Volume 12, Issue No. 3Consultation on the Board’s Revised Excessive Price GuidelinesThe Board has been consulting with all interested stakeholders on its current patented drug price regulatory regime in order to determine where and how the regime may be updated to be more appropriate, relevant and effective in today´s modern pharmaceutical environment. The Board has given careful consideration to the views expressed and comments received from stakeholders throughout its consultation process and wishes to update readers on its work in regard to the Patented Medicines Regulations and its Excessive Price Guidelines.
On August 18, the Board will be issuing a Communiqué to clarify what information patentees will be required to report pursuant to the Patented Medicines Regulations beginning in January 2009, in terms of the average transaction price. A Notice and Comment package, including draft revised Excessive Price Guidelines, will be released on August 20, 2008. The deadline for submitting comments on the draft revised Guidelines will be October 6, 2008.
The Communiqué and draft revised Guidelines will be available on our Web site under Consultations; Consultations on the Board´s Excessive Price Guidelines; Notice & Comment.
Once again, the Board thanks all stakeholders who have participated in this process to date and looks forward to their continued active involvement in the completion of this important exercise.
| Timetable |
| Deadlines |
Products |
| August 18, 2008 |
Stakeholder Communiqué |
| August 20 |
Draft revised Guidelines posted on the PMPRB Web site for consultation |
| October 6 |
Deadline for stakeholders´ submissions on the draft revised Guidelines |
| October 22 |
Board Meeting |
| November 17 |
Release of the amended Compendium of Policies, Guidelines and Procedures, and transition and implementation plans |
| November-December |
Board Staff outreach to assist patentees in the implementation of the revised Guidelines |
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