Έγγραφα - Think Tank - Ευρωπαϊκό Κοινοβούλιο

Εν συντομία - World Rare Diseases Day: Advances in research give patients new hope - 26-02-2025

Wed, 26 Feb 2025 07:43:48 GMT

Rare diseases, though seldom recognised and frequently misdiagnosed, affect approximately 36 million people in the EU. Despite their significant collective prevalence, patients with rare diseases are often overlooked by healthcare systems, facing challenges in diagnosis, treatment, and access to advances in research. Researchers are increasingly using networks to share their findings and make better progress, giving new hope to patients.

Πηγή : © Ευρωπαϊκή Ένωση, 2025 - EK

Briefing - Revision of the EU legislation on medicines for children and rare diseases - 22-06-2023

Wed, 21 Jun 2023 22:00:00 GMT

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 legislation has not been flexible enough, however, to integrate scientific and technological advances, nor has it been able to direct research and development towards areas of unmet medical needs. Given the key role of Member States in determining the availability and affordability of medicines, implementation of the legislation cannot be assessed in isolation from the national context. This concerns, notably, key aspects such as pricing and reimbursement of medicines, taxation, and healthcare organisation, but also strategic decisions by pharmaceutical companies.

Πηγή : © Ευρωπαϊκή Ένωση, 2023 - EK

Εν συντομία - What if biosensors could help treat rare diseases? - 21-06-2023

Tue, 20 Jun 2023 22:00:00 GMT

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 action addressing various EU laws and policies.

Πηγή : © Ευρωπαϊκή Ένωση, 2023 - EK

Μελέτη - Limits and Potentials of the Public Health Programme - 15-12-2017

Tue, 20 Feb 2018 23:00:00 GMT

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 �Ϸ��վ 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 States and individual organisations/projects in its first half (2014-2017). Firstly, the institutional perspectives from DG SANTE and Chafea were presented. The results of the mid-term evaluation of the Programme were discussed, both emphasising the overall positive result of the evaluation and highlighting the areas of improvement and lessons learnt from the two previous health programmes. Next steps to overcome the current limits were also outlined. Secondly, the focus was on the experience of Member States, which confirmed the value of the Programme for their National contexts, insisting, however, on the need to increase the available budget in order to achieve the targeted objectives. Finally, presentations were given by organisations and projects that have successfully utilised funds from the Health Programme.

Πηγή : © Ευρωπαϊκή Ένωση, 2017 - EK

Briefing - European Medicines Agency: A look at its activities and the way ahead - 10-07-2017

Mon, 10 Jul 2017 14:19:13 GMT

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 decision-making process for selecting the new location were announced on 22 June 2017. Interested Member States have until 31 July 2017 to submit their offers. A decision is expected to be taken in November 2017. The EMA is governed by a management board and employs 897 staff (December 2016 figures). Its executive director is Guido Rasi. Around 89 % of the agency's budget comes from fees and charges levied for services rendered. Its scientific work is conducted in its scientific committees, working parties and other groups. Its main activities include: facilitating the development of and patient access to medicines; evaluating applications for marketing authorisations; monitoring the safety of medicines throughout their use in healthcare practice; and providing information to healthcare professionals, patients and the public.

Πηγή : © Ευρωπαϊκή Ένωση, 2017 - EK

Briefing - Understanding European Reference Networks: Cooperation on rare diseases across Europe - 09-06-2017

Fri, 09 Jun 2017 08:19:32 GMT

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 regarded as bringing added value through maximising synergies. Currently, 24 thematic ERNs involve more than 900 specialised healthcare teams in over 300 hospitals in 25 EU Member States plus Norway. A public consultation fed into the establishment of the ERNs, and a number of stakeholder views were presented on the occasion of their launch. The ERN initiative has generally been well received. According to stakeholders, its strengths include opportunities for carrying out research and new treatments, breaking the isolation of specialists and patients, reducing inequalities in care, and fostering patient involvement. Among the challenges that need to be addressed, stakeholders mention questions concerning reimbursement, interoperability and data confidentiality, and legal issues. The ERNs are currently in their deployment phase, and expected to reach full capacity over the next five years.

Πηγή : © Ευρωπαϊκή Ένωση, 2017 - EK