The Patented Medicine Prices Review Board (PMPRB) has issued a discussion paper containing some specific proposals and options related to:

  • its review of the Excessive Price Guidelines; and
  • the controversy surrounding the implications of the Federal Court of Canada decision in the LEO Pharma case on the reporting of discounts and rebates.

The Paper includes specific proposals to amend the current policies and guidelines of the Board to provide for the review of prices in "any market" (i.e. by province and class of customer) in certain circumstances, rather than relying on the Average Price for all Canada. It also proposes to establish additional circumstances where it would be appropriate to re-set the maximum non-excessive price of a medicine. Among other things, these circumstances include situations where is can be shown that the costs of making and marketing the drug exceed the MNE price and where new scientific evidence supports a change in the category of the medicine.

The Board has taken the view that the LEO Pharma decision interpreted the Patented Medicines Regulations, 1994 (Regulations) to require patentees to include all discounts, rebates and other benefits in the calculation of the Average Price of the medicine for price review purposes. This interpretation reverses a previous policy of the Board and has attracted concern that it discourages patentees from supplying drugs at low or no cost for compassionate purposes. In addition, stakeholders have expressed concern with the Board's position that patentees ought to report payments to governments that have been negotiated in regard to public drug programs.

The discussion paper outlines eight options to address these concerns including some options to amend the Regulations and others to amend the Excessive Price Guidelines. The Board has not indicated a preference for any of the options.

In addition to these matters, the Board reports that work is proceeding on the other issues under study in its review of the guidelines and more reports and proposals an be expected during the year.

The Board has asked stakeholders to submit comments on the discussion paper to the Secretary of the Board by March 3, 2008.

For a copy of the PMPRB Discussion Paper, Options for Possible Changes to the Patented Medicines Regulations, 1994 and the Excessive Price Guidelines, please visit:

 http://www.pmprb-cepmb.gc.ca/CMFiles/PMPRB_Discussion_Paper_-_Jan_31_0838NBV-1312008-5967.pdf