BRUSSELS — EU lawmakers have clinched a long-awaited agreement on the bloc’s overhaul of its two decades-old pharmaceutical rules — one of the EU’s biggest health files. The revamp is designed to restore Europe’s competitive edge and give companies more certainty that the EU remains an attractive market, while also pushing for more equal access to medicines across member countries. The deal between the Parliament and the Council was struck at 5 a.m. on Thursday, more than two years after the Commission tabled the proposal, which consists of directive and regulation, in spring 2023.  It marks a major victory for the Danish presidency, which pledged to wrap up the file before the end of the year, and for Health Commissioner Olivér Várhelyi, who has pushed to seal the reform amid growing geopolitical uncertainty.

Fake weight-loss drugs are increasingly being advertised and sold across the EU, posing a serious public health threat, the bloc’s drugs regulator warned today. The European Medicines Agency said there has been a “sharp rise” in the number of illegal medicines marketed and sold as GLP-1 agonists, such as the popular semaglutide, liraglutide and tirzepatide, in recent months. Authorities have identified hundreds of sham Facebook profiles, advertisements and e-commerce listings promoting the fake drugs. These websites often mislead customers by using official logos and false endorsements, the EMA said. While genuine versions under the brand names Wegovy, Ozempic, Saxenda and Mounjaro are available through legitimate health services and with a prescription, the fake versions are “not authorised and do not meet necessary standards of quality, safety and efficacy,” the agency said. “Such illegal products pose a serious risk to public health. They may not contain the claimed active substance at all and may contain harmful levels of other substances,” the EMA warned. “People who use these products are therefore at a very high risk of treatment failure, unexpected and serious health problems and dangerous interactions with other medicines.”

The United States won’t contribute anymore to Gavi, the Vaccine Alliance, until the global health organization has “re-earned the public trust,” U.S. Health Secretary Robert F. Kennedy Jr. said Wednesday. In an inflammatory video speech delivered to the Gavi pledging summit, seen by POLITICO, Kennedy accused Gavi of neglecting vaccine safety, making questionable recommendations around Covid-19 vaccines and silencing dissenting views. “When the science was inconvenient, Gavi ignored the science,” Kennedy said. “I call on Gavi today to re-earn the public trust and to justify the $8 billion that America has provided in funding since 2001,” he said. “And I’ll tell you how to start taking vaccine safety seriously: Consider the best science available, even when the science contradicts established paradigms. Until that happens, the United States won’t contribute more to Gavi.” In response to the video, Gavi said its “utmost concern is the health and safety of children.” “Any decision made by Gavi with regards to its vaccine portfolio is made in alignment with recommendations by WHO’s  Strategic Advisory Group of Experts on Immunization (SAGE), a group of independent experts that reviews all available data through a rigorous, transparent, and independent process,” the group said. Gavi leaders are in Brussels Wednesday for the organization’s pledging summit, where they are hoping to raise $9 billion for the 2026 to 2030 period. This will allow another 500 million childhood vaccinations and save at least 8 million lives by 2030, Gavi’s plan said. Going into the summit, the question of the U.S. pledge was one of the hottest ones. While an early pledge of $1.58 billion under former President Joe Biden has been announced, it was unclear whether Kennedy was going to commit to it. The Trump administration previously signaled it planned to cut its funding for Gavi, amounting to around $300 million annually. During his speech, Kennedy accused Gavi and the World Health Organization of working together during the Covid-19 pandemic to “recommend best practices for social media companies to silence dissenting views, to stifle free speech and legitimate questions during that period.” Facebook and Twitter restricted U.S. President Donald Trump’s accounts during the pandemic. Kennedy also criticized what he alleged are Gavi’s “questionable recommendations encouraging pregnant women to receive Covid-19 vaccines.” There are things he “admires” about Gavi, Kennedy said, such as its commitment to make medicine affordable to all. But in its attempt to promote universal vaccination, he accused the alliance of having “neglected the key issue of vaccine safety.” “When vaccine safety issues have come before Gavi, Gavi has treated them not as a patient health problem, but as a public relations problem,” Kennedy alleged. “Business as usual is over, unaccountable and opaque policymaking is over. I invite all of you to join us in a new era of evidence-based medicine, old-standard science and integrity,” he added. TARGETING CHILDHOOD VACCINE In the video message, Kennedy criticized Gavi’s push for DTP (diphtheria-tetanus-pertussis) immunization, referring to a 2017 study that he claims links the vaccine to higher infant mortality in girls. Other studies have subsequently questioned that early DTP vaccines is associated with increased female mortality. In the response to the address, Gavi said that “having reviewed all available data, including any studies that raised concerns, global immunisation experts continue to recommend DTPw for infants in high-risk settings.” DTPw (whole-cell pertussis) vaccines produce a stronger, longer-lasting immune response but can cause temporary side effects, Gavi writes. “In places where access to hospitals is limited and disease risk is high, the stronger protection from DTPw against these life-threatening diseases far outweighs the temporary side-effects this vaccine may cause, such as fever or swelling at the injection site (which are signs the immune system is responding),” they continue. “Based on a full assessment of the science available, Gavi continues to have full confidence in the DTPw vaccine. As an important element in our routine vaccine portfolio, it has played a key role in helping halve childhood mortality in Gavi-supported countries since 2000,” Gavi said. Since Kennedy, a longtime vaccine skeptic, has been health secretary, he has restricted Covid-19 vaccine access and fired all members of the vaccine advisory panel for the Centers for Disease Control and Prevention, replacing them with his own picks, with several having a controversial history around immunizations. This story has been updated with Gavi’s response.

