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

LONDON — A mutated influenza strain is spreading early in Europe this winter, but some experts warn talk of a “superflu” is misleading, erodes public trust and distracts from the underlying problems of the National Health Service. The new strain has triggered dramatic headlines in the U.K., where health leaders are warning of a “worst-case scenario” for the country’s NHS. Health Secretary Wes Streeting described it as a “tidal wave of flu tearing through our hospitals” and labelled it a “challenge unlike any [the NHS] has seen since the pandemic.” While hospital admissions have been rising sharply due to the early arrival of flu season, there is currently no evidence that this season’s variant is more deadly or transmissible, experts at the World Health Organization (WHO) and the European Centre for Disease Prevention and Control (ECDC) told POLITICO. Neither does the data suggest hospital admissions will peak higher than previous years — although this is possible — just that they’re a few weeks early. But some experts in the U.K. have criticized the government’s “superflu” narrative, suggesting it’s being used as leverage in talks on doctor pay and conditions ahead of a looming strike. Prime Minister Keir Starmer wrote in The Guardian Friday it was “beyond belief” doctors would consider striking in these “potentially dire” circumstances, citing “a superflu epidemic.” The British Medical Association (BMA), the union representing resident doctors due to go on strike Wednesday, claimed it was “irresponsible to portray the current winter flu crisis as unprecedented” given that rates of infection and hospitalization were “comparable to most years,” a spokesperson told POLITICO. Mathematician Christina Pagel, a professor at University College London, said the “superflu” line was based on the “highly misleading use of statistics” and had more to do with the impending doctors’ strike than real trends. When contacted by POLITICO, the U.K. government stood by its health leaders’ warnings of the current flu season, in which they described it as an “unprecedented wave of super flu.” They said staff were being “pushed to the limit.” The government also pointed to stats showing the NHS is under pressure. A DHSC spokesperson told POLITICO the government had offered the BMA an extended mandate so they could strike in January instead, but the union rejected it. The BMA told POLITICO the extension included “several restrictive conditions.” THE IMPORTANCE OF TRUST The government and NHS bosses have warned the heavy burden on hospitals in December could set the health system up for a very severe winter. NHS statistics published last week show an average of 2,660 patients in hospital with flu per day, a record for this time of year, while the Health Foundation has said the NHS could face “major pressures” if cases continue to climb rapidly in the weeks ahead. Yet, while NHS staff are stretched, Pagel and others argue this year is largely consistent with previous severe flu seasons. However, without being clear about this with the public, some experts are concerned the government’s messaging could do more harm than good. “One of the real issues we have with governments everywhere is trust,” Martin McKee, professor of public health at the London School of Hygiene and Tropical Medicine, told POLITICO. While NHS staff are stretched, experts argue this year is largely consistent with previous severe flu seasons. | Geography Photos/Getty Images “The difficulty is we’ve seen them do all sorts of things for all sorts of motives. That then becomes a problem whenever they are saying something accurate,” McKee said, adding that the government should be more careful in its flu messaging given the declining trust in science. POLITICO put these concerns over trust in science to DHSC, but the department did not respond by the time of publication. A spokesperson for government-sponsored NHS England told POLITICO: “The NHS is not misleading the public — this is the earliest flu season we have seen in recent years with the latest data showing the numbers of patients in hospital with flu is extremely high for this time of year.” The NHS is struggling as it often does in winter, with a spike in delayed discharges — people who are ready to leave hospital but have nowhere to go — posing an extra challenge for hospitals, The Guardian reported Sunday. Hospital admissions for flu per 100,000 rose 23 percent in last week’s data, compared to 69 percent the previous week, but this doesn’t rule out another surge in the weeks ahead. McKee said the NHS was paying the price for chronic underinvestment. “We almost seem surprised that it’s arrived,” he said of the current flu wave, citing a “massive shortage” in beds, IT equipment and scanners.  WHAT THE EXPERTS SAY There is no reason to think the current flu strain (H3N2 sub-clade K) causes more severe disease than other types of flu, Hans Kluge, head of the World Health Organization’s Europe office, told POLITICO. Nor is there any solid evidence that it is more transmissible, said Edoardo Colzani, a flu expert at the European Centre for Disease Prevention and Control. It’s possible the lower level of immunity to this strain could lead to more cases “but this is still speculative at this stage,” Colzani said. “The epidemiological situation at the moment [in the EU] does not seem worse than in previous years apart from the fact that it is two-to-three weeks earlier,” Colzani said. Kluge said it was “about 4 weeks earlier than usual,” which “is not out of the ordinary” and trending similar to the 2022–2023 influenza season. There were some concerns the available flu vaccine might not be a “perfect match” for the current strain, Kluge said, but early data from the U.K. suggests it provides “meaningful protection” and may prevent severe disease and death, especially among vulnerable groups. “We [could] end up having a much bigger wave than usual but we have no evidence,” Pagel said, adding she thought it was “most likely” to peak “in a couple of weeks.” But the available data can’t tell us whether it will be a normal wave that starts and ends early, or an especially bad season, she added.  “We don’t know when it will turn the corner but the actual shape of the wave doesn’t look that different from previous years,” McKee said. The NHS has previously warned of the risk of a “long and drawn-out flu season” due to the early start. According to the WHO, some countries in the southern hemisphere had unusually long flu seasons this year.  “Based on previous trends, this season is expected to peak in late December or early January,” Kluge said. The advice from EU and U.K. authorities remains the same — get a flu vaccine as soon as possible, especially for those in a vulnerable group.

