Pharmaceutical Policy in Motion- Updates on the Trump Administration’s Drug Pricing Initiatives
Since May, the Trump administration has used tariffs and Most Favored Nation (MFN) drug pricing threats as a means to pressure pharmaceutical manufacturers to lower drug prices in the U.S. This pressure culminated in a first-of-its-kind deal with Pfizer.
Since our last update, four other manufacturers have struck deals with the Trump administration aimed at expanding drug access and improving affordability, particularly targeting the GLP-1 and fertility pharmaceutical markets. These agreements reflect the growing consumer demand for GLP-1 drugs and IVF treatments while aligning industry leaders with the federal agenda on health care affordability. In this blog post, we’ll explore the key developments that have followed the Pfizer deal, including how other pharmaceutical companies are responding.
AstraZeneca Inks Drug Pricing Deal
On October 10, 2025, AstraZeneca followed in Pfizer’s footsteps by entering into an agreement with the Trump administration to provide Most-Favored Nation (MFN) prescription drug prices to every State Medicaid program. Starting in 2026, AstraZeneca will also use TrumpRx.gov to offer DTC discounts of up to 80% on prescription drugs for chronic disease patients.
Additionally, to secure immunity for 3 years from potential tariffs, AstraZeneca announced a $50 billion investment in U.S. medicine manufacturing, research, and development.
EMD Serono Agrees to Fertility Drug Deal
On October 16, 2025, the White House announced that EMD Serono became the third pharmaceutical manufacturer to strike an MFN drug pricing deal with the Trump Administration.
In the EMD Serono announcement, the company outlined its plans to expand access to fertility treatments in the U.S. Specifically, EMD Serono plans to offer its full portfolio of in vitro fertilization (IVF) therapies through direct-to-consumer (DTC) sales at “significantly reduced prices.” Qualifying patients with prescriptions will receive an 84% discount off list prices when all three therapies are used in IVF treatment. Additionally, EMD Serono will participate in the TrumpRx.gov direct purchasing platform at its inception in 2026.
EMD Serono also simultaneously announced an agreement with the U.S. Secretary of Commerce to exempt its pharmaceutical products and ingredients from potential tariffs. This agreement is contingent on EMD Serono’s future investment in U.S. biopharmaceutical manufacturing and research; however, the announcement did not reveal any specific commitment.
Drug Pricing Deals with Novo Nordisk and Eli Lilly for Weight Loss Medications
On November 6, 2025, Novo Nordisk and Eli Lilly joined other manufacturers in agreeing to MFN pricing for every State Medicaid program and all new-to-market medications, specifically targeting the cost of medications used to treat obesity and diabetes. Notably, the deals include significant discounts on four major Type 2 diabetes and obesity drugs, Novo’s Ozempic and Wegovy, and Lilly’s Zepbound and Orforglipron (currently pending FDA approval). Novo’s drugs will be offered through TrumpRx.gov, and Lilly’s drugs will be offered through both TrumpRx.gov and Lilly’s own DTC platform, LillyDirect. These agreements will expand coverage for these drugs under Medicaid and Medicare, with Medicare beneficiaries paying only a monthly $50 copay. This Medicare coverage comes after the Centers for Medicare & Medicaid Services (CMS) previously declined to finalize a Biden-era proposal to cover Anti-Obesity Medications in the April 2025 Medicare Part D Final Rule.
Under these agreements, Novo Nordisk and Eli Lilly also committed $10 billion and $27 billion, respectively, to expand their U.S. manufacturing efforts in exchange for a reprieve from potential tariffs.
White House Announces One-Year Suspension of BIS Affiliates Rule Following US-China Trade Negotiations
Effective 10 November 2025, the US Department of Commerce’s Bureau of Industry and Security (BIS) published a rule (hereafter, the Suspension Rule) suspending implementation of the “Affiliates Rule” for one year ending on 9 November 2026. Suspension of the Affiliates Rule was first announced by Treasury Secretary Bessent on 1 November as part of trade negotiations between the United States and China.
As detailed in our prior alert, the Affiliates Rule extends Export Administration Regulations (EAR) license requirements applicable to entities designated on the BIS Entity List or Military End Users (MEU) List or subject to EAR § 744.8 to affiliates in which those entities have a 50% or greater ownership interest directly or indirectly, whether held individually or in the aggregate.
Clarification of Suspension
The Suspension Rule provides important clarity on the scope of the suspension and BIS’s enforcement priorities during the one-year period.
First, the Affiliates Rule is suspended in its entirety, covering affiliates not only of Entity List designees but also of companies on the Military End User List and subject to EAR § 744.8.
Second, the suspension is global and is not restricted to just Chinese companies.
Third, BIS will continue to monitor and evaluate U.S. national security and foreign policy interests related to non-listed foreign affiliates of listed entities during the one-year suspension, suggesting that BIS could take action to designate entities otherwise subject to the Affiliates Rule suspension.
Sector-Specific Considerations
The Affiliates Rule affects companies differently depending on product lines, ownership structures, and service obligations. For example:
Semiconductor and electronics manufacturers selling tools, components, or design software should map ownership interests in joint ventures and downstream partners, particularly in China and Southeast Asia, where cross‑ownership structures are common.
Cloud hosting, software deployment, and remote support may require authorization if a listed entity has a 50% or greater ownership interest in the customer’s parent or subsidiary receiving access to controlled technology.
Multi-year obligations for servicing of capital equipment and industrial machinery from the US or using EAR items will necessitate obtaining specific BIS licenses once the suspension expires.
Recommendations
Because the Affiliate Rule suspension is temporary, companies should continue to develop ownership screening procedures to fully comply with the Rule’s substantial due diligence requirements, and ensure recordkeeping addresses beneficial ownership to a sufficient degree for effective diligence.
For dealings with affiliates subject to the reprieve, companies should structure transactions in anticipation of the suspension’s expiry, and even the possibility of a specific designation before then. Assume transactions with multi-year performance obligations that require provision of EAR commodities, software, and technology will not be possible after 9 November 2026, absent extension of the suspension or specific BIS authorization.
