When it entered into force on June 10, Bill 81, titled An
Act to reduce the cost of certain medications covered by the basic
prescription drug insurance plan by allowing calls for tender,
introduced amendments to An Act respecting prescription drug
insurance through which the Québec government is given
the power to issue calls for tender to supply medications sold in
pharmacies. The Draft Regulation governing the mechanics of the
bidding process was recently published (available here on page 18) and is now the subject of a
45-day comment period.
What You Need To Know
Bill 81 enables Québec Minister of
Health and Social Services to issue a call for tenders for the
purpose of setting a price of a drug that will be covered by the
public drug plan in Québec. The Draft Regulation describes
the conditions and process for the call for tenders.
The Draft Regulation provides that
the Minister may conduct (i) a general call for tenders, whereby
all accredited manufacturers of medications submit a price, or (ii)
a fixed-price call for tenders to award a contract to one or more
Contracts may be awarded to a maximum
of 3 manufacturers per drug (of the same form and strength) or per
supply, and for a maximum duration of 3 years, including any
The deadline to provide comments on
the Draft Regulation is October 8, 2016.
Bill 81 enables the Minister to issue a call for tenders to
enter into contracts with manufacturers of drugs, as well as with
wholesalers, either to establish the price at which a manufacturer
will sell a drug to a wholesaler, or to establish the conditions
for the exclusive supply of a drug from a wholesaler to
The purpose of the tender process is to encourage manufacturers
and wholesalers to compete and lower drug costs for patients,
generate savings, reducing burden on the health care system.
However, concerns have been raised that: a) the bidding process may
contribute to drug shortage issues resulting from supply
disruptions; b) it may lead to less competition between
manufacturers and wholesalers and as such not generate the expected
saving; and c) cause problems in terms of access to health care
services for patients. There is also a general concern that these
new rules will heavily impact the current business model in the
pharmaceutical industry by eliminating the pharmacists' right
to choose their own brands.
To discuss these issues, please contact the
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