An estimated one-third of people in the European Union will be over the age of 65 by 2050 . Add in lifestyle risk factors and socio-economic differences, and it is clear Europe needs to act fast to upgrade its health systems to improve life for patients. To achieve this, Europe needs to improve the global competitiveness of its regulatory framework in order to get medical innovation to patients faster. Europe should be commended for the speed, transparency and efficiency of its regulators in responding to the Covid-19 pandemic. However, these efficiencies have not endured. The European regulatory system takes about 120 days longer than regulatory systems in the United States and Japan.[1] Such delays, combined with complex 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. The data means large numbers of Europeans living with cancer, cardiovascular conditions and other difficult-to-treat conditions may be missing out on medicines that could help them.  Furthermore, they have far less opportunities to access much-needed care. Alzheimer’s disease — a progressive, fatal condition — is just the latest example. After more than three decades of dedicated research investment, two new breakthrough treatments were recently approved in a number of countries, including the United States, Japan and China, the first that can delay the progression of early symptomatic Alzheimer’s disease. This makes it possible for patients to have more time to live independently, relieving some of the tremendous financial and emotional burden on families and caregivers. These new medicines have comparable efficacy, safety and costs to other biologic medicines already approved for cancer and autoimmune conditions. > The millions of people across Europe are suffering from this relentless and > fatal disease and will have to keep waiting. Yet in Europe there is little evidence that these breakthrough medicines are even available. European regulators have been reviewing one of these medicines for a staggering 26 months — and market authorization is still pending. In sharp contrast, regulators in Japan completed their review in eight months, and China and the United States each took about 13 months to issue full marketing approval for the same medicine. In the case of a second medicine, made by my company, Lilly, after 20 months from submission the scientific committee of the European Medicines Agency (EMA) recommended against approving it at all — even though regulators in 10 other countries already have. The millions of people across Europe are suffering from this relentless and fatal disease and will have to keep waiting. These delays undermine the European Commission’s goal to improve Europe’s competitiveness. Europe is at a crossroads on whether it can deliver on the recommendations of the Commission’s Draghi report, which calls out the “slow and complex EU regulatory framework” as one of the factors underpinning the EU’s competitive gap. The pharmaceutical industry spends more than four times as much on research and development in the United States than in Europe, despite our much larger population.[2] Europe’s fragmented system for clinical trial approvals has also cut the region’s share of clinical trials by nearly half over the past decade, depriving at least 60,000 Europeans of the opportunity to benefit from groundbreaking clinical studies.[3] One way to change this is to expand the use of expedited approval pathways for new medicines. In 2023, only 3 percent of reviews by the EMA used an expedited pathway, compared with 62 percent in the United States and 33 percent in Japan. > Europe is at a crossroads on whether it can deliver on the recommendations of > the Commission’s Draghi report, which calls out the “slow and complex EU > regulatory framework” as one of the factors underpinning the EU’s competitive > gap. The voice of patients is also woefully missing from the regulatory process, which needs to introduce additional ways to incorporate their perspectives in weighing benefits and risks. When medicines show clinically meaningful effects and have well-characterized, manageable and monitorable safety profiles, EU regulators should enable physicians and patients to decide whether these medicines are the right choice for them. If EU policymakers desire to encourage more companies to invest in Europe, they need a modernized regulatory framework with sufficient resources to deliver approvals for clinical trials and new medicines at pace and on a consistent scientific basis with regulators in the United States and Asia. Europe can either strengthen its competitiveness by creating a regulatory environment that improves patient access to innovative treatments for diseases like Alzheimer’s or it can continue to see declining investment in the health of its citizens. Which path will EU leaders choose? -------------------------------------------------------------------------------- [1] Centre for Innovation in Regulatory Science (2024) R&D Briefing 93: New drug approvals in six major authorities 2014-2023: Changing regulatory landscape and facilitated regulatory pathways. Centre for Innovation in Regulatory Science (CIRS), London, UK: https://cirsci.org/wp-content/uploads/dlm_uploads/2024/07/CIRS-RD-Briefing-93-six-agency-briefing-v2.0.pdf. [2] Organisation for Economic Co-operation and Development, Figure 10.12 in “Health at a Glance 2019: OECD Indicators”: https://www.oecd-ilibrary.org/docserver/4dd50c09-en.pdf?expires=1598376941&id=id&accname=guest&checksum=ACAEE105A158161FA44800557714694B. [3] IQVIA, Assessing the clinical trial ecosystem in Europe, Final Report, October 2024: efpia_ve_iqvia_assessing-the-clinical-trial-ct-ecosystem.pdf.

