The Patented Medicines Review Board and its Proposed New Regulations

The Patented Medicines Review Board and its Proposed New Regulations

On June 16, 2012, the Canada Gazette, published the proposed new regulations formalizing procedures before the Patented Medicine Prices Review Board (the Board).  These proposed new regulations represent an effort to enhance the efficiency of hearings before the Board through the formal adoption of codified practices and terminology already utilized by the board; the incorporation of relevant practices used in provincial and federal courts pertaining to expert witnesses and case management; and the amendment of various timelines.

The mandate of the Board is two-fold: Regulatory – to ensure that the prices at which patentees sell medicines in Canada are not excessive; and Reporting – to report to Parliament on the trends in pricing, research and development expenditures of patentees.  Section 96 of the Patent Act (the Act) empowers the Board, an independent quasi-judicial body, with various rights, privileges and powers parallel to that of a superior court of record.  Consequently, the Board has the capacity to issue remedial orders with respect to excessive pricing of patented medicines, and create general rules for regulating the practice and procedure of Board hearings with the consent of the Governor in Council.

Due to the growth in terms of both complexity and number of hearing, the Board has shifted its focus to its operational priority guaranteeing a transparent, efficient, and fair hearing process. The Board's objectives have catalyzed the proposed new regulations which essentially: codify practices already adopted in recent proceedings; integrate relevant procedures practiced in other judicial and quasi-judicial proceedings; and facilitate case management.  Some notable regulations include:

  • A requirement that expert witnesses appearing before the Board sign an Expert Witness Declaration form that acknowledges their duty to advance opinion evidence that is fair, objective and impartial;
  • Restrictions on the scope of expert evidence;
  • The placement of a new limit on the number of expert witnesses that are able to be called per party per issue without the permission of the Board;
  • Amendments to aid with the identification and service of documents;
  • Amended timelines for the filing of pleadings;
  • Case management conferencing to be held within 45 days of the issuance of a notice of hearing; and
  • A new requirement that the Board endeavors to issue written reasons for decisions within 180 days of completion of a hearing on the merits.

In order for the proposed rules to be implemented, the regulations would have to be communicated to stakeholders via the Board’s Web site, the quarterly NEWSletter, and the Annual Report. In regards to enforcement, as previously mentioned, the Board is an independent quasi-judicial body, with various rights, privileges and powers parallel to that of a superior court of record, and is therefore allowed to monitor the examination of witnesses, the production and inspection of documents and the enforcement of orders.  Furthermore, pursuant to section 99 of the Act, an order of the Board can be made an order of the Federal or superior court of a province and is enforceable in the same manner.

These Rules are advantageous not only to persons appearing before the Board, but also to the public, who has an interest in the Board conducting procedures fairly, transparently and efficiently, in an effort to prevent the excessive pricing of medication.  The formal adoption of the proposed new regulations will incur no additional costs to the industry, public or Government. Seemingly, the formal adoption of these proposed regulations would codify existing practices, whilst streamlining and making court practices more efficient.  It will be interesting to observe the effect that these amendments will have, if any, on the hearing process.

Tracy Ayodele is a JD Candidate at Osgoode Hall Law School.