Yesterday, the Federal Court of Canada released its decision in the judicial review challenging the validity of the Regulations Amending the Patented Medicines Regulations that were published in Canada Gazette Part II on August 21, 2019.
The judgement and reasons in Innovative Medicines Canada et al. v The Attorney General of Canada et al. found section 3(4) – which expanded the reporting requirements for price and revenue information to take into account, inter alia, discounts and rebates provided to third parties – to be void and of no force and effect and ultra vires the Patent Act.
The court upheld the amendments to sections 4 and 6 of the amending Regulations pertaining to the new price regulatory factors (pharmacoeconomic value, market size and Gross Domestic Product) and the amended basket of reference counties, respectively.
During yesterday’s PMPRB Industry Webinar on the new draft guidelines, PMPRB staff said it will review how this news may impact its ongoing Draft Guidelines Consultation. Assuming this decision is upheld on any potential appeal, it would be unclear how PMPRB could regulate a maximum rebated price (MRP) if third party discounts and rebates are not reportable to PMPRB.
HOLD THE DATE!
PDCI will host a second free webinar for industry on
July 13, 2020 between 10:30 am – 12:00 pm.
In this webinar, PDCI Staff will discuss implications for industry of new information received in PMPRB’s Industry Webinar and this Federal Court Decision.
Please contact Kimberly Robinson, Director of Pricing & Market Access, with any questions about new PMPRB Draft Guidelines.