Senator MOORE (Queensland)
The TGA is a very important part of the health system in this country. It was developed as part of the Department of Health and Ageing:
… to protect public health and safety by regulating therapeutic goods that are manufactured or supplied in, or exported from, Australia-
as well as aiming-
… to ensure the Australian community has access, within reasonable timeframes, to therapeutic advances.
This is an important responsibility for the organisation and it is absolutely critical that we have in place effective processes to ensure there is genuine trust in the role the TGA plays. Through the process of this inquiry by the Senate Community Affairs References Committee, we have heard that things should be done better. There is no doubt about that. The committee has come up with 18 recommendations and they have a similar theme. As Senator Xenophon and Senator Siewert have said-and as I know Senator Boyce will say, because we were very much in agreement about the process, about the concerns that need to be addressed and about the reasons it is important that we address those concerns-during the evidence we heard that the TGA, by and large, does a very sound job. In fact the AMA said that it served Australia well. Dr Hammett, the head of the TGA, whom we know well through Senate estimates, said:
It is a constant matter of balancing the challenges of regulating the large number of products we regulate. One of the important foundations of how we approach this is that we have an understanding that it does not matter what amount of resources we have; it is not possible to create a completely safe medical device, medicine or medical procedure.
It is important to know that. There can never be absolute guarantees, but we must have a process where we know that the best possible communication, the best possible science and the best possible cooperation has taken place so that we can come up with a sound medical system.
Our committee was shocked and saddened by the information provided to us by people who, in good faith, had received advice from practitioners in this country about a new process for hip implants which, they were told, was going to serve them better. In fact one of the biggest ironies in all of this was that many people had this particular process-the DePuy implant, DePuy being a subsidiary of Johnson and Johnson-because it was going to be the new best process in the medical arena. This was going to be the best way they could be helped. That was based on practice-this particular process had been used and had worked overseas. However, what we have seen-and we have heard some of the figures-is that there are problems with this device. This has come out through information that is fed back through the system, information which tells us there has been too much revision-people having to go back and have more surgery. There have also been way too many other kinds of medical problems caused by this process.
We heard some very sad things and I think the whole committee sends its best wishes to the people and the families who came forward with stories about what was happening in their lives. As Senator Siewert said, one of those patients, whom Senator Xenophon had been working with in South Australia, has a terminal diagnosis. We can never stop that happening, but, when we can see that things can be done better, we as a government, we as a parliament and we as the Australian community must do better.
The 18 recommendations are aimed at trying to ensure that there is much better communication and much better understanding in the process. The community affairs committee had previously inquired into the National Joint Replacement Registry, so we had already heard about some of the issues in terms of the volume of transplantation and the volume of devices available in this country. What we need to have is an assurance that the process works as well it can-that knowledge is being shared and that people are getting the necessary information as quickly as possible so they can then take action quickly.
It must be remembered through all of this that the device in question was actually removed from the Australian market several months earlier than anywhere else in the world, simply because of the pressure that the TGA process had placed on the company. I think, within the overall discussion, that we need to see that. It was not good enough, but nonetheless this process was stopped in Australia a good nine months before it was stopped overseas and I think the Australian move led to the international decision to have this device, which is proven to be dangerous-I think I can go that far-removed from the market.
One of the things that I just wanted to mention briefly-I know Senator Boyce wishes to make a contribution as well-is an issue which came up in this committee's hearings as well as in previous ones: the importance of the relationship between the consumer and the practitioner in any kind of medical process. We found that consumers were not fully informed about the surgical process or about the type of implant they were going to have. We value the concept of informed choice in our medical system, but it did not occur. I think that we as a community need to keep that concept on the agenda-to make sure that every person in this country working with our health system understands as well as they can what is going to happen to them, the options they have and the probable consequences of their decisions. They should not be reliant on a doctor-of any kind, in any place-just telling them what is going to happen and no more. This had happened consistently to the patients who came before us in the committee.
It is important to know that the TGA has been subject to two reviews. The government is working through those. There is a confidence that things can be done better. The government acknowledges that. I again thank all the people who contributed to our committee and shared their lives and their expertise with us to allow the committee system and this process, of which I am very proud, to operate again in this day.