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.

The billionaire Microsoft founder, Bill Gates, has become the world’s leading global health philanthropist, but his overture to the late, convicted sex offender Jeffrey Epstein continues to haunt him, most recently with the release of photos Friday featuring him in the American financier’s entourage. Gates appears in two images Democrats on the House Oversight and Government Reform Committee released, the first batch in what’s expected to be 95,000 photos. The committee is reviewing documents from the Epstein estate as part of its ongoing investigation. Epstein does not appear in the two pictures Gates is in. In one, Gates is standing next to Andrew Mountbatten-Windsor, formerly Prince Andrew. In 2019, Mountbatten-Windsor was accused in a civil lawsuit of sexually assaulting Virginia Giuffre, one of Epstein’s accusers, but he denied the allegations. Mountbatten-Windsor has faced backlash for his friendship with Epstein, but has not been charged with a crime in either the U.K. or the U.S. A second picture shows a younger Gates next to a man who appears to be one of Epstein’s longtime pilots. Representatives for Gates and his global health philanthropy, the Gates Foundation, did not immediately respond to requests for comment. Gates has said he had several dinners with Epstein, who promised to get his wealthy connections to donate money to global health. When that didn’t happen, Gates cut off the dinners, Gates told PBS NewsHour in 2021. “Those meetings were a mistake,” Gates said. Gates’ former wife, Melinda French Gates, has said she didn’t like her then-husband meeting with Epstein and suggested those meetings contributed to the couple’s 2021 divorce. French Gates told CBS in a 2022 interview she met Epstein once, “because I wanted to see who this man was. I regretted it from the second I stepped in the door. He was abhorrent, he was evil personified. I had nightmares about it afterwards.” When Bill Gates was asked in a January 2023 interview with ABC Australia whether French Gates had warned him against ties with Epstein, because “Epstein had a way of sexually compromising people,” as the anchor put it, Bill Gates replied: “No! I had dinner with him, and that’s all.” An interview with Gates POLITICO published Friday was conducted before the release of the photos.

BRUSSELS — Cheap packages entering the EU will be charged a tax of €3 per item from next July, the bloc’s 27 finance ministers agreed on Friday. The deal effectively ends the tax-free status for packages worth less than €150. The flat tax will apply for each different type of item in a package. If one package contains 10 plushy toys, the duty is applied once. But if the shipment also contains a charging cable, another €3 is added. The flood of untaxed and often unsafe goods prompted the European Commission to propose a temporary solution for the packages under €150 a month ago. This “de minimis” rule allows exporters like Shein and Temu to send products directly to consumers, often bypassing scrutiny. The EU has already received more packages in the first nine months of 2025 than in the entire previous year, when the counter hit 4.6 billion. French Finance Minister Roland Lescure called it “a literal invasion of parcels in Europe last year,” which would have hit “7, 8, 9 billion in the coming years if nothing was done.” An EU official told POLITICO earlier this month that at some airports, up to 80 percent of such packages arriving don’t comply with EU safety rules. This creates a huge workload for customs officials, a growing pile of garbage, and health risks from unsafe toys and kitchen items. EU countries have already agreed to formally abolish the de-minimis loophole, but taxing all items based on their actual value and product type will require more data exchange. That will only be possible once an ambitious reform of the bloc’s Customs Union, currently under negotiation, is completed by 2028. The €3 flat tax is the temporary solution to cover the period until then. The rising popularity of web shops like Shein and Temu, which both operate out of China is fueling this flood. France suspended access to Shein’s online platform this month. This €3 EU-wide tax will be distinct from the so-called handling fee that France has proposed as a part of its national budget to relieve the costs on customs for dealing with the same flood of packages. Klara Durand and Camille Gijs contributed to this report.

