BRUSSELS — The European Union needs to draft in Mario Draghi, the mastermind behind reforms to revive its single market, to ensure that member countries rally behind efforts to boost growth and prosperity, a senior European lawmaker said Tuesday. Member countries should “mandate Draghi” to build political consensus for reform and pierce through national “deep state” resistance to force a radical rethink of the single market project, Pascal Canfin, a French Renew MEP, told POLITICO’s Competitive Europe Summit in Brussels. “We need somebody that could do so at the very top level, with heads of state and government and quite deep state level,” Canfin said, arguing that the bloc has reached a “historical crossroads” where it must choose between deeper integration or economic irrelevance. In 2024, the former Italian Prime Minister and head of the European Central Bank delivered a report on Europe’s competitiveness deficit that one commissioner has referred to as the “bible” for Ursula von der Leyen’s second Commission. EU leaders backed a plan to relaunch the 30-year old single market — with its freedoms in the movement of goods, capital, services and people — at a summit earlier this month. According to Canfin, Draghi’s work is not yet done, and the former Italian leader could build a “coalition of the willing” of member states willing to integrate their economies. Canfin also suggested that the requirement for consensus among all 27 member states has become a challenge.  “It’s not an objective not to do it at 27, but maybe at the end, we will not be able to do it for political reasons,” Canfin said, specifically citing the frequent vetoes and disruptions caused by Hungarian Prime Minister Viktor Orbán.  The move toward a multi-speed Europe is increasingly viewed by proponents of integration as the only way to compete with the massive industrial subsidies and streamlined decision-making of the United States and China. Canfin described a recurring cycle of political failure where national leaders travel to Brussels and make commitments, only to see them disassembled at home. “They go to Brussels … then they go back home, and there are all the people locally, in Paris, in Berlin, in Rome, in Madrid, saying the opposite,” Canfin said. “Including in the deep state, including in some companies that have built the knowledge to manage and navigate complexity.” Canfin identified three obvious candidates for accelerated integration: defense, energy, and finance.  “The political will has always been in the hands of the capitals,” Canfin said. “Technical, yes, but today, would we be politically able?”

Europe’s competitiveness agenda is in full swing. Cutting red tape for business is now a central mantra of EU policymaking, Brussels is digesting new plans to accelerate Europe’s industrial capacity, and the single market is getting new political momentum as well as a rebrand. But as a new war in the Middle East adds to existing geopolitical turmoil and economic disruption, calls are growing for the EU to become more self-sufficient in areas such as tech, energy and defense. Against this backdrop, how is the EU’s competitiveness push shaping up so far? Is it moving quickly enough? Are the right policy levers being pulled? And how can European policymakers balance the push for growth without compromising priorities such as environmental protection and regulatory certainty? Follow all the discussions and news from our spring edition of POLITICO’s Competitive Europe Summit as we discuss these questions with politicians, policymakers and experts. See the full program here and follow along here from 9 a.m.

U.S. regulators this week proposed easing capital rules on big U.S. banks in a package of proposals that departs from globally agreed-upon standards. Now, it’s sparking calls from European trade groups to loosen the EU’s own version of the rules. On Thursday, U.S. bank regulators released a number of potential rule changes intended to align U.S. policy with a 2017 global agreement known as Basel III. Its provisions imply a 2.4 percent decrease in capital held by the largest U.S. banks and bigger cuts for smaller banks. European regulators, anticipating the U.S. move, had already been discussing loosening their own requirements, which currently call for raising the capital that banks must have on hand by around 8 percent by 2033. But the breadth of the U.S. proposal has prompted trade groups in Europe to push officials to move faster. Taken together, the moves could weaken the global regulatory framework instituted on both sides of the Atlantic after the 2008 financial crisis. “The U.S. proposal appears to mark a clear shift toward easing capital constraints to support lending and growth, while Europe seems to continue moving in a different direction,” said Sébastien de Brouwer, deputy CEO of the European Banking Federation, a trade group. The United States’ pullback is “making it more urgent than ever to review the EU framework to preserve competitiveness and financing capacity of European banks,” he said. Over the past few months, European regulators had started to reevaluate the competitiveness of the bloc’s banking sector, especially as major European economies have struggled to keep pace with U.S. growth. EU heads of government called Thursday night, in a statement agreed upon before the release of the U.S. proposal, for the European Commission “to propose targeted amendments to the prudential framework in order to enhance the capacity of the banking sector to finance the European economy.” The Commission is also authoring a report on the competitiveness of its banking sector, due after the summer, which will pave the way for legislative proposals. This is set to be a wide-ranging report that could relate to bank capital requirements or other policies. The European Central Bank has already made recommendations for simplifying the bloc’s banking rules ahead of the report, including calling for lighter Basel rules for