COVID-19 and Health-Related Authority Allocation Puzzles.

COVID-19-related controversies concerning the allocation of scarce resources, travel restrictions, and physical distancing norms each raise a foundational question: How should authority, and thus responsibility, over healthcare and public health law and policy be allocated? Each controversy raises principles that support claims by traditional wielders of authority in "federal" countries, like federal and state governments, and less traditional entities, like cities and sub-state nations. No existing principle divides "healthcare and public law and policy" into units that can be allocated in intuitively compelling ways. This leads to puzzles concerning (a) the principles for justifiably allocating "powers" in these domains and (b) whether and how they change during "emergencies." This work motivates the puzzles, explains why resolving them should be part of long-term responses to COVID-19, and outlines some initial COVID-19-related findings that shed light on justifiable authority allocation, emergencies, emergency powers, and the relationships between them.

[Vulnerability and Health Care. Law and Medical Protocols]. / Vulnerabilidad y Atención Sanitaria: Derecho y Protocolos Médicos.

The article deals with the analysis of the criteria for the allocation of scarce health resources during the pandemic produced by the COVID 19 virus in Spain. It critically analyses the absence of a legal-constitutional perspective in the elaboration of such criteria and suggests the incorporation of the criterion of equity as a guarantee of the effective exercise of the constitutional right to health protection by vulnerable persons.

Comorbidity in context: Part 2. Ethicolegal considerations around HIV and tuberculosis during the COVID-19 pandemic in South Africa.

The COVID-19 pandemic has brought discussions around the appropriate and fair rationing of scare resources to the forefront. This is of special importance in a country such as South Africa (SA), where scarce resources interface with high levels of need. A large proportion of the SA population has risk factors associated with worse COVID-19 outcomes. Many people are also potentially medically and socially vulnerable secondary to the high levels of infection with HIV and tuberculosis (TB) in the country. This is the second of two articles. The first examined the clinical evidence regarding the inclusion of HIV and TB as comorbidities relevant to intensive care unit (ICU) admission triage criteria. Given the fact that patients with HIV or TB may potentially be excluded from admission to an ICU on the basis of an assumption of lack of clinical suitability for critical care, in this article we explore the ethicolegal implications of limiting ICU access of persons living with HIV or TB. We argue that all allocation and rationing decisions must be in terms of SA law, which prohibits unfair discrimination. In addition, ethical decision-making demands accurate and evidence-based strategies for the fair distribution of limited resources. Rationing decisions and processes should be fair and based on visible and consistent criteria that can be subjected to objective scrutiny, with the ultimate aim of ensuring accountability, equity and fairness.

Public Appeals Challenging Criteria for Pediatric Organ Transplantation.

In this article, I review the ethical issues that arise in the allocation of deceased-donor organs to children and young adults. By analyzing the public media cases of Sarah Murnaghan, Amelia Rivera, and Riley Hancey, I assess whether public appeals to challenge inclusion and exclusion criteria for organ transplantation are ethical and under which circumstances. The issues of pediatric allocation with limited evidence and candidacy affected by factors such as intellectual disability and marijuana use are specifically discussed. Finally, I suggest that ethical public advocacy can coexist with well-evidenced transplant allocation if and when certain conditions (morally defensible criteria, expert evidence, nonprioritization of the poster child, and greater advocacy for organ transplantation in general) are met.

An open-source GIS-enabled lookup service for Nagoya Protocol party information.

