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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BRUSSELS — Europe needs to get its “act together” and unleash its potential in the pharmaceutical sector, supporting it with better incentives and ensuring access to innovation for patients, urged Stefan Oelrich, president of Bayer’s pharmaceuticals division. “Europe used to be the pharmacy of the world. Nine out of 10 new medicines were discovered in Europe. That’s no longer the case,” Oelrich, who is also president of the European Federation of Pharmaceutical Industries and Associations (EFPIA), said at the POLITICO 28 Gala Dinner. “We’re losing competitiveness rather than gaining.” China and the U.S. are pulling ahead on pharmaceutical innovation and clinical trials. About one third of medicines approved by the U.S. Food and Drug Administration (FDA) don’t make it to Europe, Oelrich said. And amid the U.S. tariffs threat, companies are increasingly looking outside of Europe for investments. But there is hope — both for the pharmaceutical industry and beyond. Per Franzén, CEO and managing partner at EQT, a global investment organization, said he is seeing “an unprecedented interest to invest into Europe.” “It’s a real window of opportunity, a unique moment in time for Europe,” he said. “In order to make the most out of that opportunity, what we need to do is really to drive a more business-friendly, more innovation-friendly agenda,” he said. But with the pace of change, driven by artificial intelligence, “time is of the essence,” he added. Over-regulation isn’t holding Europe back in medicines innovation, it’s a lack of substantial incentives for companies to invest in Europe, Oelrich said. But it doesn’t have to be this way, he said: “We have some of the best universities in the world that publish some of the coolest science in the world. So there is no reason why this wouldn’t work. And we need to get our act together,” he said. “Instead of trying to complicate our lives and come up with a new bureaucratic idea, we should come up with with ways of how we unleash our forces.”

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.

