Allocating a COVID-19 Vaccine: Balancing National and International Responsibilities.

Policy Points In this paper we propose a middle-ground policy for the distribution of an effective COVID-19 vaccine, between a cosmopolitan approach that rejects entirely nation-state priority and unbridled vaccine nationalism that disregards obligations to promote an equitable global allocation of an effective vaccine over time. Features of the COVAX partnership, a collaboration among the Global Alliance for Vaccines and Immunizations (GAVI), the Coalition for Epidemic Preparedness Innovations (CEPI), and the World Health Organization (WHO) to develop and distribute COVID-19 vaccines make it an appropriate framework for a middle-ground policy.

Issues and Challenges Associated with Data-Sharing in LMICs: Perspectives of Researchers in Thailand.

Data-sharing helps advance scientific research and assures the benefits of research data are maximized. Previous work has highlighted ethical challenges, especially in low- and middle-income countrie (LMIC) countries. This study examined the views of researchers in a middle-income country, Thailand, regarding the most important data-sharing challenges. The target researchers worked in biomedical and related research. The survey was distributed to 38 academic and health-science institutes, 18 university hospitals, 84 nonuniversity hospitals, and 22 research institutes across Thailand; 229 researchers in clinical/basic and social/behavioral sciences, and pubxxlic health/policy participated. Thai researchers were less concerned with informed consent and the feasibility of conducting research and sharing data, focusing on the importance of safeguards when handling data, including transfer to others, and possible lack of control over subsequent data use. The respondents felt that researchers should decide what types of project data are shareable and which data are likely useful to the scientific community. They were more concerned with appropriate acknowledgment and protecting the legal rights of the primary data collectors and providers. Although they had concerns about data access conditions, they rated sharing sufficient data and metadata to reproduce the analysis of the primary outcomes as highly important. These results are important for future efforts of the LMIC countries to develop efficient data-sharing frameworks and establish institutional data access committees. They highlight the importance, for the sustainability and fairness of these efforts, to ensure that parties in LMIC countries receive appropriate credit and are involved in determining where/when/how their data may be used.

Understanding the futility of countries' obligations for health rights: realising justice for the global poor.

BACKGROUND: Although health is a right of all individuals without any distinction, the realisation of this right has remained very difficult for the marginalised populations of poor countries. Inequitable distribution of health opportunities globally is a major factor in explaining why this is the case. Whereas the Protection, Promotion and Fulfilment of the health rights of poor country citizens are a joint responsibility of both domestic and external governments, most governments flout their obligations. So far disproportionate effort has been dedicated to reaffirming and interpreting these obligations as opposed to investigating the fundamental question regarding why these obligations have nevertheless remained largely unfulfilled. Further the normative question regarding what ought to be done about the shortcomings of current obligations has been largely ignored. METHODS: We conduct a critical content analysis of existing literature on efforts towards the realisation of the health rights of marginalised populations in our attempt to ascertain their capacity to guarantee basic health opportunities to marginalised populations. In our analysis we treat issues of 'health rights' and 'justice in global health' as having unity of purpose - guaranteeing basic health opportunities to the marginalised populations. RESULTS: We identify two sets of reasons for the failure of present obligations for global distributive justice in general: a set of 'superficial reasons' and a set of 'fundamental reasons' which account for the superficial reasons. DISCUSSION: In order to overcome these reasons we propose a strategy which consists in specifying a number of minimum and less-demanding obligations for both external and domestic governments to guarantee to all individuals a certain threshold of health goods and services. We argue that these minimum obligations can be freely accepted and fully complied with or enforced with "a thin system of enforcement" without significant threat to national sovereignty and autonomy. CONCLUSION: The futility of countries' obligations for the health rights of the global poor as is the case with global distributive injustice is because of lack of political will to specify and enforce such obligations. Minimum obligations should be specified and enforced with a "thin system" which is consistent with principles of national sovereignty and autonomy.

Eugenics and Mandatory Informed Prenatal Genetic Testing: A Unique Perspective from China.

The application of genetic technologies in China, especially in the area of prenatal genetic testing, is rapidly increasing in China. In the wealthy regions of China, prenatal genetic testing is already very widely adopted. We argue that the government should actively promote prenatal genetic testing to the poor areas of the country. In fact, the government should prioritize resources first to make prenatal genetic testing a standard routine care with an opt-out model in these area. Healthcare professions would be required to inform pregnant women about the availability of genetic testing and provide free testing on a routine basis unless the parents choose not to do so. We argue that this proposal will allow parents to make a more informed decision about their reproductive choices. Secondarily, this proposal will attract more healthcare professionals and other healthcare resources to improve the healthcare infrastructures in the less-developed regions of the country. This will help to reduce the inequity of accessing healthcare services between in different regions of China. We further argue that this policy proposal is not practicing eugenics.

Obligations of low income countries in ensuring equity in global health financing.

