Technology neutrality in European regulation of GMOs

Objections to the current EU regulatory system on genetically modified organisms (GMOs) in terms of high cost and lack of consistency, speed and scientific underpinning have prompted proposals for a more technology-neutral system. We sketch the conceptual background of the notion of ‘technology neutrality’ and propose a refined definition of the term. The proposed definition implies that technology neutrality of a regulatory system is a gradual and multidimensional feature. We use the definition to analyze two regulatory reform proposals: One proposal from the Netherlands for improving the exemption mechanism for GMOs under Directive 2001/18/EC, and one from the Norwegian Biotechnology Advisory Board, outlining a new stratified risk assessment procedure. While both proposals offer some degree of improved technology neutrality in some dimensions compared to current EU regulation, in some extents and dimensions, they do not. We conclude that proposals for more technology-neutral regulation of GMOs need, first, to make explicit to what extent and in what dimensions the proposal improves neutrality and, second, to present arguments supporting that these specific improvements constitute desirable policy change against the background of objections to current policy

Expression and functional effects of Eph receptor tyrosine kinase A family members on Langerhans like dendritic cells

BACKGROUND: The Eph receptors are the largest receptor tyrosine kinase family. Several family members are expressed in hematopoietic cells. Previously, the expression of a member of this family, EphA2, was identified on dendritic like cells in tonsils. We therefore specifically examined the expression of EphA2 on in vitro generated dendritic cells. RESULTS: In this study, expression of the EphA2 receptor was identified on in vitro generated Langerhans like dendritic cells compared to in vitro generated dendritic cells. We show that ligand induced engagement of the EphA2 receptor leads to receptor autophosphorylation indicating a functional receptor signaling pathway in these cells. We also observe phosphorylation and dephosphorylation of distinct proteins following ligand activation of EphA receptors. In co-stimulation assays, receptor-ligand interaction reduces the capacity of the Langerhans like dendritic cells to stimulate resting CD4+ T cells. CONCLUSION: Engagement of EphA receptor tyrosine kinases on Langerhans like dendritic cells induces signaling as shown by tyrosine phosphorylation and dephosphorylation of distinct proteins. Furthermore this engagement renders the cells less capable of stimulating CD4+ T cells

Caregiver perspectives on patient capacities and institutional pathways to person centered forensic psychiatric care

The ethical discourse surrounding patients’ agential capacities, vis-à-vis their active participation in shared decision-making (SDM) in forensic psychiatric (FP) contexts, is an unexplored area of inquiry. The aim of this paper is to explore caregivers’ perceptions of patient agential capacities and institutional pathways and barriers to person centered care (PCC) in the context of FP. Following an exploratory qualitative design, we conducted eight semi-structured interviews with hands-on caregivers at an in-patient FP facility in Sweden. A deductive framework method of analysis was employed, and four themes emerged: “Fundamental Variability in Patient Capacity”, “Patient Participation: Narration or Compliance?”, “Antagonism Rooted in Power Struggles”, and “System Structure Thwarts Patient Release”. While the results generally paint a bleak picture for the possibility of a person-centered FP care, we describe a constrained version of PCC with high-level SDM dynamics which promotes a certain degree of patient empowerment while allowing care strategies, within set restrictions, to promote patient adherence and treatment progress

Person Centered Care and Personalized Medicine: Irreconcilable Opposites or Potential Companions?

In contrast to standardized guidelines, personalized medicine and person centered care are two notions that have recently developed and are aspiring for more individualized health care for each single patient. While having a similar drive toward individualized care, their sources are markedly different. While personalized medicine stems from a biomedical framework, person centered care originates from a caring perspective, and a wish for a more holistic view of patients. It is unclear to what extent these two concepts can be combined or if they conflict at fundamental or pragmatic levels. This paper reviews existing literature in both medicine and related philosophy to analyze closer the meaning of the two notions, and to explore the extent to which they overlap or oppose each other, in theory or in practice, in particular regarding ethical assumptions and their respective practical implications

Digital contact tracing and exposure notification: ethical guidance for trustworthy pandemic management

