Tag - Biotechnology

How the EU’s stack of health files was a big win for industry
Faced with an ageing population and rising chronic disease rates, Europe wants to make its citizens healthier. It also needs to keep its most powerful industries happy. In the basket of health policies that EU lawmakers rushed to get across the line before Christmas, industry was the big winner: The pharmaceutical, food and drink sectors walked away with a set of major policy wins — and (potentially) healthier profits. While the pharma industry previously feared losing some of its monopoly rights on new drugs, the Commission this month offered it an extra year of patent protection for novel biotech drugs — among the most expensive treatments in the world. The food and drink sectors, meanwhile, successfully pushed back against proposals to tax ultra-processed foods and alcopops, for now. On Dec. 16 the Commission published its Biotech Act and Safe Hearts Plan, which landed just days after a long-awaited update of the pharmaceutical legislation. Taken together, they seek to incentivize industries to innovate and do business in Europe, improve access to medicines, and tackle the burden of cardiovascular disease. The pharma industry broadly celebrated the biotech proposal. The Biotech Act “reflects priorities we’ve intensively advocated to keep Europe globally competitive in life sciences,” Ognjenka Manojlovic, head of policy at European pharmaceutical company Sanofi, told POLITICO. That includes accelerating clinical trials, boosting intellectual property, and strengthening financing for Europe’s biotech ecosystem, Manojlovic said. The pharmaceutical sector had pushed for longer monopoly rights in the pharma legislation. In the end they were kept at the current standard eight years — instead of being cut by two years as the European Commission had initially proposed. For Europe’s public health insurers, who pay for drugs, the decisions taken to maintain and then extend market protections for medicines are hard to square. “We are puzzled by the Commission’s intentions,” said Yannis Natsis, director of the European Social Insurance Platform, a network of Europe’s social insurance organizations, warning that taxpayers will have to pick up the bill. Meanwhile, health campaigners are also unhappy at the Commission’s “missed opportunity” to tackle obesity and heart disease with junk food taxes — as proposed in an earlier draft of the Safe Hearts Plan. Samuele Tonello, at consumer organization BEUC, said the Safe Hearts Plan “lacks teeth” to better protect consumers from unhealthy foods, and flagged the “urgency of [cardiovascular diseases].”  A MAN ON A MISSION Health Commissioner Olivér Várhelyi has made no secret of his support for industry, and has championed the Commission’s competitiveness mantra since taking office in late 2024. Health Commissioner Olivér Várhelyi has made no secret of his support for industry, and has championed the Commission’s competitiveness mantra since taking office in late 2024. | Thierry Monasse/Getty Images The standout feature of his end-of-year bonanza was the 12-month patent extension in the Biotech Act I — legislation that was split in two late in the day, allowing Várhelyi to meet his end-of-year deadline for the pharma component. The proposal came just a week after the Commission, countries and MEPs clinched a deal to reform Europe’s pharmaceutical laws, in which IP rights were among the last issues to be settled. Updates to the pharma laws were a legacy of the last Commission, whereas the Biotech Act became something of a personal mission for Várhelyi. He repeatedly stressed that there was “no time to lose” in delivering a targeted policy aimed at revitalizing Europe’s flagging biotech industry, which risks being overtaken by competition from China and the U.S. Few commissioners are more vocal than Várhelyi about the premium they place on the competitiveness of European industry.  Industry insiders had heard whispers of his plans to expand IP incentives for the biotech sector, even if Council representatives were dismayed not to have been informed in advance — especially with the ink barely dry on the Pharma Package. That’s not to say pharma is happy with its lot. Industry lobby group the European Federation of Pharmaceutical Industries and Associations (EFPIA) tempered its praise of the Biotech Act, lamenting that the extra year of monopoly rights would only apply to a “limited subset of products.”  The extra year of protection is tied to the Commission’s efforts to locate more pharma research and manufacturing in Europe. It would apply only to new products, tested and at least partially made in Europe.  