The use of genome embryo editing tools in reproduction is often touted as a way to ensure the birth of healthy and genetically related children. Many would agree that this is a worthy goal. The purpose of this paper is to argue that, if we are concerned with justice, accepting such goal as morally appropriate commits one to rejecting the development of embryo editing for reproductive purposes. This is so because safer and more effective means exist that can allow many (...) more prospective parents to achieve the same valued goal and that offer additional benefits. (shrink)

According to psychological research, people are more eager to help identified individuals than unidentified ones. This phenomenon significantly influences many important decisions, both individual and public, regarding, for example, vaccinations or the distribution of healthcare resources. This paper aims at presenting definitions of various levels of identifiability as well as a critical analysis of the main philosophical arguments regarding the normative significance of the identifiability effect, which refer to: (1) ex ante contractualism; (2) fair distribution of chances and risks; (3) (...) anti-aggregationist principles that recommend the distribution of bad effects and the concentration of good ones. I will show that these arguments, although connected with interesting philosophical problems regarding e.g. counterfactuals, aggregation, or probability, are unconvincing. (shrink)

Principles of need are constantly referred to in health care priority setting. The common denominator for any principle of need is that it will ascribe some kind of special normative weight to people being worse off. However, this common ground does not answer the question how a plausible principle of need should relate to the aggregation of benefits across individuals. Principles of need are sometimes stated as being incompatible with aggregation and sometimes characterized as accepting aggregation in much the same (...) way as utilitarians do. In this paper we argue that if one wants to take principles of need seriously both of these positions have unreasonable implications. We then characterize and defend a principle of need consisting of sufficientarian elements as well as prioritarian which avoids these unreasonable implications. (shrink)

How to handle orphan drugs for rare diseases is a pressing problem in current health-care. Due to the group size of patients affecting the cost of treatment, they risk being disadvantaged in relation to existing cost-effectiveness thresholds. In an article by Niklas Juth it has been argued that it is irrelevant to take indirectly operative factors like group size into account since such a compensation would risk discounting the use of cost, a relevant factor, altogether. In this article we analyze (...) Juth’s argument and observe that we already do compensate for indirectly operative factors, both outside and within cost-effectiveness evaluations, for formal equality reasons. Based on this we argue that we have reason to set cost-effectiveness thresholds to integrate equity concerns also including formal equality considerations. We find no reason not to compensate for group size to the extent we already compensate for other factors. Moreover, groups size implying a systematic disadvantage also on a global scale, i.e. taking different aspects of the health condition of patients suffering from rare diseases into account, will provide strong reason for why group size is indeed relevant to compensate for. (shrink)

This paper examines the moral import of a distinction between natural and social inequalities. Following Thomas Nagel, it argues for a “denatured” distinction that relies less on the biological vs. social causation of inequalities than on the idea that society is morally responsible for some inequalities but not others. It maintains that securing fair equality of opportunity by eliminating such social inequalities has particularly high priority in distributive justice. Departing from Nagel, it argues that society can be responsible for inequalities (...) not only when they are the unintended result of justifiable projects, but even when their alleviation would be very costly. Sharing Nagel’s general concept of ‘social inequality’, then, this paper proposes a far more expansive conception. We argue that many disadvantages due to disability fall under this conception. Eliminating or alleviating those disadvantages should be regarded as securing fair equality of opportunity, not improving the condition of the worst-off. (shrink)

Background In this study, we examined the ethical implications of Egypt’s new clinical trial law, employing the ethical framework proposed by Emanuel et al. and comparing it to various national and supranational laws. This analysis is crucial as Egypt, considered a high-growth pharmaceutical market, has become an attractive location for clinical trials, offering insights into the ethical implementation of bioethical regulations in a large population country with a robust healthcare infrastructure and predominantly treatment-naïve patients. Methods We conducted a comparative analysis (...) of Egyptian law with regulations from Sweden and France, including the EU Clinical Trials Regulation, considering ethical human subject research criteria, and used a directed approach to qualitative content analysis to examine the laws and regulations. This study involved extensive peer scrutiny, frequent debriefing sessions, and collaboration with legal experts with relevant international legal expertise to ensure rigorous analysis and interpretation of the laws. Results On the rating of the seven different principles (social and scientific values, scientific validity, fair selection of participants, risk-benefit ratio, independent review, informed consent and respect for participants) Egypt, France, and EU regulations had comparable scores. Specific principles (Social Value, Scientific Value, and Fair selection of participants) were challenging to directly identify due to certain regulations embodying 'implicit' principles more than explicitly stated ones. Conclusion The analysis underscores Egypt's alignment with internationally recognized ethical principles, as outlined by Emanuel et al., through its comparison with French, Swedish, and EU regulations, emphasizing the critical need for Egypt to continuously refine its ethical regulations to safeguard participant protection and research integrity. Key issues identified include the necessity to clarify and standardize the concept of social value in research, alongside concerns regarding the expertise and impartiality of ethical review boards, pointing towards a broader agenda for enhancing research ethics in Egypt and beyond. (shrink)

