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#EAPM - State of the Union: Health in the spotlight and the question of translation into health-care system

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Good morning, good morning, and welcome to the second European Alliance for Personalised Medicine (EAPM) update of the week – plenty of news today concerning health matters in Commission President Ursula von der Leyen’s State of the Union speech earlier this week and, as ever, updates on coronavirus testing. On with the show, writes EAPM Executive Director Denis Horgan...

First, a brief reminder that EAPM is hosting the ESMO event tomorrow (18 September), agenda here, register here, and the Alliance is very much looking forward to taking its seat at the round table during the German EU Presidency conference on 12 October, agenda here, register here.

State of the Union

Lest we forget, EU citizens have always highlighted in responses to the Eurobarometer poll that health care should be a priority at a pan EU level, a sentiment that has undoubtedly been echoed in the work that EAPM has done, encouraging policymakers in the area of cancer, particularly lung cancer for pan EU action and the EU health data space.

So, it is always encouraging when health policy is mentioned in an EU State of the Union address, as Commission President Ursula von der Leyen most certainly did this week.

Addressing MEPs in the European Parliament on Wednesday (16 September), von der Leyen said her commission would try to reinforce the European Medicines Agency and European Centre for Disease Prevention and Control. The president of the European Commission urged EU members to build a stronger health union, promising a biomedical research agency and a global summit. 

In her first annual State of the European Union address, Ursula von der Leyen said the coronavirus pandemic had underlined the need for closer cooperation, stressing that people were “still suffering”. “For me, it is crystal clear – we need to build a stronger European Health Union,” she said. “And we need to strengthen our crisis preparedness and management of cross-border health threats.” 

Von der Leyen said her Commission would try to reinforce the European Medicines Agency and European Centre for Disease Prevention and Control. And she announced the creation of a new agency for biomedical advanced research and development dubbed BARDA. 

She said she would work with Italy during its presidency of the G20 - a grouping of the world’s richest countries - to convene a global health summit next year to share the lessons of the coronavirus crisis. “This will show Europeans that our Union is there to protect all,” she said. Health policy remains the responsibility of EU member states and, while Brussels has tried to coordinate the bloc’s response to the epidemic, national lockdowns and border rules have varied widely. Von der Leyen, a doctor by training, also warned countries not to act selfishly when on vaccines, which are widely seen as the solution to end the crisis.

“Vaccine nationalism puts lives at risk. Vaccine cooperation saves them,” she said. She also called for a reformed and strengthened World Health Organization “so that we can better prepare” for future pandemics. The Commission chief also tried to reassure citizens that the EU now has a grip on the coronavirus pandemic and she proclaimed the Commission’s intent to seize the moment, use the money, increase its powers and press EU countries to help “build the world we want to live in”.

She also called for the EU to “lead reforms” at the WHO and World Trade Organization “so they are fit for today’s world.”

Testing times on testing

UK Prime Minister Boris Johnson has defended the coronavirus testing system, saying it is trying to meet a "colossal spike" in demand. It comes as the government said it was drawing up a list setting out who will be prioritised for tests. Care home residents and staff are likely to be near the top of the list, as Johnson acknowledged ministers were concerned about infection rates. The PM told MPs a new "action plan" for care homes will soon be released.

Earlier, Justice Secretary Robert Buckland said schools could be considered for priority testing. On Wednesday (16 September), coronavirus cases in the UK increased by 3,991, taking the total to 378,219, according to figures from the government. A further 20 people had died within 28 days of testing positive for COVID-19. This brings the UK death total by this criteria to 41,684. 

Johnson said 89% of those who have in-person tests get them the next day. He told Prime Minister's Questions on Wednesday: "I think most people looking at the record of this country in delivering tests across this nation will see that it actually compares extremely well with any other European country."

The BBC reports that  the government will publish details of its plan to prioritize coronavirus tests in the next few days, with NHS staff and patients and those in care homes top of the list.

