Guidance Document - Disclosure of Confidential Business Information under Paragraph 21.1(3)(c) of the Food and Drugs Act

Contents

  1. Introduction
  2. Paragraph 21.1(3)(c) of the Food and Drugs Act
  3. Principles and Considerations for Health Canada's Exercise of the Authority under Paragraph 21.1(3)(c) of the Food and Drugs Act
  4. Protection of Personal Information and Respecting Participants' Informed Consent
  5. Protection against Commercial Use
  6. Maintaining Confidentiality of Disclosed Information
  7. Process to Review Requests for Disclosure
  8. Requirements for Persons Requesting Disclosure of Confidential Business Information under paragraph 21.1(3)(c)
  9. Findings Generated from Disclosed Information
  10. Annexes
    1. Review process flow chart
    2. Tools for finding regulatory information

1. Introduction

Confidential business information (CBI) may be included in a variety of regulatory documents that Health Canada requires companies to submit to support evaluation of the the safety, efficacy and quality of a given therapeutic product. In certain situations, where publicly available information is not sufficient, access to information that may contain CBI can assist the work of health researchers and practitioners, contributing to improved patient safety and better health outcomes for Canadians.

This guidance document describes how Health Canada applies the authority to disclose CBI under paragraph 21.1(3)(c) of the Food and Drugs Act. This provision gives the Minister of Health discretionary authority to disclose CBI to eligible persons for the purpose of protecting or promoting human health or the safety of the public.

This guidance document does not apply to other authorities in the Food and Drugs Act, which permit Health Canada to disclose CBI when the Minister believes that a product may present a serious risk of injury to human health, to other governments, and persons from whom the Minister seeks advice. Information on these authorities can be found in, Amendments to the Food and Drugs Act 2014 -- Guide to New Authorities.

About this guidance document

Guidance documents are meant to assist individuals and organizations to comply with Health Canada's policies and its governing statutes and regulations. They also serve to assist Health Canada staff to implement its mandates in a fair, consistent and effective manner.

Guidance documents are administrative instruments not having force of law and, as such, allow for flexibility in approach. Alternate approaches to the principles, considerations and requirements described in this document may be acceptable provided they comply with relevant laws. Discussion with the relevant program area in advance is encouraged to determine whether an alternative approach meets applicable statutory or regulatory requirements.

As a corollary to the above, it is equally important to note that Health Canada reserves the right to request information or material from a requester, or define conditions not specifically described in this guidance document, in order to allow for an adequate assessment of whether or not to disclose CBI related to a therapeutic product. Health Canada is committed to ensuring that such requests are justifiable and that decisions are clearly documented.

2. Paragraph 21.1(3)(c) of the Food and Drugs Act

21.1(3) The Minister may disclose confidential business information about a therapeutic product without notifying the person to whose business or affairs the information relates or obtaining their consent, if the purpose of the disclosure is related to the protection or promotion of human health or the safety of the public and the disclosure is to

  1. a government;
  2. a person from whom the Minister seeks advice; or
  3. a person who carries out functions relating to the protection or promotion of human health or the safety of the public.

Under paragraph 21.1(3)(c), the Minister of Health has discretionary authority to disclose CBI to a person (individual or organization) who carries out functions relating to the protection or promotion of human health or the safety of the public for the purpose of protecting or promoting human health or the safety of the public. This discretionary authority was added to the Food and Drugs Act by the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) and came into force in November 2014.

Vanessa's Law also added a definition of CBI to the Food and Drugs Act. This definition codifies common law principles and is consistent with other domestic law. It sets out three conditions that must be met in order for information to be considered CBI.

"confidential business information", in respect of a person to whose business or affairs the information relates, means - subject to the regulations - business information:

  1. that is not publicly available,
  2. in respect of which the person has taken measures that are reasonable in the circumstances to ensure that it remains not publicly available, and
  3. 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.

The Food and Drugs Act defines "person" to mean an individual or an organization as defined in section 2 of the Criminal Code.

