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In response to the COVID-19 pandemic, there has been a rapid growth in research focused on developing vaccines and therapies. In this context, the need for speed is taken for granted, and the scientific process has adapted to accommodate this. On the surface, attempts to speed up the research enterprise appear to be a good thing. It is, however, important to consider what, if anything, might be lost when biomedical innovation is sped up. In this article we use the case of a study recently retracted from the Lancet to illustrate the potential risks and harms associated with speeding up science. We then argue that, with appropriate governance mechanisms in place (and adequately resourced), it should be quite possible to both speed up science and remain attentive to scientific quality and integrity.

Ethical decision-making frameworks assist in identifying the issues at stake in a particular setting and thinking through, in a methodical manner, the ethical issues that require consideration as well as the values that need to be considered and promoted. Decisions made about the use, sharing, and re-use of big data are complex and laden with values. This paper sets out an Ethics Framework for Big Data in Health and Research developed by a working group convened by the Science, Health and Policy-relevant Ethics in Singapore (SHAPES) Initiative. It presents the aim and rationale for this framework supported by the underlying ethical concerns that relate to all health and research contexts. It also describes a set of substantive and procedural values that can be weighed up in addressing these concerns, and a step-by-step process for identifying, considering, and resolving the ethical issues arising from big data uses in health and research. This Framework is subsequently applied in the papers published in this Special Issue. These papers each address one of six domains where big data is currently employed: openness in big data and data repositories, precision medicine and big data, real-world data to generate evidence about healthcare interventions, AI-assisted decision-making in healthcare, public-private partnerships in healthcare and research, and cross-sectoral big data. Published version The development of the Framework and its application to the six Domain papers was funded and supported by the Singapore National Medical Research Council Research, Innovation and Enterprise 2020 Grant.

Background In the past decade many novel, and in some cases transformative, cancer medicines have entered the market. Their prices and the amount spent on them by governments have increased rapidly, bringing to the forefront trade-offs that must be made. In this paper we explore the Australian public’s attitude towards the funding of high cost cancer medicines (HCCM) to inform reimbursement and health technology assessment (HTA) policy. Methods A survey consisting of 49 questions about the funding of HCCMs was developed by the investigators. Recruitment was conducted via Qualtrics. 1039 Australian adults completed the survey. Results The Australian public overwhelmingly supports funding of HCCMs (95.5 %) to enhance equity of access (97.8 %), and to respond to patients’ needs (98 %). When respondents were challenged to balance equity versus access in different contexts inconsistencies emerged. Different demographic factors were important in predicting support for various strategies. Conclusion Our results suggest that the Australian public strongly supports government funding of HCCMs and values both equity and access. Equally, however, the public is uncertain about how equity and access are to be balanced and achieved, and such ambivalence needs to be both further explored and accommodated in policy processes. Our results may be used by policymakers in Australia, and countries with similar systems and values, to further develop policies and processes for funding HCCMs.

BACKGROUND: Biobanks are vital resources for genetics and genomics, and it is broadly recognised that for maximal benefit it is essential that they include samples and data from diverse ancestral groups. The inclusion of First Nations people, in particular, is important to prevent biobanking research from exacerbating existing health inequities, and to ensure that these communities share in the benefits arising from research. AIMS: To explore the perspectives of Australian Aboriginal people whose tissue - or that of their family members - has been stored in the biobank of the National Centre for Indigenous Genomics (NCIG). METHODS: Semi-structured interviews with 42 Aboriginal people from the Titjikala, Galiwinku, Tiwi Islands, Yarrabah, Fitzroy Crossing, Derby, One Arm Point and Mulan communities, as well as a formal discussion with A. Hermes, an Indigenous Community Engagement Coordinator at the NCIG who had conducted the interviews. The interviews and the structured discussion were double coded using a procedure informed by Charmaz's outline of grounded theory analysis and Morse's outline of the cognitive basis of qualitative research. RESULTS: In this article, we report on A. Hermes' interviews with members from the above Aboriginal communities, as well as on her personal views, experiences, and interpretations of the interviews she conducted with other community members. We found that participation in the NCIG biobank raised issues around broken trust, grief and loss, but also - somewhat unexpectedly - was perceived as a source of empowerment, hope and reconnection. CONCLUSIONS: This research reminds us (again) of the need to engage deeply with communities in order to respond appropriately with respect for their cultural values and norms, and to develop culturally relevant policies and processes that enhance the benefits of biobank participation and minimise potential harms.

