Developed and funded by AbbVie in collaboration with the World Ovarian Cancer Coalition (the Coalition) and based on an interview with Christel Paganoni-Bruijns, chief executive officer of the Coalition, and Frances Reid, programme director of the Coalition -------------------------------------------------------------------------------- Late diagnoses, burdensome treatments and disease recurrence are realities for many women with ovarian cancer.1,2,3,4,5 Their stories are evidence of systemic challenges impacting care that policymakers have the power to combat. The World Ovarian Cancer Coalition (the Coalition), the only global ovarian cancer patient advocacy organization, is driving evidence generation to inform tangible policy reforms that could reduce the socioeconomic burden of this disease on individuals and wider societies.6 Ovarian cancer is one of the deadliest cancers affecting women in Europe, yet it remains overlooked.7,8 While other areas of women’s health benefit from policy frameworks and public awareness, ovarian cancer continues to sit in the margins, creating real human consequences. In 2022, Europe recorded the highest rates of ovarian cancer incidence and mortality worldwide.8 Only 40 percent of women in Europe remain alive five years after being diagnosed with ovarian cancer, with advanced-stage diagnoses often having poorer outcomes.8 Despite this, ovarian cancer remains absent from many national cancer plans and there is still no unified European policy framework to address it.  In partnership with European patient groups, the Coalition is convening a series of workshops for ovarian cancer survivors to share their experiences. Alongside leading clinicians and advocates, the Coalition is leveraging these testimonies to develop policy recommendations to inform national and European cancer strategies. Christel Paganoni-Bruijns, the Coalition’s chief executive officer, and Frances Reid, programme director and Every Woman Study lead, share their insights into the challenges women with ovarian cancer face and how policy changes can offer improved support. The hidden emotional and physical cost  There are education and awareness gaps that can impede diagnosis and prioritization. Many women believe that cervical cancer screening (otherwise known as the Pap smear) can detect ovarian cancer.9 Another widespread misconception is that ovarian cancer has no symptoms until very advanced stages.10 However, the Coalition’s Every Woman Study (2021) found that nine in 10 women do experience symptoms, even during the early stages.11  “These misconceptions cause real harm. They delay diagnosis, they delay action and they stop women from being heard,” Reid comments.  The ovarian cancer journey can be distressingly complex. Women frequently undergo major surgery, multiple rounds of treatment and long recovery periods.4,12,13 Even after treatment ends, the fear of recurrence can cast a shadow over daily life.  Ovarian cancer often strikes when many women are still working, caring for children, supporting aging parents and contributing to their communities in a variety of ways. 14,15 When they fall ill, the consequences ripple outwards. Some partners have to reduce their working hours or leave employment entirely to care for their loved ones.16 Families may take on emotional strain and financial pressure that can carry lasting impacts.17,18  Reid says: “These women are mothers, daughters, employees, carers, community anchors. When they are affected, the impact is not only personal — it is economic, social and predictable.” The Coalition’s socioeconomic burden study explored the cost to health services, the impact of informal caregiving, productive time lost by patients traveling to and receiving care, and longer-term productivity impacts.17 It found that the majority of the socioeconomic impact of ovarian cancer does not come from health service costs, but from the value of lives lost.17 Across the 11 countries examined, ill-health from ovarian cancer led to lost labor productivity equivalent to 2.5 million days of work.17 In the U.K. alone, productivity losses amounted to over US$52 million per year.17 In 2026, the Coalition will look further into the socioeconomic impact across high-income countries across Europe. Despite this measurable burden, ovarian cancer remains under-prioritized in health planning and funding decisions. Why women still struggle to get the care they need  Across Europe, many women face delays at various stages along their journey, some due to policy and system design choices. For example, without screening methods for early detection, diagnosis relies heavily on recognizing symptoms and receiving timely referrals.1,19,20 Yet many women often struggle to access specialists or face long waits for investigations.2,11,21   While Europe benefits from world-class innovation in ovarian cancer research, access to that innovation can be inconsistent. Recently published data from the European Federation of Pharmaceutical Industries and Associations (EFPIA) found that average time to availability for oncology products in Europe continues to increase, with 2024 data showing time from approval to access was 33 days slower than in 2023 and 66 days slower than in 2022.22 In 2024, it took an average of 586 days — or ~19 months — for patients to access new therapies after approval, with significant variation between countries.22 Delays in treatment impact prognosis and survival for patients with ovarian cancer.23 The challenges in care also extend to psychological and emotional support. The Every Woman Study found that only 28 percent of women were offered mental health support, despite the known vulnerabilities throughout treatment, recovery and recurrence.12   Paganoni-Bruijns and Reid reinforce that through the Coalition’s work, they have often found that “women feel unseen and unheard. They see progress in other cancers and ask: why not us?” What a better future looks like A better future starts with addressing ovarian cancer as part of a holistic vision and plan for women’s health. Europe has the foundational frameworks, infrastructure and clinical expertise to lead the way. What is needed now is political attention and policy alignment that includes ovarian cancer as part of these broader programs.  Paganoni-Bruijns comments: “We cannot keep treating gynecological cancers as if they exist in separate boxes. Women experience their health as one reality, so policies must reflect that.”  Existing structures in breast and cervical cancer offer valuable lessons. Across Europe, millions of women already move through screening programs, health promotion initiatives and established diagnostic pathways.24 These systems could be used to increase awareness of ovarian cancer symptoms, improve referral routes and access to specialist care, and support earlier detection. Increased investment in genetic and biomarker testing, as well as emerging early detection research, can be accelerated by aligning with these established programs. The Coalition is partnering with global experts to translate these lessons into the first-ever evidence-based framework for ovarian cancer mortality rate reduction, however, policy action at the regional and national level must keep pace.  The EU-funded DISARM project is a promising example of the progress underway to help Europe ‘disarm’ the threat of ovarian cancer. DISARM is a coordinated, multi-country effort to strengthen ovarian cancer risk assessment, validate affordable early-detection tools and understand how these innovations can be implemented within real-world health systems. Crucially, it is designed both to generate evidence and to address feasibility, uptake and system readiness, the factors that, together, determine whether innovation actually reaches patients.   As Paganoni-Bruijns explains, “DISARM shows what progress looks like when science, policy and patient experience are designed to work together. It is not about a single breakthrough or ‘quick fix’, but about building the conditions for earlier detection — through better risk assessment, validated tools and systems that are ready to use them.”  Yet projects like DISARM, while essential, cannot carry the burden alone. Without a cohesive European or global World Health Organization framework for ovarian cancer, progress remains fragmented, uneven and vulnerable to delay. Europe has often set the pace for global cancer policy and ovarian cancer should be no exception. By recognizing ovarian cancer as a priority within European women’s health, policymakers can be part of setting the global standard for a new era of coordinated and patient-centered care. Paganoni-Bruijns shares the Coalition’s call-to-action: “The systems exist. The evidence exists. We know that we need to include ovarian cancer in national cancer plans, improve diagnostic pathways, strengthen genetic testing and commit to EU-level monitoring. What is missing is prioritization. With leadership and accountability, ovarian cancer does not have to remain one of Europe’s deadliest cancers.” The stakes are rising and the window for meaningful action is narrowing. But with focused leadership, Europe can change the trajectory of ovarian cancer. Women across the continent deserve earlier diagnoses, access to innovation and the chance to live not just longer, but better. To understand why action on ovarian cancer cannot wait, listen to the Coalition’s Changing the Ovarian Cancer Story podcast series, or visit the Coalition’s website. -------------------------------------------------------------------------------- References 1 Rampes S, et al. Early diagnosis of symptomatic ovarian cancer in primary care in the UK: opportunities and challenges. Prim Health Care Res Dev. 2022;23:e52. 2 Funston G, et al. Detecting ovarian cancer in primary care: can we do better? Br J Gen Pract. 2022;72:312-313.  3 Tookman L, et al. Diagnosis, treatment and burden in advanced ovarian cancer: a UK real-world survey of healthcare professionals and patients. Future Oncol. 2024;20:1657-1673.  4 National Cancer Institute. Ovarian Epithelial, Fallopian Tube, and Primary Peritoneal Cancer Treatment (PDQ) – Health Professional Version. Available at: https://www.cancer.gov/types/ovarian/hp/ovarian-epithelial-treatment-pdq [Last accessed: January 2026]. 5 Beesley et al. Evaluating patient-reported symptoms and late adverse effects following completion of first-line chemotherapy for ovarian cancer using the MOST (Measure of Ovarian Symptoms and Treatment concerns). Gynecologic Oncology 164 (2022):437-445.  6 World Ovarian Cancer Coalition. About the World Ovarian Cancer Coalition. Available at: https://worldovariancancercoalition.org/about-us/ [Last accessed: January 2026]. 7 Manzano A, Košir U, Hofmarcher T. Bridging the gap in women’s cancers care: a global policy report on disparities, innovations and solutions. IHE Report 2025:12. The Swedish Institute for Health Economics (IHE); 2025. 