OTTAWA, Dec. 11, 2017 /CNW/ - The Patented Medicine Prices Review Board (PMPRB) today published a scoping paper which provides its initial thoughts on how best to operationalize the Minister of Health's proposed amendments to the Patented Medicines Regulations, which were published in the Canada Gazette, Part I on December 2, 2017.
This document, which is intended to be read in conjunction with the proposed amendments and the accompanying Regulatory Impact Analysis Statement, will enable an open and informed dialogue with stakeholders on areas of the PMPRB's drug pricing guidelines in need of reform as a result of the amendments and changes to the pharmaceutical environment in Canada.
In the coming weeks, Health Canada and the PMPRB will be hosting information sessions on the proposed amendments and the scoping paper. The PMPRB will also be making Guideline reform the focus of its upcoming annual outreach sessions for patentees to be held in January 2018. It is expected that a first draft of the PMPRB's new Guidelines will be made public in the spring of 2018, to be followed by technical roundtables with stakeholders and interested members of the public.
It is hoped that this document will serve as a catalyst for a more informed, focussed and productive consultation process on framework modernization, with a view to having new Guidelines in place by early 2019.
These changes, which are an integral part of the Government of Canada's commitment to improve affordability and accessibility of pharmaceuticals, will come into force in early 2019.
Quick Facts
SOURCE Patented Medicine Prices Review Board
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This document, which is intended to be read in conjunction with the proposed amendments and the accompanying Regulatory Impact Analysis Statement, will enable an open and informed dialogue with stakeholders on areas of the PMPRB's drug pricing guidelines in need of reform as a result of the amendments and changes to the pharmaceutical environment in Canada.
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In the coming weeks, Health Canada and the PMPRB will be hosting information sessions on the proposed amendments and the scoping paper. The PMPRB will also be making Guideline reform the focus of its upcoming annual outreach sessions for patentees to be held in January 2018. It is expected that a first draft of the PMPRB's new Guidelines will be made public in the spring of 2018, to be followed by technical roundtables with stakeholders and interested members of the public.
It is hoped that this document will serve as a catalyst for a more informed, focussed and productive consultation process on framework modernization, with a view to having new Guidelines in place by early 2019.
These changes, which are an integral part of the Government of Canada's commitment to improve affordability and accessibility of pharmaceuticals, will come into force in early 2019.
Quick Facts
- The Patented Medicine Prices Review Board 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.
- Sales of patented drug products increased in 2016 by 2.6% to $15.5 billion.
- Growth in spending on drugs is outstripping that of physicians and hospitals in recent years, largely due to an influx in high cost drugs.
- High-cost drugs represent an increasingly significant share of the total cost of the patented drug market, rising steeply from 7.6% in 2006 to 40.3% in 2016.
- PMPRB Guidelines Scoping Paper
- Consultation on Patented Medicines Regulations amendments (Health Canada)
- Regulations Amending the Patented Medicines Regulations - Regulatory Impact Analysis Statement (Health Canada)
SOURCE Patented Medicine Prices Review Board
