Canada Proposes Changes to Drug Pricing Regulations

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 05-18-2017 15:10


For the first time in more than 20 years, Canada is proposing changes to its drug-pricing regulations, including a proposal to introduce new, economics-based price regulation factors.

In announcing the proposed regulations, Canadian officials stress two key market developments as it relates to drug pricing: (1) the emergence of higher-cost drugs, such as biologics and genetic therapies, which are putting increasing pressure on drug spending; and (2) a growing discrepancy between public list prices and lower actual market prices due to the increased use of confidential discounts and rebates.

The proposed amendments are intended to reverse these trends by moving to a modern, risk-based approach to drug-price regulation. These changes highlight five important improvements to the Canadian regulations: (1) introduce new, economics-based price regulation factors that would ensure prices reflect Canada’s willingness and ability-to-pay for drugs that provide demonstrably better health outcomes; (2) update the list of countries used for price comparison so that it is more aligned with the PMPRB’s consumer protection mandate and median OECD prices (OECD is the Organization for Economic Co-operation and Development, which represents 35 member countries that includ the most advanced countries but also emerging countries, such as Mexico, Chile and Turkey); (3) formalize a move to a complaints-based system of oversight for patented generics products that are at lower risk of excessive pricing for reducing regulatory burden for patentees; (4) set out the pricing information required of patentees to enable the PMPRB to operationalize the new pricing factors; and (5) require patentees to provide the PMPRB with third-party information related to rebates and discounts on domestic prices.

Public comments on the proposed amendments are open until June 28, 2017. 

Source: Government of Canada


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