Here we go again. After the SNC-Lavalin and WE Charity scandals, Prime Minister Justin Trudeau’s government is now being accused of inappropriately seeking to influence the decisions of the quasi-judicial body that oversees brand-name drug prices in Canada.
At issue is whether Health Minister Jean-Yves Duclos sought to “interfere” in the proceedings of the Patented Medicine Prices Review Board last year when he sent a letter to the PMPRB asking it to halt consultations on proposed new enforcement guidelines that had the pharmaceutical industry and patient groups up in arms. Within days of the letter being sent, the PMPRB put the new guidelines on hold indefinitely.
Dalhousie University associate professor Matthew Herder, who resigned from the PMPRB in February, this week told the House of Commons health committee that Mr. Duclos’ letter amounted to “an arrow straight to the heart of the board’s independence,” adding: “Industry now knows that it can bypass the PMPRB when it isn’t satisfied with the board’s policy direction and get the minister to do its bidding.”
This is an astonishing and frankly odd allegation considering the Trudeau government’s antagonist relationship with the patented drug industry since coming to power in 2015. Under Mr. Duclos’ predecessor, Jane Philpott, the Liberals announced sweeping reforms to the way it regulates patented medicines and gave free rein to the PMPRB to implement them. The move aimed to reduce the sticker shock of the national pharmacare program that the Liberals had promised voters.
The Quebec Court of Appeal struck down key elements of the plan as unconstitutional, concluding they amounted to a vast overreach by the PMPRB. As a result, Mr. Duclos last year announced the government would proceed with only one aspect of the reforms, changing the list of reference countries the PMPRB uses to determine whether prices for new prescription drugs introduced in Canada are “excessive.”
Under its executive director, Douglas Clark, the PMPRB then drew up new guidelines outlining the criteria it would use to decide whether to launch an investigation into excessive pricing by brand-name drug manufacturers. It opened a two-month public consultation period, during which a majority of stakeholders decried the guidelines as a PMPRB power grab that would sow more confusion, result in more litigation and stall the introduction of new drugs in Canada.
“The uncertainty that the previous PMPRB guidelines created in the Canadian pharmaceutical environment directly and negatively impacted access to game-changing therapy Trikafta, the single greatest innovation in the history of cystic fibrosis,” Cystic Fibrosis Canada said of the Vertex Pharmaceuticals treatment that has transformed the lives of CF sufferers. “The new proposed guidelines grant significant powers to staff to assess drug prices and to commence investigations, leading to greater uncertainty, but there has been no assessment of how such an approach may impact access.”
Innovative Medicines Canada, the lobby group representing the brand-name drug industry, warned the proposed guidelines would “inappropriately empower PMPRB staff to develop product specific pricing policies in an untransparent manner, while preventing [patent] rights holders from determining likely compliance requirements in advance of making decisions for a given patented medicine such as whether or not to launch a patented medicine in Canada.”
In December, the PMPRB’s acting chairperson, University of Sherbrooke law professor Mélanie Bourassa Forcier, resigned, saying she was worried the board had “not adequately fulfilled our duty to consult as prescribed by the law.” Last week, she told the health committee she feared the new guidelines represented “a legal risk” for the board by attempting “to do indirectly what it was not possible to do directly.”
Indeed, the new guidelines were bound to end up in court as industry and patient groups accused the PMPRB of again overstepping its authority. Under the Patent Act, Ottawa’s role is to prevent the abuse of monopoly power by patent holders. But it does not have broad authority to regulate drug prices, as the guidelines suggested.
That is the crux of the issue, not whether Mr. Duclos crossed the line by asking the PMPRB to slow down. There is a big difference between a minister intervening in a PMPRB investigation, which Mr. Duclos did not do, and expressing his opinion on a policy matter, which he did.
The bottom line is that the PMPRB is a mess. It has become largely dysfunctional and is deeply distrusted by the industry and patient groups. In February, Mr. Duclos appointed a new chairperson, intellectual property lawyer Thomas Digby, in the hopes of rebuilding a semblance of trust.
The departures of Mr. Herder and Mr. Clark, who is stepping down in June, provide Ottawa with the opportunity to further renew the PMPRB’s leadership so that it can pursue afresh its true mandate as a neutral adjudicator on brand-name drug prices.