Cosmetic Surgery Review

AHPRA and the Medical Boards have announced a review of cosmetic surgery regulation following recent revelations about several celebrity cosmetic surgeons. Indications of regulatory failure predate those revelations and there has been extensive public criticism such as that noted here.

AHPRA states

The review will inquire and report on: 

1. The regulatory role of Ahpra and relevant National Boards in cosmetic surgery with particular attention to its risk-based approach focusing on:

a. updates to codes of conduct and supporting guidance which aim to ensure that practitioners practise safely within the scope of their qualifications, training and experience; 

b. the methodology for risk assessment of cosmetic surgery notifications 

c. the Ahpra investigation protocol; 

d. the management of advertising offences, and; 

e. opportunities for changes, clarifications or further actions in relation to the current regulatory approach to protected titles. 

2. The way Ahpra works with other system regulators to ensure clear roles and responsibilities and appropriate information flows in support of the broader regulatory framework which involves a range of state, territory and national regulators. 

3. The best means available to strengthen the safety reporting culture within cosmetic surgery to address barriers to health professionals raising concerns when a practitioner has practised in ways that depart from accepted professional standards. 

4. Strategies relevant to the role of Ahpra and National Boards as a regulator of the registered health professions to reduce information asymmetry for consumers in order to inform safer choices and informed consent. 

5. Provide a contemporary view of current risks to patient safety in cosmetic surgery and how they should inform the work of Ahpra and relevant National Boards. For the purpose of making its recommendations, the review is requested to consider approaches adopted by professional regulators in other countries. 

The primary focus will be on cosmetic surgery because that poses the greatest risk. However, the recommendations of this review may be relevant to the work of Ahpra and relevant National Boards in the cosmetics sector more widely.

Automated Administrative Decisions

The NSW Ombudsman report The new machinery of government: using machine technology in administrative decision-making comments 

Our role at the NSW Ombudsman is to oversee government agencies and officials – helping to ensure they are conducting themselves lawfully, making decisions reasonably, and treating all individuals equitably and fairly (chapter 2). 

When agencies and officials fail to do this they are said to have engaged in maladministration or, more formally, section 26 conduct (referring to section 26 of the Ombudsman Act 1974 (NSW), which sets out the various categories of wrong conduct). Clearly, the use by government agencies of machine technology – which might be referred to as artificial intelligence or automated decision-making (see chapter 3) – is not inherently a form of maladministration. 

There are many situations in which government agencies could use appropriately-designed machine technologies to assist in the exercise of their functions, which would be compatible with lawful and appropriate conduct. Indeed, in some instances machine technology may improve aspects of good administrative conduct – such as accuracy and consistency in decision-making, as well as mitigating the risk of individual human bias. However, if machine technology is designed and used in a way that does not accord with administrative law and associated principles of good administrative practice, then its use could constitute or involve maladministration. It could also result in legal challenges, including a risk that administrative decisions or actions may later be held by a court to have been unlawful or invalid. 

1.1 Machine technology is on the rise, and offers many potential benefits 

The use and sophistication of machine technology is increasing worldwide, and it has the potential to bring many potential benefits to government and the public (chapter 4). 

These include:

• Efficiency and cost savings for government. 

• Reduced red tape. 

• Increased accuracy. 

• Improved consistency. 

• Increased productivity and re-focusing of staff to ‘higher value’ activities. 

• Better customer service and experience. 

• Insights and learning.

Of course, benefits cannot be assumed to follow as a matter of course, and it is important to be realistic about what benefits (and risks) particular technology will deliver in a particular context. Untested assumptions or utopian beliefs about technology should not drive automation strategies. 

1.2 Why we have written this report 

We were prompted to write this report after becoming aware of one agency (Revenue NSW) using machine technology for the performance of a discretionary statutory function (the garnisheeing of unpaid fine debts from individuals’ bank accounts), in a way that was having a significant impact on individuals, many of whom were already in situations of financial vulnerability. 

Following a series of complaints to our office, Revenue NSW worked responsively with us over time to ensure that its garnishee system operated more fairly, by taking account of vulnerability and situations of hardship. However, we still had questions as to whether Revenue NSW’s system of garnishee automation was legally consistent with its statutory functions. We sought legal advice from Senior Counsel, which confirmed our doubts. The full Revenue NSW case study, including the legal advice, is set out in annexure A. 

Currently, we do not know how many other NSW Government agencies are using, or developing, machine technology to assist them in the exercise of their statutory functions. 

However, our experience with Revenue NSW and a scan of the Government’s published policies on the use of ‘AI’ and other digital technologies suggests that there may be inadequate attention being given to fundamental aspects of public law that are relevant to machine technology adoption. 

1.3 Administrative law and practice must be given central attention 

Some of the broader concerns about machine technology use by the private sector, in terms of privacy, human rights, ethics and so on, also apply (in some cases with greater force) to the public sector. 

However, the powers, decisions and actions of government agencies and officials are constitutionally different from that of the general private sector. 

This means that the public sector’s use of machine technology, particularly for the purposes of statutory decision-making, must also be assessed from an administrative law perspective (chapter 5). We believe that this assessment must be central to the use of this technology. 

1.4 Administrative law requirements for good decision-making 

For simplicity, we can broadly group the requirements for good decision-making in the following ways (chapter 6):

Proper authorisation – this means that there is legal power to make the relevant decision, that the person making the decision has the legal authority to do so, and that the decision is within the scope of decision-making power (including, in particular, within the bounds of any discretion conferred by the power) (chapter 7). The requirement for proper authorisation means that statutory functions are not and cannot be directly given or delegated to a machine. It does not necessarily mean that the authorised person cannot be assisted by machine technology. There is, however, no uniform answer as to what forms of machine technology can be used, and to what extent, in the performance of a particular statutory decision-making function. This must be carefully considered on a case-by-case basis by looking at the particular statute, its purpose, and the context in which it applies. However, if the function is discretionary, machine technology must not be used in a way that would result in that discretion being fettered or effectively abandoned. In effect, this means that discretionary decision-making functions cannot be fully automated. 

Appropriate procedures – this means that the decision has followed a fair process, that it has met other legal and ethical obligations, and that reasons are given for the decision (particularly where it significantly affects the rights or interests of individuals) (chapter 8). 

