Swissmedic and the Bill & Melinda Gates Foundation (BMGF) signed a new finance agreement on 3 February 2020. Swissmedic has been involved in development cooperation under the initiative with the BMGF since 2015. The partners are now continuing their efforts to improve low-resource countries’ access to medical care for a further three years. The renewal of the finance agreement is of strategic importance to Swissmedic. Ongoing projects and development cooperation can therefore continue for the longer term.
In January 2014, the BMGF, Federal Department of Home Affairs (FDHA) and the Federal Department of Foreign Affairs (FDFA) signed a Memorandum of Understanding (MoU). Behind this statement of intent lies the goal of strengthening regulatory systems in low-resource countries. In particular, cooperation aims to improve access to therapeutic products in sub-Saharan countries and to deliver high-quality, life-saving medicinal products to sick people as quickly as possible. Swissmedic will primarily be contributing its expertise in developing effective regulatory systems.
Development of various project components
Since the first finance agreement was signed in December 2015, Swissmedic has worked with the World Health Organization (WHO), BMGF and Swiss Agency for Development and Cooperation (SDC) to develop a programme that currently comprises three project components.
- Project component I: Supporting regional harmonisation initiatives in Africa, where Swissmedic experts contribute to the development, implementation and updating of technical guidelines and to developing the capacity of local regulatory authorities and regional communities (African Medicines Regulatory Harmonization Programme, AMRH).
- Project component II: Swissmedic procedure for scientific advice and Marketing Authorisation for Global Health Products (MAGHP).
- Project component III: Swissmedic regulatory training for regulatory authorities in low-resource countries.
The legal basis for Swissmedic’s involvement in development cooperation derives from the Federal Act on Medicinal Products and Medical Devices (Therapeutic Products Act, TPA):
Art. 69 Duties
1 The Agency shall accomplish the duties assigned to it under this Act and other federal acts.
1bis The Federal Council may, against payment, delegate other duties to the Agency which are closely related to the duties assigned to it by law and which do not impair its performance.
The new finance agreement that entered into force on 3 February 2020 provides for funding of USD 900,000 in three instalments to cover activities in the period from February 2020 to March 2023. Development cooperation funding is used solely for its designated purpose (i.e. employees’ salaries, course leaders, travel expenses). The amounts in question are carried separately in Swissmedic's accounts.
Last modification 14.07.2020