Hasil untuk "Medical legislation"

André Luis Alves de Quevedo, Augusto Tanger Jardim

Este artigo teve como objetivo conhecer as características dos julgados e entendimentos jurisdicionais do Tribunal Regional Federal da 4ª Região sobre o direito à saúde na área das neoplasias no ano de 2022, especialmente quanto à prova dos fatos afirmados no processo e à decisão correspondente. Foi realizada busca em jurisprudência, entre os meses de março e abril de 2023, no site do tribunal, sendo identificados 403 acórdãos para o período de janeiro a dezembro de 2022. Desse total, 361 ações judiciais versaram sobre fornecimento de medicamentos antineoplásicos (89,58%). Relacionados aos elementos da prova, foram analisados especificamente os 361 acórdãos referentes à solicitação de medicamentos antineoplásicos. Quanto à perícia prévia, 194 (53,74%) das 361 ações judiciais de medicamentos antineoplásicos continham o entendimento de que esta poderia ser substituída quando a pessoa estava em tratamento em Unidades de Alta Complexidade em Oncologia/ Centros de Alta Complexidade em Oncologia, por parecer técnico do Núcleo de Apoio Técnico do Poder Judiciário ou decisão favorável de incorporação do medicamento pela Comissão Nacional de Incorporação de Tecnologias no Sistema Único de Saúde. Desses 194 processos, em 185 (95,36%) havia solicitação de tutela antecipada. Conclui-se que o tema da judicialização da saúde permanecerá na pauta do Poder Judiciário, seja pela exigibilidade judicial, seja pela necessidade do entendimento do papel do Estado na efetivação das políticas públicas. Assim, faz-se necessário fortalecer a construção de agendas, conjuntas e permanentes, entre os poderes e a sociedade civil para o entendimento e o enfrentamento desse fenômeno.

Darya P. Vyshkvarka, Mikael N. Akhmedov

This article is devoted to a comparative analysis of the juvenile legislation of the Russian Federation and South Korea. The article examines the specifics of regulating the protection of the rights of minors, approaches to solving problems of family problems and methods of social support for children and families. The research is aimed at identifying similarities and differences in approaches to the protection of children's rights, as well as determining the prospects for the development of the domestic child protection system in the light of international experience. The paper also highlights the features of the juvenile justice system that regulates the legal status of juvenile convicts in the Russian Federation and the Republic of Korea. The existing limitations and advantages of both systems are analyzed, the legal statuses of convicts are compared, and the prospects and directions for the further development of juvenile justice in Russia are studied. Methods. The following methods of scientific knowledge served as the methodological basis of the analysis: Historical method: the study of the historical context of the formation of juvenile legislation in Russia and South Korea. Document analysis: a study of legislative acts, international treaties, court decisions, and expert publications. The study is conducted using the method of comparative analysis of the Russian and South Korean experience, since both countries are at the stage of active modernization of their legislation, striving to integrate the best international practices and at the same time preserve their national identity. The scientific novelty of the study is an attempt to identify key points of contact and fundamental differences between the systems of the two countries, which makes it possible to propose realistic steps to bring positions closer and deepen mutual understanding. The study on the comparison of the juvenile system in the Russian Federation and the Republic of Korea is highly practical for the following reasons:  The main aspects of practical significance: Analysis of international experience It is important for Russian specialists to study successful international practices and implement positive elements in the domestic judicial system. The Republic of Korea is known for its progressive methods of preventing and correcting deviant behavior among minors, such as rehabilitation centers and specialized courts. Improving the effectiveness of juvenile justice Studying the features of the Korean system will help Russian authorities to improve the efficiency of working with juvenile offenders, reduce the level of recidivism, and promote successful re-socialization of young people. Improving Russian legislation The identified shortcomings and positive aspects of both systems will allow for the necessary amendments to Russian legislation aimed at Results. Based on the results of the analysis, the following list of possible areas for improving the Russian juvenile justice system is proposed: - improving the material and technical base of correctional institutions, ensuring decent conditions of detention and high-quality medical care. - development of a network of specialized medical and psychological centers for the diagnosis and treatment of juvenile convicts. - Strengthening the system of social adaptation and vocational rehabilitation by expanding employment programs and educational courses. - The implementation of these measures can improve the effectiveness of the juvenile justice system, reduce the number of recidivism and ensure respect for the rights of juvenile convicts. Russian legislation remains fragmented, there is a shortage of budget funds for rehabilitation programs, a low level of material equipment in correctional institutions, and poor coordination of efforts between judicial authorities and social services. The South Korean model appears to be more optimal and rational in terms of social protection and reducing the number of recidivism among juvenile convicts. EDN: DOMUIU

Anna D. Chestnikhina, Daria O. Efremenko, Natalia A. Kabina et al.

The growing volume of biomedical research requires scientists and physicians to possess not only profound professional but also modern legal competences, given the dynamic development of legislation and the high level of responsibility for upholding human rights and freedoms. This article addresses the apparent contradiction between the objective need to develop legal competences in future medical professionals for the ethical and safe implementation of biomedical projects and their insufficient legal training within existing educational programs. The purpose of this study is to assess the level of medical students’ awareness of the legal and ethical principles that are keys in research involving humans and animals, as well as to analyze the development of their legal competences. In this regard, the article focuses on the standards of the Declaration of Helsinki, which serves as a global benchmark for ethical research practices and is integrated into Russian national legislation. The authors present the results of an anonymous online survey of 177 medical students majoring in General Medicine, Pediatrics and Dentistry. These results have shown that the respondents share key ethical values in scientific research but lack the legal knowledge necessary to develop their legal competences. This represents an important pedagogical challenge in this context and underscores the need to incorporate professionally oriented legal disciplines into medical educational programs. The materials and conclusions of this article may also be useful to researchers and practicing physicians in addressing pressing scientific challenges in biomedicine and healthcare.

