Sophie Beaupère

Exciting news! 🎉 After rigorous negotiations, the European Health Data Space (EHDS) has been adopted in the European Parliament’s plenary session, just in time before the #Europeanelections and the new mandate. 🗳️ 🇪🇺 What can the EHDS bring to healthcare in Europe? 🏥 This proposal has three defining objectives ✅:  - Allowing data-sharing to enhance patient care.  - Setting the rules for health records systems and wellness applications offered on the market.  - Harnessing the potential of health data to drive research and innovation in healthcare.  🔍 Let’s take a closer look at some of the key provisions: - The final agreement includes the right for individuals to opt out from sharing their electronic health data for secondary purposes. However, Member States may override the opt-out decisions in specific situations of public health interest.  - Member States have the flexibility to implement additional safeguards for highly sensitive data, such as full genome sequences, biobanks, and wellness application data.   - In contrary to the original Commission proposal, the final text introduces a specific article dedicated to safeguarding intellectual property rights and trade secrets.  - Storage and processing of personal health data will be performed in the EU in principle, with exemptions for territories covered by an adequacy decision subject to Article 45 GDPR.  - A self-certification scheme for the electronic health records system is to be placed on the market, through a digital testing environment to be developed by the European Commission.  What’s next? 🤔 While this crucial milestone has been achieved, the agreement will need to go through legal-linguistic translation to refine the language and legal aspects of the text. This means the new Parliament and Council are expected to vote on the final version of the text after summer. The EU institutions are aiming for formal adoption of the file in Q4 2024. 🍂📅 The Regulation will apply two years after entering into force. It is expected that the EHDS infrastructure and governance framework will be fully operational within three to five years. 🕒    #EHDS #EuropeanHealthDataSpace #EU

21

📢 Navigating the French Assurance Maladie’s 30 priorities. But what matters most ? Assurance Maladie’s latest report for 2025 outlines several key initiatives aimed at improving the French healthcare system. However, a critical examination reveals a stark contrast between the proposed measures and the financial realities of the system. 📉 Proposals Overview: 💊 Reducing Medical Waste: The plan to cut down on unused medical supplies is significant. However, without clear strategies for implementation, this goal may fall short of addressing the root causes of medical waste. 🩺 Chronic Disease Management: Systematic screenings for cardiovascular and chronic conditions are proposed. Yet, the report does not fully consider the added burden on the already strained healthcare workforce or ensure equitable access across all regions. 🧪 Improving Cancer Screenings: Expanding access to cancer screenings is a step forward. However, the report does not adequately address the low participation rates driven by cultural and socioeconomic barriers. 🧠 Mental Health: Enhanced support for mental health is needed, especially given the rise in antidepressant use among youth. Yet, the lack of concrete action plans and resource allocation could undermine these efforts. 👩‍⚕️ Women’s Health: The proposed cardiovascular screenings for postmenopausal women and improved management of endometriosis are important. However, these measures need to be part of a broader strategy to address gender disparities in healthcare access and outcomes. ♻️ Environmental Impact: The ambition to decarbonize healthcare is notable. Still, the financial strain of implementing these practices in an already strained system raises questions about the relevance, feasibility and timing of such initiatives. Critical Perspective: Frederic Bizard highlights a concerning gap between Assurance Maladie’s proposals and the financial realities. The report aims for €1.6 billion in savings by 2025, but with 70% of these savings expected from price reductions, 25% from tackling fraud, and only 5% from managing chronic diseases despite these conditions driving 80% of expense growth there are serious concerns about the effectiveness of these measures. The real challenge lies in bridging the gap between the proposed initiatives and the systemic realities. While the report outlines various measures, it often lacks a cohesive strategy and actionable plans, reflecting broader governance and execution issues. As we approach 2025, it is crucial that these proposals are not just theoretical but translate into meaningful, real-world improvements for the healthcare system. 🌍💡 Antoine Bassel Amer https://lnkd.in/d5b55d28 

6

[#Article] Check out our DemoCan chair's article copublished in the European Journal of Human Genetics! ⤵ 📰 Psychological and ethical issues raised by genomic in paediatric care pathway, a qualitative analysis with parents and childhood cancer patients ✏ Marion Droin-Mollard, Sandrine de Montgolfier, GIMENEZ-ROQUEPLO Anne-Paule, Cecile Flahault, Arnaud Petit, Franck Bourdeaut, Sophia Julia, Emmanuelle Rial-Sebbag, Isabelle COUPIER, Fatoumata S., Laurence Brugières, Léa Guerrini-Rousseau, Béatrice Claret, Hélène Cavé, marion strullu, Lucile Hervouet, Khadija Lahlou-Laforêt 💻 https://lnkd.in/dwEe4nit ⬇ Abstract ⬇ In paediatric oncology, genomics raises new ethical, legal and psychological issues, as somatic and constitutional situations intersect throughout the care pathway. The discovery of potential predisposition in this context is sometimes carried out outside the usual framework. This article focuses on the views of children, adolescents, and young adults (AYA) with cancer and their parents about their experience with genomic testing. Forty-eight semi-structured interviews were performed with children or AYAs with cancer and one of their parents, before and/or after receiving the genetic test results. The interviews were fully transcribed, coded and thematically analysed using an inductive method. This analysis revealed several themes that are key issues: perceived understanding and consenting, apprehension about the test outcomes (expectations and fears), perception and attitude towards incidental findings. The main expectation was an aetiological explanation. Children and AYAs also emphasised the altruistic meaning of genetic testing, while parents seemed to expect a therapeutic and preventive approach for their child and the rest of the family. Parents were more concerned about a family risk, while patients were more afraid of cancer relapse or transmission to their descendants. Both groups suggested possible feelings of guilt concerning family transmission and imaginary representations of what genomics may allow. Incidental findings were not understood by patients, while some parents perceived the related issues and hesitated between wanting or not to know. A multidisciplinary approach would be an interesting way to help parents and children and AYAs to better grasp the complexity of genetic and/or genomic testing. #PublicHealth #Ethics #Paediatrics #Psychology Cc. Aix-Marseille Université, Inserm, IRD, Société Française de Santé Publique (SFSP), Santé publique France, EUPHA - European Public Health Association, AP-HP, Assistance Publique - Hôpitaux de Paris, EHESS - École des hautes études en sciences sociales, Université Paris-Est Créteil (UPEC), ISSPAM, Université Paris Cité, Hôpital Armand-Trousseau, Institut Curie, Hôpital Purpan, Université de Toulouse, CHU de Montpellier, Gustave Roussy

