Independent Review (PBS) - Instructions for Reviewers
Page last updated: 18 January 2018
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).
An independent review is 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), or 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 can be Information for Applicants Seeking Independent Review (PBS) page.
Conduct of the review
You are required to consider all available documents, information and other written material relating to the issues in dispute that were made available to the PBAC. No new information beyond that which was provided to the PBAC can be considered by the review.
You should focus your consideration on the issues identified by the sponsor and not comment on the recommendation(s) made by the PBAC. The review will thus function as a ‘second look’ at the issue(s) in dispute, meaning that the Final Review Report is advisory in nature and as such is for the consideration of the PBAC, as well as, 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 unforeseen 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.
Timelines and Reviewer’s Deliverables
The dates stipulated in your Contract in relation to Services for the Independent Review (PBS) (‘Contract’) for the completion and delivery of the progress reports, the Draft Review Report and the Final Review Report are critical and non-negotiable given the timeframes involved with the PBAC meeting cycle and processes.
You will need to provide the progress reports to the Convenor by email and/or telephone conference by the end of the fifth and tenth weeks of the Review. You will also need to complete and deliver the Draft Review Report and the Final Review Report by the dates specified in your Contract.
The Draft Review Report and the Final Review Report require a description on the general process of the review and must focus on the specific matters in dispute. Where possible you are encouraged to utilise the Suggested Template and the structure and format contained therein to record your findings. Any person(s) consulted in the context of the review will need to be identified in the Draft Review Report and Final Review Report.
Reviewer’s attendance at the PBAC
The Final Review Report will be provided to the PBAC who will reconsider the sponsor’s original application in light of the review findings. 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.
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 undertake the review with the upmost 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 the review.
As a reviewer, you should be aware that the sponsor will be informed of your identity once you have agreed to undertake the review and have signed the Contract. Under no circumstances should you initiate contact with the sponsor,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.
Where there are disparate issues in contention or if a reviewer identifies issues subject to review that s/he believes are outside his/her areas of expertise, the Convenor may at his/her absolute discretion decide to contract a Secondary Reviewer. If a Secondary Reviewer is appointed that person will be required to work in conjunction with, and not independently of, you as the Reviewer.
If a Secondary Reviewer is appointed you will continue to have overall responsibility for the review and will have some additional responsibilities. In particular you will be required to ensure the quality and completion of the Secondary Reviewer’s deliverables and provide feedback and comments to the Secondary Reviewer on these deliverables as appropriate. You will also be expected to incorporate and summarise the findings of the Secondary Reviewer into the Final Review Report and make the Secondary Reviewer’s Final Report an attachment to the Final Review Report. Further information about these additional responsibilities is contained in the Contract.
Please refer to the PDF version for the suggested template.
If you are having problems downloading the PDF documents please send an email to email@example.com.