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.

BRUSSELS — The European Commission has done everything in its power to accommodate the concerns of member countries over the EU’s trade deal with the Latin American Mercosur bloc and get it over the finish line, Trade Commissioner Maroš Šefčovič told POLITICO. “I hope we will pass the test this week because we really went to unprecedented lengths to address the concerns which have been presented to us,” Šefčovič said in an interview on Monday.  “Now it’s a matter of credibility, and it’s a matter of being strategic,” he stressed, explaining that the huge trade deal is vital for the European Union at a time of increasingly assertive behavior by China and the United States. “Mercosur very much reflects our ambition to play a strategic role in trade, to confirm that we are the biggest trader on this planet.” The commissioner’s remarks come as time is running short to hold a vote among member countries that would allow Commission President Ursula von der Leyen to fly to Brazil on Dec. 20 for a signing ceremony with the Mercosur countries — Brazil, Argentina, Uruguay and Paraguay. “The last miles are always the most difficult,” Šefčovič added. “But I really hope that we can do it this week because I understand the anxiety on the side of our Latin American partners.”  The vote in the Council of the EU, the bloc’s intergovernmental branch, has still to be scheduled. To pass, it would need to win the support of a qualified majority of 15 member countries representing 65 percent of the bloc’s population. It’s not clear whether France — the EU country most strongly opposed to the deal — can muster a blocking minority. If Paris loses, it would be the first time the EU has concluded a big trade deal against the wishes of a major founding member. France, on Sunday evening, called for the vote to be postponed, widening a rift within the bloc over the controversial pact that has been under negotiation for more than 25 years. Several pro-deal countries warn that the holdup risks killing the trade deal, concerned that further stalling it could embolden opposition in the European Parliament or complicate next steps when Paraguay, which is skeptical toward the agreement, takes over the presidency of the Mercosur bloc from current holder Brazil. Asked whether Brussels had a Plan B if the vote does not take place on time, Šefčovič declined to speculate. He instead put the focus on a separate vote on Tuesday in the European Parliament on additional farm market safeguards proposed by the Commission to address French concerns. “There are still expectations on how much we can advance with some of the measures which are not yet approved, particularly in the European Parliament,” he stressed.  “If you look at the safeguard regulation, we never did anything like this before. It’s the first [time] ever. It’s, I would say, very, very far reaching.” 

A fair, fast and competitive transition begins with what already works and then rapidly scales it up.  Across the EU commercial road transport sector, the diversity of operations is met with a diversity of solutions. Urban taxis are switching to electric en masse. Many regional coaches run on advanced biofuels, with electrification emerging in smaller applications such as school services, as European e-coach technologies are still maturing and only now beginning to enter the market. Trucks electrify rapidly where operationally and financially possible, while others, including long-haul and other hard-to-electrify segments, operate at scale on HVO (hydrotreated vegetable oil) or biomethane, cutting emissions immediately and reliably. These are real choices made every day by operators facing different missions, distances, terrains and energy realities, showing that decarbonization is not a single pathway but a spectrum of viable ones.  Building on this diversity, many operators are already modernizing their fleets and cutting emissions through electrification. When they can control charging, routing and energy supply, electric vehicles often deliver a positive total cost of ownership (TCO), strong reliability and operational benefits. These early adopters prove that electrification works where the enabling conditions are in place, and that its potential can expand dramatically with the right support. > Decarbonization is not a single pathway but a spectrum of viable ones chosen > daily by operators facing real-world conditions. But scaling electrification faces structural bottlenecks. Grid capacity is constrained across the EU, and upgrades routinely take years. As most heavy-duty vehicle charging will occur at depots, operators cannot simply move around to look for grid opportunities. They are bound to the location of their facilities.  The recently published grid package tries, albeit timidly, to address some of these challenges, but it neither resolves the core capacity deficiencies nor fixes the fundamental conditions that determine a positive TCO: the predictability of electricity prices, the stability of delivered power, and the resulting charging time. A truck expected to recharge in one hour at a high-power station may wait far longer if available grid power drops. Without reliable timelines, predictable costs and sufficient depot capacity, most transport operators cannot make long-term investment decisions. And the grid is only part of the enabling conditions needed: depot charging infrastructure itself requires significant additional investment, on top of vehicles that already cost several hundreds of thousands of euros more than their diesel equivalents.  