Patients taking weight-loss and diabetes drugs Wegovy and Ozempic have an increased risk of developing a rare eye condition that could lead to loss of vision, a European Medicines Agency (EMA) committee announced Friday. The EMA’s drug safety committee (PRAC) launched a review of medicines containing semaglutide — a GLP-1 agonist and the active ingredient in Novo Nordisk’s Ozempic, Wegovy and Rybelsus — in January, following concerns that the drugs could lead to an increased risk of developing non-arteritic anterior ischemic optic neuropathy (NAION). NAION is a disorder caused by reduced blood flow to the optic nerve in the eye, which can damage the nerve and lead to permanent vision loss. PRAC said it found that the condition is “a very rare side effect” of semaglutide, potentially affecting up to one in 10,000 people taking the drug. The EMA said that exposure to semaglutide in people with diabetes is linked to a twofold increase in the risk of developing NAION compared with people not taking the medicine. The regulator has requested that the product information for semaglutide medicines is updated to include NAION as a side effect with a frequency of “very rare.” The final decision needs sign off from the European Commission.

The European Medicines Agency has rejected Lilly’s Alzheimer’s drug Kisunla for a license, saying its benefits don’t outweigh the risk of brain swelling or bleeding. The treatment for early Alzheimer’s disease, which is administered via a monthly infusion, has been approved in the United States, United Kingdom, Japan and China. But the European agency’s human medicines committee CHMP said today there is a risk of “potentially fatal events due to amyloid-related imaging abnormalities (ARIA).” In a Phase 3 trial involving 1,700 people, Kisunla slowed cognitive decline by up to 35 percent in 18 months compared to a placebo group. But there were three deaths considered to be related to treatment, compared with one among those taking the placebo. “Europeans living with early symptomatic Alzheimer’s disease and their loved ones urgently need additional treatment options. Today’s disappointing CHMP opinion means they must keep waiting,” Ilya Yuffa, executive vice president and president of Lilly International said. Yuffa pointed out that Kisunla has been approved in other markets, adding that the company “remains confident” in its safety and effectiveness. This class of drug is a new approach to treating Alzheimer’s disease, by targeting amyloid plaques that build up the brain. Only one other drug has been approved in this class in Europe, Eisai’s Leqembi (lecanemab). The EMA also rejected this drug last summer in its initial assessment, but backed it in November in a restricted population after a re-examination. “We hope that through the re-examination process, we will be able to continue our discussions with the agency to bring donanemab to the millions of people across Europe suffering from this relentless, fatal disease,” Yuffa added.