Lower Tariffs Take Effect Under New China Trade Deal
Key Takeaways:
Under a new trade deal reached with China, the U.S. has agreed to lower tariffs on Chinese imports imposed under the International Emergency Economic Powers Act (IEEPA) to address the influx of opioids into the U.S. and suspend any increases to China’s reciprocal tariff rate for one year.
China, in turn, has agreed to eliminate global export controls on rare earth elements and other critical minerals and to purchase U.S. agricultural exports such as soybeans, sorghum and logs.
China has also committed to implementing certain measures designed to end the flow of fentanyl to the U.S.
Businesses should assess how these changes affect existing supply chains, tariff strategies and sourcing plans, given the deal’s limited duration and potential policy shifts after 2026.
Recent discussions between President Trump and President Xi Jinping of China concluded with the two nations reaching a major trade deal that “safeguards U.S. economic strength and national security while putting American workers, farmers and families first.” President Trump signed two executive orders on Nov. 4, 2025: one that suspended increases to China’s reciprocal duty rate for one year, and the other that modified the fentanyl duty rate applicable to Chinese imports beginning Nov. 10.
Under this deal, the countries agreed to several key measures, easing what had been escalating trade tensions and retaliatory actions.
Specifically, China committed to:
Stop the flow of fentanyl through various export control measures on certain precursor chemicals used to produce opioids;
Suspend restrictions on exports of rare earth and other critical minerals;
Purchase U.S. agricultural products, including 12 million metric tons of soybeans by the end of the year and at least 25 million metric tons annually through 2028;
Address Chinese retaliation against U.S. semiconductor manufacturers and other major companies in the semiconductor supply chain; and
Suspend or remove many other retaliatory actions against the U.S., including tariffs on a “vast swath” of agricultural products until Dec. 31, 2026.
For its part, the U.S. committed to:
Lower the fentanyl tariff rate on Chinese imports from 20% to 10%, effective Nov. 10;
Suspend increases to the reciprocal duty rate of 10% through Nov. 10, 2026;
Extend expiration of certain tariff exclusions under Section 301 of the Trade Act of 1974 (Section 301) for the same period; and
Suspend its implementation of responsive actions taken pursuant to the Section 301 investigation on China’s shipbuilding and maritime policies until Nov. 10, 2026.
This deal follows on the heels of President Trump’s agreements and frameworks reached with several Asian countries during his Asia tour, including reciprocal trade agreements with Malaysia and Cambodia, joint frameworks for trade negotiations with Thailand and Vietnam, and critical minerals cooperation agreements with Thailand and Malaysia.
Businesses involved in trade with China should keep in mind that not only are certain of the agreement’s terms set to end next year, this deal comes amidst the Trump Administration’s review of China’s compliance with a partial trade agreement reached during the president’s first term – the “Phase One Agreement” – which resulted in deferred and lowered Section 301 duties on certain Chinese imports.
ECHR Climate Decision- Five Key Takeaways for Companies
A recent European Court of Human Rights (ECHR) decision on the obligations of European states to study carbon-intensive permitting decisions crystallizes how global climate commitments may be beginning to harden into justiciable standards in some jurisdictions.
The ECHR’s judgment in Greenpeace Nordic v. Norway continues a trend in which courts reviewing climate issues grapple with the consequences of greenhouse gas emissions by requiring project-specific information be made available before government decisions are taken. Even though the judgment only directly impacts European countries, the ECHR’s judgment has at least five practical implications for governments and carbon‑intensive businesses.
Downstream combustion emissions are increasingly required in environmental assessments. Quantifying “Scope 1,” (direct emissions) “Scope 2,” (indirect emissions from purchased energy) and even “Scope 3” (other indirect emissions) is becoming routine in many multinational businesses. Courts across various jurisdictions now expect agencies, and, by extension, developers supplying the record, to quantify and analyze downstream emissions, address cumulative and transboundary effects, and situate those impacts against applicable climate targets. The ECHR has joined them.
The timing of climate-related challenges matters. While the ECHR rejected the substance of Greenpeace Nordic’s challenge as it was mounted, it accepted implicitly that later Norwegian processes would need to evaluate project-specific impacts in ways which could result in the imposition of more stringent conditions for a project’s operation or even an outright denial.
The decision emphasizes that, in Europe, public participation remains a core compliance issue and influences whether a project should be granted government permission to operate. Early, transparent presentation of climate impacts, alternatives, and mitigation reduces procedural vulnerability and aligns with social expectations in the European context that projects will generally seek to mitigate additional climate impacts.
Integrate climate diligence into investment decisions. The ECHR framework now expects Plan for Development and Operation submissions to incorporate stress‑testing against Paris Agreement‑consistent price trajectories and climate risk — an approach consistent with investor expectations and emerging due‑diligence regimes.
The decision presents a reminder that viewing trends in a single country likely generates an unwarranted level of certainty as to what the future holds. Anticipate cross‑pollination and even where ultimate remedies differ by forum, a common procedural core is taking shape. Quantify Scope 1–3 emissions, assess cumulative or transboundary effects, and disclose these early as regulators may reserve the right to revoke permits for projects when project-specific environmental assessments indicate that the project could contribute directly or indirectly to climate change.
The Decision
Greenpeace Nordic targeted Norway’s 2016 decision to award 10 petroleum exploration licenses in the Barents Sea. Two non-governmental organizations and six individuals argued that Norway breached Articles 2 and 8 of the European Convention by authorizing activities that ultimately drive greenhouse gas emissions, including downstream combustion abroad.
The case hinged on whether Article 8 — dealing with private and family life — obligates a state to act to address climate impacts from “potentially dangerous” activities. The court held that Article 8 applies to climate risks where there is a sufficiently close link between state authorization and serious adverse effects on life, health, well‑being, or quality of life. It accepted that exploration licenses are a necessary step toward extraction and eventual combustion and that this chain is adequate to trigger procedural protection, even if multiple approvals intervene and some licenses are later relinquished. Organizational applicants had standing but the individual plaintiffs did not as their injuries were, in essence, too removed from the issues they challenged.
