Overview of Procurement and Supply Management Policies Meeting of WHO Prequalification Programme with European manufacturers and EU marketing authorisation.

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 CasasPharmaceutical Management Unit

WHO/EURO, November 2009

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


The Global Fund

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

“Making a “sustainable and significant” contributionto the achievement of the Millennium Development Goals”

678 grants in 140 countries (Nov. 09)678 grants in 140 countries (Nov. 09)


Rapid scaling up of results

Interventionmid 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

distributed30 million 59 m

88 m

Malaria treatments .. .. 74 m

Global Fund Top 3 result indicators (2009)


Global Resources DistributionRounds 1-8, (July 2009)

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

by Regions

OP/140709/2

Eastern Europe & Central Asia

7%

Middle East & North Affrica

6%

Latin America & the Caribbean

7%

East Asia & Pacific14%

Sub-Saharan Africa58%

South Asia8%

Administration7%

Human Resources

21%

Commodities, Products, Drugs

45%

Monitoring and Evaluation

4%

Infrastructure and Equipment

9%

Other14%

Expenditure Component (July 2009)

Estimates from Rounds 2-8 proposals

100% = $8.2 billion USD


Disease Components DistributionRounds 1-8, (July 2009)

Global Fund Resources by Disease Component

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

OP/140709/3

Malaria29%

HIV/AIDS57%

TB14%


Overview of procurement of medicines by value

Data from 2006-2007


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.


Policies and Principles

• Quality-assured products • Lowest possible price• National laws and international

agreements• Conduct procurement processes in

a transparent and competitive manner

Guide outlines what PRs need to do


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


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)”


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.


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



• 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



• 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


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)


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


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


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


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

•Pyridoxine (vitamin B6)


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

GUIDELINES FOR THE PROGRAMMATIC MANAGEMENT OF DRUG-

RESISTANT TUBERCULOSIS, WHO 2006 (2008)


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


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


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



Overview of Procurement and Supply Management Policies Meeting of WHO Prequalification Programme with European manufacturers and EU marketing authorisation.

Documents

procurement mechanismsprs

results global fund

global fund approach

used procurement agents

global fund extract

forms of authorization

efficacyfor medicines

additional financial