Calleja. J.T. v Secretary to the Department of Community Services & Health

[1990] FCA 815

IN THE FEDERAL COURT	)	NOT FOR DISTRIBUTION
OF AUSTRALIA
WESTERN AUSTRALIA	1
DISTRICT REGISTRY	1
GENERAL DIVISION	NO. WAG129 OF 1990
B E T W E E N :	JOY TERESA CALLEJA

Applicant

and

THE SECRETARY TO THE DEPARTMENT

OF COMMUNITY SERVICES AND HEALTH

Respondent

EX TEMPORE REASONS FOR JUDGMENT

This application under the Administrative Decisions

J Judicial Review) Act 1977 ( "the ADJR Actm) seeks review of a

decision by the respondent to refuse permission to import a

L

substance known as "Laetrile" described in the material as a "therapeutic substance" within th; meaning of the Customs (Prohibited Imports) Regulations 1956 ("the Regulations").

Whether it is such a substance is placed in issue by an amendment to the application. It would be inappropriate to say anything about that, I think, at this stage on the bare material provided. It would require more material and more debate. But it is rather paradoxical that what is put against the grant of permission to import the substance is that, in

looks to the Regulations to see what they provide and it can	fact, it has no therapeutic property. Be that as it may, one
be seen that a "therapeutic substance" as defined in reg.2 may be something other than a drug defined in sub-reg.5(20)(a).
It may be a drug, but as defined it is a substance which possesses one of several characteristics one of which may be use for alleviating an ailment or injury. It includes a "surgical ligature, suture or dressing" and is certainly not limited to a drug. The regulation recognizes that a substance which has alleviating properties may not be one that is either administered or prescribed by a medical practitioner. It may be but it may not be.
Sub-regulation 5A(2) has a provision which allows such a substance to be imported into this country without permission if it is a therapeutic substance imported by a passenger for personal use or for the use of a relative of a
passenger - one presumes that the relative is resident in Australia but it does not say so - and that the amount that is
imported is not in excess of three months' supply for a person
substance. at the maximum dosage recommended by the manufacturer of the
Such a provision is part of the context in which the powers provided by the Regulations are to be understood and exercised and, of course, they are matters to which any decision-maker must have regard when exercising a discretion
provided by the legislation. They are the prime matters to look at. A decision-maker required to determine whether permission to import the substance "Laetrilen should be granted could not restrict consideration to either the drug's curative or deleterious properties. The drug's toxicity would be only one of the matters to be considered under the Regulations.
The guidelines that have been relied upon by the decision-maker in this matter are not guidelines that have been issued in respect of the Regulations. They appear to be guidelines which serve a dual function. They apply to the Thera~eutic Goods Act 1966-1986 ("the Act") and the Therapeutic Goods Regulations 1970 made under the Act and are directed to drugs rather than therapeutic substances as defined above.
Apparently, not directly but by implication, the guidelines are also available to assist the exercise of powers
under the Regulations in so far as these Regulations apply to therapeutic substances. But, as one might expect, the
guidelines are not exhaustive. They do not, and cannot, take the place of any legislative provision or any regulatory provision. The guidelines are an aid to decision-makers. They are administrative in origin and their purpose is to provide assistance. They are not, and cannot be,
instructions.
However, when referred to and relied upon they may give rise to a procedural method facultative in nature which persons who seek decisions under the legislation may expect to be followed. The guidelines in their content may also indicate that there are areas where the decision-maker may be expected to exhaust some lines of inquiry before powers were exercised under the Regulations. Such regulations would be a procedural matter standing outside the content of the Regulations.
The context and purpose of the Regulations may require a range of matters to be considered.
On the one hand there may be an importer who is seeking to carry on a business of marketing and distributing such substances and, on the other hand, there may be an individual seeking the alleviation of the effects of a
step for limited purposes and may involve quite different disease. The needs of the latter may require only a limited
considerations from those to be applied to the application by an importer conducting a business.
It would be necessary for a decision-maker to look at the particular circumstances of each request. It would not be appropriate for a decision-maker to purport to apply a standing prohibition to the importation of a particular therapeutic substance by refusing to grant permission for the importation of that substance as a matter of course. The legislation could have, but has not, provided for the prohibition against importation to be without exception. The Act and Regulations provide for permission to import to be granted in respect of prohibited substances and, therefore, each case must be looked at on its merits.
Having considered the material before me, I am quite satisfied that the decision-maker, in the matter under review, did not properly exercise his discretionary powers under the Regulations. The decision-maker was required to determine the material facts to be considered in the application for permission and to properly understand the purpose and content of the Regulations.
The decision-maker must be able to show that those requirements have been satisfied by setting out the reasoning which led to the formation of the decision. A bare denial of permission will rarely satisfy those requirements. In my view, if the Court were required to make any decision on the matter, it could be said that the decision was as fundamentally flawed as the exercise of any administrative function under the Act and Regulations.
The decision, as explained by affidavit of the decision-maker, made no finding on the consequences to be expected if the substance were used by and under the direction of the medical practitioner prepared to supervise the administration of the substance; gave no consideration to the particular circumstances of the applicant, a terminally ill patient with the prospect that any of her ailments, including anxiety, may be alleviated by that treatment; and gave no consideration to the fact that the importation was for the personal use of the applicant as administered by a medical practitioner. Failure to consider these relevant matters meant that the decision-making process simply miscarried.
Having been advised that there is on foot a review of the decision to be undertaken by the Minister, I think that the Court should, at this point, withhold any orders that
would remove that review from ministerial purview.

