Unlocking Health Canada’s cache of trade secrets: mandatory disclosure of clinical trial results

Regulating prescription drugs for patient safety: Does Bill C-17 go far enough?

“…37 These assertions overstate what the law actually requires and prevent important information about safety and effectiveness from being released. 37 International treaties simply require Canada to protect trade secrets and confidential business information without specifying the scope of those types of information. No Canadian court decision indicates that information about the safety or efficacy of a drug is proprietary, and current case law casts doubt on any such assertion.…”

North American regulatory agencies can and should make clinical trial data publicly available

“…The most common reason for refusal by Health Canada is that the request is for a third party's "confidential business information" (the third party often being a phar maceutical company when clinical trial data are requested). 4 Canadian law, however, allows Health Canada to disclose clinical trial data, and disclosure is also consistent with international treaties, including the North American Free Trade Agreement. 4 Court rulings in the United States have favoured disclosure in the public interest and have also supported nondisclosure where a public benefit of disclosure was not clearly demonstrated (e.g., information about a medication that was abandoned before being marketed).…”

“…4 Canadian law, however, allows Health Canada to disclose clinical trial data, and disclosure is also consistent with international treaties, including the North American Free Trade Agreement. 4 Court rulings in the United States have favoured disclosure in the public interest and have also supported nondisclosure where a public benefit of disclosure was not clearly demonstrated (e.g., information about a medication that was abandoned before being marketed). 5 Not all regulatory data need be released.…”

Canada finally opens up data on new drugs and devices

“…Previously, Health Canada maintained that such information must be kept confidential despite clear flexibilities in the law to allow greater transparency 3. As early as 2000, Health Canada’s own science advisory board called the “current drug review process … unnecessarily opaque,” saying it was “inconsistent with public expectation and contributes to a public cynicism about the integrity of the process.”4…”