With the Royal Assent of Québec Bill 28, the
Minister of Health and Social Services (the Minister) can now enter
into product listing agreements (PLAs) with pharmaceutical drug
manufacturers. Bill 28 was an omnibus bill tabled at
the Québec National Assembly last November, with the
overall goal of balancing the Québec
budget.1 The provisions related to PLAs are in force as
of April 21, 2015.
What You Need To Know
Bill 28 amends the Act respecting prescription drug
insurance and the Act respecting health services and
social services to permit the Minister to enter into a PLA
with a drug manufacturer prior to having the manufacturer's
drug added to Québec's provincial formulary (List of
PLAs will not be entered into with respect to drug products
that are subject to the public tender process.
In line with the overarching purpose of Bill 28 to reduce
government costs, the stated purpose of a PLA is to permit payments
to the Minister "by means of a rebate or discount which may
vary according to the volume of sales" in Québec.
The amendments provide that third parties do not have a right
of access to PLAs under provincial freedom-of-information
legislation; however, an annual report will be published that will
list the names of manufacturers that have entered into PLAs, the
products to which the PLAs pertain, and the total annual sum
received by the Minister pursuant to PLAs, provided that at least
three PLAs are in force in the given year. This level of disclosure
is consistent with the approach taken by the Ontario Ministry of
Health and Long-Term Care.
The amendments present an opportunity for drug manufacturers to
reconsider market access strategies in Québec. Many drug
manufacturers will be familiar with PLAs from their interactions
with other provincial governments, and will now have to consider
what rebates they are willing to offer the Minister given the
volume of sales in Québec, and what commercial impact these
rebates will have on Canadian business as a whole.
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Health Canada is proposing to change the way that it regulates non-prescription drugs, natural health products and cosmetics in Canada, which will now be referred to collectively as "self-care products."
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