Legislation of direct-to-consumer genetic testing in Europe: a fragmented regulatory landscape

Despite the increasing availability of direct-to-consumer (DTC) genetic testing, it is currently unclear how such services are regulated in Europe, due to the lack of EU or national legislation specifically addressing this issue. In this article, we provide an overview of laws that could potentially impact the regulation of DTC genetic testing in 26 European countries, namely Austria, Belgium, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, the Netherlands and the United Kingdom. Emphasis is placed on provisions relating to medical supervision, genetic counselling and informed consent. Our results indicate that currently there is a wide spectrum of laws regarding genetic testing in Europe. There are countries (e.g. France and Germany) which essentially ban DTC genetic testing, while in others (e.g. Luxembourg and Poland) DTC genetic testing may only be restricted by general laws, usually regarding health care services and patients’ rights

Si ocurrió un evento adverso piense en decir “lo siento”

Fundamento. La información al paciente víctima de un evento adverso (EA) presenta ciertas particularidades en función del marco legal del país en el que se produzca, especialmente en lo referido al ofrecimiento de una disculpa. En el presente trabajo se pretende establecer los límites y las condiciones que debemos considerar a la hora de trasladar una disculpa al paciente que ha sufrido un EA. Método. Conferencia de consenso entre 26 profesionales de distintas comunidades autónomas, instituciones y perfiles profesionales con experiencia acreditada en la gestión de sistemas de Seguridad del Paciente y Derecho Penal de diferentes ámbitos laborales (sanidad, aseguradoras, inspección, académico). Resultados. El paciente, tras un EA además de ser informado, debiera recibir una disculpa expresada en términos neutros (manifestación empática y de pesar por lo sucedido), sin que el informante se identifique a sí mismo como responsable del daño, culpabilice a terceros, ni ofrezca una compensación en nombre de la compañía aseguradora. El profesional que se siente más directamente involucrado en el incidente es normalmente el menos indicado para informar y disculparse. El informante debe ajustarse al tipo y gravedad del EA. La normativa y condiciones del seguro de responsabilidad aconsejan no ofrecer información concreta sobre la magnitud de la compensación. Conclusiones. La disculpa debe medirse en función del marco normativo que rige en cada país. En nuestro caso procede una respuesta de empatía hacia el paciente, manifestando pesar por lo sucedido (decir lo siento) que puede facilitar la relación con el paciente, reducir su desconfianza y el número de litigios. Background. Disclosing information to a patient who is a victim of an adverse event (AE) presents some particularities depending on the legal framework in the country where the AE occurred. The aim of this study is to identify the limits and conditions when apologizing to a patient who has suffered an AE. Methods. A consensus conference involving 26 professionals from different autonomous communities, institutions, and profiles (health, insurance, inspection, academic) with accredited experience in patient safety management systems and criminal law. Results. Open disclosure should include an apology expressed in neutral terms (showing empathy and regret for what has happened) without the informant being identified as responsible for the damage, blaming third parties, or offering compensation on behalf of the insurance company. The professional who feels most directly involved in the incident is usually the least likely to report it and apologise. The informant profile must conform to the type and severity of the AE. The rules and conditions of liability insurance advise against providing specific information on the amount of compensation. Conclusions. The apology should be offered in terms of the regulatory framework in force in each country. In Spain, an appropriate response of empathy for the patient is warranted, expressing regret for what happened (apologising), which can facilitate the relationship with the patient, mitigate their mistrust, and reduce the number of disputes