We thank Goldstein and Peterson, Caplan, and Bramstedt for engaging with our paper on the ethics of publishing and using Chinese transplant research that involves organs procured from executed prisoners.1–4 In that paper, we examine consequentialist and deontological arguments for and against using data from unethical research. Goldstein and Peterson question the relationship between the social and scientific value of the research and the decision to publish the results. They argue that the failure to publish scientifically valid and socially valuable Chinese transplant research results in potential repetition of the research and subsequent exposure of new participants to research risks for data that already exists. This argument has intuitive appeal, in both its positive form (the data are already there so let’s use them) and negative form (by not using the data we subject future participants to avoidable research risks). Prima facie, failure to use the data does seem to breach a fundamental principle of research ethics, that of only exposing people to risks in research to produce novel and socially valuable knowledge. However, this point relies heavily on the assumption that data from unethical research are valid and valuable. This is a useful assumption to make in a theoretical argument as it clarifies the challenge of weighing up the potential utility of the …

When infectious disease outbreaks strike, health facilities acquire labels such as "war zones" and "battlefields" and healthcare professionals become "heroes" on the "front line." But unlike soldiers, healthcare professionals often take on these dangerous roles without any prior intention or explicit expectation that their work will place them in grave personal danger. This inevitably raises questions about their role-related obligations and whether they should be free to choose not to endanger themselves. In this article, I argue that it is helpful to view this situation not only through the lens of "professional duty" but also through the lens of "role-related conflicts." Doing so has the advantage of avoiding exceptionalism and allowing us to draw lessons not only from previous epidemics but also from a wide range of far more common role-related dilemmas in healthcare.

Beskow and Weinfurt’s analysis of biobank consent comprehension draws attention to important epistemic and axiological questions, not the least of which concern how we can know what are the right or wrong ways to conduct contemporary biobank research. Their empirical work highlights uncertainty and dissonance among stakeholders about what immutable values should underpin biobank consent practices, as well as the differences between what experts can expect to occur and what will happen when consent and other agreed processes are put into action. These questions become potentially more complex as biobanks continue to network globally, and the moral, social, legal and political connections among and between prospective participants, researchers and regulators are disrupted. The initial findings of our Australian research of the global networking of biobanks (in progress) suggest that factors other than models of consent can be as, or more, important to people’s trust and engagement with global biobanking. Similar to Beskow and Weinfurt’s study, these perspectives exhort us to ensure that current efforts toward global harmonization of biobanking regulatory frameworks are informed by diverse perspectives garnered from both theoretical and empirical methods. NHMRC

Background & Aim Over the last decade there has been a growing prevalence of privately owned clinics in Australia providing autologous interventions to patients based on ‘stem cells’ isolated from their own fat, blood or bone marrow. These claimed stem cell-based interventions have primarily been marketed for osteoarthritis treatment, but have also been available for facial rejuvenation, hair restoration, and the treatment of motor neurone disease, Parkinson's disease and dementia. Such interventions are rarely part of a clinical research program, lack high level evidence of efficacy, and are not reimbursed by public or private insurers, resulting in patients paying significant out of pocket expenses (AUD$6,000 or more per intervention). Due to a regulatory exemption that broadly excluded the manufacturing and administration of autologous cells and tissues from the oversight of the Australian Therapeutic Goods Administration, clinics have been able to market directly and aggressively to patients in a manner that both exaggerates benefits and underplays risks. This study explores how Australian patients and their carers understood and experienced these interventions, and in particular how their presumptions about autologous stem cells, the ethics of medical practice, and the regulatory environment in Australia have conditioned their preparedness to undergo unproven treatments. Methods, Results & Conclusion Findings were drawn from two workshops conducted in 2016 with patients, their carers and family members (22 participants) and 15 semi-structured interviews (conducted in 2017). Patients’ consideration of, and decision to undergo, an autologous stem cell-based intervention was shaped by five factors: illness experience, disillusion with current medical practice, unrealistic expectations about the intervention, lack of information from providers, and trust in the health care system and clinicians more broadly. While recently announced regulatory amendments may in time provide greater patient protection, the previous ‘light touch’ regulatory approach clearly created the preconditions in Australia for clinical practices with questionable evidentiary basis, and for a market where patient vulnerability and risk could be monetized. In future, we argue, efforts to enhance consumer awareness of the unregulated and unproven nature of autologous stem cell-based interventions need to be coupled with sound regulation and periodic policy review to avoid exceptionalism and patient exploitation.

