Pharmacare

In Comptroller-General of Customs v Pharm-A-Care Laboratories Pty Ltd [2020] HCA 2 the High Court has unanimously dismissed an appeal from a judgment of the Full Court of the Federal Court of Australia regarding classification of certain goods for the purpose of the Customs Tariff Act 1995 (Cth). It is a useful judgment regarding nutraceuticals., in this instance what a sceptic would regard as lollies.

 The Act imposes duties of customs on goods imported into Australia. Chapter 30 of Sch 3 to the Act contains heading 3004 under which medicaments consisting of mixed products for therapeutic or prophylactic uses put up in measured doses are relevantly classifiable. Note 1(a) to Ch 30 states that the chapter does not cover "[f]oods ... such as ... food supplements".

 Pharm-A-Care Laboratories Pty Ltd imports pastilles (referred to as "vitamin preparations" and "garcinia preparations") containing sucrose, glucose syrup, gelatin, flavours and other substances including vitamins of specified descriptions or a quantity of hydroxycitric acid. On an application for review under the Customs Act 1901 (Cth), the Administrative Appeals Tribunal found that the vitamin preparations and the garcinia preparations were classifiable under heading 3004. The consequence was that no duty was owed on the importation of the preparations.

 The Comptroller-General of Customs appealed the Tribunal's decision to the Federal Court on questions of law under the Administrative Appeals Tribunal Act 1975 (Cth). The Comptroller-General contended that the vitamin preparations and the garcinia preparations were each classifiable as either a type of "sugar confectionery", under subheading 1704.90.00, or as "food preparations", under subheading 2106.90.90, so that each was dutiable at a rate of 5% or 4%. The Comptroller-General contended that the vitamin preparations and the garcinia preparations were excluded from heading 3004 because they answered the description of "food supplements" within Note 1(a) to Ch 30.

 The Full Court of the Federal Court upheld the Tribunal's classification of the vitamin preparations and the garcinia preparations under heading 3004. By grant of special leave, the Comptroller-General appealed to the High Court.

 The High Court has unanimously found that although the Tribunal made an error of law (in considering that the vitamin preparations and the garcinia preparations had to answer the description not just of "food supplements" but also of "[f]oods" in order to be excluded from heading 3004 by Note 1(a) to Ch 30) the Tribunal was correct in law in independently concluding that the preparations fell outside the description of "food supplements".

 The High Court further held that the Tribunal did not wrongly equate the expression "food preparations" in heading 2106 with the expressions "[f]oods" or "food supplements" in Note 1(a).

DNA Forensic Databases and Big Data

'DNA Databases and Big Data' by Helena Machado and Rafaela Granja in Forensic Genetics in the Governance of Crime (Springer, 2020) 57-70 comments

 Criminal DNA databases are expanding in different regions of the world to support the activities of the criminal justice system. The use of techniques that combine different sources of digital information for preventing and anticipating the risk of crime (one of the potential uses of so-called Big Data) is increasingly seen as a promising strategy to govern crime. This chapter provides an overview of the development of technological systems orientated towards genetic surveillance of criminalized populations. It also outlines a comprehensive mapping of the main ethical, social and political challenges related to the growing uses of DNA databases and Big Data at a global scale.

 The authors argue

Forensic genetics has become a significant resource for criminal investigation and evidence-gathering activities for court proceedings in judicial systems around the world (Hindmarsh and Prainsack, 2010). One of the most prominent aspects of the use of forensic genetics in the criminal justice system is the creation and expansion of centralized national databases that contain genetic profiles that are inserted and stored in function of criteria defined in the legislation of each country (Santos, Machado and Silva, 2013). These databases may contain genetic profiles of convicted persons, suspects, victims, volunteers and other persons of interest, in order to conduct criminal investigations. 

A database provides a matrix of genetic profiles based on biological samples collected from a set of individuals. In the context of a pending criminal investigation, traces found in the crime scene or on the victim’s body may be analysed and the resulting DNA profiles will be compared with those included in the genetic forensic database, thus making it possible to identify the origin of this vestige, in the event of a positive match. 

The process of creating forensic databases with genetic profiles began in the mid-1990s. The first forensic genetic database was set up in England and Wales in 1995, and countries such as the Netherlands (1997), Austria (1997) and Germany (1998) followed suit. It is estimated that there are now 69 countries around the world operating this type of database and that at least 34 countries are starting the process of implementing their own database (Interpol, 2016; Prainsack and Aronson, 2015). Such databases exist in different regions of the world, especially in Europe and North America: however, recent developments point to growing expansion in Asia, in particular in China, India and South Korea (Forensic Genetics Policy Initiative, 2017). 