Generally, a fair process requires decisions to be made without bias on the part of the decision maker (‘no-bias rule’) and following a fair hearing of the person affected (‘hearing rule’). Machine technology can introduce the possibility of a different form of bias known as ‘algorithmic bias’. Algorithmic bias arises when a machine produces results that are systemically prejudiced or unfair to certain groups of people. It is unclear whether the presence of algorithmic bias would necessarily constitute a breach of the no-bias rule (as that rule is traditionally concerned with actual or apprehended bias on the part of the particular decision maker). Even if it does not, however, algorithmic bias may still lead to unlawful decisions (because they are based on irrelevant consideration or contravene anti-discrimination laws) or other maladministration (because they involve or result in conduct that is unjust or improperly discriminatory). 

Where machine technology is used in the exercise of a function under a particular statute it also needs to comply with other statutes and common law requirements. Privacy, freedom of information and anti-discrimination laws, in particular, will almost always be relevant. Having appropriate procedures also means providing where required, or being able to provide where requested, reasons to those who are affected by a decision. In our view, this means also informing those affected if a machine has made (or contributed to the making of) a decision. Where reasons are required, they must be accurate, meaningful, and understandable, which can raise particular challenges when machine technology is used. 

Appropriate assessment – this means that the decision answers the right question, that the decision is based on a proper analysis of relevant material, and that the decision is based on the merits and is reasonable in all the circumstances (chapter 9). Using machine technology in the exercise of statutory functions means translating legislation and other guidance material (such as policy) into the form of machine-readable code. A key risk is the potential for errors in this translation process, and the consequent potential for errors and unlawful decisions being made at scale. When designing and implementing machine technology, it is also essential to ensure that its use does not result in any obligatory considerations being overlooked or extraneous considerations coming into play. While the use of machine technology may enhance the consistency of outcomes, agencies with discretionary functions must be conscious of the duty to treat individual cases on their own merits. 

Adequate documentation – agencies are required to properly document and keep records of decision-making (chapter 10). In the context of machine technology, this means keeping sufficient records to enable comprehensive review and audit of decisions. Documentation relating to different ‘versions’ of the technology, and details of any updates or changes to the system, may be particularly important. 

1.5 Good practice for designing and implementing machine technology 

In light of the above, there are some key proactive steps that agencies should take when considering the design and adoption of machine technology that will help them to ensure they comply with principles of administrative law and good decision-making practice. xx In particular, when setting out to design machine technology for use in the exercise of statutory functions, agencies should:

1. establish a multi-disciplinary design team that involves lawyers, policymakers, and operational experts, as well as technicians, with roles and responsibilities that are clearly defined (chapter 11) 

2. assess the appropriate degree of human involvement in the decision-making processes, having regard to the nature of the particular function and the statute in question (chapter 12) 

3. ensure appropriate transparency, including by deciding what can and should be disclosed about the use of machine technology to those whose interests may be affected (chapter 13) 

4. test before operationalising, and establish ongoing monitoring, audit and review processes (chapter 14) 

5. consider whether legislative amendment is necessary or prudent (chapter 15). 

1.6 The role of Parliament in authorising machine technology 

If legislation is introduced to enable the use of machine technology, then this provides an opportunity for public and Parliamentary debate on the properties that should be required of that technology. 

Whether or not these are ultimately prescribed as mandatory requirements in the legislation itself, the kinds of questions that might be asked of government agencies that are seeking legislative authorisation of machine technology could include: 

Is it visible? What information does the public, and especially those directly affected, need to be told regarding the involvement of the machine, how it works, its assessed accuracy, testing schedule etc? Are the design specifications and source code publicly available – for example as ‘open access information’ under the Government Information (Public Access) Act 2009? Is an impact assessment required to be prepared and published?

Is it avoidable? Can an individual ‘opt out’ of the machine-led process and choose to have their case decided through a manual (human) process? 

Is it subject to testing? What testing regime must be undertaken prior to operation, and at scheduled times thereafter? What are the purposes of testing (eg compliance with specifications, accuracy, identification of algorithmic bias)? Who is to undertake that testing? What standards are to apply (eg randomised control trials)? Are the results to be made public? 

Is it explainable? What rights do those affected by the machine outputs have to be given reasons for those outcomes? Are reasons to be provided  routinely or on request? In what form must those reasons be given and what information must they contain? 

Is it accurate? To what extent must the predictions or inferences of the machine be demonstrated to be accurate? For example, is ‘better than chance’ sufficient, or is the tolerance for inaccuracy lower? How and when will accuracy be evaluated? 

Is it subject to audit? What audit records must the machine maintain? What audits are to be conducted (internally and externally), by whom and for what purpose? 

Is it replicable? Must the decision of the machine be replicable in the sense that, if exactly the same inputs were re-entered, the machine will consistently produce the same output, or can the machine improve or change over time? If the latter, must the machine be able to identify why the output now is different from what it was previously? 

Is it internally reviewable? Are the outputs of the machine subject to internal review of a human decision maker? What is the nature of that review (eg full merits review)? Who has standing to seek such a review? Who has the ability to conduct that review and are they sufficiently senior and qualified to do so? 

Is it externally reviewable? Are the outputs of the machine subject to external review or complaint to a human decision maker? What is the nature of that review (eg for example, merits review or review for error only)? Who has standing to seek such a review? If reviewable for error, what records are available to the review body to enable it to thoroughly inspect records and detect error? 

Is it compensable? Are those who suffer detriment by an erroneous action of the machine entitled to compensation, and how is that determined? 

Is it privacy protective and data secure? What privacy and data security measures and standards are required to be adhered to? Is a privacy impact assessment required to be undertaken and published? Are there particular rules limiting the collection, use and retention of personal information? 

1.7 The way forward – starting with increased visibility 

We are hopeful that this report will contribute to public and especially Parliamentary debate about the adoption of machine technology by government, and its proper limits and regulation. In the final chapter of this report we identify avenues for future consideration, including a question around whether some forms or applications of machine technology might raise such significantly new issues and risks that consideration should be given to new forms of regulation – including mandatory requirements around transparency, pre-operation validation testing and routine auditing, and external review and oversight (chapter 16). 

