SOCI - Standing Committee

Social Affairs, Science and Technology

Past Session: Past Session:
41-1 41st Parliament, 1st Session (June 2, 2011 - September 13, 2013)
Select a different session
 

Recommendations

 
Recommendation 1

The committee therefore recommends that the Government of Canada introduce legislation which includes authorities for drug management. These authorities should include, but not be limited to:

  • The authority to require post-approval studies;
  • The authority to require label changes;
  • The authority to require re-assessment of a drug’s safety and effectiveness;
  • The authority to disclose publicly information about a drug’s risks or benefits;
  • The authority to require Risk Management Plans and Periodic Safety Update Reports; and
  • The authority to issue mandatory drug recalls.
Recommendation 2

The committee therefore recommends that the Minister of Health ensure publication of a modernized regulatory framework for drugs that applies a life-cycle approach to drug management in the Canada Gazette, beginning in 2013.
Recommendation 3

The committee further recommends that long-term studies of drug safety must be included as part of a life-cycle approach to drug management.
Recommendation 4

The committee therefore recommends that the Minister of Health work to achieve equal funding for both pre- and post-approval drug regulatory activities and ensure that post-approval resources are adequate for implementation of a comprehensive life-cycle approach to drug management.
Recommendation 5

The committee therefore recommends that the Minister of Health order a comprehensive and independent assessment of the work of the Drug Safety and Effectiveness Network (DSEN) and that a report be submitted to the President of the Canadian Institutes of Health Research (CIHR) as well as to the Minister of Health and be made publicly available. The report should provide:

  • An analysis of DSEN’s ability to operate independently from both CIHR and Health Canada;
  • A recommendation of DSEN’s budgetary needs in order to conduct the necessary post-approval studies;
  • A discussion of the findings that DSEN has conveyed to Health Canada and how these have been acted upon by the regulator;
  • A comparison of DSEN’s performance relative to other international post-approval drug research networks; and
  • Advice on whether DSEN should be re-structured in order to best fulfill its mandate.
Recommendation 6

The committee further recommends that the Minister of Health provide assurance that the Drug Safety and Effectiveness Network is:

  • a permanent entity with on-going and sustained funding; and
  • responsible for its own budget.
Recommendation 7

The committee further recommends that the Minister of Health establish an oversight mechanism to regularly review the findings of the Drug Safety and Effectiveness Network and make this information publicly available.

Recommendation 8

The committee therefore recommends that the Drug Safety and Effectiveness Network:

  • incorporate the model used by the Canadian Pharmacogenomics Network for Drug Safety as a means to apply active post-approval surveillance to adverse drug reaction reporting;
  • make use of the research network capacity proposed in the committee’s clinical trials report of November 2012.
Recommendation 9

The committee therefore recommends that the Minister of Health meet with provincial and territorial counterparts to discuss implementation of a system similar to British Columbia’s PharmaNet in all jurisdictions in order to capture data on all prescription drugs dispensed.
Recommendation 10

The committee further recommends that the Minister of Health urge provincial and territorial counterparts, through the work of Canada Health Infoway, that the national system of electronic health records must be linkable to and compatible with the electronic system that captures data on dispensed prescription drugs.
Recommendation 11

The committee therefore recommends that the Minister of Health ensure that Health Canada is represented at ongoing federal/provincial/territorial discussions regarding the implementation of electronic medical records and electronic health records to promote the inclusion of the adverse drug reaction reporting form.
Recommendation 12

The committee therefore recommends that the Minister of Health direct Health Canada to prioritize the implementation of a post-approval strategy for drug manufacturers and/or the Drug Safety and Effectiveness Network to conduct studies of new drugs in relevant, sub-groups of the population.
Recommendation 13

The committee further recommends that the Minister of Health include, within the modernized regulatory framework for drugs proposed in Recommendation 2, a requirement for systematic safety reviews of drugs used in the pediatric population.
Recommendation 14

The committee further recommends that the oversight mechanism, established under Recommendation 7, allow for the consideration of issues identified for post-approval studies by the Drug Safety and Effectiveness Collaborating Centres, any of its seven research teams or under the Strategy for Patient-oriented Research as research queries.
Recommendation 15

The committee therefore recommends that the Minister of Health direct Health Canada to develop in collaboration with stakeholders and implement within its drug approval process a requirement that all drug submissions and subsequent approvals be accompanied by Patient Information Leaflets, which must provide the Health Canada website and phone number for reporting adverse drug reactions.
Recommendation 16

The committee further recommends that the modernized legislative framework proposed in Recommendation 1 include a prohibition on the sale of prescription drugs unless accompanied by a Patient Information Leaflet.
Recommendation 17

The committee therefore recommends that the Minister of Health implement labeling requirements similar to the United States’ ‘black box’ and the United Kingdom’s ‘black triangle’ to alert health professionals and consumers to new products as well as products that have been linked to serious adverse reactions.
Recommendation 18

The committee therefore recommends greater transparency of Health Canada’s post-approval monitoring activities including, but not limited to:

  • a list of the Risk Management Plans that have been submitted;
  • a list of identified safety signals and the status of the subsequent assessments; and,
  • a list of drugs for which the manufacturer is responsible for post-approval studies, including long-term follow-up.
Recommendation 19

The committee therefore recommends that Health Canada provide assurance that all policies, programs or activities pertaining to monitoring the post-market safety of drugs have been successfully implemented in response to the recommendations from the Auditor General’s 2011 report Regulating Pharmaceutical Drugs—Health Canada.