2.1 Scope

The Food and Drugs Act defines "therapeutic product" to mean a drug or device or any combination of drugs and devices, but does not include a natural health product within the meaning of the Natural Health Products Regulations.

The authority to disclose CBI under paragraph 21.1(3)(c) therefore applies to CBI related to therapeutic products, including prescription and non-prescription drugs, vaccines, blood and blood products, radiopharmaceuticals, donor semen for assisted conception, gene and cell therapies, tissues, organs, disinfectants, and medical devices. It does not apply to CBI related to natural health products.

3. Principles and Considerations for Health Canada's Exercise of the Authority under Paragraph 21.1(3)(c) of the Food and Drugs Act

Health Canada's application of this authority is guided by principles of administrative law which require that powers be exercised fairly, reasonably and in accordance with the powers duly conferred on the body exercising them.

The following principles and considerations, consistent with the broad administrative law principles noted above, provide additional guidance on the exercise of the discretion under paragraph 21.1(3)(c).

3.1 Principles

  • Health Canada will be judicious in its exercise of this authority. The requirements of paragraph 21.1(3)(c) are broadly defined to permit the Minister to act in a variety of circumstances. In addition to considering whether or not the requirements of the Act would be fulfilled, a decision made under this authority should consider all relevant factors both for and against exercising the discretion to disclose CBI in the particular circumstances.
  • Information disclosed under this authority should contribute to improving the health of Canadians. Requests for disclosure under this authority are to clearly define how the purpose relates to this objective and should   include a formal plan to use the information to advance knowledge, including making results publicly available.
  • Use of this authority should be necessary to achieve the purpose for which the information is requested. A decision on whether or not to disclose CBI will include consideration of whether or not all other possible sources of the information, including from the originator of the information, have been exhausted. Only information that is directly related to the purpose set out in the request should be considered for disclosure.
  • Information disclosed under this authority must be kept confidential and used only for non-commercial purposes.  Health Canada expects potential recipients of CBI to sign a legally binding agreement to maintain confidentiality. The confidentiality obligations apply to the disclosed information, other than information that is specifically excluded under the agreement.  They do not prevent publication of the results of analyses of the disclosed information.  Requesters are also required to confirm that the information will not be used for commercial purposes, and to report any activities that could result in a conflict of interest.
  • Health Canada will maintain the integrity of its regulatory function and take into consideration the consequences of disclosure on its capacity to evaluate and regulate therapeutic products based on science and in the interest of the health of Canadians.

3.2. Considerations - Persons to whom CBI may be disclosed

Health Canada's decision regarding disclosure of CBI includes an assessment of whether the person to whom the CBI would be disclosed fulfills the Act's requirement that they be a person (individual or organization) who carries out functions relating to the protection or promotion of human health or the safety of the public.

Where disclosure of CBI has been requested by an individual, Health Canada expects that the principal requester would have qualifications in a health profession or clinical research and demonstrated expertise in the subject of the request.

Where disclosure of CBI has been requested by an organization, Health Canada expects that it would be a not-for-profit organization and that its mandate, as described in its articles of incorporation or other documentation, would include purposes relevant to the protection or promotion of human health or the safety of the public and the health or safety issue that is the subject of the request. In addition, it is expected that the designated representative of the organization identified in the request would have qualifications in a health profession or clinical research and demonstrated expertise in the topic of the research.

An assessment of the qualifications of a requester may include other considerations, including:

  • Relevance of the requester's qualifications to the purpose of the proposed disclosure. Requesters should have the necessary expertise to lead the proposed project. Projects requiring specialized technical expertise may involve collaborators.
  • Record of contribution to the protection and promotion of the health and safety of Canadians in an area relevant to the subject of the request. Publications and research projects related to health and safety issues other than the subject of the request may be taken into account in assessing a request.
  • Record of disseminating information to advance scientific knowledge for non-commercial purposes.

3.3 Considerations - Purpose of disclosure

Health Canada's decision regarding disclosure of CBI will also include an assessment of whether the disclosure would fulfill the Act's requirement that the "purpose of the disclosure is related to the protection or promotion of human health or the safety of the public."