This is why the EU needs two things at once: strong enablers for electrification and hydrogen; and predictability on what the EU actually recognizes as clean. Operators using renewable fuels, from biomethane to advanced biofuels and HVO, delivering up to 90 percent CO2 reduction, are cutting emissions today. Yet current CO2 frameworks, for both light-duty vehicles and heavy-duty trucks, fail to recognize fleets running on these fuels as part of the EU’s decarbonization solution for road transport, even when they deliver immediate, measurable climate benefits. This lack of clarity limits investment and slows additional emission reductions that could happen today. > Policies that punish before enabling will not accelerate the transition; a > successful shift must empower operators, not constrain them. The revision of both CO2 standards, for cars and vans, and for heavy-duty vehicles, will therefore be pivotal. They must support electrification and hydrogen where they fit the mission, while also recognizing the contribution of renewable and low-carbon fuels across the fleet. Regulations that exclude proven clean options will not accelerate the transition. They will restrict it.  With this in mind, the question is: why would the EU consider imposing purchasing mandates on operators or excessively high emission-reduction targets on member states that would, in practice, force quotas on buyers? Such measures would punish before enabling, removing choice from those who know their operations best. A successful transition must empower operators, not constrain them.  The EU’s transport sector is committed and already delivering. With the right enablers, a technology-neutral framework, and clarity on what counts as clean, the EU can turn today’s early successes into a scalable, fair and competitive decarbonization pathway.  We now look with great interest to the upcoming Automotive Package, hoping to see pragmatic solutions to these pressing questions, solutions that EU transport operators, as the buyers and daily users of all these technologies, are keenly expecting. -------------------------------------------------------------------------------- Disclaimer POLITICAL ADVERTISEMENT * The sponsor is IRU – International Road Transport Union  * The ultimate controlling entity is IRU – International Road Transport Union  More information here.

Europe prides itself on being a world leader in animal protection, with legal frameworks requiring member states to pay regard to animal welfare standards when designing and implementing policies. However, under REACH — Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) — the EU’s cornerstone regulation on chemical safety, hundreds of thousands of animals are subjected to painful tests every year, despite the legal requirement that animal testing should be used only as a ‘last resort’. With REACH’s first major revamp in almost 20 years forthcoming, lawmakers now face a once-in-a-generation opportunity to drive a genuine transformation of chemical regulation.  When REACH was introduced nearly a quarter of a century ago, it outlined a bold vision to protect people and the environment from dangerous chemicals, while simultaneously driving a transition toward modern, animal-free testing approaches. In practice, however, companies are still required to generate extensive toxicity data to bring both new chemicals and chemicals with long histories of safe use onto the market. This has resulted in a flood of animal tests that could too often be dispensed, especially when animal-free methods are just as protective (if not more) of human health and the environment.  > Hundreds of thousands of animals are subjected to painful tests every year, > despite the legal requirement that animal testing should be used only as a > ‘last resort’. Despite the last resort requirement, some of the cruelest tests in the books are still expressly required under REACH. For example, ‘lethal dose’ animal tests were developed back in 1927 — the same year as the first solo transatlantic flight — and remain part of the toolbox when regulators demand ‘acute toxicity’ data, despite the availability of animal-free methods. Yet while the aviation industry has advanced significantly over the last century, chemical safety regulations remain stuck in the past.   Today’s science offers fully viable replacement approaches for evaluating oral, skin and fish lethality to irritation, sensitization, aquatic bioconcentration and more. It is time for the European Commission and member states to urgently revise REACH information requirements to align with the proven capabilities of animal-free science.   But this is only the first step. A 2023 review projected that animal testing under REACH will rise in the coming years in the absence of significant reform. With the forthcoming revision of the REACH legal text, lawmakers face a choice: lock Europe into decades of archaic testing requirements or finally bring chemical safety into the 21st century by removing regulatory obstacles that slow the adoption of advanced animal-free science.   