A Court must be careful not to interfere with administrative functions by making orders which have the effect of substituting fresh administrative decisions. While the present case may be one where that course may need to be considered by the Court, the adminlstrative review of the

decision already under way may make it inappropriate for the Court to set aside the decision, thereby terminating the

teview .

I therefore propose to refrain, for the time being, from setting aside the decision which is under ministerial review and will direct that the applicant have leave to file a further affidavit showing the urgency of the matter and that the matter be relisted tomorrow when I will hear counsel further on the issue.

If the Court is then told that the Minister is unable to complete the review and make a decision upon it as a matter of urgency, the Court will consider whether it should set aside the decision and exercise the powers it has under

s.16 of the ADJR Act.

25 November 199Q

What is before the Court now is the question of whether the powers provided to the Court by para.l6(l)(d) of the ADJR Act should be exercised. I have previously stated that if required I would hold that grounds have been established for the Court to order the review of the decision to refuse importation of this so-called therapeutic substance on 25 September 1990.

To this point, I have declined to make such an order because had such an order been made it would have immediately nullified any steps being taken for the internal review of that decision as provided for under the Regulations. Such an order may not have been in the applicant's interests if it meant that the matter would be returned to the respondent or an authorized officer for a further decision in due course.

Meanwhile, the applicant's counsel has been given the opportunity to submit to the Court that there are circumstances of great urgency pertinent to the exercise of powers under para.l6(l)(d) and the respondent's counsel has been invited to inform the Court whether the Minister is able to carry out the review process provided for in the Regulations as a matter of urgency and obviate the need for any order by the Court setting aside the decision.

Today an affidavit has been filed on behalf of the applicant stating that there is a circumstance of great urgency and that if the importation of the substance were permitted, the opportunity for the applicant to obtain any benefit from such a decision would be extremely limited in time.

The Court has also been informed that an internal review by the Minister has been initiated and will be treated with urgency, but no estimate could be given as to when a decision pursuant to that review would be made. It could not be said that such a decision was imminent.

I now turn to the power provided to the Court in para.l6(l) (d) of the A o J R Act. The first thing to note about it is that sub-s.l6(1) is dealing with decisions that have already been made and not matters of conduct leading up to a decision and nor with a failure to make a decision.

It is ancillary to other powers set out in sub- s.16(1) to, inter alia, quash decisions, and it is to be read in conjunction with those other powers. As I stated to counsel, it is a power that is, in fact, used by the Court from time to time in appropriate cases, appropriate in the sense that para.l6(l)(d) itself describes, namely circumstances where it is necessary to exercise the power in

order to do justice between the parties.

The parties to an application for an order of review, of course, are not engaged in ordinary private civil litigation. In addition to the private interests of an aggrieved party, a public interest, represented by the due administration of the statutes of the Commonwealth, will be involved.

In the vast majority of cases there will be no cause for the Court to exercise any of the powers contained in para.l6(l)(d). A Court must observe the separation of powers and not be too ready to exercise executive powers or functions. It is important not to blur the lines of demarcation.

