European Union

Leaked documents revealed "limited progress" in talks on revising the controversial Energy Charter Treaty - triggering renewed calls from activists to pull out of the agreement, seen as a stumbling block to a clean-energy transition.

Neither Commission nor EU leaders have reacted to the Austrian government's amorphous fight against "political Islam". Their silence is deafening over French president Emmanuel Macron's controversial draft 'separatism' bill. Or Social Democrat-led Denmark's legislation relocating asylum seekers to third countries.

Could the Green Deal, the European Climate Law, the Just Transition Fund tackle illegal deforestation, arsons, water, air and soil pollution, traffic of ozone-depleting substances and protected species, poaching, overfishing etc.? The answer is clearly 'no', we need a prosecutor.

Faced with soaring numbers of new COVID-19 cases among unvaccinated young people, the Spanish city of Barcelona has announced it will shut down nightlife venues from this weekend. EURACTIV’s partner EFE reported.

Thousands rallied Tuesday (6 July) in the Georgian capital Tbilisi to denounce attacks on the LGBTQ community that shocked the Caucasus nation and forced activists to cancel a planned Pride march.

Estonia accused Russia on Tuesday (6 July) of detaining one of its diplomats after a "set-up" designed to make him look like a spy, saying the incident showed Russia was choosing confrontation in its relations with Europe.

A recent survey suggests that Europeans believe airlines should be required to pay tax on aviation fuel. The European Commission should heed the public and not the aviation lobby, writes Ciarán Cuffe.

The European Union urged London on Tuesday (6 July) to consider a Swiss-style veterinary agreement with Brussels on agri-foods to end a post-Brexit 'sausage war' row over certain goods moving between Britain and its province of Northern Ireland.

Declaration by the High Representative on behalf of the European Union on the alignment of certain third countries with the Council Decision (CFSP) 2021/1002 of 21 June 2021 implementing Decision 2012/642/CFSP concerning restrictive measures in view of the situation in Belarus.

Declaration by the High Representative on behalf of the European Union on the alignment of certain third countries with the Council Decision (CFSP) 2021/1001 of 21 June 2021 amending Decision 2012/642/CFSP concerning restrictive measures in view of the situation in Belarus.

Press briefing ahead of Eurogroup meeting will take place on 8 July 2021 at 14.30.

Parliament adopted the 2021-2027 fisheries and aquaculture fund to support the blue economy, protect biodiversity and promote international ocean governance.
Committee on Fisheries

Source : © European Union, 2021 - EP

Parliament adopted the 2021-2027 fisheries and aquaculture fund to support the blue economy, protect biodiversity and promote international ocean governance.
Committee on Fisheries

Source : © European Union, 2021 - EP

The European Parliament adopted on Tuesday (6 July) the final version of the ePrivacy derogation, a temporary measure enabling providers of electronic communication services to scan and report private online messages containing material depicting child sex abuse. The provisions also...

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.