The illicit trade of fake medicines is a “growing threat” in Europe, EU’s law enforcement agency warned today. There is a rise in the trade of either sub-standard, falsely labelled or falsified medicines, according to the Europol report. Aside from the sale of fake medicines, Europol also warns about “diversions from the legal supply chain,” such as the theft or misuse of legitimate medicines and prescriptions.   Criminals target various pharmaceutical products, such as synthetic opioids, cancer drugs, painkillers, performance-enhancing drugs and antivirals, Europol writes. But recently, there has been a “worrying trend” of illicit trade of semaglutide drugs, prescribed to treat diabetes but increasingly being illegally resold for weight loss. “Criminal actors primarily use fake prescriptions to obtain genuine diabetes pens for onward illicit resale at a higher premium, but also distribute falsified products, mainly imported from outside the EU,” Europol writes. Between April and November 2024, law enforcement agencies seized €11.1 million worth of fake medicines and arrested 418 people. A growing shortage of medicines in several countries, along with rising demand, are key elements that fuel the market. Pharmaceutical crime has a direct impact on public health and safety, causing financial losses for legitimate companies, undermining brand credibility and endangering investments in research, according to the report. “Pharmaceutical crime will continue, so long as the demand remains high and criminal actors continue to consider IP crime as a low-risk, high-profit endeavour,” Europol writes.

A French lawmaker on Tuesday admitted that police caught him trying to buy drugs last week. “On Thursday, 17 October, 2024, I was stopped in possession of narcotics,” the parliamentarian, Andy Kerbrat, said in a statement posted to X. “I immediately admitted to the charges against me.” Kerbrat, who is a member of the left-wing New Popular Front alliance and represents the northwestern region of Loire-Atlantique in the French National Assembly, issued his statement after right-leaning newspaper Valeurs Actuelles published a story revealing that Kerbrat had been detained while attempting to purchase the synthetic drug 3-MMC at a Paris metro station. Kerbrat expressed regret that his close circle, including his parliamentary team and political allies, had learned about the arrest through media revelations before he could inform them personally. The 34-year-old admitted to struggling with drug addiction for some time and vowed to seek help. “Addiction is a public health issue and must be treated as such,” he said. Several of Kerbrat’s political allies on the left voiced support for him following the news, including Sandrine Rousseau of the Greens.“Drug use and addiction are an issue of care, mental health and support. You recognized, you are in a treatment path. Come back to us in good shape,” Rousseau said on X. Right-wing politicians, however, were quick to criticize Kerbrat. Among them were new hard-line Interior Minister Bruno Retailleau, who said Kerbrat must face consequences for his actions, especially at a time when the drug trade is fueling what he called a “procession of violence” in French cities like Marseille. “It is intolerable to see a member of parliament buying synthetic drugs from a street dealer,” Retailleau said on X.

PARIS — The French government on Monday warned an American private equity firm purchasing a subsidiary of pharmaceutical giant Sanofi that it would face millions of euros in penalties if it tried to move jobs or drug production outside of France. The firm, CD&R, is attempting to acquire control of Sanofi subsidiary Opella, which manufactures over-the-counter drugs like paracetamol. Sanofi announced on Monday that it had entered exclusive talks with CD&R for the firm to buy 50 percent of Opella’s shares for around €16 billion. News of the potential deal sparked widespread criticism from across France’s political spectrum when talks were announced earlier this month, with politicians warning it could threaten manufacturing jobs in France and fall afoul of Europe’s post-pandemic push to secure its supply chains for critical medicines. Sanofi said it was selling Opella as part of its effort to focus on vaccines and innovative drugs. The French government responded to the backlash against the deal with a warning against offshoring jobs and production, but Paris is keen on the takeover. On Sunday evening, the government announced the various stakeholders had sealed an agreement requiring Opella to keep production, jobs and management in France after the American takeover. “To ensure that these guarantees are respected with the utmost rigor and firmness, [there will be] firm, immediate and far-reaching sanctions,” Economy Minister Antoine Armand told reporters on Monday morning as he presented the deal alongside Industry Minister Marc Ferracci. Under the trilateral deal signed by Sanofi, CD&R and the government, Opella will have to pay a €40 million penalty if it stops production in two of its factories that produce popular medicines like paracetamol, marketed by Sanofi in France’s omnipresent yellow boxes of Doliprane, and drugs to treat allergy and digestion problems. Workers at the two factories have been on strike since news of the American takeover broke, as they feared for their jobs. Under the deal, Opella will have to pay a €100,000 penalty for every single economic-related layoff. The biggest sanctions aim to preserve Opella’s relations with French suppliers. The pact requires Opella to purchase the active ingredient for the production of paracetamol from a future French factory to be opened by Seqens in 2026. Opella will have to pay €100 million penalty if it doesn’t keep that promise. The French government, via public investment bank Bpifrance, will also buy shares of Opella for up to €150 million to have more visibility on company strategy, but their stake amounts to just a percent or two of ownership. The Economy Ministry expressed confidence that the agreement’s strict punishments would help promote France’s strategic objectives of reshoring medicine production and keeping manufacturing jobs in the country — while also bringing in a bit of foreign cash as well. CD&R committed to invest €70 million in Opella’s French operations over the next five years and to keep the company’s headquarters and research and development activities in France.

