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The PMPRB released its June 14, 2012 decision relating to Sanofi
Pasteur's vaccines QUADRACEL and PENTACEL.
Following reconsideration, it opted to issue an order for the
identical amounts as were found to be owing under its previous
order that the Federal Court of Canada had declared a nullity.
This is the next chapter following the Federal Court's July
12, 2011 decision (Sanofi Pasteur Limited v. Attorney General of
Canada 2011 FC 859 (T-83-10)) ("Sanofi") (http://decisions.fct-cf.gc.ca/en/2011/2011fc859/2011fc859.html)
that declared a decision of the Patented Medicine Prices Review
Board ("Board") to be null and void. It
required the Board to return amounts paid by Sanofi Pasteur
pursuant to the Board's order, and directed the matter back for
reconsideration.
Upon reconsideration, the Board Panel stated that it had
jurisdiction to make an order that did not fully offset the
excessive revenues (s.83(2) uses the word "may" in
addressing the powers of the Board when excessive pricing is
found). However, absent special circumstances, the remedy
should fully offset the excess revenues calculated by the Board
Panel. In the absence of special circumstances, the choice is
among the methods of offsetting the revenues and not about whether
there are reasons not to make a remedial order or to adjust the
dollar amount. Special circumstances were not present in this case
and therefore the entire amount of excess revenues was to be
repaid.
The Board Panel stated two reasons why the patentee could not
reduce the excessive revenues in 2007 from foregone revenues when
pricing was below the maximum non-excessive ("MNE") price
in earlier years: 1) The price paid by the Government of
Canada in the prior years was as a result of a competitive
bid. It should not be deprived of the benefits of the pricing
procurement strategy by allowing those savings to offset prices in
excess of the MNE in a subsequent year; and 2) The
Guidelines' price averaging parameters for a calendar year were
appropriate in this case. These parameters balanced
flexibility and the ability to correct for unexpected revenues with
preventing patentees from charging excessive prices at will and
later reducing or eliminating excess revenues to sometime of their
choosing.
Since the March 16, 2010 order was a nullity, the Board Panel
reissued a replacement order.
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