If REACH continues to treat animal testing as the default option, it risks eroding its credibility and the values it claims to uphold. However, animal-free science won’t be achieved by stitching together one-for-one replacements for legacy animal tests. A truly modern, European relevant chemicals framework demands deeper shifts in how we think, generate evidence and make safety decisions. Only by embracing next-generation assessment paradigms that leverage both exposure science and innovative approaches to the evaluation of a chemical’s biological activity can we unlock the full power of state-of the-art non-animal approaches and leave the old toolbox behind.  > With the forthcoming revision of the REACH legal text, lawmakers face a > choice: lock Europe into decades of archaic testing requirements or finally > bring chemical safety into the 21st century. The recent endorsement of One Substance, One Assessment regulations aims to drive collaboration across the sector while reducing duplicate testing on animals, helping to ensure transparency and improve data sharing. This is a step in the right direction, and provides the framework to help industry, regulators and other interest-holders to work together and chart a new path forward for chemical safety.   The EU has already demonstrated in the cosmetics sector that phasing out animal testing is not only possible but can spark innovation and build public trust. In 2021, the European Parliament urged the Commission to develop an EU plan to replace animal testing with modern scientific innovation. But momentum has since stalled. In the meantime, more than 1.2 million citizens have backed a European Citizens’ Initiative calling for chemical safety laws that protect people and the environment without adding new animal testing requirements; a clear indication that both science and society are eager for change.   > The EU has already demonstrated in the cosmetics sector that phasing out > animal testing is not only possible but can spark innovation and build public > trust. Jay Ingram, managing director, chemicals, Humane World for Animals (founding member of AFSA Collaboration) states: “Citizens are rightfully concerned about the safety of chemicals that they are exposed to on a daily basis, and are equally invested in phasing out animal testing. Trust and credibility must be built in the systems, structures, and people that are in place to achieve both of those goals.”  The REACH revision can both strengthen health and environmental safeguards while delivering a meaningful, measurable reduction in animal use year on year.  Policymakers need not choose between keeping Europe safe and embracing kinder science; they can and should take advantage of the upcoming REACH revision as an opportunity to do both.  -------------------------------------------------------------------------------- Disclaimer POLITICAL ADVERTISEMENT * The sponsor is Humane World for Animals * The ultimate controlling entity is Humane World for Animals More information here.

Europe’s chemical industry has reached a breaking point. The warning lights are no longer blinking — they are blazing. Unless Europe changes course immediately, we risk watching an entire industrial backbone, with the countless jobs it supports, slowly hollow out before our eyes. Consider the energy situation: this year European gas prices have stood at 2.9 times higher than in the United States. What began as a temporary shock is now a structural disadvantage. High energy costs are becoming Europe’s new normal, with no sign of relief. This is not sustainable for an energy-intensive sector that competes globally every day. Without effective infrastructure and targeted energy-cost relief — including direct support, tax credits and compensation for indirect costs from the EU Emissions Trading System (ETS) — we are effectively asking European companies and their workers to compete with their hands tied behind their backs. > Unless Europe changes course immediately, we risk watching an entire > industrial backbone, with the countless jobs it supports, slowly hollow out > before our eyes. The impact is already visible. This year, EU27 chemical production fell by a further 2.5 percent, and the sector is now operating 9.5 percent below pre-crisis capacity. These are not just numbers, they are factories scaling down, investments postponed and skilled workers leaving sites. This is what industrial decline looks like in real time. We are losing track of the number of closures and job losses across Europe, and this is accelerating at an alarming pace. And the world is not standing still. In the first eight months of 2025, EU27 chemicals exports dropped by €3.5 billion, while imports rose by €3.2 billion. The volume trends mirror this: exports are down, imports are up. Our trade surplus shrank to €25 billion, losing €6.6 billion in just one year. Meanwhile, global distortions are intensifying. Imports, especially from China, continue to increase, and new tariff policies from the United States are likely to divert even more products toward Europe, while making EU exports less competitive. Yet again, in 2025, most EU trade defense cases involved chemical products. In this challenging environment, EU trade policy needs to step up: we need fast, decisive action against unfair practices to protect European production against international trade distortions. And we need more free trade agreements to access growth market and