Tag - Cancer

Alcohol too cheap in Europe as health impact mounts, WHO warns
Europeans’ world-leading drinking habits are putting their health at risk, but governments are failing to use higher taxes to help curb consumption, warned the World Health Organization. Beer has become more affordable in 11 EU countries since 2022, and less affordable in six, the WHO report revealed Tuesday. There was a similar but even more dramatic trend for spirits, which became more affordable in 17 EU countries and less affordable in two. And for wine, 14 EU countries do not tax it at all, including big producers Italy and Spain, the report found. The EU includes seven of the 10 countries with the highest per-capita alcohol consumption globally, with Romania, Latvia and Czechia among the biggest drinkers. Alcohol is a major driver of cancer, with risk scaling alongside higher consumption. It’s also linked to a wide range of illnesses including cardiovascular disease and depression, all of which are adding pressure to stretched health systems. The WHO said governments should target alcohol consumption to protect people from its ill effects. Increasing the cost of booze through taxes is one of the most effective measures governments can take, the WHO said. Yet, some EU countries have minimal or no taxes on certain types of alcohol. The fact that more than half of EU countries don’t tax wine at all is “unusual” by international standards, WHO economist Anne-Marie Perucic said. She pointed out that the more affordable alcohol is, the more people consume. “Excluding a product is not common. It’s always for political reasons, socio-economic reasons [like] trying to protect the local industry. Clearly, it doesn’t make sense from a health perspective,” Perucic told POLITICO. Those 14 countries span the EU’s northern and central regions, such as Germany, Austria and Bulgaria. “More affordable alcohol drives violence, injuries and disease,” said Etienne Krug, director of the WHO’s department of health determinants, promotion and prevention. “While industry profits, the public often carries the health consequences and society the economic costs.” The EU has touted its plans to protect its wine industry from threats including declining consumption and climate change. EU institutions agreed a package of measures to prop up the sector in December. Meanwhile, the European Commission recently backed down from proposing an EU-wide tax on alcopops; the sweet, pre-mixed alcoholic drinks that taste like sodas, as part of its Safe Hearts plan.  In a separate report, the WHO reported that sugary drinks have also become more affordable in 13 EU countries since 2022, data published in a separate WHO report found. A diet high in sugar is linked to obesity, Type 2 diabetes, heart disease, fatty liver disease and certain cancers.
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Why RFK Jr.’s plan to follow Europe on vaccines is getting panned
President Donald Trump has told his health secretary, Robert F. Kennedy Jr., to consider aligning the U.S. vaccination schedule with those in Europe, where many countries recommend fewer vaccines. Kennedy has taken up the charge with gusto and is considering advising parents to follow Denmark’s childhood schedule rather than America’s. Many who specialize in vaccination and public health say that would be a mistake. While wealthy European countries do health care comparatively well, they say, there are lots of reasons Americans are recommended more shots than Europeans, ranging from different levels of access to health care to different levels of disease. “If [Kennedy] would like to get us universal health care, then maybe we can have a conversation about having the schedule adjusted,” Demetre Daskalakis, who led the Centers for Disease Control and Prevention’s National Center for Immunization and Respiratory Diseases before resigning in protest in August, told POLITICO. Children, especially those who live in poor and rural areas, would be at greater risk for severe disease and death if the U.S. were to drop shots from its schedule, Daskalakis said. Denmark, for instance, advises immunizing against only 10 of the 18 diseases American children were historically recommended immunizations against. It excludes shots for potentially serious infections, including hepatitis A and B, meningitis and respiratory syncytial virus. Under Kennedy, the government has already changed its hepatitis B vaccine recommendations for newborns this year, even as critics warned the new advice could lead to more chronic infections, liver problems and cancer. The health department points out that the new guidance on hepatitis B — that mothers who test negative for the virus may skip giving their newborn a shot in the hospital — now align more closely with most countries in Europe. Public health experts and others critical of the move say slimmer European vaccine schedules are a cost-saving measure and a privilege afforded to healthier societies, not a tactic to protect kids from vaccine injuries. Kennedy’s interest in modeling the U.S. vaccine schedule after Europe, they point out, is underpinned by his belief that some childhood vaccines are unsafe and that American kids get too many too young. Kennedy’s safety concerns don’t align with the rationale underpinning the approach in Europe, where the consensus is that childhood vaccines are safe. Wealthy European countries in many cases eschew vaccines based on a risk-benefit calculus that doesn’t hold in America. European kids often don’t get certain shots because it would prevent a very small number of cases — like hepatitis B — or because the disease is rarely serious for them, such as Covid-19 and chickenpox. But since the U.S. doesn’t have universal access to care, vaccinating provides more return on investment, experts say. “We just have a tradition to wait a little bit” before adding vaccines to government programs, said Johanna Rubin, a pediatrician and vaccine expert for Sweden’s health agency. Swedish children are advised to get vaccines for 11 diseases before they turn 18. Rubin cited the need to verify the shots’ efficacy and the high cost of new vaccines as reasons Sweden moves slowly to add to its schedule. “It has to go through the health economical model,” she said. VACCINE SAFETY’S NOT THE ISSUE Martin Kulldorff, a Swedish native and former Harvard Medical School professor who led Kennedy’s vaccine advisory panel until this month, pointed to that country’s approach to vaccination and public health in an interview with POLITICO earlier this year. Before the Centers for Disease Control and Prevention this month dropped its recommendation that children of mothers who test negative for hepatitis B receive a vaccine within a day of birth, Kulldorff cited Sweden’s policy. “In Sweden, the recommendation is that you only do that if the mother has the infection. That’s the case in most European countries,” he said. “You could have a discussion whether one or the other is more reasonable.” The U.S. policy, as of Dec. 16, more closely resembles Sweden’s, with hepatitis B-negative mothers no longer urged to vaccinate their newborns against the virus at birth. But Sweden’s public health agency recommends that all infants be vaccinated, and the country’s regional governments subsidize those doses, which are administered as combination shots targeting six diseases starting at 3 months. Public health experts warn that even children of hepatitis B-negative mothers could catch the virus from others via contact with caregivers who are positive or shared household items. The prevalence of chronic hepatitis B in the U.S. is 6.1 percent compared to 0.3 percent in Sweden, according to the Coalition for Global Hepatitis Elimination, a Georgia-based nonprofit which receives funding from pharmaceutical companies, the CDC and the National Institutes of Health, among others. Michael Osterholm, the director of the Center for Infectious Disease Research and Policy at the University of Minnesota, said the U.S. has taken a more comprehensive approach to vaccination, in part because its population is sicker than that of some Western European countries, and the impact of contracting a disease could be more detrimental. Osterholm pointed to the Covid pandemic as an example. By May 2022, the U.S. had seen more than 1 million people die. Other high-income countries — though much smaller — had more success controlling mortality, he said. “People tried to attribute [the disparity] to social, political issues, but no, it was because [peer nations] had so many more people who were actually in low-risk categories for serious illness,” Osterholm said. Kennedy and his advisers also cited European views on Covid vaccination in the spring when the CDC dropped its universal recommendation, instead advising individuals to talk to their providers about whether to get the shot. Last month, the Food and Drug Administration’s top vaccine regulator, Vinay Prasad, linked the deaths of 10 children to Covid vaccination without providing more detailed information about the data behind his assertion. European countries years ago stopped recommending repeat Covid vaccination for children and other groups not considered at risk of becoming severely sick. Covid shots have been linked to rare heart conditions, primarily among young men. European vaccine experts say Covid boosters were not recommended routinely for healthy children in many countries — not because of safety concerns, but because it’s more cost-effective to give them to high-risk groups, such as elderly people or those with health conditions that Covid could make severely sick and put in the hospital. In the U.K., Covid-related hospitalizations and deaths declined significantly after