(P-PH-6) Regulating Blood Systems in the WHO Eastern Mediterranean Region

Background/Case Studies: Blood transfusion is an essential element of the healthcare system, contributes to saving millions of lives every year; improving patients’ life expectancy and quality of life; and supporting complex medical and surgical procedures. A National Blood System (NBS) structure depends on organization and level of development of the healthcare system. In 2013 blood components were added to WHO Model List of Essential Medicines (EM). An appropriate and effective legislative framework and functioning regulatory authority (RA) is crucial for management of blood products as EMs. All critical activities within NBS should be coordinated nationally to promote uniform standards, economies-of-scale, consistency in staff competency, quality and safety of these EMs, and best transfusion practices. Key is formulation of an appropriate legislative framework administered by a RA responsible for regulating the vein-to-vein chain in preparation and use of these EMs. However, detailed information about blood systems in the WHO Eastern Mediterranean Region (EMR) is lacking. A focused survey among the 21+1 Member states of EMR was done to study their validity for the blood supply.

Study

Design/Methods: Existing legislative instruments of WHO EMR Member States were collected, reviewed and analysed for relevance, appropriateness for preparation, use of blood and blood products, and use of associated substances and relevant medical devices. A literature search was done on matching combinations of the keywords: regulation, regulatory system, regulatory framework, and legislation, with production and use of blood and blood products. Benchmark used: WHO recommendations and EU Directives.

Results/Findings: Literature search resulted in 2 references with respect to national and international legislation. Various formal legislative documents of only 9/22 countries exist (Governments); 1960 (Egypt) till 2017 (Pakistan). Most are detailed descriptions of RA, operational establishments, and specific requirements. Validity is questionable because none complies with WHO and EU recommended formats and contents, therefore will not support effective regulatory oversight to promote and enhance quality, safety and availability of blood and blood products (EMs). WHO 2020-2023 Action Framework still mentions this as main challenge.

Conclusions: There is a paucity and inadequacy of legislative frameworks. Governments should provide effective leadership and governance in developing a NBS, fully integrated into the national healthcare system. Essential challenges of a NBS include an appropriate regulatory framework with legislation, regulations and other non-legislative instruments overseen by a RA. These documents should spell out principles and cadres, standard setting, and organization of the blood system to ensure an adequate and safe supply of blood and blood products and safe clinical transfusion.

Importance of research: Blood is a national resource which needs to be porotected and regulated by a proper legislative framework, It is an integral part of the national healthcare system and therefore shall be accesswwuble by every citizen in need. The national policy and legislative framework shall be translated in a National Blood System (NBS, governance) to govern the manufacturing (establishments) and consumption (patients, hospitals) elements of the NBS on a global level..