9

Many stakeholders discussed yesterday in #Brussels the importance of the EU’s global competitiveness for Europeans living with rare diseases. Caroline Ven , CEO of #pharmabe, stressed that competitiveness is key. pharma.be’s memorandum for the 2024 national elections is entitled “For a healthy Belgium”. Healthy in terms of both its citizens and the economy of the country. Caroline Ven: “To secure future #competitiveness of the #EU, three cornerstones need to be in place: increased fundamental R&D the right conditions for entrepreneurship and performant national #healthcare systems, including sufficient budgets for innovative treatments including for rare diseases.”. “For example, only 53% of the 19 orphan dossiers, including advanced therapy medicinal products ( #ATMPs), analysed in 2023 by the Belgian Commission of Reimbursement led to reimbursement.”. In addition, she focussed on the many Unmet Medical Needs still existing. Industry has the addressing of #UMNs at its very core. But sometimes it takes huge efforts, e.g., $ 42 billion has already been spent on clinical trials for Alzheimer’s diseases, without a cure being available yet. At the same time, it is not just about breakthrough #innovation, room for incremental innovation is absolutely crucial: this is true across industries. The return on investments, also in R&D for rare diseases, is essential to ensure the virtuous cycle of biopharmaceutical R&D: current earnings are invested in the treatments of the future. #GlobalCounsel EURORDIS-Rare Diseases Europe @Radiorg Eva Schoeters EFPIA - European Federation of Pharmaceutical Industries and Associations EUCOPE - European Confederation of Pharmaceutical Entrepreneurs EuropaBio - the European Association for Bioindustries UCB Novo Nordisk Sanofi Belgique Takeda in Belgium #rarediseases #orphandrugs #Belgium Emma Eatwell Stefan Joris Alexander Natz Daria Julkowska

103

1 commentaire

OSE Immunotherapeutics thanks the clinical experts who spoke on cancer vaccines (Le Parisien post-ESMO, 09/15) for their clinical vision of these new therapies, in particular on Tedopi®, the therapeutic vaccine against non-small cell lung cancer, the potentially targeted patient population is approximately between 100,000 to 150,000 patients expressing the HLA-A2 target worldwide. To read in Le Parisien post-ESMO : “Some vaccines are intended to fight allergies or certain rarer diseases, and the remaining third are intended to fight cancers of all types. This last group is also the most revolutionary” … “For OSE Immunotherapeutics cancer vaccine, researchers estimate that the target population represents approximately 15% of patients with lung cancer. Some vaccines will have to be personalized for each patient, if there is no common target for the same type of cancer.” #lung cancer #cancer vaccine

23

🔬 𝗡𝗲𝘄 𝗔𝗱𝘃𝗮𝗻𝗰𝗲 𝗶𝗻 𝗣𝗿𝗲𝗱𝗶𝗰𝘁𝗶𝗻𝗴 𝗥𝗲𝘀𝗽𝗼𝗻𝘀𝗲 𝘁𝗼 𝗜𝗺𝗺𝘂𝗻𝗼𝘁𝗵𝗲𝗿𝗮𝗽𝘆 𝘁𝗵𝗿𝗼𝘂𝗴𝗵 𝗰𝗳𝗗𝗡𝗔! 💡   A recent study shows that analyzing circulating cell-free DNA (cfDNA) fragmentome can predict early response to immunotherapy, regardless of cancer type or treatment. 💪 Thanks to the 𝗕𝗶𝗮𝗯𝗼𝗼𝘀𝘁𝗲𝗿 technology, which identifies specific profiles of circulating DNA fragment sizes, fragments longer than 1,650 base pairs have been identified as a key predictive marker. 🧬   📈 Patients with a higher proportion of these fragments have improved progression-free survival, paving the way for more personalized monitoring and treatment optimization.   Find the full interview with Professor SALAS at ESMO 2024: https://lnkd.in/eufJ7Ryh (English Subtitles available)   ID SOLUTIONS, exclusive partner and distributor of ADELIS Technologies' solutions.   #Immunotherapy #Cancer #cfDNA #Innovation #PersonalizedMedicine

5