Those in the pharmaceutical and biologics industry should be aware of recent changes to reporting requirements and deadlines under the Patented Medicines Regulations that came into force on March 6, 2008. Other changes, dealing with e-filing requirements, will come into effect on July 1, 2008. The stated objective of the amendments is to "increase efficiency and timeliness in the price review process by the Patented Medicines Prices Review Board (PMPRB)."
The PMPRB is the administrative body that oversees the regulations, which were originally enacted to control excessive pricing of patented medicines in Canada. Currently, patentees need to file certain information with the PMPRB for any medicines where a patent is being practiced or is capable of being practiced with respect to the medicine, whether the patent is actually being used or not. Although excessive pricing can be reviewed back to the date of publication of a patent, case law has made clear that the PMPRB cannot assert its jurisdiction with respect to excessive pricing until a patent has issued.
To facilitate compliance with the information requirements under the regulations, the PMPRB developed three key forms. These forms summarize the type of the information that patentees are required to file:
- Form 1: Medicine Identification Sheet,
previously required to be filed 30 days after issuance of a
Notice of Compliance (NOC), or 30 days after a patented drug
product has been offered for sale in Canada, whichever came
first.
- Form 2: Information on the Identity and
Prices of the Medicine, filed according to the timelines
described in Form 1.
- Form 3: Annual Revenues and Research and
Development Expenditures, formerly required to be filed 60
days after the end of the calendar year.
The main changes to the regulations are:
- Form 1 — the first information regarding the
patented medicine must be provided within the earlier of
seven days of issue of an NOC or seven days of first sale of
the medicine. This information must also be accompanied by
the product monograph or equivalent information. Updates to
Form 1, such as new patents granted, can still be provided
within 30 days of grant.
-
Form 2:
- Information pertaining to the identity and prices of
a patented prescription medicine for human use
shall now be provided for the day on which the medicine
is first sold in Canada within 30 days after that
day.
- Information pertaining to the identity and prices
for veterinary and over-the-counter medicines
shall now be provided on a complaints-based approach.
Under this approach, a patentee shall provide to the
PMPRB the necessary information for each six-month period
beginning on January 1 and July 1 of each year, within 30
days after the date on which the PMPRB sends a request in
response to a complaint about the price of a medicine,
and during the two years following the request within 30
days after each six-month period.
- Information pertaining to the identity and prices of
a patented prescription medicine for human use
shall now be provided for the day on which the medicine
is first sold in Canada within 30 days after that
day.
- New e-filing requirements apply to the information that
must be provided to the PMPRB. Patentees will need to provide
information to the PMPRB using a specified electronic
document in its original format and file type, bearing the
electronic signature of an authorized individual certifying
that the information contained in the document is true and
complete. These e-filing requirements will come into effect
on July 1, 2008.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
