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En abril de 2023, la Comisión Europea adoptó propuestas reglamentarias por las que se introducían un certificado complementario de protección (CCP) unitario y un procedimiento centralizado de evaluación de los CCP para los medicamentos. Este estudio analiza las posibles repercusiones de estas propuestas en el acceso a los medicamentos, la carga administrativa para los solicitantes y el coste para los sistemas nacionales de salud. Este documento ha sido elaborado por el Departamento Temático de Derechos ...

Most rare diseases are incurable. Research into new diagnostics and therapies is hampered by the low number of patients, limited amount of data, lack of multi-centre coordination and low profitability. Biosensors are a technology that, driven by continuous advances in artificial intelligence, can help disease detection, lower the cost of novel therapies, replace placebo groups in clinical trials and foster patient-centred, personalised (e)-medicine. Governance of biosensor technology involves targeted ...

In recent years, the use of artificial intelligence (AI) in medicine and healthcare has been praised for the great promise it offers, but has also been at the centre of heated controversy. This study offers an overview of how AI can benefit future healthcare, in particular increasing the efficiency of clinicians, improving medical diagnosis and treatment, and optimising the allocation of human and technical resources. The report identifies and clarifies the main clinical, social and ethical risks ...

As part of building a European Health Union, as well as in response to the Covid 19 pandemic, the European Commission proposed in November 2020 to reinforce the European Medicines Agency's role in crisis preparedness and the management of medicines and medical devices. The proposed regulation seeks to better anticipate possible shortages and to ensure timely development of high-quality medicinal solutions, to allow the EU to react to health crises more quickly, efficiently, and in a coordinated manner ...

The European Commission has proposed a regulation on health technology assessment (HTA). HTA is a research-based tool that supports decision-making in healthcare by assessing the added value of a given health technology compared to others. The proposal would provide the basis for permanent EU-level cooperation in four areas. Member States would still be responsible for assessing the non-clinical (economic, ethical, social, etc.) aspects of health technology, and for pricing and reimbursement. While ...

Durante el período parcial de sesiones de diciembre, se espera que el Parlamento Europeo someta a votación en segunda lectura una propuesta de la Comisión Europea para reforzar la cooperación a escala de la Unión entre los Estados miembros en la evaluación de las tecnologías sanitarias. Una mayor cooperación beneficiaría a los sistemas sanitarios nacionales y a los productores de medicamentos y productos sanitarios, ya que se simplificarían los procedimientos de aprobación, y beneficiaría a los pacientes ...

Sequencing and analysis of the human genome – all the genetic information stored in our DNA – provide us with understanding about a person's ancestry, health and other traits. Thanks to DNA sequencing, medicine and the life sciences are able to predict and cure diseases. As DNA sequencing technologies continuously improve and become less costly, what if we all soon possessed our personal, smart DNA sequencers and apps to analyse our DNA?

This At A Glance summarises the key findings of the original study, which assesses the impact of the COVID-19 crisis on the Internal Market and consumer protection, including the impact of measures introduced at national and EU level to mitigate the consequences of the pandemic. What further measures should be considered in order to reinforce the resilience of the EU's Internal Market in the face of future crises? This document was provided by the Policy Department for Economic, Scientific and Quality ...

Thermal imaging cameras are currently being installed in office buildings, hospitals, shopping malls, schools and airports as a means of detecting people with fever-like symptoms. Given that these cameras are not necessarily designed to operate as medical devices, there are questions about their suitability in the context of the current pandemic. This note provides an overview of the use of thermal imaging empowered with artificial intelligence (AI) capabilities, its suitability in the context of ...