Privacy

'What Makes Data Personal?' by Maria Lillà Montagnani and Mark Verstraete in (2023) 56(3) UC Davis Law Review comments 

Personal data is an essential concept for information privacy law. Privacy’s boundaries are set by personal data: for a privacy violation to occur, personal data must be involved. And an individual’s right to control information extends only to personal data. However, current theorizing about personal data is woefully incomplete. In light of this incompleteness, this Article offers a new conceptual approach to personal data. To start, this Article argues that personal data is simply a legal construct that describes the set of information or circumstances where an individual should be able to exercise control over a piece of information. 

After displacing the mythology about the naturalness of personal data, this Article fashions a new theory of personal data that more adequately tracks when a person should be able to control specific information. Current approaches to personal data rightly examine the relationship between a person and information; however, they misunderstand what relationship is necessary for legitimate control interests. Against the conventional view, this Article suggests that how the information is used is an indispensable part of the analysis of the relationship between a person and data that determines whether the data should be considered personal. In doing so, it employs the philosophical concept of separability as a method for making determinations about which uses of information are connected to a person and, therefore, should trigger individual privacy protections and which are not. 

This framework offers a superior foundation to extant theories for capturing the existence and scope of individual interests in data. By doing so, it provides an indispensable contribution for crafting an ideal regime of information governance. Separability enables privacy and data protection laws to better identify when a person’s interests are at stake. And further, separability offers a resilient normative foundation for personal data that grounds interests of control in a philosophical foundation of autonomy and dignity values—which are incorrectly calibrated in existing theories of personal data. Finally, this Article’s reimagination of personal data will allow privacy and data protection laws to more effectively combat modern privacy harms such as manipulation and inferences.

Fakes

Another instance of identity crime - in the form of CV 'enhancement' - with the Victorian County Court hearing that former UK police officer improved his work and education history to gain high-paying Victorian government jobs (including one where he earned over $450,000). The embroidery included claiming diplomas from a fake university. 

 Peter Ravenscroft pleaded guilty to obtaining financial advantage by deception. He claimed he had been a detective inspector for the UK National Crime Squad, rather than actual service as a detective constable at Sussex police. He told prospective employers he was a Leeds University fellow, has a Bachelor of Education from Aston University and had two diplomas from Guildford University. Alas, Guildford U does not exist. He appears to have lied about receiving diplomas from the Australian Institute of Management, Brighton University and Master Builders Victoria.

The profile helped him gain employment at the state Department of Treasury & Finance and at Frankston City Council, where he was paid a total of $456,038 as a compliance and safety manager. He subsequently moved to the state Ombudsman, where he earned $196,857 in salary and superannuation. 

As part of the deceptions he forged certificates of commendation and training from Sussex police and create a fake referee named “Dr John Marshall” who he said supervised him at Frankston.

Ellis J said 'deceiving prospective employers with such blatant and calculated lies is appalling behaviour indeed, noting that the fraud was 'probably entirely unnecessary' given that Ravenscroft performed well and was a hdecorated UK officer. 

Ravenscroft was handed a two-year community corrections order: 180 hours of unpaid community work and requirement for mental health treatment and rehabilitation. 

We might wonder about the efficacy of any vetting protocols at the three employers.

Emergencies

'The Defence Act 1903 (Cth): A Guide for Responding to Australia's Large-Scale Domestic Emergencies' by Zoe Lipsis in (2022) 45(2) Melbourne University Law Review comments 

 Drawing upon the Australian 2019–20 bushfire season and the COVID-19 pandemic, this article examines case studies highlighting the legislative impact of the increased domestic deployment of the Australian Defence Force (‘ADF’). Leveraging compa rable provisions from an analogous statutory regime, namely pt IIIAAA of the Defence Act 1903 (Cth), it considers how existing legislative provisions can provide guidance for the development of a statutory framework to govern future deployment of the ADF in response to Australia’s large-scale domestic emergencies. 

 Lippis states 

Encapsulating the tension between the civil–military divide, the domestic utilisation of the Australian Defence Force (‘ADF’) has been a ‘critical and controversial issue’ since Federation. With increased calls for the domestic deployment of the ADF, as a result of regional instability, terrorism, and natural disasters, debate has been reignited regarding the use of the military for purposes outside their traditional external defence role. The catastrophic bushfire season of summer 2019–20 reinstated the domestic utilisation of the ADF on the national political agenda.4 As the Morrison government unilaterally mobilised the military to provide support to civilian agencies,5 scrutiny of the military’s internal role intensified. Furthermore, the arrival of the COVID-19 pandemic on Australian shores in January 20206 prompted additional questions surrounding the ADF’s domestic role. For the second time in 2020, ADF members were deployed across Australia, this time to assist civilian agencies as they battled an insurmountable global public health emergency. 

