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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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Coronavirus: Commission presents 'Staying safe from COVID-19 during winter' strategy

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Today (2 December), the Commission adopted a strategy for a sustainably managing the pandemic over the coming winter months, a period that can bring a risk of increased transmission of the virus owing to specific circumstances such as indoor gatherings. The strategy recommends continued vigilance and caution throughout the winter period and into 2021 when the roll out of safe and effective vaccines will occur.

The Commission will then provide further guidance on a gradual and coordinated lifting of containment measures. A coordinated EU wide approach is key to provide clarity to people and avoid a resurgence of the virus linked to the end of year holidays. Any relaxation of measures should take into account the evolution of the epidemiological situation and sufficient capacity for testing, contact tracing and treating patients.

Promoting the European Way of Life Vice President Margaritis Schinas said: “In these extremely difficult times, guidance to Member States to promote a common approach to the winter season and in particular on how to manage the end of the year period, is of vital importance. We need to curtail future outbreaks of infection in the EU. It is only through such a sustained management of the pandemic, that we will avoid new lockdowns and severe restrictions and overcome together.”

Health and Food Safety Commissioner Stella Kyriakides said: “Every 17 seconds a person loses their life due to COVID-19 in Europe. The situation may be stabilizing, but it remains delicate. Like everything else this year, end of the year festivities will be different. We cannot jeopardise the efforts made by us all in the recent weeks and months. This year, saving lives must come before celebrations. But with vaccines on the horizon, there is also hope. All member states must now be ready to start vaccination campaigns and roll-out vaccines as quickly as possible once a safe and effective vaccine is available.”

Recommended control measures

The staying safe from COVID-19 during winter strategy recommends measures to keep the pandemic under control until vaccines are widely available.

It focuses on:

Physical distancing and limiting social contacts, key for the winter months including the holiday period. Measures should be targeted and based on the local epidemiological situation to limit their social and economic impact and increase their acceptance by people.

Testing and contact tracing, essential for detecting clusters and breaking transmission. Most member states now have national contact tracing apps. The European Federated Gateway Server (EFGS) enables cross-border tracing.

Safe travel, with a possible increase in travel over the end-of-year holidays requiring a coordinated approach. Transport infrastructure must be prepared and quarantine requirements, which may take place when the epidemiological situation in the region of origin is worse than the destination, clearly communicated.

Healthcare capacity and personnel: Business continuity plans for healthcare settings should be put in place to make sure COVID-19 outbreaks can be managed, and access to other treatments maintained. Joint procurement can address shortages of medical equipment. Pandemic fatigue and mental health are natural responses to the current situation. Member states should follow the World Health Organisation European Region's guidance on reinvigorating public support to address pandemic fatigue. Psychosocial support should be stepped up too.

National vaccination strategies.

The Commission stands ready to support member states where necessary in the deployment of vaccines as per their deployment and vaccination plans. A common EU approach to vaccination certificates is likely to reinforce the public health response in Member States and the trust of citizens in the vaccination effort.

Background

Today's strategy builds on previous recommendations such as the April European road map on the careful phasing out of containment measures, the July Communication on short-term preparedness and the October Communication on additional COVID-19 response measures. The first wave of the pandemic in Europe was successfully contained through strict measures, but relaxing them too fast over the summer led to a resurgence in autumn.

As long as a safe and effective vaccine is not available and a large part of the population not immunised, EU member Sstates must continue their efforts to mitigate the pandemic by following a coordinated approach as called for by the European Council.

Further recommendations will be presented in early 2021, to design a comprehensive COVID-19 control framework based on the knowledge and experience so far and the latest available scientific guidelines.

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Surviving the pandemic: Lessons from Germany's Mittelstand

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In Germany’s industrial heartland, engineering firms have come up with a recipe for surviving the coronavirus pandemic, write and

Keep spending on research and development even if sales drop, build a financial buffer so you can craft a long-term business plan, be flexible with dealers to keep supply chains intact, have an innovative mindset and see crises as opportunities.

It’s certainly a strategy that is paying off for some of the small and mid-sized 'Mittelstand' companies (SMEs) that together provide almost 60% of all jobs in Germany, according to Reuters interviews with six chief executives.

Commerzbank, the biggest lender to Mittelstand firms, also told Reuters that the number of companies going into “intensive care” was lower than it had feared and there was no rush by its clients to get new credit lines.