8 ENGAGe. Ovarian Cancer. Available at: https://engage.esgo.org/gynaecological-cancers/ovarian-cancer/ [Last accessed: January 2026].  9 Target Ovarian Cancer. Driving change through knowledge – updated NHS cervical screening guide. Available at: https://targetovariancancer.org.uk/news/driving-change-through-knowledge-updated-nhs-cervical-screening-guide [Last accessed: January 2026]. 10 Goff BA, et al. Frequency of Symptoms of Ovarian Cancer in Women Presenting to Primary Care Clinics. JAMA. 2004;291(22):2705–2712.  11 Reid F, et al. The World Ovarian Cancer Coalition Every Woman Study: identifying challenges and opportunities to improve survival and quality of life. Int J Gynecol Cancer. 2021;31:238-244.  12 National Health Service (NHS). Ovarian cancer. Treatment. Available at: https://www.nhs.uk/conditions/ovarian-cancer/treatment/ [Last accessed: January 2026].  13 Cancer Research UK. Recovering from ovarian cancer surgery. Available at: https://www.cancerresearchuk.org/about-cancer/ovarian-cancer/treatment/surgery/recovering-from-surgery [Last accessed: January 2026]. 14 National Health Service (NHS). Ovarian cancer. Causes. Available at: https://www.nhs.uk/conditions/ovarian-cancer/causes/ [Last accessed: January 2026].  15 American Cancer Society. Ovarian Cancer Risk Factors. Available at: https://www.cancer.org/cancer/types/ovarian-cancer/causes-risks-prevention/risk-factors.html [Last accessed: January 2026].  16 Shukla S, et al. VOCAL (Views of Ovarian Cancer Patients and Their Caregivers – How Maintenance Therapy Affects Their Lives) Study: Cancer-Related Burden and Quality of Life of Caregivers [Poster]. Presented at: International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Europe; 2022 Nov 6–9; Vienna, Austria. 17 Hutchinson B, et al. Socioeconomic Burden of Ovarian Cancer in 11 Countries. JCO Glob Oncol. 2025;11:e2400313. 18 Petricone-Westwood D, et al.An Investigation of the Effect of Attachment on Distress among Partners of Patients with Ovarian Cancer and Their Relationship with the Cancer Care Providers. Current Oncology. 2021;28(4):2950–2960.  19 World Ovarian Cancer Coalition. Ovarian Cancer Testing & Detection. Available at: http://worldovariancancercoalition.org/about-ovarian-cancer/detection-testing/ [Last accessed: January 2026]. 20 National Institute for Health and Care Excellence. Suspected cancer: recognition and referral. Available at: https://www.nice.org.uk/guidance/ng12/resources/suspected-cancer-recognition-and-referral-pdf-1837268071621 [Last accessed: January 2026]. 21 Menon U, et al. Diagnostic routes and time intervals for ovarian cancer in nine international jurisdictions; findings from the International Cancer Benchmarking Partnership (ICBP). Br J Cancer. 2022;127:844-854.  22 European Federation of Pharmaceutical Industries and Associations (EFPIA). New data shows no shift in access to medicines for millions of Europeans. Available at: https://www.efpia.eu/news-events/the-efpia-view/statements-press-releases/new-data-shows-no-shift-in-access-to-medicines-for-millions-of-europeans/ [Last accessed: January 2026].  23 Zhao J, et al. Impact of Treatment Delay on the Prognosis of Patients with Ovarian Cancer: A Population-based Study Using the Surveillance, Epidemiology, and End Results Database. J Cancer. 2024;15:473-483.  24 European Commission. Europe’s Beating Cancer Plan: Communication from the commission to the European Parliament and the Council. Available at: https://health.ec.europa.eu/system/files/2022-02/eu_cancer-plan_en_0.pdf [Last accessed: January 2026].  -------------------------------------------------------------------------------- ALL-ONCOC-250039 v1.0  February 2026 -------------------------------------------------------------------------------- Disclaimer POLITICAL ADVERTISEMENT * The sponsor is AbbVie * The ultimate controlling entity is AbbVie More information here.

January 2026 I GB-73006 Disclaimer  POLITICAL ADVERTISEMENT  * This is sponsored content from AstraZeneca.  * The advertisement is linked to public policy debates on the future of cardiovascular care in the UK.  * This content has been paid for and developed by AstraZeneca UK  Cardiovascular disease (CVD) has shaped the nation’s health for generations. It remains a leading cause of death and a major driver of long-term sickness, yet it is also one of the most preventable. Today, 8 million people in the U.K. live with CVD, and early deaths from CVD in England have reached a 14-year high.1,2 The reality is stark: without urgent action, one million more could live with CVD by 2030 — and two million by 2040.1  Tackling CVD is not only a moral imperative, it’s an economic necessity. In the U.K., 2.5 million working-age people are economically inactive due to long-term sickness, and CVD contributes to long-term sickness at unprecedented levels3 Each year, CVD costs the U.K. economy an estimated £24 billion, straining public finances, dampening productivity and widening inequalities.4  In July 2023, AstraZeneca convened the CVD-risk coalition — with charities, clinical organizations and patient groups — to shape a coordinated response to these trends.   Today, the coalition has published Getting to the heart of the matter: A national action plan for tackling cardiovascular disease5 — a blueprint for decisive action and a call for the government and the NHS to confront CVD head on. It has a clear message: the tools exist to tackle this challenge, but we need leadership, investment, and a focus on prevention and early intervention to unlock meaningful change.  > the tools exist to tackle this challenge, but we need leadership, investment, > and a focus on prevention and early intervention to unlock meaningful change. Diagnosis and prevention gaps we cannot afford   CVD often arises from detectable and treatable conditions: hypertension, high cholesterol, diabetes, chronic kidney disease. Yet millions remain undiagnosed. Six million people in the U.K. don’t know they have high blood pressure — a silent driver of heart attacks, strokes and kidney disease.6,7   This systemic diagnosis gap is not the result of a lack of evidence or clinical consensus; rather, the longstanding pressure on primary and community care, fragmentation across services, and declining investment in public health. Between 2015/16 and 2023/24, funding for key preventative services — including smoking cessation and adult obesity support — fell sharply in real terms.8  Additionally, secondary prevention remains patchy across England. Despite clear treatment guidance from NICE, less than half of patients with CVD meet recommended cholesterol levels. Almost 30 percent of hypertension patients are not meeting recommended blood pressure targets or don’t have a recent blood pressure measurement in their records.9   The consequences are clear: progress on CVD outcomes has stalled, premature deaths are rising and those in England’s most deprived areas are four times more likely to die prematurely from CVD than those in the least deprived.10  > progress on CVD outcomes has stalled, premature deaths are rising and those in > England’s most deprived areas are four times more likely to die prematurely > from CVD than those in the least deprived We must place prevention at the heart of our health system.  A vision for proactive, personalized cardiovascular care  Early CVD prevention and treatment save lives and money. It benefits patients, reduces NHS pressure and strengthens the UK’s economic resilience.   A 20 percent reduction in CVD incidence could save the NHS £1.1 billion annually within five years and place 60-70,000 more people into work.11 Recent CVDACTION modeling suggests that even modest near-term improvements in treatment could prevent approximately 61,000 events of heart attack, stroke, heart failure admission and end-stage kidney disease in three years.12   This is not theoretical. We know what integrated, proactive models can do.   Unlocking the power of data and digital tools  Platforms like CVDPREVENT and CVDACTION already demonstrate how data-driven insights from GP records can flag undiagnosed or undertreated patients — enabling clinicians to prioritize, optimize treatment and thus prevent avoidable heart attacks and strokes every year.13,14  Additionally, as the NHS App becomes a digital ‘front door’, there is an opportunity to deliver personalized risk information, lifestyle guidance and seamless access to services.  But digital transformation requires investment in workforce capability, interoperability between systems and national procurement frameworks that can scale at pace.  Tom Keith Roach A neighborhood approach to prevention  Joined-up neighborhood services — across community pharmacies, general practice, specialist teams and local authorities — could identify risk earlier, manage long-term conditions holistically and reduce avoidable admissions.   Community pharmacy hypertension screening has delivered over two million blood pressure checks in a single year, identifying thousands previously unaware of their risk.15    The LUCID program, developed as part of a joint working initiative between AstraZeneca and University Hospitals Leicester, has shown that integrated care across nephrology specialists and primary care can identify high-risk chronic kidney disease patients and optimize their treatment, reducing emergency admissions and long-term NHS costs.16    But to truly deliver change, resources must be rebalanced toward primary and community care. Cardiovascular prevention cannot be driven from hospitals alone. The neighborhood service must be properly resourced, with contracts and incentives aligned to prevention and outcomes, not activity.  A whole-system effort to transform lives and the economy  The forthcoming Modern Service Framework for CVD, promised within the Government’s 10 Year Health Plan, presents a critical opportunity. This framework must: * Embed prevention into every level of care  * Enable earlier diagnosis using digital and community-based tools  * Support optimal treatment through data and workforce innovation  * Define clear national priorities backed by accountability  CVD is a health challenge and a national prosperity challenge. We cannot afford rising sickness, worsening inequalities, and an NHS stretched by late-stage, preventable disease. The link between health and wealth has never been clearer: investing in CVD prevention will deliver both immediate and long-term returns.  > The link between health and wealth has never been clearer: investing in CVD > prevention will deliver both immediate and long-term returns. The action plan published today provides a clear, evidence-based roadmap.5 It calls for:  * National clinical and political leadership  * Ambitious targets, including a 20 percent reduction in incidence  * Investment in prevention and the expansion of Health Checks  * Improved uptake of effective treatments, guided by data  * Digital and diagnostic excellence across neighborhoods  * Partnership working at every level  A call to action  CVD has affected too many lives for too long. But progress is within reach. The decisions we make today will determine whether the next decade is defined by a widening crisis or a renewed national effort to prevent avoidable illness.  AstraZeneca stands ready to support the government, the NHS and partners to deliver the change our country needs. The time to act is now.  Find out more at astrazeneca.co.uk   References [1] British Heart Foundation. UK factsheet. January 2026. Available at: https://www.bhf.org.uk/-/media/files/for-professionals/research/heart-statistics/bhf-cvd-statistics-uk-factsheet-jan26.pdf.Last accessed: January 2026. [2] British Medical Journal. Early deaths from cardiovascular disease reach 14 year high in England. British Medical Journal. January 2024. Available at: https://www.bmj.com/content/384/bmj.q176. Last accessed: December 2025.   [3] Rising ill-health and economic inactivity because of long-term sickness, UK: 2019 to 2023. Office for National Statistics. Available at: https://www.ons.gov.uk/employmentandlabourmarket/peoplenotinwork/economicinactivity/articles/risingillhealthandeconomicinactivitybecauseoflongtermsicknessuk/2019to2023. Last accessed: December 2025.   [4] UK Government. UIN HL5942. March 2025. Available at: https://questions-statements.parliament.uk/written-questions/detail/2025-03-18/hl5942. Last accessed: December 2025. [5] Getting to the heart of the matter. A national action plan for tackling cardiovascular disease. AstraZeneca. 2025. Available at: https://qr.short.az/r/Getting-to-the-heart-of-the-matter. Last accessed: January 2026. [6] Blood Pressure UK. Why is know your numbers! needed?. Available at: https://www.bloodpressureuk.org/know-your-numbers/why-is-know-your-numbers-needed/. Last accessed: December 2025.   [7] Department of Health and Social Care. Get your blood pressure checked. March 2024. Available at: https://www.gov.uk/government/news/get-your-blood-pressure-checked. Last accessed: December 2025. [8] The Health Foundation. Investing in the public health grant. February 2025. Available at: https://www.health.org.uk/reports-and-analysis/analysis/investing-in-the-public-health-grant. Last Accessed January 2026.  [9] CVDPREVENT. CVDP Annual Audit Report 2025. March 2025. Available at: https://static1.squarespace.com/static/65eafc36395e4d64e18a3232/t/6937fb8666a6d23761182c05/1765276550824/CVDPREVENT+Fifth+Annual+Report.pdf Last Accessed: January 2026. [10] Public Health England. Health matters: preventing cardiovascular disease. February 2019. Available at: https://www.gov.uk/government/publications/health-matters-preventing-cardiovascular-disease/health-matters-preventing-cardiovascular-disease. Last accessed: December 2025. [11] Tony Blair Institute for Global Change. The economic case for Protect Britain, a preventative health care delivery programme. July 2024. Available at: https://assets.ctfassets.net/75ila1cntaeh/7CcuI38C3mxgps6lC9O2iA/825bf2a41f933cf719459087c1599190/Tony_Blair_Institute_for_Global_Change__The_Economic_Case_for_Protect_Britain__July_2024.pdf Last accessed January 2026 [12] Into-Action.Health. Powering the prevention shift – The CVDACTION impact model.  September 2025. Available at: https://www.into-action.health/_files/ugd/ee4262_81e75612f13e403aab6594727b338771.pdf. Last Accessed January 2026. [13]Data & Improvement Tool. CVDPREVENT. Available at: https://www.cvdprevent.nhs.uk/. Last accessed: December 2025.   [14] Transforming the prevention of CVD. CVDACTION. Health Innovation Network. Available at: https://thehealthinnovationnetwork.co.uk/case_studies/transforming-the-prevention-of-cvd/. Last accessed: December 2025. [15] NHS Business Services Authority. Dispensing contractors’ data. Available at: https://www.nhsbsa.nhs.uk/prescription-data/dispensing-data/dispensing-contractors-data . Last Accessed January 2026 [16] AstraZeneca UK. Executive summary of Joint Working outputs. Pan Leicester Integrated Chronic Kidney Disease (CKD) Transformation Project: a quality improvement project to identify CKD patients in primary care suitable for virtual management to improve patient outcomes. (LUCID). July 2024. Available at: https://www.astrazeneca.co.uk/content/dam/intelligentcontent/unbranded/astrazeneca/uk/en/pdf/work-with-nhs-uk/Executive_Summary_of_Joint_Working_Outputs_Pan_Leicester.pdf. Last Accessed: January 2026

Health Secretary Robert F. Kennedy Jr. came within hours of publicly promoting Denmark’s childhood vaccine schedule as an option for American parents — before legal and political concerns got in the way. A senior HHS official told POLITICO that a press conference set for Friday was canceled at the last minute after the HHS Office of the General Counsel said it would invite a lawsuit the administration could lose. A second senior official at the Department of Health and Human Services confirmed the press conference, which HHS had publicly announced, was to be about the Danish schedule. The second official said it was canceled because it was deemed politically risky. Billed as an “announcement regarding children’s health,” Kennedy was to appear alongside his top agency heads and Tracy Beth Høeg, the Food and Drug Administration’s top drug regulator. Høeg touted the Danish schedule at a vaccine advisory committee meeting earlier this month. HHS canceled the event Thursday evening, hours after announcing it. Andrew Nixon, an HHS spokesperson, called accounts of the cancellation that didn’t come directly from the department “pure speculation” in a statement. HHS officials skeptical of moving to the Danish schedule, which recommends immunization for only 10 of the 17 diseases on the U.S. list, were relieved it was never publicly recommended, the first official said. The internal confusion and disagreement follow similar management bungling within HHS’ Food and Drug Administration that has frustrated the White House. On Dec. 5, President Donald Trump signed a presidential memorandum titled “Aligning United States Core Childhood Vaccine Recommendations with Best Practices from Peer, Developed Countries.” The memorandum directed HHS and the Centers for Disease Control and Prevention, one of its subagencies that sets the vaccine schedule, to review peer-country best practices for vaccines recommended for all children and, if those practices were judged superior, to update the U.S. schedule while preserving access to vaccines already available. In the memorandum, Trump mentioned Denmark, Japan and Germany as examples of countries that recommend fewer shots than the U.S. According to the first official, Kennedy and his top aide, Stefanie Spear, helped sell the peer-country framing to West Wing officials as the clearest way to turn internal vaccine skepticism into a signed White House directive. Spear is Kennedy’s principal deputy chief of staff and senior counselor. Kennedy is a longtime vaccine skeptic who believes the U.S. schedule has grown too quickly, has not been tested in its entirety for adverse effects, and is a likely cause of rising autism rates. Numerous studies have not found a link between vaccines and the neurological disorder that now affects one in 31 U.S. children, up from one in 150 two decades ago. Experts in the condition, which affects the ability to communicate, say expanded diagnostic criteria and awareness are responsible for most of that rise. The condition’s cause is usually genetic, they believe, but researchers are studying possible environmental causes. HHS has made it a priority to learn more about what causes autism and why diagnoses are rising. The department’s research arm, the National Institutes of Health, announced an Autism Data Science Initiative on May 27 and has awarded around $50 million to fund 13 projects investigating potential causes. In April, Kennedy promised to reveal autism’s cause in September, but HHS later said it would reveal preliminary findings early next year. Autism researchers, who have studied the condition for years, have called that unrealistic. The first indication Kennedy might be considering the slimmer Danish schedule, which excludes vaccines for chickenpox, the flu, hepatitis A and B, meningitis, respiratory syncytial virus and rotavirus, came earlier this month during the CDC’s Advisory Committee on Immunization Practices meeting in Atlanta. Høeg presented a slide deck titled “U.S. vs. Danish Vaccine Schedule,” which the CDC posted among the meeting presentations. The department then circulated Høeg’s presentation to top officials at HHS, the first senior official said. In the ensuing debate, Høeg’s supporters proposed offering the Danish schedule as a government-recommended alternative to the U.S. one. The first senior official and two others inside HHS familiar with internal discussions, all of whom were granted anonymity to reveal deliberations they were not authorized to discuss publicly, said proponents of the Danish schedule felt that offering it would help restore trust in vaccines; many Americans were turned off by Covid-era vaccine mandates and claims that Covid shots would halt transmission that turned out to be incorrect, they argued. The three officials said the view of proponents inside the administration was that the Danish schedule could be pitched as a “reset” that might convince hesitant parents to vaccinate their kids. Critics inside the administration, the officials said, argued the plan to recommend the Danish schedule was not rigorous and science-based — and that promoting it publicly would invite criticism. Rather than restoring trust, they said it could undermine it by signaling doubt about the need for, and safety of, routine immunization. Going forward without laying the scientific groundwork or going through normal regulatory processes could also make the department vulnerable to lawsuits, the HHS general counsel’s office argued, according to the first senior official. Mike Stuart, who was a U.S. attorney in West Virginia in Trump’s first term, now is HHS general counsel. The American Academy of Pediatrics, which represents doctors who care for children, along with other physician and public health groups, has already sued HHS for changes it made earlier this year to Covid vaccine recommendations, saying the department violated rules governing how regulatory changes are made. That case is pending in federal district court in Boston. HHS has stopped recommending Covid boosters for previously vaccinated people under 65 who are not at high risk of the disease. Instead, the department says Americans should talk to their doctor and make a shared decision. Carmen Paun contributed to this story. Tim Röhn is senior editor of the Axel Springer Global Reporters Network.

