Is physician dismissal of vaccine refusers an acceptable practice in Canada? A 2018 overview.

Despite robust evidence that routine immunization is effective and safe, some parents refuse some or all vaccines for their children. In 2007, concern that Canadian paediatricians and family physicians might be considering dismissal of vaccine refusers from their practices prompted an ethical, legal, and public health analysis which concluded that dismissal was professionally problematic. We now reassess this important issue in the Canadian context updating ethical, legal, and public health considerations highlighting changes since 2007. In light of the recent strengthening of Ontario's school immunization requirements that include stiffer steps to qualify for a medical, conscience, or religious belief exemption, physicians and health care workers may be under more pressure from vaccine refusers in their practice leading some to contemplate dismissal or even consider no longer offering immunizations at all in their practice. Given the challenges that vaccine refusers may present, we offer an overview for managing vaccine refusal by parents/patients in a medical practice.

Implantable Smart Technologies (IST): Defining the 'Sting' in Data and Device.

In a world surrounded by smart objects from sensors to automated medical devices, the ubiquity of 'smart' seems matched only by its lack of clarity. In this article, we use our discussions with expert stakeholders working in areas of implantable medical devices such as cochlear implants, implantable cardiac defibrillators, deep brain stimulators and in vivo biosensors to interrogate the difference facets of smart in 'implantable smart technologies', considering also whether regulation needs to respond to the autonomy that such artefacts carry within them. We discover that when smart technology is deconstructed it is a slippery and multi-layered concept. A device's ability to sense and transmit data and automate medicine can be associated with the 'sting' of autonomy being disassociated from human control as well as affecting individual, group, and social environments.

The Invisibility of Disability: Using Dance to Shake from Bioethics the Idea of 'Broken Bodies'.

Complex social and ethical problems are often most effectively solved by engaging them at the messy and uncomfortable intersections of disciplines and practices, a notion that grounds the InVisible Difference project, which seeks to extend thinking and alter practice around the making, status, ownership, and value of work by contemporary dance choreographers by examining choreographic work through the lenses of law, bioethics, dance scholarship, and the practice of dance by differently-abled dancers. This article offers a critical thesis on how bioethics has come to occupy a marginal and marginalizing role in questions about the differently-abled body. In doing so, it has rendered the disabled community largely invisible to and in bioethics. It then defends the claim that bioethics - as a social undertaking pursued collaboratively by individuals from different disciplines - must take much better notice of the body and the embodied individual if it is to better achieve its ends, which include constructing a moral and just society. Finally, this article considers how the arts, and specifically dance (and here dance by differently-abled dancers), provides us with rich evidence about the body and our ability to respond positively to normally 'othered' bodies. It concludes that greater attention to empirical evidence like that being generated in InVisible Difference will help to expand the reach and significance of bioethics, and thereby its relevance to (and consciousness of) important questions about the status of bodies and bodily differences, which must be considered as central to its ambitions.

In Search of Global Health Justice: A Need to Reinvigorate Institutions and Make International Law.

The recent outbreak of Ebola in West Africa has killed thousands of people, including healthcare workers. African responses have been varied and largely ineffective. The WHO and the international community's belated responses have yet to quell the epidemic. The crisis is characteristic of a failure to properly comply with the International Health Regulations 2005. More generally, it stems from a failure of international health justice as articulated by a range of legal institutions and instruments, and it should prompt us to question the state and direction of approaches to the governance of global public health. This paper queries what might be done to lift global public health as a policy arena to the place of prominence that it deserves. It argues that there are at least two critical reasons for the past, present and easily anticipated future failings of the global public health regime. After exploring those, it then articulates a new way forward, identifying three courses of action that might be adopted in realising better health outcomes and global health justice, namely value, institutional and legal reform.

Banking (on) the brain: from consent to authorisation and the transformative potential of solidarity.

Modern technologies and biomedicine ambitions have given rise to new models of medical research, including population biobanking. One example of biobanking is brain banking, which refers to the collection and storage of brain and spinal cord samples for research into neurological diseases. Obviously, brain banking involves taking brains and tissue from deceased people, a fact which complicates the role of recruiters and makes consent a poor tool for stakeholders. After contextualising brain banking and considering the public health issues at stake, this article explores the legal definitions and demands of, and actual processes around, consent in England/Wales/Northern Ireland and authorisation in Scotland, articulating and evaluating their conceptual and practical differences. It then argues for an expanded but improved operation of 'authorisation' in the brain banking (and broader biobanking) setting, adopting 'solidarity' as our foundation and the improvement of the 'public good' our objective.