Lobbyists for some of the world’s largest drug companies are parading a new pricing deal in the U.K. as a model the rest of Europe should emulate if it wants to keep drugmakers from bailing for America. To President Donald Trump and the lobbyists’ delight, British officials agreed to spend 25 percent more on new medicines in exchange for three years of tariff relief on pharmaceutical exports to the U.S. The move comes as major drugmakers like AstraZeneca and Merck scrap projects in the U.K., and the Trump administration uses tariff threats to get pharma to raise prices on Europeans in order to cut them for Americans. For Washington’s lobbyists, the deal reflects the new influence playbook, as Trump’s tariff threats force companies to negotiate directly with the White House. Industry leaders say the U.K. deal could serve as a template for how the EU and other major trade partners handle the Trump administration’s break from free market norms, and stay competitive. “The U.K. is the canary in the coal mine,” said Stephen Farrelly, global head of pharma and health care at ING, a Dutch bank. “The pressure is rising on the EU to do something similar.” Lobbyists for drug companies are pounding the point home. Dorothee Brakmann, general manager of Pharma Deutschland, Germany’s industry lobby, warned that if Germany did not pursue a similar path to the U.K., Trump’s tariffs presented a “real geopolitical risk.” “The UK-US agreement is an important signal for Europe’s pharmaceutical landscape. …[It] reinforces the need to reassess how we can make our own reimbursement system more flexible, more innovation-friendly and more internationally competitive,” she wrote POLITICO in a statement. Alex Schriver, senior vice president of public affairs at the Pharmaceutical Research and Manufacturers of America, the U.S. industry lobby for brand-name drugmakers, echoed the German pharma group’s call for similar country deals. “The agreement establishes important first steps by the U.K. to pay its fair share for innovative medicines and directly benefits American patients by exempting medicines from tariffs. We encourage the Trump Administration to seek similar agreements with other nations,” Schriver said in a statement. Henrik Jeimke-Karge, spokesperson for Verband Forschender Arzneimittelhersteller, another German pharmaceutical group, said that the lack of an EU agreement meant continued uncertainty for the region. “The pharmaceutical industry in the U.K. has now gained planning security. Such an agreement is still pending for the EU. …The risk of customs duties remains high and uncertainty persists,” he said in a statement. Trump has repeatedly blamed European pharmaceutical companies for higher U.S. drug prices, threatened a 100 percent tariff on pharmaceutical products and demanded drugmakers implement “most favored nation pricing,” which would bring U.S. prices in line with those paid in other wealthy nations. The threats have triggered British and European drugmakers to bolster their defenses on K Street, Washington’s lobbying corridor. Lobbying spending from July to September from GSK, AstraZeneca, Novartis, NovoNordisk, and Genentech, a subsidiary of Roche, were the highest for the time period in at least a decade. Year-to-date spending from AstraZeneca, EMD Serono, Novo Nordisk and Sanofi are also at a 10-year high. European drugmakers are also ramping up their hiring of outside lobbying firms. DLA Piper, Corcoran & Associates, and B Hall Strategies registered to lobby for Novartis this year, which hired no new outside firms last year. Lobbyists for Novartis now include Richard Burr, the former top Republican on the Senate Health, Education, Labor and Pensions Committee and Michael Corcoran, a prominent Republican lobbyist from Florida. Alkermes and Novo Nordisk have hired Ballard Partners, a Trump-connected lobbying firm, and Genentech has hired lobbyists at Miller Strategies, including Jeff Miller, a long-time Republican strategist and Ashley Gunn, a former special assistant to Trump in his first term. GSK, Sanofi and Novo Nordisk, meanwhile, have all hired lobbyists at Checkmate Government Relations this year, including Fritz Vaughan, a Treasury official in the first Trump administration. “Policy is not siloed from business strategy right now,” said Allison Parker-Lagoo, deputy of the North America health practice at APCO, a public and government relations firm that advises drug companies. “The geopolitical environment is just requiring that everyone really think critically about how they’re showing up in each market that they operate in.” In exchange for tariff reprieve, five drugmakers, including AstraZeneca, EMD Serono and Novo Nordisk have cut deals with Trump to lower prices. The pharmaceutical industry has together announced more than $400 billion in commitments to U.S. manufacturing, research and development since January, according to ING, the Dutch bank, including a $50 billion commitment from Roche, $23 billion from Novartis, and $20 billion from Sanofi. “Trump is demonstrating that he’s willing to go further than anyone else to achieve his goals…Most companies and industries are having a conversation saying, ‘Let’s bring some solutions to the table,’ as opposed to just sitting back and holding the line,” said one health care lobbyist granted anonymity to speak candidly about strategy. “It’s a big shift, and you don’t want to be the last one to the dance,” the lobbyist added. Concerns over Europe’s pharmaceutical competitiveness were mounting prior to Trump’s second term. E.U. spending on research and development grew on average 4.4 percent annually from 2010 to 2022, while U.S. spending grew by 5.5 percent and China by more than 20 percent, according to the European Federation of Pharmaceutical Industries and Associations, the EU’s pharmaceutical trade group, which did not respond to request for comment. Last year, the U.S. saw $6.7 billion in pharmaceutical manufacturing investments from foreign companies, compared to $5.9 billion in Europe, according to estimates from fDi Markets, a database owned by the Financial Times. Advocates for drug companies warned that the Trump administration’s pricing and tariff policies will accelerate the shift. “It speaks to the reorienting of the global biopharmaceutical economy…For the first time, the U.S. government is getting involved in the pricing and access behaviors of other countries,” said Kirsten Axelsen, a senior policy adviser at DLA Piper, a law and lobbying firm. “[Companies] are advocating…to avoid the types of policies that would really make it almost impossible to launch a drug in European countries.”

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. 

