Substandard and falsified medical products (SFMP) constitute a major health, economic and security threat in Africa. The World Health Organization 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, DRC, Ghana, Ethiopia, Seychelles, Kenya, Uganda, Tanzania, Malawi, Rwanda and Zambia). It produced the Reference Manual on SFMP legislation (African perspective), guides and strategies on supply chain, legislation and communication, as well as the roadmap adopted in Nairobi in April 2022. It brought together more than 300 participants across 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 extends and broadens this first phase: a four-year project, funded by the European Union (NDICI) for a total amount of EUR 9 000 000, implemented by Expertise France under indirect management via a contribution agreement with the European Union Delegation in 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.

In line with the action document's approach, the project distinguishes the countries that benefited from MEDISAFE Phase 1, seven of the 13: Ghana, Burundi, DRC, Ethiopia, Kenya, Rwanda and Zambia, from the newly added countries. It combines activities tailored to the maturity level of the new countries, capitalisation and consolidation activities for the former, and cross-cutting regional activities bringing the two groups together (peer mentoring, experience-sharing, operational coordination).

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

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

SO1 - National and regional legal capacities to combat SFMP 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 actors to detect, investigate and combat SFMP is strengthened through the optimisation of inclusive operational procedures, improved intelligence and the development of transnational cooperation responding to the specific needs of the most vulnerable, in particular women and children.

SO3 - The supply chain is strengthened and secured, and public awareness of SFMP is increased, through inclusive and gender-sensitive approaches, by promoting the active role of women health professionals, women-led organisations and caregivers, 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 outputs contribute:

Output 3.1 - Civil society actors have raised their level of awareness and strengthened their knowledge, risk perception and preventive behaviours regarding SFMP, pharmaceutical crime and digitally enabled forms of trafficking.

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

The project is entering its four-month inception phase, the culmination of which is 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 accounting for the differentiated exposure of women, men and vulnerable populations, and promoting the role of women health professionals and women-led organisations, are integrated in a cross-cutting manner.

In each country, the pharmaceutical component relies on a national pharmaceutical expert who forms, together with the NMRA focal point, the national pairing. As the focal point acts as the country's principal respondent for the project's three components (pharmaceutical, legal and law enforcement), the national pharmaceutical expert leads and coordinates, at country level, the interventions of the pharmaceutical component, in articulation with the legal and law enforcement national experts and under the focal point's overall orientation.

Far from being limited to the inception phase, this role runs for the entire duration of the project (four years): the national expert is the country technical counterpart for the implementation of all the activities of the pharmaceutical component (SO3), from the initial data collection within the inception phase through to the project's final capitalisation workshop.