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A Decade of Data Protection for Innovative Drugs in Canada: Issues, Limitations, and Time for a Reassessment
Biotechnology Law Report ( IF 0.2 ) Pub Date : 2016-12-01 , DOI: 10.1089/blr.2016.29030.mk
Megan Kendall , Declan Hamill

Abstract Drug regulators in Canada and in other nations require innovative pharmaceutical companies to submit undisclosed clinical or other data as a condition of approving the marketing of new pharmaceutical products—the origination of which involves considerable effort and investment. Data protection regulations were enacted in Canada in 2006, which—to some extent—closed a loophole in intellectual property law that had previously left innovative companies with no effective data protection for their clinical data. Although the regulations were intended to clarify and effectively implement Canada's international treaty obligations in the spirit of innovation, a review of Canada's first decade of effective data protection shows that Health Canada and Canadian courts have interpreted the scope of data protection for innovative drugs in a narrow manner that undermines and is inconsistent with the intent of the regulations. As the 10-year anniversary of data protection in Canada is this year (2016), this arti...

中文翻译:

加拿大创新药物数据保护十年:问题、限制和重新评估的时间

摘要 加拿大和其他国家的药品监管机构要求创新制药公司提交未公开的临床数据或其他数据,作为批准新药品上市的条件——新药品的推出涉及相当大的努力和投资。加拿大于 2006 年颁布了数据保护法规,这在一定程度上弥补了知识产权法的漏洞,该漏洞以前使创新公司无法对其临床数据进行有效的数据保护。尽管法规旨在本着创新精神澄清和有效履行加拿大的国际条约义务,但对加拿大的审查 有效数据保护的第一个十年表明,加拿大卫生部和加拿大法院以狭隘的方式解释了创新药物的数据保护范围,破坏并与法规的意图不符。由于今年(2016 年)是加拿大数据保护 10 周年,本...
更新日期:2016-12-01
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