You are here:
AustLII >>
Databases >>
Federal Court of Australia >>
2009 >>
[2009] FCA 31
[Database Search]
[Name Search]
[Recent Decisions]
[Noteup]
[Download]
[Help]
Servier Laboratories (Aust.) Pty Ltd v Commonwealth of Australia [2009] FCA 31 (28 January 2009)
Last Updated: 28 January 2009
FEDERAL COURT OF AUSTRALIA
Servier Laboratories (Aust.) Pty Ltd v
Commonwealth of Australia
[2009] FCA 31
Constitution, s 51(xxxi)
Acts Interpretation
Act 1901 (Cth), s 8
Administrative Decisions (Judicial Review) Act
1977 (Cth)
Health Legislation Amendment Act 2007 (Cth), s 2(1),
Sch 2
Judiciary Act 1903 (Cth), s 39B
National Health
Act 1953 (Cth), ss 84(1), 84AB, 85, 85(1), 85(2), 85(3), 85(5), 85(6), 103,
103(2), 103(2)(a), 103(2A), 103(2A)(b), 103(2A)(c), Pt VII
National Health
Amendment (Pharmaceutical Benefits Scheme) Act 2007 (Cth)
Health Legislation Amendment Bill 2007 (Cth), Explanatory Memorandum
SERVIER LABORATORIES (AUST.) PTY LTD (ACN 004 838
500) v THE COMMONWEALTH OF AUSTRALIA and THE MINISTER FOR HEALTH AND
AGEING
VID 696 of 2007
GRAY J
28 JANUARY 2009
MELBOURNE
|
IN THE FEDERAL COURT OF AUSTRALIA
|
|
VICTORIA DISTRICT REGISTRY
|
|
|
|
SERVIER LABORATORIES (AUST.) PTY
LTD(ACN 004 838 500)Applicant
|
|
AND:
|
THE COMMONWEALTH OF AUSTRALIAFirst
Respondent
THE MINISTER FOR HEALTH AND AGEING Second Respondent
|
|
|
|
|
DATE OF ORDER:
|
|
|
WHERE MADE:
|
|
THE COURT ORDERS THAT:
- The
amended application be dismissed.
- The
applicant pay the respondents’ costs of the proceeding incurred after 29
April 2008.
- Otherwise,
there be no order as to costs.
Note: Settlement and entry of orders is dealt with in Order 36 of
the Federal Court Rules.
The text of entered orders can be located using
eSearch on the Court’s website.
IN THE FEDERAL COURT OF AUSTRALIA
|
|
|
VICTORIA DISTRICT REGISTRY
|
VID 696 of 2007
|
|
BETWEEN:
|
SERVIER LABORATORIES (AUST.) PTY LTD (ACN 004 838
500) Applicant
|
|
AND:
|
THE COMMONWEALTH OF AUSTRALIA First Respondent
THE MINISTER FOR HEALTH AND AGEING Second Respondent
|
|
JUDGE:
|
GRAY J
|
|
DATE:
|
28 JANUARY 2009
|
|
PLACE:
|
MELBOURNE
|
REASONS FOR JUDGMENT
The nature and history of the proceeding
- When
this proceeding was commenced on 16 August 2007, it was relatively simple. The
applicant, a manufacturer of pharmaceutical
drugs, sought judicial review of two
decisions or two episodes of conduct, pursuant to the Administrative
Decisions (Judicial Review) Act 1977 (Cth) (“the ADJR Act”) and
s 39B of the Judiciary Act 1903 (Cth). The decisions were said to have
been made or the conduct to have occurred within the Department of Health and
Ageing (“the
Department”). The Department issued a schedule of
pharmaceutical benefits, operating from 1 August 2007, in which it was stated
that two drugs manufactured by the applicant had equivalents for the purposes of
s 103(2A) of the National Health Act 1953 (Cth) (“the NH
Act”). The applicant’s drugs are perindopril arginine and
perindopril arginine with indapamide
hemihydrate. The stated equivalents are
perindopril erbumine and perindopril erbumine with indapamide hemihydrate
respectively.
The effect of these decisions or this conduct, if valid, was to
permit pharmacists who would otherwise have been required to dispense
one of the
applicant’s drugs in accordance with a prescription to dispense the
equivalent instead. The applicant contended
that each decision or episode of
conduct exceeded the power given by s 103(2A) of the NH Act and was invalid.
That contention involved
a question as to the meaning of “pharmaceutical
item”, a term used in s 103(2A) of the NH Act and defined in ss 84 and
84AB.