the pandemic, and now are “mostly in the most frail in the population, which has led to more restricted use of the vaccines following the cost-effectiveness principles,” said Andrew Pollard, the director of the Oxford Vaccine Group in the United Kingdom, which works on developing vaccines and was behind AstraZeneca’s Covid-19 shot. Pollard led the Joint Committee on Vaccination and Immunization, which advises the U.K. government, for 12 years before stepping down in September. In the U.S., more moves to follow Europe are likely. At a meeting of Kennedy’s vaccine advisers earlier this month, Tracy Beth Høeg, now acting as the FDA’s top drug regulator, pointed to Denmark’s pediatric schedule, which vaccinates for 10 diseases, while questioning whether healthy American children should be subject to more vaccines than their Danish counterparts. Danish kids typically don’t get shots for chickenpox, the flu, hepatitis A and B, meningitis, respiratory syncytial virus and rotavirus, like American children do, though parents can privately pay for at least some of those vaccines. The country offers free Covid and flu vaccines to high-risk kids. After the vaccine advisory meeting wrapped, Trump said he was on board, directing Kennedy to “fast track” a review of the U.S. vaccine schedule and potentially align it with other developed nations. He cited Denmark, Germany and Japan as countries that recommend fewer shots. Last week, Kennedy came within hours of publicly promoting Denmark’s childhood vaccine schedule as an option for American parents. The announcement 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 senior department official told POLITICO. The notion that the U.S. would drop its vaccine schedule in favor of a European one struck health experts there as odd. Each country’s schedule is based on “the local situation, so the local epidemiology, structure of health care services, available resources, and inevitably, there’s a little bit of political aspect to it as well,” said Erika Duffell, a principal expert on communicable disease prevention and control at the European Centre for Disease Prevention and Control, an EU agency that monitors vaccine schedules across 30 European countries. Vaccine safety isn’t the issue, she said. For example, even though most Europeans don’t get a hepatitis B shot within 24 hours of birth, the previous U.S. recommendation, “there is a consensus that the effectiveness and safety of the vaccine has been confirmed through decades of research” and continuous monitoring, she said. European nations like Denmark and the U.K. have kept new cases of hepatitis B low. Denmark recorded no cases of mother-to-child transmission in 2023, and Britain’s rate of such spread is less than 0.1 percent — though the latter does routinely recommend vaccinating low-risk infants beginning at 2 months of age. European experts point to high levels of testing of pregnant women for hepatitis B and most women having access to prenatal care as the reasons for success in keeping cases low while not vaccinating all newborns. The major differences between the U.S. and the U.K. in their approach to hepatitis B vaccination are lower infection rates and high screening uptake in Britain, plus “a national health system which is able to identify and deliver vaccines to almost all affected pregnancies selectively,” Pollard said. The CDC, when explaining the change in the universal birth dose recommendation, argued the U.S. has the ability to identify nearly all hepatitis B infections during pregnancy because of ”high reliability of prenatal hepatitis B screening,” which some European experts doubt. “If we change a program, we need to prepare the public, we need to prepare the parents and the health care providers, and say where the evidence comes from,” said Pierre Van Damme, the director of the Centre for the Evaluation of Vaccination at the University of Antwerp in Belgium. He suggested that, if there was convincing evidence, U.S. health authorities could have run a pilot study before changing the recommendation to evaluate screening and the availability of testing at birth in one U.S. state, for example. WHERE EUROPEANS HAVE MORE DISEASE In some cases, European vaccination policies have, despite universal health care, led to more disease. France, Germany and Italy moved from recommending to requiring measles vaccination over the last decade after outbreaks on the continent. The U.S., until recently, had all but eradicated measles through a universal recommendation and school requirements. That’s starting to change. The U.S. is at risk of losing its “measles-elimination” status due to around 2,000 cases this year that originated in a Texas religious community where vaccine uptake is low. The 30 countries in the European Union and the European Economic Area, which have a population of some 450 million people combined, reported more than 35,000 measles cases last year, concentrated in Romania, Austria, Belgium and Ireland. Europe’s comparatively high rate is linked to lower vaccination coverage than the level needed to prevent outbreaks: Only four of the 30 countries reached the 95-percent threshold for the second measles dose in 2024, according to the European Centre for Disease Prevention and Control. Kennedy touted the U.S.’s lower measles rate as a successful effort at containing the sometimes-deadly disease, but experts say the country could soon see a resurgence of infectious diseases due to the vaccine skepticism that grew during the pandemic and that they say Kennedy has fomented. Among kindergarteners, measles vaccine coverage is down 2.7 percentage points as of the 2024-2025 school year, from a peak of 95.2 percent prior to the pandemic, according to CDC data. That drop occurred before Kennedy became health secretary. Kennedy and his advisers blame it on distrust engendered by Covid vaccine mandates imposed by states and President Joe Biden. But Kennedy led an anti-vaccine movement for years before joining the Trump administration, linking shots to autism and other conditions despite scientific evidence to the contrary, and he has continued to question vaccine safety as secretary. In some EU nations, vaccines aren’t compulsory for school entry. Swedish law guarantees the right to education and promotes close consultation between providers and patients. Some governments fear mandates could push away vaccine-hesitant parents who want to talk the recommended shots over with their doctor before giving the vaccines to their children, Rubin explained. In the U.S., states, which have the authority to implement vaccine mandates for school entry, rely on the CDC’s guidance to decide which to require. Vaccine skeptics have pushed the agency to relax some of its recommendations with an eye toward making it easier for American parents to opt out of routine shots. Scandinavian nations maintain high vaccine uptake without mandates thanks to “high trust” in public health systems, Rubin said. In Sweden, she added, nurses typically vaccinate young children at local clinics and provide care for them until they reach school age, which helps build trust among parents. CHICKENPOX Another example of where the U.S. and Europe differ is the chickenpox vaccine. The U.S. was the first country to begin universal vaccination against the common childhood illness in 1995; meanwhile, 13 EU nations broadly recommend the shot. Denmark doesn’t officially track chickenpox — the vaccine isn’t included on its schedule — but estimates 60,000 cases annually in its population of 6 million. The vastly larger U.S. sees fewer than 150,000 cases per year, according to the CDC. Many European countries perceive chickenpox as a benign disease, Van Damme said. “If you have a limited budget for prevention, you will spend usually the money in other preventative interventions, other vaccines than varicella,” he said, referring to the scientific term for chickenpox. But there’s another risk if countries decide to recommend chickenpox vaccination, he explained. If the vaccination level is low, people remain susceptible to the disease, which poses serious risks to unborn babies. If it’s contracted in early pregnancy, chickenpox could trigger congenital varicella syndrome, a rare disorder that causes birth defects. If children aren’t vaccinated against chickenpox, almost all would get the disease by age 10, Van Damme explained. If countries opt for vaccination, they have to ensure robust uptake: vaccinate virtually all children by 10, or risk having big pockets of unvaccinated kids who could contract higher-risk infections later. Europe’s stance toward chickenpox could change soon. Several countries are calculating that widely offering chickenpox vaccines would provide both public health and economic benefits. Britain is adding the shot to its childhood schedule next month. Sweden is expected to green-light it as part of its national program in the coming months. While the public doesn’t see it as a serious disease, pediatricians who see serious cases of chickenpox are advocating for the vaccine, Rubin told POLITICO. “It is very contagious,” she said. “It fulfills all our criteria.” The U.K. change comes after its vaccine advisory committee reviewed new data on disease burden and cost-effectiveness — including a 2022 CDC study of the U.S. program’s first 25 years that also examined the vaccine’s impact on shingles, a painful rash that can occur when the chickenpox virus reactivates years later. Scientists had theorized for years that limiting the virus’ circulation among children could increase the incidence of shingles in older adults by eliminating the “booster” effect of natural exposure, but the U.S. study found that real-world evidence didn’t support that hypothesis.
