This past week has witnessed multiple stories about political interference in the operation of the Patented Medicine Prices Review Board (PMPRB), the federal agency that sets a maximum introductory price for new patented medicines and then keeps increases in those prices to the rate of inflation or below.
Since 2017, the PMPRB has been in the process of trying to introduce changes to how it operates in an attempt to lower drug prices in Canada, which currently sit as the third highest in the Organization for Economic Cooperation and Development.
Initially, the federal government announced that these changes would lower how much Canada was going to spend by $13 billion over a 10-year period. But those proposed changes got whittled back because of court decisions that the government declined to appeal and then suspended and possibly killed, as The Breach reports, by alleged interference from Minister of Health Jean-Yves Duclos. Before he intervened, Duclos’ aides had been heavily lobbied for weeks by the pharmaceutical industry.
The Breach article was just the beginning of the story about how much the federal government has allied with the industry to stymie any progressive changes at the PMPRB. The next day came news that a member of the board of the agency had quit. In a scathing letter to Duclos, Matthew Herder said that the federal government has “fundamentally undermined the board’s independence and credibility.”
One day further on, the executive director of the PMPRB resigned. While Douglas Clark didn’t give any reasons for leaving, it’s hard not to imagine that it wasn’t linked to the appointment of Thomas Digby as the new chair of the PMPRB a few weeks previously. In the Health Canada announcement about the appointment, Digby was identified as someone with 25 years of experience working with the pharmaceutical sector.
To people familiar with the history of the pharmaceutical industry in Canada, news of the close cooperation between the federal government and the industry wouldn’t have come as any surprise.
In 1950, at a 75th year celebration of the implementation of first federal legislation dealing with drugs, the Minister of National Health and Welfare expressed the department’s appreciation to the industries affected by the Food and Drugs Act for their support in making the act successful. The publication celebrating the event had a cartoon of two men, representing the Food & Drugs Act and industry, using a crosscut saw to cut through a piece of wood with the heading “75 years of successful industry-gov’t co-operation”.
After thalidomide was ordered off the market, a number of doctors wrote to the government protesting the move. In reply to one such letter, Dr. C.A. Morrell, head of the Food and Drugs Directorate responded: “I think if the medical profession would take a stand…that there is every possibility that thalidomide could indeed be reinstated on the Canadian market and to this end I would encourage you to urge strongly your colleagues to express themselves to us on this question”. After Morrell left the government in 1965, he joined the board of Ciba-Geigy (now part of Novartis).
As Health Minister, Judy LaMarsh delivered the welcoming address at the 1964 5th Annual General Meeting of the Pharmaceutical Manufacturers Association of Canada (PMAC) and warmly applauded the government-industry relationship. During her speech, she noted that the “task [of the Director of the Food and Drugs Directorate] would be immeasurably more difficult if he did not have access to the combined knowledge of the industry and receive its support.”
Even Monique Bégin, famous for bringing in the Canada Health Act, which cemented medicare as a core part of Canadian identity, was friendly to industry. She did not believe that Canada needed detailed regulations to control the drug approval process. In her view, “the players” involved in getting a drug onto the market—federal officials, drug manufacturers and physicians conducting clinical trials—should “be forced to continue to use their heads and judgment” in carrying out the guidelines.
One of the more illustrative examples of industry-government cooperation and how that cooperation could lead to an abrogation of public safety on the part of Health Canada, comes from an analysis of how its veterinary division dealt with Revalor-H, a growth hormone given to cattle.
Dr. Donald Landry, acting chief of the Veterinary Drugs Bureau, outlined a promise to Dr. Murray Jelinski, manager of product development with Hoechst Canada Inc., to “make up for the rough time he's had with Revalor-H when we review his next submission.” Jelinski went over the head of the reviewer and directly asked the director-general of Health Canada's Food Directorate to intervene, as the delay in getting the drug to the market cost Hoechst more than $1 million.
When Judy Erola left politics in 1984 after serving as the federal Minister of Consumer and Corporate Affairs, she went straight into the arms of the pharmaceutical industry and became the president of PMAC.
In 1991 this intermingling of government and industry officials was taken one step further. The hiring committee for a new person to head the Bureau of Non-Prescription Drugs consisted of a staffing officer in the Public Service Commission, the director general of the Drugs Directorate and Judy Erola. The official position from Health Canada was that PMAC dealt mostly with prescription drugs and as the person being hired oversaw the body dealing with non-prescription drugs there was no conflict of interest with including Erola on the hiring committee.
From late 2010 to early 2011, Health Canada organized a series of public consultations to discuss the technical details of what it called regulatory modernization, which many saw as another manifestation of deregulation.
The way that the meetings were structured reflected the nature of the relationship among Health Canada, industry and the public. I was at one of these meetings. Officials from Health Canada sat at one long table facing another table with industry representatives. In the audience, off to the side, were people from professional organizations, consumer and patient groups—many partially funded by industry, and academics. First, Health Canada would put forward proposals, then industry would respond and only last would the people in the audience be able to ask questions or offer comments.
The medical research agenda has not escaped entanglement with the pharmaceutical industry.
In late 2009, the federal minister of health announced the appointment of Dr Bernard Prigent, vice-president of medical affairs for Pfizer Canada, to the governing council of the Canadian Institutes of Health Research. Prigent was one of “the senior officers of Pfizer who are registered as lobbyists with the Office of the Commissioner of Lobbying of Canada, and CIHR is listed as one of the targets of Pfizer’s lobbying activities.”
A more recent example of how the government has not only ignored conflict of interest (COI) in its appointments but actively embraced it is in how the COVID-19 Vaccine Task Force was structured. The task force was set up early in the pandemic, in June 2020. The government took the position that COI didn’t matter because it had “a robust process in place to manage potential conflicts of interests.”
The result was a committee of 13 members, 12 of whom had a COI with one or more pharmaceutical companies. Since the minutes of the task force meetings were never made public, we have no idea how or whether COI may have affected decisions.
With that little bit of history, we can turn back to recent events at the PMPRB and recognize that what we have been seeing is not an aberration; it’s just a continuation of a long historical relationship.
But this is not a benign relationship.
Just as previous interactions between government and industry have had negative effects on how drugs are regulated, the gutting of the proposed changes to the PMPRB will ensure that drugs remain overpriced and out of reach of the many Canadians, especially those who have to pay out-of-pocket for their medications.
Finally, by keeping drug prices high it makes a universal pharmacare plan with first dollar coverage that much less likely. The drug companies are laughing all the way to the bank.
