Aspen Pharmacare Australia Pty Ltd and Minister for Health and Ageing
[2013] AATA 197
•5 April 2013
[2013] AATA 197
Division GENERAL ADMINISTRATIVE DIVISION File Number(s)
2012/0348
2012/0350
Re
Aspen Pharmacare Australia Pty Ltd
APPLICANT
And
Minister for Health and Ageing
RESPONDENT
DECISION
Tribunal President Kerr
Dr Nicoletti, Senior MemberDate 5 April 2013 Date of written reasons 5 April 2013 Place Sydney Decision Summary
Parties to file short minutes of orders within three weeks.
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President Kerr
Catchwords
Health – Therapeutic goods – Cancellation of registration of products containing dextropropoxyphene (DPP) – Whether quality, safety or efficacy is unacceptable within meaning of the Therapeutic Goods Act – Whether undertaking to ensure via Special Access Scheme the availability of an otherwise unsafe therapeutic good a relevant consideration in respect of safety and efficacy – Imposition of conditions to provide acceptable safety
Legislation
Administrative Appeals Tribunal Act 1975, Section 42D(8)
Therapeutic Goods Act 1989, Sections 19, 28, 30(2), 60(6)
Cases
Aspen Pharmacare Australia Pty Ltd and Minister for Health and Ageing [2012] AATA 362
Aspen Pharmacare Australia Pty Ltd and Minister for Health and Ageing [2012] AATA 376
Click here to enter text.
REASONS FOR DECISION
President Kerr
Dr Nicoletti, Senior Member5 April 2013
Products containing dextropropoxyphene (DPP) have been available for therapeutic use in Australia since at least 1970. Two such products, Di-Gesic and Doloxene, are currently registered in the Australian Register of Therapeutic Goods (ARTG).
Section 30(2)(a) of the Therapeutic Goods Act 1989 (the Act) provides that the Secretary of the Department of Health and Ageing may cancel that registration if it “it appears to the Secretary that the quality, safety or efficacy of the goods is unacceptable”.
On 3 November 2011, a delegate of the Secretary gave notice of an intention to cancel the registration of all products containing DPP from the ARTG as of 1 March 2012. Aspen sought review of these decisions by the Minister for Health and Ageing and on 23 January 2012, a delegate of the Minister affirmed the decision relating to each drug. Aspen then exercised its right pursuant to section 60(6)(b) of the Act to seek review of the Minister’s decisions by the Administrative Appeals Tribunal.
The Tribunal conducted a hearing of that review from 28 May to 1 June 2012 and its reasons were published in Aspen Pharmacare Australia Pty Ltd and Minister for Health and Ageing [2012] AATA 362 (15 June 2012). Those reasons should be referred to in full. What follows at [5]-[11] below is a much attenuated summary of the conclusions the Tribunal reached. The summary is intended only as a convenient introduction to the discussion that follows.
The Tribunal concluded that there was no evidence to suggest that the quality of either of the goods was unacceptable.
In respect of efficacy and safety, the Tribunal held that those words should be construed as ordinary English words, albeit read in the context of the Act as a whole. A decision-maker charged with the responsibility of forming a view as to whether the safety of particular therapeutic goods is so far from the required standard as to be unacceptable must balance the efficacy of the goods against the risks of the harm or injury that their use or misuse may give rise to.
The Tribunal concluded that Di-Gesic and Doloxene were both analgesic for mild-to-moderate pain (WHO Pain Relief Ladder Tier 2) where a weak opioid, either alone or in combination with a non-steroidal anti-inflammatory drug (NSAID) or paracetamol would be sufficient. It concluded that the safety of DPP in therapeutic doses was not sufficiently different from other weak opioids to support a finding that the safety of DPP was unacceptable when prescribed to patients for whom it was not contra-indicated. The Tribunal recognised that drugs containing DPP have been used for the purpose of deliberate suicide but noted that many other therapeutic goods shared that quality. It agreed with the conclusions reached by the Australian Drug Evaluation Committee (ADEC) in 1998 that it was not appropriate to refuse registration of a preparation simply on the basis that it may be used deliberately for the purposes of self-harm.