Having accepted that Article 8 obligates states to address climate, the ECHR held that, before authorizing potentially dangerous activities, states subject to the European Convention must ensure an adequate, timely, good‑faith, and comprehensive assessment, grounded in best available science, that (1) quantifies anticipated greenhouse gas emissions, including exported combustion emissions, (2) evaluates compatibility with national and international climate duties, and (3) enables informed public participation when all options remain open. The court aligned these requirements with converging international jurisprudence (including advisory opinions from the International Tribunal for Law of the Sea, the International Court of Justice, and the Inter‑American Court) and with European impact assessment law, emphasizing cumulative and transboundary effects and early, strategic scrutiny.The recent ICJ decision, which effectively transformed climate change from a political issue to a legal one, established that states have a binding legal duty to prevent significant harm. (Our summary of the ICJ Advisory Opinion is here.)
Applying those standards to Norway’s Barents Sea licensing, the ECHR found no violation, accepting Norway’s choice to conduct comprehensive climate review at a later, project‑specific stage. Because later stages of Norway’s licensing proceedings required a project‑level environmental impact assessment before extraction, including exported combustion emissions and public consultation, the ECHR saw no structural deficiency in Norway’s framework as climate issues could be evaluated later.
Climate in International Law
The COP30 conference this week will discuss aligning national policies with a rights-based need to hold an increase in temperatures to 1.5°C. The COP30 agenda emphasizes a need to prevent foreseeable harm from climate volatility, to conduct rigorous, lifecycle climate impact assessments that encompass exported combustion emissions, and to ensure meaningful public participation and access to information in governmental project approvals. This approach largely squares with the ECHR’s approach in Greenpeace Nordic.
The Greenpeace Nordic decision also squares with a host of other recent international decisions.
It cites the ECHR’s 2024 ruling in Verein KlimaSeniorinnen, which recognized Article 8’s application to climate harms and articulated due‑diligence minimum guardrails for state mitigation action. (We discussed this case before here.) In Greenpeace Nordic, the court adapted those guardrails to the licensing or assessment pipeline for fossil projects, focusing on procedural integrity rather than setting substantive production or phase‑out mandates.
Greenpeace Nordic echoes the European Free Trade Association court’s 2025 advisory opinion that downstream combustion emissions are “effects” that must be captured by project environmental impact assessments (EIAs) for petroleum developments, and it nodded to the UK Supreme Court’s Finch v. Surry County Council decision requiring consideration of combustion emissions in an EIA for an onshore oil project.
Comparison With Recent US Litigation
Recent US climate cases both converge and contrast with the Greenpeace Nordic decision. Some examples include the following.
In its unanimous 2025 ruling in Seven County Infrastructure Coalition v. Eagle County, the US Supreme Court recalibrated the National Environmental Policy Act’s (NEPA) scope by directing “substantial deference” to agencies on the breadth and detail of environmental reviews and by limiting required analysis to effects proximately caused by the project under review — excluding upstream and downstream impacts from “separate projects” outside the agency’s statutory authority. Framed as a procedural “course correction,” the decision emphasizes NEPA’s role as an informational process, not a substantive constraint, and signals that courts should not micromanage agencies’ choices about indirect and cumulative effects so long as the agency’s decision is reasonable and reasonably explained. This is in tension with the Greenpeace Nordic v. Norway approach, which requires states to conduct rigorous climate impact assessments, allow for meaningful public participation, and pay explicit attention to exported combustion emissions. (We discuss Seven County Infrastructure Coalition here.)
The Ninth Circuit’s 2020 decision in Juliana v. United States rejected youth plaintiffs’ constitutional claims for lack of Article III redressability, stressing separation‑of‑powers limits on ordering the United States to undertake a comprehensive, court‑managed decarbonization plan. The ECHR’s decision goes one step further: setting procedural minimums for climate‑relevant decisions. However, both decisions leave substantive policy decisions to other branches of government. Where Juliana treats broad, structural climate relief as institutionally non‑justiciable, Greenpeace Nordic accepts that rigorous climate assessment, quantification of downstream emissions, and early public input may be legally required.
Similar to Greenpeace Nordic, in Held v. State of Montana, the Montana Supreme Court invalidated statutory prohibitions on considering greenhouse gas emissions and their climate impacts in environmental reviews based on an explicit state constitutional right to a clean and healthful environment. (We summarized Held here.) Like Held, the Greenpeace Nordic approach obligates government decisionmakers to acknowledge climate effects. Held imposes a non‑discretionary duty to consider climate in environmental review, and Greenpeace Nordic imposes a similar duty. It adds specificity on exported emissions and cumulative effects yet tolerates timing flexibility if the later stage is robust and genuinely outcome‑determinative.
In a fourth case, Lighthiser v. Trump, out of Montana federal court, the court both accepted the potential that climate issues will injure plaintiffs and barred the plaintiffs’ requested declaratory and injunctive relief against a number of Trump Administration government-wide executive orders. (For more, see here.) ECHR’s deferral of remedy-related decisions to later phases focused on singular projects preempts the need for a broad injunction in favor of setting procedural minimums which can be later enforced.
European Union Adopts 19th Package of Sanctions Against Russia
On 23 October 2025, the Council of the European Union announced the 19th EU package of sanctions against Russia, reflecting the continued commitment of the European Union to respond to the ongoing conflict in Ukraine and to increase economic and political pressure on Russia and its economy. These latest measures build on previous EU sanctions packages, introducing new restrictions and reinforcing existing controls across various key sectors such as energy, finance, the military industrial base, as well as trade.
Outlined below are key measures set forth in the European Union’s 19th sanctions package against Russia and Belarus, which precede the European Union’s broader framework for the planned phase out of all Russian natural gas imports (pipeline and Liquefied Natural Gas (LNG)).
Energy
A total ban on Russian LNG and a further clamp-down on the Russian shadow fleet represent the hardest sanctions yet on Russia’s energy sector. There are also tighter sanctions on Rosneft’s and Gazprom Neft’s oil and gas imports into the European Union, and further restrictions on liquefied petroleum gas (LPG).
LNG Import Ban
Phased ban on the purchase, import, or transfer, whether directly or indirectly, of LNG originated or exported from Russia, along with associated technical assistance, brokering services, financing or financial assistance, or other services.