Mireya Matamoros , Carlos Abraham Mejía Dueñas

Justificación: El femicidio es un delito pluriofensivo, que además del daño directo, afecta al entorno familiar y social; la muerte violenta de mujeres constituye la forma más extrema de violencia contra la mujer. Objetivo: Estudiar las características de las mujeres sometidas a autopsia medicolegal, cuya manera de muerte se registró como homicida o pendiente de investigación policial. Metodología: Estudio descriptivo, retrospectivo del registro de autopsias realizadas en las oficinas forenses de Tegucigalpa, San Pedro Sula y la Ceiba, durante los años 2022 y 2023. Se seleccionaron los registros pertenecientes al sexo femenino de 14 o más años de edad y cuya manera de muerte fue clasificada como homicida o pendiente de investigación policial. Resultados: Se analizaron 574 registros de mujeres, de las cuales 386 (67%) tenían manera de muerte homicida y 188 (33%) fueron clasificadas como pendiente de investigación policial. El 61,6% de las víctimas tenían menos de 40 años, con una media de edad de 36 años, los instrumentos de lesión más utilizados fueron las armas de fuego (43%), las armas blancas (11%). El 61,6% de las víctimas tenían menos de 40 años, el 41% no superaron la secundaria.                                                                                                          Conclusión: El análisis del registro de mujeres autopsiadas cuya manera de muerte fue categorizada como homicida o pendiente de investigación policial, muestra un perfil caracterizado por ser mujeres jóvenes (Edad media de 36 años), de baja escolaridad, desempleadas o subempleadas, del área urbana y que fueron agredidas principalmente con armas de fuego y arma blanca.

Filip K Knop, Hannelouise Kissow, Maria Ebbesen Sørum et al.

Introduction Cancer treatment with high-dose chemotherapy damages the mucosal barrier of the gastrointestinal (GI) tract and is associated with severe toxicity involving mucositis, severe inflammation and organ dysfunction. Currently, there is no effective prophylaxis against this. Glucagon-like peptide 1 (GLP-1), a well-known regulator of blood glucose, has been suggested in mouse studies to possess trophic effects on gut epithelial cells as well as anti-inflammatory properties. In line with this, endogenous GLP-1 levels have been shown to be inversely correlated with toxicities after haematopoietic stem cell transplantation (HSCT) and treatment with a GLP-1 receptor agonist (GLP-1RA) was shown to limit chemotherapy-induced mucositis in rodents. This present study investigates the effects of the GLP-1RA semaglutide on GI mucositis severity score in patients with lymphoma undergoing high-dose chemotherapy followed by autologous (auto) HSCT.Methods and analysis This is a randomised, double-blind, placebo-controlled, two-centre investigator-initiated clinical study. Forty adult patients with malignant lymphoma referred for auto-HSCT will be randomised in a 1:1 manner to receive either semaglutide or placebo once-weekly for 8 weeks. This includes a run-in period of 3–4 weeks with semaglutide 0.25 mg prior to high-dose chemotherapy treatment followed by a period of 4–5 weeks with semaglutide 0.5 mg including the 1 week of high-dose chemotherapy treatment. Clinical assessment of endpoint measurements and safety will be performed weekly during treatment and in a follow-up period of 10 weeks. The primary endpoint is GI mucositis severity (mean severity grade (0–II) during week 1–4 after auto-HSCT). Secondary endpoints include C-reactive protein increment, quality of life and safety. Fever, bacteraemia, antibiotic use, weight loss, morphine consumption, duration of hospitalisation, use of parenteral nutrition, change in muscle mass and clinical and laboratory evidence of organ toxicities will also be assessed.Ethics and dissemination The study complies with Danish and European Union legislation and is approved by the Danish Medicines Agency, the Danish National Medical Research Ethics Committee (EU CT #2022-502139-20-00) and the Danish Data Protection Agency. The study is monitored by the Capital Region of Denmark’s good clinical practice unit. All results, positive, negative and inconclusive, will be disseminated at national and international scientific meetings and in peer-reviewed scientific journals.Trial registration number NCT06449625

Hayashi H, Nogita T, Maeda H

Haruto Hayashi,1 Takehide Nogita,2,3 Hideki Maeda1,2 1Department of Regulatory Science, Faculty of Pharmacy, Meiji Pharmaceutical University, Tokyo, Japan; 2Department of Regulatory Science, Graduate School of Pharmaceutical Science, Meiji Pharmaceutical University, Tokyo, Japan; 3CMIC Co Ltd., Tokyo, JapanCorrespondence: Hideki Maeda, Department of Regulatory Science, Faculty of Pharmacy, Meiji Pharmaceutical University, 2-522-1, Noshio, Kiyose-city, Tokyo, 204-5255, Japan, Tel/Fax +81-42-495-8952, Email maeda@my-pharm.ac.jpPurpose: An expanded access clinical trials (EACTs) provides exceptional patient access to investigational new drugs for life-threatening diseases for which no effective treatment exists. Based on public information, we have studied EACTs since 2016, when the EACT system was launched in Japan. In this study, we investigated the reality of EACTs by interviewing pharmaceutical companies and clarifying how they view them.Patients and Methods: We conducted semi-structured interviews with 10 pharmaceutical companies developing new drugs. This study aims to clarify the status of EACTs, so we selected pharmaceutical companies that develop innovative drugs for which they may perform EACTs (however, experience in conducting EACTs was optional).Results: All those surveyed were aware of EACTs. Twelve access clinical trials were conducted, and the EACT implementation rate for pivotal clinical trials was 2.5%. The most common reason for implementing an EACT was “requests from physicians and medical institutions” (nine companies, 90.0%), and the most common reason for not implementing an EACT was “the applicability of the system” (five companies). Improvements to EACTs were identified by eight companies (80.0%); financial assistance by six companies (60.0%); reducing the scope of data to be collected and simplifying the procedure by six companies (60.0%). Seven companies (70.0%) responded that a Single Patient Investigational New Drug Application should be conducted, suggesting that the system should be revised.Conclusion: An interview survey of ten pharmaceutical companies developing new drugs in Japan regarding expanded access clinical trials indicated that there were issues with the system. Many wished to improve the system by establishing a single patient access system, supporting resources, and simplifying procedures. Based on our interviews with 10 Japanese pharmaceutical companies, it was found that the system needed to be improved by introducing a single patient access system, providing supporting resources, and simplifying procedures. In Japan, about eight years have passed since EACT was established, and it appears a revision of the EACT legislation is due.Keywords: clinical trials, investigational new drugs, patient access, semi-structured interview

