The Patented Medicine Prices Review Board (PMPRB) has announced revised proposals to amend the Patented Medicines Regulations, 1994. The revised proposals were published in the Canada Gazette, Part I on Saturday, October 6, 2007 in the form of a notice of proposed regulations by the Governor in Council under section 101 of the Patent Act. Interested parties have been given 15 days, until October 22, 2007, to make written submissions to the Secretary to the Board.

The Regulations set out the requirements for patentees to file information on the prices and sales of patented medicines and other information to the PMPRB. The Board initially proposed substantive changes to the Regulations almost two years ago, on December 31, 2005. Patentees raised a number of concerns about those proposals and the PMPRB held further consultations with Canada's Research-based Pharmaceutical Companies (Rx&D), BIOTECanada and the Canadian Generic Pharmaceutical Association.

Although the proposed regulation withdraws or modifies some of the more contentious proposals previously advocated by the PMPRB, it would require patentees to report information on the "type" of rebates or discounts they provide. The current regulations provide that patentees report the average price or net revenue from sales of patented medicines after "any reduction given as a promotion or in the form of rebates, discounts, refunds, free goods, free services, gifts or any other benefit of a like nature." The proposed changes would now also require that patentees indicate the "type" of reduction given. The 2005 proposal had included the requirement to identify and report "the amounts and types of benefits deducted," but the new proposal would only require information on the "types" of benefits and not on the "amounts."

Despite complaints by patentees that the requirement to report more information on reductions would impose an onerous burden on them, the PMPRB takes the position that it needs to be assured that only allowable deductions are being claimed and that having information on the types of benefits would assist in determining that reporting is consistent and complete. The purpose is further explained as "to reinforce for patentees the importance of ensuring correct data filings especially regarding the quantity of products associated with discounts, rebates, free goods, etc." even though the requirement is to report only types and not amounts.

It is proposed that the requirement to file information concerning types of benefits will not come into force until July 1, 2008. The Board will also amend the current Form 2 on which patentees report price and sales information to add a column into which they would enter appropriate codes to indicate the type of reduction included.

Another change would require patentees to submit a copy of the product monograph when they file "medicine identification" information (Form 1) to the Board. Where patentees begin selling the medicine before an NOC, they would be required to file "information similar to that contained in a product monograph." This latter provision replaces an original proposal to require filing of a draft product monograph. It is not clear what "similar" information the Board would expect a patentee to file in these circumstances.

The latest proposals would also shorten the time period for filing a Form 1. Currently, patentees have 30 days from the date of issuance of the NOC or first sale, whichever comes first. The new proposal would shorten that time to seven days. Initially the Board had wanted to shorten it to one day. There would also be a reduction in the time period covered by the first report on prices and sales. Currently, patentees are required to report price and sales information for the first 30 days of sales of the patented medicine within 30 days, i.e. 60 days after the first sale. Under the new provisions, patentees would be required to report the first day's sales within 30 days. Initially, the Board had proposed to require reporting of the first day's sales within one day.

Although the proposed regulation includes certain controversial changes, others which the PMPRB originally proposed have been modified or dropped. The original proposal to require patentees to file information on patent applications has been abandoned and the time period for reporting the semi-annual price and sales information has not been reduced. Those deadlines remain the same, within 30 days of the end of the January to June and July to December periods. The original PMPRB proposals to require the reporting of proposed price increases have also been excluded from the proposed regulation.

The proposed regulation includes non-controversial proposals previously put forward to reduce the filing requirements for OTC drugs and for veterinary drugs in order to permit a complaints-based approach. In these cases, patentees would no longer be required to file price and sales information on a regular basis but would be expected to do so within 30 days of a request from the Board.

The proposals also include a number of "housekeeping" changes including requiring that all filings be made electronically in the future. This latter change will also only become effective on July 1, 2008.

Except where indicated, the proposed changes would come into effect as soon as the proposed regulations are approved.

For further information, please visit: