Prepared for the WHO Department of Public Health, Innovation and Intellectual Property by Rosanna Peeling and Ruth McNerney (London School of Hygiene & Tropical Medicine). This report forms part of the project entitled: Improving access to medicines in developing countries through technology transfer related to medical products and local production. It is implemented by the Department of Public Health Innovation and Intellectual Property of the World Health Organization (WHO/PHI) in partnership with the United Nations Conference on Trade and Development (UNCTAD) and the International Centre for Trade and Sustainable Development (ICTSD) with funding from the European Union (EU). The overall objective of the project is to increase access – especially for the poor in developing and least developed countries – to medicines, vaccines and diagnostics.

This report presents an overview of in vitro diagnostic (IVD) device technology transfer and local production of diagnostic tests for developing countries. The report identifies needs and analyses trends in the local production of diagnostics and related technology transfer. A series of recommendations are made. The objective is to assist the World Health Organization (WHO) in its support for Member States in implementing the global strategy and plan of action on public health innovation and intellectual property, with particular reference to the promotion of capacity building for local production in developing countries.

High-quality diagnostic technologies are available for infectious diseases in most developed countries, but they are neither accessible nor affordable in developing countries, where disease burdens are high. Evidence-based treatment using diagnostic test results is needed to replace syndromic management, which is often ineffective and increases the risk of development of antibiotic resistance. Although the long-term solution is to build capacity for diagnostic innovation in developing countries, technology transfer and local production can be an effective and sustainable strategy by which to increase access to diagnostic tests. This report examines current models of technology transfer and local production, identifies successes, failures, challenges and opportunities, and presents recommendations with a view to developing better models for the future...