Patented Medicine Prices Review Board Will Hear Evidence in the Matter of the Price of Orphan Drug Soliris

OTTAWA, ONTARIO--(Marketwired - Jan. 11, 2017) - Patented Medicine Prices Review Board

The Patented Medicine Prices Review Board (the Board) will hold a public hearing in the matter of the price of the patented medicine Soliris and Alexion Pharmaceuticals Inc. (Alexion), the pharmaceutical company that exercises patent rights for Soliris and sells the medicine in Canada. The hearing is scheduled to take place from 9:00 a.m. to 5:00 p.m. (EST) from January 16 to January 19 and from January 23 to January 27, 2017 at the following location:

The purpose of the hearing is to determine whether, under sections 83 and 85 of the Patent Act, Alexion is selling or has sold Soliris in any market in Canada at a price that, in the opinion of the Hearing Panel of the Board, is or was excessive and if so, what order, if any, should be made.

Soliris is the first and only treatment for patients with Paroxysmal Nocturnal Hemoglobinuria, a rare and life-threatening blood disorder characterized by excessive destruction of red blood cells; and Atypical Hemolytic Uremic Syndrome, a rare and life-threatening genetic disorder characterized by blood clots in small vessels.

Quick Facts

• The Patented Medicine Prices Review Board is an independent quasi-judicial body with a regulatory mandate to protect the interests of Canadian consumers by ensuring the prices of patented medicines sold in Canada are not excessive.
• Patented Medicine Prices Review Board staff review the prices patentees charge for each individual patented drug product sold in Canadian markets on an ongoing basis to ensure they are not excessive.
• When Patented Medicine Prices Review Board staff find that the price of a patented drug 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 Patented Medicine Prices Review Board Hearing Panel finds, after a public hearing, that the price of a patented drug is excessive, it may order the patentee to reduce the price of the patented medicine and to offset any excess revenues it may have received.

Related Products

- Statement of Allegations of Board Staff

Additional Links

- Patent Act (Justice Canada)

- Compendium of Policies, Guidelines and Procedures (Patented Medicine Prices Review Board)

- Status of Ongoing Proceedings (Patented Medicine Prices Review Board)

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