ABSTRACT In genomic research the ideal standard of free, informed, prior and explicit consent is sometimes difficult to apply. This has raised concern that important genomic research will be restricted. Different consent procedures have therefore been proposed. This paper explicitly examines the question how, in genomic research, the principles of solidarity and justice can be used to justify forms of diminished individual control over personal data and bio‐samples. After a discussion of the notions of solidarity and justice and how they (...) can be related to health care and genomic research, we examine how and in which situations these notions can form a strong moral basis for demanding certain financial sacrifices. Then we examine when these principles can justify consent procedures which diverge from the ideal standard. Because much genomic research is not expected to lead to immediate (clinical) benefits we also discuss the question of whether we can be obliged to make any sacrifices for future (not yet existing) patients. We conclude with the formulation of a number of conditions that have to be met before autonomy sacrifices can be reasonably demanded in genomic research. (shrink)

Geneticization is a broad term referring to several related processes such as a spreading tendency to use a genetic model of disease explanation, a growing influence of genetics in medical practice, and the slow changing of individual and societal attitudes towards reproduction, prevention and control of disease. These processes can be demonstrated in medical literature on preventive genetic screening and counselling programs for β-thalassaemia in Cyprus, the United Kingdom and Canada. The preventive possibilities of the new genetic and diagnostic technologies (...) have been quickly understood and advocated by health professionals, and their educational strategies have created a web of social control, in marked contrast to the alleged voluntary decision-making process and free choice. Genetic diagnostic technologies have led to considerable changes in control and management of β-thalassaemia, and have generated a number of unresolved incongruities. (shrink)

During the last decade a “technical” approach has become increasingly influential in health care priority setting. The various country reports illustrate, however, that non-technical considerations cannot be avoided. As they often remain implicit in health care package decisions, this paper aims to make these normative judgements an explicit part of the procedure. More specifically, it aims to integrate different models of distributive justice as well as the principle of solidarity in four different phases of a decision-making procedure, and to identify (...) important moral choices which present themselves. First four important justice models are discussed, then a justification is given for their inclusion in a four-step decision making procedure. This is followed by a discussion of different justice and solidarity problems—with their inherent conceptual difficulties in each of these stages. The paper concludes with a summary of the major moral choices that are to be made in health care package decisions. (shrink)

In decisions about inclusion (or exclusion) of health care services in the benefit package, different interpretations of notions like health, health risk, disease, quality of life or necessary care often remain implicit. Yet they can lead to different benefit package decisions. After a brief discussion of these concepts in definitions of the goals of medicine, the various value-judgements implicit in interpretations of key notions in health care are analysed and conclusions are drawn with regard to the composition of decision making (...) bodies at various levels. It is further argued that such a body needs to discuss the various interpretations of key-notions explicitly in the various phases of a priority-setting procedure so that more consistent choices can be made in health care priority setting. (shrink)

In genomic research the ideal standard of free, informed, prior, and explicit consent is believed to restrict important research studies. For certain types of genomic research other forms of consent are therefore proposed which are ethically justified by an appeal to the common good. This notion is often used in a general sense and this forms a weak basis for the use of weaker forms of consent. Here we examine how the notion of the common good can be related to (...) individual health, health care, and genomic research and we use this analysis to propose more precise criteria to justify forms of consent which diverge from the ideal standard. (shrink)

This paper discusses the problematic and sometimes implicit nature of some central notions and criteria used in debates about inclusion (or exclusion) of health care services in the health care benefit package. An analysis of discussions about four health care services—lungtransplantation, statins, (sildenafil (viagra) and rivastigmine—illustrates a case-by-case approach and inconsistent use of criteria, which present a challenge to develop a decision-making procedure in which important criteria or central notions can be discussed explicitly.

Healthcare package decisions are complex. Different judgements about effectiveness, cost-effectiveness and disease burden influence the decision-making process. Moreover, different concepts of justice generate different ideas about fair distribution of healthcare resources. This paper presents a decision model that is used in medical school in order to familiarise medical students with the different concepts of justice and the ethical dimension of making concrete choices. The model is based on the four-stage decision model developed in the Netherlands by the Dunning Committee and (...) the discussion that followed its presentation in 1991. Having to deal with 10 medical services, students working with the model learn to discern and integrate four different ideas of distributive justice that are integrated in a flow chart: libertarian, communitarian, egalitarian and utilitarian. (shrink)

