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Competing Interests: The author certifies that there are no funding or commercial associations (consultancies, stock ownership, equity interest, patent/licensing arrangements, etc.) that might pose a conflict of interest in connection with the submitted article related to the author or any immediate family members. All ICMJE Conflict of Interest Forms for authors and Clinical Orthopaedics and Related Research® editors and board members are on file with the publication and can be viewed on request.

Background: In British Columbia (BC), Canada, clinicians are responsible for giving involuntary psychiatric patients rights information upon admission. Yet an investigation by the BC Office of the Ombudsperson found that clinicians are not always fulfilling this responsibility. The Ombudsperson recommended that the provincial government fund an independent body to give rights advice to patients., Methods: To understand how clinicians feel about this recommendation, focus groups of clinicians who may give psychiatric patients rights information (n = 81) were conducted in Vancouver, BC, to probe their attitudes toward independent rights advisors. The focus group transcripts were thematically analyzed., Results: Most clinicians believe that giving rights information is within their scope of practice, although some acknowledge that it poses a conflict of interest when the patient wishes to challenge the treatment team's decisions. Participants' chief concerns about an independent rights-advice service were that (a) patients may experience a delay in receiving their rights information, (b) integrating rights advisors into the workflow would complicate an already chaotic admission process, and (c) more patients would be counselled to challenge their hospitalization, leading to an increased administrative workload for clinical staff. However, many participants believed that independent rights advisors would be a positive addition to the admission process, both allowing clinicians to focus on treatment and serving as a source of rights-related information., Conclusions: Participants were generally amenable to an independent rights-advice service, suggesting that the introduction of rights advisors need not result in an adversarial relationship between treatment team and patient, as opponents of the proposal fear. Clearly distinguishing between basic rights information and in-depth rights advice could address several of the clinicians' concerns about the role that independent rights advisors would play in the involuntary admission process. Clinicians' and other stakeholders' concerns should be considered as the province develops its rights-advice service., Competing Interests: The authors have declared that no competing interests exist.

Background: Over the past decade, hospitals in many countries, including Israel, have undergone an accreditation process aimed at improving the quality of services provided. This process also refers to the protection and promotion of patients' rights. However, reviewing the criteria and content included in this category in the Israeli context reveals definitions and implications that differ from those presented by the law - specifically the Patient's Rights Act 1995. Moreover, the rights included in it are not necessarily equally represented in other legislation., Methods: This study seeks to examine the question of whether and to what extent the scope, contents, and definitions of patients' rights in the JCI Standards are similar to or different from patients' rights as they are addressed and protected in national legislation. The article provides a comparison and examination of the different regulatory frameworks of patients' rights, especially those in the accreditation of healthcare institution and legislation, analyzes the gaps between such frameworks, and suggests possible implications on our understanding of the concept of patients' rights., Results: The patients' right chapter in the accreditation process introduces and promotes the concepts of patient and family rights, increases the awareness and compliance of such concepts, and may create greater consistency in their introduction and application., Conclusions: Discussion of the Israeli case not only demonstrates how regulatory frameworks are instrumental - for broader policy purposes, especially in the area of patients' rights and the rights of patients' families - but also calls for a more general examination of the concept of patients' rights in health policies and its contribution to the quality of health services. Reference to patients' rights in accreditation of healthcare institutions may promote and enhance this concept and contribute to the delivery of care, thereby complementing a lacuna in the law.

In 2018, the American Academy of Neurology, the American Congress of Rehabilitation Medicine, and the National Institute on Disability, Independent Living, and Rehabilitation Research published a systematic evidence-based review and an associated practice guideline for improved assessment, treatment, and rehabilitation of patients with disorders of consciousness. Patients with disorders of consciousness include individuals in the vegetative and minimally conscious states, as well as others with covert consciousness and cognitive motor dissociation. These landmark publications (concurrently published in Neurology and Archives of Physical Medicine and Rehabilitation) supplant the 1994 New England Journal of Medicine Multi-Society Task Force report on the vegetative state and the 2002 criteria establishing minimally conscious states. The guideline re-designates the permanent vegetative state as chronic. In our article, we consider the legal and ethical implications of the practice guideline for clinical practice and explain the vulnerability of these patients who suffer from high rates of misdiagnosis, inadequate medical surveillance, undertreatment of pain, inadequate rehabilitation, and segregation in chronic care. We argue that these deficiencies in medical care are inconsistent with our growing appreciation of the dynamic nature of these brain states and an emerging standard of care as articulated by the national guideline. These deficiencies also violate domestic and international disability law. To substantiate this latter claim, we apply disability law to this population, focusing on key Americans with Disabilities Act mandates, the relevance of the 1999 Supreme Court, Olmstead v. L.C., and the utility of Olmstead enforcement actions to integrate the care of these individuals into the medical mainstream., (Copyright © 2020 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.)

