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Germany's grand coalition is bad news for #glyphosate

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Perhaps as a sign of how unstable Germany’s political landscape has become, a weed killer has become an unlikely bargaining chip in the country’s political power-brokering. The Social Democratic Party (SPD) has mandated the discontinuation of glyphosate a prerequisite for another grand coalition to go ahead with Angela Merkel’s Christian Democratic Union (CDU). Despite facing stiff opposition to outlawing the widely used herbicide from its unruly Bavarian sister party, Merkel ultimately succeeded in getting the CSU to approve the grand coalition plan.

 

When it comes to maintaining the chancellorship, the CDU clearly decided that the widely used molecule is not a hill it is willing to die on. Merkel’s feat, although impressive, is ultimately a triumph for the SPD. Even though the draft coalition treaty remains (no doubt deliberately) vague on a deadline, the EU’s most powerful country is now a proponent of organic agriculture, restricting the use of chemicals and broadly against glyphosate. The reasons for this latest decision may be grounded in domestic politics. The reverberations, however, will be felt across the EU.

 

In relenting to the SPD’s demands, Merkel solved one of the major legislative hurdles in German politics, one that has previously hampered efforts to form a working coalition. In November 2017, the EU breathed a sigh of relief when it finally voted to renew glyphosate’s licence for five years after much torturous wrangling. As it turned out, it was German agriculture minister Christian Schmidt of the CSU who cast the decisive vote that swung the decision in the herbicide’s favour. While many hoped that the glyphosate saga was finally put to rest in Europe, the SPD was enraged by Schmidt’s actions.

 

An endorsement from the bloc did nothing to quell the discontent from the SPD or the many other activists seeking to ban glyphosate, a decision that would be based on the findings of a highly contentious report from the International Agency for Research on Cancer's (IARC). The report was found by news agency Reuters to be heavily edited in order to reach the conclusion that the substance probably causes cancer – a conclusion which is at odds with the many of the original findings used in IARC’s study.

 

The case against glyphosate becomes flimsier considering that IARC’s conclusions flout the assessments of many other esteemed researchers around the world. The European Food Safety Authority (EFSA) and the European Chemicals Agency (ECHA) both agreed that the herbicide poses no cancer risk following their own extensive evaluations. On the other side of the Atlantic, the same conclusion was reached by the Agricultural Health Study (AHS), a large-scale survey tracking the health of tens of thousands of agricultural workers and their families in Iowa and North Carolina.

 

The US Congress found the IARC’s conclusions so precarious that it prompted an inquiry into whether the US should even continue funding IARC given its seemingly tentative relationship with scientific rigour. That investigation gained more currency this week after a judge in California overturned the state’s move to slap cancer warnings on the product. U.S. District Judge William Shubb said that glyphosate does “is not in fact known to cause cancer”, and that “the required warning is factually inaccurate and controversial.”

 

Nevertheless, the fact that the CSU remains so steadfastly opposed to glyphosate – despite the weight of evidence in glyphosate’s favour – is not particularly surprising. Its stance is informed by populist considerations. The party has effectively bent to a public that has become increasingly hostile to pesticides and GMOs, thanks to the revival of green activists gathering strength across the country. Germany’s changing tack on agricultural policy and glyphosate will strengthen activists the EU over, no matter how shaky the basis for their misgivings about the chemical.

 

Seeing how France declared that it will seek to phase out the herbicide within the next three years, Berlin and Paris united against glyphosate is certain to lend extra momentum to anti-herbicide tendencies. And the impact is already being felt. The molecule is about to come under the spotlight in the EU yet again. Earlier in February, the European Parliament approved the composition of a special enquiry commission to look into the authorization procedures for pesticides, and in particular the rationale behind glyphosate’s licence being renewed last year.

 

For Brussels, revisiting a seemingly never-ending debate will without a doubt be a great source of frustration and occupy considerable resources. Despite the many other issues the EU has in its in-tray, this one just refuses to go away. It is up to the SPD to vote on the coalition draft and ultimately decide whether the SPD-CDU government can go ahead. But it has become abundantly clear that if Merkel remains in position for another four years, the battle for glyphosate in the EU is far from over.

