Facilitating local production for improved access to in vitrodiagnostics. Tuberculosis. Ruth McNerney. Ruth McNerney & Rosanna Peeling

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1 Tuberculosis Facilitating local production for improved access to in vitrodiagnostics Ruth McNerney & Rosanna Peeling Ruth McNerney London School of Hygiene & Tropical Medicine Department of Pathogen Molecular Biology, Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine. 2 nd Global Forum on Medical Devices, Geneva.

2 In vitro diagnostic (IVD) medical device working definition: a device, whether used alone or in combination, intended for the in-vitroexamination 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

3 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 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) Phase 1 ended 2011 Diagnostics report published Rosanna Peeling and Ruth McNerney

4 Production of in vitro diagnostics Manufacturing mainly occurs in high income countries and emerging economies There are quality concerns about some products Little manufacturing activity in Africa

5 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??

6 Technology transfer pathway Market research Capacity assessment Prepare workforce Financing Build R&D capacity Sales Build manufacturing capacity Build marketing & distribution network Validation Regulatory acceptance Sustainable production shall require quality manufacture andaccess to a market

7 Access to finance Product is development a major challenge cycle Market research R & D Financing Prototype Validation Regulatory acceptance Manufacture Marketing & distribution Sales

8 Novel financing avenues are needed

9 Life for a new manufacturer in a new market can be a quite a challenge... IP Standards Standards Standards Standards Standards Standards Standards Hardware Software Reagents Biologicals Packaging Instructions Disposal Training Technical support Marketing Importation of materials

10 Project Phase II: Facilitating local production for improved access to in vitro diagnostics. Weaimto 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.

11 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

12 Policy framework and strategic plan A policy framework for building local productioncapacity 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.

13 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

14 Sans diagnostic, la médecine est sans visibilité Alain Mérieux Without diagnostics, medicine is blind Alain Mérieux