secure input materials. “Open but not naïve” must become more than a slogan. It must shape policy. > Our producers comply with the strictest safety and environmental standards in > the world. Yet resource-constrained authorities cannot ensure that imported > products meet those same standards. Europe is also struggling to enforce its own rules at the borders and online. Our producers comply with the strictest safety and environmental standards in the world. Yet resource-constrained authorities cannot ensure that imported products meet those same standards. This weak enforcement undermines competitiveness and safety, while allowing products that would fail EU scrutiny to enter the single market unchecked. If Europe wants global leadership on climate, biodiversity and international chemicals management, credibility starts at home. Regulatory uncertainty adds to the pressure. The Chemical Industry Action Plan recognizes what industry has long stressed: clarity, coherence and predictability are essential for investment. Clear, harmonized rules are not a luxury — they are prerequisites for maintaining any industrial presence in Europe. This is where REACH must be seen for what it is: the world’s most comprehensive piece of legislation governing chemicals. Yet the real issues lie in implementation. We therefore call on policymakers to focus on smarter, more efficient implementation without reopening the legal text. Industry is facing too many headwinds already. Simplification can be achieved without weakening standards, but this requires a clear political choice. We call on European policymakers to restore the investment and profitability of our industry for Europe. Only then will the transition to climate neutrality, circularity, and safe and sustainable chemicals be possible, while keeping our industrial base in Europe. > Our industry is an enabler of the transition to a climate-neutral and circular > future, but we need support for technologies that will define that future. In this context, the ETS must urgently evolve. With enabling conditions still missing, like a market for low-carbon products, energy and carbon infrastructures, access to cost-competitive low-carbon energy sources, ETS costs risk incentivizing closures rather than investment in decarbonization. This may reduce emissions inside the EU, but it does not decarbonize European consumption because production shifts abroad. This is what is known as carbon leakage, and this is not how EU climate policy intends to reach climate neutrality. The system needs urgent repair to avoid serious consequences for Europe’s industrial fabric and strategic autonomy, with no climate benefit. These shortcomings must be addressed well before 2030, including a way to neutralize ETS costs while industry works toward decarbonization. Our industry is an enabler of the transition to a climate-neutral and circular future, but we need support for technologies that will define that future. Europe must ensure that chemical recycling, carbon capture and utilization, and bio-based feedstocks are not only invented here, but also fully scaled here. Complex permitting, fragmented rules and insufficient funding are slowing us down while other regions race ahead. Decarbonization cannot be built on imported technology — it must be built on a strong EU industrial presence. Critically, we must stimulate markets for sustainable products that come with an unavoidable ‘green premium’. If Europe wants low-carbon and circular materials, then fiscal, financial and regulatory policy recipes must support their uptake — with minimum recycled or bio-based content, new value chain mobilizing schemes and the right dose of ‘European preference’. If we create these markets but fail to ensure that European producers capture a fair share, we will simply create new opportunities for imports rather than European jobs. > If Europe wants a strong, innovative resilient chemical industry in 2030 and > beyond, the decisions must be made today. The window is closing fast. The Critical Chemicals Alliance offers a path forward. Its primary goal will be to tackle key issues facing the chemical sector, such as risks of closures and trade challenges, and to support modernization and investments in critical productions. It will ultimately enable the chemical industry to remain resilient in the face of geopolitical threats, reinforcing Europe’s strategic autonomy. But let us be honest: time is no longer on our side. Europe’s chemical industry is the foundation of countless supply chains — from clean energy to semiconductors, from health to mobility. If we allow this foundation to erode, every other strategic ambition becomes more fragile. If you weren’t already alarmed — you should be. This is a wake-up call. Not for tomorrow, for now. Energy support, enforceable rules, smart regulation, strategic trade policies and demand-driven sustainability are not optional. They are the conditions for survival. If Europe wants a strong, innovative resilient chemical industry in 2030 and beyond, the decisions must be made today. The window is closing fast. -------------------------------------------------------------------------------- Disclaimer POLITICAL ADVERTISEMENT * The sponsor is CEFIC- The European Chemical Industry Council  * The ultimate controlling entity is CEFIC- The European Chemical Industry Council  More information here.

