The PMPRB has issued a further Communiqué dealing with its interpretation of the implications of the LEO Pharma decision of the Federal Court of Canada in March 2007, and the Board's subsequent announcement about the reporting of discounts and rebates in its April 2007 NEWSletter.
In the most recent Communiqué, dated June 28, 2007, the Board states that following consideration of correspondence from stakeholders, it has decided not to require any change from the practice in previous years in the manner in which average transaction prices are calculated for the January to June 2007 reporting period. This means that patentees filing price reports with the PMPRB for the first half of 2007 may elect to include or exclude all benefits and reductions in the calculation of average transaction prices, provided that this is consistent with their calculations in prior periods. Patentees are required to file price and sales information for the January to June period with the Board by July 30, 2007.
In the April 2007 NEWSletter, the Board had stated that in light of the LEO Pharma decision, it would no longer permit patentees to exclude such benefits and reductions in the case of compassionate release programs, trial prescription programs, expenditure limitation agreements and other special programs as referred to in the April 2000 NEWSletter and the excessive price guidelines. In a Communiqué released on May 31, 2007 the Board revised that position to state that it would allow patentees to continue to opt to exclude compassionate release programs for 2007. It appears that the latest Communiqué expands that exemption to include all programs initially contemplated by the April 2000 NEWSletter, but only for the first half of 2007. In the June 28 Communiqué, the Board states that it will "advise patentees shortly of the requirements for subsequent periods.
The most recent Communiqué does not squarely address the concern raised by patentees regarding the statement in the April 2007 NEWSletter that the Board considers that patentees are required to take into account any payments made to provincial governments under agreements (including agreements under Ontario's Bill 102 and Québec's Bill130) in the calculation of average prices. The Communiqué is also silent on the mechanisms by which the Board will consult on the implementation of policy changes, if any, that may be required as a result of the LEO Pharma decision.
For the full text of the Board Communiqué of June 28, 2007, please see: