Tag - Pharma

All the economic wins Keir Starmer wants to bag in China
LONDON — Keir Starmer is off to China to try to lock in some economic wins he can shout about back home. But some of the trickiest trade issues are already being placed firmly in the “too difficult” box. The U.K.’s trade ministry quietly dispatched several delegations to Beijing over the fall to hash out deals with the Chinese commerce ministry and lay the groundwork for the British prime minister’s visit, which gets going in earnest Wednesday. But the visit comes as Britain faces growing pressure from its Western allies to combat Chinese industrial overproduction — and just weeks after Starmer handed his trade chief new powers to move faster in imposing tariffs on cheap, subsidized imports from countries like China. For now, then, the aim is to secure progress in areas that are seen as less sensitive. Starmer’s delegation of CEOs and chairs will split their time between Beijing and Shanghai, with executives representing City giants and high-profile British brands including HSBC, Standard Chartered, Schroders, and the London Stock Exchange Group, alongside AstraZeneca, Jaguar Land Rover, Octopus Energy, and Brompton filling out the cast list. Starmer will be flanked on his visit by Trade Secretary Peter Kyle and City Minister Lucy Rigby. Despite the weighty delegation, ministers insist the approach is deliberately narrow. “We have a very clear-eyed approach when it comes to China,” Security Minister Dan Jarvis said Monday. “Where it is in our national interest to cooperate and work closely with [China], then we will do so. But when it’s our national security interest to safeguard against the threats that [they] pose, we will absolutely do that.” Starmer’s wishlist will be carefully calibrated not to rock the boat. Drumming up Chinese cash for heavy energy infrastructure, including sensitive wind turbine technology, is off the table. Instead, the U.K. has been pushing for lower whisky tariffs, improved market access for services firms, recognition of professional qualifications, banking and insurance licences for British companies operating in China, easier cross-border investment, and visa-free travel for short stays. With China fiercely protective of its domestic market, some of those asks will be easier said than done. Here’s POLITICO’s pro guide to where it could get bumpy. CHAMPIONING THE CITY OF LONDON Britain’s share of China’s services market was a modest 2.7 percent in 2024 — and U.K. firms are itching for more work in the country. British officials have been pushing for recognition of professional qualifications for accountants, designers and architects — which would allow professionals to practice in China without re-licensing locally — and visa-free travel for short stays. Vocational accreditation is a “long-standing issue” in the bilateral relationship, with “little movement” so far on persuading Beijing to recognize U.K. professional credentials as equivalent to its own, according to a senior industry representative familiar with the talks, who, like others in this report, was granted anonymity to speak freely. But while the U.K.’s allies in the European Union and the U.S. have imposed tariffs on Chinese EVs, the U.K. has resisted pressure to do so. | Jessica Lee/EPA Britain is one of the few developed countries still missing from China’s visa-free list, which now includes France, Germany, Italy, Spain, the Netherlands, Switzerland, Australia, New Zealand, Japan, Saudi Arabia, Russia and Sweden.  Starmer is hoping to mirror a deal struck by Canadian PM Mark Carney, whose own China visit unlocked visa-free travel for Canadians.  The hope is that easier business travel will reduce friction and make it easier for people to travel and explore opportunities on the ground — it would allow visa-free travel for British citizens, giving them the ability to travel for tourism, attend business conferences, visit friends and family, and participate in short exchange activities.  SMOOTHING FINANCIAL FLOWS The Financial Conduct Authority’s Chair Ashley Alder is also flying out to Beijing, hoping to secure closer alignment between the two countries’ capital markets. He’ll represent Britain’s financial watchdog at the inaugural U.K-China Financial Working Group in Beijing — and bang the drum for better market connectivity between the U.K. and China. Expect emphasis on the cross-border investments mechanism known as the Shanghai-London and Shenzhen-London Stock Connect, plus data sovereignty issues associated with Chinese companies jointly listing on the London Stock Exchange, two figures familiar with the planning said. The Stock Connect opened up both markets to investors in 2019 which, according to FCA Chair Ashley Alder, led to listings worth almost $6 billion. “Technical obstacles have so far prevented us from realizing Stock Connect’s full potential,” Alder said in a speech last year. Alder pointed to a memorandum of understanding being drawn up between the FCA and China’s National Financial