Health Research

‘PhD thesis opposing immunisation: Failure of academic rigour with real-world consequences’ by Kerrie Wiley, Julie Leask, Margaret Burgess and Peter McIntyre in (2019) 37(12) Vaccine 1541 offers an elegant, important and alas necessary appraisal of the University of Wollongong doctorate by an anti-vaccination advocate.

The authors conclude

It might be argued that a thesis on immunisation policy conferred through a Faculty of Law, Humanities and the Arts is not expected to present a detailed and systematic literature review or undertake primary research. We argue that a thesis which explicitly sets out to examine “Government vaccination policies, including an assessment of the underpinning scientific evidence and the stakeholders who have influence in the decision-making process” (pp2), irrespective of the faculty or discipline in which it is conducted, should use methods for identifying and assessing scientific evidence of comparable rigour to those used by the academic and scientific bodies which inform policy makers. 

This thesis is notable for its lack of evidence of systematic literature review. Despite its extensive claims, there is no primary research, but there is abundant evidence of strong bias in selecting the literature cited and sometimes outright misrepresentation of facts. We agree that critique of immunisation policy is a valid academic exercise that goes beyond technical knowledge, but equally it cannot be based on incomplete, flawed technical assertions. 

The thesis legitimately highlights the importance of transparency and accessibility in the processes by which vaccines are assessed for inclusion on any national immunisation schedule. It also raises the importance of perceptions about conflicts of interest among contributors to immunisation policy development, and the need for open conversation about policy decisions among all immunisation stakeholders, including the public. These considerations are important for countries seeking to improve established National Immunisation Technical Advisory Groups (NITAGs), as noted by the Supporting Independent Vaccine Advisory Committee (SIVAC) initiative. Areas of public health importance such as immunisation are legitimate topics for scrutiny. It is important to question long-embedded policies and practices, however such scrutiny must be rigorous, disciplined, and draw on the full range of appropriate expertise. 

Almost three years after the event, the award of PhD by a reputable University has validated the thesis’ claims and allowed the author to add weight to her subsequent prolific writings, including open letters to politicians, and seminars to parents, with consequences on a national and international scale. Tangible evidence of real-world consequences come from two sources. First, two of us (KW and JL), in our research with non-vaccinating Australian parents, find some who state that material in this PhD and its endorsement by a recognised university supports their decision not to vaccinate their children. Second, the author of the thesis has put herself forward as an expert witness in legal proceedings where parents are in dispute over the need for their children’s immunisation by positioning her status as a PhD graduate to assert expert status. 

Those looking for balanced information about immunisation deserve a balanced critique of this thesis to aid them in their decision-making. We believe that our critique serves as an accessible, objective and fair appraisal of the thesis, allowing valid assessment of the quality of the information it presents and the credentials of its author, within the limitations and framework of a journal article.

Dodgy Doctors

'Phantom practitioners: accreditation fraud, corruption and health professionals' by Bruce Baer Arnold and Wendy Bonython in (2019) 27(1) Australian Health Law Bulletin 14 comments

The Independent Commission Against Corruption (ICAC) report on Eman Sharobeem and action against Raffaele Di Paolo, Vitomir Zepinic, Vincent Berg, Dusan Milosevic and Balaji Varatharaju, and raise ques- tions about misrepresentation by people who hold themselves out as health practitioners but are unregistered, and in some instances have used fake documentation to obfuscate their lack of training. 

The authors argue that

It is axiomatic that trust is a foundation of the Australian health system: trust in the competence and ethical behaviour of health professionals alongside trust in the efficacy of regulatory bodies such as the Austra- lian Health Practitioner Regulation Agency (AHPRA), courts, tribunals and professional boards that identify and respond to misbehaviour. That trust is eroded by people who successfully hold themselves out — in essence make unsubstantiated claims — to be entitled to engage in professional practice. 

Those claims may have an entirely fictive basis, with for example an individual falsely claiming that they received training from an accredited institution, passed tests of competence and duly received certification by an educational institution and/or a professional body. Claims may instead involve an individual who did indeed receive the required training and pass the corresponding tests but subsequently was either deregistered and unable to lawfully engage in professional practice or whose practice was restricted, for example through a requirement that the professional not deal with patients unless closely supervised by a peer. 

A recent report by the NSW ICAC explores one instance of a “phantom” practitioner: a high-profile individual, in a position where trust was particularly important, who invented professional qualifications, gained financial and social benefit from that identity crime and resisted investigation.  The report highlights questions about corruption rather than merely appropriation of a status to which the supposed practitioner was not entitled. It offers a perspective on recent prosecutions of several fake general practitioners and specialists, alongside action by regulators.

