Mr. Speaker, with regard to part (a) of the question, since the under-dosing incident, Health Canada has undertaken these actions.
First, on April 19, 2013, Health Canada published the “Interim Regulatory Oversight of Admixing and Compounding” statement, allowing organizations involved in these activities to continue providing these services, if they meet certain conditions, while the department and the provinces and territories, or PTs, worked together to determine the long-term oversight of these activities.
Second, Health Canada convened the Ad Hoc Federal-Provincial-Territorial Working Group on Admixing and Compounding to collaboratively work toward two goals: to examine the scope and extent of hospital pharmacy outsourcing of drug compounding and admixing across Canada; and to determine the appropriate oversight of these activities. Health Canada also convened a sub-working group to bring clarity to the delineation between federal and PT oversight of these activities.
With regard to part (b), Health Canada has also been working collaboratively with key stakeholders such as the National Association of Pharmacy Regulatory Authorities and the Canadian Society of Hospital Pharmacists to determine how best to achieve regulatory clarity to enhance patient safety, and improve predictability and transparency going forward.
In regard to (c), (d), and (e), our government is determined that Canadians will have tough, effective regulations for drug safety. Health Canada has been actively working on a proposal for a federal approach to commercial compounding and initiated consultations in June 2014 to gain feedback from PTs and other key stakeholders on elements of the proposal and its implementation.
In regard to (c), details will be developed during the regulatory process in consultation with stakeholders.
In regard to (d), the proposed regulatory requirements would be proportional to the level of risk associated with the type of activity in question.
In regard to (e), proposed federal regulations would be an extension of existing regulatory frameworks governing the manufacturing of drugs, and Health Canada would develop an appropriate compliance and enforcement approach based on existing processes and procedures.
In regard to (f), Health Canada conducts routine inspections on a risk-based cycle to monitor compliance with the regulatory requirements, including the requirement to have and follow appropriate protocols related to the manufacturing of drugs. When non-compliance is identified, Health Canada verifies the corrective action taken by the manufacturer and takes appropriate enforcement action to protect the health and safety of Canadians.
In regard to (g), Health Canada administers an inspection program to regularly monitor the compliance of drug manufacturers with the regulatory requirements. Policies, guidelines and procedures related to the inspection program are regularly reviewed and audited to support continuous improvement so that Health Canada’s inspection program provides effective oversight to help protect the health and safety of Canadians. The department also participates in ongoing assessment activities with international partners to confirm the international equivalence of the Canadian inspection system.
Health Canada is also enhancing the integrity of the health product supply chain in Canada by educating stakeholders and improving the oversight of the ingredients found in health products in accordance with the new active pharmaceutical ingredients regulations. In addition to the existing measures in place to protect the health and safety of Canadians, our government is enhancing patient safety by C-17, Vanessa’s Law, which will require the reporting of adverse drug reactions by health institutions, mandatory recalls of unsafe drugs, and increased fines and penalties.
