Mr. Speaker, the 2012 economic action plan proposes changes that will give Canadians quicker access to drugs that have gone through Health Canada's rigorous scientific drug review process. This new proposed approach will not impact the safety and efficacy of drugs in Canada. All drug submissions to Health Canada will continue to be subject to rigorous safety, efficacy, and quality assessments prior to approval.
With respect to the questions (a) to (d) above, and subject to parliamentary approval of any required legislation, with regard to (a)(i), (a)(ii), (a)(iii) and (a)(iv) there will be no impact.
With regard to (a)(v), for the Patented Medicines Prices Review Board, PMPRB, there are no changes planned for the price review process. By 2014-15, the Patented Medicine Prices Review Board’s financial resources and human resources will have been decreased, as explained below.
First, the special purpose allotment to be used for external costs of public hearings will be reduced by $630,000 from a budget of $3.1 million. To date the Patented Medicine Prices Review Board has not used the full amount in any given year. Any unused funds at the end of the fiscal year are returned to the consolidated revenue fund. The reduction of $630,000 will not limit the Patented Medicine Prices Review Board’s ability to conduct hearings.
Second, funding of studies on non-patented prescription drug prices will be reduced by $374,000, including three positions. This may not necessarily result in layoffs of employees, owing to potential vacancies and internal budget re-allocations. The PMPRB will retain capacity to undertake research, including on non-patented prescription drug prices if required, through the national prescription drug utilization system program.
With regard to (a)(vi), patent register, drug product database, notice of compliance and the progressive licensing project will not be impacted.
With regard to (a)(vii), the therapeutic products directorate will be impacted, as described below in the responses to (b)(i) and (b)(ii).
With regard to (b)(i), the proposed removal of the requirement for a regulatory amendment to schedule F and maintaining the list of prescription drugs administratively would result in the following decreases in financial resources: $32,000 for 2012-13; $270,700 for 2013-14; and $388,400 for 2014-15 and ongoing.
With regard to (b)(ii), there will be a reduction of four positions in the therapeutic products directorate from 2013-14 and ongoing.
With regard to (c), there was no value-for-money assessment conducted for the drug approval process as there were no reductions in this area.
With regard to (d), as per the above, the 2012 economic action plan had no direct impact on drug regulation, with the exception of proposed changes to the Food and Drugs Act for schedule F.
With respect to the government's financial allocation plan regarding drug regulation, Health Canada updated its cost recovery fees for drug review and approval of drugs in April 2011. These fees were increased to reflect rising costs and will increase annually by 2% to help ensure that sufficient resources are available to support these activities.
Revenues from revised fees will provide stable, long-term funding for Health Canada's core regulatory activities, including efficient drug product reviews, enhanced drug safety monitoring and inspections. Revenues have also been invested in hiring new scientific experts, replacing antiquated IT systems and improving business processes and systems.