However, the Tribunal accepted that, with respect to DPP, there was a relatively small difference between a therapeutic dose and the amount sufficient to create a risk of serious adverse harm and even the risk of fatality. The risk of accidental overdose, while it could be mitigated, could not be entirely overcome. For that reason, the Tribunal concluded that if there would always be one or more suitable and efficacious alternative pain relief medicines for mild-to-moderate pain with no such risk of accidental overdose, the balance would tip in favour of deregistration.
In assessing whether lesser risk alternative products were available, the Tribunal accepted that as a matter of general clinical practice, strong opioids should not be prescribed where a weak opioid or NSAID would provide sufficient relief from pain. In that regard, the Tribunal accepted that DPP was a weak opioid. It was the only weak opioid available for a small number of patients unable to metabolise either codeine or tramadol. The Tribunal accepted the evidence of Professor Christie that there was a small but not insignificant group of patients for whom, at present, there was no available weak opioid or NSAID analgesic alternative to DPP for mild to moderate pain. [The Tribunal regrets that the words ‘at least for the present’ in paragraph 90 of its Reasons could be taken as suggesting a tentativeness which was not intended. Those words were used only to acknowledge the possibility that at some later time a new pharmaceutical product might become available which would fill that niche].
Having reached the conclusion it had regarding the absence of available and appropriate alternatives, the Tribunal stated that it did not accept the position advanced by Dr Renwick SC for the Minister that “potential implications for a hypothetical few should not trump the safety of an identified overwhelming majority”. The Tribunal stated that in its opinion a decision maker seeking to achieve the correct or preferable decision should take the position that if the interests of the few could be reconciled with the interests of the many, then they should be, rather than overridden. The Tribunal then recorded in its reasons that it had tentatively explored with the parties, inter alia, the possibility that if the decision under review was set aside additional conditions to ensure acceptable safety could be imposed under s 28 of the Act to permit Di-Gesic and Doloxene to remain available to those for whom it was therapeutically indicated and for those who had been using the drug and wished to continue its use and who found it difficult to change. It noted that counsel for Aspen, Mr Lloyd SC, had indicated that his client would be prepared to retain ‘black box’ warnings on the product information and would be prepared to enter into contractual obligations with pharmacies so that Di-Gesic and Doloxene would only be dispensed on production of a signed statement from a doctor stating that he or she had taken into account the relevant product information and warnings before prescribing those drugs and that he or she had advised the patient of all relevant risks.
The Tribunal accordingly stated that it was considering remitting the decision under s 42D of the Administrative Appeals Tribunal Act 1975 to allow time for both parties to explore, in light of its conclusions, whether they could find an agreed solution rather than having one imposed on them. The Tribunal stated it would hear counsel as to that possible course.
The matter accordingly returned to the Tribunal on 20 June 2012. After hearing from counsel, the Tribunal ordered that the decisions under review be remitted to the Respondent for reconsideration pursuant to s 42D of the Administrative Appeals Tribunal Act 1975. The time for that reconsideration to take place was extended to 56 days. The Tribunal's reasons are published in Aspen Pharmacare Australia Pty Ltd and Minister for Health and Ageing [2012] AATA 376 (20 June 2012).
Subsequently, the Tribunal was advised that the Respondent required additional time to complete that reconsideration and the 56 days was further extended by consent.
On 12 September 2012 the Respondent made a decision in respect of the matter remitted. In respect of a number of significant points that had been in dispute before the Tribunal, the decision-maker on remittal made factual findings in respect of safety and efficacy that differed from the findings made by the Tribunal in Aspen Pharmacare Australia Pty Ltd and Minister for Health and Ageing [2012] AATA 362 (15 June 2012). Having reached those different conclusions the delegate determined that there were no conditions capable of being imposed under s 28 of the Act which would make the continued registration of Di-Gesic and Doloxene acceptable. The original decision was affirmed.
