Neighbourhood Pharmacies provided feedback to wide ranging Health Canada consultation on a package of regulatory amendment designed to increase Canada's ability to prevent, monitor and mitigate drug shortages. While we support many of the proposed regulatory changes in principle, we are concerned that some of the proposed regulatory requirements will place significant administrative and financial burden on pharmaceutical market authorization holders (MAHs), leading to reduced patient access to medications and increased strain on an already vulnerable supply chain.
In extreme circumstances, MAHs may even decide to withdraw their products from Canada; exacerbating rather than preventing medication shortages. As MAHs and other supply chain stakeholders seek to offset their increased expenses, costs will cascade through the supply chain. Pharmacies cannot pass increased costs on to patients; and may be challenged to maintain service levels.
Finally, in light of the ongoing tariff dispute between Canada and the U.S., which threatens to destabilize the entire pharmaceutical supply chain, we have urged Health urge Health Canada to pause any further implementation of these regulatory changes and new manufacturer obligations at this time.