Drawing upon these case studies, this article will examine the impact of legislation upon the increased domestic deployment of the ADF. Leveraging upon comparable provisions from an analogous statutory regime, namely pt IIIAAA of the Defence Act 1903 (Cth) (‘Defence Act’),8 it will consider how existing legislative provisions provide guidance for the development of a statutory framework to govern future internal deployment of the ADF during large-scale domestic emergencies. 

The article will commence by examining, in Part II, the ADF’s recent role in response to domestic crises, most particularly the Australian 2019–20 bushfire season and the COVID-19 pandemic. It will proceed in Part III to consider the existing legal basis for the domestic deployment of the military for disaster relief activities, including the Defence Assistance to the Civil Community (‘DACC’) policy framework. Following an analysis of the benefits of a legislative regime to govern ADF domestic operations, the article will examine in Part IV how pt IIIAAA of the Defence Act can provide guidance for the creation of a comparable Commonwealth legal framework for the domestic deployment of the ADF during large-scale disaster relief activities. The final section of the article, Part V, will recommend legislative provisions for inclusion within a new statutory regime, based upon an analysis of analogous provisions within pt IIIAAA. It will propose that while the DACC policy regime has served Australia well to date, the anticipated increase in requests for ADF domestic assistance warrants serious consideration as to whether a legislative framework is required to underpin such operations in the future. The article will conclude by proposing that existing provisions of the Defence Act provide significant guidance for the development of a Commonwealth statutory regime to govern future ADF assistance during large-scale domestic emergencies.

Vexation

'Goldsmith Collins: Footballer, Fencer, Maverick Litigator' by Simon Smith in (2008) 34(1) Monash University Law Review 191 comments 

The surge in 'litigants in person' is a challenge for contemporary courts. At the extreme end are a small group of vexatious litigants or querulents who persistently and unsuccessfully pursue litigation until banned by the court. But who are they and what motivates them? This article traces the story of one of this small band of persistent litigants, Goldsmith 'Goldie' Collins (1901-1982). As a young man Collins was a champion Australian Rules Footballer with the Fitzroy Football Club. He found later notoriety through his provocative legal proceedings as a self-represented litigant against the Northcote City Council that rapidly escalated into a legal assault against all persons and institutions drawn into that web. In 1952 Collins was the fourth Australian to be declared a vexatious litigant. As the first person declared by the High Court, his declaration the next year by the Victorian Supreme Court (its third) made him the first person to be declared in two jurisdictions. Despite his declarations and being gaoled a number of times for contempt of court, Collins continued as a legal 'maverick' into the 1970s. In providing context for Collins' litigation this article will demonstrate the difficulties faced by other litigants, the profession and the judiciary when dealing with an unpredictable, even aggressive, litigant who determinedly challenges authority. Drawing on recent psychiatric literature it will also demonstrate that the vexatious litigant sanction is an inadequate response to the challenge a litigant, such as Collins, presents to the courts.

Smith argues 

Unquestionably, Rupert Frederick Millane (1887-1969) was the pioneer of the Australian 'vexatious bar'. It was his extraordinary flood of unsuccessful litigation in the 1920s, mainly against the Melbourne and Heidelberg Councils, that led to the enactment in 1928 of the vexatious litigant sanction in Victoria. That provision empowered the Supreme Court to prohibit the issue of proceedings by such litigants without the Court's prior leave. It provided the model for similar provisions in all superior court jurisdictions in Australia. In 1930, Millane became the first person in Australia to be declared a vexatious litigant. If Millane was the leader of Melbourne's 'vexatious litigants' bar' then his associate (for a time), Goldsmith 'Goldie' Collins (1901-1982) was his natural successor.' Indeed, as one commentator has noted:

The 'fifties, the era of Dixon and Fullagar, is often regarded by Victorians as the golden age of the High Court. It was, even more certainly, the golden age of the great vexatious litigants - Millane and Collins. 

As a young man Collins was a champion Australian Rules Footballer with the Fitzroy Football Club. However, he found later notoriety through his provocative legal proceedings as a litigant in person and then as legal 'advisor' to others. His litigation started in the 1940s over a grievance with the Northcote City Council and rapidly escalated into a legal assault against all persons and institutions drawn into that web. In 1952 Collins was the fourth Australians to be declared a vexatious litigant. As the first person declared by the High Court, his declaration the next year by the Victorian Supreme Court (its third) made him the first person to be declared in two jurisdictions. Despite his declarations and being gaoled a number of times for contempt of court, Collins continued as a legal 'maverick' into the 1970s inserting himself 'pro bono' into the cases of other self-represented litigants in Victoria and interstate. 

