The discussion surrounding the digital euro is strategically important to Europe. On Dec. 12, the EU finance ministers are aiming to agree on a general approach regarding the dossier. This sets out the European Council’s official position and thus represents a major political milestone for the European Council ahead of the trilogue negotiations. We want to be sure that, in this process, the project will be subject to critical analysis that is objective and nuanced and takes account of the long-term interests of Europe and its people. > We do not want the debate to fundamentally call the digital euro into question > but rather to refine the specific details in such a way that opportunities can > be seized. We regard the following points as particularly important: * maintaining European sovereignty at the customer interface; * avoiding a parallel infrastructure that inhibits innovation; and * safeguarding the stability of the financial markets by imposing clear holding limits. We do not want the debate to fundamentally call the digital euro into question but rather to refine the specific details in such a way that opportunities can be seized and, at the same time, risks can be avoided. Opportunities of the digital euro:  1. European resilience and sovereignty in payments processing: as a public-sector means of payment that is accepted across Europe, the digital euro can reduce reliance on non-European card systems and big-tech wallets, provided that a firmly European design is adopted and it is embedded in the existing structures of banks and savings banks and can thus be directly linked to customers’ existing accounts. 2. Supplement to cash and private-sector digital payments: as a central bank digital currency, the digital euro can offer an additional, state-backed payment option, especially when it is held in a digital wallet and can also be used for e-commerce use cases (a compromise proposed by the European Parliament’s main rapporteur for the digital euro, Fernando Navarrete). This would further strengthen people’s freedom of choice in the payment sphere. 3. Catalyst for innovation in the European market: if integrated into banking apps and designed in accordance with the compromises proposed by Navarrete (see point 2), the digital euro can promote innovation in retail payments, support new European payment ecosystems, and simplify cross-border payments. > The burden of investment and the risk resulting from introducing the digital > euro will be disproportionately borne by banks and savings banks. Risks of the current configuration: 1. Risk of creating a gateway for US providers: in the configuration currently planned, the digital euro provides US and other non-European tech and payment companies with access to the customer interface, customer data and payment infrastructure without any of the regulatory obligations and costs that only European providers face. This goes against the objective of digital sovereignty. 2. State parallel infrastructures weaken the market and innovation: the European Central Bank (ECB) is planning not just two new sets of infrastructure but also its own product for end customers (through an app). An administrative body has neither the market experience nor the customer access that banks and payment providers do. At the same time, the ECB is removing the tried-and-tested allocation of roles between the central bank and private sector. Furthermore, the Eurosystem’s digital euro project will tie up urgently required development capacity for many years and thereby further exacerbate Europe’s competitive disadvantage. The burden of investment and the risk resulting from introducing the digital euro will be disproportionately borne by banks and savings banks. In any case, the banks and savings banks have already developed a European market solution, Wero, which is currently coming onto the market. The digital euro needs to strengthen rather than weaken this European-led payment method. 3. Risks for financial stability and lending: without clear holding limits, there is a risk of uncontrolled transfers of deposits from banks and savings banks into holdings of digital euros. Deposits are the backbone of lending; large-scale outflows would weaken both the funding of the real economy – especially small and medium-sized enterprises – and the stability of the system. Holding limits must therefore be based on usual payment needs and be subject to binding regulations. -------------------------------------------------------------------------------- Disclaimer POLITICAL ADVERTISEMENT * The sponsor is Bundesverband der Deutschen Volksbanken und Raiffeisenbanken e.V. , Schellingstraße 4, 10785 Berlin, Germany * The ultimate controlling entity is Bundesverband der Deutschen Volksbanken und Raiffeisenbanken e.V. , Schellingstraße 4, 10785 Berlin, Germany More information here.

