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EAPM: Keeping tabs on lung cancer and Commission pharma strategy

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Good day, and welcome, health colleagues, to the first European Alliance for Personalised Medicine (EAPM) update of the week. We have more news on the upcoming EAPM round table on lung cancer, as well as all the usual health-care updates, writes European Alliance for Personalised Medicine, Executive Director Denis Horgan.

Lung-cancer screening and European Beating Cancer Plan

Yes, we are all aware that by far the best way to reduce numbers of lung cancer patients is to persuade smokers to stop. Although not all sufferers are, or have ever been, smokers. High-risk groups exist, of course, and early diagnosis is vital. Currently, five-year survival rates stand at a mere 13% in Europe and 16% over in America. This will be discussed in our upcoming event on 10 December. 

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It is the most commonly found cancer in men and lung cancer in women is being represented by a “worrying rise” according to the World Health Organization.  Some one billion people on the planet are regular smokers. And figures show that lung cancer causes almost 1.6 million deaths each year worldwide, representing almost one-fifth of all cancer deaths. 

The European Respiratory Society and the European Society of Radiology (also a supporter of the event, as is the European Cancer Patient Coalition - ECPC), the societies have recommended screening for lung cancer under the following circumstances: “In comprehensive, quality-assured, longitudinal programmes within a clinical trial or in routine clinical practice at certified multidisciplinary medical centres.”

NELSON and victory?

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The NELSON study into computed tomography (CT) screening of lung cancer showed that such screening reduces lung cancer deaths by 26% in high-risk asymptomatic men.  The findings also indicated that, with screening, the results could be even better in women.

For screening to be cost effective, it has to be applied to the population at risk. For lung cancer, this is not simply based on age and sex, as it is in the majority of breast or colon cancer screening. Europe needs to involve all key groups in developing recommendations and guidelines for implementation, adapted according to the healthcare landscape of individual countries. 

Various member states have already shown a willingness to move forward in lung-cancer screening, and several countries representatives will take part in the event.

The Alliance and its stakeholders realize that, among other elements, what is required in Europe is: continuous screening monitoring, with regular reports; assured consistency and enhanced quality of commented data for the screening reports; reference standards for quality and process indicators should be developed and adopted. 

All of the above will be discussed at the lung-cancer screening event, and it is envisaged that a coordinated plan will emerge, which will make its way to Commission and Parliament policymakers and member state health system chiefs.

You can check out the agenda of the 10 December conference here, and register here.

EU Pharma strategy on the horizon 

Affordability, availability and sustainability are the main focus points of the EU’s new pharmaceutical strategy, due to be published tomorrow (25 November). Coming in the wake of the COVID-19 pandemic, the EU’s pharmaceutical strategy aims to “future-proof” the European health-care sector. The new strategy, set to be unveiled on Wednesday, is designed to improve and accelerate patients’ access to safe and affordable medicines while also supporting innovation in the EU pharmaceutical industry. 

Health Commissioner Stella Kyriakides has previously described the strategy as a “cornerstone” of health policy over the next five years. It is considered a key pillar of the Commission’s vision to build a stronger health union, as President von der Leyen set out in her 2020 State of the Union speech. It will also inform the newly proposed EU4Health Programme and align with the Horizon Europe programme for research and innovation, as well as contribute to Europe’s Beating Cancer plan. 

And the European Commission has unveiled the first building blocks of a broader health package aimed at increasing the range of preparedness tools to respond to future cross-border health threats. Patient-oriented approach A first part of the strategy underlines that “research priorities should be aligned to the needs of patients and health systems.” 

Therefore, the whole EU system of pharmaceutical incentives should be reoriented to stimulate innovation in areas of unmet medical needs, such as neurodegenerative and rare diseases as well as pediatric cancer. An example of unmet medical needs mentioned in the document is antimicrobial resistance (AMR), which decreases a doctor's ability to treat infectious diseases and perform routine surgery. By 2022, the Commission will explore new types of incentives for innovative antimicrobials, as well as measures to restrict and optimise the use of antimicrobial medicines.

COVID 'mabs'

The US drug regulatory agency, FDA (Food and Drug Administration), has just issued an Emergency Use Authorization (EUA) for the treatment of mild to moderate intensity COVID-19 in adult and pediatric patients who they have not been hospitalized. The therapy, still under investigation, is based on monoclonal antibodies and goes by the name of bamlanivimab. This therapeutic agent, developed by the pharmaceutical company Eli Lilly, is a monoclonal antibody (mab) similar to those that were part of the cocktail of drugs for COVID-19 that was administered to Donald Trump. 

