Probe ends into drug makers accused of stifling competition by generics

The Competition Bureau has ended its investigation into three name brand drug companies that are accused of hampering their generic rivals by restricting access to samples of their patented drugs needed for testing. The bureau concluded Celgene, Pfizer and Sanofi did not contravene the Competition Act.

Competition Bureau closes investigation with no charges despite evidence of anti-competitive tactics

Tablets move along the production line at a pharmaceutical plant of Indian drug giant Lupin. The company has entered the generics market in North America. (Danish Siddiqui/Reuters)

The Competition Bureau has ended its two-year investigation that pitted the generic drug industry against three big pharmaceutical companies with no charges against Celgene, Pfizer Canada, or Sanofi-Aventis Canada, despite finding some evidence of anti-competitive tactics.

The complaint brought to the Competition Bureau in 2016 stems from delays generic drug makers said they faced when they prepared to get cheaper versions of patented medicines to market. 

These generic versions are on average 85 per cent lower in price than the original patent-protected drugs.

To prove to Health Canada that their discount version of the drug works the same as the patented one, generic makers need access to samples of those brand name drugs.

Generic drug companies have alleged patent holders delay or block access to samples of their prescription drugs to stall the cheaper alternatives and maintain their monopoly.

In a statement, the bureau wrote "generic drug manufacturers play an important role in keeping health costs down," so it's concerned when a "manufacturer faces avoidable setbacks in bring their drugs to market."

But after its investigation, which included a court order to gather information from Celgene, Pfizer and Sanofi, the bureau ruled there was not enough evidence to pursue charges against the companies under the Competition Act.

Restricted access to pricey cancer drug

Still, investigators found patent-holder companies did at times create barriers for generic makers, but that they were not "substantial" enough to prevent competition.

In particular, the bureau highlighted how Celgene limited access to Revlimid, an expensive cancer drug which costs more than $300 per capsule. The way the company distributes its drugs through limited channels has "elements" that are "anti-competitive," the bureau wrote.

Despite losing the complaint, the president of the Canadian Generic Pharmaceutical Association, Jim Keon, said the association felt somewhat vindicated by the investigation because, by pursuing court orders, the Competition Bureau had put patented drug makers "on notice."

The association represents generic drug makers such as Apotex, Mylan, Teva and Sandoz.

 "That's why ultimately the public should care," said Keon of the association's allegations against the patented drug makers. "It means higher [drug] costs for longer periods of time."

Patent vs generic battle heats up in U.S.

While Keon said the generic drug industry lobby group won't likely take any further legal action, in the U.S. where average drug prices are the highest in the world, similar complaints have led to court battles.

The U.S. Food and Drug Administration's commissioner, Scott Gottlieb, also entered the fray last year when he accused patented drug makers of "gaming the system" to prevent generic competition.

Keon said any further complaints in Canada can be prevented if the federal government introduces legislation that guarantees access to patented drugs by generics makers that are trying to meet their regulatory requirements.

"The bureau will remain vigilant and pursue any allegations of conduct that may harm competition in this industry," Canada's Interim Commissioner of Competition said in a release.