Indemnity & Compensation Guidelines

What are the Voluntary Compensation Guidelines?
As part of Medicines Australia’s role as the peak body for innovative pharmaceutical companies, we are the custodians of the Voluntary Compensation Guidelines. The Guidelines were established by us over 20 years ago and have become part of the clinical trial landscape across Australia. 

The Voluntary Compensation Guidelines were developed as a set of ethical principles to guide practice, and we expect all companies to act in accordance with them, however they are not legally binding to our members.  

What is the ‘Form of indemnity’? 
The Form of Indemnity provided below is to be regarded as the basis for agreements between pharmaceutical companies sponsoring clinical studies and the institution that hosts the study to be conducted. There is a different Form of Indemnity for use where the Indemnified Party is providing Human Research Ethics Committee (“HREC”) Review ONLY of the study. 

What is Medicines Australia’s role? 
Whilst Medicines Australia publish the Voluntary Compensation Guidelines, it is important to note that we do not possess the legal authority to enforce these guidelines on our members. An individual participating in a clinical trial should ensure that they understand and seek the agreement they enter into for a particular clinical trial and seek individual legal advice if they are unsure. 

Medicines Australia is not in a position to provide legal advice. 

What happens if I have an injury as a result of participating in a clinical trial? 
If you believe you have sustained an injury through the participation of a clinical trial, you should contact the clinical trial coordinator and sponsor in the first instance. If the matter cannot be resolved with the sponsor, you may consider seeking your own legal advice on the matter.  

Additionally, can raise your concerns with the Ethics Committee that approved the trial. They will also have visibility over the trial details and may be of assistance.