OTTAWA, Dec. 20, 2018 /CNW/ - 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.
For more information on the Bureau's investigation and findings, including guidance for participants in the pharmaceutical industry, please consult our comprehensive position statement.
"When businesses set up roadblocks to prevent competitors from getting their products to market, the Bureau takes notice. In the pharmaceutical industry, this is critical because competition ultimately leads to more affordable drugs for Canadians. The Bureau will remain vigilant and pursue any allegations of conduct that may harm competition in this industry."
Matthew Boswell, Interim Commissioner of Competition
- Generic drugs are therapeutically equivalent to branded drugs, meaning they have nearly identical properties and similar effects.
- Generic drugs are less expensive than branded drugs because they rely on clinical testing conducted on a branded drug to prove it was safe and effective.
- Drugs are expected to account for 15.7% (nearly $40 billion) of total health care spending in Canada in 2018.
- Over the course of its investigation, the Bureau gathered information from numerous third-parties, including key private and public stakeholders in the pharmaceutical industry, as well as information directly from Pfizer, Sanofi and Celgene pursuant to a court order.
- Competition Bureau Statement Regarding Its Investigation into alleged practices of Celgene, Pfizer and Sanofi
- Guidance to the pharmaceutical industry
The Competition Bureau, as an independent law enforcement agency, ensures that Canadian businesses and consumers prosper in a competitive and innovative marketplace.
SOURCE Competition Bureau
For further information: For media enquiries, please contact: Media Relations, Telephone: 819-994-5945, Email: [email protected]; For general enquiries, please contact: Information Centre Competition Bureau, Telephone: 819-997-4282, Toll free: 1-800-348-5358, TTY (hearing impaired): 1-866-694-8389