Previously companies had to use an agreement developed with the pharmaceutical industry in mind that was not always suitable to cover the medical technology industry.
The new agreement has been developed in cooperation with the Victorian Managed Insurance Authority, New South Wales Health, and Queensland Health. The investigation agreement and associated forms have been based on similar documentation developed by Medicines Australia.
An important distinction between clinical study agreements developed for the pharmaceutical and the medical technology industries is the use of the international standard ISO 14155:2003 Parts 1 and 2 for the study of medical technology. The MTAA agreement references this standard. A number of issues in similar agreements released in the UK last year have also been incorporated into the MTAA documentation.
The agreement, forms of indemnity and compensation guidelines are available:
1.The MTAA Standard Clinical Investigation Research Agreement. 2.The MTAA Standard Indemnity Form for a clinical investigation. 3.The MTAA Indemnity Form for HREC review only. 4.The MTAA Compensation Guidelines.
Similar documentation for contract research organisations and studies by collaborative or cooperative research groups will be made available soon.
The Medical Technology Association of Australia (MTAA) is the national association representing companies in the medical technology industry. MTAA aims to ensure the benefits of modern, innovative and reliable medical technology are delivered effectively to provide better health outcomes to the Australian community.
MTAA represents manufacturers and suppliers of medical technology used in the diagnosis, prevention, treatment and management of disease and disability. The range of medical technology is diverse with products ranging from familiar items such as syringes and wound dressings, through to high-technology implanted devices such as pacemakers, defibrillators, hip and other orthopaedic implants. Products also include hospital and diagnostic imaging equipment such as ultrasounds and magnetic resonance imaging machines.
MTAA members distribute the majority of the non-pharmaceutical products used in the diagnosis and treatment of disease and disability in Australia. Our member companies also play a vital role in providing healthcare professionals with essential education and training to ensure safe and effective use of medical technology.