The ban will be effective from 25 April 2026 for short-term contracts and from 1 January 2027 for contracts whose term exceeds one year, and which were concluded prior to 17 June 2025.
This represents an important step in the European Union’s efforts to further reduce Russian energy flows into Europe, particularly given Russia’s continued LNG deliveries via European ports.
“Shadow Fleet” and Transaction Ban
In parallel, the Council has introduced additional restrictions targeting logistical and financial channels supporting Russian energy exports, including:
The designation of 117 additional vessels linked to Russia’s “shadow fleet,” subject to a port access ban and service restrictions, bringing the total number of vessels listed under EU sanctions to 557. To evade sanctions, the Russian shadow fleet of oil tankers typically use flags of convenience, as well as intricate ownership and management structures to conceal the origins of its cargo, leading to the European Union’s imposition of targeted sanctions on specific vessels.
Additional sanctions are imposed across the shadow fleet value chain, including on maritime registries providing false flags from Aruba, Curaçao, and Sint Maarten to shadow fleet vessels.
The new measures also eliminate the pre-existing exemption for Rosneft’s and Gazprom Neft’s oil and gas imports into the European Union. Neither entity can now benefit from the exemption where the transaction is strictly necessary for the direct or indirect purchase, import, or transport of oil, including refined petroleum products, from or through Russia, unless the transaction relates to the transit of oil loaded in, departing from, or transiting through Russia and the origin and owner of the goods are not Russian. The import of oil from third countries, such as Kazakhstan, and the transport of oil compliant with the Oil Price Cap to third countries, are exempted.
Import ban on a variant of LPG aimed at preventing the circumvention of existing LPG restrictions.
Sanctions on Energy Companies in Third Countries
The European union has also listed non-EU entities for their role in enabling Russian oil exports, strengthening the enforcement of EU sanctions’ extraterritorially. This includes sanctioning Chinese entities—two refineries and an oil trader, that are significant buyers of Russian crude oil. In addition, two oil trading companies in Hong Kong and the United Arab Emirates (UAE) are added to the scope of the transaction ban.
Finance
Strong measures also target financial services and infrastructure, including cryptocurrencies for the first time.
Banking and payments: No EU operator will be allowed to engage, directly or indirectly, with any of the listed banks and financial institutions in Russia, Belarus, and Kazakhstan, with five new Russian banks added to the transaction ban. In addition, new bans on Russia’s payment card and fast payment system (Mir and SBP) and related exchanges are provided.
Cryptocurrencies and exchanges: the European Union is prohibiting the use of Russian cryptocurrency stablecoin A7A5, extending sanctions to EU operators providing crypto and fintech services that could help Russia develop its own financial infrastructure and possibly circumvent sanctions, aiming to strengthen the integrity of the European Union’s financial sanctions framework.
Trade
On the trade front, the European Union has expanded export restrictions on dual-use items, advanced technologies, and various goods critical to Russia’s military-industrial complex, as well as imposed individual sanctions on businesspersons and companies involved in supplying military goods to Russia.
Individual sanctions (listings) of businesspersons and companies forming part of the Russian military industrial complex, and operators from UAE, China, India, and Thailand producing or supplying military and dual use goods to Russia.
New export restrictions on additional dual use items and advanced technologies, including metals for the construction of weapon systems and products used in the preparation of propellants, not yet under sanctions.
New export bans on items such as salts and ores, constructions materials and articles of rubber, corresponding to a value of €155 million of EU exports in 2024 prices.
Measures targeting Russia’s Special Economic Zones (SEZs): prohibition for EU businesses to enter into new contracts with any entity established within certain Russian SEZs, essentially forcing divestment from such areas.
Prohibition of reinsurance: the new measures prohibit reinsurance services regarding vessels and aircraft of the Russian government or Russian persons for up to five years after their sale to third countries.
Anti-Circumvention provisions: strengthened mechanisms to prevent the circumvention of sanctions, including extended due diligence obligations for EU companies and reporting requirements for suspected breaches.
The package arrives in the midst of a global momentum on strengthening the sanctions regimes against Russia. In the last weeks, both the United Kingdom and the United States have imposed sanctions on Lukoil and Rosneft, Russia’s two largest oil companies. The UK package also demonstrates an anti-circumvention focus, whilst the recent US sanctions focus on direct and indirect ownership by the sanctioned companies, sparking concerns among European energy facilities with Russian-held stakes.
EU Draft Regulation on Phasing Out Russian Gas
The 19th sanctions package forms part of the broader framework under the draft Regulation (COM(2025) 828), (Regulation) proposed by the European Commission on 17 June 2025, to phase out all Russian natural gas imports (pipeline and LNG) while enhancing the monitoring of energy dependencies and amending Regulation (EU) 2017/1938 on gas supply security.
As of November 2025, the draft proposal is still undergoing the EU legislative process – the Council agreed on its negotiating position on 20 October 2025, however trilogue negotiations are yet to begin. While the sanctions package accelerates the LNG-specific timeline, closing immediate loopholes, the Regulation provides a comprehensive, longer-term structure for total gas phase-out by 2028.
Key Provisions
Ban on New Contracts
A full ban on new or amended Russian gas import contracts (pipeline and LNG) from 1 January 2026.
Contract Amendments
Amendments to existing contracts will only be allowed for narrowly defined operational reasons and cannot increase the volume of gas imported. Some limited flexibility is included for landlocked Member States affected by supply route changes.
Transition Periods for Existing Contracts
Short-term contracts, whose term is shorter than one year, concluded prior to 17 June 2025: permitted until 17 June 2026 or until 1 January 2028 for certain landlocked countries under specific conditions.
Long-term contracts, whose term is longer than one year, concluded prior to 17 June 2025: permitted until 1 January 2028, limited to contracted volumes.
National Diversification Plans
All Member States must submit plans by 1 March 2026, detailing current dependencies, replacement measures (e.g. alternative suppliers, renewables, demand reduction, joint procurement), milestones for full phase-out by 31 December 2027, and potential barriers. Member States that have already completely ceased direct or indirect imports of Russian gas are exempted from this requirement.
