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受阻的准入?待决药品定价规则的意外后果。

Access Denied? The Unintended Consequences of Pending Drug Pricing Rules.

机构信息

Enhanced Care Clinic, Aurora, ON L4G 1N2, Canada.

Division of Medical Oncology, The Ottawa Hospital, University of Ottawa, Ottawa, ON K1Y 4E9, Canada.

出版信息

Curr Oncol. 2022 Apr 2;29(4):2504-2508. doi: 10.3390/curroncol29040204.

DOI:10.3390/curroncol29040204
PMID:35448178
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9025245/
Abstract

The government of Canada now plans to bring into force new federal drug pricing regulations on 1 July 2022. We do not take issue with the goal of medication affordability, which is vital in healthcare the world over. Our concern is that the new guidelines are being implemented without due consideration for three major unintended consequences: regulatory changes will lower the number of clinical trials for new medications in Canada, fewer clinical trials will mean lower research and development investments, and changes will reduce patients' access to new medications. Access to effective medications is a cornerstone of healthcare for Canadian patients. As physicians, our duty to patient care demands that we tell the government to protect the right of Canadians to timely access to life-changing medicines.

摘要

加拿大政府现计划于 2022 年 7 月 1 日起实施新的联邦药品定价法规。我们并不反对药物可负担性这项目标,因为这在全球医疗保健中至关重要。但我们担心的是,新准则的实施没有充分考虑到三个重大的意外后果:监管变化将降低加拿大新药临床试验的数量,临床试验减少意味着研发投资减少,而这些变化将减少患者获得新药的机会。获得有效的药物是加拿大患者医疗保健的基石。作为医生,我们对患者护理的责任要求我们告诉政府保护加拿大人及时获得改变生活的药物的权利。

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本文引用的文献

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Does external reference pricing deliver what it promises? Evidence on its impact at national level.外部参考定价能否如其承诺的那样发挥作用?国家层面的影响证据。
Eur J Health Econ. 2020 Feb;21(1):129-151. doi: 10.1007/s10198-019-01116-4. Epub 2019 Oct 3.
2
Potential Life-Years Lost: The Impact of the Cancer Drug Regulatory and Funding Process in Canada.潜在生命年损失:加拿大癌症药物监管和筹资过程的影响。
Oncologist. 2020 Jan;25(1):e130-e137. doi: 10.1634/theoncologist.2019-0314. Epub 2019 Sep 10.
3
Cross-comparison of cancer drug approvals at three international regulatory agencies.三个国际监管机构对癌症药物批准情况的交叉比较。
Curr Oncol. 2016 Oct;23(5):e454-e460. doi: 10.3747/co.23.2803. Epub 2016 Oct 25.