I want to very briefly respond to some of the further points that have been made. I think we should be very clear that, if this amendment is not passed, we will have less regulation on human gene therapy than we have on animal gene therapy and plant gene therapy. That is the reality. Animal gene therapy and plant gene therapy are regulated by the Office of the Gene Technology Regulator. It’s a specific, arms-length regulator. It is a regulator, not an advisory body and not a research body. It is a regulator through and through—a statutorily independent one at that. It’s appropriate for something as significant as gene therapy that we do have an independent regulator.
The review of the Gene Technology Regulator which has been referenced by a number of people says:
… stakeholders identified a potential gap in regulation pertaining to the modification of humans.
It is true that they conclude that the OGTR might not be the best body to regulate human gene therapy, but they’re saying there’s a gap today in human gene therapy. Of course, almost all human gene therapy research and clinical practices are prohibited in Australia—there are a few very limited research trials occurring—but they’re saying there’s a gap. This bill does nothing to fill that gap. This bill would instead make this gap a wide chasm, because we would remove the oversight of the OGTR—as undesigned for it as the OGTR perhaps is—and replace it with a subcommittee of the NHMRC, which is not a regulator body.
Indeed, if you go to the most recent statement of expectations the government has given the NHMRC, there is not a mention of the words ‘regulation’ or ‘regulatory’ or of anything to do with regulation. That statement says:
NHMRC is the Australian Government’s key entity for managing investment in, and the integrity of, health and medical research.
It is not a regulator. If we do not pass this amendment, we will effectively have self-regulation of human gene therapy. It is not appropriate that we have lower regulatory oversight for human gene therapy than we would for animal and plant gene therapy.