However, Parliament has given such powers to the Court to be used in appropriate cases and from time to time the powers are used to endeavour to do justice between the parties.

For example, in matters involving deprivation of liberty the need for exercise of such a power may be readily seen, and the Court does not shrink from making orders which restore liberty if in doing so it is able to do justice between the public interest and the private rights of the

party concerned.

In the ordinary course of events, a decision made under reg.5A of the Regulations ordered to be set aside would be returned to a decision-maker for a further decision and the Court would not make any further substantive order under para.l6(l)(d) of the ADJR Act.

In the present case, it has been submitted to the Court that the circumstances are unique involving as they do considerations peculiar to the applicant and of no general import or precedent. It is also said that the matter is one of the utmost urgency and that if the result of a successful application for an order for review in this Court is to be capable of any real result, then it can only be so if the Court exercises its powers under para.l6(l)(d) of the ADJR Act.

Upon being satisfied that grounds for review of the decision have been made out, the Court may either decline to make such an order and refrain from setting aside the decision in order that it remains a decision that is able to be reviewed by the Minister or the Court, in its discretion, may make such orders it considers appropriate.

For valid reasons explained to the Court, the

Minister has been unable to deal with the matter to date,

powers in the circumstances.	therefore, the Court must decide whether it should use its
In making that determination, the Court must consider whether it is in a position to direct the form of decision to be made when it is not conducting a review of the matter on the merits. In other words, the Court must keep in mind that it may be directing acts to be done without having before it all the material which would be considered by the administrator before a decision would be made on the matter in the ordinary course of events.
It is necessary to have regard to the particular provisions concerned, namely reg.5A of the Regulations. Sub- regulation SA(2) allows a person entering this country to import the substance Laetrile without hindrance provided it is for personal use or for the use of a relative, and under sub- reg.5A(4) appropriate conditions may be imposed in respect of the use of any therapeutic substance. Furthermore, much time has passed without the applicant having had the benefit of a proper decision being made under the Regulations and any order that the matter be returned to an authorized person for a further decision may be entirely pyrrhic if such a decision is not made promptly. According to Dr Staer, the likely benefit from use of the substance, at this stage, would be increased peace of mind both for the applicant and those closest to her.
However limited that benefit may be, it is something that has to be taken into account.
Having considered all of those matters, I am of the view that in the very particular circumstances of this case I should direct that there be an order that the decision made on 25 September 1990 be set aside and, having quashed that decision, that there be a direction that permission be granted forthwith under reg.5A for the importation of the substance identified in the affidavit.
If necessary the Court may order that the substance be imported only on the following conditions: that it be delivered into the possession and custody of Dr Staer for administration by him to the applicant in accordance with appropriate medical standards and practice and upon condition that Dr Staer maintain records of the use and administration of the substance and report thereon to the respondent at the conclusion of the course of administration of the substance and at that time deliver up to the respondent such amount of the substance, if any, as has not been administered to the applicant.
They are suggested conditions. An alternative may be for the Court to direct that the importation be permitted subject to a single condition that the importation be subject
to such conditions as may be imposed by the authorized officer
granting the permission. That order may allow additional
conditions to be set as are considered to be necessary and which may have been overlooked in the conditions suggested above. I will hear the parties on that question.
Having now heard counsel I will make the following orders. The decision, the subject of the application, be set aside and I direct that the applicant be permitted forthwith to import the substance identified in the affidavits filed in the application, such decision to be subject to such conditions as the respondent or authorized officer may impose pursuant to the Regulations. There will be liberty to apply.
There will also be the usual order in respect of the matter of costs, namely that the respondent pay the applicant's cost of the application.

I certify that the preceding
fourteen (14) pages are a true copy of the

Reasons for Judgment of his Honour M.r Justice Lee.

Associate:

Date: 1s- 11-cm

Counsel for the Applicant: Mr P.D. Blaxell

Solicitors for the Applicant: Messrs Lawrence and Howell

Counsel for the Respondent: MS J. Adamson on 14 November 1990,

and Mr S. Owen Conway and

MS Adamson on 15 November 1990

Solicitor for the Respondent: Australian Government Solicitor

Dates of Hearing: 14 and 15 November 1990

Date of Judgment: 15 November 1990