Biohacking

'Prescribing unapproved medical devices? The case of DIY artificial pancreas systems' by Joseph T.F. Roberts, Victoria Moore and Muireann Quigley in (2021) 21(1) Medical Law International 42-68 comments 

In response to slow progress regarding technological innovations to manage type 1 diabetes, some patients have created unregulated do-it-yourself artificial pancreas systems (DIY APS). Yet both in the United Kingdom (UK) and internationally, there is an almost complete lack of specific guidance – legal, regulatory, or ethical – for clinicians caring for DIY APS users. Uncertainty regarding their professional obligations has led to them being cautious about discussing DIY APS with patients, let alone recommending or prescribing them. In this article, we argue that this approach threatens to undermine trust and transparency. Analysing the professional guidance from the UK regulator – the General Medical Council – we demonstrate that nothing within it ought to be interpreted as precluding clinicians from initiating discussions about DIY APS. Moreover, in some circumstances, it may require that clinicians do so. We also argue that the guidance does not preclude clinicians from prescribing such unapproved medical devices. 

The authors argue

 Healthcare technology innovation in type 1 diabetes (T1D) management has until recently been a relatively slow process. Patients have become tired of waiting for commercial companies to produce effective, accessible technological solutions that fully meet their needs. As a result, some patients (sometimes called ‘loopers’) are taking matters into their own hands and constructing do-it-yourself (DIY) systems to better manage their diabetes (encapsulated by #WeAreNotWaiting used to describe the movement on social media). Utilising two increasingly available technologies – continuous glucose monitors (CGMs) and insulin pumps – patients are creating hybrid closed-loop ‘artificial pancreas’ systems (APS). They do this by connecting their pumps to their CGMs using software installed on either a small computer or their smartphones. These systems calculate and deliver the required insulin doses automatically in real time. The main aims of ‘looping’ are to optimise blood glucose and insulin control and reduce the manual (and mental) input required by patients to manage their disease. For many patients, ‘looping’ represents a welcome step forward in the management of T1D. Users of DIY APS report experiencing improved amount of ‘time in range’ (time spent with blood glucose in optimal range), reduced anxiety surrounding sleep, and reduced time spent doing diabetes-related tasks such as checking blood glucose levels and calculating insulin doses. Nevertheless, it raises a number challenges for clinicians treating patients who loop or are thinking about looping. 

These challenges, which this article will outline in detail, are exacerbated by the lack of regulatory approval for these devices. Although this article focuses on the implications of this in the United Kingdom (UK) context, the issue is an international one. No regulatory body has approved the use of these DIY devices; indeed, two have issued statements actively discouraging their use. Both the French and US regulators warn patients of the safety implications and tell healthcare professionals to be vigilant (the latter’s statement followed the report of a serious adverse event in which a DIY APS user received an excess of insulin). As such, many of the arguments in this article will be of relevance to clinicians, patients, and regulators in other jurisdictions. 

Within the UK, there is an almost complete lack of ethical or regulatory guidance for clinicians who provide care to patients using DIY systems. This results in significant uncertainty with regard to their ethical and professional obligations in this respect. Practically speaking, this has led to clinicians adopting a precautionary approach in the clinic. Generally, even clinicians who are aware of the existence of DIY systems do not discuss them as an option unless the patient raises the issue themselves. 

In this article, we do three things. First, while we acknowledge clinicians’ concerns that legal or regulatory body actions could arise if they initiate discussions around DIY APS with patients, we argue that the current approach is ethically suboptimal and stems in part from a misinterpretation of regulatory guidance. In particular, we note that the current approach may be creating a lack of transparency in clinic. Such a lack of transparency is ethically undesirable since it inhibits both clinicians’ and patients’ abilities to openly discuss the availability and benefits, as well as the potential risks associated with looping. Secondly, we examine relevant guidance from the UK regulator – the General Medical Council (GMC) (including Good Medical Practice, new consent guidance, and prescribing guidance) – and demonstrate that there is nothing in it which ought to be interpreted as requiring clinicians to refrain from discussing DIY APS with, or recommending them to, their patients. Indeed, the latest iteration of the GMC’s consent guidance, published in September 2020, could be interpreted as requiring such discussions in some circumstances. Thirdly, we go one step further and argue that, although a high degree of caution might be needed (especially as the technology diffuses out from the current core of highly expert users), GMC guidance does not preclude or prohibit clinicians from prescribing medical devices which lack regulatory approval (‘unapproved medical devices’); and to conclude otherwise is a misinterpretation of the guidance. 