Biobanks are increasingly being linked together into global networks in order to maximise their capacity to identify causes of and treatments for disease. While there is great optimism about the potential of these biobank networks to contribute to personalised and data-driven medicine, there are also ethical concerns about, among other things, risks to personal privacy and exploitation of vulnerable populations. Concepts drawn from theories of globalisation can assist with the characterisation of the ethical implications of biobank networking across borders, which can, in turn, inform more ethically sophisticated responses. Using the China Kadoorie Biobank as a case study, we show how distinguishing between the subnational, transnational, supranational and extranational spheres of operation and influence can help researchers, institutions and regulators to understand and manage the ethical issues raised by the globalisation of biobanking. National Health and Medical Research Council (Australia)

The process of globalization is commonly espoused as a means for promoting global health. Efforts to "go global" can, however, easily go awry as a result of lack of attention to local social, economic, and political contexts and/or as a result of commercial and political imperatives that allow local populations to be exploited. Critical analysis of the processes of globalization is necessary to better understand the local particularities of global projects and confront challenges more transparently. We illustrate the potential adverse impacts of globalization in the global health setting, through examination of international tuberculosis control, global mental health, and the establishment of transnational biobank networks.

In recent years, a range of initiatives have been introduced to provide patients with access to medicines outside of traditional regulatory and/or funding channels; we term these processes “accelerated access to medicines”. These generally take one of three forms- those that provide access by making existing regulatory and funding processes more efficient; those that provide access despite uncertainties surrounding safety or efficacy; and those that provide access despite uncertainties surrounding cost-effectiveness. These latter two types are the subject of intense debate, as they generally require us to suspend or override accepted standards of evidence of safety, effectiveness and/or cost-effectiveness. Ethical analysis provides valuable insights into these debates and highlights the risks and benefits that may accrue as a consequence of different accelerated access schemes. In this paper, we use the principle-based approach to ethical analysis described by Beauchamp and Childress (sometimes called the “four principles approach” because it frames analysis by reference to beneficence, non-maleficence, autonomy and justice) to analyse initiatives that provide accelerated access to medicines. We identify a number of ethical issues that may arise in the context of accelerated access initiatives, including potential patient harms, impacts on patient autonomy and informed consent, and effects on research and regulatory systems. The complex ethical issues at play emphasise that there is no single answer to questions as to whether such schemes are ‘ethical’; rather, ethical principles will need balancing, context will be critically important, and discussion among the various stakeholder groups will be needed to reach an “ethically good” outcome. Keywords: bioethics, pharmaceutical funding decisions, pharmaceutical regulation, coverage with evidence development, investigational drugs

In this paper we report on the findings from six focus groups conducted with Australian medical students. The focus groups discussed students’ perceptions of conflicts of interest and the influence of commercial values in health care and medical education. Our research revealed that students were aware of a number of structural influences that affected the medical education they received and that had the potential to shape their attitudes and practices as they progressed in becoming a doctor. We found that the pressures of educational workload and anticipated career trajectories tended to have an individualising effect that limited the perceived possibility of collective action and response to structural influences. We interpreted these findings through the lens of neoliberal governmentality to articulate the way commercial interests are negotiated and normalised by medical students. Based on these findings, we suggest that medical education should not only explicitly alert students to effects of political and commercial influences on the healthcare system, but also encourage the collective agency of students and strategies that do not place unrealistic expectations on individuals to effect structural change. KEYWORDS: Neoliberalism, conflicts of interest, medical education, medical students, ethics This work was supported by the National Health and Medical Research Council [grant number 1059732].

Despite the high level of spending on cancer medicines in Australia, consumer organisations and the pharmaceutical industry often make claims of delayed or lack of access to new cancer medicines—claims that are frequently supported by prominent coverage in the Australian media. These claims, while morally and psychologically compelling, tend to ignore the complexity of medicines funding decisions. In this commentary we summarise the current situation regarding the registration and funding of cancer medicines in Australia, elucidate the main challenges associated with access to cancer medicines in the Australian context, and describe some of the steps that have been taken to address these challenges. Refereed/Peer-reviewed

