Tuberculosis

Ruth McNerneyDepartment of Pathogen Molecular Biology,

Faculty of Infectious and Tropical Diseases,

London School of Hygiene & Tropical Medicine.

Facilitating local production

for improved access to

in vitro diagnostics

Ruth McNerney & Rosanna Peeling

London School of Hygiene & Tropical Medicine

2nd Global Forum on Medical Devices, Geneva.

In vitro diagnostic (IVD) medical deviceworking definition:

a device, whether used alone or in combination,

intended for the in-vitro examination of specimens

derived from the human body solely or principally

to provide information for diagnostic, monitoring

or compatibility purposes. This includes reagents,

calibrators, control materials, specimen receptacles,

software, and related instruments or apparatus or

other articles.

AHWP SG1/N045:2008 Principles of In Vitro Diagnostic (IVD) Medical Devices Classification

Phase I: Implemented by WHO Department of Public Health, Innovation and

Intellectual Property (WHO/PHI) in partnership with the United Nations

Conference on Trade and Development (UNCTAD) and the International Centre for

Trade and Sustainable Development (ICTSD)

http://apps.who.int/medicinedocs/en/m/abstract/Js19059en/

This project is part of EU funded initiative: Improving Access to

Medicines in Developing Countries through Technology Transfer

Related to Medical Products and Local Production

Phase 1 ended 2011

Diagnostics report publishedRosanna Peeling and Ruth McNerney

• Manufacturing mainly occurs in high income countries

and emerging economies

• There are quality concerns about some products

• Little manufacturing activity in Africa

Production of in vitro diagnostics

In Vitro Diagnostics Pipeline

Diagnostics perform differently in different geographic settings

(Population, disease burden, environmental factors)

Local production could

• Improve access to products appropriate for the local market

• Reduce distribution chains

• Lower costs??

Market research

Regulatory

acceptance

Sales

Technology transfer pathway

Capacity assessment

Prepare workforce

Build R&D capacity

Build manufacturing

capacity

Validation

Build marketing &

distribution network

Financing

Sustainable production shall require quality

manufacture and access to a market

Market

research

Financing

R & D

Prototype

Regulatory

acceptance

Marketing &

distribution SalesManufacture

Validation

Product development cycleAccess to finance is a major challenge

Novel financing avenues are needed

Standards

Hardware

Software

Reagents

Biologicals

Packaging

Instructions

Disposal

Training

Technical supportStandardsStandardsStandardsStandardsStandardsStandardsIP

Life for a new manufacturer

in a new market can be a

quite a challenge . . .

Marketing

Importation of materials

We aim to

• Diminish barriers to local production of IVD.

• Enhance IVD manufacturing opportunities in

developing countries.

• Encourage and facilitate tech transfer for local

production.

• Improve the quality of diagnostics produced in

developing countries.

• Improve access to quality diagnostics.

Project Phase II: Facilitating local production

for improved access to in vitro diagnostics.

A policy framework and strategic

plan for building sustainable local

production capacity for the

manufacture of affordable quality

diagnostic tests

Project Phase II: Facilitating local production

for improved access to in vitro diagnostics.

Policy framework and strategic plan

• A policy framework for building local production capacity to

address local/regional public health needs.

• A consensus statement on standards for clinical validity of IVDs

in developing countries.

• A road map for establishing local production.

• A generic business plan for production in Africa.

• Algorithm for assessing sustainability of potential production sites.

• Consensus standards for manufacture

• A training package on manufacturing standards

• A cohort of African companies and other potential producers

trained in diagnostic manufacturing standards.

• We shall work with the International Network of

the Institut Pasteur, WHO and other experts from

commercial and non-commercial sectors.

• We shall undertake cases studies

• We shall consult with stakeholders across sectors.

• We will publish consensus documents and slide sets

• Project start date: October 2013

Your assistance shall be greatly appreciated

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Without diagnostics, medicine is blind Without diagnostics, medicine is blind Without diagnostics, medicine is blind Without diagnostics, medicine is blind Alain Mérieux Alain Mérieux Alain Mérieux Alain Mérieux