Sergio Romeo-Malanda - Academia.edu (original) (raw)
Papers by Sergio Romeo-Malanda
Derived from the renowned multi-volume International Encyclopaedia of Laws, this convenient volum... more Derived from the renowned multi-volume International Encyclopaedia of Laws, this convenient volume provides comprehensive analysis of the law affecting the physician-patient relationship in Spain. Cutting across the traditional compartments with which lawyers are familiar, medical law is concerned with issues arising from this relationship, and not with the many wider juridical relations involved in the broader field of health care law. After a general introduction, the book systematically describes law related to the medical profession, proceeding from training, licensing, and other aspects of access to the profession, through disciplinary and professional liability and medical ethics considerations and quality assurance, to such aspects of the physician-patient relationship as rights and duties of physicians and patients, consent, privacy, and access to medical records. Also covered are specific issues such as organ transplants, human medical research, abortion, and euthanasia, as...
Most of the legal scholarship in Spain considers that the informed consent of the patient does no... more Most of the legal scholarship in Spain considers that the informed consent of the patient does not play a significat role in deciding to charge a physician with an offence of battery, because this offence requires an objective worsening of the health. This stance has been rejected by others scholars and also by the Supreme Court in any isolated decision. A recent Judgment of the Spanish Constitutional Court held that any unconsented medical treatrment means a violation of the right to phsysical integrity, which is precisely the legal interest protected by the offence of battery. In this article, the author defends that the principle of autonomy leads to the adoption of a subjective concept of health. That means to consider the unconsented medical treatments as conducts chargeable with the offence of battery.
Apunts per a una història del Comitè de Bioètica de Catalunya .
As a general rule, genetic testing are carried out in the medical sector upon referral by a medic... more As a general rule, genetic testing are carried out in the medical sector upon referral by a medical doctor. However, in recent years genetic testing offered directly to consumers came onto the market as a new "business model". The problems that arise from this fact are already a big concern for public institutions. The term "direct-to-consumer genetic testing" (DCGT) is used for testing services offered for health-related genetic variants and polymorphisms. This includes any genetic test available to the public outside the usual medical control system, comprising offers for so-called lifestyle-related genetic testing that provides recommendations regarding diet or everyday life (sports etc.). Although the access to these can be organised by over-the-counter sales in pharmacies or drugstores, the main channel for direct-to-consumer genetic testing is the internet. A sample of the material to be tested is usually taken at home and sent to a laboratory for analysis....
The Lisbon Treaty consolidated some federal elements that have an impact on the future developmen... more The Lisbon Treaty consolidated some federal elements that have an impact on the future development of the System of Criminal Justice of the EU. The question is that EU Member States do not have any experience about how to deal with a model of "federal" Criminal Law. For different reasons, the Australian Federal System is a good example to look at in order to get some responses. For instance, the Treaty of Lisbon has created, like in Australia, a System of EU Criminal Law in which there are not any "federal" courts to deal with "eurocrimes". These must be applied by regular national courts using national procedure laws. The fact is that the achievement of common or coordinated responses by groups of polities, whether in federation or not, may attract similar solutions and give rise to similar problems. Although operating on vastly different population sizes and across vastly different ranges of diversity, the European Union and Australia may benefit by m...
Los gametos humanos son productos corporales con una naturaleza juridica compleja, a partir del c... more Los gametos humanos son productos corporales con una naturaleza juridica compleja, a partir del cual, y de la diferente configuracion de todos los intereses que circulan alrededor de su utilizacion, se ha ido construyendo un regimen juridico que ha tratado de conciliar la proteccion de los sujetos fuente con el derecho a la salud reproductiva y a la investigacion biomedica de terceros, asi como con el interes general en el progreso cientifico. En este trabajo se analiza como el ordenamiento juridico ha situado la proteccion de los derechos del sujeto fuente como eje de la regulacion, las limitaciones articuladas en relacion con su obtencion, utilizacion y cesion, y las rutas y mecanismos de control establecidas, que son diferentes segun el contexto (reproduccion asistida, investigacion biomedica o circulacion internacional). Uno de los asuntos mas complejos es la identificacion de los requisitos para la obtencion de ovulos con finalidad de investigacion (los que hemos llamados ovulo...
