Saturday, June 03, 2023

Health minister's request triggered internal meltdown at Canada's drug-price regulator, documents show

Story by Catherine Lévesque • National Post

Federal Health Minister Jean-Yves Duclos in March 2023.

OTTAWA – Relations between senior leaders at the Patented Medicine Prices Review Board (PMPRB) descended into bitter acrimony last fall, documents show, as federal Health Minister Jean-Yves Duclos tried to get the board to pause its work to reformulate how patented drug prices are determined.

The House of Commons committee on health, which is studying the havoc that unfolded at the board over the last several months, culminating in the resignations of several of the board’s senior leaders, released more than 350 pages of private internal correspondence this week about the events leading up to the turmoil.

The emails, text messages and letters provide a picture of building resentment and frustration among board members, and toward Health Canada, in the days and weeks before the resignation of PMPRB acting chairperson Melanie Bourassa Forcier in December 2022. Forcier’s resignation was followed in February by board member Matthew Herder quitting, accusing the government of undermining the board’s “independence and credibility.” Days later, PMPRB executive director, Douglas Clark, resigned.

In late 2022, the PMPRB was in the midst of consultations on new guidelines for drug prices in Canada, having been tasked by then health minister Ginette Petitpas Taylor in 2019 to stem “ excessive prices” on patented medicines, as a means to “lay the foundation for national pharmacare.” The PMPRB is a quasi-judicial government agency tasked with reviewing and reporting on drug prices to Parliament, through the minister of health.

The correspondence leading up to Forcier’s resignation reveal that multiple attempts by PMPRB members in the fall of 2022 to brief Duclos on the state of the guideline consultations went unanswered or were stonewalled.

Duclos finally broke his silence in a November letter to ask the board to “consider pausing the consultation process” to work “collaboratively” with stakeholders on the proposed changes. That apparently drove a wedge between Forcier, who was willing to agree to the minister’s request, and other PMRB leaders who wanted to let the consultation process run its course, and had grown to mistrust Duclos’ motives.


The situation culminated in Clark, the executive director, accusing Forcier in an email sent on Dec. 3, 2022 of legitimizing “false allegations” by the pharmaceutical industry, and throwing board members and staff “to the wolves.”


The proposed changes to price policy that the PMPRB was consulting on included rejigging the list of countries it compares Canadian drug prices to, introducing new economic factors to determine whether a price is deemed “excessive,” and requiring drug manufacturers to report “confidential rebates” to third parties, such as public or private insurers.


The last two elements were deemed unconstitutional by the Quebec Court of Appeal last year, following court challenges from the pharmaceutical industry, and the federal government opted to not appeal the decision before the Supreme Court of Canada.

The PMPRB went ahead with drawing up a new list of comparative countries last year, but the board’s work has raised concerns that the PMPRB is overstepping its role, and that the new formulas could lead pharmaceutical companies to determine some new medicines aren’t worth offering in Canada, leaving patients without access to them.

The PMPRB still had to consult on its proposed new guidelines regarding the administration of the price review process last fall.

Duclos told the House of Commons health committee last month that he had never received a formal request for a meeting from the board, nor did he seek to obtain one, in order to keep the PMPRB at arm’s length from his ministry.

But the communications released this week show Clark was eager to meet with Duclos’ office. He contacted the minister’s chief of staff, Jamie Kippen, on Nov. 9, 2022 to offer him a briefing on the new guidelines, but never heard back. He twice called the office of the minister’s senior director of policy, Jean-Sebastien Bock, on Nov. 17, 2022. The first time he called that day, the receptionist told him Bock would call him back, and the second time Clark recorded that Bock simply declined to take his call.


“The receptionist advised me that Mr. Bock wished to know the reason for my call. I responded, ‘the PMPRB Guidelines’. She advised me Mr. Bock would not take my call,” read Clark’s notes from that day.

Clark then texted Kippen on Nov. 18, again suggesting a meeting. He followed up with an email to Kippen, offering again to meet, on Nov. 21.

Text messages show that Forcier had also asked the director of the board secretariat, Sherri Wilson, several times in November to secure a meeting with the minister. Wilson said on Nov. 29, 2022 that she was “unsure how to make it happen,” given that typically such requests go through the deputy minister’s office.

On Nov. 28, 2022, Duclos wrote a letter to Forcier noting that “many stakeholders,” including the pharmaceutical industry and provinces and territories, “have raised concerns and questions associated with the new Guidelines” and asking the board to “consider pausing the consultation process, so as to allow time to work collaboratively, with all stakeholders, to understand fully the short and long-term impacts of the proposed new Guidelines.”