Radujević Katarina, Bogavac-Stanojević Nataša, Nedeljković Rade et al.

Background/Aim. Cataract surgery is one of the most often performed surgical interventions. The predominant method in Western countries is phacoemulsification, while in developing countries, the extracapsular cataract extraction (ECCE) method remains popular. The aim of the study was to evaluate the cost-effectiveness of these two cataract surgery techniques from the provider’s perspective if operation complications were the outcome of the interest. Methods. The data were obtained from the Department of Ophthalmology of the General Hospital Kruševac during a one-year period. A total of 1,179 surgeries by five surgeons were performed. The cost-effectiveness was evaluated using the decision tree. All probabilities were calculated based on the likelihood of the occurrence during the study period. Only direct costs were considered, and values were taken from the documentation at the hospital and the official price list of health services. One- and two-way sensitivity analyses were performed. Results. The total cost per patient in the phacoemulsification group was 71,008.70 Serbian dinars (RSD), while the total cost in the ECCE group was 74,340.36 RSD. At the same time, phacoemulsification shows higher effectiveness than the ECCE method, with 87% and 57% of patients without complications, respectively. With these results, phacoemulsification was the dominant strategy compared to ECCE. The sensitivity analysis revealed that the results are sensitive to the number of performed operations per year. Conclusion. The phacoemulsification technique seems to be the preferred technique for cataract surgery. All the investment in phacoemulsification equipment and consumables is justified if the number of surgeries per year exceeds 350.

Sandra Carolina Mena Ugarte, MD, María Virginia Rodríguez Funes, MD, Jocelyn Viterna, PhD

BACKGROUND: A striking number of national and subnational governments that previously allowed legal abortion in cases of severe fetal anomaly have passed new legislation to explicitly remove these allowances. However, we know little about the maternal health implications of such restrictions. OBJECTIVE: This study aimed to examine the health outcomes of pregnant individuals in El Salvador whose fetuses were diagnosed with a fatal congenital malformation and who were legally required to carry these nonviable pregnancies to term under the nation's absolute abortion ban. STUDY DESIGN: We reviewed the charts of all 239 pregnancies with fetuses classified as having 1 of 18 congenital malformations typically considered to be incompatible with extrauterine life that were evaluated at the National Women's Hospital in El Salvador between January 1, 2013 and December 31, 2018. Because regional healthcare providers who identify pregnancy complications in El Salvador are instructed to refer those patients to the National Women's Hospital, our analysis captured the total population of lethal fetal malformations treated by the national public health system. We documented pregnant patients’ socioeconomic characteristics, pregnancy-related complications, and the medical procedures used to mitigate complications. RESULTS: Individuals who were required to carry pregnancies with severe fetal malformations to term (or until preterm labor began naturally) experienced high rates of maternal morbidity. More than half (54.9%) of pregnancies experienced at least 1 serious pregnancy-related health complication, whereas 47.9% underwent a physically-invasive medical procedure to manage complications, including cesarean deliveries, decompression amniocenteses, fetal head decompressions, and, in 1 case, a full hysterectomy. A total of 9% of patients opted to discontinue care after receiving the diagnosis of fatal fetal malformation. We also found striking variation in how physicians managed pregnancies with fatal fetal malformations, suggesting that different interpretations of the law lead to inequities in individual-level patient care. CONCLUSION: Laws prohibiting abortions in cases of severe fetal malformation can increase risks to pregnant patients by requiring clinicians to subject healthy patients to a course of treatment that generates morbidity.

B Bahtiri, Q Maxhuni, R Ferizi

Transformations in the biological, medical and legal processes of infertility, substantial modifications in family structure and the advancement of methods and techniques of reproductive technology will affect the next step in both legal and medical terms to address the regulation of bioethics and law in Kosovo. There is a need to establish perspectives in both ethical and professional terms, since the Republic of Kosovo is in the process of drafting a Civil Code. Many of these issues have been raised and addressed during the review and evaluation of family law in the context of harmonisation and inclusion of this law in the Civil Code of the Republic of Kosovo. During the several meetings of official members with different interest groups regarding family law, the need has been raised to regulate family law to be included in the Civil Code for motherhood and fatherhood in the case of reproduction with biomedical assistance, as well as for the birth contract as a donation for another person (so-called surrogate motherhood). These bioethical and legal issues indicate the urgent need for legal harmonisation of a multidimensional platform specifically based on the principles of public health and universal human rights Conclusion. These bio-ethical and legal interferences indicate the urgent need for legal harmonization of a multidimensional platform specifically designed based on the principles of public health and universal human rights.

