With the dramatic increase in product safety issues over the past couple of years – for example, unsafe lead levels in imported toys; beef, spinach and bean sprout recalls; counterfeit contaminated toothpaste; and the global withdrawal of cox-2s drugs – the federal government decided to take action late last year. It announced its ”Food and Consumer Safety Action Plan,” which is a comprehensive set of new measures that are touted to “make Canadians safer by legislating tougher federal government regulation of food, health and consumer products.” Currently, a discussion paper on the proposed Action Plan is undergoing public consultation and legislation is expected some time this year. The proposed changes would allow for mandatory product recalls, uncapped fines and increased reporting and safety assessment requirements. At the centre of the proposed Action Plan are three key action areas:
- active prevention by providing better safety information to the public and guidance to industry to ensure safety throughout the supply chain;
- identifying and targeting the highest risk products and the benefits and risk at all stages in a product’s life cycle by requiring increased safety testing results to be provided to the government for oversight; and
- enabling rapid response by providing the government with enhanced recall powers and oversight.
Summarized below are the highlights of the government’s proposal in respect of food, consumer and health products. The full discussion paper can be accessed here:
The Action Plan proposes both legislative amendments to the Food and Drugs Act and expanded program measures to enhance Canada’s food safety system, including:
- Broadening the coverage of potentially unsafe foods by addressing issues at the time of importation, including a clearer description of foods not permitted for importation or sale into Canada;
- A new enabling authority to require that high-risk foods be prepared, packed and stored using a system of preventative food safety controls (such as the “Hazard Analysis and Critical Control Point” (HACCP) or equivalent processes);
- Enhanced record-keeping requirements for importers, processors and those who prepare or sell food;
- Creating a specific prohibition against tampering with foods;
- Recognition of comparable foreign inspection systems and results to better address risks at the source;
- New registration and licensing of products, persons or establishments to enable the identification of food importers and the foods brought into Canada;
- Broadened powers of inspectors (including the power to hold, prohibit or restrict the movement of food; introduction of a new definition of “records” that inspectors may have access to; and the ability to obtain telewarrants);
- Development of new policies and standards to enhance prevention of foods safety issues e.g., concerning allergens, chemical contaminants, emerging food-borne pathogens and bioactives in foods; and
- Review of current “Product of Canada” labelling policies.
Consumer products, which include household and personal use items such as cleaning supplies, toys, cosmetics and household appliances, are regulated under a variety of legislation. Such legislation includes, for example, the Hazardous Products Act, Food and Drugs Act (and the Cosmetic Regulations) and the Radiation Emitting Devices Act. The main proposal under the Action Plan is the introduction of a new piece of legislation, the Canadian Consumer Product Safety Act. This Act is intended to modernize Canada’s consumer product safety regime. The new Act would include the following goals:
- Create a new general prohibition against the manufacture, importation, advertisement and sale of consumer products that are (or are likely to be) a danger to the health or safety of the public, whether or not such product is subject to specific legislation;
- Provide Health Canada with the authority to order corrective measures such as product recalls, stop sales, labelling and product re-design where there are identified safety concerns;
- Increased reporting obligations of industry (e.g., near-miss incidents, tests results) and recordkeeping requirements to ensure traceability of products to foreign manufacturers;
- Enhanced border surveillance for consumer products of concern; and
- Substantially increased penalties for criminal offences (up to $1 million) related to consumer products and a new Administrative Monetary Penalties Scheme to deal with non-compliance and less serious offences.
In addition, the Action Plan proposes to increase consumer awareness through improved access to credible information including educational materials related to safety and summary information on injuries, incidents, compliance reports and consultations.
The regulation of pharmaceuticals, over-the-counter medicines, natural health products and medical devices is currently focused on pre-market assessments of safety; however, the government has identified problems in the on-going assessment of health product risks post-market, including a lack of adequate tools to support post-market actions by government, such as the legislative authority to order recalls. The Action Plan proposes the following changes to address the safety regulation of health products:
- Introduction of a progressive licensing framework to assess risks and benefits of a product over its life cycle (rather than only at the pre-market stage) with an initial focus on pharmaceuticals and biologics;
- On-going safety assessments with new obligations on manufacturers to show that the benefit-risk profile of their product continues to be positive in order to maintain authorization to sell a product including, for example, active post-market surveillance and reporting; on-going submissions of safety reports; issuing risk information to the public and health professionals; and product re-evaluations;
- Authority to make binding the scientific and regulatory advice it provides manufacturers early in the product development process and to require manufacturers to set out an action plan for monitoring and mitigating the risks of a product over its lifecycle;
- Enhanced reporting requirements including the requirement to publicly register clinical trials relied upon in drug submissions and post-market reporting of safety data;
- New powers of government to order mandatory recalls of a health product where it poses a serious or imminent health or safety risk, to order a company take steps to reduce risks (including stopping manufacturing activities or requiring changes to labels) and enhanced inspector powers (as discussed above for food);
- Increased fines for offences under the Food and Drugs Act to an uncapped amount at the discretion of the courts (currently, the cap on fines for serious offences under the Food and Drugs Act is $5,000 for health products and $250,000 for food);
- Closer monitoring of imported health products and requiring industry to demonstrate ingredients meet international standards for good manufacturing practices; and
- Improved public safety information including step-up publication of drug product monographs and health product Summary Basis of Decision documents, and a requirement for manufacturers to list all non-medicinal ingredients on most non-prescription drug labels.
The Action Plan also proposes to support open and transparent regulatory decision-making and information-sharing and includes enhanced safeguards to protect confidential information, trade secrets and personal information.
We will continue to monitor legislative updates in this area and will provide updates in future issues of the Osler Franchise Review.