RESUMO
Tras la publicación en el Boletín Oficial del Estado de la Ley Orgánica 3/2021 de regulación de la eutanasia (BOE 25/03/2021), España se convierte en el cuarto país de la Unión Europea en despenalizar tal práctica. En el presente artículo analizamos esta norma, deteniéndonos en la introducción de la eutanasia en la cartera común de servicios del Sistema Nacional de Salud, que garantiza el acceso a la prestación. Por otra parte, realizaremos un estudio comparativo de otros ordenamientos jurídicos del entorno comunitario en los que esta práctica está permitida o penalizada. (AU)
The publication of Organic Law 3/2021 regulating euthanasia (BOE 03.25.2021), converted Spain in the fourth country in the European Union to decriminalize such practice. In this article we analyze this rule and the introduction of euthanasia in the Health Service of the Spanish National Health System, which guarantees access to the provision. On the other hand, we will carry out a comparative study of other legal systems in the European Union in which this practice is allowed or penalized. (AU)
Assuntos
Humanos , Sistemas Nacionais de Saúde , Eutanásia , Saúde , Qualidade de Vida , União Europeia , EspanhaRESUMO
El medicamento y la actividad profesional del colectivo farmacéutico son objeto de estudio del Derecho Farmacéutico y de la Legislación Farmacéutica. En el presente trabajo, por una parte, se examina la definición de estas disciplinas, así como su ámbito de estudio, evolución y fuentes. Por otro lado, se analiza el desarrollo de la Legislación Farmacéutica en la Unión Europea en tres periodos claramente diferenciados y relacionados con diferentes promulgaciones de generaciones de normas jurídicas que afectan a los medicamentos. Especial atención se ha prestado a las denominadas normas de tercera generación, al profundizarse en la evolución normativa a nivel de la Unión Europea y nacional en las tres últimas décadas. Finalmente, se detallan aquellas áreas del sector farmacéutico que podrían tener un desarrollo reglamentario en los próximos años. (AU)
Medicines and the professional activity of the pharmacists are the subject of study of Pharmaceutical Law and Pharmaceutical Legislation. In this paper, on the one hand, the definition of these disciplines is examined, as well as their field of study, evolution and sources. On the other hand, the development of Pharmaceutical Legislation in the European Union is analysed in three clearly differentiated periods and related to different juridic enactments of generations of norms that affect medicines. Special attention has been paid to the socalled third generation standards, as the regulatory developments at European Union level and national level have been depened in the last three decades. Finally, those areas of the pharmaceutical sector that could have a regulatory development in the coming years are detailed. (AU)
Assuntos
Humanos , Preparações Farmacêuticas , Farmácia , Terapêutica , Legislação de Medicamentos , União Europeia , EspanhaRESUMO
Tras la publicación en el Boletín Oficial del Estado de la Ley Orgánica 3/2021 de regulación de la eutanasia (BOE 25/03/2021), España se convierte en el cuarto país de la Unión Europea en despenalizar tal práctica. En el presente artículo analizamos esta norma, deteniéndonos en la introducción de la eutanasia en la cartera común de servicios del Sistema Nacional de Salud, que garantiza el acceso a la prestación. Por otra parte, realizaremos un estudio comparativo de otros ordenamientos jurídicos del entorno comunitario en los que esta práctica está permitida o penalizada.(AU)
The publication of Organic Law 3/2021 regulating euthanasia (BOE 03.25.2021), converted Spain in the fourth country in the European Union to decriminalize such practice. In this article we analyze this rule and the introduction of euthanasia in the Health Service of the Spanish National Health System, which guarantees access to the provision. On the other hand, we will carry out a comparative study of other legal systems in the European Union in which this practice is allowed or penalized.(AU)
Assuntos
Humanos , Eutanásia , Jurisprudência , Suicídio Assistido , Valor da Vida , EspanhaRESUMO
El medicamento y la actividad profesional del colectivo farmacéutico son objeto de estudio del Derecho Farmacéutico y de la Legislación Farmacéutica. En el presente trabajo, por una parte, se examina la definición de estas disciplinas, así como su ámbito de estudio, evolución y fuentes. Por otro lado, se analiza el desarrollo de la Legislación Farmacéutica en la Unión Europea en tres periodos claramente diferenciados y relacionados con diferentes promulgaciones de generaciones de normas jurídicas que afectan a los medicamentos. Especial atención se ha prestado a las denominadas normas de tercera generación, al profundizarse en la evolución normativa a nivel de la Unión Europea y nacional en las tres últimas décadas. Finalmente, se detallan aquellas áreas del sector farmacéutico que podrían tener un desarrollo reglamentario en los próximos años.(AU)
