La seguridad social: Un derecho y una obligación para el odontólogo y sus trabajadores / Social security: A right and obligation for the dentist and his workers

La seguridad social es un derecho encaminado a asegurar el bienestar de los ciudadanos que forman parte de una comunidad, y su objetivo principal es brindar a las personas aseguradas un conjunto de medidas públicas que ayuden a la protección de su salud por accidentes de trabajo o enfermedad laboral, desempleo, invalidez, vejez o muerte. De acuerdo con nuestra legislación, toda persona que preste servicios laborales a otro, tiene derecho a ser registrado ante el seguro social para que, en caso de accidente o enfermedad laboral, exista una ins- tancia que asista al trabajador afectado a recuperar su salud sin afectar su economía familiar. Es bastante frecuente que el odontólogo tenga trabajadores a su cargo, quien al fungir como patrón tiene obligaciones específicas ante el Instituto de Seguridad Social que de no cumplir, puede traer consigo sanciones y amonestaciones al profesional. El objetivo del presente artículo es informar al odontólogo sus derechos y obligaciones ante el seguro social mediante una revisión de las normas y leyes que lo imponen (AU)

Social security is a right aimed at ensuring the well-being of citizens who are part of community, and its main objective is to provide insured persons with a set of public measures that help protect their health, due to accidents at work and occupational disease, unemployment, disability, old age or death. In accordance with our legislation, any person who provides labor services to another has the right to registered with the social security so that, in the event of an accident or occupational disease, there is an instance that assists the affecter worker to recover his health without affecting his familiar economy. It is quite common for the dentist to have workers under his charge, who, acting as an employer, have specific obligations with the Social Security Institute, which, if not fulfilled, can bring sanctions and reprimands to the professional. The aim of this article is to inform dentists about their rights and obligations with the Social Security Institute through a review of the laws that impose it (AU)

How the convention on human rights affects a patient's right to life.

Richard Griffith, Senior Lecturer in Health Law at Swansea University, continues his series on human rights and health care and considers the right to life under Article 2 of the European Convention on Human Rights (1950).

Networked Health Care Governance in the European Union.

The European Union (EU) increasingly resorts to new forms of governance to establish unified health and welfare policies without member states having to transfer their sovereignty to a supranational level. European Administrative Networks are important instruments in the toolbox of new forms of governance, dealing with rulemaking, rule monitoring, and rule enforcement. Operating beyond, but not above, the state, European networks of national administrative units allow for interaction and exchange to coordinate national responses to increased interaction across their borders. The authors use social network analysis to uncover the pattern of interaction among national representatives in two central EU health care networks. Their analysis finds not only that the network in the area of pharmacovigilance has more competences, resources, and capacity to improve the enforcement of EU rules than the network regarding cross-border health care but also that the driving forces behind network interaction appear to differ quite a bit as well. While the supranational character becomes apparent in the former network, network interactions in the latter seem aimed at mitigating the impact of patient mobility rather than improving cross-border health care take up.

Emergency contraception: unresolved clinical, ethical and legal quandaries still linger.

Emergency contraception (EC) has been prescribed for decades, in order to lessen the risk of unplanned and unwanted pregnancy following unprotected intercourse, ordinary contraceptive failure, or rape. EC and the linked aspect of unintended pregnancy undoubtedly constitute highly relevant public health issues, in that they involve women's self-determination, reproductive freedom and family planning. Most European countries regulate EC access quite effectively, with solid information campaigns and supply mechanisms, based on various recommendations from international institutions herein examined. However, there is still disagreement on whether EC drugs should be available without a physician's prescription and on the reimbursement policies that should be implemented. In addition, the rights of health care professionals who object to EC on conscience grounds have been subject to considerable legal and ethical scrutiny, in light of their potential to damage patients who need EC drugs in a timely fashion. Ultimately, reproductive health, freedom and conscience-based refusal on the part of operators are elements that have proven extremely hard to reconcile; hence, it is essential to strike a reasonable balance for the sake of everyone's rights and well-being.

Measuring the impact of revised mental health legislation on human rights in Queensland, Australia.

The Convention on the Rights of Persons with Disabilities (2006) (CRPD) has been instrumental for initiating and shaping the reform of mental health legislation in many countries, including the eight Australian jurisdictions. Multiple approaches have been proposed to assess and monitor the compliance of States Parties' mental health legislation with the CRPD, and to evaluate its success in protecting and promoting the human rights of people with disabilities. This article reports an effort to index the impact of legislation on human rights by measuring changes in the prevalence of compulsory treatment orders applied to people with mental illness after the introduction of CRPD influenced mental health legislation in the Australian state of Queensland. We found that despite reforms intended to enhance patient autonomy, the prevalence of compulsory treatment orders increased after implementation of the new legislation. Possible reasons behind this unintended consequence of the legislative reform may include a lack of systematized voluntary alternatives to compulsory treatment, a paternalistic and restrictive culture in mental health services and risk aversion in clinicians and society. We recommend that the reforms in mental health policy as well as legislation need to go further in order to achieve the goals embodied in the human rights framework of the CRPD.

