Aspen Pharmacare Australia Pty Limited and Minister for Health and Ageing
[2012] AATA 93
•14 February 2012
[2012] AATA 93
Division GENERAL ADMINISTRATIVE DIVISION File Numbers
2012/0348
2012/0350
Re
Aspen Pharmacare Australia Pty Limited
APPLICANT
And
Minister for Health and Ageing
RESPONDENT
DECISION
Tribunal Justice Downes, President
Date 14 February 2012 Date of written reasons 16 February 2012 Place Sydney The Applicant gives the following undertakings to the Tribunal:
A.[product information] to, as soon as practicable and in any event by 17 February 2012:
a) request the Secretary of the Department of Health and Ageing (“the Secretary”) pursuant to section 9D(2) of the Therapeutic Goods Act 1989 (Cth) (“the TG Act”) to vary information (“PI”) included in the Australian Register of Therapeutic Goods (“ARTG”) with respect to Di-Gesic to the effect of the amendments appearing in the document marked “A” initialled by Justice Downes and placed with the file;
b) request the Secretary pursuant to section 9D(2) of the TG Act to vary the PI with respect to Doloxene to the effect of the amendments appearing in the document marked “B” initialled by Justice Downes and placed with the filed;
B.[consumer medicine information] from the date of variation contemplated in paragraph A above (“the Variation Date”), until the determination of these proceedings or until released from this undertaking by the Tribunal (and only in respect of any product manufactured after the date of these orders):
a) to supply a patient information (“CMI”) document within each pack of Di-Gesic in a form consistent with the PI contemplated by paragraph A(a) but including:
i)words to the effect of the “black box” warning in the PI as varied by the Secretary; and
ii)notice that this appeal will be heard by the Tribunal, together with a warning that the products may, following a decision by the Tribunal, cease to be available within a short timeframe;
b) to supply a CMI document within each pack of Doloxene in a form consistent with the PI contemplated by paragraph A(b) but including:
i)words to the effect of the “black box” warning in the PI as varied by the Secretary; and
ii)notice that this appeal will be heard by the Tribunal, together with a warning that the products may, following a decision by the Tribunal, cease to be available within a short timeframe;
c) to, on any reasonable request by an Australian pharmacist, supply that pharmacist with copies of the documents referred to in paragraph (a) or (b) above at the Applicant’s cost;
C.[“dear doctor” letters] to send letters to all general practitioners, cardiologists, gastroenterologists, neurologists, physicians, rehabilitation specialists, nephrologists, rheumatologists, obstetrician and gynaecologists who are recorded on the Australian Medical Directory on the Variation Date (or if later, the date of approval), in a form approved by the Respondent as soon as practicable and in any event within seven business days of the later of that approval and the Variation Date;
D.[“dear pharmacist” letters and “tear off pads”] to send letters and information sheets to all hospitals and retail pharmacies in Australia who are members of the Pharmacy Guild, as identified by the Pharmacy Guild on the Variation Date (or if later, the date of approval), in a form approved by the Respondent as soon as practicable after the form of that letter is approved (or if later, the Variation Date).
The Tribunal ORDERS:
1.Pursuant to s 41(2) of the Administrative Appeals Tribunal Act 1975 (Cth) and all other enabling powers, the operation and implementation of the following decisions are stayed until further order:
a.the decision of a delegate of the Secretary made on or about 3 November 2011 to cancel the registration of Di-Gesic from the ARTG;
b.the decision of a delegate of the Secretary made on or about 3 November 2011 to cancel the registration of Doloxene from the ARTG;
c.the decision of a delegate of the Respondent made on or about 23 January 2012 to confirm the decision referred to in paragraph (a);
d.the decision of a delegate of the Respondent made on or about 23 January 2012 to confirm the decision referred to in paragraph (b).
2.Respondent to lodge with the Tribunal and serve on the Applicant the documents required to be lodged and served pursuant to section 37 of the Administrative Appeals Tribunal Act 1975 (Cth) on or before 22 February 2012.
3.The preliminary conference listed for 22 March 2012 (before CR Desses) be vacated.
4.Applicant to serve a statement of facts, issues and contentions and the evidence upon which it proposes to rely in chief on or before 13 March 2012.
5.Respondent to serve a statement of facts, issues and contentions and the evidence upon which it proposes to rely in answer on or before 3 April 2012.
6.Applicant to serve any evidence in reply on or before 17 April 2012.
7.Matter to be listed for directions on 23 April 2012 with a view to making directions as are necessary or convenient for the purposes of finalising preparation of the matter for the final hearing.
8.Proceedings to be listed for hearing for 5 days commencing on 28 May 2012.
9.Liberty to apply on 24 hours’ notice with respect to any issue arising from the implementation of these orders or the undertakings referred to above.
................[sgd]........................................................