- Two
subsequent events made the proceeding much more complex. The first was that, on
19 September 2007, the applicant also filed
in this Court an application that
became proceeding no. VID 859 of 2007. In that proceeding, the applicant sought
against the Commonwealth
of Australia and the Secretary to the Department
damages for negligence and injurious falsehood, arising out of the same two
decisions
or episodes of conduct, and injunctive relief in relation to those
decisions or episodes of conduct.
- The
second event was the passage through Parliament of the Health Legislation
Amendment Act 2007 (Cth) (“the HLA Act”). The HLA Act contained
provisions amending s 103(2A) of the NH Act. The HLA Act received the
assent of
the Governor-General on 28 September 2007, but the provision amending s 103(2A)
of the NH Act was expressed to come into
operation retrospectively, on 1 August
2007.
- The
applicant then wished to argue that the amending provisions were invalid,
because they exceeded the legislative power of the
Commonwealth Parliament. It
wished to contend that the retrospective operation of the amending provisions
amounted to an acquisition
of property of the applicant (the choses in action on
which its two proceedings were founded) other than by affording just terms,
as
required by s 51(xxxi) of the Constitution. On 9 October 2007, pursuant to
leave granted by North J on 8 October 2007, the applicant filed in this
proceeding an amended application,
raising this ground. The particulars of the
choses in action relied on included both the cause of action in this proceeding
and
the causes of action in proceeding no. VID 859 of 2007.
- Both
proceedings were then transferred into my docket. This proceeding came on for
hearing on 4 December 2007. In the course of
that hearing, I revoked the leave
given by North J on 8 October 2007 to the extent that it permitted the applicant
to include in
its amended application the paragraph of the particulars raising
the issue of the alleged acquisition of the choses in action involved
in
proceeding no. VID 859 of 2007. Counsel for the applicant then sought to
adjourn the further hearing of the proceeding. I granted
that adjournment. The
two proceedings were listed for directions on 18 December 2007. On that date, I
ordered that the two proceedings
be heard together and referred both of them to
mediation.
- As
a consequence of the mediation, proceeding no. VID 859 of 2007 was settled. The
terms of settlement are confidential, save as
to the terms of orders that were
made by consent to dispose of the proceeding. This proceeding was not settled,
and was the subject
of further directions as to the filing of written
submissions.
- On
1 August 2008, the hearing of this proceeding resumed. Counsel for the
applicant informed the Court that the applicant no longer
wished to pursue the
proposition that the HLA Act effected an acquisition of property in terms of the
chose in action the subject
of this proceeding. He conceded that it followed
that the retrospective operation of the amending provisions made it impossible
for orders to be made setting aside the decisions, or for a declaration to be
made that s 103(2A) of the NH Act prohibits a pharmacist
from substituting the
supposed equivalents for the applicant’s drugs. Counsel for the applicant
also informed the Court that
the applicant did not press for the injunctive
relief sought in the amended application, and could not maintain its case for a
declaration
that the amending provisions of the HLA Act were invalid. This left
the applicant in the position of seeking no relief in this proceeding.
Counsel
for the applicant conceded that the proceeding must be dismissed. The only
request the applicant made was that I should
give reasons for judgment,
including reasons for the order made on 4 December 2007, revoking in part the
leave to amend the application,
previously granted by North J. With the
exception of an argument about issues of costs of the proceeding, the proceeding
was effectively
at an end.
The legislation
- Section
103 is found in Pt VII of the NH Act, which establishes a scheme under which the
Commonwealth Government subsidises the provision
of pharmaceutical drugs to the
public. Immediately before 1 August 2007, s 103(2)
provided:
Except as prescribed, a pharmacist to whom a prescription is presented shall
not:
(a) supply, in purported pursuance of this Part, anything other than
the
pharmaceutical benefit as specified in the prescription;
or
(b) in exchange for the prescription make a payment in money or give
any
other consideration to the person presenting the
prescription.
Penalty: $2,000 or imprisonment for 12 months, or both.
- At
that time, s 103(2A) provided:
Paragraph (2)(a) does not prohibit a pharmacist from supplying, in lieu of
the pharmaceutical benefit specified in a prescription
(the specified
benefit), another pharmaceutical benefit (the substitute
benefit) that is marketed under a different brand from the specified
benefit if:
(a) the person who prescribed the specified benefit did not indicate on the
prescription that only that benefit was to be supplied;
and
(b) the Schedule of Pharmaceutical Benefits issued by the Department states
that the specified benefit and the substitute benefit
are equivalent;
and
(c) a determination is in force under subsection 85(6) in respect of the
brand of the substitute benefit; and
(d) the supply of the substitute benefit under that brand is not prohibited
by a law of the State or Territory in which the substitute
benefit is
supplied.
