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#EAPM - From Global Conference to Captain Sir Tom Moore

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Welcome, all health correspondents, to the final European Alliance for Personalised Medicine (EAPM) update for the week, writes EAPM Executive Director Denis Horgan.

Conference a great success

First up, the online EAPM Global Conference on 14 July was a resounding success – more than 480 delegates attended, with key note speakers present from across the world of personalised health. A full report will be available from Monday (20 July), and there is also an EAPM academic publication regarding the revision of the Orphan Regulations, an article entitled ‘Time for change? The why, what and how of promoting innovation to tackle rare diseases’, so be sure to check it out, and there is a little more about the orphan and pediatric regulations below.

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Orphan and pediatric regulations en route from Commission

The European Commission is expected to present by the end of July an evaluation study on the pros and cons of the application of orphan and paediatric regulations, which deal with a niche segment of rare diseases that affect fewer than five in 10,000 people. The Orphan Regulation was introduced in 2000 and its main objective was to address the challenge of treating patients with rare diseases. The number of people who suffer from such diseases in the EU is around 246,000. And the Commission will publish two documents in parallel this month, one is a report commissioned by the Commission from consultancy group Technopolis on the functioning of the Orphan Regulation, which grants prolonged market exclusivity to drugs for rare conditions, and the second is a Commission staff working document that will conclude the evaluation of the regulatory frameworks for orphan and pediatric medicines.

EU health ministers' meeting

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On Thursday (16 July), three EU health ministers voiced broad agreement that the bloc needs enhanced powers in health policy, including beefing up the European Centre for Disease Prevention and Control (ECDC).

In short, the ECDC is going to get bigger, and hopefully better, and ministers agreed it needs more money, more staff and perhaps expanded powers.

WHO launches independent review panel on pandemic

Last week, World Health Organization (WHO) Director General Tedros Adhanom Ghebreyesus launched an independent review panel to evaluate the pandemic response by both the UN and diverse countries.


How much money can EU provide?

To be sure, health groups have some complaints concerning how the EU’s next seven-year budget will be apportioned. While the new EU4Health proposals have been widely acepted, Horizon Europe funding, with European Council President Charles Michel’s latest budget proposal offering €5 billion less than the Commission did for the EU’s flagship research programme, is causing a rift. The EU Health Coalition – which includes Brussels drugmaker and device lobbies, patient groups and other players – said on Thursday: “We are deeply concerned that a budget cut of Horizon Europe would put the EU’s strategic plans on hold. Also, we fear that this would undermine the fragile equilibrium between priorities and global challenges under Horizon Europe, and that the EU budget for health research would be jeopardized.”

Europe leads the field in face mask attitudes

Across Europe, nay, the world, in just a few short months, wearing a face mask has become a legal responsibility. Many now regard it as an essential act of social responsibility — even if others see it as an encroachment of the nanny state, there is no denying the social responsibility that citizens across Europe have shown on public transport, in shops, and many other areas in which individuals are confined.

COVID-19 lays inequalities bare

WHO regional director for Europe Hans Kluge, speaking this past week,
has said that the pandemic has exposed inequalities. “In Europe the people who were the richest, who could go to the ski resorts, sometimes brought COVID back to the poorer sections of the population who could not afford health care,” he said during an event on preparing for a second wave, organized by B20 Saudi Arabia.

UK scientist offers bleak coronavirus assessment

It’s clear that the outcome has not been good in the UK,” Patrick Vallance, the UK government’s chief scientific adviser, told MPs. Speaking before the House of Commons Science and Technology Committee, he said one of the lessons to be learnt from the pandemic was that data flows and data systems were “incredibly important”. At the beginning of the pandemic, he noted, the Scientific Advisory Group for Emergencies (SAGE) would have liked data that was difficult to get — for example, data on care homes. “Improvement in data flows is a key part of management of this and indeed other emergencies as we go forward,” he said.

Commission strengthens preparedness for future outbreaks

The Commission has presented immediate short-term measures to strengthen EU health preparedness for COVID-19 outbreaks. The Commission has from the outset coordinated the exchange of information and recommendations with regard to cross border health actions and measures. A continued vigilance and fast response from the Commission and the member states has been deemed essential to ensure that the spread of the virus can be contained and so that new, generalized lockdowns can be avoided.

The Commission is focusing on all necessary actions needed to enhance preparedness, including testing and contact tracing, improved public health surveillance and widened access to medical countermeasures such as personal protective equipment, medicines and medical devices. Actions also include measures on health-care surge capacity, non-pharmaceutical countermeasures, support to minorities and vulnerable persons, and activities to reduce the burden of seasonal influenza.

Worldwide pressure from pandemic

The COVID-19 pandemic has put unparalleled pressure across the EU and indeed around the world. Many countries had to face widespread transmission of the virus in the community. The EU and its member states have introduced measures to mitigate social and economic impacts, such as maintaining the functioning of the internal market, supporting the transport and tourism sectors, protecting employment and supporting medical care services for vulnerable groups. The Commission has also issued recommendations on travel and border measures necessary to protect the health of our citizens while also preserving the internal market. Member states are increasingly co-ordinating their response, which is absolutely vital in ensuring that the epidemiological situation remains low across the EU. The public health measures taken by the countries helped to decrease the numbers of new infections to a level that was manageable by health systems. This in turn allowed the progressive lifting of the various restrictions imposed and the reopening of most activities, guided by the European road map to lifting of coronavirus measures.

And, finally…

Some good news amidst the coronavirus anxiety and woe – Captain Tom Moore, the UK centenarian who went viral for his zimmer-frame aided fundraising efforts for the NHS, and who raised more than £30 million, is to receive a knighthood today (17 July).

I am certainly delighted and overawed by the fact this has happened to me," he said, according to the BBC. “I thought this can't be true, I've always said this won't happen and it appears it actually has. I certainly never anticipated that this letter would arrive for me.”

The Queen, who is coming out of lockdown for the first time for a face-to-face meeting with Tom, will conduct the ceremony at Windsor Castle.

And that is all for this week – enjoy your weekend, stay safe, see you 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.

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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