PMPRB seeks feedback on Guideline Monitoring and Evaluation Plan

The PMPRB announced a new initiative called the Guideline Monitoring and Evaluation Plan (GMEP), through which the PMPRB will seek to "monitor and evaluate trends in the pharmaceutical market that may impact patentees, as well as the consumers, patients and payers that they are mandated to protect."¹

The new initiative "will analyze trends in the pharmaceutical market before and after the implementation of the new [patented medicines] framework [on July 1, 2021²,] to assess whether it is working as intended, and to inform the need for any future adjustments." While it is not the first evaluation plan of its kind, the PMPRB says that it will be the most comprehensive due to the "unparalleled scale and scope of the changes reflected in the new Guidelines."

The proposed GMEP will assess four key areas:

1. Prices of medicines, which will include:
   • Assessment of Canadian price ceilings, list prices and average transaction prices, and
   • Alignment between the estimated therapeutic value of medicines and their Canadian prices.
2. Access to medicines, which will include:
   • Clinical trial intensity,
   • Availability of new medicines, and
   • System coordination: health technology assessment, price negotiation and reimbursement.
3. The pharmaceutical ecosystem, which will include:
   • Drug spending;
   • Research and development; and
   • Economic footprint.
4. PMPRB processes, which will include:
   • Administrative burden
   • Patentee filing compliance
   • Compliance and enforcement activities
   • Scientific review; and
   • Price tests application.

"For each of these four areas, the PMPRB, in consultation with its stakeholders, will identify relevant indicators to monitor. Baseline results (benchmarks) will be generated based on the years immediately preceding the coming-into-force of the amended Regulations. Starting with 2022, changes will be monitored on an ongoing basis and compared to the benchmarks to identify and evaluate any relevant changes in the trends in the data."

Stakeholders are invited comment on the outline by submitting feedback via the online feedback form by June 21, 2021.

[2] The patented medicines regime is undergoing an overhaul in Canada. The revised framework includes amendments to the Patented Medicines Regulations and the issuance of revised PMPRB Guidelines. The new framework is expected to come into force in July 2021. See our previous article on the revised PMPRB Guidelines: Amendments to the Patented Medicines Regulations Delayed by 6 months, until July 1, 2021.