制药商推迟部分欧洲药品上市,因警惕特朗普的定价政策


2026-03-31 6:02 AM UTC / 路透社

作者:玛吉·菲克、班维·萨蒂亚、多米尼克·帕顿

2026年3月31日 6:02 UTC 更新于1小时前

[1/2]2025年12月19日,美国总统唐纳德·特朗普在华盛顿白宫罗斯福厅就降低药品价格发表声明。路透社/伊夫林·霍克斯坦/档案照片

  • 摘要
  • 企业
  • 特朗普最惠国定价协议引发定价不确定性
  • 数据显示欧洲新药上市量下降35%
  • 企业称希望先明确美国药品定价
  • 此举强化美国作为首选市场的地位
  • 游说团体称欧洲需重新思考药品定价以保持竞争力

伦敦/巴黎,3月31日 路透社 —— 据高管、行业贸易团体及向路透社提供的数据显示,制药商正推迟部分新药在欧洲的上市,因为行业正应对美国的压力以及唐纳德·特朗普总统的定价政策转变。

白宫一直在推动降低美国处方药成本,长期以来美国的药品支出远高于其他富裕国家。特朗普称制药业对美国消费者不公,并试图将美国人支付的药品价格与其他国家(包括欧洲)的价格挂钩,即所谓的最惠国定价。

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这导致制药商暂停将部分药品推向医疗支出较低的欧洲市场,以避免拉低美国7000亿美元药品市场的价格。这也给药企首席执行官和欧洲医疗政策制定者带来了复杂的平衡难题。

“我们已经看到欧洲药品上市推迟的初步迹象,”欧洲制药工业协会联合会主席、拜耳高级高管斯特凡·厄利希说道。

他表示,这“是围绕最终将如何影响美国定价的不确定性所带来的后果”。

市场研究公司GlobalData的数据显示,自美国去年5月引入国际参考定价以来,欧洲的新药上市量大幅下降,这与行业高管和官员的说法一致。

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GlobalData的分析发现,自特朗普签署行政令后的10个月里,欧盟市场的药品上市量较此前10个月下降了约35%。推迟在定价更低的欧洲市场上市,有助于更长时间维持更高的美国药品价格。

在欧洲,各国政府就本国医保系统支付的药品价格进行谈判,以控制成本。美国则拥有一套复杂的体系,制药商需与保险公司、药房福利管理机构等谈判价格,并提供标价折扣和返利。

特朗普2025年5月签署最惠国行政令后,欧洲新药平均上市数量持续下降

特朗普上台冲击药企战略

法国国家卫生当局HAS负责人莱昂内尔·科莱表示,制药商越来越多地推迟针对法国早期准入通道的决策,该通道允许患者在正式获批前使用部分药品。去年,营销获批前的早期准入申请数量大幅下降。

“特朗普的上台改变了企业投放产品的市场战略,”他说道,并补充道,法国HAS的早期准入决策数量已从2024年的25起降至去年的10起。

他称,法国是欧洲药品定价最低的市场之一,价格约为美国的三分之一。法国和德国的价格往往会影响其他欧洲国家的定价标准。

“从去年秋天开始,制造商都在和我谈论特朗普的政策,核心都是美国的政策及其对欧洲的影响,”科莱说道。

美国药企Insmed今年2月表示,因美国定价计划存在不确定性,推迟了其抗炎药Brunspri在德国的上市。

“我们希望明确最惠国政策,”首席执行官威廉·刘易斯在财报电话会议上说道。“在我们了解政策走向之前,谨慎的做法是暂缓相关计划。”

该药物已于去年11月获得欧洲批准,但尚未在欧洲地区上市。该公司于8月获得FDA批准后,立即在美国开始销售该药物。2025年获批的药物中,超过90%首先在美国上市,多数仍未在其他地区推出。

欧洲委员会在常规办公时间之外无法立即置评。

据欧洲制药工业协会联合会数据,欧洲药品支出约占GDP的1%,而美国为2%,中国为1.8%。欧洲在研发投资、临床试验和创新疗法上市方面也已落后。

新药上市如同“蒙眼下棋”

瑞士药企罗氏、诺华以及英国阿斯利康的高管去年曾批评欧洲的药品定价和创新激励机制,呼吁增加投入。

阿斯利康高管鲁德·多贝尔表示,由于各国政府对药品价值的评估方式,欧洲有可能落后于美国和中国。

欧洲药品支出约占GDP的1%,而美国为2%,中国为1.8%。据游说团体欧洲制药工业协会联合会称,欧洲在研发投资、临床试验和创新疗法上市方面已落后。

部分企业甚至已将药品撤出欧洲市场。总部位于加州的安进公司以价格和“环境变化”为由,将其降胆固醇药物Repatha撤出丹麦市场,并未直接提及最惠国政策。Indivior公司也将其抗成瘾药物Subutex和Suboxone撤出瑞典及其他市场,同样未直接提及美国定价政策。

波士顿医疗律师罗恩·兰顿表示,美国定价基准和执法方面的不确定性,让企业在面对投资者时处境复杂。

“你必须告诉股东你预计这款新药上市能赚多少钱,但现在一切都不明确,”兰顿说道。他表示,欧洲药品上市进程陷入停滞,因为这就像“蒙眼下棋”。

“药品上市速度大幅放缓,我对此并不意外,”他说道。

路透社伦敦玛吉·菲克、班维·萨蒂亚报道;亚当· Jourdan和比尔·伯克罗特编辑

我们的标准:汤姆森路透社信任原则。

Drugmakers delay some European launches with a wary eye on Trump’s pricing policies