But the generics sector, which makes cheaper, off-patent drugs to compete with branded medicines, sees the Biotech Act as a further sweetening of what is already one of the world’s most generous IP systems. Lobby group Medicines for Europe claims each year of delayed competition for the top three biologic drugs would cost countries €7.7 billion. Longer IP “will have a dramatic impact on healthcare budgets and delayed patients’ access to essential medicines,” said Adrian van den Hoven, head of the lobby. These kinds of estimates would normally be included in an impact assessment published alongside the proposal, but in its haste to get the Biotech Act out the Commission didn’t do one. POLITICO asked the Commission for an estimate of what the extra year of patent protection would cost. A Commission spokesperson would not give a figure but said they had used the impact assessment for the pharma legislation as a reference. “It is also important to stress that the number of products eligible for an additional year of SPC will be limited to only those that are truly innovative and tested and manufactured in the EU. The approach is deliberately targeted to incentivise genuinely innovative therapies that deliver a clear added value for patients and support European innovation,” the spokesperson said. LUCKY ESCAPE FOR UPFS The big food and drink sectors are on shakier ground with Várhelyi. The commissioner has repeatedly made known his distaste for ultra-processed food, and an early leaked version of the Safe Hearts Plan included new taxes on unhealthy highly processed foods and alcopops. But the final proposal showed the Commission had undertaken a significant climbdown. Concrete targets to tax unhealthy food and drink in 2026 were gone, replaced with a much woollier commitment to “work towards” such a levy. Alcopops were excluded altogether.  Industry lobby FoodDrinkEurope took a far more measured tone on the final plan than its explosive reactions to the earlier leaks, but that may well ramp up again if and when health tax proposals emerge. The text suggests the soft drinks industry may be the Commission’s first target if it does decide to pursue new levies, while UPFs remain in Várhelyi’s sights. “In the next couple of years, we will need to tackle the issue of ultra-processed food much more,” he told MEPs in December. For now, though, the plan seems to have let industry off easy. Health NGOs saw it as a disappointment, given its lack of hard-hitting policies to reduce consumption of UPFs and other unhealthy products. While the pharma legislation is all wrapped up, the Biotech Act still needs to win the approval of EU countries and the European Parliament. For the food and pharma sectors, the proposals set out this month are confirmation they have allies in the Berlaymont.
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Europe faces a pivotal moment in health innovation
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Britain’s plan to raise NHS drug prices won’t bring back Lilly’s investment
LONDON — The American drugmaker Eli Lilly wants to see more changes to Britain’s medicine market before it pivots on its abandoned £279 million investment in a biotech incubator project. The U.K. government has drawn up proposals to increase the amount the state-funded National Health Service is allowed to pay pharmaceutical firms for drugs after intense discussions with officials from Donald Trump’s administration. The U.S. president has demanded lower drug prices for Americans, and suggested other developed countries should pay more. The British plans under consideration could increase the threshold at which the NHS pays firms for medicines by up to 25 percent. But for the U.S. pharmaceutical company — which shelved its planned facility meant to support early-stage life sciences businesses with lab space, mentorship and potential financial backing — the proposal alone is not enough. “I don’t think we have heard enough to say that we are willing to get the Lilly Gateway Lab started,” Patrik Jonsson, president of Lilly’s international business, which covers all markets outside the U.S., told POLITICO. “I think once we see the right signs from the U.K. government, we’re more than happy to restart those discussions, and we could move quite quickly,” Jonsson said. However, “we need to see some significant and sustainable change here.” The comments will be a blow to British negotiators, who are in advanced talks to agree their drug-pricing deal with the U.S. administration as part of wider trade negotiations. Officials are hoping to wrap up the pharma talks ahead of the U.K.’s budget in late November. Ministers last week granted a two-week extension to the deadline by which pharma firms must tell the government if they intend to leave the NHS’s voluntary drug pricing scheme. If Washington and London strike a deal — effectively committing the NHS to higher drug spending — Chancellor Rachel Reeves will face pressure to spell out how much the increase will cost taxpayers. ‘WE NEED THE RIGHT CONDITIONS’ Drugmakers have long called for changes to the U.K.’s tightly-controlled drug prices. Britain limits the annual cost for a year of good-quality life (QALY) for a patient at £30,000 for most drugs. Industry also pays an annual rebate to the NHS at 23 percent of their U.K. sales. These measures have contained the medicine bill for the U.K.’s publicly-funded health care system. While Jonsson acknowledged the U.K. is “well positioned to be a source of innovation” thanks to a “small but really impressive group of scientists,” he said the country needs to demonstrate sustained changes. The British plans under consideration could increase the threshold at which the NHS pays firms for medicines by up to 25 percent. | Anna Barclay/Getty Images “At the end of the day if you want us to research, develop and produce medicines in your country you need to put the right conditions in place so that your citizens can get access to those patients at least who need it most,” Jonsson said. An editorial in the Lancet medical journal last week said “the argument that paying more for medicines leads to more innovation is unfounded.” “If the U.K. Government wants to attract pharma investment, it should follow the evidence. Rather than handing over more money for medicines, it should invest in creating fertile conditions for attracting world-leading scientists, boosting public infrastructure for research and development, and facilitating clinical trials,” the article states. “Although the tangible outcomes of applied research might appeal to politicians, investing massively in a second-to-none basic science sector will allow scientific innovation to flourish.” Jonsson was speaking to POLITICO as the company announced a €2.6 billion new manufacturing facility in the Netherlands to produce oral medicines, including its first GLP-1 weight-loss pill. A Department of Health and Social Care spokesperson said: “We will always prioritise the needs of NHS patients. Investment in patient access to innovative medicines is critical to our NHS. “We are now in advanced discussions with the US Administration to secure the best outcome for the UK, reflecting our strong relationship and the opportunities from close partnership with our pharmaceutical industry,” the spokesperson added.
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Biotech Act I, CV health plan and MDR simplification coming mid-December
The European Commission is set to unveil the Biotech Act I, an EU cardiovascular health plan and a simplification of the bloc’s medical devices and in vitro diagnostics rules on Dec. 16, according to the latest Commission agenda published Monday. The first part of the Biotech Act will focus on the pharmaceutical industry and is being produced without a dedicated impact assessment. The second part — covering other biotech sectors — is expected in the third quarter of 2026. The upcoming cardiovascular health plan — inspired by the bloc’s Beating Cancer Plan — will cover prevention, early detection and screening, treatment and management, and rehabilitation. Meanwhile, simplification of the bloc’s medical devices and in vitro diagnostics rules comes after the regulations drove up assessment costs, caused certification delays, and led to product withdrawals from the market. Europe’s Health Commissioner Olivér Várhelyi has previously said the sector needs a “major overhaul.” Additionally, the Commission’s agenda includes a “drugs package” comprising new rules on drug precursors and an EU Drugs Strategy and European action plan against drug trafficking — both scheduled for Dec. 3.
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Putin, Xi and the mechanics of everlasting life
It could have been the ominous cold open to a classic Bond film. The Russian and Chinese leaders caught on a hot mic at a Beijing military parade, casually musing about cheating death. “With the development of biotechnology, human organs can be continuously transplanted and people can live younger and younger, and even achieve immortality,” Russian leader Vladimir Putin told Chinese ruler Xi Jinping, his tone half clinical, half conspiratorial. “Predictions are that this century, there is a chance of living to 150,” Xi replied. But this wasn’t a scriptwriter’s villainous fantasy. It was a jaw-droppingly real exchange between two of the world’s most powerful, heavily armed leaders. While it may have sounded absurd, behind palace walls, the obsession with longevity is more than idle chatter. The Russian and Chinese leaders were caught on a hot mic at a Beijing military parade, casually musing about cheating death. | Pool photo by Alexander Kazakov/AFP via Getty Images In 2024, the Kremlin ordered scientists to fast-track anti-aging research on cellular degeneration, cognitive decline and the immune system. Meanwhile, China has also been pouring resources into exploring nanotechnology-delivered hydrogen therapy and compounds such as betaine and lithocholic acid, hoping to slow down aging and extend healthy lifespans. But even as the world’s autocrats fantasize about replacing body parts like car tires, the science remains far less accommodating. James Markmann, executive council president at the American Society of Transplant Surgeons, called Xi and Putin’s idea of living to 150 through transplants “unfounded.” “There is currently no evidence suggesting that living to 150 years of age is possible through organ transplantation,” Markmann said. “While there is much interest in related research and some progress in intervening in the aging process, there is no evidence that a 150-year lifespan can currently be achieved.” While organ transplantation can and does save lives, there’s no data that it can also slow or reset an individual’s biological clock, Markmann said. Replacing a single organ, or even several, may improve health temporarily, but it cannot halt the overall aging process of the body. “The concerning idea here is that there is a surplus of organs available