December 20, 2018 – OTTAWA, ON – Competition Bureau

The Competition Bureau announced today that it is closing an investigation into allegations of abuse of dominance by certain brand name drug manufacturers including Celgene Inc., Pfizer Canada Inc. and Sanofi-Aventis Canada Inc.

The Bureau investigated policies and practices that were alleged to restrict generic drug manufacturers from accessing samples of brand name drugs, which are also known as Canadian Reference Products (CRPs). Generic drug manufacturers play an important role in keeping health costs down by competing against brand drugs when they lose patent protection. In general, the Bureau is concerned when a generic drug manufacturer faces avoidable setbacks in bringing their drugs to market.

Before a generic drug can enter the market, a generic drug manufacturer must prove that their drugs are safe and effective by submitting testing that demonstrates that the generic drug is bio-equivalent to a branded drug. To complete this testing, they need access to CRPs.

After a careful review of the facts, the Bureau has found that there is insufficient evidence to demonstrate that competition has been substantially lessened or prevented. Therefore, at this time, the Bureau is unable to conclude that the Competition Act has been contravened. However, the evidence gathered through the Bureau's investigation supports the position that generic drug manufacturers, at times, face barriers that impede their access to CRPs. In some cases, these barriers may be due to the actions of brand manufacturers.

While the Bureau has concluded this investigation, this type of alleged conduct may warrant further enforcement or advocacy action in the future. The Bureau will not hesitate to take appropriate action to maintain and promote competition in the pharmaceutical industry.