[LEGAL REGULATION OF TRANSPLANTOLOGY AT THE PRESENT STAGE: UKRAINIAN ISSUE AND EXPERIENCE OF FOREIGN STATES].

The objective of the research is to analyze the legal regulation in the transplantology field at the present stage in Ukraine. To address identified challenges, the author investigates the foreign countries experience and suggests ways of improving certain mechanism for legal regulation in the field of organ transplantation and anatomical materials. The empiric material of the study included a wide range of legal instruments regulating this sphere of legal relationships, information regarding the problems of their application, statistics, expert analysis of Ukrainian and foreign researchers. Methodological mechanism of current research includes such methods: systematic, logical and formal, structural-functional, comparative. The research found that the most world's successful model for the organization of transplantation is in Spain. Additionally, the criteria for the reception of such a model are singled out as well as certain aspects of their application in Ukraine are analyzed. Particularly, the most important criteria are: universal and general territorial proliferation of national health systems; relevant economic resources (special attention is paid to the fact that transplantation is not a medicine of luxury, and an adequate compensation to hospitals for transplantation operations should serve as a main economic aspect); an adequate and necessary number of doctors and nurses; the availability of advanced technical options for medical mechanical ventilation (air conditioning of dead bodies). The research led to the following overall findings. Due to the rapid development of medical and biological sciences, there is an urgent need on further investigation of legal, moral and ethical, general medical aspects of transplantation with subsequent proposals for improving legislation in the field of human organs transplantation and other anatomical materials. At the same time, development of appropriate legislation by complex groups of cross-disciplinary specialists and experts (in medicine, biology, law and bioethics) is the key to legal regulation effectiveness.

European regulation for therapeutic use of stem cells.

The regulation for the use of stem cells has evolved during the past decade with the aim of ensuring a high standard of quality and safety for human derived products throughout Europe to comply with the provision of the Lisbon treaty. To this end, new regulations have been issued and the regulatory status of stem cells has been revised. Indeed, stem cells used for therapeutic purposes can now be classified as a cell preparation, or as advanced therapy medicinal products depending on the clinical indication and on the procedure of cell preparation. Furthermore, exemptions to the European regulation are applicable for stem cells prepared and used within the hospital. The aim of this review is to give the non-specialized reader a broad overview of this particular regulatory landscape.

From sanctioning culture to safety culture: Let's stop making errors on error.

The punitive culture continues to prevail in health care organizations that rely primarily on functional systems hierarchies based on conformity. This type of culture is recognized as a major source of an unacceptable number of medical errors. The safety culture has emerged as an imperative to improve the quality and safety of patient care, but also as a shield against the judgments targeted towards the caregivers (doctor and / or nurse) involved in an undesirable event. The safety culture allows a broader view of the error by analyzing both system failures and staff incompetence. Therefore, it places caregivers in their workplace with mutual interactions and protects them from "second victim" status. It is imperative to have a reflection on the safety culture that constitutes a proof of transparency and openness towards society about the mistake that remains taboo. This attitude will avoid the risk of "judicialization of health".

The Double Helix: Applying an Ethic of Care to the Duty to Warn Genetic Relatives of Genetic Information.

Genetic testing reveals information about a patient's health status and predictions about the patient's future wellness, while also potentially disclosing health information relevant to other family members. With the increasing availability and affordability of genetic testing and the integration of genetics into mainstream medicine, the importance of clarifying the scope of confidentiality and the rules regarding disclosure of genetic findings to genetic relatives is prime. The United Nations International Declaration on Human Genetic Data urges an appreciation for principles of equality, justice, solidarity and responsibility in the context of genetic testing, including a commitment to honoring the privacy and security of the person tested. Considering this global mandate and recent professional statements in the context of a legal amendment to patient privacy policies in Australia, a fresh scrutiny of the legal history of a physician's duty to warn is warranted. This article inquiries whether there may be anything ethically or socially amiss with a potential future recommendation for health professionals or patients to universally disclose particular cancer predisposition genetic diagnosis to genetic family members. While much of the discussion remains applicable to all genetic diagnosis, the article focuses on the practice of disclosure within the context of BRCA1/2 diagnosis. An 'ethic of care' interpretation of legal tradition and current practice will serve to reconcile law and medical policy on the issue of physician disclosure of genetic results to family members without patient consent.

[Selected legal aspects of the protection of the unborn child in the light of the draft amendment to the Polish Penal Code]. / Wybrane aspekty prawne ochrony dziecka poczetego w swietle projektu nowelizacji Kodeksu Karnego.

