Blacklocks Reporter: Feds Probe Pharma Practices

Federal Competition Act investigators seek confidential records held by one of the country’s largest brand name pharmaceutical companies, Sanofi Canada Inc. The Competition Bureau detailed allegations in a Federal Court affidavit.

“If it’s true, and the allegations suggest at least one brand pharmaceutical company is trying to frustrate the process Canada employs to get generics to market, that’s unacceptable,” said MP Don Davies (Vancouver Kingsway), New Democrat Health Critic. “That would drive prices up.”

Sanofi did not comment. In company emails disclosed in Court documents, Sanofi said data on brand name products “was highly valuable and generated at considerable cost and effort by the innovators.”

The Bureau disclosed it launched its investigation last November 17 on complaints an unnamed wholesaler distributing Sanofi drugs refused to provide samples to manufacturers of low-cost generic medicines. “Sanofi-Aventis Canada Inc. has market power,” the Bureau wrote the Court.

The Bureau in an affidavit by investigator Daniel Jensen spelled out allegations against the company.

“In order to market a generic equivalent to a branded pharmaceutical product in Canada, it is necessary to obtain marketing approval from the Minister of Health,” Jensen wrote. “Generic manufacturers typically establish their generic equivalents are safe and effective by submitting testing to the Minister of Health demonstrating the generic equivalent is a bio-equivalent to the branded drug, instead of duplicating the initial testing the branded manufacturer conducted to obtain approval for the branded drug.”

Without access to drug samples, “a generic manufacturer’s ability to seek marketing approval from the Minister of Health for its generic equivalent is generally prevented or impeded,” said the affidavit.

The Bureau said it identified at least 20 cases in which access to samples was denied or restricted. “I am aware of Sanofi denying access to one of its drugs to a company that specializes in procuring pharmaceuticals for the purpose of clinical trials, including generic manufacturers,” wrote Investigator Jensen. “Sanofi’s stated position is that it may only supply the drug to licensed pharmacies.”

The Bureau seeks a Court order compelling Sanofi to disclose confidential records dating from 2014 on sales and marketing, and “all records relating to any policy, practice or incentive of Sanofi that limits or restricts the sale of specified drugs by a distributor.”

The allegations are unproven. Sanofi in emails to the Bureau expressed a willingness to cooperate with the investigation.

“We all have a great interest in ensuring the system achieves the right balance between encouraging research and innovation by brand name companies, while at the same time allowing cheaper generic drugs to come to market as soon as is reasonably possible,” said MP Davies. “On one hand it’s reassuring the government is policing this; on the other hand, it’s disturbing there’s a possibility that companies are engaging in this kind of behaviour.”

Read more posts about: ,