Rachel Siewert (WA, Australian Greens) Share this | Hansard source

As Chair of the Community Affairs References Committee, I present the report on regulatory standards for the approval of medical devices, together with the Hansard record of proceedings and documents presented to the committee.

Ordered that the report be printed.

by leave—I move:

That the Senate take note of the report.

On 16 June 2011, the Senate referred the regulatory standards for the approval of medical devices in Australia to the Senate Community Affairs References Committee for inquiry. The committee received 34 submissions: 18 from industry and industry associations and peak bodies, three from government, two from consumer groups and 11 from affected patients and consumers. We held a public hearing on 27 September 2011.

The committee examined the regulation of medical devices in Australia. This is a complex and evolving area. The committee considered whether the current mechanisms for premarket assessment and postmarket surveillance of medical devices are appropriate for ensuring patient safety. The inquiry was conducted in a dynamic policy and legal environment. It was occurring in parallel with the ongoing implementation of the recommendations of the health technology assessment review and the consideration of the Therapeutic Goods Administration transparency review.

The inquiry also focused on the consumer experience of those approximately 5,500 Australians who have received the DePuy ASR metal-on-metal hip replacement, including total hip replacements and hip resurfacing systems. This was a matter brought to the public attention on 16 May 2011 by the Four Cornersprogram Joint Reaction. That followed other stories around this issue.

The committee heard shocking evidence of patients experiencing devastating health problems as a result of being implanted with either the DePuy ASR hip or the hip resurfacing system. Many witnesses spoke of their repeated surgeries, repeated and extended hospital stays, significant financial loss and major personal and family impacts. Health problems cited included severe pain, loss of mobility and a complex process of both physical and psychological effects due to the shedding of cobalt and chromium irons from the implanted devices. The excessive levels of chromium and cobalt in these patients' bodies have produced symptoms such as bone loss, extensive damage to bone and soft tissues, and hip dislocations. The Department of Health and Ageing notes that excessive levels of these metals can also produce other significant medical complications. One submitter's condition is in fact now terminal.

I will cite only a few quotes from the report, because other members of the committee also want to contribute:

The committee was shocked by the intolerable, and unacceptable, experiences of patients who received the DePuy hip and hip resurfacing system. These very personal experiences—

which we heard—

serve to underline the need for improved pre-market clinical testing and post-market surveillance systems for medical devices, as well as improved timeliness and decisiveness when acting upon the information that is available.

These experiences brought home to the committee that the TGA could have done more in response to the concerns with the device and that Johnson & Johnson Medical did not serve patients well.

The report further states:

It appears to the committee that ASR hip devices were in use after a higher than expected revision rate had been identified. The committee believes that insufficient information was provided to consumers regarding the concerns with the device. This is regrettable.

The committee has made 18 recommendations in the report and these go to improving the regulation of medical devices by the TGA and increasing the rigour of the regulatory assessment of the higher risk medical devices, both before the devices come to market as well as through monitoring and surveillance of these devices post market. The committee has recommended that the HTA review recommendations 8c, 13, 14 and 15 are fully implemented in a timely manner—in other words, the recommendations that have been made from ongoing processes need to be implemented. We recommend investigating whether the increasing number of medical devices on the Australian market is actually improving clinical outcomes and we make a range of other recommendations.

An issue I have not touched on in my comments relates to inducements, which came up during the inquiry. We recommend the need for further work to address the issue of inducements paid by pharmaceutical companies and medical device manufacturers to doctors and teaching hospitals. This issue has been addressed in the United States through the physician payment sunshine provisions of the Patient Protection and Affordable Cure Act of 2009. The definition of inducements should include a commercial interest in a company or device, any cash payments or discounts offered to medical practitioners and any other gifts provided to medical practitioners. As I said, these are just some of the recommendations we made. I believe there was a lot of compelling evidence provided to this inquiry of the trauma and physical impacts that consumers have suffered as a result of receiving some of these hip devices.

I commend the recommendations to the government. I thank committee members and particularly thank, once again, the staff of the Community Affairs References Committee staff and the staff that we borrowed from the Standing Committee on Finance and Public Administration, Christine McDonald and Bu Wilson, who served us extremely well in a both timely and professional manner.