[Bioethics, Human Rights and COVID-19]. / Bioética, Derechos Humanos y COVID-19.

In this paper present, from a bioethical perspective, a reflection on how to reconcile efforts to combat the COVID-19 pandemic with the safeguard of human rights. To do this, I develop three points. First, the regulatory framework that justifies the restriction or suspension of rights in the face of serious threats to public health. Second, the declarations of the international bioethics committees on the way in which human rights should be protected during public health crisis. And third, a review of the main rights threatened both by the public health crisis and by the means adopted to combat it. Before going into each of these points, I offer a preliminary note to clarify certain legal concepts and underline the need to overcome disjunctive approaches in considering human rights.

Legal perspectives on liability for medical negligence and malpractices in Nigeria.

Medical practice usually involves different activities which if not professionally handled, may give rise to liabilities on the part of the medical practitioner. These liabilities may arise in tortious claims and in some other cases, may go beyond the realm of civil liabilities to criminal liabilities. This review focuses on liabilities that amount to negligence both under the civil and criminal laws in Nigeria, other instances of malpractices which may not amount to negligence but may suffice to give rise to a successful cause of action in other branches of substantive law including claims for breach of fundamental human rights; contract; and fiduciary relationship. The review concludes by emphasizing the need for caution and the need to ensure that justice is seen to be done not only to the victims but also to the medical practitioners who deserve all legal protection in the exercise of their professional duties.

An end to coercion: rights and decision-making in mental health care.

The United Nations Convention on the Rights of Persons with Disabilities requires a paradigm shift from a medical model of disability to a social model that emphasizes overcoming the barriers to equality created by attitudes, laws, government policies and the social, economic and political environment. The approach adopted by the social model recognizes that people with psychosocial disabilities have the same right to take decisions and make choices as other people, particularly regarding treatment, and have the right to equal recognition before the law. Consequently, direct or supported decision-making should be the norm and there should be no substitute decision-making. Although recent mental health laws in some countries have attempted to realize a rights-based approach to decision-making by reducing coercion, implementing the Convention on the Rights of Persons with Disabilities can be challenging because it requires continuous refinement and the development of alternatives to coercion. This article reviews the impact historical trends and current mental health frameworks have had on the rights affected by the practice of involuntary treatment and describes some legal and organizational initiatives that have been undertaken to promote noncoercive services and supported decision-making. The evidence and examples presented could provide the foundation for developing a context-appropriate approach to implementing supported decision-making in mental health care.

La Convention des Nations Unies relative aux droits des personnes handicapées nécessite un changement radical pour passer d'un modèle médical du handicap à un modèle social mettant l'accent sur la levée des obstacles en matière d'égalité, créés par des attitudes, des lois, des politiques gouvernementales ainsi que l'environnement social, économique et politique. L'approche adoptée par le modèle social reconnaît que les personnes présentant un handicap mental ont le même droit de prendre des décisions et de faire des choix que les autres, notamment en matière de traitement, et ont droit à une reconnaissance égale devant la loi. Par conséquent, la prise de décision directe ou accompagnée doit être la norme et il ne doit exister aucune prise de décision substitutive. Bien que certains pays aient récemment cherché, à travers des lois sur la santé mentale, à instaurer une approche fondée sur les droits en matière de prise de décision en réduisant la coercition, la mise en œuvre de la Convention relative aux droits des personnes handicapées peut poser problème, car elle exige une amélioration continue et l'élaboration de solutions autres que la coercition. Cet article examine l'impact que les tendances historiques et les cadres actuels en matière de santé mentale ont eu sur les droits lésés par la pratique du traitement involontaire et décrit plusieurs initiatives législatives et organisationnelles qui ont été prises pour promouvoir les services non coercitifs et la prise de décision accompagnée. Les données et les exemples présentés peuvent servir de fondement à l'élaboration d'une approche adaptée au contexte pour mettre en place la prise de décision accompagnée en matière de soins de santé mentale.