small banks and for capital buffers to be merged. None of its recommendations were as sweeping as what the U.S. has proposed, however. The U.S. proposal departs from the intent of the original Basel accords, a long process in which global regulators worked to address the root causes of the global financial crisis, critics say. Regulators in 2017 reached an agreement around the framework for jurisdictions to mitigate risks. “This definitely goes against not just the ethos but the intent, spirit and goal of Basel III,” said Dennis Kelleher, CEO of Better Markets, an advocacy group that supports stronger financial regulation. “This proposal when finalized will inevitably ignite another global race to the regulatory bottom” One of the biggest departures relates to the unwinding of the “output floor,” which sets a minimum capital threshold for banks’ trading activities. The new proposal uses a new risk-weighting approach that would do away with the threshold. “This will encourage other jurisdictions to do the same, undermining a key reform and cornerstone of the Basel III agreement,” Federal Reserve board member Michael Barr said Thursday. In the 2017 international talks, the U.S. had argued in favor of a restrictive output floor. Major European banks argued that would hike their capital requirements above and beyond those of the U.S., given the makeup of European banks’ trading books, stymieing lending to the real economy. The threshold was ultimately set at a lower rate than what American negotiators wanted. European regulators had recently moved to delay implementation of the Fundamental Review of the Trading Book, the portion of Basel focused specifically on so-called market risk, or rules governing how to capitalize banks’ trading activities. “Removing the output floor for market risk is a divergence from international standards, and we will carefully assess the impact on internationally active banks, in particular, with respect to the ongoing discussions on EU FRTB implementation and banking competitiveness in Europe,” said Caroline Liesegang, head of prudential regulation and research at the Association for Financial Markets in Europe, which represents large banks. In the past, U.S. regulators had tended to “gold plate” the country’s rules for big banks, meaning they put in provisions above and beyond what Basel requires in order to acknowledge the United State’s central role in the global financial system and push for stricter global standards. In 2023, U.S. regulators failed to pass a capital proposal that would have raised aggregate capital by 16 percent and would have adhered more strictly to the international framework. On Thursday, U.S. regulators said the international standards should not be an unnecessary barrier to the needs of the U.S. financial system. “We should not seek to punish U.S. consumers and businesses by imposing higher costs of credit, or forcing credit availability outside of the banking system, particularly if this is done only to show greater alignment with Basel or any other international standard,” said Federal Reserve Vice Chair for Supervision Michelle Bowman, who led the U.S. central bank’s crafting of the proposal. The dilution of the agreement and its pullback on capital “will make it more challenging for the U.S. to use Basel, as it so often has, to further its own agenda,” said Kathryn Judge, professor at Columbia Law School. In the U.K., which has since left the bloc, the capital rules are expected to have less of an impact on banks than EU peers. A spokesperson for the Prudential Regulation Authority, the U.K.’s main banking regulator, said that the thinking remains the same as in its final rules, which will see the market risk rules apply from 2028. The European Commission declined to comment. The Basel Committee said it doesn’t comment on individual jurisdictions. The Federal Reserve declined to comment. Bjarke Smith-Meyer and Elliot Gulliver-Needham contributed to this report.

Many describe our geopolitical moment as one of instability, but that word feels too weak for what we are living through. Some, like Mark Carney, argue that we are facing a rupture: a break with assumptions that anchored the global economic and political order for decades. Others, like Christine Lagarde, see a profound transition, a shift toward a new configuration of power, technology and societal expectations. Whichever perception we adopt, the implication is clear: leaders can no longer rely on yesterday’s mental models, institutional routines or governance templates. Johanna Mair is the Director of the Florence School of Transnational Governance at the European University Institute in Florence, where she leads education, training and research on governance beyond the nation state. Security, for example, is no longer a discrete policy field. It now reaches deeply into energy systems, artificial intelligence, cyber governance, financial stability and democratic resilience, all under conditions of strategic competition and mistrust. At the same time, competitiveness cannot be reduced to productivity metrics or short-term growth rates. It is about a society’s capacity to innovate, regulate effectively and mobilize investment toward long-term objectives — from the green and digital transitions to social cohesion. This dense web of interdependence is where transnational governance is practiced every day. The European Union illustrates this reality vividly. No single member state can build the capacity to manage these transformations on its own. EU institutions and other regional bodies shape regulatory frameworks and collective responses; corporations influence infrastructure and supply chains; financial institutions direct capital flows; and civic actors respond to social fragmentation and governance gaps. Effective leadership has become a systemic endeavour: it requires coordination across these levels, while sustaining public legitimacy and defending liberal democratic principles. > Our