Patented Medicine Prices Review Board issues a Notice of Hearing for allegations of excessive pricing of Procysbi

January 16, 2019

Ottawa, ON — Patented Medicine Prices Review Board

The Patented Medicine Prices Review Board will hold a public hearing in the matter of the price of the patented medicine cysteamine bitartrate, sold under the trade name “Procysbi” by the patentee Horizon Therapeutics Canada. Further details on the public hearing and a case management conference will be announced at a later date.

The purpose of the hearing is to determine whether under section 83 of the Patent Act, Horizon:

  • is selling or has sold the medicine known as Procysbi in any market in Canada at a price that, in the Board's opinion, is or was excessive; and
  • if so, what order, if any, should be made to remedy the excessive pricing.

Procysbi is indicated for the treatment of the rare and life-long multisystem genetic disorder nephropathic cystinosis. Among other symptoms, nephropathic cystinosis impairs the filtering function of the kidney, eventually progressing to kidney failure and necessitating a kidney transplant.

Those wishing to participate in this proceeding must apply to the Board for leave to intervene. For further information on the application process, please contact:

Guillaume Couillard
Director, Board Secretariat
Patented Medicine Prices Review Board
Box L40, 333 Laurier Avenue West, Suite 1400
Ottawa, Ontario K1P 1C1
Telephone: 613-288-9635

Quick Facts

  • The Patented Medicine Prices Review Board is an independent quasi-judicial body that protects the interests of Canadian consumers by ensuring the prices of patented medicines sold in Canada are not excessive.
  • Board Staff review the prices that patentees charge for each individual patented drug product sold in Canadian markets on an ongoing basis.
  • When Board Staff find that the price of a patented drug product appears not to comply with pricing guidelines, they will conduct an investigation to determine the facts. An investigation could result in: the closure of the file, where it is concluded that the price complies with pricing guidelines; a Voluntary Compliance Undertaking, whereby the patentee agrees to reduce the price and to offset excess revenues through a payment and/or additional price reductions; or a public hearing to determine whether the price is excessive.
  • If the Board finds, as the result of a public hearing, that the price of a patented drug is excessive, the Board may issue a remedial order to the patentee.

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