Over the course of the next three years, PMPRB is seeking to
change to its operations with the aim of becoming a more effective
and stronger consumer protection agency.
According to its recently released Strategic Plan for 2015-2018,
the PMPRB identified a number of challenges facing the PMPRB and
Canadian consumers of pharmaceuticals. These include: the
emergence of extrinsic bodies engaging in price review, absence of
publically funded universal drug coverage, and non-transparent,
fragmented drug purchasing across the country.
In response, the PMPRB has proposed a number of changes to the
way it carries out its regulatory and reporting functions, as well
as its vision for regulatory reform.
For pharmaceutical stakeholders who interact with the PMPRB,
below is a review of the key changes that are expected in the
Reporting and Information sharing: As
part of its mandate, the PMPRB reports annually on drug prices and
price trends of prescription drugs, so as to provide all levels of
government with transparent and credible price
information.1 In its Strategic Plan, the PMPRB
raised the concern that it is no longer able to provide accurate
price information to the general public or private payers, owing to
increases in the number of confidential agreements negotiated
between public payers and manufacturers, so-called Private Listing
Consequently, to assist private payers in making pricing
decisions for the benefit of patients, the PMPRB is proposing to
pursue collaboration between public and private payers that would
facilitate and standardize sharing of pricing, use and cost
data.3 It is also proposing to work closely
with international counterparts in the sharing of information and
Regulatory reform: In the long term, PMPRB is
also proposing to examine whether changes are needed to its
regulatory framework to ensure Canadians are paying fair prices for
patented drugs. Included among the possible avenues for
regulatory reform are: (i) a broader list of comparator countries
than the existing seven used for comparing prices, (ii) to
modernize and simplify the PMPRB's existing Guidelines, and
(iii) discussions with the provinces and territories regarding
implementation of international best practices on cost
effectiveness, reimbursement and pricing.5
Targeted enforcement: As part of its
regulatory mandate, the PMPRB has the authority to hold Tribunal
hearings to review the price of a patented medicine where the PMPRB
staff have determined its price is excessive.6 As
part of its plan, the PMPRB is proposing to focus enforcement
efforts in areas that would make the PMPRB a more effective
consumer champion. According to the PMPRB, these include
areas that raise issues most relevant to payers, or that could
clarify the PMPRB's legal framework.7
A full copy of the PMPRB's Strategic Plan, 2015-2018
document can be found here.
1 Strategic Plan page 7
2 Strategic Plan page 15
3 Strategic Plan page 25
4 Strategic Plan page 26
5 Strategic Plan page 19-20, 26
6 Strategic Plan 2015-2018 at page 7 ["Strategic
7 Strategic Plan page 21
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