Monica Djaja Saputera, A. Joko Purwoko, Edward Kurnia Sanusi

Abstract : The increasing anticipation of the public in using disposable masks during the COVID-19 pandemic, was not followed by proper waste management efforts. Disposable medical masks are one source of infectious B3 waste that needs to be processed in an appropriate way to prevent transmission and control the spread of COVID-19. The lack of information and procedures for managing infectious B3 waste from the government to the community and the uneven supply and distribution of dropboxes or depots to collect infectious B3 waste from the community is a problem that requires an appropriate and fast solution from the government. Keywords: COVID-19, medical B3 waste, masks, medical masks

Andrés Jesús Villalba, María Eugenia Marichal

El presente trabajo explora el ordenamiento juridico argentino para reconstruir sistematicamente el marco protectorio de la seguridad alimentaria de las personas celiacas. Se trata centralmente de analizar la Ley Nacional de Celiaquia No 26.588 que constituye la base normativa para su proteccion. Se relevan tambien otras normas importantes del marco protectorio de la salud en terminos amplios, como son las normas de derecho del consumidor. El objetivo es determinar cuales son los elementos normativos que efectivamente inciden sobre la seguridad alimentaria de la poblacion celiaca. Asi tambien, se trata de establecer cual es el nivel de proteccion de su derecho, constitucionalmente reconocido, a una alimentacion adecuada. En terminos metodologicos, el trabajo se basa centralmente en un analisis documental clássico del conjunto de normas juridicas indicado. Las claves de analisis normativo se construyeron a partir de otras fuentes documentales complementarias como manuales de buenas practicas o publicaciones de acceso abierto editadas por asociaciones de las personas celiacas. En primer lugar, se realiza una breve descripcion de la enfermedad celiaca y de las principales problematicas que afectan a la poblacion celiaca en relacion al concepto de seguridad alimentaria. Luego, se ordena cronologicamente la construccion del reciente marco normativo nacional que tutela a la poblacion celiaca. En tercer lugar, se analiza la legislacion vigente a fin de identificar tanto los derechos que reconoce el Estado nacional como los instrumentos que disena para hacerlos efectivos. Por ultimo, se esbozan algunas lineas a modo de conclusion.

Ramona Brad

Despite being an early signatory of the FCTC in 2005, transposed in local legislation, Romania “enjoyed” throughout the years a heavy interference of the tobacco industry with its’ policy development in tobacco control. As a result, multiple attempts for bringing local tobacco control legislation in line with FCTC provisions failed. Early 2015, the first broad-scale effort of the civic community, led by medical associations, resulted in the adoption (Dec. 2015) of a comprehensive smoke-free legislation and enabled its’ successful defense through consecutive attempts for reversal in 2016-2017. As of September 2016, Romania’s tobacco control community has also brought forward the first holistic end-game strategy- 2035 Tobacco-Free Romania Initiative. Engaging with policy-makers and general public, drafting support data for proposed legislative changes, the tobacco control coalition, with its’ over 350 NGO’s members, has navigated its’ way forward despite significant challenges. As a "test-playground" for the tobacco industry, especially in its’ newly reinvented forms (heated tobacco products and electronic nicotine-delivery systems) and with a significant consumption of tobacco among young age group, Romania remains at the forefront of tobacco control policy-making efforts. Its’ successes and its’ challenges portray the difficult journey of any tobacco control effort.

Martin Weihs, Anna Meyer-Weitz, Friederike Baasner-Weihs

Comprehensive HIV and AIDS workplace programmes made use of substantial lottery incentives in HIV counselling and testing drives to promote HIV testing at four companies in the automotive industry in the Nelson Mandela Bay Municipality. The main aim was to use lottery incentives to increase uptake for HIV testing. This would help to define company HIV prevalence and ensure timely support, care and treatment of employees. In total, 1 324 employees, making up about 90% of the total staff, were tested for HIV in the four companies during wellness testing days. In order to gain an understanding of employees’ experiences of the lotteries as part of the HIV counselling and testing drive, quantitative data were collected among a total of 414 employees, and 17 interviews were conducted in the four companies. In this article, we investigate the issue of whether the lotteries unduly influenced the employees’ participation in workplace HIV testing, and an approach to resolving an identified ethical dilemma is presented. The ethical question as to whether lottery incentives contribute to undue coercion was explored using both a utilitarian and a deontological approach. The analysis concluded that the use of lotteries to encourage HIV testing in the workplaces of the automotive industry in the Nelson Mandela Bay Municipality can be deemed morally acceptable.

Daniela Batalha Trettel, Lidiane Nascimento Leão

Partindo da premissa de que SUS e saúde privada são realidades que se inter-relacionam, este artigo trata da experimentação de modelos participativos na regulação dos planos de saúde pela Agência Nacional de Saúde Suplementar (ANS). Primeiramente, no campo teórico, analisou-se bibliografia e legislação referentes ao tema. Na segunda parte do trabalho, de caráter prático, analítico e opinativo, focou-se no exame da Agenda Regulatória 2011-2012 e da participação dos representantes dos usuários de planos de saúde em sua implantação – em especial das organizações de defesa do consumidor. Para tanto, foram consultadas no site da agência informações sobre mecanismos de participação utilizados na discussão da agenda, atas de reuniões, listas de presença etc. O período de pesquisa se encerra em junho de 20122. Evidenciou-se, entre outras conclusões, que a capacidade de incidência dos representantes de usuários de planos de saúde na agência ainda é pequena. Por fim, apresentaram-se sugestões para o aprimoramento da participação na ANS.

