The ethical plausibility of the ‘Right To Try’ laws

• Published in: Critical reviews in oncology/hematology Vol. 122; pp. 64 - 71
• Main Authors: Carrieri, D., Peccatori, F.A., Boniolo, G.
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier B.V 01-02-2018
• Subjects: Biomedical Research - ethics; Biomedical Research - legislation & jurisprudence; Clinical ethics; Clinical trials ethics; Ethical counselling; Humans; Right to try laws; Terminal Care - ethics; Terminal Care - legislation & jurisprudence; Terminally ill patients; Therapies, Investigational - ethics; Trusted consent; United States; United States Food and Drug Administration; Right to try laws; Terminally ill patients; Clinical ethics; Clinical trials ethics; Trusted consent; Ethical counselling
• ISSN: 1040-8428; 1879-0461
• DOI: 10.1016/j.critrevonc.2017.12.014

‘Right To Try’ (RTT) laws originated in the USA to allow terminally ill patients to request access to early stage experimental medical products directly from the producer, removing the oversight and approval of the Food and Drug Administration. These laws have received significant media attention and almost equally unanimous criticism by the bioethics, clinical and scientific communities. They touch indeed on complex issues such as the conflict between individual and public interest, and the public understanding of medical research and its regulation. The increased awareness around RTT laws means that healthcare providers directly involved in the management of patients with life-threatening conditions such as cancer, infective, or neurologic conditions will deal more frequently with patients’ requests of access to experimental medical products.
This paper aims to assess the ethical plausibility of the RTT laws, and to suggest some possible ethical tools and considerations to address the main issues they touch.