Forcier wrote in notes submitted to the committee that the minister’s request was seen by Clark and PMPRB board members as “potential interference with the board’s independence” but she, as acting chairperson, did not see it that way.

Forcier eventually secured a meeting with the deputy health minister, Stephen Lucas, on Nov. 30. Text messages show that she was already considering suspending the consultations on the guidelines as per the minister’s request. She told Clark the reason was because she did not want to “cause a crisis.”

“We’re already in a crisis,” replied Clark.

During Forcier’s meeting with Lucas, she and Forcier were exchanging texts . When she said she had mentioned to Lucas that she was open to pausing consultations, Clark texted her: “I think you want to stop there.”

The next day, Clark told her in an email that he knows she wants to “get in the good graces” of the minister, but charged that any commitments she made to Lucas were “inappropriate” and “should never have been made before meeting with the Board”.

Clark was also convinced, based on things he had heard, that Duclos had no intention of meeting with Forcier, and in fact wanted to be rid of the PMPRB board members and was hoping they would resign.

“Nothing about what is happening right now is personal. It’s one hundred percent political, which is why it is especially problematic that the Minister is ‘asking’ us to suspend our consultations,” wrote Clark in an email to Forcier.

The PMPRB board — composed of Forcier, Matthew Herder, Carolyn Kobernick and Dr. Ingrid Sketris — convened later in the day after Forcier had her meeting with the deputy health minister. (Clark, as executive director, was not on the board)

Emails show they planned to let the consultation process run its course by Dec. 5 ,as planned, and reconvene later in mid-December to reconsider the minister’s request for a “pause.”

On Dec. 1, 2022, Forcier let board members know by email she could not support that decision.

“If this is the case, unfortunately, I will not support it. I will inform the Minister and, necessarily, I will have to think about my place within the Board because it is essential for me, in the development of public policies, to take the time to listen and to consider the actors,” she wrote.

Forcier then informed the board on Dec. 2, 2022 she would take it upon herself as acting chairperson to suspend the consultation period, to which Herder replied that the decision to suspend had to be made by the board as a group.

Herder wrote in a separate email to the two other board members later that day that he had lost “complete confidence” in Forcier and said he would be open to having a discussion about “the possibility of resigning (whether individually or together).”

The following day, on Dec. 3, 2022, Forcier said she would consider seeking an independent, outside legal opinion on whether she as acting chair had the authority to make the decision to pause consultations on guidelines.

“For several years now, the PMPRB has come up with reforms that resulted in extremely costly litigation. We lost several of these cases. I don’t want any more litigation,” Forcier argued. “I don’t understand why the members have such a problem with extending the consultation period.”

Clark’s email response was virulent. He told Forcier she had “no grounds” to seek outside legal advise, dismissed her concerns about litigation, and accused her of failing the board and consumers.

“I have never seen the head of an organization demonstrate such a lack of judgment and engage in such questionable ethical behaviour in so short a time,” Clark wrote.

Forcier shot back in another email that she was facing “insubordination and attacks on (her) reputation,” that her words were “being twisted,” that she was being “smeared,” and hinted she might be taking legal action against Clark for defamation.

“At first I thought it was your lack of understanding of French but then reading your email I realize that this is a clear attempt to portray me as a Chairperson without integrity,” she wrote.

“Never did I harm you personally and what you are doing in your email has me looking into what needs to be done to stop the harm to my reputation and defamation.”

Clark answered that all of their communications on this matter had been internal, not public “and therefore cannot possibly constitute defamation”.

Forcier reiterated she would still indicate her dissent of the board’s decision. “I note that the staff does not wish to positively respond to my request for an external and independent legal advice. Thank you for this answer. It is noted,” she wrote in an email on Dec. 4, 2022.

Forcier ended up resigning as PMPRB acting chairperson and board member on Dec. 5, 2022. Her departure forced the board to pause consultations on the guidelines.

“For a variety of reasons, I realize that I will not be the person to carry this organization forward. I am hopeful that the next Chairperson will be appointed in the near future and that they will be successful in carrying out their mandate,” she wrote in a letter sent to the clerk of the Privy Council.

On Feb. 1, Duclos announced he had appointed a new chairperson, Thomas J. Digby, an attorney with over 25 years experience in pharmaceutical patent law.

Clark and Herder both resigned from their positions later that same month. In his resignation letter, Herder denounced the Liberal government for failing to defend its own drug-pricing reform plan.

“In the absence of the political courage to support meaningful policy reform, the position of the PMPRB has become untenable,” Herder wrote.

Clark has assumed a new role as a special adviser to the board, and the PMRB said in a statement he is transitioning to retirement from the federal public service.

National Post

clevesque@postmedia.com

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