Reidar Lie

This article presents a case study from the history of cardiology, namely, the development towards the acceptance of the coronary theory of angina pectoris. I show that the arguments which were considered decisive against the theory were not answered at the time the theory was accepted. I also point out that the experimental and practical success of the theory cannot be used to support the initial choice because, in the subsequent development, the field researchers became preoccupied with new questions and problems. In spite of this, there is a sense in which the field of angina research has progressed, but it remains a challenge to exactly characterise in what sense this is the case.

This is a discussion of the reaction to the recent research article publication in the journal Protein & Cell by a group of scientists at Sun Yat-sen University using the CRISPR/Cas9 technique on editing non-viable human zygotes. Many commentators condemned the Chinese scientists for overstepping ethical boundaries long accepted in Western countries and accused China of having lax regulations on genomic research in general. We argue that not only did this research follow strict ethical standards and fully comply with current regulations, but China also has a well-developed regulatory framework governing such research comparable to many developed countries. We see the reactions among Western commentators as a misunderstanding of the current situation and an expression of a lack of willingness to acknowledge China as an equal partner in the international debate about proper limits to the development of new biotechnologies.

In this issue, Alex London and Kevin Zollman provide an analysis of an influential approach to the ethics of international research, known as the “fair benefits” approach. According to them, the fair benefits approach suffers from a fatal flaw: it is either too vague to be useful, or worse, is internally inconsistent. The fair benefits approach was developed based on a presentation I gave at a workshop organized in Malawi in March 2001 by the National Institutes of Health Clinical Center’s Department of Bioethics. In this presentation, I made what I still think is a valid point, which was accepted by the diverse group of participants and formed the basis of the subsequent publications: One should not ..

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.

All health care systems face problems of justice and efficiency related to setting priorities for allocating a limited pool of resources to a population. Because many of the central issues are the same in all systems, the United States and other countries can learn from the successes and failures of countries that have explicitly addressed the question of health care priorities. We review explicit priority setting efforts in Norway, Sweden, Israel, the Netherlands, Denmark, New Zealand, the United Kingdom and the state of Oregon in the US. The approaches used can be divided into those centered on outlining principles versus those that define practices. In order to establish the main lessons from their experiences we consider the process each country used, criteria to judge the success of these efforts, which approaches seem to have met these criteria, and using their successes and failures as a guide, how to proceed in setting priorities. We demonstrate that there is little evidence that establishment of a values framework for priority setting has had any effect on health policy, nor is there evidence that priority setting exercises have led to the envisaged ideal of an open and participatory public involvement in decision making.

This article tries to present a broad view on the values and ethicalissues that are at stake in efforts to rationalize health policy on thebasis of economic evaluations (like cost-effectiveness analysis) andrandomly controlled clinical trials. Though such a rationalization isgenerally seen as an objective and `value free' process, moral valuesoften play a hidden role, not only in the production of `evidence', butalso in the way this evidence is used in policy making. For example, thedefinition of effectiveness of medical treatment or health care serviceis heavily dependent on dominant individual or social views about thegoals of the particular treatment or service. There is also a concernthat a reliance on EBM in health policy will occur at the expense ofwidely shared social values like equity and solidarity. Moreover, thereis a concern that when economic considerations and rational proceduresbecome more influential, various `outside' groups third parties likeinsurance companies and policy makers will get a stronger influence onmedical practice which may lead to a change in the patient-providerrelationship. The authors conclude that social values and patientpreference should be explicitly addressed when health policy making isbased on economic and other scientific evidence

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.

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 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. Summary. Although achieving justice in global health will depend on fulfilment 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.

Decision analysts sometimes use the results of clinical trials in order to evaluate treatment alternatives. I discuss some problems associated with this, and in particular I point out that it is not valid to use the estimates from clinical trials as the probabilities of events which are needed for decision analysis. I also attempt to show that an approach based on objective statistical theory may have advantages over commonly used methods based on decision theory. These advantages include the recognition of uncertain data, the introduction of a third alternative, namely suspension of judgement, and the possibility of modifying the choice of probabilities based on a clinical trial with reference to other available knowledge. I have not, however, shown in detail how this modification is done, but I think the concept is sufficiently promising to be applied to an actual clinical decision problem.