The Nagoya Protocol on Access and Benefit Sharing is a transparent legal framework, which governs the access to genetic resources and the fair and equitable sharing of benefits arising from their utilization. Complying with the Nagoya regulations ensures legal use and re-use of data from genetic resources. Providing detailed provenance information and clear re-usage conditions plays a key role in ensuring the re-usability of research data according to the FAIR (findable, accessible, interoperable and re-usable) Guiding Principles for scientific data management and stewardship. Even with the framework provided by the ABS (access and benefit sharing) Clearing House and the support of the National Focal Points, establishing a direct link between the research data from genetic resources and the relevant Nagoya information remains a challenge. This is particularly true for re-using publicly available data. The Nagoya Lookup Service was developed for stakeholders in biological sciences with the aim at facilitating the legal and FAIR data management, specifically for data publication and re-use. The service provides up-to-date information on the Nagoya party status for a geolocation provided by GPS coordinates, directing the user to the relevant local authorities for further information. It integrates open data from the ABS Clearing House, Marine Regions, GeoNames and Wikidata. The service is accessible through a REST API and a user-friendly web form. Stakeholders include data librarians, data brokers, scientists and data archivists who may use this service before, during and after data acquisition or publication to check whether legal documents need to be prepared, considered or verified. The service allows researchers to estimate whether genetic data they plan to produce or re-use might fall under Nagoya regulations or not, within the limits of the technology and without constituting legal advice. It is implemented using portable Docker containers and can easily be deployed locally or on a cloud infrastructure. The source code for building the service is available under an open-source license on GitHub, with a functional image on Docker Hub and can be used by anyone free of charge.

[Legal Issues of Resource Allocation in the COVID-19 Pandemic - Between Utilitarianism and Life Value Indifference]. / Rechtsfragen der Ressourcenzuteilung in der COVID-19-Pandemie ­ Zwischen Utilitarismus und Lebenswertindifferenz.

The COVID-19 pandemic poses unprecedented challenges for the German health care system. What is already the case in some other countries, may occur in Germany in the near future also: Faced with limited ICU resources, doctors will be forced to decide which patients to treat and which to let die. This paper examines the legal implications of such decisions. It takes up arguments from the general discussion on prioritization in medicine. A constitutional hurdle for the application of utilitarian criteria (in particular patients' age or social role) comes from the principle that every human life is of equal value and must not be traded off against others ("life value indifference"). However, the limits that the Grundgesetz (German Basic Law) sets for state actions do not apply directly to doctors. According to the Musterberufsordnung (professional code of conduct), doctors act based on their conscience and the requirements of medical ethics and humanity. The implications of this normative standard for the prioritizing in an exceptional situation as the COVID 19 pandemic have not been sufficiently clarified. This uncertainty leads to emotional and moral burdens for doctors. The authors conclude that the German law grants a limited freedom of choice that allows physicians to apply utilitarian criteria in addition to purely medical decision algorithms.

[Ethical, deontologic and legal considerations about SIAARTI Document "Clinical ethics recommendations for the allocation of intensive care treatments, in exceptional, resource-limited circumstances".] / Considerazioni etiche, deontologiche e giuridiche sul Documento SIAARTI "Raccomandazioni di etica clinica per l'ammissione a trattamenti intensivi e per la loro sospensione, in condizioni eccezionali di squilibrio tra necessità e risorse disponibili".

On 6 March 2020, the Italian Society of Anaesthesia Analgesia Resuscitation and Intensive care (SIAARTI) published the document "Clinical Ethics Recommendations for Admission to and Suspension of Intensive Care in Exceptional Conditions of Imbalance between Needs and Available Resources". The document, which aims to propose treatment decision-making criteria in the face of exceptional imbalances between health needs and available resources, has produced strong reactions, within the medical-scientific community, in the academic world, and in the media. In the current context of international public health emergency caused by the CoViD-19 epidemic, this work aims to explain the ethical, deontological and legal bases of the SIAARTI Document and to propose methodologic and argumentative integrations that are useful for understanding and placing in context the decision-making criteria proposed. The working group that contributed to the drafting of this paper agrees that it is appropriate that healthcare personnel, who is particularly committed to taking care of those who are currently in need of intensive or sub-intensive care, should benefit from clear operational indications that are useful to orient care and, at the same time, that the population should know in advance which criteria will guide the tragic choices that may fall on each one of us. This contribution therefore firstly reflects on the appropriateness of the SIAARTI standpoint and the objectives of the SIAARTI Document. It then turns to demonstrate how the recommendations it proposes can be framed within a shared interdisciplinary, ethical, deontological and legal perspective.

