Mr. Speaker, the Government of Canada recognizes the serious public health and safety issues associated with the abuse and misuse of prescription drugs and the burden it is placing on Canadian families and communities.
In the October 2013 Speech from the Throne, the Government of Canada made a commitment to expand the scope of our national anti-drug strategy to include addressing prescription drug abuse. In budget 2014, the Government of Canada announced $44.9M in funding over five years in support of this commitment. Working closely with the provinces and territories, and the non-governmental organization community, this expanded scope will enable the government to move forward on key issues, including enhancing prevention and treatment initiatives in communities; improving the evidence-based guidance on the treatment of pain and use of drugs for prescribers and other health care practitioners to support them in providing appropriate care to patients; and engaging in public awareness activities about prescription drug abuse.
Health Canada strives to maintain a balance between the potential health benefits and risks posed by health products available on the Canadian market. Products with identified risks, including addiction, are subject to increased scrutiny, monitoring, and risk mitigation. In Canada, the regulation and monitoring of prescription opioids, such as Suboxone, draws upon two distinct legislative frameworks: the Food and Drugs Act, F&DA, which regulates drugs for safety, efficacy, and quality for its recommended use; and the Controlled Drugs and Substances Act, CDSA, which controls access to drugs with risk of individual or societal harm.
To prevent undue influence of the pharmaceutical industry on the drug approval process, the department introduced measures to address real or potential conflicts of interest between drug reviewers and drug manufacturers.
Health Canada is an evidence-based organization.The F&DA require that sponsors provide scientific evidence to support the benefit-risk assessment that underpins drug regulatory decision-making.
Under the drug regulatory framework, manufacturers must obtain authorization to conduct a clinical trial on Canadian subjects. This clinical trial in support of market authorization may also be run outside of the country. Results from clinical trials submitted to Health Canada, regardless of where they are run, must be conducted in accordance with internationally accepted good clinical practice guidelines that help protect the rights and well-being of participants and ensure that the data generated are valid. All clinical trials sites in Canada are subject to monitoring and inspection by Health Canada.
Before a drug is authorized for sale in Canada, it goes through the drug review process in order to demonstrate that the drug is safe and effective. For an innovative drug, the standard means to establish safety and efficacy is via clinical trials whereby the sponsor, that is, the individual or organization, must submit a clinical trial application for review. The acceptability of a trial is based on the totality of information and always considers the balance between the anticipated benefits and potential risks to trial subjects. For generic drug reviews, since safety and effectiveness has already been established by the innovator product, a generic drug application needs only to submit bioequivalence studies, usually in volunteers, comparing their product with a Canadian reference product. The results of the bioequivalence studies must meet the standards outlined in published guidance documents. Also, a complete chemistry and manufacturing dossier must be filed. The labelling of the generic product must be the same as the innovator's labelling, that is, for the same uses and restrictions.
Once any new drug is on the market, regulatory controls continue. The distributor must report any new information concerning serious adverse effects and notify Health Canada of any studies that have provided new safety information. Health Canada monitors adverse events, investigates complaints and problem reports, and manages recalls, as needed. A drug can be removed from the market should the benefits of the drug no longer outweigh its risks.
Products containing controlled substances have further oversight through the CDSA. This legislative framework balances access to controlled substances for legitimate medical, scientific or industrial purposes with minimizing the risk of diversion to illicit markets or uses. Narcotics are some of the most controlled substances, and illegal activities with this class of drugs are subject to the maximum penalties under the CDSA.