Health Canada ordered to release clinical trial information to researcher without confidentiality restrictions

July 25, 2018

By Andrea Berenbaum

 

The recent Federal Court decision in Doshi v Canada (AG)[1] granted the judicial review applications of a researcher who sought access to clinical trial data submitted during the regulatory review process for five drugs but who did not wish to sign the confidentiality agreement required by Health Canada. This result was heralded as “a milestone decision for clinical trial transparency”[2] by the Applicant and two law professors who worked on the case in an unpaid capacity. However, there are aspects of this decision that are difficult to rationalize. After an overview of the relevant legislation and background to the case, this article discusses its reasons regarding the disclosure of confidential business information (CBI) submitted to Health Canada during the drug regulatory review process.

 

Legislation and Guidance Documents

This is the first decision in which a court has considered Vanessa’s Law.[3] Vanessa’s Law came into force on November 6, 2014 and amended the Food and Drugs Act[4] (the FDA) to add a number of new provisions aimed at improving safety of therapeutic products.[5]

The new provisions include one that empowers Health Canada to disclose CBI[6] about a therapeutic product to certain individuals or organizations “if the purpose of the disclosure is related to the protection or promotion of human health or the safety of the public”[7]. Sanctioned individuals or organizations include one that “carries out functions relating to the protection or promotion of human health or the safety of the public” (FDA, s 21.1(3)(c)). In any instance, Health Canada is not required to notify or obtain the consent of the third party that submitted the information. This is in contrast to requests under the Access to Information Act[8], where notice is given to the third party who submitted the information.

On March 10, 2016, Health Canada released a Draft Guidance Document regarding s 21.1(3)(c) of the FDA that stated CBI would only be released to requesters if they signed a confidentiality agreement binding the requester to certain restrictions[9] on the use of the information. The final Guidance Document on s 21.1(3)(c) of the FDA was released one year later and specified additional restrictions[10] on the use of the CBI. Most of the restrictions fall within the typical provisions of a standard Confidentiality or Non-Disclosure Agreement dealing with CBI except for the provision that “Health Canada expects requesters to communicate with it to help inform any consequent regulatory decisions and risk communications”. Full details on the provisions are in the footnotes.[9][10]

Vanessa’s Law also amended the FDA to add provisions under s 30(1.2) that authorize the creation of regulations specifying what information is not CBI and concerning the disclosure of the CBI.[11] Drafts of these regulations were published in the Canada Gazette on December 9, 2017.[12] The proposed regulations would amend the Food and Drug Regulations[13] to provide that certain clinical information submitted during the drug regulatory process[14] would cease to be CBI upon issuance of marketing authorization (in the form of a notice of compliance) or other final decision (a notice of non-compliance-withdrawal or a notice of deficiency-withdrawal). According to the proposed regulations, Health Canada would then be authorized to disclose any such information that ceased to be confidential without notifying the originator or obtaining their consent. The Regulatory Impact Analysis Statement (RIAS) released with the proposed regulations indicates that Health Canada intends to release this information to the public.

However, two categories of information would continue to be treated as CBI under the proposed regulations. The first category would be information that was not used by the manufacturer to support the proposed conditions of use for the new drug or the purpose for which the new drug is recommended. The RIAS indicates the rationale for this information remaining CBI is that it could provide competitors with clues on the drug’s future uses. The second category would be information describing tests, methods or assays that are used exclusively by the manufacturer. The rationale provided in the RIAS for this information remaining CBI is that disclosure of it may prejudice the competitive position of the submission sponsor. Health Canada has indicated that clinical study reports, overviews and summaries may include such information and intends to establish in guidance a process that allows a manufacturer to propose redactions on information falling in these two categories prior to public release. Additionally, manufacturers would be asked to de-identify any personal information. On April 10, 2018 Health Canada released a Draft Guidance Document with more detail on this proposed process.