As a result, pursuant to s 42D(8) of the Administrative Appeals Tribunal Act1975, the proceedings automatically resumed before the Tribunal. The decision on remittal and a large volume of supplemental “T” documents were duly filed with the Tribunal.
When the matter returned to the Tribunal for directions a further consideration was raised by the Respondent. Dr Renwick SC advised the Tribunal that while there remained a dispute about the size of the class, his client accepted the findings of the Tribunal that there was a small but not insignificant group of patients for whom, at present, there was no available weak opioid or NSAID analgesic alternative to DPP for mild to moderate pain. The Respondent did not dispute that a decision-maker seeking to achieve the correct or preferable decision should take the position that if the interests of the few can be reconciled with the interests of the many, then they should be, rather than overridden. However, he submitted, it was his client’s view that such a reconciliation did not require the continued registration of Di-Gesic and Doloxene because, if those products were removed from the ARTG, his client would undertake that both products would continue to remain readily and conveniently available for the small subgroup of the community that required them by way of a purpose-designed Special Access Scheme under s 19 of the Act. A detailed description of the proposed scheme was put forward.
Mr Lloyd SC for Aspen expressed doubts that the alternative scheme proposed by the Respondent could provide an available or appropriate alternative but did not oppose further discussions between the parties as to whether some common ground might be found. The parties later participated in mediation facilitated by Deputy President Tamberlin QC. However, agreement could not be reached and the matter returned to the Tribunal for a continuation of the hearing on 27 and 28 February 2013.
At the resumed hearing Dr Renwick SC advised the Tribunal that he would not be putting into evidence the reasons of the Secretary’s delegate, Dr McEwan, for his decision upon remittal. Counsel explicitly eschewed reliance on those reasons. Dr Renwick informed the Tribunal that, notwithstanding the remittal decision, the Respondent no longer disputed any of the findings of the Tribunal in Aspen Pharmacare Australia Pty Ltd and Minister for Health and Ageing [2012] AATA 362 (15 June 2012).
Dr Renwick stated that he would be seeking to persuade the Tribunal only in respect of those aspects of the Tribunal’s reasons where the Tribunal had expressed tentative views (such as the possibility that s 28 rather than any other provision of the Act might present the means to achieve a sensible reconciliation of the needs of the individual with those of the population at large) and would take the Tribunal to evidence only if the Tribunal had not reached a firm conclusion on a matter (such as the size, rather than the existence, of the class for whom the products would have therapeutic benefit).
At the resumed hearing Dr Renwick put into evidence the details of the purpose-designed Special Access Scheme for Di-Gesic and Doloxene that the Secretary proposed to establish pursuant to s 19 of the Act if the Tribunal came to the view that the correct or preferable decision was that the quality, safety or efficacy of Di-Gesic and Doloxene was unacceptable and both should be removed from the ARTG. A senior Departmental witness was called to explain the Respondent’s proposal and was cross-examined by Mr Lloyd regarding it. The Tribunal also received evidence from Aspen regarding the comparative merits, convenience and cost of the alternative Special Access Scheme proposed by the Respondent.
The reception of that evidence was subject to the Tribunal ruling upon a submission by Mr Lloyd SC that what the Secretary might or might not do if the products were refused registration fell outside of the penumbra of relevant considerations open to the Tribunal to consider as a reason for concluding that Di-Gesic and Doloxene’s quality, safety or efficacy was unacceptable.
It is necessary therefore to resolve as a threshold issue whether the undertaking by the Respondent to establish a purpose-designed Special Access Scheme under s 19 of the Act is a relevant consideration open to the Tribunal to consider.
Mr Lloyd SC submitted that a decision-maker charged with the responsibility of forming a view as to whether the efficacy or safety of a particular therapeutic good is unacceptable must confine themselves to considerations regarding its suitability for registration and such conditions to be imposed under s 28 which might be relevant. Such a decision-maker would be aware that if the good was removed from the ARTG there would be provisions under the Act, including s 19, which might permit the supply of unapproved therapeutic goods to patients who required them. However, what might be done under s 19 would become relevant if, and only if, registration was refused. If appropriate conditions under s 28 would ensure that the safety and efficacy of a therapeutic good was acceptable, the good was entitled to remain on the ARTG. It would be a mistake of law to confuse the two concepts and to enter into a comparative assessment of the respective merits of conditions under s 28 as contrasted with whatever the Secretary put forward by way of an undertaking to ensure the availability of a drug for those who needed it if it was to be removed from the ARTG.