Authorization and Transparency
A uniform prior authorization system is introduced for both Russian and non-Russian gas imports, requiring disclosure of contract terms, volumes, amendments, and proof of non-Russian origin for mixed LNG cargoes. Importers and LNG operators must submit detailed information to customs authorities (e.g., parties, quantities, origins, delivery points), with full contracts (excluding prices) available upon request. A rebuttable presumption of Russian origin applies to gas entering via specified EU-Russia interconnection points.
Monitoring and Enforcement
Customs authorities, the EU Agency for the Cooperation of Energy Regulators and national regulatory authorities will be given powers to request detailed contract information (excluding price) to ensure effective implementation and cooperation between Member States.
Force Majeure Clause
The restrictions in the Regulation bans may be considered to amount to sovereign acts rendering imports unlawful, which may subsequently enable operators to invoke force majeure for contract termination, treating the prohibition as an external event beyond their control. Importers must report force majeure provisions in contracts.
Emergency Safeguards
The Commission may temporarily suspend prohibitions via implementing acts if supply security is threatened, subject to strict conditions and consultations.
Implications For Businesses
Operators in the energy sector should closely monitor both the new sanctions package and the evolution of the future legislative proposal to phase-out Russian gas, with a specific focus on the direct consequences for oil, LNG and natural gas contracting (in particular the country of origin of these commodities), infrastructure planning, and risk assessment/compliance across the European Union. Key considerations include:
Reviewing supply chains and business relationships for exposure to newly sanctioned entities or restricted goods;
Updating risk assessments and internal compliance policies to reflect the latest EU requirements and screening lists;
Monitoring for updates and guidance from EU authorities regarding the implementation and interpretation of new measures; and
Assessing the impact on ongoing contracts, transactions, and cross-border activities.
Conclusion
This framework—combining the adopted 19th sanctions package with the evolving draft Regulation— aims to strengthen EU energy security, align with the European Economic Security Strategy, minimize circumvention risks, and increase attention on third country enablers. However, this will require continuous monitoring, as Russia is constantly adapting to sanctions restrictions, including by evolving its payment methods using digital assets and foreign currencies in response to the rubel being excluded from global payment systems.
Implementation of the LNG import ban and related measures will require further clarification, particularly regarding reporting obligations, contract wind-down processes, and compliance mechanisms at Member States level and at a business level in terms of compliance monitoring of the value chains concerned.
Rosie Naylor, Petr Bartoš, Hanna Walczak, Ben Holland, Tariq A. Fedda, Steven C. Sparling, and Theo Hall contributed to this article
What to Expect When the Government Reopens- Key Considerations for Businesses
When the federal government reopens after a shutdown, the return to “business as usual” is rarely immediate. Agencies face backlogs, funding adjustments, and operational hurdles that can directly impact companies, contractors, and regulated entities. Below we outline several key issues businesses should anticipate in the days and weeks following a reopening of the federal government.
1. Agency Backlogs and Delays
Most agencies operate with a reduced staff or are closed entirely during a shutdown, leading to significant backlogs. Once reopened, entities should expect:
Permitting and Licensing Delays: Applications for approvals, licenses, or permits may take longer to process as agencies work through accumulated submissions.
Investigations and Audits Resuming: Agencies such as the Securities Exchange Commission (“SEC”) and Department of Justice (“DOJ”) will pick up paused enforcement actions and investigations, often with heightened urgency to meet statutory deadlines. This may result in a flurry of requests with quick turnarounds.
Regulatory Filings: Entities with reporting obligations should be prepared for bottlenecks as staff triage incoming and backlogged filings.
Litigation: Bid protests (i.e., government contracts litigation), most civil litigation, and any other litigation that may have been paused during the shutdown will resume, meaning filing deadlines will need to be recalculated and some filings will be due almost immediately.
2. Contracting and Procurement Impacts
For government contractors, the reopening has immediate and practical implications. Your contract performance will resume but some changes may be necessary given the lost time during the shutdown. Contractors will seek modifications to their performance schedules as well as adjustments to costs depending on the shutdown’s impact. Requests for equitable adjustment can take time to process and any increases in cost may need to work their way through approvals. Whether an equitable adjustment is available may depend on agency budgets, which will need to be re-aligned.
For opportunities that were open prior to the shutdown, solicitations that were delayed or suspended may be extended or reissued. These updates likely will occur quickly after the shutdown ends, so stay alert for rapid-fire updates in SAM.gov and other databases for open acquisition opportunities.
Communication with agency officials regarding a particular procurement or contract will be critical once the shutdown ends.
3. Enforcement and Oversight Priorities
Shutdowns do not usually eliminate ongoing investigations and compliance risks; they typically just delay them. After reopening, agencies may seek to “make up for lost time.” Agencies like the DOJ, Federal Trade Commission (“FTC”), and SEC often restart paused investigations with aggressive timetables. Agencies will attempt to make up for lost time in investigations and some prosecutions. You are likely to have outreach from agency attorneys within one to two weeks after the shutdown ends. You should be ready to provide updates on any outstanding requests and expect new requests on expedited timelines. Federal auditors (e.g., DCAA, FDA inspectors) typically move quickly to reschedule site visits and compliance checks. Sectors like healthcare, defense, energy, and financial services may see increased scrutiny, particularly where public funds are involved.
4. Rulemaking and Policy Timelines
Shutdowns can freeze or delay regulatory actions, but once reopened, agencies may attempt to accelerate rulemaking agendas. Stakeholders may have shorter windows to submit feedback on proposed rules. Agencies may pivot resources toward urgent policy objectives set by the Administration or Congress. Agencies also may use quicker regulatory actions, such as interim final rules, may accelerate in order to make up for lost time.
Takeaways
Once the shutdown is over, the federal government will move quickly to try and get back up to speed. This means entities working in the government space, particularly government contractors, should stay vigilant and monitor agency announcements in SAM.gov and other acquisition-related portals, outreach by their federal government points of contact (e.g., contracting officer), and industry alerts. Additionally, contractors should reach out to their contracting officers to discuss any impact the shutdown had on contract performance and ensure appropriate timing for restarting performance. Entities should compile all records associated with the impact of the shutdown on operations as they may be important during negotiations for extensions and modifications to contracts and potential disputes.