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., Competing Interests: The authors declare no competing interests., (© Oludamilola Adebola Adejumo et al.)

Patients with cancer who have exhausted standard treatments often seek access to investigational drugs. Often, however, such access is unavailable, due to either the unavailability of a trial, lack of an open recruiting spot on the trial, even when the trial itself is open, or the inability of the patient to meet one or more trial eligibility criteria. In such settings patients often seek access to investigational agents outside of a trial. The federal "Right to Try" legislation was passed to create an additional avenue, different from the FDA's Expanded Access, or "Compassionate Use" Program, through which patients might obtain access to investigational drugs. A year after this legislation was signed into law, there remains both a limited awareness of it and a substantial degree of misunderstanding on the part of those who are aware of it. The law creates an avenue to greatly facilitate off-study administration when patient, physician, and the manufacturer are all in agreement regarding the off study use of an eligible investigational agent. The law does not, however, empower a patient to impose a demand on either a provider or a drug manufacturer, nor does it require any entity to provide financial coverage for the drug. Eligible drugs are those which are not approved by the FDA for any indication, have completed a phase I trial, have an ongoing pivotal trial, and have an active registration plan. We review the specific law with commentary on its implications for improved access to investigational drugs outside of clinical trials., (©2019 American Association for Cancer Research.)

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., ((c) 2020 The authors; licensee World Health Organization.)

Patients with epilepsy face innumerable obstacles in daily life, related to work, permission to drive and interpersonal relationships, which require medical guidance. This paper reports a literature review based on scientific articles and civil and traffic system, as a way to resolve doubts about medical obligations in the patient's permission to drive and work. An employment agreement requires the contractor to guarantee safety conditions as well as requiring the patient, at the pre-employment medical examination, to let the physician know previous medical conditions, including epilepsy. More than 90% of patients with epilepsy omit this information during the application assessment, thus being subject to imputation of ideological falsehood crime as disposied on article 299 of Brazilian Penal Code. Medical confidentiality breaches may only occur in specific situations. In Brazil, the authorization and driver's license renewal is governed by the Brazilian Traffic Code (Federal Law n° 9503/1997). For patient evaluations, two groups are considered: those on antiepileptic medication and those on medication withdrawal. A favorable report from the attending physician is also required, in both categories. Seizures that occur exclusively during sleep, and focal aware events or prolonged aura are not differentiated from other seizure types disposed in the traffic law. It is the responsibility of the attending physician to analyze each patient individually to resolve conflicts between public safety and the individual patient's independence. A frank and honest doctor-patient relationship is essential for the patient to understand the public and individual consequences of epileptic seizures and to feel comfortable seeking medical help.

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.

The Philippine community internship program, originally created to supplement the country's thinning health workforce while providing training to student doctors, poses a legal and ethical challenge for medical interns. Inherent characteristics of the program-such as financial disparities and burdens, the lack of supervision by senior doctors, the competence of student doctors, and short rotation times-can predispose interns to cause harm to the patients and communities they serve. As currently designed, the internship program has the capacity to leave interns unsupervised, at risk of legal ramifications, constantly questioning the correctness of their interventions, and perpetually straddling conflicting role virtues. By failing to ensure that the community internship program has appropriate safeguards in place, the government not only jeopardizes the welfare of interns but also threatens the quality and continuity of care that patients and communities receive, potentially violating their right to the highest attainable standard of health. One medical school recently started a novel internship program that could address the issues mentioned., Competing Interests: Competing interests: Aimee Capinpuyan is currently enrolled as a medical intern at the Ateneo School of Medicine and Public Health. Red Miguel received his doctor of medicine from the same school.

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., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

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.

