I. Canada's Food & Drugs Act – Major Changes
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, as of November 2014, things changed.
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.
In November 2014, an Act to Amend the Food and Drugs Act, also known as Protecting Canadians from Unsafe Drugs Act or Vanessa's Law, came into force. The Act takes 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.
The major changes include:
- Requiring health care institutions to report serious adverse drug reactions and medical device incidents to Health Canada
- Allowing Health Canada to pursue faster regulatory action when a serious health risk is identified, including ordering a product recall or a change to the product's label to prevent injury to health
- Giving Health Canada greater powers to demand and obtain information in the person's control if Health Canada believes that the health product may present a serious risk of injury to human health
- Allowing Health Canada to disclose confidential business information about a health product without notifying, or obtaining the consent of, the person to whose business or affairs the information relates if Health Canada believes that the health product may present a serious risk of injury to human health
- Promoting greater confidence in the oversight of health products by encouraging transparency and openness in Health Canada's communication of risk-related information to the public
- 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, and additional officer, director and agent liability should such individuals direct, authorize, assent to, acquiesce or participate in an offence committed by the corporation
II. Risk Management Plans
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 Regulations – Coming
A rare disease is a life-threatening, seriously debilitating, or serious and chronic condition that affects a small number of people. Over 7,000 rare diseases have been identified worldwide, and about 80% of them have a genetic origin, and the remainder 20% from viral or bacterial infection or other environment causes.
An 'orphan drug' regulatory framework is currently under development in Canada. Health Canada will allow greater flexibility in the design of clinical trials and in the evaluation of the results given the smaller patient population, while placing greater emphasis on post-market activities. A 'product life-cycle' approach will be taken to assess the ongoing risks and benefits of an orphan drug. Patient input throughout the product's life-cycle will be taken into consideration by Health Canada as part of the assessment at the time of (i) designation as an orphan drug, (ii) market authorization application review and (iii) reassessment stages.
Adherence to a risk management plan, a pharmacovigilance plan (which may include establishing patient registries), 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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