Drew and Minister for Health and Ageing

[2011] AATA 586

Administrative Appeals Tribunal

DECISION AND REASONS FOR DECISION [2011] AATA 586

ADMINISTRATIVE APPEALS TRIBUNAL      )

)          No 2011/2646

GENERAL ADMINISTRATIVE DIVISION		)
Re		Leslie Drew

Applicant

And Minister for Health and Ageing

Respondent

DECISION

Tribunal Professor RM Creyke, Senior Member

Date25 August 2011

PlaceCanberra

Decision The Tribunal does not have jurisdiction to consider the decisions made by the Secretary, Department of Health and Ageing in relation to the drug Clozapine.

...................[sgd]...........................

Professor RM Creyke, Senior Member

CATCHWORDS

PRACTICE AND PROCEDURE – jurisdiction – application for review of a decision under the Therapeutic Goods Act 1988 – initial decision made – no request for reconsideration – no reconsideration decision by the Minister – Tribunal does not have jurisdiction.

Administrative Appeals Tribunal Act 1975 (Cth) s 25

Therapeutic Goods Act 1988 (Cth) ss 9D, 25, 25AA, 60

Re Control Investments Pty Ltd and Australian Broadcasting Tribunal (No 1) (1980) 3 ALD 74

Re McHattan and Collector of Customs (NSW) (1977) 1 ALD 67

REASONS FOR DECISION

25 August 2011 Professor RM Creyke, Senior Member   

1.      Dr Leslie Drew is a practising psychiatrist with extensive experience treating mentally ill patients. He is authorised to prescribe the anti-psychotic medication, Clozapine, a drug prescribed to patients suffering from schizophrenia that is resistant to other forms of treatment.

2.      Since 1992, Clozapine has been listed on the Australian Register of Therapeutic Goods (Register) and has been subject to special controls on its supply, prescription and use. The Register is maintained and administered by the Therapeutic Goods Administration (TGA), a statutory authority within the Department of Health and Ageing (Department).

3.      The use of Clozapine has been associated with a high risk of agranulocytosis, a serious blood disorder, and to protect against the risk of patients developing this disorder, monthly blood tests and monitoring are among the special controls imposed on the use of Clozapine. If any of the blood test results are abnormal, patients must be taken off Clozapine.

4.      Dr Drew believes that the most recent evidence does not support a need for monthly blood monitoring, and wishes to amend the special controls on the supply and use of Clozapine to reflect this evidence. Dr Drew has contacted the TGA on numerous occasions, urging the special controls on Clozapine be reviewed and amended. Responses from the TGA and the Secretary, Department of Health and Ageing (Secretary) have stated that no further reviews are intended and that the special controls on the supply of Clozapine do not need to be amended. Dr Drew has sought review of these decisions.

5.      The issue for the Tribunal is whether the Tribunal has the jurisdiction to review a decision in relation to the special controls for Clozapine. This involves consideration of the following further issues, taking into consideration the review processes in the therapeutic goods legislation:

·Whether the prescribing and monitoring of Clozapine is an ‘initial decision’ as defined under the Therapeutic Goods Act 1988 (Cth);

·Whether Dr Drew has sought review by the Minister of that ‘initial decision’ within the 90 day time limit; and

·If so, whether Dr Drew is a person whose interests are affected by the ‘initial decision’; and

·Whether the Minister has made a ‘reviewable decision’, as defined in the Therapeutic Goods Act 1988 (Cth).

6.      The Tribunal heard the matter on 1 August 2011. At the hearing Dr Drew appeared in person and Mr Teoh appeared on behalf of the TGA.

Legislative Background

The Tribunal’s jurisdiction

7.      The Tribunal has no general review powers and may only review decisions where jurisdiction has been conferred by an enactment (section 25 Administrative Appeals Tribunal Act 1975 (Cth)).

8.       Section 60 of the Therapeutic Goods Administration Act 1989 (Cth) (Act) provides for review of certain decisions by the Tribunal. Before the Tribunal has jurisdiction to review a decision made under the Act, three pre-conditions must be satisfied: the decision must be an ‘initial decision’ as defined in section 60(1); a person whose interests are affected must apply for the Minister to reconsider the decision within 90 days of becoming aware of the decision (section 60(2)); and the Minister must reconsider the decision (section 60(3)). It is only the reconsideration decision of the Minister that the Tribunal has been granted jurisdiction to review (section 60(6), (8)).

Controls on the use of Clozapine

9.      The TGA regulates the supply, prescription and use of Clozapine and other ‘restricted medicines’ through the use of a ‘product information’ document that is included in the Register (sections 23, 25). Product information is defined in section 3 of the Act as ‘information relating to the safe and effective use of the goods, including information regarding the usefulness and limitations of the goods’. Product information must be approved by the Secretary under section 25AA, and it can be varied by the Secretary under section 25(4).