Orphan drug policy often gives ‘special treatment’ to rare diseases, by giving additional priority or making exceptions to specific drugs, based on the rarity of the conditions they aim to treat. This essay argues that the goal of orphan drug policy should be to make prevalence irrelevant to funding decisions. It aims to demonstrate that it is severity, not prevalence, which drives our judgments that important claims are being overlooked when treatments for severe rare diseases are not funded. It shows (...) that prioritising severity avoids problems caused by prioritising rarity, and that it is compatible with a range of normative frameworks. The implications of a severity-based view for drug development are then derived. The severity-based view also accounts for what is wrong with how the current system of drug development unfairly neglects common diseases that burden the developing world. Lastly, the implications of a severity-based view for current orphan drug policies are discussed. There are no data in this work. (shrink)

We propose a principle of sustainability to complement established principles used for justifying healthcare resource allocation. We argue that the application of established principles of equal treatment, need, prognosis and cost-effectiveness gives rise to what we call negative dynamics: a gradual depletion of the value possible to generate through healthcare. These principles should therefore be complemented by a sustainability principle, making the prospect of negative dynamics a further factor to consider, and possibly outweigh considerations highlighted by the other principles. We (...) demonstrate how this principle may take different forms, and show that a commitment to sustainability is supported by considerations internal to the ethical principles already guiding healthcare resource allocation. We also consider two objections. The first of these, we argue, is either based on implausible assumptions or begs the question, whereas the second can be adequately accommodated by the principle we propose. (shrink)

In recent years, the issue of accepting a higher cost per health improvement for orphan drugs has been the subject of discussion in health care policy agencies and the academic literature. This article aims to provide an analysis of broadly egalitarian arguments for and against accepting higher costs per health improvement. More specifically, we aim to investigate which arguments one should agree upon putting aside and where further explorations are needed. We identify three kinds of arguments in the literature: considerations (...) of substantial equality, formal equality, and opportunity cost. We argue that considerations of substantial equality do not support higher costs per health improvement orphan drugs, even if such considerations are considered valid. On the contrary, arguments of formal equality may support accepting a higher cost per health improvement for orphan drugs. However, in order to do so, a number of both normative and empirical issues must be resolved; these issues are identified in the article. For instance, it must be settled to what extent the opportunity cost in terms of foregone health for other patients is acceptable in order to uphold formal equality. We conclude that certain arguments can be set aside, and future focus should be put on the unresolved normative and empirical issues related to formal equality and opportunity cost. (shrink)

The Danish healthcare system must meet the need for easy and equal access to healthcare for every citizen. However, investigations have shown unfair prioritization of cancer patients and unfair prioritization of resources for expensive medicines over care. What is needed are principles for proper prioritization. This article investigates whether American ethicists Tom Beauchamp and James Childress’s principle of justice may be helpful as a conceptual framework for reflections on prioritization of expensive biological therapies in the Danish healthcare system. We present (...) an empirical study exploring the principles for prioritizing new expensive biological therapies. This study includes qualitative interviews with key Danish stakeholders experienced in antibody therapy and prioritizing resources for expensive medicines. Beauchamp and Childress’s model only covers government-funded primary and acute healthcare. Based on the interviews, this study indicates that to be helpful in a Danish context this model should include equal access for citizens to government-funded primary and acute healthcare, costly medicine, and other scarce treatments. We conclude that slightly modified, Beauchamp and Childress’s principle of justice might be useful as a conceptual framework for reflections on the prioritization of expensive biological therapies in the Danish healthcare system. (shrink)

Recent health legislation in Norway significantly increases access to specialist care within a legally binding time frame. The paper describes the contents of the new legislation and introduces some of the challenges with proliferations of rights to health care. The paper describes some of the challenges associated with the proliferation of legal rights to health care. It explains the benefits of assessing the new law in the light of a rights framework. It then analyses the problematic aspects of establishing additional (...) priority rules as solutions to rights conflicts. It then defends adequacy criteria for acceptable priority rules when such rules are unavoidable. It finally defends our proposed method and explores concrete applications. (shrink)