[The perspective of migrants on access to health care in the context of austerity policies in Andalusia (Spain)]. / La perspectiva de personas migrantes sobre el acceso a la atención sanitaria en el contexto de políticas de austeridad en Andalucía.

OBJECTIVE: To conduct an assessment of migrant people regarding their access to the health system following entry into force of Royal Decree-Law 16/2012 along with the impact of economic cuts on such access. METHOD: Qualitative phenomenological study with semi-structured interviews, conducted in Andalusia (Spain), in two phases (2009-2010 and 2012-2013), with 36 participants. The sample was segmented by length of stay, nationality and area of residence. The nationalities of origin are Bolivia, Morocco and Romania. RESULTS: Elements facilitating access in both periods: regular administrative situation, possession of Individual Health Card, knowledge of the language, social networks and information. The results show differences in access to health care for migrants before and after the enforcement of the RDL 16/2012, within austerity policies. In the second period, access barriers such as waiting times or incompatibility of schedules are aggravated and the socio-economic and administrative conditions of participants worsen. CONCLUSIONS: The design of policies, economic and regulatory health care, should take into account barriers and facilitators of access as fundamental main points of health protection for migrants and, therefore, for the general population.

Subfinanciamento e orçamento federal do SUS: referências preliminares para a alocação adicional de recursos / Underfunding and federal budget of SUS: preliminary references for additional resource allocation

Resumo Este artigo objetiva identificar novas fontes de receitas para a alocação adicional de recursos para o atendimento das necessidades de saúde da população fixadas nas despesas do orçamento federal, no contexto do processo de subfinanciamento do Sistema Único de Saúde e dos efeitos negativos da Emenda Constitucional 95/2016 para esse processo - queda verificada na proporção da receita corrente líquida federal destinada para o SUS. Nessa perspectiva, é preciso enfrentar o problema do subfinanciamento vinculando à busca por recursos adicionais junto a novas fontes de financiamento com as ações e serviços públicos de saúde que serão aprimoradas, ampliadas e criadas, cujos critérios são: quanto às fontes, exclusividade para o SUS, não regressividade tributária e revisão da renúncia de receita; e, quanto aos usos, priorização da atenção básica como ordenadora da rede de atenção à saúde e valorização dos servidores. O resultado calculado para as fontes variou entre R$ 92 bilhões e R$ 100 bilhões, superior aos R$ 30,5 bilhões apurados para os usos nos termos descritos. Foi realizada pesquisa documental para o levantamento de dados junto a fontes secundárias, especialmente nos relatórios encaminhados ao Conselho Nacional de Saúde pelo Ministério da Saúde.

Abstract This paper aims to identify new sources of revenue for the additional allocation of resources to meet the population's health needs fixed in the federal budget expenses, in the context of the Unified Health System (SUS) underfunding process and the negative effects of Constitutional Amendment 95/2016 for this process - verified decrease in the proportion of federal net current revenue destined to SUS. From this perspective, it is necessary to address the problem of underfunding by linking the search for additional resources with new sources of funding with actions and public health services that will be improved, expanded and created, of which criteria are: regarding sources, exclusivity for SUS, non regressive taxing and review of revenue waiver; and, regarding uses, prioritization of primary care as reference of the health care network and appreciation of civil servants in the health area. The result calculated for the sources ranged from R$ 92 billion to R$ 100 billion, higher than the R$ 30.5 billion calculated for uses under the described terms. A documentary research was conducted to collect data from secondary sources, especially in the reports sent to the National Health Council by the Ministry of Health.

