Amendments To The Patented Medicines Regulations Lose Some Teeth

The proposed amendments to the Patented Medicines Regulations had the projected effect of lowering drug prices by billions of dollars over the next ten years. But by overreaching its jurisdiction, these amendments have lost some of its bite. The Quebec Court of Appeal determined several provisions to be ultra vires.

Since their introduction in August 2019, proposed amendments to the Patented Medicines Regulations  (the "PM Regulations") have faced ongoing scrutiny. The amendments:

1. extend the factors to be considered when assessing whether a patented medicine has been excessively priced;
2. modify the list of comparator countries; and
3. broaden the price and sale disclosure requirements for drug manufacturers to include discounts or rebates to third parties.