Iris Ferguson is a global adviser to Loom and a former U.S. deputy assistant secretary of defense for Arctic and global resilience. Ann Mettler is a distinguished visiting fellow at Columbia University’s Center on Global Energy Policy and a former director general of the European Commission. After much pressure, European leaders delayed a decision this week amid division on whether to tighten market access through a “Made in Europe” mandate and redouble efforts to reduce the bloc’s strategic dependencies — particularly on China. This decision may appear technocratic, but the hold-up signals its importance and reflects a larger strategic reality shared across the Atlantic. Security, industry and energy have all fused into a single race to control the systems that power modern economies and militaries. And increasingly, success will hinge on whether the U.S. and Europe can confront this reality together, starting with the one domain that’s shaping every other: energy. While traditional defense spending still grabs headlines, today’s battlefield is being reshaped just as profoundly by energy flows and critical inputs. Advanced batteries for drones, portable power for forward-deployed units and mineral supply chains for next-generation platforms — these all point to the simple truth that technological and operational superiority increasingly depends on who controls the next generation of energy systems. But as Europe and the U.S. look to maintain their edge, they must rethink not just how they produce and move energy, but how to secure the industrial base behind it. Energy sovereignty now sits at the center of our shared security, and in a world where adversaries can weaponize supply chains just as easily as airspace or sea lanes, the future will belong to those who build energy systems that are resilient and interoperable by design. The Pentagon already understands this. It has tested distributed power to shorten vulnerable fuel lines in war games across the Indo-Pacific; it has watched closely how mobile generation units keep the grid alive under Russian attack in Ukraine; and it is exploring ways to deliver energy without relying on exposed logistics via new research on solar power beaming. Each of these cases clearly demonstrates that strategic endurance now depends on energy agility and security. But currently, many of these systems depend on materials and manufacturing chains that are dominated by a strategic rival: From batteries and magnets to rare earth processing, China controls our critical inputs. This isn’t just an economic liability, it’s a national security vulnerability for both Europe and the U.S. We’re essentially building the infrastructure of the future with components that could be withheld, surveilled or compromised. That risk isn’t theoretical. China’s recent export controls on key minerals are already disrupting defense and energy manufacturers — a sharp reminder of how supply chain leverage can be a form of coercion, and of our reliance on a fragile ecosystem for the very technologies meant to make us more independent. So, how do we modernize our energy systems without deepening these unnecessary dependencies and build trusted interdependence among allies instead? The solution starts with a shift in mindset that must then translate into decisive policy action. Simply put, as a matter of urgency, energy and tech resilience must be treated as shared infrastructure, cutting across agencies, sectors and alliances. Defense procurement can be a catalyst here. For example, investing in dual-use technologies like advanced batteries, hardened micro-grids and distributed generation would serve both military needs and broader resilience. These aren’t just “green” tools — they’re strategic assets that improve mission effectiveness, while also insulating us from coercion. And done right, such investment can strengthen defense, accelerate innovation and also help drive down costs. Next, we need to build new coalitions for critical minerals, batteries, trusted manufacturing and cyber-secure infrastructure. Just as NATO was built for collective defense, we now need economic and technological alliances that ensure shared strategic autonomy. Both the upcoming White House initiative to strengthen the supply chain for artificial intelligence technology and the recently announced RESourceEU initiative to secure raw materials illustrate how partners are already beginning to rewire systems for resilience. Germany gave the bloc one such example by moving to reduce its reliance on Chinese-made wind components in favor of European suppliers. | Tan Kexing/Getty Images Finally, we must also address existing dependencies strategically and head-on. This means rethinking how and where we source key materials, including building out domestic and allied capacity in areas long neglected. Germany recently gave the bloc one such example by moving to reduce its reliance on Chinese-made wind components in favor of European suppliers. Moving forward, measures like this need EU-wide adoption. By contrast, in the U.S., strong bipartisan support for reducing reliance on China sits alongside proposals to halt domestic battery and renewable incentives, undercutting the very industries that enhance resilience and competitiveness. This is the crux of the matter. Ultimately, if Europe and the U.S. move in parallel rather than together, none of these efforts will succeed — and both will be strategically weaker as a result. The EU’s High Representative for Foreign Affairs and Security Policy Kaja Kallas recently warned that we must “act united” or risk being affected by Beijing’s actions — and she’s right. With a laser focus on interoperability and cost sharing, we could build systems that operate together in a shared market of close to 800 million people. The real challenge isn’t technological, it’s organizational. Whether it be Bretton Woods, NATO or the Marshall Plan, the West has strategically built together before, anchoring economic resilience with national defense. The difference today is that the lines between economic security, energy access and defense capability are fully blurred. Sustainable, agile energy is now part of deterrence, and long-term security depends on whether the U.S. and Europe can build energy systems that reinforce and secure one another. This is a generational opportunity for transatlantic alignment; a mutually reinforcing way to safeguard economic interests in the face of systemic competition. And to lead in this new era, we must design for it — together and intentionally. Or we risk forfeiting the very advantages our alliance was built to protect.

