Biobank donation in search of public benefits and the potential impact of intellectual property rights over access to health-technologies developed: A focus on the bioethical implications.

The availability of biomaterials is a key component of health research and the development of new health-technologies (including, diagnostics, medicines, and vaccines). People are often encouraged by biobanks to donate samples altruistically to such biobanks. While empirical evidence suggests many donors are motivated by the desire to contribute towards developing new health-technologies for society. However, a tension can arise as health-technologies whose development is contributed to by donors' biomaterials will often be protected by intellectual property rights (IPRs), including patents. Patents give rightsholders control over how patented technologies are used and can be used in a way that impedes public access to technologies developed. Yet, there are no binding European legal obligations mandating disclosure to donors of how IPRs can operate over downstream health-technologies and how they could impact access to health-technologies developed, nor are there legally binding obligations to ensure public accessibility of technologies developed. Focusing on the bioethical implications posed, this article argues that the current situation can impact donors' autonomy and dignity interests. A more holistic approach is needed for biobank donation, which embeds a consideration of donors' expectations/interests from the point of donation through to how such samples are used and how health-technologies developed are accessed. We put forward avenues that seek to address such issues.

Return to Status Quo Ante: The Need for Robust and Reversible Pandemic Emergency Measures.

This paper presents a normative analysis of restrictive measures in response to a pandemic emergency. It applies to the context presented by the Corona virus disease 2019 (COVID-19) global outbreak of 2019, as well as to future pandemics. First, a Millian-liberal argument justifies lockdown measures in order to protect liberty under pandemic conditions, consistent with commonly accepted principles of public health ethics. Second, a wider argument contextualizes specific issues that attend acting on the justified lockdown for western liberal democratic states, as modeled on discourse and accounted for by Jürgen Habermas. The authors argue that a range of norms are constructed in societies that, justifiably, need to be curtailed for the pandemic. The state has to take on the unusual role of sole guardian of norms under emergency pandemic conditions. Consistently with both the Millian-liberal justification and elements of Habermasian discourse ethics, they argue that that role can only be justified where it includes strategy for how to return political decisionmaking to the status quo ante. This is because emergency conditions are only justified as a means to protecting prepandemic norms. To this end, the authors propose that an emergency power committee is necessary to guarantee that state action during pandemic is aimed at re-establishing the conditions of legitimacy of government action that ecological factors (a virus) have temporarily curtailed.

It is never lawful or ethical to withdraw life-sustaining treatment from patients with prolonged disorders of consciousness.

In English law there is a strong (though rebuttable) presumption that life should be maintained. This article contends that this presumption means that it is always unlawful to withdraw life-sustaining treatment from patients in permanent vegetative state (PVS) and minimally conscious state (MCS), and that the reasons for this being the correct legal analysis mean also that such withdrawal will always be ethically unacceptable. There are two reasons for this conclusion. First, the medical uncertainties inherent in the definition and diagnosis of PVS/MCS are such that, as a matter of medical fact, it can never be established, with the degree of certainty necessary to rebut the presumption, that it is not in the patient's best interest to remain alive. And second (and more controversially and repercussively), that even if permanent unconsciousness can be unequivocally demonstrated, the presumption is not rebutted. This is because there is plainly more to human existence than consciousness (or consciousness the markers of which can ever be demonstrated by medical investigations). It can never be said that the identity of the patient whose best interests are at stake evaporates (so eliminating the legal or ethical subject) when that person ceases to be conscious. Nor can it be said that the best interests of an unconscious person do not mandate continued biological existence. We simply cannot know. That uncertainty is legally conclusive, and (subject to resource allocation questions and views about the relevance of family wishes and the previously expressed wishes of the patient) should be ethically conclusive.

Print Me an Organ? Ethical and Regulatory Issues Emerging from 3D Bioprinting in Medicine.

Recent developments of three-dimensional printing of biomaterials (3D bioprinting) in medicine have been portrayed as demonstrating the potential to transform some medical treatments, including providing new responses to organ damage or organ failure. However, beyond the hype and before 3D bioprinted organs are ready to be transplanted into humans, several important ethical concerns and regulatory questions need to be addressed. This article starts by raising general ethical concerns associated with the use of bioprinting in medicine, then it focuses on more particular ethical issues related to experimental testing on humans, and the lack of current international regulatory directives to guide these experiments. Accordingly, this article (1) considers whether there is a limit as to what should be bioprinted in medicine; (2) examines key risks of significant harm associated with testing 3D bioprinting for humans; (3) investigates the clinical trial paradigm used to test 3D bioprinting; (4) analyses ethical questions of irreversibility, loss of treatment opportunity and replicability; (5) explores the current lack of a specific framework for the regulation and testing of 3D bioprinting treatments.