Beginning EU Health Union

The European Commission is beginning the building of the new European Health Union to help strengthen the EU’s health security framework, and to reinforce the crisis preparedness and response role of key EU agencies. The creation of the European Health Union was announced by the European Commission‘s President, Ursula von der Leyen, in her State of the Union address. The Commission is putting forward a set of proposals to reinforce Europe’s health framework as more co-ordination is needed at an EU level in order to step up the fight against the COVID-19 pandemic and future health emergencies. 

Protecting the health of European citizens

The proposals focus on revamping the existing legal framework for serious cross-border threats to health, as well as reinforcing the crisis preparedness and response role of key EU agencies such as the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA). President of the European Commission, Ursula von der Leyen stated: “Our aim is to protect the health of all European citizens.

The coronavirus pandemic has highlighted the need for more coordination in the EU, more resilient health systems, and better preparation for future crises. We are changing the way we address cross-border health threats. Today, we start building a European Health Union, to protect citizens with high quality care in a crisis and equip the Union and its member states to prevent and manage health emergencies that affect the whole of Europe.” 

Von der Leyen urges gradual lifting of coronavirus lockdowns

European governments should lift coronavirus lockdowns and other social restrictions gradually to prevent a third wave of infections, according to European Commission President Ursula von der Leyen. Europe has been grappling with a second surge in Covid-19 infections since September which has led to the re-introduction of lockdowns in certain countries and an overall stepping up of restrictions across the region. 

Despite a slowdown in cases in some countries in recent days, the numbers are still high and are not yet showing clear signs of a cresting. In the meantime, Europeans are pondering whether they’ll be able to gather with their families over the holiday period.

Vaccine hope

News that the AstraZeneca/Oxford vaccine is effective and could have up to 90% efficacy was met with widespread joy on Monday (23 November). “We expect COVID-19 vaccines to develop into a significant market as new products gain approval and begin to meet the high demand for protection from the disease,” according to a brief analysis by Fitch Solutions. It notes that with more products looking likely to pass regulatory hurdles, “these products will help to develop COVID-19 vaccines into a multi-billion-dollar commercial opportunity”. 

Prices are expected to rise in the short-term as countries look to secure access in light of positive Phase 3 trial results, but over the long-term are expected to fall back as new products enter the market,” the briefing added. “Companies will soon be in a position to capitalize on success in Phase III trials through commanding high prices for vaccines,” the analysis states.

Extra plenary session between Christmas and New Year’s Eve

The European Parliament is preparing for an extra plenary session between Christmas and New Year’s Eve to give its consent to a possible post-Brexit trade deal with the UK, according to several EU officials and diplomats. It is likely to be held on 28 December, to give EU governments the opportunity to have the very last say, as foreseen by the bloc’s procedures, before the end of the UK’s Brexit transition period on 31 December.

Private Greek hospitals compelled to take COVID-19 patients

The Greek government took over two private hospitals in Thessaloniki on 19 November in which transmission of the coronavirus has been particularly widespread. The decision was reached after the private clinics failed to voluntarily provide 200 beds for COVID-19 patients despite appeals by the Health Ministry. Public hospitals in Thessaloniki and other parts of northern Greece have been struggling to cope with the influx of coronavirus patients, adding beds from other wards and setting up isolation tents after reaching their official capacities.

And that is everything from EAPM for now, do stay tuned during the week for further updates on all health-related issues, stay safe, and remember to check out the agenda of EAPM’s 10 December lung cancer round table here, and register here.

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EAPM: Headline event on the crest of a wave in fight against cancer!

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Good afternoon, health colleagues, and welcome to the European Alliance for Personalised Medicine (EAPM) update – the upcoming EAPM event is tomorrow, 17 September! It’s called ‘The need for change: Defining the health-care ecosystem to determine value’ and it will take place during the ESMO Congress, details below, writes EAPM Executive Director Denis Horgan.

Cancer screening, cancer priorities at the political level

The EAPM event comes at a propitious time for forward progress on cancer - Commission President Ursula von der Leyen has announced a new initiative to update a 17-year-old Council recommendation on cancer screening. The new 2022 initiatives were proposed in a letter of intent published during the president’s State of the Union address yesterday (15 September).  

