RESUMO
RESUMEN Objetivo: Analizar la regulación de la venta de medicamentos por procedimientos telemáticos en España, así como los riesgos y ventajas que esta presenta. Metodología: Se analizó e interpretó la legislación en materia de regulación de venta de medicamentos de uso humano a través de Internet en el ordenamiento jurídico español. Resultados: Dicha regulación se encuentra en el Real Decreto 870/2013, de 8 de noviembre, por el que se regula la venta a distancia al público, a través de sitios web, de medicamentos de uso humano no sujetos a prescripción médica. Este Real Decreto limita la venta de medicamentos a través de Internet a aquellos que no requieran prescripción médica, ya que en Internet se pueden vender medicamentos ilegalmente, lo cual supone una amenaza para la salud pública. No obstante, también existen ventajas de dicha actividad como es la garantía de acceso a los medicamentos por parte de la población. En la presente contribución se analiza el caso de las nuevas condiciones de dispensación establecidas durante la pandemia provocada por el nuevo coronavirus SARS-CoV-2. Conclusiones: Para garantizar la seguridad de los pacientes se limita la venta de medicamentos vía online, no obstante, en situaciones especiales, como la crisis sanitaria generada por el nuevo coronavirus se amplió el marco normativo para garantizar el acceso de la población a los medicamentos.
SUMMARY Aim: To analyze the regulation of the sale of medicines by telematic procedures in Spain, as well as the risks and advantages that it presents. Methodology: The legislation on the regulation of the sale of medicines for human use through the Internet in the Spanish legal system was analysed and interpreted. Results: Said regulation is found in Royal Decree 870/2013, of November 8, which regulates the distance sale to the public, through websites, of medicines for human use not subject to medical prescription. This Royal Decree limits the sale of medicines through the Internet to those that do not require a medical prescription, since medicines can be sold illegally on the Internet, which poses a threat to public health. However, there are also advantages of this activity, such as the guarantee of access to medicines by the population. This contribution analyses the case of the new dispensing conditions established during the pandemic caused by the new SARS-CoV-2 coronavirus. Conclusions: To guarantee the safety of patients, the sale of medicines online is limited, however, in special situations, such as the health crisis generated by the new coronavirus, the regulatory framework was expanded to guarantee the population's access to medicines.
RESUMO Objetivo: Analisar a regulamentação da comercialização de medicamentos por procedimentos telemáticos em Espanha, bem como os riscos e vantagens que apresenta. Metodologia: A legislação foi analisada e interpretada sobre a regulamentação da comercialização de medicamentos de uso humano pela Internet no ordenamento jurídico espanhol. Resultados: O referido regulamento consta do Real Decreto 870/2013, de 8 de novembro, que regulamenta a venda à distância ao público, através de websites, de medicamentos para uso humano não sujeitos a receita médica. Este Decreto Real limita a venda de medicamentos pela Internet aos que não necessitem de receita médica, uma vez que os medicamentos podem ser comercializados ilegalmente na Internet, o que representa uma ameaça para a saúde pública. Porém, também há vantagens dessa atividade, como a garantia de acesso a medicamentos por parte da população. Esta contribuição analisa o caso das novas condições de dispensação estabelecidas durante a pandemia causada pelo novo coro-navírus SARS-CoV-2. Conclusões: Para garantir a segurança dos pacientes, a venda de medicamentos online é limitada, porém, em situações especiais, como a crise de saúde gerada pelo novo coronavírus, o marco regulatório foi ampliado para garantir o acesso da população aos medicamentos.
RESUMO
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.