This article is presented by EFPIA with the support of AbbVie I made a trip back to Europe recently, where I spent the vast majority of my pharmaceutical career, to share my perspectives on competitiveness at the European Health Summit. Now that I work in a role responsible for supporting patient access to medicine globally, I view Europe, and how it compares internationally, through a new lens, and I have been reflecting further on why the choices made today will have such a critical impact on where medicines are developed tomorrow. Today, many patients around the world benefit from medicines built on European science and breakthroughs of the last 20 years. Europeans, like me, can be proud of this contribution. As I look forward, my concern is that we may not be able to make the same claim in the next 20 years. It’s clear that Europe has a choice. Investing in sustainable medicines growth and other enabling policies will, I believe, bring significant benefits. Not doing so risks diminishing global influence. > Today, many patients around the world benefit from medicines built on European > science and breakthroughs of the last 20 years I reflect on three important points: 1) investment in healthcare benefits individuals, healthcare and society, but the scale of this benefit remains underappreciated; 2) connected to this, the underpinning science for future innovation is increasingly happening elsewhere; and 3) this means the choices we make today must address both of these trends. First, let’s use the example of migraine. As I have heard a patient say, “Migraine will not kill you but neither [will they] let you live.”[1] Individuals can face being under a migraine attack for more than half of every month, unable to leave home, maintain a job and engage in society.[2] It is the second biggest cause of disability globally and the first among young women.[3] It affects the quality of life of millions of Europeans.[4] From 2011-21 the economic burden of migraine in Europe due to the loss of working days ranged from €35-557 billion, depending on the country, representing 1-2 percent of gross domestic product (GDP).[5]   Overall socioeconomic burden of migraine as percentage of the country’s GDP in 2021 Source: WifOR, The socioeconomic burden of migraine. The case of 6 European Countries.5 Access to effective therapies could radically improve individuals’ lives and their ability to return to work.[6] Yet, despite the staggering economic and personal impacts, in some member states the latest medicines are either not reimbursed or only available after several treatment failures.[7] Imagine if Europe shifted its perspective on these conditions, investing to improve not only health but unlocking the potential for workforce and economic productivity? Moving to my second point, against this backdrop of underinvestment, where are scientific advances now happening in our sector? In recent years it is impressive to see China has become the second-largest drug developer in the world,[8] and within five years it may lead the innovative antibodies therapeutics sector,[9] which is particularly promising for complex areas like oncology. Cancer is projected to become the leading cause of death in Europe by 2035,[10] yet the continent’s share of the number of oncology trials dropped from 41 percent in 2013 to 21 percent in 2023.10 Today, antibody-drug conjugates are bringing new hope in hard-to-treat tumor types,[11] like ovarian,[12] lung[13] and colorectal[14] cancer, and we hope to see more of these advances in the future. Unfortunately, Europe is no longer at the forefront of the development of these innovations. This geographical shift could impact high-quality jobs, the vitality of Europe’s biotech sector and, most importantly, patients’ outcomes. [15] > This is why I encourage choices to be made that clearly signal the value > Europe attaches to medicines This is why I encourage choices to be made that clearly signal the value Europe attaches to medicines. This can be done by removing national cost-containment measures, like clawbacks, that are increasingly eroding the ability of companies to invest in European R&D. To provide a sense of their impact, between 2012 and 2023, clawbacks and price controls reduced manufacturer revenues by over €1.2 billion across five major EU markets, corresponding to a loss of 4.7 percent in countries like Spain.