Expert Consensus Statement on achieving self‐sufficiency in safe blood and blood products, based on voluntary non‐remunerated blood donation (VNRBD)*

Abstract

All countries face challenges in making sufficient supplies of blood and blood products available and sustainable, while also ensuring the quality and safety of these products in the face of known and emerging threats to public health. Since 1975, the World Health Assembly (WHA) has highlighted the global need for blood safety and availability. WHA resolutions 63AE12, 58AE13 and 28AE72, The Melbourne Declaration on 100% Voluntary Non-Remunerated Donation of Blood and Blood Components and WHO Global Blood Safety Network recommendations have reaffirmed the achievement of 'Self-sufficiency in blood and blood products based on voluntary non-remunerated blood donation (VNRBD)' as the important national policy direction for ensuring a safe, secure and sufficient supply of blood and blood products, including labile blood components and plasma-derived medicinal products. Despite some successes, self-sufficiency is not yet a reality in many countries. A consultation of experts, convened by the World Health Organization (WHO) in September 2011 in Geneva, Switzerland, addressed the urgent need to establish strategies and mechanisms for achieving self-sufficiency. Information on the current situation, and country perspectives and experiences were shared. Factors influencing the global implementation of self-sufficiency, including safety, ethics, security and sustainability of supply, trade and its potential impact on public health, availability and access for patients, were analysed to define strategies and mechanisms and provide practical guidance on achieving self-sufficiency. Experts developed a consensus statement outlining the rationale and definition of selfsufficiency in safe blood and blood products based on VNRBD and made recommendations to national health authorities and WHO.

Family donors are critical and legitimate in developing countries

“…The ISBT code of ethics published in 1980 already indicated: “No pressure of any kind must be brought to bear upon the donor”[ 22 ] and as modified in 2006: “No coercion should be brought to bear upon the donor”. [ 12 ] In a recent document, advisers to WHO indicate: “In many countries, systems based on family/replacement donation often lead to coercion and place undue burden on patients’ families and friends to give blood.”[ 23 ] This statement is essentially unjustified as unsupported by evidence and ethically unsound since the blood collected under the pressure of life or death outcome is the result of blood shortage related to the incapacity of governments and blood systems to ensure adequate health care for patients. Pressure, even coercion or payment could be considered acceptable when the survival of patients depends on the collected blood.…”

“…Hence, why is it, that WHO in its recent declaration in Melbourne, Australia stigmatized FD indicating: “[experts] Believe that family replacement and paid donation can compromise the establishment of sustainable blood collection from voluntary nonremunerated blood donors.”[ 10 ] There is no evidence that this indeed takes place. In the follow-up document on self-sufficiency authored by a WHO expert group largely overlapping with the Melbourne group[ 23 ] several statements are made:…”

Transfusion Challenges in Patients with Hematological Malignancies in Sub-Saharan Africa: A Prospective Observational Study from the Uganda Cancer Institute

“…The World Health Assembly expressed concern about the global inequality of access to blood products leaving many patients without this needed treatment and urged Member States to ensure achieving self-sufficiency in the supply of safe blood without shortages 14 . Few studies have examined the demand for and availability of blood products in SSA 6 , and we are not aware of any prior prospective study quantifying the challenges of transfusion support for cancer care in SSA.…”

Repeat voluntary non-remunerated blood donor is the best quality indicator for blood safety

“…Based on the 2012 Consensus Declaration of WHO 12 there are 12 recommendations that national health authorities need to act on to ensure self-sufficiency of blood supply based on VNRBD. While India has gone a long way towards addressing these through the activities of the Blood Safety Division under the National AIDS Control Organization, it is now time to review the current status of VNRBD and streamline the efforts between private and public sectors to move towards achieving targets we have set for ourselves.…”