Senate Committee Releases its Report on
Post-Approval Monitoring of Pharmaceuticals
Ottawa (March 26, 2013) – Canada needs to improve and modernize the monitoring of drugs that have already been approved and are in use currently, says a report entitled Prescription Pharmaceuticals in Canada: Post-Approval Monitoring of Safety and Effectiveness tabled today by the Standing Senate Committee on Social Affairs, Science and Technology.
The report is a thorough assessment of the current situation with regards to post-approval monitoring of pharmaceuticals in Canada, with insightful perspectives provided by a large number of witnesses. It also contains 19 recommendations on the ways to enhance post-approval monitoring and to make it an integral part of the safety and effectiveness system.
Currently, drugs are approved for use by Health Canada based on the results of clinical trials involving a relatively small sampling of patients. There is very little follow-up or review of the drug’s safety and efficacy afterwards. This is a cause for concern because the clinical trials only use a select group of patients that don’t completely represent the general population. The elderly, children and pregnant women are rarely ever included in clinical trials, yet these groups are often prescribed the drugs once they are on the market.
"The collection of information on the impact of pharmaceuticals on human health post-approval is a highly inefficient process.” says Kelvin K. Ogilvie, Chair of the Committee. “With the electronic capabilities available today, it is inexcusable that we do not have a much better system for the monitoring of prescription drug effects on Canadians. We are missing the biggest and best source of information on the benefits and risks of drugs for our citizens."
The monitoring of drugs after their approval is the responsibility of Health Canada and has traditionally been conducted only following the receipt of adverse drug reaction reports from manufacturers and the public, as well as actions by other regulators, like the FDA. These are the actions that trigger further risk evaluation and more investigation.
"Health Canada currently does not have the authority to require that post-approval studies be conducted. The recommendations in our report aim to provide regulators with stronger means and clear processes to address this issue." says Art Eggleton, Deputy Chair of the Committee.
Health Canada has been taking steps in recent years to adopt a more active approach to drug surveillance, to consistently assess drugs for quality, benefits, harms and uncertainties both before and after they enter the general market. This is referred to as the life-cycle approach to drug regulation. The committee heard overwhelming testimony in support for this approach and the need for legislative authorities to properly implement it.
At the present time, because Health Canada has no authority in the matter, post-approval studies are not enforceable. The committee heard a number of concerns related to the inadequacy of resources dedicated to post-approval monitoring activities, issues of transparency in the approval and post-approval process, as well as suggestions for improving the system.
This report follows the second phase of a four-phase study undertaken by the committee on prescription pharmaceuticals. In November 2012, it tabled a first report entitled Canada’s Clinical Trial Infrastructure: a Prescription to Improved Access to New Medicines following the first phase of the study.
Between October 3 and November 21, 2012, the committee heard from witnesses in regard to the second phase of this study – the post-approval monitoring of pharmaceuticals. Over the course of eight meetings, the committee heard from Health Canada and the Canadian Institutes of Health Research as well as officials from the Office of Auditor General of Canada, representatives from the pharmaceuticals industry, patient advocates, medical, ethical and legal academics, and finally, representatives from national organisations concerned by pharmaceutical policy.
To read the report and recommendations or learn more about the Standing Senate Committee on Social Affairs, Science and Technology, go to http://senate-senat.ca/soci-e.asp.
The Senate of Canada is on Twitter: @SenateCA, follow the committee using the hashtag #SOCI.