Globalización y derecho: desafíos y tendencias, 2013, ISBN 978-84-15759-06-5, págs. 695-705, 2013
Sin embargo, no podemos olvidar que existe una Ley estatal que se ocupa esta misma materia y que ... more Sin embargo, no podemos olvidar que existe una Ley estatal que se ocupa esta misma materia y que tiene el carácter de básica, esto es, es de aplicación obligada por todas las Comunidades Autónomas, las cuales podrán completarla en aquellos aspectos sobre los que ésta no se pronuncia o requiere un desarrollo, pero no pueden contradecirla. En concreto, me refiero a la Ley 41/2002, de 14 de noviembre, Básica Reguladora de la autonomía del paciente y de derechos y obligaciones en materia de información y documentación clínica. De esta forma, no puede hacerse un análisis independiente de cada una de la legislaciones autonómicas sin tener el cuenta la Ley estatal y sin poner de relieve la relación existente entre las mismas y los efectos de una eventual contravención de ésta por parte de la regulación autonómica.
Cadernos Ibero-Americanos de Direito Sanitário
Objetivo: analizar la regulación jurídica existente en España relativa a la capacidad de las jóve... more Objetivo: analizar la regulación jurídica existente en España relativa a la capacidad de las jóvenes menores de edad para tomar decisiones por sí mismas en relación con la interrupción del embarazo. Metodología: se comparan las normas legales vigentes en España en las últimas décadas, así como la literatura jurídica más relevante sobre la temática de estudio y los posicionamientos al respecto de organismos internacionales. Resultados: se puede comprobar muy fácilmente el alto componente ideológico de esta problemática. La legislación ha sufrido numerosas reformas a lo largo de los años, otorgando una mayor o menor autonomía a las mujeres menores de edad dependiendo de la ideología política del partido político en el gobierno. Conclusión: se trata de un tema de gran trascendencia, por desgracia altamente ideologizado. Ante los diversos intereses en conflicto, parece que debe primar el respecto a los derechos sexuales y reproductivos de la mujer, aunque sea menor de edad, siempre que ...
La introducción de nuevas herramientas de <strong>diagnóstico genético</strong> en lo... more La introducción de nuevas herramientas de <strong>diagnóstico genético</strong> en los sistemas sanitarios representa un impacto en su organización y también en la articulación de garantías de los <strong>derechos de los pacientes</strong>. El Consejo de Europa ha publicado recientemente una recomendación al respecto que alude a las principales cuestiones implicadas (Recommendation CM/Rec(2010)11 of the Committee of Ministers to member states on the impact of genetics on the organisation of health care services and training of health professionals). La utilización de <strong>microarrays de CGH</strong> es un ejemplo paradigmático en este sentido. Los microarrays de CGH se han utilizado para determinar pérdidas o ganancias en el número de copias (CNV, del inglés <strong>copy number variations</strong>) en pacientes con distintas patologías, con el objetivo de intentar determinar su efecto sobre las <strong>enfermedades cromosómica...