Introduction: The lack of availability of the Therasuit Method by the Unified Health System associated with its high cost has led to the prosecution of this treatment. The study aimed to outline the profile of this judicialization, as well as to estimate the direct costs resulting from compliance with the deferred judicial decisions., Method: Weanalyzed the cases submitted to the Court of Justice of Rio de Janeiro between January 2013 and January 2017, in which the Therasuit Method was applied. Demographic, clinical, advocacy and legal data were extracted, as was the timing of the court's decision and the required technology budgets., Results: Atotal of 11 processes was analyzed. The authors had a mean age of 6.8 years and a median of 6, the majority being male, and resident in thestate capital. Quadriparesis was the most reported condition. The gratuity of justice was requested by all, and the Public Defender's Officewas used by 9 of the 11 processes. The judicial decisions at first instance were considered. In all of processes there was application of the legal tool called guardianship. The time of the judicial decision was on average of 266.5 days with a median of 35.5. The deferral index was 90%, totaling an annual direct cost of R$501,894.09., Discussion: The judicialization of this treatment can cause an unforeseen displacement of public funds, transgressing the principles of equity and the integrality of Unified Health System., Conclusion: It was observed a high rate of deferred processes, resulting in a high cost spent by the Public Power to attend a small portion of patients.

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.

In 2016, four US cancer patients legally challenged Myriad by claiming full access to all genomic information produced in the course of Myriad's testing of their risks for a variety of cancers. Asserting that Myriad's refusal to provide them with this information violated the HIPAA Privacy Rule, the patients sought a determination of a right to access all their genetic information from testing laboratories. Such access would not only serve their own care, but also enable them to share their genetic data with the scientific community which they alleged Myriad failed to do. A similar case may be brought in Europe under the novel EU GDPR. Specifically, it would put the GDPR right of access to personal data against Myriad's database right under the EU Database Right Directive. The outcome of this case could impact the fate of personalized medicine, which depends on the one hand on patients' having control over their genetic data, and on the other hand on incentives for genetic testing companies to generate these data. We first address the issue of whether the GDPR applies to medical records. We then analyse how GDPR rights could play out in the context of clinical genetic testing and conclude that the GDPR access right stops short of granting unconditional access to all data generated in the process of testing, to the extent that its exercise would result in the violation of medical-professional norms, expose the testing company to potential liability, or compromise normal exploitation of the database of which the personal data form part.

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.

Background: Under structural conditions of non-governability, most players in the policy arena in Israel turn to two main channels that have proven effective in promoting the policies they seek: the submission of petitions to the High Court of Justice and making legislative amendments through the Economic Arrangements Law initiated by the Ministry of Finance. Nevertheless, an analysis of the principal trends emerging from the High Court of Justice rulings and legislative amendments through the Economic Arrangements Law indicates that these channels are open to influence, primarily by forces that are essentially neo-liberal. Little is known about the effects of these trends on the right to healthcare services, which in Israel has not been legislated as an independent constitutional law in Basic Laws., Methods: We use four major legal cases decided by the Supreme Court of Israel in the past 10 years where the Court reviewed new legislative initiatives proposed by the Economic Arrangements Law in the area of healthcare. We utilize an institutional approach in our analysis., Results: A neo-institutional analysis of the legal cases demonstrates that petitions against the Economic Arrangements Law in the area of healthcare services have been denied, even though the Court uses strong rhetoric against that law and the government more generally in addressing issues that concern access to healthcare services and reforms in the healthcare system. This move strengthens the trend toward a neo-liberal public policy and significantly weakens the legal protection of the right to healthcare services., Conclusion: In deciding petitions against the Economic Arrangements Law in the area of healthcare, the Supreme Court allows the Ministry of Finance to be a dominant player in the formation of public policy. In doing so, it may be promoting a goal of strengthening its position as a political institution that aspires to increase the public's trust in the judiciary and especially in the Supreme Court itself, in addition to exercising judicial restraint and allowing more leeway to the executive and legislative branches more generally.

Aim: We set out to explore the question, what ethical challenges do medical students identify when asked to perform or observe a sensitive examination, given a historical background relevant to this context., Method: Thematic analysis of 21 Ethics Reports from 9 female and 12 male students., Results: Overall 14 students undertook a sensitive examination without the patient's consent; three did not carry out a sensitive examination because of a lack of consent; and two students (or their senior colleagues) gained the patient's written consent for the student to undertake the examination. One patient refused the student's request for consent to perform a digital rectal examination; and in the final case, verbal consent was given by the patient for the student to observe a bimanual examination only. Three interrelated core themes arose from thematic analysis of the research question: systemic constraints on getting consent; internal conflicts of interest; and, power and hierarchy., Conclusions: A number of senior medical students at our institution disclosed observing or performing sensitive examinations on patients without the patients' knowledge or consent., Competing Interests: Dr Merry chairs the Health Quality and Safety Commission and is Head of the School of Medicine.

