Alexion: No Blank Cheques Here

In Alexion Pharmaceuticals Inc v Canada (Attorney General), 2021 FCA 157, the Federal Court of Appeal clarified the law of judicial review post-Vavilov (particularly as it applies to reasonableness review) and set out an important reminder: administrators are not a law unto themselves. In order to make sure that this is the case, particularly in situations of legislative interpretation, administrators must explain their decisions. They must do so in a way that engages with the statute under interpretation. In this way, Alexion says something important: when administrators interpret statutes, there is only so much of a margin of appreciation. They must deal with the law.

I first describe the controversy in Alexion and the Court’s holding. Then I outline why this decision is a landmark one for the post-Vavilov world.

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Alexion is a pharmaceutical company that produces a drug called Soliris. The Patented Medicine Prices Review Board had to decide whether Alexion priced Soliris excessively under the Patent Act. The relevant section is s.85 (1), which lists a number of factors that the Board must consider to make a determination. One of the factors is “the prices at which the medicine and other medicines in the same therapeutic class have been sold in countries other than Canada” (s.85(1)(c)). Only after a consideration of these factors can the Board turn its attention (if necessary) to s.85(2), which asks the Board to also consider “the costs of making and marketing the medicine and any other factors it considers relevant.”

As the Court aptly notes, “Section 85 is the law. The Board’s analysis should start with the law. Whatever the Board does must be consistent with the law” (Alexion, at para 34). The Board, in making its excessive pricing decision, noted that it is charged with determining “the relevance and weight of each factor” in s.85 (Alexion, at para 43). The Board concluded that Soliris was priced excessively, largely because it was priced more than the lowest international price in a list of seven comparator countries (Alexion, at para 3).  Put differently, out of all the seven countries, the Board found Soliris to be priced excessively because it was not the cheapest option. This was despite the fact that the Board’s own guidelines suggested that, normally, “the highest international price” is a key comparator (Alexion, at para 57). In reaching this conclusion, the Board seemingly followed a standard of “reasonableness”: because Soliris is price higher than one of the comparator countries, the Board implicitly concluded that the price of Soliris is unreasonable (see Alexion, at para 51).

For the Court, Stratas JA concluded that the Board failed to properly justify its decision with reference to the statute at hand: Alexion, at para 64, 66. The Court made a number of important comments justifying this decision:

  1. Prior to Vavilov, “…the Supreme Court instructed us to do our best to try to sustain the outcomes reached by administrators” which included “reviewing courts [picking] up an administrator’s pen and [writing] supplemental reasons supporting the administrators’ outcomes” (Alexion, at para 8). This “ghostwriting” was, as is evident, “antithetical to the reviewing courts’ role as an independent reviewer” (Alexion, at para 8).
  2. In this sense, there is a clear relationship between reasons and outcome on judicial review (Alexion, at para 28 et seq). While Vavilov speaks of outcome and reasons as separate, there are many cases where the reasoning on a particular legal question will lead to an illegal outcome; for example, in this case, “certain words the Board used suggest that it went beyond its permissible statutory mandate by regulating the reasonableness of pricing, rather than preventing abusive pricing…” (Alexion, at para 11).  In this case, when the Board spoke of “reasonableness” rather than abusive pricing, “[i]t may be that the Board was trying to reach an outcome that on the facts and the law was not reasonably open to it” (Alexion, at para 32).
  3. The failure of explanation in this case arose on a few different fronts:
  • The Board utterly failed to deal with the most important and central restriction on its authority: s.85 of the Patent Act. We  know that in paras 120-122 of Vavilov the Court notes that “the merits of an administrative decision maker’s interpretation of a statutory provision must be consistent with the text, context and purpose of the provision,” and that the decision-maker must demonstrate that its alive to these “essential elements.” This is because “the governing statutory scheme is likely to be the most salient aspect of the legal context relevant to a particular decision” (Vavilov, at para 108). So when the Board adopted a standard of reasonableness rather than addressing the actual point of the statute—set out in s.85 and the associated case law—it transgressed its authority.
  • The Board’s failure to explain its departure from its own Guidelines was problematic from a reasonableness perspective. While Guidelines adopted by the Board cannot supercede an analysis based on s.85 itself, they can validly guide discretion. Here, the Board did not explain why it did not follow its own Guidelines, which stressed the highest price comparator country.

**

There is a lot packed into Alexion, but I think it is worth noting the various things the Court does with Vavilov, especially when it comes to the reasonableness standard.

First, the Court arguably doubles down on the statute as the most important restraint on administrative power. Many of us who read Vavilov for the first time in December 2019 fastened onto paras 108-110 (and also paras 120-122) of that decision as quite important. Those paragraphs hardened a cardinal rule of administrative interpretations of law: it is the statute that the administrator is interpreting (its text, context, and purpose) that cabin the discretion of an interpreting administrator. Now, how this happens is where the rubber meets the road. But the fact that the statement was made by the Supreme Court—and that it is adopted wholeheartedly by the Court of Appeal in this case—is promising.