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Cancer care cannot fall off the EU agenda
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]
Health Care
Clinical trials
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healthcare
Innovation
Decisions today, discoveries tomorrow: Europe’s Choice for the next decade of medicine development
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.
Health Care
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healthcare
Industry
EU officials acted to aid tobacco giant abroad, documents show
By Kathryn Kranhold and Jason McLure of The Examination and Rory O’Neill and Antonia Zimmermann of POLITICO. This article was reported in collaboration with The Examination, a nonprofit newsroom that investigates global health threats. BRUSSELS — When the world’s largest tobacco company needed help lifting international restrictions on its products, it enlisted an unlikely ally: the European Union, a leader in tobacco control.  EU officials met with Philip Morris International representatives at least six times from September 2022 through 2024, according to documents released through public records requests. The tobacco giant’s agenda: Enlist EU officials’ help in loosening restrictions or setting favorable tax rates on its products — including IQOS, a heated tobacco device key to the company’s future — in 10 countries outside the EU. Officials with the European Commission, the EU’s executive arm, took action at least three times that would have benefitted the company, The Examination and POLITICO found. They published a notice saying Mexico’s ban on new nicotine products was a possible barrier to free trade. They asked Turkish officials whether they planned to maintain the country’s requirement that cigarettes contain a minimum amount of local tobacco. And in a high-level report for EU officials, they flagged that rule and Turkey’s cigarette tax rate as issues that could affect ties between it and the EU.  The Commission’s actions regarding Turkey were “of great help for us,” a PMI representative wrote to staffers at the Commission. “We would like to express our gratitude in regard of (sic) the actions that you took.”  A Philip Morris International representative thanked European Commission trade officials for flagging Turkey’s cigarette tax and a rule on domestic tobacco as possible trade issues. (Redactions by the European Commission. Highlighting by The Examination) The revelations, contained in documents released through public information requests by the French anti-tobacco group Contre-Feu, raise questions about whether the EU breached its commitment to a global treaty to combat smoking signed by the EU and member countries. Guidelines to implement that treaty — the Framework Convention on Tobacco Control (FCTC) — say that when setting and implementing public health policies, governments should restrict their dealings with the tobacco industry and disclose any meetings whenever possible. None of the meetings with PMI or other industry groups cited in the documents were disclosed, according to The Examination and POLITICO’s review of the EU’s disclosure websites. The “fact that EU officials acted upon PMI’s requests signals a troubling willingness to give the tobacco industry privileged access. That is precisely what the FCTC was designed to prevent,” said Tilly Metz, a member of the European Parliament with the Greens. “It undermines both public trust and the EU’s credibility as a global leader in tobacco control.” A spokesperson for the European Commission told The Examination and POLITICO  that it “strictly follows” the treaty guidelines. But tobacco products are covered by EU trade policy, and the Commission can negotiate tariffs and trade rules, the spokesperson said.  “The Commission does not shape, influence or lobby for specific health policies in third countries on behalf of any industry,” the spokesperson said.  While industry associations and companies can share concerns on market access in non-EU countries with the Commission, and the Commission may meet with complainants to get more information, the spokesperson said such meetings are “strictly related to trade facilitation and market access.” European parliamentarians appeared divided over whether the dealings were improper.  Vytenis Andriukaitis with the Socialists and Democrats and a former EU health commissioner said the European Commission “cannot represent the interests of tobacco companies,” nor “press other countries to weaken” their tobacco controls. Barry Andrews, a member of the centrist Renew Europe Group, said: “These regular meetings with big tobacco lobbyists and the flurry of emails should not have happened.” By contrast, Stine Bosse, a member of the same political group, said: “The tobacco industry has every right to employ lobbyists.” However, Bosse added: “Morally, I stand in a very different place. While they constantly try to reinvent new products to get people hooked on nicotine and tobacco, I am fighting for precisely the opposite.”  Philip Morris International did not answer questions from The Examination and POLITICO about its dealing with EU officials. On its website, the company said it shares its perspectives with policymakers and it is “particularly active with respect to policies regarding less harmful alternatives to cigarettes, trade and fiscal matters, and intellectual property.” (The company is separate from Philip Morris USA, which is part of Altria Group.) The Examination and POLITICO have not found evidence that any of the 10 countries targeted by PMI altered their tobacco taxes or regulations following meetings with EU officials, including where the EU took action with regard to Mexico and Turkey. Most of PMI’s entreaties focused on IQOS, which it says is better than cigarettes because heating tobacco releases fewer toxins than burning it. Public health experts say the long-term risks of heated tobacco are unknown and products like IQOS could increase tobacco use. IQOS devices with heated tobacco sticks. Philip Morris International says IQOS is better than cigarettes because heating tobacco releases fewer toxins than burning it. Public health experts say the long-term risks of heated tobacco are unknown. | Roberto Pfeil/picture alliance via Getty Images Public health advocates said Commission officials’ actions were especially surprising because the EU has been one of the strongest supporters of the FCTC.  This year, the Commission proposed hiking EU-wide taxes on most tobacco products and setting minimum taxes for vapes and heated tobacco for the first time. Health Commissioner Olivér Várhelyi has pledged to drive e-cigarette taxes even higher; his tax counterpart, Wopke Hoekstra, has called vapes the “revenge of the tobacco industry.” The countries that PMI sought help with were outside the EU. Nearly all of them — Argentina, Brazil, India, Mexico, Singapore, Thailand, Turkey and Vietnam — had banned heated tobacco. Taiwan had what PMI described as a burdensome approval process. Japanese leaders were in discussions to raise taxes on heated tobacco to the same rate as cigarettes. Philip Morris International asked for the EU’s help in loosening restrictions or setting favorable tax rates on its IQOS product in 10 countries outside the EU. (Redactions by the European Commission. Highlighting by The Examination) PMI officials wanted people in those countries to be able to buy IQOS as easily as cigarettes. The company calls IQOS part of its “dream team” of alternative nicotine products, including e-cigarettes and nicotine pouches, that are meant to offset declining cigarette consumption.  So the company sought help in the EU’s distinctive 15-story glass trade building, the Charlemagne, in Brussels. PMI SEEKS HELP IN MEXICO Mexico was the first country that PMI sought help with, according to the documents. That country was a key market for IQOS, but a ban on vapes and heated tobacco was set to go into effect in December 2022.  In an investor meeting on Sept. 6, 2022, an analyst asked about IQOS’ “lack of success” in the Americas. Emmanuel Babeau, the company’s chief financial officer, blamed “some restrictions” in Mexico but said, “it’s going to be a very successful market for IQOS once we can really sell the device really without any issue.” That same day, company staff had an online meeting with EU officials to discuss the ban. It was one of several discussions about Mexico. After the ban went into effect, PMI sought more help from EU officials. In an April 3, 2023, email, an executive at the company’s Swiss office asked for another meeting, explaining that Mexico’s “business environment is still marked by uncertainty, judicial processes, interpretations, and doubtful, temporary and unclear administrative acts.”    After a ban on vapes and heated tobacco went into effect in Mexico, Philip Morris International sought more help from EU officials. (Redactions by the European Commission. Highlighting by The Examination) Soon after the email, European trade officials issued what is known as a barrier to trade notice, reporting Mexico’s IQOS ban as a potential trade treaty violation. PMI representatives and trade officials met later that month, when the company contended similar bans in Argentina, Brazil and Vietnam were trade barriers, according to a Commission report summarizing the meeting. The Commission spokesperson said it had acted in response to a formal complaint that “involved discriminatory treatment of like products” and that it did not undertake any further action regarding Mexico. Mexico’s Supreme Court struck down the ban in November 2024, allowing PMI to continue selling IQOS there.  