La Convención de las Naciones Unidas sobre los Derechos de las Personas con Discapacidad requiere un cambio de paradigma, de un modelo médico de discapacidad a un modelo social que haga hincapié en la superación de las barreras a la igualdad creadas por las actitudes, las leyes, las políticas gubernamentales y el entorno social, económico y político. El enfoque adoptado por el modelo social reconoce que las personas con discapacidad psicosocial tienen el mismo derecho a tomar decisiones y a elegir como cualquier otra persona, especialmente en lo que se refiere al tratamiento, y tienen derecho a un reconocimiento igualitario ante la ley. Por lo tanto, la toma de decisiones directa o apoyada debería ser la norma y no debería haber un responsable sustituto de la toma de decisiones. Aunque las recientes leyes sobre salud mental de algunos países han tratado de aplicar un enfoque basado en los derechos para la adopción de decisiones mediante la reducción de la coerción, la implementación de la Convención sobre los Derechos de las Personas con Discapacidad puede ser un reto, ya que requiere un continuo perfeccionamiento y el desarrollo de alternativas a la coerción. Este artículo evalúa el impacto que las tendencias históricas y los marcos actuales de salud mental han tenido sobre los derechos afectados por la práctica del tratamiento involuntario y describe algunas iniciativas legales y organizativas que se han emprendido para promover servicios no coercitivos y apoyar la toma de decisiones. La evidencia y los ejemplos presentados podrían servir de base para desarrollar un enfoque apropiado al contexto para la implementación de la toma de decisiones apoyada en la atención de la salud mental.

The implementation of European Union (EU) rules on cross-border care: moving towards convergence?

This article studies the implementation of the European Union (EU)'s Patients' Rights Directive in Germany and Norway. The objective of the Directive was to allow EU member states to have a say in the regulatory work, ensure predictability and uniformity in the application of EU rules on cross-border care, and enhance a move towards EU harmonisation in this area. So far, the implementation processes in Norway and Germany have mixed results regarding the likelihood of achieving uniformity and harmonisation. Although the Directive has had convergent effects on certain areas of cross-border care, such as setting up National Contact Points and providing patients with the basic right to treatment abroad, implementation also shows divergent patterns. In both countries, adapting to EU rules has strengthened patients' rights to choose freely among health-service providers in a wider European health-service market. However, due to legal discretion and country-specific institutions within which the new rules are applied, divergent patterns prevail.

Ethical assessment of the EU health policy under the Directive 2011∕24∕EU: approaching patients' rights and cross-border healthcare.

PURPOSE: The purpose of the present article is to discuss the ethical challenges of the European Union (EU) health legislation framing the patients' rights and the cross-border healthcare (CBHC). BACKGROUND: The paper reviews the EU main legislation in the field, namely the Directive 2011∕24∕EU (CBHC Directive) of the European Parliament and of the Council of 9 March 2011, on the application of patients' rights in CBHC. CONTENT: The aim of the study is to analyze the patients' rights and the CBHC, enhancing the healthcare support and coordination under this regulatory framework. An exploratory and descriptive analysis will be conducted based on these legal provisions by focusing the ethical choices, the ethical duty, the ethical reasons and the patients' rights. An introductory literature overview will be provided and an analysis of the recent data reports published by the European Commission (EC) on the application of the CBHC Directive will be detailed. Therefore, six main themes emerged: (i) the protection of the patients' rights; (ii) the examination of the ethical challenges to address the EU public health issues; (iii) the monitoring of the data reports on the operation of the CBHC Directive; (iv) the reimbursement of costs of CBHC; (v) the European reference networks (ERNs); (vi) the eHealth network and the health technology assessment (HTA). CONCLUSIONS: The paper reviews the existing legal framework aimed to support the Member States (MS) in achieving a harmonized implementation of the CBHC Directive. Hence, particular ethical issues will be developed under this regulatory framework.

An examination of organisational policies for healthcare and lifestyle decision-making among Australian aged care providers.

OBJECTIVE: Examine policies of aged care organisations relating to healthcare and lifestyle decision-making. METHODS: Seven aged care organisations submitted policy documents. Policies were analysed using the Australian Law Reform Commission (ALRC) "Decision-Making Principles" as a framework. Senior staff (N = 9) with policy development roles participated in follow-up interviews. RESULTS: The structure and content of policy documents varied significantly between organisations. Most acknowledged the need to support the rights of care recipients in decision-making; however, the nature of this support was often unclear. Interview themes included factors relating to "organisational contexts" "policy development and implementation" and "ethical challenges." An overarching theme among high-performing organisations was "proactive response aimed at pre-empting decision-making dilemmas". We provide recommendations for policy development, including a self-assessment audit tool. CONCLUSION: Aged care provider organisations may need to review policies in the areas of healthcare and lifestyle decision-making to meet current best practice principles.

Unproven stem cell therapies: is it my right to try?