But who are vexatious litigants and what motivates them? How do courts deal with them and is the vexatious litigant sanction effective? There has been little scholarly attention given to these and related questions. Accordingly, at a time when contemporary courts are experiencing a surge in 'litigants in person' and a perceived rise in persistent vexatious litigants, this article explores these issues through the story of one vexatious litigant, Goldsmith Collins. It will trace his life using material not previously accessed and gathered together and will provide a context for his persistent litigation. In seeking to explain his extraordinary litigation it will suggest that the underlying explanation for the behaviour that led to his being declared a vexatious litigant was an abnormality of his mental functioning. In doing so it will draw on the recent work of Australian psychiatrists Paul Mullen and Grant Lester who have been at the forefront of renewed attention being given to the challenge of managing vexatious litigants - or in medical parlance - 'querulents'. These are broadly defined as individuals who exhibit:

[A] pattern of behaviour involving the persistent pursuit of a personal grievance in a manner seriously damaging to the individual's economic, social, and personal interests, and disruptive to the functioning of the courts and/or other agencies attempting to resolve the claim.

They suggest querulousness is foremost a disorder of behaviour and only secondarily an abnormality of mental function and that personality traits, social situation, contemporary sources of distress and disturbance, even the dispute resolution systems themselves only contribute to querulous behaviour. They are positive on the potential of modern anti-psychotic medication alongside psychotherapy, to normalise the behaviour and thinking of the patient/litigant over a period of month. This of course assumes a level of patient/litigant insight and co-operation that may be difficult, if not impossible, to engender. 

Of particular interest is the profile of the querulent that Lester and Mullen derive from the psychiatric literature and their own research. Querulousness is said to most commonly develop in the middle-aged adult between 30 and 50. There is a preponderance of men (4:l) and prior to onset the individual is said to have functioned competently, had a sound secondary education and fair work history. Relationships are more problematic with only 30 per cent having ever married, 18 per cent having divorced and 50 per cent having never married 

Of further interest are the identifying characteristics that Lester and Mullen draw from the written communications of querulents that they examined as part of their 2003 research. They are:

Form 

• Curious formatting. 
• Many, many pages. 
• Odd or irrelevant attachments - eg copies of letters from others and legal decisions, United Nations human rights instruments etc, all usually, extensively annotated. 
• Multiple methods of emphasis including

•  Highlighting (various colours) 

• Underlining 

• Capitalisation. 

• Repeated use of "",???, !!!. 

• Numerous foot and marginal notes.

Content

• Rambling discourse characterised by repetition and a pedantic failure to clarify. 

• Rhetorical questions. 

• Repeated misuse of legal, medical and other technical terms. 

• Referring to self in third person. Inappropriately ingratiating statements. 

• Ultimatums. 

• Threats of violence to self or others. 

• Threats of violence directed at individuals or organization

This article will draw on this research to demonstrate that the litigious behaviour of Collins departs from the general proposition of Mullen and Lester that posits querulousness is foremost a disorder of behaviour and only secondarily an abnormality of mental function. In the case of Collins it will be suggested that it was a mental disorder that was the major contributor and that unlike with other vexatious litigants where personality traits, social situation, contemporary sources of distress and disturbance, even the dispute resolution systems themselves only contribute to querulous behaviour, with Collins, they aggravated his condition. 

Further, the article will canvass the dispute resolution approach of a local government authority to by-law enforcement and argue that the availability of Alternate Dispute Resolution (ADR) mechanisms (had they existed) may have forestalled the litigation that resulted from its persistent enforcement. Instead, the subsequent reliance by the Council and judiciary on the legal system with its emphasis on forms, rules, procedures, professional advocacy and sanctions such as costs and even gaol contributed to the escalation, indeed became, the dispute. This will bring into focus the difficulty that the small and intimate 1950s Melbourne judiciary faced in dealing with an unpredictable, mentally disordered and aggressive litigant, who determinedly challenged their authority. Here, it will be argued that the vexatious litigant sanction was an inadequate response to the challenge which a litigant such as Collins presents to the courts and that a multidisciplinary approach involving the medical profession may have been more effective

Citizens, Straw and Sovereigns

Another two unsurprisingly unsuccessful sovereign citizen claims in Queensland, alongside one in New Zealand. 

