8.7 Preparation and finalisation of additional access arrangements
The PBAC’s advice to the Minister may include specific comment if it considers that some elements of the evidence are not strongly convincing or that the government should take actions to ensure access is limited to the cost-effective population, or to otherwise limit unjustified financial expenditure or obtain additional evidence for a future review.
Applicants and the Australian Government may negotiate an RSA or a MAP after the PBAC has made its recommendation. Where a comparator medicine has an existing RSA, it is government policy that single brand medicines entering the same therapeutic market are also included in the existing RSA. Examples of this include sharing a cap on government expenditure across a number of medicines.
The majority of RSAs and MAPs are supported by deeds of agreement between the responsible person (as defined in the National Health Act 1953) and the Australian Government Department of Health.
8.7.1 Procedure for preparation of deeds of agreement
Based on the advice in the PBAC Minutes, the department prepares a draft deed of agreement, based on the standard template on the PBS website. This draft is provided to the applicant as soon as possible after the estimates of utilisation and financial impact have been considered by the Department of Finance. Where the applicant enters into the same therapeutic market as an already listed medicine, the applicant will be required to make confidentiality undertakings prior to a draft Deed being provided.
This draft deed of agreement is forwarded by email to the responsible person. The applicant has up to 10 working days to respond. If more time is required, an extension can be requested by email to the contact officer in the Department of Health.
The standard clauses in the deed of agreement will not be amended unless the attributes of a particular arrangement associated with a medicine are identified by the PBAC as requiring different treatment, or the Australian Government delegate determines that the change is necessary based on an identifiable detriment to the applicant.
The deed of agreement must be completed and signed at least six weeks before the date the medicine is proposed to be listed on the PBS.
Negotiation of financial-based agreements are based on the finalised financial estimates (refer to Section 8.2).
All documents are handled in accordance with the Australian Government’s standards for confidentiality and transparency (see Section 3).
Where the operation of the deed results in monies being owed to the Australian Government, all invoices are raised by the department and forwarded to the applicant. The accompanying letter will provide additional documentation explaining the basis for the monies owing and the date monies are due.
8.7.2 Revision of deeds and other useful information
The department reviews all deeds at the end of the term of the deed or following a recommendation by the PBAC that affects the operation of the deed. Deeds can be lapsed or renewed following a review.
The department may seek advice about a deed from the PBAC or, through the PBAC, from DUSC or ESC. The department will email the applicant, advising them of the outcomes of any review of the deed.
If applicants have concerns about the operation of a deed, there is a dispute resolution mechanism included in the deed.
Refer to Appendix A for contact details.