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PMPRB Annual Report 2007
PMPRB Annual Report Tabled in Parliament:
Pharma Trends:
- Since 1997, sales of patented pharmaceuticals has more than tripled. Declined in 2007, as a percent of total pharma sales. (Table 8)
- Price has had a negative effect overall on revenue growth (Table 9). Patented Medicine Price index decreased in 2007 (Figure 5), despite +ve inflation.
- However, prices to pharmacies and wholesalers rose overall offset by a substantial decrease in prices to hospitals. (Figure 7)
- European prices are well below Canadian prices. US prices remain above Canadian prices (Figure 11)
R&D to sales ratio (Table 17) increased to 8.3% of all patentees and to 8.9% for Rx&D patentees. 2006 saw the lowest ratios since 1989.
Failure to File:
- In 2007 there were 5 new drug products which failed to report complete information within the time frames specified in the Regulations. No Board Orders were issued with respect to failure to file, although 2 Notices of Application were made by the Board Staff requesting a Board Order in the matters of Celgene and Apotex to file information regarding their patented medicines.
New Medicines in 2007:
- In 2007, the HDAP reviewed a total of 50 new drug products.
- There were a total of 64 new patented medicines that came under the PMPRB’s jurisdiction in 2007, 20 of which were new active substances, representing 34 drug products. 11 new drug products and 4 new active substances were sold prior to 2007.
- Of the new active substances reviewed in 2007, 3 were category 2, 13 were category 3, and 4 were not yet categorized as of March 31, 2008.
- As of March 31, 2008, 43 were within guidelines, 6 were under investigation, and 11 were still under review.
- OTC and Vet products are no longer reviewed except when a complaint is received.
Existing Drug Products in 2007:
- There were 1,114 existing drug products (DINs) in 2007.
- Of these, 88% were within guidelines, 2% were under review, 9% were under investigation, and 2% were subject to a hearing.
CDR/PMPRB:
- Of those products with a positive CDR recommendation (13), 77% were within guidelines, 8% were under investigation, and 15% were not under PMPRB jurisdiction.
- Of those products that received a negative CDR recommendation (13), 46% were within guidelines, 23% were under investigation, and 15% were not under PMPRB jurisdiction.
9 VCUs were approved in 2007 - 3 following an issuance of notice of hearing and one as a result of a Board Order.
13 Active Notices of Hearing during 2007. Table 7 provides a summary of all the Board Staff Hearings. A few highlights below:
- Adderall XR (Shire Canada Inc.) - Decision made, but order not yet issued. Shire has appealed the Federal Court decision to include patent pending period.
- Apotex Inc. - Notice of Hearing issued with a pre-hearing conference on October 6, 2008.
- Concerta (Janssen-Ortho Inc.) - Board Decision is pending
- Copaxone (Teva Neuroscience) - Decision rendered - judicial review sought.
- Nicoderm (Hoechst Marion Roussel Canada) - After 9 years since the Notice of Hearing was issued (April 1999), the Hearing Panel will hear the parties on this matter on July 3, 2008.
- Penlac (sanofi-aventis Canada Inc.) - The Hearing Panel will complete the evidentiary portion of this hearing on July 14-15 and hear final arguments on August 20.
- Quadracel and Pentacel (sanofi pasteur Ltd.) - Hearing is ongoing.
- Strattera (Eli Lilly Canada Inc.) - Hearing dates have not yet been scheduled.
- Thalomid (Celgene Corp.) - On January 21, 2008 the Board ruled that it has jurisdiction over Thalomid. Celgene Corp has filed a Notice of Application with the Federal Court for a judicial review. Hearing dates have not been scheduled.
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