I suspect that I won't follow Professor Herder's example in that regard. I may need a little more time.
Good morning.
Thank you for the invitation to appear before the committee today.
I have been the executive director of the Patented Medicine Prices Review Board, or PMPRB, since 2013, including during the latest consultation on new guidelines that took place last fall. However, I am currently on leave from the PMPRB and will be formally stepping down as executive director on June 1.
Any facts I cite in my opening remarks or in my ensuing answers to your questions can be corroborated by either the relevant documentary record, which I understand the committee is seeking to obtain or by remaining members of the board who were involved in last fall's consultation, the management team at the PMPRB, and of course Professor Herder who is with me today. I will try my best to limit my remarks to those facts and to keep any expressions of opinion to a minimum.
I want to first address the confusion from last week's testimony around the protocol for briefing the minister and who dialogues with whom between the PMPRB and Health Canada. Before doing so, I should point out that the PMPRB chairperson position is a part-time appointment and has always been occupied by persons residing outside of the National Capital Region and who juggle multiple other professional responsibilities. As such, in order for the PMPRB to operate effectively day to day, the executive director is often called upon to exercise functions that, based on a pedantic interpretation of the PMPRB's org chart and reporting structure, would normally fall to the chairperson.
Accordingly, with the exception of the current minister, I have personally briefed every minister of Health on guidelines reform as far back as Minister Ambrose under the previous government, either on behalf of the chairperson or together. Some of these ministers I have briefed on this topic multiple times. To the best of my recollection, every such briefing was initiated and arranged by the deputy minister's office, often at the behest of the minister's office.
In addition, as Mr. Bélair indicated in his testimony last Thursday, it is routine for meetings to take place at the working level between PMPRB staff and Health Canada officials. Insofar as last fall's guidelines consultation is concerned, PMPRB policy staff met with and briefed their Health Canada counterparts a total of seven times between early October and late November. At no time over the course of those consultations did Health Canada officials express concern about the proposed guidelines. On the contrary, the feedback we got from them was consistently supportive and that our policy approach was sound.
While it's perfectly fair to describe the guidelines proposed last fall as a departure from the status quo, their content was informed by recent developments in our operating environment and based on the best advice of our policy and legal experts. It was also endorsed by our board, the members of which are appointed based on career-long knowledge and expertise in subject areas relevant to our mandate.
Although the initial reaction from stakeholders was muted, it did not take long for anti-PMPRB rhetoric from industry to ramp up along recent lines.
On November 10, IMC—Innovative Medicines Canada—issued a news release calling on Health Canada to direct the PMPRB to suspend its consultations, failing which “Canadian patients will be deprived of potentially life-saving new medicines.” On November 22, IMC issued another news release claiming that the PMPRB was “misleading” Canadians because the findings in our latest annual report about domestic R and D did not agree with the report IMC commissioned from StatsCan. This is the same annual report that the PMPRB has published every year for the past 35 years, which is bound by a legislative definition of R and D set by Parliament and the Minister of Health.
Despite assurances from Health Canada officials about the proposed guidelines, the acting chairperson became increasingly concerned that no briefing with the minister had been scheduled, and industry reaction to them had me sharing that concern. She directed me and one of my senior staff to seek out such a briefing. She also instructed me to push back on industry claims in my meeting with them.
As a result, I personally made multiple overtures to the minister's chief of staff and senior policy adviser via texts, emails and phone calls. The chief of staff told me he would get back to me on my offer of a briefing, which he never did, and the senior policy adviser refused to take or return my calls.
Again, in my 10 years as executive director, under all previous ministers I would routinely speak or meet with members of her staff to discuss matters of overlapping concern, as authorized by the chairperson, and most such meetings were initiated by staff, not me.
On November 22, I and several other senior PMPRB staff met in person with IMC and approximately 20 industry representatives to discuss the proposed guidelines. At the end of that meeting, I urged those present to cease calling for a suspension of the consultations. I explained to them that under the act, the board was the master of its consultations on changes to its guidelines and that it was highly inappropriate for them to be calling for such an intervention on the part of Health Canada or any other third party.
A colleague and I met virtually with the acting chair later that same day. She was pleased to learn of my having passed that message along on behalf of the board.
Nevertheless, as you know, on November 28 the minister wrote to the acting chairperson to request precisely what the industry had called for in its November 10 news release. To say that I was surprised by that letter would be an understatement. Its content was of grave concern to me and my senior staff and our general counsel.
As you know, the acting chairperson responded to the minister in a letter dated November 30, in which she expressed her own surprise at learning of the minister's concerns. She also drew his attention to the fact that consulting on changes to the guidelines is a legislative function that goes to the heart of the board's expertise and independence.
In closing, I would like to try to put these recent events in their broader context.
The PMPRB is a microagency of fewer than 80 people that regulates a market of about 1,300 products that account for about $20 billion in annual sales in Canada. It has no legal obligation to issue guidelines—only to consult if it does so—and any guidelines it chooses to issue are not binding on anyone. They have no force of law. The only binding authority the board has in relation to pricing is to make a determination, following a public hearing, that a patented medicine has been priced excessively.
Thank you.
I will be pleased to answer any questions you may have.
