Human Drug Advisory Panel
The Board established the Human Drug Advisory Panel (HDAP) to provide recommendations for the categorization of new drug products and the selection of comparable drug products.
The mandate of the HDAP is to provide credible, independent, and expert scientific advice to the PMPRB respecting the development and application of the Guidelines as they relate to the scientific evaluation of patented drug products. The approach is evidence-based and the recommendations reflect medical and scientific knowledge and current clinical practice.
The HDAP currently has six members:
- Dr. Peter Jamieson, Associate Zone Medical Director in Calgary for Alberta Health Services and Clinical Associate Professor in the Department of Family Medicine at the University of Calgary
- Dr. Michael Rieder, Professor with the Department of Paediatrics (with a cross-appointment to the Department of Physiology and Pharmacology) in the Faculty of Medicine and Dentistry at the University of Western Ontario in London
- Dr. Adil Virani, Director of Pharmacy Services at the Fraser Health Authority and Associate Professor in the Faculty of Pharmaceutical Sciences at the University of British Columbia
- Dr. Fred Y. Aoki, Professor of Medicine, Medical Microbiology and Pharmacology and Therapeutics at the University of Manitoba
- Dr. Jacques LeLorier, Professor in the Departments of Medicine and Pharmacology at the University of Montreal and Adjunct Professor in the Department of Epidemiology and Biostatistics at McGill University
- Dr. Muhammad Mamdani, Director of the Applied Health Research Centre, Li Ka Shing Knowledge Institute at St. Michael´s Hospital, Toronto and Associate Professor in the Department of Health Policy, Management and Evaluation at the University of Toronto
Terms of Reference
Mandate
The mandate of the Human Drug Advisory Panel (HDAP) is to provide credible, independent and expert scientific advice to the PMPRB respecting the development and application of the PMPRB Guidelines related to the scientific evaluation of patented medicines. 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
1. To review and evaluate scientific information available to the PMPRB respecting patented drug products, including any submission by a patentee with respect to the proposed level of therapeutic improvement, selection of drug products to be used for comparison purposes and comparable dosage regimens.
2. To assist the PMPRB in identifying and seeking out other experts as necessary.
3. To make recommendations respecting the level of therapeutic improvement, primary use (where required) and the selection of drug products to be used for comparison purposes and dosage regimens for patented drug products submitted for review by the HDAP. The HDAP may be called upon to make advance recommendations respecting drug products for which a patent has not yet been granted (i.e. patent pending) or before the products are approved or put on the market, provided sufficient information is available to complete a reasonable assessment.
4. To provide advice to support the development of PMPRB policies and procedures respecting the scientific evaluation of patented drug products.
5. 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 drug products which have been reviewed by the HDAP.
Membership
The HDAP shall be composed of up to six members who hold qualifications as a physician, a pharmacist or other professional designation with recognized expertise in drug therapy and who have experience in clinical research methodology, statistical analysis and the evaluation of new drugs. Members of the HDAP have usually had experience on a hospital or provincial Pharmacy and Therapeutics Committee.
The names of the members of the HDAP are publicly available.
Appointment of HDAP Members
Members of the HDAP will be appointed by the Executive Director 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 conducts an annual review of HDAP 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 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.
New Medicines
Subsection C3.2 of the PMPRB's Compendium of Policies, Guidelines and Procedures sets out that:
In general, new patented drug products are referred to HDAP. However, the following new patented drug products will not be referred to HDAP unless the patentee files a submission claiming therapeutic improvement:
The new patented drug product represents a new DIN of an existing dosage form of an existing drug product, or a new DIN of another dosage form of the existing drug product that is comparable to the existing dosage form as per Schedule 2 of the Compendium of Policies, Guidelines and Procedures and has the same indication or use as the existing DIN; or
- The new patented drug product is a combination drug product, the individual components of which are sold in Canada and have the same indication or use; or
- The new patented generic drug product is considered by Health Canada to be bioequivalent to the reference brand drug product sold in Canada; or
- The new patented generic drug product is a licensed version of an existing brand drug product sold in Canada.