- The
term “pharmaceutical benefit” was defined in s 84(1) as meaning
“a drug or medicinal preparation in relation
to which, by virtue of
section 85, this Part applies.” By s 85(1), benefits were to be provided
by the Commonwealth in accordance
with Pt VII, in respect of the drugs and
medicinal preparations in relation to which Pt VII applied. By s 85(2), those
drugs and
medicinal preparations were those declared by the Minister in writing,
or those in a class declared by the Minister in writing, to
be drugs and
medicinal preparations, or a class of drugs and medicinal preparations, as to
which s 85 then empowered the Minister
to make various forms of determinations
or declarations. The forms of determinations or declarations included the
following:
(3) The Minister may determine, by reference to strength, type of unit, size
of
unit or otherwise, the form or forms of a drug or medicinal
preparation
referred to in subsection (2) that is or are allowable
for the purposes of
this Part and, where such a determination is in
force in relation to a drug
or medicinal
preparation:
(a) the drug or medicinal preparation in the form, or in each of
the
forms, so determined is a drug or medicinal preparation in
relation
to which this Part applies; and
(b) this Part does not apply in relation to the drug or
medicinal
preparation in any other form.
...
(6) The Minister may determine, in respect of a drug or medicinal
preparation
in relation to which this Part applies, a brand or brands
under which the
drug or medicinal preparation may be supplied under
this Part, and where
such a determination is in force in relation to
a drug or medicinal
preparation, this Part does not apply in relation
to the drug or medicinal
preparation as marketed under any other
brand.
- The
National Health Amendment (Pharmaceutical Benefits Scheme) Act 2007 (Cth)
introduced a number of amendments to Pt VII of the NH Act. This Act did not
amend s 103(2) of the NH Act, but did amend s 103(2A) in significant ways. The
amendments came
into operation on 1 August 2007. Immediately after that date, s
103(2A) was in the following form:
Paragraph (2)(a) does not prohibit a pharmacist from supplying, in lieu of a
listed brand of a pharmaceutical item specified in a
prescription (the
specified benefit), another listed brand of the
pharmaceutical item (the substitute benefit)
if:
(a) the person who prescribed the specified benefit did not indicate on
the
prescription that only that benefit was to be supplied;
and
(b) the Schedule of Pharmaceutical Benefits issued by the Department
states
that the specified benefit and the substitute benefit are
equivalent; and
(d) the supply of the substitute benefit is not prohibited by a law of the
State
or Territory in which the substitute benefit is
supplied.
- At
the same time, the definition of “pharmaceutical benefit” in s 84(1)
was amended to read:
pharmaceutical benefit means the following:
(a) if a declaration under subsection 85(2) is in force in relation to a drug
or
medicinal preparation (the drug) and paragraph (b),
(c) and (d) do not
apply—the drug;
(b) if a determination under subsection 85(3) is in force in relation to a
form of
the drug and paragraph (c) and (d) do not apply—the
drug in that form;
(c) if a determination under subsection 85(5) is in force in relation to a
manner
of administration of that form of the drug and paragraph (d)
does not
apply—the drug in that form with that manner of
administration;
(d) if a determination under subsection 85(6) is in force in relation to a
brand
of a pharmaceutical item that is the drug in that form with
that manner of
administration—that brand of the drug in that
form with that manner of
administration.
- A
new definition of “pharmaceutical item” was also introduced. That
term was assigned the meaning given by s 84AB.
The new s 84AB provided as
follows:
If:
(a) a declaration under subsection 85(2) is in force in relation to a drug
or
medicinal preparation (the drug);
and
(b) a determination under subsection 85(3) is in force in relation to a form
of
the drug; and
(c) a determination under subsection 85(5) is in force in relation to a
manner
of administration of that form of the
drug;
then the drug in that form with that manner of administration is a
pharmaceutical item.
- Also
inserted into s 84(1) were the following definitions of the terms “listed
brand” and “listed drug”:
listed brand of a pharmaceutical item means a brand of the
pharmaceutical item in relation to which a determination under subsection 85(6)
is in
force.
listed drug means a drug or medicinal preparation in relation
to which a declaration under subsection 85(2) is in force.
- At
the same time, s 85 of the NH Act was amended. As from 1 August 2007, that
section empowered the Minister to determine the form
or forms of a listed drug
(subs (3)), the manner of administration of a form of a listed drug (subs (5))
and a brand of a pharmaceutical
item (subs (6)).