To meet this requirement, CBI considered for disclosure should relate to a therapeutic product that is available to the public. Consequently, Health Canada expects that requests for disclosure will relate to CBI obtained in the course of its regulatory activities to evaluate and monitor the safety, efficacy and quality of therapeutic products for use in Canada.

Health Canada may also consider the following to assess the purpose of disclosure.

  • Demonstrated relevance of the proposed project to the purpose of protecting or promoting human health or the safety of the public. Evidence should be provided regarding the health and safety issue to which the request relates, and requests should explain how the disclosed information would be used to advance efforts in this area.
  • The severity of the health or safety issue to which the request relates, or the vulnerability and size of the affected population.
  • The feasibility of the proposed use of the CBI. A project summary should outline how its objectives will be accomplished with the available expertise and resources.
  • The anticipated impact of the proposed use of the CBI on the health and safety of Canadians.
  • The type of information requested may include:
    • CBI that relates to a therapeutic product that has been authorized for sale in Canada.
    • CBI related to an amendment of a market authorization to obtain approval for new uses or indications for a product already authorized for sale, or authorization for changes that may affect the safety, efficacy or quality of an authorized product. CBI in such submissions or applications may add to the body of knowledge regarding the safety, efficacy and quality of a product to which Canadians are exposed. Consideration should be given to the consequences of disclosure for the integrity of Health Canada's regulatory function, particularly for information related to amendments to a market authorization (for example, supplemental submissions) that are in review, cancelled, withdrawn, or rejected.
    • Interim clinical study results related to a therapeutic product authorized for sale in Canada provided the disclosure does not jeopardize the completion of the study or the integrity of Health Canada's regulatory function. The personal information of all study participants will be protected as described in section 4. Consideration of requests related to interim study results will involve an assessment on whether the benefits of a disclosure outweigh any risks associated with the creation of study bias and implications for completion of an ongoing study in Canada or another jurisdiction.
    • Other information obtained by Health Canada for post-market surveillance purposes, for example, information obtained from the market authorization holder indicating a potential but not established new risk, information obtained pursuant to a risk management plan (RMP) through a periodic safety update report (PSUR), information that was provided by a market authorization holder used to conduct a signal assessment or other safety review or to issue a risk communication.
    • Other information obtained by Health Canada for compliance and enforcement purposes concerning a therapeutic product for sale in Canada, e.g., information that is obtained during the course of an inspection.

4.  Protection of Personal Information and Respecting Participants' Informed Consent

All personal information contained within the records considered for disclosure will be protected from release according to the Privacy Act and other applicable laws.

Access to patient-level data can advance medical research by allowing secondary research for non-commercial purposes or the validation of clinical trial results. Health Canada will use appropriate methods of redaction or de-identification if a request is made to access patient-level data.

Health Canada will respect the participants' consent for data sharing when that information is available.

5. Protection against Commercial Use

Health Canada will exercise this authority taking into account the importance of protecting CBI against commercial use. Health Canada will only consider projects that describe a non-commercial purpose for the requested information. For the purpose of this authority, commercial purpose means the use of the information to support a marketing authorization anywhere in the world or selling or trading the data to another person. The use of clinical information for comparative effectiveness research is not considered to be a commercial use.

Health Canada also requires requesters to complete a Conflict of Interest declaration. Health Canada reviews the information provided in the declaration to determine whether or not to disclose CBI to a requester whose financial interests, employment and other affiliations (for example, a role as a witness in litigation or as a consultant to an industry member) could conflict with their commitment to use the CBI exclusively for non-commercial purposes that supports the protection or promotion of human health or the safety of the public.