A resposta brasileira à epidemia de HIV/AIDS em tempos de crise / The Brazilian response to the HIV/AIDS epidemic amidst the crisis

Resumo A "crise" é um fenômeno que corresponde a políticas globais e locais com repercussões sociais, políticas e econômicas e é o contexto para este artigo, que visa refletir sobre a resposta brasileira à epidemia de HIV/AIDS. Examinamos dimensões deste fenômeno, como a revisão de consensos das políticas de austeridade, seus impactos e a construção de "antiagendas" que dificultam a narrativa dos direitos humanos, gênero, sexualidade e saúde e obstaculizam o trabalho de prevenção e o cuidado na área de HIV/AIDS. Tal guinada conservadora pode ser associada à censura a materiais especializados e à mudança recente na estrutura de gestão do Ministério da Saúde, à extinção de centenas de conselhos participativos no âmbito do executivo federal e à nova Política Nacional sobre Drogas que substitui a orientação de "redução de danos" para a de "abstinência". Todos esses fenômenos reaquecem uma antiga preocupação: que o "vírus ideológico" venha a suplantar o vírus biológico, acentuando o quadro de estigma e de discriminação. Somados à agressiva orientação socioeconômica neoliberal que ameaça o Estado brasileiro, tais fatos afetariam a continuidade das respostas institucionais ao HIV/AIDS.

Abstract "Crisis" is a phenomenon that is part of global and local policies with social, political, and economic repercussions. It is the context of this paper that aims to reflect on the Brazilian response to the HIV/AIDS epidemic. We examined the realms of this phenomenon, such as the review of the consensus on austerity policies, their impact and the construction of "anti-agendas" that hinder the narrative of human rights, gender, sexuality, and health and hamper HIV/AIDS prevention and care. Such a conservative move can be associated with censorship of specialized materials and the recent change of management in the structure of the Ministry of Health, the extinction of hundreds of participatory councils within the Executive Branch and the new National Policy on Drugs that replaces the guidance "harm reduction" with one of "abstinence". All these phenomena revive an old concern, that is, that the "ideological virus" will outweigh the biological virus, exacerbating the situation of stigma and discrimination. Besides the neoliberal socioeconomic orientation that threatens the Brazilian state, such facts would affect the continuity of institutional responses to HIV/AIDS.

Underfunding and federal budget of SUS: preliminary references for additional resource allocation. / Subfinanciamento e orçamento federal do SUS: referências preliminares para a alocação adicional de recursos.

This paper aims to identify new sources of revenue for the additional allocation of resources to meet the population's health needs fixed in the federal budget expenses, in the context of the Unified Health System (SUS) underfunding process and the negative effects of Constitutional Amendment 95/2016 for this process - verified decrease in the proportion of federal net current revenue destined to SUS. From this perspective, it is necessary to address the problem of underfunding by linking the search for additional resources with new sources of funding with actions and public health services that will be improved, expanded and created, of which criteria are: regarding sources, exclusivity for SUS, non regressive taxing and review of revenue waiver; and, regarding uses, prioritization of primary care as reference of the health care network and appreciation of civil servants in the health area. The result calculated for the sources ranged from R$ 92 billion to R$ 100 billion, higher than the R$ 30.5 billion calculated for uses under the described terms. A documentary research was conducted to collect data from secondary sources, especially in the reports sent to the National Health Council by the Ministry of Health.

Este artigo objetiva identificar novas fontes de receitas para a alocação adicional de recursos para o atendimento das necessidades de saúde da população fixadas nas despesas do orçamento federal, no contexto do processo de subfinanciamento do Sistema Único de Saúde e dos efeitos negativos da Emenda Constitucional 95/2016 para esse processo ­ queda verificada na proporção da receita corrente líquida federal destinada para o SUS. Nessa perspectiva, é preciso enfrentar o problema do subfinanciamento vinculando à busca por recursos adicionais junto a novas fontes de financiamento com as ações e serviços públicos de saúde que serão aprimoradas, ampliadas e criadas, cujos critérios são: quanto às fontes, exclusividade para o SUS, não regressividade tributária e revisão da renúncia de receita; e, quanto aos usos, priorização da atenção básica como ordenadora da rede de atenção à saúde e valorização dos servidores. O resultado calculado para as fontes variou entre R$ 92 bilhões e R$ 100 bilhões, superior aos R$ 30,5 bilhões apurados para os usos nos termos descritos. Foi realizada pesquisa documental para o levantamento de dados junto a fontes secundárias, especialmente nos relatórios encaminhados ao Conselho Nacional de Saúde pelo Ministério da Saúde.