After more than three decades in the pharmaceutical industry, I know one thing: science transforms lives, but policy determines whether innovation thrives or stalls. That reality shapes outcomes for patients — and for Europe’s competitiveness. Today, Europeans stand at a defining moment. The choices we make now will determine whether Europe remains a global leader in life sciences or we watch that leadership slip away. It’s worth reminding ourselves of the true value of Europe’s life sciences industry and the power we have as a united bloc to protect it as a European good. Europe has an illustrious track record in medical discovery, from the first antibiotics to the discovery of DNA and today’s advanced biologics. Still today, our region remains an engine of medical breakthroughs, powered by an extraordinary ecosystem of innovators in the form of start-ups, small and medium-sized enterprises, academic labs, and university hospitals. This strength benefits patients through access to clinical trials and cutting-edge treatments. It also makes life sciences a strategic pillar of Europe’s economy. The economic stakes Life sciences is not just another industry for Europe. It’s a growth engine, a source of resilience and a driver of scientific sovereignty. The EU is already home to some of the world’s most talented scientists, thriving academic institutions and research clusters, and a social model built on universal access to healthcare. These assets are powerful, yet they only translate into future success if supported by a legislative environment that rewards innovation. > Life sciences is not just another industry for Europe. It’s a growth engine, a > source of resilience and a driver of scientific sovereignty. This is also an industry that supports 2.3 million jobs and contributes over €200 billion to the EU economy each year — more than any other sector. EU pharmaceutical research and development spending grew from €27.8 billion in 2010 to €46.2 billion in 2022, an average annual increase of 4.4 percent. A success story, yes — but one under pressure. While Europe debates, others act Over the past two decades, Europe has lost a quarter of its share of global investment to other regions. This year — for the first time — China overtook both the United States and Europe in the number of new molecules discovered. China has doubled its share of industry sponsored clinical trials, while Europe’s share has halved, leaving 60,000 European patients without the opportunity to participate in trials of the next generation of treatments. Why does this matter? Because every clinical trial site that moves elsewhere means a patient in Europe waits longer for the next treatment — and an ecosystem slowly loses competitiveness. Policy determines whether innovation can take root. The United States and Asia are streamlining regulation, accelerating approvals and attracting capital at unprecedented scale. While Europe debates these matters, others act. A world moving faster And now, global dynamics are shifting in unprecedented ways. The United States’ administration’s renewed push for a Most Favored Nation drug pricing policy — designed to tie domestic prices to the lowest paid in developed markets — combined with the potential removal of long-standing tariff exemptions for medicines exported from Europe, marks a historic turning point. A fundamental reordering of the pharmaceutical landscape is underway. The message is clear: innovation competitiveness is now a geopolitical priority. Europe must treat it as such. A once-in-a-generation reset The timing couldn’t be better. As we speak, Europe is rewriting the pharmaceutical legislation that will define the next 20 years of innovation. This is a rare opportunity, but only if reforms strengthen, rather than weaken, Europe’s ability to compete in life sciences. To lead globally, Europe must make choices and act decisively. A triple A framework — attract, accelerate, access — makes the priorities clear: * Attract global investment by ensuring strong intellectual property protection, predictable regulation and competitive incentives — the foundations of a world-class innovation ecosystem. * Accelerate the path from science to patients. Europe’s regulatory system must match the speed of scientific progress, ensuring that breakthroughs reach patients sooner. * Ensure equitable and timely access for all European patients. No innovation should remain inaccessible because of administrative delays or fragmented decision-making across 27 systems. These priorities reinforce each other, creating a virtuous cycle that strengthens competitiveness, improves health outcomes and drives sustainable growth. > Europe has everything required to shape the future of medicine: world-class > science, exceptional talent, a 500-million-strong market and one of the most > sophisticated pharmaceutical manufacturing bases in the world. Despite flat or declining public investment in new medicines across most member states over the past 20 years, the research-based pharmaceutical industry has stepped up, doubling its contributions to public pharmaceutical expenditure from 12 percent to 24 percent between 2018 and 2023. In effect, we have financed our own innovation. No other sector has done this at such scale. But this model is not