In Bradley v The Crown [2020] QCA 252 Sofronoff P states 

 The applicant was charged with one count of unlicensed driving. He was convicted and fined $150 with no conviction recorded. He applied to the magistrate to dismiss the charge on the ground that for reasons that are not clear a police officer had no power to charge him or to commence the proceedings in question. The argument was obvious nonsense and the magistrate rightly rejected it. After hearing the evidence led by the prosecution, the magistrate found the applicant guilty as charged. 

Not satisfied with this outcome, the applicant appealed to the District Court and argued that he was something which he called a citizen sovereign and that the laws of Queensland did not apply to him. If that was true, then it would be hard to understand why the applicant was agitating his complaints before this court, which is one that has been established under the laws that he says do not apply to him. This paradox did not trouble the applicant and he has now applied for leave to appeal against Judge Moynihan QC’s order dismissing his appeal. That the applicant is merely persisting in putting forward a jumble of gobbledygook to support his application in this court can be seen at once if one reads only the two opening sentences of his purported outline of argument:

“My BRADLEY person (conjoined with the BRADLEY ‘spiritual’ family body-politic) is my own “body politic” by succession, at Law. It is my natural body incorporated at the supreme Christian Law and is my own jurisdiction.” 

This application is an abuse of the court’s process and should be dismissed.

Bradley and Sweet are cited in Sorensen v Queensland Police Service [2022] QDC 121 ... 

 I have had regard, of course, to the submissions he has made and the submissions file. The notice of appeal he has filed is largely unintelligible but he did allege that evidence was tampered with and he has new evidence. In his written submissions, Mr Sorensen alleges the Magistrates Court had no jurisdiction to hear the matter. He was not allowed to present his case and he was unlawfully arrested. He also alleges the Constitution of Queensland is invalid. 

The respondent, on the other hand, submits the evidence established the elements of the offence and the convictions are valid. 

In order to consider this appeal, it is necessary for me to review the evidence. The Magistrate, at page 5, was at pains to explain the procedure to Mr Sorensen. He explained the rule in Browne v Dunn and the right to object to evidence. He did explain to the appellant that he could choose whether or not to call or give evidence and explained the consequences of such decision. He explained the good character rule and the charges to the appellant. 

The appellant chose not to give or call evidence. The prosecution submitted the police gave truthful evidence and the charges were proved. The appellant was using the phone whilst driving and there was no issue he was subject to a SPER suspension and the charges were proved beyond reasonable doubt. The appellant submitted he was not guilty, as the police were mistaken. He pointed to the difference in phone colour, which I have already mentioned. He said there were no admissions made by him. He submitted the police acted illegally. He said double jeopardy applied to charge 2, which I have already mentioned. He said he was a citizen and had been discriminated against. ... 

As to the arguments raised by the appellant concerning the Court’s jurisdiction, a Magistrates Court clearly had jurisdiction to hear these charges. See section 19 and 22A of the Justices Act 1886 and section 123V of the TORUM Act. As to his arguments concerning the invalidity of the Constitution and his rights as a sovereign citizen, they provide no defence to the charge. See Brady v R [2020] QCA 252 and R v Sweet [2021] QDC 216. 

Having reviewed the evidence and giving due weight to the Magistrate’s credibility findings, I find, on the evidence, each element of each charge was established beyond reasonable doubt. I find the decision is not attenuated by either factual or legal error and I dismiss the appeal. Anything else at this stage?

In Warahi v Chief Executive of the Department of Corrections [2022] NZCA 105  Katz J states

 [1] The appellant, Maui Warahi, also known as Jay Maui Wallace, is currently detained at Northland Region Corrections Facility. (We will refer to him as “Maui” in the remainder of this judgment, as that is his preferred form of address). Maui faces charges of contravening a protection order, common assault, threatening to kill and injuring with intent to injure. 

[2] On 3 November 2021, Maui filed a document in the High Court at Auckland headed “Application for a Writ of Habeas Corpus”. The document included portions of the Habeas Corpus Act 2001 and various other material. A supporting “Statutory Declaration of Identity” and an “Affidavit of Identity” were also filed, which Brewer J noted “fit the “sovereign being” model that the Court is well familiar with”. 

[3] An application for the writ of habeas corpus is a challenge to the legality of a person’s detention.As no specific allegations regarding the lawfulness of Maui’s detention were raised in the documents that Maui filed, Brewer J held that the application was invalid. It was accordingly struck out. 

[4] Maui appeals that decision. On appeal, the Crown engaged with the merits of what it understood Maui’s arguments to be, based on his written and oral appeal submissions (which were more comprehensive than those advanced in the High Court). We will take the same approach, rather than focus on the validity of Maui’s original habeas corpus application. 

Is Maui lawfully detained? 