Sebastian Agredo

Starting in December 2015, Wales will be the first nation in the United Kingdom to break away from convention and join the twenty-four European countries that have adopted presumed consent legislation to address the stagnant transplant rate and shortage of human organs. Hailed by many ministers in the National Assembly for Wales as the “most significant piece of legislation” since the United Kingdom was granted full lawmaking powers in 2011, the law hopes to alleviate the transplant list and save the lives of those who would normally die from waiting. [1] As is the case worldwide, there is a remarkable deficiency in donor organs, which fails to meet the demand for organ transplantation. In the United Kingdom, the active transplant waiting list has increased approximately eight percent each year, with the aging population and rising incidence of type-2 diabetes likely to worsen the strain on the transplantation system.[2],3 Support for the legislation has stemmed from the rising donation rates of other European countries, especially Spain, which has the highest rate of donors per million population (pmp) in the world, attributing this trend to the adoption of presumed consent legislation. With Wales being the latest country to go down the road of presumed consent, the question will inevitably rise: Should the United States take a more critical look at its current system of explicit consent and “required referral” for organ donation? In light of all the available empirical data, should the United States follow suit of its European counterparts and adopt presumed consent? What are the ethical concerns regarding such a proposal; and how does the nation’s previous attitudes toward presumed consent shape the conversation? Opt-out vs. Opt-in Presumed consent for organ donation is the systematic framework in which a deceased person’s consent to be an organ donor is assumed. Those wishing not to be donors must express their objection in a national registry or a family member must object to organ donation after the person’s death. Thus, presumed consent differentiates itself by being an “opt-out” system, whereas the majority of the world’s organ donation systems are “opt-in”, requiring an individual to register their intent as organ donors. Advocates of presumed consent often point to the successes of European nations such as Spain, Belgium, and Austria, highlighting how their donation rates significantly increased after the implementation of presumed consent. While Spain’s donation rate of 34.8 pmp is certainly remarkable on a global scale, 2,[3] it is necessary to undertake a systematic review of the empirical data in order to arrive at any assertive conclusion as to presumed consent’s potential for use in the United States. In addition to the umbrella terms “presumed consent” or “opt-out” system, legislation can vary between countries, leading to the use of additional terms such as “hard” and “soft” to characterize the degree of emphasis placed on the views of the decedent’s relatives.2 For instance, in Spain physicians must take active steps to make sure that the decedent’s family does not object to the procurement of their organs. Therefore, the presumed consent law in Spain is “soft.” This is in direct contrast with the case in Austria where procurement will proceed under all circumstances, barring evidence of the decedent’s objection before death. The law in this case is relatively “hard” because the family is not consulted by doctors about their own objections to organ extraction. Irrespective of the “soft” or “hard” terminology, both forms of presumed consent have seemingly proven to be significant factors influencing the organ donation rate. Before the enactment of the legislation, the Austrian donation rate was 4.6 pmp. Within four years the rate increased to 10.1 pmp, and five years later the rate was 27.2 pmp. Three years after the adoption of presumed consent legislation, Belgium saw a rate increase from 18.9 to 41.3 pmp; and Singapore also saw an extraordinary increase from 4.7 to 31.3 pmp over a three-year period. In 1989, Spain’s donation rate was similar to that of the United Kingdom – 14 pmp – and over the past twenty years the rate has climbed to its current levels. To further contrast the United Kingdom and Spain, the rate of families refusing to give consent to organ removal has dropped to 15 percent in Spain, while the refusal rate in the United Kingdom still sits at approximately 40 percent, which is an attributing factor to the lagging donation rate overall. [4],[5] Learning from the Spanish Experience Have these notable increases in the rate of deceased organ donation simply resulted from the implementation of a presumed consent law? Or are there other factors that are hiding behind the numbers? The facts tend to favor towards the latter. For example, the jump from 10.1 to 27.2 donors pmp found in Austria is not only because of the presumed consent law. Rather, the five years that reflect this increase was a time of focused improvement upon the country’s transplantation infrastructure, which included the training of full-time transplant coordinators.2,[6] In addition, Spain’s rate increase was only measured a full ten years after the Spanish government passed the presumed consent legislation. From 1979 to 1989, the donation and refusal rate did not change much relative to the other European nations.2,4 It was in 1989 that Spain comprehensively reformed its organ procurement system, which included a number of innovations. In Spain, the defining characteristic of the innovations is the placement of transplant coordinators at every procurement hospital—these coordinators have a unique educational profile that helps them quickly identify potential donors. Many coordinators are intensive care physicians that play increasingly active roles in the organ procurement process, such as approaching the potential donor’s family and checking for potential donors in and out of the intensive care unit on a daily basis. Because transplant coordinators are not members of the transplant team, but rather part of the in-house hospital staff, they can be placed throughout the country and especially in hospitals that have lower rates of deceased organ donation.4Moreover, the coordinators are trained and organized by a central agency, the Organización Nacional de Transplantes, which provides regular courses on the organ procurement process. This model has led to more than 11,000 medical professionals being trained as coordinators since 1991. 4 Thus, it was not the new presumed consent law by itself that triggered the rise and steady maintenance of a high donation rate but a widespread overhaul of how potential donors were identified in the places they are most likely to be found: the intensive care unit. The systematic review of various studies conducted by Rithalia et al. also indicates that a number of other factors have a positive impact on the donation rate. The most obvious component of an increased donation rate is the availability of potential donors. Without a sizeable and renewable pool of donors from which to procure organs, the donation rate will remain stagnant and will fail to respond as the need increases. Interestingly, three studies conducted in Organization for Economic Cooperation and Development (OECD) countries considered the mortality rate from road traffic accidents and showed a significant correlation with donation rate.2 Additional studies illustrated that wealth and healthcare expenditures, measured in gross domestic product (GDP) per capita and health expenditure per capita, were strong predictors of high donation rates. 2 A review of European countries by Gimbel et al. also discovered that the percentage of the population enrolled in third-tier education, used to assess the influence of social demographics on donation rates, had a significant positive association.[7]Finally, there was an overall favorable relationship between the percent of the population that identified themselves as Roman Catholic and the donation rate.7,[8] This result is consistent with the popular suggestion that Catholicism tends to have more encouraging attitudes toward organ donation, recognizing it as a “service of life.”2 These statistics and correlations drive home the sentiment that presumed consent in and of itself cannot account for the rise in donation rates in European countries. Nor is the adoption of a presumed consent law a guarantee that the country will achieve high donation numbers.