sustainable. Pharmaceutical innovation must be treated not as a cost to contain, but as a strategic investment in Europe’s future. The choice before us Europe has everything required to shape the future of medicine: world-class science, exceptional talent, a 500-million-strong market and one of the most sophisticated pharmaceutical manufacturing bases in the world. What we need now is an ambition equal to those assets. If we choose innovation, we secure Europe’s jobs, research and competitiveness — and ensure European patients benefit first from the next generation of medical breakthroughs. A wrong call will be felt for decades. The next chapter for Europe is being written now. Let us choose the path that keeps Europe leading, competing and innovating: for our economies, our societies and, above all, our patients. Choose Europe. -------------------------------------------------------------------------------- Disclaimer POLITICAL ADVERTISEMENT * The sponsor is European Federation of Pharmaceutical Industries and Associations (EFPIA) * The ultimate controlling entity is European Federation of Pharmaceutical Industries and Associations (EFPIA) * The political advertisement is linked to the Critical Medicines Act. More information here.

When the Franco-German summit concluded in Berlin, Europe’s leaders issued a declaration with a clear ambition: strengthen Europe’s digital sovereignty in an open, collaborative way. European Commission President Ursula von der Leyen’s call for “Europe’s Independence Moment” captures the urgency, but independence isn’t declared — it’s designed. The pandemic exposed this truth. When Covid-19 struck, Europe initially scrambled for vaccines and facemasks, hampered by fragmented responses and overreliance on a few external suppliers. That vulnerability must never be repeated. True sovereignty rests on three pillars: diversity, resilience and autonomy. > True sovereignty rests on three pillars: diversity, resilience and autonomy. Diversity doesn’t mean pulling every factory back to Europe or building walls around markets. Many industries depend on expertise and resources beyond our borders. The answer is optionality, never putting all our eggs in one basket. Europe must enable choice and work with trusted partners to build capabilities. This risk-based approach ensures we’re not hostage to single suppliers or overexposed to nations that don’t share our values. Look at the energy crisis after Russia’s illegal invasion of Ukraine. Europe’s heavy reliance on Russian oil and gas left economies vulnerable. The solution wasn’t isolation, it was diversification: boosting domestic production from alternative energy sources while sourcing from multiple markets. Optionality is power. It lets Europe pivot when shocks hit, whether in energy, technology, or raw materials. Resilience is the art of prediction. Every system inevitably has vulnerabilities. The key is pre-empting, planning, testing and knowing how to recover quickly. Just as banks undergo stress tests, Europe needs similar rigor across physical and digital infrastructure. That also means promoting interoperability between networks, redundant connectivity links (including space and subsea cables), stockpiling critical components, and contingency plans. Resilience isn’t theoretical. It’s operational readiness. Finally, Europe must exercise authority through robust frameworks, such as authorization schemes, local licensing and governance rooted in EU law. The question is how and where to apply this control. On sensitive data, for example, sovereignty means ensuring it’s held in Europe under European jurisdiction, without replacing every underlying technology component. Sovereign solutions shouldn’t shut out global players. Instead, they should guarantee that critical decisions and compliance remain under European authority. Autonomy is empowerment, limiting external interference or denial of service while keeping systems secure and accountable. But let’s be clear: Europe cannot replicate world-leading technologies, platforms or critical components overnight. While we have the talent, innovation and leading industries, Europe has fallen significantly behind in a range of key emerging technologies. > While we have the talent, innovation and leading industries, Europe has fallen > significantly behind in a range of key emerging technologies. For example, building fully European alternatives in cloud and AI would take decades and billions of euros, and even then, we’d struggle to match Silicon Valley or Shenzhen. Worse, turning inward with protectionist policies would only weaken the foundations that we now seek to strengthen. “Old wines in new bottles” — import substitution, isolationism, picking winners — won’t deliver competitiveness or security. Contrast that with the much-debated US Inflation Reduction Act. Its incentives and subsidies were open to EU companies, provided they invest locally, develop local talent and build within the US market. It’s not about flags, it’s about pragmatism: attracting global investments, creating jobs and driving innovation-led growth. So what’s the practical path? Europe must embrace ‘sovereignty done right’, weaving diversity, resilience and autonomy into the fabric of its policies. That means risk-based safeguards, strategic