In making these arguments, it is important to note that we do not include either adults who lack capacity to make treatment decisions or children. While similar issues may arise for each of these groups, there are significant differences in relation to both the legal and regulatory landscape and the ethical arguments. For example, with regard to both of these groups, consideration of whether DIY APS is in the patient’s best interests is paramount. This is likely to further influence doctors’ decision-making processes and deserves careful consideration. As such, these patient groups are outside the scope of this piece. Our primary focus within this article is on regulatory matters surrounding prescribing; this particular focus reflects concerns raised among clinicians. It should, however, be noted that although GMC guidance is designed to be consistent with UK law, it is not intended to be a statement of legal principles. Nevertheless, we acknowledge that clinicians have concerns regarding legal liability and make some brief comments on this later in ‘Discussing DIY APS: What counts as a prescription?’ and ‘Professional judgement, clinical discretion and prescribing DIY APS’ sections.

Registries

Transparency International Australia's position paper 'A Stronger Corporate Registry' states 

Australia has inadequate corporate regulatory systems. This enables people who have been involved in corruption and other illegal activities to register companies in Australia. 

Individuals can register a company without adequate due diligence checks, beneficial ownership disclosure, identification of potential links to politically exposed persons, or a robust assessment of their business activities and legitimacy. Both in Australia and transnationally. 

This lack of transparency makes it easier for dishonest and criminal individuals to hide corruption, misconduct and crime, including money laundering, fraud, and embezzlement. 

A stronger corporate regulatory system requires greater transparency and proper due diligence. In 2020, the Australian government allocated funding for implementation of the Modernising Business Registers (MBR) program. This program aims to improve the administration of business registers and unify the Australian Business Register and the 31 business registers held with the Australian Securities and Investments Commission (ASIC). This is long overdue and a welcomed step. It goes some way in addressing the flaws in the current system, but greater reform is required for it to be fit for purpose. It appears it will assist with preventing phoenixing activities and tax evasion, but is a missed opportunity to overhaul the system to address arguably the more important issue of having a reliable system for due diligence.

Modernising Business Registers Program: What reforms will it include? The MBR Program will progressively establish a new business registry service between 2021 and 2024. This will unify the Australian Business Register managed by the Australian Tax Office (ATO) and 31 registers currently managed by ASIC in to one place. 

The new registry service will modernise and streamline the way businesses register, view and maintain business registration details with government on a more contemporary, digital registry system. As part of the MBR Program, a new director ID – a unique identifier that a director will keep forever, will also be introduced.

TIA's recommendations are 

• Australia must remove excessive costs and allow free access to the register • Australian regulators must close the loophole allowing the anonymous appointment of directors and beneficial shareholders, ensuring nominees make their role apparent and reveal who they are a nominee for • Australian regulators must verify current data and collect additional data to properly identify the individuals registering companies, and identify whether they have been involved in corrupt or criminal conduct in Australia or overseas • Australia must establish a centralised public beneficial ownership register • Australia must establish a trust register and require full disclosure of beneficial owners and ultimate beneficiaries

TIA comments 

Australia’s corporate system in its current form is not fit for purpose as it does not properly identify individuals registering associations with private companies. The MBR Program is an important step in improving the system, but does not go far enough, leaving the public and private sector in the dark into the integrity of businesses registering in Australia. Though the Australian Transaction Reports and Analysis Centre (AUSTRAC), the regulator responsible for protecting the financial system from serious and organised crime, requires Australian entities to properly identify their customers, the corporate register is not required to1. This registration system therefore enables private companies with opaque business structures to be registered in Australia with no verification of the data supplied, in addition to a great deal of essential identification data not collected at all.

It notes ASIC's admission that Elvis Presley, Homer Simpson and Bob Marley could be installed as Australian Company directors. TIA comments  

Australia is a founding member of the Financial Action Task Force (FATF), the global money laundering and terrorist financing watchdog. We have committed to fully and effectively implementing its standards for combating money laundering, specifically in respect to requiring greater transparency from both companies and trusts. As Australia does not have a robust corporate registry we are unable to meet these global commitments. The system in its current form fails to provide legitimacy and protection to businesses as well as to support regulators to undertake compliance activities. 

