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Talk is good, action is better on improving European health care

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There is plenty of talk at European level of improving health care, with the COVID pandemic adding its own impetus to the trend – but talk will not be enough to secure real advances for European patients. A policy framework with real actionable agendas, concrete detailed targets and timelines, and clear links among all stakeholders will be essential to integrate innovation and efficiency into Europe’s health-care provision.  

This was argued by speakers from across the health-care sector at the 9th Annual EAPM EU Presidency conference held as a video-conference in Brussels on Monday (8 March) attended by over 180 delegates.

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Science and technology are every day putting new opportunities for care at the disposal of health policy, but health policy is moving more slowly in Europe – too slowly, it was suggested. As Denis Horgan, the executive director of the European Alliance for Personalised Medicine (EAPM), which organized the Presidency conference, put it: “There is an implementation gap in translating Europe’s grand plans into concrete actions. It is necessary to set up systems and investment and instruments that can deliver on the obvious potential.”

There was plenty of evidence of valuable and valiant ambitions at EU level. 

Ceri Thompson, Deputy Head of Unit DG CNECT H3 in the European Commission, responsible for eHealth, Well-being and Ageing, listed the ambitions in digital health, with the upcoming Data Governance Act, Digital Market Act, Implementing Act for the Open Data Directive, and the Data Act – each scheduled to bring new advantages to the health sector.

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The European Health Data Space was scheduled to appear before the end of this year, and will be followed by a cascade of other initiatives, in cancer imaging, diagnostics and treatment, genomics, cybersecurity, and work on digital twins over the next five years.

Ortwin Schulte, Health Attaché at the Permanent Representation of Germany to the EU, spelled out the recent progress on the EU plan for a more coordinated approach to health technology assessment – which might, he revealed, reach the stage of joint talks between Commission, Parliament and Council this month after three years of discussion among member states. He also observed how Covid had given an impulse to EU political coordination on health, which – despite some continuing national reservations about the precise division of competences – was now leading to a new level of integrated health policy.

Christine Chomienne, vice chairman of the Mission Board Cancer at the European Commission and Professor of Cellular Biology at the Université de Paris, described the joint work of the Cancer Mission as an unprecedented level of co-operation. 

Ciaran Nicholl, head of the Health in Society Unit, Joint Research Council outlined the evolution of the Knowledge Centre on Cancer, scheduled for launch in mid-2021, as an example of working across the Commission services and with stakeholders to build an aligned approach to tackling cancer.

And Daria Julkowska, co-ordinator of the European Joint Programme on Rare Diseases, reported on progress with new approaches to data coordination, working with stakeholders towards the creation of a virtual platform that can offer federated, standardised GDPR- compliant, sustainable and quality assessed data.

Stephen Hall, European Regional Director for Precision Oncology at Novartis, expressed industry's full support for the move towards developing personalised medicine with a constant move to greater selection of treatments in line with individual patients'responsiveness.

But – and it was a big but – there was also plenty of evidence of where the opportunities are not being fully taken advantage of.

Former European health commissioner Vytenis Andriukaitis pointed to a continuing lack of appreciation among national governments of the merits of working together on health – typified, he said, by the spectacle of member states cutting spending on the Europe4Health programme in the teeth of a pandemic. He spoke of a long history of member states failing to coordinate, paying only lip-service to the concept - as the still-unresolved three-year stand-off in agreeing on joint health technology assessment demonstrated.

Nicholl admitted it was a persistent challenge for many stakeholders to work together: "We know what the needs are, but the question is whether we can work together to meet them."

Julkowska recognised that co-ordination on rare disease "is difficult because of the intrinsic complexity of the issues and the wide range of stakeholders". It is, she said, important to remove barriers to innovation.

Hall pointed to the contrasting priorities of the industry and of society on the development and deployment of biomarkers, and cautioned against excessively rigid interpretation of the upcoming new EU legislation on diagnostics. "We will have to work with policy makers to adjust it to obtain more flexibility," he said.

Thompson  also recognised, on issues such as disparate national implementation of the General Data Protection Regulation, "different member states with their different health systems have their own approaches, and this is a task for them.

Chomienne said success of the Cancer Mission would depend largely on ensuring effective links with all stakeholders – "and that takes time", she said. "It is important to bring all member states on board – not just the 'usual suspects'".

And speaker after speaker identified bottlenecks and unresolved issues that still demanded a stronger sense of coordination, and more senior-level policy support.

Horgan summed it up in his conclusions to the meeting: "There is an implementation gap that must be filled", he said. "To translate the grand plans into concrete actions, support will be needed in terms of systems and investment and instruments, and a greater sense of engagement by all member states."

"Successful development and deployment of health-care innovation depends on a policy framework in which countries would find it easier to reach consistent decisions and to provide clearer funding arrangements, thus boosting access and continued development."

An editorial report will be available in the next few days. 

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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.

More information

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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