that can consistently be replenished for a single individual to prolong their life; this is simply not the case,” Markmann said. THE OLDEST OBSESSION The Xi-Putin exchange didn’t happen in a vacuum. History is littered with rulers who believed they could outsmart death. Qin Shi Huang, China’s first emperor, swallowed mercury pills in pursuit of eternal life, a habit that eventually killed him. Egyptian pharaohs mummified themselves for eternity, Cleopatra dabbled in youth potions and medieval alchemists peddled elixirs. By the 20th century, Russia’s last czar, Nicholas II, and Empress Alexandra were consulting Rasputin and other mystics for advice on health and longevity. Today, the same quest has migrated to Silicon Valley, where the mega-rich pour fortunes into cryonics, anti-aging biotech and “biohacking” in the hope of buying more time. According to Elizabeth Wishnick, an expert on Sino-Russian relations and senior research scientist at the Center for Naval Analyses (CNA), a non-partisan research and analysis organization, this fixation is typical of the world’s wealthiest and most powerful. “They want to go into outer space, they want to go underwater … the human body for them is just another frontier,” she told POLITICO. “It’s logical for people who don’t feel limits to try to extend those boundaries.” But there’s a stark contrast close to home. Life expectancy in Russia remains just over 73 years, while in China, it hovers around 79 years, with access to healthcare being deeply unequal. In Wishnick’s view, Xi and Putin “would do better to focus on that, but instead their focus seems to be on their own longevity, not the health of their societies.” UNFINISHED BUSINESS There’s also a significant cultural dimension agitating Xi and Putin. Robert Jay Lifton, the American scholar who coined the term “symbolic immortality,” argued that humans invent religions, nations and political legacies as ways of cheating death. Xi’s mantra of “national rejuvenation” and Putin’s mission to restore a “great Russia” fit neatly into that framework — even if they can’t physically live forever. “Both of them are really hostage to their own propaganda,” said Wishnick. “They truly believe they are the only leaders who can do the job. They’re concerned about their legacy and how they’ll be remembered in history.” That, she said, helps explain their obsession with reclaiming “lost” territories — Taiwan for Beijing; Ukraine for Moscow — as if completing unfinished maps might also complete their historical destinies. Qin Shi Huang’s attempt at immortality, the Terracotta Army, still stands today. | Forrest Anderson/Getty Images They’ve made creeping moves toward that goal domestically. Xi has upended China’s tradition of leadership turnover to maintain his dominance, while Putin has dismantled elections and eliminated rivals until only he remains. “It’s not surprising they would look to science as a way of extending that,” Wishnick added. While the scientific limitations persist, immortality will — at least for the time being — remain tied to public consciousness and memory. See, for example, Qin Shi Huang’s Terracotta Army, which still stands, or Russia’s expansionist czar, Peter the Great, an 18th-century leader who inspires Putin even today. But even in a world of nanotech and organ swaps, immortality has a catch: you still have to live with yourself. And for the world’s Bond villains, that might be the cruelest sentence of all.
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Putin and Xi wanna live forever
Be afraid. Be very afraid. Russian President Vladimir Putin and Chinese President Xi Jinping were captured privately talking about living to at least 150 years old on the sidelines of China’s massive Victory Day parade in Beijing. According to audio picked up on CCTV, the two were overheard musing about the possibility of immortality through organ transplants and advanced medical procedures. “Earlier, people rarely lived to 70, but these days at 70 you are still a child,” Xi told Putin according to the translator in Russian. “With the development of biotechnology, human organs can be continuously transplanted and people can live younger and younger, and even achieve immortality,” Putin replied, according to translation in Mandarin. “Predictions are, this century, there is also a chance of living to 150,” Xi responded. Xi hosted 26 world leaders, including Putin and North Korean dictator Kim Jong Un in Beijing on Wednesday, for a huge military parade which commemorated 80 years since Japan’s surrender in World War II and China’s victory over occupying forces. The event marked the first time the three rulers — Xi, Putin and Kim — have appeared together in public. China has a long history of organ harvesting from executed prisoners, which was officially banned in 2015. That hasn’t curtailed the practice, however, with the government turning to targeted minorities for organs, including the Uyghers facing a genocide in the western part of the country. Putin and Xi are both 72. Last year, The Times of London reported that Kremlin officials had directed scientists to fast-track anti-aging research, focusing on cellular degeneration, cognitive decline and strengthening the immune system.