Towards a European code of medical ethics. Ethical and legal issues.

The feasibility of a common European code of medical ethics is discussed, with consideration and evaluation of the difficulties such a project is going to face, from both the legal and ethical points of view. On the one hand, the analysis will underline the limits of a common European code of medical ethics as an instrument for harmonising national professional rules in the European context; on the other hand, we will highlight some of the potentials of this project, which could be increased and strengthened through a proper rulemaking process and through adequate and careful choice of content. We will also stress specific elements and devices that should be taken into consideration during the establishment of the code, from both procedural and content perspectives. Regarding methodological issues, the limits and potentialities of a common European code of medical ethics will be analysed from an ethical point of view and then from a legal perspective. The aim of this paper is to clarify the framework for the potential but controversial role of the code in the European context, showing the difficulties in enforcing and harmonising national ethical rules into a European code of medical ethics.

Against the accommodation of subjective healthcare provider beliefs in medicine: counteracting supporters of conscientious objector accommodation arguments.

We respond in this paper to various counter arguments advanced against our stance on conscientious objection accommodation. Contra Maclure and Dumont, we show that it is impossible to develop reliable tests for conscientious objectors' claims with regard to the reasonableness of the ideological basis of their convictions, and, indeed, with regard to whether they actually hold they views they claim to hold. We demonstrate furthermore that, within the Canadian legal context, the refusal to accommodate conscientious objectors would not constitute undue hardship for such objectors. We reject concerns that refusing to accommodate conscientious objectors would limit the equality of opportunity for budding professionals holding particular ideological positions. We also clarify various misrepresentations of our views by respondents Symons, Glick and Jotkowitz, and Lyus.

CRISPR Critters and CRISPR Cracks.

This essay focuses on possible nonhuman applications of CRISPR/Cas9 that are likely to be widely overlooked because they are unexpected and, in some cases, perhaps even "frivolous." We look at five uses for "CRISPR Critters": wild de-extinction, domestic de-extinction, personal whim, art, and novel forms of disease prevention. We then discuss the current regulatory framework and its possible limitations in those contexts. We end with questions about some deeper issues raised by the increased human control over life on earth offered by genome editing.

The grand leap of the whale up the Niagara Falls: converting philosophical conclusions into policy prescriptions.

This article analyzes a neat conjuring trick employed in bioethics, that is, the immediate conversion of a philosophical conclusion into a policy prescription, and compares it to the "grand leap of the whale up the Niagara Falls" mentioned by Benjamin Franklin. It is shown that there is no simple and easy way to achieve the conversion, by considering arguments falling under four headings: (1) reasonable disagreement about values and theories, (2) general jurisprudential arguments, (3) the differences between policymaking and philosophy, and (4) the messy world of implementation. The particular issue used to illustrate the difficulties in moving from philosophical conclusion to policy description is infanticide of healthy infants, but the analysis is general, and the conclusion that the immediate move to policy is illegitimate is quite general.

The French bioethics public consultation and the anonymity doctrine: empirical ethics and normative assumptions.

The French bioethics laws of 1994 contain the principles of the anonymity and non commodification of all donations of body parts and products including gametes in medically assisted reproduction. The two revisions of the law, in 2004 and 2011 have upheld the rule. In view of the latest revision process, the French government organized a large public consultation in 2009 ("Etats généraux de la bioéthique"). Within the event a "consensus conference" was held in Rennes about different aspects of assisted reproduction (access, anonymity, gratuity and surrogacy). In what follows we shall first describe the anonymity clause for gamete donations in the French law and the debates surrounding it. We shall then analyse the procedure used for the 2009 public consultation and the related consensus conference, as well as its upshot concerning the anonymity doctrine. In this respect we shall compare the citizens' own recommendations on the gamete anonymity issue and its translation in the consultation's final report drafted by a philosopher mandated by the organizing committee. Whereas the final report cited some fundamental ethical arguments as reason for upholding the provisions of the law-most notably the refusal of the 'all biological' approach to reproductive issues-citizens were more careful and tentative in their position although they also concluded that for pragmatic reasons the anonymity rule should continue to hold. We shall argue that the conservative upshot of the public consultation is due to some main underlying presuppositions concerning the citizens' role and expertise as well as to the specific design of the consensus conference. Our conclusion will be that public consultations and consensus conferences can only serve as an empirical support for devising suitable bioethics norms by using second-order normative assumptions.