The ASIC is currently primarily responsible for maintaining corporate registration. n its current form the corporate registration system in Australia is disjointed, outdated, unreliable and lacking the necessary verification, due diligence and technology to make it fit for purpose to assist in the prevention and detection of corporate misconduct and money laundering. The MBR Program will go some way in addressing these issues by unifying the registers administered by ASIC onto a single more contemporary platform. This platform will be administered by the Commonwealth Registrar (the Registrar) under legislation and as a separate statutory function of the Australian Taxation Office (ATO). However, the program still fails to address many flaws, particularly relating to its reliability and verification. 

Australia’s Corporate Register System currently has: • 31 different commonwealth business registers: This makes good governance and due diligence almost impossible, provides an opportunity for individuals to set up companies with opaque business structures and questionable motives to thrive, and provides little reliability for people who are genuinely interested in undertaking due diligence and ‘knowing their customer’. Unifying the registers into one central Registrar will make it easier to cross-check information. • No verification or cross referencing of data: The ASIC undertakes only basic data entry functions on the corporate register. It does not verify the identity of individuals, entities or their addresses, and takes information provided at face value, without any due diligence or verification checks. The government has announced that the MBR Program will include additional validation steps, yet these still fall short. It is vital that validation goes beyond software assessing whether the data is in the correct format (e.g. a mobile number has the correct number of digits, or an email includes an @ symbol). It will still fail to verify the identity of individuals and entities, and takes information provided at face value, without any due diligence or proper verification checks. There will also continue to be no due diligence checks for politically exposed persons. This means limited transparency around the relationships between directors and multiple companies will remain, enabling opaque business structures, phoenix activity and potentially money laundering and other corporate misconduct and crime to thrive in a sought after ‘rule of law’ jurisdiction. • No requirement for beneficial ownership disclosure: Australia’s corporate register system has no trust register. This makes ultimate beneficiary ownership confirmation impossible. This is despite the fact that Australia’s financial regulator, AUSTRAC, requires all reporting entities to identify the beneficial owners of their customers and assess the money laundering/terrorism financing risk they pose. There has been no indication from the government that it will progress beneficial ownership disclosure as part of the MBR Program. This is a clear implementation gap and disconnect in Australia’s corporate governance. • High usage costs: Australia’s corporate register is one of the most expensive in the world.7 People must pay a high fee to access information in the register. There has been no indication from the government that it will decrease the cost of accessing data. This discourages robust due diligence by not having free and accessible public information. 

Factors contributing to the problem are: • Undue influence, lobbying and revolving doors: The Australian political and business landscape can be characterised as a ‘culture of mateship’.8 Undue influence and lobbying by special interest groups and powerful individuals, and the revolving door between elected officials, the private sector and their in- house lobbyists and consultants is contributing to a policy reform agenda of winding back regulatory oversight. This is frequently framed within a ‘regulatory burden’ narrative by the Australian government. This is evident in the what the government has released on the MBR Program. The ‘why the register is needed’ section on the ATO website states an aim is “to make it easier for businesses to meet their registration obligations – leaving them with more time to focus on their customers and business operations”. • No appetite for robust due diligence: There is a lack of political will in Australia to ensure we have robust due diligence mechanisms in place. An example of this is the research conducted by TIA that found significant corruption risks in the mining sector approvals process. This is associated with a lack of due diligence into the integrity, character and track record of mining companies that are applying for mining licences and project approvals. Our research into the process of approving mining permits in Queensland and Western Australia found the current due diligence checks to be lacking.  They are limited to financial capacity and environmental records of companies within Australia, but do not look at companies’ conduct overseas, and do not include any examination of the beneficial owners - those who will ultimately benefit from mining Australia’s resources. The MBR Program fails to include the necessary reforms to improve due diligence, instead focusing on preventing phoenixing and tax evasion activities. This is a missed opportunity to address the broader risks that result from a lax corporate registry system.

TIA characterises Australian risks as  

A weak corporate register allows companies and their associated entities - often with opaque business structures - to use Australia as a launching pad for dubious activity. This could include businesses with: • Histories of breaches of Australian corporate law and Director duties; • Associations with politically exposed persons known for corruption; and • Potential money laundering through the property and luxury goods market in Australia.12 Money laundering activities13 could include: • Concealing the proceeds of crime; • Obscuring the beneficial ownership of assets through complex corporate and trusts structures; • Avoiding or evading tax through exploitation of tax havens or offshore financial centres and • Evading regulatory regimes, particularly the detection, freezing and confiscation of illicit assets

