Cristian Timmermann

This paper aims to analyze the ethical challenges in experimental drug use during the early stage of the COVID-19 pandemic, using Germany as a case study. In Germany uniform ethical guidelines were available early on nationwide, which was considered as desirable by other states to reduce uncertainties and convey a message of unity. The purpose of this ethical analysis is to assist the preparation of future guidelines on the use of medicines during public health emergencies. The use of hydroxychloroquine, remdesivir and COVID-19 convalescent plasma in clinical settings was analyzed from the perspective of the ethical principles of beneficence, non-maleficence, justice and autonomy. We observed that drug safety and drug distribution during the pandemic affects all four ethical principles. We therefore recommend to establish ethical guidelines (i) to discuss experimental treatment options with patients from all population groups who are in urgent need, (ii) to facilitate the recording of patient reactions to drugs in off-label use, (iii) to expand inclusion criteria for clinical studies to avoid missing potentially negative effects on excluded groups, and (iv) to maintain sufficient access to repurposed drugs for patients with prior conditions.

New technologies such as smart sensors improve rehabilitation processes and thereby increase older adults’ capabilities to participate in social life, leading to direct physical and mental health benefits. Wearable smart sensors for home use have the additional advantage of monitoring day-to-day activities and thereby identifying rehabilitation progress and needs. However, identifying and selecting rehabilitation priorities is ethically challenging because physicians, therapists, and caregivers may impose their own personal values leading to paternalism. Therefore, we develop a discussion template consisting of a series of adaptable questions for the patient–physician encounter based on the capability approach. The goal is to improve geriatric rehabilitation and thereby increase participation in social life and well-being. To achieve this goal, we first analyzed what is considered important for participation on basis of the capability approach, human rights, and ethics of care. Second, we conducted an ethical analysis of each of the four identified dimensions of participation: political, economic, socio-cultural, and care. To improve compliance with rehabilitation measures, health professionals must align rehabilitation measures in an open dialogue with the patient’s aspiration for participation in each dimension. A discussion template based on the capability approach allows for a proactive approach in patient information and stimulates a critical assessment of treatment alternatives while reducing the risk of imposing personal values.

Definition of the problem The umbrella term “explicability” refers to the reduction of opacity of artificial intelligence (AI) systems. These efforts are challenging for medical AI applications because higher accuracy often comes at the cost of increased opacity. This entails ethical tensions because physicians and patients desire to trace how results are produced without compromising the performance of AI systems. The centrality of explicability within the informed consent process for medical AI systems compels an ethical reflection on the trade-offs. Which levels of explicability are needed to obtain informed consent when utilizing medical AI? Arguments We proceed in five steps: First, we map the terms commonly associated with explicability as described in the ethics and computer science literature, i.e., disclosure, intelligibility, interpretability, and explainability. Second, we conduct a conceptual analysis of the ethical requirements for explicability when it comes to informed consent. Third, we distinguish hurdles for explicability in terms of epistemic and explanatory opacity. Fourth, this then allows to conclude the level of explicability physicians must reach and what patients can expect. In a final step, we show how the identified levels of explicability can technically be met from the perspective of computer science. Throughout our work, we take diagnostic AI systems in radiology as an example. Conclusion We determined four levels of explicability that need to be distinguished for ethically defensible informed consent processes and showed how developers of medical AI can technically meet these requirements.

Background: The internationalization of clinical studies requires a shared understanding of the fundamental ethical values guiding clinical studies. It is important that these values are not only embraced at the legal level but also adopted by clinicians themselves during clinical studies. Objective: Our goal is to provide an insight on how clinicians in Germany and Poland perceive and identify the different ethical issues regarding informed consent in clinical studies. Methods: To gain an understanding of how clinicians view clinical studies in the countries they work in, we carried out semi-structured problem-centered interviews per telephone in Poland (n = 6) and Germany (n = 6). Our interviewees concentrated on three main topics: an appraisal of the normative framework, challenges in the information process and the protection of all participants in clinical studies. Results: Clinicians generally supported the normative framework, even though they considered it quite complex. In the two study countries, a widely noted dilemma in the information process was whether to overburden participants with extensive information or risking leaving out important facts. Clinicians were ready to exclude larger population groups from participating in clinical studies when the information process could not be carried out with standard procedures or when their inclusion was ethically sensitive. Conclusion: Clinicians need to gain a better understanding of the consequences of excluding larger population groups form participating in clinical studies. They should seek assistance in improving the information process for the inclusion of underrepresented groups in clinical studies.