- As
a result of the HLA Act, a minor amendment was made to s 103(2)(a) of the NH
Act, the effect of which was to delete the words
“as specified”,
following the phrase “pharmaceutical benefit”, and to substitute for
the deleted words the
words “that is directed to be supplied”. That
amendment was effected by item 9 in Sch 2 to the HLA Act. Items 10 and
11 in
the same schedule amended s 103(2A). The effect of item 10 was to delete the
words “in lieu of a listed brand of a pharmaceutical
item specified in a
prescription (the specified benefit), another listed brand of the
pharmaceutical item” and to substitute for them the words “instead
of the pharmaceutical
benefit that is directed to be supplied in a prescription
(the specified benefit), another pharmaceutical benefit”. Item 11
inserted after s 103(2A)(b) a new paragraph (c), consisting of the words
“the
substitute benefit is a listed brand of a pharmaceutical item”.
- By
virtue of s 2(1) of the HLA Act, items 8 to 11 of Sch 2 commenced on 1 August
2007. Thus, by retrospective amendment, from 1
August 2007, s 103(2A) of the NH
Act provided:
Paragraph (2)(a) does not prohibit a pharmacist from supplying, instead of
the pharmaceutical benefit that is directed to be supplied
in a prescription
(the specified benefit), another pharmaceutical benefit (the
substitute benefit) if:
(a) the person who prescribed the specified benefit did not indicate on
the
prescription that only that benefit was to be supplied;
and
(b) the Schedule of Pharmaceutical Benefits issued by the Department
states
that the specified benefit and the substitute benefit are
equivalent; and
(c) the substitute benefit is a listed brand of a pharmaceutical item;
and
(d) the supply of the substitute benefit is not prohibited by a law of the
State
or Territory in which the substitute benefit is
supplied.
- The
effect of these successive amendments may be summarised for present purposes as
follows. Prior to 1 August 2007, substitution
of an equivalent was permitted if
the equivalent was another pharmaceutical benefit, as defined. Immediately
after 1 August 2007,
the only substitution permitted was of one listed brand of
a pharmaceutical item for another listed brand of the pharmaceutical item.
Following the passage of the HLA Act, a pharmacist was again permitted to
substitute for one pharmaceutical benefit another pharmaceutical
benefit.
The facts
- On
24 July 2007, the then Minister for Health and Ageing made two instruments,
designated as No. PB48 of 2007 and No. PB49 of 2007
respectively. Each provided
that it was to commence on 1 August 2007. Instrument No. PB48 of 2007 included
a declaration, pursuant
to s 85(2) of the NH Act, that various drugs and
medicinal preparations were drugs and medicinal preparations to which Pt VII of
the NH Act applied. Among those drugs and medicinal preparations were
perindopril and perindopril with indapamide. Instrument No.
PB49 of 2007
included determinations pursuant to the powers conferred by s 85(3), (5) and (6)
of the NH Act, once those powers came
into effect on 1 August 2007. The
determinations were expressed in columns in schedules to Instrument No. PB49 of
2007. Relevantly,
they were as
follows:
|
Listed Drug
|
Form
(strength, type, size, etc.)
|
Manner of administration
|
Maximum quantity
|
Maximum number of repeats
|
Brand
|
|
Perindopril
|
Tablet containing perindopril erbumine 2 mg
|
Oral
|
30
|
5
|
Chem mart Perindopril
|
|
|
|
|
|
GenRx Perindopril
|
|
|
|
|
|
Perindo
|
|
|
|
|
|
Perindopril 2
|
|
|
|
|
|
Perindopril-DP
|
|
|
|
|
|
Terry White Chemists Perindopril
|
|
Tablet containing perindopril arginine 2.5 mg
|
Oral
|
30
|
5
|
Coversyl 2.5mg
|
|
Tablet containing perindopril erbumine 4 mg
|
Oral
|
30
|
5
|
Chem mart Perindopril
|
|
|
|
|
|
GenRx Perindopril
|
|
|
|
|
|
Perindo
|
|
|
|
|
|
Perindopril 4
|
|
|
|
|
|
Perindopril-DP
|
|
|
|
|
|
Terry White Chemists Perindopril
|
|
Tablet containing perindopril arginine 5 mg
|
Oral
|
30
|
5
|
Coversyl 5mg
|
|
Tablet containing perindopril erbumine 8 mg
|
Oral
|
30
|
5
|
Chem mart Perindopril
|
|
|
|
|
|
GenRx Perindopril
|
|
|
|
|
|
Perindo
|
|
|
|
|
|
Perindopril 8
|
|
|
|
|
|
Perindopril-DP
|
|
|
|
|
|
Terry White Chemists Perindopril
|
|
Tablet containing perindopril arginine 10 mg
|
Oral
|
30
|
5
|
Coversyl 10mg
|
|
Perindopril with Indapamide
|
Tablet containing perindopril arginine 2.5 mg with indapamide
hemihydrate 0.625 mg
|
Oral
|
30
|
5
|
Coversyl Plus LD 2.5mg/0.625mg
|
|
Listed Drug
|
Form
(strength, type, size, etc.)
