Terms of Reference for the Human Drug Advisory Panel
As of October 2025
Table of Contents
Mandate
The mandate of the Human Drug Advisory Panel (HDAP) is to, on request, assist with scientific evaluations of patented medicines as outlined in the Guidelines for PMRPB Staff (The Guidelines). This includes assisting staff with the selection of comparators and comparable dosage regimens for the purpose of conducting a Therapeutic Class Comparison (TCC) and assigning a level of similarity in accordance with the framework outlined in the Guidelines. The approach is evidence based, and the recommendations reflect medical and scientific knowledge and current clinical practice.
Role
Section 94(3) of the Patent Act gives authority for the PMPRB to engage the services of persons having specialized knowledge to advise and assist in the performance of its duties.
Functions of HDAP
- To review and evaluate, on request, scientific information available to the PMPRB respecting patented medicines, including any submission by a rights holder with respect to the selection of medicines to be used for comparison purposes and comparable dosage regimens.
- To assist the PMPRB in identifying and seeking out other experts as necessary.
- To make recommendations, on request, respecting the selection of medicines to be used for comparison purposes and/or dosage regimens for patented medicines submitted for review by the HDAP.
- To provide, on request, advice to support the development of PMPRB policies and procedures respecting the scientific evaluation of patented medicines.
- To give, on request, written or verbal evidence under oath before the Board in the course of any proceedings under the Patent Act respecting patented medicines which have been reviewed by the HDAP.
Membership
The HDAP shall be composed of up to six members who hold qualifications as physicians, pharmacists, or other professional designations with recognized expertise in drug therapy, drug evaluation, or drug utilization and who have experience in clinical research methodology, statistical analysis and the evaluation of new medicines. Members of the HDAP generally have experience in a hospital, provincial, or national Pharmacy and Therapeutics Committee.
The names of the members of the HDAP are publicly available.
Two members of the HDAP constitute a quorum.
Appointment of HDAP Members
Members of the HDAP will be appointed by the Director General of the PMPRB. HDAP members are appointed on the basis of their individual expertise. They do not represent a business, organization or association directly, but may be linked to one or more interest groups (within the bounds of conflict-of-interest considerations).
The PMPRB endeavours to ensure that the required expertise is maintained through membership renewal. Members of the Panel are requested to serve for a minimum of one year. However, upon the PMPRB’s request Panel members may serve for several years to provide for continuity.
Organization and Structure
Each member of the HDAP has equal status. Primary and secondary reviewers may be appointed for the scientific evaluation of patented medicines.
The Regulatory Affairs and Outreach Branch provides HDAP with secretariat and administrative support to facilitate drug product review and HDAP meetings.
Referral of Medicines
The process for identification of medications that are candidates for scientific review is detailed in the current version of the PMPRB Guidelines. Staff responsible for the scientific review perform the initial scientific analysis of all approved indications for the medication under review and have the option of referral to HDAP as required.
Medicines may be referred to HDAP (all members or a subset thereof) by the Staff as per the current Guidelines at the time of referral, or on an ad hoc basis when clarification or advice is required on scientific evaluation issues (e.g., selection of drug products to be used for comparison purposes, comparable dosage regimens, and/or any other scientific evaluation issues).
Review Process
Recommendations of the HDAP will be based on the criteria set out in the PMPRB's current Guidelines when the medication is reviewed, or as otherwise set out in relevant PMPRB policies.
Board Staff will refer to the HDAP any information the rights holders choose to submit regarding the scientific review that is received within the deadlines set out in the PMPRB’s current guidelines and before the HDAP meets to reach its recommendations.
After consideration of any submission made by the rights holder; staff recommendations; publicly available scientific literature; its collective expertise; and, where necessary, the advice of other experts; the HDAP will provide its recommendations Such recommendations of the HDAP are based on a majority vote. The HDAP may call on other experts, as required, to provide additional advice in support of its analysis; these additional outside experts are not members of the HDAP and do not vote. The HDAP is not required to consult any expert recommended by a rights holder or other stakeholder.
The recommendations of the HDAP may be made available to the rights holder. The comments or recommendations of individual HDAP members are not disclosed, unless required by law.
The HDAP is not involved in mediating or resolving disputes between Staff and rights holders over the selection of drug products to be used for comparison purposes, comparable dosage regimens, or ratings of comparability relative to the medication under review.
