Development Cooperation – Regulatory Systems Strengthening

In 2013 the Federal Council issued a revised mandate to Swissmedic to conduct projects in the area of development cooperation, in conjunction with the Swiss Agency for Development Cooperation (SDC) and/or non-profit organisations, provided that the funding of the activities (at full cost) is guaranteed through third-party resources. In addition, the independence and functioning of Swissmedic must not be put at risk by these activities.

In view of the above, the Bill & Melinda Gates Foundation[1] (BMGF), the Federal Department of Home Affairs (FDHA) and the Federal Department of Foreign Affairs (FDFA) agreed in January 2014 on a Memorandum of Understanding (MoU) (Link) to improve and accelerate access to health interventions and therapeutic products in low and middle-income countries by strengthening regulatory systems.[2] This is to be achieved by leveraging and coordinating resources through cooperation between the three parties to the MoU and the WHO. The engagement of Swissmedic was re-confirmed by the Federal Council in 2018 through its strategic objectives for 2019-2022 (Link). The promotion of regulatory systems in low and middle-income countries is no longer incorporated as a separate objective in the new strategy period 2023-2026 because the commitment has been consolidated in recent years and will now be continued as part of operational activities. The support is aligned with the Swiss Health Foreign Policy (Link) and contributes to the implementation of the priority action area “Access to medicine”.

The new Grant Agreement, which entered into force on 27 March 2024, provides for a total contribution of USD 900,000, divided into three yearly tranches. This grant amount will be exclusively deployed for supporting the agreed activities from May 2024 to May 2024. Thanks to this new agreement, Swissmedic will be able to continue to support LMICs in improving their regulatory systems for the next three years. The contributions for development cooperation are earmarked for specific purposes (salary payments of staff, instructors, travel expenses). The expenses are recorded separately in Swissmedic’s accounts.

Within this framework, activities are currently being implemented in the following three main areas of engagement:

  • Harmonisation: Support for the implementation of the African Medicines Regulatory Harmonization (AMRH) Programme (Link)
  • Access: Swissmedic procedure for scientific advice and Marketing Authorisation for Global Health Products (MAGHP) (Link)
  • Capacity Building: Swissmedic training courses (Link)