 

Background to the Application

The Applicant is a professor who conducts research on policies relating to drug safety and effectiveness evaluation. Subsequent to the coming into force of Vanessa’s Law, he applied to Health Canada under s 21.1(3)(c) of the FDA to obtain unpublished clinical trial information relating to three vaccines for human papillomavirus (GardasilTM, GardasilTM 9 and CervarixTM) and two medications for treating influenza (TamifluTM and RelenzaTM 3).

According to the reasons in Doshi v Canada (AG),[15] Health Canada made it clear that it would only disclose the data upon execution of a confidentiality agreement, which was consistent with the Draft Guidance Document on s 21.1(3)(c). The Applicant refused to sign such an agreement and because of this, Health Canada denied his request.[16] He then filed the present two applications seeking judicial review of these rejections.

 

The Federal Court Decision

The Federal Court ultimately held that it was “unreasonable for Health Canada to impose a confidentiality requirement as a condition for the disclosure of the data”[17] and ordered Health Canada to disclose the requested copies of all sections of all clinical study reports and all electronic datasets from the trials, including participant level datasets. The reasons provided by the Federal Court as to why Health Canada’s decision was unreasonable included that “it entirely disregards one of the main purposes of Vanessa’s Law, namely to improve clinical trial transparency, [and] it amounts to a fettering of discretion” [18].

Regarding the first point, the Federal Court held that requiring a confidentiality undertaking was unreasonable as “Health Canada cannot ignore that Parliament intended to make clinical trial data public and adopt a policy that is in direct contradiction with that purpose”[19]. Regarding the second point, the Federal Court stated that:

[t]he publication of draft regulations in the Canada Gazette only makes Health Canada’s position more untenable. By announcing those regulations, the government is in effect accepting that there is no legitimate interest in keeping the results of clinical trials private. In its accompanying statement … the government recognized the value of clinical trial transparency. It is difficult to understand how Health Canada can disregard such a statement and insist on a confidentiality undertaking as a condition of disclosing clinical trial reports and data to Dr. Doshi, even if the disclosure is pursuant to section 21.1(3) and not pursuant to regulations made under section 30(1.2).[20]

One of the complexities in this case was that the regulations specifying what information is not CBI and concerning the disclosure of the CBI are not yet in force. Consequently, while the Federal Court held that the information could be considered CBI within the meaning of s 21.1(3) for the purposes of these applications[21] it actually contained information that would cease to be CBI upon the coming into force of such regulations. This appears to have influenced the reasons for holding that the confidentiality undertaking was unreasonable and that Health Canada fettered its discretion. The reasons do not consider (or even mention) the two categories of information the proposed regulations would maintain as CBI. It is not clear whether the requested information may include information that would not cease to be CBI under the proposed regulations.

In its reasons, the Court also stated that while “some information may be disclosed pursuant to section 21.1(3) on the condition that it remain confidential, Health Canada cannot take the position that it will always be so”[22] and that Health Canada’s blanket policy reverses a choice made by Parliament because Vanessa’s Law did not contain specific language stipulating information disclosed under s 21.1(3)(c) would remain confidential. However, especially once the proposed regulations are in force, it is difficult to imagine a circumstance where it would be appropriate for Health Canada to disclose CBI of a manufacturer in the absence of any confidentiality undertaking. It also seems improbable that the intent of Parliament was to authorize Health Canada to release such CBI to an individual who would then be free to publish or distribute it to the general public. That would essentially mean the only difference between disclosure pursuant to s 21.1(3)(c) and that pursuant to the regulations made under section 30(1.2) is a middleman whose qualifications and proposed purpose falls within the requirements of s 21.1(3)(c).

 

Summary and Outlook

It is possible this decision will be appealed and we will receive clarification from a higher court on the disclosure of CBI under s 21.1(3) of the FDA. As the relevant regulations have not yet come into force, it may be some time before a case comes before the courts in which their operation on the information falling within s 21.1(3) is squarely at issue. In the interim, it would appear prudent for those making regulatory submissions to Health Canada to take a cautious approach when deciding whether to include information not directly relevant to the submission or supplement such as that not used to support the proposed conditions of use for the new drug or the purpose for which the new drug is recommended.

