I am writing to you to provide advice in relation to the decision letter received from the Therapeutic Goods Administration stating they have removed Healthwart+ from the Australian Therapeutic Goods Register (TGR).
In order to respond to the decision I suggest the following,
Step 1 Freedom of information request
The Therapeutic Goods Act (Cth) (TGA) operates under commonwealth jurisdiction, therefore a request needs to be made under the Freedom of Information Act 1982 (Cth) (FOIA)
Reasons for request
- The decision maker has set out inadequate findings on material questions.
- The decision maker must set out findings on material questions.
- There must be sufficient evidence to understand whether the decision was made for proper purposes without errors of law.
- There is inadequate provision of notice of intention to remove Healthwart+ from the register.
In order to determine how the decision maker has arrived at their conclusion you can request copies of the information used to make the decision under s 11 of the FOIA, if those documents are not provided a request for access can be made under s 15 of the FOIA.
The following must be requested in a written request,
- Material Submitted to the Administration by Gonzo
- Information provided to the TGA by the University of Brisbane
- All email Correspondence between Australian Medical Association and Pharmacy Guild of Australia
- Any application forms, case notes, ministerial directions, policy and any other material used in making the decision, including the power with which the Secretary delegates power to the compliance officer to make such a decision.
Possible exemptions to FOI request
In relation to the request for information supplied by University of Brisbane, it is possible that these documents may fall under an exemption for documents that disclose trade secrets or commercially viable information , however this does not apply where the making the request is the organisation or person acting on behalf of the organisation.
An exemption for documents that might involve an unreasonable disclosure of personal privacy, this may apply to any email correspondence requested however problematic sections can be redacted and therefore should be supplied.
Step 2 Reconsideration of Decisions (Merits Review)
Is the decision reviewable?
Until the decision maker responds we are unsure under which authority she has made her decision, however if the decision was made under the TGA, using the interpretation set out in the TGA s 60 and AATA s25(1) and (4), the decision is reviewable.
Standing to request review of decision
You are able to request a review if you are affected by the decision. Clearly your interests are affected by the decision and therefore would have standing to request a review to both the Minister and further to the Administrative Appeals Tribunal,  then a further request to review a decision by the AAT.
You are able to request a full merits review of the decision. Importantly on review to the AAT the question will be whether the decision was the ‘correct or preferable one on the material before the tribunal’.
The Minister may confirm the initial decisions, revoke the initial decisions or revoke the initial decision and make a decision in substitution of the initial decision. When reviewing the decision it may be prudent to request that the Minister bases his decision on the law and excludes any policy considerations.
Timelimit – A request must be made within 90 days after notice of the initial decision is made.
Following a decision by the Minister the TGA sets out that decisions are reviewable by the the Administrative Appeals Tribunal, the standing requirements are satisfied, there are no complicated standing issues to deal with. The following sets outs the steps for you to request a review of the Ministers decision.
- Application in writing
- Within 28 days of the decision
- An extension is available
- Pay the fee
The AAT allows new evidence to be submitted when reviewing a decision.
The AAT may affirm, vary or set aside (and either substitute or remit the decision back to the original decision maker).
Issues for Review
- Gonzo’s evidence should be preferred with regard to the safety of the long term use of Healthwart+. This evidence does not appear to have been used in reaching the decision based on the letter received.
- We are unsure of any connection between the illness at St Margarets hospital and Healthwart+ and therefore this evidence may be irrelevent.
- The decision maker has not set out what information she is referring to that was provided in 2006, not how it was deficient.
- The decision maker has not set out her findings.
- Upon what evidence Strophanthus is used as a poison and therefore may be irrelevant.
- What Strophanthantis is and what evidence supports it on mice and what relevance that has.
- The decision maker had legitimate choices that were set out in the TGA that were not adhered to, most notably a failure to invite to make submissions.
- The decision maker should have taken the information provided by Gonzo in relation to the safety of Healthwart+.
- The decision maker had a copy of the contract between the University of Brisbane and Gonzo and new therefore should have known that the results were preliminary and should not have been relied on.
- The decision maker does not set out her findings.
- The decision maker has included irrelevant material.
- We are unsure under which authority the decisions maker had appropriate delegation from the Secretary to make the decision.
- Findings use evidence upon which the finding is made.
- The TGA utilizes the exception in s 28(4) of the AATA, in this case no findings were provided.
- Procedural Fairness has not been followed in making the decision whereby no invitation to respond was given to Gonzo.
- The decision maker has made an error of law whereby she has based her decision on irrelevant material, being the illness at St Margarets hospital, and information from University of Brisbane whereby it was preliminary and should not have been used.
- Furthermore, by not setting out her findings the decision maker has made a jurisdictional error.
A full merits review by the Minister and the AAT are available to Gonzo, failing that, appeals to the Federal Circuity Court and ultimately the High Court are a potential option.
There are various credible arguments that might lead to the decision to remove Healthwart+ from the register to be set-aside and remitted back to the original decision maker or possibly have a new decision substituted. Should a review be undertaken by the AAT Gonzo may be able to submit new evidence containing reasons and evidence.
 Administrative Appeals Tribunal Act (1975), s 28(5)
 Ibid, s 28(1)
 Soldatow v Australia Council (1991) 28 FCR 1, at 2
 S 9(F)(3) Therapeutic Goods Act 1989 (Cth)
 Freedom of Information Act 1982 (Cth) S 47c.
 Ibid, S 11A(5) and s11B.
 Ibid, S 47(1).
 Ibid, S 47(2)(c).
 Ibid, S 47(f).
 Ibid, s 22.
 Therapeutic Goods Act 1989 (Cth), S 60(2).
 Administrative Appeals Tribunal Act (1975) s 27.
 Drake v MIEA (no 1)(1979) 2 ALD 60 per Bowen CJ and Deane J at 68.
 Therapeutic Goods Act 1989 (Cth), s 60(2).
 Ibid, S 60(2A).
 Therapeutic Goods Act 1989 (Cth) S 60(3).
 Ibid, S 60(2).
 Allan v Transurban City Link (2001) 208 CLR 167.
 Administrative Appeals Tribunal Act (1975) S 29(1).
 Ibid, S 29(2).
 Ibid, S 29(7).
 Ibid, S 29A(1).
 Shi v MARA (2008) 248 ALR 390.
 Administrative Appeals Tribunal Act (1975) S 43(1).
 Yusuf (2001) 206 CLR 323, per Kirby J at 25-26.
 Therapeutic Goods Act 1989 (Cth), S 9F(3).
 Acts Interpretation Act s 25(d).
 Yusuf (2001) 206 CLR 323.