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.

Chapitre 18. Loi relative à la bioéthique 2021 : de quelques interrogations dans la pratique des équipes médicales.

The law on bioethics of 2 August 2021 introduced a number of innovations that have raised many questions for professionals. For the medical teams at assisted reproduction centres, the disappearance of the notion of medical indication represents a real paradigm shift. Should there be limits on access to MAP methods? The legal texts set certain limits. Are these limits related to human physiology, to the benefit-risk ratio or to social or medico-economic considerations? We will discuss the issues of the age at which a person can benefit from PGM, self-preservation of gametes for his or her own benefit, access to the donor’s identity and special interviews with the multidisciplinary team. Finally, the need for clear, objective information will be emphasised, especially as article 4 of the law provides for a public health plan: prevention/public education, information/female and male fertility, which to date has not been mentioned.

Informe del Comité de Bioética de España acerca de las implicaciones éticas y jurídicas de incluir información adicional sobre “sexo sentido” y “nombre deseado” en la base de datos de población protegida del Sistema Nacional de Salud / [Report from the Spanish Bioethics Committee on the ethical and legal implications of including additional information on “felt sex” and “desired name” in the protected population database of the National Health System]

Con fecha 7 de febrero de 2023, la secretaria general de Salud Digital, Información e Innovación del Sistema Nacional de Salud eleva una consulta al Comité de Bioética de España, solicitando informe en el que se valoren las implicaciones éticas y jurídicas que se deriven del hecho de incluir información adicional sobre “sexo sentido” y “nombre deseado” en la Base de Datos de Población Protegida (BDPP) del Sistema Nacional de Salud. El Comité de Bioética de España en la reunión Plenaria extraordinaria del día 5 de junio de 2023 acuerda aprobar el siguiente informe por unanimidad conforme a lo dispuesto en el artículo 78.1 a) de la Ley 14/2007, de 3 de julio, de Investigación Biomédica, que fija entre las funciones del Comité emitir informes, propuestas y recomendaciones para los poderes públicos de ámbito estatal y autonómico en asuntos con implicaciones éticas relevantes. (AU)

Distinguishing grounds between gene editing and neoeugenic conduct: bioethical and legalconsiderations / Fundamentos de distinción entre edición genética y conducta neoeugenica: consideraciones bioéticas y legales

The present work has the objective of analyzing whether the practice of gene editing, from the teleological foundation, can generate a scenario of neoeugenic choices. This study analyzes the current stage of gene editing, together with the panorama of neoeugenic practices, to delimit the distinctive aspects between these concepts, based on the desired purpose in the practice of gene editing. For that, the analytical-discursive method was used, identifying fundamental connections related to the problem and interpreting the concepts presented in search of an adequate response to the objectives raised. The research was based on scientific articles published in specialized journals, as well as books and chapters in collective works. (AU)

El presente trabajo tiene como objetivo analizar si la práctica de la edición genética, desde el fundamento teleológico, puede generar un escenario de elecciones neoeugenésicas. Este estudio analiza la etapa actual de la edición de genes, junto con el panorama de las prácticas neoeugenésicas, con el fin de delimitar los aspectos distintivos entre estos conceptos, en función de la finalidad deseada en la práctica de la edición de genes. Para ello se utilizó el método analítico-discursivo, identificando conexiones fundamentales relacionadas con el problema e interpretando los conceptos presentados en busca de una respuesta adecuada a los objetivos planteados. La investigación se basó en artículos científicos publicados en revistasespecializadas, así como en libros y capítulos de obras colectivas. (AU)

Chapitre 3. Dignité humaine et droit de la bioéthique dans la jurisprudence des Cours européenne et interaméricaine des droits de l'homme.

This contribution analyses the way in which the European and Inter-American Courts of Human Rights handle the concept of Human Dignity in cases that present bioethical stakes. As they do not comprehend it in the same way – ‘Dignity-Freedom’ on the one hand, ‘Dignity-Equality’ on the other – it implies differences of solutions in areas such as the definition of the human person, the right to personal autonomy, the right to health or even the right to a healthy environment. This comparative analysis also allows us to grasp better the limits that a too liberal reading of human rights can represent and to propose some means of improvement. That would involve a review of the equal dignity of human beings by the European Court, thanks to different tools that can be put into action without the Court’s being forced to reconsider the theoretical basis on which its whole system is founded.

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.

