On June 24, the Patented Medicine Prices Review Board (PMPRB)
published the PMPRB Guidelines Modernization – Discussion
Paper (Discussion Paper)1 in which it announced that, in
response to high patented medicine prices and low R&D
investment in Canada, it is undertaking public consultations
regarding a possible reform of its Compendium of Policies,
Guidelines and Procedures (Guidelines).
What You Need To Know
The Guidelines outline how PMPRB staff determines whether the
price of a patented medicine is excessive.
The PMPRB is seeking written comments on a series of questions;
specific changes to the Guidelines are to be proposed based on the
feedback received. The questions relate, generally, to:
how excessive pricing should be identified;
whether other aspects of the Guidelines warrant reform;
whether any changes to the Guidelines should apply to all
patented medicines or only those introduced subsequent to the
whether there should also or alternatively be changes to
relevant regulation or legislation.
The deadline for submitting written comments to the questions
is October 24, 2016.
The PMPRB anticipates it will publish its proposed changes to
the Guidelines for comment in the spring or summer of 2017.
The Discussion Paper hints that the PMPRB may propose a number
of reforms to the Guidelines which would likely lower the maximum
allowable prices of many patented medicines at and after
In particular, the Discussion Paper suggests the PMPRB may
support reforms that would change how it determines whether the
price of a medicine is excessive at introduction. These reforms
could involve: (i) conducting initial screenings based on
indicators of potential for patent monopoly abuse rather than
levels of therapeutic improvement; (ii) either changing the
composition of the countries used for international price
comparisons, or lowering price ceilings relative to the currently
considered countries; and (iii) lowering price ceilings at
introduction for drugs providing slight or no therapeutic
improvement relative to other drugs sold in Canada.
The Discussion Paper also suggests the PMPRB may support reforms
that would change how it determines whether the price of a medicine
is excessive after introduction. These reforms could involve: (i)
allowing for a different consideration of the consumer price index,
or providing for periodic reassessment of drug prices to determine
whether a decrease may be warranted; and (ii) having an assessment
of prices in different Canadian markets play a more prominent role
in determining whether the price of a patented medicine is
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