[5] The onus is on the Department of Corrections to establish that Maui’s detention is lawful. If it is not, the Court must order his release. 

[6] The Crown has provided the Court with copies of the warrants to detain in respect of Maui covering the period that is relevant to this appeal. At the time of the appeal hearing Maui was detained pursuant to a warrant to detain issued by Judge Bayley in the Whangarei District Court on 9 February 2022. The earlier warrants provided by the Crown cover the period from 27 October 2021 until March 2022. They were issued in respect of various charges including assault, breach of conditions of intensive supervision, obtaining by deception and assaulting Police. 

[7] In Bennett v Superintendent, Rimutaka Prison (No 2), this Court held that once a prison superintendent or other official produces a committal warrant or other authorisation, the applicant for a writ of habeas corpus must show why the warrants are not a sufficient answer to his application: In practice, once a prison superintendent or other official named as respondent produces a committal warrant or other authorisation ... it would then be necessary for an applicant for habeas corpus to demonstrate that the documentation did not in fact provide a lawful justification in the particular circumstances. 

[8] The onus, therefore, shifts to Maui to show why the warrants provided by the Crown do not provide a lawful basis for his detention. 

[9] Maui adheres to a belief system that has its roots in the Sovereign Citizen movement, an ideology that first emerged in the United States in the 1970s. His core belief, for present purposes, is that he is not subject to the jurisdiction of the State (including legislation enacted by Parliament or decisions made by the courts). This belief is based (at least in part) on the dual persona theory — the proposition that individuals have two personas, one of flesh and blood and the other a separate legal or “corporate” personality that is subject to the jurisdiction of the State. Followers of the Sovereign Citizen movement believe that it is possible to dissociate themselves from their legal or corporate persona, and hence free themselves from the jurisdiction of the State. Maui believes that he has successfully done this and, as a result, the State has no authority over him. Applying this reasoning, Maui believes that his current detention is unlawful. This is reflected in his “Affidavit of Identity” which states, in full:

1. That My Christian name is Jay Maui: with the initial letters capitalised as required by the Rules of English Grammar for the writing of names of sovereign soul flesh and blood people. My patronymic or family name of Wallace with the initial letters capitalised. 

2. That the name JAY MAUI WALLACE or any other drivitation [sic] of that name is a dead fictitious foreign situs trust or quasi corporation/legal entity not the sovereign soul flesh and blood Man that I am. 

3. That I am a free will flesh and blood Suri Juris sovereign man and as such I am private, non resident, non domestic, non person, non citizen, non individual and not subject to any real or imaginary statutory acts, rules, regulations or quasi laws. 

4. That I am who I say that I am NOT who the overt or covert agents of the State say that I am. 

5. That I do not knowingly, willingly, intentionally, or voluntarily surrender my sovereign inalienable rights according to the law of nature. 

6. That the state has no legal jurisdiction or sovereign authority justified in origin to hear this matter. 

7. That it is the responsibility of the complainant to bring the correct parties before the courts.

[10] Arguments about a person’s legal personality, including the “dual persona” theory associated with the Sovereign Citizen movement, are not uncommonly raised in applications for habeas corpus. They are also raised in a variety of other contexts. 

[11] Arguments along such lines have been consistently rejected by the courts as legally untenable, including in a number of cases involving Maui. Acts of Parliament, including criminal enactments, are binding on all persons within the geographical territory of New Zealand. The Courts of New Zealand must uphold all Acts of Parliament as enacted. The Crimes Act 1961 is one such Act of Parliament. The courts have the power to deal with all actions that may amount to criminal offences in this country. No person within New Zealand is able to dissociate themselves from their “legal persona” so as to remove themselves from the jurisdiction of the courts. The arguments advanced by Maui are untenable and without legal foundation. 

[12] In conclusion, we are satisfied that the warrants to detain produced by the Chief Executive demonstrate a lawful basis for Maui’s detention. Maui has not advanced any arguments that might justify a conclusion that his detention is unlawful.

The Court accordingly dismissed  Maui’s appeal.

There was a similar dismissal in Warahi v Department of Corrections [2020] NZCA 587, with the Court stating 

 [1] The appellant, Maui Warahi, also known — amongst other names — as Jay Maui Wallace, appeals the refusal by Muir J on 4 November 2020 to grant him a writ of habeas corpus. 

[2] Using the name Maui Warahi the appellant says he is not the person Jay Maui Wallace and, moreover, that Maui Warahi is not subject to the laws of New Zealand, pursuant to which he is currently remanded in custody on various charges. Accordingly, contrary to the Judge’s decision, that detention is unlawful, entitling him to a writ of habeas corpus. 