 


[1] Doshi v Canada (AG), 2018 FC 710.

[2] M Herder et al, “Precedent pushing practice: Canadian court orders release of unpublished clinical trial data” thebmjopinion, online: <https://blogs.bmj.com/bmj/2018/07/19/precedent-pushing-practice-canadian-court-orders-release-of-unpublished-clinical-trial-data/>.

[3] Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law), SC 2014, c 24 [“Vanessa’s Law”]. The Act is named in honour of the late daughter of a Canadian Member of Parliament who died at the age of 15 of a heart attack after taking a prescription medication.

[4] Food and Drugs Act, RSC 1985, c F-27 [“FDA”].

[5] Vanessa’s Law applies to “therapeutic products” which are defined as a drug or device or any combination of drugs and devices and does not include a natural health product within the meaning of the Natural Health Products Regulations, SOR/2003-196. FDA, s 2.

[6] Subject to regulations which are not yet in force, section 2 of the FDA was amended by Vanessa’s Law to define CBI as meaning, in respect of a person to whose business or affairs the information relates, business information (a) that is not publicly available, (b) in respect of which the person has taken measures that are reasonable in the circumstances to ensure that it remains not publicly available, and (c) that has actual or potential economic value to the person or their competitors because it is not publicly available and its disclosure would result in a material financial loss to the person or a material financial gain to their competitors.

[7] FDA, s 21.1(3).

[8] Access to Information Act, RSC 1985, c A-1.

[9] These included that (1) the information can be used only for the purposes of the proposed project and must be kept confidential using appropriate safeguards; (2) reproduction of disclosed information is prohibited; and (3) that the requester is free to publish results of the analysis as long as the confidentiality of the disclosed information is maintained. Exclusions to the confidentiality obligations included information in the public domain, received from another source or for information that the originator has consented to be released.           

[10] In the final Guidance Document, the prohibition on reproducing disclosed information was removed and the permitted publication limited to peer-reviewed journals. In addition, the following points were added: (1) if necessary for the project, the requester may share the information with a third party subject to a confidentiality agreement; (2) recipients are required to destroy the information upon completion of the project, and to notify Health Canada of the destruction; (3) in some circumstances, Health Canada may also seek indemnification by an institution associated with the requester; (4) requesters are required to notify Health Canada of publications and draft manuscripts based on the information; and (5) Health Canada expects requesters to communicate with it to help inform any consequent regulatory decisions and risk communications.

[11] FDA, ss 30(1.2)(d.1) and 30(1.2)(d.2).

[12] For those relating to drugs, see: Regulations Amending the Food and Drug Regulations (Public Release of Clinical Information), (2017) C Gaz I, 4637. For those relating to medical devices, which are not addressed in the present article, see: Regulations Amending the Medical Devices Regulations (Public Release of Clinical Information), (2017) C Gaz I, 4651.

[13] Food and Drug Regulations, CRC, c 870.

[14] This would apply to information submitted for a new drug submission, an extraordinary use new drug submission, an abbreviated new drug submission or an abbreviated extraordinary use new drug submission for a new drug for human use or a supplement to any of these submissions.

[15] Doshi v Canada (AG) at paragraph 23.

[16] Ibid at para 25.

[17] Ibid at para 87.

[18] Ibid at para 75. The Federal Court also held that “it does not result in a proportionate balance between Dr. Doshi’s freedom of expression and Health Canada’s purposes.” The Charter aspect of these reasons is outside the scope of the present article.

[19] Ibid at para 80.

[20] Ibid at para 82.

[21] The Applicant had argued that clinical trial results should usually not be considered CBI but agreed with the Respondent that for the purpose of these applications, the information constitutes CBI within the meaning of s 21.1(3). Otherwise, as the Federal Court noted, “this would undercut his position that this information is covered by section 21.1(3)”. Ibid at para 27.

[22] Ibid at para 81.

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Author(s):

Andrea Berenbaum Andrea Berenbaum
B.Sc., Ph.D. (Inorg. Chem.), M.Sc.BMC, J.D.
Associate