Not how you start, it’s how you’re Finnish...

A new app, intended to stop the spread of the novel coronavirus by tracing contacts, has been downloaded nearly two million times in Finland, a country of 5.5 million. Its neighbours have by contrast either declined to launch a national app or cancelled it due to privacy concerns. 

Nearly one in three Finns have downloaded the new coronavirus contact tracing app, according to the Finnish Institute for Health and Welfare, THL. The Koronavilkku app (“Corona blinker”), released barely a week ago on iOS and Android, has already been downloaded over 1.8 million times. Finland's total population is about 5.5 million people, national broadcaster Yle reported. The THL's initial goal was to reach up to a million users in September. Users of the app send randomly-generated codes via Bluetooth signal to each other when they come into close contact for at least 15 minutes. The smartphones then store anonymous information about the contact.

During the first week, a total of 41 of Koronavilkku's users have entered so-called unlock codes into the app. These unlock codes are given to users diagnosed with the coronavirus infection, THL's director of information services, Aleksi Yrttiaho, explained. The unlock codes thus enable the infected person's phone to alert other app users of exposure risk. 

The number of exposure notifications is not received, Yrttiaho added. “In the first couple of days, the application has been downloaded significantly more than we had anticipated. People want help in preventing the spread of coronavirus,” he mused. 

The app is available in Finnish and Swedish, and an English version is currently in the works. With 8,327 Covid-19 cases, 336 deaths and over 7,300 recoveries, Finland has been the least-hit Nordic nation.

Funding

We’ll never be prepared for the next pandemic if we only invest in R&D targeting diseases grabbing headlines at the time,” said Nick Chapman, CEO of Policy Cures Research. Concerning an earlier epidemic, a G-FINDER report shows that funding to fight Ebola fell as the West African pandemic waned. Similarly, clinical trials and funding for Zika dwindled in 2018. Total funding in this area reached a peak of $886 million in 2018 – a 14% increase on the previous year.

New restrictions in Netherlands' cities

New coronavirus restrictions will be introduced in parts of the Netherlands where coronavirus cases are mounting, and Amsterdam, Rotterdam, The Hague, Delft and Leiden are on the hit list. Health minister Hugo de Jonge said on Wednesday that the rising number of coronavirus infections is ‘not good’, particularly in the big cities in the west of the country. 

On Wednesday, a further 1,500 positive test results were reported to public health institute RIVM, and Germany and Belgium have put Noord and Zuid-Holland provinces on their code red list – which means they should be avoided. De Jonge and prime minister Mark Rutte will hold a press conference on Friday evening (18 September) at 19h to announce what measures are being brought in on a regional basis. “There is no single solution to reduce the number of infections,” De Jonge said. “We want to hit the virus hard, but keep the impact on society and the economy to a minimum.”

And that is everything for this week – do enjoy the ESMO event, agenda here, register here,

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EAPM: Why increasing trust between stakeholders must be way forward for health

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Good morning, and welcome one and all to the first European Alliance for Personalised Medicine (EAPM) update of the week. We come off the back of a busy month for EAPM in October, following our 1 Million Genome meeting and German EU Presidency Conference, as well as engagement with the EU Beating Cancer Plan, which is aiming to set the framework to tackle cancer. And, a little later this week, there is the monthly EAPM Newsletter to look forward to, writes EAPM Executive Director Denis Horgan.

Trust and governance

Despite member state competence in many areas, there is undoubtedly a need for common European health legislation as much as possible, but it must be the right legislation. Unfortunately, experience has shown that having separate rules in every member state does not really work, for a variety of reasons. For example, it often leads to an R&D environment that is not competitive, slows the innovative dynamic and ultimately represents a barrier to the emergence of effective therapies for untreated disease. With more integration, collaboration, dialogue and increased trust among each and every one in the field, stakeholders can help mould the right frameworks, in the right place, at the right time. More about EAPM’s aims in this regard later.