FY1 doctors' ethicolegal challenges in their first year of clinical practice: an interview study.

BACKGROUND: There is little evidence of junior trainee perspectives in the design and implementation of medical ethics and law (MEL) curriculum in UK medical schools. AIM: To determine the ethical issues the foundation year 1 (FY1) doctors (first year after graduation)  encountered during clinical practice and the skills and knowledge of MEL, which were useful in informing MEL curriculum development. METHOD: The National Research Ethics Service gave ethical approval. Eighteen one-to-one interviews were conducted in each school with FY1 doctors. ANALYSIS: Interviews were recorded and transcribed verbatim; a thematic analysis was undertaken with the transcriptions and saturation of themes was achieved. KEY FINDINGS: Themes closely overlapped between the two study sites. (1) Knowing my place as an FY1 (this theme consisted of four subthemes: challenging the hierarchy, being honest when the team is titrating the truth, taking consent for unfamiliar procedures and personal safety vs competing considerations); (2) Do not attempt resuscitation)/end-of-life pathway and its implications; (3) 'You have to be there' (contextualising ethics and law teaching through cases or role plays to allow students to explore future work situations); and (4) advanced interpersonal skills competency for ethical clinical practice. CONCLUSIONS: The data provide a snapshot of the real challenges faced by MEL FY1 doctors in early clinical practice: they may feel ill-prepared and sometimes unsupported by senior members of the team. The key themes suggest areas for development of undergraduate and postgraduate MEL curricula. We will work to develop our own curriculum accordingly. We intend to further investigate the applicability of our findings to UK medical ethics and law curriculum.

[Health agencies and the every day management of bioethics]. / Les agences sanitaires: gérer la bioéthique au quotidien?

Taking into account their acquired experience, would not health agencies become the place where biomedical practices will be managed on an every day basis? Would in a near future these agencies have the role to interprete the principles of the bioethics law to adapt them to concrete issues?

[Conflict of interest and bioethics]. / Conflicto de intereses y bioética.

"Conflicts of interests" is a multi-meaning expression. To give a juridical concept is not easy because this concept is applied in public and private law. Maybe this is the reason of not having a law giving a valid definition in any case In health area, a conflict of interests is present many times, i.e. at the beginning of a research, when informing its results, etc. This conflict of interests may affect different aspects of the research work, economic or not; sometimes totally or partially. The economic resources is one of the most common reasons of the conflict of interests. The mass media often cause conflicts of interests informing the general public about new scientific discovery in a simple way to be understood but without been quite assertive. Other times, great enterprises hide information about new and better medicines due to the fact that they have many old medicines that should be sold before introducing in the market the new ones. From the academic point of view, conflicts may arise when the public funds are wrongly used to support unworthy researches.

The competency of New Zealand new graduate occupational therapists: perceived strengths and weaknesses.

BACKGROUND/AIM: There is a paucity of research examining the issues faced by New Zealand new graduate occupational therapists entering practice, including understanding graduates' abilities to translate knowledge and skills gained in their professional training, into the clinical setting. This study sought to explore the perceived strengths and weaknesses of newly graduated occupational therapists in New Zealand. METHODS: A mixed methods approach was used including: (i) online survey completed by 458 New Zealand registered occupational therapists, and (ii) five focus groups, in four cities, with occupational therapists, educators and managers. Survey and focus group questions explored new graduates' preparedness for practice based on the Occupational Therapy Board of New Zealand competencies for registration. RESULTS: New graduates were perceived to be strong in the competencies of 'communication' and 'continuing professional development', and weaker in the areas of 'implementation of occupational therapy' and 'management of environment and resources'. Perceptions of graduates' preparedness in relation to 'culturally safe practice', 'safe, ethical and legal practice' and 'management of self and people' were mixed. CONCLUSION: The profession has not raised any serious concerns about new graduates' preparedness for practice; however, there were some identified weaknesses. Currently, there is no clear evidence that increasing undergraduate training time would address these weaknesses and some indication that postgraduate focus may be preferable. Furthermore, the findings highlight the inconsistency in previous studies regarding perceptions of graduate preparedness. Further research regarding new graduates preparedness for practice, from multiple perspectives and taking into consideration length and stage of education, is recommended.