Gates Foundation

Swissmedic has been involved in development cooperation with the Gates Foundation since 2015. Under the current grant agreement, covering the period from mid-2024 to mid-2027, the partners are continuing their efforts to improve low-resource countries’ access to medical care for a further three years. Ongoing projects and development cooperation can therefore continue for the longer term.

In January 2014, the Bill & Melinda Gates Foundation, as it was then still known (today Gates Foundation), the 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, this collaboration aims to improve access to high-quality, safe and effective therapeutic products in sub-Saharan countries. Swissmedic primarily contributes its expertise in supporting the development of effective regulatory systems.

Development of various areas of engagement
Since the first agreement was signed in December 2015, Swissmedic has worked with the World Health Organization (WHO), the Gates Foundation and the Swiss Agency for Development and Cooperation (SDC) to develop a programme that currently comprises three main areas of engagement.

• Harmonisation: Support for global regulatory harmonisation and system-strengthening programmes, including regional harmonisation initiatives in Africa (Link).
• Access: Marketing Authorisation Procedure for Global Health Products (MAGHP) (Link)
• Capacity Building: Swissmedic training courses for regulatory authorities in low-resource countries (Link)

Legal basis
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.
² The Agency may, in return for payment, provide services to other authorities and international organisations within the scope of its duties under this Act, provided that such services do not jeopardise the independence of the Agency.

Funding framework
The current agreement that entered into force on 27 March 2024 provides for funding of USD 900,000 in three instalments to cover activities in the period from May 2024 to May 2027. The contributions for development cooperation are earmarked for specific purposes (salary payments of staff, travel expenses and other direct costs, e.g. translational services). The expenses are recorded separately in Swissmedic’s accounts.