Social Science Research Network, Oct 4, 2018
Los gametos humanos son productos corporales con una naturaleza jurídica compleja, a partir del c... more Los gametos humanos son productos corporales con una naturaleza jurídica compleja, a partir del cual, y de la diferente configuración de todos los intereses que circulan alrededor de su utilización, se ha ido construyendo un régimen jurídico que ha tratado de conciliar la protección de los sujetos fuente con el derecho a la salud reproductiva y a la investigación biomédica de terceros, así como con el interés general en el progreso científico. En este trabajo se analiza cómo el ordenamiento jurídico ha situado la protección de los derechos del sujeto fuente como eje de la regulación, las limitaciones articuladas en relación con su obtención, utilización y cesión, y las rutas y mecanismos de control establecidas, que son diferentes según el contexto (reproducción asistida, investigación biomédica o circulación internacional). Uno de los asuntos más complejos es la identificación de los requisitos para la obtención de óvulos con finalidad de investigación (los que hemos llamados óvulos DOI-Directamente Obtenidos para Investigación-). El análisis de la legislación, fragmentada y compleja, plantea serias dudas en relación con esta posibilidad, teniendo en cuenta el tipo de procedimiento al que se tendría que someter a la mujer con aquel propósito. Human gametes are products with a complex legal nature. With this basis, and taking into account all the interests around their use, a legal regime has been drafted, trying to reconcile the protection of the subject with the right to reproductive health and biomedical research of third parties, as well as the general interest in scientific progress. This paper analyzes how the legal system has placed the protection of the rights of the subject as the axis of regulation, the constraints articulated regarding the collection, use and circulation of gametes, and the itinerary or control mechanisms, which are different according to the context (assisted reproduction, biomedical research or international circulation). One of the most complex issues is the identification of the requirements for obtaining ovules for research purposes (which we have called DOI-Óvulos Directamente Obtenidos para Investigación/Directly Obtained for Research-ovules). The analysis of the legislation, fragmented and complex, raises serious doubts in relation to this possibility, taking into account the physical procedure that the woman must undergo for donation).
Nuevos Instrumentos Juridicos En La Lucha Contra La Delincuencia Economica Y Tecnologica 2012 Isbn 978 84 9045 020 8 Pags 657 847, 2012
Revista de derecho y genoma humano = Law and the human genome review
The Spanish penal Code of 1995 creates various crimes in relation to biotechnology, namely, the o... more The Spanish penal Code of 1995 creates various crimes in relation to biotechnology, namely, the offence of genetic manipulation, the offence of cloning and the offence of fertilization of human eggs for purpose others than procreation. These new offences seek to protect new legal interests. But besides these interests, we must not forget that there also exist certain rights of the person that rely on reproductive and genetic technologies to be fully effective. That is why it is inevitable to bring to the discussion other interests of a different nature that may be in conflict with these new legal interests. This is the case in relation to the right to procreate and the right to scientific research. According to Article 20.7 of the Spanish penal Code, a person may justifiably engage in conduct that satisfies the elements of an offence if he has a right to do so. In this work the author analyses if certain conduct that could harm some legal interests, and therefore would be criminally...
Revista de derecho y genoma humano = Law and the human genome review, 2007
This article is based in three ideas, namely: 1. All the questions in the field of "privacy&... more This article is based in three ideas, namely: 1. All the questions in the field of "privacy" and "confidentiality" derived from genetic tests only must be taken into account if we deal with "personal data". 2. When we are dealing with personal genetic data, two aspects must be especially guaranteed: a) the freedom and autonomy of the individual; and b) the duty of secrecy in order to protect the privacy of the person. 3. Some conflicts can appear between these two aspects and we have to deal with them. The author analyses the supranational European legislation referring to this topic, according to with, genetic privacy must be guarantee. He also notes how Genetic medicine can give rise to a variety of conflicts of interests, and points out how the different legal texts object of study deal with this issue.
This paper analyzes, from a strictly legal perspective, the different legislative initiatives pre... more This paper analyzes, from a strictly legal perspective, the different legislative initiatives presented in the Spanish Congress of Deputies during the present legislature aimed at the regulation of End-of-life decision making. To this end, starting from the legislative reality currently in force in Spain, the paper proceeds to analyze, on the one hand, two Proposals of Law on rights and guarantees of the dignity of the person during the final process of his life and, in the other hand, the Proposal of Organic Law for the Regulation of euthanasia which, in view of the concurrent parliamentary majorities in Spain, is called to constitute the norm that regulates this field in the near future in Spain.
