A efetividade do processo de doação de órgãos frente a nova legislação / The effectiveness of the organ donation process fronts new legislation / La eficacia del proceso de donación de órganos frente a nueva legislaciónl

O decreto Nº 9.175, de 18 de outubro de 2017 trouxe consideráveis e necessárias mudanças ao texto da Lei de Doação de Órgãos, visando dar maior rapidez e garantia para que os procedimentos sejam realizados com pleno êxito, levando-se em consideração que o Brasil figura em posição privilegiada na lista dos países que mais realizam transplantes no mundo. Por este motivo, este estudo tem por objetivo verificar a efetividade da agilização da doação de órgãos frente a nova legislação brasileira. Utilizou-se como metodologia a revisão integrativa, com busca nos bancos de dados BVS, SciELO e LILACS, que levou a seleção de 10 artigos que analisados levaram a criação de três categorias temáticas: A Conduta da enfermagem frente ao Provável Doador; Fatores que levam a doação ou não de órgãos e A Efetividade da Nova Legislação na Agilização da Doação de Órgãos. Concluiu-se que fica nítida a necessidade de verificação mais aprofundada junto aos órgãos competentes, que forneçam dados a respeito da efetivação da doação de órgãos e que aumentem o número de publicações informando e auxiliando o profissional da saúde na minimização de filas e na melhoria de qualidade de vida daquele que tanto almeja uma chance de transplante.(AU)

Decree No. 9,175 of October 18, 2017 brought considerable and necessary changes to the text of the Organ Donation Law, with a view to speeding up and ensuring that procedures are carried out with full success, taking into account that the Brazil is in a privileged position in the list of countries that perform the most transplants in the world. For this reason, this study aims to verify the effectiveness of the agility of organ donation in front of the new Brazilian legislation. The integrative review was used as a methodology, with a search in the VHL, SciELO and LILACS databases, which led to the selection of 10 articles that analyzed led to the creation of three thematic categories: Nursing Conduct versus Probable Donor; Factors that lead to donation or not of organs and The Effectiveness of New Legislation in Streamlining Organ Donation. It was concluded that there is a clear need for more detailed verification to the competent organs, to provide data regarding the effectiveness of organ donation and to increase the number of publications informing and assisting the health professional in minimizing queues and improving quality of life of those who long for a chance of transplantation.(AU)

El Decreto No. 9.175, de 18 de octubre de 2017, trajo cambios considerables y necesarios al texto de la Ley de Donación de Órganos, con el objetivo de proporcionar mayor velocidad y garantía para que los procedimientos se lleven a cabo con pleno éxito, teniendo en cuenta que Brasil se encuentra en una posición privilegiada en la lista de países que realizan más trasplantes en el mundo. Por esta razón, este estudio tiene como objetivo verificar la efectividad de la donación racionalizada de órganos en virtud de la nueva legislación brasileña. La revisión integradora se utilizó como metodología, con una búsqueda en las bases de datos de BVS, SciELO y LILACS, lo que condujo a la selección de 10 artículos que analizados condujeron a la creación de tres categorías temáticas: la conducta de enfermería hacia el donante probable; Factores que conducen a la donación de órganos o no y La efectividad de la nueva legislación en la racionalización de la donación de órganos. Se concluyó que existe una clara necesidad de una verificación más profunda con los organismos competentes, para proporcionar datos sobre la efectividad de la donación de órganos y para aumentar el número de publicaciones que informan y ayudan al profesional de la salud a minimizar las colas y mejorar calidad de vida de quienes anhelan una posibilidad de trasplante.(AU)

Legal bases for improving legislation on the transplantation of human anatomical materials.

