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EAPM – German Presidency conference a big date, Commission pushes for healthy planet

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Welcome, one and all, to the first European Alliance for Personalised Medicine (EAPM) update of the week, and there is much to look forward to and much to discuss, writes EAPM Executive Director Denis Horgan.

German EU Presidency Conference

EAPM is looking forward very much to its participation in the upcoming German EU Presidency conference on 12 October. Given the present circumstances with COVID-19, the conference will naturally be virtual, but it will be featuring keynote speakers from the world of health and elsewhere – EAPM’s role in the conference has always proved popular in previous years, agenda here, register here.

EAPM on Biomarker Testing

EAPM’s publication, which was launched during ESMO, Bringing Greater Accuracy to Europe’s Health Care Systems: The Unexploited Potential of Biomarker Testing in Oncology, is already winning plaudits, and it can be read here. The report of our series of round tables at ESMO will also be available later this week. 

Concerns raised over accuracy of UK’s 'Operation Moonshot' tests

The scary thing about the UK’s much-publicized problems with Covid-19 testing is not that the system is encountering difficulties — those were inevitable. It’s that the government failed to anticipate them, it has not been transparent about what went wrong or convincing on the question of when the problems will be resolved. Boris Johnson and Health Secretary Matt Hancock have been getting an earful from lawmakers from all parties as stories mounted of a meltdown in the country’s testing system. Many people with COVID-19 symptoms have been instructed to travel hundreds of miles for tests, and those were the lucky ones. 

Hancock has told Parliament on that it would take “weeks” to fix the current problems. Johnson has said only that capacity would be up to 500,000 tests per day by the end of October, compared with capacity of about 375,000 currently. In the meantime, the government will be working out its “prioritization” system for existing testing. 

It is ironic that Johnson has spoken of Operation Moonshot — a bold stretch goal to test 10 million people a day by early 2021 — while now the government is focused on rationing a small fraction of that number of tests. The number of new coronavirus cases seems to be doubling roughly every seven days. Hospital admissions are rising, even if fatalities are still low. In an effort to slow the spread, the government has restricted private gatherings to just six people. Schools in England are already seeing a higher absence rate compared to the same time last year as the merest sniffle or cough sets in motion a chain of reactions that has in some cases resulted in entire year groups being sent home, consequently driving up demand for testing. 

Commission: Healthy planet, healthy people 

Air and noise pollution, the impacts of climate change such as heatwaves, and exposure to dangerous chemicals cause ill health in Europe. Poor quality environments contribute to 13 % (one in every eight) of deaths according to a major assessment on health and environment released today by the European Environment Agency (EEA). Improving the health and well-being of European citizens is more important than ever, with attention currently focused on addressing the COVID-19 pandemic. 

The pandemic provides a stark example of the complex links between the environment, our social systems, and our health. A significant proportion of the burden of disease in Europe continues to be attributed to environmental pollution resulting from human activity, according to the EEA report ‘Healthy environment, healthy lives: how the environment influences health and well-being in Europe.' 

The report, which draws extensively on World Health Organization data on the causes of death and disease, highlights how the quality of Europe's environment plays a key role in determining our health and well-being. It shows how social deprivation, unhealthy behaviours and shifting demographics in Europe influence environmental health, with the most vulnerable hardest hit.

“There is a clear link between the state of the environment and the health of our population. Everyone must understand that by taking care of our planet we are not only saving ecosystems, but also lives, especially the ones who are the most vulnerable. The European Union is devoted to this approach and with the new Biodiversity Strategy, the Circular Economy Action Plan and other forthcoming initiatives we are on the path to build a more resilient and healthier Europe for European citizens and beyond,” said Environment, Oceans and Fisheries Commissioner Virginijus Sinkevičius.

Parliament says common standards essential 

The European Parliament has passed a resolution calling for common definitions for coronavirus cases across member countries. Differences in methodologies in the bloc have made cross-country comparisons more difficult, creating difficulties in interpreting data on the pandemic. The lack of common standards has also meant difficulties in imposing travel policies that depend on data. 

Securing COVID-19 vaccines for EU citizens

The health and industry committees in the European Parliament have hosted a joint meeting about “how to secure access to COVID-19 vaccines for EU citizens: clinical trials, production and distribution challenges”. Clinics are being set up where patients with coronavirus or flu symptoms can go. The idea is that they don’t potentially infect other patients when visiting their doctor, according to the Data Protection Authority. Rapid coronavirus tests and testing in vulnerable nursing homes are also a central part of Germany’s plan for the autumn and winter.

How the EU’s COVAX financing works 

Following the Commission’s announcement on Friday (18 September) about its financing offer for the global COVAX Facility, co-led by Gavi, the Vaccine Alliance, the Coalition for Epidemic Preparedness Innovations (CEPI) and WHO, the facility now aims to accelerate the development and manufacture of COVID-19 vaccines and to guarantee fair and equitable access for every country in the world. 

As part of a EU joint engagement (Commission, member states and European financial institutions, notably EIB) to mobilize resources for the Coronavirus Global Response, the Commission intends to mobilize up to €400 million in guarantees to support COVAX and its underlying objectives as part of a Team Europe effort. The detailed terms and conditions for the EU's participation and contribution will be worked out in the coming days and weeks.

Team Europe is ready to put its expertise and resources at work within COVAX to accelerate and scale-up development and manufacturing of a global supply of vaccines for citizens across the world, in poor and rich countries. The EU's participation in COVAX will be complementary to the ongoing EU negotiations with vaccine companies that aim at scaling up manufacturing capacity of vaccine producers, contributing to global efforts.

The European Commission is committed to ensuring that everyone who needs a vaccine gets it, anywhere in the world and not only at home. No one will be safe until everyone is safe. This is why it immediately responded to the WHO's call for action and has raised almost €16 billion since 4 May under the Coronavirus Global Response, the global action for universal access to tests, treatments and vaccines against coronavirus and for the global recovery, and the Commission also published new testing guidelines joining a similar set of indications put out by the ECDC on Friday. 

French regulator approves saliva tests in certain cases

France’s health technology assessment body has said that it’s acceptable to use saliva-based coronavirus tests in the place of nasal swabs in certain cases. These tests are less sensitive than nasal swabs and should not be used for asymptomatic individuals, the Haute Autorité de Santé said. However, saliva tests should be considered for individuals for whom nasopharyngeal swabs are not ideal, such as for children, the elderly, and those who have any psychiatric disorders.

And that is everything for the start of the week – don’t forget to register for EAPM at the German EU Presidency conference on 12 October, agenda here, register hereEnjoy your week and stay safe.

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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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