Derived from the renowned multi-volume International Encyclopaedia of Laws, this convenient volum... more Derived from the renowned multi-volume International Encyclopaedia of Laws, this convenient volume provides comprehensive analysis of the law affecting the physician-patient relationship in Spain. Cutting across the traditional compartments with which lawyers are familiar, medical law is concerned with issues arising from this relationship, and not with the many wider juridical relations involved in the broader field of health care law. After a general introduction, the book systematically describes law related to the medical profession, proceeding from training, licensing, and other aspects of access to the profession, through disciplinary and professional liability and medical ethics considerations and quality assurance, to such aspects of the physician-patient relationship as rights and duties of physicians and patients, consent, privacy, and access to medical records. Also covered are specific issues such as organ transplants, human medical research, abortion, and euthanasia, as...
Most of the legal scholarship in Spain considers that the informed consent of the patient does no... more Most of the legal scholarship in Spain considers that the informed consent of the patient does not play a significat role in deciding to charge a physician with an offence of battery, because this offence requires an objective worsening of the health. This stance has been rejected by others scholars and also by the Supreme Court in any isolated decision. A recent Judgment of the Spanish Constitutional Court held that any unconsented medical treatrment means a violation of the right to phsysical integrity, which is precisely the legal interest protected by the offence of battery. In this article, the author defends that the principle of autonomy leads to the adoption of a subjective concept of health. That means to consider the unconsented medical treatments as conducts chargeable with the offence of battery.
Apunts per a una història del Comitè de Bioètica de Catalunya .
As a general rule, genetic testing are carried out in the medical sector upon referral by a medic... more As a general rule, genetic testing are carried out in the medical sector upon referral by a medical doctor. However, in recent years genetic testing offered directly to consumers came onto the market as a new "business model". The problems that arise from this fact are already a big concern for public institutions. The term "direct-to-consumer genetic testing" (DCGT) is used for testing services offered for health-related genetic variants and polymorphisms. This includes any genetic test available to the public outside the usual medical control system, comprising offers for so-called lifestyle-related genetic testing that provides recommendations regarding diet or everyday life (sports etc.). Although the access to these can be organised by over-the-counter sales in pharmacies or drugstores, the main channel for direct-to-consumer genetic testing is the internet. A sample of the material to be tested is usually taken at home and sent to a laboratory for analysis....
The Lisbon Treaty consolidated some federal elements that have an impact on the future developmen... more The Lisbon Treaty consolidated some federal elements that have an impact on the future development of the System of Criminal Justice of the EU. The question is that EU Member States do not have any experience about how to deal with a model of "federal" Criminal Law. For different reasons, the Australian Federal System is a good example to look at in order to get some responses. For instance, the Treaty of Lisbon has created, like in Australia, a System of EU Criminal Law in which there are not any "federal" courts to deal with "eurocrimes". These must be applied by regular national courts using national procedure laws. The fact is that the achievement of common or coordinated responses by groups of polities, whether in federation or not, may attract similar solutions and give rise to similar problems. Although operating on vastly different population sizes and across vastly different ranges of diversity, the European Union and Australia may benefit by m...
Los gametos humanos son productos corporales con una naturaleza juridica compleja, a partir del c... more Los gametos humanos son productos corporales con una naturaleza juridica compleja, a partir del cual, y de la diferente configuracion de todos los intereses que circulan alrededor de su utilizacion, se ha ido construyendo un regimen juridico que ha tratado de conciliar la proteccion de los sujetos fuente con el derecho a la salud reproductiva y a la investigacion biomedica de terceros, asi como con el interes general en el progreso cientifico. En este trabajo se analiza como el ordenamiento juridico ha situado la proteccion de los derechos del sujeto fuente como eje de la regulacion, las limitaciones articuladas en relacion con su obtencion, utilizacion y cesion, y las rutas y mecanismos de control establecidas, que son diferentes segun el contexto (reproduccion asistida, investigacion biomedica o circulacion internacional). Uno de los asuntos mas complejos es la identificacion de los requisitos para la obtencion de ovulos con finalidad de investigacion (los que hemos llamados ovulo...