mission is to teach and train current and future leaders, equipping them > with the knowledge, skills and networks to tackle global challenges in ways > that are both innovative and grounded in democratic values. The Florence School of Transnational Governance (STG) at the European University Institute was created precisely to respond to this need. Located in Florence and embedded in a European institution founded by EU member states, the STG is a hub where policymakers, business leaders, civil society, media and academia meet to work on governance beyond national borders. Our mission is to teach and train current and future leaders, equipping them with the knowledge, skills and networks to tackle global challenges in ways that are both innovative and grounded in democratic values. What makes this mission distinctive is not only the topics we address, but also how and with whom we address them. We see leadership development as a practice embedded in real institutions, not a purely classroom-based exercise. People do not come to Florence to observe transnational governance from a distance; they come to practice it, test hypotheses and co-create solutions with peers who work on the frontlines of policy and politics. This philosophy underpins our portfolio of programs, from degree offerings to executive education. With early career professionals, we focus on helping them understand and shape governance beyond the state, whether in international organizations, national administrations, the private sector or civil society. We encourage them to see institutions not as static structures, but as arrangements that can and must be strengthened and reformed to support a liberal, rules-based order under stress. At the same time, we devote significant attention to practitioners already in positions of responsibility. Our Global Executive Master (GEM) is designed for experienced professionals who cannot pause their careers, but recognize that the governance landscape in which they operate has changed fundamentally. Developed by the STG, the GEM convenes participants from EU institutions, national administrations, international organizations, business and civil society — professionals from a wide range of nationalities and institutional backgrounds, reflecting the coalitions required to address complex problems. The program is structured to fit the reality of leadership today. Delivered part time over two years, it combines online learning with residential periods in Florence and executive study visits in key policy centres. This blended format allows participants to remain in full-time roles while advancing their qualifications and networks, and it ensures that learning is continuously tested against institutional realities rather than remaining an abstract exercise. Participants specialize in tracks such as geopolitics and security, tech and governance, economy and finance, or energy and climate. Alongside this subject depth, they build capabilities more commonly associated with top executive programs than traditional public policy degrees: change management, negotiations, strategic communication, foresight and leadership under uncertainty. These skills are essential for bridging policy design and implementation — a gap that is increasingly visible as governments struggle to deliver on ambitious agendas. Executive study visits are a core element of this practice-oriented approach. In a recent Brussels visit, GEM participants engaged with high-level speakers from the European Commission, the European External Action Service, the Council, the European Parliament, NATO, Business Europe, Fleishman Hillard and POLITICO itself. Over several days, they discussed foreign and security policy, industrial strategy, strategic foresight and the governance of emerging technologies. These encounters do more than illustrate theory; they give participants a chance to stress-test their assumptions, understand the constraints facing decision-makers and build relationships across institutional boundaries. via EUI Throughout the program, each participant develops a capstone project that addresses a strategic challenge connected to a policy organization, often their own employer. This ensures that executive education translates into institutional impact: projects range from new regulatory approaches and partnership models to internal reforms aimed at making organizations more agile and resilient. At the same time, they help weave a durable transnational network of practitioners who can work together beyond the programme. Across our activities at the STG, a common thread runs through our work: a commitment to defending and renewing the liberal order through concrete practice. Addressing the rupture or transition we are living through requires more than technical fixes. It demands leaders who can think systemically, act across borders and design governance solutions that are both unconventional and democratically legitimate. > Across our activities at the STG, a common thread runs through our work: a > commitment to defending and renewing the liberal order through concrete > practice. In a period defined by systemic risk and strategic competition, leadership development cannot remain sectoral or reactive. It must be interdisciplinary, practice-oriented and anchored in real policy environments. At the Florence School of Transnational Governance, we aim to create precisely this kind of learning community — one where students, fellows and executives work side by side to reimagine how institutions can respond to global challenges. For policymakers and professionals who recognize themselves in this moment of rupture, our programs — including the GEM — offer a space to step back, learn with peers and return to their institutions better equipped to lead change. The task is urgent, but it is also an opportunity: by investing in transnational governance education today, we can help lay the foundations for a more resilient and inclusive order tomorrow.

