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Competition Bureau concludes investigation into alleged restrictions of off-label use of vaccines

The Competition Bureau conducted a preliminary investigation into allegations that a vaccine manufacturer was trying to contractually restrict the off-label uses for which a provincial public immunization program could use the vaccine product. 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. In July, the Bureau announced that it was concluding its investigation because the alleged conduct did not materialize. In concluding its investigation, the Bureau published a position statement that identifies and provides guidance on some of the competition issues relevant to off-label use of vaccines and pharmaceutical drugs. In the statement, the Bureau advised that it does not understand the Food and Drugs Act prohibition against selling products in a manner that is false, misleading or deceptive, which may include the promotion of off-label use, as a prohibition of the drug manufacturer from entering into a supply contract with a publically-administered program that may use the product for an off-label use. The Bureau further advised that it would not hesitate to take appropriate action if it was provided with “compelling evidence of harm resulting from a manufacturer imposing restrictions on off-label use or any other conduct that excludes competitors.”

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