Elon Musk has forged a relationship with a Republican figure who could open up a geyser of federal cash for his Starlink satellite internet business — and it’s not the person running for president. Online and in person, the tech titan has been building a public alliance around his company’s policy goals with Brendan Carr, the senior Republican on the Federal Communications Commission — an unusual link between a regulator and his potential beneficiary that could mean a payday for the world’s richest man. With Musk emerging as one of Donald Trump’s top supporters for president, their embrace offers a window into how Musk could use personal connections and the power of his X platform to push his own business agenda if he becomes part of a Trump administration. Trump has said that if elected, he would name Musk to run a new commission to trim government waste. Musk appeared at a Trump rally and is pumping $75 million into a pro-Trump super PAC. At the same time, one of Musk’s companies — SpaceX, which runs Starlink — is in line to collect hundreds of millions, if not billions, of dollars in federal subsidies if some key federal decisions go his way in the next administration. As a widely rumored contender for FCC chair under a Trump administration, Carr could exert critical influence over those decisions. He has already inserted himself into Musk’s business before the government, saying the FCC treated the SpaceX founder unfairly. The public relationship goes back to at least late 2023, when Carr said on X that the FCC and six other agencies were subjecting Musk to “regulatory harassment” under President Joe Biden. The post sparked discussion on the popular “All In” Silicon Valley podcast, which Musk amplified to his 200 million followers on X. Musk began following Carr’s account himself on July 1. Over the past year, Carr has attacked Democratic FCC commissioners for denying Starlink money from a rural broadband subsidy program, blamed Vice President Kamala Harris for slow progress on broadband expansion (“Truly staggering levels of waste and incompetence!” Musk responded), and sent a confrontational letter to Brazilian regulators who tried to place limits on X and Starlink. Musk boosted each move online. “Much appreciated,” he wrote to Carr after the letter to Brazil. In August, Carr visited the SpaceX Starbase in Boca Chica, Texas, and posed for a photo with Musk, which he posted on X with a warm endorsement of Musk’s business practices. For Carr, a longtime conservative gadfly on telecom issues — and author of a chapter of the Heritage Foundation’s Project 2025 — the sharp public critiques of Democrats are familiar. But his apparently tailored courting of one business leader is something new. In an interview, Carr downplayed the idea he’s showing any special favor to Musk, saying he has held meetings and engaged with many industry figures over the years. He pledged even-handedness as a regulator — but said he does want the U.S. government to play a bigger role in fostering the expansion of Starlink and future satellite broadband players. And he said he has only met Musk in person once. “I understand the focus on Musk is on a lot of people’s minds in the media space and otherwise,” Carr told POLITICO. “But I feel like my own conduct and my amount of posting on social media and the style and the type is pretty consistent with what I’ve done for the last four years.” Spokespeople for SpaceX, which owns Starlink, did not respond to a request for comment from Musk. For Musk, the potential payoff is clear. Under the Biden administration, the FCC denied $885 million in broadband subsidies to his Starlink satellite internet service. Separately, the Commerce Department limited Starlink’s eligibility for Biden’s $42 billion program to expand broadband access. The agencies have said Starlink’s service — which relies on thousands of satellites orbiting the Earth in low orbit to beam down their internet signals — is still too new to count as proven technology at scale, and requires users to buy expensive receivers. The administration sees fiber-optic cable as a better choice. Both Carr and Musk have brushed off the government’s technical concerns and accused the Democrats of playing favorites. “Starlink could play a lead role if we ensure that they’re eligible to participate,” Carr told a conservative radio host in August. “But the Biden-Harris administration, you know their position on any Elon Musk business.” The two men seized on hurricanes Helene and Milton to make the case for Starlink’s utility: Musk rushed Starlink kits to communities hit by the storms, while Carr has posted stories suggesting “Elon succeeded where FEMA failed.” Critics see Musk’s approach as a symptom of the problem with Starlink: He promised free service to hurricane victims, but in fact they still had to pay nearly $400 for the equipment and shipping. With Musk increasingly close to Trump, what looked at first like a policy position for Carr — an embrace of new technology over old — has taken on a more personal cast, in the eyes of many observers. “It seems like it’s all for the audience of Elon,” Craig Aaron, the co-CEO of consumer advocacy group Free Press, said in an interview. “It looks to me like Carr is reading the