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 article demonstrates the need to advance Canada's data protection regime into one that consistently contributes to the promotion of investment in pharmaceutical research and development, to the mutual advantage of innovators and patients, in a manner conducive to the social and economic welfare of Canadians.
Highlights
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
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
Summary
When an innovator company is seeking regulatory approval for a new innovative drug in Canada, it is required by law to submit the results of its clinical testing data to Health Canada so that the product’s safety and efficacy may be verified. Biotechnology Law Report Volume 35, Number 6 such illnesses as diabetes, heart disease, or cancer is extremely expensive, time consuming, and risky: taking the situation in the United States as an example, the economic cost to develop, win marketing approval, and conduct post-approval research and development (R&D) for a new drug as required by the U.S Food and Drug Administration averages between US$2.6 billion and US$2.9 billion, while there is a less than 12% probability that a drug entering clinical testing will eventually be approved for marketing.3 These risks are growing alongside Canada’s rapidly evolving biopharmaceutical market: some of the most promising new therapeutic products are biologic drugs (products derived from living sources), which on average do not recover their R&D costs until 17 years after they start being sold.. If a patent period has expired, or there is no patent on a product (possibly as a result of being judicially invalidated), data protection will act independently to prevent entry of a competitor product on the market until the period of data protection ends ( a competitor is free to develop a product and conduct its own testing to seek authorization)
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