One risk, for example, may be that machine technology will be capable of producing new forms of extremely large-scale systemic injustices, to which the existing framework and institutions of administrative law are ill-equipped to respond. However, a significant impediment to meaningful debate about the future governance of machine technology use by government is an almost complete lack of transparency about that use. 

As mentioned above, we do not know how NSW Government agencies may currently be using machine technology to assist them in the exercise of statutory decision-making functions – and so we do not know how those systems have been designed, what they are being used for, and what (if any) assurance has been obtained that they are operating lawfully and in accordance with principles of good administrative practice. This is a significant problem. Some technology use may be lawful and appropriately designed and used, but other technology may not. While we do not consider that visibility is, of itself, a sufficient remedy to address potential concerns that might arise with the use of machine technology, it is an essential starting point. 

Following this report, therefore, we will seek to work with relevant bodies, including Digital NSW (part of the Department of Customer Service) and the Office of Local Government, to comprehensively map current and proposed types and uses of machine technology (chapter 2). We will also look inward to consider what more we can do to support agencies and citizens, as well as our own staff, to understand the use of machine technology – and to ensure that administrative law and the enduring values of good public administration, including legality, transparency and fairness, are given central attention.

Regulatory Gaps

'Narrowing Data Protection's Enforcement Gap' by Filippo Lancieri in (2022) 74(1) Maine Law Reviewcomments 

The rise of data protection laws is one of the most profound legal changes of this century. Yet, despite their nominal force and widespread adoption, available data indicates that these laws recurrently suffer from an enforcement gap—that is, a wide disparity between the stated protections on the books and the reality of how companies respond to them on the ground. Indeed, Annex I to this Article introduces a novel literature review of twenty-five studies that analyzed the impact on the ground of the GDPR and the CCPA: none found a meaningful improvement in citizen's data privacy. This raises the question: what accounts for this gap and what can be done to improve the performance of these laws? 

This Article begins by describing three core building blocks of data protection regimes in the United States and Europe—namely, market forces, tort liability and regulatory enforcement—that these jurisdictions combine in different ways to ensure that companies act in accordance consumers’ privacy preferences. It then identifies two key reasons—particularly deep information asymmetries between companies and consumers/regulators, and high levels of market power in many data markets—that enable companies to behave strategically to protect private interests and undermine legal compliance. 

The conclusion looks at the institutional design of antitrust and anti-fraud laws, two regulatory regimes that face similar challenges in their implementation, to argue that an effective online privacy regulatory system should be built around three key principles. First, the system must multiply monitoring and enforcement resources, and antitrust demonstrates how litigation can fund sophisticated civil-society intermediaries that safeguard consumers. Second, the system must bring violations to light, and anti-fraud policies demonstrate the importance of establishing effective whistleblower programs for data protection. Third, the system must increase governmental accountability, and antitrust provides examples on how to promote public transparency without sacrificing enforcement capacity.

Adverse Possession

More lapidary writing from Master Sanderson. Crage v Wooles [2021] WASC 406 considers a claim for adverse possession - 

[3] ... the plaintiffs reside at 42 The Esplanade, Peppermint Grove and the defendants reside at 40 The Esplanade, Peppermint Grove. In other words, they are next door neighbours. The plaintiffs plead in or about 1991 they constructed a wall which separated the two lots but which was entirely on the plaintiffs' lot. In other words, instead of building the wall on the boundary line, the plaintiffs built the wall and its footings entirely on the plaintiffs' lot. Why the wall was constructed in the position it was is of no relevance to this dispute. What is relevant is that the wall – which is described in the pleading as the 'First Wall' - was built by the plaintiffs and was built entirely on their land. The plaintiffs then plead in 2009 the defendants constructed a wall on the footings of the First Wall for a length of 26 metres from The Esplanade. This is referred to as the 'Second Wall'. The plaintiffs allege the Second Wall was constructed entirely on the plaintiffs' land. 

[4] The plaintiffs say that the defendants have 'previously committed the tort of trespass by planting vines and allowing them to grow over and damage the First and Second Walls'. They allege that unless restrained from doing so, the defendants intend to commit further such heinous acts and that requires this court to issue an injunction to stop the defendants painting the First and Second Walls or doing anything which is inconsistent with the plaintiffs' ownership of the walls. In addition, the plaintiffs want a declaration they are the owners of their lot up to the boundary and a declaration that the defendants have no proprietary interest in the land of which the plaintiffs claim ownership. 

[5] It is worth pausing at this point to marvel at the nature of the relief sought. There is nothing to indicate the plaintiffs intend to demolish either the First Wall or the Second Wall and build a wall on the boundary line. Presumably, what they wish to do is lean over the walls from time to time and ensure that the defendants are not in some way interfering with the surface of the wall facing the defendants' property. Presumably, they may also from time to time point out to the defendants that the wall is on their land and emphasise that fact ought not be forgotten. Otherwise the status quo, which has existed since 2009 when the Second Wall was constructed, would continue. ... 

[8] The defendants plead that the First Wall is, at its greatest point of deviation from the boundary, no more than 135 millimetres inside the plaintiffs' lot. In other words, this case concerns a sliver of land hardly wide enough to accommodate a punnet of petunias. Such is the value of land in Peppermint Grove. ...   

[10] Before detailing that plea I should make some general comments about what constitutes adverse possession. As the title of the cause of action suggests, one party must possess another's real property in a manner which is inconsistent – or adverse - to the owner's title. In other words, the party claiming title by adverse possession must trespass on the registered proprietor's property and act as if that property belonged to the trespasser. If that possession, adverse to the interests of the owner, continues for a period of 12 years, then the right and title to the property upon which the person is trespassing passes to the trespasser. Adverse possession is one of the very few, if not the only instance in Australian jurisprudence where a wrongdoer is rewarded for his or her wrongful acts. 

[11] What constitutes adverse possession has been the subject of numerous decisions.Perhaps the best analysis of the principles is provided by the decision of Murray J in Petkov v Lucerne Nominees Pty Ltd (1992) 7 WAR 163 at 165 ‑ 168. The Transfer of Land Act 1893 (WA), by sections 68 and 222 to 225, recognise the possibility of a claim in adverse possession. But these sections do not actually deal with the legal basis of the claim. In fact, the claim is based on limitation of actions as defined in the Limitation Acts of 1935 and 2005. The act of trespass becomes actionable by a landowner when the trespass first occurs. If the landowner does nothing for 12 years the right of action for trespass is statute barred. That is how the claim arises. So properly viewed, a claim in adverse possession is really a defence to an action in trespass based upon the Limitation Act. 