Existing Medicines
These products will be referred to the HDAP by the Board Staff when clarification or advice is required on scientific evaluation issues (e.g., level of therapeutic improvement, selection of drug products to be used for comparison purposes, comparable dosage regimens and any other scientific evaluation issues).
Review Process
Recommendations of the HDAP will be based on the criteria set out in the PMPRB's Compendium of Policies, Guidelines and Procedures. Board Staff will refer any information submitted on time by the patentee to the HDAP for review before the HDAP reaches its recommendations. This provides for fairness to the patentee, but also serves to expedite the process. If following the HDAP review, the patentee provides new and important information, the HDAP will be asked to consider this information.
After consideration of the patentee's submission, publicly available scientific literature, its collective expertise, and where necessary the advice of other experts, the HDAP will provide its recommendations as considered appropriate. Each member of the HDAP conducts an independent review of the drug product which will be discussed during the HDAP meetings or conference calls. 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 patentee or other stakeholder.
The recommendations of the HDAP are made available to the patentee (HDAP Report). The comments or recommendations of individual HDAP members are not disclosed.
The HDAP is not involved in mediating or resolving disputes between Board Staff and patentees over a medicine's level of therapeutic improvement, selection of drug products to be used for comparison purposes or comparable dosage regimens. HDAP members do not meet or discuss PMPRB related matters with patentees.
Reporting of Results
The recommendations of the HDAP will be included in the information that is reported on the PMPRB website once the review has been completed.
Duration and Frequency of Meetings
An HDAP meeting includes a meeting being held by means of face-to-face meetings, teleconferences or videoconferences.
The HDAP will meet as required, generally holding one face-to-face meeting per year. The exact date of the face-to-face meeting will be selected so as to ensure that all members that evaluated a drug product are available and to ensure a quorum of members.
Three additional meetings will be held by teleconference or videoconference. The exact dates of these meetings will be selected so as to ensure that all members that evaluated a drug product are available and to ensure a quorum of members. Documentation of discussions which take place in this manner will be the same as for the face-to-face meetings.
Ad hoc teleconference calls may be scheduled to expedite the completion of a particular review.
Location of Meetings
HDAP meetings will take place on PMPRB premises in Ottawa.
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:
a. Conducting clinical research;
b. Giving education lectures;
c. Organizing conferences;
d. Writing articles or editorials; or,
e. Any other activity.
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 that no potential conflict of interest exists that might preclude the member from serving on the HDAP. HDAP members will be reminded that they must disclose any relevant potential conflict of interest each time they are requested to review information respecting a particular drug product.
HDAP members shall not participate in a review for the PMPRB of any pharmaceutical product in which he/she has a financial or other interest, including circumstances where:
a. If they, or their group, are receiving a grant from the manufacturer or its direct competitors;
b. If they are receiving compensation from the manufacturer or its direct competitors;
c. If they have an equity interest (other than mutual funds) in the manufacturer's company or its direct competitors;
d. If they have an ongoing consultancy with the manufacturer;
e. If they serve on an advisory committee of such a company; or,
f. any other circumstances.
When performing an evaluation, HDAP members will, whenever possible, use data published in peer reviewed journals or in publications that have a policy governing conflict of interest.
Declared conflict of interest shall be recorded in the minutes respecting discussion of the review of a drug product. 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 are expected to respect the confidentiality of any materials provided by the PMPRB and those parts of the discussions dealing with confidential 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. 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 Patentees
In order to maintain impartiality, HDAP members have no contact with patentees regarding PMPRB matters. An HDAP member who is contacted directly by a patentee respecting a review of a patented medicine must advise that patentee to contact the Regulatory Affairs and Outreach Branch directly and must advise the Director of the Regulatory Affairs and Outreach Branch of the contact.