political tea leaves to say being in good with Elon is how you advance in the next Trump administration.” ‘A TON OF UPSIDE’ Access to federal money is critical to Musk. His SpaceX rocket company is a major federal contractor, and Starlink stands to gain directly from Biden’s immense investment in federal broadband buildout. Musk “can get a ton of upside when these regulatory decisions are going his way,” telecom analyst Roger Entner told POLITICO. “The bulk of his wealth comes from government contracts or government subsidized businesses.” Musk has complained extensively about government decision-making, especially when it goes against him, and he found a ready-made ally in Carr — a minority Republican commissioner of a Democratic-dominated agency, appointed by Trump in 2017. On the commission, Carr was a frequent messenger for Trump on cable news, backing Trump’s unsuccessful attempt to end the Section 230 liability shield for tech companies, discrediting the Senate impeachment trial against the former president and bashing social media companies for what he perceived as bias against conservatives. In 2022, Carr praised Musk’s purchase of Twitter on Fox Business as a portent of “greater embrace of free speech.” And as Starlink increasingly became a player in Washington regulatory fights, he kept up the support. As a relatively new company on the broadband scene — obtaining U.S. authorization to launch its batches of satellites only in 2018 — Starlink has had to fight for a spot in the world of telecom permits and subsidies. Because it is satellite- and not land-based, it has been able to deliver service to conflict areas, including Ukraine, which also puts it in the public eye for different reasons. Carr has backed Musk’s operation at many turns, particularly in the last two years. In April, the Ukrainian Congress Committee of America called for an FCC investigation into whether to revoke Starlink licensing over Musk’s “erratic” behavior, from reports around how he’s handled Starlink use in foreign conflicts to his reported use of illegal drugs. In response, Carr dashed off a statement accusing the “activist” group of seeking to weaponize the government against Musk for ideological reasons. One seemingly permanent source of anger for both Carr and Musk is a 2022 FCC decision to revoke $885 million in rural broadband subsidies. Starlink applied for the money under the agency’s Trump-era Rural Digital Opportunity Fund, and provisionally won approval in 2020 — but the commission’s Democratic majority later decided to deny it. Democrats point out that multiple bids, including Starlink’s, were denied for falling short of qualifications, and a spokesperson for the Democratic FCC chair maintains that “any notion that its decisions are politically motivated and not fact-based is false.” Musk has never been mollified, and was still complaining about it on X this October. Carr told POLITICO that while he thinks that bid money is likely lost to Starlink “as a practical matter” now, he still believes “it would be fair to get [Starlink] back” into the FCC’s broadband program. ‘WE SHOULD BE LIKE “GO GO GO”’ The biggest federal subsidy available to Starlink would be a chunk of Biden’s $42 billion broadband expansion program, a Commerce Department effort that gives states funding to pay internet providers to build out infrastructure to rural areas. The program’s current rules limit Starlink’s involvement to extremely rural spots, and favor fiber-optic cable for the rest. None of the expansion projects have yet broken ground, giving the next president leeway to shake up the effort. Although Carr’s current agency isn’t running the program, he has become its number one critic, writing social media posts almost daily blasting its sluggishness, blaming Harris and capturing those grievances in op-eds and in testimony this September before the House Oversight Committee — all moves Musk has readily amplified. Musk responded to Carr’s advocacy on X at least 14 times in September alone. While assailing the rollout of the program, Carr and Musk have advocated a bigger role for Starlink. Some telecom industry officials, who stand to reap some of the subsidies now, worry about handing Starlink too expansive a role in scaling up its service. “We have no proof of concept that shows that [Starlink] could serve millions of Americans or more, on a widespread basis, on a simultaneous basis,” Michael Romano, the executive vice president of rural telecom trade group NTCA, said in a recent interview. But Starlink has racked up customers — over four million worldwide at this point — and some officials increasingly believe the company can function at larger scale, even as it faces questions about pricey service, and grapples with the challenges of global growth and technical headaches like a growing cascade of space junk. Carr believes much of the broadband program’s $42 billion broadband should still flow to land-based connections, but believes a big share — perhaps close to a third, he told POLITICO — could be used for satellite internet. The beneficiaries would include Starlink and, if it’s ready in time, a similar low-earth satellite system being launched by Amazon. Despite some skepticism, and Musk’s politics, many Democrats share enthusiasm for Starlink as a rural broadband provider, and the service has counted some victories in addition to setbacks. FCC Chair Jessica Rosenworcel launched a new Space Bureau in 2023, which promises a speedier regulatory treatment for satellite providers. She also sided with SpaceX in a key spectrum fight over frequencies that Musk says Starlink needs. And the FCC has worked with SpaceX on its partnership with T-Mobile to help supplement the carrier’s cellular service, which they received emergency permission to trial following Hurricane Helene. Carr argued in the interview that his goal is less to support Musk personally than to boost U.S.