 In relation to International risks 

When companies of any nationality exploit the natural resources of resource-rich, but corruption-prone countries, such as in the Pacific, the impacts are devastating. Citizens of these countries do not get a fair share of their natural resource wealth, communities are side-lined in decision making processes, land and livelihoods are lost, and what revenue is generated more often ends up in deep pockets of corrupt officials with little or no expenditure on essential services such as health and education. While Australia’s ongoing commitment to the Pacific through development aid is welcome, unless Australia’s corporate laws are strengthened, Australia will continue to be a potential launching pad for companies (both Australian and international) that have not been properly ‘checked out’. Other countries have legitimate expectations that associated individuals have already been properly scrutinised by Australia in line with international commitments. The lack of a robust system in Australia provides a vacuum where potentially corrupt conduct fills, impacting already vulnerable populations. Elite capture and corruption can rapidly undermine institutions of governance which Australia’s development spending tries to support in places such as the Pacific.

TIA's critique states 'what is Australia (not) doing' -  

Modernising Business Registers Program 

As part of this program a Director Identification Number (DIN), a unique identifier for company directors, will be introduced requiring all directors to confirm their identity.18 This is a step in the right direction in preventing the appointment of fictitious directors and facilitating traceability of their profile and relationships with companies over time. 

However, control and ownership of private companies in Australia will continue to be conducted by anonymous nominees. Trust structures existing behind this anonymous ownership then accentuates opaqueness due to a lack of any centralised recording. The countless risks these nominee relationships create for any stake holder include money laundering, financing of terrorism and profiting from criminal and/or corrupt behaviour. Given that the nominee ‘non-beneficial’ owner is merely a legal owner, not liable for tax and with no compulsion to reveal who they are, there is the additional risk of tax fraud. 

Though MBR Program is welcome, it must also address the above risks of non-transparent control and ownership. If these risks remain, Australia will continue to be a ‘go to destination’ for money laundering, and an attractive launching pad for dubious companies and individuals to conduct business in Australia and abroad. To achieve this the program must ensure nominees are required to make their role apparent and reveal who they are a nominee for. 

An Australian business registration, may assist a company to obtain registration in other jurisdictions, on the assumption that due diligence checks have been done in Australia – effectively supporting the global reach of corrupt behaviour. 

If the government is to be a more effective regulator, it must take its role of “promote(ing) confident and informed participation by investors and consumer in the financial system” seriously and undertake robust due diligence, and check and verify data provided, rather than simply playing a data entry role. As stated by the ASIC Commissioner John Price in 2018, the ASIC is a “registration system not a checking system...we don’t validate the information given to us”. 

Beneficial ownership 

Australia has made numerous commitments to progress beneficial ownership disclosure on the global stage, but with no progress. There is a lack of political will to implement commitments made at the 2014 G20 (High- Level Principles on Beneficial Ownership), and the 2016 UK Anti-Corruption Summit. 

Civil society and private sector efforts to include beneficial ownership disclosure in the third Open Government Partnership National Action Plan were also rejected by Federal Treasury.25 There has also been no information released about what the Australian Government intends to do about beneficial ownership transparency as part of the MBR program. The last consultation process on the issue was held in early 2017. Whilst lack of political will is a key factor, until the corporate register is fixed, reliable and accurate information that can be crosschecked and validated - the system upon which to build a public register of beneficial owners, just does not exist.

The Government and Regulators must accordingly 

• Remove excessive costs and allow free access to the register Data access need to be free as the public and private sector have the right to know who is doing business here in Australia. Having one of the most expensive systems to access public information from discourages robust due diligence. Australia is lagging behind and needs to catch up with other countries who either charge a fraction of the cost of Australia’s hefty fees, or don’t charge at all. 

• Close the loophole allowing the anonymous appointment of directors and beneficial shareholders, ensuring nominees make their role apparent and reveal who they are a nominee for As long as companies are able to appoint nominee directors and shareholders, Australia’s Corporate system will not be fit for purpose. Corporate transparency ensures everyone knows who they work with and who they work for. This transparency does not include anonymous nominee relationships, which enable individuals with questionable reputations and histories to conduct business both in and from Australia. Australia needs to lift the veil on who is behind companies to identify potential links to politically exposed persons, criminal and corrupt actors to enable a robust assessment of their business activities and legitimacy both in Australia and transnationally. 