La investigación biomédica y conductual en prisiones. Claves para un cambio de marco normativo / Biomedical and behavioral research in prisons. Criteria for a legal reform in Spain

La investigación biomédica y conductual si bien se erige en una actividad fundamental de cara al desarrollo científico en áreas básicas para el bienestar de la humanidad, constituye una temática que plantea cuestiones éticas de calado, en particular, cuando la misma se lleva a cabo en poblaciones vulnerables. El presente trabajo se configura como un estudio de naturaleza bioética y jurídica acerca de la investigación biomédica y conductual en el entorno penitenciario que, partiendo de la normativa actualmente vigente en España, se adentra en las concepciones sostenidas en las últimas décadas a nivel comparado en materia de investigación en el medio carcelario, con el fin de establecer una serie de pautas que coadyuven a sentar criterios sólidos en dicha esfer (AU)

Biomedical and behavioral research, despite being a fundamental activity so as to increase scientific knowledge in basic areas for the well-being of humanity, is a topic that raises ethical issues of importance, particularly, when the aforementioned experimentation is carried out in vulnerable populations. The present paper constitutes a study of bioethical and legal nature about biomedical and behavioral research on prisoners. To this end, regulations currently in force in Spain on this topic are analyzed. Additionally, the author reviews the different conceptions held in recent decades at international level related to research in the prison environment, in order to establish useful guidelines in this field (AU)

La recerca biomèdica i conductual si bé s'erigeix en una activitat fonamental de cara al desenvolupament científic en àrees bàsiques per al benestar de la humanitat, constitueix una temàtica que planteja qüestions ètiques de calat, en particular, quan la mateixa es duu a terme en poblacions vulnerables. El present treball es configura com un estudi de naturalesa bioètica i jurídica sobre la recerca biomèdica i conductual en l'entorn penitenciari que, partint de la normativa actualment vigent a Espanya, s'endinsa en les concepcions sostingudes en les últimes dècades a nivell comparat en matèria de recerca en el mitjà carcerari, amb la finalitat d'establir una sèrie de pautes que coadjuvin a asseure criteris sòlids en aquesta esfera (AU)

National survey on the opinions of French specialists in assisted reproductive technologies about social issues impacting the future revision of the French Bioethics laws.

INTRODUCTION: France is known for its conservative and unique position in assisted reproductive technologies (ARTs). At the eve of the future revision of French Bioethics laws, we decided to conduct a national survey to examine the opinions of French specialists in ARTs about social issues. MATERIAL AND METHODS: Descriptive study conducted in May 2017 in a university teaching hospital using an anonymous online questionnaire on current issues in ARTs. The questionnaire was sent by email to 650 French ARTs specialists, both clinicians and embryologists. RESULTS: After 3 reminders, 408 responses were collected resulting in a participation rate of 62.7% (408/650). Concerning pre-implantation genetic testing, 80% of the physicians were in favor of expanding the indications, which in France are presently limited to incurable genetic diseases. Authorizing elective Fertility Preservation was supported by 93.4% of the specialists, but without social coverage for 86.3% of them. Concerning gamete donation, 77.4% of the French ARTs specialists were in favor of giving a financial compensation to donors, 92% promoted preserving their anonymity and 80.9% were against a directed donation. ARTs for single heterosexual women were supported by 63.4% of the French specialists and by 72.5% for lesbian couples. The legalization of surrogacy was requested by 55.2%. DISCUSSION: Pending the revision of the French Bioethics laws, this survey provides an overview of the opinion of the specialists in ARTs on expanding ARTs for various social indications.Because of the evolution of social values, a more liberal and inclusive ART program is desired by the majority of ART specialists in France.

"The Hopkins Mongol Case": The Dawn of the Bioethics Movement.

One of the earliest controversies in the modern history of bioethics was known at the time as "the Hopkins Mongol case," involving an infant with Trisomy 21 and duodenal atresia whose parents declined to consent to surgery. Fluids and feeding were withheld, and the infant died of dehydration after 15 days. The child's short life had a profound impact on the author's career and that of several others and ultimately led to changes in the care of children and adults with disabilities and the way difficult end-of-life decisions are made in US hospitals today. It also contributed to the growth of the modern bioethics movement and scholarship focused on pediatric bioethics issues.