Dr Renwick SC disputed that analysis. He submitted that the Act had to be read as a whole having regard to its objects. Section 19 dealing with unapproved therapeutic products was equally part of the Act. Dr Renwick submitted that whether (and if so the terms upon which) the Secretary would undertake to ensure the availability of an otherwise unsafe therapeutic product was a relevant consideration in respect of the question of whether the efficacy or safety of a particular therapeutic good was so far from the required standard as to be unacceptable for inclusion on the ARTG. To illustrate the logic of that position, Dr Renwick put forward the example of a hypothetical therapeutic good that might be lethally dangerous to all but one or two persons, for whom it would be a life-saving medicine. In such circumstances, he submitted, it would be relevant for the Tribunal to be made aware of, and to take into account, an undertaking by the Secretary that if the product was not permitted to be placed or remain on the ARTG, purpose‑designed arrangements under s 19 would be put in place to ensure its availability to those one or two people.
The proposition advanced by Dr Renwick has some common-sense appeal and might be persuasive if the issue was at large but the Tribunal’s jurisdiction to review is not unconstrained. It is as conferred by s 60(6) of the Act. Section 60(6) confers power on the Tribunal to review, inter alia, a decision of the Minister or her delegate under Part 3-2 (registration and listing of therapeutic goods). Part 3-2 consists of sections 23 to 30E of the Act. In the Tribunal’s view it forms a self-contained code. The substantive considerations relevant to a therapeutic good’s registration are set out in s 25. Those that are material to a therapeutic good’s removal from the ARTG appear in s 30(2). We have concluded that in reviewing a decision taken under s 30(2) the Tribunal cannot take into account factors extraneous to those referred to in that section, understood in its context as part of Part 3-2 of the Act. In that task, we do not think it is open to the Tribunal to weigh any alternatives proposed under s 19, which is outside Part 3-2 of the Act and addresses a quite different subject matter.
If the Tribunal had to decide in respect of a drug with the properties described by Dr Renwick SC, the considerations referred to at [24] of the Tribunal’s reasons in Aspen Pharmacare Australia Pty Ltd and Minister for Health and Ageing [2012] AATA 362 (15 June 2012) govern what should be found to be the correct or preferable decision. It might be of comfort to the Tribunal to know that should those considerations compel the conclusion that the hypothesised drug should be denied registration, the Secretary would still ensure that it could be made available as an unapproved product under a purpose‑designed scheme under s 19 of the Act for those one or two people who required it as a lifesaving therapy, but it would be a legal error (and dangerous) for the Tribunal to decide to keep a pharmaceutical good whose safety and efficacy had been found to be so far from the required standard as to be unacceptable on the ARTG because the Secretary had refused to give such an undertaking. In the Tribunal’s opinion, it would be equally an error of law to remove a therapeutic good from the ARTG where its safety and efficacy was not found to be unacceptable by reasoning that the Secretary had given such an undertaking and an alternative means of ensuring its availability should be preferred.
Lest the Tribunal’s conclusion in that regard be misunderstood, the Tribunal records its view that it was appropriate and constructive for the Secretary to have planned for, and make known to the parties and the Tribunal, the processes the Department would put in place were the Tribunal to reach the conclusion that the products containing DPP should be removed from the ARTG. While the Tribunal has not had regard to those undertakings as relevant considerations for the purpose of determining whether or not Di‑Gesic and Doloxene should be removed from the ARTG, the Tribunal regards it as a mark of good administration that the Secretary gave early attention to the interests of those persons within the class for whom Di-Gesic and Doloxene had been found to have therapeutic benefits. It was appropriate for the Secretary to anticipate the possibility that the decision to cancel the registration of all products containing DPP from the ARTG may have been confirmed by the Tribunal.