RICORS2040 : The need for collaborative research in chronic kidney disease

Chronic kidney disease (CKD) is a silent and poorly known killer. The current concept of CKD is relatively young and uptake by the public, physicians and health authorities is not widespread. Physicians still confuse CKD with chronic kidney insufficiency or failure. For the wider public and health authorities, CKD evokes kidney replacement therapy (KRT). In Spain, the prevalence of KRT is 0.13%. Thus health authorities may consider CKD a non-issue: very few persons eventually need KRT and, for those in whom kidneys fail, the problem is 'solved' by dialysis or kidney transplantation. However, KRT is the tip of the iceberg in the burden of CKD. The main burden of CKD is accelerated ageing and premature death. The cut-off points for kidney function and kidney damage indexes that define CKD also mark an increased risk for all-cause premature death. CKD is the most prevalent risk factor for lethal coronavirus disease 2019 (COVID-19) and the factor that most increases the risk of death in COVID-19, after old age. Men and women undergoing KRT still have an annual mortality that is 10- to 100-fold higher than similar-age peers, and life expectancy is shortened by ~40 years for young persons on dialysis and by 15 years for young persons with a functioning kidney graft. CKD is expected to become the fifth greatest global cause of death by 2040 and the second greatest cause of death in Spain before the end of the century, a time when one in four Spaniards will have CKD. However, by 2022, CKD will become the only top-15 global predicted cause of death that is not supported by a dedicated well-funded Centres for Biomedical Research (CIBER) network structure in Spain. Realizing the underestimation of the CKD burden of disease by health authorities, the Decade of the Kidney initiative for 2020-2030 was launched by the American Association of Kidney Patients and the European Kidney Health Alliance. Leading Spanish kidney researchers grouped in the kidney collaborative research network Red de Investigación Renal have now applied for the Redes de Investigación Cooperativa Orientadas a Resultados en Salud (RICORS) call for collaborative research in Spain with the support of the Spanish Society of Nephrology, Federación Nacional de Asociaciones para la Lucha Contra las Enfermedades del Riñón and ONT: RICORS2040 aims to prevent the dire predictions for the global 2040 burden of CKD from becoming true

La gestió de suports vitals escassos en contextos de pandèmia. Reflexions sobre l''aplicació de triatges en el marc de la COVID-19 La gestión de soportes vitales escasos en contextos de pandemia. Reflexiones acerca de la aplicación de triajes en el marco del COVID-19

En el marco de una pandemia a escala mundial como la que representa el COVID-19 uno de los mayores dilemas bioéticos que se plantean es el de la gestión de determinados medios asistenciales escasos, tales como los respiradores (ventilación mecánica asistida), pues del acceso a los mismos dependen las posibilidades de supervivencia de numerosos pacientes en estado crítico. El presente trabajo trata de determinar los criterios para la gestión de dichos soportes vitales en un contexto de escasez extrema de los mismos para hacer frente a las necesidades de la totalidad de los pacientes que los requieren, analizando la literatura comparada sobre el particular, así como diferentes informes institucionales y de organismos en la esfera de la bioética. In the context of a worldwide pandemic such as COVID-19, one of the greatest bioethical dilemmas that arise is the management of certain scarce medical devices, such as ventilators (mechanical ventilation), since the survival of many critically ill patients depends on the access to these ventilators. The present paper tries to determine the criteria applicable for the management of these medical devices in a context of extreme scarcity to face the needs of all the patients who require them. To this end, the comparative literature on the subject as well as different institutional and academic reports in the field of bioethics are analysed. Copyrigh

Regulation of artificial human reproduction and European social regulations

Observing the practical situation of the techniques of assisted procreation in European societies, one is allowed to affirm that these techniques are largely in use in our societies, it did not find resistance among the secular groups of the society. It is not the case of the representatives of the Catholic church, hostile to each intervention on the reproductive mechanisms as being a violation against natural law, the most virulent opposition is linked to intervention on embryos or to each way of reproduction outside of the canonic marriage, considering therefore artificial insemination as immoral and anti-juridical. The opposition between secular and the catholic groups is of unequal intensity in the different European countries, it did not stop the application and the use of these reproductive techniques although it made the adoption difficult of measures in some states, and even in the European Parliament. However, they could not oppose the scientific and medical corporation and their arguments of treatment of diseases and of sterility of men or women. This way to present these reproductive techniques in terms of lowering of suffering of couples not able to reproduce naturally received a full social acceptance and legitimation, acceptation because the origin of these techniques is incontestably scientific and legitimation because the goal is essentially medical.info:eu-repo/semantics/publishe

Non-coding recurrent mutations in chronic lymphocytic leukaemia

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