The Competition Bureau (Bureau) recently conducted a preliminary investigation into possible competition concerns arising from a proposal to include a clause in a procurement contract that would restrict off-label use of a vaccine.  The Bureau concluded that there was no abuse of dominance as the provision was not included in the procurement contract; however, it issued a statement providing guidance on off-label use of vaccinations.

After outlining vaccine approval and reimbursement, and administration of immunization programs in Canada, the statement indicates that, while manufacturers are prohibited from selling or advertising vaccines for off-label use, off-label use can and does occur in the administration and delivery of health care. From the Bureau’s perspective, public health authorities may elect to use a vaccine off-label if it deems it appropriate.

The Bureau has identified the potential for abuse of dominance in certain circumstances, for example where a manufacturer attempts to restrict an off-label use when that use is in conjunction with a competitor’s product.  The Bureau focused on conduct that may hinder a public health authority’s jurisdiction and discretion to administer its immunization programs in a way that would exclude competitors.

The Bureau will look to the underlying intent of the conduct in question when engaging in its analysis. The statement suggests that where the conduct is motivated by legitimate health concerns backed by scientific evidence rather than to exclude current or potential competitors, that the conduct may not contravene the Competition Act. The effect on competitors or potential competitors, and the scientific basis should therefore be considered when contemplating anything that could restrict the off-label use.