• Verify current data and collect additional data to properly identify the individuals registering companies, and identify whether they have been involved in corrupt or criminal conduct in Australia or overseas Robust corporate registers provide legitimacy and protection to businesses and support regulators to undertake compliance activities. However, for as long as the corporate registration system in Australia is unreliable and lacking the necessary verification and due diligence, it will not be fit for purpose to assist in the prevention and detection of corporate misconduct and money laundering. The verification should include checking if a person registering is convicted of a serious offence, whether they are on a sanctions list or that they’re a politically exposed, in addition to basic name, date/place of birth and residential address verification. 

• Establish a centralised public beneficial ownership register Companies can be used to disguise the identity of those involved in illicit activities, including tax evasion, money laundering, bribery, corruption and terrorism financing. This will continue to occur in Australia through mechanisms such as the use of shell companies, the use of complex ownership and control structures and nominee shareholders if Australia does not establish a beneficial ownership register. In order to do so, it needs accurate and verified data in the corporate register. 

• Establish a trust register requiring full disclosure of beneficial owners and ultimate beneficiaries As long as Australia does not have a trust register and beneficial ownership disclosure, it will continue to have inadequate due diligence mechanisms. Companies are able to register in Australia with no verification of who the ultimate beneficiaries are, their character, integrity and track record. These systems need to be put in place to order to make ownership confirmation possible.

Blockchain

'Blockchain and CCPA' by Gustavo Alza Jr in (2021) 37 Santa Clara High Technology Law Journal 231 comments 

 Privacy laws and blockchain technology have been around for over a decade; however, each continues to evolve and adapt to new technological capabilities and realities. As users and jurisdictions have recognized an individual’s rights to privacy, entrepreneurs, engineers, and businesspeople have continued to develop and enhance blockchain technology. Today, blockchain technology not only transfers value via the exchanging, creation/offering, and selling of cryptocurrencies, but has also been developed to serve national security interests, supply chain management, and a plethora of other applications. With the amount of personal information stored on these networks (where many aim to be completely ‘permissionless’ and ‘decentralized’), some have written on how such may interfere with individuals’ privacy rights with regards to the GDPR. Since then, the California Consumer Privacy Act (‘CCPA’) came into effect on January 1st, 2020. As a result, California residents now have the right to delete their data, request an accounting of data shared with third parties, correct inaccurate information, and/or request that a business cease the selling of their personal data. Given the permissionless, decentralized, and immutable nature of many blockchains, complying with the CCPA presents challenges. This article will explore how and when a blockchain may be subject to the CCPA, how to develop such (privacy by design) in order to comply with the CCPA, and demonstrate that although many see blockchain as a means for entities to escape governmental and international regulation via decentralization, recognizing and complying with user’s privacy rights may not only be just, but potentially good for business/trust.

Services

The Productivity Commission's paper 'Things you can’t drop on your feet: An overview of Australia’s services sector productivity' (PC Productivity Insights, April 2021) comments 

 Over the past 70 years the Australian economy has undergone a fundamental shift from agriculture and manufacturing to services. Services now account for about 80 per cent of production and 90 per cent of employment. Although the goods sector, including mining, will continue to be of economic importance, as Australia continues to become a more service-centric economy, long-run wages and national welfare will be increasingly linked to service sector productivity. 

This said, services are not one monolithic industry; the service sector covers a wide range of jobs and outputs, from brick laying to neurosurgery. The Commission’s latest series, Productivity in the service sector, aims to better understand these industries, their different characteristics, factors affecting their productivity performance and potential implications for policy. The series will delve beyond national aggregates, using industry-sourced data and bespoke analytical approaches. This paper is the series launch — outlining the significance of and issues in service sector productivity, while future papers will be vignettes on subindustries. 

Australia’s shift towards service production, and away from manufacturing in particular, has raised concerns. These include worries about services dragging on productivity performance and service sector jobs being lower paid or of lower quality. For the most part, these fears are unfounded. Many service sector industries provide jobs that pay as well as or better than manufacturing, with good job security. And the increased prevalence of casual work has been proportionally as large in the goods sector as in the service sector. Several service sector industries — including financial and insurance services and information, media and telecommunications — have also experienced productivity growth that outpaced the goods sector. 

The service sector also faces challenges. COVID 19 has caused Australia’s first recession in nearly 30 years and parts of the service sector (especially hospitality, accommodation, recreation and retail) have been hit hard. Between 14 March and 11 April 2020, the food and accommodation industry laid off a third of its employees, and the recreation industry shed nearly 30 per cent of its workforce. Though employment has since improved, neither industry has fully recovered and concerns about COVID-19 continue. 

