The World Health Organization has recommended the use of novel weight-loss drugs to curb soaring obesity rates, and urged pharma companies to lower their prices and expand production so that lower-income countries can also benefit. The WHO’s new treatment guideline includes a conditional recommendation to use the so-called GLP-1s — such as Wegovy, Ozempic and Mounjaro — as part of a wider approach that includes healthy diet, exercise and support from doctors. The WHO described its recommendation as “conditional” due to limited data on the long-term efficacy and safety of GLP-1s. The recommendation excludes pregnant women. While GLP-1s are a now well-established treatment in high-income countries, the WHO warns they could reach fewer than 10 percent of people who could benefit by 2030. Among the countries with the highest rates of obesity are those in the Middle East, Latin America and Pacific islands. Meanwhile, Wegovy was only available in around 15 countries as of the start of this year. The WHO wants pharma companies to consider tiered pricing (lower prices in lower-income countries) and voluntary licensing of patents and technology to allow other producers around the word to manufacture GLP-1s, to help expand access to these drugs. Jeremy Farrar, an assistant director general at the WHO, told POLITICO the guidelines would also give an “amber and green light” to generic drugmakers to produce cheaper versions of GLP-1s when the patents expire. Francesca Celletti, a senior adviser on obesity at the WHO, told POLITICO “decisive action” was needed to expand access to GLP-1s, citing the example of antiretroviral HIV drugs earlier this century. “We all thought it was impossible … and then the price went down,” she said.  Key patents on semaglutide, the ingredient in Novo Nordisk’s diabetes and weight-loss drugs Ozempic and Wegovy, will lift in some countries next year, including India, Brazil and China. Indian generics giant Dr. Reddy’s plans to launch a generic semaglutide-based weight-loss drug in 87 countries in 2026, its CEO Erez Israeli said earlier this year, reported Reuters. “U.S. and Europe will open later … (and) all the other Western markets will be open between 2029 to 2033,” Israeli told reporters after the release of quarterly earnings in July. Prices should fall once generics are on the market, but that isn’t the only barrier. Injectable drugs, for example, need cold chain storage. And health systems need to be equipped to roll out the drug once it’s affordable, Celletti said. 

Lawmakers in the European Parliament voted on Tuesday to pursue legal action against the European Commission for spiking a highly disputed bill to regulate the licensing of patents. After a lawsuit was filed earlier this month to the Court of Justice of the European Union, lawmakers today voted with 334 MEPs in favor of pursuing the legal action. There were 294 votes against and 11 abstentions. The standard essential patents (SEPs) regulation sparked a fierce lobbying war between patent holders — including Nokia, Ericsson, Qualcomm and Huawei — and the companies that license their tech, ranging from phone to carmakers. The Parliament had agreed a position on the file but the Commission said in February that it planned to scrap its proposal to regulate the licensing of certain patents, arguing there was no “foreseeable agreement” with the Council, where negotiations had become drawn out. The Parliament’s legal affairs committee voted earlier this month to sue the Commission. President Roberta Metsola put the lawsuit to a final plenary confirmation amid pushback from a right-wing majority. The case can now move ahead to the EU’s top court in Luxembourg, which will have to decide whether the Commission was within its rights to scrap the proposal or whether it overstepped its powers. “The Commission’s right to withdraw a proposal … cannot be used as a political instrument to short-circuit Parliament’s work or to enforce a deregulation agenda from above,” German Social Democrat René Repasi, who led the motion in committee, has said. “This is not in line with how the democratic processes in the European Union are meant to function.” The Commission didn’t immediately respond to a request for comment.