Globalización y derecho: desafíos y tendencias, 2013, ISBN 978-84-15759-06-5, págs. 695-705, 2013
Sin embargo, no podemos olvidar que existe una Ley estatal que se ocupa esta misma materia y que ... more Sin embargo, no podemos olvidar que existe una Ley estatal que se ocupa esta misma materia y que tiene el carácter de básica, esto es, es de aplicación obligada por todas las Comunidades Autónomas, las cuales podrán completarla en aquellos aspectos sobre los que ésta no se pronuncia o requiere un desarrollo, pero no pueden contradecirla. En concreto, me refiero a la Ley 41/2002, de 14 de noviembre, Básica Reguladora de la autonomía del paciente y de derechos y obligaciones en materia de información y documentación clínica. De esta forma, no puede hacerse un análisis independiente de cada una de la legislaciones autonómicas sin tener el cuenta la Ley estatal y sin poner de relieve la relación existente entre las mismas y los efectos de una eventual contravención de ésta por parte de la regulación autonómica.
Cadernos Ibero-Americanos de Direito Sanitário
Objetivo: analizar la regulación jurídica existente en España relativa a la capacidad de las jóve... more Objetivo: analizar la regulación jurídica existente en España relativa a la capacidad de las jóvenes menores de edad para tomar decisiones por sí mismas en relación con la interrupción del embarazo. Metodología: se comparan las normas legales vigentes en España en las últimas décadas, así como la literatura jurídica más relevante sobre la temática de estudio y los posicionamientos al respecto de organismos internacionales. Resultados: se puede comprobar muy fácilmente el alto componente ideológico de esta problemática. La legislación ha sufrido numerosas reformas a lo largo de los años, otorgando una mayor o menor autonomía a las mujeres menores de edad dependiendo de la ideología política del partido político en el gobierno. Conclusión: se trata de un tema de gran trascendencia, por desgracia altamente ideologizado. Ante los diversos intereses en conflicto, parece que debe primar el respecto a los derechos sexuales y reproductivos de la mujer, aunque sea menor de edad, siempre que ...
La introducción de nuevas herramientas de <strong>diagnóstico genético</strong> en lo... more La introducción de nuevas herramientas de <strong>diagnóstico genético</strong> en los sistemas sanitarios representa un impacto en su organización y también en la articulación de garantías de los <strong>derechos de los pacientes</strong>. El Consejo de Europa ha publicado recientemente una recomendación al respecto que alude a las principales cuestiones implicadas (Recommendation CM/Rec(2010)11 of the Committee of Ministers to member states on the impact of genetics on the organisation of health care services and training of health professionals). La utilización de <strong>microarrays de CGH</strong> es un ejemplo paradigmático en este sentido. Los microarrays de CGH se han utilizado para determinar pérdidas o ganancias en el número de copias (CNV, del inglés <strong>copy number variations</strong>) en pacientes con distintas patologías, con el objetivo de intentar determinar su efecto sobre las <strong>enfermedades cromosómica...