Uruguay has witnessed an ever-increasing number of domestic court claims for high-priced medicines despite its comprehensive universal coverage of pharmaceuticals. In response to the current national debate and development of domestic legislation concerning high-priced medicines, we review whether Uruguayan courts adequately interpret the state's core obligations to provide essential medicines and ensure non-discriminatory access in line with the right to health in the International Covenant on Economic, Social and Cultural Rights. Using a sample of 42 amparo claims for the reimbursement of medicines in 2015, we found that the circuits of appeal fail to offer predictable legal argumentation, including for nearly identical cases. Moreover, the judiciary does not provide an interpretation of state obligations that is consistently aligned with the right to health in the International Covenant on Economic, Social and Cultural Rights. These findings illustrate that medicines litigation in Uruguay offers relief for some individual claims but may exacerbate systemic inequalities by failing to address the structural problems behind high medicines prices. We recommend that the judiciary adopt a consistent standard for assessing state action to realize the right to health within its available resources. Moreover, the legislature should address the need for medicines price control and offer a harmonized interpretation of the right to health. These transformations can increase the transparency and predictability of Uruguay's health and legal systems for patients and communities., Competing Interests: Competing interests: None declared.

Judicial readings of the right to health-and related rights-frequently possess something of an "all or nothing" quality, exhibiting either straightforward deference to allocative choices or conceptualizing the right as absolute, with consequent disruption to health systems, as witnessed in Latin America. This article seeks to identify pathways through which a normatively intermediate approach might be developed that would accord weight to rights claims without overlooking the scarcity of health resources. It is argued that such development is most likely both to accompany and support a role for courts as institutions functioning within a society that is characterized by a deliberative conception of democracy., Competing Interests: Competing interests: None declared.

This article analyzes how states are complying with their periodic reporting obligations under the Protocol of San Salvador (PSS) in one specific area: access to justice as a key component of the right to health. The sources of information for this analysis are seven reports submitted by the States parties, together with the observations and final recommendations made by the experts of the monitoring mechanism of the PSS. The reports are based on progress indicators, a group of indicators that the states must use to measure progress in compliance with its rights obligations. This system of indicators presents the cross-cutting category "access to justice," which allows the identification of each branch of government's involvement in the design of a health system and the guarantees of judicial protection of the right to health. The analysis focuses on the articulation of the empirical evidence presented by the States in the context of protection and fulfillment of the right to health, identifying progress made or limitations faced in the compliance with state responsibilities. The main findings reveal the weakness of the current mechanisms of access to justice in health and the reticence of the judiciary to take an active role towards accountability., Competing Interests: Competing interests: None declared.

In response to the incremental creation of an expansive constitutional right to health in Costa Rica, the country's rights-friendly constitutional chamber of the Supreme Court (known as the Sala IV) unleashed a flood of litigation for medications, treatments, and other health care issues. This development was met by widespread criticism from within the health sector, which complained that the court's jurisprudence routinely elevated the right to health above financial considerations, thus posing a threat to the financial well-being of the state-run health care system. 1 Further, a 2014 study by Ole Frithjof Norheim and Bruce Wilson examining successful health rights litigation revealed that more than 70% of favorable rulings were for low-priority medications, suggesting a lack of fairness in access to medications in Costa Rica. 2 To address some of these criticisms, the Sala IV initiated a partnership in 2014 with the Cochrane Collaboration to incorporate medical expert evaluations into its decision-making process for claims seeking access to medications. This article examines the court's reformed decision-making process to determine whether the increased reliance on medical expertise has changed health rights jurisprudence. We reviewed all medication claims from 2016 and classified the successful cases into four groups using standard priority-setting criteria. We then compared these results with rulings issued in 2008, prior to the court's reform (and the year analyzed in Norheim and Wilson's study). Our analysis reveals that under the court's new rules, the probability of winning a medication lawsuit has increased significantly; moreover, the percentage of rulings granting experimental medications has declined while the percentage granting high-priority medications has increased. Based on these results, in comparison to the court's pre-reform jurisprudence, we can tentatively conclude that the new process has led to some minor gains in fairness., Competing Interests: Competing interests: None declared.

