Addressing Risks Derived From the Commodification of Substances of Human Origin: A European Proposal Applicable Worldwide.

In view of the public consultation recently launched by the World Health Organization on Regulatory Convergence of Cell and Gene Therapy Products and the Proposal for a Regulation on substances of human origin (SoHO) repealing the European Union Directives on Blood and on Tissues and Cells, an opportunity arises to define an ethical and transparent framework of collaboration between industry and authorities responsible for SoHO-derived products, comprising medicines, medical devices, transfusion, and transplantation. The commodification of SoHO-derived medicinal products and medical devices entails important risks to the sustainability of healthcare systems and threatens the equitable access of patients to innovative therapies. It may also jeopardize the principle of altruistic donation of SoHO that is required for the treatment and survival of thousands of patients every year. This article puts forward several proposals aimed at reconciling the ethical principles of voluntary and unpaid SoHO donation and the noncommercialization of the human body with obtaining a profit that allows business activities, while ensuring high quality, safety, and efficacy standards of tissues and cells for clinical use.

An Analysis by the European Committee on Organ Transplantation of the Council of Europe Outlining the International Landscape of Donors and Recipients Sex in Solid Organ Transplantation.

Discrepancies in donation and transplantation by sex and gender have previously been reported. However, whether such differences are invariably the inevitable, unintended outcome of a legitimate process has yet to be determined. The European Committee on Organ Transplantation of the Council of Europe (CD-P-TO) is the committee that actively promotes the development of ethical, quality and safety standards in the field of transplantation in Europe. Whilst the ultimate objective is to shed light on the processes underlying potential gender inequities in transplantation, our initial goal was to represent the distribution by sex among organ donors and recipients in the CD-P-TO Member States and observer countries. Our survey confirms previous evidence that, in most countries, men represent the prevalent source of deceased donors (63.3% in 64 countries: 60.7% and 71.9% for donation after brain and circulatory death, respectively). In contrast, women represent the leading source of organs recovered from living kidney and liver donors (61.1% and 51.2% in 55 and 32 countries, respectively). Across countries, most recovered organs are transplanted into men (65% in 57 countries). These observations may be explained, at least in part, by the higher burden of certain diseases in men, childbearing related immune sensitization in women, and donor-recipient size mismatch. Future research should establish whether gender-related socially-constructed roles and socioeconomic status may play a detrimental role reducing the access of women to transplantation.

Clinical long-term nocturnal sleeping disturbances and excessive daytime sleepiness in Parkinson's disease.

OBJECTIVE: To prospectively evaluate nocturnal sleep problems and excessive daytime sleepiness (EDS) in Parkinson's disease (PD) patients, and analyze the influence of motor symptoms, treatment, and sex differences on sleep problems in PD. METHODS: Sleep disturbances of 103 PD patients were assessed with Parkinson's Disease Sleep Scale (PDSS) and the Epworth Sleepiness Scale (ESS). Student's t-test for related samples, one-way ANOVA with Tukey's HSD post hoc test were used to assess group differences. Bivariate correlations and mixed-effects linear regression models were used to analyze the association between clinical aspects and sleep disturbances over time. RESULTS: At baseline, 48.5% of PD patients presented nocturnal problems and 40% of patients presented EDS. The PDSS and ESS total score slightly improve over time. Nocturnal problems were associated with age and motor impartment, explaining the 51% of the variance of the PDSS model. Males presented less nocturnal disturbances and more EDS than females. Higher motor impairment and combined treatment (L-dopa and agonist) were related to more EDS, while disease duration and L-dopa in monotherapy were related to lower scores, explaining the 59% of the model. CONCLUSIONS: Sleep disturbances changed over time and age, diseases duration, motor impairment, treatment and sex were associated with nocturnal sleep problems and EDS. Agonist treatment alone or in combination with L-dopa might predict worse daytime sleepiness, while L-dopa in monotherapy is related to lower EDS, which significantly affects the quality of life of PD patients.

Access of non-residents to transplantation of deceased donor organs: practices and strategies in the European setting.

The access of non-resident patients to the deceased donor waiting list (DDWL) poses different challenges. The European Committee on Organ Transplantation of the Council of Europe (CD-P-TO) has studied this phenomenon in the European setting. A questionnaire was circulated among the Council of Europe member states to inquire about the criteria applied for non-residents to access their DDWL. Information was compiled from 28 countries. Less than 1% of recipients of deceased donor organs were non-residents. Two countries never allow non-residents to access the DDWL, four allow access without restrictions and 22 only under specific conditions. Of those, most give access to non-resident patients already in their jurisdictions who are in a situation of vulnerability (urgent life-threatening conditions). In addition, patients may be given access: (i) after assessment by a specific committee (four countries); (ii) within the framework of official cooperation agreements (15 countries); and (iii) after patients have officially lived in the country for a minimum length of time (eight countries). The ethical and legal implications of these policies are discussed. Countries should collect accurate information about residency status of waitlisted patients. Transparent criteria for the access of non-residents to DDWL should be clearly defined at national level.

