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Eve of EAPM’s third 2021 conference, HERA oversight demanded, French EU presidency priorities – Register now!




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Greetings everyone! Registration for our upcoming Autumn EU Presidency conference is still open which will be a ‘virtual’ event, held online, on Wednesday 10 November, writes European Alliance for Personalised Medicine (EAPM) Executive Director Denis Horgan.

Presidency Regulatory health Conference, Wednesday, 10 November
This event will be the third Presidency conference that EAPM will be holding during 2021. All three events reflect the nature of the relative presidency policies in the health-care arena, but also act as major events during what will be the second full year of the two new legislative bodies - the European Parliament and the European Commission.

With the string of regulatory dossiers being discussed at the EU level, the Conference is timely and it is entitled "Redefining the Unmet needs in Healthcare and the Regulatory Challenge".  It will take place from 08.30 CET – 15.00 CET.  Please find the link to the agenda here and the link to register here

Key sessions include:

  • 08.30 – 09.45  Session 1: EU's in vitro diagnostics regulation.
  • 09.45-11.00 Session II: Pharmaceutical Strategy
  • 11.00 -12.30 Digital Health Europe - Data space for Genomics
  • 13.30-15.00 EU Beating Cancer Plan – Unmet Medical Need 

Attendees will be drawn from key stakeholders whose interaction will create a cross-sectoral, highly relevant and dynamic discussion forum. These participants will include public health decision makers, representatives from the European Commission, Members of the Parliament, patient organisations, and umbrella organisations representing interest groups and associations actively engaged in the field. Each session will comprise panel discussions as well

Please find the link to the agenda here and the link to register here

A healthy presidency for France for 2022


In just under two months, France takes over the European Council’s rotating presidency from Slovenia. 

France is very keen on a stronger health union. The so-called EU Health Union currently comprises several key elements: a joint health technology assessment for the bloc (signed off last presidency); greater powers and closer working of the European Medicines Agency and the European Center for Disease Prevention and Control (currently in trilogues); the creation of the Health Emergency Preparedness and Response Authority, HERA (recently established); and revising rules on cross-border health threats (still being discussed in parliament).

But France wants to go further, with a “European public health policy that goes beyond health security,” the documents state, wanting to set up a committee of high-level experts to work on the broader health union and to come up with proposals.

And France is also very keen on accelerating the revision of the general pharmaceutical legislation, which was set out in the Commission’s Pharmaceutical strategy That would mean pulling negotiations forward considerably; the Commission had  previously indicated that the package is expected for the fourth quarter of 2022. 

France’s health proposals will also be discussed in the EAPM conference on 10 November.

HERA ‘should remain accountable to citizens’ 

During the annual State of the Union speech on the 16th of September 2021, Commission President Ursula von der Leyen delivered on her promise by announcing the creation of the European Health Emergency Preparedness Authority (HERA) whose main goal is to ensure that vaccines and other medical countermeasures can be rapidly developed, manufactured, and are readily available for EU citizens. HERA has the potential to fill a major structural gap in the EU’s crisis preparedness and response infrastructure, however, the proposal has moved forward without a meaningful discussion with the European Parliament and civil society. 

The EU must ensure the new authority works for the public interest and that it remains accountable to its citizens. The European Public Health Alliance (EPHA) , together with 18 organizations representing patients, consumers, health professionals, and civil society, urges the Council and the Commission to reconsider crucial aspects of the recently launched HERA and its proposed Regulatory framework. 

The signatories call for: A democratic and participatory debate Good governance, transparency and accountability Involving stakeholders, including patients, civil society, healthcare professionals, and researchers The protection of other public health priorities Accessibility and affordability of the outputs that HERA will support A clear global vision for HERA A supporting not-for profit EU infrastructure professionals and researchers should be facilitated and required at least at critical points of HERA’s operation.

Data watchdog warns Europe ‘is not ready’ for AI-powered surveillance 

The man responsible for ensuring the EU's institutions stick to its data protection laws believes Europe isn't ready for facial recognition tech that watches people in public. European “society is not ready,” European Data Protection Supervisor (EDPS) Wojciech Wiewiórowski said. The tech and its applications have divided Europe. The EU’s proposed AI legislation bans most applications of remote biometric identification, such as facial recognition, in public places by law enforcement, but makes exceptions for fighting "serious" crime, which could include terrorism. 

Proponents of the technology, which include law enforcement and some security-minded governments, argue that the police need the technology to catch criminals. But privacy activists, some European lawmakers and Wiewiórowski himself advocate for an outright ban. The use of the technology would “turn society, turn our citizens, turn the places we live, into places where we are permanently recognizable … I'm not sure if we are really as a society ready for that.” 

COVID-19 Delta outbreak: WHO warning of 500,000 more deaths in Europe this winter 

The World Health Organization has warned that Europe is facing a grim winter, as COVID-19 cases spike and vaccination rates stall just as the colder months arrive. In fact, the situation is now so dire some countries are facing their biggest Covid battle yet. Germany has confirmed its highest daily increase in cases this week since the start of the pandemic.

There have already been 1.4 million Covid-19 deaths in Europe over the course of the pandemic so far. He said 43 out 53 counties in his region were bracing for high or extreme stress when it came to hospital beds. According to one reliable projection, if we stay on this trajectory, we could see another half a million Covid-19 deaths in Europe and Central Asia by the first of February next year." To put the seriousness of the situation into perspective, Europe has recorded 1.8 million new infections and 24,000 deaths this past week alone.

Good news to finish - New campaign to 'Stop COVID-19 hanging around' 

A new campaign launches today (Friday 5 November) across digital channels, radio stations and newspapers, demonstrating the importance of simple ventilation techniques to reduce the risks of catching COVID-19 this winter. An explainer film - to be used on NHS and government digital channels - has been released by scientists from the Universities of Cambridge and Leeds, in collaboration with the government, demonstrating the positive impact of reducing COVID-19 levels indoors by opening a window for just 10 minutes every hour when socializing with others. Part of a wider campaign, including national radio and press adverts, the key message will be to ‘Stop COVID-19 hanging around’. 

And that is all from EAPM for this week – don’t forget to register for next Wednesday’s conference, the agenda is here and the link to register here, have a splendid weekend, see you next week!  

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