War
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Foreign Affairs
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Unleashing Europe’s biotech prowess requires radical reinvention
Bill Anderson is the CEO of Bayer. Europe was once the epicenter of progress. After centuries of the Dark Ages, a radical new way of acquiring knowledge — the scientific method — cemented the continent’s place at the apex of civilization. Problem is, that was around 400 years ago. Today, Europe is home to strong research universities and prodigious talent, but it has been losing ground, particularly to the U.S. and China. In the 1990s, for example, half of all new medicines originated in Europe — now, the figure’s down to one in five. And the life sciences is just one of many such industries. Europe must reverse this trend, and now is the time to act. We stand on the precipice of a new world order, with increasing trade uncertainty and multipolarity, and it’s not yet clear how things will shake out. In this period of flux, Europe’s leaders rightly want to elevate science and innovation to the heart of its economy. But for this to become a reality, its member countries need to step up their game in terms of simplifying regulation. Starting a business in Italy or Greece, for example, can take months due to needless hurdles like in-person meetings, notary fees and bank account setups. It’s no wonder that advances in AI are almost exclusively happening in the U.S. and China. The biotech revolution attracts 75 percent of its talent in the U.S. and Asia, and Brazil is at the forefront of agricultural innovation. Meanwhile Europe is all too often sitting on the sidelines, asking “what’s allowed?” rather than “what’s possible?” Here’s the thing: Europe can produce world-changing innovation. In fact, some of today’s pioneering startups, like CRISPR Therapeutics, emerged from Europe. But thanks to a more accommodating regulatory environment, proximity to research hubs and access to venture capital, these companies have expanded heavily in the U.S. This isn’t to say the U.S. is without problems, or that Europe should try to refashion itself into Silicon Valley. In fact, Europe publishes about twice as many scientific articles as the U.S., and is home to multiple research hubs that foster international collaboration. However, we need a distinctly European course correction to once again unleash Europe’s innovative spirit. I am confident that with the right mindset and conditions, this can be done — but not if we continue down the path of business — or rather, bureaucracy — as usual. As last year’s Draghi report on EU competitiveness stated: “The only way to become more productive is for Europe to radically change.” I’ve personally had the rare privilege of working and living in five different European countries, including in Germany for the last two years, as the CEO of Bayer — a 160-year-old life sciences company headquartered in Germany. And we’ve now kicked off the most radical transformation since the company’s founding. Upending decades of tradition is not for the faint of heart, but sometimes it’s essential. And here are a few lessons worth bearing in mind, whether modernizing a company or a continent: Firstly, it’s time to simplify regulations and embrace the new technologies required to solve our biggest challenges, just like the U.S., Canada and other countries have already done. The U.K., for example, passed a bill allowing the development and marketing of gene-edited crops in 2023. As last year’s Draghi report on EU competitiveness stated: “The only way to become more productive is for Europe to radically change.” | Teresa Suarez/EFE via EPA On this front, we welcome the EU’s increased openness toward gene editing in agriculture, which carries tremendous potential to help farmers adapt to climate change. For instance, Italy showed courageous leadership last year, breaking with two decades of policy to allow the first field trial of a gene-edited crop, which scientists developed to improve the rice plant’s resistance to a prevalent fungus. The rest of the continent ought to follow this lead. Next, Europe also needs investment. While innovation in Europe has grown, prices for pharmaceuticals have decreased. And why is it that one of the most advanced continents, with a market of 450 million people, is seen less and less as a place to invest for developing the drugs of tomorrow? We need to change that. Everyone deserves reliable and affordable access to medicines, and everyone has a role to play. Investing in research and development (R&D) is the beating heart of the life sciences — and it comes at an enormous financial cost: More than 90 percent of pharmaceutical research ends in failure. But without R&D, our industry would be dead on arrival and have little to offer patients. So, it’s time for Europe to step up and view paying fair prices for new pharmaceutical innovation as an investment in the future — not just another cost to be minimized. At Bayer, we operate in a new model called “dynamic shared ownership,” where employees enjoy the autonomy to make decisions, share resources and direct their focus toward the biggest priorities. And we’re seeing the model pay off already, with rapid growth in our pharmaceuticals business — together, our two biggest launch medicines have grown 80 percent in sales year over year, and one is now a blockbuster. The truth is, the expat scientists who come to Europe won’t have an easy time translating their discoveries into impactful products and therapies without systemic changes. Supporting scientists also requires robust IP protection, a speedier regulatory framework and a better environment for high-risk, high-reward investors. Any innovative life sciences company in Europe would welcome these dramatic changes to the status quo. And as the world’s economic order shifts, it’s Europe’s turn to level the playing field. In 50 years, will we look back on 2025 as the moment our continent rose to the challenge and opened its arms to the future? Will we celebrate the biotech hub of Berlin as we now do Boston, with scientists flocking there to start companies, test cures for diseases and develop tools to help farmers feed the world? Or will we utter a collective sigh, pondering what could have been? It’s time to decide.