BRUSSELS — Europe needs to get its “act together” and unleash its potential in the pharmaceutical sector, supporting it with better incentives and ensuring access to innovation for patients, urged Stefan Oelrich, president of Bayer’s pharmaceuticals division. “Europe used to be the pharmacy of the world. Nine out of 10 new medicines were discovered in Europe. That’s no longer the case,” Oelrich, who is also president of the European Federation of Pharmaceutical Industries and Associations (EFPIA), said at the POLITICO 28 Gala Dinner. “We’re losing competitiveness rather than gaining.” China and the U.S. are pulling ahead on pharmaceutical innovation and clinical trials. About one third of medicines approved by the U.S. Food and Drug Administration (FDA) don’t make it to Europe, Oelrich said. And amid the U.S. tariffs threat, companies are increasingly looking outside of Europe for investments. But there is hope — both for the pharmaceutical industry and beyond. Per Franzén, CEO and managing partner at EQT, a global investment organization, said he is seeing “an unprecedented interest to invest into Europe.” “It’s a real window of opportunity, a unique moment in time for Europe,” he said. “In order to make the most out of that opportunity, what we need to do is really to drive a more business-friendly, more innovation-friendly agenda,” he said. But with the pace of change, driven by artificial intelligence, “time is of the essence,” he added. Over-regulation isn’t holding Europe back in medicines innovation, it’s a lack of substantial incentives for companies to invest in Europe, Oelrich said. But it doesn’t have to be this way, he said: “We have some of the best universities in the world that publish some of the coolest science in the world. So there is no reason why this wouldn’t work. And we need to get our act together,” he said. “Instead of trying to complicate our lives and come up with a new bureaucratic idea, we should come up with with ways of how we unleash our forces.”

U.S. President Donald Trump’s top envoy to the EU told POLITICO that overregulation is causing “real problems” economically and forcing European startups to flee to America. Andrew Puzder said businesses in the bloc “that become successful here go to the United States because the regulatory environment is killing them.” “Wouldn’t it be great if this part of the world, instead of deciding it was going to be the world’s regulator, decided once again to be the world’s innovators?” he added in an interview at this year’s POLITICO 28 event. “You’ll be stronger in the world and you’ll be a much better trade partner and ally to the United States.” Puzder’s remarks come as the Trump administration launched a series of blistering attacks on Europe in recent days. Washington’s National Security Strategy warned of the continent’s “civilizational erasure” and Trump himself blasted European leaders as “weak” and misguided on migration policy in an interview with POLITICO. Those broadsides have sparked concerns in Europe that Trump could seek to jettison the transatlantic relationship. But Puzder downplayed the strategy’s criticism and struck a more conciliatory note, saying the document was “more ‘make Europe great again’ than it was ‘let’s desert Europe’” and highlighted Europe’s potential as a partner.

BRUSSELS — The EU has struck a political agreement to overhaul the bloc’s foreign direct investment screening rules, the Council of the EU announced on Thursday, in a move to prevent strategic technology and critical infrastructure from falling into the hands of hostile powers. The updated rules — the first major plank of European Commission President’s Ursula von der Leyen’s economic security strategy — would require all EU countries to systematically monitor investments and further harmonize the way those are screened within the bloc. The agreement comes just over a week after Brussels unveiled a new economic security package. Under the new rules, EU countries would be required to screen investments in dual-use items and military equipment; technologies like artificial intelligence, quantum technologies and semiconductors; raw materials; energy, transport and digital infrastructure; and election infrastructure, such as voting systems and databases. As previously reported by POLITICO, foreign entities investing into specific financial services must also be subject to screening by EU capitals. “We achieved a balanced and proportionate framework, focused on the most sensitive technologies and infrastructures, respectful of national prerogatives and efficient for authorities and businesses alike,” said Morten Bødskov, Denmark’s minister for industry, business and financial affairs. It took three round of political talks between the three institutions to seal the update, which was a key priority for the Danish Presidency of the Council of the EU. One contentious question was which technologies and sectors should be subject to mandatory screening. Another was how capitals and the European Commission should coordinate — and who gets the final say — when a deal raises red flags. Despite a request from the European Parliament, the Commission will not get the authority to arbitrate disputes between EU countries on specific investment cases. Screening decisions will remain firmly in the purview of national governments. “We’re making progress. The result of our negotiations clearly strengthens the EU’s security while also making life easier for investors by harmonising the Member States’ screening mechanism,” said the lead lawmaker on the file, French S&D Raphaël Glucksmann. “Yet more remains to be done to ensure that investments bring real added value to the EU, so that our market does not become a playground for foreign companies exploiting our dependence on their technology. The Commission has committed to take an initiative; it must now act quickly,” he said in a statement to POLITICO. This story has been updated.

BRUSSELS — EU lawmakers have clinched a long-awaited agreement on the bloc’s overhaul of its two decades-old pharmaceutical rules — one of the EU’s biggest health files. The revamp is designed to restore Europe’s competitive edge and give companies more certainty that the EU remains an attractive market, while also pushing for more equal access to medicines across member countries. The deal between the Parliament and the Council was struck at 5 a.m. on Thursday, more than two years after the Commission tabled the proposal, which consists of directive and regulation, in spring 2023.  It marks a major victory for the Danish presidency, which pledged to wrap up the file before the end of the year, and for Health Commissioner Olivér Várhelyi, who has pushed to seal the reform amid growing geopolitical uncertainty.