BRUSSELS ― Two wars on Europe’s doorstep loomed over a 12-hour summit of EU leaders ― and for very different reasons they found themselves paralyzed rather than able to do much about either. Rarely has the bloc’s inability to take a lead on international affairs been so obvious. Between Germany’s Friedrich Merz, France’s Emmanuel Macron and Italy’s Giorgia Meloni ― heads of three of the world’s top 10 economies ― and the other 24 in attendance, they could only look the other way, squabble with each other, or offer little but words as the bombing, missile-firing and killing continued. “In these very troubled moments in which we are living, more than ever it’s decisive to uphold the international rules-based order,” European Council President  António Costa, who chaired the gathering in Brussels, told reporters. “The alternative is chaos. The alternative is the war in Ukraine. The alternative is the war in the Middle East.” And that speech was about as far as it went. As Tehran pounded its neighbors, disrupting Europe’s energy supplies, Kyiv attacked Russian factories repairing military planes, and Donald Trump in Washington joked about the Pearl Harbor attack alongside the Japanese prime minister, European leaders used their talks to tinker with the bloc’s carbon permit scheme, the Emissions Trading System. It’s not a wholly unrelated matter to the global energy shock, but hardly an issue where the continent could demonstrate its geopolitical might. On Iran, leaders found they had little leverage or will to make any significant intervention. On Ukraine, more than four years after Russia’s full-scale invasion ― a conflict where they do have leverage and they do have will ― they were unable to overcome internal divisions to approve sending €90 billion Kyiv’s way. There was “no willingness to get involved across the table” on the Iran conflict, said a senior European government official, granted anonymity like others quoted in this article to discuss the talks behind closed doors. German Chancellor Merz even complained that focusing on Iran risked shifting attention away from measures to boost Europe’s flagging economy — the summit’s original raison d’être before would affairs got in the way — according to three officials. “The world looked very different at Alden Biesen,” an EU official said, referring to last month’s competitiveness-focused meeting in a Belgian castle that was meant to set the stage for this summit. That was before Iran’s war and Ukraine’s funding dilemma, brought about by Hungarian Prime Minister Viktor Orbán going back on his promise to approve the loan, radically reshaped the agenda. NOT OUR WAR That’s not to say Iran was ignored completely. There was some renewed discussion about sending French warships to protect the Strait of Hormuz, the vital oil transit point that Tehran has effectively shut down by threatening to strike ships, potentially with backing from the U.N. Security Council. “We have begun an exploratory process, and we will see in the coming days if it has a chance of succeeding,” Macron said. But the summit’s final statement stopped short of pledging any new mission, referring only to strengthening existing EU naval operations in the region. Italian Prime Minister Giorgia Meloni at a press conference at the end of the European Council summit on March 19, 2026 in Brussels. | Pier Marco Tacca/Getty Images By the end of the talks, the EU’s leaders reached a sobering conclusion: Europe has little power or inclination to shape events. “Middle East impacts us a lot — but are we a player in the game?” an EU official who was party to the leaders’ discussions asked. “They’re trying to find a place in this debate and we have a lot of statements and positions [but] is there a role for Europeans for solving this process?” Evidently not, according to Kaja Kallas, the EU’s foreign policy chief, who warned leaders that “starting war is like a love affair — it’s easy to get in and difficult to get out,” according to two diplomats briefed on her remarks. Translation: This is not Europe’s war — and it’s not going to be. The EU was left with doing “what we always do,” an EU official said, writing “nice statements.” BURNING GAS FIELDS Europe already angered U.S. President Trump earlier this week when its top envoys rejected his call to secure the Strait of Hormuz. The summit’s final conclusions leaned heavily on familiar calls for “de-escalation” and “restraint,” without proposing concrete action, sticking to that earlier position. That’s despite Qatar warning Thursday it would not be able to fulfill its liquefied natural gas contracts with Belgium and Italy after Iran directed its wrath — and its ballistic missiles — over U.S.-Israeli strikes at the Gulf country, knocking out almost a fifth of its LNG export capacity. Yet rather than grapple head-on with the rapidly expanding energy shock, Europe’s leaders spent hours debating the bloc’s climate policy, including its ETS, which a group of countries are eager to reform. “To say ETS is the biggest issue when big gas fields are burning is a bit weird,” an EU official said. European Commission President Ursula von der Leyen said the consequences of the war extended far beyond the Middle East, adding its most “immediate impact” was on energy supply and prices. She announced a slate of emergency measures to lower costs, from lowering taxes to boosting investment in ETS. ‘JUST CRAZY’ If anything, the summit exposed where the wars in Iran and Ukraine overlap. In what could be his final EU gathering after 16 years if he loses next month’s election, Hungary’s Orbán slammed Europe’s approach to the unfolding energy crisis. “The behavior and the strategy that the Europeans have here is just crazy,” he said — adding the EU needed to buy Russian oil to “survive.” Orbán has blocked a €90 billion EU loan to Kyiv because of a dispute about a damaged pipeline carrying Russian oil through Ukraine to Hungary and other central European countries. For that reason, the bloc was similarly unable to offer much more than assurances on the Ukraine war either. Orbán maintained his opposition on Thursday and even won the sympathy of Meloni, who told leaders she understood his position. As frustration inside the room boiled over, many leaders sharply criticized the Hungarian premier, according to Swedish Prime Minister Ulf Kristersson. “I have never heard such hard-hitting criticism of anyone, ever,” he told reporters during a break in the talks. Merz concurred that leaders were “deeply upset” at Orbán. “I am firmly convinced that this will leave a lasting mark,” he said. But the pressure from his peers failed to sway Orbán and questions of the EU loan will roll on to another summit next month ― by which time Hungary could have a new leader, or at least an old one not desperate for votes. On Iran and on Ukraine, the EU didn’t get anywhere. Earlier predictions by diplomats that leaders might continue discussions through the night or even reconvene for a second day as the urgency of a world in turmoil forced them to face up to the challenges before them failed to materialize. Things were done and dusted before midnight. After 12 hours of few decisions, leaders were left with little new to tell people back home. “There are many things worrying about this war” in the Middle East, while Orban’s veto of the loan to Kyiv “is still there and we are extremely unhappy about this, and so of course is Ukraine,” Sweden’s Kristersson told reporters upon leaving the summit. And that was that. Zoya Sheftalovich, Nette Nöstlinger, Nicholas Vinocur, Gerardo Fortuna, Gabriel Gavin, Hans von der Burchard, Sonja Rijnen, Zia Weise, Seb Starcevic, Giorgio Leali, Hanne Cokelaere, Ferdinand Knapp, Milena Wälde, Aude van den Hove, Gregorio Sorgi, Koen Verhelst, Victor Jack, Ben Munster, Jacopo Barigazzi and Bartosz Brzezińksi contributed reporting.