partnerships and investment in European capabilities while staying open to global innovation. Trusted European operators can play a key role: managing encryption, access control and critical operations within EU jurisdiction, while enabling managed access to global technologies. To avoid ‘sovereignty washing’, eligibility should be based on rigorous, transparent assessments, not blanket bans. The Berlin summit’s new working group should start with a common EU-wide framework defining levels of data, operational and technological sovereignty. Providers claiming sovereign services can use this framework to transparently demonstrate which levels they meet. Europe’s sovereignty will not come from closing doors. Sovereignty done right will come from opening the right ones, on Europe’s terms. Independence should be dynamic, not defensive — empowering innovation, securing prosperity and protecting freedoms. > Europe’s sovereignty will not come from closing doors. Sovereignty done right > will come from opening the right ones, on Europe’s terms. That’s how Europe can build resilience, competitiveness and true strategic autonomy in a vibrant global digital ecosystem.

Europe’s security does not depend solely on our physical borders and their defense. It rests on something far less visible, and far more sensitive: the digital networks that keep our societies, economies and democracies functioning every second of the day. > Without resilient networks, the daily workings of Europe would grind to a > halt, and so too would any attempt to build meaningful defense readiness. A recent study by Copenhagen Economics confirms that telecom operators have become the first line of defense in Europe’s security architecture. Their networks power essential services ranging from emergency communications and cross-border healthcare to energy systems, financial markets, transport and, increasingly, Europe’s defense capabilities. Without resilient networks, the daily workings of Europe would grind to a halt, and so too would any attempt to build meaningful defense readiness. This reality forces us to confront an uncomfortable truth: Europe cannot build credible defense capabilities on top of an economically strained, structurally fragmented telecom sector. Yet this is precisely the risk today. A threat landscape outpacing Europe’s defenses The challenges facing Europe are evolving faster than our political and regulatory systems can respond. In 2023 alone, ENISA recorded 188 major incidents, causing 1.7 billion lost user-hours, the equivalent of taking entire cities offline. While operators have strengthened their systems and outage times fell by more than half in 2024 compared with the previous year, despite a growing number of incidents, the direction of travel remains clear: cyberattacks are more sophisticated, supply chains more vulnerable and climate-related physical disruptions more frequent. Hybrid threats increasingly target civilian digital infrastructure as a way to weaken states. Telecom networks, once considered as technical utilities, have become a strategic asset essential to Europe’s stability. > Europe cannot deploy cross-border defense capabilities without resilient, > pan-European digital infrastructure. Nor can it guarantee NATO > interoperability with 27 national markets, divergent rules and dozens of > sub-scale operators unable to invest at continental scale. Our allies recognize this. NATO recently encouraged members to spend up to 1.5 percent of their GDP on protecting critical infrastructure. Secretary General Mark Rutte also urged investment in cyber defense, AI, and cloud technologies, highlighting the military benefits of cloud scalability and edge computing – all of which rely on high-quality, resilient networks. This is a clear political signal that telecom security is not merely an operational matter but a geopolitical priority. The link between telecoms and defense is deeper than many realize. As also explained in the recent Arel report, Much More than a Network, modern defense capabilities rely largely on civilian telecom networks. Strong fiber backbones, advanced 5G and future 6G systems, resilient cloud and edge computing, satellite connectivity, and data centers form the nervous system of military logistics, intelligence and surveillance. Europe cannot deploy cross-border defense capabilities without resilient, pan-European digital infrastructure. Nor can it guarantee NATO interoperability with 27 national markets, divergent rules and dozens of sub-scale operators unable to invest at continental scale. Fragmentation has become one of Europe’s greatest strategic vulnerabilities. The reform Europe needs: An investment boost for digital networks At the same time, Europe expects networks to become more resilient, more redundant, less dependent on foreign technology and more capable of supporting defense-grade applications. Security and resilience are not side tasks for telecom operators, they are baked into everything they do. From procurement and infrastructure design to daily operations, operators treat these efforts as core principles shaping how networks are built, run and protected. Therefore, as the Copenhagen Economics study shows, the level of protection Europe now requires will demand substantial additional