For regulated entities or companies facing government investigations, expect the government focus to return, albeit with some necessary ramp-up time. Where time is of the essence for the government in the form of statutes of limitations or other specific timelines, expect the government to be newly aggressive in making up for lost time.
The reopening of the federal government marks only the beginning of a complex recovery process. Companies that anticipate these challenges, remain flexible, and maintain open communication with agencies and counsel will be best positioned to manage the transition effectively.
Antitrust and Competition Law – Competition Law in the Americas Episode 3 | Building Bulletproof Compliance: Effective Antitrust Programs in the Americas [Podcast]
In this episode of Greenberg Traurig’s Big Law Redefined Podcast Competition Law in the Americas miniseries, host Miguel Flores Bernés explores how companies can create robust, operational antitrust compliance programs amid evolving legal landscapes and heightened enforcement across the Americas.
Joined by Amparo Martinez, General Counsel at Tiendas Tres B, and Tonya Esposito, Co-Chair of Greenberg Traurig’s Antitrust Practice, the discussion dispels common compliance myths, examines recent regulatory reforms—including Mexico’s new voluntary certification process—and highlights practical steps for embedding compliance into corporate culture.
The guests share real-world examples, digital tools, and actionable strategies for tailoring programs to different jurisdictions, fostering buy-in at all levels, and measuring program effectiveness.
Whether you’re a multinational or an emerging business, this episode offers insights for turning compliance from a checkbox into a competitive advantage.
BIS Issues One-Year Suspension of Affiliates Rule Expansion
On November 10, 2025, the US Department of Commerce’s Bureau of Industry and Security (BIS) issued a final rule titled “One Year Suspension of Expansion of End-User Controls for Affiliates of Certain Listed Entities.” As the title indicates, the final rule formally enacts a one-year suspension of the BIS Affiliates Rule, which had been in effect since September 29, 2025, as we previously reported in “BIS Expands Entity List Controls to All Unlisted Foreign Affiliates Owned 50% or More by Listed Parties.”
This action follows the November 1 White House fact sheet released after a meeting between President Trump and President Xi that occurred in Busan, South Korea, ahead of last month’s APEC summit.
Trade Context
In exchange for the one-year suspension of the Affiliates Rule—scheduled to end on November 9, 2026—China has agreed to suspend the global implementation of its export controls on rare earths and related measures announced on October 9, 2025.
China will also issue general licenses authorizing exports of rare earths, gallium, germanium, antimony, and graphite to US end users and their global suppliers. This effectively removes certain controls that China has maintained since 2023.
Implementation Details
The interim final rule was in effect from September 29, 2025, through November 9, 2025. Under the BIS final rule, the suspension will be implemented in two phases:
Phase I – BIS will temporarily suspend all changes made to the Export Administration Regulations (EAR) by the Affiliates Rule, effective November 10, 2025, through November 9, 2026.
Phase II – The suspended changes will be reintroduced into the EAR upon expiration of the one-year period.
The final rule’s Federal Register summary notes that the suspension will end on November 9, 2026, “absent a future extension.” This language indicates that the Affiliates Rule may continue to serve as a negotiating instrument in US-China trade discussions that have been ongoing during President Trump’s second term.
A recent letter from House Select Committee on the CCP Chairman John Moolenaar—co-signed by House Foreign Affairs Committee Chairman Brian Mast, House Permanent Select Committee on Intelligence Chairman Rick Crawford, and House Homeland Security Committee Chairman Andrew Garbarino, all Republicans—urged Secretary Lutnick and the Commerce Department to investigate several specific companies under, for example, Commerce’s ICTS authority “to protect the U.S. market from technology threats.” While Chairman Moolenaar had not, as of the date of the this alert’s publication, commented on the one-year suspension of the BIS Affiliates Rule, the letter reaffirms Congress’s close scrutiny of unlisted affiliates of Chinese technology firms.
Recommended Actions
Although the final rule allows for the possibility of an extension, companies should use this one-year suspension to proactively:
Review and strengthen existing export compliance programs;
Develop or enhance internal processes to ensure compliance prior to reinstatement of the Affiliates Rule’s broad compliance obligations; and
Analyze business partner vulnerabilities that may be affected by intervening changes to the Affiliates Rule’s effective date.
Because BIS merely postponed—rather than rescinded—the Affiliates Rule, it can be reactivated with little notice through a short Federal Register notice. The suspension, while significant, should therefore be treated as temporary. A snap-back could occur if Washington views Beijing as failing to meet commitments under the Busan framework—such as delays in implementing the rare-earth licensing regime—or if broader geopolitical developments prompt a policy response. In that event, transactions involving China-affiliated counterparties could again face midstream restrictions. Companies should mitigate this risk by incorporating protective clauses, monitoring BIS communications closely, and avoiding assumptions that the current pause provides lasting certainty.
Shifts in U.S. Trade in Asia- Key Agreements from President Trump’s October 2025 Asia Trip – Part I, Southeast Asia
Capping off a highly eventful week in Asia, President Donald J. Trump has further reshaped the landscape of U.S. trade with the Asia-Pacific region through a series of new agreements. This latest round of negotiations includes new reciprocal trade deals and market access commitments across Cambodia, Thailand, Malaysia, Vietnam, China, South Korea, and Japan. Some of these agreements build upon the foundation laid by Executive Order 14346 (Sept. 5, 2025). That order provided for zero percent tariffs on products listed in Annex 3, once a qualifying trade deal was announced.[1] With some agreements now in place, Annex III of the EO is being actively implemented.
Below, we highlight the key terms and commitments made under these new agreements for the Southeast Asian countries (Vietnam, Malaysia, Cambodia, and Thailand). We will return with Part II of this post to cover the East Asian countries (China, South Korea, and Japan).
We also include a summary table for quick reference.
Vietnam
The Framework for an Agreement on Reciprocal Trade between the United States and Vietnam represents another milestone in the expansion of bilateral trade relations over the past three decades. Vietnam has committed to removing tariffs on virtually all U.S. goods, including food and agriculture products. In return, the United States will maintain its current 20 percent reciprocal tariff rate on imports from Vietnam, while certain Vietnamese products listed in Annex III of Executive Order 14346 will be eligible for a zero percent reciprocal tariff rate once a final agreement is signed and entered into force.