Medical research data-sharing: the 'public good' and vulnerable groups.

One of the moral tests of governments is how they treat those in the twilight of life (the elderly). As such, it is important not only to take care of the needs of the elderly, but also to place their reality in the forefront of deliberations and actions. Now that we are in the so-called century of biology, we must ensure that the newly transformed and increasingly relied on biosciences not only respond to the needs of the elderly but also reflect the reality of the elderly. While many arguments can be made in support of increased data-sharing in biomedical research (and indeed within and across healthcare systems more generally), there are some persuasive age-based arguments that might serve to encourage science regulators, through both funding structures and the law, to fundamentally reshape the research environment so as to enhance its potential to achieve public goods such as improved health and more effective healthcare systems. In this paper, after noting the new research model arising from population genomics, with its intense data needs, we advance three age-based arguments, in favour of increased and improved data-sharing, and we conclude with some brief observations about how increased data-sharing might be achieved.

An equitable vaccine delivery system: Lessons from the COVID-19 vaccine rollout in Canada.

BACKGROUND: The COVID-19 pandemic exacerbated existing health disparities and disproportionately affected vulnerable individuals and communities (e.g., low-income, precariously housed or in institutional settings, racialized, migrant, refugee, 2SLBGTQ+). Despite their higher risk of infection and sub-optimal access to healthcare, Canada's COVID-19 vaccination strategy focused primarily on age, as well as medical and occupational risk factors. METHODS: We conducted a mixed-methods constant comparative qualitative analysis of epidemiological data from a national database of COVID-19 cases and vaccine coverage in four Canadian jurisdictions. Jurisdictional policies, policy updates, and associated press releases were collected from government websites, and qualitative data were collected through 34 semi-structured interviews of key informants from nine Canadian jurisdictions. Interviews were coded and analyzed for themes and patterns. RESULTS: COVID-19 vaccines were rolled out in Canada in three phases, each accompanied by specific challenges. Vaccine delivery systems typically featured large-venue mass immunization sites that presented a variety of barriers for those from vulnerable communities. The engagement and targeted outreach that featured in the later phases were driven predominantly by the efforts of community organizations and primary care providers, with limited support from provincial governments. CONCLUSIONS: While COVID-19 vaccine rollout in Canada is largely considered a success, such an interpretation is shaped by the metrics chosen. Vaccine delivery systems across Canada need substantial improvements to ensure optimal uptake and equitable access for all. Our findings suggest a more equitable model for vaccine delivery featuring early establishment of local barrier-free clinics, culturally safe and representative environment, as well as multi-lingual assistance, among other vulnerability-sensitive elements.

Public health communication in Canada during the COVID-19 pandemic.

OBJECTIVES: Communication is central to the implementation and effectiveness of public health measures. Informed by theories of good governance, COVID-19 pandemic public health messaging in 3 Canadian provinces is assessed for its potential to encourage or undermine public trust and adherence. METHODS: This study employed a mixed-methods constant comparative approach to triangulate epidemiological COVID-19 data and qualitative data from news releases, press briefings, and key informant interviews. Communications were analyzed from January 2020 to October 2021 in Nova Scotia, Ontario, and Alberta. Interview data came from 34 semi-structured key informant interviews with public health actors across Canada. Team-based coding and thematic analysis were conducted to analyze communications and interview transcripts. RESULTS: Four main themes emerged as integral to good communication: transparency, promptness, clarity, and engagement of diverse communities. Our data indicate that a lack of transparency surrounding evidence and public health decision-making, delays in public health communications, unclear and inconsistent terminology and activities within and across jurisdictions, and communications that did not consider or engage diverse communities' perspectives may have decreased the effectiveness of public health communications and adherence to public health measures throughout the COVID-19 pandemic. CONCLUSION: This study suggests that increased federal guidance with wider jurisdictional collaboration backed by transparent evidence could improve the effectiveness of communication practices by instilling public trust and adherence with public health measures. Effective communication should be transparent, supported by reliable evidence, prompt, clear, consistent, and sensitive to diverse values. Improved communication training, established engagement infrastructure, and increased collaborations and diversity of decision-makers and communicators are recommended.