Criminal Law Codification Commission, acting at the Ministry of Justice prepared proposals for amendments in the Polish Penal Code, related to offenses against life and health that were presented to the public in 2013. The draft provides for the protection of the child in the prenatal stage, introducing a new category of the entity to be protected, which is "unborn child" and "unborn child able to live outside the mother's body". These regulations provide for mothers criminal liability and responsibility of the medical staff (a doctor), as well as the child's father to the extent in which he is obliged to take steps aimed at rescuing the fetus. It is doctor's responsibility to show particular care for human health and life since a doctor has special medical knowledge and that is regulated by art. 30 of the act on professions of doctor and dentist. The proposed rule changes were not brought before the legislature in the current term of the Sejm (2011-2015), but due to the development of medicine, including obstetrical ultrasound, which enables visualization of a child that moves in the womb and is treated as a separate entity with distinct personal features the grounds are given for the opinion that the issue of the legal status of the unborn child, particularly in the context of causing death of a child in the last phase before birth as a result of medical malpractice or other external factors will be back in the public discussion.

[Lack of evidence of benefit - using the example of low dose rate brachytherapy for the treatment of localised prostate carcinoma]. / Fehlende Nachweise über den Nutzen - Beispiel: Low-Dose-Rate-Brachytherapie zur Behandlung des lokal begrenzten Prostatakarzinoms.

The appraisal of new diagnostics or therapies performed by the Federal Joint Committee in Germany often reveals a dramatic lack of evidence of the benefit of such medical treatments. For example, the evaluation of low dose rate brachytherapy used to treat men with local prostate cancer demonstrates that controlled trials still need to be conducted to ensure evidence-based patient care. In Germany, legal incentives are missing to regularly assess the benefits of medical devices and operative techniques. For the sake of patient safety there is an urgent need for a change in law in order to initiate a systematic evaluation of these new medical technologies before their widespread use.

[Euthanasia and other decisions at the end of life (Proposal for a more transparent terminology and some thoughts on the legal framework of medical treatment)]. / Az életvégi orvosi döntésekrol, közöttük az eutanáziáról. (Javaslat egy áttekinthetobb terminológiára és gondolatok az orvoslás jogi szabályozásáról).

Indication of euthanasia is only one of several medical decisions at the end of life. Precise definition of this topic related to the clinical events happening around the sick-bed is not complete in the legal and medical literature. The present review attempts to classify the different end of life events with the aim of clarifying which of these do not belong to the concept of passive euthanasia. Euthanasia is not a legal category. The everyday expressions of active and passive euthanasia are simplifications, which cover actions of different purposes. Use of these in medical and legal literature can be confusing and misleading. We differentiate decisions at the end of life on basis of their purpose. Based on the definition and category of the Hungarian Doctors' Chamber, euthanasia is the act or the lack of action in order to mercifully shorten or end the life of a suffering fellow-man to help him. Concepts of active, passive and forced euthanasia are defined. The terms of indirect and intermediate euthanasia are not used in order to avoid misunderstanding. Help and participation of non-professionals in the implementation cannot be completely excluded from the concept of euthanasia, and we believe euthanasia is not merely related to doctors. We outline those medical decisions at the end of life which do not belong to the category of passive euthanasia, namely: withdrawal of ineffective and life sustaining treatments, letting go of the patient, contra-indication of therapy escalation, use of palliative therapy, pain-relieving treatment, compromise medicine, consideration of reanimation and choosing cost-effective therapy. We touch upon the subject of the living will, why it cannot be applied, and its relation to active and passive euthanasia. With reference to the legal regulation of life saving and life sustaining treatment, we deal with the expected spirit of medical legislation.

Novo Código de Ética Médica

O Código de Ética vigente até abril de 2009 é o referente ao ano de 1988. É um código cujo conteúdo baseia-se na Constituição Federal, na legislação vigente no País e, sobretudo, no respeito aos direitos individuais e de cidadania. Considerando a grande evolução científica na área médica, a divulgação e a implantação dos princípios fundamentais da bioética e, também, que grandes demandas sociais expõem os médicos e envolvem a população, foi necessário um estudo profundo dessas questões, contemplando-as no Código de Ética Médica. Após exaustivos trabalhos em todos os estados da federação com assistência e apoio de uma comissão central, chegou-se a um texto apropriado, e, em reunião federativa com mais uma semana de discussão, foi aprovado o Novo Código de Ética Médica de 2009 - Resolução CFM 1.931 de 17/9/2009. Algumas mudanças merecem destaque: os princípios fundamentais foram ampliados, agora com 25 artigos; o capítulo que contempla a diceologia do código (direitos dos médicos) foi objeto de análise profunda e escrito em dez artigos; a parte deontológica (deveres dos médicos) teve 118 artigos e sua redação contempla os deveres dos médicos. Dentre os deveres dos médicos, alguns capítulos e artigos merecem destaque: o artigo primeiro do código (antigo art. 29) é um deles. Dentro da responsabilidade profissional, inclui-se: o parágrafo único, no qual a responsabilidade médica é sempre pessoal, não pode ser presumida. A figura da não-presunção não estava no Código de 1988 e a sequência dos capítulos foi mantida. O termo sigilo substituiu o termo segredo médico e ficou mais preciso. O cap. XII intitula-se Ensino e pesquisa englobando aspectos atuais. Auditoria e perícia médica ficaram em um único capítulo. O capítulo sobre atestado e boletim médico passou a se chamar Documentos Médicos, pois o termo é mais abrangente. Conclui-se que o Código de 2009 aperfeiçoou o de 1988. Ficou claro também que revisões serão necessárias a mais curto prazo

