Patented Medicine Prices Review Board
| Author | T. Nessim Abu-Zahra/Simon Carvalho/David Edwards |
| Pages | 287-315 |
SEVENTEEN
Patented Medicine Prices
ReviewBoard
A. OVERVIEW
An important aspect of federal regulation of pharmaceutical products relates
to the costs of patented medicines and the role of the Patented Medicine
Prices Review Board (PMPRB or the Board). e PMPRB’s mandate is to
oversee the prices of “medicines” (the term used in the legislation relating to
the PMPRB) that are subject to Patent Act protection. e Board does not
have the power to actually set the price of the medicine; rather, its jurisdic-
tion is limited to protecting Canadians from excessive prices.
is chapter will use the term “medicine” when referring to the PMPRB sections of
the Patent Act, RSC , c P- [Patent Act], as this is the term that is used in the
relevant sections of the Patent Act. However, generally a “medicine” covers products
that fall within the denition of “drug” under the Food and Drugs Act (the meaning
of which is explained in Chapter ). Amendments to s () of the Patent Act, which
came into force on June , add, for the rst time, a denition of “medicine,”
providing that “medicine includes a drug, as dened in section , and a medicinal
ingredient.” Section , in turn, which denes “drug” for the purposes of the CSP
regime, as follows:
drug means a substance or a mixture of substances manufactured, sold or
represented for use in
(a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or
abnormal physical state, or its symptoms, in human beings or animals; or
(b) restoring, correcting or modifying organic functions in human beings or
animals.
The Regulation of Drugs in Canada
e PMPRB and its mandate are set out in sections to of the
Patent Act, and associated regulations, which give the Board the power to
hold a hearing to determine if the price charged for a patented medicine in
Canada is excessive. If a price is found to be excessive, the PMPRB can order
a drug company to take steps to reduce the price to a non-excessive level.
e legislation also compels patentees to provide the Board with information
about the patented medicines that they sell so that the Board can investigate
whether there is a need to hold a hearing to determine if the price charged
is excessive. More recently, the PMPRB’s jurisdiction has been extended to
also include medicines that are subject to protection by way of a certicate
of supplementary protection, which is discussed in Chapter .
1) Legislative History
e PMPRB originally came into existence as part of a broad series of
reforms to the Patent Act made in by way of Bill C-. As described
in Chapter , these reforms removed the prohibitions on patenting certain
types of pharmaceutical inventions and took the rst steps toward eliminat-
ing Canada’s compulsory licensing regime. Together, these changes greatly
expanded the ability of patentees to maintain exclusivity in the marketplace
and, accordingly, charge prices that reect that exclusivity. As a balance to
these changes, the PMPRB was created and was given powers to monitor the
prices at which patented medicines were sold.
During the debates leading to the enactment of Bill C-, the Honour-
able Harvie Andre, the then-Minister of Corporate and Consumer Aairs,
explained the purpose of the amendments to the House of Commons as
follows:
In essence, the amendments I propose in Bill C- will create a climate
favourable to new investment in research and development by giving
patent holding pharmaceutical rms in Canada a guaranteed period of
Sections and of the Patent Act, above note , also require patentees to report cer-
tain sales and expense information, including expenditures in relation to research and
development in Canada. ese sections of the Act are supplemented by ss & of
the Patented Medicines Regulations, SOR/-, which, among other things, dene
“research and development.”
House of Commons Debates, vol I, nd Sess, rd Parl, November ,at and
.
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