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European Alliance for Personalised Medicine

Coronavirus – It’s not the only pandemic scourging the world, and empowering data

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Good morning, health colleagues, and welcome to the European Alliance for Personalised Medicine (EAPM) update. A salutary reminder, in this update, that COVID-19 is not the only pandemic in town, what with non-communicable diseases (NCDs) and cancer (a harrowing fact is that one in three people at some point in their lives get cancer). These are both ongoing issues for EAPM, and regulations could be improved to ensure early diagnosis and treatment, More on this below writes EAPM Executive Director Dr. Denis Horgan.

Commission policy road map to target individual NCDs

The Commission’s health department, DG SANTE, is set to publish a policy roadmap targeting individual non-communicable diseases (NCDs).

Under the plans laid out in the Commission memo is a ‘Policy Implementation Roadmap’ for NCDs due to be launched in June 2022. WHO is supporting the integration of noncommunicable diseases (NCD) services into primary health care. As of September, 283 workers from 64 primary care facilities have taken the WHO training to better respond to the increasing prevalence of NCDs. The growing burden of NCDs–such as cardiovascular and chronic respiratory diseases, diabetes, cancer – has led to a shift of focus in emergency response. 

Apart from improving access to health services, preventing premature deaths and improving the well-being of refugee communities, the successful outcomes of this programme have contributed to the standardization of practices to be replicated in other humanitarian settings. Cancer is excluded because it already was covered in a separate plan published early this year.

With the exception of the cancer plan, this disease-focused approach marks a change for DG SANTE. According to the document, the Commission’s health directorate has preferred to avoid addressing NCDs discretely because the approach risks underdelivering due to fragmentation between different diseases.

According to the document, December 2022 would see the launch of action proposals for cardiovascular diseases, diabetes, and lifestyle risk factors. One year later, in December 2023, it would be followed by actions on respiratory illnesses and mental and neurological diseases.

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Digital transformation market worth $1,247.5 billion by 2026 – what room for health?

The Digital Transformation Market by vertical has been categorized into banking, IT and telecom, and, most importantly for EAPM, health care and life sciences. Making the case for digital transformation in healthcare -  external shocks like the COVID-19 pandemic and advances in new digital and medical technologies, such as artificial intelligence and whole genome sequencing, generate the conditions for disruption and transformation in healthcare. 

Consider just a few examples of digital transformation: disinfecting robots during the COVID-19 pandemic; on-demand behavioural therapy sessions on a smartphone; scheduling apps that send patient appointment reminders; AI that can cross-reference every peer-reviewed paper ever written. For new entrants and incumbents alike, applying digital technologies to solve your patient care and business concerns is the path to thriving in this industry. Adopting digital tools for diagnosis, treatment and management is critical – in fact, it can be lifesaving – but it is still by no means routine for many organisations.

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EU ‘ready to face Omicron’, so says the EMA...

“We know that viruses mutate, and we’re prepared,” said Emer Cooke, executive director of the European Medicines Agency, addressing the European Parliament’s health committee (ENVI).

Cooke specified that regulations in place since February would allow vaccine-makers to fast-track approval of modified vaccines—if needed—within three to four months of starting the process. “A decision needs to be made first whether that’s necessary, and that’s not a decision for the European Medicines Agency,” she said, noting that this would depend on many factors such as the epidemiological situation, the circulation of the variant and the effectiveness of current vaccines.

In interim, get boosted: As member states roll out their booster campaigns, the EMA and the ECDC are working on a joint statement expected as early as the end of this week on mix-and-match booster strategies, where the booster vaccine differs from that of the initial vaccination. 

EU lawmakers clinch deal on data-sharing bill

Negotiators from the European Parliament and Council clinched a deal late on Tuesday (30 November) that should foster the data availability across the bloc. The EU’s Data Governance Act was introduced by the Commission late last year and is meant to unlock public-sector data for businesses, while also imposing rules on data-sharing services that broker data in a neutral way.

These services will need to be listed in a register, with the aim of boosting trust in voluntary data-sharing. There are also new contractual arrangements for the re-use of public-sector data, for which the Commission will also set up a register.