BACKGROUND: Despite common recognition of joint responsibility for global health by all countries particularly to ensure justice in global health, current discussions of countries' obligations for global health largely ignore obligations of developing countries. This is especially the case with regards to obligations relating to health financing. Bearing in mind that it is not possible to achieve justice in global health without achieving equity in health financing at both domestic and global levels, our aim is to show how fulfilling the obligation we propose will make it easy to achieve equity in health financing at both domestic and international levels. DISCUSSION: Achieving equity in global health financing is a crucial step towards achieving justice in global health. Our general view is that current discussions on global health equity largely ignore obligations of Low Income Country (LIC) governments and we recommend that these obligations should be mainstreamed in current discussions. While we recognise that various obligations need to be fulfilled in order to ultimately achieve justice in global health, for lack of space we prioritise obligations for health financing. Basing on the evidence that in most LICs health is not given priority in annual budget allocations, we propose that LIC governments should bear an obligation to allocate a certain minimum percent of their annual domestic budget resources to health, while they await external resources to supplement domestic ones. We recommend and demonstrate a mechanism for coordinating this obligation so that if the resulting obligations are fulfilled by both LIC and HIC governments it will be easy to achieve equity in global health financing. Although achieving justice in global health will depend on fulfillment of different categories of obligations, ensuring inter- and intra-country equity in health financing is pivotal. This can be achieved by requiring all LIC governments to allocate a certain optimal per cent of their domestic budget resources to health while they await external resources to top up in order to cover the whole cost of the minimum health opportunities for LIC citizens.

Attitudes towards transfers of human tissue samples across borders: an international survey of researchers and policy makers in five countries.

BACKGROUND: Sharing of tissue samples for research and disease surveillance purposes has become increasingly important. While it is clear that this is an area of intense, international controversy, there is an absence of data about what researchers themselves and those involved in the transfer of samples think about these issues, particularly in developing countries. METHODS: A survey was carried out in a number of Asian countries and in Egypt to explore what researchers and others involved in research, storage and transfer of human tissue samples thought about some of the issues related to sharing of such samples. RESULTS: The results demonstrated broad agreement with the positions taken by developing countries in the current debate, favoring quite severe restrictions on the use of samples by developed countries. CONCLUSIONS: It is recommended that an international agreement is developed on what conditions should be attached to any sharing of human tissue samples across borders.

Principles versus procedures in making health care coverage decisions: addressing inevitable conflicts.

It has been suggested that focusing on procedures when setting priorities for health care avoids the conflicts that arise when attempting to agree on principles. A prominent example of this approach is "accountability for reasonableness." We will argue that the same problem arises with procedural accounts; reasonable people will disagree about central elements in the process. We consider the procedural condition of appeal process and three examples of conflicts over coverage decisions: a patients' rights law in Norway, health technologies coverage recommendations in the UK, and care withheld by HMOs in the US. In each case a process is at the center of controversy, illustrating the difficulties in establishing procedures that are widely accepted as legitimate. Further work must be done in developing procedural frameworks.

[Biomedical model of disease and criteria of distributive justice in disability pension cases]. / Biomedisinsk sykdomsmodell og rettferdig fordeling av uførepensjon.

As an expert in disability pension cases, the physician lays down important premises for the distribution of financial resources in society. The aim of this article is to present the material criteria of distributive justice of the Norwegian National Insurance Act and to carry out a constructive critique of how physicians are supposed to objectively evaluate their patients in light of these criteria. The form "Medical assessment of work disability" of the National Insurance Administration and central legal texts have been examined by using the method of text analysis. The material criteria of the Norwegian National Insurance Act, the criterion of need, of equality and of effort, are all implicitly contained in the form "Medical assessment of work disability". According to the form, the situation of the claimant should, in the light of these criteria, be evaluated by means of the biomedical model of disease. The central criterion of objectivity when applied in light of this model proves to be the ontological concept of objectivity, i.e. what exists as "objective findings". Our analysis indicates that a description and an evaluation of the claimant's situation in relation to the criteria of need, equality and vocational rehabilitation, when combined with the ontological concept of objectivity, tends to become arbitrary, insufficient and inaccurate. It is considered as problematic and unjust that little attention is given to the criterion of equality, defined as equal right for all citizens to the same actual possibilities of participation in the society, working life included, by an evaluation of disability based exclusively on the classical biomedical model of disease. The medical model of national insurance and of medicine should become more coordinated. Moreover, more weight should be given to impartial, varied and accurate evaluation according to an epistemological concept of objectivity. In this way the disability claimant's individual needs can be better clarified.

The standard of care debate: can research in developing countries be both ethical and responsive to those countries' health needs?

To avoid exploitation of host communities, many commentators argue that subjects must receive the best methods available worldwide. Others worry that this requirement may block important research intended to improve health care, especially in developing countries. To resolve this dilemma, we propose a framework for the conditions under which it is acceptable to provide subjects with less than the best methods. Specifically, institutional review boards should assume a default of requiring the "worldwide best" methods, meaning the best methods available anywhere in the world, in all cases.However, institutional review boards should be willing to grant exceptions to this default for research studies that satisfy the following 4 conditions: (1) scientific necessity, (2) relevance for the host community, (3) sufficient host community benefit, and (4) subject and host community non-maleficence.

Evidence-based medicine as an instrument for rational health policy.

This article tries to present a broad view on the values and ethical issues that are at stake in efforts to rationalize health policy on the basis of economic evaluations (like cost-effectiveness analysis) and randomly controlled clinical trials. Though such a rationalization is generally seen as an objective and 'value free' process, moral values often play a hidden role, not only in the production of 'evidence', but also in the way this evidence is used in policy making. For example, the definition of effectiveness of medical treatment or health care service is heavily dependent on dominant individual or social views about the goals of the particular treatment or service. There is also a concern that a reliance on EBM in health policy will occur at the expense of widely shared social values like equity and solidarity. Moreover, there is a concern that when economic considerations and rational procedures become more influential, various 'outside' groups third parties like insurance companies and policy makers will get a stronger influence on medical practice which may lead to a change in the patient-provider relationship. The authors conclude that social values and patient preference should be explicitly addressed when health policy making is based on economic and other scientific evidence.