The Federal Governments own website says:
“At its simplest, gene therapy involves inserting DNA or RNA into cells to treat or prevent diseases that are not treatable with medicines.”
This is exactly what the Pfizer vaccine does – it inserts mRNA encoding proteins into cells to prevent disease. (Well that was the idea at least)
So S30C of the Therapeutics Act does apply. The Department of Health must seek advice from the Office of the Gene Technology on the safety and efficacy of products which use GMO technology.
Seriously these bureaucrats don’t understand how to apply their own legislation.
Quote from:
https://www.genetechnology.gov.au/using-gene-technology/human-health
Legislation at:
https://classic.austlii.edu.au/au/legis/cth/consol_act/tga1989191/s30c.html
Chamber: Committee on 16/02/2023
Item: Community Affairs Legislation Committee – 16/02/2023 – Estimates – HEALTH AND AGED CARE
PORTFOLIO – Office of the Gene Technology Regulator
Questioner: CHAIR; Rennick, Sen Gerard
Answer: Dr Bhula; Gallagher, Sen Katy
Office of the Gene Technology Regulator
[18:20]
CHAIR: Do we have senators at the table with questions for the Office of the Gene Technology Regulator? Senator Rennick.
Senator RENNICK: Under section 30C of the Therapeutic Goods Act, the secretary of the Commonwealth Department of Health must seek advice from the Office of the Gene Technology Regulator on the safety and efficiency of any product which uses GMO as defined by the Gene Technology Act. Do you have evidence of where the secretary has written to you asking for advice on the safety and efficacy of the COVID-19 vaccines?
Dr Bhula : Thank you for your question, Senator. Where the particular vaccine involves a GMO, there’s reciprocal arrangement, if you like, for OGTR to seek advice from the TGA in terms of a risk assessment around that GM vaccine and vice versa. The TGA may also request advice from the OGTR.
Senator RENNICK: Do you have documentation of that?
Dr Bhula : For GM vaccines, yes.
Senator RENNICK: Where they’ve written to you for the Pfizer one?
Dr Bhula : No, because the mRNA vaccines are not required to be regulated through the OGTR.
Senator RENNICK: Did they write to you and actually ask you that question?
Dr Bhula : No, because they’re not required to be regulated through the OGTR.
Senator RENNICK: But how would they know, because you’re the expert? And, by the way, gene technology involves both replication and transcription.
Dr Bhula : Yes.
Senator RENNICK: Which is what the mRNA vaccine does.
Dr Bhula : But the mRNA COVID-19 vaccines did not involve any step of genetic modification—
Senator RENNICK: They produce proteins.
Dr Bhula : or a GMO—
CHAIR: Senator Rennick, would you allow Dr Bhula to finish her answers.
Dr Bhula : which meant that that didn’t require regulatory oversight by the OGTR.
Senator RENNICK: Well, I dispute that. Look up gene technology. But, anyway, thank you.
CHAIR: Senator Rennick, is that your last question.
Senator RENNICK: Yes.
CHAIR: Are we happy to dismiss the agency?
Senator Gallagher: I just don’t think we need to patronise witnesses in that way, Senator Rennick. To tell the Office of the Gene Technology Regulator to look up gene technology is patronising and disrespectful.
Senator RENNICK: Yes, it’s both replication and transcription.
Senator Gallagher: Anyway, I just think it reflects poorly on the Senate—that behaviour.
CHAIR: Thank you, Dr Bhula, for your attendance today. We appreciate it. I will call the Australian Digital Health Agency.
Senator Gallagher: Can I just deal with a matter that Senator Rennick raised?
CHAIR: Sure.
Senator Gallagher: Clearly—I’m not sure it’s fair to take it on notice—there were a range of compensation programs run for people who were infected with hepatitis C through the late eighties and nineties. It seems to have been run across governments—state, territory and Commonwealth. There is quite a bit of literature if you want to look it up. You can see the compensation arrangements.
Senator RENNICK: What would be good is if I could get Infected Blood Australia to actually meet with the health minister, because he won’t meet with them. They’re the best people, because they’re the victims who can explain their situation.
Senator Gallagher: It looks like there were compensation arrangements.
Senator RENNICK: They’re telling me something different. I’m not going to argue with you.
CHAIR: Senators, I have called the Australian Digital Health Agency, who probably aren’t the best to engage on this.