|
Manner of administration
|
Maximum quantity
|
Maximum number of repeats
|
Brand
|
|
Tablet containing perindopril erbumine 4 mg with indapamide
hemihydrate 1.25 mg
|
Oral
|
30
|
5
|
Chem mart
Perindopril/
Indapamide 4/1.25
GenRx Perindopril/
Indapamide 4/1.25
Terry White
Chemists
Perindopril/
Indapamide
4/1.25
|
|
Tablet containing
Perindopril
arginine 5 mg
with indapamide
hemihydrate
1.25 mg
|
Oral
|
30
|
5
|
Coversyl Plus 5mg/1.25mg
|
Coversyl was the brand name by which the applicant sold its perindopril and
Coversyl Plus was the brand name by which the applicant
sold its perindopril
with indapamide.
- Each
month, the Department publishes a book entitled Schedule of Pharmaceutical
Benefits for Approved Pharmacists and Medical Practitioners.
It duly published
such a schedule, described as “effective 1 August 2007 - 31 August
2007”. On the page following its
title page, this schedule bears the
following words in a printed rectangle:
This Schedule provides information on the arrangements for the prescribing of
pharmaceutical benefits by medical practitioners and
participating dental
practitioners, and the supply of pharmaceutical benefits by approved
pharmacists, approved medical practitioners
and approved hospital authorities.
These arrangements operate under the National Health Act 1953. However,
at the time of printing, the relevant legislation giving authority for the
changes included in this issue of the Schedule
may still be subject to the usual
Parliamentary scrutiny. This book is not a legal document, and, in cases of
discrepancy, the legislation
will be the source document for payment for the
supply of pharmaceutical benefits. The legislation is available from the
Federal
Register of Legislative Instruments website at
http://www.frli.gov.au.
- At
p 66 of the schedule appears the following:
BRAND EQUIVALENCE
‘a’ located immediately before brand names of a particular
strength of an item indicates that the sponsors of these brands
have submitted
evidence that they have been demonstrated to be bioequivalent or therapeutically
equivalent, or that justification
for not needing bioequivalence or therapeutic
equivalence data has been provided to and accepted by the Therapeutic Goods
Administration.
It would thus be expected that these brands may be interchanged
without differences in clinical effect.
- The
schedule contained the following relevant entries:



- The
Department issued another monthly schedule effective from 1 September to 30
September 2007. In all relevant respects, this schedule
was in the same terms
as the schedule for the month of August. The two schedules containing the
entries relating to the bioequivalence
of the applicant’s products and
other products constitute the two decisions, or episodes of conduct, the subject
of challenge
in this proceeding.
The applicant’s case on invalidity of the decisions
- The
applicant contended that the Department had exceeded its powers under s 103(2A)
of the NH Act in the August 2007 schedule (and,
necessarily, in the September
2007 schedule), when it represented that the applicant’s products and the
products of other manufacturers
or suppliers were equivalent. The underlying
proposition was that, as s 103(2A) stood after the coming into operation of the
amendments
that first took effect on 1 August 2007, such a representation could
only be made with respect to a listed brand of one pharmaceutical
item,
specified in a prescription, and another listed brand of the same pharmaceutical
item.
- On
the face of it, the definition of “pharmaceutical item” in s 84AB of
the NH Act appears to dictate the conclusion
that s 103(2A) as it stood at 1
August 2007 and 1 September 2007 only permitted substitution of a drug with
respect to which there
was in force a declaration that it was a listed drug, and
a determination in relation to the form of the drug, and a determination
in
relation to the manner of administration of that form of the drug. Having
regard to the forms of the determinations made in Instrument
No. PB49 of 2007,
particularly the descriptions listed in the column headed “Form”, it
would seem that each determined
dosage of perindopril was to be regarded as a
separate pharmaceutical item, and that perindopril erbumine was a different
pharmaceutical
item from perindopril arginine. The argument derives support
from the amendments effected by the HLA Act, which reinstated the term
“pharmaceutical benefit” in s 103(2A), so that different
pharmaceutical benefits could be regarded as equivalents. The
argument is also
supported by the Explanatory Memorandum to the Bill that became the HLA Act,
which explained the purpose of Item
10 in Sch 2 in the following
terms:
This item, together with item 11, amends subsection 103(2A), which was
unintentionally narrowed in meaning by amendments to the NH
Act which commenced
on 1 August 2007. The current provision enables the substitution of other
listed brands of the same pharmaceutical
item. The amendment proposed by this
item will enable the substitution of different pharmaceutical benefits, as was
the case prior
to the 1 August 2007 amendments. In each case substitution is
only permitted if each of the other requirements of subsection 103(2A)
are
satisfied, including that the Schedule of Pharmaceutical Benefits states that
the two benefits are equivalent.