Disclaimer POLITICAL ADVERTISEMENT * This is sponsored content from AstraZeneca. * The advertisement is linked to public policy debates on the future of cancer care in the EU. More information here. Europe has made huge strides in the fight against cancer.[1] Survival rates have climbed, detection has improved and the continent has become home to some of the world’s most respected research hubs.[2],[3] None of that progress came easy — it was built on years of political attention and cooperation across borders. However, as we look to 2026 and beyond, that progress stands at a crossroads. Budget pressures and tougher global competition threaten to push cancer and health care down the EU agenda. Europe’s Beating Cancer Plan — a flagship initiative aimed at expanding screening, improving early detection and boosting collaboration — is set to expire in 2027, with no clear plan to secure or extend its gains.[4],[5] “My [hope is that we can continue] the work started with Europe’s Beating Cancer Plan and make it sustainable… [and] build on the lessons learned, [for other disease areas] ” says Antonella Cardone, CEO of Cancer Patients Europe. A new era in cancer treatment Concern about the lapsing initiative is compounded by two significant shifts in health care: declining investment and increasing scientific advancement. Firstly, Europe has seen the increased adoption of cost-containment policies by some member states. Under-investment in Europe in cancer medicines has been a challenge — specifically with late and uneven funding, and at lower levels than international peers such as the US — potentially leaving patients with slower and more limited access to life-saving therapies.[6],[7],[8] Meanwhile, the U.S., which pays on average double for medicines per capita than the EU,[9] is actively working to rebalance its relationship with pharmaceuticals to secure better pricing (“fair market value”) through policies across consecutive administrations.[10] All the while, China is rapidly scaling investment in biotech and clinical research, determined to capture the trials, talent, and capital that once flowed naturally to Europe.[11] The rebalancing of health and life-science investment can have significant consequences. If Europe does not stay attractive for life-sciences investment, the impact will extend beyond cancer patient outcomes. Jobs, tax revenues, advanced manufacturing, and Europe’s leadership in strategic industries are all at stake.[12] Secondly, medical science has never looked more promising.[7] Artificial intelligence is accelerating drug discovery, clinical trials, and diagnostics, and the number of approved medicines for patients across Europe has jumped from an average of one per year between 1995 and 2000 to 14 per year between 2021 and 2024.[13],[14],[15], [7] Digital health tools and innovative medtech startups are multiplying, increasing competitiveness and lowering costs — guiding care toward a future that is more personalized and precise.[16],[17] Europe stands at the threshold of a new era in cancer treatment. But if policymakers ease up now, progress could stall — and other regions, especially the U.S. and China, are more than ready to widen the innovation gap. Recognizing the strategic investment Health spending is generally treated as a budget item to be contained. Yet investment in cancer care has been one of Europe’s smartest economic bets.[18],[19] The sector anchors millions of high-skilled jobs (it employs around 29 million people in the EU[11]) and attracts global life sciences investment. According to the European Commission, the sector contributes nearly €1.5 trillion to the EU economy.[12] Studies from the Institute of Health Economics confirm that money put into research directly translates into better survival outcomes.[20] The same report shows that although the overall spend on cancer is increasing, the cost per patient has actually decreased since 1995, suggesting that innovative treatments are increasing efficiency.[20] Those gains matter not only to patients and families, but to Europe’s long-term stability: healthier populations mean fewer costs down the line, stronger productivity, and more sustainable public finances.[20] Fixing Europe’s access gap Cancer medicines bring transformative value — to patients, to society and to the wider economy. [21] However, even as oncology therapies advance, patients across Europe are not benefiting equally. EFPIA’s 2024 Patients W.A.I.T. indicator shows that, on average, just 46 percent of innovative medicines approved between 2020 and 2023 were available to patients in 2024.[22] On average, it takes 578 days for a new oncology medicine to reach European patients, and only 29 percent of drugs are fully available in all member states.[23] This is not caused by a lack of breakthrough medicines, but by national policy mechanisms that undervalue innovation. OECD and the Institute for Health Economics data show that divergent HTA requirements, rigid cost-effectiveness thresholds, price-volume clawbacks, ad hoc taxes on pharmaceutical revenues and slow national reimbursement decisions collectively suppress timely access to new cancer medicines across the EU.[24] These disparities cut against Europe’s long-standing reputation as a collection of societies that values equitable, high-quality care for all of its citizens. It risks eroding one of the EU’s defining strengths: the commitment to fairness and collective progress. Cancer policy solutions for the EU Although this is ultimately a matter for member states, embedding cancer as a permanent EU priority — backed by funding, coordination, and accountability — could give national systems the incentives and strategic direction to buck these trends. These actions will reassure pharmaceutical companies that Europe is serious about attracting clinical trials and the launch of new medicines, ensuring that its citizens, societies and economies enjoy the benefits this brings. Europe’s Beating Cancer Plan delivered progress, but its expiry presents a pivotal moment. 2026 and beyond bring a significant opportunity for the EU to build on this by ensuring that member states implement National Cancer Control Plans and have clear targets and accountability on their national performance, including on investment and access. To do this, EU policymakers should consider three actions as an immediate priority with lasting impact: * Embed cancer and investment within EU governance. Build it into the European Semester on health with mandatory indicators, regular reviews, and accountability frameworks to ensure continuity. This model worked well during Covid-19 and should be adapted for non-communicable diseases starting with cancer as a pilot. * Secure stable and sufficient funding. The Multiannual Financial Framework must ensure adequate funding for health and cancer to encourage coordinated initiatives across member states. * Strengthen EU-level coordination. Ensure that pan-EU structures such as the Comprehensive Cancer Centres and Cancer Mission Hubs are adequately funded and empowered. These are the building blocks of a lasting European commitment to cancer. With action, Europe can secure a sustainable foundation for patients, resilience and continued scientific excellence. -------------------------------------------------------------------------------- [1] European Commission, OECD/European Observatory on Health Systems and Policies. 2023. State of Health in the EU: Synthesis Report 2023. Available at: https://health.ec.europa.eu/system/files/2023-12/state_2023_synthesis-report_en.pdf [Accessed December 2025] [2] Efpia. 2025. Cancer care 2025: an overview of cancer outcomes data across Europe. Available at: https://www.efpia.eu/news-events/the-efpia-view/statements-press-releases/ihe-cancer-comparator-report-2025/ [Accessed December 2025] [3] Cancer Core Europe. 2024. Cancer Core Europe: Advancing Cancer Care Through Collaboration. Available at: https://www.cancercoreeurope.eu/cce-advancing-cancer-care-collaboration/ [Accessed December 2025] [4] European Commission. 2021. Europe’s Beating Cancer Plan. Available at:https://health.ec.europa.eu/system/files/2022-02/eu_cancer-plan_en_0.pdf [Accessed December 2025] [5] European Parliament. 2025. Europe’s Beating Cancer Plan: Implementation findings. https://www.europarl.europa.eu/RegData/etudes/STUD/2025/765809/EPRS_STU(2025)765809_EN.pdf [Accessed December 2025] [6] Hofmarcher, T., et al. 2024. Access to Oncology Medicines in EU and OECD Countries (OECD Health Working Papers, No.170). OECD Publishing. Available at: https://www.oecd.org/content/dam/oecd/en/publications/reports/2024/09/access-to-oncology-medicines-in-eu-and-oecd-countries_6cf189fe/c263c014-en.pdf [Accessed December 2025] [7] Manzano, A., et al. 2025. Comparator Report on Cancer in Europe 2025 – Disease Burden, Costs and Access to Medicines and Molecular Diagnostics (IHE). Available at: https://ihe.se/app/uploads/2025/03/IHE-REPORT-2025_2_.pdf [Accessed December 2025] [8] Efpia. [no date]. Europe’s choice. Available at: https://www.efpia.eu/europes-choice/ [Accessed December 2025] [9] OECD. 2024. Prescription Drug Expenditure per Capita. https://data-explorer.oecd.org/vis?lc=en&pg=0&snb=1&vw=tb&df[ds]=dsDisseminateFinalDMZ&df[id]=DSD_SHA%40DF_SHA&df[ag]=OECD.ELS.HD&df[vs]=&pd=2015%2C&dq=.A.EXP_HEALTH.USD_PPP_PS%2BPT_EXP_HLTH._T..HC51%2BHC3.._T…&to[TIME_PERIOD]=false&lb=bt [Accessed December 2025] [10] The White House. 2025. Delivering most favored-nation prescription drug pricing to American patients. Available at: https://www.whitehouse.gov/presidential-actions/2025/05/delivering-most-favored-nation-prescription-drug-pricing-to-american-patients/ [Accessed December 2025] [11] Eleanor Olcott, Haohsiang Ko and William Sandlund. 2025. The relentless rise of China’s Biotechs. Financial Times. Available at: https://www.ft.com/content/c0a1b15b-84ee-4549-85eb-ed3341112ce5 [Accessed December 2025] [12] European Commission, Directorate-General for Communication. 2025. Making Europe a Global Leader in Life Sciences. Available at: https://commission.europa.eu/news-and-media/news/making-europe-global-leader-life-sciences-2025-07-02_en [Accessed December 2025] [13] Financial Times. 2025. How AI is reshaping drug discovery. Available at: https://www.ft.com/content/8c8f3c10-9c26-4e27-bc1a-b7c3defb3d95 [Accessed December 2025] [14] Seedblink. 2025. Europe’s HealthTech investment landscape in 2025: A deep dive. https://seedblink.com/blog/2025-05-30-europes-healthtech-investment-landscape-in-2025-a-deep-dive [15] European Commission. [No date]. Artificial Intelligence in healthcare. Available at: https://health.ec.europa.eu/ehealth-digital-health-and-care/artificial-intelligence-healthcare_en [Accessed December 2025] [16] Codina, O. 2025. Code meets care: 20 European HealthTech startups to watch in 2025 and beyond. EU-Startups. Available at: https://www.eu-startups.com/2025/06/code-meets-care-20-european-healthtech-startups-to-watch-in-2025-and-beyond [Accessed December 2025] [17] Protogiros et al. 2025. Achieving digital transformation in cancer care across Europe: Practical recommendations from the TRANSiTION project. Journal of Cancer Policy. Available at: https://www.sciencedirect.com/science/article/pii/S2213538325000281 [Accessed December 2025] [18] R-Health Consult. [no date]. The case for investing in a healthier future for the European Union. EFPIA. Available at: https://www.efpia.eu/media/xpkbiap5/the-case-for-investing-in-a-healthier-future-for-the-european-union.pdf [Accessed December 2025] [19] Pousette A., Hofmarcher T. 2024.Tackling inequalities in cancer care in the European Union. Available at: https://ihe.se/en/rapport/tackling-inequalities-in-cancer-care-in-the-european-union-2/ [Accessed December 2025] [20] Efpia. 