Further to our last newsletter update regarding Health Canada’s Revised NHP Cost Recovery Proposal, the comment period has been extended from 30 days to 60 days, closing on May 25th. This is the result of a joint lobbying effort by several trade associations including CA. CA is now working with our Technical Committees to develop and submit comments on the proposal, but the reality remains that although the price has been significantly reduced, it is still based on an outdated and inefficient regulatory model rather that the modernized Self-Care Framework with its efficiencies and larger product base.
As the Health Canada officials suggested a possible meeting to discuss the timing of completing the Self-Care Framework, CA is pursuing this with the Deputy Minister and calling for the meeting to be advanced so that “dates and gates” can be established that will ensure the completion of the Framework as soon as possible. Continuing the current status quo just continues to create unnecessary issues for Health Canada and stakeholders including both the NHP Cost Recovery Proposal as well as the NHP GMP Proposal which appears ignore the Self-Care risk-based approach (applying inappropriate drug GMPs to NHPs). As CA has pointed out, failure to finish Self-Care will continue to tie up Health Canada in unnecessary disputes which would be appropriately avoided with risk-based regulation.
