Background: Assuring the quality and safety of blood and blood components is an essential element of health care in all countries and requires government commitment and legal frameworks. Ineffective regulation of blood and blood components has far-reaching consequences that are not limited to the affected countries but also have extensive global implications. Summary: In this review, we summarize the work of the project BloodTrain funded by the German Ministry of Health within the framework of the Global Health Protection Programme to strengthen regulatory structures in Africa that are imperative to guarantee the improved availability, safety, and quality of blood and blood products. Key Messages: Intense interaction with the stakeholders in African partner countries lead to first measurable successes in the strengthening of blood regulation, as shown here for hemovigilance.

The recognition of blood and blood products as essential medicines highlights their crucial importance in health care systems [1]. This further stresses the need for governments to assure adequate supply, quality, and safety of blood and blood products, in line with the 2010 World Health Assembly Resolution [1]. However, despite these global recognitions, available data from African countries highlight a huge gap between need and supply for blood, blood components, and blood products [2].

To ensure equitable availability and access to safe blood products in African countries, organized national blood systems are required. Within that system, a competent blood regulatory authority assures that appropriate standards are met for production of blood products and monitoring of blood safety [3]. Strengthening of national and regional blood regulatory authorities is therefore a fundamental need to assure global supply of safe blood products [3].

Within the context of strengthening blood regulation, the World Health Organization (WHO) Global Benchmarking Tool plus Blood (WHO GBT + Blood) provides the basis to identify regulatory capacity and barriers for the National Regulatory Authorities (NRAs) to meet minimum regulatory functioning goals [4, 5]. The WHO GBT + Blood also reflects current global best practices in blood regulation and allows the collection of quantitative and qualitative data which can be analyzed simultaneously to give a context-specific interpretation of regulatory performance over time [6].

BloodTrain is a project of the Paul-Ehrlich-Institut – the German Federal Institute for Vaccines and Biomedicines – conducted under the aegis of the Global Health Protection Programme (GHPP) of the German Federal Ministry of Health. The pilot focused on improving availability of quality-assured blood and blood products and emergency treatment options through the strengthening of the regulation of blood, blood components, and blood products.

With four partner countries, namely, Ghana, Tanzania, Zambia, and Zimbabwe, BloodTrain developed approaches in different topics to strengthen blood regulatory systems. In this review, an overview of the BloodTrain approach is given, focusing on activities supporting the development of stable, well-functioning hemovigilance systems in the four countries.

The goal of the BloodTrain project is to improve availability of quality-assured blood products and emergency treatment options, achieved through the strengthening of blood regulatory systems. The BloodTrain works with the partner countries to reinforce the regulatory structures through provision of technical support and in parallel enhance regulatory expertise with capacity-building training workshops.

The technical support is based on the result of a systematic benchmarking to identify a baseline of already existing regulatory structures. This is followed by the development of a detailed work plan for each partner country, defining which laws, policies, frameworks, and guidelines need to be strengthened and/or developed. This individual work plan also defines the areas, where capacity building within the national regulatory agencies is needed, and the resulting training workshops that are needed to train the regulators in each country.

A critical component of this work involves the collaboration of NRAs and National Blood Services (NBSs) of the countries, in line with requirements of the WHO Good Regulatory Practices, to build and strengthen regulatory systems and improve regulatory functions. This collaboration provides for enhanced understanding of both stakeholders and improves compliance. It also supports the regulatory system in keeping the requirements realistically feasible. The strategic framework applied by the BloodTrain to implement its regulatory system strengthening work is illustrated in Figure 1.

Fig. 1.

BloodTrain strategic approach (adopted from the WHO RSS 5-step capacity-building programme and the Promoting Quality Medicines Program, implemented by the US Pharmacopeial Convention (USP).

Fig. 1.

BloodTrain strategic approach (adopted from the WHO RSS 5-step capacity-building programme and the Promoting Quality Medicines Program, implemented by the US Pharmacopeial Convention (USP).

Close modal

Benchmarking Using WHO GBT + Blood

As a starting point, using the WHO GBT + Blood, all four countries were assessed to determine the status of implementation and performance of blood regulatory systems [7]. The WHO GBT + Blood was designed by WHO as a standardized benchmarking and assessment tool [7]. The GBT + Blood is used to evaluate and measure the performance of each regulatory function, that is, national regulatory system; marketing authorization and registration, hemovigilance, licensing of blood establishments (BE), market control and post-marketing surveillance, regulatory inspections, clinical trial authorization, lot release and laboratory access, approval of blood (product/process) and approval of medical devices and associated substances, and in vitro diagnostic (IVD) medical devices. This is described in greater detail in [7]. During the establishment of the WHO GBT + Blood, the BloodTrain team did benchmarking for a total of twelve countries in sub-Saharan Africa, as listed in Table 1.