Suppression

The NSW Law Reform Commission is consulting about terms of reference for its inquiry into Court and tribunal information: access, disclosure and publication.

The Terms are

the NSW Law Reform Commission is to review and report on the operation of: legislative prohibitions on the disclosure or publication of NSW court and tribunal information, NSW court suppression and non-publication orders, and tribunal orders restricting disclosure of information, and access to information in NSW courts and tribunals.  

In particular, the Commission is to consider:

a) Any NSW legislation that affects access to, and disclosure and publication of, court and tribunal information, including: The Court Suppression and Non-Publication Orders Act 2010 (NSW); The Court Information Act 2010 (NSW); and The Children (Criminal Proceedings) Act 1987.  

b) Whether the current arrangements strike the right balance between the proper administration of justice, the rights of victims and witnesses, privacy, confidentiality, public safety, the right to a fair trial, national security, commercial/business interests, and the public interest in open justice.   

c) The effectiveness of current enforcement provisions in achieving the right balance, including appeal rights.  

d) The appropriateness of legislative provisions prohibiting the identification of children and young people involved in civil and criminal proceedings, including prohibitions on the identification of adults convicted of offences committed as children and on the identification of deceased children associated with criminal proceedings.  

e) Whether, and to what extent, suppression and non-publication orders can remain effective in the digital environment, and whether there are any appropriate alternatives.  

f) The impact of any information access regime on the operation of NSW courts and tribunals.  

g) Whether, and to what extent, technology can be used to facilitate access to court and tribunal information.  

h) The findings of the Royal Commission into Institutional Responses to Child Sexual Abuse regarding the public interest in exposing child sexual abuse offending.  

i) Comparable legal and practical arrangements elsewhere in Australia and overseas.  

j) Any other relevant matters.

DTC

“I would rather have it done by a doctor”— laypeople’s perceptions of direct-to-consumer genetic testing (DTC GT) and its ethical implications' by Manuel Schaper, Sabine Wöhlke and Silke Schicktanz in (2018) 22(3) Medicine Health Care and Philosophy 1-10 comments 

Direct-to-consumer genetic testing (DTC GT) has been available for several years now, with varying degrees of regulation across different countries. Despite a restrictive legal framework it is possible for consumers to order genetic tests from companies located in other countries. However, German laypeople’s awareness and perceptions of DTC GT services is still unexplored. We conducted seven focus groups (participants n = 43) with German laypeople to explore their perceptions of and attitudes towards commercial genetic testing and its ethical implications. Participants were critical towards DTC GT. Criticism was directed at health-related, predictive testing, while lifestyle tests were accepted and even welcomed to some extent. Participants expressed strong reservations regarding commercial provision of genetic diagnostics and expressed a lack of trust in respective companies. They preferred non-commercial distribution within the public healthcare system. Participants also expressed high expectations of physicians’ abilities to interpret information obtained via DTC GT companies and provide counseling. Legal restrictions on commercial distribution of genetic tests were opposed, with participants arguing that it should be available to consumers. DTC GT companies are not perceived as trustworthy when compared to the public healthcare system and its professional ethical standards and practices. Laypeople rated general consumer autonomy higher than their own concerns, thus recommending against strong legal regulation. We conclude that medicine’s trustworthiness may be negatively affected if commercial provision is not visibly opposed by the medical professions, while DTC GT companies may gain in trustworthiness if they adapt to standards and practices upheld in medicine.

University Data Governance

Data Governance and the Emerging University' by Michael J. Madison inJacob H. Rooksby (ed) Research Handbook on Intellectual Property and Technology Transfer (Edward Elgar, Forthcoming) comments 

Knowledge and information governance questions are tractable primarily in institutional terms, rather than in terms of abstractions such as knowledge itself or individual or social interests. This chapter offers the modern research university as an example. Practices of data-intensive research by university-based researchers, sometimes reduced to the popular phrase “Big Data,” pose governance challenges for the university. The chapter situates those challenges in the traditional understanding of the university as an institution for understanding forms and flows of knowledge. At a broad level, the chapter argues that the new salience of data exposes emerging shifts in the social, cultural, and economic identities of the university, from missions defined in terms of knowledge as such to missions now defined in terms of data and evidence. University-based knowledge production practices framed by the distinction between basic research and “technology transfer” may no longer be sufficient as a comprehensive rhetorical and institutional paradigm for aligning the university with broad social goals or with intellectual property and information law and policy. The concept of the data-intensive university offers a general outline of a new paradigm.