RéSUMé: OBJECTIFS: La communication est centrale à l'implantation et au succès des mesures de santé publique. À partir des théories de bonne gouvernance, les messages de santé publique sur la COVID-19 de trois provinces canadiennes ont été analysés afin d'évaluer si ces messages renforçaient ou diminuaient la confiance et l'adhésion de la population. MéTHODES: Cette étude utilise une approche comparative constante et des méthodes mixtes pour trianguler des données épidémiologiques sur la COVID-19 avec des données qualitatives provenant de communiqués de presse, de conférences de presse et d'entretiens avec des informateurs clés. Les communications ont été analysées entre janvier 2020 et octobre 2021 en Nouvelle-Écosse, Ontario et Alberta. Les données proviennent également de 34 entretiens semi-dirigés avec des acteurs de santé publique à travers le Canada. Une codification en équipe et une analyse de contenu thématique ont été réalisées pour analyser les communications et les verbatim des entretiens. RéSULTATS: Quatre thèmes principaux sont apparus comme faisant partie intégrante d'une bonne communication : la transparence, la rapidité, la clarté et l'engagement des diverses communautés. Nos données indiquent qu'un manque de transparence en ce qui a trait aux données probantes et aux processus de prise de décision en santé publique, que les retards dans les stratégies de communication de santé publique, qu'une terminologie et des activités incohérentes et inconsistantes dans les provinces et entre elles, ainsi que des communications qui ne tenaient pas compte des points de vue ou qui n'incluaient pas les diverses communautés, ont pu réduire l'efficacité des communications et l'adhésion aux mesures de santé publique tout au long de la pandémie de COVID-19. CONCLUSION: Cette étude suggère que des lignes directrices nationales et une collaboration accrue entre les provinces et les territoires soutenues par des données probantes transparentes pourraient améliorer l'efficacité des communications en suscitant la confiance du public et l'adhésion aux mesures de santé publique. Une communication efficace doit être transparente, appuyée sur des données probantes fiables, rapide, claire, cohérente et sensible aux différentes valeurs. Il est recommandé d'améliorer la formation en communication, d'établir une infrastructure pour accroître l'engagement, et de soutenir la collaboration et la diversité des décideurs et des communicateurs.

Ethics check-up of public health immunization programs in Canada.

The World Health Organization (WHO) recognizes immunization as one of the most successful and effective public health interventions for saving lives. In developing a roadmap for prioritizing use of the coronavirus disease 2019 (COVID-19) vaccines in the context of limited supply, WHO highlighted the importance of a values (ethical principles) framework. Immunization does need to be subject to independent ethical scrutiny of vaccine research data, manufacturing practices, the legal and ethical assurance of informed consent, and also social justice issues with respect to program equity, including right to access. An ethics review of Australia's immunization program was reported in 2012. This CANVax (Canadian Vaccination Evidence Resource and Exchange Centre) Brief offers an ethics review of immunization in Canada using the criteria utilized for Australia.

Mandatory immunization and vaccine injury support programs: A survey of 28 GNN countries.

BACKGROUND: Despite the proposed ethical link between mandatory immunization and Vaccine Injury Support Programs (VISPs), relatively few jurisdictions, even those with mandatory immunization, have implemented such programs. Although it may be assumed that individuals injured by a vaccine in a non-VISP country receive less support than in countries possessing such programs, the extent of the discrepancy is not clear; nor is the nature of any discrepancy. METHODS: In our 2018 survey of 28 Global NITAG (National Immunization Technical Advisory Group) Network (GNN) countries, we asked respondents about mandatory immunization and the availability of VISPs. Responses were supplemented with desktop research and review of scholarly literature for further information regarding VISP availability and details. RESULTS: Although only two of 14 (14%) surveyed jurisdictions with mandatory immunization had formal VISPs, responses from additional countries suggested the presence of less formal avenues of compensation for serious Adverse Events Following Immunization (AEFIs); similarly, we found five of 15 (33%) of countries without mandatory immunization had implemented formal VISPs, but another three such countries suggested similar informal methods of compensation. CONCLUSIONS: From our data, it is evident that at least some countries with mandatory immunization may discharge their (perceived or actual) ethical obligation to provide financial assistance to vaccine-injured individuals through more informal avenues rather than structured VISPs, although the extent and impact of this practice is by its nature difficult to assess. Further, the nature of VISPs may vary significantly from jurisdiction to jurisdiction, and simple VISP/non-VISP classification of jurisdiction may fail to capture nuance in support for AEFI victims in many jurisdictions. Future assessments of VISPs should consider the possibility of these more informal avenues of support for vaccine injuries.