Medicines and the professional activity of the pharmacists are the subject of study of Pharmaceutical Law and Pharmaceutical Legislation. In this paper, on the one hand, the definition of these disciplines is examined, as well as their field of study, evolution and sources. On the other hand, the development of Pharmaceutical Legislation in the European Union is analysed in three clearly differentiated periods and related to different juridic enactments of generations of norms that affect medicines. Special attention has been paid to the socalled third generation standards, as the regulatory developments at European Union level and national level have been depened in the last three decades. Finally, those areas of the pharmaceutical sector that could have a regulatory development in the coming years are detailed.(AU)
Assuntos
Humanos , Jurisprudência , Preparações Farmacêuticas , Farmácia , União Europeia , EspanhaRESUMO
The pandemic caused by the new SARS-CoV-2 coronavirus has created a climate of uncertainty. The application of the precautionary principle is therefore justified for some of the measures taken by the competent authorities. In Spain, these measures have been aimed, on the one hand, at stopping its spread by means of a state of alarm for the restriction of daily activities. On the other hand, they aimed at recommending the most appropriate treatment according to scientific research developments, as well as containment measures based on the use of health care products. These latest measures have led to an extraordinary increase in the use of medicines and health care products, which compromises their supply. Thus, authorities were forced to regulate certain actions in the legal supply chain of medicines and healthcare products, such as procurement and dispensing.
Assuntos
COVID-19 , SARS-CoV-2 , Atenção à Saúde , Humanos , Espanha , IncertezaRESUMO
BACKGROUND: The disease caused by the novel coronavirus SARS-CoV-2 has rapidly spread escalating the situation to an international pandemic. The absence of a vaccine or an efficient treatment with enough scientific evidence against the virus has generated a healthcare crisis of great magnitude. The precautionary principle justifies the selection of the recommended medicines, whose demand has increased dramatically. METHODS: we carried out an analysis of the healthcare risk management and the main measures taken by the state healthcare authorities to a possible shortage of medicines in the most affected countries of the European Union: Spain, France, Italy and Germany. RESULTS: the healthcare risk management in the European Union countries is carried out based on the precautionary principle, as we do not have enough scientific evidence to recommend a specific treatment against the new virus. Some measures aimed to guarantee the access to medicines for the population has been adopted in the most affected countries by the novel coronavirus. CONCLUSIONS: in Spain, Italy and Germany, some rules based on the precautionary principle were pronounced in order to guarantee the supply of medicines, while in France, besides that, the competences of pharmacists in pharmacy offices have been extended to guarantee the access to medicines for the population.
Assuntos
Antivirais/provisão & distribuição , Tratamento Farmacológico da COVID-19 , COVID-19 , Atenção à Saúde/tendências , Acessibilidade aos Serviços de Saúde , Gestão de Riscos , Estoque Estratégico/organização & administração , COVID-19/epidemiologia , União Europeia , Acessibilidade aos Serviços de Saúde/organização & administração , Acessibilidade aos Serviços de Saúde/normas , Acessibilidade aos Serviços de Saúde/estatística & dados numéricos , Humanos , Melhoria de Qualidade/organização & administração , Indicadores de Qualidade em Assistência à Saúde/organização & administração , Indicadores de Qualidade em Assistência à Saúde/normas , Gestão de Riscos/métodos , Gestão de Riscos/normas , SARS-CoV-2RESUMO
La regulación del ejercicio profesional farmacéutico nos hace reflexionar sobre un amplio y complejo abanico de circunstancias sociales, económicas y políticas que forman parte de un proceso en continua evolución. Éstas deberían tener como fin ulterior el dotar a la humanidad de un experto en medicamento, el cual cumple una función social como parte de un equipo dedicado a salvaguardar la salud de la población.
The regulation of the professional pharmaceutical makes us think about one extends and complex social, economic and political circumstances that are a part of a process in continuous evolution. These should have as subsequent end the humanity of an expert in medicine, which fulfills a social function as part of the specialist dedicated to safeguarding the health of the population.