6. Maintaining Confidentiality of Disclosed Information

Health Canada expects requesters to sign a legally binding Confidentiality Agreement to maintain the confidentiality of disclosed information. Among other things, this Agreement provides that the disclosed information can be used only for the purposes of the proposed project and must be kept confidential using appropriate safeguards. If it is necessary for the purposes of the project, the requester may share the disclosed information with a third party if the disclosure is subject to a confidentiality agreement. The Confidentiality Agreement also requires recipients to destroy the disclosed information upon completion of the project, and to notify Health Canada of the destruction. In some circumstances, Health Canada may also seek indemnification by an institution associated with the requester. The Agreement provides exclusions to the confidentiality obligations, such as for information that is in the public domain, received from another source or for information that the originator has consented to be released. The requester is free to publish results of the analysis in peer-reviewed journals as long as the terms of the confidentiality agreement are respected. The agreement requires requesters to notify Health Canada of publications and draft manuscripts based on the disclosed information. Health Canada expects requesters to communicate with it to help inform any consequent regulatory decisions and risk communications.

7. Process to Review Requests for Disclosure

Health Canada's decision is based on a rigorous evaluation and a review process that is fair, reasonable and takes into account all relevant factors. The review process is overseen by a committee of senior Health Canada officials mandated to recommend a decision based on relevant technical and scientific expertise. The Review Committee's recommendation is considered by a senior Health Canada official, not involved in the review process, who has been designated to exercise the Minister's authority to disclose CBI under the Food and Drugs Act (section 21.1(3)(c)). Typically, the following key steps in the process can be expected:

  1. Screening: Requests are reviewed to ensure that they are complete, including professional qualifications, mandate of an organization (if applicable), and a project description that includes a specific purpose for seeking access to CBI. Requesters may be asked to provide missing information required to review their requests.
  2. Assessment: Complete requests are referred to a Review Committee for assessment. The Committee will assess whether or not the request meets the requirements of the Act, taking into account the requester's qualifications, the organization's mandate (where relevant) and the proposed project. Where a request does not meet the requirements of the Act, the Committee will recommend that it be denied. Where a request meets the requirements of the Act, the Committee will proceed to the next step in the review process.
  3. Record search: For requests that meet the requirements of the Act, Health Canada will conduct a search of its records. The search will identify records that include information described in the request and that are directly related to the project described in the request.
  4. Communication with requester: If CBI is included in records relating to an assessed request, the requester may be notified and, where large volumes of records have been identified, may be consulted to refine their request. At this stage the requester will be asked to complete a Conflict of Interest Declaration and to sign a Confidentiality Agreement. The signing of a Confidentiality Agreement by the requester at this point in the process does not mean that information will be disclosed. Further information may also be required in order to complete Health Canada's review of the request.
  5. Recommendation: Once the requester has provided a completed Conflict of Interest Declaration, signed Confidentiality Agreement and any other required information, the Review Committee will prepare a recommendation regarding whether to disclose records containing CBI identified in the record search. The recommendation will include the assessment that a request meets the requirements of the Act and an assessment of whether or not the designated decision maker should exercise the Minister's authority to disclose CBI, based on the principles and considerations in section 3 of this guidance document and other factors relevant to the particular request. Some records relevant to a particular request may contain other protected information. Personal information will be redacted in accordance with the Privacy Act.  Health Canada will respect the confidentiality arrangements that it has in place with regard to information obtained in confidence from another regulator.
  6. Decision: The Review Committee recommendation is considered by a senior Health Canada official designated to exercise the Minister's authority to disclose CBI under the Food and Drugs Act (paragraph 21.1(3)(c)). When the decision is to disclose CBI, Health Canada will give effect to the Confidentiality Agreement.
  7. Notification to requester: Health Canada will notify the requester of its decision. When the decision is to disclose CBI, arrangements will be made to ensure secure transmission of the information to the recipient. When the decision is to refuse to disclose CBI, the requester will be notified with an explanation for the decision and advised that they may submit a revised request.
  8. Notification to originator: Health Canada does not notify the originator of the CBI when it is considering a request for disclosure. As a voluntary practice, Health Canada may notify the originator following disclosure of CBI.
  9. Notification of the public: Information regarding the request, including the requester, a description of the project, date filed, date the review was complete, and the review outcome, will be made public.

