Health and Biosciences: Targeted Regulatory Review – Program and Policy and Initiatives and Novel Regulatory Approaches

Scientific and technological advances are accelerating the pace of innovation in the healthcare system, leading to the development of a range of innovative health products that make use of technologies such as 3D printing and gene editing. Increasingly, health products are personalised, developed at point of care, and manufactured, distributed, and used in ways that differ significantly from traditional health products.

Industry has noted that the traditional regulatory frameworks for drugs and medical devices are ill-suited to the growing suite of advanced or personalized health products and are presenting as a barrier to innovation. For example, gene-editing capabilities may offer opportunities for potential new diagnostics and therapies that can be tailored to individuals in a hospital setting by health professionals who are not typically subject to oversight by Health Canada. Similarly, the versatility of 3D printing allows for the manufacturing of individualized products at the point of care including implants, surgical tools, or personalized drugs for small populations or individuals rather than the more typical mass manufacturing processes of large, complex, global supply chains.

Health Canada has identified "advanced therapeutic products" as health products that are novel, complex and distinct in the ways they are developed, fabricated, and delivered to patients and consumers. Health Canada has well-established protocols for both pre- and post-market oversight of traditional drugs and devices, but as more companies make use of these new technologies, it is becoming evident that the current framework for health products under the Food and Drugs Act and its regulations do not adequately address the characteristics of these new products. As such, a mechanism is needed for the Minister to authorize these advanced therapeutic products in a risk-based and flexible way that allows for innovation, while still protecting the health and safety of Canadians.

Health Canada is proposing the creation of a new regulatory pathway for advanced therapeutic products designed to support patient safety while allowing for significant flexibility. Sometimes referred to as a regulatory sandbox, this mechanism is designed to address key challenges to regulation presented by these products while enabling innovation and maintaining Health Canada's high standards for evidence to protect patient safety and decision-making.  The Minister would establish customized requirements to enable the authorization of an advanced therapeutic product with the ability to attach terms and conditions to each product authorization. The authorization requirements as well as any terms and conditions could be amended from time to time to allow for flexible oversight as new information and experience is gained. As more becomes known about a specific advanced therapeutic product, longer term regulatory requirements may be established, as appropriate, to set standard rules for a product type and remove it from the sandbox.

Health Canada also recognizes that rapid advancements related to health products require different approaches to post-market oversight. The modernization of inspector powers would enable an agile and flexible compliance and enforcement approach to address challenges associated with novel and rapidly evolving products and innovative business practices. For example, amending the places where an inspector may enter would provide the capacity to oversee compliance at a range of points in the supply chain, including entering a conveyance, records storage facility, or virtual space. It would also provide the legislative framework for compliance approaches and tools to capture content that is online or stored in a cloud, related to the use of artificial intelligence and software in health products, or to conduct the inspection of a facility remotely. These changes would help assure Canadians that their health and safety will be protected when using products approved through the advanced therapeutic product pathway.

The ability to create tailored authorization pathways for advanced therapeutic products will support timely access for patients while optimizing safety and benefits, as well as strengthening innovation in the health and biosciences sector. The enhanced post-market authorities will help reduce harm and ensure these advanced therapeutics are subject to enforceable oversight throughout their lifecycle.

Where appropriate, Health Canada proposes to work with regulated parties, health care professionals, patients, medical colleges, researchers, environmental stakeholders, health technology assessment and reimbursement bodies, other governments, and health care system planners and decision-makers to develop the appropriate requirements that would enable industry to market advanced therapeutic products in Canada.  The purpose of the requirements would be to protect the health and safety of Canadians while introducing agility and flexibility in the pre- and post-market oversight of these advanced therapeutic products. Following the introduction of this new pathway in the Food and Drugs Act, the pathway would be available to those drugs and devices that are determined by the Minister to be "advanced therapeutic products".

Legislative amendments are proposed as part of the Bill C-97, Budget Implementation Act, 2019, No. 1, tabled in the House of Commons on April 8, 2019.

Not applicable.