capital. > It is unrealistic to expect world-class, defense-ready infrastructure to > emerge from a model that has become structurally unsustainable. This is the right ambition, but the economic model underpinning the sector does not match these expectations. Due to fragmentation and over-regulation, Europe’s telecom market invests less per capita than global peers, generates roughly half the return on capital of operators in the United States and faces rising costs linked to expanding security obligations. It is unrealistic to expect world-class, defense-ready infrastructure to emerge from a model that has become structurally unsustainable. A shift in policy priorities is therefore essential. Europe must place investment in security and resilience at the center of its political agenda. Policy must allow this reality to be reflected in merger assessments, reduce overlapping security rules and provide public support where the public interest exceeds commercial considerations. This is not state aid; it is strategic social responsibility. Completing the single market for telecommunications is central to this agenda. A fragmented market cannot produce the secure, interoperable, large-scale solutions required for modern defense. The Digital Networks Act must simplify and harmonize rules across the EU, supported by a streamlined governance that distinguishes between domestic matters and cross-border strategic issues. Spectrum policy must also move beyond national silos, allowing Europe to avoid conflicts with NATO over key bands and enabling coherent next-generation deployments. Telecom policy nowadays is also defense policy. When we measure investment gaps in digital network deployment, we still tend to measure simple access to 5G and fiber. However, we should start considering that — if security, resilience and defense-readiness are to be taken into account — the investment gap is much higher that the €200 billion already estimated by the European Commission. Europe’s strategic choice The momentum for stronger European defense is real — but momentum fades if it is not seized. If Europe fails to modernize and secure its telecom infrastructure now, it risks entering the next decade with a weakened industrial base, chronic underinvestment, dependence on non-EU technologies and networks unable to support advanced defense applications. In that scenario, Europe’s democratic resilience would erode in parallel with its economic competitiveness, leaving the continent more exposed to geopolitical pressure and technological dependency. > If Europe fails to modernize and secure its telecom infrastructure now, it > risks entering the next decade with a weakened industrial base, chronic > underinvestment, dependence on non-EU technologies and networks unable to > support advanced defense applications. Europe still has time to change course and put telecoms at the center of its agenda — not as a technical afterthought, but as a core pillar of its defense strategy. The time for incremental steps has passed. Europe must choose to build the network foundations of its security now or accept that its strategic ambitions will remain permanently out of reach. -------------------------------------------------------------------------------- Disclaimer POLITICAL ADVERTISEMENT * The sponsor is Connect Europe AISBL * The ultimate controlling entity is Connect Europe AISBL * The political advertisement is linked to advocacy on EU digital, telecom and industrial policy, including initiatives such as the Digital Networks Act, Digital Omnibus, and connectivity, cybersecurity, and defence frameworks aimed at strengthening Europe’s digital competitiveness. More information here.

The European Space Agency’s members approved a record €22.1 billion three-year budget and widened its mandate to include security and defense — a big change for an organization that had been dedicated “exclusively” to the peaceful use of space. “ESA’s intergovernmental framework provides the credentials and tools for developing space technologies and systems … for security and defence,” read the resolution adopted this week by the organization’s 23 members, according to a slide shared with reporters Thursday The ESA called the move a “historic change.” The war in Ukraine has shown the importance of space assets, both for intelligence gathering and secure communications. Europe is also looking to cut its reliance on U.S. companies, including Elon Musk’s SpaceX. In one example of the shift, the ESA’s new dual-use Earth observation project dubbed the European Resilience from Space, could have both civilian and military applications. Poland played a leading role in pushing for the ESA to be more involved in defense, the agency’s Director General  Josef Aschbacher told reporters. Warsaw and the organization are currently discussing setting up a new ESA centre in Poland that would focus on security. The budget includes €3.4 billion for Earth observation, €2.1 billion for secure communications and €900 million to develop European rocket launchers. That’s a significant increase compared to the previous budget of nearly €17 billion. “This is amazing,” Aschbacher said of the larger budget. Germany is the lead contributor, at about €5 billion, with France and Italy following at more than €3 billion each.