Biotechnology is central to modern medicine and Europe’s long-term competitiveness. From cancer and cardiovascular disease to rare conditions, it is driving transformative advances for patients across Europe and beyond . 1         Yet innovation in Europe is increasingly shaped by regulatory fragmentation, procedural complexity and uneven implementation across  m ember s tates. As scientific progress accelerates, policy frameworks must evolve in parallel, supporting the full lifecycle of innovation from research and clinical development to manufacturing and patient access.  The proposed EU Biotech Act seeks to address these challenges. By streamlining regulatory procedures, strengthening coordination  and supporting scale-up and manufacturing, it aims to reinforce Europe’s position in a highly competitive global biotechnology landscape .2       Its success, however, will depend less on ambition than on delivery. Consistent implementation, proportionate oversight and continued global openness will determine whether the  a ct translates into faster patient access, sustained investment and long-term resilience.  Q: Why is biotechnology increasingly seen as a strategic pillar for Europe’s competitiveness, resilience and long-term growth?  Gilles Marrache, SVP and regional general manager, Europe, Latin America, Middle East, Africa and Canada, Amgen:  Biotechnology sits at the intersection of health, industrial policy and economic competitiveness. The sector is one of Europe’s strongest strategic assets and a leading contributor to  research and development  growth . 3    At the same time, Europe’s position is under increasing pressure. Over the past two decades, the EU has lost approximately 25  percent of its global share of pharmaceutical investment to other regions, such as the  United States  and China.   The choices made today will shape Europe’s long-term strength in the sector, influencing not only competitiveness and growth, but also how quickly patients can benefit from new treatments.  > Europe stands at a pivotal moment in biotechnology. Our life sciences legacy > is strong, but maintaining global competitiveness requires evolution .” 4   > >  Gilles Marrache, SVP and regional general manager, Europe, Latin America, > Middle East, Africa and Canada, Amgen. Q: What does the EU Biotech Act aim to do  and why is it considered an important step forward for patients and Europe’s innovation ecosystem?  Marrache: The EU Biotech Act represents a timely opportunity to better support biotechnology products from the laboratory to the market. By streamlining medicines’ pathways and improving conditions for scale-up and investment, it can help strengthen Europe’s innovation ecosystem and accelerate patient access to breakthrough therapies. These measures will help anchor biotechnology as a strategic priority for Europe’s future  —  and one that can deliver earlier patient benefit  —  so long as we can make it work in practice.  Q: How does the EU Biotech Act address regulatory fragmentation, and where will effective delivery and coordination be most decisive? Marrache: Regulatory fragmentation has long challenged biotechnology development in Europe, particularly for multinational clinical trials and innovative products. The Biotech Act introduces faster, more coordinated trials, expanded regulatory sandboxes and new investment and industrial capacity instruments.   The proposed EU Health Biotechnology Support Network and a  u nion-level regulatory status repository would strengthen transparency and predictability. Together, these measures would support earlier regulatory dialogue, help de-risk development   and promote more consistent implementation across  m ember  s tates.   They also create an opportunity to address complexities surrounding combination products  —  spanning medicines, devices and diagnostics  —  where overlapping requirements and parallel assessments have added delays.5 This builds on related efforts, such as the COMBINE programme,6 which seeks to streamline the navigation of the In Vitro Diagnostic Regulation , 7 Clinical Trials Regulation8 and the Medical Device Regulation9 through a single, coordinated assessment process. Continued clarity and coordination will be essential to reduce duplication and accelerate development timelines .10 Q: What conditions will be most critical to support biotech scale-up, manufacturing  and long-term investment in Europe?  Marrache: Europe must strike the right balance between strategic autonomy and openness to global collaboration. Any new instruments under the Biotech Act mechanisms should remain open and supportive of all types of biotech investments, recogni z ing that biotech manufacturing operates through globally integrated and highly speciali z ed value chains.   Q: How can Europe ensure faster and more predictable pathways from scientific discovery to patient access, while maintaining high standards of safety and quality?   Marrache: Faster and more predictable patient access depends on strengthening end-to-end pathways across the lifecycle.  The Biotech Act will help ensure continuity of scientific and regulatory experti z e, from clinical development through post-authori z ation. It will also support stronger alignment with downstream processes, such as health technology assessments, which  are  critical to success.   Moreover, reducing unnecessary delays or duplication in approval processes can set clearer expectations, more predictable development timelines and earlier planning for scale-up.    Gilles Marrache, SVP and regional general manager, Europe, Latin America, Middle East, Africa and Canada, Amgen. Via Amgen. Finally, embedding a limited number of practical tools (procedural, digital or governance-based) and ensuring they are integrated within existing  European Medicines Agency and EU regulatory structures can help achieve faster patient access . 11 Q: What role can stronger regulatory coordination, data use and public - private collaboration play in strengthening Europe’s global position in biotechnology?  