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#EAPM - EU and WHO in firing line. But is it fair?

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Another day, a further EAPM despatch for your delight and delectation…and more developments in the current COVID-19 crisis as the holiday looms, writes European Alliance for Personalised Medicine, Executive Director, Denis Horgan.

UK Prime Minister Boris Johnson is unlikely to be having the best run-up to Easter of his life, having spent a couple of nights (so far) in the ICU at St Thomas' Hospital in London "for close monitoring".

But at least Britain’s Health minister Edward Argar has said Johnson is "comfortable, he's stable, he's in good spirits”.

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With or without Boris, it is unlikely that the UK Government’s three-week review into whether the coronavirus lockdown could be eased will go ahead as planned on Monday, with Asgar saying that the scientific evidence "isn't yet there to allow us to make us a decision".

The minister added: ”We have to be over that peak before we can think about making changes…It’s too early to say when we will reach that peak."

With the aforementioned Easter weekend coming up, it will be interesting to see how many Brits defy strong recommendations to stay at home. It’s fair to say that at the first excuse and during any sunny weather they’ve been a bit naughty.

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EU faces criticism…again

Given the fact that the EU does not have competence in health, as that is the much-guarded gift of Member States, it must be somewhat demoralizing at times for the European Commission to face criticism about what it is doing right now to fight the novel coronavirus and the fall-out on all fronts, fiscal and more.

A good case in point is the resignation of the president of the EUs top science funding agency this week, firing on all cylinders as he left.

Mauro Ferrari, an Italian-American scientist, has only led the European Research Council since January, but in that time has clearly been unimpressed with the EU’s action over the coronavirus crisis.

He says he resigned in the wake of a dispute over the EUs approach and has lost faith in the system”.

Ferrari spoke dramatically of an “internal political thunderstorm” involving the highest levels of the European Commission, adding that: “I have been extremely disappointed by the European response to Covid-19.”

OK, because more broadly, it has in fact been admitted that not everything was right across Europe, but crucially not just at EU level, as the crisis broke.

There were certainly important gaps in the readiness of member states, while those in the Berlaymont didn’t properly realise that individual countries were so badly prepped.

Tellingly, the day after the WHO declared a public health emergency, only four countries across the Union reported they might be short of personal protective equipment in an emergency. That’s come back to haunt everyone.

So is the criticism all fair? 

While the EU is far from perfect, as we at EAPM have noted again and again in our own sphere, it does its best to perform what is a unique balancing act and influences Europe-wide healthcare where it can.

“Hands off our taxation, hands off our pension rates and hands off our healthcare systems!” cry the Member States (funny that these areas involve loads and loads and loads of cash and resources).

Like Frank Sinatra, they do it their way - which is not exactly conducive to the EU trying to coordinate matters in a situation as evidently serious as this one, despite the fact that it is a communal problem and not one that any individual member country is facing toute seule. (Although some are more in the merde than others, at the moment.)

Every member state differs in its history, culture and resources, but one of the key reasons for having the Union in the first place is that we all share a common desire to give citizens a better quality of life.  

The EU provides a framework for that system to work. But it is not allowed to dictate, especially in areas such as healthcare. Therefore the only way forward is by consensus and a willingness on the part of Member States to cooperate for the good of all. That is often woefully lacking in the arena of health.

A quick look at data in the coronavirus context

Data is the big thing these days, and Big Data is the even bigger thing. 

It has become abundantly clear via the current crisis (despite the fact the EAPM and its partners and stakeholders already knew it) that we need better systems of data collection, reporting, centralization and visualization.

Some good systems of surveillance exist in this context but, unfortunately, in the case of crisis situations, they have not been stress tested and arguably do not work effectively. (Remember the banking system of the 2008 crisis? The similarities are scary and, yet, we still have the banking system.)

Meanwhile, despite being theoretically data-rich, we do not accurately know how many deaths there actually have been from Covid-19 across the EU, given that each Member State employs its own methodology. This hardly helps to formulate a truly effective response.