-based satellite broadband technology in general. He says some of his casual references to Starlink are shorthand for the low Earth orbit satellite industry overall, which is competing globally with Chinese efforts to set up its own satellite broadband player. “Right now we should not be putting brakes or harassing any U.S.-based satellite company,” Carr said. “We should be like ‘go go go — we’ve got your back.’” A BIGGER HAND MUSK COULD PLAY What happens to Musk’s bids for federal cash if Trump wins? There’s no guarantee Trump would pick Carr to run the FCC — though Trump, clearly a fan of Musk, appears to now share Carr’s enthusiasm for Starlink. He has said the recent hurricane convinced him. While campaigning with Musk in Butler, Pennsylvania, Trump recounted asking people how the new satellite-beamed service was working. “They said, ‘much better than the wires,’” Trump remarked. It’s already clear Musk would have other telecom allies in a Republican-controlled Washington. Nathan Simington, the FCC’s junior Republican, declared in one 2023 dissent to a commission vote on Starlink subsidies that “SpaceX’s technology is proven” and said the “proof is the millions of subscribers.” On Capitol Hill, Republicans have long worried the Biden administration placed a thumb on the scale in favor of wired technologies like fiber, and they hope a Trump victory could change that. “I have a very rural district that struggles with connectivity, and we don’t particularly care who is competing or how it delivers, whether it’s from a Starlink satellite or if it’s fiber in the ground,” Rep. Kat Cammack (R-Fla.), a House Energy and Commerce Committee member who has pressed Biden administration officials over their digital agenda, told POLITICO. “They need to have options, and currently, we have none.” Telecom analyst Blair Levin believes Musk has an even bigger hand he can play, and would be able to reshape the broadband program in his image under a Republican White House, when a Trump-friendly official would become the new Commerce secretary. In a recent New Street Research note to investors, Levin wrote that Musk might seek to, “as part of his promised job related to government efficiency, end the [broadband] program, return most of the $42.5 billion to the Treasury, while spending just enough to enable locations in unserved areas to obtain a subsidy for a satellite dish.” If Carr gains power and begins shifting money toward Musk, observers foresee possible backfire, or at least some legal vulnerability. Agency officials generally don’t call out companies by name and seek to avoid impressions of regulatory favoritism. It’s possible these cozy relations could become fodder for future regulatory fights — or lawsuits. “That would be my favorite line of attack,” Entner said. “The two of them have to think about it.”

BRUSSELS — Belgium is reaching peak surrealism. A man who has spent his entire political career trying to break up the country is now on track to become its prime minister — even though he insists he doesn’t want the job. Local elections on Sunday have paved the way for Bart De Wever, Belgium’s highest-profile politician and the winner of its June national elections, to finally run the country. Talks to form a new government have dragged on for months and had been losing steam, but the local elections have now given a new impetus to the process. The parties who won in June held their ground and now hope De Wever of the New Flemish Alliance (N-VA) will take the helm before Christmas. Belgium’s king met with De Wever on Thursday, asking him to land an agreement “within a reasonable period” — royal code for “hurry up” — and to report back on his progress Nov. 4. For De Wever, the situation poses a delicate dilemma.  The party president of the Flemish nationalists is also the mayor of the large port of Antwerp — Belgium second biggest city — where he maintained a comfortable winning cushion over other parties on Sunday. Belgium’s king met with De Wever on Thursday, asking him to land an agreement “within a reasonable period.” | Dirk Waem/BELGA MAG/AFP via Getty Images He describes the choice between staying in Antwerp and leading Belgium as a tussle between his heart and his head. As a Flemish nationalist, stepping up to lead the country is a difficult circle to square. Even as he was appealing to voters last spring to become prime minister, he said that “as a person, I’m not looking forward to becoming prime minister. Really, I am dreading it immensely.” Despite those reservations, he’s now precariously close to the job, leading negotiations for the formation of a national government between his N-VA party, the centrists of the CD&V and Les Engagés, the French-speaking liberals of the Reformist Movement (MR), and Dutch-speaking socialist party Vooruit. BRUSSELS’ WORST NIGHTMARE? From a European perspective, a Flemish nationalist prime minister — on paper at least —is Brussels’ worst nightmare. What would happen to the European institutions, and NATO, if their host country were governed by a man who has been bashing Belgium his entire political career?   