The Quebec Court of Appeal released this week a significant
decision on the proposed amendments to the Patented
Medicines Regulations ("PM
Regulations"). In Merck Canada inc. c.
Procureur général du Canada, 2022 QCCA 240 (the
"QCCA Decision"), the QCCA found that
certain parts of the proposed amendments to the federal patented
medicines pricing regime were unconstitutional.
The QCCA decision relates to proposed amendments to
the PM Regulations (the
"Proposed Amendments")
to include new price regulatory factors, an updated schedule of
comparator countries and new patentee information reporting
requirements. If the Proposed Amendments were enacted, the
pharmaceutical industry has estimated that their losses could be
over $26 billion and would have a chilling effect on research and
development in Canada.