Justice Downes, President
REASONS FOR DECISION
Justice Downes, President
16 February 2012
On 3 November 2011 a delegate of the Secretary of the Department of Health and Ageing gave notice of intention to remove from the Australian Register of Therapeutic Goods four analgesic drugs from 1 March 2012. The analgesics are all based on dextropropoxyphene (DPP). The drugs are Di-Gesic, Doloxene, Paradex and Capadex. The first three of the drugs are marketed in Australia by Aspen Pharmacare Australia Proprietary Limited. The fourth drug is marketed by an associated company. Aspen sought review of these decisions by the Minister and on 23 January 2012 a delegate of the Minister affirmed the decision relating to each of the drugs.
Aspen has now sought review in the Tribunal of the decisions to cancel the registration of Di-Gesic and Doloxene. No application has been made relating to Paradex or Capadex. Di-Gesic is marketed as a combination containing DPP and paracetamol. The active ingredient of Doloxene is DPP alone.
Di-Gesic and drugs containing DPP have been marketed in Australia since at least 1970. They are used for pain relief and have been used, on the evidence, widely in Australia throughout the period between 1970 and now. There have, however, been concerns developing relating to the safety of drugs containing DPP for some time and, perhaps, more recently, concerns relating to its effectiveness. These concerns were addressed in Australia in the late 1990s and led to changes in the packet sizes of the drugs to reduce the risk of overdose.
Further studies and examination of the safety of the drug has led to the drug being withdrawn from the market in the European Union, the United States of America, the Republic of South Africa and, with some qualification, the details of which I am not fully aware of, in the United Kingdom. These decisions have been prompted by the developing concerns relating to the safety of the drug and have been further progressed by studies of the drug and, in particular, a multiple ascending dose study (the MAD study) and a review of that study which was carried out under the auspices of the Federal Drug Administration of the United States or was at least given careful consideration by that body.
The review decisions of the Minister’s delegate were made on 23 January 2012, some two months after the initial decision to deregister the drugs. The operative date for these decisions was not changed and remains 1 March 2012. These proceedings were commenced in the tribunal on 27 January 2012, only four days after the review decisions, and notice was given promptly to the Tribunal of the applicant’s intention to apply for a stay of the decision. The first available date for the hearing of an application for stay which accommodated the requirements of the parties to prepare an interlocutory case was today. I have accordingly today heard the application for a stay of the deregistration decision relating to Di-Gesic and Doloxene.
A final hearing of this matter will involve a considerable amount of evidence that has not been available to me in this interlocutory application. It is always desirable in cases such as this for a person considering an interlocutory application for a stay to address the merits of the case only to the extent to which that is an essential part of dealing with the issues that arise in the application for a stay. This is partly because the evidence will be more extensive on a hearing and partly because the final determination of the correctness of the decision should depend upon the evidence at that final hearing. I have, however, had before me a significant amount of evidence relating to the issues of safety and efficacy with the drug. This evidence has not, because of the interlocutory nature of this application, been subject to any cross-examination and there has not been an opportunity for evidence responding to all of the evidence to be provided to the tribunal.
The result of my reading of the evidence is to conclude that there is a significant case relating to the safety, and even the efficacy, of the products. I was particularly impressed by the evidence of Professor Nicholas Buckley on the issues relating to safety. I do not propose to set any of the evidence out in these reasons, but the material that I have in mind appears particularly in paragraphs 11 and following of his statement down to perhaps paragraph 33. There is also evidence of Professor Steven Kalowski and Professor John Horowitz which seeks to qualify the seriousness of the case which the Minister seeks to make relating to safety. It is the evidence of Professor Horowitz in particular which the Minister has not had an opportunity to respond to. The evidence relating to safety concerns both the administration of the drug in prescribed doses and in overdoses.
There has for a considerable time been evidence of risk when drugs containing DPP have been taken in excess. The risk is the potential for the drug to lead to cardiac arrhythmias, which have been known to be fatal. What has recently happened so far as the drug is concerned is to raise a suggestion through the MAD study that this risk can also be found when the drug is being taken in prescribed doses, although I apprehend that the risk is not as great as with overdoses. Safety issues with a drug which has the potential to lead to fatalities are always extremely concerning. Nevertheless, it does seem to me that there is a serious issue to be presented by Aspen as to the extent of the risks. It must be remembered that all drugs produce side effects and that there are regulated drugs which can cause fatalities from overdoses. A balance must always be found between safety and efficacy.
As I understand the case to be presented by Aspen, it does not say that there are no risks. It accepts that there are risks, but suggests that they are less than the findings of the Minister’s delegate would suggest and seeks to compare them with similar risks in other drugs which are still registered.
Beginning with the issue of the merits of the appeal, it seems to me that, on the evidence that I have at present, the Minister is able to present a strong case, but that it is not so strong as to lead me to conclude that no serious case can be presented in answer to it. What does seem to me to be the most significant matter in this application is what in a court would be called the balance of convenience and for the Tribunal is described in s 41 of the Administrative Appeals Tribunal Act 1975 (Cth).
