In a notice issued late Thursday, May 31, 2007, the PMPRB announced that it has decided not to proceed with implementation of a policy change, announced earlier in the month in its April 2007 NEWSletter, concerning the reporting of compassionate release programs and their impact on the calculation of the average transaction price (ATP) of a medicine for PMPRB purposes. (See full text of communiqué below.)

In the April 2007 NEWSletter, the PMPRB had stated that, as a result of a recent decision of the Federal Court of Canada in the LEO Pharma case:

… patentees will no longer be permitted to exclude from the ATP calculation any reductions or benefits of a like nature, whether or not they are supplied under a compassionate release program, trial prescription program or expenditure limitation agreements.

The new communiqué, sent to the CEOs of patentees, stated the Board will continue to consider the implications of the Federal Court decision and will consult with stakeholders on possible changes. In the mean time, it will permit manufacturers to exclude, from the calculation of the price of a medicine for price review purposes, products supplied under a compassionate release program during 2007.

The latest announcement refers only to drugs supplied under compassionate release programs. It does not specifically address the second part of the Board's announcement in the April 2007 NEWSletter where it stated that rebates or discounts required through provincial/territorial legislation, regulation or negotiated agreement, for example under Ontario's Bill 102 or Quebec's Bill 130, should be included in the price reports to the Board and included in the calculation of the ATP.

Text of the PMPRB Communiqué May 31, 2007

In its April 2007 NEWSletter, the Board reported on the LEO Pharma decision in the Federal Court of Canada and advised that, as a result of that decision, all reductions or benefits associated with the distribution of medicines under the Board's jurisdiction would be included in the calculation of the Average Transaction Price (ATP) of the medicines.

As noted in the April 2007 NEWSletter, the Board continues to give consideration to the implications of the LEO Pharma decision. The Board has determined that, pending the consideration of possible options and consultations with stakeholders, for the 2007 reporting periods, patentees will be permitted to exclude, from the calculation of the ATP of a medicine, medicines supplied pursuant to a compassionate use program, provided that the reporting is consistent in all periods.

The Board supports the use of compassionate programs by patentees, and, as such, is continuing to consider issues associated with compassionate use programs. The Board will advise of any developments in this area for future reporting periods and will consult stakeholders on any changes it may contemplate.

For further information on the PMPRB's April 2007 NEWSletter, please see:

http://www.gowlings.com/resources/enewsletters/DrugPricingReimbursement/Htmfiles/V1N06_20070502.en.html 

http://www.pmprb-cepmb.gc.ca/CMFiles/April07-e38HZF-522007-7332.pdf