Background: Smart sensors have been developed as diagnostic tools for rehabilitation to cover an increasing number of geriatric patients. They promise to enable an objective assessment of complex movement patterns. Objective: This research aimed to identify and analyze the conflicting ethical values associated with smart sensors in geriatric rehabilitation and provide ethical guidance on the best use of smart sensors to all stakeholders, including technology developers, health professionals, patients, and health authorities. Methods: On the basis of a systematic literature search of the scientific databases PubMed and ScienceDirect, we conducted a qualitative document analysis to identify evidence-based practical implications of ethical relevance. We included 33 articles in the analysis. The practical implications were extracted inductively. Finally, we carried out an ethical analysis based on the 4 principles of biomedical ethics: autonomy, beneficence, nonmaleficence, and justice. The results are reported in categories based on these 4 principles. Results: We identified 8 conflicting aims for using smart sensors. Gains in autonomy come at the cost of patient privacy. Smart sensors at home increase the independence of patients but may reduce social interactions. Independent measurements performed by patients may result in lower diagnostic accuracy. Although smart sensors could provide cost-effective and high-quality diagnostics for most patients, minorities could end up with suboptimal treatment owing to their underrepresentation in training data and studies. This could lead to algorithmic biases that would not be recognized by medical professionals when treating patients. Conclusions: The application of smart sensors has the potential to improve the rehabilitation of geriatric patients in several ways. It is important that patients do not have to choose between autonomy and privacy and are well informed about the insights that can be gained from the data. Smart sensors should support and not replace interactions with medical professionals. Patients and medical professionals should be educated about the correct application and the limitations of smart sensors. Smart sensors should include an adequate representation of minorities in their training data and should be covered by health insurance to guarantee fair access.

Introduction: There is currently no binding, internationally accepted and successful approach to ensure global equitable access to healthcare during a pandemic. The aim of this ethical analysis is to bring into the discussion a legally regulated vaccine allocation as a possible strategy for equitable global access to vaccines. We focus our analysis on COVAX (COVID-19 Vaccines Global Access) and an existing EU regulation that, after adjustment, could promote global vaccine allocation. Methods: The main documents discussing the two strategies are examined with a qualitative content analysis. The ethical values reasonableness, openness and transparency, inclusiveness, responsiveness and accountability serve as categories for our ethical analysis. Results: We observed that the decision-making processes in a legal solution to expand access to vaccines would be more transparent than in COVAX initiative, would be more inclusive, especially of nation states, and the values responsiveness and accountability could be easily incorporated in the development of a new regulation. Discussion: A legal strategy that offers incentives to the pharmaceutical industry in return for global distribution of vaccines according to the Fair Priority Model is an innovative way to achieve global and equitable access to vaccines. However, in the long term, achieving the Sustainable Development Goals will require from all nations to work in solidarity to find durable solutions for global vaccine research and development. Interim solutions, such as our proposed legal strategy for equitable access to vaccines, and efforts to find long-term solutions must be advanced in parallel.

Agroecology has been criticized for being more labor-intensive than other more industrialized forms of agriculture. We challenge the assertion that labor input in agriculture has to be generally minimized and argue that besides quantity of work one should also consider the quality of work involved in farming. Early assessments on work quality condemned the deskilling of the rural workforce, whereas later criticisms have concentrated around issues related to fair trade and food sovereignty. We bring into the discussion the concept of contributive justice to welcome the added labor-intensity of agroecological farming. Contributive justice demands a work environment where people are stimulated to develop skills and learn to be productive. It also suggests a fairer distribution of meaningful work and tedious tasks. Building on the notion of contributive justice we explore which capabilities and types of social relationships are sustainably promoted and reinforced by agroecological farming practices. We argue that agroecological principles encourage a reconceptualization of farm work. Farmers are continuously stimulated to develop skills and acquire valuable experiential knowledge on local ecosystems and agricultural techniques. Further, generalized ecological studies recognize the significance of the farmer’s observations on natural resources management. This contributes to the development of a number of capabilities and leads to more bargaining power, facilitating self-determination. Hereby farm work is made more attractive to a younger generation, which is an essential factor for safeguarding the continuity of family farms.

