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European Alliance for Personalised Medicine

Update: Cancer screening takes centre stage following oncology event in Paris

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Greetings health colleagues, and welcome to the European Alliance for Personalised Medicine (EAPM) update, writes EAPM Executive Director Dr. Denis Horgan.

Screening for the biggest cancer killer: Beating lung cancer through screening guidelines?

Today (20 September) is the day that the European Commission will publish its proposal to update Council recommendations on cancer screening. It’s long overdue: the last Council recommendation dates back to 2003. At the time, testing was only recommended for breast, cervical and colorectal cancer. But since then both technology and our understanding of population health has evolved. 

The benefits of lung cancer screening in terms of economic as well as human outcomes are clear. 

Speaking at an event on Monday night (19 September), Health Commissioner Stella Kyriakides did not miss the opportunity to link the screening recommendations to the EU’s landmark cancer initiative: “Improving early detection is a key priority for the Cancer Plan, and strong screening tools and programmes are crucial for this.”

EAPM held a side event during the premier oncology event at ESMO in Paris last week regarding implementation of the incoming Council recommendation, where we launched a statement of principles regarding the implementation.  This statement of principles leaves no ambiguity about what is at stake, for the European Commission, for EU Member States and for EU citizens. This statement seeks the support of the widest range of stakeholders to urge the creation and endorsement of a comprehensive and effective guideline - and above all, a commitment to implement it so as to make a reality of a fine concept.

At present, despite strides in treatment, lung cancer continues to kill. It is the second leading cause of mortality in EU countries. 2020 figures are expected to show that 2.7 million people were diagnosed with the disease across the 27 member states, causing 1.3 million deaths. By 2035, cancer cases are projected to increase by almost 25%, which could make lung cancer the leading cause of death in the EU. Worldwide, lung cancer is the most commonly diagnosed cancer (accounting for 11.6% of all cancer diagnoses) and the leading cause of cancer-related mortality (18.4% of overall cancer mortality) in both men and women. 

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EAPM has been working on putting lung and prostate cancer screening on the EU political map since 2016 when its first Presidency Conference on this topic was organized. Unfortunately, it seems that lung cancer as well as prostate cancer have taken six years to be included since this first event and 20 years since the recommendations themselves were updated. 

It will be an important next step in the fight against lung cancer that lung and prostate cancer are included in the EU Recommendation on Screening, but it is crucial to ensure it is not merely a tick-the-box exercise with little real benefit for citizens or for the EU: the recommendation themselves should include clear commitments.   

Joint procurement

HERA, has signed a joint procurement Framework Contract with the company HIPRA Human Health for the supply of their protein COVID-19 vaccine. 14 member states and countries are participating in this joint procurement, under which they can purchase up to 250 million doses. As the number of cases is again on the rise in Europe, this agreement will make the HIPRA vaccine rapidly available to the participating countries, as soon as this vaccine has received a positive assessment by the European Medicines Agency.

Health and Food Safety Commissioner Stella Kyriakides said: “With COVID-19 infections on the rise in Europe, we need to ensure maximum preparedness as we head into the autumn and winter months. The HIPRA vaccine adds yet another option to complement our broad vaccine portfolio for our Member States and citizens. An increase in vaccination and boosting is essential over the coming months. We are working tirelessly to make sure there are vaccines available for all. This is our European Health Union in action – preparing ahead and being ready to act.”

Disease knows no borders and nor does EU health care 

The worldwide COVID-19 pandemic highlighted many aspects of world health, but perhaps the most obvious and most important is that diseases have no borders.

So it’s more important than ever to share the health data of EU patients to healthcare professionals, wherever they are in Europe. This growing need for cross-border healthcare in recent years has consequently been a trigger in the adoption of digital health tools.

Currently, two cross-border e-health services are already operational in several European countries. The e-prescription and dispensation allows European citizens to get their medicines from a pharmacy in another member state.

Patient Summary services provide essential background medical information to ensure healthcare for patients coming from another EU country.

Luxembourg has been running the Patient Summary service for two years now. Once the patient agrees to share their health data, doctors can access the necessary medical information for diagnosis and treatment.

At European level the full potential of digital health will be reached in the next few years with the implementation of the European Health Data Space. 

ENVI and LIBE to share health data space file

The much-anticipated European Health Data Space file will be jointly led by the European Parliament’s environment, public health and food safety (ENVI) committee, along with the civil liberties, justice and home affairs (LIBE) committee, according to a parliamentary insider. The two committees will lead on the file under the Parliament’s Rule 58, which allows committees to share responsibilities for files and draft joint reports.

