Canada's drug price watchdog reaches agreement with drug-maker on reporting requirements for leukemia drug

OTTAWA, ONTARIO--(Marketwired - Nov. 3, 2016) - Patented Medicine Prices Review Board

A Patented Medicine Prices Review Board (PMPRB) Hearing Panel issued an Order on October 28, 2016 requiring that Baxalta Canada Corporation (Baxalta) provide the PMPRB with the pricing and sales information required by section 80 of the Patent Act and sections 3 and 4 of the Patented Medicines Regulations. The Order relates to the medicine Oncaspar, which is sold in Canada under Health Canada's Special Access Programme and is used in the treatment of patients with Acute Lymphoblastic Leukemia.

Baxalta agreed to provide the information sought by the PMPRB for the period commencing July 1, 2015, when Baxalta began selling Oncaspar in Canada.

The Hearing Panel's Order resolved this matter and, as such, no hearing will be held in November 2016.

Quick Facts

• The Patented Medicine Prices Review Board is an independent quasi-judicial body that protects the interests of Canadian consumers by ensuring the prices of patented medicines sold in Canada are not excessive, and provides stakeholders with price, cost, and utilization information to help them make timely and knowledgeable drug pricing, purchasing, and reimbursement decisions.
• Patentees must file price and sales information with the Patented Medicine Prices Review Board at introduction, and twice a year afterward, for each strength of each dosage form of each patented medicine sold in Canada.
• Patented Medicine Prices Review Board staff review the prices patentees charge for each individual patented drug product sold in Canadian markets on an ongoing basis to ensure their prices are not excessive.
• If the Patented Medicine Prices Review Board (PMPRB) Hearing Panel finds a patentee to be in breach of its reporting requirements, the Panel may order the patentee to provide the PMPRB with the required pricing and sales information.

Related Documents

- Board Order (PDF - 115 kb)

Associated Links

- Patent Act (Justice Canada)

- Patented Medicines Regulations (Justice Canada)

- Status of Ongoing Proceedings (Patented Medicine Prices Review Board)