VCU accepted on October 21, 2003
Dostinex - Voluntary Compliance Undertaking (Excerpt, October 2003 Newsletter)
On October 21, 2003, the Chairperson approved a VCU from Pfizer Canada Inc. for Dostinex (cabergoline).
Dostinex was introduced in Canada by Pharmacia Canada Inc. (now Pfizer Canada Inc.) on June 30, 2000 and is used for the treatment of hyperprolactinaemia, inhibition of physiological lactation and suppression of established lactation. On November 8, 2000 the patent pertaining to Dostinex expired and the manufacturer submitted that it was not subject to the jurisdiction of the PMPRB after that date. There are four patent applications which pertain to Dostinex, but none of the patents have issued. Dostinex continues to be available on the Canadian market. It is listed in the June 2003 edition of the Liste de médicaments du Québec at $12.65 per tablet.
For the purposes of the PMPRB's Guidelines, Dostinex was classified as a category 2 new medicine in that it represented a substantial improvement in therapeutic effects. The median of international prices identified in an International Price Comparison Test was applied; the introductory price of Dostinex exceeded the maximum non-excessive (MNE) price with resulting excess revenues of $42,116.31 during the period June 30 to November 8, 2000.
The terms and conditions of the VCU were agreed to between Board Staff and the patentee. Having considered the evidence before it, the Chairperson approved the VCU submitted by Pfizer. Under the terms of the VCU, Pfizer has undertaken to offset excess revenues received for the sales of Dostinex for the period June 30 to November 8, 2000 by making a payment to Her Majesty the Queen in right of Canada, within 30 days of the acceptance of the undertaking, in the amount of $42,116.31.
Pursuant to section 103 of the Patent Act, the Minister of Health may enter into agreements with any province respecting the distribution of amounts collected as a result of orders made under the Act.
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