 

 

 

 

 

 

Cancer

EAPM: Keeping tabs on lung cancer and Commission pharma strategy

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Good day, and welcome, health colleagues, to the first European Alliance for Personalised Medicine (EAPM) update of the week. We have more news on the upcoming EAPM round table on lung cancer, as well as all the usual health-care updates, writes European Alliance for Personalised Medicine, Executive Director Denis Horgan.

Lung-cancer screening and European Beating Cancer Plan

Yes, we are all aware that by far the best way to reduce numbers of lung cancer patients is to persuade smokers to stop. Although not all sufferers are, or have ever been, smokers. High-risk groups exist, of course, and early diagnosis is vital. Currently, five-year survival rates stand at a mere 13% in Europe and 16% over in America. This will be discussed in our upcoming event on 10 December. 

It is the most commonly found cancer in men and lung cancer in women is being represented by a “worrying rise” according to the World Health Organization.  Some one billion people on the planet are regular smokers. And figures show that lung cancer causes almost 1.6 million deaths each year worldwide, representing almost one-fifth of all cancer deaths. 

The European Respiratory Society and the European Society of Radiology (also a supporter of the event, as is the European Cancer Patient Coalition - ECPC), the societies have recommended screening for lung cancer under the following circumstances: “In comprehensive, quality-assured, longitudinal programmes within a clinical trial or in routine clinical practice at certified multidisciplinary medical centres.”

NELSON and victory?

The NELSON study into computed tomography (CT) screening of lung cancer showed that such screening reduces lung cancer deaths by 26% in high-risk asymptomatic men.  The findings also indicated that, with screening, the results could be even better in women.

For screening to be cost effective, it has to be applied to the population at risk. For lung cancer, this is not simply based on age and sex, as it is in the majority of breast or colon cancer screening. Europe needs to involve all key groups in developing recommendations and guidelines for implementation, adapted according to the healthcare landscape of individual countries. 

Various member states have already shown a willingness to move forward in lung-cancer screening, and several countries representatives will take part in the event.

The Alliance and its stakeholders realize that, among other elements, what is required in Europe is: continuous screening monitoring, with regular reports; assured consistency and enhanced quality of commented data for the screening reports; reference standards for quality and process indicators should be developed and adopted. 

All of the above will be discussed at the lung-cancer screening event, and it is envisaged that a coordinated plan will emerge, which will make its way to Commission and Parliament policymakers and member state health system chiefs.

You can check out the agenda of the 10 December conference here, and register here.

EU Pharma strategy on the horizon 

Affordability, availability and sustainability are the main focus points of the EU’s new pharmaceutical strategy, due to be published tomorrow (25 November). Coming in the wake of the COVID-19 pandemic, the EU’s pharmaceutical strategy aims to “future-proof” the European health-care sector. The new strategy, set to be unveiled on Wednesday, is designed to improve and accelerate patients’ access to safe and affordable medicines while also supporting innovation in the EU pharmaceutical industry. 

Health Commissioner Stella Kyriakides has previously described the strategy as a “cornerstone” of health policy over the next five years. It is considered a key pillar of the Commission’s vision to build a stronger health union, as President von der Leyen set out in her 2020 State of the Union speech. It will also inform the newly proposed EU4Health Programme and align with the Horizon Europe programme for research and innovation, as well as contribute to Europe’s Beating Cancer plan. 

And the European Commission has unveiled the first building blocks of a broader health package aimed at increasing the range of preparedness tools to respond to future cross-border health threats. Patient-oriented approach A first part of the strategy underlines that “research priorities should be aligned to the needs of patients and health systems.” 

Therefore, the whole EU system of pharmaceutical incentives should be reoriented to stimulate innovation in areas of unmet medical needs, such as neurodegenerative and rare diseases as well as pediatric cancer. An example of unmet medical needs mentioned in the document is antimicrobial resistance (AMR), which decreases a doctor's ability to treat infectious diseases and perform routine surgery. By 2022, the Commission will explore new types of incentives for innovative antimicrobials, as well as measures to restrict and optimise the use of antimicrobial medicines.