- It
is unnecessary to determine whether the applicant would have succeeded in
relation to this argument. Counsel for the applicant
were not able to point to
any statutory authority for the production of the monthly schedules, other than
the reference to “Schedule
of Pharmaceutical Benefits issued by the
Department” appearing in para (b) of each of the successive forms of s
103(2A) of
the NH Act. In other words, there is some difficulty determining
exactly what power the Department was exercising when making the
representations
about equivalence, and consequent difficulty about determining whether it
exceeded that power in doing so. The applicant
has abandoned its claims for any
of the relief that might have flowed from its success in establishing invalidity
of the decisions.
There is therefore no longer any controversy between the
parties capable of judicial determination. It is enough to say, for the
purposes of these reasons for judgment, that I assume that the applicant would
have been entitled to succeed in establishing that
the representations as to
equivalence of its products and the products of other manufacturers or suppliers
were invalid. In addition,
as appears below, the respondents appear to have
taken substantially the same position as the applicant about the application of
s 8 of the Acts Interpretation Act 1901 (Cth) (“the Acts
Interpretation Act”). In the absence of a contradictor on that point, it
is undesirable that I should attempt a final determination of the
point.
The effect of the retrospective amendment
- When
the hearing of this proceeding began, the parties appeared to be of one view,
that the retrospective operation of the relevant
provisions of the HLA Act
deprived the applicant of any entitlement to succeed in this proceeding. The
parties remained at odds
as to whether, as a consequence of this deprivation,
there was an acquisition of the applicant’s property other than on just
terms. In the course of argument, I raised the question of the operation of s 8
of the Acts Interpretation Act, which provides relevantly:
Where an Act repeals in the whole or in part a former Act, then unless the
contrary intention appears the repeal shall not...
(b) affect the previous operation of any Act so repealed, or anything duly
done
or suffered under any Act so repealed; or
(c) affect any right privilege obligation or liability acquired accrued or
incurred
under any Act so repealed; or
...
(e) affect any investigation legal proceeding or remedy in respect of any
such
right privilege obligation liability penalty forfeiture or
punishment as aforesaid;
and any such investigation legal proceeding or remedy may be instituted
continued or enforced...as if the repealing Act had not been
passed.
- There
appeared to me to be a real question whether the mere provision that an amending
act should operate retrospectively was sufficient
to demonstrate a contrary
intention, for the purposes of s 8, in relation to an existing proceeding in a
court. A conclusion that such a contrary intention is not demonstrated, without
some
more explicit words, is all the more likely when there exists an obvious
purpose for the choice of retrospective operation. In this
case, such an
obvious purpose existed. As things stood before the HLA Act was passed,
pharmacists who had dispensed substitute drugs
to those presenting prescriptions
for the applicant’s products, on the faith of the Department’s
statements that the
substitute drugs were equivalents of the applicant’s
products, were potentially liable to criminal conviction for contravention
of s
103(2) of the NH Act. Retrospective operation of the HLA Act served to remove
this potential criminal liability. It was altogether
a different thing to say
that retrospective operation was sufficient to put an end to the right that the
applicant claimed to have
(and is assumed to have had) to seek judicial review
of invalid decisions or conduct, which the applicant had exercised in the form
of this proceeding. It seemed to me that there was a strong case for saying
that the right to pursue its claim for judicial review
remained alive and that,
subject to discretionary considerations, the applicant would have been entitled
to declaratory relief as
to the invalidity of the decisions at the time they
were made. Whether injunctive relief would have been appropriate is another
question, which may have been affected by the subsequent passage of the HLA Act.
If this argument were accepted, at the most there
would have been a diminution
in value of the applicant’s chose in action, rather than an acquisition of
any property.
- This
argument did not commend itself to the respondents. When the hearing of the
proceeding resumed, they did not propose to rely
on it if the applicant had
continued to press for the relief sought in the amended application. Despite
the respondents’ lack
of enthusiasm for the argument, I am by no means
convinced that it is entirely without merit. Because of the applicant’s
abandonment
of the claims for relief that might have been available to it, no
occasion arises to determine whether the argument is correct or
not.
