18 www.lexpert.ca
Feature
excessive: the pharmacoeconomic value
of the treatment; the market size; and the
gross domestic product and GDP per capita
in Canada.
e amendments
also revised the list of
comparator countries
for patented medicines.
ose 11 countries are
Australia, Belgium,
France, Germany, Italy,
Japan, Netherlands,
Norway, Spain, Sweden
and the United
Kingdom, with the
United States and Switzerland both removed
from the list.
When the new pricing regime does come
into force and effect, it will affect pricing
on patented drugs already on the market,
as well as new patented drugs. But there are
court proceedings challenging jurisdiction,
says Lainson, regarding how regulatory
changes fall within the jurisdiction and
authority of the PMPRB under the Patent
Act, as well as a constitutional challenge to
the law itself.
Pharmaceutical companies have vehe-
mently opposed the new regime. ere are
several changes in calculating the maximum
price that pharmaceutical companies can
charge in Canada, says Gravelle. Under the
current regime, the price of a patented medi-
cine had to be compared to those in seven
other countries. e new rules expand this
to 11 countries, with lower-priced countries
substituting for the U.S. and Switzerland.
"is is a regime that controls the price,
but now they've made some changes that
are probably going to [mean] that drug
companies can charge less in Canada,"
Gravelle says.
In August, Life Sciences Ontario — a
not-for-profit organization representing
and promoting the interests of Ontario's life
sciences sector — wrote an open letter to the
PMPRB charging that "from the outset, the
PMPRB's approach to drug price regulation
has been rife with problems . . . e applica-
tion of economic factors makes it difficult
for companies to appropriately price their
products, which also makes the return on
investment highly uncertain. is, in turn,
makes it difficult for companies to make a
compelling business case to prioritize the
Canadian market for new medicine launches
and investments in clinical research, patient
support programs, compassionate funding or
even Special Access Programs."
A report commissioned by Life Sciences
Ontario found that Canada had been
getting faster and more extensive access to
new therapies relative to other countries
until the drug price controls were adopted
in 2019. e number of new, globally
launched drugs commercialized in Canada
"THE BIOPHARMA INDUSTRY AS A
WHOLE IS VERY STRONG AND HAS
BEEN INNOVATING THROUGHOUT —
EVEN THOUGH THINGS ARE NOT IN
THEIR USUAL PATTERN."
Daphne Lainson
SMART & BIGGAR LLP