Payments, innovation and Incentives

Payment Transactions Under the EU Second Payment Services Directive (PSD2) – An Outsider’s View' by Benjamin Geva in (2018) Texas International Law Journal comments 

In its proposal for a Directive on payment services in the internal market (hereafter: the Proposal), the Commission of the European Communities (“the Commission”) purported to provide for “a harmonised legal framework” designed to create “a Single Payment Market where improved economies of scale and competition would help to reduce cost of the payment system.” Being “complemented by industry’s initiative for a Single Euro Payment Area (SEPA) aimed at integrating national payment infrastructures and payment products for the euro-zone,” the Proposal was designed to “establish a common framework for the Community payments market creating the conditions for integration and rationalisation of national payment systems.” Focusing on electronic payments, and designed to “leave maximum room for self-regulation of industry,” the Proposal purported to “only harmonise what is necessary to overcome legal barriers to a Single Market, avoiding regulating issues which would go beyond this matter.” Stated otherwise, the measure was designed to fall short of providing for a comprehensive payment law.

'Jefferson's Taper' by Jeremy N. Sheff comments 

This Article reports a new discovery concerning the intellectual genealogy of one of American intellectual property law’s most important texts. The text is Thomas Jefferson’s often-cited letter to Isaac McPherson regarding the absence of a natural right of property in inventions, metaphorically illustrated by a “taper” that spreads light from one person to another without diminishing the light at its source. I demonstrate that Thomas Jefferson likely copied this Parable of the Taper from a nearly identical passage in Cicero’s De Officiis, and I show how this borrowing situates Jefferson’s thoughts on intellectual property firmly within a natural law theory that others have cited as inconsistent with Jefferson’s views. I further demonstrate how that natural law theory rests on a pre-Enlightenment Classical Tradition of distributive justice in which distribution of resources is a matter of private judgment guided by a principle of proportionality to the merit of the recipient — a view that is at odds with the post-Enlightenment Modern Tradition of distributive justice as a collective social obligation that proceeds from an initial assumption of human equality. Jefferson’s lifetime correlates with the historical pivot in the intellectual history of the West from the Classical Tradition to the Modern Tradition, but modern readings of the Parable of the Taper, being grounded in the Modern Tradition, ignore this historical context. Such readings cast Jefferson as a proto-utilitarian at odds with his Lockean contemporaries, who supposedly recognized property as a pre-political right. I argue that, to the contrary, Jefferson’s Taper should be read from the viewpoint of the Classical Tradition, in which case it not only fits comfortably within a natural law framework, but points the way toward a novel natural-law-based argument that inventors and other knowledge-creators actually have moral duties to share their knowledge with their fellow human beings.

'Unfair Disruption' (Stanford Law and Economics Olin Working Paper No. 532) by Mark A. Lemley and Mark P. McKenna comments

New technologies disrupt existing industries. They always have, and they probably always will. Incumbents don’t like their industries to be disrupted. And they often rely on intellectual property (IP), unfair competition, or related legal doctrines as tools to prevent disruptive entry. What that means is that many of the cases in these areas are really about whether competition from new players can force incumbents to change their business models, generally to the advantage of particular players and the detriment of others. These cases are, in an important sense, all unfair competition cases; they are about the ways in which the law permits new entrants to compete with incumbents.

Unfortunately, we lack any comprehensive way of thinking about market disruption in these settings. As a result, courts react quite differently to disruptive technology or business models in different cases. As one example, consider intellectual property (IP) cases brought against new technologies. Sometimes courts find the disruptive technology to infringe existing IP rights. New technology might fit within the legal definition of a prior invention, appropriately construed. Sometimes the technology might not itself infringe any prior invention, but makes it easier for third parties to infringe IP rights and is deemed illegal for that reason.

Other areas of law reflect similarly mixed feelings about market disruption. Business tort claims like unjust enrichment—and even nominally procompetitive laws like antitrust—are often asserted by companies with a vested interest in restricting a competitor’s new technology. We have seen similar variability in antitrust, unfair competition, and business tort cases. Antitrust and unfair competition cases are brought against incumbents that try to prevent competition, but they are also brought by incumbents upset that their markets are being disrupted. Whether those laws encourage or inhibit market disruption depends critically on what kinds of competition courts deem “unfair.”

Our goal in this paper is to address the broader question of when competition by market disruption is “unfair.” In our view, courts are often overly receptive to market disruption arguments because they tend to be concerned about upsetting the status quo and affecting the settled expectations of market players, particularly when presented with arguments that some new technology will radically alter the industry.

