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EAPM: Stronger together against cancer and with good data sharing

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Good morning, one and all, and welcome to the European Alliance for Personalised Medicine (EAPM) update – there is much positivity concerning the battle against cancer and the consultation on the health data sharing plan, so some refreshing good news after all the recent COVID-related despondency, writes EAPM Executive Director Dr. Denis Horgan.

Porto Declaration on Cancer Research

The Porto Declaration on Cancer Research was launched during the European Cancer Research Summit 2021, held on 3 May at the Portuguese Institute of Oncology (IPO) in Porto under the Portuguese Presidency of the Council of the European Union.

The declaration presented by Portuguese Minister Manuel Heitor is the result of the work done by several researchers, scientific and clinical leaders and political decision-makers, who have reinforced the need to broaden Europe's Beating Cancer Plan over recent months, particularly through extending and reinforcing the European network of Comprehensive Cancer Centres (CCCs), based on the reinforcement of three types of research infrastructure:

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Translational research infrastructure
Clinical and prevention trial infrastructure
Outcomes research infrastructure

These infrastructure components are increasingly being deemed critical to prevention, early detection, diagnosis, treatment, monitoring disease treatment and patient support and assistance. National participation in the European network of Comprehensive Cancer Centres is led in Portugal by the “Porto Comprehensive Cancer Centre”, based in the Porto IPO, in partnership with its associated laboratory, i3S, which recently received funding of around EUR 15 million for new equipment under the North Regional Operational Programme.

The Porto Declaration on Cancer Research strengthens the commitment of the Trio Presidency of the Council of the European Union (Germany, Portugal and Slovenia) to significantly reduce cancer mortality by 2030, with a goal of 75% of cancer patients in Europe surviving for at least 10 years. Ensuring this goal across Europe means reinforcing the development of a continuum of research activities, from basic to clinical research, including the reinforcement of the European network of Comprehensive Cancer Centres and the three research infrastructure components mentioned above, as well as active participation by the patients and their associations in order to mitigate social and economic inequalities.

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The Porto Declaration on Cancer Research thus calls on all European citizens and their Member States to stimulate the synergies in the areas of regional, national and European funding so that cancer research infrastructure access will be easier and fairer.

Speaking at the Cancer Research Summit on 3 May, Health Commissioner Stella Kyriakides said that it’s key the Commission’s Cancer Plan “works hand in hand” with the Horizon Europe Mission on Cancer in order to “ensure coherence between research goals and policy objectives.”  screening program was suspended five years ago due to low turnout and needs to be upgraded, she explained. 

Consultation on health data sharing plan opened by Commission

On 3 May, the Commission published an open public consultation on the European Health Data Space (EHDS) - an important building block of the European Health Union. The EHDS aims to make full use of digital health to provide high-quality healthcare and reduce inequalities. It will promote access to health data for prevention, diagnosis and treatment, research and innovation, as well as for policy-making and legislation. The EHDS will place individuals' rights to control their own personal health data at its core. The consultation will remain open for responses until 26 July 2021. Health and Food Safety Commissioner Stella Kyriakides said: ″The European Health Data Space will be a crucial component of a strong European Health Union. It will enable EU-wide collaboration for better healthcare, better research and better health policy making. I invite all interested citizens and stakeholders to take part in the consultation and help us leverage the power of data for our health. This will have to rest on a strong foundation of non-negotiable citizens' rights, including privacy and data protection.″

Innovative solutions and digital technologies including artificial intelligence (AI), can transform healthcare systems. They make them more sustainable and improve people's health. The development of these technologies requires secure access by researchers and innovators to substantial amounts of health data.

This public consultation focuses on:

the access to and use of health data for healthcare provision, research and innovation, policy-making and regulatory decision;

fostering a genuine single market for digital health services and products, including innovative ones.

The creation of a European Health Data Space is one the key priorities of this Commission in the area of health. The purpose of the EHDS is to promote health-data exchange and support research on new preventive strategies, as well as on treatments, medicines, medical devices and outcomes. In the Communication on the European Strategy for Data, the Commission announced its objective to deliver concrete results in the area of health data and to understand the potential generated by developments in digital technologies. The collection, access, storage, use and re-use of data in healthcare present specific challenges that need to be addressed.

This requires a regulatory framework that best serves individuals' interests and rights, especially as regards the processing of sensitive personal health data. In this context, the Commission adopted its Data Governance Act proposal (2020) with conditions regarding access to data, and provisions to foster trust in voluntary data sharing. Facilitating better access to, and exchange of, health data is essential to ensure increased accessibility, availability and affordability of healthcare. It will stimulate innovation in health and care for better treatment and outcomes, and encourage innovative solutions that make use of digital technologies, including AI.

