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On 26 April 2023, the European Commission launched a revision of the EU's pharmaceutical legislation, including legislation on medicines for children and for rare diseases. Since the early 2000s, the EU legislative framework has provided a complex set of obligations, incentives and rewards to stimulate the development of medicines for children and for rare disease patients. Over the last 20 years, the EU legislation has led to the development of new medicines for these categories of patients. The ...

What if biosensors could help treat rare diseases?

Mad-Daqqa t’Għajn 21-06-2023

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 ...

This document summarises the presentations and discussion taking place at the workshop organised by Policy Department A on the limits and opportunities of the Third Public Health Programme, held at the European Parliament in Brussels. The aim of the workshop was to inform the Members of the ENVI Committee and all participants on the limits and potentials of the Public Health Programme, and to have an overview of the outcomes and impact the Third Health Programme had for EU institutions, Member ...

The European Medicines Agency (EMA) is a decentralised agency of the EU. Its mission is to foster scientific excellence in the evaluation and supervision of medicines in the Member States of the EU and the European Economic Area. The EMA began operating in London in 1995. In the context of the United Kingdom's withdrawal from the EU (Brexit), the EMA will have to move to another location that will be decided upon by common agreement among the remaining 27 Member States (EU-27). The criteria and the ...

European Reference Networks (ERNs) are newly established virtual platforms for voluntary cross-border collaboration between specialists in rare and complex diseases. ERNs were set up under Directive 2011/24/EU on the application of patients' rights in cross-border healthcare, and go back to a 2009 Council recommendation on an action in the field of rare diseases. Since specialist knowledge of rare diseases is both scarce and scattered across countries, the EU-level cooperation afforded by ERNs is ...