On May 16, 2017, Health Canada published a consulting paper titled “Protecting Canadians from Excessive Drug Prices.” The paper describes five proposed amendments to the Patented Medicines Regulations that are meant to help better assess whether the price of a patented drug is excessive.
Stakeholders can provide feedback on the proposed amendments by June 28, 2017.
Further to the PMPRB’s initial consultation on guidelines modernization (as reported here), the proposed amendments are meant to “provide the PMPRB with new regulatory tools and information to better protect Canadian consumers from excessive prices while reducing regulatory burden on patentees.” Further consultations on the PMPRB guidelines will follow from the regulatory amendments. The proposed regulatory amendments are as follows:
(1) Introduce new “pricing factors.” The current framework for assessing whether the price of a new patented drug is excessive is largely based on three factors: (1) the degree of therapeutic benefit of the drug relative to existing drugs on the market; (2) the price of that same drug in seven comparator countries (PMPRB7); and (3) the highest priced drug in Canada in the same therapeutic class. Under the proposed amendments, three new factors would be added: (i) the pharmacoeconomic evaluation for the medicine; (ii) the size of the market for the medicine; and (iii) the gross domestic product in Canada.
(2) Update the list of countries used for price comparison. The proposed amendments suggest revising the list of comparator countries to those that are “more aligned with Canada economically and from a consumer protection standpoint.” The proposed revised list would remove the United States and Switzerland from the list of comparator countries, and add Australia, Belgium, Japan, Netherlands, Norway, South Korea and Spain.
(3) Formalize a move to a complaints-based system for generic drugs. Under the proposed amendments, patentees of generic drugs (e.g., drugs that have obtained approval based on an ANDS), would only be required to report the identity and price information in the event of a complaint or at the board’s request (as reported here).
(4) Detail the new pricing information required from patentees. To facilitate the use of the “new pricing factors” by the board, patentees would be required to submit additional information to the board, where available, including: (i) a cost utility analysis by approved indication of the medicine; and (ii) information on the estimated market uptake of the medicine.
(5) Require patentees to provide rebates and discounts information. To more accurately determine the true market price of a drug, the board proposes that patentees be required to report all indirect price reductions to the Board (e.g., promotions, rebates, discounts, refunds, free goods, free services, gifts or any other benefit).
Call for Feedback: Consulting on Proposed Amendments to the Patented Medicines Regulations