Celia Lourenco, PhD
Director General
Biologics and Genetic Therapies Directorate
Health Products and Food Branch
Health Canada
E-mail: celia.lourenco@canada.ca
Telephone: 613-946-0099

As part of the Workplace Hazardous Materials Information System, suppliers are required to disclose the chemical name and concentration of hazardous ingredients in their products on safety data sheets. The Hazardous Materials Information Review Act allows suppliers and employers to file a claim for exemption from these disclosure requirements. The process in Canada is unpredictable, burdensome and slow.

The Act, which has not undergone a comprehensive review since coming into force in 1987, has out-dated language and enforcement tools; is very prescriptive, with out-dated models (e.g. Canada Gazette notices, paper based communication via registered mail); and is not well aligned with other federal legislation within the health and bio-sciences sectors. The Act, as currently written, results in frequent requests from Health Canada to industry for additional information regarding a claim for exemption. These occur at unpredictable points in time, in some cases many months/years after a claim for exemption had been filed. As a result, industry cannot predict how long a decision will take and the level of interaction required with Health Canada officials.

In addition, the Act does not currently allow the sharing of information submitted under the claims for exemption mechanism with other programs or departments, even if this information is essential when significant issues impacting the health and safety of Canadians have been identified.

This proposal also addresses the recommendation from Canada's Economic Strategy Tables that call for agile and modernized regulatory system that focus on outcomes.

In order to address these issues, Health Canada is proposing a targeted review of the Hazardous Materials Information Review Act to help promote innovation, while at the same time, enhance its ability to further advance worker safety. More specifically, Health Canada proposes to update the Act in order to focus resources in a strategic fashion and allocate efforts on activities of higher risk and value that would maximize the impact on worker's safety (e.g., carcinogens, mutagens, reproductive toxicants and respiratory sensitizers and products of high use in the workplace). Additionally, changes will be made to allow the Minister to share information gathered by the program (as part of the exemption process), under specific conditions, within Health Canada and with other Canadian regulators; and to modernize various other elements of the Act, such as to remove unnecessary and out-dated activities (e.g., the appeals process, paper-based transactions).

Health Canada has already carried out early engagement with key stakeholders, including sharing consultation documents that detail proposed changes and identify impacts and potential benefits.

Health Canada administers the provisions of the Hazardous Materials Information Review Act on behalf of the federal, provincial and territorial regulators of employers. As provincial and territorial legislation cross-references the Act directly, any changes made to it would also impact these regulatory bodies. Close collaboration between jurisdictions is maintained through regular meetings, and Health Canada will ensure continued engagement through the process of this amendment. No significant impact is expected.

The ability to share relevant confidential information for the purpose of protecting human health and safety or the environment from significant risk will improve the ability for governments at the federal, provincial and territorial levels to protect worker health and safety under the cooperative Workplace Hazardous Materials Information System.

The proposed legislative amendments to the Hazardous Materials Information Review Act are included in the Budget Implementation Act, 2019, No. 1, tabled in the House of Commons on April 8, 2019.

• Workplace Hazardous Materials Information System (WHMIS)

Workplace Hazardous Materials Bureau
Consumer Product Safety Directorate
Health Canada
Email: WHMIS_SIMDUT@hc-sc.gc.ca

The health or safety requirements for consumer products are not always aligned with those of other international regulatory partners.

Industry stakeholders have expressed a clear preference for relying more heavily on standards, particularly those that strengthen further alignment with major trading partners, for the protection of consumers from the potential hazards of consumer products. Standards allow for all stakeholders—industry, consumers, and regulators—to create an environment in which innovative products can be developed and alignment across jurisdictions can be improved supporting economic growth and competitiveness.

Traditionally, Health Canada has used regulations to protect consumers against potential hazards from consumer products. However, with the coming into force of the Canada Consumer Product Safety Act in 2011, new authorities were created to more effectively address unregulated consumer products as well. These powers allow for new tools, in addition to regulations, to respond to the potential hazards that could arise from consumer products.

Notwithstanding these new authorities and tools, the regulations predating the Act were carried over and have continued to be relied upon as the primary basis for protecting consumer health and safety. While Health Canada has existing processes in place to determine when prescriptive regulations or other forms of regulatory tools could be used, there is no overarching public-facing policy framework that describes how decisions are made on what regulatory tools should be considered under the Act, including the general prohibitions.