[3] The appellant acknowledges that at birth he was given the name, and was subsequently known as, Jay Maui Wallace. But, he says, he subsequently disclaimed that name. Materials he filed for the purposes of this appeal included a copy of a document entitled “Certified Copy of birth entry in the Māori Chief Registrar Office”, recording the birth of “Maui Warahi ” on 16 December 1974. Others comprise standard forms of a statutory declaration, an affidavit of identity, and a declaration of rights, all premised on the assertion that the holder is Māori and not subject to the laws of New Zealand which authorise the appellant’s detention. 

[4] The respondent, the Chief Executive, has placed before the Court a copy of a warrant to detain Jay Maui Wallace on charges of breach of conditions of intensive supervision, assaulting a person, obtaining by deception and failing to answer District Court bail dated 28 October 2020. That warrant is directed to every Constable and to the Manager of the Mt Eden Corrections Facility and authorises Jay Maui Wallace’s detention until Wednesday 2 December, when he is to be presented to the Manukau District Court at 11.45 am. 

[5] Mr Warahi ’s challenge to the prima facie authorisation of his detention that warrant provides is based on propositions of identity, jurisdiction and sovereignty that he has, under a number of names, advanced on many occasions before. 

[6] As to the specific issue of identity, in December 2016 this Court observed:

[9] We note in particular that there is no issue about the appellant’s identity. He admits that the name Jay Wallace was given to him by his natural parents at birth. He wishes to be known as Abdullah Maui Warahi and says he has taken steps through his Tribal Councils to achieve this. However, on his own admission, Jay Maui Wallace and Abdullah Maui Warahi are one and the same person.

Those comments apply equally here. 

[7] As to the broader questions of jurisdiction and sovereignty, in declining the application of Jay Maui Wallace (also known as Abdullah Maui Warahi) to appeal that decision, the Supreme Court observed in February 2017:

[4] The applicant filed a number of documents in this Court in support of his application for leave, but none of these provided any basis for calling into question the lawfulness of his detention. Rather, the documentation appears to challenge the jurisdiction of the Courts over the applicant on Maori sovereignty grounds and assert that the applicant is himself sovereign and therefore beyond the jurisdiction of the Courts. There is nothing in these documents that provides any support for the applicant’s assertions. 

[5] Similar arguments have been rejected by this Court in earlier cases.

Autonomy and Genomics

'Reevaluating the “right not to know” in genomics research' by Nina B.Gold and Robert C.Green in (2022) 24(2) Genetics in Medicine 289-292 comments 

In clinical exome or genome sequencing, the American College of Medical Genetics and Genomics (ACMG) has recommended that a minimum set of secondary findings for actionable conditions should always be offered to patients. In the research domain, millions of individuals have been sequenced, but the return of actionable genomic results is rarely offered. In most research projects that do offer the return of genomic information, participants are asked at the outset whether they wish to be contacted with genomic results of medical importance in a consent process that often stresses potential harms, such as privacy threats or psychological distress, over potential benefits. If participants answer “no,” they are rarely asked again or offered the opportunity to change their response. Participants who decline the return of genomic information about themselves in research are said to be asserting their autonomy around the “right not to know.” The recent report by Schupmann et al challenges this paradigm by showing that participants’ decisions about receiving unanticipated genomic information in research may change when they are given more information and an opportunity to reconsider. These findings prompt us to ask if we can expand autonomy by offering participants opportunities to change their choices, given new experiences in their lives or advances in medical science. Furthermore, should we more fundamentally reappraise the “right not to know” in research by routinely alerting participants to a specific finding within their own DNA and only then allowing them to decide how to proceed? 

Although there is no accepted standard for the variants or genes to be returned in genomic research studies, many investigators return pathogenic and likely pathogenic variants in the genes on the ACMG list of secondary findings described earlier. Even within this limited list, the type of disorder, penetrance and expressivity, and available treatments and surveillance protocols can vary widely. Some research participants who decline genetic information may not fully understand how such information might impact their lives. A man with syncopal episodes might not appreciate that a variant associated with arrhythmogenic right ventricular cardiomyopathy could provide an explanation for his symptoms and a course of action to address them. A woman with a family history of breast cancer might not recognize the scope of surveillance protocols available to BRCA1-positive individuals, wrongly assuming that her only option in the case of a positive finding would be mastectomy. In these cases, prioritizing the right not to know with a single global question about returning genomic findings could preclude the disclosure of life-saving information. We rarely ask what happens to people who could have learned about medically actionable genomic information but declined results. 