While some services industries have performed consistently well over the long run, others have had persistently low productivity growth. For example, administrative support and arts and recreation have both had productivity growth below the market sector average since 1994 95. While this may partly reflect the challenges of measuring productivity in the service sector, it mainly reflects the intrinsic characteristics of many services, such as the need for face to face interaction, which limits market size and opportunities for trade, scale and capital deepening. Technological developments have and will continue to change some of the characteristics of the (historically) slow productivity growth services and increase their resource efficiency. For example, online learning increases access to, and competition within, education as well as increasing the scope for capital deepening and economies of scale. Likewise, digitisation of other services can lower search costs and asymmetries of information, further increasing competitive pressures and allowing greater diffusion of technology between firms. The Productivity in the service sector series aims to help identify such instances and where governments may have a role in facilitating this innovation.

Key points are 

• The service sector constitutes the bulk of Australia’s economy, contributing 79 per cent of value added and 88 per cent of employment.  This sector is diverse, encompassing all industries outside of mining, agriculture and manufacturing (the goods sector). This diversity (for example, from cleaning services to medicine) means that different service industries operate in very different ways.  

• The rise of the service sector over the past 70 years, and the associated displacement of manufacturing as a share of economic activity, has raised fears of worsening labour market conditions, slower wage growth and slower productivity growth. Such fears are misplaced as:

•  a large service sector is a feature of a mature and prosperous economy. As incomes increase we spend proportionately more on services relative to goods which stimulates output in the service sector, increasing its share of economic activity 

•  almost all advanced economies have had rapid growth in their service sector (and relative shrinking of their manufacturing sector). This is the case even for the ‘workshop of the world’, China, since 2005 

• productivity growth in many service industries (including finance, ICT and transport) has outpaced the goods sector by a significant margin over the past few decades

•  many service industries also have higher wages and total take-home pay than manufacturing, and the rise in casualised employment has been (proportionately) on par with the goods sector.

• However, some parts of the service sector (particularly labour-intensive and face-to-face services) have experienced persistently low growth in productivity and capital investment.

• Mostly this is due to their ‘intrinsic’ characteristics — they often need to be delivered in person (relative to goods); and in some instances, their quality is hard for consumers to reliably observe prior to consumption (and equally hard for statistical agencies to capture in data).

•  In the ‘non-market’ sector, limited competition and a lack of market determined prices weaken incentives to innovate or contain cost growth. 

• Numerous measurement issues that affect the service sector may explain some of the poor performance as there are possible quality changes (potentially positive or negative) not currently captured by productivity statistics.

• The issues affecting the service sector are as diverse as the sector itself. This paper is the first of several studies. Subsequent releases will examine particular service industries, highlighting the unique characteristics influencing their productivity in ways that are not possible using national accounts data alone. This paper marks the launch of a new series, Productivity in the service sector, looking at individual service industries. The series aims to explore the characteristics that differentiate service industries, how particular industries are performing, and factors playing a role in their productivity performance. There are several reasons the Commission has chosen to report on the factors that affect productivity improvement in the service sector, and to do so industry by industry. 

First, the size and importance of the sector justifies attention. Like almost all developed nations, Australia is a service-intensive economy — services employ almost 90 per cent of Australian workers and account for around 80 per cent of GDP. 

Second, the service sector displays great diversity in the nature of its output and methods of production. Services range from online retail platforms to dentists and accountants, and it does not always make sense to account for them as a group (box 1 and 2). For this reason, deeper analysis at an industry level can shed light on possible drivers of, barriers against and opportunties for service sector innovation. Morever, there are measurement issues that mean output estimates can sometimes be a misleading indicator of economic activity. These issues tend to be industry specific: the conflation of market risk premiums with genuine value add in finance, or the rapid obsolescence of old products and creation of new ones in information technology, for example. 

Third, the COVID 19 pandemic has been especially difficult for the service sector. Behavioral changes in response to the pandemic along with mandatory closures have reduced face-to-face interactions, greatly increased the tendency to work from home and driven down or prohibited the use of some transport services. This has translated to signficantly lower demand for many services, particularly personal services (hospitality, accommodation, and recreation) and retail services. Between March and October 2020, the personal services sector collectively lost over 20 per cent of its workforce and, although it has recovered significantly since, employment remains 12 per cent below pre COVID levels (figure 1) (ABS 2020d, 2020f). Some of the pandemic induced changes, such as increased use of food delivery and online healthcare, may become permanent, with significant productivity implications. 