BRUSSELS — Lawmakers in the European Parliament’s legal affairs committee have voted to go ahead and sue the European Commission for axing a proposal to regulate patent licensing. The JURI committee on Tuesday voted in favor of referring the Commission to the Court of Justice of the European Union for breaching EU law by withdrawing a proposal to regulate standard essential patents. The patents, for 4G and 5G networks used in mobile phones and connected cars, have been at the center of a long-running battle between the companies that own them and those that use them. European lawmakers have supported efforts to resolve the fight — and some accuse the EU executive of attacking democracy by killing off the initiative. President Roberta Metsola now needs to mandate the Parliament’s legal service to draft and file a case by Nov. 14, a Parliament official said, citing rules of procedure. If she intends to depart from JURI’s conclusions, she could also bring it to the Conference of Presidents or, in an unlikely scenario, submit it to a plenary vote, they added. Fourteen MEPs voted in favor of the action, against eight who opposed it, the official said. The vote was held behind closed doors.  The motion was spearheaded by German Social Democrat René Repasi, coordinator for the Committee on Legal Affairs and standing rapporteur for disputes involving the Parliament. “With today’s vote, we send a clear message: we will not stand by when the Commission oversteps its mandate,” Repasi said in an emailed statement following the vote. “The Commission’s right to withdraw a proposal, as was conducted with the Standard-Essential Patents (SEP) proposal, cannot be used as a political instrument to short-circuit Parliament’s work or to enforce a deregulation agenda from above. This is not in line with how the democratic processes in the European Union are meant to function.” Members of the European People’s Party, the center-right party allied to Commission President Ursula von der Leyen, were instructed to vote against taking legal action. “Today’s vote reflects Parliament’s concern about the balance of powers between EU institutions, but we must be clear: This legal action will not bring back the withdrawn legislative proposal,” Adrián Vázquez Lázara, the EPP’s lead on the issue, told POLITICO.  While he acknowledged that the withdrawal of the SEP bill raised some question marks, Vázquez Lázara said that legal action was not the right solution. “What can be questioned, however, is the wording and justification used in this specific withdrawal, which raises legitimate concerns about institutional transparency and communication,” Vázquez Lázara said. “Those Members who wish to see the proposal revived should seek political and legislative avenues to achieve that goal, rather than resorting to institutional confrontation.” Patent implementers, which historically supported the regulation and range from carmakers to Big Tech companies and SMEs, cheered the move. “There is still hope for democracy and fairness in the EU legislature,” said Evelina Kurgonaite of the Fair Standards Alliance, which represents the patent users. “We thank MEP [Marion] Walsmann and other JURI members for their leadership in fighting for a fair chance at innovation for  businesses in Europe, especially SMEs.” The Commission declined to comment.

CLIMATEWIRE | A once-outlandish idea for reversing global warming took a major step toward reality Friday when Israeli-U.S. startup Stardust Solutions announced the largest-ever fundraising round for any company that aims to cool the Earth by spraying particles into the atmosphere. Its plan to limit the sun’s heat raised $60 million from a broad coalition of investors that included Silicon Valley luminaries and the Agnelli family, an Italian industrial dynasty. The disclosure, critics said, raises questions about involvement of venture capital firms in driving forward a largely untested, thinly researched and mostly unregulated technology that could disrupt global weather patterns and trigger geopolitical conflict. The investors were “putting their trust in the concept of, we need a safe and responsible and controlled option for sunlight reflection, which for me is [a] very important step forward in the evolution of this field,” Stardust CEO Yanai Yedvab said during an interview this week in POLITICO’s London office. He and co-founder Amyad Spector, who also flew in for the interview, are both nuclear physicists who formerly worked for the Israeli government. The startup’s fundraising haul was led by Lowercarbon Capital, a Wyoming-based climate technology-focused firm co-founded by billionaire investor Chris Sacca. It was also backed by the Agnellis’ firm Exor, a Dutch holding company that is the largest shareholder of Chrysler parent company Stellantis, luxury sports car manufacturer Ferrari and Italy’s Juventus Football Club. Ten other firms — hailing from San Francisco to Berlin — and one individual, former Facebook executive Matt Cohler, also joined Stardust’s fundraising round, its second since being founded two years ago. The firm has now raised a total of $75 million. It is registered in the U.S. state of Delaware and headquartered