Rohwer and Marris (2015) question the existence of a prima facie duty to preserve genetic integrity leaving open the question of what we should preserve. Many of the arguments used to justify their position could set the platform to defend a duty to preserve the diversity of both wild and domesticated species. In times where agricultural land covers a third of world’s land area and major efforts are undertaken to green urban areas a defense of biodiversity could benefit hugely by intelligently incorporating human-induced diversification. It still remains critical to assess in how far new introductions compensate for losses and here the insights of those defending genetic integrity are an important tool. By acknowledging the added value of human-induced biodiversity we could slow down massive extinction of domesticated and semi-wild varieties by giving these a greater space in human-made environments.

In order to enlarge the pool of knowledge available in the public domain, temporary exclusive rights are granted to innovators who are willing to fully disclose the information needed to reproduce their invention. After the 20-year patent protection period elapses, society should be able to make free use of the publicly available knowledge described in the patent document, which is deemed useful. Resistance to pesticides destroys however the usefulness of information listed in patent documents over time. The invention, here pesticides, will have a decreased effectiveness once it enters the public domain. In some cases pesticides lose most of their efficacy shortly after temporary exclusive rights expire. Society’s share of the patent bargain—having new useful knowledge available in the public domain—is lost. Resistance can be slowed down, if pesticide use is limited by optimal compliance. Stimulating proper use is generally not compatible with existing market incentives for patent holders, since these have to be able to maximize profits in order to recoup research and development costs and satisfy obligations to the company’s stakeholders. Another incentive system is needed to ensure longevity of pesticides, which at the same time does not hamper future research

Any system for the protection of intellectual property rights (IPRs) has three main kinds of distributive effects. It will determine or influence: (a) the types of objects that will be developed and for which IPRs will be sought; (b) the differential access various people will have to these objects; and (c) the distribution of the IPRs themselves among various actors. What this means to the area of pharmaceutical research is that many urgently needed medicines will not be developed at all, that the existing medicines will not be suitable for countries with a precarious health infrastructure or not target the disease variety that is prevalent in poorer regions. Such effects are commonly captured under the rubric of the “10/90 gap” in biomedical research. High prices will also restrict access to medicines as well endanger compliance to treatment schemes. IPRs are mainly held by multinational corporations situated in the developed world, which not only raises egalitarian concerns, but also severely limits the possibilities of companies in poorer countries to realize improvements on existing inventions, as they cannot financially afford to secure freedom to operate, which systematically shrinks the number of potential innovators. Those inequities lead to an enormous burden for the global poor and since no institution is willing to assume the responsibility to fulfil the right to health and the corresponding right of access to essential medicines, we have to analyse alternatives or additions to the actual intellectual property regimes in order to create new incentives to fill this gap.

The intellectual property regimes we have currently in place are heavily under attack. One of the points of criticism is the interaction between two elements of article 27 of the Universal Declaration of Human Rights, the widely discussed issue of being able to benefit from scientific progress and the less argued for position of having a right to take part in scientific enterprises. To shine light on the question if we should balance the two elements or prioritize one of them, an exploration will be offered on how benefiting from scientific progress and the ability to participate in the advancement of science relate to securing human capabilities. A different perspective to the question will be gained by identifying the problem as an issue of misrecognition, especially the failure to recognize many willing collaboration partners in scientific research as peers. Lastly, I will argue that cooperative justice requires that if we have an innovation incentive system that disproportionally benefits one particular group, a certain duty to counterbalance this advantage exists when we are relying on mutual cooperation for the recognition of intellectual property rights.