Courts should intervene to prevent market disruption only when they have very good reasons—reasons connected to the fundamental policy concerns of the legal systems called upon to prevent the disruption. To achieve that goal, we must know what the legitimate ends of the asserted law are. Sometimes the legal doctrine used to prevent market disruption is one like unjust enrichment, interference with economic advantage, or unfair competition that doesn’t have a clear animating principle. We think those doctrines should be disfavored, and courts should employ them only when they are tied to some independent metric for deciding whether the defendant’s conduct is unfair or unjust. Other doctrines, like antitrust and IP, have clearer purposes. There, we can evaluate legal challenges to market disruption by testing the fit between the goals of the statute and its use in a particular case.

Courts in many types of cases have recognized this problem and begun to develop tools for dealing with them. But IP law has lagged behind, rarely even recognizing that what seem to be cases of infringement are really challenges to market disruption. We suggest a test that helps separate legitimate cases of IP infringement from cases of pure market disruption. Drawn from the antitrust injury doctrine, our test would treat market disruption as relevant to an IP case only if the disruption is traceable to the act of infringement itself. If the plaintiff would suffer the same injury from a market intervention that is not infringing, that injury cannot be evidence of IP infringement.

Defamation Model Provisions

The Council of Attorneys-General (formerly SCAG) has released its 43 page  Review of Model Defamation Provisions discussion paper.  The paper reflects the Council's agreement in June last year  to reconvene its Defamation Working Party to consider whether the policy objectives of the Model Defamation Provisions remain valid and whether the provisions remain appropriate to achieve these objectives.

The paper states

The Defamation Working Party (DWP) is comprised of one nominated representative from each Australian state and territory jurisdiction and established under the auspices of the Council of Attorneys General (CAG). The DWP is to be chaired by a representative from the New South Wales (NSW) Department of Justice. NSW will also be represented by its Solicitor General. All other jurisdictions will have one nominated representative. 

The DWP will consider whether the policy objectives of the Model Defamation Provisions (MDPs) remain valid and whether the MDPs remain appropriate to achieve these objectives. The objectives of the MDPs are stipulated in section 3 and are as follows:

(a) to enact provisions to promote uniform laws of defamation in Australia; 

(b) to ensure that the law of defamation does not place unreasonable limits on freedom of expression and, in particular, on the publication and discussion of matters of public interest and importance; 

(c) to provide effective and fair remedies for persons whose reputations are harmed by the publication of defamatory matter; and 

(d) to promote speedy and non-litigious methods of resolving disputes about the publication of defamatory matter. 

In considering the above, the DWP will have reference to the following:

(a) the recommendations and findings of the June 2018 statutory review of the Defamation Act 2005 (NSW); 

(b) any proposals for reform tabled by individual members of the DWP; 

(c) relevant developments in case law in Australian jurisdictions and internationally; 

(d) relevant developments in technology since the commencement of the MDPs; and (e) any other relevant matters. 

The DWP will make recommendations to CAG for any reforms to the MDPs it considers necessary and report on progress to each CAG meeting. Each State and Territory in Australia has substantially uniform defamation law. The Model Defamation Provisions were endorsed by the former Standing Committee of Attorneys-General in November 2004 and each state and territory enacted legislation to implement them, collectively referred to as the National Uniform Defamation Law. The Model Defamation Provisions are available on the Australasian Parliamentary Counsel’s Committee website at www.pcc.gov.au.

The paper features the following questions

Question 1 Do the policy objectives of the Model Defamation Provisions remain valid? 

Question 2 Should the Model Defamation Provisions be amended to broaden or to narrow the right of corporations to sue for defamation? 

Question 3 (a) Should the Model Defamation Provisions be amended to include a ‘single publication rule’? (b) If the single publication rule is supported: (i) should the time limit that operates in relation to the first publication of the matter be the same as the limitation period for all defamation claims? (ii) should the rule apply to online publications only? (iii) should the rule should operate only in relation to the same publisher, similar to section 8 (single publication rule) of the Defamation Act 2013 (UK)? 

Question 4 (a) Should the Model Defamation Provisions be amended to clarify how clauses 14 (when offer to make amends may be made) and 18 (effect of failure to accept reasonable offer to make amends) interact, and, particularly, how the requirement that an offer be made ‘as soon as practicable’ under clause 18 should be applied? (b) Should the Model Defamation Provisions be amended to clarify clause 18(1)(b) and how long an offer of amends remains open in order for it to be able to be relied upon as a defence, and if so, how? (c) Should the Model Defamation Provisions be amended to clarify that the withdrawal of an offer to make amends by the offeror is not the only way to terminate an offer to make amends, that it may also be terminated by being rejected by the plaintiff, either expressly or impliedly (for example, by making a counter offer or commencing proceedings), and that this does not deny a defendant a defence under clause 18? 