Fourth, the differences in industry and regulation structure typically mean an economywide, ‘cookie cutter’ approach to policymaking is not necessarily appropriate for many service industries. Although some policy areas have economy wide implications (such as industrial relations and taxation), reform of many service sector industries demands a more bespoke approach, requiring detailed knowledge of the industry’s structure and regulatory environment.

Counterfeiting

The judgment in Hayward v R (Cth) [2021] NSWCCA 63 offers insights about the use of fake passports and counterfeit currency 

 The Offender arrived in Perth on a flight from Abu Dhabi on 25 September 2014. He entered the country using a German passport in his name with his date of birth. The following day he started committing money laundering type offences by exchanging counterfeit euro notes for Australian currency in Western Australia. He facilitated his offending in that regard by opening various bank accounts using a false Spanish passport thereby committing offences contrary to subs 137(2). He then used the accounts to exchange counterfeit euro notes into Australian currency. He committed 13 offences encompassed in counts 1 to 13 on the indictment in Western Australia from 26 September to 8 October 2014. 

The day after his arrival in Perth he entered the ANZ bank at Mt Lawley and using a false Spanish passport in the name Juan Sanchez opened an account. He then exchanged four counterfeit euro notes with a face value of €800 for $2,078.60. This gives rise to counts 1 and 2. 

On the same day he used the false passport to open an account at the Commonwealth Bank of Australia (CBA) in the same suburb giving rise to count 3. 

On the same day he used the same false passport to open an account at the National Australia Bank (NAB) in Morley, Western Australia and then exchanged six counterfeit euro notes with a face value of €1,200 for $1,594.49, giving rise to counts 4 and 5. 

Four days later on 30 September he entered the NAB branch at Mt Lawley and, utilising the account in the name of Juan Sanchez that he had opened on the 26th, exchanged 14 counterfeit euro notes with a face value of €2,800 for $3,745.87, giving rise to count 6. 

About a week later, the Offender went to the ANZ Bank located in Innaloo Plaza at Innaloo and opened another account this time using a false French passport in the name of Yean Leroux. He then utilised that account to exchange 26 counterfeit euro notes with a face value of €5,200 into $6,975.18, giving rise to count 7 and 8. 

The same day he opened another account, this time at the CBA in Innaloo using the same false French passport which gives rise to count 9. 

The following day at the CBA Bank located in St George’s Terrace, Perth, and using the CBA account he had opened in the name of Yean Leroux on 7 October at a different branch, he exchanged 10 counterfeit euro notes with a face value of €5,000 for $6,647.13, giving rise to count 10. 

On the same day he used the same false French passport to open an account at the NAB branch at Kendenup and then exchange 25 counterfeit euro notes with a face value of €5,000 for $6,642.47, giving rise to counts 11 and 12. 

The same day he used the same false French passport to open an account at the St George Bank located in St George’s Terrace Perth, giving rise to count 13. 

Subsequent enquiries and investigations revealed that the two individuals named in the false passports that the Offender used in Western Australia never entered Australia and the Australian Immigration entry stamp on each was fraudulent. Apparently a person cannot open a bank account in this country using a foreign passport unless it has an immigration stamp on it. 

Over the six transactions in the indictment within counts 1 to 13 the Offender laundered counterfeit euro notes with a face value of €20,000 obtaining $26,683.74. 

The Court notes that in addition to the offences on the indictment committed in Western Australia there are nineteen offences on the schedule of receiving a designated service contrary to subs140(1). The Court notes all matters contrary to that subsection on the Schedule relate to either opening a bank account or exchanging currency at a bank and are closely connected to the offences of uttering. In addition, whilst in Western Australia he was involved in 10 further offences of uttering counterfeit money that occurred in that state which involved him uttering counterfeit euro notes with a face value of €30,100, which at the time was equivalent to $46,596.84. 

... On 9 October 2014 the Offender flew from Perth to Melbourne. He flew back to Perth on 18 October 2014. Sometime between then and 21 October he travelled to Melbourne by unknown means. He then started committing offences in Victoria using a similar modus operandi to that employed in Western Australia. Over the two days of 21 October and 22 October 2014 he committed 11 offences in Victoria that give rise to counts 14 to 24 on the indictment. It is not necessary to go through the detail of those offences, they can be found in paras 24 to 34 of the facts, exhibit A1. The money laundering that he engaged in in Victoria was facilitated by his opening bank accounts using a false Spanish passport in the name of Miguel Augusto. As with the two passports he used in Western Australia the Australian Immigration Entry stamp on this passport was also fraudulent. 