[16] Moreover, we should address health technology assessment approaches in Europe, or mandatory discount policies, which are simply not adequately accounting for the wider societal value of medicines, such as in the migraine example, and promoting a short-term approach to investment. By broadening horizons and choosing a long-term investment strategy for medicines and the life science sector, Europe will not only enable this strategic industry to drive global competitiveness but, more importantly, bring hope to Europeans suffering from health conditions. AbbVie SA/NV – BE-ABBV-250177 (V1.0) – December 2025 -------------------------------------------------------------------------------- [1] The Parliament Magazine, https://www.theparliamentmagazine.eu/partner/article/unmet-medical-needs-and-migraine-assessing-the-added-value-for-patients-and-society, Last accessed December 2025. [2] The Migraine Trust; https://migrainetrust.org/understand-migraine/types-of-migraine/chronic-migraine/, Last accessed December 2025. [3] Steiner TJ, et al; Lifting The Burden: the Global Campaign against Headache. Migraine remains second among the world’s causes of disability, and first among young women: findings from GBD2019. J Headache Pain. 2020 Dec 2;21(1):137 [4] Coppola G, Brown JD, Mercadante AR, Drakeley S, Sternbach N, Jenkins A, Blakeman KH, Gendolla A. The epidemiology and unmet need of migraine in five european countries: results from the national health and wellness survey. BMC Public Health. 2025 Jan 21;25(1):254. doi: 10.1186/s12889-024-21244-8. [5] WifOR. Calculating the Socioeconomic Burden of Migraine: The Case of 6 European Countries. Available at: [https://www.wifor.com/en/download/the-socioeconomic-burden-of-migraine-the-case-of-6-eu­ropean-countries/?wpdmdl=358249&refresh=687823f915e751752703993]. Accessed June 2025. [6] Seddik AH, Schiener C, Ostwald DA, Schramm S, Huels J, Katsarava Z. Social Impact of Prophylactic Migraine Treatments in Germany: A State-Transition and Open Cohort Approach. Value Health. 2021 Oct;24(10):1446-1453. doi: 10.1016/j.jval.2021.04.1281 [7] Moisset X, Demarquay G, et al., Migraine treatment: Position paper of the French Headache Society. Rev Neurol (Paris). 2024 Dec;180(10):1087-1099. doi: 10.1016/j.neurol.2024.09.008. [8] The Economist, https://www.economist.com/china/2025/11/23/chinese-pharma-is-on-the-cusp-of-going-global, Last accessed December 2025. [9] Crescioli S, Reichert JM. 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BRUSSELS — The French government called on Sunday to postpone a crucial vote by countries on the EU-Mercosur trade agreement, widening a rift within the bloc over the controversial pact. “France is asking for the December deadlines to be pushed back so we can keep working and get the legitimate protections our European agriculture needs,” the office of Prime Minister Sébastien Lecornu said Sunday evening. The statement confirmed a POLITICO report on Thursday that Paris was pushing for a delay. It comes within sight of the finish line for the European Union to finally close the agreement with Argentina, Brazil, Uruguay and Paraguay that has been in negotiations for over 25 years and would create a common market of over 700 million people. Denmark, which holds the presidency of the Council of the EU, has vowed to hold the vote in time for European Commission President Ursula von der Leyen to fly to Brazil on Dec. 20 to sign the deal. Several countries warn that the holdup risks ultimately killing the trade deal, concerned that further stalling it could embolden opposition in the European Parliament or complicate next steps when Paraguay, which is skeptical toward the agreement, takes over the presidency of the Mercosur bloc from current holder Brazil. Pro-deal countries, including Germany, Sweden and Spain, argue that France’s concerns have already been accommodated, pointing to proposed additional safeguards designed to protect European farmers in the event of a surge in Latin American beef or poultry imports. But with those safeguards still not finalized, France says it still can’t back the deal, wary that it could enrage the country’s politically powerful farming community. Brussels also announced this month it was planning to strengthen its border controls on food, animal and plant imports. “These advances are still incomplete and must be finalized and implemented in an operational, robust and effective manner in order to produce and appreciate their full effects,” Lecornu’s office said. Denmark, which holds the presidency of the Council of the EU, has vowed to hold the vote in time for European Commission President Ursula von der Leyen to fly to Brazil on Dec. 20 to sign the deal. | Wagner Meier/Getty Images Despite Denmark’s resolve to hold the vote in time, final talks among EU member countries may not be wrapped up before a summit of European leaders on Thursday and Friday this week. A big farmers’ protest is planned in Brussels on Thursday. The Commission declined to comment.