10.1007/s10676-020-09566-8Ethics and Information Technology233285-29

Public policies, law and bioethics: : a framework for producing public health policy across the European Union

Unlike the duties of clinicians to patients, professional standards for ethical practice are not well defined in public health. This is mainly due to public health practice having to reconcile tensions between public and private interest(s). This involves at times being paternalistic, while recognising the importance of privacy and autonomy, and at the same time balancing the interests of some against those of others. The Public Health specialist operates at the macro level, frequently having to infer the wishes and needs of individuals that make up a population and may have to make decisions where the interests of people conflict. This is problematic when devising policy for small populations; however, it becomes even more difficult when there is responsibility for many communities or nation states. Under the Treaty on European Union, the European Commission was given a competence in public health. Different cultures will give different moral weight to protecting individual interests versus action for collective benefit. However, even subtle differences in moral preferences may cause problems in deriving public health policy within the European Union. Understanding the extent to which different communities perceive issues such as social cohesion by facilitating cultural dialogues will be vital if European institutions are to work towards new forms of citizenship. The aim of EuroPHEN was to derive a framework for producing common approaches to public health policy across Europe. Little work has been done on integrating ethical analysis with empirical research, especially on trade-offs between private and public interests. The disciplines of philosophy and public policy have been weakly connected. Much of the thinking on public health ethics has hitherto been conducted in the United States of America, and an ethical framework for public health within Europe would need to reflect the greater respect for values such as solidarity and integrity which are more highly valued in Europe. Towards this aim EuroPHEN compared the organisation of public health structures and public policy responses to selected public health problems in Member States to examine how public policy in different countries weighs competing claims of private and public interest. Ethical analysis was performed of tensions between the private and public interest in the context of various ethical theories, principles and traditions. During autumn 2003, 96 focus groups were held across 16 European Union Member States exploring public attitudes and values to public versus private interests. The groups were constructed to allow examination of differences in attitudes between countries and demographic groups (age, gender, smoking status, educational level and parental and marital status). Focus group participants discussed issues such as attitudes to community; funding of public services; rights and responsibilities of citizens; rules and regulations; compulsory car seat belts; policies to reduce tobacco consumption; Not-In-My-Back-Yard arguments; banning of smacking of children; legalising cannabis and parental choice with regards to immunisation. This project proposes a preliminary framework and stresses that a European policy of Public Health will have to adopt a complex, pluralistic and dynamic goal structure, capable of accommodating variations in what specific goals should be prioritised in the specific socio-economic settings of individual countries

Functional Analysis of Ficolin-3 Mediated Complement Activation

The recognition molecules of the lectin complement pathway are mannose-binding lectin and Ficolin -1, -2 and -3. Recently deficiency of Ficolin-3 was found to be associated with life threatening infections. Thus, we aimed to develop a functional method based on the ELISA platform for evaluating Ficolin-3 mediated complement activation that could be applicable for research and clinical use. Bovine serum albumin (BSA) was acetylated (acBSA) and chosen as a solid phase ligand for Ficolins in microtiter wells. Binding of Ficolins on acBSA was evaluated, as was functional complement activation assessed by C4, C3 and terminal complement complex (TCC) deposition. Serum Ficolin-3 bound to acBSA in a calcium dependent manner, while only minimal binding of Ficolin-2 and no binding of Ficolin-1 were observed. No binding to normal BSA was seen for any of the Ficolins. Serum C4, C3 and TCC deposition on acBSA were dependent only on Ficolin-3 in appropriate serum dilutions. Deposition of down stream complement components correlated highly significantly with the serum concentration of Ficolin-3 but not with Ficolin-2 in healthy donors. To make the assay robust for clinical use a chemical compound was applied to the samples that inhibited interference from the classical pathway due to the presence of anti-BSA antibodies in some sera. We describe a novel functional method for measuring complement activation mediated by Ficolin-3 in human serum up to the formation of TCC. The assay provides the possibility to diagnose functional and genetic defects of Ficolin-3 and down stream components in the lectin complement pathway