BRUSSELS — The vast majority of businesses in the European Union would no longer have to disclose their impact on the environment or exposure to the risks of climate change under a proposed bill that significantly winds back the scope of key EU green laws. The European Commission announced Wednesday it wants to exempt 80 percent of companies from its mandatory sustainability disclosure requirements as part of its eagerly anticipated omnibus simplification package. The first of a planned series of red tape-slashing laws, the bill proposes to amend four key rules from the European Green Deal: The corporate sustainability reporting directive (CSRD), the corporate sustainability due diligence directive (CSDDD), the EU taxonomy on sustainable investments and the carbon border tax. Under the proposed changes, implementation of the CSRD will be delayed by two years and only companies with more than 1,000 employees and either at least €50 million in turnover or a balance sheet of more than €25 million would have to report. That would slash the number of businesses affected by the law from 50,000 to around 10,000, said one EU official on condition of anonymity because they were not authorized to speak publicly. An earlier leaked draft, obtained by POLITICO, had put the turnover threshold higher, at €450 million. However, companies will still have to report on both their exposure to climate risk and the effects of their activities on the environment — a concept known as double materiality that is a core part of the CSRD and a paradigm-shifting approach to green reporting. An earlier draft had removed double materiality, according to three people briefed on the matter. The bill proposes reducing by half the number of data points companies must collect, and dropping sector-specific reporting standards due in 2026. The proposal also significantly waters down the CSDDD, which holds companies accountable for human right violations and environmental damage in their supply chains. The changes would require companies to only look at direct suppliers. The law’s implementation would be postponed until negotiations are completed. Under the changes, the frequency with which companies are expected to monitor suppliers would be reduced to once every five years, down from annually. The bill also proposes making the taxonomy voluntary for up to 85 percent of companies — meaning they would not have to report on whether they are aligned with the EU’s list of economic activities considered green. Finally, the bill suggests changing the Carbon Border Adjustment Mechanism (CBAM) to exempt roughly 90 percent of importers of goods covered by the tax, which it says are only responsible for about 1 percent of imported emissions. The Commission is not suggesting delaying its implementation, however. The Commission said the changes would save businesses “around €6.3 billion” in administrative costs and “mobilize additional public and private investment capacity of €50 billion.” ‘DISGRACEFUL‘ The announcement immediately drew criticism from members of the European Parliament and green groups. “Today is a contradictory day for European climate action,” said Pascal Canfin, a French MEP with centrist group Renew. While the Clean Industrial Deal, announced earlier Wednesday, affirms green goals, he said the omnibus package “weakens certain foundations of the Green Deal.” “While we managed to preserve double materiality in the CSRD, the drastic reduction of its scope weakens our ability to attract transition capital,” he said, adding that the CSDDD change “looks like massive deregulation.” Beate Beller, a campaigner at Global Witness, said: “Commission President von der Leyen’s attack on her own sustainability agenda is disgraceful.” But Commissioner for Financial Services Maria Luís Albuquerque rejected suggestions the bill amounted to deregulation, saying at a press conference: “This does not mean that 80 percent of companies will no longer report, it just means they won’t have to — which is a substantial difference.” She said some elements of green reporting rules had “proven to be too burdensome and in some cases disproportionate.” Valdis Dombrovskis, the commissioner for simplification, added the EU executive had “been very clear that our simplification agenda is not deregulation, and we are not changing our Green Deal goals and targets.” He said the bill would help deliver the aims of the European Green Deal “in a more efficient and less costly way.” The bill must be approved by the European Parliament and the Council of the EU before it becomes law. Leonie Cater and James Fernyhough contributed to reporting. This article has been updated with additional details and quotes.