The Brazilian response to the HIV/AIDS epidemic amidst the crisis. / A resposta brasileira à epidemia de HIV/AIDS em tempos de crise.

"Crisis" is a phenomenon that is part of global and local policies with social, political, and economic repercussions. It is the context of this paper that aims to reflect on the Brazilian response to the HIV/AIDS epidemic. We examined the realms of this phenomenon, such as the review of the consensus on austerity policies, their impact and the construction of "anti-agendas" that hinder the narrative of human rights, gender, sexuality, and health and hamper HIV/AIDS prevention and care. Such a conservative move can be associated with censorship of specialized materials and the recent change of management in the structure of the Ministry of Health, the extinction of hundreds of participatory councils within the Executive Branch and the new National Policy on Drugs that replaces the guidance "harm reduction" with one of "abstinence". All these phenomena revive an old concern, that is, that the "ideological virus" will outweigh the biological virus, exacerbating the situation of stigma and discrimination. Besides the neoliberal socioeconomic orientation that threatens the Brazilian state, such facts would affect the continuity of institutional responses to HIV/AIDS.

A "crise" é um fenômeno que corresponde a políticas globais e locais com repercussões sociais, políticas e econômicas e é o contexto para este artigo, que visa refletir sobre a resposta brasileira à epidemia de HIV/AIDS. Examinamos dimensões deste fenômeno, como a revisão de consensos das políticas de austeridade, seus impactos e a construção de "antiagendas" que dificultam a narrativa dos direitos humanos, gênero, sexualidade e saúde e obstaculizam o trabalho de prevenção e o cuidado na área de HIV/AIDS. Tal guinada conservadora pode ser associada à censura a materiais especializados e à mudança recente na estrutura de gestão do Ministério da Saúde, à extinção de centenas de conselhos participativos no âmbito do executivo federal e à nova Política Nacional sobre Drogas que substitui a orientação de "redução de danos" para a de "abstinência". Todos esses fenômenos reaquecem uma antiga preocupação: que o "vírus ideológico" venha a suplantar o vírus biológico, acentuando o quadro de estigma e de discriminação. Somados à agressiva orientação socioeconômica neoliberal que ameaça o Estado brasileiro, tais fatos afetariam a continuidade das respostas institucionais ao HIV/AIDS.

Does Information Asymmetry Impact Sub-Regions' Cooperation of Regional Water Resource Allocation?

Water resources allocation is an urgent problem for basin authorities. In order to obtain greater economic benefits from limited water supplies, sub-regions must cooperate with each other. To study the influence of cooperation among sub-regions and the symmetry of cooperation information on the interests of the basin authority and each sub-region, this study proposes a regional water allocation model in three different situations: (1) non-cooperation; (2) cooperation and information symmetry; (3) cooperation and information asymmetry. The proposed model clearly reflects the Stackelberg game relationship between the basin authority and sub-regions. Finally, the model is applied to the Qujiang River Basin in China, and the decisions of the basin authority and sub-regional managers of the Qujiang River Basin under three different situations are discussed. The results show that regional cooperation benefits both the cooperative regions and the social welfare value of the entire river basin, when compared with non-cooperation.

Impact of the 2016 revision of US Pediatric Heart Allocation Policy on waitlist characteristics and outcomes.