COVID-19 in older adults: What are the differences with younger patients?

AIM: The present study aimed both to gain knowledge on the distinctive clinical characteristics of older adults with coronavirus disease 2019 (COVID-19), in comparison with those of younger patients, and to identify risk factors for mortality. METHODS: A retrospective observational study was carried out of patients consecutively admitted to Doctor Peset University Hospital, Valencia (Spain) for COVID-19 from 11 March to 28 April 2020. Every case was diagnosed by reverse transcription polymerase chain reaction or by serology test to detect antibodies. Demographic details, clinical characteristics, laboratory findings on admission and complications of each case were collected from electronic medical records. RESULTS: The dataset comprised 340 patients. Of them, 152 (44.6%) were aged >70 years. Comorbidities were more common in the older groups. Confusion was more common in older adults, whereas typical symptoms of COVID-19, such as fever, cough and myalgia, were less common. Oxygen saturation ≤93% on room air, neutrophilia, D-dimer >0.5 µg/mL, creatinine >1.5 mg/dL, lactate dehydrogenase ≥250 U/L and elevation of creatine kinase were higher in the older adult groups. Complications during hospitalization, such as acute respiratory distress syndrome (53.3% vs 33.2%, P < 0.001), acute kidney injury (11.8% vs 5.3%; P = 0.030) and mortality (28.9% vs 6.5%; P < 0.001) were more common in patients aged >70 years. Oxygen saturation ≤93% on room air on admission was a predictor of mortality (odds ratio 11.65, 95% confidence interval 3.26-41.66, P < 0.001) in patients aged >70 years. CONCLUSIONS: Older adults with COVID-19 have more atypical presentation, more complications and higher mortality. Oxygen saturation ≤93% on room air on admission is a predictive factor of death. Geriatr Gerontol Int 2021; 21: 60-65.

The global diffusion of organ transplantation: trends, drivers and policy implications.

Rising incomes, the spread of personal insurance, lifestyle factors adding to the burden of illness, ageing populations, globalization and skills transfer within the medical community have increased worldwide demand for organ transplantation. The Global Observatory on Donation and Transplantation, which was built in response to World Health Assembly resolution WHA57.18, has conducted ongoing documentation of global transplantation activities since 2007. In this paper, we use the Global Observatory's data to describe the current distribution of - and trends in - transplantation activities and to evaluate the role of health systems factors and macroeconomics in the diffusion of transplantation technology. We then consider the implications of our results for health policies relating to organ donation and transplantation. Of the World Health Organization's Member States, most now engage in organ transplantation and more than a third performed deceased donor transplantation in 2011. In general, the Member States that engage in organ transplantation have greater access to physician services and greater total health spending per capita than the Member States where organ transplantation is not performed. The provision of deceased donor transplantation was closely associated with high levels of gross national income per capita. There are several ways in which governments can support the ethical development of organ donation and transplantation programmes. Specifically, they can ensure that appropriate legislation, regulation and oversight are in place, and monitor donation and transplantation activities, practices and outcomes. Moreover, they can allocate resources towards the training of specialist physicians, surgeons and transplant coordinators, and implement a professional donor-procurement network.