[9] This is further exhibited in Greece, where despite “presumed consent” legislation the donation rate remains at 6.9 pmp; thus supporting the argument that economic and social factors have influential roles to play.[10] Conclusions such as these certainly make the case that presumed consent is not the sole predictor for improving the donation rate. Evaluating, understanding, and reforming the underlying economic and social circumstances hold great promise in changing the trend of organ donation. What presumed consent could provide, however, is a framework for expanding the availability of potential donors.[11] With a national survey finding a disparity between the number of Americans willing to donate organs and the number who are currently registered as donors,[12] the discussion concerning the adoption of presumed consent takes on a more significant role and scholars have urged for this change.[13],[14],[15] In the United States, the donation rate is 26.1 pmp,[16],[17] placing it fourth worldwide.9 Yet, the waiting list for organ transplants has exceeded 122,000 and is anticipated to grow roughly 10 percent each year, which results in thousands of people dying while waiting for an organ.[18]This is all despite the fact that more than 28,000 transplants are performed each year in the United States, more than any other country.16 These facts are what drive the debate in the direction of presumed consent, for if the country is to save as many people as possible who are currently waiting on the transplant list, then legislators believe that presumed consent holds the key to reforming the decades-old “opt-in,” explicit consent model. Philosophical Arguments Promoters shape their arguments around the need to fundamentally change the American assumption that “absent specific notification to the contrary, decedents are best protected if we act as though they had autonomously willed that their organs not be donated for transplantation.”14 This is precisely the principle governing explicit consent for organ donation, in which a person during their lifetime, or a family member after their death, must clearly express the will to donate the organs. Cohen  argues that this ideology should be reformed and replaced with the notion that the best way to protect the autonomous wishes of the deceased would be to assume that they would have willed for their organs to be used for “beneficial medical uses.” Furthermore, he espouses the “hard” form of presumed consent, stating that no permission should be sought from anyone in the absence of express refusal from the deceased. The basis for Cohen’s reasoning lies in his appeal to the moral argument: it is morally just—not only for the decedent, but also for the members of society who need organs—to remove the organs from the majority of individuals who would have wanted to donate their organs but left behind no indication of that wish. It is therefore morally unjust to violate their wishes and bury them with all their organs intact inside their bodies. Cohen characterizes this as a breach of autonomy; a breach that only a presumed consent policy would rectify, resulting in an increase in the number of decedents whose wishes are respected. Veatch and Pitt counter Cohen’s claims by asserting that presumed consent is morally unacceptable because it results in the violation of a person’s fundamental right to be able to autonomously choose what happens to his or her body after death.[19] Whereas Cohen’s majority would have wished to have their organs removed, Veatch and Pitt’s minority prefer not to have their organs removed after death. If presumed consent were instated, then it would be easy to assume that many in the minority would fail to properly indicate their desire not to donate, much like the many in the majority who fail to properly indicate their desire to donate. What would result are instances in which individuals who wished to be buried with all their organs inside their body would have their organs removed. Veatch and Pitt posit this as a far more egregious violation of autonomy than the one found in Cohen’s argument. The current system of explicit consent, therefore, is in a better position to protect autonomy and respect the wishes of those who do not wish to donate. Michael Gill attempts to reconcile the two sides of this debate, ultimately reaching the conclusion that presumed consent provides the most morally acceptable solution. He starts by acknowledging that mistakes will be made in either consent scheme. Regardless of how well explicit consent is instituted, there will be cases where those who wished to donate their organs will be buried with their organs intact. Similarly, regardless of how well presumed consent is instituted, there will be cases where those who did not wish to donate are buried with their organs removed. Gill emphasizes the moral duty to respect a person’s wishes concerning his or her body, but asserts that violating this duty by either mistakenly removing or not removing organs is equal. Both of these mistakes fail to bring about the “state of affairs the individual desired.” With the moral gravity of these mistakes being equal in Gill’s view, the moral question then becomes: Which consent scheme minimizes the moral harms and maximizes the moral benefits? It becomes easy to see from this line of thinking that the ethical fortitude sides with presumed consent, which is prone to make fewer mistakes than explicit consent. How Does the United States Fit In? Although Gill’s conclusion would certainly appease those fighting for the implementation of presumed consent, his notion is meant for a country with a stronger communitarian ethic; one in which the tenets of utilitarian moralism outweigh those of individual autonomy. Such a policy, however, goes “against the grain of American individualism.”13 As Orentlicher  states, the United States has actually tried presumed consent on a limited basis for the past forty years, and it failed because it went either too far or not far enough. In allowing family members to overrule the presumption that the decedent would have preferred donation, presumed consent did not go far enough. This deference to the family in regard to organ donation never allowed presumed consent to surpass the real reason why decedents do not become organ donors, namely the refusal of family members to give consent.13 This is akin to the kind of “soft” presumed consent found in Spain. Spain places great importance upon the fact that death is not an isolated event involving the deceased, but instead engages the whole family. Spain realizes that any organ procurement system relies on the trust that exists between the patient’s family and the physicians or transplant coordinators. Undermining that trust would completely damage the entire organ donation process. This serves to highlight Spain’s accomplishment in keeping the refusal rate so low at 15 percent; which is achieved mainly through its extensive training of transplant coordinators, lack of donor registry , and enhanced capacity to identify potential donors.4 In essence, the Spanish model succeeds without much need for presumed consent. According to Orentlicher, presumed consent in the United States went too far in regard to the fact that public officials attempted to bypass family members in an effort to avoid the possibility of family refusal. Such attempts only exacerbated concerns and fears that physicians would harvest organs from those who would not have wished for their removal. Starting in the late 1960s, state legislatures passed measures that authorized the removal of corneas, pituitary glands, and sometimes even hearts, lungs, kidneys, and livers if the decedent’s body came under the custody of a medical examiner or coroner. The lawmakers’ reasoning was rather simple – since the body of these individuals would already be subjected to a major intrusion in the form of an autopsy, then removal of an organ for the benefit of living persons was acceptable. This practice was supported and reinforced by the 1987 Uniform Anatomical Gift Act, but has since been discarded since the document’s 2006 revision and adoption by a vast majority of states.13 Therefore, the largest hurdle for presumed consent to conquer is that of public perception and attitudes against it. Because the registration process varies from state to state, many state legislatures have tried to bring up the issue of presumed consent, proposing opt-out systems. These have never gotten very far due to concerns about individual rights—another testament to the importance of autonomy, which