10. As a Commonwealth statutory authority, the scope of the TGA’s regulatory authority is limited by the legislative powers granted to the Commonwealth under section 51 of the Constitution. As there is no constitutional head of power relating directly to health or medication, the Act only applies to things done by corporations, or in connection with interstate trade and existing Commonwealth benefits and laws (section 9). This means the TGA has no legislative authority directly to enforce the restrictions contained in the product information against prescribers or patients.

11.     Mr Teoh explained at the hearing, that as a means of ensuring the restrictions contained in the product information are complied with, the TGA imposes conditions on pharmaceutical companies, requiring them only to supply the medication in accordance with the product information.

12.     Dr Drew contended that the protocol for the use of Clozapine, issued by the pharmaceutical company Novartis, was not consistent with the TGA’s product information for Clozapine. He stated that only the Novartis protocol, and not the product information, included the requirement of monthly blood tests to which he objects to. No further evidence was provided to the Tribunal on this issue.

Consideration

Has an initial decision been made?

13.     Dr Drew contends that the TGA has made a decision regarding the control of the supply of Clozapine under either section 9D, 25(4) or 25AA(4) of the Act. These sections provide, as relevant, for entries on the Register of therapeutic goods (section 25), approval of product information for medicines on the Register (section 25AA), and variation of entries on the Register (section 9D):

25 Evaluation and registration of therapeutic goods
 (1)  If an application is made for the registration of therapeutic goods in relation to a person in accordance with section 23, the Secretary must evaluate the goods for registration having regard to:
…

4)  If:

(a)  the therapeutic goods are not therapeutic devices; and

(b)  the evaluation of the goods for registration has been completed;

the Secretary must:

(c)  notify the applicant in writing of his or her decision on the evaluation within 28 days of the making of the decision and, in the case of a decision not to register the goods, of the reasons for the decision; and

(d)  if the decision is to register the goods:

(i)  notify the applicant in writing that the goods will be included in the Register if the applicant gives the Secretary either the certificate required under subsection 26B(1) or a notice (in accordance with a form approved, in writing, by the Secretary) that a certificate under that subsection is not required in relation to the application; and

(ia)  if the goods are restricted medicine or the goods are medicine in respect of which the applicant has been given a notice of the kind referred to in subparagraph (1)(da)(ii)--notify the applicant in writing of the product information that is approved in relation to the medicine; and

(ii)  include the goods in the Register and give the applicant a certificate of registration if the applicant gives the Secretary either the certificate required under subsection 26B(1) or a notice (in accordance with a form approved, in writing, by the Secretary) that a certificate under that subsection is not required in relation to the application.

…

25AA Approved product information for medicine

(4)  If:

(a)  there is medicine included in the Register in relation to a person and there is product information approved under this section in relation to the medicine; and

(b)  either:

(i)  under section 9D, the Secretary varies the entry in the Register in relation to the medicine; or

(ii)  there is a change in the conditions to which the inclusion of the medicine is subject; and

(c)  as a result of that variation or change, the Secretary is satisfied that a variation to that product information is required;

the Secretary may, by notice in writing given to the person, make any variations that the Secretary considers appropriate to the product information that is approved in relation to the medicine.

9D Variation of entries in Register
(1)  The Secretary may:

(a)  following a request by a person in relation to whom therapeutic goods are entered on the Register; or

(b)  on the Secretary's own initiative;

vary the entry in the Register in relation to the goods if the entry contains information that is incomplete or incorrect …

14.     Decisions made under sections 9D, 25 and 25AA are defined as initial decisions under section 60 of the Act.

15.     Dr Drew seeks review of the Secretary’s decision to enter Clozapine on the Register and to approve the product information that restricts the use of Clozapine. The Tribunal accepts that a decision to register Clozapine and approve product information is a decision made under Part 3.2 of the Act, and is an initial decision as defined in section 60(1)(c).

16.     Dr Drew also contended that the refusal or failure to undertake a review of Clozapine, and therefore vary the entry on the Register in accordance with section 9D, should be reviewable. The Tribunal accepts that a decision made under section 9D would constitute an initial decision under section 60(1)(ab), however no evidence has been provided that such a decision has been made. It also appears unlikely that a failure to vary an entry in the Register under section 9D, would amount to a decision made under that section.

Has Dr Drew sought reconsideration of the initial decision?

17.     On the materials before the Tribunal, it is clear that Dr Drew has made numerous attempts to encourage a review of the restrictions on the use of Clozapine. Dr Drew has written to various officers within the TGA, as well as the Secretary and Minister for Health and Ageing. Dr Drew has also contacted Novartis, the pharmaceutical company that manufactures Clozapine, Medicare, and the Royal Australian and New Zealand College of Psychiatrists as alternative means of changing the Clozapine restrictions.