This article investigates policy and bureaucracy changes provoked by individual litigation for health care rights in Brazil, especially the one regarding access to medicines, looking at the effects it produced in relation to health technology assessment (HTA) and health care governance. The article first contextualizes the social, legal, and political conditions for the development of individual litigation for health care rights in Brazil. Then it points out the changes brought about by this litigation model and discusses their potential to contribute to efficiency and fairness in the health care system by the improvement of the HTA decision-making process and health care governance., Competing Interests: Competing interests: None declared.

Introduction: The ruling by the French Court of Cassation dated February 25, 1997 obliged doctors to provide proof of the information given to patients, reversing more than half a century of case law. In October 1997, it was specified that such evidence could be provided by "all means", including presumption. No hierarchy in respect of means of proof has been defined by case law or legislation. The present study analyzed judicial decisions with a view to determining the means of proof liable to carry the most weight in a suit for failure to provide due patient information., Material and Method: A retrospective qualitative study was conducted for the period from January 2010 to December 2015, by a search on the LexisNexis ® JurisClasseur website. Two hundred and one judicial decisions relating to failure to provide due patient information were selected and analyzed to study the characteristics of the practitioners involved, the content of the information at issue and the means of proof provided. The resulting cohort of practitioners was compared with the medical demographic atlas of the French Order of Medicine, considered as exhaustive., Results: Two hundred and one practitioners were investigated for failure to provide information: 45 medical practitioners (22±3%), and 156 surgeons (78±3%) including 45 orthopedic surgeons (29±3.6% of surgeons). Hundred and ninety-three were private sector (96±1.3%) and 8 public sector (4±1.3%). Hundred and one surgeons (65±3.8% of surgeons), and 26 medical practitioners (58±7.4%) were convicted. Twenty-five of the 45 orthopedic surgeons were convicted (55±7.5%). There was no significant difference in conviction rates between surgeons and medical practitioners: odds ratio, 1.339916; 95% CI [0.6393982; 2.7753764] (Chi 2 test: p=0.49). Ninety-two practitioners based their defense on a single means of proof, and 74 of these were convicted (80±4.2%). Forty practitioners based their defense on several means of proof, and 16 of these were convicted (40±7.8%). There was a significant difference in conviction rate according to reliance on single or multiple evidence of delivery of information: odds ratio, 0.165; 95% CI [0.07; 0.4] (Chi 2 test: p=1.1×10 -5 )., Discussion: This study shows that surgeons, and orthopedic surgeons in particular, are more at risk of being investigated for failure to provide due patient information (D=-0.65 [-0.7; -0.6]). They are not, however, more at risk of conviction (p=0.49). Being in private practice also appeared to be a risk factor for conviction of failure to provide due information. Offering several rather than a single means of proof of delivery of information significantly reduces the risk of conviction (p=1.1×10 -5 )., Level of Evidence: Level IV: Retrospective study., (Copyright © 2018 Elsevier Masson SAS. All rights reserved.)

The purpose of the research is to analyze specific problems of the realization of the right to protect the health of people who take narcotic drugs or psychotropic substances. To achieve this goal, statistics have been analyzed on the number of people using narcotic drugs or psychotropic substances (including drug-addicted children) placed on medical records and the number of their applications for medical care. It has been found out that people in this category often face a denial of medical care that causes extremely strong physical and mental suffering. The analysis of the understanding of the legal design of the «right to health care» in the scientific literature, national legislation and international legal documents was made. State institutions and local authorities providing «the right to health care» of people taking narcotic or psychotropic drugs are singled out. The absence of grounds for restricting the right to protect the health of people who take narcotic or psychotropic drugs who are not registered is justified. In the course of the research, it was found out that people who take narcotic drugs or psychotropic substances are more likely than other patients to need medical assistance and, when requesting the right to health care, face a number of problems that require immediate solution: incomplete provision of quality free medical care; unimplementation of rehabilitation programs for such categories of patients; the lack of the right of children who take narcotic drugs or psychotropic substances to make their own decisions at the age of 14 and apply to public health institutions for the treatment of drug addiction; violations of the continuity of SMT programs and their absence in penal institutions for drug dependent people. It was proposed to introduce a number of changes in the relevant normative legal acts.