2025. Comparator Report Cancer in Europe 2025. Available at: https://www.efpia.eu/media/0fbdi3hh/infographic-comparator-report-cancer-in-europe.pdf [Accessed December 2025] [21] Garau, E. et al. 2025. The Transformative Value of Cancer Medicines in Europe. Dolon Ltd. Available at: https://dolon.com/wp-content/uploads/2025/09/EOP_Investment-Value-of-Oncology-Medicines-White-Paper_2025-09-19-vF.pdf?x16809 [Accessed December 2025] [22] IQVIA. 2025. EFPIA Patients W.A.I.T. Indicator 2024 Survey. Available at: https://www.efpia.eu/media/oeganukm/efpia-patients-wait-indicator-2024-final-110425.pdf [Accessed December 2025] [23] Visentin M. 2025. Improving equitable access to medicines in Europe must remain a priority. The Parliament. Available at: https://www.theparliamentmagazine.eu/partner/article/improving-equitable-access-to-medicines-in-europe-must-remain-a-priority [Accessed December 2025] [24] Hofmarcher, T. et al. 2025. Access to novel cancer medicines in Europe: inequities across countries and their drivers. ESMO Open. Available at: https://www.esmoopen.com/action/showPdf?pii=S2059-7029%2825%2901679-5 [Accessed December 2025]

Thirty-six million Europeans — including more than one million in the Nordics[1] — live with a rare disease.[2] For patients and their families, this is not just a medical challenge; it is a human rights issue. Diagnostic delays mean years of worsening health and needless suffering. Where treatments exist, access is far from guaranteed. Meanwhile, breakthroughs in genomics, AI and targeted therapies are transforming what is possible in health care. But without streamlined systems, innovations risk piling up at the gates of regulators, leaving patients waiting. Even the Nordics, which have some of the strongest health systems in the world, struggle to provide fair and consistent access for rare-disease patients. Expectations should be higher. THE BURDEN OF DELAY The toll of rare diseases is profound. People living with them report health-related quality-of-life scores 32 percent lower than those without. Economically, the annual cost per patient in Europe — including caregivers — is around €121,900.[3] > Across Europe, the average time for diagnosis is six to eight years, and > patients continue to face long waits and uneven access to medications. In Sweden, the figure is slightly lower at €118,000, but this is still six times higher than for patients without a rare disease. Most of this burden (65 percent) is direct medical costs, although non-medical expenses and lost productivity also weigh heavily. Caregivers, for instance, lose almost 10 times more work hours than peers supporting patients without a rare disease.[4] This burden can be reduced. European patients with access to an approved medicine face average annual costs of €107,000.[5] Yet delays remain the norm. Across Europe, the average time for diagnosis is six to eight years, and patients continue to face long waits and uneven access to medications. With health innovation accelerating, each new therapy risks compounding inequity unless access pathways are modernized. PROGRESS AND REMAINING BARRIERS Patients today have a better chance than ever of receiving a diagnosis — and in some cases, life-changing therapies. The Nordics in particular are leaders in integrated research and clinical models, building world-class diagnostics and centers of excellence. > Without reform, patients risk being left behind. But advances are not reaching everyone who needs them. Systemic barriers persist: * Disparities across Europe: Less than 10 percent of rare-disease patients have access to an approved treatment.[6] According to the Patients W.A.I.T. Indicator (2025), there are stark differences in access to new orphan medicines (or drugs that target rare diseases).[7] Of the 66 orphan medicines approved between 2020 and 2023, the average number available across Europe was 28. Among the Nordics, only Denmark exceeded this with 34. * Fragmented decision-making: Lengthy health technology assessments, regional variation and shifting political priorities often delay or restrict access. Across Europe, patients wait a median of 531 days from marketing authorization to actual availability. For many orphan drugs, the wait is even longer. In some countries, such as Norway and Poland, reimbursement decisions take more than two years, leaving patients without treatment while the burden of disease grows.[8] * Funding gaps: Despite more therapies on the market and greater technology to develop them, orphan medicines account for just 6.6 percent of pharmaceutical budgets and 1.2 percent of health budgets in Europe. Nordic countries — Sweden, Norway and Finland — spend a smaller share than peers such as France or Belgium. This reflects policy choices, not financial capacity.[9] If Europe struggles with access today, it risks being overwhelmed tomorrow. Rare-disease patients — already facing some of the longest delays — cannot afford for systems to fall farther behind. EASING THE BOTTLENECKS Policymakers, clinicians and patient advocates across the Nordics agree: the science is moving faster than the systems built to deliver it. Without reform, patients risk being left behind just as innovation is finally catching up to their needs. So what’s required? * Governance and reforms: Across the Nordics, rare-disease policy remains fragmented and time-limited. National strategies often expire before implementation, and responsibilities are divided among ministries, agencies and regional authorities. Experts stress that governments must move beyond pilot projects to create permanent frameworks — with ring-fenced funding, transparent accountability and clear leadership within ministries of health — to ensure sustained progress. * Patient organizations: Patient groups remain a driving force behind awareness, diagnosis and access, yet most operate on short-term or volunteer-based funding. Advocates argue that stable, structural support — including inclusion in formal policy processes and predictable financing — is critical to ensure patient perspectives shape decision-making on access, research and care pathways. * Health care pathways: Ann Nordgren, chair of the Rare Disease Fund and professor at Karolinska Institutet, notes that although Sweden has built a strong foundation — including Centers for Rare Diseases, Advanced Therapy (ATMP) and Precision Medicine Centers, and membership in all European Reference Networks — front-line capacity remains underfunded. “Government and hospital managements are not providing  resources to enable health care professionals to work hands-on with diagnostics, care and education,” she explains. “This is a big problem.” She adds that comprehensive rare-disease centers, where paid patient representatives collaborate directly with clinicians and researchers, would help bridge the gap between care and lived experience. * Research and diagnostics: Nordgren also points to the need for better long-term investment in genomic medicine and data infrastructure. Sweden is a leader in diagnostics through Genomic Medicine Sweden and SciLifeLab, but funding for advanced genomic testing, especially for adults, remains limited. “Many rare diseases still lack sufficient funding for basic and translational research,” she says, leading to delays in identifying genetic causes and developing targeted therapies. She argues for a national health care data platform integrating electronic records, omics (biological) data and patient-reported outcomes — built with semantic standards such as openEHR and SNOMED CT — to enable secure sharing, AI-driven discovery and patient access to their own data DELIVERING BREAKTHROUGHS Breakthroughs are coming. The question is whether Europe will be ready to deliver them equitably and at speed, or whether patients will continue to wait while therapies sit on the shelf. There is reason for optimism. The Nordic region has the talent, infrastructure and tradition of fairness to set the European benchmark on rare-disease care. But leadership requires urgency, and collaboration across the EU will be essential to ensure solutions are shared and implemented across borders. The need for action is clear: * Establish long-term governance and funding for rare-disease infrastructure. * Provide stable, structural support for patient organizations. * Create clearer, better-coordinated care pathways. * Invest more in research, diagnostics and equitable access to innovative treatments. Early access is not only fair — it is cost-saving. Patients treated earlier incur lower indirect and non-medical costs over time.[10] Inaction, by contrast, compounds the burden for patients, families and health systems alike. Science will forge ahead. The task now is to sustain momentum and reform systems so that no rare-disease patient in the Nordics, or anywhere in Europe, is left waiting. -------------------------------------------------------------------------------- [1] https://nordicrarediseasesummit.org/wp-content/uploads/2025/02/25.02-Nordic-Roadmap-for-Rare-Diseases.pdf [2] https://nordicrarediseasesummit.org/wp-content/uploads/2025/02/25.02-Nordic-Roadmap-for-Rare-Diseases.pdf [3] https://media.crai.com/wp-content/uploads/2024/10/28114611/CRA-Alexion-Quantifying-the-Burden-of-RD-in-Europe-Full-report-October2024.pdf [4] https://media.crai.com/wp-content/uploads/2024/10/28114611/CRA-Alexion-Quantifying-the-Burden-of-RD-in-Europe-Full-report-October2024.pdf [5] https://media.crai.com/wp-content/uploads/2024/10/28114611/CRA-Alexion-Quantifying-the-Burden-of-RD-in-Europe-Full-report-October2024.pdf [6] https://www.theparliamentmagazine.eu/partner/article/a-competitive-and-innovationled-europe-starts-with-rare-diseases? [7] https://www.iqvia.com/-/media/iqvia/pdfs/library/publications/efpia-patients-wait-indicator-2024.pdf [8] https://www.iqvia.com/-/media/iqvia/pdfs/library/publications/efpia-patients-wait-indicator-2024.pdf [9] https://copenhageneconomics.com/wp-content/uploads/2025/09/Copenhagen-Economics_Spending-on-OMPs-across-Europe.pdf [10] https://media.crai.com/wp-content/uploads/2024/10/28114611/CRA-Alexion-Quantifying-the-Burden-of-RD-in-Europe-Full-report-October2024.pdf Disclaimer POLITICAL ADVERTISEMENT * The sponsor is Alexion Pharmaceuticals * The entity ultimately controlling the sponsor: AstraZeneca plc * The political advertisement is linked to policy advocacy around rare disease governance, funding, and equitable access to diagnosis and treatment across Europe More information here.