Concerns over conflicts of interest (COI) in academic research and medical practice continue to provoke a great deal of discussion. What is most obvious in this discourse is that when COIs are declared, or perceived to exist in others, there is a focus on both the descriptive question of whether there is a COI and, subsequently, the normative question of whether it is good, bad or neutral. We contend, however, that in addition to the descriptive and normative, COI declarations and accusations can be understood as performatives. In this article, we apply J.L. Austin’s performative speech-act theory to COI discourses and illustrate how this works using a contemporary case study of COI in biomedical publishing. We argue that using Austin’s theory of performative speech-acts serves to highlight the social arrangements and role of authorities in COI discourse and so provides a rich framework to examine declarations, accusations and judgements of COI that often arise in the context of biomedical research and practice. Keywords J.L. Austin Conflicts of interest Discourse analysis Research ethics

Concern is growing about the implications of rising drug prices for individuals and health systems around the world. With little transparency around the costs of drug development, Narcyz Ghinea and colleagues call for greater accountability from drug companies to ensure a fair price for new medicines Key messages The cost of drugs, particularly new biological agents, is overwhelming health budgets around the world Little is known about how much it really costs to develop new medicines and, therefore, what they are really worth This limits the ability of public and private payers to negotiate affordable prices and show that they are achieving “value for money” Basic information about drug development costs needs to be available to both payers and the public to ensure greater accountability NHMRC project grant 1080673

Importance Decision support tools can assist people to apply population-based evidence on benefits and harms to individual health decisions. A key question is whether “personalising” choice within decisions aids leads to better decision quality. Objective To assess the effect of personalising the content of a decision aid for prostate cancer screening using the Prostate Specific Antigen (PSA) test. Design Randomized controlled trial. Setting Australia. Participants 1,970 men aged 40–69 years were approached to participate in the trial. Intervention 1,447 men were randomly allocated to either a standard decision aid with a fixed set of five attributes or a personalised decision aid with choice over the inclusion of up to 10 attributes. Outcome Measures To determine whether there was a difference between the two groups in terms of: 1) the emergent opinion (generated by the decision aid) to have a PSA test or not; 2) self-rated decision quality after completing the online decision aid; 3) their intention to undergo screening in the next 12 months. We also wanted to determine whether men in the personalised choice group made use of the extra decision attributes. Results 5% of men in the fixed attribute group scored ‘Have a PSA test’ as the opinion generated by the aid, as compared to 62% of men in the personalised choice group (χ2 = 569.38, 2df, p< 0001). Those men who used the personalised decision aid had slightly higher decision quality (t = 2.157, df = 1444, p = 0.031). The men in the personalised choice group made extensive use of the additional decision attributes. There was no difference between the two groups in terms of their stated intention to undergo screening in the next 12 months. Conclusions Together, these findings suggest that personalised decision support systems could be an important development in shared decision-making and patient-centered care. funded by the National Health and Medical Research Council of Australia under Program Grant number 6633003.

The labels of off-patent medicines can be obsolete and even misleading when compared to the contemporary, evidence-based use of the medicine. Apart from serious adverse drug reactions that can lead to rapid changes to the label, regulatory agencies can only review and approve proposed changes to the label submitted by the sponsor of the medicine. There are many reasons why a sponsor may not wish or have incentive to submit proposed changes, particularly once a medicine is off-patent. The problem of misleading and potentially dangerous medicines labels post-patent expiry needs to be addressed. Consideration is needed of the roles of the label at patent expiry, how well that role is fulfilled and the possible alternatives. Our preference is for a ‘partnership’ approach to support production and maintenance of up to date, and relevant information for generic medicines that is pragmatically situated within the context of other sources of high quality information and advice. Reform is clearly needed but progress will be dependent on convincing stake-holders of that need and will require much lateral and innovative thought from all stakeholders best facilitated by an ‘honest broker’ such as the DIA. The importance of drug labels A medicine is more than a pill, solution for injection or a topical product. It includes at least as significantly, the medicines information that optimizes the chance for safe and effective therapy in individual patients. This information is contained within the product ‘label’, ‘approved product information’ [PI] or ‘summary of product characteristics’ [SPC]— henceforth referred to as the ‘label’. The label, which is the Regulatory agency’s officially approved information document, accompanies each registered medicine. Despite these expectations, for reasons that will be discussed below, it is unavoidable that the longer a drug has been available on the market the more the official information in the label is likely to be obsolete, less relevant or even misleading. Furthermore, information for the patient, for example the corresponding patient information that is derived from the ‘label’, may also be inconsistent with the contemporary use of the medicine or the indication/s for which the medicine is being prescribed. Labels or consumer information that are not up-to-date and consistent with contemporary, evidence-based practice can, therefore, lead to stress and uncertainty for clinicians or patients who want to make use of this information.