BRUSSELS — European Parliament members this week rubbished the EU executive’s Democracy Shield plan, an initiative aimed at bolstering the bloc’s defenses against Russian sabotage, election meddling and cyber and disinformation campaigns. The Commission’s plan “feels more like a European neighborhood watch group chat,” Kim van Sparrentak, a Dutch member of the Greens group, told a committee meeting on Monday evening. On Tuesday, EU Justice Commissioner Michael McGrath faced the brunt of that censure before the full Parliament plenary, as centrist and left-leaning lawmakers panned the plan for its weaknesses and far-right members warned that Brussels is rolling out a propaganda machine of its own. “We want to see more reform, more drive and more actions,” Swedish center-right lawmaker Tomas Tobé, who leads the Parliament’s report on the matter, told McGrath. The European Democracy Shield was unveiled Nov. 12 as a response to Russia’s escalating meddling in the bloc. In past months, Europe has been awash in hybrid threats. Security services linked railway disruptions in Poland and the Baltics to Russian-linked saboteurs, while unexplained drone flyovers have crippled public services in Belgium and probed critical infrastructure sites across the Nordics. At the same time, pro-Kremlin influence campaigns have promoted deepfake videos and fabricated scandals and divisive narratives ahead of elections in Moldova, Slovakia and across the EU, often using local intermediaries to mask their origins.   Together these tactics inform a pressure campaign that European security officials say is designed to exhaust institutions, undermine trust and stretch Europe’s defenses.  The Democracy Shield was a key pledge President Ursula von der Leyen made last year. But the actual strategy presented this month lacks teeth and concrete actions, and badly fails to meet the challenge, opponents said. While “full of new ways to exchange information,” the strategy presents “no other truly new or effective proposals to actually take action,” said van Sparrentak, the Dutch Greens lawmaker.  EU RESPONSE A WORK IN PROGRESS Much of the Shield’s text consists of calls to support existing initiatives or proposed new ones to come later down the line.   One of the pillars of the initiative, a Democratic Resilience Center that would pool information on hybrid warfare and interference, was announced by von der Leyen in September but became a major sticking point during the drafting of the Shield before its Nov. 12 unveiling.  The final proposal for the Center lacks teeth, critics said. Instead of an independent agency, as the Parliament had wanted, it will be a forum for exchanging information, two Commission officials told POLITICO.  The Center needs “a clear legal basis” and should be “independent” with “proper funding,” Tobé said Tuesday.   Austrian liberal Helmut Brandstätter said in a comment to POLITICO that “some aspects of the center are already embedded in the EEAS [the EU’s diplomatic service] and other institutions. Instead of duplicating them, we should strive to consolidate and streamline our tools.” EU countries also have to opt into participating in the center, creating a risk that national authorities neglect its work.  RIGHT BLASTS EU ‘CENSORSHIP’  For right-wing and far-right forces, the Shield reflects what they see as EU censorship and meddling by Brussels in European national politics.   “The stated goals of the Democracy Shield look good on paper but we all know that behind these noble goals, what you actually want is to build a political machinery without an electoral mandate,” said Csaba Dömötör, a Hungarian MEP from the far-right Patriots group.   “You cannot appropriate the powers and competence of sovereign countries and create a tool which is going to allow you to have an influence on the decisions of elections” in individual EU countries, said Polish hard-right MEP Beata Szydło.   Those arguments echo some of the criticisms by the United States’ MAGA movement of European social media regulation, which figures like Vice President JD Vance have previously compared to Soviet-era censorship laws.  The Democracy Shield strategy includes attempts to support European media organizations and fact-checking to stem the flood of disinformation around political issues. Romanian right-wing MEP Claudiu-Richard Târziu said her country’s 2024 presidential elections had been cancelled due to “an alleged foreign intervention” that remained unproven.  “This Democracy Shield should not create a mechanism whereby other member states could go through what Romania experienced in 2024 — this is an attack against democracy — and eventually the voters will have zero confidence,” he said.  In a closing statement on Tuesday at the plenary, Commissioner McGrath defended the Democracy Shield from its hard-right critics but did not respond to more specific criticisms of the proposal.  “To those who question the Shield and who say it’s about censorship. What I say to you is that I and my colleagues in the European Commission will be the very first people to defend your right to level robust debate in a public forum,” he said.

