ARCHIVED - Consultation on the Amendments to the Food and Drugs Act: Guide to New Authorities - What We Heard

Health Canada is pleased to announce the finalized Amendments to the Food and Drugs Act: Guide to New Authorities (Guide). The purpose of the document is to help Health Canada implement the new authorities that came into force upon Royal Assent of Bill C-17, the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law), on November 6, 2014, including the Minister's authority to:

• require and disclose information
• order a label change/package modification, and
• order a recall.

The Guide sets out principles, policies and standards to follow when Health Canada identifies situations in which it may be appropriate for the Minister to exercise these new authorities. Specifically, the Guide:

• sets out guiding principles, policies and standards that should govern all decisions made by Health Canada acting as a regulatory decision-maker;
• covers "when", "how", and "what" triggers the Minister's ability to make use of these authorities and explains to "whom" the authorities apply; and
• increases the consistency and predictability for both Health Canada and industry as to how the authorities will be applied, resulting in improved quality of regulatory decision-making and improved compliance.

The Guide is also intended to support the development of the operational tools [e.g., standard operations procedures (SOPs), guidance documents, process maps, templates] needed for those authorities which came into force immediately upon Royal Assent. It will also guide future regulatory and operational development for those authorities which require accompanying regulations. As a guidance document and administrative tool, the Guide should be read in conjunction with the amended Food and Drugs Act and the Food and Drug Regulations.

Results of the Consultation

The Guide was posted on the Health Canada website for a 75 day consultation period on March 25, 2015, ending June 8, 2015. In total 25 stakeholders, comprised of industry, healthcare professional associations and academia submitted comments during this timeframe. All comments were considered and the final Guide incorporates changes to improve the clarity and precision of language to better reflect the legislative provisions. While stakeholders expressed general support for the Guide, many of the comments received pointed to issues that fall outside the scope of the Guide. These comments will be considered in the future in more detail, through further policy, guidance or regulatory development. A high level "what we heard" summary of these comments is provided below, along with a clarification regarding the application of certain terms.

Confidential Business Information

Twenty stakeholders submitted comments on a broad range of issues related to confidential business information (CBI), including, for example, linkages with domestic and international legislation and treaties. While the Guide provides the principles the Minister will follow when using the power to disclose CBI, it is not a comprehensive Guide on this matter. Health Canada is considering comments received as the Department moves forward on further policy and process development and will provide more information to stakeholders in the coming months.

Operational Issues

Several stakeholders asked for information on how current operational processes will align and change with the new authorities afforded through Vanessa's Law (e.g., Dear Healthcare Professional Letters, Class Labelling requests). While these operational issues are relevant to the implementation of Vanessa's Law, they are beyond the scope of the Guide. Comments received during the consultation will be shared with the appropriate Directorates within the Health Products Food Branch responsible for the development of guidance, SOPs and other tools that will help support implementation.

Transparency Initiatives

Nine stakeholders raised questions regarding transparency and more specifically what information Health Canada would now make public. Health Canada is committed to transparency and openness to further strengthen trust in its regulatory decisions. Any Orders made under sections 21.1 to 21.3 of the Food and Drugs Act will be publicly available as required by the legislation. Further to this, Health Canada will continue to improve access to timely, useful and relevant health and safety information through the Regulatory Transparency and Openness Framework.

Consumer Health Products

A few stakeholders raised some questions regarding the impact of Vanessa’s Law on products such as non-prescription drugs. In November 2014, Health Canada consulted on a proposed Consumer Health Products Framework. This Framework seeks to establish a consistent and aligned approach to the regulation of health products intended for consumer use.  While Health Canada is moving forth with this proposal, the amendments to the Food and Drugs Act from Vanessa’s Law will continue to apply to all therapeutic products, including non-prescription drugs.

Mandatory Reporting of Serious Adverse Drug Reactions by Healthcare Institutions

A couple of stakeholders raised questions related to mandatory adverse drug reaction reporting by healthcare institutions, which is beyond the scope of this Guide. Health Canada will consider comments received during this consultation as the Department continues work towards policy and process development related to this issue.

For Greater Clarity - Application of Terms

Several stakeholders requested more guidance and clarification regarding how Health Canada would make a determination of serious risk as it relates to the Minister’s powers to recall a therapeutic product and to require and disclose information. The determination of serious risk is a complex analysis and is conducted on a case-by-case basis when new information becomes available. Annex A to the Guide sets out some of the considerations to be used to determine whether a therapeutic product presents a serious risk of injury to human health.