PMPRB Price Guidelines Consultation

The PMPRB today released a Stakeholder Communiqué as a follow up to its Excessive Price Guidelines review commenced with the May 2006 Discussion Guide. The key points of interest are summarized below:

1. Board is proposing to eliminate situations where CPI methodology forces a non-excessive price down from one year to the next. Language to follow.

2. Board will create a working group to clarify the definitions of substantial improvement, breakthrough, moderate improvement etc.

3. Board will establish a small 'expert' working group for identifying "appropriate therapeutically comparable medicines in comparator countries." as a first step along the road towards incorporating international therapeutic class comparisons into Board practice. (as per Section 85(1c)) of Patent Act).

4. Board will consult to define the circumstances under which patentee costs of making and marketing (as per Section 85(2)) may be considered in the price review process.

5. Board is considering further its policies regarding re-benching and when to do a by-market price review.

6. Board is redefining its mandate to include: "protecting the interests of consumers".

Brogan would be pleased to provide additional analysis or answer any questions you may have.