Bioethics and the Law in Mexico / Bioética y el derecho en México / Bioètica I dret a Mèxic

The results of an empirical study show that,taken as a group, physicians in Mexico do not know what is legal and what is not legal with respect to certain areas of clinical practice.   A number of legal cases are cited showing the ways in which the legal system is ineffective with respect to providing guidance on bioethicalissues.   We conclude that physicians in Mexico do not know what is legal and what is illegal with respect to bioethics because they cannot know (the law is unclear) and because they do not need to know (there is no effective legal precedent or enforcement).   We suggest that the way forward must be through institutional policies establishing standards that depend only upon the traditional contract for medical care

Los resultados de un estudio empírico (Hall, 2017) muestran que, tomados como grupo, los médicos en México no saben qué es legal y qué no lo es con respecto a ciertas áreas de la práctica clínica. Se citan varios casos legales que muestran las formas en que el sistema legal es inefectivo con respecto a proporcionar orientación sobre cuestiones bioéticas. Concluimos que los médicos en México no saben qué es legal porque no pueden saberlo (la ley no es clara) y porque no necesitan saberlo (no existe un sistema legal efectivo). Sugerimos que el camino a seguir debe ser a través de políticas institucionales que establezcan estándares que dependan únicamente del contrato tradicional para la atención médica

Els resultats d'un estudi empíric (Hall, 2017) mostren que, considerats com a grup, els metges a Mèxic no saben què és legal I què no ho és pel que fa a certes àrees de la pràctica clínica. Se citen diversos casos legals que mostren les formes en què el sistema legal és inefectiu pel que fa a proporcionar orientació sobre qüestions bioètiques. Concloem que els metges a Mèxic no saben què és legal perquè no poden saber-ho (demostrem diverses maneres en què la llei no és clara) I perquè no necessiten saber-ho (el sistema legal no proporciona una aplicació efectiva). Suggerim que el camí a seguir ha de ser a través de polítiques institucionals que estableixin estàndards que depenguin únicament del contracte tradicional per a l'atenció médica

Navigating the Intersection between Genomic Research and Clinical Practice.

The Risk Assessment Program (RAP) at Fox Chase Cancer Center (Philadelphia, PA) is a multi-generational prospective cohort, enhanced for personal and family history of cancer, consisting of over 10,000 individuals for whom data on personal and family history of cancer, risk factors, genetic and genomic data, health behaviors, and biospecimens are available. The RAP has a broad research agenda including the characterization of genes with known or potential relevance to cancer, gene-gene and gene-environment interactions, and their contribution to clinically useful risk assessment and risk reduction strategies. Increasingly, this body of research is identifying genetic changes which may have clinical significance for RAP research participants, leading us to confront the issue of whether to return genetic results emerging from research laboratories. This review will describe some of the important fundamental points that must be debated as we develop a paradigm for return of research results. The key issues to address as the scientific community moves toward adopting a policy of return of research results include the best criteria for determining which results to offer, the consent document components necessary to ensure that the participant makes a truly informed decision about receiving their results, and associated logistical and cost challenges.See all articles in this Special Collection Honoring Paul F. Engstrom, MD, Champion of Cancer Prevention.

How Bioethics and Case Law Diverge in Assessments of Mental Capacity: An Argument for a Narrative Coherence Standard.

Clinical assessments of mental capacity have long been guided by four basic cognitive criteria (understanding, appreciation, ability to reason, communication of decision), distilled directly from widespread legal precedent in common law cases of informed consent and refusal. This article will challenge the sufficiency of these legal criteria at the bedside on the assertion that clinicians and bioethicists who evaluate decisional capacity face questions far deeper than the mere presence or absence of a patient's informed consent. It will then present an additional standard beyond the existing cognitive criteria - to be called the Narrative Coherence Standard - that may begin to bridge the gap between the existing legal standards and higher-order bioethical priorities. This standard will be treated with a philosophical argument for its use, as well as a detailed exploration of its technical components and conceptual underpinnings.

Does Resolution 8430 of 1993 respond to the current needs of ethics in health research with human beings in Colombia? / ¿Responde la Resolución 8430 de 1993 a las necesidades actuales de la ética de la investigación en salud con seres humanos en Colombia?

Verifying the compliance with the ethical principles of health research legitimizes its exercise in the eyes of the society and allows for the resolution of ethical dilemmas that emerge from new research interests and methods. Resolution 8430 of 1993 is one of the main ethical guidelines governing health research on human beings in Colombia. Considering that the resolution has not been revised or updated since its promulgation it becomes necessary to evaluate its current validity and adequacy to address the potential ethical dilemmas in the existing country's health research. Some gaps, contradictions, and aspects that require a deep review are detailed in this paper from a wide conception of health research areas and methods. After discussing the main weaknesses and inaccuracies, some alternatives are proposed to adjust the resolution to the present needs in health research with human beings.