Regulatory Administration, which he said is “critical” to allow information to be shared quickly and for firms to be supervised across borders. But that raises its own concerns about Chinese use of data. “The goods wins are easier,” said a senior British business representative briefed on the talks. “Some of the service ones are more difficult.” TAPPING INTO CHINA’S BIOTECH BOOM Pharma executives, including AstraZeneca’s CEO Pascal Soriot, are among those heading to China, as Britain tries to burnish its credentials as a global life sciences hub — and attract foreign direct investment. China, once known mainly for generics — cheaper versions of branded medicine that deliver the same treatment — has rapidly emerged as a pharma powerhouse. According to ING Bank’s global healthcare lead, Stephen Farrelly, the country has “effectively replaced Europe” as a center of innovation. ING data shows China’s share of global innovative drug approvals jumped from just 4 percent in 2014 to 27 percent in 2024. Pharma executives, including AstraZeneca’s CEO Pascal Soriot, are among those heading to China, as Britain tries to burnish its credentials as a global life sciences hub — and attract foreign direct investment. | John G. Mabanglo/EPA Several blockbuster drug patents are set to expire in the coming years, opening the door for cheaper generic competitors. To refill thinning pipelines, drugmakers are increasingly turning to biotech companies. British pharma giant GSK signed a licensing deal with Chinese biotech firm Hengrui Pharma last July. “Because of the increasing relevance of China, the big pharma industry and the U.K. by definition is now looking to China as a source of those new innovative therapies,” Farrelly said. There are already signs of progress. Science Minister Patrick Vallance said late last year that the U.K. and China are ready to work together in “uncontroversial” areas, including health, after talks with his Chinese counterpart. AstraZeneca, the University of Cambridge and Beijing municipal parties have already signed a partnership to share expertise. And earlier this year, the U.K. announced plans to become a “global first choice for clinical trials.” “The U.K. can really help China with the trust gap” when it comes to getting drugs onto the market, said Quin Wills, CEO of Ochre, a biotech company operating in New York, Oxford and Taiwan. “The U.K. could become a global gold stamp for China. We could be like a regulatory bridgehead where [healthcare regulator] MHRA, now separate from the EU since Brexit, can do its own thing and can maybe offer a 150-day streamlined clinical approval process for China as part of a broader agreement.” SLASHING WHISKY TARIFFS  The U.K. has also been pushing for lowered tariffs on whisky alongside wider agri-food market access, according to two of the industry figures familiar with the planning cited earlier. Talks at the end of 2024 between then-Trade Secretary Jonathan Reynolds and his Chinese counterpart ended Covid-era restrictions on exports, reopening pork market access. But in February 2025 China doubled its import tariffs on brandy and whisky, removing its provisional 5 percent tariff and applying the 10 percent most-favored-nation rate. “The whisky and brandy issue became China leverage,” said the senior British business representative briefed on the talks. “I think that they’re probably going to get rid of the tariff.”  It’s not yet clear how China would lower whisky tariffs without breaching World Trade Organization rules, which say it would have to lower its tariffs to all other countries too. INDUSTRIAL TENSIONS The trip comes as the U.K. faces growing international pressure to take a tougher line on Chinese industrial overproduction, particularly of steel and electric cars. But in February 2025 China doubled its import tariffs on brandy and whisky, removing its provisional 5 percent tariff and applying the 10 percent most-favored-nation rate. | Yonhap/EPA But while the U.K.’s allies in the European Union and the U.S. have imposed tariffs on Chinese EVs, the U.K. has resisted pressure to do so. There’s a deal “in the works” between Chinese EV maker and Jaguar Land Rover, said the senior British business representative briefed on the talks quoted higher, where the two are “looking for a big investment announcement. But nothing has been agreed.” The deal would see the Chinese EV maker use JLR’s factory in the U.K. to build cars in Britain, the FT reported last week. “Chinese companies are increasingly focused on localising their operations,” said another business representative familiar with the talks, noting Chinese EV makers are “realising that just flaunting their products overseas won’t be a sustainable long term model.” It’s unlikely Starmer will land a deal on heavy energy infrastructure, including wind turbine technology, that could leave Britain vulnerable to China. The U.K. has still not decided whether to let Ming Yang, a Chinese firm, invest £1.5 billion in a wind farm off the coast of Scotland.