Health commissioner offers sweeping ambitions for pharma reform and health committee publishes draft response to pharma strategy

No patient in Europe should have to go without medicines that he or she needs due to money or other obstacles, Health Commissioner Stella Kyriakides has said. 

Speaking at an event organized by the European Commission and the Portuguese EU presidency, Kyriakides pledged that EU’s pharmaceutical strategy will tackle the core issues that make medicines unavailable to those who need them. 

The strategy will culminate with a legislative proposal, planned for 2022, revising the EU’s basic pharma rules, which will open the door to the overhaul. 

Kyriakides’ willingness to tear up the current rules may make drugmakers nervous, since they rely on perks like market exclusivity to protect their bottom line. The 2022 reform will take into account “the relationship with intellectual property rights to address aspects that impede the competitive functioning of markets,” she noted. “The failures of markets should not be the failures of our health systems.”

The European Parliament’s Committee on the Environment, Public Health and Food Safety has published a draft response to the Commission’s Pharmaceutical Strategy. The draft report is authored by Spanish MEP Dolors Montserrat from the European People’s Party who is rapporteur for the pharmaceutical strategy. The document calls on the Commission to push ahead with a number of priorities that it identified in the pharmaceutical strategy, which it published in November. Among the demands made in the draft is a call on the Commission “to incorporate new criteria into the system of incentives for research into and the development of new medicines for unmet therapeutic needs.” It also asks the Commission to review incentives and improve price transparency.

EU pharma vulnerabilities

The executive arm of the European Union on Wednesday (5 May) moved to reduce the bloc's dependence on foreign supplies of products in key fields such as pharmaceuticals and digital technology. The initiative forms part of an updated industrial strategy aimed at strengthening the EU's single market, and was presented alongside a proposal for new regulations to tackle distortions caused by foreign subsidies in the bloc.

The European Commission's new industrial strategy is an update from one made in March 2020, before the World Health Organization declared COVID-19 a pandemic. Coronavirus has wreaked havoc in the 27-member EU, making itaware that over-reliance on imports for key components such as those required in drug production and semiconductors could disrupt entire sectors.

"We are updating our industrial strategy, applying the knowledge we have accumulated during the pandemic, drawing on lessons learned and the available evidence," European Commission Executive Vice President Valdis Dombrovskis told a news conference on Wednesday. He said that three key factors have influenced the thinking on the new strategy. The pandemic has highlighted some fragilities in the single market when exposed to particular types of disruption. There has been a growing trend in many jurisdictions to analyze vulnerabilities in key strategic value chains. And the business case for the EU's green and digital transition has become even stronger, Dombrovskis said.

Europe depends on third countries, primarily China and India, in its pharmaceutical supply chains, according to a Commission staff working document.

WHO’s emergencies programme ‘can't deal with multiple crises’

The coronavirus pandemic has revealed that the World Health Organization’s health emergencies programme is “inadequately equipped to deal with a global pandemic while simultaneously responding to other emergencies”, with chronic under-funding and under-staffing leaving it overstretched in some areas, a new report has found.

The report, penned by the Independent Oversight and Advisory Committee for the WHO’s health emergencies programme, covers May 2020 to April 2021 and will be presented at the World Health Assembly later this month. The committee is chaired by Felicity Harvey, a visiting professor at Imperial College London’s Institute of Global Health Innovation.

The programme had to leverage the entire organization during the pandemic and strengthen partnerships with member countries and expert groups to overcome those challenges, the panel found.

The report made specific mention of the Access to COVID-19 Tools Accelerator, of which COVAX is part of, noting that it has “struggled with shortfalls of political will and global solidarity, limited production capacity of vaccines and insufficient financial investment.”

Digital Green Certificate

The EU’s so-called COVID passport – the Digital Green Certificate – to travel freely during the pandemic should be ready for use from the end of June, according to Justice Commissioner Didier Reynders. At the Committee on Civil Liberties, Justice and Home Affairs (LIBE) of the European Parliament on Tuesday (4 May), Reynders said that the certificate will be in use before the summer. “We want to ensure that all EU citizens receive the same treatment when member states lift restrictions on free movement for holders of vaccines, recovery or test certificates,” he said. Last month, the European Commission presented its proposal for the certificate, which will provide proof that a person has been vaccinated against COVID-19, has natural immunity from it, or has a recent negative test result.

On 26 March, the European Parliament launched an accelerated procedure to fast-track the certificate’s approval, and the Parliament and the Member States are currently negotiating the practical details. In principle, however, the individual member states decide which consequences are attached to the document. These could include, for example, free access to the territory without mandatory quarantine.

And that is all from EAPM for this week – stay safe, stay well, have an excellent weekend, and see you next week.

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

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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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