outside Tel Aviv but is not affiliated with the state of Israel. The surge of investor enthusiasm for Stardust comes amid stalled political efforts in Washington and other capitals to reduce the use of oil, gas and coal — the main drivers of climate change. Meanwhile, global temperatures continue to climb to new heights, worsening wildfires, floods, droughts and other natural disasters that some U.S. policymakers have baselessly blamed on solar geoengineering. The new influx of cash is four times the size of the startup’s initial fundraising round and, Yedvab argued, represents a major vote of confidence in Stardust and its strategy to land government contracts for deploying its technology at a global scale. It also shows that a growing pool of investors are willing to bet on solar geoengineering — a technology that some scientists still consider too dangerous to even study. Even advocates of researching solar geoengineering question the wisdom of pursuing it via a for-profit company like Stardust. “They have convinced Silicon Valley [venture capitalists] to give them a lot of money, and I would say that they shouldn’t have,” said Gernot Wagner, a climate economist at Columbia Business School and author of the book “Geoengineering: The Gamble.” “I don’t think it is a reasonable path to suggest that there’s going to be somebody — the U.S. government, another government, whoever — who buys Stardust, buys the [intellectual property] for a billion bucks [and] makes the VC investors gazillions. I don’t think that is, at all, reasonable.” Lowercarbon Capital did not respond to emailed questions. Stardust claims to have created a particle that would reflect sunlight in the same way debris from volcanic eruptions can temporarily cool the planet. The company says its powder is inert, wouldn’t accumulate in humans or ecosystems, and can’t harm the ozone layer or create acid rain like the sulfur-rich particles from volcanoes. It plans to seek government contracts to manufacture, disperse and monitor the particles in the stratosphere. The company is in the process of securing patents and preparing academic papers on its integrated solar geoengineering system. The startup would use the money it has raised to begin “controlled outdoor experiments” as soon as April, Yedvab told POLITICO. Those tests would release the company’s reflective particles inside a modified plane flying about 11 miles (18 kilometers) above sea level. The idea, Yedvab explained, is that “instead of displacing the particles out to the stratosphere and start following them, to do the other way around — to suck air from the stratosphere and to conduct in situ experiments, without dispersing essentially.” He said the company could have raised more money but only sought the funding it believes is necessary for the initial stratospheric testing. Stardust only took cash from investors who are aligned with the company’s cautious approach, he added. The fundraising round wasn’t conducted “from a point of view of, let’s get as much money as we can, but rather to say, this is what we need” to advance the technology, Yedvab said. Stardust’s new investors include the U.S. firms Future Ventures, Never Lift Ventures, Starlight Ventures, Nebular and Lauder Partners, as well as the British groups Attestor, Kindred Capital and Orion Global Advisors. Future Positive Capital of Paris and Berlin’s Earth.now also joined the fundraising round. Corbin Hiar reported from Washington. Karl Mathiesen reported from London.

The European Commission has opened a door marked danger. In July it issued a guidance letter blessing the creation of what is known as an Automotive Licensing Negotiation Group (Auto LNG). In doing so, it gave the green light to rival carmakers to form a cartel-like entity to negotiate licenses for patents that underpin standardized technologies (standards essential patents, or SEPs).   > SEPs are vital in many industries because they enable devices and services to interoperate seamlessly across different manufacturers, platforms and geographies. They cover technologies such as Wi-Fi, 5G and video coding, and are integral to the Internet of Things.   > SEPs are vital in many industries because they enable devices and services to > interoperate seamlessly across different manufacturers, platforms and > geographies. For decades, EU competition law treated the collective bargaining among competitors that LNGs of any kind represent as off-limits. The timing of the change was not incidental.   In September the Commission also released draft revisions of its Technology Transfer Block Exemption Regulation and Technology Transfer Guidelines (TTG). Together, these texts shape how Europe manages its innovation economy, including its SEP licensing market.  A success story at stake  On the positive side, the drafts reaffirm the importance of transparent patent pools. Such pools bring together complementary SEPs owned by multiple parties and make them available through a single license. Pools cut transaction costs, create efficiencies and provide clarity to technology implementers.    