The creation of databases to support criminal investigation is aligned with the social, economic and political context of the so-called information society, which many authors consider to be a society of maximum surveillance that began to emerge in the mid-1980s (Boersma, Van Brakel, Fonio and Wagenaar, 2014; Garland, 2001; Lyon, 1992, 2006; Marx, 2002; Norris and Armstrong, 1999). The phenomenon of Big Data emerges in the context of technological development and the growing importance of the digital world, which is associated with large-scale collection of citizens’ data. It can be defined as a technique that aggregates and analyses a massive amount of data, converting it into algorithms, numerically categorized and identified by employing a calculated index, from which information may be extracted. The technique can be applied in several spheres of social life, including commerce, consumption, health, social security, marketing and immigration. In the context of this book, the authors will pay careful attention to expectations associated to the potential of applying Big Data in the fields of criminal investigation and security (Brayne, 2017; Chan and Moses, 2015, 2017; Tsianos & Kuster, 2016). The complexities and challenges arising from the use of forensic DNA databases and Big Data in the context of criminal investigation will be presented and briefly discussed in the different sections of this chapter.

Sentencing

A report by Victoria's Sentencing Advisory Council examines the 640% increase over the past seven years in use by Victorian courts of time-served prison sentences, ie sentences of imprisonment equal to the time the offender has already spent on remand.

 The Council notes that from June 2014 to June 2019 the state’s prison population rose 33%, from 6,113 prisoners to 8,102 prisoners. Most of that increase (over 92%) was due to more people being held in custody awaiting trial (unsentenced prisoners/remandees). The number of prison sentences imposed in Victoria each year rose from 5,800 in 2013–14 to 9,300 in 2017–18 but the number of people actually serving a prison sentence has only risen by about 150.

 The report explores how the increase in unsentenced prisoners may be indirectly affecting sentencing outcomes. In particular, it examines whether more people are receiving prison sentences, rather than a less serious sentence such as a community correction order (CCO), because they have already effectively been punished through time served in custody on remand.

The Key Findings are

•  the number of time served prison sentences imposed by Victorian courts each year between 2011–12 and 2017–18 rose 643%, from 246 to 1,828. They now account for 20% of all prison sentences imposed, whereas previously it was 5%. 
• Just over half of all time served prison sentences were combined with a CCO, with the CCO taking effect upon the person’s release. 96% of time served prison sentences were less than six months in length. 
• Almost all time served prison sentences (95%) were imposed in the Magistrates’ Court, while 5% were imposed in the County and Supreme Courts. 
• Time served prison sentences accounted for 39% of the increase in prison sentences imposed in Victoria in the five financial years to 30 June 2018. There were 3,500 additional prison sentences imposed in 2017–18 than in 2013–14. Nearly 1,400 of those were time served prison sentences. 

The Council comments

This strongly suggests that Victoria’s increasing remand population is causing courts to impose prison sentences more often, without actually requiring people to spend more time in prison. The report flags important criminal justice policy implications arising from this increase in time served prison sentences, including:

• the limited opportunities for someone sentenced to a time served prison sentence to make transitional arrangements for their release (e.g. housing, employment, transport);

• the limited opportunities for the criminal justice system to provide targeted programs addressing offending behaviour to someone held on remand, given that they are presumed innocent until proven guilty; 

• the extent to which a time served prison sentence is capable of achieving key sentencing purposes such as rehabilitation or community protection; and 

• whether the increasing likelihood of receiving a time served prison sentence might inappropriately encourage some people on remand to plead guilty in the hope of being released earlier than if they proceeded to trial.

Accreditation, Forgery and Good Character

Posts in this blog - and an article in Australian Health Law Bulletin noted here - have noted controversial litigant Vito Zepinic. In Vito Zepinic v Health Care Complaints Commission [2020] NSWSC 13 the NSW Supreme Court has refused Zepinic's appeal from a NSW Civil and Administrative Tribunal decision.

