Page 526 - Week 02 - Wednesday, 19 March 2014
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MS GALLAGHER: It is my understanding that between 2009 and 2012 nine patients had stem cell harvest conducted, and eight patients with transplants were completed at Canberra Hospital. There was no ethics approval for this at that time either. It was not something that I knew of; it was not something that the Director-General of Health knew. When management were made aware of it, they were encouraged to seek ethics approval for their work, and that ethics approval was not granted.
MADAM SPEAKER: A supplementary question, Mr Hanson.
MR HANSON: Minister, can you give an outline of what those ethical considerations were?
MS GALLAGHER: I can. It is quite detailed. I think, from the briefings I have had today, it was around certainly the numbers of people doing it and the nature of the patients. Patients with a particular type of MS were eligible for it, so there was an eligibility criterion for it. And research support for it. They were certainly two of the main criteria, but I can provide that to you, Mr Hanson. It was looked at at length, and they were two of the main issues that were not able to be covered off. Certainly the very clear advice from the ethics committee was that it should not be allowed to continue at Canberra Hospital.
MADAM SPEAKER: Supplementary question, Mr Hanson.
MR HANSON: I ask firstly if you could table that advice and advise whether there will be any review of that decision in the future should this treatment become more established or more evidence come to light in terms of its effectiveness.
MS GALLAGHER: Yes, I can certainly table it. My understanding is that the ethics committee operates in accordance with the national statement on ethical conduct in human research ethical guidelines. These are established nationally. So I can certainly have a look at what I can provide further. My understanding was that the advice from the ethics committee to the professionals doing the treatment was that you can cover off these concerns and re-submit it for ethics approval, which at this point has not been done.
But I think members would understand that if a treatment is in experimental stage, if there are questions amongst the profession about the suitability of this treatment, particularly for certain eligible patients, and it is not granted ethics approval, it would be a very brave health minister who would override that decision and allow that treatment anyway. So as much as I have sympathy for the patients who would like to access that treatment, we have done what we can to provide them with connections to the hospital in Sydney that is undertaking a tightly-controlled, ethics-approved trial into this treatment.
Mr Coe: What about interstate?
MS GALLAGHER: That is where we have referred them, yes.
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