Agriculture
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Medicines
Covid-19 vaccine-maker BioNTech to acquire former rival CureVac
BERLIN — Germany’s BioNTech has signed a deal to acquire its former Covid-19 vaccine competitor CureVac for around $1.25 billion (€1.08 billion), the companies announced today. Both biotechs are developers of mRNA vaccine technology and were rivals in the race to produce a Covid-19 vaccine in the height of the pandemic. BioNTech joined forces with U.S. pharma Pfizer and continues to dominate the market with its updated Covid-19 shots. After U.S. President Donald Trump’s attempt to buy the company, CureVac failed to get its candidate approved and sold the rights to its Covid-19, flu and bird flu vaccine programs last year.  Both German companies have continued mRNA programs on so-called cancer vaccines. “We intend to bring together complementary capabilities and leverage technologies with the goal of advancing the development of innovative and transformative cancer treatments,” Uğur Şahin, BioNTech CEO, stated.  CureVac shareholders will get an exchanged BioNTech share for approximately $5.46. In total, the current shareholders will hold 4-6 percent of BioNTech. CureVac will be absorbed by BioNTech and the brand will no longer exist. Germany invested €300 million into CureVac during the pandemic and held 23 percent of its shares. While the government has sold some shares in recent years, it still remains a shareholder and has to accept the offer. The news lands as Europe hatches a plan to boost its bioeconomy with a forthcoming Biotech Act, which is expected to support the growth of smaller companies and smooth out the regulatory processes for innovative therapies.
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Medicines
Vaccines
Regulation
Cancer
Europe looks to poach US researchers as Trump cuts funding
A group of European countries is devising a strategy to poach researchers in the United States in response to American government cuts in education and research. Twelve governments said the European Union needs an “attractivity boom” to bring over talent from abroad “who might suffer from research interference and ill-motivated and brutal funding cuts,” in a letter to the European Commission seen by POLITICO. The undated letter was addressed to EU Innovation Commissioner Ekaterina Zaharieva and signed by France, the Czech Republic, Austria, Slovakia, Estonia, Latvia, Spain, Slovenia, Germany, Greece, Bulgaria and Romania. “It is urgent … to organize ourselves to welcome talents who would like or need to leave the United States,” French Research Minister Philippe Baptiste told POLITICO in a statement. The U.S. is not mentioned by name in the letter but there are explicit references. “The current international context reminds us that freedom of science can be put at risk anywhere and at any time,” the text read. Since Donald Trump took office in January, the U.S. research and education landscape has been hit with massive cuts. The U.S. Education Department has started cutting roughly half of its workforce and several universities including the Johns Hopkins University have cut jobs because of the loss of government funding. The letter included several suggestions on how to attract researchers, including dedicated funding, an immigration framework and strengthening partnerships with “other leading scientific nations.” The countries want the Commission to organize a meeting of EU research ministers in coming weeks to devise a plan, they wrote. In past weeks, several universities across Europe have launched attempts to attract U.S.-based researchers. One of Brussels’ universities, the Free University Brussels (VUB), on Monday announced 12 positions for international researchers “with a specific focus on American scholars.” The French Aix-Marseille University also launched a “safe space for science program,” referring to “a context where some scientists in the United States may feel threatened or hindered in their research.”
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