OBJECTIVE: Introduction: From January 1, 2019, the Law of Ukraine "On application of the transplantation of anatomical materials to a human being" dated May 17, 2018, № 2427-VIII (hereinafter referred to as Law № 2427), which defined a new system of legal relationship in the field of transplantation and related activities. Simultaneously the validity of the Law of Ukraine "On transplantation of organs and other anatomical materials to a human being" adopted in July 16, 1999. № 1007-XIV was canceled. The development of medical science overlooks the prospect of humanity's salvation from many incurable diseases. One of the directions of medical advancing is the development of transplantation, which is special method of treatment that involves the transplantation of anatomical human material from a donor to a recipient and a focuses on the restoration of human health. Admitting the fact that life or health can be saved for hundreds of thousands of people with its' usage today and the need for it is growing relentlessly. Therefore, research and improvement of legislation on the transplantation of human anatomical materials is well-grounded and timely. The aim: To establish and specify the problematic issues of legal regulation that arise in the transplantation of human anatomical materials sphere. PATIENTS AND METHODS: Materials and methods: During the study, international acts, national legislation and Conclusions of scientists were used. The article is based on dialectical, legal comparative, systemic, historical and complex methods of research. RESULTS: Review: In this paper the main problems of legal regulation of transplantation of human anatomical materials according to the Ukrainian legislation are analyzed and specific suggestions for their solution are proposed. CONCLUSION: Conclusions: The solution to this problem is to create a legislative framework and provide an effective and effective mechanism for regulating and implementing transplantation of human anatomical materials.

[THE LEGAL FRAMEWORK FOR THE RESOLUTION OF THE VARIOUS TYPES OF RELATIONSHIPS].

The objective of the article is to study the main organizational and legal problems of carrying out transplantation of organs and anatomical materials in Ukraine. To achieve this objective, the author has formulated the methodological complex, which included both general scientific methods and special methods of cognition. The application of the historical method made it possible to analyze the retrospective of legal provision of transplantation, to find out the errors (shortcomings) and to establish achievements both in theory and in the activities of medical institutions in the field of transplantation. Systemic and functional analysis allowed us to characterize transplantation as the comprehensive system and its components. By using the comparative and legal method, the author has analyzed international legal acts on the organization and conduction of transplantation in order to formulate propositions for the improvement of Ukrainian legislation. The author in the course of the research has highlighted legal problems that lie in the lack of legal regulation of mutual relations in the process of transplantation between donors, recipients and health care professionals. The author has stressed on the need to revise the principles of conducting transplantation in Ukraine, which is necessary to provide an orderly, acceptable structural basis for the procedures of the acquisition and transplantation of human cells, tissues and organs for therapeutic purposes in compliance with ethical principles. The current situation in the health care system directly indicates the fact that prohibitions and control do not save lives of people. It is necessary to stipulate by the law the possibility of realizing human rights under the condition of inadmissibility of the state's monopoly on transplantation surgeries.

Organización Nacional de Trasplantes (ONT). Reflexiones en su 25 aniversario / National Transplant Organization (ONT). Reflections from the 25th anniversary

No disponible

Autopsy issues in German Federal Republic transplantation legislation until 1997.

This article analyzes the relevance of autopsy issues for German Federal Republic transplantation legislation until 1997 against the background of legal traditions and the distribution of constitutional legislative powers. It is based on Federal Ministry of Justice records and German Parliament documents on transplantation legislation. Transplantation and autopsy legislation started with close ties in the 1970s. Viewing transplantation legislation as relevant for future autopsy regulation contributed to the decision to stall transplantation legislation, because the interests of the federal government and the medical profession converged to avoid subsequent restrictions on the practice of conducting autopsies and procuring tissues for transplantation. Sublegal norms were insufficient for the prosecution of the organ trade and area-wide transplantation regulation after the reunification of Germany. In contrast to autopsy issues, legislative power for transplantation issues was extended to the federal level by an amendment to the constitution, allowing decision making for Germany as a whole.