And then there is his political affiliation.  De Wever’s Flemish nationalists hail from the right-wing European Conservatives and Reformists in the European Parliament, which would mean one less leader around the European Council table who is linked to the centrist forces that backed Ursula von der Leyen to stay on as European Commission president. So why, then, does nobody seem too panicky?  In the Belgian elections, De Wever surprisingly defeated the far-right Vlaams Belang, which had been leading the polls for months. The anti-immigration party wants to turn Flanders into an independent breakaway state — risking months, or possibly years of political instability.  So on June 9, the country’s elite was relieved, rather than terrified, by the prospect of De Wever as Belgium’s next leader rather than an ultra-hardliner. De Wever is far from being able to take a breather, though. He faces a choice that will define his political legacy: statesmanship, or ideology?  Vlaams Belang chairman Tom Van Grieken. | Nicolas Maeterlinck/BELGA MAG/AFP via Getty Images DICK OF THE YEAR Explaining De Wever’s political success to a non-Belgian (or even a French-speaking Belgian) is challenging. He is cynical, arrogant, and easily outsmarts everyone around the table. He’s also bad at making polite small-talk and has mild germophobia, making campaigns extra challenging. How, then, has he proven so durable? He has been party president since 2004, remarkable in an age when most politicians rise and fall faster than the stock market.   “You could see that he was a man who picks up things very quickly, who reacts very fast,” said Geert Bourgeois, who founded the party and handed the reins to De Wever two decades ago. “Bart is a chess player. I could tell he had a lot of capacities. He doesn’t just have the strategic vision, but he’s also a good debater.” In those two decades, De Wever managed to transform the N-VA from a fringe party with just one elected member in parliament to the biggest political force in the country. Throughout that period, he became and remained one of the country’s most popular politicians. In the early days of his career, a wildly popular TV quiz show catalyzed his bigger public breakthrough. Belgium got to know the intellectual who was obsessed with ancient history, but at the same time indulged in Burgundian cuisine (De Wever weighed 142 kilograms at the time) and was razor sharp and quick-witted.  He had a legendary response to being awarded maximum points after naming various animal species on the quiz show: “You can’t have shit thrown at your head all day without learning something from it.”  He had a point. It’s not just that De Wever has a love-hate relationship with Belgium: The country also has a love-hate relationship with him. In a poll he once won both “Politician of the year” and “Dick of the year.”  While deeply respected by his political opponents for his intellect and his debating skills, he is also known to be ice cold when required.   “He can be brutal in his strategy. As a historian he likes to read about the battles of Julius Caesar, who was unrelenting,” said Egbert Lachaert, a former party president of the Flemish liberals of Open VLD and a counterpart with whom De Wever had a long, public falling-out.  Egbert Lachaert, a former party president of the Flemish liberals of Open VLD.| Benoit Doppagne/BELGA MAG/AFP via Getty Images Lachaert stressed that once you get into De Wever’s bad books, “you’ll feel it, and he’ll proceed to destroy his opponents.” De Wever once referenced a famous quote from former U.S. President Harry Truman, that “if you want a friend in Washington, get a dog.” The same seems true in Belgium.   Politically, De Wever transformed the N-VA from a one-issue movement to a party with a far broader appeal, economically to the right and culturally conservative, labelling it the “Flemish CSU” in a reference to the conservative Bavarian Christian Democrats.  “He’s a conservative, always has been and always stayed one,” said Karl Drabbe, who published some of De Wever’s books and has roots in the Flemish movement.  De Wever’s latest book, “On Woke,” is branded as a pamphlet “against the war of self-destruction that a good part of the intellectual élite is waging against modern, Western society.” While his conservative ideology has remained steadfast over the years, De Wever’s preferred means to achieve greater Flemish autonomy has evolved. To transform the N-VA into a governing party, De Wever had to think more in terms of power, Drabbe said, and of trying to change the country from within.  Eventually, this led to a massive power grab.  The N-VA has led the Flanders regional government for a decade and was part of the Belgian governing coalition between 2014 and 2018.  