特朗普政府针对品牌药的新一轮关税本周生效,生物制药界部分人士对此感到担忧。
A wave of new Trump administration tariffs on brand-name drugs took effect this week, and some in the biopharma world are worried.
为何重要:周二生效的高额关税对将制造外包的中小型生物技术公司构成了威胁。
Why it matters: The steep tariffs that took effect on Tuesday pose a threat to small and midsize biotech firms that outsource their manufacturing.
这些关税旨在迫使企业达成更多“最惠国”药价协议,但据业内观察人士称,这同样可能促使一些公司出售给大型药企,或缩减业务规模。
They're intended to pressure the firms to enter into more "most favored nation" drug pricing deals, but could just as easily convince some companies to sell out to Big Pharma companies or scale back operations, according to industry watchers.
部分制造商也可能通过提高标价或降低给采购方的回扣,将增加的成本转嫁出去。
Some manufacturers could also pass through the added cost in the form of higher list prices or lower rebates to purchasers.
新闻驱动因素:针对特定专利药及原料的100%关税于周二生效,这是特朗普总统4月签署的关于调整美国药品进口行政令的最新行动。
Driving the news: 100% tariffs on certain patented drugs and ingredients took effect on Tuesday, in the latest action stemming from President Trump's April order on adjusting pharmaceutical imports to the U.S.
商务部表示,目前超过一半的品牌药产品至少有一个制造商位于美国境外,这构成了国家安全威胁,并为其征收类似汽车、钢铁和铝行业的部门关税提供了理由。
The duties hit at a time when more than half of branded drug products have at least one manufacturer outside of the U.S. The Department of Commerce says that poses a national security threat and justifies the kind of sectoral tariffs that it's levied on autos, steel and aluminum.
关税的第一阶段于7月底对大型药企生效。这一阶段瞄准的是资源有限、因严重依赖海外制造而风险更高的小型公司。
The first phase of the tariffs took effect at the end of July on large drug manufacturers. This stage takes aim at smaller companies with limited resources that are more at risk, because of their heavy reliance on overseas manufacturing.
政府为签署自愿最惠国协议并承诺将生产迁回国内的公司提供为期三年的关税豁免。
The administration is offering three-year exemptions from tariffs to companies that enter into voluntary MFN agreements and commit to onshoring production.
仅同意将制造业迁回国内的公司,将面临持续至2030年的20%关税。
Those that just agree to onshore manufacturing would face a 20% tariff until 2030.
上周,商务部澄清称,来自与美国有贸易协定的司法管辖区(包括欧盟、英国、瑞士、日本和韩国)的九类特种药也将获豁免。
Last week, the Commerce Department clarified that nine categories of specialty drugs from jurisdictions that have trade agreements with the U.S. — including the European Union, the U.K., Switzerland, Japan and South Korea — would also be exempt.
如果制造商能证明符合紧迫公共卫生需求,其他产品也可能获得豁免。
Other products could win carve-outs, if manufacturers demonstrate that they meet an urgent public health need.
布鲁金斯学会经济研究高级研究员玛尔塔·沃辛斯卡(Marta Wosińska)表示,仍有100多家公司的产品受到关税影响,且它们可能没有足够的资源将生产转移到美国。
That still leaves more than 100 firms that have products that are subject to the duties and may not have the resources to shift production to the U.S., according to Marta Wosińska, a senior fellow in economic studies at the Brookings Institution.
其中一些公司可能没有任何生产设施,只是与印度或新加坡等制药中心地区的制造商签订合同。
Some of the firms may not have any production facilities and simply contract with manufacturers in pharma hubs like India or Singapore.
“问题在于这些公司有多大的操作空间,”她说。“如果行不通,更简单的做法可能是与大型制药商合并,或者出售该产品。”药品和生物技术制造商表示,新的关税将从研发中抽走资金,并削弱企业的竞争力。
"The question is how easy is it for these companies," she said. "If it isn't possible, the easier thing might be to merge [with a big drugmaker] or sell the product." Drug and biotech manufacturers say new duties will siphon money away from R&D and erode companies' competitiveness.
生物技术创新组织(Biotechnology Innovation Organization)的一位发言人表示:“通过这些关税,美国推翻了数十年来稳健的贸易政策,为生物技术创新者制造了新的不确定性,并增加了负责未来许多突破性药物的中小型企业的负担。”
"With these tariffs, the United States has reversed decades of sound trade policy, creating new uncertainty for biotech innovators, and increasing the burden on the small- and mid-sized companies responsible for many of tomorrow's breakthrough medicines," a spokesperson for the Biotechnology Innovation Organization said.
该贸易组织首席执行官约翰·克劳利(John Crowley)本月敦促政府撤销关税或设立广泛的豁免权,并指出“不一致和不可预测的决策”可能会危及患者的用药渠道。
The trade group's CEO, John Crowley, this month urged the administration to withdraw the tariffs or create broad exemptions, citing the risk of "inconsistent and unpredictable decision-making" that could compromise patient access.
我们关注的重点:目前尚不清楚商务部将以多快的速度做出豁免决定,如何定义紧迫的公共卫生需求,或者获得豁免的制造商是否能获得在审查过程中所缴纳关税的退款。
What we're watching: It's not clear how quickly the Commerce Department will make exemption decisions, how it will define an urgent public health need, or whether manufacturers that win a carve-out will get the tariffs they paid during the review process refunded.
一些行业观察人士表示,针对这些关税及其征收的国家安全理由,可能会出现法律挑战。
Some industry observers say there could be legal challenges to the tariffs and the national security rationale for levying them.
那些选择将生产转移回国内以规避关税的小型企业可能会与国内合同制造商达成协议,因为投资新设施和雇佣员工的成本可能高得令人望而却步。
Those smaller firms that do opt to onshore production to avoid tariffs could strike deals with domestic contract manufacturers, since investing in new facilities and hiring workforces could be prohibitively expensive.