What cannot be ignored in considering this issue is the fact that, first, the drug and variations of the drug have been on the market in Australia for more than 40 years; secondly, there have, increasingly throughout that period, been concerns relating to the safety of the drug; thirdly, in 1998, the Therapeutic Goods Administration addressed concerns relating to overdose; fourthly, the Therapeutic Goods Administration commenced looking at the safety of the drug a considerable time ago, at least as far back as early 2009; fifthly, notice of a proposal to cancel the registration of the drug was issued as long ago as 6 April 2011, and the actual initial cancellation followed by the affirmation of the cancellation on review, were in November 2011 and January 2012 respectively.
This timetable cannot be ignored in determining whether or not a stay should be granted. I say this because it shows that the drug has been on the market for more than 40 years, considerations relating to its safety have been apparent for more than 10 years and the initial consideration that the drug should be cancelled was nearly 12 months ago. Those events have to be put next to the fact that what is being sought is a stay of the decision to deregister for what should be a maximum of six months and probably less. That time contrasts starkly with the more than four decades that the drug has been on the market and taken in very large numbers by Australians.
There is some anecdotal evidence before me, which is not scientific in its basis, which shows that there are Australians who take this drug and who value it greatly, who rightly or wrongly, and possibly wrongly, consider that it is essential to their pain-free living and who are opposed to its being de-registered. As to those people, I ask the question, is leaving the drug available on the market for a few more months, so that a more rigorous examination of the safety of the drug can take place, a matter which should be put to one side?
What s 41 of the AAT Act actually requires the Tribunal to do is to take into account the interests of any persons who may be affected by the review and to make such order or orders staying, or otherwise affecting the operation of the decision, as may be appropriate for the purpose of securing the effectiveness of the hearing and determination of the application.
If no stay is granted, the drug will no longer be available in Australia approximately two weeks from today. That seems to me to be a very strong factor in favour of the grant of a stay and reflects the words of the section referring to a purpose of securing the effectiveness of the hearing and determination of the application for review. If no stay is granted supply of the drug will be interrupted, affecting patients, and considerable cost will be incurred in restoring the drug to the market. Indeed, although I do not base my decision on this, Aspen has indicated that if no stay is granted it will not continue with the application for review. To that, I add that the stay should not be more than six months, and might be less, and put that in the context of the time during which the drug has been available. It does seem to me that the interests of persons who use the drug, who wish it to continue to be made available, and the interests, although I count this at a lower level, of Aspen, tend towards the granting of a stay.
Against those matters, however, I need to balance other interests, such as the interest of the Minister, and the Minister’s delegate, in ensuring the safety of Australian citizens, in and about their health and measures related to their health, and also that group, which I have no doubt exists, which holds a different view to the view of the few patients from whom I have anecdotal evidence of their attachment to the use of the drug. Finally, I need to return to the seriousness of the case that is made out relating to the drug.
When I take all these things into account, it seems to me that the balance falls in favour of the granting of a stay, but only if a stay can be granted which will have as little impact as possible on issues of safety relating to the drug. In anticipation of this, Aspen has proposed a number of conditions associated with the stay. Those conditions will lead to the preparation of product information which contains significant warnings relating to the drug, including a suggestion that patients currently using the drug should attempt to replace it and patients not currently using the drug should not use it. They are also proposing that patient information should contain appropriate information relating to the drug, and that both doctors and persons who might prescribe or use the drug, such as hospitals, and pharmacists who might fill prescriptions for the drug, should also be sent letters.
I think that conditions of this kind present a minimum of what would be necessary to justify the stay that I propose. I would also propose that a regime be put in place so that the product information is itself contained in every packet of either of the drugs that are sold, so that any patient taking the drug will have the warning information that I have referred to, to hand. I also propose that the thrust of that warning, which is at pages 4 and 5 of the proposed draft production information for Di-Gesic, should be very prominently displayed, and displayed in a way which looks similar to the warning on pages 4 and 5, in the information supplied to doctors and pharmacists.
I am a little uncertain as to the association between what is called the product information and the patient information, but I am clear that patients should receive the warning that I have just referred to and I will discuss that matter with counsel. However, providing the applicant, Aspen, is agreeable to conditions of the kind I have referred to, and a document setting out those conditions is agreed to by the parties or determined by me, I am prepared to grant a stay of the proceedings until the hearing of the application, or until further order, with one final proviso, namely, that the hearing should take place before the end of May.
I certify that the preceding 19 (nineteen) paragraphs are a true copy of the reasons for the decision herein of the Honourable Justice Downes, President.
......[sgd]..................................................................
Associate
Dated 16 February 2012
Date of hearing 14 February 2012 Date final submissions received 14 February 2012 Counsel for the Applicant S Lloyd SC with S Robertson Solicitors for the Applicant Mallesons Stephen Jaques Counsel for the Respondent Dr J Renwick SC Solicitors for the Respondent Corrs Chambers Westgarth
2
0
0