On top of this, health security has been shown to be inadequate, in the sense that - EU-wide - health resources have not been rationally moved from point A to point B when needed.

Blaming and shaming. What’s the point?

So. Where to point the finger? Is there actually any sense in playing the ‘blame game’ when it comes down to it?

Not really.

What’s more important is to identify the issues and fill in the gaps going forward. One of those is EU competence. Don’t blame the EU if you, as an individual member state, tie its hands and refuse to let it do what it actually could do, given the permissions, support and the better degree of legal competence it could actually have in theory.

And spare a thought for the WHO… That, too, is coming under the cosh, not least from everybody’s favourite self-proclaimed ‘stable genius’, US President Donald Trump.

This week, The Man in the White House first announced plans to put a hold on US funding for the WHO, calling it “very China centric” while blasting its guidance early in the crisis.

Then, mere minutes later, he changed his mind and told reporters in Washington DC that he was looking into it”. Heavens above - he then even went so far as to admit that slap-bang in the middle of a devastating global pandemic is “maybe not” the best time to freeze funding. Do you think?

Either way, it is true that the WHO has changed its stance on face masks for the public since the earliest days. Well, sort of. Throughout, however, it has made the consistent point that the very top-quality medical masks should be reserved for healthcare workers”.

OK, so it’s fair to say that the Geneva-based organisation has been a bit waffly on the value (or not) of wearing face masks but, like everyone else, it’s reacting as well and and as quickly as it can and trying to use data that is constantly emerging.

It is a little bit too convenient for countries that haven’t invested enough in their own public healthcare systems and the state/citizen social contract to blame a body with regional offices scattered around the globe.

It’s even more convenient to expect it to act as a gamekeeper in a pandemic situation by chucking a few euros, pounds and dollars at it and expecting miracles. especially back-dated ones.

Like the the powers-that-be in the Berlaymont, the WHO only has certain competences, and certainly not enough funding - nor any God-like powers - that would allow it to contain a potential pandemic on its own. 

The XHO aside, there is, in the end, a serious discussion necessary about competence and funding in regional (ie EU-wide) healthcare. And whether in this context we need more Europe - much more - rather than less.

Meetings…and delays

The European Parliaments Environment, Public Health and Food Safety committee (ENVI) is set to meet on 20 or 21April, with Health Commissioner Stella Kyriakides likely to address it.

However, the Commission’s expected “roadmap to exit” presentation has been put back until after Easter, when it will presumably unveil its thoughts on how Europe can find a common way out of the lockdown. 

Don’t worry. There’s no rush. Most of us aren’t going anywhere, anytime soon…

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US-EU agenda for beating the global pandemic: Vaccinating the world, saving lives now, and building back better health security

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Vaccination is the most effective response to the COVID pandemic. The United States and the EU are technological leaders in advanced vaccine platforms, given decades of investments in research and development.

It is vital that we aggressively pursue an agenda to vaccinate the world. Co-ordinated US and EU leadership will help expand supply, deliver in a more coordinated and efficient manner, and manage constraints to supply chains. This will showcase the force of a Transatlantic partnership in facilitating global vaccination while enabling more progress by multilateral and regional initiatives.

Building on the outcome of the May 2021 G20 Global Health Summit, the G7 and US-EU Summits in June, and on the upcoming G20 Summit, the US and the EU will expand cooperation for global action toward vaccinating the world, saving lives now, and building better health security.  

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Pillar I: A Joint EU/US Vaccine Sharing Commitment: the United States and the EU will share doses globally to enhance vaccination rates, with a priority on sharing through COVAX and improving vaccination rates urgently in low and lower-middle income countries. The United States is donating over 1.1 billion doses, and the EU will donate over 500 million doses. This is in addition to the doses we have financed through COVAX.