Creación, funcionamiento y control de bancos de córneas y esclerótica: acuerdo gubernativo No. 440-2013 / Creation, operation and control of corneal and scleral banks: government agreement No. 440-2013

El documento tiene algunos problemas de nitidez, que dificultan un tanto su lectura, pero solo al inicio. Las afecciones de córnea, son una de las 5 enfermedades que causan ceguera y que son prevenibles. Describe las normas y requisitos para su autorización y funcionamiento. Incluye varias definiciones de conceptos inherentes al tema del acuerdo. Además de describir la organización y estructura de los bancos de córneas, propone la conformación de un comité de trasplantes, describiendo los profesionales que deben conformarlo y sus específicas funciones. Describe también las funciones de los técnicos de cada establecimiento, público y/o privado. Enumera y describe las características físicas (infraestructura), así como el equipamiento y detalles complementarios que deberán ser cumplidas por cada establecimiento solicitante. Otro tanto hace con los detalles, tanto de donadores como de receptores.

Human tissue and organ transplant provisions: chapter 8 of the National Health Act and its Regulations, in effect from March 2012 - what doctors must know.

Where provisions that were in the Human Tissue Act have been left out of the National Health Act they have been included in its regulations. However, new provisions in the latter Act provide strict controls for the transplantation of organs into non-South African citizens or non-permanent residents, and outlaw the charging of fees for human organs. The provisions also expand the list of persons who can give consent to donations from deceased persons to include 'partners', who now take precedence over all other relatives except spouses. Some of the matters in the Human Tissue Act that were not covered by the National Health Act have now been included in the regulations, such as: (i) the parties responsible for determining death of a person whose organs are to be removed for transplantation purposes; (ii) the requirement that tissue must be harvested within 24 hours from donated bodies; (iii) the removal of eye tissue; (iv) the exclusivity of rights in respect of tissue donations; and (v) confidentiality and publicity regarding tissue and organ transplants.

Temporal bone bank: complying with European Union directives on human tissue and cells.

BACKGROUND: Availability of allograft tympano-ossicular systems (ATOS) provides unique reconstructive capabilities, allowing more radical removal of middle ear pathology. To provide ATOS, the University of Antwerp Temporal Bone Bank (UATB) was established in 1988. ATOS use was stopped in many countries because of safety issues concerning human tissue transplantation. Our objective was to maintain an ATOS tissue bank complying with European Union (EU) directives on human tissues and cells. METHODS: The guidelines of the Belgian Superior Health Council, including EU directive requirements, were rigorously applied to UATB infrastructure, workflow protocols and activity. Workflow protocols were updated and an internal audit was performed to check and improve consistency with established quality systems and changing legislations. The Belgian Federal Agency of Medicines and Health Products performed an inspection to examine compliance with national legislatives and EU directives on human tissues and cells. A sample of important procedures was meticulously examined in its workflow setting next to assessment of the infrastructure and personnel. RESULTS: Results are reported on infrastructure, personnel, administrative workflow, procurement, preparation, processing, distribution, internal audit and inspection by the competent authority. Donors procured: 2006, 93 (45.1%); 2007, 64 (20.6%); 2008, 56 (13.1%); 2009, 79 (6.9%). The UATB was approved by the Minister of Health without critical or important shortcomings. The Ministry accords registration each time for 2 years. CONCLUSIONS: An ATOS tissue bank complying with EU regulations on human allografts is feasible and critical to assure that the patient receives tissue, which is safe, individually checked and prepared in a suitable environment.

Beyond the 'embryo question': human embryonic stem cell ethics in the context of biomaterial donation in the UK.

Discussion about the ethics of human embryonic stem cell (ESC) research in the UK tends to be dominated by the divisive and potentially intractable issue of the moral status of the embryo. This can have the effect of silencing or marginalizing other concerns, especially in the context of public engagement with science in this field. One such area of potential public concern is the donation of oocytes and embryos to stem cell research. Contemporary research on the views of donors and potential donors about a wide range of biomaterials, from solid organs to gametes and bone marrow, is reviewed and used to illustrate the range and types of ethical concerns articulated by this important group of stakeholders. Attitudes to donation are found to vary according to the type of tissue being donated or collected, the purpose for which donation is being sought and the nature of the recipient of the donation. Pertinently, attitudes towards donating oocytes are found to differ in some respects from donation of embryos or fetal tissue. The implications of these findings for ensuring ethically robust informed consent and publicly acceptable sourcing of human biomaterials for stem cell research are then considered.