Stihl, for example, took an unusual step when lockdowns hit sales of its chainsaws, lawn mowers and hedge trimmers - it carried on making them and helped some of its struggling retailers stay afloat by extending their payment terms, Chief Executive Bertram Kandziora (pictured) told Reuters.

The gambit paid off.

After a tough couple of months, demand soared for Stihl’s tools as people stuck in lockdowns spruced up their gardens. Since May, Stihl has enjoyed double-digit sales growth and is working on Sundays to fill its orders.

To be sure, the landscaping industry has been a sweet spot during the crisis but Stihl’s ability to navigate the lean lockdown months reflects a particular advantage of Mittelstand firms - they are typically family owned, with long-term horizons and strong balance sheets to see them through rough patches.

SMEs in Germany are also generally larger than in other European Union states, surveys by the European Statistics Office, Eurostat, show. Moreover, 90% of German companies - specialist engineering firms featuring prominently among them - are family controlled, says the BVMW Mittelstand association.

The upshot is that fewer German SMEs turned to banks for loans in the April-September period than similar companies in Spain, Italy and France, a European Central Bank survey shows.

An August survey by management consulting firm McKinsey of over 2,200 SMEs in five European countries showed fewer German firms feared they would have to postpone growth programmes than companies in France, Italy, Spain and the United Kingdom.

“Due to the fact that the majority is still family owned, the equity ratio is high and offers a good cushion for difficult times,” said McKinsey partner Niko Mohr, a Mittelstand expert.

Stihl, a family business founded in 1926, took the decision not to become hostage to banks several decades ago.

It has since built up its equity ratio to 70% to ensure it can take business decisions independently of any lenders who may be more focused on the short term.

“Because of the negative attitude of the banks, the family owning the company then came to the conclusion that they should not let the banks dictate their policy but should in future finance the company from their own resources,” Kandziora said.

Arburg GmbH, a family-owned manufacturer of injection moulding machines for plastics processing near Stuttgart, also went into the pandemic with solid finances, which allowed it to look through the crisis.

“The corona pandemic has no impact on our medium- and long-term development and production strategy,” Arburg managing partner Michael Hehl told Reuters. “We firmly believe that it would be completely wrong to put the brakes on innovation now.”

A survey in September survey by Germany’s Mechanical Engineering Industry Association (VDMA) showed a majority of members aim to maintain or raise investment budgets next year, with nearly a fifth planning an increase of 10% or more.

Reuters Graphic

Success stories like Stihl’s belie a mixed COVID-19 picture in Germany. Across all sectors, one in 11 firms is threatened by insolvency, a survey of 13,000 companies by the Association of German Chambers of Industry and Commerce (DIHK) showed.

Patrik-Ludwig Hantzsch at Germany credit agency Creditreform expects 24,000 corporate insolvencies in Germany in 2021 after 16,000 to 17,000 this year.

And businesses more reliant on monthly cash flow are suffering. The German hotel and restaurant association (DEHOGA) said a survey last month of 8,868 businesses in the sector found 71.3% of them feared for their existence.

Commerzbank, however, says many industrial Mittelstand companies have the financial buffers to ride out the storm.

The bank has a team closely scrutinizing the health of its clients, studying everything from business models to figures on customer traffic and holding regular discussions with managers. It is expecting a modest rise in insolvencies once a waiver introduced to keep firms afloat during the crisis is lifted in January, but not the massive rise predicted by some.

“There isn’t a mad rush (for credit),” said Christine Rademacher, head of financial engineering at the bank. “Many of our customers have a buffer and no liquidity issues.”

Koerber in Hamburg is another Mittelstand company - with businesses from artificial intelligence to machines to package toilet paper - that went into the pandemic with solid finances and it has no intention of taking its foot off the pedal.

“We have made and will continue to make sustained and significant investments in research and development and further digitisation this year and next year. The demand for digital solutions has been given a further enormous boost by corona - this is a huge opportunity for us,” Chief Executive Stephan Seifert told Reuters.

In Munich, construction equipment maker Wacker Neuson said it is reviewing some of its investments, but it too is keeping up its R&D.

“The crisis is a balancing act between cost optimisation, a much shorter planning horizon and pressure to innovate,” said Chief Executive Martin Lehner.

The ebm-papst Group, which makes electric motors and high-tech fans, has also kept R&D investment stable this year despite a drop in turnover of almost 30% in April. “Now we are catching up month by month,” said Chief Executive Stefan Brandl.