HDAP members do not meet or discuss PMPRB-related matters with rights holders.
Frequency of Meetings
An HDAP meeting includes a meeting being held by means of teleconferences, videoconferences, or in-person.
The HDAP will meet as required. The exact dates of these meetings will be selected to ensure that all members that evaluated a drug product are available and to ensure a quorum of members.
A minimum of two meetings per year of the full HDAP is expected but will be at the discretion of the PMPRB, with the potential for more as required. The additional meetings may include the full HDAP or a subset thereof, depending on the requirements of the work.
Ad hoc teleconference or videoconference calls may be scheduled to expedite the completion of a particular review.
Conduct and Conflict of Interest
As independent contractors to the PMPRB, members of the HDAP must comply with similar standards to those established under the Conflict of Interest and Post-Employment Code for the Public Service. During their tenure, members of the HDAP will disclose direct financial support received from any pharmaceutical manufacturer for:
- Conducting clinical research;
- Giving education lectures;
- Organizing conferences;
- Writing articles or editorials; or,
- Any other activity.
The PMPRB recognizes the limited availability of expertise and the degree of specialization of the expertise sought for HDAP members. As such, conflict situations can sometimes be difficult to avoid. It is the goal of the PMPRB to identify, assess and manage these conflicts appropriately.
An HDAP member shall disclose in writing the potential for any conflict of interest at the earliest opportunity. HDAP members are required to confirm annually whether any potential conflicts of interest exist that might preclude the member from serving on the HDAP or impact their participation on the HDAP. Conflicts occurring within the last three years shall be declared as outlined below. HDAP members will be reminded that they must also disclose any relevant potential conflict of interest each time they are requested to review information respecting a particular drug product. PMPRB staff will ensure that HDAP members with a real or perceived conflict of interest will not act as the primary or secondary reviewer for a medicine for which the conflict exists. HDAP members will also be asked to disclose any conflicts of interest related to the medicines on the agenda at the commencement of every Panel meeting.
In cases where a real conflict of interest arises directly related to a medicine under review, such as where a Member:
- has a pecuniary or financial interest related to the medicine under review;
- has participated in clinical trials or other studies directly evaluating the medicine;
- received funds or honoraria for writing articles or editorials related to the medicine under review; or
- has an equity interest (other than mutual funds) in the manufacturer's company or its direct competitors,
the Panel member will recuse themself from discussions, deliberations and recommendations with respect to that medicine.
In cases where the conflict of interest may be potential or perceived, after full disclosure of the conflict, HDAP members may participate in the Panel discussion related to the medicine under review. However, the Panel member is to recuse his/herself from the final consensus decision or voting portion of the meeting. Such conflicts may include, but are not limited to:
- If they, or their group, are receiving an unconditional grant from the manufacturer or its direct competitors;
- If they are receiving compensation from the manufacturer or its direct competitors for a product unrelated to the medicine under review;
- If they have an ongoing consultancy with the manufacturer;
- If they serve on an advisory committee of such a company; or,
- Any other circumstances as identified in consultation with the Senior Director, Regulatory Affairs and Outreach.
If due to a disclosure of a conflict of interest, an HDAP member is disqualified from review of a product, the PMPRB may, if required, appoint an alternate HDAP member on a temporary basis to ensure that the opportunity exists for a majority vote to be taken respecting recommendations related to the scientific review of the product.
Confidentiality
Members of the HDAP shall respect the confidentiality of any materials or information provided by the PMPRB, including materials and/or information covered by any privilege, and those parts of the discussions dealing with confidential or privileged information. No member shall knowingly divulge any such information to any person other than another member of the HDAP or Board Staff unless the member is legally required to divulge the information, in which case the member shall inform the Senior Director, Regulatory Affairs and Outreach of the disclosure. An HDAP member shall not use information obtained as a result of his/her appointment for personal benefit. Members should avoid activities which might create the appearance that they have benefited from confidential information.
Communication with Rights Holders
In order to maintain impartiality, HDAP members have no contact with rights holders regarding PMPRB matters. An HDAP member who is contacted directly by a rights holder respecting a review of a patented medicine must advise that rights holder to contact the Regulatory Affairs and Outreach Branch directly and must advise the Senior Director, Regulatory Affairs and Outreach of the contact.