In this chapter, we will explore the value of Little's theory of 'modest foundationalism' as a means of shedding a fresh perspective on the medical profession. In particular, we seek to determine whether we can explain why the medical profession exists, and persists, in the form it does in Western societies, without resorting to the almost taken-for-granted assumptions about self-interested striving for power and status that prevail in much of the sociological literature. We first review the development of theories about the emer¬gence and maintenance of the medical profession, drawing primarily from sociological traditions in the USA and UK. Next, we articulate our understanding of the main elements of Little's theory, in which he identifies three pre-normative values - survival, security and flourishing - that, he argues, exist and are expressed in any culture or society. We then propose that a shift in the level of analysis from that of society to that of the collective - in this case the medical profession - can offer new insights into the nature of the profession and its role in society. We conclude with observations about the relevance of this wider perspective for theory and for medical education and governance.

The pharmaceutical industry has been criticised for pervasive misconduct. These concerns have generally resulted in increasing regulation. While such regulation is no doubt necessary, it tends to assume that everyone working for pharmaceutical companies is equally motivated by commerce, without much understanding of the specific views and experiences of those who work in different parts of the industry. In order to gain a more nuanced picture of the work that goes on in the “medical affairs” departments of pharmaceutical companies, we conducted 15 semi-structured interviews with professionals working in medical departments of companies in Sydney, Australia. We show that this group of pharmaceutical professionals are committed to their responsibilities both to patients, research participants, and the public and to their companies. Despite the discrepancies between these commitments, our participants did not express much cognitive dissonance, and this appeared to stem from their use of two dialectically related strategies, one of which embraces commerce and the other of which resists the commercial imperative. We interpret these findings through the lens of institutional theory and consider their implications for pharmaceutical ethics and governance. Keywords: Qualitative research; Social values; Pharmaceutical industry; Pharmaceutical ethics NHMRC

Despite widespread support, the implementation of patient-centred care (PCC) remains a challenge and it is often assumed that further clinical education and culture change are needed. To inform such efforts, we need to know whether the principles underpinning PCC accord with doctors’ personal and cultural values. In this chapter, we report the results of a qualitative interview study of clinicians, conducted in order to establish whether PCC emerges in the narratives of Australian doctors, and, if so, how. Our findings suggest that doctors both understand and value the principles underpinning PCC. This suggests that patient-centeredness is part of the professional culture of medicine, and that those wanting to ensure that this patient-centeredness remains an integral part of practice for succeeding generations of doctors might need to focus not as much on education and culture change as on ensuring that there are structures and processes in place to support PCC. a grant for values based medicine research awarded by the Medical School Foundation, University of Sydney

Drug subsidy recommendations should be informed by active assessment of current evidence and emerging treatments. Decisions about which medicines should be subsidised by the Australian Government on the Pharmaceutical Benefits Scheme (PBS) are based on recommendations made by the Pharmaceutical Benefits Advisory Committee (PBAC) — an independent statutory body appointed by the government. The PBAC lists among its goals maximising the “value” that Australia derives from its health expenditure and “meet[ing] the health needs of the majority of the Australian community”. While the PBAC is generally thought to have in place good processes for working towards these goals, its decisions are increasingly contested by consumers, governments, clinicians and the pharmaceutical industry

Health industries attempt to influence the public through the news media and through their relationships with expert academics and opinion leaders. This study reports journalists' perceptions of their professional roles and responsibilities regarding the relationships between industry and academia and research results. Journalists believe that responsibility for the scientific validity of their reports rests with academics and systems of peer review. However, this approach fails to account for the extent of industry-academy interactions and the flaws of peer review. Health journalists' retention of a critical stance regarding industry-academia relationships will include advocacy for and adoption of mandatory reporting of these relationships.

Objective: To explore the key motivators behind selection of analgesics (non-steroidal anti-inflammatory drugs (NSAIDs), paracetamol and complementary medications (CMs)) by patients with osteoarthritis (OA). Methods: A qualitative study, in which in-depth semi-structured interviews were conducted with 15 OA patients, recruited from four general practices in Sydney, Australia. Patients were aged 65 or above, and were currently taking, or had recently taken, an NSAID for osteoarthritis. Results: Three key themes emerged from the data: reliance, routine and pill load. Reliance: Patients were strongly reliant upon NSAIDs because they consistently satisfied their needs. By contrast, they were much less reliant upon paracetamol because of uncertainty or scepticism about its effectiveness. They were not reliant upon CMs but were willing to take them indefinitely because they were perceived as being without risk. Routine and pill load: Many patients took an NSAID, as well as CMs as part of a ‘daily routine’. By contrast, patients had difficulty developing a routine around using paracetamol at the recommended maximum dose because of the implicit frequency of dosing required and an aversion to the associated ‘pill load’. Conclusion: The results highlight the importance of exploring the perceptions and preferences of patients with regard to analgesics for OA. Clinician advice regarding analgesia for OA should take account of the possible reliance of the patient upon an NSAID, their medicine routines, and their potential concern about the pill load associated, in particular, with paracetamol. NHMRC