SEP owners who contribute technology to a standard promise to license their patents on fair, reasonable and non-discriminatory (FRAND) terms. Pools put that commitment into practice by offering a single license that the market can accept or reject.   The draft TTG strengthens requirements for transparency and governance in pools by emphasizing the importance of essentiality checks, published terms, open participation and safeguards against collusion. These measures codify practices many pools already follow. In doing so, the Commission is rightly cementing transparent pools’ role as trusted intermediaries in SEP licensing.  LNGs and FRAND cannot co-exist  Properly structured pools only succeed if implementers view their terms as balanced; they cannot ‘enforce’ acceptance into existence. When the market pushes back, pools adjust. That responsiveness makes them both pro-competitive and self-correcting.   LNGs invert that logic. As coalitions of buyers, their explicit objective is to aggregate purchasing power to secure discounts from the prevailing FRAND rate — all while their members continue to use the technology. However, the non-discrimination limb of FRAND makes across the board ‘group discounts’ very hard to square with commitments owed to all implementers, including those that have already taken licenses, directly or through a pool. This distorts competition by enabling buyers to exert undue pressure on licensors.  The draft TTG seeks to allay concerns by requiring LNG participation to be open and internally non-discriminatory, yet it does not grapple with the external effect on the SEP holder’s non-discrimination duty. That omission risks forcing a de facto “LNG rate” onto the whole market.   Asymmetry and holdout risk  The asymmetry here is striking. If price talks fail for tangible inputs, suppliers can simply stop shipments. Not so with SEPs: once standardized, the technology is embedded and keeps being used unless long, costly litigation is pursued. This reality gives coordinated buyers leverage to delay or avoid paying – a textbook recipe for holdout and cartel-like behavior.  Some argue that if licensors can license jointly through pools, licensees should be able to do so in LNGs. This is false logic. Pools aggregate non-competing assets to make complementary patents accessible. LNGs aggregate competing buyers to dictate price, a monopsony dynamic that competition law has long treated with suspicion. Pools, by contrast, have no such power. They live or die by market acceptance. Their incentive is to align with existing demand.  Process shortcuts, shaky justifications  Equally troubling is how the Commission chose to act. The July letter was issued under an ‘informal guidance’ procedure, an opaque tool usually used to clarify cutting-edge cases. SEP holders and smaller innovators were not consulted, despite being directly affected.  The substantive justification is no better. Both the Commission and Germany’s Bundeskartellamt, which had previously authorized the ALNG in June 2024, leaned on a market-share threshold, finding automakers represent less than 15 percent of the ‘general mobile communications’ market.   However, connected cars represent a completely separate vertical, with distinct technical features like vehicle-to-vehicle communication, and the market threshold should apply to it specifically. Furthermore, in licensing markets, a coordinated 15 percent holdout can freeze dealmaking across the board. That risk is ignored.  > Connected cars represent a completely separate vertical, with distinct > technical features. Meanwhile, the invocation of decarbonization as a reason to tolerate cartel-like structures conflates policy domains. Climate objectives, however worthy, cannot excuse weakening competition law guardrails.  Keep the back door closed  Pools already deliver the benefits LNGs claim — lower transaction costs, broader access, transparent terms, market efficiencies — without cartel risks. Most importantly, the FRAND framework, tested in courts and practice, continues to support rapid technology rollouts across the EU and is fully compatible with pools. It is utterly incompatible with LNGs. To adhere to FRAND principles that are the cornerstone of SEP licensing worldwide, LNGs cannot exist.  > Pools already deliver the benefits LNGs claim — lower transaction costs, > broader access, transparent terms, market efficiencies — without cartel risks. If the Commission wants to modernize SEP policy, it should do so openly and only when market failures are identified. This involves consultation to establish clear criteria and evidence of consumer benefit. By contrast, its current approach threatens to disrupt efficient markets, squeeze royalties that fund research and development, and slow Europe’s pace of innovation.  In reinforcing transparent pools, the Commission got one big thing right with its draft TTG. It should not squander that by blessing LNGs.  Roberto Dini has more than 40 years’ experience in patent licensing and is recognized as one of the global market’s most respected experts.    For a detailed analysis of the legal, economic and procedural defects in the Auto LNG approach — and a fuller comparison between pools and LNGs — see: Auto Licensing Negotiation Groups are a Bad, Anticompetitive Idea.   