The European Commission’s Competitiveness Compass plots a course — or a “growth strategy,” according to Commission President Ursula von der Leyen — for policymakers to follow over the next five years It’s a dense 27-page document crammed with recommendations to get the European Union’s economy going. We’ve boiled down the main points and explained where they’re heading. CUTTING RED TAPE Von der Leyen told reporters she’d had a “very clear signal from the European business sector that there is too much complexity” in EU regulation, much of it stemming from new climate-related laws. A move to simplify legislation for sustainable finance, due diligence and taxonomy rules — the “omnibus package” — will be the first of several, she said, promising these will ultimately save companies €37 billion a year by 2029.  The plans have alarmed climate campaigners and others that Brussels’ new deregulation agenda might prioritize innovation and growth over the environment and echo conservative demands, including a mention of allowing e-fuels to keep combustion engine cars alive, and the “simplification” of a carbon border tax. STAYING THE CLIMATE COURSE Von der Leyen insisted that the European Union was “staying the course on the objectives of the European Green Deal” and that climate targets wouldn’t change. The Commission even rearranged some paragraphs while drafting the Compass to emphasize innovation and decarbonization. The green transition of traditional industry and the expansion of new, climate-friendly technologies are at the heart of the Competitiveness Compass. More detailed measures on how to achieve that are expected in next month’s Clean Industrial Deal, due Feb. 26. The Commission will, as expected, also focus on “resource efficiency and boosting circular use of materials” — signaling that niche sustainability topics like recycling and eco-design are highly strategic. We knew the Circular Economy Act would not land before 2026, and the Compass confirms the Commission’s plans for the last quarter of that year. CARS VS. CLIMATE TARGETS Bowing to carmakers’ pleas for leniency over looming fines for failing to hit new emissions targets, the document promises “immediate solutions to safeguard the industry’s capacity to invest, by looking at possible flexibilities.” What that means will be negotiated during a strategic dialogue with the automotive industry that kicks off Thursday. Car lobby ACEA estimates that the industry will pay €15 billion in fines if the Commission doesn’t act. Industry Commissioner Stéphane Séjourné pushed for the language to be included over the objections of Climate Commissioner Wopke Hoekstra, said an EU official privy to the discussions and granted anonymity because they are not authorized to comment. ENERGY PRICES European companies pay significantly more for electricity and gas than do their U.S. and Chinese counterparts. That’s a problem, and von der Leyen is keen to fix it.  Her plan, in short, is to invest in more grids and connect them up, and also change how contacts are made and fees are charged. That costs money — and so far there isn’t much of that. The EU also can’t wave a wand and make some of its other preferred reforms happen overnight. Still, the ambition is there, which has encouraged energy and industrial lobby groups. But the vital details are still to come: For starters, an Affordable Energy Action Plan is due at the end of February. MAKING BREAKTHROUGHS Von der Leyen said improving competitiveness means “that we really have to focus more on breakthrough innovation and breakthrough technologies.” She promises a startup and scaleup strategy as well as a “broad AI strategy for our continent.” U.S. President Donald Trump’s $500 billion artificial intelligence infrastructure plan and the emergence of a cut-price AI model, China’s DeepSeek, show that the global AI race is on. The EU wants to get in the game and needs computing power, cloud infrastructure and access to data, the document said. The Commission has already doled out funding for AI factories and AI-optimized supercomputers. It plans to follow that up with a cloud and AI development plan to enable the training of very large AI models, a plan expected late this year or early next. It will separately try to address the feeble adoption of AI by companies (only 13 percent of businesses are using the tech so far). An Apply AI strategy due later this year aims to fix that. Taking action means lots of tech action plans, with von der Leyen promising strategies for advanced materials, quantum, biotech, robotics and space technologies, all “components of the markets of the future.” WHERE’S THE MONEY? The EU plans to make it easier for businesses to access private funding by making progress on the long-discussed but never-completed capital markets union, now rebranded as the Savings and Investment Union. In concrete terms, that means