This article is presented by EFPIA with the support of AbbVie I made a trip back to Europe recently, where I spent the vast majority of my pharmaceutical career, to share my perspectives on competitiveness at the European Health Summit. Now that I work in a role responsible for supporting patient access to medicine globally, I view Europe, and how it compares internationally, through a new lens, and I have been reflecting further on why the choices made today will have such a critical impact on where medicines are developed tomorrow. Today, many patients around the world benefit from medicines built on European science and breakthroughs of the last 20 years. Europeans, like me, can be proud of this contribution. As I look forward, my concern is that we may not be able to make the same claim in the next 20 years. It’s clear that Europe has a choice. Investing in sustainable medicines growth and other enabling policies will, I believe, bring significant benefits. Not doing so risks diminishing global influence. > Today, many patients around the world benefit from medicines built on European > science and breakthroughs of the last 20 years I reflect on three important points: 1) investment in healthcare benefits individuals, healthcare and society, but the scale of this benefit remains underappreciated; 2) connected to this, the underpinning science for future innovation is increasingly happening elsewhere; and 3) this means the choices we make today must address both of these trends. First, let’s use the example of migraine. As I have heard a patient say, “Migraine will not kill you but neither [will they] let you live.”[1] Individuals can face being under a migraine attack for more than half of every month, unable to leave home, maintain a job and engage in society.[2] It is the second biggest cause of disability globally and the first among young women.[3] It affects the quality of life of millions of Europeans.[4] From 2011-21 the economic burden of migraine in Europe due to the loss of working days ranged from €35-557 billion, depending on the country, representing 1-2 percent of gross domestic product (GDP).[5]   Overall socioeconomic burden of migraine as percentage of the country’s GDP in 2021 Source: WifOR, The socioeconomic burden of migraine. The case of 6 European Countries.5 Access to effective therapies could radically improve individuals’ lives and their ability to return to work.[6] Yet, despite the staggering economic and personal impacts, in some member states the latest medicines are either not reimbursed or only available after several treatment failures.[7] Imagine if Europe shifted its perspective on these conditions, investing to improve not only health but unlocking the potential for workforce and economic productivity? Moving to my second point, against this backdrop of underinvestment, where are scientific advances now happening in our sector? In recent years it is impressive to see China has become the second-largest drug developer in the world,[8] and within five years it may lead the innovative antibodies therapeutics sector,[9] which is particularly promising for complex areas like oncology. Cancer is projected to become the leading cause of death in Europe by 2035,[10] yet the continent’s share of the number of oncology trials dropped from 41 percent in 2013 to 21 percent in 2023.10 Today, antibody-drug conjugates are bringing new hope in hard-to-treat tumor types,[11] like ovarian,[12] lung[13] and colorectal[14] cancer, and we hope to see more of these advances in the future. Unfortunately, Europe is no longer at the forefront of the development of these innovations. This geographical shift could impact high-quality jobs, the vitality of Europe’s biotech sector and, most importantly, patients’ outcomes. [15] > This is why I encourage choices to be made that clearly signal the value > Europe attaches to medicines This is why I encourage choices to be made that clearly signal the value Europe attaches to medicines. This can be done by removing national cost-containment measures, like clawbacks, that are increasingly eroding the ability of companies to invest in European R&D. To provide a sense of their impact, between 2012 and 2023, clawbacks and price controls reduced manufacturer revenues by over €1.2 billion across five major EU markets, corresponding to a loss of 4.7 percent in countries like Spain.[16] Moreover, we should address health technology assessment approaches in Europe, or mandatory discount policies, which are simply not adequately accounting for the wider societal value of medicines, such as in the migraine example, and promoting a short-term approach to investment. By broadening horizons and choosing a long-term investment strategy for medicines and the life science sector, Europe will not only enable this strategic industry to drive global competitiveness but, more importantly, bring hope to Europeans suffering from health conditions. AbbVie SA/NV – BE-ABBV-250177 (V1.0) – December 2025 -------------------------------------------------------------------------------- [1] The Parliament Magazine, https://www.theparliamentmagazine.eu/partner/article/unmet-medical-needs-and-migraine-assessing-the-added-value-for-patients-and-society, Last accessed December 2025. [2] The Migraine Trust; https://migrainetrust.org/understand-migraine/types-of-migraine/chronic-migraine/, Last accessed December 2025. [3] Steiner TJ, et al; Lifting The Burden: the Global Campaign against Headache. Migraine remains second among the world’s causes of disability, and first among young women: findings from GBD2019. J Headache Pain. 2020 Dec 2;21(1):137 [4] Coppola G, Brown JD, Mercadante AR, Drakeley S, Sternbach N, Jenkins A, Blakeman KH, Gendolla A. The epidemiology and unmet need of migraine in five european countries: results from the national health and wellness survey. BMC Public Health. 2025 Jan 21;25(1):254. doi: 10.1186/s12889-024-21244-8. [5] WifOR. Calculating the Socioeconomic Burden of Migraine: The Case of 6 European Countries. Available at: [https://www.wifor.com/en/download/the-socioeconomic-burden-of-migraine-the-case-of-6-eu­ropean-countries/?wpdmdl=358249&refresh=687823f915e751752703993]. Accessed June 2025. [6] Seddik AH, Schiener C, Ostwald DA, Schramm S, Huels J, Katsarava Z. Social Impact of Prophylactic Migraine Treatments in Germany: A State-Transition and Open Cohort Approach. Value Health. 2021 Oct;24(10):1446-1453. doi: 10.1016/j.jval.2021.04.1281 [7] Moisset X, Demarquay G, et al., Migraine treatment: Position paper of the French Headache Society. Rev Neurol (Paris). 2024 Dec;180(10):1087-1099. doi: 10.1016/j.neurol.2024.09.008. [8] The Economist, https://www.economist.com/china/2025/11/23/chinese-pharma-is-on-the-cusp-of-going-global, Last accessed December 2025. [9] Crescioli S, Reichert JM. Innovative antibody therapeutic development in China compared with the USA and Europe. Nat Rev Drug Discov. Published online November 7, 2025. [10] Manzano A., Svedman C., Hofmarcher T., Wilking N.. Comparator Report on Cancer in Europe 2025 – Disease Burden, Costs and Access to Medicines and Molecular Diagnostics. EFPIA, 2025. [IHE REPORT 2025:2, page 20] [11] Armstrong GB, Graham H, Cheung A, Montaseri H, Burley GA, Karagiannis SN, Rattray Z. Antibody-drug conjugates as multimodal therapies against hard-to-treat cancers. Adv Drug Deliv Rev. 2025 Sep;224:115648. doi: 10.1016/j.addr.2025.115648. Epub 2025 Jul 11. PMID: 40653109.. [12] Narayana, R.V.L., Gupta, R. Exploring the therapeutic use and outcome of antibody-drug conjugates in ovarian cancer treatment. Oncogene 44, 2343–2356 (2025). https://doi.org/10.1038/s41388-025-03448-3 [13] Coleman, N., Yap, T.A., Heymach, J.V. et al. Antibody-drug conjugates in lung cancer: dawn of a new era?. npj Precis. Onc. 7, 5 (2023). https://doi.org/10.1038/s41698-022-00338-9 [14] Wang Y, Lu K, Xu Y, Xu S, Chu H, Fang X. Antibody-drug conjugates as immuno-oncology agents in colorectal cancer: targets, payloads, and therapeutic synergies. Front Immunol. 2025 Nov 3;16:1678907. doi: 10.3389/fimmu.2025.1678907. PMID: 41256852; PMCID: PMC12620403. [15] EFPIA, Improving EU Clinical Trials: Proposals to Overcome Current Challenges and Strengthen the Ecosystem, efpias-list-of-proposals-clinical-trials-15-apr-2025.pdf, Last accessed December 2025. [16] The EU General Pharmaceutical Legislation & Clawbacks, © Vital Transformation BVBA, 2024.