There are, of course, different ways that a court can ask an administrator to abide by the terms of its statute, and these ways can be more or less interventionist. Alexion is somewhat reminiscent of another case decided post-Vavilov, Richardson. I blogged about that case here. While the comments made by Nadon JA in that case were obiter, they staked out an even more radical understanding of Vavilov’s paragraphs 108-110 and 120-122. In that case, the administrator at hand erroneously applied the “implied exclusion” rule of interpretation, which the Supreme Court has held is insufficient as the sole basis on which to understand the meaning of statutory provisions (see Green, at para 37). Imposing the Supreme Court’s method of interpretation, particularly with regards to particular canons, is one way to force an administrator to abide by a statute. Another, more general and less stringent way, is what Stratas JA did in Alexion. There the Board misapprehended its own statutory purpose and failed to actually deal with the overriding goal of s.85: excessive & abusive pricing. It also ignored many of the factors set out in s.85(1). This is just a different way of getting at paras 108-110 of Vavilov: the Board failed to address its statute under the governing approach to statutory interpretation.

The fact that the Court in Richardson and Alexion did the same thing in different ways is perhaps indicative of a challenge with Vavilov. The decision says a lot, not all of it always internally consistent. Specifically, the challenge going forward with this rather legalistic vision of reasonableness review is how it meshes with the deference that is built-in to the Vavilov framework. Vavilov makes clear at various points that administrators are not asked to engage in a formalistic interpretation exercise (para 119), and that ‘[a]dministrative justice’ will not always look like ‘judicial justice’…” (para 92). Accordingly, as Professor Daly notes, “some portions of Vavilov are liable to become battlegrounds between different factions of judges, those who favour more intrusive review on questions of law in one camp, their more deferential colleagues in the other” (at 15). One could conceive, as Professor Daly does, of Richardson as “betraying a favouritism for an interventionist standard of reasonableness review on issues of statutory interpretation” (at 14).

However, I would say that Alexion and Richardson are of the same ilk, different points on a similar spectrum. Both are directed towards subjecting administrators to legal requirements, but Alexion does so in a more general way, faulting the administrator for failing to address the relevant statutory purpose (among other things). Richardson does the same thing in a more specific way, faulting an administrator for applying a proper tool of interpretation to the exclusion of the statutory purpose. Both, in my view, are plausible views of Vavilov.

Methodologically, there are other important elements of Alexion. One element is the connection that Stratas JA draws between reasons and outcome. Vavilov speaks of reasons and outcome as separate things, but in reality, they are probably intrinsically connected in at least some cases. Alexion provides a good example. In many cases, it was simply impossible for the Court to determine whether the Board had ventured an opinion on the core legal issue at play in the case. Where the Board did offer an opinion, it cast its decision in terms of the wrong legal standards.  This led it astray, and it was led astray because its reasoning failed to glom onto the important part of the entire thing: the statute.

This leads to a final point about Alexion. Thank goodness we no longer need to worry about courts coopering up deficient decisions under the Nfld Nurses line of cases. As the Court in Alexion mentions, this decision could have gone a very different way under pre-Vavilov case law. The Court would have asked itself to supplement reasons for decision instead of supplanting them.  But as the Court notes, “[m]any of us recoiled at this” (Alexion, at para 9). Why? Because it offends the principle of legality, fundamental to the administrative law system, for a court to uphold a decision that is legally flawed. Of course, deference sometimes asks us to abridge the principle of legality in a strict sense; but there are extremes, and a court making a decision for an administrator is to my mind (and, apparently the mind of the Supreme Court) a bridge too far. As the Court in Alexion says, there are no blank cheques in the law of judicial review (Alexion, at para 44).

All told, Alexion is an important recap of developments post-Vavilov. Particularly on the application of the reasonableness standard, the Court moves the needle in important ways.

Author: Mark Mancini

I am a PhD student at Allard Law (University of British Columbia). I am a graduate of the University of New Brunswick Faculty of Law (JD) and the University of Chicago Law School (LLM). I also clerked at the Federal Court for Justice Ann Marie McDonald. I have interests in: the law of judicial review, the law governing prisons, and statutory interpretation.

2 thoughts on “Alexion: No Blank Cheques Here”

  1. Definite Rashomon moment here, because this looks like judicial overreach and micromanagement to me.

  2. I see the AGBC was a party, so maybe I shouldn’t say much (no personal involvement). I do, however, find it a bit baffling that anyone would see some fundamental difference between whether a price is “reasonable” and whether it is “excessive”. If anything, I could (kind of) imagine a price that is excessive, but not unreasonable. I have grave difficulty, just as an English speaker, with a price that is unreasonable, but not excessive.

    More importantly, these are important policy issues that should not be decided by judges squinting at the text of a statute. The right of a patent holder to charge a monopoly price is just a matter of public policy, designed to promote future investment in R&D. I do not understand how judges are better suited to decide it than specialized members of a board, responsible to a minister who is ultimately responsible to the public. I do not see any sensible analogy to criminal prosecution: this is just about how much ROI patentees should be expected to get on their investment, in light of the fact that virtually all the payors will be provincial governments. This is not Adam Smith’s marketplace.

    I haven’t gone back and looked at the Board’s reasoning and maybe it was terrible. But it seemed OK to the FC judge and none of the reasons the FCA gives for saying it was bad make any sense to me, let alone justifying the rhetoric about being “tendentious”. The statute seems to give a pretty wide berth to decide when a price is “excessive” and this is hardly the kind of question that can be deduced Platonically from pure legal logic.

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