Pharmaceutical companies will no longer be allowed to pay fees to Canadian doctors for overseeing intravenous infusions of their medications under a revised ethical code written by the industry group for brand-name drug makers.
Innovative Medicines Canada, which represents the Canadian branches of more than 40 drug companies, recently unveiled an updated Code of Ethical Practices that prohibits members from making direct or indirect payments to prescribing physicians for services provided to their own patients.
Among the types of payments that IMC aims to ban are the per-infusion fees that The Globe and Mail uncovered in an investigation last year of Canada’s most lucrative drug, a biological treatment for rheumatoid arthritis and Crohn’s disease called Remicade.
The Globe found that Remicade-maker Janssen Inc. and rival Pfizer Inc., which makes a product that competes with Remicade, were paying doctors $275 for every IV infusion performed inside their offices – a practice that some pharmaceutical policy experts derided as an inappropriate financial incentive to prescribe those drugs.
If physicians prescribed alternatives to Remicade that were swallowed or injected, they would not receive the payments.
At the time The Globe published its stories, Janssen and Pfizer defended the per-infusion payments, saying they were necessary for physicians to cover the cost of administering an IV drug.
IMC’s old code, previously updated in 2014, did not explicitly prohibit drug companies from paying such fees.
Most of the new code takes effect Jan. 1. The changes related to patient support programs and medical practice activities – the sections of the code that govern infusion fees – are scheduled to take effect July 1, 2020.
The revised code also clarifies that drug makers should not hold business meetings in places where the location itself would be the main draw for attendees, and adds new rules for ethical funding partnerships.
“We wanted to make sure that we are mitigating the potential perception of a conflict of interest,” said Lama Abi Khaled, an executive director who oversees ethical, legal and regulatory matters for IMC.
IMC’s Code of Ethical Practices is an example of an industry trying to police itself through voluntary compliance, an approach that some experts warn is not as effective at stamping out conflicts of interest in medicine as government regulation.
But Ottawa and the provinces have shied away from passing laws that would govern financial dealings between pharmaceutical companies and doctors.
“I guess there is an assumption that physicians are going to make clinical decisions based on what’s best for the patient," said Nav Persaud, a family doctor and associate professor at the University of Toronto, who holds a Canada Research Chair in health justice.
“I think, to a large extent, governments and other authorities have ignored the reality that doctors are human beings who can be influenced.”
Matthew Herder, director of the Health Law Institute at Dalhousie University, said Innovative Medicines Canada should be lauded for trying to raise the ethical bar within the pharmaceutical industry.
“But it remains to be seen how this is actually going to play out in practice,” he said. “The challenge is that we often have a hard time figuring out what their record really looks like. We can’t often see what’s happening internally to police compliance with their code of ethics.”
IMC has an Industry Practices Review Committee that adjudicates alleged breaches of the code, but the committee rarely finds fault. Since 2010, the committee has dealt with 11 complaints – most of them levelled by rival companies – and identified ethical breaches just twice, according to case summaries posted on IMC’s website.
As well, IMC membership is voluntary; if pharmaceutical companies don’t want to follow IMC’s rules, they don’t have to join IMC.
However, both Janssen and Pfizer say they intend to comply with the industry organization’s new ethical standards.
Pfizer currently pays fees to doctors for in-office infusions of Inflectra, a biosimilar version of Remicade.
Biosimilars are almost like generics: They are cheaper near-copies of biologic drugs whose patents have expired. However, biologics, unlike simple chemical pills, are complex drugs grown in living organisms that can’t be replicated perfectly from batch to batch, even within the same brand.
Health Canada says biosimilars are as safe and effective as the original biologics they mimic.
Most of the 175 sites across Canada where Inflectra is delivered are private infusion clinics run by a third-party company called Innomar, Pfizer spokeswoman Christina Antoniou said. The rest of the sites – approximately 40 in total – are inside doctors’ offices, and that’s where infusion fees are being paid to prescribing physicians.
Ms. Antoniou said Pfizer intends to work with stakeholders to make a smooth transition away from paying those fees by next summer.
Jennifer McCormack, a spokeswoman for Janssen, a unit of Johnson & Johnson, declined to answer detailed questions, except to say: “As a member of Innovative Medicines Canada, we are very supportive of the updates to the Code of Ethical Practices.”