President Donald Trump promised that a wave of emergency tariffs on nearly every nation would restore “fair” trade and jump-start the economy. Eight months later, half of U.S. imports are avoiding those tariffs. “To all of the foreign presidents, prime ministers, kings, queens, ambassadors, and everyone else who will soon be calling to ask for exemptions from these tariffs,” Trump said in April when he rolled out global tariffs based on the United States’ trade deficits with other countries, “I say, terminate your own tariffs, drop your barriers, don’t manipulate your currencies.” But in the time since the president gave that Rose Garden speech announcing the highest tariffs in a century, enormous holes have appeared. Carveouts for specific products, trade deals with major allies and conflicting import duties have let more than half of all imports escape his sweeping emergency tariffs. Some $1.6 trillion in annual imports are subject to the tariffs, while at least $1.7 trillion are excluded, either because they are duty-free or subject to another tariff, according to a POLITICO analysis based on last year’s import data. The exemptions on thousands of goods could undercut Trump’s effort to protect American manufacturing, shrink the trade deficit and raise new revenue to fund his domestic agenda. In September, the White House exempted hundreds of goods, including critical minerals and industrial materials, totaling nearly $280 billion worth of annual imports. Then in November, the administration exempted $252 billion worth of mostly agricultural imports like beef, coffee and bananas, some of which are not widely produced in the U.S. — just after cost-of-living issues became a major talking point out of Democratic electoral victories — on top of the hundreds of other carveouts. “The administration, for most of this year, spent a lot of time saying tariffs are a way to offload taxes onto foreigners,” said Ed Gresser, a former assistant U.S. trade representative under Democratic and Republican administrations, including Trump’s first term, who now works at the Progressive Policy Institute, a D.C.-based think tank. “I think that becomes very hard to continue arguing when you then say, ‘But we are going to get rid of tariffs on coffee and beef, and that will bring prices down.’ … It’s a big retreat in principle.” The Trump administration has argued that higher tariffs would rebalance the United States’ trade deficits with many of its major trading partners, which Trump blames for the “hollowing out” of U.S. manufacturing in what he evoked as a “national emergency.” Before the Supreme Court, the administration is defending the president’s use of the 1977 International Emergency Economic Powers Act to enact the tariffs, and Trump has said that a potential court-ordered end to the emergency tariffs would be “country-threatening.” In an interview with POLITICO on Monday, Trump said he was open to adding even more exemptions to tariffs. He downplayed the existing carveouts as “very small” and “not a big deal,” and said he plans to pair them with tariff increases elsewhere. Responding to POLITICO’s analysis, White House spokesperson Kush Desai said, “The Trump administration is implementing a nuanced and nimble tariff agenda to address our historic trade deficit and safeguard our national security. This agenda has already resulted in trillions in investments to make and hire in America along with over a dozen trade deals with some of America’s most important trade partners.” To date, the majority of exemptions to the “reciprocal” tariffs — the minimum 10 percent levies on most countries — have been for reasons other than new trade deals, according to POLITICO’s analysis. The White House also pushed back against the notion that November’s cuts were made in an effort to reduce food prices, saying that the exemptions were first outlined in the September order. The U.S. granted subsequent blanket exemptions, regardless of the status of countries’ trade negotiations with the Trump administration, after announcing several trade deals. Following the exemptions on agricultural tariffs, Trump announced on Monday a $12 billion relief aid package for farmers hurt by tariffs and rising production costs. The money will come from an Agriculture Department fund, though the president said it was paid for by revenue from tariffs (by law, Congress would need to approve spending the money that tariffs bring in). In addition to the exemptions from Trump’s reciprocal tariffs, more than $300 billion of imports are also exempted as part of trade deals the administration has negotiated in recent months, including with the European Union, the United Kingdom, Japan and more recently, Malaysia, Cambodia and Brazil. The deal with Brazil removed a range of products from a cumulative tariff of 50 percent, making two-thirds of imports from the country free from emergency tariffs. For Canadian and Mexican goods, Trump imposed tariffs under a separate emergency justification over fentanyl trafficking and undocumented migrants. But about half of imports from Mexico and nearly 40 percent of those from Canada will not face tariffs because of the U.S.