RINGASKIDDY, Ireland — When Pfizer started manufacturing its anti-impotence drug Viagra in southwestern Ireland, locals experienced a spike in sexual arousal, five-legged rabbits proliferated, and visitors took U-turns back to their spouses after fumes from its local plant drifted in through their car windows.   That’s according to local legend, at least.  These stories “transited through the local pub,” said Pat Hennessy, a long-term resident of Shanbally, just up the road from the coastal village of Ringaskiddy. “There was a girl there and she said: ‘One whiff and they’re stiff.’”   The impact of Big Pharma on the area, however, goes far beyond amusing anecdotes: Its arrival in the 1970s turned a sleepy fishing village into an industrial powerhouse and turbocharged economic growth in County Cork. But today, the industry — and the region that depends on it — are in the eye of U.S. President Donald Trump’s tariff storm.  As he drives to slash the massive U.S. trade deficit, Trump says he is determined to reshore the production of weight-loss drugs, cancer treatments and other pharmaceuticals. He has threatened to eventually slam tariffs as high as 250 percent on the sector.  Ireland, Trump says, “took our pharmaceutical companies away” with its tax policies: Of the $213 billion of medicines the U.S. imports, the largest share comes from Ireland, a global leader in the production of expensive brand-name medicines. Dublin’s liberal tax regime has exerted an irresistible pull on U.S. Big Pharma for decades.  Locals find only limited solace in a deal struck in July between the European Union and the White House which — at least on paper — caps U.S. tariffs on pharmaceutical imports from the EU at 15 percent and exempts generic medicines. Ireland, as one of the EU’s most open economies, is particularly vulnerable to the tariffs, and uncertainty persists over Trump’s next moves and the damage they could inflict.  “It’s still like an axe hanging over us,” said David Collins, the fifth-generation owner of a family-run store in Carrigaline, a commuter town 20 minutes by bike from Ringaskiddy. “It’s a constant threat.”  The area is home to seven of the 10 largest pharma companies worldwide. More than 11,000 people in County Cork work in the industry — with tens of thousands more in ancillary jobs. Ringaskiddy alone hosts Pfizer and Johnson & Johnson, Sterling Pharma Solutions producing for Novartis, as well as smaller firms such as Recordati, BioMarin and Hovione. In addition to Viagra’s active ingredient, critical components of cardiology, immunology and oncology medications are made here.   PITCH AND PUTT  When Pfizer arrived in 1969, its workers spent their lunch breaks building a course to play pitch and putt — a scaled-down version of golf — for the local community, recalled Michael Goably, a pensioner, while enjoying his morning coffee at the clubhouse of Raffeen Creek Golf Club, nestled on the lush shores of Cork harbour.  As the name suggests, a nine-hole golf course, also built on land owned by Pfizer, now complements the pitch and putt. It’s just one example of how the area has benefited from big pharma: Ask the locals, and they’ll tell you the industry’s contribution far outweighs the side effects, such as commuter traffic and environmental pollution.  “I couldn’t say a bad word,” said Ray Keohane, another golfer taking a break on a bench between rounds.  The town of Carrigaline, once an agricultural village, now counts 20,000 residents, as well as a hotel, several supermarkets and a lively shopping street.  “When I was a child growing up in Carrigaline, there was one main industry, and it was called Carrigaline Pottery … there wasn’t a family in the area of Carrigaline that didn’t at least have one person working in the pottery,” said Collins, the supermarket owner.  “Roll on 50 years later, that’s been replaced by the pharmaceutical industries.”  CELTIC TIGER  The arrival of multinational corporations softened the impact of the closure of manufacturing sites by carmaker Ford and Dunlop, a tyre company, in the 1980s. “Ireland as a country wasn’t doing well, but Cork was a particularly black spot then,” said John O’Brien, a lecturer in finance at University College Cork. “The combination of pharmaceuticals and IT … together really have brought up the city,” he added, referring to Ireland’s second-largest city Cork, which hosts the EU headquarters of tech giant Apple.   Nationally, the success in the pharma sector helped drive economic growth in Ireland’s “Celtic Tiger” era from the 1990s to the late 2000s. That’s thanks to large-scale foreign investment — especially from the U.S. — low corporate taxes, a skilled English-speaking workforce and EU membership.  According to Louis Brennan, an emeritus professor at Trinity College Dublin, pharma’s contribution was threefold: It created high-value and high-paying jobs, led to the development of an ecosystem of suppliers and subcontractors, and generated government revenues.   Cork has also established itself as a hub for higher education in pharma-related fields.   