Additionally, under the framework agreement, Vietnam has committed to removing various non-tariff barriers. Specifically, Vietnam will accept vehicles built to U.S. federal motor vehicle safety and emissions standards, allow importation of remanufactured goods from the United States, approve marketing authorizations for medical devices legally approved in the United States, and streamline regulatory approval of U.S. pharmaceutical products. Vietnam will also continue to increase market access for U.S. agricultural exports by accepting certificates issued by U.S. regulatory authorities, and commit to refrain from imposing customs duties on digital products and services.
The framework agreement also includes a mutual commitment to align on economic security issues such as supply chain resilience, duty evasion, and export controls. Additionally, Vietnam committed to strengthening its environmental protections and addressing the market-distorting effects of its state-owned enterprises. Finally, Vietnam has pledged to purchase $8 billion worth of aircraft from Boeing and $2.9 billion in U.S. agricultural commodities.
In the coming weeks, the United States and Vietnam will continue negotiations to reach a finalized trade agreement.
Malaysia
The Agreement on Reciprocal Trade between the United States and Malaysia seeks to expand bilateral economic relations, with the hope of achieving further mutual market access.
Malaysia has agreed to provide preferential access, with rates lower than its Most Favored Nation (MFN) duty rates, to various U.S. products as identified in Schedule 1 to Annex I of the agreement.[2] Selected U.S. goods, including those within the chemicals, machinery and electrical equipment, metals, passenger vehicle, food, and agriculture sectors, will receive reduced or duty free treatment. Other U.S. products will remain subject to MFN rates.
The United States, on the other hand, will maintain its overall 19 percent reciprocal tariff rate on Malaysian goods, while eliminating duties on select goods identified in Schedule 2 to Annex I,[3] once the agreement enters into force. The duty free treatment under Schedule 2 reflects the White House’s prior commitment to provide duty exemptions on certain products to trade partners who have sufficiently aligned with the United States, as reflected in a finalized trade agreement.
Additional key provisions include the reduction of non-tariff barriers, including Malaysia’s commitment to accept U.S. vehicles built to U.S. motor vehicle safety and emissions standard, streamline import requirements for U.S. steel products and Halal products, and accept certificates issued by U.S. regulatory authorities for food and agricultural products. Malaysia has also pledged increased enforcement with regards to environmental protections, counterfeiting and piracy, intellectual property, and forced labor. With regards to the trade in digital products and services, Malaysia agreed not to impose service taxes on U.S. service providers, and to support the United States position in favor of a permanent moratorium on customs duties on electronic transmissions at the World Trade Organization.
Significantly, the agreement includes a requirement for Malaysia to align its economic security policies with those of the United States. Under the terms of the agreement, if the United States imposes a customs duty, quota, prohibition, fee, charge, or other import restriction on a good or service of a third country for economic or national security reasons, upon notification, Malaysia will be required to adopt an equally restrictive measure within a timeline acceptable to both parties. Malaysia also agreed to address dumping by third party countries, to align with all unilateral export controls in force by the United States, and to enhance its processes for export control and inbound investment review. Notably, the agreement contains a clause permitting the United States to terminate the agreement if Malaysia enters into a trade agreement with a “country that jeopardizes essential U.S. interests” (e.g., China).
The agreement will enter into force 60 days after the parties certify they have completed all necessary legal procedures for implementation (or on any other date the parties agree to).
Cambodia
The Agreement on Reciprocal Trade between the United States and Cambodia represents a another step toward deepening economic ties and mutual market access. Cambodia has committed to zero percent tariffs on all U.S. industrial and food/agricultural goods as identified in Schedule 1[4] to Annex I. The United States will maintain its original reciprocal tariffs at a maximum of 19 percent, while allowing zero percent tariffs for specific Cambodian-origin products as identified in Schedule 2 to Annex I once the agreement enters into force. The agreement further prohibits Cambodia from imposing quotas on U.S. goods entering Cambodia unless mutually agreed upon.
Other key provisions include the reduction of non-tariff barriers, aiming for transparent and streamlined import licensing, recognition of U.S. standards and certificates for both industrial and agricultural products, and elimination of duplicative regulatory requirements. On digital trade, Cambodia has agreed to refrain from imposing discriminatory digital services taxes and to facilitate cross-border digital commerce—including unrestricted data transfer and cooperation on cybersecurity. A notable commercial commitment includes Cambodia’s purchase of Boeing aircraft.
On the national security front, Cambodia has agreed to align its own export controls with those of the United States on a case-by-case basis upon U.S. request, taking steps to ensure that Cambodian companies do not act as intermediaries for third-country actors seeking to circumvent these controls—commonly referred to as “backfilling”—or otherwise undermine the efficacy of U.S. restrictions. Cambodia will also assist the United States in restricting transactions between Cambodian nationals and individuals/entities from third countries who are featured on key U.S. sanctions and restricted parties lists. These lists include the Department of Commerce’s Bureau of Industry and Security Entity List, as well as the Department of the Treasury’s Specially Designated Nationals (SDN) and Blocked Persons List, plus the Non-SDN Consolidated Sanctions List.
The agreement will enter into force immediately after each party notifies the other that it has completed all internal procedures necessary to implement the agreement.
Thailand
The Framework for an Agreement on Reciprocal Trade between the United States and Thailand represents a significant expansion of bilateral market access. Thailand will remove tariffs on approximately 99 percent of goods, including a broad array of U.S. industrial and agricultural exports. In return, the United States will maintain a 19% tariff rate on imports from Thailand, with certain products identified for zero percent tariffs per Annex III of Executive Order 14346 once a final agreement is signed and enters into force.
Beyond tariffs, the agreement commits Thailand to removing a wide array of non-tariff barriers. These include accepting U.S. manufactured vehicles manufactured to comply with U.S. federal motor vehicle safety and emissions standards and FDA certificates and prior marketing authorizations for medical devices and pharmaceuticals, and issuing import permits for U.S. ethanol for fuel. In agriculture, Thailand will expedite access for USDA-certified meat and poultry, among others.