is present in American minds. For example, Colorado tried to pass an opt-out law in 2011, but the lawmaker who introduced the bill was forced to pull it due to negative reactions from the public.10 There has been abundant skepticism about the possibility of presumed consent as a solution to close the organ gap that exists in the United States.11,[20] Researchers have concluded that despite the substantive differences in the laws themselves, presumed consent, in countries like Spain, does not differ dramatically from the application of explicit consent in the United States. In both the United States and Spain, primacy is given to respecting the wishes of the individual and the family. If anything, the experience in Spain has shown that what can truly improve the donation rate is diligent attention to the infrastructure of the organ transplantation system, using it to quickly and efficiently identify patients in the intensive care unit who are potential donors and taking the necessary steps to ensure that the organs are procured ethically and respectfully once death occurs. With respect to the procurement system currently in place in the United States, legislation was introduced by the Surgeon General that legally requires all hospitals to identify and refer potential donors to an organ donor organization.3 Potential donors are identified using clinical markers that are present in patients likely to be diagnosed as brain dead, and organ donor organizations are well-staffed with an extensive network of trained organ coordinators. Alternatives to Presumed Consent Comparatively, the transplantation environment of Spain and the United States is very similar. What is lacking, then, in the United States is not the adoption of presumed consent, but a method of improving the family refusal rate. This can be achieved through public policy that aims to increase the likelihood that individuals will document their wishes. Family members who are aware and confident in the decedent’s wish to donate his or her organs after death are more likely to respect these wishes and consent to organ procurement upon request. Orentlicher suggests that if everyone willing to donate were to officially register, then organ donation rates could increase by as much as 50 percent.13 Efforts such as the Hero Act in New Jersey have taken the initiative by mandating that New Jersey public schools provide information about organ and tissue donation and that material be included in the state’s Core Curriculum Content Standards for Comprehensive Health and Physical Education for grades 9–12.[21] The goal is to ensure that all residents have the “fundamental responsibility to choose whether to help save another’s life.” Overcoming high refusal rates can also be done by combating the misconceptions that seem to be at the root of the refusals,13 such as the notion that organ donation violates certain religious ideals or that donation would affect the body’s appearance at an open casket funeral. Motivated physicians dedicated to the cause of organ donation have been the key for success in Spain,4and as such, physicians in the United States must develop the skills to delicately approach families. Gortmaker  has found that this is best realized when the discussion about the patient’s death is separated from the discussion about organ donation, when organ procurement professionals join with hospital staff in the donation discussion, and when the request for donation takes place in a quiet, private setting.[22] Procurement professionals have also begun utilizing a “presumptive approach” when discussing organ donation with families, which is an approach that takes on a more value-positive tone and strives to encourage the family to consent to donation.[23] Application of strategies such as these may see refusal rate in the United States drop significantly, altering the transplantation landscape in ways that presumed consent legislation simply could not. In all, the talk about presumed consent seems to have taken a back seat since its abandonment in the latest version of the Uniform Anatomical Gift Act and public sentiment has proven to be a difficult obstacle to clear in recent years. Although it may always seem like an attractive solution to an issue that is at the forefront of medicine, the data illustrates that presumed consent is not what the United States is clamoring for. It begs for a solution that makes use of the current organ procurement infrastructure, expands the base of information available to potential donor registrants, and continues to build upon the trust between families and hospitals. REFERENCES [1] BBC News Wales. “Organ donation: Presumed consent to start in December 2015.” September 10, 2013. [2] Amber Rithalia, Catriona McDaid, Sara Suekarran, Lindsey Myers, and Amanda Sowden. “Impact of presumed consent for organ donation on donation rates: a systematic review.” British Medical Journal, 2009. [3] Simon Bramhall. “Presumed consent for organ donation: a case against.” Annals of the Royal College of Surgeons of England, 2011: 268-272. [4] John Fabre, Paul Murphy, and Rafael Matesanz. “Presumed consent is unnecessary.” British Medical Journal, 2010: 922-924. [5] European Union Directorate-General for Health and Consumers. “Key facts and figures on EU organ donation and transplantation.” 2010. [6] M.F.X. Gnant, P. Wamser, P. Goetzinger, T. Sautner, R Steininger, and F. Muehlbacher. “The impact of the presumed consent law and a decentralized organ procurement system on organ donation: quadruplication in the number of organ donors.” Transplantation Proceedings, 1991: 2685-2686. [7] Gimbel, RW, MA Strosberg, SE Lehrman, Gefenas E, and F Taft. “Presumed consent and other predictors of cadaveric organ donation in Europe.” Progress in Transplantation, 2003: 17-23. [8] Neto, Giacomo Balbinotto, Ana Katerina Campelo, and Everton Nunes da Silva. “Impact of presumed consent law on organ donation: an empirical analysis from quantile regression for longitudinal data.” Latin American and Caribbean Law and Economics Association Annual Papers, 2007. [9] Remco Coppen, Roland Friele, Richard Marquet, Sjef Gevers. “Opting-out systems: no guarantee for higher donation rates.” Transplant International, 2005: 1275-1279. [10] Sydney Lupkin. Organ donation rates: How the US stacks up. June 18, 2013. http://abcnews.go.com/Health/organ-donation-rates-us-stacks/story?id=19437070# (accessed May 5, 2014) [11] Alberto Abadie and Sebastien Gay. The Impact of Presumed Consent Legislation on Cadaveric Organ Donation: A Cross Country Study. Working Paper, Cambridge, MA: National Bureau of Economics Research, 2004. [12] Astellas Pharma US, Inc. Survey Finds Disconnect Between Number of Americans Willing to Donate Organs and Number Currently Registered as Donors. April 15, 2013. http://newsroom.astellas.us/news-releases (accessed May 3, 2014). [13] David Orentlicher. “Presumed consent to organ donation: Its rise and fall in the United States .” Rutgers Law Review, 2009: 295-331. [14] Carl Cohen. “The case for presumed case to transplant human organs after death.” Transplantation Proceedings, 1992: 2168-2172. [15] Gill, Michael B. “Presumed Consent, Autonomy, and Organ Donation.” Journal of Medicine and Philosophy, 2004: 37-59. [16] Donate Life California. Presumed Consent: An Attractive Concept with Unattractive Results. May 8, 2014. http://donatelifecalifornia.org/education/faqs/presumed-consent/ (accessed May 8, 2014). [17] Howard M. Nathan, Suzanne L. Conrad, Philip J. Held, Keith P. McCullough, Richard E. Pietroski, Laura A. Siminoff, Akinlou Ojo. “Organ donation in the United States.” American Journal of Transplantation, 2003: 29-40. [18] U.S. Department of Health and Human Services. Organdonor.gov. May 8, 2014. http://www.organdonor.gov/index.html (accessed May 8, 2014). [19] RM Veatch and JB Pitt. “The myth of presumed consent: ethical problems in new organ procurement strategies.” Transplant Proceedings, 1995: 1888-1892. [20] BJ Boyarksy, EC Hall, NA Deshpande, RL Ros, RA Montgomery, DM Steinwachs, DL Segev. “Potential limitations of presumed consent legislation.” Transplantation, 2012: 136-140. [21] New Jersey Driver Education. For Organ/Tissue Donation. http://www.njdrivereducation.com/organ-donation (accessed May 7, 2014). [22] Steven L. Gortmaker. "Improving the request process to increase family consent for organ donation." Journal of Transplant Coordination, 1998. [23] Robert Truog. "Consent for organ donation - balancing ethical obligations." New England Journal of Medicine, 2008: 1210-1211.

