Document Type

Article

Publication Date

2012

Keywords

Trade Secrets, Data Exclusivity, Patents, Patent Medicines, Biopharmaceuticals, Federal Regulation, Canada

Abstract

Health Canada should publicly disclose information about the safety and efficacy of pharmaceuticals, biologics and medical devices, and should especially disclose the designs and results of clinical trials. This disclosure is necessary to preserve public trust, address weaknesses in the evidence base, and protect Canadians from harm.

A prime example of the need for this disclosure involves selective serotonin reuptake inhibitors (SSRIs). Health Canada did not authorize SSRIs for sale to people younger than 19 years because of data from clinical trials showing risks of harm, including self-harm, associated with use of SSRIs in that age group. But Health Canada also did not publicly disclose that evidence, and by 2004 SSRIs were being widely prescribed for teenagers. Physicians had no idea they were invoking their discretion to prescribe “off label” on the basis of incomplete information — the balance of which Health Canada had in hand.

Assessing how often harm results from nondisclosure is difficult because reporting of adverse events remains poor. What is clear from several analyses is that there is often a chasm between the published scientific literature (which is biased toward positive results) and the information that regulators possess about a given drug.

Why does Health Canada not divulge information from clinical trials until reports surface of widespread off-label prescribing? The reason is legal: the companies that manufacture these therapeutic products and devices claim that information is “confidential business information” or a “trade secret,” which they own, and which Health Canada is not free to disclose.

I witnessed this pas de deux while attending Health Canada’s “technical discussions on regulatory modernization” held between October 2010 and January 2011. Each proposal put on the table by Health Canada to increase transparency — from making final decisions regarding applications for market authorization publicly available, to creating an online register of therapeutic products — was met with proprietary claims from MEDEC, BIOTECanada or Rx&D, the respective associations of medical device, biotechnology and pharmaceutical companies in Canada. Each time, Health Canada acknowledged that the law controlled what they could and could not disclose.

In this article, I argue that the law, in fact, poses a minimal barrier to the disclosure of the designs and results of clinical trials. I begin by illustrating Health Canada’s tendency to keep third-party information secret, then show why — insofar as protecting third-party information has prevented the disclosure of the designs and results of clinical trials — this goes beyond what the law requires, in principle. I go on to highlight institutional barriers to changes in policy.

Comments

https://doi.org/10.1503/cmaj.110721

© 2012 Canadian Medical Association or its licensors

Single copies of articles published prior to January 1, 2021 may only be copied or shared for non-commercial educational purposes. Appropriate credits must be given. The distribution of derivative works is not permitted

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