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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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Technological solutions are the key to tackling Europe’s second wave of Covid-19

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Europe is suffering a brutal second wave of the coronavirus pandemic, with a number of major economies back in lockdown after a brief reprieve over the summer. Last week, Italy joined a growing list of countries with more than a million recorded cases of the virus, Poland’s National Stadium has been transformed into a field hospital, and Spain has declared a national state of emergency that may extend well into 2021. The total number of cases on the continent now exceeds 14 million, and hospital systems are stretched near to their breaking point.

Slivers of good news, however, have begun to emerge. Several hard-hit countries may be experiencing the turning of the tide: though infection rates remain elevated, Germany has noted the “first signs” that the curve is flattening, while the virus’ reproduction rate (R0) recently dropped below 1 in France. Even in Belgium, which was recently so badly-off that coronavirus-positive nurses in Liège were asked to continue working as long as they were asymptomatic, the situation is slowly stabilising after daily new infections dropped by 40 percent week-on-week.

With the approaching holiday season heightening pressure on policymakers to re-open economies by the end of the year, ensuring that the right tools are in place will prove essential if a devastating third wave is to be prevented. That said, the roll-out of reliable COVID-19 testing regimes has already proved far more difficult than health authorities may have anticipated, and a persistent onslaught of virus-related scams has thrown a further wrench into public health authorities’ attempts to control the deadly virus’s spread.

One such scandal recently surfaced from within Europe’s decimated travel industry, where a criminal gang was found to be selling fake negative COVID-19 tests to passengers departing from Paris Charles de Gaulle airport amid tighter immigration rules. The counterfeit certificates bore the names of real Parisian medical laboratories, and the scheme was only exposed after a passenger bound for Ethiopia was found to be carrying a false certificate. If Europe is to safely emerge from this latest lockdown, the independent and trustworthy verification of health information will need to be the cornerstone of any new policy.

More secure and more convenient COVID test results

Fortunately, a number of promising high-tech solutions have already popped up. Swiss company SICPA’s CERTUS MyHealthPass, for example, uses an existing blockchain-based technology to allow the universal verification of health credentials, and is currently being trialled to help both maritime crews and airline passengers.

The CERTUS solution will be a particularly welcome development for seafarers, who have struggled to go about their usual duties since the beginning of the pandemic. Many national authorities have questioned the validity of seafarers’ COVID-19 tests and taken an inordinately long time to approve their health documents, leaving seafarers often left stranded onboard months after their scheduled disembarkation. Moreover, the rejection of health and travel documents often prevents potential replacements from boarding these same vessels, damaging the mental wellbeing of the workers in limbo and bringing vital transnational operations to a grinding halt.

The airline industry, unsurprisingly, is wrestling with a similar challenge. Countries are increasingly requiring negative PCR tests for entry—while some are already planning for how to integrate coronavirus vaccination certificates into their border control procedures—but scandals like the false COVID test ring discovered at Charles de Gaulle airport have ratcheted up the need for internationally-recognised procedures like the technological solution offered by MyHealthPass. The scheme is capable of authenticating both paper documents and digital information so as to guarantee the validity of WHO-approved COVID-19 test results. Seafarers, airline staff and international travellers can then carry their authenticated digital health pass on their smartphones, allowing the re-opening of essential international services in the short-term and helping national and local authorities better anticipate and prepare for future outbreaks.

Self-isolation still falling short

In addition to ensuring that easily-verified coronavirus tests & other health information can help open borders and allow normal economic activity to resume as soon as possible, governments should also be using this time to resolve the missing links that have so far caused testing and isolation strategies to fall through. If rapid and widespread COVID-19 testing is finally beginning to take off, bolstered by more accurate blood tests to detect past infection, authorities must also be doing more to encourage—and compensate—populations which may have been exposed to the disease to self-isolate so as to allow these developments to adequately take hold.