COVID 'mabs'

The US drug regulatory agency, FDA (Food and Drug Administration), has just issued an Emergency Use Authorization (EUA) for the treatment of mild to moderate intensity COVID-19 in adult and pediatric patients who they have not been hospitalized. The therapy, still under investigation, is based on monoclonal antibodies and goes by the name of bamlanivimab. This therapeutic agent, developed by the pharmaceutical company Eli Lilly, is a monoclonal antibody (mab) similar to those that were part of the cocktail of drugs for COVID-19 that was administered to Donald Trump. 

Beginning EU Health Union

The European Commission is beginning the building of the new European Health Union to help strengthen the EU’s health security framework, and to reinforce the crisis preparedness and response role of key EU agencies. The creation of the European Health Union was announced by the European Commission‘s President, Ursula von der Leyen, in her State of the Union address. The Commission is putting forward a set of proposals to reinforce Europe’s health framework as more co-ordination is needed at an EU level in order to step up the fight against the COVID-19 pandemic and future health emergencies. 

Protecting the health of European citizens

The proposals focus on revamping the existing legal framework for serious cross-border threats to health, as well as reinforcing the crisis preparedness and response role of key EU agencies such as the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA). President of the European Commission, Ursula von der Leyen stated: “Our aim is to protect the health of all European citizens. 

The coronavirus pandemic has highlighted the need for more coordination in the EU, more resilient health systems, and better preparation for future crises. We are changing the way we address cross-border health threats. Today, we start building a European Health Union, to protect citizens with high quality care in a crisis and equip the Union and its member states to prevent and manage health emergencies that affect the whole of Europe.” 

Von der Leyen urges gradual lifting of coronavirus lockdowns

European governments should lift coronavirus lockdowns and other social restrictions gradually to prevent a third wave of infections, according to European Commission President Ursula von der Leyen. Europe has been grappling with a second surge in Covid-19 infections since September which has led to the re-introduction of lockdowns in certain countries and an overall stepping up of restrictions across the region. 

Despite a slowdown in cases in some countries in recent days, the numbers are still high and are not yet showing clear signs of a cresting. In the meantime, Europeans are pondering whether they’ll be able to gather with their families over the holiday period.

Vaccine hope

News that the AstraZeneca/Oxford vaccine is effective and could have up to 90% efficacy was met with widespread joy on Monday (23 November). “We expect COVID-19 vaccines to develop into a significant market as new products gain approval and begin to meet the high demand for protection from the disease,” according to a brief analysis by Fitch Solutions. It notes that with more products looking likely to pass regulatory hurdles, “these products will help to develop COVID-19 vaccines into a multi-billion-dollar commercial opportunity”. 

Prices are expected to rise in the short-term as countries look to secure access in light of positive Phase 3 trial results, but over the long-term are expected to fall back as new products enter the market,” the briefing added. “Companies will soon be in a position to capitalize on success in Phase III trials through commanding high prices for vaccines,” the analysis states.

Extra plenary session between Christmas and New Year’s Eve

The European Parliament is preparing for an extra plenary session between Christmas and New Year’s Eve to give its consent to a possible post-Brexit trade deal with the UK, according to several EU officials and diplomats. It is likely to be held on 28 December, to give EU governments the opportunity to have the very last say, as foreseen by the bloc’s procedures, before the end of the UK’s Brexit transition period on 31 December.

Private Greek hospitals compelled to take COVID-19 patients

The Greek government took over two private hospitals in Thessaloniki on 19 November in which transmission of the coronavirus has been particularly widespread. The decision was reached after the private clinics failed to voluntarily provide 200 beds for COVID-19 patients despite appeals by the Health Ministry. Public hospitals in Thessaloniki and other parts of northern Greece have been struggling to cope with the influx of coronavirus patients, adding beds from other wards and setting up isolation tents after reaching their official capacities. .

And that is everything from EAPM for now, do stay tuned during the week for further updates on all health-related issues, stay safe, and remember to check out the agenda of EAPM’s 10 December lung cancer round table here, and register here.

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Quality, quantity and the question of politics – EAPM Lung Cancer Screening event, 10 December

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Good day, health colleagues, and welcome to the second European Alliance for Personalised Medicine (EAPM) update of the week. In spite of the travails of coronavirus, and concerns about just what will happen at Christmas this year, there is still plenty of positive news in the health arena, writes EAPM Executive Director Denis Horgan. 

