After two months of active investigation, the Competition Bureau announced today that it is closing an inquiry after Otsuka Canada Pharmaceutical Inc. addressed its concerns. This is the second time the Bureau has looked into branded pharmaceutical companies’ refusals to supply samples of brand name drugs – also known as Canadian Reference Products (CRPs) – to generic manufacturers.
The Bureau launched this inquiry shortly after receiving a complaint alleging that Otsuka restricted a generic drug manufacturer from accessing samples of its branded product, Jinarc. The complaint alleged that actions by Otsuka prevented or delayed the entry of competing generic drugs to the market.
Shortly after the launch of the investigation and after the Bureau applied to the Federal Court for an order requiring Otsuka to produce information, Otsuka provided a supply of Jinarc to the generic manufacturer, and in doing so, resolved the Bureau’s concerns.
The Bureau remains very concerned that this sort of conduct has persisted despite its previous investigation and guidance to the pharmaceutical industry. Branded drug manufacturers should be aware that the Bureau will treat any explanation for a failure to supply CRPs in a timely manner with an extremely high degree of skepticism. Even if CRPs are eventually supplied after an initial delay, the Bureau will take the necessary steps to address past anti-competitive conduct, including seeking administrative monetary penalties.
Should any generic manufacturers face similar issues in the future, the Bureau encourages them to bring their concerns to the Bureau’s attention early on.
“I remain very concerned that this type of conduct persists despite our previous investigation and guidance we’ve provided to industry. We will keep a very close eye on this sector and use all the tools at our disposal to take action against companies who would harm competition in this industry, which is vital to the health of thousands of Canadians.”
Commissioner of Competition
The Bureau launched this inquiry on October 11, 2019, a few days after receiving a six-resident application alleging that Otsuka had restricted access to samples of Jinarc.
Jinarc is the only pharmacological therapy approved in Canada for the treatment of autosomal dominant polycystic kidney disease, a genetic disease in which numerous cysts develop in both kidneys, enlarging them and impairing their function.
Without access to CRPs, generic manufacturers cannot conduct bioequivalence testing, and therefore in many cases cannot receive the necessary regulatory approval to market their generic versions.