Important Food And Drug Regulatory Changes “Hidden” In Omnibus Budget Bill

Over the past few years, regulatory amendments have permitted linking of outside “technical” documents to various regulations administered by Health Canada, especially the Food and Drug Regulations (the Regulations). Although this allows timely updates to technical standards, it also takes important regulatory matters outside of the Canada Gazette process (which permits public comment) and by outsourcing requirements to international bodies, defeats in-Canada democratic oversight of bureaucratic actors. This is part of a process of “outsourcing” Canadian law to external bodies which has been ongoing for some time.

Similar issues have been raised by the omnibus budget bill (Bill C-69, the Budget Implementation Act, 2024, Division 31 (the Bill)) introduced April 16 of this year. The Bill is currently undergoing second reading in the Senate. 

This Bill would make significant changes to the power of the Minister of Health (the Minister) to make decisions about drug and other health product approvals by making exceptions to the Regulations or issuing direct orders about particular Therapeutic Products (which is now defined as Drugs, Medical Devices, and Natural Health Products, but not cosmetics). 

There is a serious legal question as to whether this is constitutionally appropriate.

The new law will allow the Minister to exempt any Therapeutic Product from the application of the regulations.  The Minister may make an exemption order only if the Minister believes it “necessary for a health or safety purpose” or is otherwise in the public interest, and the Minister believes that, having regard to its benefits and conditions, any exemption is unlikely to result in unacceptable health, safety or, if applicable, environmental risks, or an unacceptable degree of uncertainty respecting health, safety or, if applicable, environmental risks. Since “otherwise in the public interest” is not explicitly limited to scientific grounds, there is little restriction on the ability of the “Minister” (i.e. Health Canada) to use this provision.

These exemption orders are defined by the act as not being a “Statutory Instrument” and thus not subject to the Statutory Instruments Act; this exempts such orders from the Canada Gazette comment process.

Interestingly, the new law will also permit the Minister to make orders about particular products to prevent a use of a product from “being appealing.” This is assumed to be directed to smoking cessation products and e-cigarettes.

In essence, this Bill will permit the Minister of Health to permit or ban import, advertising, manufacture, preparation, packaging, and labelling, of any “Therapeutic Product”. This dramatically changes Canada’s approval process for this type of product and makes it much more susceptible to political pressure.

Summary By: Gordon Jepson