[12] ... the defendants rely principally on three matters. First, they say the plaintiffs built a wall which enclosed, on the defendants' side of the wall, the land over which adverse possession is claimed. Second, they say the AP Land has been used by the defendants and their predecessors in title for a period of more than 12 years. Third, they say that a building has been constructed on the defendants' land and, in the course of the building works, the defendants possessed the AP Land. 

[13] Against that, the plaintiffs make a number of points. First, and perhaps most importantly, they say adverse possession cannot lie when the enclosure of the land is undertaken, not by the defendants, but by the plaintiffs. It is true that one of the most common indicators of adverse possession is the trespasser fencing the subject land. This is seen as an unequivocal demonstration of the requisite intent to exclude the world at large. The defendants were unable to point to a case where the enclosure had been undertaken, not by the party claiming adverse possession, but by the owner. Furthermore, the plaintiffs say that even on the defendants' plea, there is a break in the chain of adverse possession such that the claim could not run. They also dispute there has been use made by the defendants of the land which is consistent only with adverse possession. ... 

[15] More than that, it does seem to me, on balance, the defendants' position is arguable. True it is, there is no authority for the proposition that enclosure by a registered proprietor can lead to a claim for adverse possession. On the face of it that would seem an odd result. But the fact is the land is enclosed and, on the defendants' case, has been used inconsistent with the plaintiffs' ownership. So the position is arguable. 

[16] In any event, this matter is best litigated once and for all so that the respective interests of the parties can be finally determined. If the plaintiffs are confident that the defendants' pleas in relation to adverse possession cannot be made good on the facts as pleaded, they can simply admit those facts and argue the matter on the law. It might even be possible to produce a statement of agreed facts – although the chance of these parties agreeing on anything would seem to be no more than a pious hope. Nonetheless, it remains a possibility. It is certainly an open question whether, on the facts pleaded in the statement of claim, the relief sought by the plaintiffs is open. This is one of those cases where there is nothing to be gained by interlocutory skirmishing. ... 

[18] The great American poet, Robert Frost, said 'good fences make good neighbours'. In this case there is no doubting the quality of the fences.

Health Regulation

The 'New Frontier - Delivering better health for all Australians' report by the House of Representatives Standing Committee on Health, Aged Care & Sport covers the Committee's Inquiry into approval processes for new drugs and novel medical technologies in Australia. It picks up a submission by myself and Dr Wendy Bonython (Bond University) and my testimony at a hearing of the Committee.

The Committee offers the following recommendations 

 Recommendation 1 

The Committee recommends the Australian Government establish a Centre for Precision Medicine and Rare Diseases within the Department of Health.

• The objective of the Centre should be to ensure that the capacity of the Department of Health is enhanced to provide Australians with timely access to new drugs and novel medical technologies, including for rare diseases, and that the HTA process and government research agenda aligns with this outcome. 

• The Centre should provide advice to the Department of Health and the Australian Medical Research Advisory Board on research priorities. 

• The Centre should provide education and training information including support for patients and a comprehensive horizon scanning unit for new medicines and novel medical technologies. 

• The Centre should provide advice to governments on the establishment of a dedicated regulatory Health Technology Assessment pathway for cell and gene technologies, in consultation with state and territory governments, industry, patients and other relevant stakeholders. The Centre should regularly provide advice to government on the effectiveness of those pathways and areas for further reform. 

Recommendation 2 

The Committee recommends that, consistent with Recommendation 1 and the establishment of a Centre for Precision Medicine and Rare Diseases, the Health Technology Assessment (HTA) process for cell and gene therapies be simplified to establish a clear and certain pathway for such therapies.

• This simplified process should be considered together with a new HTA pathway for cell and gene therapy. 

• Building on the Medical Research Fund Genomics Mission, the Australian Government and state and territory governments should establish a jointly funded national genomics testing program to provide equitable access to genomic testing nationwide. As part of the program, governments should ensure the provision of genomics counselling for all patients. 

• The Australian Government should prioritise and simplify the regulation of cell and gene therapy pathways for clinical trials in Australia.

Recommendation 3   

The Committee recommends the Australian Government establish an Office of Clinical Evaluation within the Department of Health to assess the best and most effective care for patients in the context of new and emerging health technologies.

• The Office should enable evaluation of both pharmacological and non-pharmacological interventions, combination products and products with different sponsors. It should also establish a “living evidence” function to ensure Health Technology Assessment is based on the most up-to-date global health practices. 

• The Office, in consultation with relevant stakeholders, should conduct a review of how the Department’s Health Technology Assessment system assesses combination products, particularly combinations with different sponsors, with a focus on: - Value attribution between the different products - Challenges to cooperation between sponsors due to competition law - Disincentives for a sponsor with an already listed product to participate in its combination listing 

• The Office should consider collaboration with the National Institute for Health and Care Excellence (NICE) in the United Kingdom to establish similar clinical evaluation processes in Australia that links in with Australian Health Technology Assessment processes. 

• The Office should cooperate and share information with the state and territory governments to ensure that patients receive treatment where it is safest and most efficacious for them and that there are no gaps in continuity of care. 

Recommendation 4   

The Committee recommends that the assessment process for the Life Saving Drugs Program (LSDP) be streamlined and delays in access to treatments be reduced by ensuring that a sponsor only need lodge one application for one Health Technology Assessment pathway. The Committee recommends either:

• Providing sponsors with an immediate pathway to the LSDP Expert Panel (instead of waiting for a PBAC determination), or 

• Providing a pathway by adjusting the Pharmaceutical Benefits Scheme section 100 program, with specific criteria, as with other section 100 programs.

The Committee believes it is critical that consideration be given to how the LSDP will integrate with an increasing number of precision medicine applications into the future. 

Recommendation 5   

The Committee recommends that the Australian Government develop a labour market and skills strategy to expand the number of health economists in Australia. This could include encouraging training within Australia as well as seeking expertise from overseas. 