Marrache: To unlock biotechnology’s full potential, consistent implementation is essential. Fragmented approaches to secondary data use, divergent  m ember   state interpretations and uncertainty for data holders still limit access to high-quality datasets at scale. The Biotech Act introduces key building blocks to address this.   These include Biotechnology Data Quality Accelerators to improve interoperability, trusted testing environments for advanced innovation, and alignment with the EU AI Act ,12  European Health Data Space13 and wider EU data initiatives. It also foresees AI-specific provisions and clinical trial guidance to provide greater operational clarity.  Crucially, these structures must simplify rather than add further layers of complexity.   Addressing remaining barriers will reduce legal uncertainty for AI deployment, support innovation and strengthen Europe’s competitiveness.  > These reforms will create a moderni z ed biotech ecosystem, healthier > societies, sustainable healthcare systems and faster patient access to the > latest breakthroughs in Europe .” 14 > > Gilles Marrache, SVP and regional general manager, Europe, Latin America, > Middle East, Africa and Canada, Amgen.  Q: As technologies evolve and global competition intensifies, how can policymakers ensure the Biotech Act remains flexible and future-proof?  Marrache:  To remain future-proof, the Biotech Act must be designed to evolve alongside scientific progress, market dynamics and patient needs. Clear objectives, risk-based requirements, regular review mechanisms and timely updates to guidance will enhance regulatory agility without creating unnecessary rigidity or administrative burden.  Continuous stakeholder dialogue combined with horizon scanning will be essential to sustaining innovation, resilience and timely patient access over the long term. Preserving regulatory openness and international cooperation will be critical in avoiding fragmentation and maintaining Europe’s credibility as a global biotech hub.  Q: Looking ahead, what two or three priorities should policymakers focus on to ensure the EU Biotech Act delivers meaningful impact in practice?  Marrache: Looking ahead, policymakers should focus on three priorities for the Biotech Act:    First, implementation must deliver real regulatory efficiency, predictability and coordination in practice. Second, Europe must sustain an open and investment-friendly framework that reflects the global nature of biotechnology.  And third, policymakers should ensure a clear and coherent legal framework across the lifecycle of innovative medicines, providing certainty for the use of  artificial intelligence   —  as a key driver of innovation in health biotechnology.  In practical terms, the EU Biotech Act will be judged not by the number of new instruments it creates, but by whether it reduces complexity, increases predictability and shortens the path from scientific discovery to patient benefit. An open, innovation-friendly framework that is competitive at the global level will help sustain investment, strengthen resilient supply chains and deliver better outcomes for patients across Europe and beyond. -------------------------------------------------------------------------------- References 1. Amgen Europe, The EU Biotech Act Unlocking Europe’s Potential, May 2025. Retrieved from https://www.amgen.eu/media/press-releases/2025/05/The_EU_Biotech_Act_Unlocking_Europes_Potential 2. European Commission, Proposal for a Regulation to establish measures to strengthen the Union’s biotechnology and biomanufacturing sectors, December 2025. Retrieved from https://health.ec.europa.eu/publications/proposal-regulation-establish-measures-strengthen-unions-biotechnology-and-biomanufacturing-sectors_en 3. EFPIA, The pharmaceutical sector: A catalyst to foster Europe’s competitiveness, February 2026. Retrieved from https://www.efpia.eu/media/zkhfr3kp/10-actions-for-competitiveness-growth-and-security.pdf 4. The Parliament, Investing in healthy societies by boosting biotech competitiveness, November 2024. Retrieved from https://www.theparliamentmagazine.eu/partner/article/investing-in-healthy-societies-by-boosting-biotech-competitiveness#_ftn4 5. Amgen Europe, The EU Biotech Act Unlocking Europe’s Potential, May 2025. Retrieved from https://www.amgen.eu/docs/BiotechPP_final_digital_version_May_2025.pdf   6. European Commission, combine programme, June 2023. Retrieved from https://health.ec.europa.eu/medical-devices-topics-interest/combine-programme_en  7. European Commission. Medical Devices – In Vitro Diagnostics, March 2026. Retrieved from https://health.ec.europa.eu/medical-devices-vitro-diagnostics_en 8. European Commission, Clinical trials – Regulation EU No 536/2014, January 2022. Retrieved from https://health.ec.europa.eu/medicinal-products/clinical-trials/clinical-trials-regulation-eu-no-5362014_en 9. European Commission, Simpler and more effective rules for medical devices – Commission proposal for a targeted revision of the medical devices regulations, December 2025. Retrieved from https://health.ec.europa.eu/medical-devices-sector/new-regulations_en#mdr 10. Amgen Europe, The EU Biotech Act Unlocking Europe’s Potential, May 2025. Retrieved from https://www.amgen.eu/docs/BiotechPP_final_digital_version_May_2025.pdf   11. AmCham, EU position on the Commission Proposal for an EU Biotech Act 12. European Commission, AI Act | Shaping Europe’s digital future, June 2024. Retrieved from https://digital-strategy.ec.europa.eu/en/policies/regulatory-framework-ai 13. European Commission, European Health Data Space, March 2025. Retrieved from https://health.ec.europa.eu/ehealth-digital-health-and-care/european-health-data-space-regulation-ehds_en 14. The Parliament, Why Europe needs a Biotech Act, October 2025. Retrieved from https://www.theparliamentmagazine.eu/partner/article/why-europe-needs-a-biotech-act -------------------------------------------------------------------------------- Disclaimer POLITICAL ADVERTISEMENT * The sponsor is Amgen Inc * The ultimate controlling entity is Amgen Inc * The political advertisement is linked to advocacy on the EU Biotech Act. More information here.