TARIFF GAMES  Since Trump’s return to the White House, that engine of the Irish economy finds itself under (verbal) attack, exposing just how much Irish success hinges on the country’s capacity to remain the go-to location for U.S. firms, which beyond welcoming tax benefits have also long shifted their profits and patents there.  “We want pharmaceuticals made in our country,” Trump told CNBC in August.  As part of his vow to slash drug prices and bring manufacturing back to the U.S., Trump in April opened a so-called Section 232 investigation into the pharmaceutical sector to probe the impact of imports on national security and impose tariffs if needed.   Analysts estimate that Trump is unlikely to impose a tariff as high as the threatened 200 or 250 percent. However, a first “lower tariff” — no higher than 15 percent, provided Trump does indeed stick to the terms of the EU-U.S. agreement — could yet be followed by a heavily disruptive tariff of around 50 percent after a year or two. The message isn’t lost on big pharma: Giants such as Eli Lilly and Johnson & Johnson have this year announced new investments in the U.S. Yet experts warn Trump’s tariff policy risks driving up drug prices and leading to shortages, rather than spurring large-scale relocation.  While the 15 percent tariff cap foreseen by the EU-U.S. deal offers the industry a reprieve, companies need to make tricky calculations, warned Dan O’Brien, chief economist at the Institute of International and European Affairs, an Irish think tank.  “For those products that are uniquely made in Ireland there is at least some element of a buffer: It’ll take a few years for production to move out of Ireland, in a worst-case scenario,” he said. For products also made elsewhere, it will be easier to shift production and “could happen more quickly,” he added.  RISKY BUSINESS   For now, those scenarios remain hypothetical — but the unpredictability is already leaving its mark.   As companies rushed to export their goods, Irish pharma exports to the U.S. surged by nearly 50 percent in the first five months of this year. “Geopolitical concerns” now rank among the top three threats to business in the Cork Chamber of Commerce’s last survey of its members.  Companies are mostly keeping quiet. Pfizer and Johnson & Johnson declined to comment for this story, whereas Sterling Pharma Solutions, BioMarin, Recordati and Hovione did not respond to requests for comment. Novartis, which is supplied by Sterling Pharma Solutions, warned that “the introduction of tariffs risks creating additional barriers that could further delay access to life-saving treatments.”  Giants such as Eli Lilly and Johnson & Johnson have this year announced new investments in the U.S. | Cristina Arias/Getty Images Reacting to the deal between the EU-U.S. deal, the Irish Pharmaceutical Healthcare Association warned that “tariffs on medicines would be a substantial new cost where there was none before and a drag on investment, jobs and innovation.”  A worker at a pharma plant in the area, granted anonymity to protect their job security, told POLITICO output had slowed in the last couple of months as the company waited to regain planning certainty. Similarly, Dan Boyle, a Green Party councillor for Cork and the city’s former mayor, said companies told him that “our hope was that we would have announced future investment for 2030, and that’s being sat on, until we know what the situation is going to be.”  UNDER PRESSURE  Local, national and European politicians are acutely aware of just how much is at stake.  Séamus McGrath, a Dáil deputy for the Cork South-Central constituency, called for a “continuous process of renegotiation and engagement” with Washington.   “We need to renew our pitch and renew our attraction as a country for foreign direct investment,” said McGrath, sitting in the lobby of the Carrigaline Court Hotel, the town’s only hotel. “You cannot sit back.”   The politician with the co-governing centrist Fianna Fáil party entertains strong ties with Brussels, not least thanks to his brother, EU Justice Commissioner Michael McGrath.  In the EU capital, lawmakers from the region are urging the EU to boost the bloc’s competitiveness. Cynthia Ní Mhurchú, of the liberal Renew Europe group, called for cutting “excessive red tape” for businesses. And Seán Kelly, an MEP with the centre-right European People’s Party, welcomed the European Commission’s plans to secure access to new markets through trade deals.  After all, for locals back on the Irish coast, power politics determine no less than their personal future.  “They say they [the big companies] will go away,” said Amy Lyons, a bartender at Ringaskiddy’s only pub, The Ferry Boat Inn.    “I’m doing a biopharma course in college. So, imagine I get my degree, and they are gone,” she added as she drew pints for the regulars, who were discussing a new road being built to ease road congestion — caused by commuter traffic to the pharma plants.  Graphics by Hanne Cokelaere.