The correspondence shows how PMI leveraged its status as a major European employer and exporter. The company employed more than 21,500 people in Europe as of 2023 and had 20 manufacturing sites there. In one email, a PMI representative told a European trade official that a meeting would be a “good opportunity to update you [on] the most recent data on EU exports in the tobacco sector and PMI’s investments in the EU.” OFFICIALS QUESTION TURKEY’S TAXES, RULES ON LOCAL TOBACCO EU officials also assisted PMI in trying to change rules on cigarettes.  In July 2023, a company representative complained to EU officials about Turkey’s cigarette tax, saying in an email that Turkey had “one of the highest ad valorem duty levels in the world.” The representative also flagged Turkey’s “local content” rule, which required that cigarettes made and sold in the country contain a certain amount of domestic tobacco. The PMI representative wrote that the company had “prepared a few suggestions” for the Commission’s upcoming report on Turkey’s economic and diplomatic relationships with the EU.  That report, which came out in November 2023, flagged Turkey’s taxes and the local content rule. That elicited the email from PMI thanking EU officials for their help. Meanwhile, the company was pushing European Commission officials to raise the local content rule again, but in a different forum: an upcoming World Trade Organization (WTO) review of Turkey’s trade policies. PMI provided EU trade officials with questions to ask Turkey. EU officials then submitted a question prior to the review, asking whether the local content requirement for tobacco and other industries would continue, according to meeting minutes. The Commission spokesperson did not directly answer questions from The Examination and POLITICO about its actions regarding Turkey. Turkey has not changed its requirements on local tobacco or its tax rate.  MEETINGS PART OF A MULTIMILLION-DOLLAR LOBBYING EFFORT The meetings are part of an industry lobby that spends $16.2 million (14 million euros) a year in the EU, according to a report by Contre-Feu and STOP, another anti-tobacco group, released Wednesday. Contre-Feu mapped a network of 49 organizations and companies, including Philip Morris International and British American Tobacco, that lobbied the European Commission and Parliament to weaken tobacco regulations and set lower taxes on new nicotine products, both within and outside the EU. (British American Tobacco did not respond to requests for comment.) The interactions between the tobacco industry and EU officials appear to be extensive, according to the documents. They include several dozen email exchanges and refer to at least nine meetings between EU officials and tobacco companies or industry-supported groups.  In addition to the six meetings with PMI, there were three other meetings with tobacco representatives. Trade staff met with three other companies and a tobacco trade group in March 2024 to hear their requests for more favorable tariff rules for new nicotine products. In a separate video conference, British American Tobacco asked trade staff to intervene at a WTO hearing over Saudi Arabia’s proposed tax hike on e-cigarette cartridges. (The EU did not take action, according to the documents.) And in a third meeting, the EU’s former agriculture commissioner, a Polish member of the EU parliament and two tobacco farming lobby groups discussed tobacco subsidies and the Commission’s position on the global tobacco treaty. Nathalie Darge, secretary general of Tobacco Europe, the trade group included in one of those meetings, said its input focused on technical requirements and that it wanted to “ensure legal certainty for operators and customs authorities.” One European Commission report recapping a meeting with PMI was sent to 32 trade department officials and staff, including EU representatives assigned to Mexico, Brazil, Argentina and Vietnam and division directors. Contre-Feu wrote that the dealings between government officials and tobacco representatives showed that “current rules to limit industry influence are falling short and European policymakers continue to be heavily lobbied by the tobacco industry and those working on its behalf.” PMI’s efforts are part of a long history of the tobacco industry using trade and investment pacts to expand markets and undermine health policies, said Suzanne Zhou, who works for the World Health Organization FCTC Knowledge Hub on Legal Challenges and a senior fellow at the Melbourne Law School in Australia. “Tobacco companies have lost the argument from a health perspective,” Zhou said. “So they are reframing the issue as a trade issue in the hopes that they can advance their interests in that forum instead.”  In the 1980s, the U.S. Trade Representative threatened sanctions if Japan, Taiwan, South Korea and Thailand didn’t open their markets to U.S. cigarette companies. A study later concluded that cigarette consumption in those four markets was nearly 10 percent higher than it would have been if they had remained closed to U.S. companies.  More recently, Australia and Uruguay faced trade litigation from the industry or industry-aligned governments over their tobacco control policies.  COMMISSION CRITICIZED FOR UNDISCLOSED MEETINGS Contre-Feu contended that the documents also show that EU officials didn’t disclose meetings with the industry when they should have. To aid countries in implementing the tobacco treaty, delegates wrote a set of guidelines. They state that when setting and implementing public health policies, interactions with the tobacco industry should be limited to what is strictly necessary for effective regulation. Interactions should be conducted in public and disclosed whenever possible. And the guidelines emphasize that “all branches of government” should be made aware of industry efforts to interfere with policies. The Commission spokesperson said that’s exactly what it does: “Meetings with the tobacco industry are avoided, unless they are strictly necessary. If the applicable conditions are met, meetings are held in a fully transparent manner and are appropriately documented.” But EU trade officials did not disclose any of these meetings on the website where the trade department reports such contacts. One batch of documents was released through a request for access; another batch was obtained by Contre-Feu. One of the meetings not disclosed by trade officials occurred in July 2023. Global health leaders were scheduled to meet that November to update the FCTC. The European Commission was considering supporting strict limitations on heated tobacco products.  A Commission report summarizing a July 19, 2023, meeting with PMI said that the company had “alerted” the Commission about language “calling on WHO members to adopt import bans on heated tobacco products.” The company asserted that EU tobacco policy should take into account WTO agreements, which the company has contended would preclude countries from banning IQOS.  Philip Morris International met with European Commission trade officials in July 2023 to discuss a proposed change to a global tobacco control treaty that would have banned heated tobacco. Though such meetings are supposed to be disclosed, this one wasn’t. (Redactions by the European Commission. Highlighting by The Examination) The documents don’t say anything about whether the Commission took action, and tobacco-friendly countries in the EU such as Italy and Greece pushed back against restrictive guidelines. But in the end, the Commission took no position on heated tobacco— a victory for the industry.  During the period covered by the documents, the EU required only high-ranking Commission officials to report meetings with companies or special-interest groups. In December 2024, the Commission tightened rules to require disclosure by additional staff. It’s unclear whether those rules would’ve required disclosure of these meetings.  Former EU ombudsman, Emily O’Reilly, found other instances in which the Commission didn’t disclose meetings with the tobacco industry, which she concluded failed to meet transparency rules required under international law.  Contre-Feu has urged the EU to tighten transparency guidelines even further by extending disclosure requirements to all staff, among other things. The group said in its report that the extensive lobbying and lack of disclosure “reveal either a repeated violation of the FCTC by the European Commission or, at the very least, an insufficient implementation of the treaty’s measures.” Mathieu Tourliere of Proceso contributed reporting. STOP has received support from Bloomberg Philanthropies, which also provides financial support to The Examination. The Examination operates independently and is solely responsible for its content. Correction: This story has been corrected to say that the report on tobacco industry lobbying was jointly published by Contre-Feu and STOP, and that STOP has received support from Bloomberg Philanthropies.