As Europe redefines its life sciences and biotech agenda, one truth stands out: the strength of our innovation lies in its interconnection between human and animal health, science and society, and policy and practice. This spirit of collaboration guided the recent “Innovation for Animal Health: Advancing Europe’s Life Sciences Agenda” policy breakfast in Brussels, where leading voices from EU politics, science and industry came together to discuss how Europe can turn its scientific excellence into a truly competitive and connected life sciences ecosystem. Jeannette Ferran Astorga / Via Zoetis Europe’s role in life sciences will depend on its ability to see innovation holistically. At Zoetis we firmly believe that animal health innovation must be part of that equation, as this strengthens resilience, drives sustainability, and connects directly to the wellbeing of people. Innovation without barriers Some of humanity’s greatest challenges continue to emerge at the intersection of human, animal and environmental health, sometimes with severe economic impact. The recent outbreaks of diseases like avian influenza, African swine fever and bluetongue virus act as reminders of this. By enhancing the health and welfare of animals, the animal health industry and veterinarians are strengthening farmers’ livelihoods, supporting thriving communities and safeguarding global food security. This is also contributing to protecting wildlife and ecosystems. Meanwhile, companion animals are members of approximately half of European households. Here, we have seen how dogs and cats have become part of the family, with owners now investing a lot more to keep their pets healthy and able to live to an old age. Because of the deepening bonds with our pets and their increased longevity, the demand for new treatment alternatives is rising continuously, stimulating new research and innovative solutions making their way into veterinary practices. Zoonotic diseases that can be transferred between animals and humans, like rabies, Lyme disease, Covid-19 and constantly new emerging infectious diseases, make the rapid development of veterinary solutions a necessity. Throughout the world, life sciences are an engine of growth and a foundation of health, resilience and sustainability. Europe’s next chapter in this field will also be written by those who can bridge human and animal health, transforming science into solutions that deliver both economic and societal value. The same breakthroughs that protect our pets and livestock underpin the EU’s ambitions on antimicrobial resistance, food security and sustainable agriculture. Ensuring these innovations can reach the market efficiently is therefore not a niche issue, it is central to Europe’s strategic growth and competitiveness. This was echoed at the policy event by Dr. Wiebke Jansen, Policy Lead at the Federation of Veterinarians of Europe (FVE) when she noted that ‘innovation is not abstract. As soon as a product is available, it changes the lives of animals, their veterinarians and the communities we serve. With the many unmet needs we still face in animal health, having access to new innovation is an extremely relevant question from the veterinary perspective.’ Enabling innovation through smart regulation To realize the promise of Europe’s life sciences and biotech agenda, the EU must ensure that regulation keeps pace with scientific discovery. The European Commission’s Omnibus Simplification Package offers a valuable opportunity to create a more innovation-friendly environment, one where time and resources can be focused on developing solutions for animal and human health, not on navigating overlapping reporting requirements or dealing with an ever increasing regulatory burden. > In animal health, biotechnology is already transforming what’s possible — for > example, monoclonal antibodies that help control certain chronic conditions or > diseases with unprecedented precision. Reviewing legislative frameworks, developing the Union Product Database as a true one-stop hub or introducing digital tools such as electronic product information (e-leaflets) in all member states, for instance, would help scientists and regulators alike to work more efficiently, thereby enhancing the availability of animal health solutions. This is not about loosening standards; it is about creating the right conditions for innovation to thrive responsibly and efficiently. Science that serves society Europe’s leadership in life sciences depends on its ability to turn cutting-edge research into real-world impact, for example through bringing new products to patients faster. In animal health, biotechnology is already transforming what’s possible — for example, monoclonal antibodies that help control certain chronic conditions or diseases with unprecedented precision. Relieving itching caused by atopic dermatitis or alleviating the pain associated with osteoarthritis significantly increases the quality of life of cats and dogs — and their owners. In addition, diagnostics and next-generation vaccines prevent outbreaks before they start or spread further. Maintaining a proportionate, benefit–risk for veterinary medicines allows innovation to progress safely while ensuring accelerated access to new treatments. Supporting science-based decision-making and investing in the European Medicines Agency’s capacity to deliver efficient, predictable processes will help Europe remain a trusted partner in global health innovation. Continuum of Care / Via Zoetis A One Health vision for the next decade Europe is not short of ambition. The EU Biotech Act and the Life Sciences Strategy both aim to turn innovation into a driver of growth and wellbeing. But to truly unlock their potential, they must include animal health in their vision. The experience of the veterinary medicines sector shows that innovation does not stop at species’ borders; advances in immunology, monoclonal antibodies and the use of artificial intelligence benefit both animals and humans. A One Health perspective, where veterinary and human health research reinforce each other, will help Europe to play a positive role in an increasingly competitive global landscape. The next five years will be decisive. By fostering proportionate, science-based adaptive regulation, investing in digital and institutional capacity, and embracing a One Health approach to innovation, Europe can become a genuine world leader in life sciences — for people and the animals that are essential to our lives. -------------------------------------------------------------------------------- Disclaimer POLITICAL ADVERTISEMENT * The sponsor is Zoetis Belgium S.A. * The political advertisement is linked to policy advocacy on the EU End-of-Life Vehicles Regulation (ELVR), circular plastics, chemical recycling, and industrial competitiveness in Europe. More information here.

With multiple legislative processes underway, we are now in an important moment for Europe’s ambition to boost access and be a global leader in innovation. An agile, modernized regulatory system — coupled with supportive intellectual property and access policies — can attract research and development and advanced manufacturing to Europe. This will contribute to the earlier availability of new cures for European patients and a healthier innovative ecosystem. Unfortunately, today we see that Europe is falling behind global competition. Over the last decade, there has been a 10 percent decrease in clinical trials in the European Union, which has led to 60,000 fewer European patients participating in trials.[1] Europe’s fragmented system for clinical trial approvals is a leading cause of this decline, impacting early access to innovative treatments. As scientific breakthroughs can deliver better health outcomes for patients, governments need to keep pace with this speed of innovation. > Draghi report on EU competitiveness importantly identified pharmaceutical > innovation as a strategic sector for growth in Europe. That said, the report > also noted that what is missing is a simple and strong execution plan behind > it, with simplified regulation and coherent and predictable policies that > could drive the European goals of increased competitiveness and strategic > autonomy. Europe’s marketing authorisation process now exceeds 14 months (444 days), causing patients to wait nearly three months longer than in the US (356 days) and over five months longer than in Japan (290 days) for access to innovative medicines.[2] Such delays, combined with complex and lengthy country-level market access systems, mean patients in Europe are waiting an average of 20 months longer than people living in the United States to benefit from scientific innovation.[3] Last year’s Draghi report on EU competitiveness importantly identified pharmaceutical innovation as a strategic sector for growth in Europe. That said, the report also noted that what is missing is a simple and strong execution plan behind it, with simplified regulation and coherent and predictable policies that could drive the European goals of increased competitiveness and strategic autonomy. Ongoing discussions on the revision of the General Pharmaceutical Legislation and the In Vitro Diagnostic Regulation (IVDR), the Critical Medicines Act and the upcoming Biotech Act (Part 1) mark crucial opportunities for Europe to become a global leader for innovation. However, to make this vision a reality, the EU must address structural challenges that undermine innovation and patient access to novel, lifesaving medicines. > To reverse the worrying decline in European clinical trial activity, the EU > should implement a maximum two-month approval process for clinical trial > applications (CTAs), encompassing the reviews of both regulators and ethics > committees consistent with other global leaders. The successful implementation of structural, future-proof policy changes can ensure timely access to innovative medicines for EU citizens, and this can be achieved through five key policy recommendations: Facilitate and accelerate clinical trial applications To reverse the worrying decline in European clinical trial activity, the EU should implement a maximum two-month approval process for clinical trial applications (CTAs), encompassing the reviews of both regulators and ethics committees consistent with other global leaders. It is equally important to increase collaboration among EU member states to remove unique and specific national CTA requirements and questions, and to also introduce opportunities for an informal dialogue with regulators to expediently address smaller challenges that can be quickly fixed. Legislative overlaps and fragmentation between the Clinical Trials Regulation (CTR) and the IVDR should also be addressed to avoid delays in clinical trials that utilize companion diagnostics. Expand expedited pathways Despite their potential, the EU’s expedited pathways (such as the European Medicines Agency’s PRIME scheme for unmet medical needs, Conditional Marketing Authorisation and Accelerated Assessment) are underutilised, limiting rapid patient access to important medicines. Similar expedited pathways are widely used by other regulators around the world, like the United States and Japan. Expanding the use of expedited pathways in the EU to new indications and aligning eligibility criteria with global standards would ensure that the EU has more competitive regulatory pathways and