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How the EU’s stack of health files was a big win for industry
Faced with an ageing population and rising chronic disease rates, Europe wants to make its citizens healthier. It also needs to keep its most powerful industries happy. In the basket of health policies that EU lawmakers rushed to get across the line before Christmas, industry was the big winner: The pharmaceutical, food and drink sectors walked away with a set of major policy wins — and (potentially) healthier profits. While the pharma industry previously feared losing some of its monopoly rights on new drugs, the Commission this month offered it an extra year of patent protection for novel biotech drugs — among the most expensive treatments in the world. The food and drink sectors, meanwhile, successfully pushed back against proposals to tax ultra-processed foods and alcopops, for now. On Dec. 16 the Commission published its Biotech Act and Safe Hearts Plan, which landed just days after a long-awaited update of the pharmaceutical legislation. Taken together, they seek to incentivize industries to innovate and do business in Europe, improve access to medicines, and tackle the burden of cardiovascular disease. The pharma industry broadly celebrated the biotech proposal. The Biotech Act “reflects priorities we’ve intensively advocated to keep Europe globally competitive in life sciences,” Ognjenka Manojlovic, head of policy at European pharmaceutical company Sanofi, told POLITICO. That includes accelerating clinical trials, boosting intellectual property, and strengthening financing for Europe’s biotech ecosystem, Manojlovic said. The pharmaceutical sector had pushed for longer monopoly rights in the pharma legislation. In the end they were kept at the current standard eight years — instead of being cut by two years as the European Commission had initially proposed. For Europe’s public health insurers, who pay for drugs, the decisions taken to maintain and then extend market protections for medicines are hard to square. “We are puzzled by the Commission’s intentions,” said Yannis Natsis, director of the European Social Insurance Platform, a network of Europe’s social insurance organizations, warning that taxpayers will have to pick up the bill. Meanwhile, health campaigners are also unhappy at the Commission’s “missed opportunity” to tackle obesity and heart disease with junk food taxes — as proposed in an earlier draft of the Safe Hearts Plan. Samuele Tonello, at consumer organization BEUC, said the Safe Hearts Plan “lacks teeth” to better protect consumers from unhealthy foods, and flagged the “urgency of [cardiovascular diseases].”  A MAN ON A MISSION Health Commissioner Olivér Várhelyi has made no secret of his support for industry, and has championed the Commission’s competitiveness mantra since taking office in late 2024. Health Commissioner Olivér Várhelyi has made no secret of his support for industry, and has championed the Commission’s competitiveness mantra since taking office in late 2024. | Thierry Monasse/Getty Images The standout feature of his end-of-year bonanza was the 12-month patent extension in the Biotech Act I — legislation that was split in two late in the day, allowing Várhelyi to meet his end-of-year deadline for the pharma component. The proposal came just a week after the Commission, countries and MEPs clinched a deal to reform Europe’s pharmaceutical laws, in which IP rights were among the last issues to be settled. Updates to the pharma laws were a legacy of the last Commission, whereas the Biotech Act became something of a personal mission for Várhelyi. He repeatedly stressed that there was “no time to lose” in delivering a targeted policy aimed at revitalizing Europe’s flagging biotech industry, which risks being overtaken by competition from China and the U.S. Few commissioners are more vocal than Várhelyi about the premium they place on the competitiveness of European industry.  Industry insiders had heard whispers of his plans to expand IP incentives for the biotech sector, even if Council representatives were dismayed not to have been informed in advance — especially with the ink barely dry on the Pharma Package. That’s not to say pharma is happy with its lot. Industry lobby group the European Federation of Pharmaceutical Industries and Associations (EFPIA) tempered its praise of the Biotech Act, lamenting that the extra year of monopoly rights would only apply to a “limited subset of products.”  The extra year of protection is tied to the Commission’s efforts to locate more pharma research and manufacturing in Europe. It would apply only to new products, tested and at least partially made in Europe.  But the generics sector, which makes cheaper, off-patent drugs to compete with branded medicines, sees the Biotech Act as a further sweetening of what is already one of the world’s most generous IP systems. Lobby group Medicines for Europe claims each year of delayed competition for the top three biologic drugs would cost countries €7.7 billion. Longer IP “will have a dramatic impact on healthcare budgets and delayed patients’ access to essential medicines,” said Adrian van den Hoven, head of the lobby. These kinds of estimates would normally be included in an impact assessment published alongside the proposal, but in its haste to get the Biotech Act out the Commission didn’t do one. POLITICO asked the Commission for an estimate of what the extra year of patent protection would cost. A Commission spokesperson would not give a figure but said they had used the impact assessment for the pharma legislation as a reference. “It is also important to stress that the number of products eligible for an additional year of SPC will be limited to only those that are truly innovative and tested and manufactured in the EU. The approach is deliberately targeted to incentivise genuinely innovative therapies that deliver a clear added value for patients and support European innovation,” the spokesperson said. LUCKY ESCAPE FOR UPFS The big food and drink sectors are on shakier ground with Várhelyi. The commissioner has repeatedly made known his distaste for ultra-processed food, and an early leaked version of the Safe Hearts Plan included new taxes on unhealthy highly processed foods and alcopops. But the final proposal showed the Commission had undertaken a significant climbdown. Concrete targets to tax unhealthy food and drink in 2026 were gone, replaced with a much woollier commitment to “work towards” such a levy. Alcopops were excluded altogether.  