ALERT! PMPRB WEBINAR RESCHEDULED
Given all the new information this week, as well as the consultation extension, PDCI is postponing its PMPRB webinar. Our second free webinar for industry will now be held on July 22, 2020 between 10:30 am – 12:00 pm.
Join the PDCI pricing team for a discussion of areas of concern in the current draft of the Guidelines. Kimberly Robinson, Dylan Lamb-Palmer and Neil Palmer will lead this conversation aimed at pharmaceutical manufacturers.
1. PMPRB Has Extended The Consultation Deadline for Draft Guidelines to August 4, 2020
PMPRB has announced an extension to the consultation period for the Draft Guidelines. The deadline to submit written feedback has been changed from July 20, 2020 to August 4, 2020. Further details related to submitting a consultation response can be found on the PMPRB website linked here.
2. Impact of the recent Federal Court decision and deadline extension for written submissions
PMPRB Staff continues to evaluate the impact of the June 29, 2020 decision by Justice Manson of the Federal Court which struck down subsection 3(4) of the Amended Regulations, requiring patentees to report benefits and discounts paid to third parities. At this time, however, the Board has stated that it believes the draft 2020 Guidelines do not require any substantive changes. PMPRB invites stakeholders to share their views on how the Guidelines should reflect the judicial review decision as part of their written submission of the Guideline consultation.
Please also note that, due to the Federal Court’s summer recess, the Attorney General of Canada and IMC have until September 2020 to appeal the decision to the Federal Court of Appeal.
3. Release of the 2018 PMPRB Annual Report
The 2018 PMPRB Annual Report was released earlier this week, after a delay of over a year. Key findings of the report include:
- Canadian prices of patented medicines were at the median of the PMPRB 7 reference countries, and at the same level as UK prices.
- 2018 sales of patented medicines decreased by 0.6% compared to 2017
- Patented medicines accounted for 59% of total medicine sales in 2018, down from 61.5% in 2017
- Average transaction prices of existing patented medicines fell by 0.4% in 2018 compared to 2017, while the consumer price index rose by 2.3% during the same period.
- R&D expenditures in Canada rose by 2.4% to $ 892.6 million in 2018, while the R&D to sales ratio dropped slightly to 4.0% compared 4.1% in 2017.
Please contact Kimberly Robinson, Director of Pricing & Market Access, with any questions about new PMPRB Draft Guidelines.