The report by Schupmann et al begins to address this question. The authors contacted more than 150 participants in a genomic research study who initially declined genetic results (“refusers”) and a cohort of individuals who had accepted them (acceptors). The researchers then provided participants with an educational intervention and asked if they would reconsider their original decision about receiving genetic findings. Importantly, roughly half of participants who had originally declined the return of results changed their decision (“reversible refusers”). Three-quarters of the reversible refusers believed that they had initially chosen to receive genetic results. The proportion of “persistent refusers,” those who were steadfast in their decision not to learn secondary genetic findings, was found to be less than 1% of the initial study population. The finding that a high percentage of refusers reconsidered their decision (and incorrectly recalled their initial choice) requires us to rethink how we ask about the return of genetic information in research. Should we take no for an answer, or at least for a permanent answer, when research participants initially decline actionable genetic results? 

In considering this issue, we address 3 separate but interrelated questions.

Those questions are 

•  Should Actionable Genetic Results Routinely Be Offered for Return in Genomic Research Studies?  
• Should Research Participants Be Offered Genomic Information More Than Once?
•  Can Autonomy Be Enriched by an Incremental Disclosure and Choice Process?

innovation

'Profitability and drug discovery' by Enes Işık and Özgür Orhangazi in (2022) Industrial and Corporate Change comments 

Pharmaceutical firms are highly profitable due to high markups enabled by high drug prices. This is justified by the argument that high profits provide incentives for innovation and help fund high research and development (R&D) costs. We investigate the link between past profitability and drug discovery for large publicly-listed pharmaceutical firms between 1980 and 2018. Our sample includes 118 firms with 2534 firm-year observations and in terms of sales corresponds to 55% of the global spending on drugs. By merging three data sets on firm financials, new patent applications, and new drug approvals, we show that pharmaceutical firms’ markups and profitability are consistently higher than average nonfinancial firm profitability, with secularly increasing trends since 1980. Whereas R&D spending has also increased, the number of new drug approvals has not increased at the same pace and the productivity of R&D spending has been declining. In statistical analysis, we fail to identify any strong positive relationship between profitability and new drug discovery. Results are broadly in line with the earlier findings of research on the pharmaceutical industry and provide a contribution to the discussion on the link between profitability and innovation as well as on formulating policies for increasing drug innovation and ensuring the provision of essential drugs while keeping their costs low. 

 The authors argue 

 The Covid-19 pandemic once again put the pharmaceutical industry under the spotlight. While developing a number of vaccines in a historically short time span was recognized as an extraordinary achievement and the perception about pharmaceutical firms turned “from greedy patent exploiters to the saviors of humankind,” 1 some were quick to point out the essential role of public funds and technology behind this success2 and how monopolization of the vaccine production through patents decreases the overall social welfare of the world population.3 In fact, profitability, productivity, and innovation capacity of the pharmaceutical industry have long been subject to detailed investigations and controversy. The recent body of research suggests that it has consistently been among the most profitable industries (Spitz and Wickham, 2012; Ledley et al., 2020), while, at the same time, it is one of the most research-intensive industries measured by research and development (R&D) spending and the number of patents (Rikap, 2021: 99). However, despite high profitability and high R&D spending, a productivity crisis has been affecting the industry as indicated by a decline in pharmaceutical innovation (e.g., Munos, 2009; Paul et al., 2010; Pammolli et al., 2011; Khanna, 2012; Scannell et al., 2012; Scannell and Bosley, 2016), which, according to some, is due to the increased financialization and shareholder value focus of the industry (Montalban and Sakınç, 2013; Lazonick et al., 2017; Tulum and Lazonick, 2018). The high cost of drugs in the USA has also led to a criticism of the high markups of the industry (Kesselheim et al., 2016), while others defended the high profits on two grounds: it gives incentives for innovation and helps pharmaceutical firms recoup high R&D costs to continue investment in R&D and innovation (e.g., DiMasi et al., 2003, 2016). Yet, these grounds have also been challenged as it has been argued that most of the new drugs that come to the market are not invented by the large and highly profitable pharmaceutical firms but by smaller labs and through partnerships with publicly funded research labs (Jung et al., 2019; Rikap, 2021). 

