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Without Clear Evidence of its Confidential Nature, Drug Data can be Released Under Access to Information Rules
In Canada, as elsewhere, pharmaceutical companies must submit voluminous information to the Federal government (Health Canada) for approval of a new drug. Much of this information is confidential. Therein lies a quandary: submission of the information is mandatory, but government agencies are under legal pressure to release such information to the public on request. While Canada is probably better than many other countries in maintaining the confidentiality of drug information, a recent decision of the Federal Court of Appeal has exposed a vulnerability under Canada’s Access to Information Act. This law permits any person to file an “ATI” request for the release of information held by a government institution, including information submitted to the government by private parties. The government must release the requested information unless they determine that the information is within one of three exempted categories: a trade secret, confidential information, or information whose release could reasonably result in harm to the competitive or financial position of the submitter.
In Merck Frosst Canada Inc. v. Canada (Minister of Health) 2009 FCA 166 (recently published in an English translation), Merck had submitted information to Health Canada in support of its New Drug Submission (NDS) for its drug Singulair. A commercial competitor subsequently filed an ATI request to obtain this information. Health Canada released a portion of the requested information without prior notice to Merck, and also gave notice to Merck that it intended to release additional information. Merck sought an order from the Federal Court for a declaration that the release of information without notice was unlawful, and a second order to prevent release of the additional information.
The Court made the initial observation that the purpose of the ATI Act is to establish a public right of access to information held by the government. Exemptions should be narrow and specific. The Court then concluded that the government institution is not required to provide prior notice to a third party source of information, if the institution is satisfied that the information does not fall within one of the three exempted classes. If the government does provide notice to the third party, as was the case with Merck’s additional information, the third party bears a heavy burden of proving by specific, objective and detailed evidence that the information is exempted from release. The evidence must be more than mere conjecture that the release might result in harm or that the information is of a type which is generally considered confidential or a trade secret.
Information may constitute a “trade secret” if:
1) The information is secret in an absolute or relative sense in that it is known by at most a few people
2) The possessor of the information has taken steps to maintain secrecy
3) The information is capable of commercial or industrial application
4) The possessor has an economic or other interest worthy of legal protection.
Information may be “confidential” if:
1) The information is not available from a public source, nor by observation or independent study by a member of the public
2) The information was compiled and communicated by it originator in a manner which suggested a reasonable expectation that it would not be disclosed
3) The information was communicated to the government body in the context of a fiduciary relationship, or a relationship in which it is in the public interest to maintain confidentiality
In the present case, the Court concluded that Merck had not provided conclusive evidence that an exemption applied to the information which had been previously released nor the information which was proposed to be released. The Minister was entitled to release the information to the requestor.
This case suggests precautions that should be taken to maintain confidentiality in information submitted to a government agency. Some of these are:
1) Establish (and enforce) clear written policies regarding confidentiality of information, especially information and data which may be subject to release to a government agency
2) When developing such information, maintain strict confidentiality, bearing in mind the requirements for establishing confidentiality.
3) Ensure that information submitted to a government body is treated as confidential when it is supplied, for example with clear markings on all documents
4) Avoid mixing confidential and non-confidential information where possible, for information submitted to the government; while the government may redact individual documents, the possibility of inadvertent release of information will be reduced by maintaining a clear demarcation between such classes.
5) When faced with the prospect of a release of information pursuant to an ATI request, respond with detailed and concrete evidence showing that the information is a trade secret and/or confidential. If necessary, seek extensions of time for responding in order to prepare the required evidence.
While this case highlights the challenges facing companies required to disclose information to the government, it also highlights the active steps that can be taken in advance as well as when an ATI request is received to maintain confidentiality in sensitive information.