The biotechnology patent debates have revealed deep moral concerns about basic genetics research, RD and specific biotechnological products, concerns that are seldom taken into consideration in Technology Assessment. In this paper important moral concerns are examined which appear at the various stages of development of a specific genetic product: a predictive genetic test. The purpose is to illustrate the need for a more contextual approach in technology assessment, which integrates the various forms of interaction between bio-technology and society or societal (...) segments. Such an approach will generate greater insight in the moral issues at all stages of a products life-cycle and this will facilitate decision-making on the morality of a specific biotechnological product. (shrink)

Three recent reports on genetic screening published in the United Kingdom, Denmark and the Netherlands are discussed. Comparison of the Dutch report with the Danish and the Nuffield reports reveals that the Dutch report focuses on the aim of enlarging the scope for action, emphasising protection of autonomy and self-determination of the screenee more than the other two reports. The three reports have in common that the main concern is with concrete issue such as stigmatisation, discrimination, protection of the private (...) sphere and issues linked with labour and insurance. Some potential long term consequences, however, tend to be neglected or underestimated. These omissions are pointed out. (shrink)

: The gene patenting debate, which proved to be a focal point for divergent moral concerns about recent developments in genome research and biotechnology, has revealed that the moral status of DNA is not clear. One of the arguments used to stop undesirable developments was that DNA possesses a unique status, which renders it unfit for patenting. This paper investigates the allegedly unique (moral) status of genetic material and the information it holds from different perspectives. Several properties of DNA prove (...) to be unique. We examine the relevance of these for patentability of genes and conclude that only the unique symbolic meaning of DNA is a relevant factor, which should be taken into account but weighed against other interests involved. (shrink)

This paper explores usage of the concept ofabnormality in medical genetics and proposesdirectives for more careful usage of this concept.The conceptual difficulties are first explored, thena model is developed to assess actual usage, followedby analysis of a sample of genetic textbooks andgenetics literature. It appears that fact andvaluation are often intermingled, that referencestandards used to define 'genetic abnormalities' areoften not clear and that the concept of abnormality isoften used independent of the degree of certainty withwhich the altered genetype develops into (...) a (seriously)harmful phenotype. On the basis of these findings itis argued that more restraint and more careful use ofthe concept of genetic abnormality of medical geneticsis appropriate as well as more agreement on the use ofreference standards. (shrink)

The project Euroscreen 2 has examined genetic screening and testing with particular reference to implications for insurance, commercialization through marketing of genetic tests direct to the public, and issues surrounding raising public awareness of these and other developments in genetics, including the practical experiment of a Gene Shop. This paper provides a snapshot of the three year project. The study groups work included monitoring developments in different European countries and exploring possibilities for regulation in insurance and commercialization together with public (...) attitudes to regulation. The success or failure of different strategies is not independent of public awareness. Exploration of policy, however, also requires examination of fundamental concepts such as solidarity and geneticization. (shrink)

This paper investigates which of the variouslegal notions proposed for human DNA is themost appropriate from an ontological viewpoint – unique legal status, private property, commonproperty, person, or information. The focus is onthe difficulties that private property, commonproperty and person present. By usingHarré''s notion of ``file-self'''' we arguethat, ontologically, the most appropriate legalnotion to be applied is information. This hasconsequences for storage, control and use ofgenetic information as well as identifiablehuman body material.

In Europe a process of harmonisation of standards and regulations on genetic testing has started. Public discussion and consultation are recommended, but it is not clear in every European country how the decision making process as regards the further introduction of genetic testing services should be formed. In this paper the usefulness and importance of an overseeing body for genetic screening and testing is founded on four lines of reasoning: analysis of the role of value judgments in the use of (...) the concept of abnormality; a balancing of potential benefits for all parties involved; a balancing of potential disadvantages, and the greater availability of commercial genetic tests in the future. It is further argued that such an overseeing body has advantages for all the interested parties. (shrink)

After ten years of debate Directive 98/44/EG on the legal protection of biotechnological inventions was adopted in 1998. This directive takes decisions on some controversial bioethical and legal issues and offers the European biotech industries more space to develop their inventions, but leaves a number of philosophical and moral issues unresolved. This paper distinguishes between different layers in the debate and maps its modes of argumentation. Major philosophical, ethical and conceptual issues are located. It is argued that further analysis of (...) these issues can help resolve further ethical and legal difficulties as regards patenting of human DNA. As the allegedly special status of genetic material remains unclear, the status of (human) DNA and its relation to the human body and personal identity should be further explored. (shrink)