On March 10, 2015, the Standing Senate Committee on Social Affairs, Science and Technology (the Committee) released a final report entitled "Prescription Pharmaceuticals in Canada" (the Report). Nearly three years in the making, the Report summarizes the Committee's four-phase study, earlier reports and recommendations to improve Canada's prescription drug regulatory regime.
Background
The Senate authorized the Committee to examine and report on prescription pharmaceuticals in Canada on November 19, 2013. The Committee's mandate was to examine:
- the process to approve prescription pharmaceuticals with a particular focus on clinical trials;
- the post-approval monitoring of prescription pharmaceuticals;
- the off-label use of prescription pharmaceuticals; and
- the nature of unintended consequences in the use of prescription pharmaceuticals.
The Committee previously released the following reports: Canada's Clinical Trial Infrastructure: A Prescription for Improved Access to New Medicines; Prescription Pharmaceuticals in Canada: Post-Approval Monitoring of Safety and Effectiveness; Prescription Pharmaceuticals in Canada: Off-Label Use; and Prescription Pharmaceuticals in Canada: Unintended Consequences.
The Committee's Key Recommendations
Through its four-phase study, the Committee made a total of 79 recommendations to enhance Canada's prescription drug regulatory regime. The following are ten of the Report's key recommendations:
- Ensure certain clinical trial information is made available to the public;
- Ensure more effective monitoring of prescription drugs by Health Canada once drugs reach the market and may be prescribed to sub-groups often excluded from clinical trials (i.e. children, elderly persons, and pregnant and nursing women);
- Collect data about physicians' off-label prescribing practices;
- Create electronic databases, with controlled access to data, to address unintended consequences of prescription drug use;
- Increase transparency regarding inspection results and inform the public whenever a drug manufacturer has violated their product authorization or establishment license requirements;
- Amend the Food and Drug Act Regulations to require more drug discontinuance notifications;
- Clarify the roles of the Minister of Health and Minister of Environment in monitoring the levels of pharmaceuticals in ground water;
- Take measures to reduce the increasing number of antibiotic resistant infections in Canada and abroad;
- Increase internet pharmacy regulation and enhance enforcement against counterfeit practices involving multi-jurisdictional collaboration; and
- Strengthen Health Canada's inspection activities and implement prescription drug batch testing.
Vanessa's Law
In Canada, prescription drugs are regulated under the federal Food and Drug Act (the Act) and the Food and Drug Act Regulations. In December 2013, the Minister of Health introduced Bill C-17, an Act to amend the Food and Drugs Act or Vanessa's Law, to the House of Commons. Vanessa's Law received royal assent in November 2014, and is the first substantial update to the Act in over fifty years. The new legislation was designed to further protect Canadians from the risks associated with using drugs and medical devices.
Vanessa's Law has strengthened the Minister of Health's pre and post-authorization oversight powers, and incorporated some of the Committee's key recommendations. The Committee recommended that Act be amended to increase both transparency and penalties for contravening the Act. Vanessa's Law has improved clinical trial transparency by requiring certain information be publicly released in a manner to be determined by the regulations, and increased the penalties for contravening the Act from a $5,000 fine to a maximum daily fine of $5 million and a sentence of up to two years imprisonment.
The Committee also recommended that the Minister of Health be granted the authority to issue mandatory drug recalls and require post-approval studies; label changes; re-assessment of a drug's safety and effectiveness; and public disclosure of information about a drug's risks or benefits. Vanessa's Law has given the Minister of Health a number of these powers, including the authority to recall drugs; to require product label or packaging changes; and to order authorized products undergo further tests, studies or monitoring and to provide the results to the Minister of Health. The Minister of Health's power to recall drugs also follows the Committee's recommendation to increase transparency around substandard and counterfeit drugs in Canada and enhance the Minister of Health's ability to combat such drugs.
Finally, Vanessa's Law implemented the Committee's recommendation to improve adverse drug reaction reporting to Health Canada. Health care institutions will now be required to provide the Minister of Health, within a time and manner to be prescribed be regulations, information about serious adverse drug reactions.
A First Step Towards Reform
Although Vanessa's Law incorporated some of the Committee's recommendations, it has been criticized for not going as far as it could have. The Committee heard expert testimony criticizing Health Canada's passive role in drug regulation; Health Canada's lack of transparency when relaying safety information to the public; and Health Canada's inability to conduct inspections at all phases of a drugs' life cycle. While the Report acknowledged that the federal government drafted some of its recommendations into Vanessa's Law, the Committee stated that further reforms are necessary.
Overall the Committee found there was a sense from stakeholders that Vanessa's Law was a positive first step towards updating the Act and bringing Canada in line with global pharmaceutical drug regulatory trends.
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