Table 1.

Benchmarked countries

 Benchmarked countries
 Benchmarked countries

The benchmarking appraised the development of practical and directly proportional institutional development plans. The BloodTrain’s technical support to NRAs is then specifically customized to fit the specific needs of the individual countries and relevant regulatory authorities to build sustained capacities. Further, the BloodTrain’s approach fosters sustainability by actively engaging relevant in-country stakeholders such as the NBS.

Call for Expression of Interest

A call was made in collaboration with the New Partnership for Africa’s Development (now AUDA-NEPAD) agency for countries interested in strengthening their regulatory systems for blood, blood components, and blood products to submit applications. Admission into the pilot BloodTrain project was open to all NRAs across the African continent. Four countries, namely, Ghana, Tanzania, Zambia, and Zimbabwe, were selected as partners to the BloodTrain through an evaluation process based on the following criteria: the presence of independent NRA, willingness of NRAs and NBSs to collaborate, and support from the Ministry of Health. These criteria were important to ensure that a productive and sustainable cooperation with the partner countries would be possible.

Work Plan Development

A work plan highlighting priority areas to improve the regulatory system for blood, blood components, and blood products was developed from the institutional development plans for each country from the benchmarking using WHO GBT + Blood. The work plan goals were also targeted to address the following themes: legal provisions, regulations, and guidelines; organization and governance; human resources; and regulatory processes in maturity levels 1–3 of WHO GBT + Blood. The time frame for implementation of the work plans was 3 years (2019–2021). A team was designated in each country to support the implementation of the work plans.

Blood regulatory systems in Ghana, Tanzania, Zambia, and Zimbabwe were assisted to establish, define, redefine, and execute their regulatory mandates to competently manage blood, blood components, and blood products. To kick-start the implementation of activities according to the work plans, a placement or fellowship at the Paul-Ehrlich-Institut was scheduled to give partner countries a better understanding of how blood regulation was organized in Germany. During the placement, participants got the opportunity to interact with different teams supporting different areas of blood regulation in Germany including visits to a BE and a plasma collection center. Following this, a series of basic training workshops on inspection of BEs [8], implementation of blood, blood components, and blood products regulation [9], and on hemovigilance were conducted in Zimbabwe, South Africa, and Zambia, respectively (Fig. 2). In total, through all the capacity-building activities of the BloodTrain performed to date, 301 personnel from NRAs, NBSs, hospitals, and related stakeholders in African countries have been trained in different areas of blood regulation (Fig. 2).

Fig. 2.

Implementation of BloodTrain strategic plan.

Fig. 2.

Implementation of BloodTrain strategic plan.

Close modal

The hemovigilance support began with the hemovigilance workshop in Lusaka, in 2019, where staff from the NBS and the NRA of the partner countries Ghana, Tanzania, Zambia, and Zimbabwe were brought together to learn about basic principles of hemovigilance, to discuss the current state of the hemovigilance systems, and to define the needs in each of their countries. It was agreed to constitute hemovigilance task teams in each country to coordinate the strengthening and establishment of nationally organized hemovigilance systems with clearly defined roles and responsibilities.

The BloodTrain supported the task teams by coordinating and facilitating the meeting and discussions of in-country stakeholders on the planned or proposed hemovigilance systems. Further, the BloodTrain developed templates of national frameworks/policies for hemovigilance, best practice guidelines, and reporting forms. This was based on already existing national frameworks and complemented with regulatory documents from the WHO and, where feasible, from the European Union.

While it was initially planned to meet with task teams in the partner countries at regular time intervals to further the development of documents, it became necessary to perform these meetings on a virtual platform due to the COVID-19 pandemic, which made traveling impossible. This virtual platform, the e-learning platform, was provided by the BloodTrain. BloodTrain also supported participation by enabling internet access, where needed.