We focus on the profitability and productivity of large pharmaceutical firms by combining and analyzing three different data sets on firm financial statements, patents, and new drugs approved by the Food and Drug Administration (FDA). We specifically focus on the link between profitability and innovation as measured by new drug approvals. Our analyses reveal four things: First, large pharmaceutical firms indeed charge higher markups and earn higher profits compared with the average markups and profitability of the rest of the nonfinancial corporate sector; and both rates have significantly increased over time. Second, while it is true that they devote a higher share of their profits to R&D, this share has declined in the late 2000s and only recovered to its previous high after the mid-2010s, whereas payments to shareholders have been taking up a much larger share of pharmaceutical firms’ profits. Third, even though the total number of patents filed by the pharmaceutical firms has significantly increased, new drug or biologics license approvals, especially ones constituting highly innovative forms have slowed down and R&D productivity measured in terms of drug innovation has been declining. Fourth, firm-level statistical analyses show no evidence of a positive relationship between profitability and drug innovation. These results are broadly in line with the earlier findings of research on the pharmaceutical industry and provide a contribution to the discussion on the link between profitability and innovation as well as on formulating policies for increasing drug innovation, ensuring the provision of essential drugs, while keeping their costs low. 

2. Profitability and innovation 

The pharmaceutical industry is perhaps one of the most researched industries. There is a voluminous literature in economics, business, and finance investigating various dynamics of the industry. While we will not attempt to present yet another review of this literature (for a recent review of the literature, see Lakdawalla, 2018), it is important to highlight that a central question regarding the industry has been the link between its high profitability and innovation capacity. This is because the pharmaceutical firms are among the most profitable in the nonfinancial corporate sector and their business model essentially depends on continuous innovation. A number of recent studies compare the profitability of large pharmaceutical firms with the rest of the nonfinancial corporate sector and find that pharmaceutical firms’ profitability has been significantly higher than average profitability (e.g., Spitz and Wickham, 2012; Ledley et al., 2020). This high profitability has been accompanied by high R&D spending and a large number of patents produced (Rikap, 2021: 99). The high markups and profitability of the industry drew criticism, especially because of the high costs of drugs in the USA (Kesselheim et al., 2016). 

It has generally been argued that the monopoly rents arising from patent protections and the resultant high profits are necessary rewards for high risk-taking. Innovations that provide monopoly rents and high profits will generate larger funds to further invest in R&D and for further innovation. These arguments are reminiscent of Schumpeter’s (1942) two types of innovative regimes. The first one, Mark 1, is the entrepreneurial regime that is mostly dominated by small innovative firms; and the second one, Mark 2, is the regime where innovations are mostly carried out by large established firms While the former is referred to as “creative destruction”, the latter is referred to as “creative accumulation.” In the latter, the R&D efforts of the large firms are sustained by the high profits of the previous periods that help finance innovative activities. Along these lines, Nordhaus (1969) argues that investments in innovation increase with high expected profits from innovation. Hence, the high profitability of the pharmaceutical firms is defended. First, on the ground that the monopoly rents that are behind the high profits generate incentives for taking risks and innovating. Second, since not all R&D activity results in profitable innovation, high profits are also seen as necessary for recouping these high R&D costs (e.g., DiMasi et al., 2003, 2016). 

There has been a number of empirical studies looking at profitability, cash flow, and R&D relationship for pharmaceutical firms. For example, Scherer (2001) finds that short-term deviations in profitability predict R&D expenditures, while works such as Grabowski (1968) and Grabowski and Vernon (2000) find that cash flow is an important determinant of R&D expenditures. However, as Lakdawalla (2018: 415) also notes most of this literature has not been clear whether the explanation relies on a financial constraints argument or a profitability argument. Yet, a number of recent studies point out that the industry has been suffering from a productivity crisis as revealed by the decline in pharmaceutical innovation (e.g., Munos, 2009; Paul et al., 2010; Pammolli et al., 2011; Khanna, 2012; Scannell et al., 2012; Scannell and Bosley, 2016). Focusing on this productivity crisis, Montalban and Sakınç (2013), for example, emphasize that the business model of the pharmaceutical industry in the USA has historically been based on “the exploitation of monopoly rents of innovation” and was supported by large amounts of public funding of basic research and strong patent protections. (p. 992). They go on to argue that a large part of this productivity crisis is due to increased financialization and shareholder value focus of the industry (Montalban and Sakınç, 2013; Lazonick et al., 2017; Tulum and Lazonick, 2018). In fact, some recent works argue that the existing innovation models of the pharmaceutical industry not only lack directionality to meet key needs but also lead to inefficient collaboration (Mazzucato and Li (2021: 39). 

Another significant challenge to the argument about profitability and innovation is that most of the new drug innovation does not come from highly profitable, large pharmaceutical firms but from smaller labs and/or publicly funded research labs (Jung et al., 2019; Rikap, 2021). In fact, according to this argument, large pharmaceutical firms profit from the marketing of the innovations that are due to small labs and/or publicly funded research labs. 

In the light of these discussions on the link between profitability and innovation, we ask in the following sections whether it is possible to empirically identify a link between profitability of the large pharmaceutical firms and their drug innovation.