Health products policy and standards
Our team provides authoritative guidance and standards on quality, safety and efficacy of health products and supports countries to formulate evidence-based policies and ensure good practice throughout the value chain.

Local production and technology transfer

Appropriate, affordable and good quality medical devices are indispensable in healthcare services. They serve for the prevention, diagnosis and treatment of diseases. 

Local production is essential to bridge inequity gaps in access to medical devices. Successful medical technologies in High Income Countries (HIC), often fail under demanding challenges of Low and Middle Income Countries (LMIC). Moreover, imports in LMIC do not offer the features necessary to provide devices that are:

  • Accessible
  • Affordable
  • Available
  • Sustainable
  • Durable
  • Robust

Availability of service, spare parts and power back-up are also lacking in many LMICs.

 

WHO Initiatives

World Local Production Forum

The World Local Production Forum: Enhancing access to medicines and other health technologies (WLPF) is a WHO initiative that provides Member States and the global community with a regular platform to shape strategies, galvanize collective action, and foster partnerships on sustainable local production to improve timely and equitable access to quality assured health products.

WHO Health Technology Access Pool

WHO announces the Health Technology Access Pool (HTAP) as the successor to the COVID-19 Technology Access Pool (C-TAP) C-TAP was launched in May 2020 by WHO, the Government of Costa Rica and other partners to facilitate equitable and affordable access to COVID-19 health products for people in all countries by providing a platform for technology developers to voluntarily share intellectual property, knowledge, and data, thereby accelerating technological innovation and expanding global production capacity.

WHO Strategic guidance for technology transfer and local production processes in LMIC

How to select the right technology to produce locally?

The first step is the evaluation of the available technology. The technology to be developed locally should:
  • meet the regional clinical requirements
  • follow regional / international regulatory requirements
  • follow strategies to overcome the economic and infrastructure challenges.

WHO Guidance

Technology developers in LMICs encounter complex regulatory and manufacturing processes. WHO collaborates with multiple stakeholders to provide guidance through those processes. The main aim is to ensure medical devices are available to all by:

  • identifying priority devices
  • building local capacities
  • facilitating information exchange
  • selecting the technology
  • developing transfer processes
  • guiding through clearance of IP & regulatory processes
  • promoting successful navigation of business markets.

In the context of the Global Strategy and Plan of Action on Public Health Innovation and Intellectual Property, the World Health Organization (WHO) with support from the European Union developed this two project reports on medical devices access through local production.