Through a series of online and face-to-face meetings, templates were customized by the respective task team in line with their national structures. These documents were also discussed with the relevant stakeholders in order to incorporate their views, namely, the BEs and the hospitals that will be involved in hemovigilance activities in the future. Subsequently, the documents were finalized, and implementation of nationally coordinated hemovigilance systems is currently ongoing.

During the process, the specific hemovigilance sub-indicators from the WHO GBT + Blood served as a tool to get a picture of the work system and to measure the improvements. Currently, Ghana, Tanzania, Zambia, and Zimbabwe finalize their hemovigilance system documents and await to have national launches of their nationally coordinated hemovigilance systems in 2022.

The continued recognition of blood regulation as a critical element at a global level is a positive development that promotes universal availability and equitable access to transfusion therapies. The goal of the BloodTrain is to improve availability of quality-assured blood and blood products in Africa, for which blood regulation is considered to be a prerequisite.

With the progress that has been made by partner countries and BloodTrain to strengthen blood regulatory systems, e.g., by developing a legal basis for blood regulation and fostering cooperation with BEs, the program has faced significant challenges, basically due to the pandemic. The BloodTrain has also captured lessons from the implementation phase of the programme, e.g., by developing and supporting individual approaches for partner countries.

Regulation of blood and blood components is a relatively new concept in Africa, which was introduced for the first time in most BloodTrain partner countries. Because of this, the roles and responsibilities of the key stakeholder NRAs and NBSs within this process needed to be clearly defined and stipulated. Bringing together NRAs and NBSs, to decide on how to develop and implement their respective blood regulatory system best according to their local operating environment and their needs, yielded positive results. In some instances, country work plans had to be revisited and adjusted accordingly as stakeholders became more aware and proposed alternative activities to achieve objectives better. The key learning from all this is that in order to improve and strengthen the regulatory system for blood and blood products, it is important to be open to individual and often unique country situations and necessities. Only with the capacity to flexibly respond to the needs of the partner countries and to adapt to new situations like, e.g., the COVID-19 pandemic, and only with a good communication with the local key stakeholders, a sustainable progress can be achieved.

The onset of the COVID-19 pandemic at the beginning of the second year of implementation of the BloodTrain programme threatened success of the project. Quick adaptation by the BloodTrain to virtual modes of working ensured continuity and showed that remote technical support is also effective in strengthening regulatory systems in Africa. This is, however, not a perfect substitute for face-to-face interaction which is essential for discussions and decision-making. Through this experience, a hybrid approach with a balance between remote and onsite support activities has been found to be ideal for the BloodTrain and partner countries to efficiently and effectively achieve their objectives.

As the first funding period of the GHPP comes to an end in December 2022, there is still a lot of work to be done. On hemovigilance, the implementation of the new hemovigilance regulations and guidelines by training the regulators, BEs, and hospitals in partner countries is key to ensure supply of safe blood products for patients.

For licensing of BE, inspections of BE, and IVD assessment, the regulatory framework needs to be further developed and corresponding collaboration and training established. To achieve this goal, further workshops and technical support activities are planned.

For the highest level of sustainability, partner countries in this pilot project should be strengthened to act as capacity-building hubs for training of other countries in Africa, within the context of the Regional Centres of Regulatory Excellence, a concept of the AUDA-AMRH Programme on sustainable capacity development. As such, the plan is to continue with BloodTrain work in phase 2 of the GHPP from 2023 to 2025.

Since the start of the GHPP in 2016, the BloodTrain has been supporting African partner countries in developing further capacities to improve access to safe blood and blood products for patients. During this time, the following four areas of regulation have been the main focus of the BloodTrain, namely, licensing of BE, inspection of BE, assessment of technical files for blood screening IVDs, and hemovigilance. In this review, BloodTrain’s activities in the field of hemovigilance have been selected to demonstrate the successful collaboration with partner countries to strengthen their regulatory capacities in a sustainable way. This review of the BloodTrain’s capacity-building approach and activities provides useful insights on the development of regulatory systems and structures to improve the availability of blood and blood products in Africa.

