Notice and Comment October 18, 2013

Stakeholders were consulted on the Regulatory Burden Reduction initiatives in a Notice and Comment from May 16 to June 13, 2013. The Notice and Comment is available at http://www.pmprb-cepmb.gc.ca/francais/view.asp?x=1747&mp=1746 and stakeholder submissions are available at http://www.pmprb-cepmb.gc.ca/english/View.asp?x=1767.

On the CPI initiative, it was proposed that the current CPI-Adjustment Methodology be maintained for existing drug products, except the use of the forecast CPI will be replaced with the actual CPI in calculating the CPI-Adjustment Factor for the forecast period. In the April 2013 NEWSletter, patentees were provided with the 2014 forecast CPI-Adjustment Factors. For 2014, the existing CPI-Adjustment Methodology will be applied.

The new CPI initiative will be implemented for 2015. The January 2014 NEWSletter will announce the actual CPI for the 2013 year, a 12-month period ending in December 2013. This actual lagged 2013 CPI will be used to calculate the CPI-Adjustment Factors for 2015. Because the CPI initiative will not be implemented until 2015, it is not necessary to have any transitional measures.

For a summary of the changes to the Guidelines arising from this policy decision, please see the Side by Side Comparison of Current and Proposed Text in the Compendium of Policies, Guidelines and Procedures.

Interested parties are invited to submit their written comments on the new CPI Initiatives by November 15, 2013 to Sylvie Dupont, Director, Board Secretariat and Communications. Submissions should be sent to:

Box L40
333 Laurier Avenue West
Suite 1400
Ottawa, Ontario K1P 1C1