Lung-cancer screening

With the launch of the European Beating Cancer, EAPM will be organizing a round table on lung-cancer screening in association with the European Respiratory Society, European Radiology Society as well the European Cancer Patient Coalition. The round table is entitled ‘Lung Cancer & Early Diagnosis: The Evidence Exists for Lung Screening Guidelines in the EU’, and the idea is to present a case for the coordinated implementation of lung-cancer screening across the EU Region.

Brexit and Christmas celebration may still be uncertain. The value of lung-cancer screening, however, is not. 

One of the aims of the conference is to put forward an implementation action plan to facilitate the drawing-up of lung cancer screening guidelines by the EU. Comprehensive screening programmes have been in place for some time in respect of several other cancers, but not so lung cancer, the biggest killer of all, while guidelines and best practices shared across member states are urgently required.

What next? 

A stage-shift related to lung cancer screening will allow EU countries to reduce the cost of treatment given that treating early-stage lung cancer has half the cost of treatment at an advanced stage. The Alliance and its stakeholders realize that, among other elements, what is required in Europe is: continuous screening monitoring, with regular reports; assured consistency and enhanced quality of commented data for the screening reports; reference standards for quality and process indicators should be developed and adopted, 

For screening to be cost effective, it has to be applied to the population at risk. For lung cancer, this is not simply based on age and sex, as it is in the majority of breast or colon cancer screening. Europe needs to involve all key groups in developing recommendations and guidelines for implementation, adapted according to the healthcare landscape of individual countries. 

All of the above will be discussed at the lung-cancer screening event on 10 December, and it is envisaged that a co-ordinated plan will emerge, which will make its way to Commission and Parliament policymakers and member state health system chiefs. You can check out the agenda of the conference here, and register here.

WHO envoy: ‘Cautiously optimistic, extremely concerned’

The World Health Organization (WHO) on Monday (16 November) said it was "cautiously optimistic" about encouraging news on the coronavirus vaccine. However, it added it was "extremely concerned" over surging cases in Europe and the Americas where health workers and systems are being pushed to the "breaking point". 

"This is not the time for complacency," said WHO Director-General Tedros Ghebreyesus in a news conference from the organization's headquarters for the first time in two weeks since he self-quarantined after making contact with a person who tested positive for COVID-19. 

"While we continue to receive encouraging news about COVID-19 vaccines and remain cautiously optimistic about the potential for new tools to start to arrive in the coming months, right now, we are extremely concerned by the surge in cases we're seeing in some countries, particularly in Europe and the Americas, health workers and health systems are being pushed to the breaking point," cautioned Tedros, who said he had not tested himself for the virus during his quarantine.

Looking to future of European Health Union

DG SANTE Director General Sandra Gallina made a brief appearance at an OECD webinar unveiling its Health at a Glance: Europe 2020 paper on Thursday (19 November), saying she hopes there will be new chapters to add next year after the European Health Union becomes reality.

Gallina highlighted various EU successes during the pandemic, including procurement of various items and the creation of a clearinghouse for medical goods. But she also warned there “remains significant scope to step up our effectiveness … not all things went well”. 

Germany looks to health data developments 

Germany has agreed to spend €3 billion to digitize its hospitals. This has been “discussed for years,” said Thomas Renner, head of directorate, digitization and innovation at the German health ministry. The country has also developed a single data protection supervising authority.

Interoperable coronavirus apps were developed within a few months. This is a very good example that if we want to achieve something we can,” Renner said.

EU could approve two COVID-19 vaccines in December, says von der Leyen 

The European Commission has agreed deals with several pharmaceutical companies to buy millions of doses of vaccines on behalf of EU member states. European Commission President Ursula von der Leyen has said that two COVID-19 vaccines could receive conditional market authorization as early as the second half of December. 

Speaking after a meeting of EU leaders, von der Leyen said the vaccines developed by Moderna and Pfizer, which created its serum with German drugmaker BioNTech, could be approved by the end of the year by the European Medicines Agency (EMA) “if all proceeds now without any problem”. She added: “This is the very first step to be able to be on the market.”

