Expert Patient Advocates & 21st Century Therapies Forum Nov 19 - 20, 2015

1. Patented Medicine Prices Review Board
Jeffrey Biggs
Manager of Policy Development
PMPRB
Strategic Direction
2015-2018

2. Vision and Mandate
Vision:
A sustainable pharmaceutical system where payers have the information they need to make
smart reimbursement choices and Canadians have access to patented drugs at affordable
prices.
Mandate:
The PMPRB has a two-fold regulatory and reporting mandate.
1) Ensuring the prices at which patented medicines are sold in Canada are not excessive.
2) Reporting on pharmaceutical trends of all medicines and R&D spending by patentees.
Mission Statement:
We are a respected public agency that makes a unique and valued contribution to sustainable
spending on pharmaceuticals in Canada by:
1) Providing stakeholders with price, cost and utilization information to help them make
timely and knowledgeable drug pricing, purchasing and reimbursement decisions.
2) Active as an effective check on the patent rights of pharmaceutical manufacturers
through the responsible and efficient use of our consumer protection powers.
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3. PMPRB Role in Context
The PMPRB is an independent, quasi-judicial consumer protection agency. Although part of
the Health Portfolio, the PMPRB carries out its mandate at arm’s length from the Minister of
Health because of its quasi-judicial responsibilities.
Jurisdiction covers all patented drug products sold in Canada.
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Patented GenericR&DDrug Life Cycle
Review for Safety,
Efficacy and
Quality
Post market surveillanceHealth Canada
Excessive Price Monitoring and InvestigationPMPRB
ReimbursePrivate Drug Plans
Common
Drug
Review
CADTH
ReimburseProvinces
Market Approval
PCPA
CADTH: Canadian Agency for Drugs and Technologies in Health
PCPA: Pan-Canadian Pharmaceutical Alliance

4. Prices are high
Average Foreign-to-Canadian price ratios paint a clear picture (Patented Drugs, 2014)
4
2.21
1.04
1.04
1.00
0.98
0.96
0.90
0.87
0.86
0.82
0.80
0.78
0.77
0.74
0.74
0.73
0.73
0.72
0.72
0.72
0.69
0.68
0.66
0.66
0.66
0.64
0.64
0.61
0.60
0.58
0.46
0.33
0.00
0.50
1.00
1.50
2.00
2.50
USA
Mexico
Japan
Canada
Switzerland
Germany
Chile
Sweden
New
Zealand
Austria
Australia
Ireland
Finland
Median
-­‐
OECD
Luxembourg
Spain
Italy
France
Belgium
Great
Britain
Norway
Hungary
Slovakia
Portugal
Netherlands
Poland
Slovenia
Czech
Republic
Estonia
Greece
South
Korea
Turkey
Source: IMS MIDAS database, 2005-2014, IMS AG.

5. Cost Drivers
Net growth in spending has been low recently
because of the “pull” effects of generic
substitution and generic price reductions.
The cost drivers behind “push” effects are
growing and posing an increased challenge.
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Source: IMS Brogan. Canadian Drug Stores and Hospitals Purchases, MAT December 2014
0
2
4
6
8
10
12
0
50
100
150
200
250
300
350
2007
2008
2009
2010
2011
2012
2013
2014
Spending
per
Product
(million
C$)
Spending
on
New
Ac8ve
Substances
(million
C$)
Product
Launch
Revenues
(2007-­‐2014)
Total
Spending
Per
Product
Launched

6. Strategic Objectives
Consumer-focused regulation and reporting
If the PMPRB is to remain true to its purpose it must adopt a more consumer-centric
approach to how it carries out its regulatory and reporting functions.
Framework modernization
The Canadian regime has remained essentially unchanged since 1987. The PMPRB must
consult stakeholders on guidelines reform and engage with federal, provincial and territorial
partners on broader reform.
Strategic partnerships and public awareness
The PMPRB must deepen its partnership with public payers to provide timely and relevant
market intelligence while adopting a more proactive approach to communicating with the
general public.
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7. Questions?
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