Phenytoin, carbamazepine, valproic acid, phenobarbital
WHO/EURO, November 2009
Pyridoxine (vitamin B6)
 GUIDELINES FOR THE PROGRAMMATIC MANAGEMENT OF DRUG-
RESISTANT TUBERCULOSIS, WHO 2006 (2008)

Amitriptyline
Meclizine, dimenhydrinate, prochlorperazine, promethazine
Ibuprofen, paracetamol, codeine
Hydrocortisone cream, calamine, caladryl lotions
Antihistamines (diphenhydramine, chlorpheniramine, reactions
dimenhydrinate), corticosteroids (prednisone, dexamethasone)
Inhaled beta-agonists (albuterol, etc.), inhaled corticosteroids
(beclomethasone, etc.), oral steroids (prednisone), injectable
steroids (dexamethasone, methylprednisolone)
Levothyroxine
Potassium and magnesium replacement

WHO/EURO, November 2009

 Which medicines are procured? AIDS

Antiretrovirals
Medicines to treat HIV/AIDS related conditions:
Mainly those listed in WHO-PQ EOI
Some additions depending on country:
Methadone and buprenorphine
Metronizadole
Amoxicillin, erythromycin, cloxacillin

WHO/EURO, November 2009

 Medicines to treat HIV/AIDS related conditions,
WHO PQ, EOI July 2009

WHO/EURO, November 2009

Which medicines are procured? Malaria

WHO PQ EOI
ACTs

Artemisinin-based single-ingredient formulations

Artemether, oily injection
Artesunate, powder for injection
Artesunate, suppositories
Artesunate, tablet*

* GF discourages the use of Artemisnin-

based monotherapy products

WHO/EURO, November 2009

 Other antimalarial medicines

Mefloquine, tablet 250 mg

Sulfadoxine + Pyrimethamine, tablet 500 mg + 25 mg

Amodiaquine tablet 153 mg (or 200 mg as hydrochloride)

Some additions to those listed in WHO PQ EOI :

Quinine Di Hydrocloride 300mg/ml inj, or Sulphate 300mg tab
Chloroquine 150mg tab
Primaquine tab 15mg

WHO/EURO, November 2009

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