Substandard and falsified medical products (SFMPs) pose a major threat to public health, the economy and security in Africa. The World Health Organisation estimates that one in ten medical products circulating in low- and middle-income countries is substandard or falsified, causing more than 250,000 preventable deaths per year. In response to this challenge, the European Union and Expertise France are implementing the MEDISAFE programme.

MEDISAFE Phase 1 (2018–2023) covered 11 countries in East and Central Africa (Burundi, the DRC, Ghana, Ethiopia, the Seychelles, Kenya, Uganda, Tanzania, Malawi, Rwanda and Zambia). It led to the production of: the Reference Manual on SFMP Legislation (an African perspective), guides and strategies on supply chain management, legislation and communication, as well as the roadmap adopted in Nairobi in April 2022. It brought together more than 300 participants at 14 regional and national events, in partnership with the European Union (CBRN network), UNODC, INTERPOL, the Council of Europe and AUDA-NEPAD.

MEDISAFE 2.0 builds on and expands this initial phase: it is a four-year project, funded by the European Union (NDICI) to the tune of EUR 9,000,000, implemented by Expertise France under indirect management via a contribution agreement with the European Union Delegation to Nigeria. It covers 13 countries organised into two regional clusters.

Cluster A (West Africa): Benin, Côte d’Ivoire, Ghana, Guinea (Conakry), Nigeria, Senegal, Togo.

Cluster B (East and Southern Africa): Burundi, Democratic Republic of the Congo, Ethiopia, Kenya, Rwanda, Zambia.

The project distinguishes between countries that benefited from MEDISAFE Phase 1; of the 13, seven are former participants: Ghana, Burundi, the DRC, Ethiopia, Kenya, Rwanda and Zambia, alongside newly integrated countries. It combines activities tailored to the maturity level of the new countries, capitalisation and consolidation activities for the existing ones, and cross-cutting regional activities bringing both groups together (peer mentoring, experience sharing, operational coordination).

Overall objective: To mitigate the health, economic and security threats posed by substandard and falsified medical products (SFMPs) in West and East Africa.

The project pursues this objective through three complementary specific objectives, linked within a single theory of change and all underpinned by an inclusive and gender-sensitive approach:

•     SO1 – National and regional legal capacities to combat SFMPs are strengthened through an inclusive and gender-sensitive harmonisation of legal frameworks and the implementation of key regulations.

•     SO2 – The capacity of national and regional law enforcement agencies to detect, investigate and combat SFMP is strengthened through the optimisation of inclusive operational procedures, improved intelligence and the development of transnational cooperation that addresses the specific needs of the most vulnerable, particularly women and children.

•     SO3 – The supply chain is strengthened and secured, and public awareness of SFMPs is raised, through inclusive and gender-sensitive approaches, by promoting the active role of women healthcare professionals, women-led organisations and care , in order to ensure people’s safety and equitable access to safe and effective medical products.

These Terms of Reference fall under the pharmaceutical component (SO3), to which two outcomes contribute:

•     Output 3.1 – Civil society actors have increased their awareness and strengthened their knowledge, risk perception and preventive behaviours regarding SFMPs, pharmaceutical crime and forms of trafficking facilitated by digital technology.

•     Output 3.2 – Partner countries establish and operationalise risk-based systems for the traceability, post-market surveillance and regulatory control of medical products, in order to prevent, detect and combat the circulation of SFMPs in national and cross-border supply chains.

The project is entering its four-month Inception phase, which will culminate in the MEDISAFE 2 Action Plan, validated by the countries and Expertise France, to be submitted to the European Union Delegation. Gender-sensitive approaches, in particular taking into account the differing levels of exposure among women, men and vulnerable populations, and promoting the role of female healthcare professionals and women-led organisations, are integrated across the board.

Raising awareness amongst key stakeholders and the general public constitutes Output 3.1 of the pharmaceutical component. The component is engaging a public health communications specialist, with a focus on gender, to support national communication strategies and awareness-raising plans and with knowledge in the pharmaceutical field.