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A Room with a View (and with a Gene Therapy Drug): Gene Therapy Medicinal Products and Genetic Tourism in Europe
European Journal of Health Law Pub Date : 2022-04-08 , DOI: 10.1163/15718093-bja10083
Vera Lúcia Raposo 1
Affiliation  

In contrast to the extreme caution that has been imposed on genetic medical procedures, in European law genetic drugs, or medications, have found a legal loophole that allows flexible (perhaps too flexible) access to these drugs. In Europe, Gene Therapy Medicinal Products are a form of Advanced Therapy Medicinal Products and as such submitted to the marketing authorization procedure. However, there are legal mechanisms in place — such as compassionate use, named patient use, and hospital exception — that allow for their provision to patients without proper approval. This is not, de per se, problematic; the problem arises, though, because such mechanisms are neither properly regulated nor monitored, and their application differs substantially according to the jurisdiction. This disparity and lack of control have given rise to situations of genetic tourism, where patients in desperate need travel to so-called genetic paradises, looking for a miraculous, and extremely expensive cure. The outcome is sometimes tragic, endangering patients’ safety and undermining confidence in genetic products.



中文翻译:

有风景的房间(还有基因治疗药物):欧洲的基因治疗药品和基因旅游

与对基因医疗程序的极度谨慎相反,欧洲法律中的基因药物或药物发现了一个法律漏洞,允许灵活(也许太灵活)获得这些药物。在欧洲,基因治疗药物产品是高级治疗药物产品的一种形式,因此需提交营销授权程序。然而,现有的法律机制——例如同情使用、指定患者使用和医院例外——允许在未经适当批准的情况下向患者提供这些服务。这本身并没有问题;然而,问题的出现是因为这些机制既没有得到适当的监管也没有受到监督,而且它们的应用根据司法管辖区的不同而有很大差异。这种差异和缺乏控制导致了基因旅游的情况,迫切需要的患者前往所谓的基因天堂,寻找神奇且极其昂贵的治疗方法。结果有时是悲剧性的,危及患者的安全并破坏人们对基因产品的信心。

更新日期:2022-04-08
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