Health Care
Public health
Regulation
Cancer
Non Communicable diseases
The FDA’s top drug regulator submits his resignation to the agency
Rick Pazdur, the FDA’s top drug regulator, told staff Tuesday he submitted his resignation to the agency, an abrupt departure weeks after he was convinced by Commissioner Marty Makary to take the post to help bring stability to an agency reeling from months of upheaval, according to four people familiar with the decision granted anonymity to discuss the move. The decision — which comes days after top vaccine regulator Vinay Prasad said the agency would ratchet up regulatory requirements for new vaccines — is almost certain to raise new questions about Makary’s leadership of the FDA. Pazdur in recent weeks clashed with Makary over the Commissioner’s National Priority Voucher program, according to media reports. That program — which aims to speed final review of drugs that address health priorities, pose a transformative innovative impact, address an unmet medical need, help onshoring efforts or increase affordability — was also criticized by Pazdur’s predecessor, George Tidmarsh. FDA experts have worried the involvement of political appointees in the process of choosing which firms receive a voucher could raise questions about the program’s integrity. STAT first reported the news of Pazdur’s decision to retire. It is unclear if the decision is final — one person familiar with the decision said the longtime cancer drug regulator has 30 days to change his decision. “We respect Dr. Pazdur’s decision to retire and honor his 26 years of distinguished service at the FDA,” an FDA spokesperson said in a statement. “As the founding director of the Oncology Center of Excellence, he leaves a legacy of cross-center regulatory innovation that strengthened the agency and advanced care for countless patients. His leadership, vision, and dedication will continue to shape the FDA for years to come.” The White House and Pazdur did not immediately respond to requests for comment. Pazdur, a 26-year agency veteran, initially rebuffed efforts by Makary to convince him to assume leadership of the FDA’s Center for Drug Evaluation and Research — but ultimately agreed to take the job after being assured he would be given autonomy in the role free from political influence and the ability to rehire staff.
Media
Services
Health Care
Innovation
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PMQs: Lammy launches tirade as second asylum seeker mistakenly released from jail
Prime minister’s questions: a shouty, jeery, very occasionally useful advert for British politics. Here’s what you need to know from the latest session in POLITICO’s weekly run-through. What they sparred about: Asylum seekers and prison. It was a duel of the deputies as Keir Starmer’s second in command, David Lammy, took on Shadow Defence Secretary, James Cartlidge, while the PM hung out at COP30 in Brazil. The deputy PM admitted he had expected to face Shadow Justice Secretary (and wannabe Tory leader) Robert Jenrick. The hardest word: Cartlidge, admittedly not the best known figure outside Westminster, referenced an ITV News interview with the father of the 14-year-old girl who had been sexually assaulted by Ethiopian national Hadush Kebatu … the man who was mistakenly freed for 48 hours. “Will he apologise to the family concerned?” Moment of contrition: Lammy insisted he’d already obliged with that request. “In the debate, of course, I said sorry for the anxiety caused whilst Kebatu was at large, and I repeat that.” Who knew a direct question could get a direct answer? Not so fast: The shadow defence secretary made clear Kebatu’s quick capture wasn’t good enough. Cartlidge wanted Lammy, the justice secretary after all, to guarantee that “no other asylum-seeking offender has been accidentally let out of prison” since the mistaken release. Answer, er, came there none. The justice secretary slammed Cartlidge’s former tenure as a justice minister, “who let our prisons get into that state in the first place.” This may be why: Just after their exchange, the Telegraph reported a manhunt was underway for an Algerian asylum seeker mistakenly released from HMP Wandsworth last week, but the Met Police was only informed on Tuesday. Hell yes, I’m tough enough: Aware that his question had gone unanswered, Cartlidge had another go, given how embarrassing Kebatu’s release was for the government. Lammy spoke about implementing the “toughest checks we have ever had in the prison system” and ripped into the “complicated system” introduced by, obvs, the Tories. Trappings of office: If at first you don’t succeed, try again — Cartlidge channeled interviewing legend Jeremy Paxman, no matter how awkward it became. “He’s the justice secretary. He’s responsible for the justice system. He needs to take responsibility,” the shadow defense secretary stressed. “Get a grip, man!” Lammy boomed back. “I know I’m the justice secretary. That’s why I’m at the despatch box.” Just wait till you get back to the MoJ … As per: There was the usual back and forth as Cartlidge continued probing and Lammy slammed his questioning efforts. “I spent 14 years in opposition, and I did a hell of a lot better than he has just done,” Lammy said, though MPs, hacks, and the public were left none the wiser until the Telegraph’s story broke. Six not out: Speaker Lindsay Hoyle originally went back to Cartlidge even after all six of the questions had been asked (if not answered). Much hilarity ensued as the Tory spokesperson briefly rose to the despatch box … before getting slapped down by the speaker. Admittedly, few people kept count, given it was the same question again and again. Helpful backbench intervention of the week: Erewash MP Adam Thompson praised the national minimum wage increase despite Tory and Reform UK’s opposition, asking whether any of Nigel Farage’s extra jobs paid below the minimum wage. Lammy, no changes here, took the bait and laid into the Reform UK chief’s outside earnings accordingly. Totally unscientific scores on the doors: Lammy 5/10. Cartlidge 6/10. Who knows whether Cartlidge had a tip-off about the Telegraph’s scoop, bringing yet more headaches for the government? Regardless, Lammy’s inability to provide certainty about mistaken releases became clearer after the revelation. Though Cartlidge didn’t specifically probe him on the manhunt, and incorrectly thought he had an extra question, pushing mistakenly released asylum seekers back up the news agenda has left ministers in a far weaker position.
UK
Politics
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Asylum
British politics
Biotech Act I, CV health plan and MDR simplification coming mid-December
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.
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Nigel Farage’s party is trying to step out of his shadow. Can it?
