PMPRB reporting season has been a semi-annual event for Canadian patentees for more than two decades. The mandatory reporting provides necessary information for PMPRB to fulfill its mandate: both to ensure patented drug prices are not excessive relative to those in other comparable jurisdictions, and to report to Parliament on price trends of patented medicines in Canada.

Depending on the nature of a patentee’s Canadian pricing strategy, the Form 2 Block 4 and 5 data filings may be a complex but necessary administrative exercise for a typically compliant roster of patented medicines. For other patentees, closely monitoring Canadian and international prices (as well as currency exchange rates) throughout the year can make the critical difference between a compliance checkmark from PMPRB and costly investigations and potentially large excess revenues to repay. These days, as significant amendments to the Patented Medicines Regulations are forthcoming, even those patentees for whom Form 2 filings have been a relatively routine exercise will need to take a much closer look at their Form 2 reporting practice to ensure they stay on the right side of PMPRB’s rules into 2018 and beyond.

With more than 30 years of collective experience with PMPRB Semi-Annual Compliance reporting, PDCI’s pricing experts have put together the below Top 5 tips to effectively handle a patentee’s Semi-Annual Filing Season.

1. Start Early: If a potential pricing issue is on the horizon, it is important to identify it early. More time means
   1. the ability to accurately assess the magnitude of the issue;
   2. more levers available for the patentee to potentially address the issue;
   3. more time to thoughtfully consider strategic options and their implications;
   4. more time for the strategy to be approved and effectively executed prior to the end of the reporting period.

PDCI recommends starting the process for H1 reporting by May 1 (due to PMPRB end of July each year), and by October 1 for the year end reporting (due to PMPRB end of January each year).[1]

2. Do Spring Cleaning: Regular maintenance can ensure the PMPRB reporting remains smooth year over year. Do an annual inventory check to ensure you are reporting all products that fall under PMPRB jurisdiction. If you have Canadian sales for products you have NOT been reporting to PMPRB, ensure that they clearly do not fall under PMPRB jurisdiction and seek assistance from your legal department (See #3) to confirm if patents pertain. You want to be sure there are no potential large Failure to Report issues that have gone unnoticed, not to mention potential excess revenues that would be associated with drugs that had not been reported. Also check that you do not report products that are NOT under PMPRB jurisdiction and inform PMPRB when products go off-patent or no longer require reporting for any other reason.

Remember also, that even if you’ve recently completed a first day of sale notification (Form 1) for a new product, it will still need to be added and reported in your semi-annual filing. It is important to still verify the PMPRB reference countries in the event there was a price increase since submitting the first day of sale.

3. Engage Internal Stakeholders (Local & Global if necessary): While Canadian patentees’ local pricing staff are often responsible for research, analyzing, and submitting the semi-annual reports, information may be required from other departments to effectively complete the filing. For example,
   1. The finance department typically must gather appropriate sales data to inform Form 2 Block 4 reports;
   2. Patentee lawyers may assist to determine if a product is patented and falls under PMPRB jurisdiction;
   3. Assistance from other affiliates (e.g. in PMPRB7 countries) may help with price research.

Reaching out to these stakeholders early in the process (See #1) will be greatly appreciated.

4. Keep on top of frequent PMPRB policy & reporting procedure changes: Perhaps the most challenging these days given competing demands of pricing staff throughout the year, it is necessary to remain up to date on the many changes that can affect how reporting is done. Some tips include:
   1. Familiarize yourself with the PMPRB published formulas and recognized sources for foreign price verification which PMPRB updates annually;
   2. Attend PMPRB Outreach Sessions;
   3. Review recent PMPRB Voluntary Compliance Undertakings (VCU) and hearing decisions to assess how interpretations of the reporting rules may affect your products and compliance status.

5. Think strategically
   1. Ensure your filings are consistent between Block 4 and Block 5 and between one reporting period and the next;
   2. When a potential compliance issue is identified be sure you know all the options available to address it.

Bonus tip: Don’t forget Form 3. With the hustle and bustle of completing the full year filing in January each year it is easy to put the data away until the mid-year filing is due, but Form 3 presenting R&D expenditures to sales ratios, comes due at the end of Q1 each year.

PDCI’s PMPRB Semi-Annual Filing team includes:
Nancy Paul Roc, Associate Director, Pricing & Market Access
Jean-François Belanger, Manager, Information Systems & Pricing Analytics
Jennifer Mathews, Pricing Data Analyst

[1] Note: We recommend allocating more time for the full year reporting because PMPRB will review compliance based on the full year of sales, meaning any potential compliance issues identified in the first half of the year can still be resolved in the second half of the year, whereas if a compliance issue is identified in the second half of the year, the patentee may be better positioned by choosing to resolve it prior to December 31.