On June 9, 2009, the Patented Medicine Prices Review Board (PMPRB), Canada's federal price control body, released its final revised Compendium of Policies, Guidelines and Procedures, containing the new Excessive Price Guidelines. This concludes the consultation process which took place over the past few years as part of the PMPRB's plan to overhaul the Guidelines. The revised Guidelines will come into effect on January 1, 2010.

The last proposal document was published for comment in March 2009. While the PMPRB largely adopted the proposals from March 2009, there are some important changes to the final version of Guidelines, including most notably:

* The Guidelines now provide a list of publicly available sources of price information that it will use in looking at comparator drug product prices. Board Staff are to use the "lowest public price" from these sources in cases where the comparator drug is sold by either the same patentee or a different patentee. If these sources do not provide a price, Board Staff are to explore additional sources until a public price is found. The last draft version provided that Board Staff would find "the public price that is sufficiently close to the National Non-Excessive Average Price of the patented drug product used for comparison purposes" for the purpose of applying the price tests.

* The PMPRB's mandate statement now mirrors the language in the Patent Act. The PMPRB has removed reference to "consistent with the interests of consumers and the Canadian health care system" as had been contained in the mandate of the prior proposed version.

* The PMPRB has decided not to publish the maximum average potential price inflated by the consumer price index. However, the PMPRB will publish the maximum average potential price at introduction as part of the new medicine summary reports. As included in the revised draft, the term "maximum average potential price" sets the upper threshold for the introductory average price in all "markets".

* The Highest International Price Comparison (HIPC) Test will not apply to the wholesaler class of customer but will be conducted at the national level, for the pharmacy and hospital customer classes, and for each province and territory. The previous draft proposal provided the HIPC test applied to "the National Average Transaction Price and the Market-Specific Average Transaction Prices (pharmacy, hospital, wholesaler, provinces/territories)".

* The PMPRB has modified the methodology that ensures that when a special benefit programs ends, a price may rebound to the pre-benefit, non-excessive price level. In the revised Guidelines, the ability to rebound to the highest non-excessive average price in another market is contingent on the patentee's evidence demonstrating that the benefits are no longer offered in that market. The evidence required is extensive and patentees are expected to demonstrate that the recipient of the benefit was aware in advance that it was receiving a benefit not offered to all customers. Patentees must also identify the type and value of the benefit, when/how they were offered and provide evidence of whether the same customer is still receiving other benefits. In markets where some benefits are ongoing, the rebound in price will correspond to the remaining benefit.

* If a drug product exceeds the maximum average potential price at introduction, or the national non-excessive price post-introduction, but does not meet the criteria to commence an investigation, it will be reported on the PMPRB website as "does not trigger investigation". The revised draft had proposed using the phrase "appears excessive". The PMRPB believes the new designation more accurately reflects the compliance status of a drug product and does not allude to the presumption of excessive pricing.

A copy of the revised Guidelines may be found at: http://www.pmprb-cepmb.gc.ca/cmfiles/COMPENDIUM_REVISED_June909.pdf

A copy of the Board's response to the consultations may be found at: http://www.pmprb-cepmb.gc.ca/cmfiles/RESULTS_ConsultationonGuidelines-June909.pdf