I. Canada's Food & Drugs Act – Major Changes Proposed
In Canada, the sale and marketing of pharmaceuticals, biologics, medical devices and other healthcare products are regulated under the Food & Drugs Act and regulations. Since the creation of this legislation in the 1950's, it has remained virtually unchanged. However, things are about to change.
Due to increased publicity and litigation over Health Canada's failure to warn the public about the dangers of certain drugs, particularly when the same dangers were raised by the World Health Organization and foreign regulatory authorities a few years earlier, concerns over insufficient detection and management of potential safety issues caused legislators to re-examine the current legislation for the purpose of strengthening Health Canada's regulatory powers.
Bill C-17, also known as the Protecting Canadians from Unsafe Drugs Act or Vanessa's Law, was formed. Bill C-17 proposes taking a 'product life-cycle' approach to the regulation of health products. What this means is that a health product's risks and benefits will not only be assessed before the product enters the Canadian market but also continually after it has entered the market. Health products subject to such assessments will be prescription and over-the-counter drugs, radiopharmaceuticals, vaccines and other biologics, gene and cell therapies, and medical devices, but not natural health products. Another major change is to give Health Canada the ability to order a recall of an unsafe drug, because under the current legislation, drug recalls are undertaken voluntarily by manufacturers and distributors.
Other proposed major changes include:
- Stronger requirements for adverse reaction reporting (including requiring health care institutions to report serious adverse drug reactions and medical device incidents to Health Canada)
- Giving Health Canada greater powers to demand and obtain safety information
- Allowing Health Canada to pursue faster regulatory action when a serious health risk is identified, including the right to order a product recall or a change to the product's label to make new safety information available
- Imposing stiffer fines and penalties to reflect the seriousness of the violation – up to a maximum of $5,000,000 and/or 2 years' imprisonment (from the current $5,000 fine and/or 3 years' imprisonment)
II. Risk Management Plans – Proposed Requirements
In keeping with adopting a 'product life-cycle' approach to assessing the risks and benefits of a health product, Health Canada requires sponsors/market authorization holders to provide risk management plans. A risk management plan is a dynamic, stand-alone document that is to be updated throughout a product's life cycle and contains descriptions of pharmacovigilance activities and interventions designed to identify, characterize, prevent or minimize risks related to medicinal products, as well as an assessment of the effectiveness of those interventions.
In recognizing that risk management planning has become a global activity, Health Canada has indicated that it will accept the EU format that adheres to the "Notice Regarding Implementation of Risk Management Planning including the adoption of International Conference on Harmonisation (ICH) Guidance Pharmacovigilance Planning – ICH Topic E2E". Health Canada will also accept the U.S. Risk Evaluation and Mitigation Strategies (REMS) as long as the essential risk minimization elements outlined in the EU format are covered. Even though the use of an EU and a US format is acceptable, Health Canada has indicated that where special considerations exist with respect to medical practice or populations in Canada, the sponsor/market authorization holder must address the special Canadian context in its risk management
plan. A risk management plan should include all available post-market data (if marketed in Canada or elsewhere) in the form of an annual summary report or a periodic safety update report. The plan should also provide a rationale in situations where additional pharmacovigilance (e.g. a drug utilization study, registry) or risk minimization activities (e.g. contraindication, restricted distribution) are proposed or implemented outside of Canada even if it is not proposed or implemented in Canada.
A risk management plan is required to be submitted for a drug, biologic or radiopharmaceutical that is intended for human use, in the following circumstances:
- as part of a new drug submission
- when a serious safety issue has been identified
- when a previously acceptable risk management plan has undergone significant changes
- significant change in what is known about the risks and benefits or in the frequency or severity of a known risk or the identification of a previously unknown risk
III. Orphan Drugs
With over 7,000 rare diseases identified in Canada, an 'orphan drug' regulatory framework is currently under development in Canada. A 'product life-cycle' approach will also be taken to assess the risks and benefits of an orphan drug both before and after market entry into Canada.
Applicants seeking 'orphan drug' designations for their drugs must demonstrate all of the following:
- prevalence of the disease in Canada is less than 5 in 10,000
- the severity of the disease
- the medical plausibility of the drug
- a lack of existing therapy or potential for significant improvement
Adherence to a risk management plan, a pharmacovigilance plan, a commitment to carry out confirmatory studies, and the implementation of quality controls will be conditions that must be satisfied in order to obtain and maintain market authorization for the orphan drug in Canada.
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