Whilst in Victoria on five separate occasions the Offender exchanged a total of 50 counterfeit euro notes with a face value of €25,000 for $33,822.71. 

The Court should note that one offence in Victoria did not follow the pattern established by the other offences in the sense that, although he opened an account by presenting the false Spanish passport at the NAB branch in Chadstone, (count 18) he failed to replicate the signature on the passport and the bank officer refused to complete the transaction and subsequently closed the account. 

Whilst in Victoria he was involved in 23 offences contrary to subs 140(1)) and 12 offences of uttering that are on the schedule. The uttering offences involved counterfeit euros with a face value of €63,000 that had an equivalent value of $85,313. 

Using his true identity the Offender flew from Melbourne to Adelaide on 26 October 2014. Once in South Australia he committed a further 10 offences reflected by counts 25 to 34 inclusive. He committed those 10 offences over two days, 28 and 29 October 2014, using a false Portuguese passport in the name of Eduardo Durante. As with the other passports the Australian Immigration stamp on this false passport was also false. The modus operandi that he had used to launder money in South Australia was similar to that employed in both Victoria and Western Australia. It is unnecessary to set out the detail of the transactions in South Australia, they can be found at paras 39 to 48 of the facts Exhibit A1. 

Over the two days in South Australia on five separate occasions he exchanged 178 counterfeit euros with a face value of €21,800 for $29,187.67. 

The Court should note that in para 47 of the facts Exhibit A1 it refers to a Spanish passport in connection with count 3[?] [sic – count 33]. This is an error as the Crown assured the Court that all offences committed in South Australia that are on the indictment were facilitated by the same false Portuguese passport. Defence counsel made no submission to the contrary. 

During the same period in South Australia he committed a further 18 offences under subs 140(1)) and a further 12 offences of uttering counterfeit money that are on the schedule. Those uttering offences involved counterfeit euro notes with a face value of €52,700 that have an equivalent value of $70,000. ... 

It appears that by unknown means the Offender travelled from Adelaide to Melbourne sometime between 30 October and 1 November. On 1 November 2014 using his true identity the Offender flew from Melbourne to Perth and, on the following day using his German passport, he flew from Perth to Abu Dhabi. 

The Offender returned to Australia on 4 January 2015. He flew into Melbourne from Doha using his German passport. He flew to Sydney on 7 January and committed the remaining five offences on the indictment, counts 35 to 39, at Parramatta the following day. 

At 11.55am on 8 January 2015 the Offender went to the ANZ bank located in Level 2 of the Westfield Shopping Centre in Parramatta and, using a false Spanish passport and licence, he opened an account in the name of Jose Kamino, giving rise to counts 27 and 28 [sic – counts 37 and 38]. He then deposited 50 counterfeit euro notes with a face value of €10,000 euros into the account giving him a balance $13,655.60. He immediately withdrew $10,000 that gives rise to count 35. He apparently wanted to withdraw the balance from the account and staff directed him to another branch located on level 5 in the same complex. 

The Offender then made his way to the ANZ branch located on level 5 in order to withdraw the balance from the account that he had just opened downstairs. Paragraph 58 of the facts Exhibit A1 makes reference to count 39 in the context of his attendance at the branch on level 5 but does not identify the act that constitutes the offence. However, in light of the terms of count 39 and his guilty plea the Court infers that he produced the false Spanish passport in the name of Jose Camino in order to withdraw the $1,355.60 that remained in the account that he had opened at the branch on level 2. 

His desire to withdraw all the money he had deposited into the account raised the suspicion of staff who realised that his appearance matched the description of the person who had completed similar transactions involving counterfeit currency. Consequently, staff contacted the police. 

When the police arrived, they arrested the Offender who at the time was in possession of a backpack and a bum-bag. Inside the bum bag, the police located a false Spanish passport in name of Jose Kamino and a further 203 counterfeit euros with a face value of at least €6,600. His possession of these counterfeit notes gives rise to the offence count 36. The police also recovered the $10,000 he had withdrawn from the branch downstairs. The Court notes there are two offences of the schedule committed at Parramatta contrary to subs 140(1) that involve opening the bank account and exchanging currency. Following his arrest, the Offender participated in an ERISP interview but, as was his right, chose not to comment on any of the questions the police asked of him. 

The Court notes that, when he opened the account on that day, he provided an address of 25 Rush Street, Woollahra. Subsequent inquiries revealed he was not known at that address and had no links to it.”