If the Tribunal had reached a conclusion that the quality, safety or efficacy of Di-Gesic and Doloxene was unacceptable, knowledge of what arrangements the Secretary would have put in place in those circumstances as to how Di-Gesic and Doloxene might have continued to be accessed as unapproved products would have been highly relevant to the orders regarding the timing of implementation that the Tribunal would have been required to make.
However, the Tribunal has determined that, subject to the imposition of appropriate conditions under s 28 of the Act, the quality, safety or efficacy of Di-Gesic and Doloxene is not unacceptable.
It has reached that conclusion despite rejecting Mr Lloyds primary submission that, having regard to the findings recorded in Aspen Pharmacare Australia Pty Ltd and Minister for Health and Ageing [2012] AATA 362 (15 June 2012), the only conclusion properly open to the Tribunal was that the quality, safety and efficacy of Di-Gesic and Doloxene is not unacceptable within the meaning of s 30(2)(a) of the Act.
We specifically reject Mr Lloyds submission that there is nothing to distinguish these therapeutic goods from any other potentially dangerous pharmaceutical products where ordinary product warnings, including ‘black box’ warnings, suffice to ensure an appropriate balance between safety and efficacy. Our earlier reasons included findings of fact that the difference between a therapeutic amount of products containing DPP and a potentially fatal dose was smaller than in many other therapeutic products and that the risk of accidental overdose, while it could be mitigated, could not be entirely overcome. Further, although the Tribunal found that Doloxene and Di-Gesic were both analgesic for mild-to-moderate pain and that there was no presently available suitable alternative for a relatively small class of patients who required pain relief, the Tribunal made no findings that those products had exceptional efficacy of the kind that would bring into consideration the matters referred to in paragraph 24 of its reasons in Aspen Pharmacare Australia Pty Ltd and Minister for Health and Ageing [2012] AATA 362 (15 June 2012).
It was in the light of those findings, inter alia, that the Tribunal’s tentative conclusion at [102] that s 28 of the Act might enable conditions to be imposed which would sensibly reconcile the needs of the individuals for whom the products have clinical value with the needs of the population at large had to be read.
A conclusion that Di-Gesic and Doloxene should remain on the ARTG given those findings was thus far from inevitable. For its tentative conclusion to become the ultimate conclusion, the Tribunal needed to be satisfied that appropriate conditions could be imposed to effect that reconciliation. It was open for the Respondent to seek to persuade the Tribunal that no conditions could be devised under s 28 to provide adequate safety so as to accommodate that reconciliation.
Before turning to that question, the Tribunal should acknowledge that Dr Renwick SC requested that the Tribunal make specific findings regarding the size of the potential class actually suffering pain and for whom Di-Gesic and Doloxene would have therapeutic benefit and for whom no other appropriate drug would be suitable. Dr Renwick took the Tribunal to recent evidence of sales in the United Kingdom since market authorisation for drugs containing DPP had been withdrawn but where those products remained available for prescription in the terms referred to in the Tribunal’s previous decision. He submitted, based on relative population sizes, that the Australian class might be as small as some 2000 persons.
However, it is not at all clear what purpose it would serve for the Tribunal to make firmer findings than those expressed at [90] of its reasons in Aspen Pharmacare Australia Pty Ltd and Minister for Health and Ageing [2012] AATA 362 (15 June 2012). The Tribunal has concluded, albeit based on calculations not susceptible to producing a numerically defined subset, that there is a group of patients for whom there is unlikely to be an adequate suitable analgesic alternative to DPP for mild to moderate pain. We have accepted Professor Christie’s evidence that the size of that subset might be around 1% or less of the Australian population.
The Tribunal finds that the proportion of that subset who will require pain relief for mild to moderate pain (and for whom DPP is not clinically contra-indicated) cannot be identified with exactitude on the basis of the evidence advanced by either of the parties. The Respondent indicated that the alternative Special Access Scheme it proposed would be able to cope with up to 15,000 applications a year. The actual number of patients who might require the product in any one year is likely to fall somewhere between that number and the estimate Dr Renwick extrapolated from the UK data. We are not convinced that it is possible to be more precise.
