PMPRB Notice & Comment

PMPRB Notice & Comment on Price Increases for Patented Medicines: Discussion Paper

PMPRB Notice & Comment on Proposed Amendments to the Patented Medicines Regulations



PMPRB Notice & Comment on Price Increases for Patented Medicines: Discussion Paper

In a follow-up to the January 2005 NEWSletter, the Board issued a discussion paper providing commentary on a number of background issues. Comments are requested from stakeholders on 5 questions relating to PMPRB Guidelines:

1. Should they continue to allow for automatic price increases?

2. Are there considerations other than or in addition to the CPI that should be used to review price increases?

3. How often should price increases occur?

4. If justification is required, what criteria should be considered?

5. Given that the CPI is established in the Patent Act as a factor to be considered by the PMPRB, do you have any comments on its appropriate application in future Guidelines?

The Board has put forward three different hypothetical regulatory frameworks in which stakeholders should consider the responses to the above questions, based on the outcome of the Regulatory changes being proposed. The three regulatory frameworks are:

1. Framework 1: Patentees take an automatic price increase in a given period for each product based on the Guidelines. The Board reviews the price increase after the fact and take action if needed.

2. Framework 2: Patentees will take a price increase as per the Guidelines but have to notify the Board and the Board approving the price increase before it is actually implemented

3. Framework 3: Patentees are required to apply for a price increase but also provide justification for the price increase as well as the extent of that increase. The Board will have to determine based on the appropriateness and the extent of the increase whether it should be accepted. The Guidelines will have to reflect the criteria that may be used in a patentee's rationale, the methodology used by the Board to determine if a price increase is excessive as well as the maximum limit allowed.

The deadline to submit a response to the discussion paper is May 9, 2005. A copy of the discussion paper can be found at:
http://www.pmprb-cepmb.gc.ca/CMFiles/
notice-Mar05-E15GGG-392005-5938.pdf