Competition Bureau concludes investigation into alleged restrictions on off-label use

From: Competition Bureau Canada

The Competition Bureau announced today that it is closing its investigation into competition concerns related to the supply of vaccines for a provincial public immunization program.

The Bureau began its investigation in response to an allegation that a vaccine manufacturer was trying to restrict off-label use of its product by public health authorities through a provision in a procurement contract. The alleged conduct could have resulted in higher costs to the province by potentially preventing public health authorities from using competing products in their immunization programs.

Ultimately, the Bureau concluded that there was no contravention of the Competition Act at this time given that the alleged conduct did not materialize.

Nonetheless, the Bureau is very mindful of the importance of competition in the pharmaceutical industry. It is the Bureau’s view that this type of conduct may raise serious concerns under the abuse of dominance provisions of the Act in certain circumstances.

Accordingly, the Bureau has published a position statement regarding this type of conduct to provide guidance to the pharmaceutical industry.

Quick facts

  • Off-label use includes any use of a vaccine or drug that is not set out in the Product Monograph. The Product Monograph describes the properties, claims, indications and conditions for optimal, safe and effective use of the drug.

  • In Canada, only the manufacturer can apply to modify the Product Monograph to include additional uses. A manufacturer may decide not to update a Product Monograph to include an off-label use even where evidence supporting such use becomes available following initial approval.

  • Off-label use can and does occur in the administration and delivery of health care by public health authorities.

  • Competition can be an important factor in the administration of vaccination programs as provinces may seek to lower their costs by leveraging competing products.

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