La verificación del cumplimiento de los principios éticos en la investigación en salud legitima su ejercicio ante la sociedad y posibilita la resolución de dilemas éticos frente a nuevos intereses y métodos de investigación. En Colombia, la Resolución 8430 de 1993 es una de las principales pautas éticas que regulan la investigación en salud. Dado que no ha sido revisada ni actualizada desde su adopción, se hace necesario valorar su vigencia y suficiencia para abordar los potenciales dilemas éticos que se plantean actualmente en la investigación en salud en el país. En este contexto, se detallan algunos vacíos y contradicciones, así como aspectos que requieren de una revisión profunda, a partir de una concepción amplia de las áreas y los métodos de investigación en salud. Tras discutir las principales falencias e imprecisiones, se proponen alternativas para que la Resolución responda a las necesidades actuales del país frente a la ética en investigación en salud con seres humanos.

¿Responde la Resolución 8430 de 1993 a las necesidades actuales de la ética de la investigación en salud con seres humanos en Colombia? / Does Resolution 8430 of 1993 respond to the current needs of ethics in health research with human beings in Colombia?

Resumen La verificación del cumplimiento de los principios éticos en la investigación en salud legitima su ejercicio ante la sociedad y posibilita la resolución de dilemas éticos frente a nuevos intereses y métodos de investigación. En Colombia, la Resolución 8430 de 1993 es una de las principales pautas éticas que regulan la investigación en salud. Dado que no ha sido revisada ni actualizada desde su adopción, se hace necesario valorar su vigencia y suficiencia para abordar los potenciales dilemas éticos que se plantean actualmente en la investigación en salud en el país. En este contexto, se detallan algunos vacíos y contradicciones, así como aspectos que requieren de una revisión profunda, a partir de una concepción amplia de las áreas y los métodos de investigación en salud. Tras discutir las principales falencias e imprecisiones, se proponen alternativas para que la Resolución responda a las necesidades actuales del país frente a la ética en investigación en salud con seres humanos.

Abstract Verifying the compliance with the ethical principles of health research legitimizes its exercise in the eyes of the society and allows for the resolution of ethical dilemmas that emerge from new research interests and methods. Resolution 8430 of 1993 is one of the main ethical guidelines governing health research on human beings in Colombia. Considering that the resolution has not been revised or updated since its promulgation it becomes necessary to evaluate its current validity and adequacy to address the potential ethical dilemmas in the existing country's health research. Some gaps, contradictions, and aspects that require a deep review are detailed in this paper from a wide conception of health research areas and methods. After discussing the main weaknesses and inaccuracies, some alternatives are proposed to adjust the resolution to the present needs in health research with human beings.

[Bioethical issues on the access to drugs in the practice of ophthalmology in Colombia]. / Cuestiones bioéticas relacionadas con el acceso a medicamentos en el ejercicio de la oftalmología en Colombia.

Ophthalmology is a high-cost specialty in terms of medical, surgical and technological innovation and treatment. It is worrisome that in some countries patients are affected in their visual health, and therefore in their quality of life because they do not have the necessary resources for timely access to medications, medical appointments or surgical procedures. We searched in four electronic databases (ScienceDirect, MEDLINE/PubMed, ClinicalKey and SciELO), as well as in books on bioethics and Colombian laws, for articles related to bioethical issues and access to medicines in the exercise of ophthalmology. We reflect on the problem of access to ophthalmological drugs, with particular interest on how to apply the principles of bioethics on the clinical practice of patients with ophthalmological conditions. Ethical considerations are approached from the principles of Beauchamp and Childress, especially regarding the principle of justice, in order to provide health professionals in this field with arguments for medical and ethical decisions that benefit the healthcare and access to medicines for patients with ophthalmological conditions.

La oftalmología se constituye como una especialidad de alto costo en lo que respecta a tratamiento médico, quirúrgico y de innovación tecnológica. Es preocupante que en algunos países los pacientes se vean afectados en su salud visual, y por ende en su calidad de vida, por no contar con los recursos necesarios para un acceso oportuno a medicamentos, citas médicas o procedimientos quirúrgicos. A partir de la búsqueda de artículos relacionados con cuestiones bioéticas y el acceso a medicamentos en el ejercicio de la oftalmología en cuatro bases de datos electrónicas (ScienceDirect, MEDLINE/PubMed, ClinicalKey y SciELO ), así como en libros de bioética y leyes de la jurisdicción colombiana, realizamos una reflexión sobre el problema del acceso a los medicamentos oftalmológicos, centrándonos en el interés por la aplicación de la bioética en la práctica clínica y en el acceso a medicamentos de los pacientes con patologías oftalmológicas. Las consideraciones éticas se abordan desde una mirada del modelo principialista de Beauchamp y Childress, en especial considerando el principio de justicia, de modo que brinde a los profesionales de la salud en este campo, argumentos para la toma de decisiones médicas y éticas que beneficien la atención y el acceso a medicamentos de los pacientes con patologías oftalmológicas.