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强制许可之后:加拿大制药政策与政治中的新问题

After compulsory licensing: coming issues in Canadian pharmaceutical policy and politics.

作者信息

Lexchin J

机构信息

Toronto Hospital, Toronto Western Division, Ontario, Canada.

出版信息

Health Policy. 1997 Apr;40(1):69-80. doi: 10.1016/s0168-8510(96)00886-x.

DOI:10.1016/s0168-8510(96)00886-x
PMID:10165902
Abstract

Bills C-22 and C-91 eliminated compulsory licensing for pharmaceutical products in Canada. However, in the wake of these bills there are pressing issues of pharmaceutical policy that need to be decided. The value of additional spending in pharmaceutical R and D has yet to be evaluated. There needs to be a public debate about how far government policy should go in encouraging pharmaceutical R and D as opposed to investing resources in other areas. There has been a continuing escalation in the cost of the average prescription, due to the introduction of newer, but not necessarily more effective, medications. So far government has not been willing to commit resources to promote cost-effective prescribing. Pharmaceutical companies are now lobbying for more rapid approval of products and an extension to the normal patent period to make up for the time that drugs spend in the regulatory process. The process that the government uses to resolve these issues will be just as important as the ultimate decisions.

摘要

加拿大的C-22法案和C-91法案取消了药品的强制许可。然而,在这些法案之后,仍有一些紧迫的药品政策问题需要做出决定。药品研发额外支出的价值尚未得到评估。对于政府政策在鼓励药品研发方面应走多远,相对于在其他领域投入资源而言,需要进行一场公开辩论。由于引入了更新但不一定更有效的药物,平均处方成本持续攀升。到目前为止,政府一直不愿投入资源来推广具有成本效益的处方。制药公司现在正在游说加快产品审批速度,并延长正常专利期限,以弥补药品在监管过程中所花费的时间。政府解决这些问题的过程与最终决定同样重要。

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Healthc Policy. 2023 Feb;18(3):17-24. doi: 10.12927/hcpol.2023.27038.
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Canada and access to medicines in developing countries: intellectual property rights first.加拿大与发展中国家的药品可及性:知识产权优先。
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The politics behind the implementation of the WTO Paragraph 6 Decision in Canada to increase global drug access.
加拿大实施 WTO 第 6 段决定以增加全球药物获取机会的背后政治因素。
Global Health. 2012 Apr 3;8:7. doi: 10.1186/1744-8603-8-7.
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Canada's patented medicine notice of compliance regulations: balancing the scales or tipping them?加拿大专利药品合规通知法规:平衡天平还是颠覆天平?
BMC Health Serv Res. 2011 Mar 24;11:64. doi: 10.1186/1472-6963-11-64.