Shemie Genevieve, Nguyen Minh Thu, Wallenburg John, Ratjen Felix, Knoppers Bartha Maria
Centre of Genomics and Medicine, Department of Human Genetics, Faculty of Medicine, McGill University, Montreal, QC H3A 0C7, Canada.
Cystic Fibrosis Canada, Toronto, ON M4P 2C9, Canada.
J Pers Med. 2021 May 7;11(5):382. doi: 10.3390/jpm11050382.
This article identifies the potential sources of inequity in three stages of integrating cystic fibrosis personalized medicines into the Canadian healthcare system and proposes mitigating strategies: (1) clinical research and diagnostic testing; (2) regulatory oversight and market authorization; and (3) implementation into the healthcare system. There is concern that differential access will cast a dark shadow over personalized medicine by stratifying the care that groups of patients will receive-not only based on their genetic profiles, but also on the basis of their socioeconomic status. Furthermore, there is a need to re-evaluate regulatory and market approval mechanisms to accommodate the unique nature of personalized medicines. Physical and financial accessibility ought to be remedied before personalized medicines can be equitably delivered to patients. This article identifies the socio-ethical and legal challenges at each stage and recommends mitigating policy solutions.
本文确定了将囊性纤维化个性化药物纳入加拿大医疗保健系统的三个阶段中潜在的不公平来源，并提出了缓解策略：（1）临床研究和诊断测试；（2）监管监督和市场授权；（3）在医疗保健系统中的实施。有人担心，获得医疗服务的差异会给个性化医疗蒙上一层阴影，因为患者群体接受的护理将不仅基于他们的基因概况，还基于他们的社会经济地位而分层。此外，有必要重新评估监管和市场批准机制，以适应个性化药物的独特性质。在个性化药物能够公平地提供给患者之前，身体和经济上的可及性问题应该得到解决。本文确定了每个阶段的社会伦理和法律挑战，并推荐了缓解性的政策解决方案。
