Mr. Speaker, there is a dangerous grey area in the regulation of medical drugs in Canada, namely with respect to drug compounds prepared by mixing together two or more ingredients, of which at least one is a drug, to create a final product in an appropriate form or dosing for administration in a patient-health care professional relationship, typically in a hospital.
The emergence of this new form of drug delivery—through pre-filled syringes and bags, for example—has become problematic because companies in this sector fall between the definition of a drug manufacturer and that of a pharmacy. The latter is regulated by the provinces and the former by the federal government.
The absence of sufficient and appropriate regulatory oversight of drug compounders has led to mistakes and human tragedy both in Canada and the U.S. In Canada, the Marchese fiasco resulted in patients receiving diluted doses of a chemotherapy drug. In the U.S., in late 2012, there was an outbreak of viral meningitis associated with a compounded steroid injectable, known as MPA, which was contaminated when it was administered—64 people died and 750 others became sick.
The U.S. compounding industry was operating in the same kind of balkanized regulatory environment as drug compounders in Canada today. The tragedy prompted the U.S. to adopt the Drug Quality and Security Act. Under the act, compounders register as outsourcing facilities, which brings the same type of regulatory oversight by the FDA as is reserved for drug manufacturers, with the same standards of compliance, risk-based inspections, record retention, and adverse event reporting.
The question is this. Why does the federal government in Canada not step in and deploy its expertise in the regulation of drug manufacturers to drug compounders? It would seem a logical extension of federal authority and a wise application of existing federal know-how, all in the interests of the general health welfare of Canadians from coast to coast to coast, who as citizens of this great country, deserve to benefit from common standards of health protection.
Why do the Conservatives fail to show initiative? Are they afraid of the costs? Is it because doing so would require discussion with provincial health ministers, who are not pleased with Ottawa's growing neglect of co-operative federalism in health care?