Summary Report on the Consultation on a Framework for Consumer Health Products: What We Heard
In November 2014, Health Canada launched a consultation on a Framework for Consumer Health Products (Framework), which proposed to modernize the oversight of health products intended for consumer use, while continuing to ensure that Canadians have access to safe and effective products.
Consumer health products are sold directly to consumers and do not require a prescription or the oversight of a health care professional. Based on the supporting information and instructions available on the label, Canadians can select and use these products to maintain and improve their health. Consumer health products cover a broad range of products including cosmetics (e.g. make-up, deodorants), disinfectants (e.g. for use on countertops, contact lens solution), non-prescription drugs (e.g. pain relievers, cold and allergy remedies) and natural health products (e.g. vitamin and mineral supplements, traditional and homeopathic products, toothpastes).
The proposed Framework was designed to protect the health and safety of Canadians while providing more clarity to consumers about the consumer health products they use so that they can make informed choices about their health. The Framework was also designed to provide flexible and proportional oversight of these products based on their risk profiles.
The consultation document set out the objective of the Framework, including the proposed scope and policy intent, and a proposal for a new set of regulations for non-prescription drugs with an overview of key design and technical elements. The consultation document was posted on Health Canada's website and the comment period began November 27, 2014 and continued until February 27, 2015. The document is still available to view here.
Health Canada received over 300 pages of comments submitted by 31 respondents. In order to understand the nature of the feedback received, respondents were asked to identify themselves from one of the following perspectives: consumer, health professional, industry or other. The breakdown of responses, by perspective, was as follows:
- Industry - 74%
- Consumer - 10%
- Health Professional - 10%
- Other - 6%
Out of 31 respondents to the consultation on the Framework, only three (3) self-identified as consumers.
While efforts were made to make the consultation document user-friendly, including the use of plain language, it provided detailed information on regulatory requirements which was likely more relevant to industry stakeholders.
Going forward, the Department will be providing more opportunities for consumer engagement on proposals related to consumer health products.
The following represents a summary of 'What We Heard' during the consultation, and will be considered in future policy development and operational improvements.
Feedback on the Objective of the Consumer Health Products Framework
Numerous respondents indicated that they strongly support the efforts of Health Canada to establish appropriate regulatory oversight for consumer health products. Many respondents agreed that protecting the health and safety of Canadians should be the primary focus of the Framework and the proposed non-prescription drug regulations.
Respondents noted that the Framework should provide sufficient flexibility to address the range of risk profiles of health products, and reflect how they are manufactured and supplied, and how Canadians use these products. It was also noted that regulatory standards for safety should not be lowered.
Respondents recommended that steps be taken to create a greater harmonization across product lines through a variety of tools, such as policy, operational changes, and regulations.
Respondents also suggested that Health Canada continue to be transparent about information on consumer health products, including information on safety and quality. Suggestions to support greater transparency included more information on recent inspections, and more clarity on the connection between regulatory requirements and the risk profile of a product.
Did you know?
Since suggestions were made during the consultation, more information about sites that manufacture drugs and health products has been made available on Health Canada's website, including searchable lists that provide information on recent inspections.
Also, Health Canada publishes summary safety reviews on consumer health products - such as natural health products and non-prescription drugs - that have been authorized for sale. These can help Canadians make informed decisions by providing access to safety review information, including what was assessed, what was found, and what action was taken. You can find information on the potential safety issues that Health Canada is reviewing in the tables of New Safety Reviews.
While the consultation document outlined information on consumer health products and how they fit within the Framework, respondents indicated there is room for improvement. It was suggested that Health Canada define more clearly which products are considered consumer health products, and explain why some - such as medical devices - are excluded.
The opportunity for Health Canada to further harmonize with its international partners was also highlighted.
Some respondents recommended that the Department examine the issue of drug scheduling in collaboration with provincial and territorial governments and relevant stakeholders. Drug scheduling pertains to decisions about the where and how non-prescription drugs can be sold, such as whether they should be placed behind or in front of the pharmacy counter.
Some respondents also recommended that the Department consider removing the limits on personal importation for consumer health products.
Feedback on the Proposed Non-prescription Drug Regulations
Labelling and Packaging
Some respondents recommended that the Department consider the nature of a consumer health product in assigning labelling requirements to ensure that they are proportional to the risk of the product. For instance, plain language labelling, small package labelling and security packaging requirements for prescription drugs may not be required to the same degree for all consumer health products.
Respondents identified the need to minimize confusion related to brand names and brand name extensions.
Did you know?
Health Canada recognizes that labels are integral to communicating information about health products. Work is already underway, as part of the Plain Language Labelling initiative, to make labels and packaging easier to read and understand, and minimize opportunities for confusion with labels, packages or product names.
For example, Health Canada is working to make the labels of non-prescription drugs easier to understand by requiring companies to ensure that the outer labels have a Product Facts table containing the most important information about the non-prescription drug. This information will be presented in a standardized format for all non-prescription drugs so that Canadians can find what they need to know easily and quickly.