Recommendation 6   

The Committee recommends that the Department of Health increase its efforts to educate and engage with patients, clinicians, industry and the public and develop education campaigns on all aspects of the regulation and reimbursement system.  The Committee recommends that the Department of Health improve information available on the websites of the Therapeutic Goods Administration (TGA) and its Health Technology Assessment (HTA) bodies for all users including patients, clinicians, industry and the public. This would include:

• Using plain English language, infographics and videos to explain general processes and timelines 

• Explanations on the TGA and all HTA’s websites of how that entity fits into the overall regulation and reimbursement system, similar to the Medical Services Advisory Committee’s Australian Government HTA Processes factsheet. 

• The Department of Health expanding the Pharmaceutical Benefits Scheme Medicines Status website to include technologies funded through the Medicare Benefits Schedule or create an equivalent website for such technologies. 

Recommendation 7   

The Committee recommends that the Department of Health and the National Blood Authority, in consultation with state and territory governments, reform the Health Technology Assessment processes for blood products to provide better alignment with the Health Technology Assessment system, including:

• Publication of guidance documents for applicants 

• Establishment of timelines for applications, and publication of an assessment cycle calendar 

• Creation of a parallel Therapeutic Goods Administration and Health Technology Assessment process. 

Recommendation 8   

The Committee recommends that the Australian Government make the following changes to submission fees for the Therapeutic Goods Administration (TGA) and the Pharmaceutical Benefits Advisory Committee (PBAC) and where appropriate Medical Services Advisory Committee (MSAC) assessments in the following separate circumstances: 

• Replace the current orphan drug fee waivers with a HECS-style fee waiver, in which orphan drug application fees are payable on successful application, only once the drug has earned the sponsor a certain amount of revenue. The Department of Health should determine this threshold value in consultation with industry 

• To support smaller companies, HECS-style fee waivers for any sponsor company with revenue at or below $50 million per annum 

• HECS-style fee waivers for Australian start-up companies with a specified amount of revenue in the Australian market to promote innovation. The Committee also recommends introducing a sliding scale for fees for resubmissions, with fees being lower for resubmissions. 

Recommendation 9   

The Committee recommends that the Australian Government establish a fund to support patients, clinicians and non-profit organisations to sponsor registration and reimbursement applications where there is no realistic prospect of a company serving as sponsor, and where the Department of Health is otherwise supportive of the application.

• Such a fund should be targeted at treatments for conditions where low patient numbers in Australia serve as a market barrier and where there is a clinical demand and need. The fund should be available for applications to repurpose previously listed medicines and technologies. 

• The fund should be annually capped with clear and transparent eligibility rules. 

Recommendation 10 

The Committee recommends that the Australian Government amend the National Health Act 1953 (Cth) to give the Pharmaceutical Benefits Advisory Committee the power to authorise Managed Access Programs. The eligibility criteria for these Managed Accessed Programs should be aligned as far as possible with the eligibility criteria for the Therapeutic Goods Administration’s provisional registration. 

Recommendation 11   

The Committee recommends that the Department of Health conduct a comprehensive consultation process with industry to establish a more flexible way forward for the repurposing of drugs in Australia. This should include: 

• Establishing a new pathway that incentivises the repurposing of drugs for all diseases, not just rare disease. 

Recommendation 12   

The Committee recommends that the Therapeutic Goods Administration make the following changes to its Orphan Drugs Program:

• Provide automatic access to the Priority Review Pathway for all medicines granted an orphan drug designation 

• Treat paediatric patient populations as separate to adult patient populations for the purposes of the eligibility criteria 

• Better account for the extra costs incurred by a sponsor in expanding its medicine to paediatric indications, for the purposes of assessing commercial viability as part of the eligibility criteria 

• Where the prevalence of a disease is unknown in Australia, accept evidence of prevalence in other comparable countries or, in diseases of extremely low prevalence, worldwide for the purposes of the eligibility criteria. 

Recommendation 13   

The Committee recommends that the Department of Health reform its regulatory and reimbursement processes to enable therapeutic goods to be registered and reimbursed by molecular indication in addition to by disease indication. This should include legislative change if necessary. 

Recommendation 14   

The Committee recommends that the Australian Government reconsider the current cost recovery funding model for the Therapeutic Goods Administration, paying attention to future staffing and IT infrastructure needs in an environment where demand on its services and systems are expected to increase in future years. The Committee recommends funding specifically for: 

• IT systems upgrades, to modernise and match the IT capability of other overseas Tier 1 regulators. 

• An expansion of its staffing capacity in areas of new medical and technological advances including for horizon scanning. 

• The release of TGA Australian Public Assessment Reports at the same time as a prescription medicine is listed. 

• The implementation of the HECS-style fee waivers outlined in Recommendation 8. 

Recommendation 15   

The Committee recommends that the Australian Government ensure the membership of the Pharmaceutical Benefits Advisory Committee and Medical Services Advisory Committee provides the appropriate expertise for all applications. This should include the possibilities of enhanced cross-membership between the two committees and the appointment of temporary members to consider individual applications. 

• Recognising the nature of health challenges in Indigenous communities, membership should include representation from Aboriginal and Torres Strait Islander Peoples. 

Recommendation 16   

The Committee recommends that the Department of Health investigate further opportunities for the formation of an international Health Technology Assessment consortium similar to the Access Consortium to streamline the regulatory process for certain medicines and medical technologies. This investigation should include discussions with representatives of the Health Technology Assessment bodies of the United Kingdom, Canada and other countries with systems similar to Australia’s.

• The Committee recommends that the Therapeutic Goods Administration work with the United States Food and Drug Administration and other overseas regulators to establish an equivalent of Project Orbis for non-cancer rare diseases, or to expand Project Orbis to include such diseases. 

Recommendation 17   

The Committee recommends that the Australian Government establish a scheme that supports the domestic medical technology sector, similar to the Food and Drug Administration’s Breakthrough Devices Program in the United States. 

Recommendation 18   

Recognising the vital role that vaccines play in addressing many diseases, including its importance in providing protection against Covid-19, the Committee recommends that the Department of Health conduct a review of the National Immunisation Program. This review should focus on reforming existing approaches used to value vaccines to ensure early and rapid deployment of vaccines in Australia. 