-Mexico-Canada free trade agreement that Trump negotiated in his first term. Last year, importers claimed USMCA exemptions on $405 billion in goods; that value is expected to increase, given that the two countries are facing high tariffs for the first time in several years. The Trump administration has also exempted several products — including autos, steel and aluminum — from the emergency reciprocal tariffs because they already face duties under Section 232 of the U.S. Trade Expansion Act of 1962. The imports covered by those tariffs could total up to $900 billion annually, some of which may also be exempt under USMCA. The White House is considering using the law to justify further tariffs on pharmaceuticals, semiconductors and several other industries. For now, the emergency tariffs remain in place as the Supreme Court weighs whether Trump exceeded his authority in imposing them. In May, the U.S. Court of International Trade ruled that Trump’s use of emergency authority was unlawful — a decision the U.S. Court of Appeals upheld in August. During oral arguments on Nov. 5, several Supreme Court justices expressed skepticism that the emergency statute authorizes a president to levy tariffs, a power constitutionally assigned to Congress. As the rates of tariffs and their subsequent exemptions are quickly added and amended, businesses are struggling to keep pace, said Sabine Altendorf, an economist with the Food and Agriculture Organization of the United Nations. “When there’s uncertainty and rapid changes, it makes operations very difficult,” Altendorf said. “Especially for agricultural products where growing times and planting times are involved, it’s very important for market actors to be able to plan ahead.” ABOUT THE DATA Trump’s trade policy is not a straightforward, one-size-fits-all approach, despite the blanket tariffs on most countries of the world. POLITICO used 2024 import data to estimate the value of goods subject to each tariff, accounting for the stacking rules outlined below. Under Trump’s current system, some tariffs can “stack” — meaning a product can face more than one tariff if multiple trade actions apply to it. Section 232 tariffs cover automobiles, automobile parts, products made of steel and aluminum, copper and lumber — and are applied in that order of priority. Section 232 tariffs as a whole then take priority over other emergency tariffs. We applied this stacking priority order to all imports to ensure no double-counting. To calculate the total exclusions, we did not count the value of products containing steel, aluminum and copper, since the tariff would apply only to the known portion of the import’s metal contentand not the total import value of all products containing them. This makes the $1.7 trillion in exclusions a minimum estimate. Goods from Canada and Mexico imported under USMCA face no tariffs. Some of these products fall under a Section 232 category and may be charged applicable tariffs for the non-USMCA portion of the import. To claim exemptions under USMCA, importers must indicate the percentage of the product made or assembled in Canada or Mexico. Because detailed commodity-level data on which imports qualify for USMCA is not available, POLITICO’s analysis estimated the amount that would be excluded from tariffs on Mexican and Canadian imports by applying each country’s USMCA-exempt share to its non-Section 232 import value. For instance, 38 percent of Canada’s total imports qualified for USMCA. The non-Section 232 imports from Canada totaled around $320 billion, so we used only $121 billion towards our calculation of total goods excluded from Trump’s emergency tariffs. Exemptions from trade deals included those with the European Union, the United Kingdom, Japan, Brazil, Cambodia and Malaysia. They do not include “frameworks” for agreements announced by the administration. Exemptions were calculated in chronological order of when the deals were announced. Imports already exempted in previous orders were not counted again, even if they appeared on subsequent exemption lists.

BRUSSELS — Denmark is holding the line and pressing ahead with plans to schedule a crucial vote of EU ambassadors on the EU-Mercosur trade deal next week, in a tug-of-war splitting countries across the bloc. “In the planning of the Danish presidency, the intention is to have the vote on the Mercosur agreement next week to enable the Commission President to sign the agreement in Brazil on Dec. 20,” an official with the Danish presidency of the Council of the EU told POLITICO. This is the first official confirmation from Copenhagen that it will go ahead with scheduling the vote over the deal with the Latin American countries in the coming days, despite warnings from France, Poland and Italy that the texts as they stand would not garner their support.  This risks leaving the Danish presidency of the Council short of the supermajority needed to get the deal over the line. Under EU rules, this would require the support of a “qualified” majority of EU member countries — meaning 15 of the bloc’s 27 members representing 65 percent of its population. The outcome of the vote will determine whether European Commission President Ursula von der Leyen can fly, as is now planned, to Brazil on Dec. 20 for a signing ceremony with her Mercosur counterparts. France however has been playing for time in an effort to delay its approval of the accord, which has been more than 25 years in the making — a strategy several diplomats warn could ultimately kill the trade deal.  They cite fears that further stalling could embolden opposition in the European Parliament or complicate the next steps when Paraguay, which is more skeptical of the agreement, takes over the presidency of the Mercosur bloc. “If we can’t agree on Mercosur, we don’t need to talk about European sovereignty anymore. We will make ourselves geopolitically irrelevant,” said a senior EU diplomat. European leaders, including French President Emmanuel Macron, are expected to descend on Brussels on Thursday for a high-stakes EU summit. While not formally on the agenda, the trade deal with Brazil, Argentina, Paraguay and Uruguay is expected to loom large. A farmers demonstration is also expected in Brussels on the same day.  Countries backing the deal, including Germany and Sweden, argue that France has already been accommodated, pointing to proposed additional safeguards designed to protect European farmers in the event of a surge in Latin American beef or poultry imports. The instrument, which still requires validation by EU institutions, was a proposal from the Commission to placate Poland and France, whose influential farming constituencies worry they would be undercut by Latin American beef or poultry.  The texts submitted for the upcoming vote were published last week and include a temporary strengthened safeguard, committing to closely monitor market disruptions — one of the key conditions for Paris to back the deal.