|
Amendments to Patented Medicines Regulations, Responses to Discussion Paper, Apotex Hearing, and VCUs
Amendments to the Patented Medicines Regulations, 1994
The PMPRB yesterday published Amendments to the Patented Medicines Regulations, 1994 in the Canada Gazette, Part II (http://canadagazette.gc.ca/partII/index-e.html). The following table (also attached separately) compares these amendments with the 3 previous rounds of proposed changes. Note that patentees are now required to file all forms electronically using the electronic forms available on the PMPRB’s web site.
| Proposed amendments Jan 05 |
Updated proposed amendments Dec 05 |
Further updated proposed amendments October 2007 |
Regulations Amendments Canada Gazette Part II March 2008 |
| Notification of proposed price filed 60 days prior to first sale |
Removed |
Removed |
Not implemented |
| Notification of a proposed price increase 120 days prior to the effective day of increase |
Notify PMPRB as soon as possible after a note is sent to any class of customers in any province about the price increase |
Removed |
Not implemented |
| Details on the calculation of net price and net revenues – amounts and types of benefits to be reported |
A column with explanatory notes (identifying the type of each transaction) is to be added to the Form 2 – codes provided for every type of transactions related to “any amounts” |
Proposed amendments have been changed so that patentees would be required to report the types of benefits deducted in the average price calculation but not the amounts of each benefit – change, if approved, will come into force July 1, 2008 |
Not implemented |
Product monograph
/draft monograph submitted automatic-
ally |
A product monograph should be filed along with the Form 1 within the earlier of 7 days after NOC or 1 day after first sale in Canada |
Filing of draft monograph removed and replaced by filing of “information similar to that contained in a product monograph” This is when a NOC is not issued yet. For products with NOC, a product monograph should be filed |
Product monograph to accompany Form 1, or information similar to that contained in a product monograph if NOC has not yet been issued. |
| Recognition of electronic signatures |
No mention |
Electronic signatures accepted and will be mandatory - change, if approved, will come into force July 1, 2008 |
Filing must be made using electronic forms on the Board’s web site and sent by email in original format and file type, bearing electronic signature. Comes into force July 1, 2008. |
| Other minor changes |
Form 1 to include the patent application number and the date of filing of each patent application pertaining to the medicine |
Removed |
Not implemented |
| Other minor changes |
Form 1 due the earlier of seven (7) days after receipt of NOC or one (1) day after the first sale |
Form 1 due the earlier of seven (7) days after receipt of NOC or seven days (7) days after the first sale |
Form 1 due the earlier of seven (7) days after receipt of NOC or seven days (7) days after the first sale |
| Other minor changes |
Form 2 due one (1) day after the first sale [currently this includes the first 30 days of sale] and 15 days after the end of each reporting period [currently this is due 30 days after the end of each reporting period] |
Form 2 due 30 days after the first sale and should include the first day of sales only [currently this includes the first 30 days of sale and is due 30 days after the end of the first 30 days of sales period]. For the semi-annual data filing, the 15 days after the end of each reporting period has been removed and reverted back to the current status of filing semi-annual data 30 days after the end of this period |
Form 2 to include the date on which the medicine is first sold in Canada.
Form 2 due 30 days after the first sale and should include the first day of sales only, and after the end of each 6-month period ending June and Dec.
Form 2 to be filed only for drugs for human use (excluding OTC and vet drugs). |
| Vet and OTC drugs filed on a complaints-basis. |
Unchanged |
Unchanged |
Form 2 filed only as response to complaint, for 2 years following the request to file. |
Responses to Discussion Paper
All responses to the PMPRB’s January 2008 Discussion Paper have been posted on the Board’s web site:
http://www.pmprb-cepmb.gc.ca/english/View.aspx
Apotex Hearing
A Notice of Hearing has been issued in the matter of Apotex Inc, a generic manufacturer. The Notice of Application requires Apotex to disclose if it is entitled to any benefits as a patent owner or is entitled to exercise benefits, and to provide Board Staff with any information pertaining to those patented medicines (Forms 1, 2, and 3) pursuant to Section 80(1) of the Patent Act and the Patented Medicines Regulations. No dates for a hearing have been set.
VCUs
- Lantus (Sanofi-aventis Canada Inc.) – On March 4, Sanofi-Aventis signed a VCU agreeing to bring the price of the Lantus cartridge in compliance with the MNE, and to offset excessive revenues of $694,239 by making a cheque to the government, and of $3,969,555 by lowering the price of Altace HCT. Any remaining excess by the end of 2008 will be paid by cheque to the government within 30 days.
- Vaniqa (Barrier Therapeutics Canada Inc.) – On February 8, Barrier Therapeutics signed a VCU agreeing to pay back excessive revenues of $70,860 by cheque to the government. Vaniqa is no longer sold in Canada since December 2007.
PMPRB Fundamentals Seminar
Our next semi-annual "PMPRB Fundamentals" seminar will be held in May of 2008 in Montréal and Toronto.
Montréal – Thursday, May 1
Toronto – Friday, May 2
To register, please go to: http://www.broganinc.com/english/seminars/pmprbF.html
|