WALDMAN, Tatiana Chang

A despeito de a saúde ser um direito constitucionalmente garantido a todos e um dever do Estado, é necessário questionar se seu acesso universal e igualitário efetivamente alcança a população de estrangeiros residentes no Brasil. O objetivo deste trabalho foi identificar a potencial existência de entraves ao acesso aos serviços de saúde por parte de imigrantes bolivianas residentes na cidade de São Paulo. A hipótese era a de que, apesar da universalidade do acesso à saúde ser garantida pela legislação pátria, as imigrantes teriam ressalvas em relação à utilização destes serviços. As informações alcançadas com a pesquisa sugerem, no entanto, que a grande maioria das entrevistadas já havia sido assistida, pelo menos uma vez, por algum serviço médico na cidade de São Paulo, e indicam, ainda, que foi alto o índice de procura por medidas preventivas de promoção da saúde, particularmente o atendimento pré-natal, sugerindo, inclusive, um elevado índice numérico de consultas para este mesmo tipo de atendimento por parte das entrevistadas. Para a realização deste projeto, ademais da pesquisa bibliográfica, foram realizadas entrevistas com vinte e oito mulheres imigrantes, no Centro de Apoio ao Migrante (CAMI/SPM), nos meses de abril e maio de 2010, que serviram para identificar a percepção do grupo estudado com relação ao sistema de saúde nacional e, ainda, compreender o comportamento do mesmo diante da legislação nacional.

Marlon Alberto Weichert

O artigo aborda os aspectos constitucionais da proposta do governo federal brasileiro de instituição de uma nova espécie de pessoa jurídica para a prestação de serviços públicos de saúde: as fundações estatais. Utilizou-se o método lógico-sistemático de pesquisa, com uso de fontes bibliográficas e jurisprudenciais. O projeto governamental de criar fundações estatais em saúde é positivo ao pretender a retomada pela administração pública da gestão de serviços públicos que estão sendo geridos pela iniciativa privada. Porém, alguns elementos essenciais do modelo jurídico adotado são incompatíveis com a Constituição. A fundação estatal não poderá atuar na prestação do serviço público de saúde em caráter permanente. Sua atuação deverá ser estritamente na realização de atividades econômicas. A criação das fundações estatais em saúde significará também um retrocesso na proteção do patrimônio público e social.

HAGE, Eduardo

Apresentação da seção "Tema em Debate" sobre o Regulamento Sanitário Internacional.

Gilson Carvalho

Comentário à ação pública 81/97.

Revista de Direito Sanitário

Seleção de decisões judiciais sobre o direito à saúde da América Latina.