The company based in Mulfingen is looking to benefit from three trends: air quality, which is at a premium due to the pandemic; digitalisation, which it can serve with fans to cool servers; and demand for products that use less electricity.

For many survivors, the crisis is also accelerating change.

One such company is MAHLE GmbH, which makes auto parts from electric powertrains to air conditioning. It plans to close two German plants and cut other costs to adjust to technological change in its sector and reduced demand due to the pandemic.

But despite an expected drop in sales of about 20% this year, Chief Executive Joerg Stratmann said it is maintaining R&D at a “high level”, such as spending millions on a development centre near Stuttgart with 100 engineers that opened recently.

It remains to be seen whether the Mittelstand is undergoing “creative destruction” - the term popularised in the 1940s by Austrian economist Joseph Schumpeter to describe unviable firms folding to make way for more dynamic enterprises.

But those firms in the right sector with healthy balance sheets say they’re ready to adapt with confidence.

“We want to seize the opportunity of this crisis,” said ebm-papst’s Brandl.

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UK approves Pfizer-BioNTech COVID-19 vaccine, first in the world

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Britain today (2 December) became the first western country to approve a COVID-19 vaccine, jumping ahead of the United States and Europe after its regulator cleared a shot developed by Pfizer for emergency use in record time, write and

The vaccine will be rolled out from early next week in a major coup for Prime Minister Boris Johnson’s government, which has faced criticism over its handling of the coronavirus crisis with Britain enduring the worst official COVID-19 death toll in Europe.

A vaccine is seen as the best chance for the world to get back to some semblance of normality amid a pandemic which has killed nearly 1.5 million people and upended the global economy.

“The government has today accepted the recommendation from the independent Medicines and Healthcare products Regulatory Agency (MHRA) to approve Pfizer-BioNTech’s COVID-19 vaccine for use,” the government said.

Britain touted the approval as a global win and a ray of good hope amid the gloom as big powers race to approve an array of vaccines and inoculate their citizens.

“I’m obviously absolutely thrilled with the news, very proud that the UK is the first place in the world to have a clinically authorized vaccine,” British Health Secretary Matt Hancock said.

China has already given emergency approval for three experimental vaccines and has inoculated around 1 million people since July. Russia has been vaccinating frontline workers after approving its Sputnik V shot in August before it had completed late-stage testing on safety and efficacy.

Pfizer and its German partner BioNTech have said their vaccine is 95% effective in preventing illness, much higher than expected.

The US drugmaker said Britain’s emergency use authorization marks a historic moment in the fight against COVID-19.

“This authorization is a goal we have been working toward since we first declared that science will win, and we applaud the MHRA for their ability to conduct a careful assessment and take timely action to help protect the people of the UK,” said CEO Albert Bourla.

“As we anticipate further authorizations and approvals, we are focused on moving with the same level of urgency to safely supply a high-quality vaccine around the world.”

Britain’s medicines regulator approved the vaccine in record time. Its U.S. counterpart is set to meet on 10 December to discuss whether to recommend emergency use authorization of the Pfizer/BioNTech vaccine and the European Medicines Agency said it could give emergency approval for the shot by 29 December.

“The data submitted to regulatory agencies around the world are the result of a scientifically rigorous and highly ethical research and development program,” said Ugur Sahin, chief executive and co-founder of BioNTech.

Britain’s vaccine committee will decide which priority groups will get the jab first: care home residents, health and care staff, the elderly and people who are clinically extremely vulnerable will be first in line.

Hancock said hospitals were ready to receive the shots and vaccination centres would be set up across the country but he admitted distribution would be a challenge given that the vaccine must be shipped and stored at -70C, the sort of temperature typical of an Antarctic winter.

Pfizer has said it can be stored for up to five days at standard refrigerator temperatures, or for up to 15 days in a thermal shipping box.

Johnson said last month that Britain had ordered 40 million doses of the Pfizer vaccine - enough for just under a third of the population as two shots of the jab are needed per person to gain immunity.

Other frontrunners in the vaccine race include U.S. biotech firm Moderna, which has said its shot is 94% successful in late-stage clinical trials. Moderna and Pfizer have developed their shots using new messenger RNA (mRNA) technology.

AstraZeneca said last month its COVID-19 shot, which is based on traditional vaccine technology, was 70% effective in pivotal trials and could be up to 90% effective.

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