Recommendation 19 

The Committee recommends that the Australian Government continue to address the following matters in its reforms to the Prostheses List:

• The lack of coverage for non-implantable devices under the current arrangements. 

• Improving coordination between the Medical Services Advisory Committee and the Prostheses List Advisory Committee to provide faster access for patients. 

Recommendation 20   

The Committee recommends that the Australian Government establish a last resort mechanism for directly securing ongoing supply of medicines that meet a high clinical need and lack suitable alternatives that are at risk of being delisted from the Pharmaceutical Benefits Scheme. 

Recommendation 21 

The Committee recommends:

• The federal, state and territory health authorities complete the standardisation of newborn screening across Australia 

• As part of that process, the Australian Government work with states and territories to expand the newborn screening program based on new understandings of genomic testing for conditions and international best practice 

• That the Australian Government in collaboration with states and territories, conduct reviews every two years to determine whether the screening program should be further expanded based on new Australian and international scientific and medical knowledge. While not in the terms of reference for this inquiry, the Committee recognises and supports the calls from rare disease patient groups for more funding for treatment pathways for actionable disorders across states and territories, where identified through newborn screening. 

Recommendation 22 

The Committee recommends that all levels of government prioritise and implement with urgency the harmonisation of Human Research Ethics Committee (HREC) and Site-Specific Assessment submissions into one Australian online platform and enable parallel review by HRECs and Research Governance Offices.

• The platform should be developed within the purview of the Australian Commission on Safety and Quality in Health Care. 

• This work should be a continuation from the work prepared as part of the National Clinical Trials Governance Framework. 

Recommendation 23 

The Committee recommends that all levels of government jointly provide funding for the development of a national clinical trial register. It should include:

• Development of a sophisticated digital platform to collect and facilitate patient identification, patient recruitment, patient retention and completion rates for clinical trials. 

• Linked data from existing national registers and consideration should be given to whether the register is best operated by a government agency or an existing Non-Government Organisation, or an academic body with appropriate experience. 

Recommendation 24 

The Committee recommends the Australian Government develop policies that encourage modernising digital technologies and practices to position Australia as the premier destination for international clinical trials. This would include developing national standards for the use of e-consent, e-signature, and electronic medical records to enable remote monitoring and participation in clinical trials across Australia.

• National standards should include standardising clinical costs and fees that are competitive with international fees. 

Recommendation 25 

The Committee recommends the Australian Government should develop a national standard approach, including nationally agreed systems and standard operating procedures to support and strengthen the capacity to conduct clinical tele-trials in rural, regional and remote areas. 

• This approach should be developed in consultation with industry and allied health workers. 

• This would include the need for education and training opportunities for General Practitioners and all allied health workers engaging in clinical trials using tele-trials and multi-centre trials. 

Recommendation 26 

The Committee recommends the Australian Government should continue to fund Clinical Trial Networks with a particular focus on developing seed funding for Indigenous Health Clinical Trial Networks. 

Recommendation 27 

The Committee recommends the Australian Government reform data exclusivity provisions in Australia with a view to extending data exclusivity for orphan drugs and vaccines to a period of up to 10 years. The Australian Government should:

• Develop additional reforms to data exclusivity timeframes to support research and development into new drugs and novel medical technologies in areas of unmet need. 

• Consider future funding initiatives for novel drug discovery and support research and development partnerships in Australia. This would assist new drugs and novel medical technologies in early stage and pre-commercial development. 

• In partnership with the states and territories, develop and implement a pilot scheme for value-based payments for new antimicrobial drugs. This pilot should apply the lessons learned from the Australian Government’s pilot scheme for payment for Hepatitis C drugs, as well as from overseas antimicrobial drug schemes. 

• Promote the recent research and development tax initiatives internationally as a way of encouraging industry to look to Australia for future investments in the healthcare sector. 

• Conduct a full review of the patent box scheme every two years after implementation to ensure it is operating effectively and driving increased expenditure and innovation within Australia. 

• Collaborate with the states and territories to review the funding of the research and development sector in health care to distribute funding in a methodical way that provides sufficient support throughout the research funding ‘pipelines’. 

• Noting the work underway through the Modern Manufacturing Program, the Committee supports the development of an updated roadmap to facilitate the manufacturing and commercialisation of novel drugs and technologies in Australia. 

Recommendation 28 

The Committee recommends that:

• The Department of Health integrate the patient voice upfront into the Health Technology Assessment system. Earlier patient engagement with the Health Technology Assessment system would include: 

• Representation from peak patient bodies that is refreshed every three – five years 

• Representation of Aboriginal and Torres Strait Islander Peoples. 

• The Department of Health implement a notification system for all HTA bodies and the TGA to advise relevant patient groups of the receipt of an application. 

• The Department of Health provide patients and stakeholders with a concise sponsor’s submission summary to help facilitate their own involvement in the Health Technology Assessment process. 

• The Department of Health should consider making patient evidence compulsory for certain applications, and should consider the role of patient evidence in the decisions of the Therapeutic Goods Administration. 

• The Department of Health should notify relevant patient groups of the outcome of the assessment process by all HTA bodies. 

• The Department of Health be funded to implement these recommendations. 

• The Australian Government provide funding for organisations to support participation in the HTA process, including for very rare disease patient groups that have limited capacity for fundraising or access to alternative funding. 

Recommendation 29 

The Committee recommends that:

• The Committee recommends that the Australian Government amend the National Health Act 1953 (Cth) to formalise the role and powers of the Pharmaceutical Benefits Advisory Committee Executive. The scope of the Executive’s role and powers should be determined by agreement between the Executive and the Department of Health. 

• The Department of Health produce a pre-submission advice framework for submissions to the Therapeutic Goods Administration, Pharmaceutical Benefits Advisory Committee, Medical Services Advisory Committee and other Health Technology Assessment bodies, explaining the interaction between those bodies and their evidentiary and other requirements, to be provided to sponsors before they make their submissions. 

• The independent Health Technology Assessment Review reassess relevant aspects of the Health Technology Assessment process to ensure there are future pathways for treatments and therapies that do not fit neatly into the current system such as rare cancers, antimicrobials, orphan drugs, and precision medicines. 