La hausse des revenus, le développement des assurances personnelles, les facteurs de mode de vie ajoutant à la charge de morbidité des maladies, le vieillissement des populations, la mondialisation et le transfert des compétences au sein de la communauté médicale ont augmenté la demande mondiale de transplantation d'organe. L'Observatoire Mondial du Don et de la Transplantation, qui a été fondé en réponse à la résolution WHA57.18 de l'Organisation mondiale de la Santé, a rassemblé une documentation sur les activités de transplantation dans le monde de façon continue depuis 2007. Dans cet article, nous utilisons les données de l'Observatoire Mondial pour décrire la distribution actuelle (et les tendances) des activités de transplantation et pour évaluer le rôle des facteurs de systèmes de santé et de la macroéconomie dans la diffusion des technologies de transplantation. Nous considérons ensuite les implications de nos résultats sur les politiques de santé relatives au don et à la transplantation d'organe. La majorité des États Membres de l'Organisation mondiale de la Santé s'engagent maintenant dans la transplantation d'organe et plus d'un tiers d'entre eux ont réalisé des transplantations avec des organes provenant de donneurs décédés en 2011. En général, les États Membres qui se sont engagés dans la transplantation d'organe, ont un meilleur accès aux services médicaux et des dépenses totales de santé plus élevées par habitant que les États Membres où la transplantation d'organe n'est pas réalisée. La disponibilité de la transplantation avec des organes provenant de donneurs décédés était étroitement associée avec des niveaux élevés de revenu national brut par habitant. Il existe plusieurs manières possibles pour les gouvernements de soutenir le développement éthique des programmes de don et de transplantation d'organe. En particulier, ils peuvent s'assurer que la législation, la réglementation et la surveillance sont en place, et contrôler les activités, les pratiques et les résultats des dons et des transplantations. En outre, ils peuvent affecter des ressources pour la formation des médecins spécialistes, des chirurgiens et des coordinateurs de transplantation, et mettre en œuvre un réseau professionnel de recrutement des donneurs.

El aumento de la renta, la proliferación de los seguros personales y los factores del estilo de vida, sumados a la carga de enfermedades, el envejecimiento de la población, la globalización y la transferencia de conocimientos en la comunidad médica, han aumentado la demanda mundial de trasplantes de órganos. El Observatorio Mundial de Donación y Trasplante, creado en respuesta a la resolución WHA57.18 de la Asamblea Mundial de la Salud, ha llevado a cabo una documentación continua de las actividades mundiales de trasplantes desde 2007. En este informe, se emplean los datos del Observatorio Global para describir la distribución actual (y las tendencias) de las actividades de trasplante y para evaluar el papel de los factores de los sistemas sanitarios y de la macroeconomía en la difusión de la tecnología de trasplante. A continuación, se consideraron las repercusiones de los resultados en las políticas de salud relacionadas con la donación y el trasplante de órganos. En la actualidad, la mayoría de los Estados miembros de la Organización Mundial de la Salud participa en el trasplante de órganos y más de un tercio realizó trasplantes de donantes fallecidos en 2011. En general, los Estados miembros que participan en el trasplante de órganos cuentan con mayor acceso a los servicios médicos y tienen un mayor gasto total en salud per cápita que los Estados miembros donde no se realizan el trasplantes de órganos. La prestación de los trasplantes de donantes fallecidos se asoció estrechamente con altos niveles de renta nacional bruta per cápita. Existen varias formas en que los gobiernos pueden fomentar el desarrollo ético de los programas de donación y trasplante de órganos. En concreto, pueden garantizar que se adopte una legislación, regulación y supervisión adecuadas, así como realizar un seguimiento de las actividades, las prácticas y los resultados de la donación y el trasplante. Además, pueden destinar recursos a la formación de médicos especialistas, cirujanos y coordinadores de trasplantes, así como poner en marcha una red profesional de adquisición de donantes.

Global Database on Donation and Transplantation: goals, methods and critical issues (www.transplant-observatory.org).

The Global Database on Donation and Transplantation represents the most comprehensive source to date of worldwide data concerning activities in organ donation and transplantation derived from official sources, as well as information on legal and organizational aspects. The objectives are to collect, analyse and disseminate this kind of information of the WHO Member States and to facilitate a network of focal persons in the field of transplantation. They are responsible for providing the legislative and organizational aspects and the annual activity practices through a specific questionnaire. 104 out of the 194 WHO Member States that cover the 90% of the global population contribute to this project.Although we know the numerous limitations and biases as a result of the different interpretations of the questions, based on cultural factors and language, there is no other similar approach to collect information on donation and transplantation practices all over the world. The knowledge of demand for transplantation, availability of deceased and living donor organs and the access to transplantation is essential to monitor global trends in transplantation needs and donor organ availability. Information regarding the existence of regulatory oversight is fundamental to ensure the ethical practice of organ donation and transplantation.

2009 global data in organ donation and transplantation: activities, laws, and organization.

The Global Observatory on Donation and Transplantation represents the most comprehensive source of worldwide data concerning activities in organ donation and transplantation and information on legal and organizational aspects. Of the countries reporting information, 84.7% have a national structure supervising or coordinating donation and transplantation and 91% have specific legislation. Worldwide approximately 104,065 solid organ transplants are performed each year. There is a vast difference in rates of kidney and liver transplantation, especially from deceased donor depending on the level of development. This analysis provides an overview of existing organizational structures, related legislation, and activities.