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In addition, political party the EPP has made clear its cancer policy priorities in a 15-point programme. The policy document outlines proposed amendments to the Cancer Committee’s own initiative report. This, along with reform of the cross border health care directive — which in theory allows for patients in one member country to be treated in another — and data sharing being key to applying artificial intelligence and machine learning tools to research, and to enable the digital transformation of health care, have been issues very much at the forefront of EAPM’s recent work, to tackle disparities in cancer prevention, use of data, diagnosis, and treatment around Europe. 

The event will take place from 8h30–16h CET tomorrow; here is the link to register and here is the link to the agenda

Parliament passes two more European Health Union files

Two more European Health Union proposals will move to trilogues after passing in the Parliament’s plenary today (16 September). The proposals for the regulation on serious cross-border health threats passed with 594 votes in favor, 85 against and 16 abstentions. Meanwhile, the mandate change for the European Centre for Disease Prevention and Council (ECDC) passed with 598 votes in favor, 84 against and 13 abstentions.

The first proposal to increase the mandate of the European Medicines Agency (EMA) is already in trilogues. The second meeting will be held later this month.

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Data Governance Act

In preparation of a proposal for a new Data Act expected by December 2021, the European Commission has opened a public consultation.

The main objective of this initiative is to support data sharing within the EU economy, in particular business-to-business and business-to-government, with a horizontal scope (e.g., covering industrial data, Internet of Things, etc.). 

It aims at complementing other data-related files, such as the Data Governance Act, the GDPR and ePrivacy Regulation, Competition Law (e.g. the Horizontal Cooperation Guidelines) and the Digital Markets Act. As reported in politico, this will be tackled by deputy ambassadors in Coreper I on 1 October. An EU official familiar with the process said a few countries asked for minor changes on data intermediaries and international data transfers.

‘Risky’ artificial intelligence 

The U.N. human rights chief is calling for a moratorium on the use of artificial intelligence technology that poses a serious risk to human rights, including face-scanning systems that track people in public spaces. Michelle Bachelet, the U.N. High Commissioner for Human Rights, also said Wednesday that countries should expressly ban AI applications which don’t comply with international human rights law. Applications that should be prohibited include government “social scoring” systems that judge people based on their behavior and certain AI-based tools that categorize people into clusters such as by ethnicity or gender. 

AI-based technologies can be a force for good but they can also “have negative, even catastrophic, effects if they are used without sufficient regard to how they affect people’s human rights,” Bachelet said in a statement. 

Her comments came along with a new U.N. report that examines how countries and businesses have rushed into applying AI systems that affect people’s lives and livelihoods without setting up proper safeguards to prevent discrimination and other harms. “This is not about not having AI,” Peggy Hicks, the rights office’s director of thematic engagement, told journalists as she presented the report in Geneva. “It’s about recognizing that if AI is going to be used in these human rights — very critical — function areas, that it’s got to be done the right way. And we simply haven’t yet put in place a framework that ensures that happens.”

EU digital targets for 2030

The Commission has proposed a plan to monitor how EU countries move forward on the bloc’s digital targets for 2030. The EU will promote its human-centred digital agenda on the global stage and promote alignment or convergence with EU norms and standards. It will also ensure the security and resilience of its digital supply chains and deliver global solutions. 

These will be achieved by setting a toolbox combining regulatory cooperation, addressing capacity building and skills, investment in international co-operation and research partnerships, designing digital economy packages financed through initiatives that bring together the EU and combining EU internal investments and external co-operation instruments investing in improved connectivity with the EU’s partners. The Commission will soon launch a wide-ranging discussion and consultation process, including with citizens, on the EU vision and the digital principles.

EIB backs money for vaccines 

The European Investment Bank’s (EIB) board of directors have approved €647 million to help countries buy and distribute COVID-19 vaccines and other health projects. Vaccine distribution will benefit Argentina, as well as South Asian countries like Bangladesh, Bhutan, Sri Lanka and the Maldives. At the start of the crisis, European Investment Bank staff started working on the health emergency and the economic downturn at the same time. The Bank divided its support for biotechnology and medical companies into three main sectors: vaccines, therapies and diagnostics. The aim: to track infections, stop the spread of the disease and care for those who get sick.

Earlier this year, the Bank approved €5 billion in new financing to support urgent action in fields such as health care and medical innovation for COVID-19. Since then, more than 40 biotechnology or medical companies and projects have been approved for EIB financing worth about €1.2 billion. This put the Bank at the forefront of the fight against COVID-19.

The European Investment Bank is also backing global programmes to distribute COVID-19 vaccines, especially in the developing world. For example, the Bank recently approved a €400 million deal with COVAX, a global initiative supported by hundreds of countries, the private sector and philanthropic organisations to promote equal access to a vaccine.