Zepinic emigrated to Australia from the former Yugoslavia in 1993, having apparently served as a Deputy Interior Minister in the government of Bosnia-Herzogovina and allegedly subsequent security chief in Republika Srpska (a breakaway Serb republic headed by Radovan Karadzic during the 1992-95 Bosnian war). He applied for registration as a health practitioner with the Psychologist’s Registration Board of New South Wales. He was registered as a psychologist in 1994, having provided documentation concerning his qualifications in the former Yugoslavia. He worked as a psychologist in positions in New South Wales and Queensland.

The NSW Health Care Complaints Commission persuasively alleged that Zepinic in preparing medico-legal reports prior to 2009 held out that he was a medical practitioner, using the initials 'MBBS' (the degrees of Bachelor of Medicine and Bachelor of Surgery) after his name, in breach of the Medical Practice Act 1992 (NSW). Elsewhere there are indications he modestly claimed a mere two PhDs.

In 2010 NCAT  was also satisfied that Zepinic made false representations that he had medical qualifications to the RANZCP in 1996 and 1998, to the Australian Medical Council in 1997 and 1998 (and also that he had postgraduate qualifications in psychiatry) and the University of Sydney in or about 2005. In addition, in April 1999 he had created an “unauthorised” letter and forged the signature of a colleague at St John of God Hospital Burwood purporting to confirm an offer of a position as “Medical Officer” at the hospital in order to support his application for registration to the NSW Medical Board. He had also given false evidence to Burwood Local Court on 14 April 2008 in stating that he had a Doctor of Medicine from the University of Sarajevo.

NCAT found

Whilst not every act of dishonesty (forgeries, false declarations and a failure to disclose to the Board in this instance) would in itself allow a finding of ‘not of good character’ to be made, the level of dishonesty of the Appellant found by the Tribunal is remarkable. When considered in its totality there is a pattern of the Appellant providing information that would progress his various applications rather than of providing truthful information. His reliance on the difficulties that are expected when leaving a country in the throws [sic] of civil unrest is disingenuous and deceitful. This conduct shows no regard for those people who genuinely hold qualifications to which they have no access because of such upheavals and may be deserving of the trust of a registration authority. 

The Tribunal has evidence before it that when the District Court considered a personal injuries claim made by one of the Appellant’s clients in 2001 it was argued that his evidence should be rejected on the basis that there was (at that stage) an allegation that the Appellant was holding himself out as a medical practitioner. On this occasion this argument was rejected. However, the potential for an adverse outcome for a client of the Appellant as a result of the Appellant’s conduct is clearly demonstrated (see volume 1 – exhibit C1, page 58). 

The Appellant engaged in a pattern of misleading conduct, providing false information whenever it suited his purposes. 

The Appellant forged documents and signatures. He provided the false and misleading information not only to various relevant professional bodies but also to numerous registration authorities. He was prepared to provide this information as statutory declarations and solemn declarations which in some cases were witnessed by Justices of the Peace. 

The Appellant made these representations knowingly, for his own purposes and benefit. His aim was to gain professional standing to which he was not entitled. The Tribunal notes the provisions of the Oaths Act 1900 (NSW). 

His reliance on his refugee status compounds the abysmal nature of his conduct. 

Although the Tribunal has viewed the Particulars cumulatively in forming the view of a reasonable satisfaction as to the conduct demonstrating a lack of good character, there are a number of Particulars that would in and of themselves allow the Tribunal to reach such a finding. The falsification of the letter on the St John of God letterhead and the forging of Ms McCabe’s signature is one such act and the representations made to the effect that he held an undergraduate medical qualification is another. 

The conduct occurred over a significant period of time. The Decision of the Board Inquiry indicates that the Appellant was not acting in a manner expected of a professional person. The Appellant has not taken any steps to correct the misleading information he has provided to various entities even after the falsity of the documents was beginning to be uncovered.

Further

The Appellant made blatant and wilful misrepresentations to the Board, to other registration authorities and to other professional organisations. The misrepresentations may well have denied these bodies the opportunities to act appropriately to protect the public and to otherwise carry out their important functions. 

The primary function of the Tribunal is to protect the public. Other matters to be considered by the Tribunal as relevant considerations are the maintenance of discipline within the profession, a general deterrent effect and the maintaining of public confidence in the profession. The Tribunal therefore must consider Orders that fulfil these requirements. Whilst it is an established principle of law that the Tribunal should impose the least restrictive Orders possible in the circumstances, the protection of the public is paramount and outweighs consideration of the onerous burdens that Orders may place upon a practitioner. In this matter protection of the reputation of the profession and the maintenance of confidence that the public is entitled to expect in the profession of psychology are prominent considerations. 