In the draft Framework, Health Canada proposed sampling rules that would allow for the distribution of samples of any authorized non-prescription drug. Respondents asked for the proposed rules to be aligned across all consumer health product types, including natural health products.
Similar to other health products, many consumer health products today are sourced from fast-paced, global supply chains that have, in many ways, outpaced regulation designed for a less complex landscape. As a result, the roles of key players in the chain have become intertwined and determining who is responsible for the production and marketing of a product is not always clear. To ensure a responsive and accountable regulatory system, the proposed non-prescription drug regulations outlined, among others, the responsibilities of the brand owner - that is, the party who is ultimately responsible for the sale of the product in Canada. Many respondents were supportive of clarifying ownership rights and responsibilities, noting that the addition of clear brand owner responsibilities will support supply chain control.
Most respondents were generally supportive of the proposed pathways to market for non-prescription drugs. It was recommended that the pathways could be further enhanced by creating electronic solutions for administrative filings to reduce burden to applicants, and by developing guidance on both evidence requirements for various pathways and the benefit, harm and uncertainty profile of a product.
Many respondents supported the use of incorporation by reference, a regulatory tool that would enable information that the Department already knows about a product and/or ingredient to be referenced in any new application so that a full review is not necessary. Such information could include safety, quality and efficacy information in the form of monographs and acceptable ingredient lists; use of these could streamline the review process and make it faster for companies to bring their products to market.
Respondents asked to have the flexibility to bring novel and innovative products to the market while, at the same time, protecting a company's new scientific information provided during the review process. Industry respondents noted the importance of ensuring the protection of their data and proprietary business information, and a period of market exclusivity was also recommended.
Good Manufacturing Practices (GMP)
Respondents recommended that GMP requirements be designed in such a way to offer flexibility to accommodate all product types, while ensuring that these requirements support the safe use of products by Canadians.
The consultation document included a proposal to modernize some GMP provisions, such as including good distribution practice components to enhance tracking and traceability of health products and to strengthen requirements for the identification and swift removal of falsified products from the legitimate supply chain. Many stakeholders recommended that more information be provided about these components and the impacts on affected parties.
Establishment Licence / Site Registration
Respondents recommended that Health Canada apply a risk-based approach to the interpretation of GMP requirements with respect to manufacturing activities involving consumer health products, and develop guidance in that regard to ensure consistent application. They also suggested that the Department continue to enable export and reduce burden as it relates to foreign site information by examining foreign site inspection cycles.
It was also suggested that Health Canada further its reliance on inspection reports from credible agencies, rather than requiring its own inspection in all instances. In order to maintain an appropriate quality standard, it was suggested that proposed requirements be based on benefit, harm and uncertainty information.
Stakeholders had diverse points of views on how the clinical trial provisions should be applied to all product types, and recommended that confidentiality of information generated by clinical trials be protected, while acknowledging the need for some transparency as well.
Respondents have asked Health Canada to consider the risk profile of consumer health products as it relates to proposed post-market requirements, such as adverse drug reporting, label changes, record keeping, complaint trend reporting and the maintenance of annual summary reports. It was suggested that post-market efforts should focus on proactive elements, such as prioritizing post-market surveillance of non-prescription drugs that have switched from prescription drug status, rather than focusing efforts on all consumer health products.
Stakeholders suggested examining how inspections and audits could be used as effective post-market compliance tools. They asked the Department to examine recall notification timelines, and indicated that the compliance response should remain risk-based and be equipped with the appropriate post-market tools to manage safety issues and product uncertainties.
Industry respondents indicated interest in knowing more about how the cost recovery model will be developed under the proposed regulations.
We heard diverse views on the impact of how information will be made accessible to all parties, as it relates to the approval of non-prescription drugs.
Some respondents suggested that disinfectants - specifically, those that are not subject to the Pest Control Products Act - be regulated separately from non-prescription drugs.These include, for example, disinfectants used in food preparation areas in cafeterias and restaurants, and those used to sanitize hospital rooms. These respondents noted that disinfectants are not used on or in the body, as non-prescription drugs are, and should therefore be subject to a different regulatory framework.
Health Canada continues to work with its Health Portfolio partners to protect the health and safety of Canadians, while supporting a regulatory system for consumer health products that is more open, transparent and nimble. We want to ensure that Canadians have more access to meaningful information that supports informed choices about consumer health products.
Canadians, health care professionals and industry stakeholders are partners in the discussion about the future regulation of consumer health products. The first consultation on the Framework marked the beginning of a journey that will continue for many months. During this time, there will be multiple opportunities to provide ideas and comments.
Health Canada would like to hear more from consumers. We plan to further engage and consult to ensure that our work is informed by the way consumer health products are perceived and used by Canadians in their everyday lives. The Department is currently exploring opportunities in this regard.
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