Listen on * Spotify * Apple Music * Amazon Music EU leaders gather in Brussels for a high-stakes summit — with Viktor Orbán once again at the center of the debate over funding Ukraine. As tensions rise, the big question is whether the Hungarian prime minister will hold the line or shift under pressure from fellow leaders. At the same time, divisions are emerging over how Europe should respond to the war in Iran — from ways to tackle rising energy prices to how far to go in coordinating with Washington. Meanwhile, in the European Parliament, lawmakers will vote on a key part of the EU-U.S. trade deal, deciding whether to move ahead with lowering tariffs on American industrial goods — even as doubts remain about U.S. reliability. And finally, a very Belgian problem — too many fries. Zoya Sheftalovich is joined by Sarah Wheaton to break down the politics — from summit dynamics to transatlantic trade. Send any questions or comments to us on our WhatsApp: +32 491 05 06 29.

BRUSSELS — An EU summit once billed as a chance to boost the bloc’s economy is now a full-blown stress test. Leaders gathering Thursday face a combustible agenda: Ukraine’s financial survival, Middle East escalation, transatlantic tensions, and deep internal rifts over energy and climate policy. Thursday’s meeting has been dramatically reshaped in recent days by the U.S.-Israeli war in Iran and a standoff with Hungary over a €90 billion lifeline for Kyiv — turning what had been meant to be a forward-looking discussion into a scramble to manage multiple crises at once. Leaders will still try to push ahead on plans to strengthen Europe’s competitiveness, from deepening the single market to easing the burden on businesses. But those longer-term ambitions risk being overshadowed by more immediate geopolitical fires, alongside intense discussions on continent’s energy, defense and migration policies, according to a draft version of the post-summit joint statement obtained by POLITICO.   Expect a packed — and likely fractious — day in Brussels. Here’s POLITICO’s cheat sheet of the five biggest clashes to look out for at the European Council. THE €90B QUESTION: HUNGARY VS. EVERYONE  A €90 billion lifeline for Ukraine — which will determine Kyiv’s ability to continue defending itself against Russian aggression — hangs on whether Hungary lifts its veto. EU leaders agreed in December to provide the funding. But Hungarian Prime Minister Viktor Orbán later reneged and blocked the deal over a dispute with Ukraine about a damaged pipeline carrying Russian oil to Central Europe. Budapest has accused Kyiv of trying to engineer an energy crisis in Hungary by cutting off Russian oil supplies and says it won’t approve the cash disbursement until flows resume. The European Commission said Tuesday it had offered to help repair the pipeline and that Ukraine had accepted, raising hopes of a breakthrough. The move could prompt Hungary to lift its veto, one diplomat familiar with Budapest’s thinking said, speaking on condition of anonymity like others in this article to discuss sensitive negotiations. But Orbán struck a defiant tone in a video posted after the Commission’s announcement, saying: “If there is no oil, there is no money.” That leaves him isolated from almost all other leaders, aside from Slovakia’s Robert Fico. “The behavior from Hungary is a new low,” Sweden’s Europe Minister Jessica Rosencrantz told POLITICO ahead of the meeting. Another diplomat said that “if we fail on the loan, [Ukrainian leader Volodymyr] Zelenskyy will rightly be furious.” The latest draft conclusions still point to disbursement by early April — a timeline leaders will be endeavoring to rescue in their negotiations. HORMUZ DILEMMA: IRAN’S THREATS VS. A RELUCTANT EUROPE Tehran’s attacks on ships in the Strait of Hormuz — a vital oil transit point — have jacked up the global price of oil and forced Europe to weigh whether to get involved. One idea was to expand the mandate of the EU’s Middle East naval mission, Aspides, to allow European warships to patrol the waterway. That was quickly ruled out by the bloc’s foreign ministers on Monday. “Nobody wants to go actively in this war,” the EU’s top diplomat, Kaja Kallas, said after the foreign envoys met. Instead, leaders will call for the reinforcement of existing naval missions, Aspides and Atalanta, with “more assets” (read: ships) — while stopping short of extending their reach to Hormuz, according to the draft summit conclusions. The text stresses that operations must remain “in line with their respective mandates.” A diplomat from the Gulf region said they were watching closely but did not expect any major shift from EU leaders, such as expanding the Aspides mandate or launching joint operations with third countries. TRANSATLANTIC TREMORS: TRUMP VS. EUROPEAN CAPITALS  Europe’s refusal to step in around the Strait of Hormuz has angered U.S. President Donald Trump, who said it would be “very bad for the future of NATO” if EU countries failed to act. That frustration is only growing. Republican Senator Lindsey Graham said he had spoken to Trump