Recent years have witnessed intensive efforts to specify which requirements ethical artificial intelligence (AI) must meet. General guidelines for ethical AI consider a varying number of principles important. A frequent novel element in these guidelines, that we have bundled together under the term explicability, aims to reduce the black-box character of machine learning algorithms. The centrality of this element invites reflection on the conceptual relation between explicability and the four bioethical principles. This is important because the application of general ethical frameworks to clinical decision-making entails conceptual questions: Is explicability a free-standing principle? Is it already covered by the well-established four bioethical principles? Or is it an independent value that needs to be recognized as such in medical practice? We discuss these questions in a conceptual-ethical analysis, which builds upon the findings of an empirical document analysis. On the example of the medical specialty of radiology, we analyze the position of radiological associations on the ethical use of medical AI. We address three questions: Are there references to explicability or a similar concept? What are the reasons for such inclusion? Which ethical concepts are referred to?

By examining the global public good nature of pandemic preparedness we can identify key social justice issues that need to be confronted to increase citizens’ voluntary compliance with prevention and mitigation measures. As people tend to cooperate on a voluntary basis only with systems they consider fair, it becomes difficult to ensure compliance with public health measures in a context of extreme inequality. Among the major inequalities that need to be addressed we can find major differences in the extensiveness and intensiveness of quarantine experiences, lack of opportunities to participate in common efforts, hardship in complying with disease control recommendations, and an unfair distribution of the cooperative surplus.

An idea is a public good. The use of an idea by one person does not hinder others to benefit from the same idea. However in order to generate new life-saving ideas, e.g. inventions in the life sciences, a huge amount of human and material resources are needed. Powerful, but highly criticized tools to speed up the rate of innovation are exclusive rights, most prominently the use of patents and plant breeders’ rights. Exclusive rights leave by nature a number of people empty-handed, with starvation, stuntedness, prevalence of disease and death as preventable and quotidian consequences. To stimulate a human rights compatible use of exclusive rights a wide range of moral frameworks have been developed to condemn current praxes. Most prominent in the debate are theories building on (1) utilitarian calculations of weighing benefits with Peter Singer as a prominent advocate, (2) Pogge’s vindication of compensatory duties for institutional harms, (3) a comprehensive analysis on how the current innovation incentive system fails to secure human rights and human capabilities and lastly (4) showing how the status quo nurtures misrecognition. With help of those theories modest targets as well as a thorough restructure of the innovation incentive system can be justified. Those theories have the mammoth task of restraining well-established ideas supporting the permissibility of a reckless use of property rights that are deeply anchored in the property law discourse. Life sciences raise a range of special problems when justifying pro-poor innovation. Healthy people living in a society with a good sanitary infrastructure need far less resources to tackle health problems than people in places with a poor infrastructure. Patents that involve gene sequences (or part thereof) make inventing around impossible, making the seeking of licenses mandatory for investigators wanting to make follow-up research with the molecule. Speedy sharing of data concerning public health hazards or threats to food security are vital to maintain living standards.

Employing a social justice framework, this book examines the effects of innovation incentives and policies in agriculture. It addresses access to the objects of innovation, the direction of science and the type of innovations that are available, opportunities to participate in research and development, as well as effects on future generations. The book examines the potential value of preventive and reconciliatory measures, drawing on concepts from procedural and restorative justice. As such it offers a comprehensive analysis of the main social justice dimensions affected by agricultural innovation. It gives academics and policy analysts an extensive overview of the deep impact of innovation on society and the environment, and the expectations the general public has from the scientific community.

The scope and type of property rights recognized over the effectiveness of antibiotics have a direct effect on how those claiming ownership engage in the exploitation and stewardship of this scarce resource. We examine the different property claims and rights the four major interest groups are asserting on antibiotics: (i) the inventors, (ii) those demanding that the resource be treated like any other transferable commodity, (iii) those advocating usage restrictions based on good stewardship principles and (iv) those considering the resource as common heritage of humankind.

