IPC meeting: December 2012

Quality assurance for essential medicines and health products

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Pharmaceutical Products

QA Policy

(June 2009)

December 2010: requirements to purchase ACTs FDC in priority

Condoms

Procurement guidelines (WHO 2010)

Diagnostic Products

QA Policy

(Dec 2010 )

Long Lasting Insecticidal Nets

WHOPES recommendations and specs

Global Fund Quality Assurance

for Health Products

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the Global Fund’s QA policy(issued December 2010):

Clinical Criteria• Medicines must be

listed in WHO or national or institutional Standard Treatment Guidelines (or appropriate technical justification)

Quality Criteria

All medicines must be authorized for use in recipient countries

+ Additional stringent criteria for all ARVs, anti-TB products and

antimalarials

Quality Monitoring

Grant recipients must organize:

• Monitoring quality all along the supply chain (storage, distribution)

• Systematic random quality control testing

+ +

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Category

WHO-PQ:

Prequalifi-

cation

Stringent

Regulatory

Authority

(SRA)

authorization

Expert

Review

Panel (ERP):

Time-limited

advice

National

Medicines

Regulatory

Authority (NMRA)

authorization

Procurement as

per principles of

WHO Model

Quality

Assurance

System for

procurement

agencies

Antiretroviral,

anti-TB,

antiMalarial

(ATM) medicines

� �

(if <2 WHO-

prequalified

or SRA-

authorized)

�

� �

Other essential

medicines� �

Less Quality criteria for non ATM essential medicines

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Pros and cons of QA approaches for non-ATM essential

medicinesApproach Advantages Challenges

WHO-

prequalification (PQ)

Stringent assessment & follow-up of issues in

countries

Limited capacity of WHO-PQP

Cost - no incentives for manufacturers

to reach and maintain PQ status

Stringent

regulatory auth.

(SRA) approval

Stringent assessment Cost – no incentives for manufacturers

operating in non-stringent environment

Expert Review

Panel – risk

assessment

↑availability & competition of

expertly QA’d products

Known, accepted approach

Time-limited approval

Less stringent when not linked to PQ /

SRA approval

Regulatory

approval in

country of use

Responsible authority

Best placed for post-market

surveillance

Weak capacity and enforcement in

most recipient countries

Qualification of procurement agencies (PAs)

Holistic approach to QAInvolvement of PAs from recipient countries

Current diverse QA capacityCommercial entities – conflict of interest?

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A proposed risk-based approachAssessing

entity /

Approach :

Risk level:

WHO

Prequalification

Program

Expert Review

Panel (hosted by

WHO):

Time-limited

approval

Stringent

Regulatory

Authority (SRA)

approval

National Medicines

Regulatory Authority

(NMRA) approval

Capacity- building

/cooperation

Procurement Entity

Qualified by an

independent body

(need common

standards)

MQAS standards

High HIV/AIDS, TB, Malaria

("ATM") medicines

Non-ATM medicines on

WHO-EOI list (for

opportunistic infections &

other)

HIV/AIDS, TB,

Malaria ("ATM")

medicines

Could be extended

to Non-ATM

medicines

HIV/AIDS, TB,

Malaria ("ATM")

medicines

Non-ATM

medicines

Through WHO-Prequalification

Programme / regional

initiatives (e.g. Joint

assessments)

High-risk medicines (to be

defined)

HIV/AIDS, TB, Malaria

("ATM") medicines

Non-ATM medicines

Medium Non-ATM

medicines

Through regional initiatives

(e.g. qualification for minimum

regulatory functions):

Non-ATM medicines

Medium-risk medicines (to be

defined)

Non-ATM medicines

Low Non-ATM

medicines

Non-ATM medicines Low-risk

medicines (to be defined)

Non-ATM medicines

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Recommendations

• Donors and procurement agencies should work towards common quality requirements for non-ATM medicines

• WHO work on risk categorization of essential medicines

• Towards qualification of Procurement Agencies

• WHO will host a website of completed and planned manufacturing site inspections, affiliation of lead inspector and contact details of person responsible for clarifications

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Outline

A model quality Assurance system for procurement agenciesdevelopment of an harmonized tool

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• Some partners already developed their own tool to assess procurement agencies capacity to comply with the MQAS Guidelines:

– Different interpretation of the MQAS by the partners

• Need for an harmonized tool for the assessment of procurement agencies,

to be utilized by all with the aim of better use of resources by coordinating PA assessments and working towards mutual recognition of PA assessment findings

• Working group : QUAMED, PFSCM, UNICEF, MSF, IDA, Crown Agents, GDF, MSH, UNION, UNOPS, USAID, ICRC and CHMP

• The Global Fund Secretariat agreed to facilitate the work of the working group and appointed a consultant in December 2011 for developing the tool with the working group

Assessment of procurement agencies based on MQAS

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Development of an Harmonized tool and MQAS review Q4 2011Step 1

Q1 2012Step 2 and 3

Q2 2012Steps 4 and 5

Q3 2012/ to Q2 2013

Liaise with

organizations of the

working group

Obtain the existing

tools

Review the

information and tools

provided

Prepare a report on

the organizations

tools

Review the MQAS

and identify areas for

amendments

Organize meeting

with the organizations

to present the outcome of reviews:

March 21012

Review each MQAS

module, propose tool (

including scoring) collect participants

comments

Prepare an update of the MQAS with the

recommendations

for changes

Organize a meeting to

discuss the tool and

the updated MQAS : June 2012

Formalize the tool ,and submit

comments on MQAS

to WHO (Q3 2012)

Pilot phase : each

participant to use the common tool for a period of 6 months

( self assessment or

external assessment) ( Q4

2012-Q1 2013)

Finalization of the

tool based on comments received

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Procurement of Quality Assured Diagnostics, Inter Agencies collaboration

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• Product types must be selected in compliance with: National guidelines and WHO guidance

• A technical justification should be provided if included only in one of above

Clinical Criteria

• ISO 13485: for All diagnostics

Quality standards for manufacturing

sites

• Assessed according to requirements of authorities member of GHTF or

• Approved by WHO after technical assessment

Quality standards for, Malaria and

HIV RDTs, ELISA and WB

Genev

a

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Quality Assurance Policy for Diagnostic Products:

Selection of quality products

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Implementation : challenges (1)

• Few products prequalified/assessed by WHO

• No centralized information system available to identify products approved by authorities member of GHTF, except for USAID List of Approved HIV/AIDS Rapid Test Kits

• Challenges to follow upgrades of products

• Lack of standardization of products, (including nomenclature, packaging … ). � RBM PSM WG RDT harmonization initiative

• Difficulties to monitor the quality at country level

Genev

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Implementation: challenges

Genev

a

14

• Lack of knowledge and capacity at country level in regulating

diagnostics, and in procurement process

• Lack of sufficient guidance for quality monitoring, including quality control, at country level, adapted to programs/countries

• Multiplicity of stakeholders, at country level: too often lack of collaboration, need to reinforce communication among all

stakeholders.

• Procurement policies for diagnostics

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Pharmaceutical Products

QA Policy

(June 2009)

December 2010: requirements to purchase ACTs FDC in priority

Condoms

Procurement guidelines (WHO 2010)

Diagnostic Products

QA Policy

(Dec 2010 )

Long Lasting Insecticidal Nets

WHOPES recommendations and specs

Insecticides for IRS

Global Fund Quality Assurance

for Health Products