Social Science Research Network, Oct 4, 2018
Los gametos humanos son productos corporales con una naturaleza jurídica compleja, a partir del c... more Los gametos humanos son productos corporales con una naturaleza jurídica compleja, a partir del cual, y de la diferente configuración de todos los intereses que circulan alrededor de su utilización, se ha ido construyendo un régimen jurídico que ha tratado de conciliar la protección de los sujetos fuente con el derecho a la salud reproductiva y a la investigación biomédica de terceros, así como con el interés general en el progreso científico. En este trabajo se analiza cómo el ordenamiento jurídico ha situado la protección de los derechos del sujeto fuente como eje de la regulación, las limitaciones articuladas en relación con su obtención, utilización y cesión, y las rutas y mecanismos de control establecidas, que son diferentes según el contexto (reproducción asistida, investigación biomédica o circulación internacional). Uno de los asuntos más complejos es la identificación de los requisitos para la obtención de óvulos con finalidad de investigación (los que hemos llamados óvulos DOI-Directamente Obtenidos para Investigación-). El análisis de la legislación, fragmentada y compleja, plantea serias dudas en relación con esta posibilidad, teniendo en cuenta el tipo de procedimiento al que se tendría que someter a la mujer con aquel propósito. Human gametes are products with a complex legal nature. With this basis, and taking into account all the interests around their use, a legal regime has been drafted, trying to reconcile the protection of the subject with the right to reproductive health and biomedical research of third parties, as well as the general interest in scientific progress. This paper analyzes how the legal system has placed the protection of the rights of the subject as the axis of regulation, the constraints articulated regarding the collection, use and circulation of gametes, and the itinerary or control mechanisms, which are different according to the context (assisted reproduction, biomedical research or international circulation). One of the most complex issues is the identification of the requirements for obtaining ovules for research purposes (which we have called DOI-Óvulos Directamente Obtenidos para Investigación/Directly Obtained for Research-ovules). The analysis of the legislation, fragmented and complex, raises serious doubts in relation to this possibility, taking into account the physical procedure that the woman must undergo for donation).
Nuevos Instrumentos Juridicos En La Lucha Contra La Delincuencia Economica Y Tecnologica 2012 Isbn 978 84 9045 020 8 Pags 657 847, 2012
Revista de derecho y genoma humano = Law and the human genome review
The Spanish penal Code of 1995 creates various crimes in relation to biotechnology, namely, the o... more The Spanish penal Code of 1995 creates various crimes in relation to biotechnology, namely, the offence of genetic manipulation, the offence of cloning and the offence of fertilization of human eggs for purpose others than procreation. These new offences seek to protect new legal interests. But besides these interests, we must not forget that there also exist certain rights of the person that rely on reproductive and genetic technologies to be fully effective. That is why it is inevitable to bring to the discussion other interests of a different nature that may be in conflict with these new legal interests. This is the case in relation to the right to procreate and the right to scientific research. According to Article 20.7 of the Spanish penal Code, a person may justifiably engage in conduct that satisfies the elements of an offence if he has a right to do so. In this work the author analyses if certain conduct that could harm some legal interests, and therefore would be criminally...
Revista de derecho y genoma humano = Law and the human genome review, 2007
This article is based in three ideas, namely: 1. All the questions in the field of "privacy&... more This article is based in three ideas, namely: 1. All the questions in the field of "privacy" and "confidentiality" derived from genetic tests only must be taken into account if we deal with "personal data". 2. When we are dealing with personal genetic data, two aspects must be especially guaranteed: a) the freedom and autonomy of the individual; and b) the duty of secrecy in order to protect the privacy of the person. 3. Some conflicts can appear between these two aspects and we have to deal with them. The author analyses the supranational European legislation referring to this topic, according to with, genetic privacy must be guarantee. He also notes how Genetic medicine can give rise to a variety of conflicts of interests, and points out how the different legal texts object of study deal with this issue.
This paper analyzes, from a strictly legal perspective, the different legislative initiatives pre... more This paper analyzes, from a strictly legal perspective, the different legislative initiatives presented in the Spanish Congress of Deputies during the present legislature aimed at the regulation of End-of-life decision making. To this end, starting from the legislative reality currently in force in Spain, the paper proceeds to analyze, on the one hand, two Proposals of Law on rights and guarantees of the dignity of the person during the final process of his life and, in the other hand, the Proposal of Organic Law for the Regulation of euthanasia which, in view of the concurrent parliamentary majorities in Spain, is called to constitute the norm that regulates this field in the near future in Spain.