Introduction: The development of patient rights and increasing number of lawsuits based on medical malpractice make medical doctors constantly improve knowledge regarding the acceptability of changing the scope of operation. This is particularly important when patients have expressed their refusal to changing the scope and type of procedure (ESTP) or no informed consent (IC) has been obtained from the patient prior to the procedure., Material and Methods: The method of study comprised content analysis of existing legislation. The current jurisprudence and doctrine were confronted with existing regulations. An algorithm of correct formal procedures was elaborated., Results: The doctor has right to realize ESTP when the patient has not given the consent to it or the refusal expressed by him was not fully conscious. Healthcare providers are absolutely prohibited from realizing ESTP when patient objected to any changes being thoroughly informed by the physician prior to the operation. When patient refuses possible ESTP, the doctor has the right to withdraw from performing surgery but should inform the patient about other places, where a similar procedure can be provided.

Background: The Israel Mental Health Act of 1991 stipulates a process for involuntary psychiatric hospitalization (IPH). A patient thus hospitalized may be discharged by either the treating psychiatrist (TP) or the district psychiatric committee (DPC). The decision rendered by the DPC is often at odds with the recommendation of the TP. Although much has been written about the ethical issues of restricting patients' rights and limiting their freedom, far less attention has been devoted to the psychiatric, medical, and social outcome of legal patient discharge against the doctor's recommendation., Methods: In our study we examined the outcomes of the decisions made by the DPC using readmission data, an internationally recognized indicator of the quality of hospital care, and compared them to the outcomes of patients discharged by the TP. All IPH discharges resulting from the DPC's determination for the year 2013 (N = 972) were extracted from the Israel national register. We also collected all IPH discharges owing to the TP's decision for 2013 (N = 5788). We defined "failure" as readmission in less than 30 days, involuntary civil readmission in less than 180 days, and involuntary readmission under court order in less than 1 year., Results: The rehospitalization pattern was compared in the two groups of patients discharged from their psychiatric hospitalization during 2013 (index discharges) and followed up individually for a year. We found a statistically significant difference between the DPC and the TP group for each of the time frames, with the DPC group returning to IPH much more frequently than the TP group. Using cross-sectional comparison with logistic regression adjusted for age, gender, diagnosis and length of hospitalization, we found the probability of a decision failure in the TP group was significantly less with an OR of 0.7 (95% CI .586-.863), representing a 30% adjusted decrease in the probability for failure in the TP group., Conclusions: The results we present show that the probability of decision "failure" (readmission) was found to be significantly higher in the DPC group than in the TP group. It is often assumed that IPH patients will fare better at home in their communities than in a protracted hospitalization. This is frequently the rationale for early discharge by the DPC (30.1 days vs. 75.9 DPC and TP groups, respectively). Our results demonstrate that this rationale may well be a faulty generalization.

Competing Interests: Disclosures of potential conflicts of interest may be found at the end of this article.

Background: Health care professionals and patients are partners in health care delivery, and this partnership is critical in the treatment of adolescents. International children's rights law establishes that all children have a right to participate in decisions that affect their lives. Fulfillment of that right is as critical in health care settings as any other area of children's lives., Objectives: In this article we examine the right to participate under international children's rights law, its relevance to health care settings, and how health care professionals can foster adolescents' participation to fulfill children's rights and improve health care outcomes., Findings: The Convention on the Rights of the Child establishes a legal mandate-where ratified-that adolescents have the right to express their views in health care settings and that such views must be given due consideration. In many health care settings, adolescents are not adequately consulted or have limited opportunities to express their views. A review of research finds that both processes and outcomes can improve when youth participation is cultivated., Conclusions: Health care providers and organizations have numerous opportunities to cultivate adolescent's participation rights and in doing so improve health care delivery and outcomes. Health care providers and organizations should further develop structures and processes to ensure opportunities for children and adolescents to be heard on matters relevant to their health care and health status. Creating opportunities for adolescents to realize their right to participate means engaging youth at every stage in the process, beginning with the design of such opportunities. It also means addressing all aspects of health care, from the built environment to patient-provider communication to follow-up services, so that the entire process fosters an environment conductive to meaningful participation by adolescents., (Copyright © 2017 Icahn School of Medicine at Mount Sinai. Published by Elsevier Inc. All rights reserved.)