BIRMINGHAM — It had suits, wonks, outriders, sponsors, lobbyists, receptions, and a rapidly-growing party flock. But Reform UK’s conference remained in many ways the Nigel Farage show. From the scrum around the populist leader to the teal “No. 10” football shirts in his name, Farage — a 30-year veteran of right-wing insurgency — dominated. He filled most of the hall at Birmingham’s National Exhibition Centre for his Friday speech, despite a last-minute timing change. Much of Reform’s runaway lead in U.K. opinion polls is down to one man’s charisma. “It’s like going on tour with the Pope,” said one party figure, granted anonymity (like other officials and politicians quoted in this piece) to speak candidly. But to survive in government, Reform will need more. And Farage, who turns 65 in 2029, knows it. He and his allies are now conspicuously trying to emphasize that Reform is not just about him. Attendees could barely move for talk of new party structures and policy fringes. Farage tries to farm out media interviews and visits to his allies, particularly his deputy Richard Tice and new Head of Policy Zia Yusuf (neither of whom have ruled out eyeing the job of chancellor). Yet Farage’s word is still gospel. The leader personally pushed to have Aseem Malhotra, an adviser to Trump’s Health Secretary Robert F. Kennedy Jr, on the conference’s main stage due to his links with the U.S. administration, one party figure said. Malhotra then used the platform to suggest Covid vaccinations may have caused King Charles’ cancer (Reform distanced itself from his comments). Like the MAGA movement — reflected in the conference’s “Make Britain Great Again” caps, stage pyrotechnics and talk of the death of the old right — Reform is still vested in an ultra-high-profile figurehead. But Britain does not have presidents, and Downing Street has far fewer political appointees than the White House. Reform must prepare for a system that is bigger than the principal. That begins, for now, with policy. THE SMALL TENT Reform now has three fully-fledged paid policy officials, said a party figure, including Simon Marcus, a former Tory councilor in London. This is a small number for a party hoping to reach government, though soon he will have more backup. Reform is recruiting at least four more paid policy officials, several officials told POLITICO, including two on central policy and one each for Scotland and Wales ahead of devolved elections in May 2026. There are unpaid officials too, such as Yusuf, and the party relies on enthusiastic volunteers. In Scotland, where the party does not yet have a paid policy official, party figures pointed to an unpaid activist as the main backroom thinker on policy (as part of a committee). Neil Hall/EPA Broadly speaking, though, the circle of people in the room for key decisions is small. As well as key elected representatives and Yusuf, Reform figures who were asked by POLITICO pointed to Farage’s Director of Communications and effectively his chief of staff Dan Jukes; long-time Farage ally and strategist Chris Bruni-Lowe; Director of Operations Aaron Lobo; and Reform Director of Communications Ed Sumner. A second Reform figure described Farage’s core team as “very tight.” A third Reform figure suggested four people plus Farage were in the room at key moments, adding: “Ultimately Nigel is the leader and he makes the decisions.” Yusuf told a conference event that Reform’s recent immigration policy — a sprawling pledge that would lead to around 600,000 deportations — was drawn up “entirely in-house.” On policy, though, Reform figures are keen to show that they know they’ll need a wider pool of thinkers. “Our biggest weakness is we have no experience in government,” said a fourth Reform figure. “We have no one that knows the ropes.” Sometimes it seems to show. Farage’s big announcement in his Friday speech, to stop migrant boat crossings in the English Channel “within two weeks of winning government,” became “within two weeks of legislation being passed” by the time he gave press interviews Saturday. Tory strategists are separately keen to pick at what they paint as fiscal incoherence in Farage’s call to ease a two-child limit on benefits — a pledge that emerged from his desire for more British babies — at the same time as “serious cuts” to the welfare budget. A fifth Reform figure argued the leader is a factor: “Nigel’s not a huge policy guy,” they said. “Nigel’s role is to drive the party forward, to inspire the ranks.” AND SO, ENTER THE WONKS Reform’s nine-member party board met for the first time last week. It consists of Farage, Yusuf, chairman David Bull, racehorse trainer Andrew Reid, the former leader of UKIP (Reform’s predecessor party) Paul Nuttall, ex-GB News presenter Darren Grimes, regional mayor Andrea Jenkyns, former Tory Greater Manchester mayoral candidate Dan Barker, and Farage’s former press chief Gawain Towler. Yusuf, who Farage named as head of policy on Friday, told a fringe event that board will have a “subordinate committee” that essentially “rubber-stamps” party policy. Then there is a nascent ecosystem of think tanks including the Reform-friendly Centre for a Better Britain (referred to verbally by supporters as CFABB). Its chief executive Jonathan Brown — Reform’s former chief operating officer — meets Tice roughly every couple of weeks, said a person with knowledge of the meetings. While the group declined to say who funds it, a document leaked to the Sunday Times suggested it wanted to raise more than £25 million by 2029 — much of it from the U.S. (A CFABB official insisted to POLITICO that all current donors are either British or reside in Britain.) The chair of its advisory board, James Orr, has been a friend of U.S. Vice President JD Vance since 2019. Neill Hall/EPA But CFABB also has a British flavor — as a home for Brexit warriors of old. Veteran Tory Euroskeptic John Redwood is helping with some of its work. Christopher Howarth, the former fixer for the Tory European Research Group, is one of its seven or so current staff. Brown is in a WhatsApp group with right-wing Conservative peers, including Boris Johnson’s former Brexit negotiator David Frost. And his fellow CBB director David Lilley — who has donated more than £250,000 to Reform — previously funded Johnson and the Vote Leave campaign. A CAST OF THOUSANDS Yusuf told members he will take the “best ideas” from right-wing think tanks — others include the Prosperity Institute (formerly known as Legatum) and the Taxpayers’ Alliance — at the same time as building out internal policy. But at other times they will disagree. Brown has also met Robert Jenrick, the ambitious Conservative shadow minister who is pushing on law and order. Reform is keen to stress that CFABB is independent of the party. Reform is involving its own MPs (Richard Tice, Lee Anderson and Sarah Pochin) in policy development, while Farage is also leaning on outsiders with real-world experience such as detective Colin Sutton and prison governor Vanessa Frake. Yusuf told a fringe event: “We have draughtsmen working on legislation. We will have thousands of pages of legislation ready to go.” Reform can rely too on its growing pool of elected officials in councils and mayoralties across England — expected to increase dramatically after May 2026 elections in Scotland and Wales. Yet this growing cast leaves some of Reform’s own foot soldiers in the dark. Helen Manson, interim chair of the South Cambridgeshire branch, told Yusuf — who focuses both on red meat policies such as migration and his personal interests like cryptocurrency — that she receives many questions on the doorstep about whether the party is ready for government. “We don’t know what Reform is doing. We can’t respond to that,” she said. Lobbyists at the conference for the first time felt similarly. One industry figure complained that Tice, when holding private business round tables, tends to lay out his “talking points” but does not respond well to challenge. A second said: “It was obvious that a small group of think tanks are currently the only engine room for ideas beyond Reform’s pet interests.” Speaking to POLITICO, Brown said: “You can’t really judge them on the policy for the next election because it’s early days. I think the idea is to build out a full and integrated policy platform and an implementation strategy before the next election.” But some senior Reform-linked figures resist opening the conversation too widely — as the center would lose control. Orr told a fringe event: “Don’t underestimate how much effect a small band of dedicated people in the cockpit of the nation can do.” Orr looked to an unlikely comparison — what he called Tony Blair’s “catastrophic and extremely consequential” Labour government in 1997. That, argued Orr, was run by “a gang of six … [and] they completely overturned the constitutional, legal, political and cultural landscape of the U.K. for 25 years. In fact, we’re going to spend the best part of the next 15 years trying to unravel it.” NO SUCCESSION PLAN? Small team or not, the importance of elevating the background players out of Farage’s shadow isn’t just desirable for Reform — it’s existential. When Farage denied on stage that his party is a “one-man band,” he used the example of the branded football shirts in the conference shop — pointing out that several other party figures had their names on shirts as well. Tellingly, when POLITICO visited the shop, only the “Farage” shirts were filling the shelves. An announcement that Farage was to sign shirts for 45 minutes (price for a signed shirt: £100) caused a jolt of excitement in the venue. More importantly, it was Farage’s return to the party last year that turbocharged its (already healthy) poll rating, and has senior Reform figures beginning to eye up which Whitehall department they would like to lead. Contrary to protestations by Farage’s allies, aides and the man himself, the party is still tied closely to him — to the point where some in Reform darkly wonder how the party would survive if he suddenly wasn’t on the scene. “If something happens [to Nigel] now, we’re fucked,” a Reform candidate in the last election said. In four years “maybe we’d be fine,” they said, but right now “there’s no one else with the charisma or the ability to pull people together.” Towler, his longtime former aide, has a more nuanced view. “There is nobody else in Britain who can do what he does,” he said, but “there is a bunch of driven people who want to change the country and I think they would still do it without him. It would be awful and it would be harder, but I really think the mood of the country is so febrile and so anti-the last two, that we need change. Nigel is a vector for that change — he’s not the only vector.” Farage is keen for the public to agree. He closed the conference by inviting all the main speakers for an on-stage singalong of the U.K’s national anthem led by the Greater Lincolnshire Mayor Andrea Jenkyns — who had earlier surprised attendees with a solo musical performance of her own-self written song Insomniac. The hope in Reform circles is that by boosting those around him, Farage will create figures substantial enough to be major players in a future government, while also reducing the party’s reliance on his oratory and leadership skills. “I think Reform is coming out of Nigel’s shadow to some extent,” said Brown. “All of a sudden there’s a raft of elected officials who are there. Are any of them Nigel yet? No, of course not. But Nigel has had 30 years so it’s very unfair to pick the consummate performer of his generation and say ‘why aren’t you like him?’ Nigel wasn’t like that in 2005.” Others point out that Farage, despite being electoral dynamite, remains a Marmite figure with harder-to-reach sections of the electorate. “Yes he’s a brilliant communicator and no one’s doubting that, but he’s a known quantity and a lot of voters don’t like him,” said one Labour Party official. Then there is the question of whether Farage — who spent years in lucrative TV work — really wants the grim responsibilities of being prime minister at all. His allies insist he does. Towler said: “He made a decision last year to get back involved. Is it his want, is it his ambition? Really, I don’t think it is. But does he think he’s the only person to break the duopoly of failure in this country? Yes. And he takes that responsibility deeply seriously.” Wherever things go from here, though, Farage remains a godhead for now — sometimes quite literally. “His body is stronger than anybody else’s,” said a sixth Reform figure, when asked about what the party would be without him. “He’s survived a plane crash and everything.” Some Reform figures are daring to dream of the party’s fortunes as similarly immortal. But things don’t always work out that way. John Johnston and Abby Wallace contributed reporting.
