Review of existing legislative instruments for blood systems of Countries in the WHO Eastern Mediterranean Region

Abstract

Blood transfusion is an essential part of health-care systems; contributes to saving millions of lives; improves patient expectancy and quality of life; and supports medical and surgical procedures. Blood and blood products-whole blood, red blood cells, platelets, and plasma were added to the WHO Model List of Essential Medicines (EMs) in 2013. Effective blood regulation is crucial for establishing blood products as EMs which requires countries to implement an appropriate regulatory framework and functioning regulatory authority (RA). There are numerous situations, for example, in the less developed world, where these prerequisites have barely been implemented. Existing legislative tools of the Eastern Mediterranean Region countries were collected, analyzed for relevance and appropriateness for the regulation of blood products, associated substances and relevant medical devices. Literature search on matching combinations of regulatory system/framework, legislation, regulation, with production and use of blood products resulted in few references on national and international legislation. The WHO recommendations and EU Directives were used as reference. Formal legislative and regulatory documents issued by nine countries from 1960 to 2017 were reviewed. Most are descriptions of RA, operational establishments, and specific requirements. None comply with the WHO/EU recommended format and contents; will not support effective regulatory oversight to promote and enhance the quality, safety, and availability of blood and blood products. National authorities should provide effective leadership and governance in developing a national blood system (NBS), fully integrated into the national health system. Essential functions of NBS include an appropriate regulatory framework; legislation, regulations, and nonlegislative instruments administered by an RA. These should spell out ethics, principles and boundaries, standard setting, and organization of NBS to ensure and sustain an adequate supply of quality-assured blood products and safe clinical use.

Keywords

• Legislation
• regulation
• regulatory authority
• regulatory framework
• safe blood
• transfusion medicine