This allowed the Flemish nationalists to spread their influence — not just within key Flemish positions such as the Port of Antwerp but also in top Belgian economic institutions such as the National Bank or in Belgian diplomacy. De Wever’s role in Antwerp gave him a platform to style himself as a strong right-winger who is tough on crime, domestic terror networks and drugs. That deliberate, step-by-step power accumulation has a very different feel from the provocative De Wever who in 2005 drove 12 trucks loaded with fake money to the southern, French-speaking region of Wallonia — just to make the point that Flanders was bleeding too much money toward its poorer neighbor. De Wever has a great talent for reinventing himself, said Bart Maddens, a political scientist at the Catholic University of Leuven.  “He grew up as a rebellious figure, with a lot of wit,” Maddens said. “Then he gradually transformed into more of a statesman with a more presidential allure.” WHAT ABOUT FLEMISH INDEPENDENCE? Throughout that climb to power, however, De Wever has failed to deliver on his most important pledge: more Flemish autonomy, which would ultimately lead to Flemish independence.  “It is an evangelical certainty in my mind that it is done with Belgium,” De Wever said in an interview with De Tijd. “History has a direction and it cannot be reversed. There were really only two other countries in Europe like Belgium: Czechoslovakia and Yugoslavia. Two of the three are already down the drain.” Despite his political pragmatism, the Flemish cause is deeply engrained in his politics and his family history. His father put a membership card of the Flemish nationalist party that preceded the N-VA in De Wever’s diaper shortly after his birth. His brother Bruno is one of the most renowned historians on Flemish nationalism. (Bruno De Wever declined a request for comment for this story. Bart De Wever himself is declining all interviews not to jeopardize the government negotiations.) “De Wever and his party have gone a long way,” said Wouter Beke. Beke, a current member of the European Parliament, was party president for the Flemish Christian Democrats between 2010 and 2019, often negotiating with his N-VA-counterpart over the years. Beke and De Wever, who got to know one another during their previous academic careers at the same university, always shared a deep mutual respect.  Beke noted, in particular, that the party was now more ready to adapt to the country’s political realities. He made particular reference to the epic coalition negotiations of 2010, when N-VA bigwig Jan Jambon said he would rather have “no agreement than a compromise.” Things are now very different.   De Wever saw the June Belgian elections as a “now-or-never” moment for his political lifelong goal. The only way to get things moving, he argued during the campaign, was to take the highest office himself. “There is great frustration within the N-VA that despite electoral successes, the party has never been able to achieve anything in terms of state reform,” said Maddens, the political scientist.  “That is beginning to weigh both on De Wever personally and on N-VA in general. They don’t  want to miss this historic opportunity or go down in history as the Flemish-nationalist party that has been unable to achieve anything in terms of autonomy.” But the 53-year-old historian is now facing an almost impossible conundrum. To achieve greater Flemish autonomy, he needs to win round his French-speaking counterparts, which risks leading to years of political chaos.  For years, Francophone politicians have prided themselves on not negotiating with a man whom they see as the devil. However, now that the far-right Vlaams Belang has gained ground in Flanders, De Wever almost looks mainstream in Francophone Belgium as well. Still, while accepting him as the Belgian prime minister would work, they aren’t keen on negotiating another institutional reform.  That means De Wever has been negotiating for months with the Flemish Christian Democrats, the Flemish socialists and the French-speaking liberals to set up a center-right government to get the country’s derailing finances in order. In parallel, that new government would lay the groundwork for more regional autonomy, albeit in small steps. Inevitably, this risks kicking the can down the road when it comes to additional Flemish autonomy. It also provides easy ammunition to the far-right opposition: Is De Wever again giving up his principles in return for power?   “Those who try to drain the Belgian swamp risk, above all, drowning in it themselves,” said Tom Van Grieken, the party president of Vlaams Belang.  The N-VA strongman is well aware of that risk, said Belgian officials briefed on his thinking, who were not allowed to speak freely because of the government negotiations.  It was no coincidence that De Wever started his victory speech on June 9 with the Latin tag ad astra per aspera: Through adversity to the stars. Just getting to where he is now has been hard enough for De Wever, but the adversity to come could be worse. He will be wondering whether he can endure a potentially reputation-shredding federal premiership to reach the heights of Flemish independence. Camille Gijs contributed reporting.