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The controversial Georgian mine fueling Europe’s new industrial arms race
CHIATURA, Georgia — Giorgi Neparidze, a middle-aged man from near the town of Chiatura in western Georgia, still has marks on his lips from where he sewed his mouth shut during a hunger strike last year. He says Georgian Manganese, a mining company with close links to the government, has wrought environmental devastation around his home and has ignored the rights of its workers. He is seeking compensation.  Europe, which imports Georgia’s manganese, is partly to blame for the black rivers and collapsing houses in Chiatura district, Neparidze says. The former miner-turned-environmental and civil rights activist claims that in one village, Shukruti, toxic dust from the pits is making people unwell. Filthy black water, laced with heavy metals, periodically spurts out of pumps there. Houses are collapsing as the tunnels underneath them cave in.  Manganese, a black metal traditionally used to reinforce steel, is crucial for Europe’s green energy transition as it is used in both wind turbines and electric car batteries. The metal is also vital for military gear like armor and guns. In 2022, the European Union bought 20,000 metric tons of manganese alloys from Georgia — almost 3 percent of its total supply. A year later the bloc added manganese to its list of critical minerals. But Chiaturans say their lives are being ruined so that Western Europeans can breathe cleaner air. “We are sacrificed so that others can have better lives,” Neparidze says. “There are only 40,000 people in Chiatura. They might feel ill or live in bad conditions but they are sacrificed so that millions of Europeans can have a cleaner environment.” Neparidze says cancer rates in the region are unusually high. Doctors at a hospital in Chiatura back up the observation, but no official study has linked the illnesses to the mines. An aerial view of Chiatura with the polluted Kvirila River running through the town | Olivia Acland Hope that things will improve appears dim. European companies often don’t know where their manganese is sourced from. As ANEV, Italy’s wind energy association, confirms: “There is no specific obligation to trace all metals used in steel production.”  Last year the EU enacted a law that was meant to change that. The Corporate Sustainability Due Diligence Directive obliges companies to run closer checks on their supply chains and clamp down on any human rights violations, poor working conditions and environmental damage.  But barely a year after it took effect, the European Commission proposed a major weakening of the law in a move to reduce red tape for the bloc’s sluggish industry. EU member countries, motivated by this deregulation agenda, are now pushing for even deeper cuts, while French President Emmanuel Macron and German Chancellor Friedrich Merz want to get rid of the law altogether.  Meanwhile, Europe’s appetite for mined raw materials like manganese, lithium, rare earths, copper and nickel is expected to skyrocket to meet the needs of the clean energy transition and rearmament. Many of these resources are in poorly regulated and often politically repressive jurisdictions, from the Democratic Republic of Congo to Indonesia and Georgia. Weakening the EU supply chain law will have consequences for communities like Neparidze’s. “Only an empty shell of the directive remains,” says Anna Cavazzini, a member of the European Parliament’s Green Party, adding that the legislature caved to pressure from businesses seeking to reduce their costs. “Now is not the time to abandon the defense of human rights and give corporations a free hand,” she says.  A resident of Chiatura standing on a collapsed house following a mining-related landslide in Itkhvisi village. | Olivia Acland As Georgia’s government pivots toward Russia and stifles dissent, life is becoming increasingly dangerous for activists in Chiatura. On April 29, four activists including Neparidze were arrested for allegedly assaulting a mine executive. A statement put out by Chiatura Management Company, the firm in charge of staffing Georgian Manganese’s underground operations, says that Tengiz Koberidze, manager of the Shukruti mine, was “verbally abused and pelted with stones.” Supporters call it a staged provocation in which Koberidze tried to incite violence, and say it’s part of a broader campaign to silence resistance. If convicted they face up to six years behind bars. Koberidze did not respond to requests for comment. Chiatura residents are protesting over two overlapping issues. On one side, miners are demanding safer working conditions underground, where tunnel collapses have long been a risk, along with higher wages and paid sick leave. When the mine was temporarily shut in October 2024, they were promised 60 percent of their salaries, but many say those payments never materialized. Workers are also raising concerns about mining pollution in the region. “The company doesn’t raise wages, doesn’t improve safety, and continues to destroy the natural environment. Its profits come not just from extracting resources, but from exploiting both workers and the land,” says one miner, David Chinchaladze. Georgian Manganese did not respond to interview requests or written questions. Officials at Georgia’s Ministry of Mines and the government’s Environment Protection and Natural Resources Department did not respond to requests for comment. A collapsing building in Shukruti. | Olivia Acland.  The second group of protesters comes from the village of Shukruti, which sits directly above the mining tunnels. Their homes are cracking and sinking into the ground. In 2020, Georgian Manganese pledged to pay between 700,000 and 1 million Georgian lari ($252,000 to $360,000) annually in damages — a sum that was meant to be distributed among residents. But while the company insists the money has been paid, locals — backed by watchdog NGO Social Justice — say otherwise. According to them, fewer than 5 percent of Shukruti’s residents have received any compensation.  Their protest has intensified in the last year, with workers now blocking the roads and Shukruti residents barring entry to the mines. But the risks are intensifying too. Since suspending EU accession talks last year amid deteriorating relations with the bloc, Georgia’s ruling party has shuttered independent media, arrested protestors and amplified propaganda. The country’s democracy is “backsliding,” says Irakli Kavtaradze, head of the foreign department of the largest opposition political party, United National Movement. Their tactics “sound like they come from a playbook that is written in the Kremlin,” he adds. ‘KREMLIN PLAYBOOK’ In the capital Tbilisi, around 200 kilometers east of Chiatura, protesters have taken to the streets every night since April 2, 2024 when the government unveiled a Kremlin-style “foreign agents” law aimed at muzzling civil society.  Many demonstrators wear sunglasses, scarfs and masks to shield their identities from street cameras, wary of state retaliation.  A scene from the 336th day of protests in Tbilisi in April 2025. | Olivia Acland. Their protests swelled in October last year after the government announced it would suspend talks to join the EU. For Georgians, the stakes are high: Russia already occupies 20 percent of the country after its 2008 invasion, and people fear that a more profound drift from the EU could open the door to further aggression. When POLITICO visited in April, a crowd strode down Rustaveli Avenue, the city’s main artery. Some carried EU flags while others passed around a loudspeaker, taking it in turns to voice defiant chants. “Fire to the oligarchy!” one young woman yelled, the crowd echoing her call. “Power lies in unity with the EU!” another shouted. They also called out support for protestors in Chiatura, whose fight has become something of a cause célèbre across the country: “Solidarity to Chiatura! Natural resources belong to the people!”  