2026-03-31 6:02 AM UTC / Reuters

By Maggie Fick, Bhanvi Satija and Dominique Patton

March 31, 2026 6:02 AM UTC Updated 1 hour ago

[1/2]U.S. President Donald Trump arrives to makes an announcement about lowering the cost of drug prices, at the Roosevelt Room of the White House in Washington, D.C., U.S., December 19, 2025. REUTERS/Evelyn Hockstein/File Photo

  • Summary
  • Companies
  • Trump most-favored-nation deals cause pricing uncertainty
  • Data shows 35% drop in European new drug launches
  • Companies say they want more clarity on US prices first
  • Situation bolsters US position as first go-to market
  • Europe needs to rethink drug pricing to stay competitive, lobby group says

LONDON/PARIS, March 31 (Reuters) – Drugmakers are delaying launches of some new medicines in Europe as the industry grapples with U.S. pressure ​and pricing policy shifts from President Donald Trump, according to executives, an industry trade group and data shared with Reuters.

The White House has been pushing to lower the cost ‌of prescription drugs in the United States, which has traditionally paid significantly more than other wealthy countries. Trump says the industry has been unfair to U.S. consumers and has sought to tie the cost for Americans to what is paid elsewhere, including in Europe, known as most-favoured-nation pricing.

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That has led drugmakers to press pause on bringing some medicines to European markets, where health spending is lower, to avoid pulling down prices in the $700 billion U.S. market. It has also created a ​complex balancing act for CEOs and Europe’s healthcare policy makers.

“We’re seeing first signs of delayed introductions into Europe,” said Stefan Oelrich, president of trade body the European Federation of Pharmaceutical Industries ​and Associations and a senior executive at Bayer.

He said it was “a consequence of uncertainty around what that ultimately does to U.S. pricing.”

New drug launches in ⁠Europe have fallen sharply since the U.S. introduced international reference pricing in May, according to market research firm GlobalData, echoing comments from industry executives and officials.

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Drug launches in EU markets fell by some 35% in ​the 10 months since Trump’s executive order, compared with the previous 10 months, a GlobalData analysis found. Delaying launches at lower EU prices could help secure higher U.S. prices for longer.

In Europe, governments negotiate the ​prices paid by their national health systems, keeping costs down. The U.S. has a complex system in which drugmakers negotiate prices with insurers, pharmacy benefit managers and others, along with offering rebates and discounts from list prices.

Average number of new medicine launches in Europe have declined on average since Trump’s MFN executive order in May 2025

TRUMP’S ARRIVAL HITS PHARMA STRATEGIES

Lionel Collet, head of France’s HAS health authority, said drugmakers were increasingly deferring decisions on France’s early-access pathway, which allows patients to receive some medicines before formal approval. Applications for early access before marketing approval have fallen sharply over ​the last year.

“The arrival of Trump has altered companies’ strategy of how they put products on the market,” he said, adding the number of HAS early-access decisions fell to 10 last year from 25 ​in 2024.

France is among Europe’s lowest-priced medicines markets, with prices around a third of the United States, he said. Prices in France and Germany tend to in turn affect how other European countries set prices.

“Manufacturers all talk ‌to me about ⁠Trump, since the autumn. It’s all about the policy in the U.S. and what it means for Europe,” Collet said.

U.S. drugmaker Insmed said in February it postponed the Germany launch of its anti-inflammatory drug Brunspri due to uncertainty over U.S. pricing plans.

“We want clarity on the MFN policies,” CEO William Lewis said on an earnings call. “It seems to us that the prudent thing to do is to sort of put things on hold until we know what that’s going to look like.”

The drug won European approval in November but has yet to launch in the region. The company began selling it immediately in the U.S. ​after receiving FDA approval in August. Over 90% ​of drugs approved in 2025 first launched in ⁠the U.S., with most still not available elsewhere.

The European Commission was not immediately available for comment outside regular business hours.

Europe spends some 1% of GDP on pharmaceuticals, compared with 2% in the United States and 1.8% in China, and has also lost ground in research and development investment, clinical trials and launching innovative therapies, according to EFPIA.

NEW LAUNCHES LIKE ‘PLAYING CHESS’ WITH A BLINDFOLD

Executives at Swiss drugmakers Roche and Novartis and Britain’s AstraZeneca have in the last year criticized European drug pricing and incentives for innovation, calling for more spending.

AstraZeneca ​executive Ruud Dobber said Europe risked falling behind the U.S. and China because of governments’ approach to valuing medicines.

Europe spends some 1% of GDP ​on pharmaceuticals, compared with 2% ⁠in the United States and 1.8% in China. It has lost ground in research and development investment, clinical trials and launching of innovative therapies, according to lobby group EFPIA.

Some companies have even pulled their drugs from European markets. California-based Amgen withdrew its cholesterol drug Repatha from Denmark, citing prices and a “changed environment”, without directly citing MFN. Indivior pulled anti-addiction drugs Subutex and Suboxone from Sweden and other markets, also without directly citing U.S. ⁠pricing.

Boston-based healthcare lawyer ​Ron Lanton said the uncertainty around U.S. pricing benchmarks and enforcement was complicating things for companies with their investors.

“You have ​to tell your shareholders exactly how much money you expect to earn from this new launch. And none of that’s clear,” Lanton said. Launching drugs in Europe has stalled, he said, because it’s like “playing a game of chess” wearing a “blindfold”.

“I’m not surprised that ​things are going to be launched a lot slower,” he said.

Reporting by Maggie Fick and Bhanvi Satija in London; Editing by Adam Jourdan and Bill Berkrot

Our Standards: The Thomson Reuters Trust Principles.

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