8. Requirements for Persons Requesting Disclosure of Confidential Business Information under Paragraph 21.1(3)(c)

Requesters should submit a request form to Health Canada with the following information:

  • Personal and contact information for the principal requester.
  • Professional information for the principal requester, including professional qualifications, employment and relevant research experience.
  • A description of the information requested, including the therapeutic product and regulatory functions to which the information relates. Requesters are encouraged to consult Health Canada's on-line databases of regulatory information and other resources in order to specify their requests as much as possible.
  • Indication as to whether the requester has exhausted other sources of the information requested, including from the originator of the information.
  • A project summary that clearly indicates the non-commercial purpose of the proposed disclosure and how it relates to the protection or promotion of human health or the safety of the public.
  • How the results of the proposed project will be disseminated to the Canadian public.

If a request is incomplete, a requester will be asked to provide missing information.

Prior to making a recommendation regarding disclosure, Health Canada will ask the requester to provide additional information that includes:

  • A completed Conflict of Interest Declaration that provides information required by Health Canada to assess whether or not the requester's financial interests and other affiliations may conflict with their use of the requested information.
  • A signed Confidentiality Agreement with Health Canada that would take effect only if and when Health Canada decides to disclose CBI to the requester.

9. Findings Generated From Disclosed Information

Recipients of disclosed information are expected to make the findings of their studies with the disclosed information publicly available when the findings provide additional knowledge about the therapeutic product under study. If the recipient of disclosed information has made a determination that the safety, efficacy or quality of a product(s) may change as a result of the evaluation of the CBI then the results should be submitted to Health Canada. Information regarding therapeutic products authorized for the Canadian market should be sent to MHPD-stakeholders_intervenants-DPSC@hc-sc.gc.ca. Health Canada considers and assesses on a regular basis a multitude of sources when deciding the priority of a potential signal. This includes literature, decisions made in a foreign jurisdiction, as well as information provided by a recipient of CBI, which could lead to the prioritization of a signal for a safety review, and engagement with the affected sponsor.

As always, Health Canada will take the necessary actions to safeguard the health and safety of Canadians should the benefit, harm and uncertainty profile of a product(s) be determined to have changed. Publications and draft manuscripts must be provided to Health Canada upon acceptance for publication or prior to otherwise disseminating it.

10. Annexes

Annex A

Review Process Flow Chart

Review Process Flow Chart - Text Description

Screening, assessment, record search, if no confidential business information, obtain information through Health Canada office, yes confidential business information, consultation, recommendation, decision, notification to requestor, disclosure – secure transfer of information, or denied – opportunity to submit revised request.

Annex B

Tools for finding regulatory information

Health Canada publishes information of interest to Canadians on its regulatory decisions, inspections, compliance and enforcement activities. The information you want may be available publicly on Health Canada's website or databases.

If the information you are seeking is not available publicly and contains CBI, you may be able to obtain it on request from Health Canada. A request for disclosure of CBI should be as specific as possible. Consult the Health Canada web site to learn more about the types of records that may be requested. Useful links include:

Additional information for requesters

There are other authorities in the Food and Drugs Act that permit Health Canada to disclose CBI when there is a risk of serious injury to human health, and for Health Canada to disclose CBI to other government agencies, including regulatory counterparts and members of advisory bodies.

  • Serious risk of injury to human health (section 21.1(2))
  • To a government (section 21.1(3)(a))
  • To a person from whom the Minister seeks advice (section 21.1(3)(b))

For more information on the implementation of the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) - (in force November 6, 2014) please refer to the following guide:

Other sources of clinical trial-related information

Clinical trial information is available through the following registries and databases:

Many clinical trial sponsors provide access to clinical data on request, and provide information on-line to assist requesters.  In addition to individual company sites, the Clinical Study Data Requests portal provides access to data from a number of clinical trial sponsors.

Yale University Open Data Access project (YODA), is a university-industry partnership that provides access to clinical trial data.

The European Medicines Agency (EMA) publishes clinical data on medicines for human use submitted for market authorization since January 1, 2015. Publications are available at: www.clinicaldata.ema.europa.eu.

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