Behr-Gross M-E, Heiden M, Norda R
CS30026, direction européenne de la qualité du médicament et des soins de santé (DEQM), Conseil de l'Europe, 7, allée Kastner, 67081 Strasbourg, France.
Transfus Clin Biol. 2013 May;20(2):127-38. doi: 10.1016/j.tracli.2013.03.002. Epub 2013 Apr 17.
In November 2009, the Council of Europe's Blood Transfusion Steering Committee created a group of experts to explore the problem of behaviors having an impact on the management of donors of blood and blood components and on blood transfusion safety in Europe. This ad hoc group sought a harmonised interpretation of temporary exclusion (or temporary deferral), as opposed to permanent exclusion (or permanent deferral), in the context of the selection of donors of blood and blood components. It was also given the mandate to assess, on the basis of available data, the possibility of differentiating "at risk" behaviours from behaviours "at high risk" of contamination by serious infectious diseases transmitted by blood, blood components or derived therapeutic products. The primary objective of this work was to ensure the safety of blood, blood components and derived therapeutic products for future recipients by promoting a risk analysis-based approach, given that some countries envisaged amending their provisions for donor selection. However, a risk analysis can only be performed on groups, not individuals, which may give the impression of a discriminatory approach, so it needed to be justified in the context of transfusion safety. A collaborative project, which included an investigation phase, led to the drafting of a technical memorandum that summarised the data collected in ten Council of Europe member states on the selection criteria for blood donors and the epidemiology of infectious diseases (with a focus on human immunodeficiency virus) in the general population and among blood donors. The technical memorandum was published in 2011 on the European Directorate for the Quality of Medicines and Healthcare website dedicated to this project. A draft resolution of the Committee of Ministers of the Council of Europe was then developed by the Council of Europe's Blood Transfusion Steering Committee. This text was circulated among member and observer states of the Council of Europe for review and comments.
2009年11月，欧洲委员会输血指导委员会成立了一个专家小组，以探讨影响欧洲献血者及血液成分管理以及输血安全的行为问题。该特设小组力求在献血者及血液成分选择的背景下，对临时排除（或临时延期）与永久排除（或永久延期）作出统一解释。它还被授权根据现有数据评估区分“有风险”行为与因血液、血液成分或衍生治疗产品传播严重传染病而“高风险”行为的可能性。鉴于一些国家设想修订其献血者选择规定，这项工作的主要目标是通过推广基于风险分析的方法，确保未来受血者使用的血液、血液成分及衍生治疗产品的安全。然而，风险分析只能针对群体而非个体进行，这可能给人一种歧视性做法的印象，因此需要在输血安全的背景下加以论证。一个包括调查阶段的合作项目促成了一份技术备忘录的起草，该备忘录总结了欧洲委员会十个成员国收集的关于献血者选择标准以及普通人群和献血者中传染病流行病学（重点是人类免疫缺陷病毒）的数据。该技术备忘录于2011年发表在欧洲药品和医疗保健质量局专门为此项目设立的网站上。随后，欧洲委员会输血指导委员会起草了一份欧洲委员会部长委员会决议草案。该文本在欧洲委员会成员国和观察员国之间传阅以供审查和评论。