This final rule revises the conditions of participation (CoPs) that home health agencies (HHAs) must meet in order to participate in the Medicare and Medicaid programs. The requirements focus on the care delivered to patients by HHAs, reflect an interdisciplinary view of patient care, allow HHAs greater flexibility in meeting quality care standards, and eliminate unnecessary procedural requirements. These changes are an integral part of our overall effort to achieve broad- based, measurable improvements in the quality of care furnished through the Medicare and Medicaid programs, while at the same time eliminating unnecessary procedural burdens on providers.

Objective: To describe the profile of lawsuits related to drug requests filled at the Federal Justice of the State of Paraná., Methods: A cross-sectional study, and the data were obtained through consulting the lawsuits at the online system of the Federal Justice of Paraná., Results: Out of 347 lawsuits included in the study, 55% of plaintiffs were women, with a median age of 56 years. Oncology was the field with more requests (23.6%), and the highest mean costs. A wide variety of diseases and broad variety of requested drugs were found in the lawsuits. Approximately two-thirds of them were requested by the brand name, and the most often requested drugs were palivizumab and tiotropium bromide. Only 14.5% of the requested medicines were registered in the National Medication Register. The Public Defender's Office filled actions in 89.6% of cases and all lawsuits had an interim relief. The mean time for approval was 35 days and 70% of requests were granted., Conclusion: Oncology was the field with the highest demand for medicines at the Federal Justice of Paraná in 2014. A great variety of medications was requested. The Public Defender´s Office represented most lawsuits. All demands had an interim relief, and the majority of requests were granted, within an average of 35 days., Objetivo: Descrever o perfil das ações que solicitam medicamentos ajuizadas na Justiça Federal do Paraná., Métodos: Estudo transversal descritivo, cujos dados foram obtidos por meio de consulta aos processos no sistema on-line da Justiça Federal do Paraná., Resultados: Dentre os 347 processos incluídos no estudo, 55% dos autores eram mulheres, com mediana da idade de 56 anos, sendo a área mais procurada a oncologia (23,6%). A área oncológica também foi a que apresentou maiores custos médios. Foi ampla a variedade de doenças geradoras das ações e também foi consequentemente grande a variedade de medicamentos solicitados. Cerca de dois terços dos fármacos foram solicitados pelo nome comercial, e os mais requeridos foram o palivizumabe e brometo de tiotrópio. Apenas 14,5% dos medicamentos solicitados estavam cadastrados no Registro Nacional de Medicamentos. A Defensoria Pública impetrou as ações em 89,6% dos casos. Todos os processos pediam antecipação de tutela do medicamento. O tempo médio para deferimento foi de 35 dias, sendo que 70% dos pedidos foram deferidos., Conclusão: A área com maior número de casos de demanda de medicamentos na Justiça Federal do Paraná no ano de 2014 foi de Oncologia. Observou-se grande variedade de medicamentos solicitados. A maioria das ações foi impetrada pela Defensoria Pública. Todas as demandas exigiram antecipação de tutela, sendo que a maioria dos pedidos foram deferidos, num prazo médio de 35 dias.

This article tracks the shifting place of the international right to health, and human rights-based approaches to health, in the scholarly literature and United Nations (UN). From 1993 to 1994, the focus began to move from the right to health toward human rights-based approaches to health, including human rights guidance adopted by UN agencies in relation to specific health issues. There is a compelling case for a human rights-based approach to health, but it runs the risk of playing down the right to health, as evidenced by an examination of some UN human rights guidance. The right to health has important and distinctive qualities that are not provided by other rights-consequently, playing down the right to health can diminish rights-based approaches to health, as well as the right to health itself. Because general comments, the reports of UN Special Rapporteurs, and UN agencies' guidance are exercises in interpretation, I discuss methods of legal interpretation. I suggest that the International Covenant on Economic, Social and Cultural Rights permits distinctive interpretative methods within the boundaries established by the Vienna Convention on the Law of Treaties. I call for the right to health to be placed explicitly at the center of a rights-based approach and interpreted in accordance with public international law and international human rights law., Competing Interests: Competing interests: None declared.

