The patient experience and health outcomes.

status of blood­collecting organi­ zations — policies that the WHO endorses and that were stressed again in a 2011 World Health As­ sembly resolution. These principles can also be established within a country through legislation or policy and can be achieved with­ in a biologics manufacturing en­ vironment. Additional concerns are that treating blood as a medication might increase costs and interfere with the function of blood sys­ tems that have grown up outside the oversight of health ministries and other regulatory agen cies. The immediate direct costs of intro­ ducing regulated manufacturing systems are high, but indirect sav­ ings from improved patient out­ comes and donor safety, though harder to calculate, are substan­ tial. Furthermore, the manufac­ ture of blood components that meet set quality standards might allow costs to be recovered through provision of separated plasma suitable for fractionation. Finally, national investment in and oversight of blood systems, far from being disruptive, have led to improved availability and quality of blood for transfusion. The Expert Committee on Se­ lection and Use of Essential Medi­ cines will hold its biennial meet­ ing in April 2013. An application to include whole blood and red cells on the next Model List has been submitted and posted on the WHO website (www.who.int/ selection_medicines/committees/ expert/19/en/index.html) for pub­ lic comment. Patient advocacy groups, professional associations, national blood services, regula­ tory agencies, and others should review and comment on this ap­ plication. Adding blood to the Model List would encourage gov­ ernments to invest in infrastruc­ ture and the governance of blood systems and increase their efforts in blood­donor recruitment and blood collection, which should lead to the provision of safe and cost­effective therapy, prevent deaths and disabilities from blood shortages, and improve health globally.