Whatever the size of the class, it was not submitted by Dr Renwick SC that its membership was so small that the Tribunal could regard it as insignificant. Nor do we take Dr Renwick to have suggested that the Tribunal ought to ignore the interests of the members of that class. The undertaking proffered on behalf of the Respondent that the Respondent would establish a purpose-designed scheme under s 19 of the Act so as to accommodate the interests of the class if Di-Gesic and Doloxene were removed from the ARTG is, in any event, entirely inconsistent with that proposition. The Tribunal has framed the balance of its reasons on the above findings and that understanding.
What then are the conditions under s 28 of the Act that, once imposed, would ensure the reconciliation necessary for the Tribunal to find that the quality, safety and efficacy of Di-Gesic and Doloxene is not unacceptable?
The first group of conditions relates to the products’ use in therapeutic doses. The Tribunal has previously found that for patients for whom DPP is not contra-indicated the safety of DPP at therapeutic doses is not significantly different from other weak opioids. The evidence did not support a conclusion that for those patients the safety of DPP was unacceptable. However, the evidence also established that there are many potential patients for whom DPP is contra-indicated. For that reason, the Tribunal finds that the quality, safety and efficacy of Di-Gesic and Doloxene would be unacceptable without a continuation of the significant safety warnings in the product information (PI) and consumer medicines information (CMI), including the ‘black box’ warnings that were added to the PI so that Aspen could obtain a stay of the operative decisions which would have otherwise taken effect and resulted in their deregistration. Similarly, the quality, safety and efficacy of Di-Gesic and Doloxene would be unacceptable without periodic reminders to doctors and pharmacists of the kind imposed as a condition of the stay.
However, the Tribunal does not accept Aspen's submission that simply continuing those conditions would be sufficient to justify the Tribunal reaching the conclusion that its products’ safety and efficacy is acceptable.
Aspen presented the Tribunal with evidence that 97% of medical practitioners pay some attention to ‘black box’ warnings. Aspen also drew attention to their confidential sales data which showed a significant decline in the volume of the products sold since the additional PI and ‘black box’ warnings were imposed.
Responding to that evidence, Dr Renwick drew the Tribunal’s attention to various statements from respected medical professional bodies that busy doctors overwhelmed by a myriad of prescribing data often give only cursory attention, if any, to the flood of warnings and product information they receive.
Evaluating the evidence and the parties’ respective contentions as best it can, the Tribunal accepts that the great majority of doctors will take PI and ‘black box’ warnings into account and modify their prescribing behaviour accordingly. However, the Tribunal is not satisfied that 97% of medical practitioners (or any like proportion) will fully and comprehensively address the prescribing criteria, and fully and comprehensively explain to their patients the risks and dangers of accidental overdose.
Given that neither Di-Gesic nor Doloxene have been found to have exceptional efficacy and that the Tribunal has found that the risk of accidental overdose is real — such that it was common ground between the parties that the amount of DPP contained in a single blister pack of either Doloxene or Di-Gesic, if combined with alcohol, could in a vulnerable patient be sufficient to create a risk of sudden death — the Tribunal has concluded that the safety and efficacy of Di Gesic and Doloxene would be acceptable if, and only if, additional conditions were imposed which provide a high level of assurance that doctors will prescribe the products (a) only if therapeutically justified; (b) only after they have considered any contraindications and any recent changes to the patient's clinical presentation or medical status; and (c) only after they have discussed with their patient the appropriate use of the products and the risks of overdose.
The Tribunal also made findings in Aspen Pharmacare Australia Pty Ltd and Minister for Health and Ageing [2012] AATA 362 (15 June 2012) that some patients are likely to seek out these products for the purpose of suicide. While the Tribunal concluded that it was not appropriate to refuse registration for any preparation simply on the basis that it may be used deliberately for the purposes of self-harm and noted that many other therapeutic products shared that characteristic, in the opinion of the Tribunal, the safety and efficacy of Di-Gesic and Doloxene would be acceptable if, and only if, there were conditions put in place directed at minimising the risk that doctors might prescribe the product if a patient’s history indicates that he or she is at risk of intentional self-harm.