Given the length of time the Appellant engaged in the deceptive conduct detailed in this matter and the nature of the deficits in character exposed by the findings of this Tribunal the Appellant will require a lengthy period of time to address these issues. The Tribunal will fix a period of five years from the date of the decision during which the Appellant will not be entitled to apply for a review of the Orders. 

The Tribunal is satisfied that the Appellant lacks the character required to be a registered psychologist; further, he has conducted himself in an improper and unethical manner over a lengthy period of time. 

The Tribunal is of the view that conditions on registration would not be appropriate in this matter. Not only is the conduct of the Appellant so appalling that it would attract the most severe criticism, the Appellant has demonstrated he cannot be trusted to act in an honest and truthful manner. 

The Appellant poses a significant risk to the public safety, particularly having regard to the manner in which he has repeatedly made false and misleading statements to various regulatory and professional organisations. The Appellant did not attend the Inquiry and has not provided a full and frank account of his conduct to the Tribunal. The conduct of the Appellant extended beyond the profession of psychology, and beyond registration authorities. The Tribunal therefore considers it appropriate to proceed to make a Prohibition Order.

All in all rather damning.

Zepinic did not have the MBBS qualification from the former Yugoslavia and has never been registered  in Australia as a surgeon or general practitioner. After conviction and removal from the register (avoiding time in prison) he moved to the United Kingdom, engaging in what would conventionally be characterised as identity crime.

In August 2013 he was convicted in a jury trial in the Crown Court at Wood Green (UK) of three counts of fraud. The convictions arose from failure to disclose his 2008 convictions in his September 2009 employment application to Queen Mary University London, alongside failure to disclose

• disclose in applications between November 2010 to August 2011 for 22 jobs with National Health Service employers that he had previous convictions and had been removed from the register; 
• that removal in his August 2011 application for employment as Board Secretary of the Royal Free Hampstead NHS Trust.

Zepinic returned to Australia in October 2016, seeking a reinstatement order so that he could be registered as a psychologist in New South Wales. NCAT understandably refused to make a reinstatement order. Zepinic went to the Supreme Court, arguing several grounds

1: The NCAT erred in delivering its orders and appellant relied on res judicata principle. 

2: The NSW Psychologists Tribunal decision against the appellant delivered on 12 August 2010 is based on the falsified certificates [ie the Tribunal had accepted forged documentation]. 

3: On 10 March 2009, the appellant left Australia and has never been served with any documents regarding ex parte proceedings of the NSW Psychologist’s Tribunal conducted on 24 June 2009, 27 and 28 April 2010, and 2 July 2010. 

4: The certificates of alleged criminal conviction forwarded from the NSW Medical Council to the Queen Mary University of London were falsified. 

5: Due to the falsified certificates submitted by the NSW Medical Council to the Queen Mary University of London and taken legal proceedings, the appellant has suffered a substantial financial loss, psychological distress upon him and his family, and damages upon his dignity and professional career. 

6: NCAT decision delivered on 10 October 2018 has no legal grounds but to make further financial and damages on the appellant’s professional reputation and dignity, and distress upon him and his family. 

The Court was satisfied that Zepinic failed to establish any error of law or fact in the NCAT decision regarding reinstatement, commenting

I am satisfied that none of these grounds are made out. Nowhere in Dr Zepinic’s lengthy written submissions, his affidavits or his oral submissions was any error of law in the decision of NCAT identified. Nor, putting to one side the question of leave, was any other ground clearly articulated by Dr Zepinic. Rather, Dr Zepinic’s grounds all sought to challenge an earlier decision of the Psychologists Board in 2010 to deregister him: Zepinic v Psychologists Registration Board of NSW [2010] NSWPST 6. No appeal or judicial review proceedings have ever been brought against that earlier decision.

The appeal was dismissed.

Nefarious and subtle

From last week's LA Times

The maker of [free] health-records software used by tens of thousands of doctors’ offices was in on a scheme to get doctors to prescribe opioids to patients. 

To doctors opening patients’ electronic records across the U.S., the alert would have looked innocuous enough. A pop-up would appear, asking about a patient’s level of pain. Then, a drop-down menu would list treatments ranging from a referral to a pain specialist to a prescription for an opioid painkiller. 

Click a button, and the program would create a treatment plan. From 2016 to spring 2019, the alert went off about 230 million times. 

