IN THE MATTER OF the Patent Act R.S.C. 1985, c. P-4, as amended AND IN THE MATTER OF Sanofi-Synthelabo Canada Inc. (the “Respondent”) and the medicine “Fasturtec”
Pursuant to the provisions of section 83 of the Patent Act, the Patented Medicine Prices Review Board (the “Board”) issued a Notice of Hearing on May 20, 2004, pertaining to allegations of the Board Staff that the medicine Fasturtec had been, and was being, sold by Sanofi-Synthelabo Canada Inc. (“Sanofi”) in Canada at prices that exceeded the prices calculated in accordance with the Board's Price Guidelines (the Guidelines”). A pre-hearing conference was scheduled for July 6, 2004, and the hearing to commence on August 23, 2004.
On June 25, 2004, Sanofi filed a Voluntary Compliance Undertaking (“VCU”) by which it proposed to resolve the issues raised by the Notice of Hearing. Sanofi and Board Staff presented their respective views on the merits of the VCU.
The Board has reviewed the VCU and submissions and approved the terms of the undertaking. By Order of this Board, which Order shall be entered as an order of the Federal Court of Canada:
1. The MNE price of Fastutec in 2002 at the time of its introduction in Canada was $119.1838 per vial and the MNE price in 2004 is $124.7854 per vial.
2. Sanofi will reduce the price of Fasturtec, within 30 days of acceptance of the VCU, therefore no later than July 26, 2004, so that the average transaction price for 2004 does not exceed the MNE price of $124.7854 per vial.
3. Sanofi will offset excess revenues received from May 21, 2002 to December 31, 2003 by making payments to each of the customers that purchased Fasturtec over this period. The method of calculation is described in the VCU. All payments shall be made no later than July 26, 2004.
4. Sanofi will provide no later than July 26, 2004, copies to the PMPRB of the cheques made to each of the customers that purchased Fasturtec and the documentation to support the calculation of the said payments.
5. Sanofi will provide, in addition to the price and sales data to be filed pursuant to the Patented Medicines Regulations by January 30, 2005, the PMPRB with customer specific price and sales information as evidence of Sanofi's compliance with the VCU.
6. Sanofi will ensure that the average transaction price of Fasturtec remains within the Guidelines in all future periods in which it remains under the Board's jurisdiction, and that no customer in Canada shall pay a price higher than the MNE price.
7. The proceeding that was commenced by the issuance of the Notice of Hearing is hereby concluded.
Robert G. Elgie
Thomas (Tim) Armstrong
Secretary of the Board
June 28, 2004