We call for nations that are able to vaccinate their populations to double their dose-sharing commitments or to make meaningful contributions to vaccine readiness. They will place a premium on predictable and effective dose-sharing to maximize sustainability and minimize waste.

Pillar II: A Joint EU/US Commitment to Vaccine Readiness: the United States and the EU will both support and coordinate with relevant organisations for vaccine delivery, cold chain, logistics, and immunization programs to translate doses in vials into shots in arms. They will share lessons learned from dose sharing, including delivery via COVAX, and promote equitable distribution of vaccines.

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Pillar III: A Joint EU/US partnership on bolstering global vaccine supply and therapeutics: the EU and the United States will leverage their newly launched Joint COVID-19 Manufacturing and Supply Chain Taskforce to support vaccine and therapeutic manufacturing and distribution and overcome supply chain challenges. Collaborative efforts, outlined below, will include monitoring global supply chains, assessing global demand against the supply of ingredients and production materials, and identifying and addressing in real time bottlenecks and other disruptive factors for global vaccine and therapeutics production, as well as coordinating potential solutions and initiatives to boost global production of vaccines, critical inputs, and ancillary supplies.

Pillar IV: A Joint EU/US Proposal to achieve Global Health Security. The United States and the EU will support the establishment of a Financial Intermediary Fund (FIF) by the end of 2021 and will support its sustainable capitalization.  The EU and United States will also support global pandemic surveillance, including the concept of a global pandemic radar. The EU and the United States, through HERA and the Department of Health and Human Services Biomedical Advanced Research and Development Authority, respectively, will cooperate in line with our G7 commitment to expedite the development of new vaccines and make recommendations on enhancing the world's capacity to deliver these vaccines in real time. 

We call on partners to join in establishing and financing the FIF to support to prepare countries for COVID-19 and future biological threats.

Pillar V: A Joint EU/US/Partners Roadmap for regional vaccine production. The EU and the United States will coordinate investments in regional manufacturing capacity with low and lower-middle income countries, as well as targeted efforts to enhance capacity for medical countermeasures under the Build Back and Better World infrastructure and the newly established Global Gateway partnership. The EU and the United States will align efforts to bolster local vaccine manufacturing capacity in Africa and forge ahead on discussions on expanding the production of COVID-19 vaccines and treatments and ensure their equitable access.

We call on partners to join in supporting coordinated investments to expand global and regional manufacturing, including for mRNA, viral vector, and/or protein subunit COVID-19 vaccines.

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Joint statement on the launch of the joint COVID-19 Manufacturing and Supply Chain Taskforce

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Coronavirus: 200th EU disinfection robot delivered to European hospital, a further 100 confirmed

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On 21 September, the Commission delivered the 200th disinfection robot – to Consorci Corporació Sanitària Parc Taulí hospital in Barcelona. The robots, donated by the Commission, help sanitize COVID-19 patient rooms and are part of the Commission's action to supply hospitals across the EU to help them cope with the effects of the coronavirus pandemic. Further to these initial 200 robots announced in November last year, the Commission secured the purchase an additional 100, bringing the total donations to 300.

A Europe fit for the Digital Age Executive Vice President for Margrethe Vestager, said: “Assisting member states overcome the challenges of the pandemic continues to be a number one priority and these donations – a very tangible form of support – are a prime example of what can be achieved. This is European solidarity in action and I am pleased to see the Commission can go the extra mile in donating an additional 100 disinfection robots to hospitals in need.”

Twenty-five disinfection robots have already been working night and day across Spain since February to help tackle the spread of the coronavirus. Nearly every EU Member State has now received at least one disinfection robot, which disinfects a standard patient room in under 15 minutes, alleviating hospital staff and offering them and their patients greater protection against potential infection. This action is made possible through the Emergency Support Instrument and the devices are supplied by Danish company UVD robots, which won an emergency procurement tender.