The authors would like to acknowledge the following colleagues: Alaa Magdy, Razieh Ostad Dehaghi, Mohammed Refaat, and Alireza Khadem from the WHO regulatory system strengthening team for providing technical assistance during the benchmarking and facilitating at some training workshops; Andre Loua, Stanislav Kniazkov, and Yetmgeta Abdella from the WHO regional offices for providing technical assistance; Abena Asamoa-Amoakohene, Theodora Asa-Eck, Shirley Owusu-Ofori, Lucy Asamoah-Akuoko, Dilys John-Teye, and Alex Owusu-Ofori from the Ghana Haemovigilance Task Team; Elirehema Mfinanga, Alex Nkiyamba, Haninu Nakuchema, Juma Abdu Bhombo, Dunstan Haule, and Oscar Mwashiuya from the Tanzania Haemovigilance Task Team; Beatrice Kabaso, Florence Tirane, Mulubwa Chilambe, Alfred Mangani, David Chama, Joseph Mulenga, Dia Phiri, and Chitindi Sakala from the Zambia Haemovigilance Task Team; Priscilla Nyambayo, Tatenda Nyamandi, Rumbidzai Manyevere, Sisodwa Zamani Nkomo, Gibson Mutasa, Mernard Mutenherwa, Tanyaradzwa Brenda Kahonde, and Lucy Marowa from the Zimbabwe Haemovigilance Task Team; and Margareth Ndomondo-Sigonda, Nancy Ngum, Brian Ng’andu, and Paul Tanui from AUDA for their contribution to the implementation of the BloodTrain programme. We would also like to express our gratitude to all the institutions that have partnered with the BloodTrain, that is, Ghana Food and Drug Authority, National Blood Service Ghana, Tanzania Medicines and Medical Devices Authority, National Blood Transfusion Service Tanzania, Zambia Medicines Regulatory Authority, Zambia National Blood Transfusion Services, Medicines Control Authority of Zimbabwe, National Blood Service Zimbabwe, African Union Development Agency, World Health Organization, and the African Regional Office. We also thank all colleagues in the PEI BloodTrain team and the colleagues from PEI that have continuously supported our work.

The authors have no conflicts of interest to declare.

The work was supported by the German Federal Ministry of Health’s Global Health Protection Programme based on a decision by the German Bundestag (Grant project number: 323 123002).

Washington T. Samukange, Chancelar Kafere, Kristina Heinrich, and Jens Reinhardt wrote the first draft together. Washington T. Samukange, George T. Sabblah, Mwewa M. Siame, and Libert Chirinda did the acquisition of data and data validation. Washington Tendekai. Samukange, Chancelar Kafere, Kristina Heinrich, Jens Reinhardt, and Anneliese Hilger were involved in project management and administration. Jens Reinhardt and Anneliese Hilger were the review supervisors and reviewed the manuscript for important intellectual content. All authors contributed to the review design, interpretation of results, and editing of the manuscript. The author(s) read and approved the final manuscript.

1.
Burnouf T. Blood products: unmet needs for essential medicines. Lancet Haematol. 2019;6:e598–9.
2.
Roberts N, James S, Delaney M, Fitzmaurice C. The global need and availability of blood products: a modelling study. Lancet Haematol. 2019;6:e606–15.
3.
Epstein JS. Best practices in regulation of blood and blood products. Biologicals. 2012;40:200–4.
4.
Khadem Broojerdi A, Baran Sillo H, Ostad Ali Dehaghi R, Ward M, Refaat M, Parry J. The World health organization global benchmarking tool an instrument to strengthen medical products regulation and promote universal health coverage. Front Med. 2020;7:457.
5.
Guzman J, O'Connell E, Kikule K, Hafner T. The WHO Global Benchmarking Tool: a game changer for strengthening national regulatory capacity. BMJ Glob Health. 2020;5.
6.
Dube-Mwedzi S, Kniazkov S, Nikiema JB, Kasilo OMJ, Fortin A, Tumusiime P, et al. A rapid assessment of the national regulatory systems for medical products in the southern african development community. J Pharm Pol Pract. 2020;13:64.
7.
Samukange WT, Kluempers V, Porwal M, Mudyiwenyama L, Mutoti K, Aineplan N, et al. Implementation and performance of haemovigilance systems in 10 sub-saharan African countries is sub-optimal. BMC Health Serv Res. 2021;21(1):1258.
8.
Samukange WT, Klümpers V, Kafere C, Schuler F, Tirane FJ, Kabaso B, et al. Report from the GHPP-BloodTrain inspection workshop in harare the 20th to the 24th of may 2019. Biologicals. 2020;68:125–8.
9.
Kafere C, Tayou TC, Tapko JB, Mbunkah HA, Samukange WT, Mutoti K, et al. Implementation of blood and blood product regulation training workshop, South Africa. Afri Sang. 2020;22(1):5–9.