Combined with a continuation of the warnings referred to in [39] conditions that would meet the objectives set out in [44] and [45] would, in the Tribunal’s view, achieve a suitable reconciliation of individual and population level interests.
The above propositions have been stated only in general terms. The Tribunal has refrained from stating its final position regarding the specific draft that was submitted to it by Aspen headed “Applicant’s Proposed Amended Final Decision”. That is because the parties agreed that if the Tribunal was to find that the quality, safety and efficacy of Di-Gesic and Doloxene was not unacceptable, they preferred the Tribunal not to make final orders in those or any other terms but rather to indicate the nature of the conditions which the Tribunal would regard as consistent with that conclusion. In broad terms, the Tribunal is satisfied that the conditions Aspen has proposed, provided they include both of the so called “alternative” conditions in clauses 5 and 6 of Schedule 1 of that draft, would be consistent with that conclusion and meet the criteria discussed above. Those provisions of the draft include requirements that the Applicant will not supply Di-Gesic and Doloxene to a pharmacist unless that the pharmacist has undertaken not to dispense those therapeutic goods, save in circumstances where a patient has presented a form signed by a prescriber certifying, inter alia, that: (a) the prescriber was aware that the product was only approved for use in patients not able to be adequately treated with other analgesics; (b) the prescriber had considered the contraindications; (c) the prescriber had considered any recent changes to their patient’s clinical presentation or biochemical status; (d) the prescriber had warned the patient about the appropriate use of the product; and (e) the prescriber was satisfied that the patient’s history did not indicate that the patient was at risk of accidental or intentional self-harm.
The Tribunal acknowledges that the contractually-based mechanisms Aspen has proposed cannot guarantee 100% compliance. Within the range of practicable measures available, no mechanism, including the s 19 mechanism which the Secretary undertook to implement if the Tribunal reached the conclusion that the quality, safety and efficacy of the products was unacceptable, can guarantee 100% compliance. However, the interlocking system of safeguards for patient protection that were put forward by Aspen as conditions it was prepared to accept is sufficient to give the Tribunal confidence that the products will, with few and unavoidable exceptions, be supplied only to those for whom they are clinically appropriate and that those patients will be warned of the danger of the products’ misuse. The level of confidence is of an order of magnitude greater than that which applies in the ordinary supply of other pharmaceutical products, many of which, if prescribed when contra-indicated or taken in larger than prescribed doses, are also extremely dangerous, if not lethal. The Tribunal is satisfied that once those arrangements are in place it is unlikely that a medical practitioner would prescribe Di-Gesic or Doloxene without completing the Prescriber Form, given the likelihood that pharmacies will decline to fill such a prescription without it. The process will require both the medical practitioner and the patient to be made acutely aware of the considerations relevant to those products’ use.
Additionally, the Tribunal would want to be satisfied that a practical but not unduly burdensome system will be put in place to monitor the effectiveness of those arrangements.
On the above basis, the Tribunal has concluded that the quality, safety and efficacy of both Di-Gesic and Doloxene is not unacceptable. In consequence, the products will remain on the ARTG.
The parties are directed to bring in short minutes of orders, incorporating any necessary timetable for their implementation, consistent with the tenor of these reasons within a period of three weeks from the date hereof. The parties, or either of them, have leave to relist the matter for further directions if agreement on the terms of the short minutes cannot be agreed.
I certify that the preceding fifty-one (51) paragraphs are a true copy of the reasons for the decision herein of Justice D Kerr, President & Senior Member T Nicoletti.
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Associate
Dated 5 April 2013
Dates of hearing
27 and 28 February 2013
Counsel for the Applicant
Mr S Lloyd SC
Mr S Robertson
Solicitors for the Applicant
King & Wood Mallesons
Counsel for the Respondent
Dr J Renwick SC
Dr H Bennett
Solicitors for the Respondent
Corrs Chambers Westgarth
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