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Coronavirus: Commission signs contract for the supply of a monoclonal antibody treatment

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The Commission has signed a joint procurement framework contract with the pharmaceutical company Eli Lilly for the supply of a monoclonal antibody treatment for coronavirus patients. This marks the latest development in this first portfolio of five promising therapeutics announced by the Commission under the EU COVID-19 Therapeutics Strategy in June 2021. The medicine is currently under rolling review by the European Medicines Agency. 18 member states have signed up to the joint procurement for the purchase of up to 220,000 treatments.

Health and Food Safety Commissioner Stella Kyriakides said: “Over 73% of the EU adult population is now fully vaccinated, and this rate will still increase. But vaccines cannot be our only response to COVID-19. People still continue to be infected and fall ill. We need to continue our work to prevent illness with vaccines and at the same time ensure that we can treat it with therapeutics. With today's signature, we conclude our third procurement and deliver on our commitment under the EU Therapeutics Strategy to facilitate access to state-of-the-art medicines for COVID-19 patients.”

While vaccination remains the strongest asset both against the virus and its variants, therapeutics play a critical role in the COVID-19 response. They help to save lives, speed up recovery time, reduce the length of hospitalisation and ultimately ease the burden of health care systems.

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The product from Eli Lilly is a combination of two monoclonal antibodies (bamlanivimab and etesevimab) for the treatment of coronavirus patients who do not require oxygen but are at high risk of severe COVID-19. Monoclonal antibodies are proteins conceived in the laboratory that mimic the immune system's ability to fight the coronavirus. They fuse to the spike protein and thus block the virus's attachment to the human cells.

Under the EU Joint Procurement Agreement, the European Commission has concluded until now nearly 200 contracts for different medical countermeasures with a cumulative value of over €12 billion. Under the joint procurement framework contract concluded with Eli Lilly, member states can purchase the combination product bamlanivimab and etesevimab if and when needed, once it has received either a conditional marketing authorisation at EU level from the European Medicines Agency or an emergency use authorisation in the member state concerned.

Background

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Today's joint procurement contract follows the contract signed with Roche for the product REGN-COV2, a combination of Casirivimab and Imdevimab, on 31 March 2021 and the contract with Glaxo Smith Kline on 27 July 2021 for the supply of sotrovimab (VIR-7831), developed in collaboration with VIR biotechnology.

The EU Strategy on COVID-19 Therapeutics, adopted on 6 May 2021, aims to build a broad portfolio of COVID-19 therapeutics with the goal of having three new therapeutics available by October 2021 and possibly two more by the end of the year. It covers the full lifecycle of medicines from research, development, selection of promising candidates, fast regulatory approval, manufacturing and deployment to final use. It will also coordinate, scale-up and ensure that the EU acts together in ensuring access to therapeutics via joint procurements.

The Strategy forms part of a strong European Health Union, using a coordinated EU approach to better protect the health of our citizens, equip the EU and its Member States to better prevent and address future pandemics, and improve resilience of Europe's health systems. Focusing on the treatment of patients with COVID-19, the Strategy works alongside the successful EU Vaccines Strategy, through which safe and effective vaccines against COVID-19 have been authorised for use in the EU to prevent and reduce transmission of cases, as well as hospitalisation rates and deaths caused by the disease.

On 29 June 2021, the strategy delivered its first outcome, with the announcement of five candidate therapeutics that could soon be available to treat patients across the EU. The five products are in an advanced stage of development and have a high potential to be among the three new COVID-19 therapeutics to receive authorization by October 2021, the target set under the strategy, provided the final data demonstrate their safety, quality and efficacy.

Global co-operation on therapeutics is crucial and a key component of our strategy. The Commission is committed to working together with international partners on COVID-19 therapeutics and make them available globally. The Commission is also exploring how to support the enabling environment for manufacturing health products, while strengthening research capacity in partner countries around the globe.

More information

EU Therapeutics Strategy

Coronavirus response

Safe COVID-19 vaccines for Europeans

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