18.     The responses from the Secretary and officers from the TGA that have been made available to the Tribunal do not indicate that any of Dr Drew’s letters have been considered as a request for review of decisions made under section 9D or Part 3.2 of the Act. On the material available to the Tribunal, the only substantive action that the TGA or Department of Health has taken in response to Dr Drew’s correspondence is to remit letters outlining his concerns to the Safety and Quality Partnership Sub Committee of the Australian Health Ministers’ Conference Mental Health Standing Committee. It appears the Sub Committee supported the current Clozapine restrictions.

19.     Although Dr Drew may not have been satisfied with responses from the TGA and the Department, he acknowledged at the hearing that it was not until he contacted the Tribunal that he was aware of the need to review an ‘official decision’. Dr Drew also acknowledged he was not aware of the restrictions on what is an ‘initial decision’ regarding the registration of Clozapine and the restrictions on its use. Without this information it would have been difficult for Dr Drew to take the steps formally to seek reconsideration of the relevant initial decisions. It was equally difficult for the TGA to construe Dr Drew’s correspondence as a request for reconsideration of an initial decision in accordance with section 60(2).

20.     Accordingly, the Tribunal finds that Dr Drew has not formally sought reconsideration of the Secretary’s initial decisions under Part 3.2 of the Act. As no review has been sought, the Minister has not reconsidered the initial decisions, and there is no reviewable decision under section 60(3) that the Tribunal, in turn, may reconsider.

21.     Even if Dr Drew’s correspondence was construed as a request for reconsideration, further problems arise in relation to standing and time limits. Section 60(2) provides that only ‘persons whose interests are affected by an initial decision’ have standing to request the reconsideration of an initial decision.  Further this request must be made within 90 days after the decision first came to that person’s notice.

Time limits for application for review by the TGA

22.     The application of the 90 day time limit prescribed by section 60(2) is problematic as it is unclear when Dr Drew became aware of the initial decisions in relation to Clozapine. Clozapine was entered on the Register in 1992 and it was last reviewed in 2003. While Dr Drew acknowledged at the hearing that ‘the initial decision was taken 20 years ago’, he also claimed that it was only once he initiated proceedings in the Tribunal that he became aware of any official decision in relation to Clozapine. Without further information on when Dr Drew became aware of the initial decisions for the purposes of the Act, the Tribunal is unable to make a finding that Dr Drew’s correspondence was, or may still be, within the 90 day time limit.

Is Dr Drew a person whose interests are affected by the ‘initial decision’?

23.     The question of whose interests are affected by a decision must be answered by reference to the character, subject matter and context of a decision (Re Control Investments Pty Ltd and Australian Broadcasting Tribunal (No 1) (1980) 3 ALD 74 at 70). However, at a minimum, there must be some evidence to show that the interests of the person seeking review are ‘in truth affected’ (Re McHattan and Collector of Customs (NSW) (1977) 1 ALD 67 at 70).

24.     A manufacturer of Clozapine, or a patient who is prescribed the medication, would be persons whose interests are clearly affected by an initial decision under Part 3.2. To establish that the interests of a doctor who prescribes Clozapine are also affected, may be more problematic. As the restrictions in the product information directly affect the way doctors such as Dr Drew can conduct their practice, depending on the nature of the restrictions imposed, it is arguable his interests would be affected by the initial decision under Part 3.2. However, even though Dr Drew may be a person eligible to seek reconsideration of an initial decision under Part 3.2, that does not negate the finding that no formal request for reconsideration was made.

Conclusion

25.     As Dr Drew has not sought review of an initial decision relating to the supply, prescription and use of Clozapine, and no reviewable decision has been made by the Minister, the Tribunal does not have jurisdiction to review any of the decisions Mr Drew seeks to challenge.

26.     However, the Tribunal recognises there appears to be some merit in Dr Drew’s concerns and, as discussed at the hearing, the Tribunal encouraged Dr Drew to pursue other options for review of restrictions on the use of Clozapine. In particular, Dr Drew may want to pursue the issue with the Commonwealth Ombudsman, or to again contact the Minister for Health and Ageing, or his local parliamentary representative.

27.     The Tribunal also notes that Mr Teoh made an undertaking on behalf of the TGA to provide a written response to the concerns raised by Dr Drew in the hearing and in particular to look further into the nature of decisions made by the Secretary in relation to Clozapine. Those responses were to be made to Dr Drew, copied to the Tribunal.  If made, the responses have not been communicated to the Tribunal.

I certify that the 27 preceding paragraphs are a true copy of the reasons for the decision herein of Professor RM Creyke, Senior Member

Signed:         ................................[sgd]............................................
  Caitlin Baillie, Associate

Date/s of Hearing  1 August 2011
Date of Decision  25 August 2011

For the Applicant  Dr Leslie Drew
Solicitor for the Respondent     Mr Kenneth Teoh