LONDON — The U.K. has agreed to raise how much its National Health Service spends on new drugs, in a concession made under pressure from the Trump administration in return for tariff-free access to the U.S. market. “Today’s agreement is a major win for American workers and our innovation economy,” U.S. Commerce Secretary Howard Lutnick said in a statement on Monday. “This deal doesn’t just deepen our economic partnership with the United Kingdom — it ensures that the breakthroughs of tomorrow will be built, tested, and produced on American soil.”  The deal will see Britain increase the National Institute for Health and Care Excellence (NICE) cost-effectiveness threshold by 25 percent, as POLITICO first reported in October, and slash the cap on revenue the NHS can reclaim from drugmakers to no more than 15 percent.  The new NICE threshold will be £25,000 to £35,000 per quality adjusted life year gained over and above current treatments. The U.S. said the combined changes would increase the net price the NHS pays for new medicines by 25 percent. In exchange, the administration will grant an exemption for U.K.-made pharmaceuticals, ingredients and medical technology from U.S. tariffs for the remainder of President Donald Trump’s term.  U.K. Business and Trade Secretary Peter Kyle said: “This deal guarantees that UK pharmaceutical exports – worth at least £5 billion a year – will enter the US tariff free, protecting jobs, boosting investment and paving the way for the UK to become a global hub for life sciences. “We will continue to build on the UK-US Economic Prosperity Deal, and the record-breaking investments we secured during the US State Visit, to create jobs and raise living standards as part of our Plan for Change.” The breakthrough comes after months of back-and-forth between both sides, with the sector not covered in the Economic Prosperity Deal and Washington demanding a “preferential environment” to lift the threat of steep import duties. The administration had threatened to impose up to 100 percent tariffs on drugs.  In July, the President issued a letter to 17 drugmakers, demanding they offer their drugs to Medicaid at most-favored-nation prices, prices tied to lower prices abroad, and shift manufacturing to U.S. soil.  Update: This story has been updated following confirmation from the U.S. and U.K. governments.

LONDON — American pharmaceutical giants will start to shutter their U.K. operations unless Keir Starmer’s government agrees to pay more for their drugs, U.S. Ambassador to the U.K. Warren Stephens warned ministers on Wednesday. “The U.K. needs to continue addressing its pricing structures for medicines to ensure it can compete for investment from U.S. firms,” Stephens told a U.K.-U.S. business gathering in central London attended by British trade and foreign ministers. “If there are not changes made, and fast, pharma businesses will not only cancel future investments, they will shut down their facilities in the U.K.,” the diplomat said. “This would be a major blow to a country that prides itself, rightly so, on its life sciences sector.”  The U.K. is locked in drug-pricing negotiations with the Trump administration and pharmaceutical firms about how much the National Health Service pays for their products through the so-called Voluntary Scheme for Pricing, Access and Growth (VPAG) scheme. Britain has offered to increase the threshold at which the NHS pays firms for medicines by up to 25 percent, POLITICO first reported in October. But pharmaceutical executives are pushing the government to go further. American drugmaker Eli Lilly’s international business chief said on Monday that it wants to see more changes to Britain’s medicine market before it pivots on its abandoned £279 million investment in a biotech incubator project. “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. The focus of talks has turned to the government’s “clawback” system, where firms have to pay back part of their revenue if the total amount the NHS spends on drugs rises above a certain cap. Unless ministers agree to also raise that cap, any extra NHS spending will mean a larger clawback bill for pharma companies. Pricing talks feature in the U.K.’s ongoing trade negotiations with Washington after Starmer struck a framework trade deal with Trump in May, promising to “improve the overall environment” for pharmaceutical firms operating in Britain. U.K. negotiators are currently in Washington and “progress is being made on this literally as we speak,” Stephens said, adding he hopes “that will yield some success.”  The U.K.’s “chief obstacle” to growth is also its high energy costs, Stephens added. “If there are not major reforms to U.K. energy policy, then the U.K.’s position as a premier destination in the global economy is vulnerable.”  Britain’s Labour government is “completely signed up to an ambitious agenda for business,” said Trade Minister Chris Bryant, in an address following Stephens’ speech. He set out how the government plans to “integrate” its industrial, small business and trade strategies to grow the economy.

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.

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.