Good news to finish - Coronavirus vaccines cut risk of long Covid, study finds 

Being fully vaccinated against COVID-19 not only cuts the risk of catching it, but also of an infection turning into long Covid, research led by King's College London suggests. It shows that in the minority of people who get Covid despite two jabs, the odds of developing symptoms lasting longer than four weeks are cut by 50%. This is compared with people who are not vaccinated. 

So far, 78.9% of over-16s in the UK have had two doses of a Covid vaccine. Many people who get Covid recover within four weeks but some have symptoms that continue or develop for weeks and months after the initial infection - sometimes known as long Covid. It can happen after people experience even mild coronavirus symptoms. The researchers, whose work was published in The Lancet Infectious Diseases, say it is clear that vaccinations are saving lives and preventing serious illness, but the impact of vaccines on developing long-lasting illness has been less certain.

That is all from EAPM for this week – we look forward very much to the event tomorrow, and will be reporting on it next week. Until then, stay safe, well, and here is the link to register and here is the link to the agenda

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European plan to fight cancer: Commission reduces presence of carcinogenic contaminants in food

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The Commission is setting new maximum levels for cadmium and lead in a wide range of food products. These measures aim to further reduce the presence of carcinogenic contaminants in food and to make healthy food more accessible. This desire stems from the commitments made within the framework of the European plan to fight cancer. These measures will apply from August 30 for the maximum level of lead and from August 31 for that of cadmium.

Health and Food Safety Commissioner Stella Kyriakides said: “We know that an unhealthy diet increases the risk of cancer. Today's decision aims to put consumers at the forefront by making our food safer and healthier, as we committed to under the European plan to fight cancer. It is also a further step in strengthening the European Union's already high and world-class standards in the EU food chain and providing safer, healthier and more sustainable food to consumers. our citizens. The maximum levels of cadmium, a carcinogenic environmental contaminant, potentially contained in foodstuffs such as fruits, vegetables, cereals and oilseeds, will be made lower for some of these foodstuffs. Certain commodities will also have to fulfill this requirement from the date of entry into force of the new regulation. This measure will enhance the safety of food sold and consumed in the EU and help withdraw food products with the highest cadmium concentrations from the market. In addition, the maximum levels of lead in many food products, including foods intended for infants and young children, will be reduced."

New maximum lead levels will also be established for several foodstuffs such as wild mushrooms, spices and salt. The decisions taken follow years of continuous work by the Commission, member states and the European Food Safety Authority, as well as consultations with food businesses. Cadmium is a toxic heavy metal present in the environment, both naturally and as a result of agricultural and industrial activities. The main source of cadmium exposure for non-smokers is food. As lead is also a naturally occurring contaminant in the environment, food is the main source of human exposure to lead.

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EAPM: Virtual cancer institute on the cards, EMA reform and infectious disease agency

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Good afternoon and welcome, health colleagues, to the European Alliance for Personalised Medicine (EAPM) update – it is the last shout for the upcoming EAPM Slovenian EU Presidency conference (1 July), so don’t forget to register and download your agenda, writes EAPM Executive Director Dr. Denis Horgan.

EAPM Presidency conference a few days away...

The EAPM conference will act as a bridging event between the EU Presidencies of Portugal and Slovenia on Thursday 1 July.

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We’ll be discussing, at some point during the day, most or all of what we’ll be talking about below. The conference is divided into sessions which cover the follows areas:   Session 1: Generating alignment in the regulation of Personalized Medicine: RWE and Citizen Trust; Session 2: Beating Prostate Cancer and Lung Cancer - The Role of the EU Beating Cancer: Updating EU Council Conclusions on Screening; Session 3: Health Literacy - Understanding Ownership and Privacy of Genetic Data and Session 4: Securing patient Access to Advanced Molecular Diagnostics.

Each session will comprise panel discussions as well as Q&A sessions to allow the best possible involvement of all participants, so now is the time to register here, and download your agenda here.

Virtual cancer institute proposed by Committee draft report 

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As highlighted last Friday, the draft report from the European Parliament’s special cancer committee was made available last week.  Presently, this will be open to amendment from European politicians. 

One additional aspect which was included in the report was the proposal of creation of a “virtual European Cancer Institute” was made public today (29 June).  EAPM supports this. 

As discussed last week, the report, authored by France’s MEP Véronique Trillet-Lenoir (Renew Europe), reiterates many of the points and concerns raised in the Commission’s Beating Cancer Plan.