The fight in Chiatura is a microcosm of the country’s broader struggle: The activists are not just taking on a mining company but a corporate giant backed by oligarchs and the ruling elites.  Georgian Manganese’s parent company, Georgian American Alloys, is registered in Luxembourg and counts Ukrainian oligarch Ihor Kolomoisky as a shareholder. He is in custody in Kyiv over allegations that he hired a gang to kill a lawyer who threatened his business interests in 2003. Kolomoisky has also been sanctioned by the United States for his alleged involvement in siphoning billions out of PrivatBank, Ukraine’s largest bank.  Giorgi Kapanadze — a businessman closely connected with the ruling Georgian Dream party of Bidzina Ivanishvili — is listed as general manager of Georgian American Alloys.  Until recently, Kapanadze owned Rustavi TV, a channel notorious for airing pro-government propaganda. The European Parliament has called on the EU to hit Kapanadze with sanctions, accusing him of propping up the country’s repressive regime. Kolomoisky and Kapanadze did not respond to POLITICO’s requests for comment. The government swooped in to help Georgian Manganese in 2016 when a Georgian court fined it $82 million for environmental destruction in the region. The state placed it under “special management” and wrote off the fine. A new government-appointed manager was tasked, on paper, with cleaning up the mess. He was supposed to oversee a cleanup of the rivers that flow past the mines, among other promises. Manganese mining pit in Chiatura region, Georgia. | Olivia Acland But POLITICO’s own tests based on four samples taken in April 2025 from the Kvirila River, which runs through Chiatura, as well as its tributary, the Bogiristiskali, which were examined in a U.K. licensed laboratory, show the manganese levels in both rivers are over 10 times the legal limit. Iron levels are also higher than legally permitted. Locals use the polluted water to irrigate their crops. Fishermen are also pulling in increasingly empty nets as the heavy metals kill off aquatic life, according to local testimonies. The water from the Kvirila River flows out into the Black Sea, home to endangered dolphins, sturgeons, turtles and sharks.  A 2022 analysis by the Georgian NGO Green Policy found even worse results, with manganese in the Kvirila River averaging 42 times the legal limit. The group also detected excessive levels of iron and lead. Chronic manganese exposure can lead to irreversible neurological damage — a Parkinson’s-like condition known as manganism — as well as liver, kidney and reproductive harm. Lead and iron are linked to organ failure, cancer and cardiovascular disease. On Georgian Manganese’s website, the company concedes that “pollution of the Kvirila River” is one of the region’s “ecological challenges,” attributing it to runoff from manganese processing. It claims to have installed German-standard purification filters and claims that “neither polluted nor purified water” currently enters the river. Protesters like Neparidze aren’t convinced. They claim the filtration system is turned on only when inspectors arrive and that for the rest of the time, untreated wastewater is dumped straight into the rivers. BLOCKING EXPORTS Their protests having reaped few results, Chiaturans are taking increasingly extreme measures to make their voices heard.  Gocha Kupatadze, a retired 67-year-old miner, spends his nights in a tarpaulin shelter beside an underground mine, where he complains that rats crawl over him. “This black gold became the black plague for us,” he says. “We have no choice but to protest.” Kupatadze’s job is to ensure that manganese does not leave the mine. Alongside other protesters he has padlocked the gate to the generator that powers the mine’s ventilation system, making it impossible for anyone to work there. Kupatadze says he is only resorting to such drastic measures because conditions in his village, Shukruti, have become unlivable. His family home, built in 1958, is now crumbling, with cracks in the walls as the ground beneath it collapses from years of mining. The vines that once sustained his family’s wine-making traditions have long since withered and died. Gocha Kupatadze, an activist sleeping in a tarpaulin tent outside a mine. | Olivia Acland. For over a year, protesters across the region have intermittently blocked mine entrances as well as main roads, determined to stop the valuable ore from leaving Chiatura. In some ways it has worked: Seven months ago, Chiatura Management Company, the firm in charge of staffing Georgian Manganese’s underground operations, announced it would pause production.  “Due to the financial crisis that arose from the radical protests by the people of Shukruti village, the production process in Chiatura has been completely halted,” it read. Yet to the people of Chiatura, this feels more like a punishment than a triumph.  Manganese has been extracted from the area since 1879 and many residents rely on the mines for their livelihoods. The region bears all the hallmarks of a mining town that thrived during the Soviet Union when conditions in the mines were much better, according to residents. Today, rusted cable cars sway above concrete buildings that house washing stations and aging machinery.   While locals had sought compensation for the damage to their homes, they now just find themselves out of work.  Soviet-era buildings and mining infrastructure around Chiatura. | Olivia Acland.  Making matters worse, Georgian Manganese, licensed to mine 16,430 hectares until 2046, is now sourcing much of its ore from open pits instead of underground mines. These are more dangerous to the communities around them: Machines rip open the hillsides to expose shallow craters, while families living next to the pits say toxic dust drifts off them into their gardens and houses.  MORE PITS The village of Zodi is perched on a plateau surrounded by gently undulating hills, 10 kilometers from Chiatura. Many of its residents rely on farming, and cows roam across its open fields. “It is a beautiful village with a unique microclimate which is great for wine-making,” says Kote Abdushelishvili, a 36-year-old filmmaker from Zodi.  Mining officials say the village sits on manganese reserves. In 2023, caterpillar trucks rolled into Zodi and began ripping up the earth. Villagers, including Abdushelishvili, chased them out. “We stopped them,” he says, “We said if you want to go on, you will have to kill us first.” A padlocked gate to the mine’s ventilation system. | Olivia Acland Abdushelishvili later went to Georgian Manganese’s Chiatura office to demand a meeting with the state-appointed special manager. When he was turned away, he shouted up to the window: “You can attack us, you can kill us, we will not stop.” Two days later, as Abdushelishvili strolled through a quiet neighborhood in Tbilisi, masked men jumped out of a car, slammed him to the pavement and beat him up. Despite the fierce resistance in Chiatura, Georgian Manganese continues to send its metal to European markets. In the first two months of 2025, the EU imported 6,000 metric tons of manganese from Georgia. With the bloc facing mounting pressures — from the climate crisis to new defense demands — its hunger for manganese is set to grow. As the EU weakens its corporate accountability demands and Georgia drifts further into authoritarianism, the voices of Chiatura’s people are growing even fainter.  “We are not asking for something unreasonable,” says activist Tengiz Gvelesiani, who was recently detained in Chiatura along with Neparidze, “We are asking for healthy lives, a good working environment and fresh air.” Georgian Manganese did not respond to requests for comment. This article was developed with the support of Journalismfund Europe.
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