Transcript Document 7312629

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
distributed
30 million
59 m
88 m
..
..
74 m
Malaria treatments
WHO/EURO, November 2009
Global Resources Distribution
Rounds 1-8, (July 2009)
by Regions
Expenditure Component (July 2009)
Middle East &
North Affrica
6%
Other
14%
Monitoring and
Evaluation
4%
Infrastructure
and Equipment
9%
Eastern Europe
& Central Asia
7%
Commodities,
Products, Drugs
45%
Latin America &
the Caribbean
7%
Administration
7%
Human
Resources
21%
Estimates from Rounds 2-8 proposals
100% = $8.2 billion USD
East Asia &
Pacific
14%
Sub-Saharan
Africa
58%
South Asia
8%
100% = US$ 15.9 billion
% 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 DRUGRESISTANT 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 DRUGRESISTANT 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 Artemisninbased 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
WHO/EURO, November 2009
WHO/EURO, November 2009