BACKGROUND: Nowadays one of the most critical aspects of innovative cell-based therapies is the unregulated industry, as it is becoming a competitor of the regulated system. Many private clinics, worldwide, advertise and offer cell-based interventions treatments directly to the consumer and this poses a risk to both vulnerable patients and health systems. Several countries have implemented Compassionate Use Programmes (CUP) that provide patients with medicines that have not yet completed the approval pathway, in the event that no reasonable alternative exists. Recently, in the public discourse, compassionate use has been increasingly associated with a patient's right to try. Thus, the aim of this study was to assess public knowledge of the clinical trials process with specific reference to innovative stem cell treatments, and trust in the institutions responsible for regulatory activities. We also asked people about their "right" to use unregulated therapies. METHODS: We developed an ad hoc questionnaire on three main areas of concern and administered it to 300 people in the patient waiting room at an Italian university hospital. RESULTS: Our findings suggest that people have a good knowledge of the clinical trials process and trust in healthcare institutions. Nonetheless, one person in two believes it is a right to use unregulated therapies. CONCLUSIONS: We stress the need, in the age of cellular therapies, for a commitment to support vulnerable patients and to strengthen awareness among the public about the substantial boundary that differentiates experimental therapies from unproven therapies. There should not be a "right to try" something that is unsafe but rather approved treatments and in line with good clinical practice. The trend, which emerged on this issue from our study, is quite different, confirming the urgent need to improve health information so that it is as complete as possible.

Inequalities in realised access to healthcare among recently arrived refugees depending on local access model: study protocol for a quasi-experimental study.

INTRODUCTION: In many countries, including Germany, newly arriving refugees face specific entitlement restrictions and access barriers to healthcare. While entitlement restrictions apply to all refugees who seek protection in Germany during the first months, the barriers to access depend on the model that the states and the municipalities implement locally. Currently, two different models exist: the healthcare voucher model (HcV) and the electronic health card model (eHC). The aim of the study is to analyse the consequences of these two different access models on newly arrived refugees' realised access to healthcare. METHODS AND ANALYSIS: The random assignment of refugees to municipalities allows for a quasi-experimental design by comparing realised access to healthcare among refugees in six municipalities in North Rhine-Westphalia which have implemented HcV or eHC. We compare realised access to healthcare using ambulatory care sensitive conditions and health expenditure as outcome indicators, and use of emergency care, preventive care, psychotherapeutic or psychiatric care, and of therapeutic devices as process indicators. Results will be adjusted for aggregated information on age, sex, socioeconomic structure of the municipalities and density of general practitioners or specialists. ETHICS AND DISSEMINATION: We cooperated with local welfare offices and the statutory health insurance for data collection. Thereby, we were able to avoid recruiting large numbers of refugee patients immediately after arrival while their access and entitlement to healthcare are restricted. We developed an extensive data protection concept and ensured that all data collected are fully anonymised. Results will be published in peer-reviewed journals and summarised in reports to the funding agency.

Who should pay for the continuity of post-trial health care treatments?

BACKGROUND: The bioethical debate in the world on who should pay for the continuity of post-trials treatment of patients that have medical indication remains obscure and introduces uncertainties to the patients involved in the trials. The continuity of post-trial treatment was only incorporated in the 2000s by the Helsinki Declaration. The Universal Declaration on Bioethics and Human Rights, published in 2006, points out that post-trial continuity may present a broader scope than just the availability of the investigated medicine. In the latest version of this Declaration, in 2013, it was stated that "prior to the start of the clinical trial, funders, researchers and governments of the countries participating in the research should provide post-trial access for all participants who still require an intervention that was identified as beneficial. This information should also be disclosed to participants during the informed consent process". However, a systematic review on the registration of phase III and IV clinical trials, from the clinical trials website, demonstrated that the understanding of the various guidelines and resolutions is conflicting, generating edges in the post-trial setting. For the health authorities of countries where clinical trials take place, the uncertainties about the continuity of the treatments generate gaps in care and legal proceedings against health systems, which are forced to pay for the treatments, even if they are not included in the list of medicines available to the population. METHODS: Fifty-one representatives from the health, judicial, legislative, patient and academic organizations of eight countries of Latin American and South Korea took part in a meeting in Chile, in 2017, to discuss the responsibility of the treatment continuation after clinical trials. From a hypothetical case of development of a new drug and its studies of efficacy and safety, the participants, divided in groups, proposed recommendations for the problem and pointed out the pros and cons of adopting each recommendation. The groups were, afterwards, confronted by a simulated jury and, finally, issued a final recommendation for the problem. Then, an analysis was made on the content of the recommendations and the pros and cons in adopting conservative or liberal positions, besides the possible impacts of a restrictive regulation regarding the conduction of clinical trials, pointed out by the groups, before and after the simulated jury. RESULTS: The theme was widely discussed and about 12 recommendations were proposed by the participants. The main ones took into account aspects related to patients' rights, economic factors and the development of new technologies, above the position of industry and research institutes, as well as the legislation in force in each country. CONCLUSION: The countries of Latin America and South Korea, currently, do not have laws that address patients' rights, moreover, there is no definition on who should be responsible for post-trial treatments. It is suggested that the World Health Organization issue a resolution recommending that all associated countries determine that the pharmaceutical and medical device industries, or those that sponsored it, should continue to provide treatment to all patients who participated in clinical trials and have medical indication to the continuity.