Guidelines for Deeds of Agreement

Page last updated: 14 February 2011

Guidelines for Deeds of Agreement for the Pharmaceutical Benefits Scheme (Version 1.3).

Preface

These guidelines aim to improve the understanding of, and public access to, information regarding the requirement for, and development of deeds of agreement.  They are intended to improve the level of understanding in relation to terminology, timing and risk-sharing components.

These guidelines are also intended to improve sponsor awareness of the processes involved in developing deeds and identify the importance of initiating the negotiations early.  These guidelines have been developed to account for experience.  This is a living document that will evolve to allow for inevitable change.

Disclaimer

These guidelines have been developed to provide readers with information about deeds of agreements. 

Material in these guidelines is made available on the understanding that the Commonwealth is not providing legal or professional advice.   While reasonable care has been taken in preparing these guidelines, the Commonwealth provides no warranties and makes no representations that the information contained in these guidelines is correct, complete or reliable.  These guidelines are subject to change from time to time and the Commonwealth provides no warranties and makes no representations about the currency of the information contained in these guidelines.  The Commonwealth expressly disclaims liability for any loss, however caused, whether due to negligence or otherwise arising from the use of, or reliance on, the information contained in these guidelines by any person. 

The information contained in these guidelines is necessarily general and these guidelines may not apply in all circumstances.  The Commonwealth may, at its sole discretion, choose not to adhere to these guidelines.  If a deed of agreement is entered into between the Commonwealth and a sponsor then that deed of agreement will record the entire agreement between the parties in relation to its subject matter and will not be affected in any way by the content of these guidelines.

Purpose

The purpose of these guidelines is to provide the history, context and processes to assist sponsors when developing deeds of agreement in the context of listing medicines on the Pharmaceutical Benefits Scheme (PBS).

Also available:

PDF printable version of Guidelines for Deeds of Agreement for the Pharmaceutical Benefits Scheme (Version 1.3) (PDF 132 KB)

Attachment A – The Deed of Agreement Process (PDF 32 KB)

Attachment B – Basic De-identified Deed (example only) (PDF 118 KB) 

The Basic De-identified Deed is for instructional purposes only and is expected to change from time to time.

Please note:
- This template is the basis of all agreements.
- Negotiations will not be entered into regarding these standard clauses unless the attributes of a particular arrangement associated with a drug are identified by the PBAC or PBPA as requiring different treatment or the Commonwealth Delegate determines the change is necessary based on an identifiable detriment to the sponsor if it is not changed.

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