International negotiations on anthropogenic climate change are far from running smoothly. Opinions are deeply divided on what are the respective responsibilities of developed and developing countries with regard to the reduction of greenhouse gas emissions and the alleviation of the negative effects of global warming. A major bone of contention concerns the role of intellectual property rights (especially patents) in the development and diffusion of climate-friendly technologies. While developing countries consider IPRs as a formidable barrier to the rapid transfer and the widest possible diffusion of such technologies, developed countries, by contrast, see IPRs as a vital prerequisite for the development and transfer of these same technologies. This debate shows some similarity with the earlier debate on patents and access to lifesaving medicines, although there are also important differences. In our contribution we will explore both the analogies and the differences with this earlier debate. To provide a focus for our discussion, we will examine whether something similar to the Health Impact Fund (HIF), which has been proposed by philosopher Thomas Pogge as a reasonable solution to the ethical dilemmas of protection and accessibility in the field of pharmaceuticals, can also be elaborated for the development and diffusion of climate-friendly technologies. Thus the central question is how an analogous ‘Climate Impact Fund’ would look like and how it would work. This whole exercise will also yield a normative yardstick for assessing the various designs for a Green Climate Fund or a Technology Mechanism that are currently on the table of the international climate negotiations.

Engaging citizens in science projects has a number of epistemic benefits in terms of improving scientific out- comes and adjusting research to develop innovative solu- tions that are likelier to be used. Yet the emphasis on the epistemic benefits of citizen science projects and its risks, such as exploitation and a lack of benefit-sharing, a fail- ure to sufficiently inform participants of possible hazards and privacy issues, and unacknowledged authorship, which we can find in Wiggins and Wilbanks (2019), should not shift to the background important justice- related interests regarding increasing participation, in particular as a prerequisite to providing the human right to participate in science (Timmermann 2014; Vayena and Tasioulas 2015). Beside the social interest in benefiting from scientific advancement—due to its major role in improving welfare—and keeping scientific practice within ethical boundaries, we need to acknowledge sci- entific participation to be very much in the interests of society.

So-called climate-ready GM crops can be of great help in adapting to a changing climate. Climate change, caused in great part by anthropogenic greenhouse gases released in the atmosphere since the industrial revolution by the developed world, is felt much stronger in the developing world, causing unexpected droughts and floods that will cause large harvest loss, leading to more hunger and malnutrition, rising death tolls and disease vulnerability. The current intellectual property regime (IPR) strikes an unfair balance between profit oriented seed industry giants and low-acreage farmers. The biotechnology industry, mainly headquartered in the developed world, has started to patent new seed varieties, taking biomaterials from developing countries, with the claim, that they will be more tolerant to flood, drought, heat, and cold. Special sales contracts prohibit saving seeds from the harvest for the next season, thus forcing the farmers to buy them every season anew, which goes against traditional farming. Using a widely accepted concept of global justice, that tackles the fact that around 10% of the world's population profits from 90% of the earth's resources, and by taking into account the feasibility of a fair IPR, we will discuss three issues. First, an ethically acceptable IPR should prevent unjust and unfair assignments of property rights (e.g. patents) that completely ignore small-scale farmers inventiveness and efforts to save agrobiodiversity. As a second task, this regime should encourage globally a just distribution of the objects of innovation that are covered by patents. Third, such a regime should encourage innovations at a rate that is effective to cope with climate change.

Agriculture is one of the dimensions where climate change is having its most devastating effects. As the impact of climate change affects disproportionally those who have contributed the least to it, i.e., the smallholder farmers in the Global South, and who at the same time are the ones with the least disposable income to adapt to these changes, it leads to a major challenge for global justice. This chapter introduces different forms of inequality that are aggravated by climate change, discusses the implications of emphasizing on mitigation and adaptation to the new climatic conditions, argues for the need to reduce the multiple wastages in agriculture and food consumption and the importance of building resilient farming systems, presents the challenges of innovating fairly to respond to the climate emergency, and analyzes the ethical implication of changing landscapes and land uses. It concludes by listing the main challenges of compensating for climate injustices.