Senate Inquiry findings

Media Release        
23 November 2011

Senate findings in line with reforms already underway

The Medical Technology Association of Australia (MTAA) has welcomed the release of the report from the Australian Senate’s Inquiry into the regulatory standards for the approval of medical devices. MTAA lodged a submission to the Inquiry and was represented at the Senate Committee hearing on 27 September 2011.

The report includes a range of recommendations not confined to the regulation of medical devices but extending to reimbursement of medical devices, and to ethical conduct in the relationship between companies and healthcare professionals.

The Senate Committee acknowledged the current reforms underway with the implementation by government of the recommendations of the review of Health Technology Assessment. It also noted the recommendations of the recent review of transparency of the Therapeutic Goods Administration (TGA). Both reports incorporated a broad range of stakeholder views and balance regulatory requirements with timely access to the latest medical technology to sustain and improve quality of life.

“MTAA has been working with the TGA on a range of regulatory reforms stemming from the review of Health Technology Assessment and will continue to do so,” said MTAA CEO Anne Trimmer.

MTAA believes that reforms to the regulation of medical devices in Australia, and the requirements for assessment prior to market entry, must be consistent with requirements in other major economies. Australia is a small market and the imposition of unique requirements may reduce the availability of life-saving and life-enhancing medical technologies to Australian patients.

“We believe that Australian patients should have access to the most appropriate treatment based on clinical assessment by a healthcare professional and should not be subject to rationing of treatment as a result of unique requirements in Australia,” Ms Trimmer concluded.

Medical technologies provide life-saving assistance to patients in need, deliver long-term sustaining quality of life, and provide aid to improve the day-to-day comfort of patients. Without medical technologies patients would not be able to walk (implantable hips and knees), to hear (cochlear implants and hearing aids), to see (intraocular lenses), or to survive (cardiac pacemakers and implantable defibrillators). Each of these innovations has significantly changed the way people with life-threatening or life-challenging conditions are cared for. With the rapid evolution of medical devices, the regulatory systems in advanced economies have also evolved to ensure that they remain appropriate.

For a copy of The regulatory standards for the approval of medical devices in Australia report, please follow this link.

For more information about the Inquiry including a list of submissions, please follow this link.

The Medical Technology Association of Australia (MTAA) is the national association representing companies in the medical technology industry.

MTAA media contact: Marion Demann 0416 625 678