The tool existed thanks to a secret deal. Its maker, a software company called Practice Fusion, was paid by a major opioid manufacturer to design it in an effort to boost prescriptions for addictive pain pills — even though overdose deaths had almost tripled during the previous 15 years, creating a public-health disaster. The software was used by tens of thousands of doctors’ offices. 

Its existence was revealed this week thanks to a government investigation. Practice Fusion agreed to pay $145 million to resolve civil and criminal cases, according to documents filed in a federal court in Vermont. Practice Fusion admitted to the scheme. The opioid maker was not named, though the details of the government case closely match a public research partnership between Practice Fusion and Purdue Pharma Inc., which makes OxyContin. ... 

The Practice Fusion case shows a more subtle method of reaching drug consumers. Employees estimated internally that the drug company could add almost 3,000 patients and bolster opioid sales by as much as $11.3 million through the partnership. Under the contract, the drugmaker paid Practice Fusion almost $1 million. 

“The pharmaceutical industry was egregious in advancing and propelling the access of opioids to a wider and wider population,” said Bertha Madras, a professor at Harvard Medical School who served on the President’s Commission on Combating Drug Addiction and the Opioid Crisis. She described the Practice Fusion arrangement as “nefarious and subtle.” 

Big tech companies have large-scale plans to reinvent healthcare, promising to revolutionize areas such as electronic records, which are a crucial source of data about consumer health. But the Practice Fusion case shows how such plans can be exploited and even provide a new avenue for financial interests to influence treatment. 

The San Francisco company was founded in 2005 and became known for its unique model of providing free, ad-supported health-records software to independent doctors. The company says its cloud-based platform has grown to be used in roughly 30,000 practices. Groundwork for the deal between the companies began in 2013, according to the statement of facts agreed to by Practice Fusion under a deferred prosecution agreement. The idea was to get the opioid maker’s pain drugs to certain kinds of patients: ones who weren’t taking opioids or those being prescribed the company’s less profitable products. It also aimed to secure longer prescriptions, according to the court papers.

Trans Fats Regulation

'The Regulation of Trans Fats in Food Products in the US and the EU' by Suzanne Bloks in (2019) 15(3) Utrecht Law Review 57-77 comments

 The regulation of trans fats sets an interesting precedent for the regulation of other legal but harmful food ingredients, such as salt, sugar and saturated fat. In this paper, we distinguish three regulatory measures to reduce such ingredients in food and population intakes: the labelling of an ingredient, a limit on the amount of the ingredient in food products and a ban on the production technology that creates the ingredient. We will compare the regulations promulgated in the US and in the EU to reduce trans fats in food and population intakes. This comparison will identify a common focus on scientific risk assessment and precautionary action but a different orientation towards regulating the internal market and towards producer interests. The comparison also lays bare differences in the regulatory systems of the US and the EU that may inspire US and EU regulators to reflect on possible improvements for future fights against legal but harmful food ingredients.

Power

'Mobilizing Market Power: Jurisdictional Expansion as Economic Statecraft' by Nikhil Kalyanpur and Abraham L. Newman in (2019) 73(1) International Organisation 1-34 comments

States with large markets routinely compete with one another to shield domestic regulatory policies from global pressure, export their rules to other jurisdictions, and provide their firms with competitive advantages. Most arguments about market power tend to operationalize the concept in economic terms. In this paper, we argue that a state's ability to leverage or block these adjustment pressures is not only conditioned by their relative economic position but also by the political institutions that govern their markets. Specifically, we expect that where a state chooses to draw jurisdictional boundaries over markets directly shapes its global influence. When a state expands its jurisdiction, harmonizing rules across otherwise distinct subnational or national markets, for example, it can curtail a rival's authority. We test the theory by assessing how changes in internal governance within the European Union altered firm behavior in response to US extraterritorial pressure. Empirically, we examine foreign firm delisting decisions from US stock markets after the adoption of the Sarbanes–Oxley accounting legislation. The act, which included an exogenous compliance shock, follows the harmonization of stock market governance across various European jurisdictions. Econometric analysis of firm-level data illustrates that EU-based companies, which benefited from jurisdictional expansion, were substantially more likely to leave the American market and avoid adjustment pressures. Our findings contribute to debates on the role of political institutions in economic statecraft and suggest the conditions under which future regulatory conflicts will arise between status quo and rising economic powers.