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Cancer

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

Cancer

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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Cancer

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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Breast cancer

EU health chief: Access to gynaecological cancer treatment differs widely across EU

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There is a large inequality in access to women’s cancer services and treatments across the EU, according to the bloc’s health chief, who highlighted the role of Europe’s Beating Cancer plan in bridging these disparities.

Health Commissioner Stella Kyriakides said there is a need to “break the silence” and talk openly about gynaecological cancers. 

The EU, she added, has “to assure that all women in all corners of the EU, get the support, have access to the screening and the vaccination, the information and the multidisciplinary care that they should be having”.

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Her hopes are on Europe’s beating cancer plan, which must bring “real change”. 

“This is what European citizens expect from us. And I also believe that we don’t have a right to fail them. We have an opportunity and we need to seize it,” Kyriakides said.

Europe’s Beating Cancer Plan was set in 2020 to tackle the entire disease pathway, from prevention to treatment, with the goal to equalise access to high-quality care, diagnosis and treatment across the block.

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Inequalities across the bloc

However, access to cancer detection and treatment currently differs widely across the bloc. 

Antonella Cardone, director of the European cancer patient coalition (ECPC), said screening programs lead to a remarkable reduction in incidence and mortality but “there are major disparities in screening between the different EU member states”.

This means many women are not being diagnosed early enough when the disease is still treatable and “often curable”.

The highest incidence among all women cancers is breast cancer, which accounts for 88% of cancer cases among women. 

But the access to screening that helps early detection of cancer for people at risk ranges from 6% to 90% among member states. Screening for cervical cancer for people at risk ranges from 25% to 80% in the EU.

“These statistics represent […] early detection, which leads to early treatment, and life saved. Or late detection, which often leads to life lost,” said Kyriakides. About 40% of cancer cases are preventable through effective cancer prevention strategies. 

The Commissioner added that the EU cancer plan “aims to offer breast cancer screening to 90% of people who qualify for it by 2025.”

In addition to this, new European guidelines for breast cancer screening diagnosis are being finalised and will be launched at the end of June.

After several years, guidelines on colorectal and cervical cancer should be also released. 

They should “result in better screening and diagnosis, better information and awareness for women and better training for health workers”, Kyriakides said.

Treatment, as well as detection, is also unequal between member states. 

For example, survival rates following treatment for breast cancer vary by 20% among EU countries. 

“I am determined that all patients have the same opportunities for care, no matter where they live in the European Union. The cancer plan aims to support this goal,” Kyriakides said, adding that “psychological, social, nutritional, sexual counselling and rehabilitation programs” will be offered to patients.

More to be done to tackle women cancer

Detection and treatment are not the only parts of the plan that specifically focus on women. 

Human papillomavirus is another target. It causes cervical cancer, which is the second most common cancer among women aged 15 to 39.

The goal, Kyriakides said, “is to eliminate cervical cancer caused by the human papillomaviruses by vaccinating at least 90% of the EU target population of girls by 2030″. 

Romana Jerković, the Croatian socialist MEP and a member of the intergroup on cancer, said that although cervical cancer is preventable with immunisation “vaccination rates against the human papillomavirus are worryingly low in some European countries. It is about time that the member states wrap up their efforts and ensure that their target population is vaccinated”.

Kyriakides added that the plan also addresses “challenges faced by cancer survivors”. 

“We aim to launch the ‘better life for cancer patients’ initiatives, including the creation of a virtual European cancer patient digital centre. This will support the exchange of patient data, and monitoring of survivors’ health conditions,” she said. 

Jerković also highlighted the importance of digitalisation and better data management. 

“Better and faster exchange of the data and the information can be life-saving factors in someone’s treatment,” she said, adding that European health data space will play a huge role in cancer patients’ health data access. 

sra Urkmez, the previous co-chair of The European Network of Gynaecological Cancer Advocacy Groups (ENGAGe), warned that although Europe’s Beating Cancer Plan addresses the issues well, “it’s easier said than done”. She highlighted the importance of staying united “when it comes to such goals”.

Europe’s Beating Cancer Plan will have €4 billion of funding, including €1.25bn from the future EU4Health programme.

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