In the report, which aims at strengthening the EU’s response to the disease, Trillet-Lenoir suggests the creation of a virtual cancer institute. The aim of the organization would be to create a road map to co-ordinate “large-scale prevention campaigns and effective communication campaigns on health promotion in educational programmes.” 

The planned institute would also be responsible for connecting and helping to implement many of the elements introduced by the Commission Cancer Plan. For example, it could host the planned Knowledge Centre on Cancer. It could also help create best practices between European Reference Networks and Comprehensive cancer centers. The institute could also help with “identifying research priorities and possibly enable the development of a coordinated and efficient cancer research force in Europe.” 

Of course and as ever, the issue of budgeting is also tackled in the report with a call to member countries to put aside enough money to implement the Commission’s plan, as well as their own national-level cancer plans. “No more than 30 [percent] of Europe’s Beating Cancer Plan should be allocated to the implementation of the [National Cancer Control Programs]”.  A limited budget of €4 billion is set aside at the pan-EU level. 

Parliament's health committee OKs mandate change for infectious disease agency

The European Parliament’s health committee voted today (29 June) in favour of bolstering the mandate of the European Centre for Disease Prevention and Control (ECDC). Sixty-seven MEPs voted in favour, eight against and one abstained, according to the health committee press service. 

Rights and wrongs during pandemic

Commission Vice President Margaritis Schinas spoke to MEPs in the health committee on Monday (28 June), detailing the Commission’s COVID-19 lessons learned document, concerning the rights and wrongs during the pandemic’s past 16 months. The overall lesson? The EU has “not taken health preparedness seriously enough before the pandemic”, Schinas said. 

Schinas didn’t hold back when he said the EU’s early response was “fragmented, ad hoc, temporary,” and measures “were patchy and unco-ordinated” at the EU level. He reminded MEPs of the export bans and personal protective equipment fights colouring the early days of the pandemic, which were an embarrassment for the EU. 

Schinas used the lessons learned to push for more health coordination at the EU level, arguing that only someone with “ill faith … would challenge” that things were better when countries worked together. Schinas drew a parallel to the 2008 financial crisis, which prompted the EU to establish the “banking union”, saying: “There again the EU action was decisive.” 10 different proposals in the lessons learned would help establish a similar health union.

The EPP’s Peter Liese blamed both the Greens and the Left for being wary of advance purchasing agreements for vaccines. He also pushed for more investment on manufacturing capacity, pointing to how the EU allowed exports “without any control” for too long. Michele Rivasi from the Greens, meanwhile, wanted more in the Commission’s communication on the vaccine delivery delays and the “fiasco” on joint purchasing of vaccines, as well as the transparency — or lack thereof — over their contracts and costs. 

WHO says Biased AI health tech could disadvantage poorer countries

While artificial intelligence has the potential to make healthcare more accessible and efficient, it also is vulnerable to the social, economic and systemic biases that have been entrenched in society for generations.

The truth is, humans choose the data that goes into an algorithm, which means these choices are still subject to unintentional biases that can negatively impact underrepresented groups. These biases can occur at any phase of AI development and deployment, whether it's using biased datasets to build an algorithm, or applying an algorithm in a different context than the one it was originally intended for. The most common source of bias is data that doesn't sufficiently represent the target population. 

This can have adverse implications for certain groups. For example, women and people of color are typically underrepresented in clinical trials. As others have pointed out, if algorithms analyzing skin images were trained on images of white patients, but are now applied more broadly, they could potentially miss malignant melanomas in people of colour.

Italian PM Draghi backs EMA reform 

“We need a reinforcement and reform of the EMA,” Italian Prime Minister Mario Draghi has said. As for vaccines: “The controversy is that Sputnik failed to get EMA approval and probably never will. The Chinese vaccine is not enough to fight the epidemic.” 

“The epidemic is not over, we are not out yet. A few weeks ago the UK had more or less equal cases compared to France today. Today they are twenty times more likely, so the epidemic needs more determination, attention and awareness. 

“We need to keep the pressure on the swaps high and we continue to do them. It is very important to immediately identify the development of new variants and infections. We are deploying a lot more,” Draghi added. 

Draghi later responded to a question about how the announced EMA reform would work. “It’s very quick to say, but I’m raised this issue myself. There’s been a certain co-ordination. I hope that other agencies use it in other countries and think about the United States.

That is all from EAPM for now – enjoy the rest of your week, stay safe and well, and don’t forget, it’s your last chance to register for the EAPM Slovenian EU Presidency conference on 1 July here, and download your agenda here!

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