The right to health has many dimensions. On the one hand, it entails positive duties for states to protect the health of individuals. On the other, it encompasses patient decision making regarding personal health, an idea which is closely linked to the right to autonomy and the right to free development of the individual-that is, to dignity. 1 This is why the informed consent of the patient and her right to make a choice according to her own values should be honored, even when her decision may seem irrational or imprudent. When patients are incapable of providing informed consent-for example, if the patient is unconscious-the law can authorize certain persons to act as a proxy on their behalf. In Argentina, the Patients' Rights Act (2009) as amended by the Death with Dignity Act (2012) states that if a patient is unable to provide informed consent, consent may be provided on her behalf by her close relatives, affinal kin, or legal guardian, in this order of preference. 2 The Patients' Rights Act also permits patients to set up advance directives regarding health decisions to be made if they become terminally ill. In 2015, the Argentine Supreme Court of Justice discussed the scope of patient autonomy in the case D., M.A. s/ declaración de incapacidad . 3 This case presented a question that had yet to be explored by the court: how can we determine an unconscious patient's will if she does not have written advance directives concerning whether a life-sustaining medical treatment should be continued? This article examines the grounds of the Argentine Supreme Court's decision in D., M.A. First, we describe the case law that existed prior to D., M.A. Then, after explaining the facts of the case, we discuss the ruling and raise doubts about its scope. 4 ., Competing Interests: Competing interests: None declared.

Background: Jewish medical ethics is a term coined by the late Lord Rabbi Immanuel Jacobovits in the mid-20th century. Its principles and emphases differ in some significant ways from the currently accepted axioms in Western secular ethics. The emphasis is lesser on autonomy and more on the value of human life and on communitarianism. The Israel Patient's Rights Law reflects these differences from the Western norms.

Background: Health is a basic human right necessary for the exercise of other human rights. Every human being is, therefore, entitled to the highest possible standard of health necessary to living a life of dignity. Establishment of patients' Charter is a step towards protecting the rights and responsibilities of patients, but violation of patients' rights is common in healthcare institutions, especially in the developing world. This study which was conducted between May 2013 and May 2014, assessed the operationalization of Ghana's Patients Charter in a peri-urban public hospital., Methods: Qualitative data collection methods were used to collect data from 25 healthcare workers and patients who were purposively selected. The interview data were analyzed manually, using the principles of systematic text condensation., Results: The findings indicate that the healthcare staff of the Polyclinic are aware of the existence of the patients' Charter and also know some of its contents. Patients have no knowledge of the existence or the contents of the Charter. Availability of the Charter, community sensitization, monitoring and orientation of staff are factors that promote the operationalization of the Charter, while institutional implementation procedures such as lack of complaint procedures and low knowledge among patients militate against operationalization of the Charter., Conclusion: Public health facilities should ensure that their patients are well-informed about their rights and responsibilities to facilitate effective implementation of the Charter. Also, patients' rights and responsibilities can be dramatized and broadcasted on television and radio in major Ghanaian languages to enhance awareness of Ghanaians on the Charter., (© 2016 by Kerman University of Medical Sciences)

Background: Continuous deep sedation at the end of life is a practice that has been the topic of considerable ethical debate, for example surrounding its perceived similarity or dissimilarity with physician-assisted dying. The practice is generally considered to be legal as a form of symptom control, although this is mostly only assumed. France has passed an amendment to the Public Health Act that would grant certain terminally ill patients an explicit right to continuous deep sedation until they pass away. Such a framework would be unique in the world., Discussion: In this paper we will highlight and reflect on four relevant aspects and shortcomings of the proposed bill. First, that the bill suggests that continuous deeps sedation should be considered as a sui generis practice. Second, that it requires that sedation should always be accompanied by the withholding of all artificial nutrition and hydration. In the most recently amended version of the legal proposal it is stated that life sustaining treatments are withheld unless the patient objects. Third, that the French bill would not require that the suffering for which continuous deep sedation is initiated is unbearable. Fourth, the question as to whether the proposal should be considered as a way to avoid having to decriminalise euthanasia and/or PAS or, on the contrary, as a veiled way to decriminalise these practices. The French proposal to amend the Public Health Act to include a right to continuous deep sedation for some patients is a unique opportunity to clarify the legality of continuous deep sedation as an end-of-life practice. Moreover, it would recognize that the practice of continuous deep sedation raises ethical and legal issues that are different from those raised by symptom control on the one hand and assisted dying on the other hand. Nevertheless, there are still various issues of significant ethical concern in the French legislative proposal.