Europe needs 'serious acceleration' in fight against coronavirus: WHO

Europe needs a “serious acceleration” in the fight against the coronavirus and a lack of contact-tracing capacity could drive the disease into the darkness, a top World Health Organization official said on Monday (26 October). In Europe the picture is unrelentingly grim as a string of countries reported record increases, led by France, which posted more than 50,000 daily cases for the first time on Sunday, while the continent passed the threshold of 250,000 deaths. The 46 countries at World Health Organization level accounted for 46% of global cases and nearly one third of deaths, said Mike Ryan, the WHO’s top emergencies expert. “Right now we are well behind this virus in Europe, so getting ahead of it is going to take some serious acceleration in what we do,” Ryan told a news conference.

Placing confidence in the hands of others

From man's earliest ventures into health care, when shamans, priests or medicine men ministered to the sick, trust has been at the centre of the compact between patient and carer. People at their most vulnerable moments choose to place themselves in the hands of others, in the confidence – or at least the belief – of benefit and relief. That compact remains just as valid in today's world of science and technology. The rapid development of medicine in the last 50 years, and more particularly the exponential leaps of the last 25, have created opportunities unimaginable only a couple of generations ago. Genomics is increasingly permitting a focus on the underlying nature of disease – and the underlying processes of health. As a result, at one end of the scale there is a growing ability to treat smaller populations – with orphan drugs for rare disease, or validated paediatric medicines, or advanced therapies, and with an unfurling range of possibilities as personalised medicine evolves. And at the other end of the scale health authorities begin to tap into a wealth of information about health trends, susceptibilities and the value of distinct treatment options that can radically improve health systems management.So the trust invested in the shaman is even more crucial today. The emergence of evidence-based medicine and organised health services that are overseen by governments entitle patients to a degree of certainty that their best interests are being attended to on the basis of reason and equity as well as of faith.

Council welcomes prospect of European health data space

The European Council has welcomed the European strategy for data, which supports the EUʼs global digital ambitions to build a true European competitive data economy. The European Council welcomes the creation of common European data spaces in strategic sectors, and in particular invites the Commission to give priority to the health data space, which should be set up by the end of 2021, and which is being cited as a means to strengthen the immediate response to COVID-19.

And it is not just the Commission that’s working on digital health, with the World Health Organization also presents its global strategy for digital health, which is set to be brought to the World Health Assembly in November. The WHO is currently putting together an investment case to implement this strategy, with member state approval being awaited, the WHO’s Chief Information Officer Bernardo Mariano Jr has said. But public trust is again a big consideration, with critics asking whether people will be willing to share their data on a pan-EU platform, and whether governance will be equired to ensure full participation.

Improving precision and power in randomized trials for COVID‐19 treatments

Time is of the essence in evaluating potential drugs and biologics for the treatment and prevention of COVID‐19. There are currently 876 randomized clinical trials (phase 2 and 3) of treatments for COVID‐19 registered on clinicaltrials.gov. Covariate adjustment is a statistical analysis method with potential to improve precision and reduce the required sample size for a substantial number of these trials. Though covariate adjustment is recommended by the U.S. Food and Drug Administration and the European Medicines Agency, it is underutilized, especially for the types of outcomes (binary, ordinal, and time‐to‐event) that are common in COVID‐19 trials. In simulated trials with sample sizes ranging from 100 to 1000 participants, there have been substantial precision gains from using covariate adjustment–equivalent to 4–18% reductions in the required sample size to achieve a desired power.

EAPM to discuss trust and governance in early 2021 upcoming Presidency Conferences

In Europe, the interdependence of member states makes it both necessary and desirable that much of that task of oversight is organized at EU level. It is, inevitably, of course, a more complex compact nowadays. Each component of the systems on which people now routinely depend for their health has to fulfil its part of the bargain. These issues of trust will be discussed in EAPM’s two presidency conferences being planned for January and July 2021 that will address these elements of governance.