Health Canada will develop an Instrument of Choice Framework that sets out the considerations and the process for how it determines which regulatory tool or instrument will be used to address a consumer product safety hazard, in compliance with the Cabinet Directive on Regulation. More specifically, the Framework will establish clear terms for how the Consumer Product Safety Program can use its general prohibitions to address those risks that pose a danger to human health or safety through the identification of rigorous voluntary standards.  This approach will provide industry partners with a clear indication of the department's expectations for product safety on unregulated products or known unregulated hazards.  A key deliverable of this work will be the establishment of a more formal and public facing approach for how the Consumer Product Safety Program will enforce the general prohibition through a web-based format that will:

• Identify what unregulated hazards or products Health Canada may be considering to take action on in the future;
• List known standard(s) or other requirements that may help serve to mitigate the unregulated hazard or product; and
• Establish a documented list of the standards that the Program has assessed and found to be sufficient to address the unregulated hazard. Companies would be expected to ensure their products comply with these accepted standards.

This approach would provide stakeholders with an earlier indication of the unregulated hazards the Consumer Product Safety Program is considering to take action on, thereby allowing companies to understand compliance expectations earlier. It would provide opportunity for stakeholders to provide advice and to inform the decision-making process.

Through both of these projects, Health Canada will consider international standards and the requirements of other product safety regulators, including the U.S. and the European Union, and will align where such alignment would be appropriately protective of health and safety. In support of this work, Health Canada will continue to leverage its participation in international standard bodies in collaboration with its U.S. counterpart, on critical product categories, such as its work with children's toys and the ongoing collaborations with the American Society for Testing and Materials and the International Organization for Standardization.

• Winter 2019: Complete internal evaluation of the general prohibitions and other instruments.
• Spring 2019: Draft a modernized public-facing Instrument of Choice Framework.
• Fall 2019: Consult stakeholders on the modernized public-facing Instrument of Choice Framework.
• Winter 2020: Publish the modernized Instrument of Choice Framework.

• Consumer products and cosmetics

Risk Management Bureau
Consumer Product Safety Directorate
Health Canada
Email: cps-spc@canada.ca

Additional IT tools are needed to facilitate industry interaction with Health Canada across all business lines.

For example, Health Canada's current system for required reporting by regulated parties under the Controlled Drugs and Substances Act (such as reporting of loss and theft, seizure and disposition, and inventory data) is burdensome and inefficient, for both stakeholders and the regulator. The existing system does not adequately support Health Canada's need to assess data in a timely fashion and take appropriate regulatory actions in response to higher risk issues. An upgraded system will provide benefits for more efficient reporting such as the ability to amend reports, view all reports in a centralized location, access a searchable controlled substances database, receive automatic email notification that reports have been received, and share reports with colleagues through a print-to-PDF function. The system will also enable Health Canada to process information more efficiently and support new types of analysis, such as heat mapping to identify high risk areas, and long-term trending. Other benefits include the ability to more effectively respond to provincial regulatory college requests, Access to Information/media requests, and potentially identifying diversion risks at an early stage.

This proposal will partially address the issue of providing Health Canada's stakeholders with electronic tools for regulatory submissions and communications while working toward a more complete solution for all required reporting.

To improve the ability of industry regulated under the Controlled Drugs and Substances Act to meet its reporting obligations through the use of technology, Health Canada is developing new reporting tools including an online portal, with accompanying procedures and guidance for stakeholder use.

Stakeholders are being consulted on the development of the new electronic platform, and guidance on its use will be shared once developed.

Although the initial focus is for controlled substances, the system is being designed to accommodate other business lines within Health Canada.

Not applicable.

Currently, Health Canada is developing an outward-facing portal focused on enabling the reporting of required regulatory information for controlled substances and precursors. Plans are in place to enable licensees and pharmacies to report loss or theft data, or sales and inventory, and for law enforcement to submit seizure and disposition data. Consultations with stakeholders have commenced and will continue through 2019.

The initial release of the portal enabling reporting of loss and theft is expected for winter 2020.

• Controlled substances

Office of Controlled Substances
Controlled Substances Directorate
Health Canada
Email: hc.ocs-bsc.sc@canada.ca