Industry lobby FoodDrinkEurope took a far more measured tone on the final plan than its explosive reactions to the earlier leaks, but that may well ramp up again if and when health tax proposals emerge. The text suggests the soft drinks industry may be the Commission’s first target if it does decide to pursue new levies, while UPFs remain in Várhelyi’s sights. “In the next couple of years, we will need to tackle the issue of ultra-processed food much more,” he told MEPs in December. For now, though, the plan seems to have let industry off easy. Health NGOs saw it as a disappointment, given its lack of hard-hitting policies to reduce consumption of UPFs and other unhealthy products. While the pharma legislation is all wrapped up, the Biotech Act still needs to win the approval of EU countries and the European Parliament. For the food and pharma sectors, the proposals set out this month are confirmation they have allies in the Berlaymont.
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Medicines
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Europe faces a pivotal moment in health innovation
C-ANPROM/EUC/NON/0052 -------------------------------------------------------------------------------- Disclaimer POLITICAL ADVERTISEMENT * The sponsor is Takeda * The advertisement is linked to policy advocacy around and industrial policy agenda, including the Pharma Package, Biotech Act, Life Sciences Strategy, and related digital and innovation frameworks. More information here
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Research and Development
Europe must get its act together to regain global competitiveness, industry says
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.”
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EU legislators strike pharmaceutical deal
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.
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Pharma lobbyists to EU: Cut deals with Trump
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.”
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Trade
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Medicines
Ozempic-style drugs should be available to all, not just the rich, says WHO
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. 
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Doctors
Health systems
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Trump admin claims win as UK bows to pressure on NHS drug spending
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.
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Can the Critical Medicines Act deliver for Europe?
As trilogue discussions on the Critical Medicines Act (CMA) approach, its potential effects on medicine supply, patient access and Europe’s competitiveness are increasingly in focus. From an industry standpoint, several considerations are central to understanding how this act can best achieve its objectives and support a robust pharmaceutical ecosystem in Europe.  Keeping the CMA focused where it matters  Much of the debate around the CMA has centered on its promises to strengthen the availability and security of supply of critical medicines in the EU while improving accessibility to other medicines. These are goals that our industry fully supports.   The European Commission’s proposal is designed to focus on critical medicines, with a vulnerability assessment foreseen to identify which products are truly at risk of disruption and tailor solutions accordingly. Alongside critical medicines, the proposal also introduces a new definition of ‘medicinal products of common interest’. Under current wording, this would include any medicine unavailable in at least three member states, regardless of the underlying reason.   Such a broad definition risks turning a targeted framework for resilience into an all-encompassing mechanism covering almost every medicine on the market, blurring the distinction between supply and access challenges. These are fundamentally different issues that require fundamentally different policy tools.   > Applying the CMA’s tools across the entire medicines market would dilute > priorities, stretch healthcare budgets and create administrative burdens for > industry without delivering real benefits for patients.   The act will be far more effective if it remains focused on where the risks are greatest — in other words, by limiting the ‘medicinal products of common interest’ definition to cases of demonstrable market failure and directing measures toward genuinely critical medicines with a proven risk of supply disruption.  Fixing supply and access hurdles needs more than joint procurement   The CMA places joint procurement at the center of its strategy to address both supply and access challenges. While this approach can contribute to improving availability in certain circumstances, joint procurement will only deliver lasting results if it is designed to address the underlying causes of access delays and shortages, which vary across geographies and products.  