• It is imperative that appropriate clear pathways are considered for inclusion for paediatric medicines and technologies. 

• The Committee is of the clear view that precision medicine approval pathways will require a different application assessment than current approaches designed for treatments for common conditions, with large data sets and comparative evaluations. 

• The Department of Health publish data on application processing times and positive recommendation rates for the Pharmaceutical Benefits Advisory Committee and other Health Technology Assessment bodies. In addition:

• The Department of Health should publish Health Technology Assessment processing times annually, benchmarked against other nations with advanced HTA processes. 

• The Australian Government, in collaboration with relevant stakeholders, develop a suite of clear and measurable benchmarks to track the Commonwealth’s implementations of the recommendations made by the Committee and accepted by the Australian Government.

• These agreed benchmarks along with measurable KPIs/metrics should be developed in such a way as to best facilitate the Department of Health, including its agencies and other relevant statutory bodies, in the tabling of an annual update to the Australian Parliament. 

Recommendation 30 

The Committee recommends that the Australian Government’s independent Health Technology Assessment Review (which is scheduled to commerce in July 2022) consider and develop reforms in the following areas:

• Reducing the frequency and need for applications to HTA bodies to be resubmitted. 

• Streamlining the interaction between hospitals and the Health Technology Assessment system  

• Streamlining the interaction of the Therapeutic Goods Administration, the Pharmaceutical Benefits Advisory Committee, the Medical Services Advisory Committee and other Health Technology Assessment bodies 

• Cooperation and harmonisation between Australian Health Technology Assessment bodies and equivalent bodies overseas 

• Improving the measurement of the performance of the Pharmaceutical Benefits Advisory Committee and the publication of data on that performance 

• Improving the mechanisms for communication between sponsors and the Pharmaceutical Benefits Advisory Committee during the submission process 

• Increasing the use of Managed Access Programs to facilitate earlier access to innovative medicines 

• Increasing the use of Real World Evidence in Health Technology Assessment 

• Improving flexibility when choosing a comparator in Health Technology Assessment 

• Introducing a scoping process that includes patients and clinicians at an early stage to agree on the framework that the submission will be considered. This process could draw on the approach taken by the United Kingdom’s National Institute for Health and Care Excellence 

• Improving the independent review process for HTA decisions, including the potential for this to be made available to groups of patients and clinicians in addition to sponsors. 

Recommendation 31 

The Committee recommends that:

• The Department of Health should consider, in consultation with state and territory governments, industry, patients and clinicians, the introduction of fees for Medical Services Advisory Committee applications on a cost recovery basis, if this is necessary to increase the speed and effectiveness of assessments. If fees are introduced they should have similar features to those recommended by the Committee for Pharmaceutical Benefits Advisory Committee fees (including those arrangements outlined at Recommendation 8). 

• The Medical Services Advisory Committee increase the involvement of clinicians in its assessments of technologies with which its members lack relevant expertise. 

• The Department of Health introduce an equivalent to the Managed Access Programs for medical devices. The details of this scheme including eligibility criteria and duration should be formulated in consultation with patient groups, clinicians and industry. 

• The Therapeutic Goods Administration introduce parallel processing of applications with the Medical Services Advisory Committee. 

• The Medical Services Advisory Committee increase opportunities for sponsors of particularly complex applications to present to it at its meetings and expand the opportunities for pre-submission meetings. 

• The Medical Services Advisory Committee consider developing international collaboration for complex assessment proposals. 

• The Department of Health expand the independent Health Technology Assessment Review in July 2022 to include Medical Service Advisory Committee processes. 

• The Medical Services Advisory Committee publish a full calendar timeline of meeting agenda and outcomes, including dates when minutes and Public Summary Documents will be made public. 

• The Medical Services Advisory Committee publish additional guidance for sponsors of digital health technologies. 

• The Department of Health establish a benchmarking system for MSAC assessments, including benchmarking against comparable overseas organisations

Ransomware Insurance

Reuters reports that insurers have halved the amount of cyber cover they provide to customers following an increase in ransomware attacks that resulted in large payouts. 

Major EU and US insurers  have been able to charge higher premiums to cover 'ransoms, the repair of hacked networks, business interruption losses and even PR fees to mend reputational damage'. However growth in ransomware attacks and claims that the criminals are increasingly sophisticated result in insurers 'changing their appetites, limits, coverage and pricing', with one Reuters source commenting

Limits have halved – where people were offering 10 million pounds ($13.50 million), nearly everyone has reduced to five.

 Lloyd's of London (reported as having around 20% of the global market for cyber insurance) has reportedly discouraged its syndicate members from taking on cyber insurance next year. Reuters comments 

Combined ratio - a measure of profitability in which a level of more than 100% indicates a loss - climbed by more than 20 percentage points from 2019 to 95.4%. While insurers struggle to cope, companies are under-insured. "It's very unlikely people are getting the same limits - if they are, they are paying an extraordinary amount," ... 

[O]ne technology client had previously bought 130 million pounds of professional indemnity and cyber cover for 250,000 pounds. Now the client could only get 55 million pounds of cover and the price was 500,000 pounds. Insurers who issued $5 million cyber liability policies last year have scaled back to limits of between $1 million and $3 million in 2021... 

Where hackers previously took a scattergun approach with methods such as sending out thousands of phishing emails, they have become more targeted, reading balance sheets and focusing on specific sectors. ... [A]ttacks were moving away from healthcare facilities and municipalities - which have weak IT controls but also little money - to manufacturing or logistics companies. Such firms have deep pockets and cannot afford extended outages to fix their systems, so would rather pay ransoms, especially if they have insurance to cover them. ... 

Premium rates have almost doubled in the United States and jumped by 73% in Britain as a result of the frequency and severity of ransomware attacks, insurance broker Marsh said. RPS said rates for some policies had risen by as much as 300%. Where ransom payments were typically $600 a few years ago, they now are as high as $50 million, said Michael Shen, head of cyber and technology at insurer Canopius, and insurers are sometimes asking policyholders to pay half of the ransom. 

