Lusaka, 8 March 2017 - Blood transfusion is a potentially life-saving medical intervention. Blood products such as clotting factors and immunoglobulins are designated by WHO as essential medicines. The World Health Assembly (WHA) 63.12 resolution of 2010 highlighted concerns about the unequal access to blood products, especially plasma-derived products, which may result in needy patients, including those with severe congenital and acquired disorders, failing to have access to quality and safe transfusion services. Equitable and timely access to safe blood products requires a functional and well-organized national blood regulatory system. Consequently, WHO advocates for the establishment and sustenance of strong national regulatory authorities in developed and developing countries.

Against this background, a mission was undertaken to Zambia by WHO Experts from 28 February to 1 March 2017 to assess the regulatory system for blood and blood products. The Medicines and Allied Substances Act (2013) of Zambia provides the authority to develop regulations for biological products which include blood/components and Plasma Derived Medicinal Products (PDMPs).  However, there is no manufacturer of PDMPs in Zambia. Safety and quality requirements for different biological products were successfully developed by ZAMRA and for blood and blood components, respective requirements were developed and implemented by ZNBTS. A Laboratory independent of manufactures is part of ZAMRA.

This assessment involved the participation of WHO/HQ, WHO/AFRO and the WHO Country Office in Zambia, Zambia Medicines Regulatory Authority (ZAMRA) and Zambia National Blood Transfusion Services (ZBNTS). The team of external assessors included the following: Dr. Claudius Micha Nübling (Group Lead, Blood Products and related Biologicals, WHO/HQ); Dr. André Loua - Technical Officer (Blood Safety) WHO/AFRO and Dr. Jens Reinhardt, Expert with WHO, Germany.

The Blood Regulator Network (BRN) Assessment Tool was used as the basis of the assessment to gather information on the essential elements that are necessary to establish a legal basis, authority and general characteristics of a National Regulatory Authority (NRA); Specific core functions of an NRA required for comprehensive oversight of blood/products, allied substances and medical devices. At ZAMRA, the assessment observed that legal provisions and vigilance are in place for medicines but not for blood and blood products. Although the Vigilance committee meets on a regular basis, there is need for inclusion of a transfusion expert on the committee. The licensing and/or registration of blood establishments has not yet been established. Epidemiological data was also not available for blood and blood products, hence only a few immunoglobulins / antivenoms are licensed.

This assessment also showed that at the ZBNTS, there was centralized coordination, guidelines for procurements; and international standards were followed for collection, testing, storage and distribution of blood. Furthermore, it was noted that a Quality Management System (QMS) was in place. Ten provincial blood centres / establishments have been established. However, the haemovigilance is not yet fully established.

The recommendations from the mission report include:

1.      A  clear division of roles and responsibilities should be implemented between the ZAMRA as the regulator and the ZNBTS as the operator;

2.      Regulations/guidelines/standards  for blood and blood components should be developed by ZAMRA together with ZNBTS and enforced by ZAMRA;

3. A list of blood establishments in Zambia needs to be developed and  blood establishments need to be licensed as manufacturing sites;
4. Haemovigilance to be covered by ZAMRA with inclusion of a transfusion expert on the vigilance committee;
5. Review the current standards of ZNBTS, amend and reinforce them as necessary.
6. Expertise needs to be developed within the ZAMRA Inspectorate for enforcement and  define procedures to take action in instances of any non conformity;

7.      There should be capacity building activities including blood Good Manufacturing Practice (GMP);

8. An adequate number of ZAMRA staff is needed to be specifically trained to carry out regulatory functions such as evaluation of dossiers and enforcement activities ;

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For more information, please contact :

Dr. Freddie Masaninga, National Professional Officer, Malaria Control, masaningaf [at] who.int

Nora Mweemba, National Professional Officer, Health Information and Promotion, mweemban [at] who.int