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EAPM enjoys great success with virtual German EU Presidency conference,  ENVI adopts EU4Health amendments, EU Beyond 1 Million Genomes Event on 21 October

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Greetings colleagues, and welcome to the first European Alliance for Personalised Medicine (EAPM) update of the week. The autumn weather is drawing in, and COVID-19 restrictions appear to be proliferating, but there is thankfully much good news in the health arena, writes EAPM Executive Director Denis Horgan. 

Over and Above: EU Beyond 1 Million Genomes (B1MG) Stakeholders Co-ordination meeting on 21 October, register now

On 21 October, we will be organizing an external meeting for the EU Beyond 1 Million Genomes (B1MG) Stakeholders Co-ordination, which will take place at 8-16h BST/9-17h CET. Register here and read the full agenda here.

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The aim of Beyond 1 Million Genomes (B1MG) is to establish the support and coordination structure for the European 1+ Million Genomes initiative (1+MG), which is based upon the commitment of 22 European member states and Norway that have signed the Declaration ‘Towards access to at least 1 million sequenced genomes in the EU by 2022’. 

The purpose of the meeting is to set the framework for engagement through the lens of the Working Packages which include sessions that address the topics of:  Session 1: Setting the Framework for Co-operation; Session II: Ethics, Legal, Societal Impact; Session III: Standards & Quality Guidelines; Session IV:  Federated Secure Cross-border Technical Infrastructure; Session V: Session V: Delivering Personalised Medicine cross-borders: Implementation in Health Care Systems and Societal Impact and finally, Session VI: Communication, Governance and Sustainability. 

EAPM will of course be providing updates and full reportage on the meeting. Register here and read the full agenda here.

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EAPM German EU Presidency Conference

On Monday (12 October), more than 200 delegates were in attendance at EAPM’s virtual conference. The event, entitled ‘Ensuring Access to Innovation and Data-rich Biomarker Space to Speed Better Quality of Care for Citizens’, was a great success, with many notable contributions from keynote speakers that truly succeeded in pushing the personalised health debate and discussion forward.

There were contributions from more than 15 European politicians, as well as notable input from the European Commission, European Medicine Agency (EMA) and a multitude of key stakeholders from countries including Germany, which is presently hosting the EU Presidency. Look out for a full report later in the week. 

ENVI adopts all EU4Health compromise amendments

The European Parliament’s health committee has passed all compromise amendments for the EU4Health programme. The amendments establish that the Parliament will campaign from €9.4billion — which was the budget originally proposed by the Commission — for the programme, after the Council reduced this to €1.7 billion during budget talks in summer. The health committee’s report sets the Parliament and Commission on the same side of negotiations against the Council. The vote, planned for Monday (12 October), was delayed until this morning due to technical difficulties. 

Kyriakides sees ‘good co-ordination’ on coronavirus border rules

Health Commissioner Stella Kyriakides is citing good co-ordination among countries, citing the new agreement on border rules: “The more harmonization we have, the more we’re able to deal with this crisis,” she said. However, Kyriakides stressed that she wants more EU in health. “This is why the Commission proposed an ambitious EU4Health programme to tackle cross border health threats,” she said. 

European health union plans to be unveiled on 11 November

The Commission will propose its new plans for a European health union on November 11, according to a new College of Commissioners agenda. The agenda shows four proposals scheduled for 11 November, including a plan for “building a European health union: preparedness and resilience”, proposing a regulation on handling serious cross-border health threats and mandate changes for the European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC). The Commission’s pharmaceutical strategy is nevertheless scheduled for 24 November, and Europe’s Beating Cancer Plan for 9 December.

WHO head criticizes 'herd immunity' approach 

The head of the World Health Organization has ruled out a herd immunity response to the pandemic. Herd immunity occurs when a large portion of a community becomes immune to a disease through vaccinations or through the mass spread of a disease. Some have argued that coronavirus should be allowed to spread naturally in the absence of a vaccine. But WHO chief Tedros Ghebreyesus said such an approach was "scientifically and ethically problematic". Speaking at a news conference on Monday, Dr Tedros argued that the long-term impacts of coronavirus - as well as the strength and duration any immune response - remained unknown. "Herd immunity is achieved by protecting people from a virus, not by exposing them to it," he said.

Coronavirus travel restrictions – EU ministers agree first step

EU countries have agreed to common criteria and risk assessments that will be used to create a color-coded map labeling the bloc’s areas of coronavirus low-risk (green), medium-risk (orange), high-risk (red) or unknown (gray). Travel to or from green areas would not be restricted.

The deal is a “first step, which of course must also be followed by others,” Germany’s Minister of State for Europe Michael Roth said ahead of the General Affairs Council meeting, stressing that the principles of the Schengen open border area and the internal market must be upheld as much as possible.

The Commission welcomed the agreement: “The coming together of member states sends a strong signal to citizens and is a clear example of the EU acting where it absolutely should,” it said.

Tougher restrictions for London 'inevitable' in 'next few days' 

It is "inevitable" that London will pass a "trigger point" to enter tougher coronavirus restrictions in the "next few days", Sadiq Khan has said. "All the indicators I have, hospital admissions, ICU occupancy, the numbers of older people with cases, the prevalence of the disease, the positivity are all going the wrong direction," the London mayor said. "Which means, I'm afraid, it's inevitable over the course of the next few days London will have passed a trigger point to be in the second tier." The capital is currently in Tier 1 of the government's three-tier system of coronavirus restrictions, which means an alert level of ‘medium’. 

And that’s all for now from EAPM – enjoy your week, stay safe, and look out for our report on the EAPM conference over the next few days.  Once again, register here and read the full agenda for the Beyond 1 Million Genomes (B1MG).

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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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