about Europe’s unwillingness to provide assets to keep the strait open and had “never heard him so angry in my life.” The flare-up comes with EU-U.S. ties already under strain. Spain has openly defied Trump over the Iran conflict, refusing to allow the U.S. to use its bases and drawing threats of trade retaliation from Washington. French President Emmanuel Macron has stepped in to back Madrid and signal European solidarity, while other leaders have taken a more cautious or mixed line on how far to push back. Trump may not be on the formal agenda, but his pressure will loom over the summit — and sharpen already fraught debates over defense, trade and Europe’s reliance on the U.S. ETS BRAWL: ITALY, POLAND AND OTHERS VS. THE COMMISSION  A major brawl is brewing over the EU’s Emissions Trading System between a cadre of member countries and the EU’s executive.  Ten EU member countries sent a letter to the Commission ahead of Thursday’s summit asking to speed up a planned review of the ETS, a cornerstone of the bloc’s climate policy that forces big polluters to cough up.  Poland, Czechia, Slovakia, Romania, Greece, Hungary, Italy, Bulgaria, Austria and Croatia are urging the EU executive to reexamine the scheme by the end of May at the latest, arguing it harms their industries and is contributing to rising energy prices.  But not everyone agrees, with two EU officials from ETS-supporting countries saying the cap-and-trade system must remain in place. The first official argued it is not contributing to the energy crisis and is actually helping Europe’s economy, with its revenues needed for the green transition.   On the topic of energy, the Commission’s proposed gas price cap is also likely to be raised, though not all countries are likely to get on board with that either, according to a senior German government official. According to the draft conclusions, EU leaders will instruct the Commission to “present without delay a toolbox of targeted temporary measures” to bring down energy prices.  COMPETITIVENESS, ANYONE? EU VS. ITSELF Despite the crises crowding the agenda, leaders will still try to push forward plans to revive Europe’s economy, building on talks at a February summit at Alden Biesen in Belgium. Most of the proposals fall under the “One Europe, One Market” push to deepen the single market — easing the movement of goods, services, capital and people across the bloc. The draft conclusions say leaders will back new corporate rules, dubbed “EU Inc.,” to help startups scale across borders, as well as a “simple, unified and voluntary e-declaration system” to make it easier to work across countries. The aim is to move from talk to delivery, with concrete steps and deadlines, another EU diplomat said. But while there is broad agreement on the need for reform, divisions persist over whether EU energy and climate policies — particularly the Emissions Trading System — are holding back growth. That split, with Central, Eastern and Southern European countries pushing for changes and others, including the Nordics, resisting, will likely be the main battleground on competitiveness. Nick Vinocur contributed reporting.

EU leaders were supposed to be discussing how to make the economy stronger, but that will have to wait until after they have talked about how to unblock a €90 billion loan to Ukraine, as well as the situation in Iran and the resulting rise in energy prices. Scroll down for the latest updates.

The European liberal political family is urging EU leaders to form a pact with Japan, Canada, and South Korea to deter U.S. President Donald Trump and China from exerting undue pressure on trade partners, according to a paper seen by POLITICO. In what is dubbed a “Geoeconomic Deterrence Pact” addressed to EU leaders ahead of a summit in Brussels on Thursday, the liberal Renew Europe group in the European Parliament asks the Commission “to identify and negotiate joint export control agreements” by the end of 2026. The paper will be published late Wednesday and sent to EU leaders. “This pact will map shared critical dependencies (e.g., semiconductors, rare earths) and propose mutual response clauses in trade deals to deter coercion from the US or China. If one country is attacked by aggressive tariffs, all countries should react,” the paper reads. Renew Europe is home to French President Emmanuel Macron as well as the leaders of Estonia, Ireland, Slovenia and the Netherlands. The idea is the liberal group’s response to Canadian Prime Minister Mark Carney’s call for what he called “middle powers” to come together to “build something bigger, better, stronger, more just” during a speech at the World Economic Forum in Davos. “This is the task of the middle powers, the countries that have the most to lose from a world of fortresses and most to gain from genuine cooperation,” Carney said. Thursday’s summit was meant to discuss European ways to boost the bloc’s economy but that has been sidelined by the war in Iran driving up energy costs, and Hungarian Prime Minister Viktor Orbán continuing to veto a €90 billion EU loan for Ukraine.