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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.

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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Norway again postpones end to COVID lockdown

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A man wearing a protective mask carries shopping bags as he walks on the streets of Oslo following an outbreak of the coronavirus disease (COVID-19), in Oslo, Norway. NTB Scanpix/Hakon Mosvold Larsen via REUTERS

Norway postponed for a second time on Wednesday (28 July) a planned final step in the reopening of its economy from pandemic lockdown, due to the continued spread of the Delta variant of COVID-19, the government said, writes Terje Solsvik, Reuters.

"A new assessment will be made in mid-August," Health Minister Bent Hoeie told a news conference.

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Measures that will be kept in place to halt the spread of COVID-19 include bars and restaurants being limited to table service and limits of 20 people on gatherings in private homes.

The government in April launched a four-step plan to gradually remove most pandemic restrictions, and had completed the first three of those steps by mid-June.

On July 5, Prime Minister Erna Solberg said the fourth step could come in late July or early August at the earliest because of concerns about the Delta coronavirus variant. Read more.

About 80% of adults in Norway have received a first dose of a COVID-19 vaccine and 41% of adults are fully vaccinated, according to the Norwegian Institute of Public Health.

Thanks to an early lockdown in March 2020 and tight restrictions that followed, the nation of 5.4 million people has seen one of Europe's lowest rates of mortality from the virus. Some 800 Norwegians have died from COVID-19.

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EU signs deal with GSK for supply of potential COVID drug

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Company logo of pharmaceutical company GlaxoSmithKline is seen at their Stevenage facility, Britain October 26, 2020. REUTERS/Matthew Childs/File Photo

The European Union has signed a contract with GlaxoSmithKline (GSK.L) for the supply of up to 220,000 treatments of its investigational monoclonal antibody therapy sotrovimab against COVID-19, it said on Wednesday (28 July), write Francesco Guarascio with additional reporting by Jo Mason, Reuters.

The drug, which is developed together with U.S. firm Vir Biotechnology (VIR.O), can be used for the treatment of high-risk coronavirus patients with mild symptoms who do not require supplemental oxygen, according to the Commission.

The deal is a boost to GSK work on potential treatments for COVID-19 after the company played a limited role in the development of vaccines. Rather than making its own coronavirus shot, GSK has focused on supplying its booster to other developers and has partnered with Sanofi (SASY.PA) to develop a jab.

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GSK confirmed the deal in a statement on Wednesday, saying it represented "a crucial step forward for treating cases of COVID-19" in Europe.

The drug is currently being assessed by the European Medicines Agency (EMA) under a rolling review.

It has received emergency authorisation in the United States to treat mild-to-moderate COVID-19 patients who are at high risk of developing a severe infection.

The contract has been backed by 16 of the 27 EU states, which can buy the drug only after it is approved by EMA or by national drug regulators. The price agreed for potential purchases has not been disclosed. A spokesman for the Commission declined to comment on the matter.

Monoclonal antibodies mimic natural antibodies that the body generates to fight infection.

The deal with GSK follows a contract the EU signed in April with Swiss pharmaceutical giant Roche (ROG.S) to secure about 55,000 doses of a potential treatment based on a cocktail of monoclonal antibodies developed by Roche together with U.S. drugmaker Regeneron (REGN.O). Read more.

Apart from monoclonal treatments, the only other anti-COVID drug the EU has bought is Gilead's (GILD.O) remdesivir, an antiviral medicine. Last year, the EU reserved half a million courses after the drug obtained a conditional EU approval.

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Coronavirus disinformation: Online platforms take new actions and call for more players to join the Code of Practice

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The Commission has published the reports by Facebook, Twitter, TikTok, Microsoft and Google on measures taken in June to combat coronavirus disinformation. The current signatories and the Commission are also calling on new companies to join the Code of Practice on disinformation as it will help broaden its impact and make it more effective. Values and Transparency Vice President Věra Jourová said: “The COVID-19 disinformation monitoring programme has allowed to keep track of important actions put in place by online platforms. With new variants of the virus spreading and vaccinations continuing at full speed, it is crucial to deliver on the commitments. We look forward to the strengthening of the Code of Practice.”

Internal Market Commissioner Thierry Breton added: “The EU stood by its promise to deliver enough doses to safely vaccinate every EU citizen. All stakeholders now need to assume their responsibility to beat vaccine hesitancy spurred by disinformation. While we are strengthening the Code of Practice with platforms and signatories, we are calling for new signatories to join the fight against disinformation”. 

For example, TikTok's campaign supporting vaccination, with the Irish government, reached over one million views and over 20,000 likes. Google continued to work with public health authorities to show information about vaccination locations in Google Search and Maps, a feature available in France, Poland, Italy, Ireland, and Switzerland. On Twitter, users can now train automated systems to better identify violations of the platform's COVID-19 disinformation policy.

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Microsoft extended its partnership with NewsGuard, an Edge extension that warns about websites spreading disinformation. Facebook cooperated with international health authorities to increase public awareness of vaccine efficacy and safety and with Michigan State University (MSU) researchers to better detect and attribute deepfakes. These joint efforts need to continue in view of the persisting and complex challenges that online disinformation still presents. The Commission's COVID-19 disinformation monitoring programme has been extended until the end of 2021 and reports will now be published every two months. The next set of reports will be published in September. Following the recently published Guidance, the signatories have kicked off the process to strengthen the Code and launched a joint call for interest for potential new signatories.

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