European Union

MEPs endorsed a temporary regulation that allows web-based service providers to continue fighting child sexual abuse material online on a voluntary basis.
Committee on Civil Liberties, Justice and Home Affairs

Source : © European Union, 2021 - EP

MEPs endorsed a temporary regulation that allows web-based service providers to continue fighting child sexual abuse material online on a voluntary basis.
Committee on Civil Liberties, Justice and Home Affairs

Source : © European Union, 2021 - EP

The EU’s regulatory framework on gene editing is insufficient and risks pushing out research and innovation from the EU, according to a Green MEP, diverging from her party’s strong stance on the matter.

The development of novel health technologies is a complex and costly process that follows an extensive set of regulatory guidelines and legal provisions intended to ensure that the treatments reach the patients that need them in a highly controlled and standardised manner. In the European Union (EU), the first step in the path to market access for a new therapeutic intervention is the marketing authorisation procedure coordinated by the European Medicines Agency (EMA), in which applicants have to provide evidence of the safety, quality and efficacy of their product, which is mainly derived from the conduct of clinical trials. Once approval has been granted, each individual EU Member State will decide on how the drug will be introduced into their healthcare systems based on nationally diverging criteria determining its price setting, reimbursement conditions and clinical application.

However, in recent years, this established paradigm has faced increasing criticism from authors in the field, especially in relation to cancer treatment, who have highlighted its contribution to the existence of a research gap between the pre-approval development of anticancer medicines and their post-approval use in real-life practice. A drug-centred attitude dominates the present framework, leaving important patient-focused aspects relating to the real-world utilisation of antitumor therapies unaddressed, including how to combine them with existing health technologies, how their effectiveness compares to that of therapeutically relevant alternatives, how long they have to be administered to achieve the desired effects, whether a lower dose could produce the same results with potentially fewer toxic side effects and how they perform in terms of patient-relevant outcome measures such as quality of life and overall survival.

This situation has led to calls for a transition towards a new paradigm that puts the patient at the centre of clinical drug development and places a strong emphasis on treatment optimisation.Treatment optimisation, which has also been called applied research, seeks to optimise the way health technologies are used in real-world conditions through the conduct of studies designed to provide an answer to one or more of the above mentioned questions. It is not intended to replace the current clinical research framework; instead, it aims to generate results complementing those of the registrational trials as a way to bridge the research gap. However, a number of crucial questions remain regarding the ideal features of treatment optimisation studies, as well as their acceptability among the actors involved in the development and adoption into practice of novel therapies.

Read the complete study on ‘Treatment optimisation in drug development‘ in the Think Tank pages of the European Parliament.

The European Union will require countries to renovate energy-guzzling buildings faster and meet tougher targets on energy savings as part of its drive to meet its climate goals, according to a draft document seen by Reuters.

The idea of wearing face masks on public transport used to be anathema. The small number of people who did wear masks on the metro, at least in the UK, got odd looks, as though they were being insulting by refusing to share the same air as us.

France aims to invest nearly €1.7 billion in its 5G market, Industry Minister Agnès Pannier-Runacher and Secretary of State for Digital Cédric O announced on Tuesday morning while presenting the country's 5G and future telecommunications strategy that is eyeing a 5G market worth €15 billion by 2025. EURACTIV France reports.

The Google.org Impact Challenge on Climate commits €10M to fund bold ideas that aim to use technology to accelerate Europe’s progress toward a greener, more resilient future. “This kind of support that NGOs like Snowchange are now receiving from Google...

Nordic countries have registered near-record temperatures over the weekend, including highs of 34C (93.2F) in some places. EURACTIV's media partner, The Guardian, reports.

Entry into office of a new member of the General Court of the European Union

A court in Belarus jailed former presidential contender Viktor Babariko for 14 years on Tuesday (6 July) after convicting him on corruption charges he denied, sparking condemnation from the West and the embattled opposition-in-exile.

The European Commission is set to do the previously unthinkable – tax aviation jet fuel. Reversing a long-standing policy, the EU executive will apply an EU-wide minimum tax rate on fossil-based kerosene for flights travelling within the bloc.

MEPs discussed the planned activities of the Slovenian Presidency of the Council of the EU with Prime Minister Janez Janša and Commission President von der Leyen.

Source : © European Union, 2021 - EP

MEPs discussed the planned activities of the Slovenian Presidency of the Council of the EU with Prime Minister Janez Janša and Commission President von der Leyen.

Source : © European Union, 2021 - EP

The European savoury snacks industry is determined to do its part to move towards more Sustainable Food Systems (SFS), building on the significant achievements of the recent years.

Little progress has been made to modernise a controversial agreement on energy investments that activists warn could derail decarbonisation efforts in Europe and across the globe, according to leaked documents.

Countries in Europe now have some of the highest vaccination rates in the world. But the pace is slowing down in many areas, with people not turning up for their vaccination appointments. The summer weather and low infection rates are making people hesitate even if they are not anti-vaxxers. Governments are fighting back with a number of incentives - not always with media approval.