Yearworth v. North Bristol NHS trust: a property case of uncertain significance?

It has long been the position in law that, subject to some minor but important exceptions, property cannot be held in the human body, whether living or dead. In the recent case of Yearworth and Others v North Bristol NHS Trust, however, the Court of Appeal for England and Wales revisited the property debate and threw into doubt a number of doctrines with respect to property and the body. This brief article analyses Yearworth, (1) reviewing the facts and the Court's decision with respect to the originators' proprietary and contractual interests in their body and bodily products, (2) considering the significance of relying on property and its use a legal metaphor, (3) questioning the scope of the property right created, and (4) querying whether an alternate conceptual approach to extending rights and a remedy was warranted. It concludes that, while Yearworth engages with, and impacts on, important theoretical and practical issues--from legal, healthcare and research perspectives--it does not offer a great deal of guidance and, for that reason, its precedential significance is in doubt.

Immunization governance: Mandatory immunization in 28 Global NITAG Network countries.

International trends currently favour greater use of mandatory immunization. There has been little academic consideration or comparison of the existence and scope of mandatory immunization internationally. In this paper, we examine mandatory immunization in 28 Global NITAG (National Immunization Technical Advisory Group) Network (GNN) countries, including countries from every WHO region and World Bank income level classification. We found that although mandatory immunization programs, or mandatory elements within broader immunization programs, are relatively common, jurisdictions vary significantly with respect to the immunizations required, population groups affected, grounds for exemptions, and penalties for non-compliance. We also observed some loose associations with geography and income level. Based on these data, we categorized policies into a spectrum ranging from Narrow to Broad scope.

Strengthening vaccination frameworks: Findings of a study on the legal foundations of National Immunization Technical Advisory Groups (NITAGs).

In 2017, the Strategic Advisory Group of Experts on Immunization's Assessment Report of the Global Vaccine Action Plan noted the need to "better document the ways in which legislation and regulations have been used to promote or undermine immunization at the national level". Despite National Immunization Technical Advisory Groups (NITAGs) now existing in over 134 countries worldwide, there has been very little academic consideration of their legal underpinnings. In this paper, we compare the legal foundations and authority of 28 NITAGs from the six WHO Regions. All are members of the Global NITAG Network. We categorize the NITAGs based on their legal foundation and on the authority granted to them by their government, organizing them into a taxonomy of models. We then propose legal considerations for governments contemplating establishing or reforming a NITAG.

International public health law: not so much WHO as why, and not enough WHO and why not?

To state the obvious, "health matters", but health (or its equitable enjoyment) is neither simple nor easy. Public health in particular, which encompasses a broad collection of complex and multidisciplinary activities which are critical to the wellbeing and security of individuals, populations and nations, is a difficult milieu to master effectively. In fact, despite the vital importance of public health, there is a relative dearth of ethico-legal norms tailored for, and directed at, the public health sector, particularly at the international level. This is a state of affairs which is no longer tenable in the global environment. This article argues that public health promotion is a moral duty, and that international actors are key stakeholders upon whom this duty falls. In particular, the World Health Organization bears a heavy responsibility in this regard. The article claims that better health can and must be better promoted through a more robust interpretation of the WHO's role, arguing that neither the WHO nor international law have yet played their necessary part in promoting health for all.

Emerging technologies and developing countries: stem cell research regulation and Argentina.

Given its intimate relationship with the human body and its environment, biotechnology innovation, and more particularly stem cell research innovations as a part thereof, implicate diverse social and moral/ethical issues. This paper explores some of the most important and controversial moral concerns raised by human embryonic stem cell research (and the closely associated field of cloning), focusing on concerns relating to the wellbeing of the embryo and the wellbeing of society (the collective). It then considers how and whether these concerns are dealt with in regulatory instruments in Argentina, a southern developing country, examining in particular whether the values underlying these concerns have been translated into practical and effective rules reflective of the primary moral positions advanced. It concludes that Argentina's current state of stem cell research governance fails to consistently reflect the moral positions that have formed and is inadequate given Argentina's activity in this field.

Body Extension and the Law: Medical Devices, Intellectual Property, Prosthetics and Marginalisation (Again).