WHO says lockdowns would not be needed if mask use reached 95%

World Health Organization Europe Regional Director Hans Kluge has said that if 95% of people wore masks, lockdowns wouldn’t be needed. Speaking at a briefing, Kluge said that mask use is currently at around 60% or less in Europe and that lockdowns should be “last resort” measures. However, he also said that mask use isn’t a panacea and needs to be done in combination with other measures.

UK leaders in talks over 'four-nation approach' to Christmas COVID rules

Health Secretary Matt Hancock has said the government hopes to implement “UK-wide” measures to allow people to see some family members from different households over Christmas “but still keep the virus under control”.

Hancock said the government was in talks with leaders in Scotland, Wales and Northern Ireland to agree a united front that would allow festive cross-border travel within the UK. Wales’s first minister, Mark Drakeford, said he had held discussions with the Cabinet Office minister, Michael Gove, and the other first ministers of the devolved administrations on Wednesday (18 November) about a UK-wide approach to Christmas restrictions, with another meeting planned next week. 

He told BBC Radio 4’s Today programme: “We agreed some broad parameters on Wednesday (18 November) and remitted officials of all four administrations to work now on the detail, so I remain hopeful that it will be possible to reach a four-nation approach to Christmas.”

Drakeford said that an agreement on permitting travel across the UK during the Christmas season was “top of the list of things to agree”, even if a wider agreement was not possible. Hancock added: “I think it is important that we have an agreed set of rules over Christmas. It is the most important holiday for people in this country. 

"What we are trying to do over Christmas is ensure we have a set of rules across the whole UK so there’s talks going on with the devolved authorities as well to try to agree a common set of rules over Christmas. I think that people would welcome that."

And that is everything for this week – don’t forget to register for EAPM’s lung-cancer screening round table on 10 December here, read the agenda here, and have a safe and happy weekend.

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EAPM: Cancer is key for health experts as EU Beating Cancer Plan approaches

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Welcome, health colleagues, to the latest update from the European Alliance for Personalised Medicine (EAPM) – November and December will see a renewed focus, both from EAPM and the EU institutions, to issues of cancer mortality and treatment, which have not gone away, pandemic or no pandemic. The EU Beating Cancer Plan is taking shape from 10 December and, ahead of that, EAPM is focusing on its own approach to the disease based on our multi-stakeholder engagement and the role of diagnostics during the month ahead. In addition, the EAPM Newsletter will be available from tomorrow (30 October), writes EAPM Executive Director Denis Horgan. 

Beating cancer – the road to success

While the Europe’s Beating Cancer Plan aims to reduce the cancer burden for patients, their families and health systems. It is set to address cancer-related inequalities between and within member states with actions to support, co-ordinate and complement member states’ efforts.

In terms of its implementation, EAPM have advocated that the European Beating Cancer Plan needs to be realistic and measurable, so it should come with a dashboard of indicators that can be monitored, and which would enable evaluation to monitor the effectiveness of this plan.

In cancer, the important role of high-quality diagnostics as well as pathological expertise is not yet broadly recognized. If you have a symptom or a screening test result that suggests cancer, your doctor must find out whether it is due to cancer or some other cause. The doctor may start by asking about your personal and family medical history and do a physical exam. The doctor also may order lab tests, imaging tests (scans), or other tests or procedures. You may also need a biopsy, which is often the only way to tell for sure if you have cancer. To identify the right treatment, early diagnosis is essential. 

As such for the area of lung cancer, a more targeted approach to screening is warranted and appropriate stratification should be considered.

Taking into account the shortage of expertise within countries, the role of cross-country molecular tumour board will have an important role.  A governance framework for the way that data can be shared between countries will be essentials here.

EAPM has brought these and other issues before MEPs over recent months since our successful seminar series at the European Society of Medical Congress during the recent EU Presidency conference. 

Commission plan receives support from cancer committee for treatment

With more than 40% of cancers preventable, the EU can do more to tackle the disease, one of the leading causes of mortality in Europe, according to the European Parliament’s cancer committee. “By pooling all our talents, knowledge and resources, we can truly join all our forces in the fight against cancer.” So claimed Manfred Weber during the 2019 elections, paving the way for a special committee in the fight against cancer. Today this committee is a reality. This fight will be a priority for many in the coming years. Commission President Ursula von der Leyen announced a European Plan to fight Cancer in her political guidelines and Health Commissioner Stella Kyriakides has shown her ambitions in presenting the EU Beating Cancer Plan in the Parliament, which will be finalised by the end of 2020. This special committee is needed now more than ever. 

