Health Canada recently published a Draft Guidance Document (PDF) (“Draft Guidance”) on the distribution of information regarding prescription drug labels through electronic platforms, including, websites and mobile applications. Under the Draft Guidance, Health Canada explains that drug manufacturers can provide a link or a barcode to their electronic platforms on prescription drug labels, provided that the information on the platform is compliant with applicable laws and regulations. The Draft Guidance is currently open for comment until May 7, 2021.
With the increasing reliance of health care providers and patients on digital technologies for access to health information, a considerable quantity of product-specific information is available online. To facilitate access to this information, industry actors often seek authorization from Health Canada to include barcodes and web addresses/URLs on their prescription drug labels so that users could access additional product-specific health information easily via electronic platforms. The Draft Guidance outlines Health Canada’s expectations for drug manufacturers interested in providing links to their electronic platforms on their product labelling.
Scope and Application
Electronic media requirements are supplementary to Health Canada’s existing legal framework for labelling and advertising. Information distributed through an electronic platform cannot replace information that is required by law to appear on a drug’s physical label. The Draft Guidance explains that manufacturers are permitted to submit more information to help patients better understand the product and the condition for which it was prescribed. For example, a manufacturer could provide a link to a video demonstrating how to administer the drug or provide disease management information.
The scope of the Draft Guidance is only limited to prescription drugs for human use – it does not extend to electronic labelling for other health products or purposes, e.g. clinical trials.
Overview of the Guidelines
Include Clear Links and Barcodes
The Draft Guidance indicates that links or barcodes must be incorporated on the drug label in a way that maximizes user accessibility and ensures the overall legibility of the label.
When designing an electronic platform for health care providers or patients, the Draft Guidance recommends the incorporation of a “gating” mechanism, i.e., a virtual barrier requiring user authentication, as well as a “noindex” meta tag to prevent public access through search engine results. This is because prescription drug information (beyond name, price and quantity) that is accessible to the general public in any media format could be considered promotional and potentially be in violation of federal advertising laws. For more information about what constitutes promotional and non-promotional advertising in health products, please read our earlier bulletin, "IT'S HERE: Health Canada’s new draft Guidance on Advertising versus Other Activities is now available".
Seek Health Canada Approval
Under the Food and Drugs Act (“FDA”), any information that speaks directly to topics covered by a drug label and is linked to the drug label (including the inner and outer label, package insert or Product Monograph) meets the definition of a label. Like physical labels, electronic labels will be assessed by, and must receive authorization from, Health Canada prior to distribution. Disease-related information or general health information goes beyond the scope of Health Canada’s regulatory oversight. Of course, precaution should be taken to avoid sharing information that may create false or misleading impressions about the drug.
To facilitate the submission and review of labelling materials, and to help patients distinguish between approved labels and other types of information, the Draft Guidance recommends separating the two types of information on the platform (i.e., placing them on different areas or webpages of a website).
Use Plain Language Labelling
Information on electronic platforms should be presented in a way that is clear, understandable and accessible.
The Draft Guidance highlights the importance of maintaining control over an electronic platform, as well as any information linked to it. Access to third-party platforms that are beyond the drug manufacturer’s control and that may be non-compliant with federal requirements may lead to a violation of federal legislation by the manufacturer.
Submission and Assessment
Requests for incorporation of a link to an electronic platform can be done through existing submission pathways, e.g. via the initial application for market authorization, as well as the post-market application procedure.
The consultation is currently open for comment until May 7, 2021.
The Fasken Life Sciences team has extensive experience in this area and is available to consult with stakeholders interested in commenting on the Draft Guidance.