New Patented Medicine Regulations in Canada: Updated Case Study. (EN/FR)

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AUTHORS: Nigel SB Rawson, Ph.D.; Donna Lawrence, M.Sc. 

SUBMISSION DATE: January 1, 2020

PUBLICATION DATE: January 20, 2020

CITATION: Rawson, Nigel SB; Lawrence, Donna (2020). New Patented Medicine Regulations in Canada: Updated Case Study of a Manufacturer’s Decision-Making about a Regulatory Submission for a Rare Disorder Treatment. Canadian Health Policy, January 2020. Toronto: Canadian Health Policy Institute, 

COPYRIGHT: ©Canadian Health Policy Institute Inc. All rights reserved. Unauthorized reproduction or distribution of this article in whole or in part is strictly prohibited.

ABSTRACT: The Canadian federal government is imposing sweeping changes for the price review guidelines of the Patented Medicine Prices Review Board (PMPRB), the quasi-judicial agency whose role is to set ceiling prices for patented medicines sold in Canada.  The revisions are due to come into effect in July 2020. The objective of this article is to examine the planned changes in the draft PMPRB guidelines and to apply them to a hypothetical case study of the decision-making process that the pharmaceutical manufacturer of a new medication for a rare disorder is likely to go through when assessing whether to seek regulatory approval in Canada under the new regulations. The case study demonstrates that the changes in the PMPRB’s draft guidelines will create a high level of uncertainty among manufacturers of drugs for rare disorders due the major price reductions that will be forced upon them. Manufacturers will be faced with a decision of whether to delay the introduction of a new product into Canada or not launch it at all. The high level of uncertainty being generated by the changes in the PMPRB’s draft guidelines will imperil the launch of all new medicines in Canada because it will significantly decrease the attractiveness of the country as a jurisdiction in which pharmaceutical companies seek regulatory approval for new products. The uncertainty will especially impact manufacturers of new specialty high-cost medications, but it will not be limited to them. The result will be long delays in patient access to important new therapies. In some cases, manufacturers may not seek regulatory approval in Canada if they decide that the market is not worth the risk of failing to secure a reasonable price in both Canada and other jurisdictions. This would eliminate access for all patients, even those with private insurance. Access to drugs for rare disorders with private and (especially) public insurance coverage is already difficult, if not impossible, to obtain for many Canadian patients. The changes in the PMPRB’s regulations will make the situation much worse.

OPEN ACCESS SPONSOR: RAREi, a collaboration of innovative pharmaceutical companies focused on the development of medicines for rare disorders, including Alexion Pharma Canada Corp., Amicus Therapeutics Canada Inc., Biogen Canada Inc., Biomarin Pharmaceutical Inc., Horizon Therapeutics Canada, Ipsen Biopharmaceuticals Canada Inc., Mitsubishi Tanabe Pharma Canada, Recordati Rare Disease Canada Inc., Sobi Canada Inc., Ultragenyx Pharmaceutical Inc., and Vertex Pharmaceuticals (Canada) Inc. 

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