By pooling resources and expertise, a comprehensive European cancer masterplan can be created, acting as a catalyst for thorough and innovative cancer care and research, which should be focused on prevention, specialized care and treatment that puts the patients at its heart, as well as a zero-pollution environment. Prevention is key in the fight against cancer, and cancer treatment requires the correct specialized therapy. As early as 2003, the Council issued recommendations to roll out cancer screening programmes for some of the more prevalent cancers, but their implementation is far from complete. Increased investment through programmes such as Horizon 2020, as well as knowledge-sharing bodies like the European Reference Networks, are invaluable policy tools that the EU has at its disposal in the Beating Cancer Plan.

EU needs more power on health policy, says Commission's Irish rep

The European Commission’s representative to Ireland Gerry Kiely, speaking on Wednesday (28 October), told the Irish parliament that the EU’s contribution to fighting COVID-19 was initially limited because member states wanted it so. But the member states must collectively manage a long and difficult shared crisis, he added, going on to say that surveillance across the EU, and indeed within Member States, is still slow, inconsistent and patchy. The ECDC can provide common methodologies for information gathering, but it has no way to ensure that member states provide information in the prescribed manner.

To make information flows more integrated and useful, the EU could direct resources and create obligations for member states to improve surveillance and reporting. As far as the ECDC is concerned, it has very little power, let alone budget, to respond in a way comparable to its US counterpart. The Commission is set to announce just how this agency’s role will change in two weeks’ time. 

COVID-19 co-ordination

European leaders are set to meet online today to discuss COVID-19 co-ordination, following the 15 October European Council. “Even though member states are better prepared and more co-ordinated than in the early months of the pandemic, citizens, families and communities across Europe continue to face an unprecedented risk to their health and well-being,” said a Commission statement.

UK under pressure as COVID-19 epidemic doubles every nine days 

The British government is under pressure to develop a national strategy to combat a surge of COVID-19 cases and "rescue Christmas'' as scientists warn that the number of people hospitalized with the disease in the UK could almost triple by the end of next month unless something more is done now. Mark Walport, a former chief scientific officer, said Britain only needs to look across the English Channel to see what's coming. Britain's current measures are similar to those in France and Spain, where authorities are struggling to control the virus and daily cases have already far outstripped those in the UK. "With our current measures… there's little evidence that there is as much social distancing as there was when we clamped down on the first wave and so we know that the risk is significant that cases will continue to grow," Walport told the BBC. It is "not unrealistic'' that 25,000 people in the UK could be hospitalized by the end of November—up from about 9,000 now, he said. 

Germany shuts up shop

On Wednesday (28 October), Chancellor Angela Merkel and Germany’s state premiers agreed to close bars, restaurants, gyms, pools, cinemas and other non-essential businesses nationwide for the month of November. “We have to act now to avoid an acute national emergency,” Merkel said. “The experts told us we have to reduce the number of contacts by 75% — that’s a lot.”

France est fermé

President Emmanuel Macron has announced his own national lockdown starting Friday (30 October), with restaurants and bars to be closed but schools, public services and some factories remaining open. Unlike in the first lockdown, visits to nursing homes will be allowed. 

Von der Leyen: EU could vaccinate 700M people against coronavirus

The EU could vaccinate 700 million people with large supplies of vaccines due to begin in April 2021, Commission President Ursula von der Leyen has said today (29 October). Von der Leyen also reiterated her call for the harmonization of countries’ vaccination plans. “There are many issues to be considered for an effective vaccine deployment,” she said, pointing to questions around infrastructure, such as cold chains. 

Health data space en route

The Commission is pushing forward plans for a European health data space, with an interim report from recent expert workshops to be published before the end of 2020, said Health Commissioner Stella Kyriakides on Monday (26 October) during the World Health Summit. However, important questions remain about public trust and whether people will be willing to share their data on a pan-EU platform.

And that is everything from EAPM for now – do stay safe and well, look out for the EAPM Newsletter from tomorrow, and have a splendid afternoon.

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