The reasons for revoking leave to amend
- The
question of the acquisition of property, being the choses in action constituting
or underlying proceeding no. VID 859 of 2007,
raised issues different from those
concerning the acquisition of property, being the chose in action constituting
or underlying this
proceeding. Those issues would have arisen inevitably if
proceeding no. VID 859 of 2007 were to be prosecuted to its conclusion.
The
causes of action on which the applicant chose to rely in that other proceeding
by no means assured it of success. To succeed
in its cause of action for
negligence, the applicant would first have had to establish that the
Commonwealth of Australia, or the
Secretary to the Department, owed to it a duty
of care. There is a considerable line of authority concerning the co-existence
of
a common law duty of care and the performance of a public function,
particularly a statutory function. Collateral challenge to an
administrative
decision by way of action for damages in negligence is possible, but not in the
case of every administrative decision.
It is necessary to look at the terms of
the statute concerned, the nature of the public function being exercised, and
the availability
of remedies which can be pursued to challenge the correctness
of the administrative decision. In addition, where the negligent act
alleged is
a negligent misstatement (as in the present case), there are inevitably more
difficult questions as to the reasonable
foreseeability of reliance on the
misstatement. In that respect, it is necessary to consider the effect of any
disclaimer, such
as the one appearing at the commencement of each of the
schedules, which I have set out in [20] above. Next, it would be necessary
for
the applicant to establish breach of the duty. Although I am assuming that the
applicant would have been able to establish that
the decisions exceeded any
relevant legislative power, that would not necessarily conclude the question
whether there had been want
of reasonable care. Thirdly, it would be necessary
to establish that damage flowed from any breach. If the applicant failed at
any
of these stages, although it might be said that it had a chose in action by way
of a cause of action for negligence, it might
fail altogether so that its cause
of action, and consequently its chose in action, was worthless.
- Similarly,
the applicant would not be able to succeed on its cause of action for injurious
falsehood without establishing the necessary
falsity. The invalidity of each of
the administrative decisions, on the basis that the decision-maker exceeded the
limits of any
relevant statutory power, would not establish such falsity. It
would be necessary to examine the meaning and effect of the representations
that
were actually made from the point of view of those who made use of the schedule.
The applicant would have needed to establish
that the use of the letter
‘a’ in relation to its products and the products of others did not
in fact indicate that the
sponsors of any of those products had submitted
evidence that they had been demonstrated to be bioequivalent or therapeutically
equivalent,
or that justification for not needing bioequivalence or therapeutic
equivalence data had been provided to and accepted by the Therapeutic
Goods
Administration. Alternatively, the applicant would need to establish that it
was incorrect for users of the schedule to expect
that the brands with
‘a’ before their names could be interchanged without differences in
clinical effect. Otherwise,
the applicant would have been forced to rely on
establishing the falsity of the representations that bioequivalence had been
demonstrated
between particular preparations. Again, a failure to establish the
falsity of these representations would have meant that the applicant’s
cause of action in injurious falsehood was of no value.
- The
respondents were prepared to concede that the applicant possessed a chose or
choses in action in the form of its causes of action
in proceeding no. VID 859
of 2007. They were not prepared to concede that the retrospective removal of
those causes of action (if
such occurred) involved an acquisition of property
other than on just terms. If it were to turn out that each of the causes of
action,
and therefore each of the choses in action, was valueless, a question
might have arisen as to the content of any possible just terms,
if it were found
that there had been an acquisition of property. It is difficult to see what
just terms might be required by s 51(xxxi) of the Constitution, to make valid
the acquisition of property that was of no value.
- At
the time when I revoked the leave previously given that would have enabled the
applicant to argue its case about acquisition of
property in the form of the
chose or choses in action constituting or underlying proceeding no. VID 859 of
2007, that proceeding
had not yet had its first directions hearing. It was then
some distance away from readiness for trial, whereas this proceeding was
in the
course of its final hearing. It was obvious that the issues to which I have
referred, and which I saw as bearing upon the
acquisition of property point,
would have to be litigated in proceeding no. VID 859 of 2007 in any event, if it
were to be pursued
to its conclusion. It was not practicable to litigate those
issues in the present proceeding as things then stood. It was always
open to
the applicant to raise the question of the acquisition of property, being the
chose or choses in action constituting or underlying
proceeding no. VID 859 of
2007 in that proceeding.
- For
those reasons, which were essentially practical reasons at the time, I revoked
in part the leave previously given by North J
to the applicants to amend their
application in the present case.
Conclusion
- It
follows from what I have said previously that the applicant must fail in this
proceeding. The revocation of leave to which I
have referred deprived the
applicant of any opportunity to argue in this proceeding that its property,
being the chose or choses
in action constituting or underlying proceeding no.