This interdisciplinary paper, drawing on empirical and doctrinal research regarding artificial limbs and digital avatars, analyses two concepts which are argued to be core to the person - integrity and identity. From the perspective of a person who is a prosthetic user, the paper then evaluates the extent to which two legal regimes which are highly relevant to prosthetics, medical devices regulation (and its delivery) and intellectual property (and its power), engage with the person, integrity and identity with a focus on approaches taken to authority and control. The paper criticises the meaning which law generates regarding the person. It calls for new approaches to be taken by the legal regimes explored to the person, identity and integrity; and for a new multifaceted interdisciplinary driven approach to the person.

Mandatory infant & childhood immunization: Rationales, issues and knowledge gaps.

Globally, infant and childhood vaccine uptake rates are not high enough to control vaccine preventable diseases, with outbreaks occurring even in high-income countries. This has led a number of high-, middle-and low income countries to enact, strengthen or contemplate mandatory infant and/or childhood immunization to try to address the gap. Mandatory immunization that reduces or eliminates individual choice is often controversial. There is no standard approach to mandatory immunization. What vaccines are included, age groups covered, program flexibility and rigidity e.g. opportunities for opting out, penalties or incentives, degree of enforcement, and whether a compensation program for causally associated serious adverse events following immunization exists vary widely. We present an overview of mandatory immunization with examples in two high- and one low-income countries to illustrate variations, summarize limited outcome data related to mandatory immunization, and suggest key elements to consider when contemplating mandatory infant and/or child immunization. Before moving forward with mandatory immunization, governments need to assure financial sustainability, uninterrupted supply and equitable access to all the population. Other interventions may be more effective and less intrusive than mandatory. If mandatory is implemented, this needs to be tailored to fit the context and the country's culture.

20-carboxy-arachidonic acid is a dual activator of peroxisome proliferator-activated receptors alpha and gamma.

20-carboxy-arachidonic acid (20-COOH-AA) is a metabolite of 20-hydroxyeicosatetraenoic acid (20-HETE), an eicosanoid produced from arachidonic acid by cytochrome P450 (CYP) omega-oxidases. Alcohol dehydrogenases convert 20-HETE to 20-COOH-AA, and we now find that a microsomal preparation containing recombinant human CYP4F3B converts arachidonic acid to 20-HETE and 20-COOH-AA. Studies with transfected COS-7 cell expression systems indicate that 20-COOH-AA activates peroxisome proliferators-activated receptor (PPAR) alpha and PPARgamma. 20-COOH-AA was twice as potent as either 20-HETE or ciglitazone in stimulating PPARgamma-mediated luciferase expression. While 20-COOH-AA also was more potent than 20-HETE in increasing PPARalpha-mediated luciferase expression, the increase was only half as much as that produced by Wy-14643. 20-COOH-AA did not increase PPARalpha or PPARgamma expression in the transfected cells. Radiolabeled 20-COOH-AA was detected intracellularly when the COS-7 cells were incubated with either [3H]20-COOH-AA or [3H]20-HETE, and binding studies indicated that [3H]20-COOH-AA bound to the isolated ligand binding domains of PPARalpha (Kd=0.87+/-0.12 microM) and PPARgamma (Kd=1.7+/-0.5 microM). These findings suggest that 20-COOH-AA, a relatively stable metabolite of 20-HETE, might function as an endogenous dual activator of PPARalpha and PPARgamma.

The European General Data Protection Regulation: challenges and considerations for iPSC researchers and biobanks.

Increasingly, human induced pluripotent stem cells (iPSC) and their associated genetic and clinical information are being used in a wide range of applications, with large biobanks being established to support and increase their scientific use. The new European General Data Protection Regulations, which comes into effect in 2018, will have implications for biobanks that generate, store and allow research access to iPSC. This paper describes some of the challenges that iPSC biobanks face and suggests some points for the development of appropriate governance structures to address these new requirements. These suggestions also have implications for iPSC research in general.

Struggling to be Fit: Identity, Integrity, and the Law.

This interdisciplinary co-authored Analysis piece introduces identity and integrity, which are argued to sit at the core of the person. It analyses approaches taken to these concepts by legal regimes, particularly in the context of individuals using artificial limbs or digital avatars. The piece concludes that law engages with identity and integrity to a limited and incomplete extent; and that law is thus inadequate in its engagement with the person, and its meaning making in this respect. This piece draws on two interdisciplinary funded projects, funded by the Wellcome Trust and the Arts and Humanities Research Council.