Price Disclosure Dispute Resolution Administrative Process
Page last updated: 13 July 2017
The Price Disclosure process is provided for by the National Health Act 1953 (the Act), and the National Health (Pharmaceutical Benefits) Regulations 2017 (the Regulations). The legislation provides the requirements of Price Disclosure for both the Department of Health (the Department) and the Responsible Person.
While dispute resolution is not contained within the Act or Regulations, in February 2011 the Department agreed the Price Disclosure Dispute Resolution Administrative Process with industry representatives at the meeting of the Price Disclosure Working Group. While Responsible Persons will have the right to raise a dispute, it should be noted that a dispute is a serious matter which involves a number of formal steps. These are presented below.
To further reduce the likelihood of dispute, the following measures have also been implemented:
- Data collection and Price Disclosure calculations have been outsourced to an independent service provider, Australian Healthcare Associates (AHA), the Price Disclosure Data Administrator (PDDA).
- All Price Disclosure calculations will undergo quality assurance checks by an independent third party, Pitcher Partners.
- The Department has provided industry with opportunities to gain further understanding of price disclosure and its requirements through meetings of the Price Disclosure Working Group and in Price Disclosure Educational Workshops, with the aim of decreasing the risk of potential errors in data collection and submissions.
- The PDDA has developed software (the Price Disclosure Submission Utility or PDSU) for Responsible Persons to easily and directly submit, review and check the status of data. The PDSU provides a highly secure environment for the submission and transfer of data.
- All Data submissions will continue to be accompanied by a declaration from the Responsible Person’s Authorised Representative stating that the information provided in the submission is true, complete and accurate.
- Confirmation reports for data submissions will continue to be sent to Responsible Persons within two working days* of receipt of submission. Data in confirmation reports is used in the Price Disclosure calculations.
- The PDDA will perform data analysis checks on data submissions to try and identify anomalies and possible discrepancies.
- Responsible Persons are encouraged to contact the Department informally in circumstances where there are questions regarding an outcome, prior to a formal dispute being raised (between steps one and two).
* Working days exclude all weekends, recognised public holidays and the Department of Health shutdown period between Christmas and New Year’s Day.
The Price Disclosure Dispute Resolution Administrative Process
The Price Disclosure Dispute Resolution Administrative Process provides guidance for both industry and the Department, allowing a streamlined approach to the prevention and resolution of possible disputes that may arise.
The process is outlined on the diagram above and is as follows:
Following notification by the Department (via publishing on the FRLI/ComLaw website and the PBS website) of price disclosure outcomes, a Responsible Person identifies an issue.
Responsible Persons need to formally lodge a dispute in writing to the Department, including the nature of the dispute, within five working days*of the outcome being published on the FRLI/ComLaw website and the PBS website.
The Responsible Person will receive written confirmation from the Department that the dispute will be considered under the Price Disclosure Dispute Resolution Administrative Process. The Department will notify all affected Responsible Persons within three working days* of the receipt of the initial dispute.
The Department will provide the Responsible Party raising the dispute with an additional five working days* from the date the initial dispute was lodged, to provide further data supporting the claim. The Responsible Person which lodged the dispute may subsequently decide to withdraw the dispute, upon further consideration of the evidence. This should be formally notified to the Department so that all affected Responsible Persons are then notified.
Depending on the nature of the dispute, Responsible Persons for all affected brands may be required to reconfirm data used in the calculation for the drug under dispute. The request for this reconfirmation will be forwarded by the PDDA, through the PDSU. An alert of this request will also be forwarded to Responsible Person’s authorised representatives, via email.
On receiving a request to reconfirm data, Responsible Persons will need to provide an additional declaration, once the data has been reviewed, providing that it is true and correct. If a Responsible Person identifies a discrepancy in the data, immediate contact will need to be made to the PDDA as instructed in the reconfirmation request. Data will need to be reconfirmed within five working days* of the request being made.
The Department will continue to work with the PDDA to conduct other internal reviews, as required, for other types of disputes such as those dealing with process or calculations. These reviews may result in a new determination being made and published on the FRLI/ComLaw website as well as the PBS website.
Once the Department has completed all necessary reviews and, depending on the outcome, the Department will notify all affected Responsible Persons to advise that the dispute has been resolved (within two working days* of resolution) with either:
- no change to the outcomes listed in the determination, or
- notification that a new outcome has been determined. If a new outcome is determined, the Department will also provide Responsible Persons with links to the new determination.
Contacting the Department:
Department of Health
GPO Box 9848
Canberra ACT 2601
Telephone: 02 6289 2303
Contacting the Price Disclosure Data Administrator:
Price Disclosure Data Administrator
Australian Healthcare Associates
Locked Bag 32005
Collins Street East
Melbourne VIC 8003
Telephone: 1300 336 062