US Pediatric Heart Allocation Policy was recently revised, deprioritizing candidates with cardiomyopathy while maintaining status 1A eligibility for congenital heart disease (CHD) candidates on "high-dose" inotropes. We compared waitlist characteristics and mortality around this change. Status 1A listings decreased (70% to 56%, P < .001) and CHD representation increased among status 1A listings (48% vs 64%, P < .001). Waitlist mortality overall (subdistribution hazard ratio [SHR] 0.96, P = .63) and among status 1A candidates (SHR 1.16, P = .14) were unchanged. CHD waitlist mortality trended better (SHR 0.82, P = .06) but was unchanged for CHD candidates listed status 1A (SHR 0.92, P = .47). Status 1A listing exceptions increased 2- to 3-fold among hypertrophic and restrictive cardiomyopathy candidates and 13.5-fold among dilated cardiomyopathy (DCM) candidates. Hypertrophic (SHR 6.25, P = .004) and restrictive (SHR 3.87, P = .03) cardiomyopathy candidates without status 1A exception had increased waitlist mortality, but those with DCM did not (SHR 1.26, P = .32). Ventricular assist device (VAD) use increased only among DCM candidates ≥1 years old (26% vs 38%, P < .001). Current allocation policy has increased CHD status 1A representation but has not improved their waitlist mortality. Excessive DCM status 1A listing exceptions and continued status 1A prioritization of children on stable VADs potentially diminish the intended benefits of policy revision.

Geographic Location and Moral Arbitrariness in the Allocation of Donated Livers.

The federal system for allocating donated livers in the United States is often criticized for allowing geographic disparities in access to livers. Critics argue that such disparities are unfair on the grounds that where one lives is morally arbitrary and so should not influence one's access to donated livers. They argue instead that livers should be allocated in accordance with the equal opportunity principle, according to which US residents who are equally sick should have the same opportunity to receive a liver, regardless of where they live. In this paper, we examine a central premise of the argument for the equal opportunity principle, namely, that geographic location is a morally arbitrary basis for allocating livers. We raise some serious doubts regarding the truth of this premise, arguing that under certain conditions, factors closely associated with geographic location are relevant to the allocation of livers, and so that candidates' geographic location is sometimes a morally non-arbitrary basis for allocating livers. Geographic location is morally non-arbitrary, we suggest, since by taking it into account, the UNOS may better fulfill its central goals of facilitating the effective and efficient placement of organs for transplantation and increasing organ donation.

Allocation of liver grafts worldwide - Is there a best system?

BACKGROUND & AIMS: An optimal allocation system for scarce resources should simultaneously ensure maximal utility, but also equity. The most frequent principles for allocation policies in liver transplantation are therefore criteria that rely on pre-transplant survival (sickest first policy), post-transplant survival (utility), or on their combination (benefit). However, large differences exist between centers and countries for ethical and legislative reasons. The aim of this study was to report the current worldwide practice of liver graft allocation and discuss respective advantages and disadvantages. METHODS: Countries around the world that perform 95 or more deceased donor liver transplantations per year were analyzed for donation and allocation policies, as well as recipient characteristics. RESULTS: Most countries use the model for end-stage liver disease (MELD) score, or variations of it, for organ allocation, while some countries opt for center-based allocation systems based on their specific requirements, and some countries combine both a MELD and center-based approach. Both the MELD and center-specific allocation systems have inherent limitations. For example, most countries or allocation systems address the limitations of the MELD system by adding extra points to recipient's laboratory scores based on clinical information. It is also clear from this study that cancer, as an indication for liver transplantation, requires special attention. CONCLUSION: The sickest first policy is the most reasonable basis for the allocation of liver grafts. While MELD is currently the standard for this model, many adjustments were implemented in most countries. A future globally applicable strategy should combine donor and recipient factors, predicting probability of death on the waiting list, post-transplant survival and morbidity, and perhaps costs. LAY SUMMARY: An optimal allocation system for scarce resources should simultaneously ensure maximal utility, but also equity. While the model for end-stage liver disease is currently the standard for this model, many adjustments were implemented in most countries. A future globally applicable strategy should combine donor and recipient factors predicting probability of death on the waiting list, post-transplant survival and morbidity, and perhaps costs.