The decision comes after months of deliberation over which committee would take charge of the file on the health data space, a project to reshape access to medical data and its use in research and policy.

A lawmaker from the EPP group will also lead the work on the substances of human origin (SoHO) report in the European Parliament’s ENVI committee, according to the document.

The European Commission’s proposed regulation, published in mid-July, aims to improve the safety and quality standards for people treated with substances of human origin, donors, and children conceived through medically assisted reproduction.

The decision to give both ENVI rapporteur-ships to the EPP group was confirmed Monday evening, and the search for the MEPs who will lead on the EHDS and SoHO files is on.

Those keen to be at the helm have until September 26 at noon to declare their interest, the document says. 

Supply-chain breakdowns

The European Commission’s new emergency tool for handling supply-chain breakdowns faces criticisms that it would grant regulators wide powers to intervene in business decisions, according to some governments and industry groups.

The Commission wants to draw lessons from shortages that hit the European economy during the COVID-19 pandemic. Its Single Market Emergency Instrument (SMEI), which Executive Vice President Margrethe Vestager presented on Monday (19 September), would monitor in-demand products, demand the stockpiling of certain goods and require companies to prioritize certain orders. It would also prohibit export bans between EU countries.

“We fear that the new tool will be too interventionist, giving the Commission the power to steer industries in non-crisis times,” one EU government representative said.

A group of nine countries, including Belgium, Denmark, the Netherlands and Slovenia, has already warned the Commission not to go too far. The diplomat said that some of those countries are still unhappy with the text, as it doesn’t seem to take their concerns into consideration, and pointed to stockpiling measures and extra requirements for companies as key issues.

Internal Market Commissioner Thierry Breton has pushed for an emergency plan, saying until now “we have managed crises with ad hoc, not to say improvised, actions”.

“Now, if a new crisis occurs, we will be better prepared,” he told reporters. 

AI Act: Czech Presidency puts forward narrower classification of high-risk systems

A new partial compromise on the AI Act, on Friday (16 September) further elaborates on the concept of the ‘extra layer’ that would qualify an AI as high-risk only if it has a major impact on decision-making. The AI Act is a landmark proposal to regulate Artificial Intelligence in the EU following a risk-based approach. Therefore, the category of high-risk is a key part of the regulation, as these are the categories with the strongest impact on human safety and fundamental rights. 

On Friday, the Czech Presidency of the EU Council circulated the new compromise, which attempts to address the outstanding concerns related to the categorisation of high-risk systems and the related obligations for AI providers. The text focuses on the first 30 articles of the proposal and also covers the definition of AI, the scope of the regulation, and the prohibited AI applications. The document will be the basis for a technical discussion at the Telecom Working Party meeting on 22 September. 

High-risk systems’ classification In July, the Czech presidency proposed adding an extra layer to determine if an AI system entails high risks, namely the condition that the high-risk system would have to play a major factor in shaping the final decision. 

The central idea is to create more legal certainty and prevent AI applications that are “purely accessory” to decision-making from falling under the scope. The presidency wants the European Commission to define the concept of purely accessory via implementing act within one year since the regulation’s entry into force. 

Health workforce

Europe’s health and care workforce is getting older, and that spells trouble ahead. With many countries facing staff shortages, the situation is concerning as efforts to replace retiring workers are “suboptimal,” the World Health Organization’s Europe office warned in a report published Wednesday.  

At least 40% of doctors are aged 55 or older in 13 of the 44 countries in the WHO European region with available data. 

Care strategy

The European Commission is delivering a long-awaited Care Strategy for Europe. It comes after the pandemic shone a spotlight on countries’ dependency on carers, at home and in the community, and the huge challenges they face in their daily lives and work.

The proposals will be discussed by the European Parliament. They are likely to see pushback from far-right groups which see care of young children as a mother’s role. In cases where families cannot care for their elderly relatives, some on the far right think religious groups should step in. Left-leaning parties want to see carers properly paid, respected and protected, for work done in the family as well as in the community, such as at care homes.

Once Parliament reaches its position, the proposals will go to the Council. But that’s not likely to be this year; the Czech presidency has already got a full agenda of files. That will put pressure on the Swedish and Spanish presidencies to follow through.

And that is everything from EAPM for now. Stay safe and well, and enjoy the week.

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