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

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

BELÉM, Brazil — A group of countries is calling for a U.N. agreement to triple the amount of money for preventing the impacts of a hotter planet, as climate pollution keeps rising and funding for adaptation falls further behind. The move to increase adaptation funding to $120 billion annually at the COP30 climate talks comes as wealthy nations have cut back international aid and as President Donald Trump moves to withdraw the U.S. from the Paris Agreement, hampering global efforts to inject additional funding into climate actions. Even before Trump took office, nations worldwide had a spotty record of meeting their financial commitments to lower pollution and offer interest-free funding for protective infrastructure, agriculture and ecosystems. “Adaptation must move from vague aspirations to concrete action. It requires strong targets backed by finance, technology transfer and capacity building,” Sierra Leone’s climate and environment minister, Jiwoh Abdulai, told U.N. officials Monday. Sierra Leone is among a group of least-developed countries, small island states and African nations that is trying to boost funding for projects that can protect people, property and crops from storms, drought and extreme heat. They’re also working to agree on a set of metrics that measure the effectiveness of adaptation funding — something that’s been used to promote money for reducing climate pollution for years. Negotiators and officials say adaptation funding is more important as temperatures risk breaching the 1.5-degree-Celsius limit — the most ambitious aim of the Paris Agreement. The call for tripling adaptation money would build on a 2021 commitment by wealthy countries to provide poorer nations with $40 billion in adaptation funding by 2025. A recent United Nations report predicted that goal would not be met. It found that $26 billion in adaptation funding flowed to countries in 2023, a fraction of the $310 billion that the U.N. estimates countries will need each year by 2035. The move unfolding at COP30 comes a year after countries agreed to a vague commitment to boost climate finance from $100 billion to $300 billion annually by 2035 — for reducing pollution and increasing adaptation. Countries say it needs to be clear how much money would go toward adaptation and whether it will be offered as grants or loans, reflecting their concern about mounting debt. Much of the interest-free funding they say they need is expected to flow through multilateral development banks and climate-focused institutions like the Green Climate Fund. “Without an outcome that doesn’t just give us indicators — it also gives us money — everything we’re discussing here is symbolic. We will go back home and nothing tomorrow will change,” said Lina Yassin, an adaptation negotiator from Sudan who’s working with the least-developed country group. Jennifer Morgan, Germany’s former climate envoy, said it is legitimate for the poorest, most vulnerable countries to ask for an agreement on the next round of adaptation funding as the previous goal expires. The challenge will be getting donor countries on board. “It’s really important, especially now, that countries like Japan, Australia, Canada, but also those that are able to do so [contribute],” Morgan said. “It’s about the wealthy Arab nations. It’s about, will China contribute as well?” Finding donors is just one challenge. Another is ensuring that vulnerable countries can access the money quickly. Many have had to wait years for funding under current processes. They’re also pushing for changes to ensure poorer nations aren’t saddled with additional debt. U.K. Energy Secretary Ed Miliband drew attention to those challenges earlier this week. “If we are serious about supporting climate action, serious about supporting adaptation and resilience, the quantums matter, but also quality matters, access matters, the funds actually flowing matters,” he said during a renewable energy event in Belém. For years, vulnerable countries warned they would need to adapt to climate dangers as global efforts to reduce warming pollution failed to gain traction. Now those dangers are here, they say, and more adaptation funding is needed. They’re pushing for less paperwork and fewer reporting requirements, as well as faster, more efficient procedures to approve funding requests. Evans Njewa from Malawi, who chairs the 44-member Least Developed Country Group said countries have already agreed to provide adaptation money. Now they need to deliver. “If you need the resources now, you shouldn’t go through so much paperwork, procedures,” he said. Karl Mathiesen contributed to this report.