For medicines where the main challenge lies in fragile supply chains, joint procurement can play a role, particularly when it enhances predictability and economic viability for suppliers. Experience from the Covid-19 pandemic has shown that coordinated purchasing can be effective in targeted situations. For medicines facing access delays, joint procurement could help improve availability in countries where genuine market failures exist. However, the value of joint procurement for countries where products are already available, or where access barriers can be better addressed by improving national pricing and reimbursement systems, is very questionable.  To ensure that joint procurement does not hinder access, several safeguards are essential. Tenders should reward quality and promote innovation, recognizing the value that innovative medicines bring to patients and society. Price confidentiality must be protected to prevent unintended spillovers, such as reference pricing effects. Once joint procurement agreements are concluded, to ensure commercial and supply predictability there should be no additional national renegotiations or expenditure control measures. Finally, allowing national procurement processes to run in parallel will be key to avoid delays and maintain flexibility.  Beyond these design safeguards, real progress will depend on tackling the broader root causes of shortages and access delays. For supply fragility, this means, among other actions, reducing strategic dependencies where necessary, improving transparency across supply chains and avoiding rigid national stockpiling rules. For access delays, progress will require addressing national pricing and reimbursement challenges, and a greater willingness from governments to reward the value that innovative medicines deliver.  Protectionism won’t make Europe stronger  Few elements of the CMA debate have attracted as much attention as the idea of prioritizing EU-made medicines. The rationale is straightforward: producing more within Europe is expected to reduce reliance on third countries, reinforce strategic autonomy and, ultimately, improve supply security. While this narrative is understandable, taking it at face value risks overlooking the realities of how medicines are manufactured and supplied today.  Europe already has one of the world’s strongest pharmaceutical manufacturing footprints and, unlike some other pharma manufacturing regions, Europe exports 71 percent of its pharmaceutical production. This output depends on global supply networks for active substances, raw materials and specialized technologies. Introducing local-content requirements or preferential treatment for EU-made products would disrupt those networks, fragment supply chains and drive up costs, with limited evidence that such measures would enhance resilience. Local-content requirements could also affect Europe’s trade relationships and weaken, rather than strengthen, its industrial base in the long term, while distorting competition within the single market and undermining the competitiveness of both European and international companies operating in Europe. The likely outcome would be less diversity and greater concentration in supply chains: the opposite of what a resilient system requires.  If procurement criteria referencing resilience or strategic autonomy are used, they should be proportionate and tied to clearly demonstrated dependencies or supply risks. Protectionist approaches, however well-intentioned, cannot substitute for the broader policy environment needed to keep Europe attractive for investment in research and development and manufacturing. A competitive European ecosystem depends first and foremost on predictable intellectual-property rules, timely regulatory processes, access to capital, and a strong scientific and technical skills base.  The EU institutions still have time to steer the CMA on course  The CMA offers a real chance to get things right. The European Parliament’s proposal for more consistent contingency stock rules could help if it stays focused on medicines genuinely at risk of shortage. The act can also make reporting more efficient by using existing systems rather than creating new ones. Policymakers should also be aware that wider regulatory initiatives directly affect Europe’s ability to manufacture and supply medicines. A more coherent policy framework will be essential to strengthen resilience.  Europe’s goal must be to build an environment where pharmaceutical innovation and production can thrive. Europe’s choice is clear: supply security cannot be achieved by weakening the industry that ensures it. The CMA will only work if it tackles the right problems with the right tools and keeps competitiveness at its core.   > Europe’s goal must be to build an environment where pharmaceutical innovation > and production can thrive. Our industry remains ready to engage with EU and national policymakers to make that happen. A high-level forum on the CMA involving all stakeholders could help guide the act’s implementation in a way that improves supply security and speeds up access for patients, while reinforcing Europe’s position as a global player in life sciences.  Disclaimer POLITICAL ADVERTISEMENT * The sponsor is European Federation of Pharmaceutical Industries and Associations (EFPIA) * The political advertisement is linked to the Critical Medicines Act More information here.
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US pharma to abandon UK unless NHS pays more, says Trump’s ambassador
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.
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