La judicialización de la salud: gestión de conflictos / The prosecution of health: conflict management

Esta investigación parte de la observación de nuestro Sistema de Salud, que junto a la multiplicidad de actores que lo integran conforman una intrincada red de relaciones que en los últimos tiempos ha generado un creciente aumento de la conflictividad, provocando una excesiva injerencia de los Tribunales de Justicia para la solución de las controversias que surgen entre los mismos. Así las cosas, esta situación no hizo más que quebrantar el paradigma de confianza mutua entre médicos y pacientes, aumentar el gasto en salud, generar prácticas propias de medicina defensiva y soslayar el cúmulo de derechos y garantías que tutelan a los usuarios de los servicios de salud. El tipo de investigación utilizado es de tipo exploratoria dado que busca indagar sobre una problemática de escaso desarrollo en el campo sanitario y del derecho -La Judicialización de la Salud-, promoviendo desde la gestión una manera amigable de resolver conflictos sin la intervención de Tribunales. Para recolectar datos se utilizó el análisis documental y la realización de entrevistas en profundidad a profesionales de la salud y el derecho, como así también, recopilación de Doctrina y Jurisprudencia. Las conclusiones arribadas nos dejan observar la necesidad, viabilidad y factibilidad de la gestión de conflictos, mediante creación de un órgano técnico que utilizando procedimientos propios de la mediación, es capaz de atemperar el problema de la judicialización, evitar la trascendencia de las disidencias al marco de los tribunales e impulsar la difusión de los derechos de usuarios de servicios de salud, intentando reestablecer la relación entre profesionales – pacientes y lograr así una mejor calidad prestacional. Para finalizar se adjunta un proyecto de ley a fin de crear un Instituto reglamentado y administrado por el Estado provincial, dedicado a la Solución de Conflictos en la órbita de la Salud Pública y a la difusión y tutela de los derechos de los usuarios de servicios sanitarios.

Oestrous synchronisation in cattle--current options following the EU regulations restricting use of oestrogenic compounds in food-producing animals: a review.

Oestrous synchronisation is an important strategy to improve reproductive management of cattle. The use of oestradiol-17beta, and its related ester derivatives, in food-producing cattle for the purposes of oestrous synchronisation is prohibited in the European Union since October 2006; a serious limitation in the implementation of large-scale use of cost effective synchronisation regimens in both dairy and beef herds. This has obvious consequences within the EU and also in other countries that have restricted the use of oestradiol following the EU ban. Oestrous synchronisation is an important facilitator for the use of artificial insemination, a necessary part of any national herd genetic improvement scheme. Presently, only 35% of the Irish dairy herd is bred by artificial insemination; and facilitation rather than restriction is required to increase this percentage. Ideally synchronisation of oestrus should increase submission rates, improve or at least not affect conception rates, and thus, increase overall pregnancy rate at the end of the breeding season. This should reduce the proportion of cows to be culled. This paper aims to review the oestrous synchrony options available in EU countries and other countries affected by the European ban on oestrogenic compounds being used for oestrous synchrony protocols. Currently, the options available for oestrous synchronisation are generally not as effective, efficient or cost effective as those that incorporated use of oestrogenic compounds.

Proceso de Normalización para la Regulación Sanitaria / Process Sanitary Standards for the Regulation

En el artículo dos de la la Ley General de Salud se define que el Ministerio de Salud es el órgano competente para aplicar, supervisar, controlar y evaluar el cumplimiento de la presente ley y su reglamento; así como elaborar, aprobar, aplicar, supervisar y evaluar normas técnicas, formular polìticas, planes, programas, proyectos, manuales e instructivos que sean necesarios para su aplicación. Por la importanciaa y trascendencia que el proceso de regulación y normalización implica, la Dirección General de Regulación de Establecimientos de Salud, Profesionaels, Medicinas y Alimentos presenta la recopilación de todos los instrumentos básicos que permitan a todos y todas, cumplir con la Ley. En este documento se incluyen los acuerdos ministeriales del año 2003 y 2004, así como la comparación de la Ley General de Salud y su Reglamento con otras leyes especiales

Standardization of the medical record in plastic surgery

The objective of the present study is to propose a standardization of the medical record for plastic surgery. The record model proposed would work for most plastic surgeons, and could be filled out in an automated and oriented manner by the physician and also allowadaptations according to individual needs. Data on Identification, Chief Complaints, History of Present Illness, Systems Investigation, Personal Background andFamily Background could also be filled out alternatively by the patient him/herself, by using language andexpressions accessible to the lay public, and in order to support the physician more effectively in the case of legal disputes. The record can be viewed quickly and objectively due to the use of figures and diagrams. It has a simple cataloguing and filing system for photographic documents and registered data are numbered in order; so that they may be computerized, making scientific research easier and minimizing data collecting errors. The record model may be used in hospitals, outpatient clinics and individual medical offices. The resolutions of the medical entities that regulate the utilization of Medical Records or Medical Files are also discussed.