Health minister cites ‘strongest EU position on WHO in years’

German Health Minister Jens Spahn has recently spoken of “the strongest EU-level position concerning WHO at least in recent years”. Spahn added that he advocates “for a stronger role of the EU” in the WHO and in global health in general. “We should not leave [it] to the USA and China to call the shots,” he said. 

Public consultation on breast implants

On Friday (23 October) the European Commission launched a public consultation on a preliminary opinion on the safety of breast implants. The Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) opinion is based on anaplastic large cell lymphoma (ALCL). Interested parties can submit their comments by 7 December.

Intensive care units ‘could be overrun in weeks’ warns WHO

The World Health Organization has warned that intensive care units in Europe could be overwhelmed in a matter of weeks and that immediate action was essential to prevent essential health systems collapsing and schools closing. In many cities around Europe, the capacity for ICU is going to be reached in the coming weeks,” said Maria Van Kerkhove, the WHO’s technical lead for COVID-19. WHO Director General Tedros Adhanom Ghebreyesus warned that the entire world, and particularly the northern hemisphere, was at a “critical juncture”.

And that is everything for now – do look out for the EAPM Newsletter, which will be available later this week, and stay safe and well.

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New French COVID cases could be 100,000 per day: Government medical advisor

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France may be experiencing 100,000 new COVID-19 cases per day - twice the latest official figure - Professor Jean-François Delfraissy, who heads the scientific council that advises the government on the pandemic, told RTL radio on Monday (26 October), writes Sudip Kar-Gupta.

“There is probably more than 50,000 cases per day. We estimate, on the scientific committee, that we are more in the region of 100,000 cases per day,” said Delfraissy.

France, the eurozone’s second-biggest economy, is currently examining whether to tighten lockdown measures further to curb the resurgence of the COVID-19 virus, having already imposed night-time curfews on major cities including Paris.

The health ministry reported on Sunday a record 52,010 new confirmed coronavirus infections over the past 24 hours, as a second wave of cases surges through Europe.

The new cases took the French total to 1,138,507, with France overtaking Argentina and Spain in registering the world’s fifth-highest number of cases.

The ministry said 116 people had died from coronavirus infection in the 24 hours to Sunday, down from 137 a day earlier, taking total deaths to 34,761.

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Coronavirus: First rescEU ventilators dispatched to Czechia 

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Following a request for assistance from Czechia, the EU is immediately sending a first batch of 30 ventilators from rescEU - the common European reserve of medical equipment set up earlier this year to help countries affected by the coronavirus pandemic.

As President von der Leyen (pictured) said: “Czechia is facing one of the most difficult situations in Europe right now. The number of coronavirus cases is rising rapidly. And it needs medical equipment to treat patients in hospitals. We do not leave our European friends alone in these hard times. The European Commission is mobilizing medical material through our Civil Protection Mechanism. I called the Prime Minister Andrej Babiš to tell him that we are dispatching rapidly to Czechia a set of 30 ventilators from our RescEU reserve. We created this reserve in record time in spring, to stockpile essential medical material that we can send to European countries in need. And we are in touch with other EU countries, to mobilize more ventilators for the Czech Republic. We are in this together.”

Crisis Management Commissioner Janez Lenarčič added: ”We have been working around the clock to avoid a repetition of the situation experienced at the end of February, when whole EU was overwhelmed in the fight against the pandemic. We created the rescEU medical reserve so no member state is left alone when dealing with the same challenge. After already delivering protective face masks across Europe, this will be the first time the European Commission is dispatching ventilators from the EU level reserve."

The EU's Emergency Response Co-ordination Centre is in constant contact with authorities in Czech and more EU assistance can be channelled in the coming days via the EU Civil Protection Mechanism, coming from member states. In order to give member states time to assess their response capacity and taking into account the gravity of the situation in the Czech Republic, the EU has proactively initiated the rescEU deployment of medical reserve. The full press release is available online.

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