VID 859 of 2007, had been acquired other than on just terms through the
retrospective
operation of the relevant provisions of the HLA Act. The
applicant did in fact raise that issue in its pleading in proceeding no.
VID 859
of 2007, but settled that proceeding and therefore did not seek to have that
question, along with the issues on which its
outcome may have depended,
determined in that proceeding. Otherwise, the applicant abandoned its quest for
all of the relief it
sought in this proceeding, on which it might have been
entitled to succeed. An order must be made that the application be
dismissed.
Costs
- The
normal presumption is that costs follow the event. The proceeding having been
dismissed, it would be expected that the applicant
would be ordered to pay the
respondents’ costs of the proceeding. For a number of reasons, this is
not an ordinary proceeding.
It is one in relation to which I have assumed that
the applicant had a good cause of action, at least up to and perhaps beyond 28
September 2007, when the HLA Act received the Governor-General’s assent.
The respondents appear to have assumed that the cause
of action was good until
that date, but that the effect of the relevant provisions of the HLA Act was to
destroy the cause of action
validly, and retrospectively.
- Counsel
for the applicant sought an order that the respondent should pay the
applicant’s costs up to 28 September 2007, and
that thereafter there
should be no order as to costs. I am disinclined to give the applicant its
costs even up to that point. The
schedule for the month of August 2007 operated
from the first day of that month. This proceeding was commenced on 6 August
2007.
Prior to its commencement, there was no letter or other form of demand,
or warning, sent by the applicant or its solicitors to the
Department. The
first step that the applicant took was to begin litigation. That is a step
likely to place the respondents on an
adversarial footing, rather than to
produce a negotiated resolution of the problem that had occurred. Once a legal
proceeding had
been commenced, and process had been served on the respondents,
legal costs became an issue. If, instead of acting as precipitately
as it did,
the applicant had approached the Department to notify it of the error, and had
sought to have the problem resolved by
negotiation, it may well have succeeded
in achieving that end, and litigation would have been unnecessary. Counsel for
the respondents
sought an order that the applicant pay the respondents’
costs of the proceeding. In the alternative, counsel for the respondents
sought
an order that the applicant pay the respondents’ costs of the proceeding
after 28 September 2007, or a reasonable time
after that date, to enable the
applicant to assess the effect of the HLA Act.
- The
applicant has lost this proceeding by its own decision not to pursue such relief
as might have been available to it. It has
abandoned its claims for relief to
the extent that there has been nothing left for me to decide. In those
circumstances, it ought
to pay the respondents’ costs after a time at
which it should reasonably have concluded that it could not continue the
proceeding
with any hope of success, or that it did not wish to continue the
proceeding. In determining that date, the order of North J giving
the applicant
leave to amend, and my partial revocation of that leave must be borne in mind.
The proceeding, along with proceeding
no. VID 859 of 2007, was sent for
mediation. The applicant apparently chose to settle proceeding no. VID 859 of
2007. Subsequently,
the applicant chose to abandon this proceeding. In my
view, at the time when it decided to abandon its opportunity to pursue its
acquisition of property point in proceeding no. VID 859 of 2007, by settling
that proceeding, it would have been reasonable for the
applicant to have
discontinued this proceeding as well. According to the records of the Court,
the registrar who conducted the mediation
of the two proceedings recorded this
one as having been finalised without being resolved on 28 February 2008.
Proceeding no. VID
859 of 2007 was recorded as having been settled on 29 April
2008. The applicant should be ordered to pay the respondents’
costs of
the proceeding after this latter date. For the reasons I have given, as to the
circumstances in which the applicant commenced
the proceeding without prior
warning, there should be no order as to costs prior to that date.
I certify that the preceding thirty-eight (38)
numbered paragraphs are a true copy of the Reasons for Judgment herein of the
Honourable
Justice Gray.
|
Associate:
Dated: 28
January 2009
Counsel for the
Applicant:
|
Mr P Hanks QC with Dr S Donaghue on 4 December
2007 Mr R Niall on 1 August 2008
|
|
|
|
Solicitor for the Applicant:
|
Allens Arthur Robinson
|
|
|
|
Counsel for the Respondents:
|
Mr C Caleo SC with Mr P Gray
|
|
|
|
Solicitor for the Respondents:
|
Australian Government Solicitor
|
|
|
4 December 2007, 1 August 2008
|
|
|
|
Date of Judgment:
|
28 January 2009
|
AustLII:
Copyright Policy
|
Disclaimers
|
Privacy Policy
|
Feedback
URL: http://www.austlii.edu.au/au/cases/cth/FCA/2009/31.html