Rwanda: Coordination of European Technical Expertise Supporting Access to Medicines

Strengthening and operationalising the drug regulatory authority in Rwanda is a crucial issue for sustaining the pharmaceutical market and improving health security in Africa. To address this need, Europe is mobilising expertise under a twinning project financed by the European Union and implemented by Expertise France.

Expertise France, by playing its role as a lead contractor for European expertise, will be helping its Rwandan partners meet WHO minimum requirements for an effective regulatory oversight of the local production of quality, safe and affordable health products, including vaccines. The provision of expertise to the RFDA should also have a leverage effect in the current health context and create a dynamic on pharmaceutical regulations in Africa. It will also promote cooperation and the sharing of technical expertise between the European Medicines Agency (EMA) and the African Medicines Agency (AMA) whose headquarters are also in Rwanda.

This twinning, a first for Expertise France in Rwanda, is in line with the diplomatic rapprochement between France and Rwanda since 2019. It is also part of the increased presence of Expertise France and AFD Group in the country. Indeed, AFD’s return to Rwanda with projects through sovereign loans and grants in 2019 has also resulted in the allocation of a first emblematic project for Expertise France in the vocational training sector. In close cooperation with AFD and the European Union, the agency will continue to support Rwanda’s development strategy in the future.

In this interview, Valérie Denux, Director for Europe and Innovation of the French National Agency for Medicines and Health Products Safety (ANSM), tells us about the issues concerning access to medicines in Africa and ANSM’s role in this project.

Can you tell us about the aim of this project and the issues for Rwanda?

This project aims to increase the capacity of the Rwandan drug regulatory body, by working on the framework, procedures and main regulatory functions related to drugs, in order to facilitate imports, as well as local production and the use of health products in their country.

This project is part of Rwanda’s overall approach to improve its health sector. It should allow the Rwandan regulatory agency, which is still young and needs to be strengthened, to be accredited by WHO and recognised as a fully-fledged regulatory authority.

This is a major issue for Rwanda, which will then be able to host producers on its territory and approve medical products from national production, through the regulatory framework and the actions that will be implemented to control imported products.

This twinning project should therefore result in an increase in access to safe health products for Rwandan patients and Rwanda’s partner countries.

Why has France called on European partners to implement this project?

It also makes it possible to share the workload and the human resources of each agency. Germany, Belgium and Lithuania are also major contributors to this project. Countries such as Sweden, Austria and Greece are also contributing. So, this diverse and complementary structural approach allows us to increase the force for action and offer a coherent and high-level range of expertise in the regulation of health products, in order to provide a more effective response to Rwanda’s needs.

The various areas of expertise and experiences of the members of this consortium will not only benefit the Rwandan agency, but also the European member agencies, as it will give them the opportunity to get to know each other better and share good practices.

Can you tell us about the range of technical expertise offered by the consortium?

They have a wide array of requests, including the regulatory framework, managerial strategies, procedures for clinical trials and marketing authorisations, inspection, control, pharmacovigilance and regional cooperation.

More specifically, what will ANSM’s role be in this project?

This project is based on three components and France is managing the first one. So, ANSM will be the leader for this component, with assistance from the French National Health Authority (HAS), and support from Germany (BfArM) and Lithuania (SMCA). This first component is essential, as it concerns the structuring and organisation of the Rwandan agency. This determines the way in which we will implement the entire project. There are seven sub-activities in this component.

This structuring process involves a work of transmission, although our European legislation cannot be fully transposed to the Rwandan context. We’re going to look at the fundamentals of our regulations and dialogue with Rwanda to see how these basic principles can be adapted and implemented in their national regulations.

It's also necessary to work on planning, the strategy and the organisation, to ensure the sustainability of the pharmaceutical market and develop the Rwandan agency’s capacity to cope better with health crisis situations.

Finally, several key issues will be addressed, such as marketing authorisations, product development, inspection, and imports of products and their distribution. It should also be noted that France is supporting the other two components which focus more on pharmacovigilance and the release of batches of vaccines.

What will be the next stages for the implementation of the project?

We’re going to carry out an initial analysis with them of what they want to do and their level of maturity on various issues. Once we’ve conducted this diagnostic, we’ll be able to propose them various options for the implementation.

Our objective is to work as much as possible with our Rwandan colleagues on implementing sustainable activities to ensure that this project has long-term impacts.

It’s especially important to strengthen their national agency, as African countries have elected Rwanda to set up the African Medicines Agency on its territory. This will probably be subject to further support from Europe and closer relations with the European Medicines Agency.