Establishing blood regulation in Africa: From 0 to 100 in …? – Insights into working globally

Blood and blood components for transfusion are essential medicines for which there is a high demand in African countries. Many children and mothers require transfusions to treat sickle cell disease, parasitic anemia or postpartum hemorrhage. However, although in most parts of sub-Saharan Africa, the national blood services are functional to a certain degree, both the amount and the quality of blood need improvement. Also, blood is mostly not subject to regulatory oversight.

The establishment of regulatory oversight for blood will further improve its quality and safety. Many countries already regulate pharmaceuticals and vaccines. The BloodTrain project at the Paul-Ehrlich-Institut which is part of the Global Health Protection Programme supports the integration of blood into the regulatory system by developing and implementing the corresponding legal documents.

The work of the project is based on three pillars: structure building through specialized technical support including the development of legal documents, capacity development through training workshops, and harmonization of regulation through the support of continental technical working groups.

We also support the train-the-trainer principle and the establishment of so-called Regional Centers of Regulatory Excellence to further promote sustainability.

However, setting up and supporting regulatory systems often presents very specific challenges.

The intercultural challenges, political delays, and high staff turnover were already largely expected, but those can always happen at unexpected times. Moreover, some challenges only became obvious during the project: changing and/or contradicting mandates, strong hierarchical structures, and changing focus of the health system (i.e. during and after the pandemic).

International work is subject to many challenges on the way from 0 to 100 % implementation. In this presentation we give insights into the global work of regulatory systems strengthening, the upcoming expected and unexpected challenges and how we meet these challenges to support the availability of safe and quality-assured blood in Africa.

The views expressed in this presentation are the personal views of the presenter(s). They shall not be understood or cited as opinions of the Paul-Ehrlich-Institut. The presenter has not received any funding or grants from companies or from associations representing companies.

We have no conflicts of interest to declare.