Question 5 Should a jury be required to return a verdict on all other matters before determining whether an offer to make amends defence is established, having regard to issues of fairness and trial efficiency? 

Question 6 Should amendments be made to the offer to make amends provisions in the Model Defamation Provisions to: (a) require that a concerns notice specify where the matter in question was published? (b) clarify that clause 15(1)(d) (an offer to make amends must include an offer to publish a reasonable correction) does not require an apology? (c) provide for indemnity costs to be awarded in a defendant’s favour where the plaintiff issues proceedings before the expiration of any period of time in which an offer to make amends may be made, in the event the court subsequently finds that an offer of amends made to the plaintiff after proceedings were commenced was reasonable? 

Question 7 Should clause 21 (election for defamation proceedings to be tried by jury) be amended to clarify that the court may dispense with a jury on application by the opposing party, or on its own motion, where the court considers that to do so would be in the interests of justice (which may include case management considerations)? 

Question 8 Should the Federal Court of Australia Act 1976 (Cth) be amended to provide for jury trials in the Federal Court in defamation actions unless that court dispenses with a jury for the reasons set out in clause 21(3) of the Model Defamation Provisions – depending on the answer to question 7 – on an application by the opposing party or on its own motion? 

Question 9 Should clause 26 (defence of contextual truth) be amended to be closer to section 16 (defence of contextual truth) of the (now repealed) Defamation Act 1974 (NSW), to ensure the clause applies as intended?  

Question 10 (a) Should the Model Defamation Provisions be amended to provide greater protection to peer reviewed statements published in an academic or scientific journal, and to fair reports of proceedings at a press conference? (a) If so, what is the preferred approach to amendments to achieve this aim – for example, should provisions similar to those in the Defamation Act 2013 (UK) be adopted? 

Question 11 (a) Should the ‘reasonableness test’ in clause 30 of the Model Defamation Provisions (defence of qualified privileged for provision of certain information) be amended? (b) Should the existing threshold to establish the defence be lowered? (c) Should the UK approach to the defence be adopted in Australia? (d) Should the defence clarify, in proceedings where a jury has been empanelled, what, if any, aspects of the defence of statutory qualified privilege are to be determined by the jury? 

Question 12 Should the statutory defence of honest opinion be amended in relation to contextual material relating to the proper basis of the opinion, in particular, to better articulate if and how that defence applies to digital publications? 

Question 13 Should clause 31(4)(b) of the Model Defamation Provisions (employer’s defence of honest opinion in context of publication by employee or agent is defeated if defendant did not believe opinion was honestly held by the employee or agent at time of publication) be amended to reduce potential for journalists to be sued personally or jointly with their employers? 

Question 14 (a) Should a ‘serious harm’ or other threshold test be introduced into the Model Defamation Provisions, similar to the test in section 1 (serious harm) of the Defamation Act 2013 (UK)? (b) If a serious harm test is supported: (i) should proportionality and other case management considerations be incorporated into the serious harm test? (ii) should the defence of triviality be retained or abolished if a serious harm test is introduced? 

Question 15 (a) Does the innocent dissemination defence require amendment to better reflect the operation of Internet Service Providers, Internet Content Hosts, social media, search engines, and other digital content aggregators as publishers? (b) Are existing protections for digital publishers sufficient? (c) Would a specific ‘safe harbour’ provision be beneficial and consistent with the overall objectives of the Model Defamation Provisions? (d) Are clear ‘takedown’ procedures for digital publishers necessary, and, if so, how should any such provisions be expressed? 

Question 16 (a) Should clause 35 be amended to clarify whether it fixes the top end of a range of damages that may be awarded, or whether it operates as a cut-off? (b) Should clause 35(2) be amended to clarify whether or not the cap for noneconomic damages is applicable once the court is satisfied that aggravated damages are appropriate? 

Question 17 (a) Should the interaction between Model Defamation Provisions clauses 35 (damages for non-economic loss limited) and 23 (leave required for further proceedings in relation to publication of same defamatory matter) be clarified? (b) Is further legislative guidance required on the circumstances in which the consolidation of separate defamation proceedings will or will not be appropriate? (c) Should the statutory cap on damages contained in Model Defamation Provisions clause 35 apply to each cause of action rather than each ‘defamation proceedings’? 

Question 18 Are there any other issues relating to defamation law that should be considered?