In the months since the heady days of summer, a clearer image of Europe’s failures to control the pandemic has indeed begun to emerge. In the UK, where COVID-19 cases have exceeded 1.3 million, less than one-fifth of people who reported coronavirus symptoms complied with national self-isolation regulations, and authorities handed out a paltry handful for fines for quarantine violations when returning from a high-risk area.

Here again, countries with high marks handling the coronavirus outbreak have turned to technological solutions to both ease the burden of complying with self-isolation requirements and ensure compliance with rules in force. Taiwan, for example, has emerged as the international gold standard for COVID-19 control measures. After closing international borders and regulating travel early, Taiwan has successfully maintained a rigorous regime of contact tracing and technology-enhanced quarantine which has helped the island nation keep cases and fatalities low. In particular, the Pacific country adeptly implanted an “electronic fence system”, which uses cell phone location data to ensure that quarantined individuals stay at home. Technology also provided a solution for the practical and mental health concerns of those in quarantine, from offering easy food delivery options to a chatbot developed with popular messaging app LINE.

European authorities failed over the summer to implement the technological solutions they needed to stop a second wave in its tracks. This second round of lockdowns has given them a fresh chance to construct the pillars of a comprehensive and secure strategy for testing and quarantining which could stave off a third wave of the virus.

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Coronavirus: Commission to provide 200 disinfection robots to European hospitals

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As part of its continued efforts to tackle the spread of coronavirus and provide member states with necessary equipment, the Commission launched the purchase of 200 disinfection robots that will be delivered to hospitals across Europe. Overall, a dedicated budget of up to €12 million is available from the Emergency Support Instrument (ESI). Hospitals from most Member States expressed a need and interest in receiving these robots, which can disinfect standard patient rooms, using ultraviolet light, in as quickly as 15 minutes, and thus help prevent and reduce the spread of the virus. The process is controlled by an operator, who will be located outside of the space to be disinfected, in order to avoid any exposure to the UV light.

Executive Vice President Margrethe Vestager said: “Developing technologies can set up forces of change and we see a good example of this in the disinfection robots. I welcome this action to help our hospitals in Europe reduce the risk of infection – an important step in containing the spread of coronavirus.” Commissioner for the Internal Market, Thierry Breton, added: “Europe has remained resilient and solidary during the current crisis. From repatriating EU citizens stranded abroad to increasing the production of masks and ensuring that medical equipment reaches those who need it within the single market, we are acting to protect our citizens. Now we are deploying disinfection robots in hospitals so that our citizens can benefit from this potentially life-saving technology.”

The robots are expected to be delivered in the coming weeks.

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Italy reports 28,337 new coronavirus cases on Sunday, 562 deaths

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Italy had registered 28,337 new coronavirus infections over the previous 24 hours, the health ministry said on Sunday (22 November), down from 34,767 the day before. The ministry also reported 562 COVID 19-related deaths, down from 692 on Saturday and 699 on Friday. There were 188,747 coronavirus swabs carried out in the past day, the ministry said, against a previous 237,225.

Italy was the first Western country to be hit by the virus and has seen 49,823 COVID-19 fatalities since its outbreak emerged in February, the second highest toll in Europe after Britain’s. It has also registered 1.409 million cases. While Italy’s daily death tolls have been the highest in Europe over recent days, the increase in hospital admissions and intensive care occupancy has slowed.

The number of people in hospital with COVID-19 stood at 34,279 on Sunday, a rise of 216 from the day before. That compared with a daily increase of 106 on Saturday. The number of patients in intensive care rose by 43, following an increase of just 10 on Saturday (21 November), and now stands at 3,801. When Italy’s second wave of the epidemic was accelerating fast, until around a week ago, hospital admissions were rising by around 1,000 per day, while intensive care occupancy was increasing by about 100 per day.

The northern region of Lombardy, centred on Italy’s financial capital Milan, remained the hardest hit area on Sunday, reporting 5,094 new cases. The southern region of Campania, which has only about 60% of Lombardy’s population, chalked up the second highest number of new cases, at 3,217.

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