EU privacy watchdog wants to unite bloc’s regulatory powers against Big Tech

It’s all for one, one for all for European regulators policing Big Tech.

The European Union’s data protection supervisor is calling on privacy, competition and consumer watchdogs from across the bloc to join forces in a bid to strengthen the region’s fight against abuse and harm in the tech sector.

“Next year we will have the new ‘Digital Clearinghouse’ proposal,” Wojciech Wiewiórowski, who leads the European Data Protection Supervisor (EDPS) has said.

The EU watchdog wants to launch the new initiative in the second half of 2022, Wiewiórowski added.

The news comes as concerns grow that Europe’s fractured approach to digital regulation is hampering attempts to rein in powerful tech companies.

Wiewiórowski refused to be drawn on whether he would prefer a more centralized system of enforcement — like giving the power to scrutinize Big Tech’s privacy protections to a single, pan-European watchdog — saying that it was only “one of the possible outcomes.”

Asked whether his office would accept more enforcement responsibilities under a new system, he said: “I only can answer that we are accepting more powers every year.”

Commission faces complaint over GDPR ‘failure to act’

The European Commission is being accused of failing to monitor the application of the EU’s data protection rulebook, a new complaint filed with the EU ombudsperson shows. The complaint was issued by the Irish Council for Civil Liberties (ICCL) and argued EU executives neglected to act against Ireland’s alleged shortfalls in applying the bloc’s data protection rules. It also argued the Commission did not gather the data to monitor how the GDPR is enforced across the EU. 

“The Commission has taken its eye off the ball, and the GDPR is now in disarray,” said Johnny Ryan, Senior Fellow of the ICCL.The complaint comes on the heels of a report from the ICCL earlier this year, which found that 98 percent of major GDPR cases referred to Ireland’s data protection authority remain unresolved. The organization says that it had brought the findings of the study to the attention of the EU’s Justice Commissioner Didier Reynders, but received no reply. 

“Not only did the Commission fail to act, but it did not even equip itself with the knowledge required to make the decision to act,” Ryan said.

The EU ombudsperson can decide to open an inquiry in response to the complaint. It has the power to issue a finding of maladministration against the Commission.

Commission president: Children’s vaccines coming in mid-December

European Commission President Ursula von der Leyen said today that coronavirus vaccines for children were on their way, with first deliveries to start on December 13.

Appealing to Europeans to get vaccinated and have their booster shots, the Commission president told journalists said that a new surge in infections in Europe combined with the emergence of the new Omicron variant posed a “double threat.”

The European Medicines Agency last week recommended that the BioNTech/Pfizer vaccine be approved for children aged 5-11. The modified vaccine has a lower dosage — containing a third of the active ingredient in an adult shot.

Von der Leyen said she’d spoken to BioNTech and Pfizer about the children’s vaccine, and the drugmakers had indicated they were able to deliver the children’s doses early, starting from December 13.

12 million waiting for treatment by 2025 - Post Brexit England

That’s the forecast in England if just 50 percent of the missing referrals for elective care during the pandemic return to the National Health Service, and the activity within the NHS grows in line with pre-pandemic plans, according to a report out today from the National Audit Office (NAO).  

Providing extra beds and operating-theatre capacity beyond the levels that were planned before the COVID-19 pandemic; managing the ongoing pressure on the NHS workforce, including long-standing staff shortages; and ensuring that existing health inequalities are not perpetuated or exacerbated, the report argues.

Good news to end: EU negotiators reach deal on expanding ECDC mandate

Negotiators from the European Parliament and Council reached a deal late Monday night (29 November) on the proposal to expand the mandate of the European Centre for Disease Prevention and Control (ECDC). The agreement means the ECDC will help coordinate responses to and data collection on communicable disease threats at the EU level.

The proposal also entails creating a new EU Health Task Force “to assist with preparedness and response planning as well as with local response to outbreaks.” More controversially, the agency would gain the responsibility to monitor national health systems for their ability to respond to disease outbreaks. 

The European Chronic Disease Alliance had been pushing for the inclusion of non-communicable diseases in the agency’s mandate as well. The Parliament’s press release suggests that didn’t happen, with the agency’s remit still limited to communicable disease.

And that is all from EAPM for now - see you again soon.

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