the EU investment programs will be wider and the European Investment Bank will be asked to offer more public guarantees, loans and even investments in equities, starting with a new fund to help companies buy growing businesses or to support their going public. The EU’s executive is also working on a 28th business code that offers an alternative to fragmented national systems and will cover “aspects of corporate law, insolvency, labor, and tax law.” While the Compass promotes better coordination of national government investments, it lacks a clear plan on other common sources of money. It does, however, pave a way for countries to repurpose regional funds — often used to build schools and bridges — for critical technologies. This is only a taster of what’s to come. Von der Leyen supported linking public funding under the next budget from 2028-2034 to implement key economic reforms that will make countries more competitive. BUY EUROPEAN Governments could favor Made-in-Europe goods via planned public procurement reforms, potentially a powerful boost for local companies and an irritant for trading partners since such tenders account for 14 percent of the EU’s gross domestic product. Like the carbon border tax or deforestation regulation, it may amount to protectionism in all but name. The EU executive also plans to set up an industry platform for buying strategic raw materials. The bloc is dependent on imports of scarce minerals such as the lithium used in electric vehicle batteries — where industry leader China dominates both supply and processing. GETTING STRATEGIC ABOUT INDUSTRY Competition policy is “an important lever,” the compass said, pitching a review of merger guidelines to take account of innovation and “investment intensity” in strategic sectors.  The steel and metal industry will get an action plan this spring that will cover investment, inputs and the use of trade defense measures against cheap imports. The chemicals industry will get a similar plan near the end of the year. A Competitiveness Coordination Tool aims to knock some EU government heads together and funnel money to joint industrial goals, building on the Important Projects of Common European Interest that have funded hydrogen, battery and semiconductor projects. TRAINS AND SHIPS A High-Speed Rail Plan will arrive this year to “strengthen EU cross-border rail connectivity,” the final document said. It also plans a European Port Strategy this year along with an Industrial Maritime Strategy. Aviation doesn’t get a mention, but attention will likely focus on a Sustainable Transport Investment Plan, due in the third quarter, which is expected to stimulate investment in sustainable aviation fuels along with other low-carbon transport fuels. HEALTH The European Biotech Act will provide a forward-looking framework “conducive to innovation” in clinical trials, the document said, ditching a suggestion in earlier drafts of a more radical reworking of clinical trial regulations. The Life Sciences strategy has been penciled in for the second quarter and a Critical Medicines Act will drop by mid-March. The new draft also mentions short-term measures to simplify rules on medical devices. RAMPING UP DEFENSE Since the war in Ukraine started, Brussels and EU capitals have urged defense contractors to ramp up production, but companies have complained that the current rules and regulations are too burdensome and that finding financing is too difficult. The broader simplification push may help them. One of their key asks of Brussels is to “defense-optimize horizontal instruments,” as the  Aerospace, Security and Defence Industries Association of Europe put it last year. Defense companies are now likely to start lobbying the EU executive to ensure their sector is at least taken into account, if not prioritized in future proposals. NO GAME CHANGE FOR FARMING Tucked into the fine print of the Compass are a few modest nods to farming — because it’s hardly Europe’s next economic rocket. The strategy gestures at fostering agricultural entrepreneurship and linking farming to the bioeconomy. But let’s be real — no one expects farmers to start churning out unicorn startups. Still, the Commission wants to squeeze out more efficiency and ease the administrative burden on both farmers and regulators. A Vision for Agriculture and Food lands on Feb. 19, promising sustainability and resilience. The EU also aims to cut red tape and push circular economy principles. But will it bring real change? Expect consultations, strategies, and tweaks — but not so much game-changing shifts. Marianne Gros, Zia Weise, Gabriel Gavin, Pieter Haeck, Giovanna Faggionato, Gregorio Sorgi, Kathryn Carlson, Douglas Busvine, Jordyn Dahl, Tommaso Lecca, Aoife White, Rory O’Neill, Laura Kayali, Bartosz Brzeziński, Aude van den Hove, Francesca Micheletti, Giovanna Coi and Hanne Cokelaere contributed to this report.