earlier patient access to life-saving medicines. Shorten scientific advice and approval timelines Shortening the EU’s scientific advice procedure is critical to optimise the development of innovative products, ensure timely and efficient resource management for both applicants and regulators, and maintain the EU’s influence in global scientific and clinical research. By evolving to a more integrated and agile dialogue, the EU can provide comprehensive, consistent guidance throughout the product lifecycle and remain competitive with other regions. Given their growing number, scientific advice should be available for medicines used with all types of medical devices and in vitro diagnostics (including combinations diagnostics) to address the complexities of working across these regulatory frameworks. > An agile, modernized regulatory system — coupled with supportive intellectual > property and access policies — can attract research and development and > advanced manufacturing to Europe. Regarding the current lengthy approval times, the proposed reduction of EMA’s standard assessment timelines from 210 to 180 days — as suggested in the revision of the pharmaceutical legislation — would allow regulators to accelerate their scientific assessments. Furthermore, the European Commission can streamline its decision phase (currently requiring up to 67 days) by conducting its activities in parallel with the scientific assessment. Strengthen the EU Medicines Regulatory Network and embrace regulatory sandboxes Achieving greater speed and agility within a regulatory system requires an appropriately resourced, sustainable regulatory infrastructure. We support transparent regulatory budgets across the network, backed by consistent investments in expertise, funding and infrastructure to support continuous capacity and capability advancements. Collaborative regulatory pathways (such as the EMA OPEN framework) could be further expanded to encourage simultaneous approvals and supply chain resilience across geographies. Additionally, regulatory sandboxes would be beneficial to pilot and adapt frameworks for disruptive future innovations, while ensuring appropriate guardrails to enable the safe development and implementation of these innovations. Enhance patient engagement Effective regulatory decision-making requires both inclusivity and adaptability. Limited patient and expert input can hinder effective regulatory decision-making, while rapid pharmaceutical innovation requires adaptable frameworks. Expert and patient perspectives are crucial for informed benefit-risk and clinical meaningfulness determinations. Disclaimer POLITICAL ADVERTISEMENT * The sponsor is Eli Lilly & Company * The advertisement is linked to General Pharmaceutical Legislation (GPL), In Vitro Diagnostic Regulation (IVDR), Critical Medicines Act (CMA), Biotech Act (Part 1), Clinical Trials Regulation (CTR), EU Medicines Regulatory Network More information here. -------------------------------------------------------------------------------- [1] IQVIA, Assessing the clinical trial ecosystem in Europe, Final Report, October 2024: efpia_ve_iqvia_assessing-the-clinical-trial-ct-ecosystem.pdf. [2] Lara J, Kermad A, Bujar M, McAuslane N. 2025. R&D Briefing 101: New drug approvals in six major authorities 2015-2024: Trends in an evolving regulatory landscape. Centre for Innovation in Regulatory Science. London, UK: https://cirsci.org/wp-content/uploads/dlm_uploads/2025/08/CIRS-RD-Briefing-101-v1.1.pdf. [3] The Patients W.A.I.T. Indicator 2024 Survey. https://www.efpia.eu/media/oeganukm/efpia-patients-wait-indicator-2024-final-110425.pdf

The European Commission is set to unveil the Biotech Act I, an EU cardiovascular health plan and a simplification of the bloc’s medical devices and in vitro diagnostics rules on Dec. 16, according to the latest Commission agenda published Monday. The first part of the Biotech Act will focus on the pharmaceutical industry and is being produced without a dedicated impact assessment. The second part — covering other biotech sectors — is expected in the third quarter of 2026. The upcoming cardiovascular health plan — inspired by the bloc’s Beating Cancer Plan — will cover prevention, early detection and screening, treatment and management, and rehabilitation. Meanwhile, simplification of the bloc’s medical devices and in vitro diagnostics rules comes after the regulations drove up assessment costs, caused certification delays, and led to product withdrawals from the market. Europe’s Health Commissioner Olivér Várhelyi has previously said the sector needs a “major overhaul.” Additionally, the Commission’s agenda includes a “drugs package” comprising new rules on drug precursors and an EU Drugs Strategy and European action plan against drug trafficking — both scheduled for Dec. 3.

Today, as the world reaches a critical juncture in the fight against HIV/AIDS, tuberculosis (TB) and malaria, the EU must choose: match scientific breakthroughs with political will and investment or retreat, putting two decades of hard-won progress at risk. Having saved over 70 million lives, the Global Fund to Fight AIDS, Tuberculosis, and Malaria (the Global Fund) has proven what smart, sustained investment can achieve.  But the impact of its work — the lives protected, the life expectancy prolonged, the systems strengthened, the innovations deployed — is now under threat due to declining international funding.  > The real question is no longer whether the EU can afford to invest in the > Global Fund, but whether it can afford to let these hard-won gains unravel. The real question is no longer whether the EU can afford to invest in the Global Fund, but whether it can afford to let these hard-won gains unravel. Declining international funding, climate change, conflict and drug resistance are reversing decades of progress. HIV prevention is hampered by rising criminalization and attacks on key populations, with 1.3 million new infections in 2024 — far above targets. TB remains the deadliest infectious disease, worsened by spreading multidrug resistance, even in Europe. Malaria faces growing resistance to insecticides and drugs, as well as the impacts of extreme weather. Without urgent action and sustained investment, these threats could result in a dangerous resurgence of all three diseases. The stakes could not be higher  The Global Fund’s latest results reveal extraordinary progress. In 2024 alone: * 25.6 million people received lifesaving antiretroviral therapy, yet 630,000 still died of AIDS-related causes; * 7.4 million people were treated for TB, with innovations like AI-powered diagnostics reaching frontline workers in Ukraine; and * malaria deaths, primarily among African children under five, have been halved over two decades, with 2.2 billion mosquito nets distributed and ten countries eliminating malaria since 2020. Yet one child still dies every minute from this treatable disease.  What makes this moment unprecedented is not just the scale of the challenge, but the scale of the opportunity. Thanks to extraordinary scientific breakthroughs, we now have the tools to turn the tide:  * lenacapavir, a long-acting antiretroviral, offers new hope for the possibility of HIV-free generations; * dual active ingredient mosquito nets combine physical protection with intelligent vector control, transforming malaria prevention; and  * AI-driven TB screening and diagnostics are revolutionizing early detection and treatment, even in the most fragile settings. Some of these breakthroughs reflect Europe’s continued research and development and the private sector’s leadership in global health. BASF’s dual-active-ingredient mosquito nets, recently distributed by the millions in Nigeria, are redefining malaria prevention by combining physical protection with intelligent vector control. Delft Imaging’s ultra-portable digital X-ray devices are enabling TB screening in remote and fragile settings, while Siemens Healthineers is helping deploy cutting-edge AI software to support TB triage and diagnosis.  But they must be deployed widely and equitably to reach those who need them most. That is precisely what the Global Fund enables: equitable access to cutting-edge solutions, delivered through community-led systems that reach those most often left behind. A defining moment for EU Leadership The EU has a unique chance to turn this crisis into an opportunity. The upcoming G20 summit and the Global Fund’s replenishment are pivotal moments.  President Ursula von der Leyen and Commissioner Síkela can send a clear, unequivocal signal: Europe will not stop at “almost”. It will lead until the world is free of AIDS, tuberculosis and malaria.  The Global Fund is a unique partnership that combines financial resources with technical expertise, community engagement and inclusive governance. It reaches those often left behind — those criminalized, marginalized or excluded from health systems.  > Even in Ukraine, amid the devastation of war, the Global Fund partnership has > ensured continuity of HIV and TB services — proof that smart investments > deliver impact, even in crisis. Its model of country ownership and transparency aligns with Africa’s agenda for health sovereignty and with the EU’s commitment to equity and human rights. Even in Ukraine, amid the devastation of war, the Global Fund partnership has ensured continuity of HIV and TB services — proof that smart investments deliver impact, even in crisis. The cost of inaction Some may point to constraints in the Multiannual Financial Framework. But history shows that the EU has consistently stepped up, even in difficult fiscal times. The instruments exist. What’s needed now is leadership to use them. Failure to act would unravel decades of progress. Resurgent epidemics would claim lives, destabilize economies and undermine global health security. The cost of inaction far exceeds the price of investment. For the EU, the risks are strategic as well as moral. Stepping back now would erode the EU’s credibility as champion of human rights and global responsibility. It would send the wrong message, at precisely the wrong time.  Ukraine demonstrates what is at stake: with Global Fund support, millions continue to receive HIV and TB services despite war. Cutting funding now would risk lives not only in Africa and Asia, but also in Europe’s own neighborhood. A call to action Ultimately, this isn’t a question of affordability, but one of foresight. Can the EU afford for the Global Fund not to be fully financed? The answer, for us, is a resounding no. We therefore urge the European Commission to announce a bold, multi-year financial commitment to the Global Fund at the G20.  This pledge would reaffirm the EU’s values and inspire other Team Europe partners to follow suit. It would also support ongoing reforms to further enhance the Global Fund’s efficiency, transparency and inclusivity. > Ultimately, this isn’t a question of affordability, but one of foresight. Can > the EU afford for the Global Fund not to be fully financed? The answer, for > us, is a resounding no. This is more than a funding decision. It is a moment to define the kind of world we choose to build: one where preventable diseases no longer claim lives, where health equity is a reality and where solidarity triumphs over short-termism. Now is the time to reaffirm Europe’s leadership. To prove that when it comes to global health, we will never stop until the fight is won.