Pragmatism

'The Human Pared Away: Hilary Mantel’s Thomas Cromwell as an Archetype of Legal Pragmatism' by David Kenny in (2020) Law and Literature comments 

Hilary Mantel's Wolf Hall trilogy are iconic pieces of literature, but also represent a hugely insightful commentary on the law. Her protagonist, Thomas Cromwell, is the archetype of a philosophical legal pragmatist: willing to use the law and its language to achieve his ends, but regarding adherence to any principled or abstract account of the law as misleading and even dangerous. With striking parallels to the pragmatist philosophy of William James, Richard Rorty, Richard Posner and others, Mantel's Cromwell illustrates both the promise of legal pragmatism—its ability to get results without false compunction about means—but also its dangers: that one may pick the wrong prince, or make flawed or base calculations on how to act. The Wolf Hall trilogy shows this in a manner far more clear and far more vivid than any purely philosophical accounts, and capture something deep about the theory and practice of law. As such, their commentary on the law, authority and governance deserves our close attention.

Kenny states

Hilary Mantel’s Wolf Hall trilogy is not, in a direct sense, about law. It is about the politics of the Tudor court: the intrigue, the plotting, the struggles for influence and power. It is about the whims and vicissitudes of Henry VIII, and the incredible competence and brilliance of his chief minister, Thomas Cromwell, in carrying them out. But law looms large in the books: Cromwell is a lawyer, in self-image and self-presentation, and law is the primary tool he wields in executing his schemes and stratagems to do Henry’s will. But his respect for the law seems, from some perspectives, to be severely lacking. He bends the law—fudges it, manipulates it, cynically exploits it—to achieve his ends. In short, he is unprincipled in his use of the law. 

In other works of fiction—most famously, a Man for All Seasons — the author clearly wants our sympathies set against the unprincipled Cromwell and with the saintly Thomas Moore, whose respect for principle is so unmatched that it costs him his head. Mantel’s vision is very different. First, in Mantel’s telling, Cromwell — while being unprincipled in his use of the law — has a clear, deep, abiding respect for the law. He believes it to be extremely important that the law is respected, obeyed and upheld, even at the same moment he is manipulating it to get his way. He is wedded to law’s appearance—its form, its seeming coherence—and to preserving the respect which it is owed, while seemingly agnostic as to its substance. This is a complexity that Bolt’s play entirely lacks. 

Secondly, Mantel’s portrait of Cromwell is deeply sympathetic. He is our protagonist. We are in Cromwell’s head - the present tense prose making ancient events feel immediate - and are with him through his brilliant execution of the will of the king. We are on his side, and his unprincipled actions start to make sense to us, even as he effectively frames Henry’s wife and courtiers for treason. Mantel’s account seems to justify Cromwell, for the most part, or at least to explain him. 

It is my case that Cromwell’s use of the law in Mantel’s novels are coherent and justifiable, from a certain point of view: the viewpoint of philosophical pragmatism as applied to the law, or legal pragmatism. This philosophy, found in the writings of Stanley Fish, Richard Rorty, Richard Posner and others, is derived from the “American pragmatism” of Dewey and James, and makes the case for not adhering to principles but focussing on outcomes. It requires you to set your highest goals, and to do whatever you need to do to bring them about, calculating the worth of particular actions not by principled accounts of their rightness but by their effects. Principles, on this view, are meaningless abstractions that get in the way, muddy the water, and distract you from your goals. The pragmatist, William James tell us

turns away from obstruction and insufficiency, from verbal solutions, from a priori reasons, from fixed principles, closed systems, and pretend absolutes and origins. He turns towards concreteness and adequacy, towards facts, towards action, and towards power. 

He is against “going by principles”; his optimism “is apt to be decidedly conditional and tremulous”; he is “hard headed” or “tough minded”; he is a fatalist in respect of free will. These traits, as we shall see, perfectly describe Mantel’s Thomas Cromwell. 

Many lawyers, whether framing it in philosophical language or not, come to view the law in this way. It is often interpreted as cynicism, but this is not necessarily so. It does not mean that you have no limits, that you will do anything. It rather means that, having set your priorities and highest values, nothing is a priori off the table to achieve them: all things must be considered in context, and if you think the outcome is so important that it worth the cost, you should take the action without regard to principles that are, in the end, without meaning. 

By these lights, Cromwell’s actions are almost all either justified or potentially justifiable on the basis of upholding his priorities: to serve the will of his master, and to be true to God. In the end, when these priorities begin to clash, Cromwell has to choose between them. But if there is fault in Cromwell’s actions, the fault is in his king’s desires, or in what Cromwell might call “base calculation” - misjudging the pragmatic balance on which actions are necessary and appropriate. Cromwell is an archetype of legal pragmatism, and Mantel’s account paints clearly the merits of this approach when Cromwell excels, and its dangers when he veers into error. 

In Part I, I explore philosophical pragmatism, setting out its case against abstraction and principle, and its application to law, where it counsels adherence to form and use of principles only as rhetorical tools to achieve legal ends. Part II describes Cromwell’s pragmatist world view, which maps perfectly onto James’ and Dewey’s: based on an epistemological uncertainty, but armed with his experience and knowledge of the world, Cromwell will act in a profoundly unprincipled way to achieve his ends. He does not care about principle or consistency, only results and effects. In Part III, I examine how this pragmatism relates to lawyers in the world of Hilary Mantel, and the power law has in spite of—and indeed because of—the ability of lawyers to manipulate it and spin stories to achieve their ends. This shows the power of the legal pragmatist’s approach, facilitating as it does Cromwell’s exceptional competence. In Part IV, I examine how Cromwell’s mistakes in the books—in particular, his bloody and vindictive killing of Henry’s courtiers as Anne Boleyn’s alleged loves, and his equivocation between different masters that leads to his downfall—show the problems of legal pragmatism: that you can pick the wrong prince, devote yourself to the wrong objectives, or engage in base calculation, making judgments that are (by some measure) ultimately prove incorrect. In this, the books show us both the promise and the perils of legal pragmatism. 

Mantel, who studied law at the LSE and Sheffield, reaches the heart of the law and what it is to be a lawyer: to both respect it and manipulate it all at once; to circumvent its restrictions while insisting you are not; to construct a new path as you walk along it and insist it was there all along. To understand Cromwell as she paints him is to understand this view of the law all the way down. Her books are masterpieces of law and literature that merit our close attention.