In this article we explore the concept of balance in the context of health. We became interested in balance during a grounded theory study of lay conceptualizations of cancer risk, in which participants were concerned with having a good life, which relied heavily on balancing processes. This led us to the qualitative literature about balance in the context of health, which was large and in need of synthesis. We identified 170 relevant studies and used Thomas and Harden’s technique of “thematic synthesis” to identify key balance-related themes and to develop these into more abstract analytic categories. We found that balance and balancing were salient to people in three health-related contexts: health maintenance, disease or disability management and lay or professional caregiving. In each of these contexts, balance or imbalance could be a state or a process. In addition, those using the word had either an internally- or externally focused orientation to the world around them. Clinicians and public health practitioners might benefit from using these insights in their research and communication. Keywords communication, medical; concept analysis; health and well-being; health promotion; qualitative analysis NHMRC

Evidence Based Medicine (EBM) has now been part of the dominant medical paradigm for 15 years, and has been frequently debated and progressively modified. One question about EBM that has not yet been considered systematically, and is now particularly timely, is the question of the novelty, or otherwise, of the principles and practices of EBM. We argue that answering this question, and the related question of whether EBM-type principles and practices are unique to medicine, sheds new light on EBM and has practical implications for those involved in all EBM. This is because one’s answer to the question (whether explicit or implicit) affects the amount and type of funding and attention received by EBM, the extent to which EBM, and the generation, judgment and use of evidence more generally, can be appropriated by certain groups and questioned by others, and the extent to which truly unique socio-political developments in evidence, and in medicine more generally, are recognized and harnessed. Keywords: Evidence-based medicine, Exceptionalism

Legislation and regulation are one means of controlling biomedical research and its clinical applications. This is seldom a one-off process since biomedical science evolves rapidly, dynamically and often unpredictably, and legislative and regulatory reviews are often required in response to the emergence of apparently new ethical and legal issues. In recent years, there have been several reviews of Australian biomedical legislation including the Australian Law Reform Commission’s “Inquiry into the Protection of Genetic Information in Australia” (“the ALRC Inquiry”) released in 2003 1, and the Legislative Review of the Prohibition of Human Cloning Act 2002 and the Research Involving Human Embryos Act 2002, (“the Lockhart Review”) which was released in December 2005 2. The ALRC Inquiry was a response to developments in genetic research, particularly genetic epidemiological research involving powerful new techniques such as microarrays (gene chips). The Lockhart Review was concerned with developments in stem cell research, including the use of embryos produced in the course of assisted reproductive technology (ART) and through cloning. These two reviews, when juxtaposed, highlight the key elements—both recurring and review-specific—of biomedical legislative review.

In the biomedical field, calls for the generation of new regulations or for the amendment of existing regulations often follow the emergence of apparently new research practices (such as embryonic stem cell research), clinical practices (such as facial transplantation) and entities (such as Avian Influenza/’Bird Flu’). Calls for regulatory responses also arise as a result of controversies which bring to light longstanding practices, such as the call for increased regulation of human tissue collections that followed the discovery of unauthorised post-mortem organ retention. Whilst it seems obvious that new regulations should only be generated if existing regulations are inadequate (a practice referred to in this paper as ‘regulatory syncretism’), this does not always occur in practice. This paper examines the conceptual steps involved in generating regulatory responses to emerging phenomena. Two decision points are identified. First, a stance is taken as to whether the emerging phenomenon raises unique ethical or legal issues (exceptionalism versus non-exceptionalism). Second, the decision is made as to whether new regulation should be generated only for truly unique phenomena (syncretism versus asyncretism). It is argued here that it is important to make a careful assessment of novelty, followed by a reflective and deliberate choice of regulatory syncretism or asyncretism, since each type of regulatory response has advantages which need to be harnessed and disadvantages which need to be managed—something that can only occur if regulators are attentive to the choices they are making. Keywords: Exceptionalism, regulation, tissue banking, health policy