Instructions for Secondary Reviewers and Suggested Template
Independent Review (PBS)
The Independent Review (PBS) was established as part of Australia’s implementation of the pharmaceutical provisions of the Australia-United States Free Trade Agreement (AUSFTA).
From 1 January 2005, independent review has been available to any applicant whose submission to the Pharmaceutical Benefits Advisory Committee (PBAC) has not resulted in a recommendation to list the drug on the Pharmaceutical Benefits Scheme (PBS). From the July 2006 PBAC meeting, independent review is also available where the PBAC has declined to recommend an extension of the listing of an already listed drug.
Further information on the eligibility requirements for independent review is contained in the document Information for Applicants Seeking Independent Review (PBS) (PDF 84 KB) .
Conduct of the Secondary Review
You have been appointed as a Secondary Reviewer because there are disparate issues in contention and/or because the Reviewer has identified issues that are subject to review that s/he believes are outside his/her areas of expertise, and the Convenor has in his/her absolute discretion decided to appoint a Secondary Reviewer.
As a Secondary Reviewer you are required to work in conjunction with, and not independent of the Reviewer who will have the overall responsibility for the review. As part of this arrangement you are required to consider all available documents, information and other written material that the Convenor has provided to you. No new information beyond that which has been provided by the Convenor can be considered by you in your work as a Secondary Reviewer.
You should focus your consideration on the issues identified by the Convenor for your review and not comment on the recommendation made by the PBAC. The review will thus function as a ‘second look’ at the issue(s) in dispute that are within the scope of the review. This means that your final report is advisory in nature and as such is for the consideration of the PBAC preceded if applicable by the PBAC Drug Utilisation Sub-Committee and/or the PBAC Economics Sub-Committee.
If during the course of the review you encounter any unforseen events or circumstances that may or will affect your ability to conduct the review you should immediately notify the Convenor of the Independent Review (PBS).
Should you believe that clarification is required on any matter/s you should contact the Convenor in the first instance. The Convenor will then determine if, and in what circumstances clarification will be sought and will make the necessary arrangements to enable this to proceed.
The following deliverables must be delivered to the Reviewer and copied to the Convenor by the stipulated dates in your Contract in relation to Services for the Independent Review (PBS) (‘Contract’) (PDF 431 KB)
- Weekly Progress Reports;
- Secondary Reviewer’s Draft Report; and
- Secondary Reviewer’s Final Report.
The Reviewer may provide feedback and comments to you on these deliverables as appropriate. The Reviewer will also incorporate and summarise the findings of your Final Report
into the Final Review Report
that s/he is responsible for. The Reviewer will also make your Final Report
an attachment to the Final Review Report
Further information about your responsibilities as a Secondary Reviewer is contained in your Contract.
Timelines and Reviewer’s Deliverables
The dates stipulated in your Contract for the completion and delivery of the progress reports, the Draft Report
and the Final Report
are critical and non-negotiable given the timeframes involved with the PBAC meeting cycle and processes.
The Secondary Reviewer’s Draft Report
and the Final Report
require a description of the general process of the review and must focus on the specific issues that you are considering as a Secondary Reviewer. Where possible you are encouraged to utilise the Suggested Template
and the structure and format contained therein to record your findings. Any person(s) that you consult as part of your work as a Secondary Reviewer will need to be identified in your Draft Report
and Final Report
Secondary Reviewer’s attendance at the PBAC meeting
The Secondary Reviewer’s Final Report
will be provided by the Convenor to the PBAC who will reconsider the sponsor’s original application in light of findings from the review. The sponsor will also be asked to provide comments on your findings to the PBAC. To facilitate this process you may be asked to attend a PBAC meeting to present and discuss your findings on the work you completed on the review.
You will be contacted by the Convenor if you are required to present and discuss your findings at the PBAC meeting. At this time the Convenor will also provide you with details on the PBAC meeting and travel arrangements.
Professional and Confidentiality requirements
Under the Contract, you must complete the work you are required to undertake for the review with a high level of professional skill, competence, care and diligence. As part of this requirement you must ensure the confidentiality and security of all the material that is supplied to you, and produced by you, as part of your work for the review.
You should be aware that the sponsor will be informed of your identity once you have agreed to be a Secondary Reviewer and have signed the Contract. Under no circumstances should you initiate contact with the sponsor or the Department or another party. The sponsor should not under any circumstances contact you directly. If you are contacted by a sponsor or another party you should immediately notify the Convenor.
You are reminded that you are not permitted to publicly discuss the review, the review process or the selection process for reviewers.
Conflict of interest
A conflict of interest arises where there is a reasonable concern that a person’s performance of his or her duties in one capacity may be affected by other interests. This may be found where a person has an interest of their own in a matter which may affect or be perceived to affect their obligations in undertaking a review. A conflict may also exist where a person has a duty or loyalty to a person or organisation which may affect or be perceived to affect his or her obligations as a reviewer.
If, during the course of the review you believe you have acquired a direct or indirect pecuniary interest, or other conflict of interest, in a matter that is being considered, you must immediately notify the interest to the Convenor and you should not proceed further with the review unless, or until, you receive the approval of the Convenor.
Please refer to the PDF version for the suggested template.
If you are having problems downloading the PDF documents please send an email to firstname.lastname@example.org
for a copy to be sent to you.
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Page currency, Latest update: 27 July, 2006