Canada: Federal Court Of Appeal Confirms Onus On Applicant To Demonstrate Safety And Efficacy Of Natural Health Products

In Canada RNA Biochemical Inc. v. Canada (Health)¹, the appellant Canada RNA Biochemical Inc. (C-RNA) was unsuccessful in its application to set aside the decision of Health Canada refusing to grant a Natural Health Product (NHP) licence for C-RNA's product Boluoke (oral lumbrokinase capsules). This decision affirms the point that Health Canada will be afforded broad discretion when determining whether an applicant has demonstrated that a product is safe and effective in the pre-market approval process.

What you need to know

• NHPs are Canada's version of U.S. dietary supplements. NHPs are sold over the counter². They are regulated under Canada's Food and Drugs Act and Natural Health Product Regulations as a subset of drugs.
• The regulatory approval process for NHPs places the onus on an applicant to provide sufficient evidence to Health Canada to demonstrate that a product would be safe and efficacious in the circumstances under which it would be used and sold.
• There is no obligation on Health Canada to approve a product, even where there is some evidence demonstrating safety and efficacy submitted by an applicant. Health Canada may properly refuse to approve a product when its refusal is rationally supported by scientific analysis, regulatory criteria and relevant policies.
• While this decision involved an NHP, applicants for marketing authorizations for other categories of products will note FCA's deference to Health Canada's decisions on safety and efficacy.

Commentary

C-RNA sought approval from Health Canada under the Natural Health Products Regulations (NHP Regulations) for its product Boluoke lumbrokinase, a capsule containing an enzyme derived from earthworms as its medicinal ingredient. According to the applicant, the enzyme enhances the breakdown of blood clots and prevents them from forming, reducing the viscosity of blood and improving circulation.

The application was rejected by Health Canada on the basis that the evidence submitted was insufficient to support the safe use of lumbrokinase. C-RNA pursued a reconsideration of the decision, under the process outlined in the NHP Regulations, but Health Canada upheld its original decision and would not issue a product licence. C-RNA next applied to the Federal Court for judicial review of Health Canada's decision. The Court concluded that Health Canada's refusal to issue the licence was reasonable. The matter was then further appealed to the Federal Court of Appeal (FCA).

In its decision, the FCA indicated that C-RNA had not identified any reviewable error in Health Canada's refusal to issue the licence, or in the manner by which Health Canada's decision was reached. The FCA noted that C-RNA's position was grounded in a misunderstanding of the legislative regime under the NHP Regulations: Health Canada bears no onus to demonstrate that a product is safe and efficacious. Health Canada has complete discretion in determining whether the applicant has demonstrated to the satisfaction of Health Canada that the product is safe and efficacious. Further, even in the face of contradictory or competing evidence as to safety and efficacy, Health Canada has no obligation to decide in favour of the applicant. Health Canada is not required to prove that a substance is not safe or efficacious. The FCA was clear that this onus is on the applicant, and in this case, Health Canada was not satisfied that the burden had been met. Its decision was grounded in an appropriate evidentiary record. The FCA cautioned that Health Canada's reason for refusing a product licence must be rationally supported by the scientific analysis, regulatory criteria and relevant policies. 

The FCA pointed out that many of the arguments put forth by C-RNA, relating to procedural fairness, were mischaracterized as C-RNA as actually challenging the substantive decision of Health Canada itself. To this point, the FCA held that the Federal Court properly applied a reasonableness standard to the review of the decision of Health Canada. For example, C-RNA asserted that Health Canada's consultation with an external hematologist to assess C-RNA's post-marketing surveillance plan was a breach of C-RNA's right to procedural fairness on the basis that the hematologist made unfounded assumptions and issued an opinion that was contrary to other expert opinions obtained by C-RNA. However, a review of the record revealed that Health Canada had considered all of the expert opinions and had provided reasons for rejecting C-RNA's evidence. Thus, the FCA concluded that C-RNA's arguments to breach of procedural fairness had no merit.

In the course of the review by Health Canada, it was suggested to C-RNA that it could explore whether the product could be sold under a discretionary 'professional use' option. This option would allow for the product to be made available to consumers through a health care professional. Through this option, safety data could potentially be generated to support ultimately moving the product to over-the-counter distribution. After further consideration, Health Canada determined that this was not a viable option for Boluoke. While C-RNA asserted that it had been misled by Health Canada's proposal, and that it had a legitimate expectation that its approval would follow this route, the Federal Court found no evidence for this assertion. Rather, the Federal Court found that Health Canada had genuinely considered the option. The FCA agreed and held that C-RNA's argument that it had a legitimate expectation that this route would lead to licencing of Boluoke had no merit.

Conclusion

Provided that Health Canada's refusal to approve a health product is rationally supported by scientific assessments and regulatory criteria, the courts will defer to Health Canada in its risk-benefit analysis and decision on licencing. Applicants that are not satisfied with Health Canada's review of an application can take advantage of reconsideration mechanisms under applicable legislation and policies, and Health Canada may be open to alternative pathways for marketing authorization. However, it is clear that Health Canada is entitled to engage its own experts to guide its regulatory assessments and there is no obligation on Health Canada to approve a product even where some evidence of safety and efficacy is provided by an applicant.