Canada: Changes At PMPRB To Safeguard Against Excessively Priced Medicines

Overview

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 coming years.

Key Changes

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 Agreements (PLAs).²

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 best practices.⁴ 

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. 

Footnotes

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 Plan"]

7 Strategic Plan page 21

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