Additional provisions focus on protections for labor and the environment, intellectual property enforcement, and fostering digital trade and investment.
The agreement also anticipates substantial commercial transactions between U.S. and Thai companies in agriculture, energy, and aviation, with billions of dollars in annual purchases and procurement of U.S.-manufactured aircraft. Over the coming weeks, both sides will negotiate and finalize the agreement, paving the way for signature and implementation of these forward-looking commitments.
The United States and Thailand also signed a Memorandum of Understanding designed to enhance cooperation and investment in the development of secure, diversified, and resilient global critical minerals supply chains.
Trade Agreements Table
Country
Major Foreign Commitments
Major U.S. Commitments
Announcement
China
– Suspend export controls on rare earth minerals for 1 year. See China Fact Sheet, Nov 1, 2025.– Issue general licenses for exports of rare earths, gallium, germanium, antimony, and graphite. See China Fact Sheet, Nov 1, 2025. (“The general license means the de facto removal of controls China imposed in April 2025 and October 2022.”).– Remove all retaliatory tariffs, and non-tariff countermeasures, imposed on U.S. since March 4. See China Fact Sheet, Nov 1, 2025.– Purchase 12 million metric tons of U.S. soybeans in Nov./Dec. 2025; purchase 25 MMT in each of 2026, 2027, and 2028. See China Fact Sheet, Nov 1, 2025.– Take “significant measures” to stop flow of fentanyl. See China Fact Sheet, Nov 1, 2025.
– Reduce fentanyl related duties on Chinese imports from current 20% to 10%. See China Fact Sheet, Nov 1, 2025.– Retain current 10% reciprocal tariff on Chinese imports through November 10, 2026, reflecting a continued suspension of previously announced 34% rate. See China Fact Sheet, Nov 1, 2025.– Suspend implementation of BIS affiliates rulemaking until November 10, 2026. See China Fact Sheet., Nov 1, 2025.– Suspend implementation of Section 301 duties on Chinese shipbuilding until November 10, 2026. See China Fact Sheet, Nov 1, 2025.
China Fact Sheet, Nov 1, 2025.
South Korea
– Investments including commitments to purchase U.S. aircraft, LNG, AWS Cloud services; investment in U.S. shipbuilding industry. See South Korea Fact Sheet, Oct. 29, 2025.
– 25% tariff on South Korean autos and auto parts lowered to 15%. Reuters Article, Oct. 29, 2025.– Reductions in tariffs for wood products, pharmaceuticals, aircraft parts, generic drugs. Reuters Article, Oct. 29, 2025.
South Korea Fact Sheet, Oct. 29, 2025 (only discusses investments).
Pending official announcement on tariffs; See Reuters (Oct. 29, 2025).
Japan
– Investment commitments in U.S. energy infrastructure, AI infrastructure, electronics industry, U.S. ports, purchases of U.S. LNG, which were previously announced in July, 2025. See Japan Fact Sheet, October 28, 2025.
– Implementation of 15% baseline tariff rate previously announced in July, 2025. See Japan Fact Sheet, October 28, 2025.
Japan Fact Sheet, October 28, 2025.
Implementation Statement, Oct. 27, 2025.
Vietnam
– Provide preferential market access for “substantially all” U.S. industrial and agricultural exports. See USTR Vietnam Fact Sheet, Oct. 26, 2025.– Commitment to lower/drop various non-tariff barriers. See USTR Vietnam Fact Sheet, Oct. 26, 2025.– Commitment to purchase U.S. aircraft and agricultural products. See Joint Statement on Framework Agreement, Oct. 26, 2025.– Commitment to strengthen cooperation on supply chain security, transshipment, and export controls. See USTR Vietnam Fact Sheet, Oct. 26, 2025.
– Maintenance of current 20% tariff rate on Vietnam. See Joint Statement on Framework Agreement, Oct. 26, 2025.– Identify products to receive 0% tariff treatment for aligned partners under Annex III. See Joint Statement on Framework Agreement, Oct. 26, 2025.
USTR Vietnam Fact Sheet, Oct. 26, 2025.
Joint Statement on Framework Agreement, Oct. 26, 2025.
Malaysia
– Commitment to lower/drop various non-tariff barriers. See Agreement, Oct. 26, 2025.– Preferential access for U.S. agriculture. See Agreement, Oct. 26, 2025.– Commitment to align with U.S. policy on supply chain security, dumping, transshipment, and export control issues. See Agreement, Oct. 26, 2025.– Implementation of revised tariff rates according to agreed upon schedule. See Agreement, Oct. 26, 2025.
– Implementation of revised tariff rates according to agreed upon schedule. See Agreement, Oct. 26, 2025.– U.S. maintains overall 19% tariff rate, products under Schedule 2 to Annex I will receive 0% tariff treatment. See USTR Malaysia Fact Sheet, Oct. 26, 2025.
USTR Malaysia Fact Sheet, Oct. 26, 2025.
Agreement, Oct. 26, 2025.
Joint Statement, Oct. 26, 2025.
Cambodia
– Implementation of revised tariff rates according to agreed upon schedule. See Agreement, Oct. 26, 2025.– Commitment to eliminate tariffs on 100 percent of U.S products exported to Cambodia. See USTR Cambodia Fact Sheet, Oct. 26, 2025.– Commitment to drop/lower various non-tariff barriers. See USTR Cambodia Fact Sheet, Oct. 26, 2025.– Commitment to cooperate with U.S. policy on supply chain security, dumping, transshipment, and export control issues. See Agreement, Oct. 26, 2025.
– Implementation of revised tariff rates according to agreed upon schedule. See Agreement, Oct. 26, 2025.– U.S. maintains overall 19% tariff rate, products under Schedule 2 to Annex I receive 0% tariff treatment. See USTR Cambodia Fact Sheet, Oct. 26, 2025.
USTR Cambodia Fact Sheet, Oct. 26, 2025.
Agreement, Oct. 26, 2025.
Joint Statement, Oct. 26, 2025.
Thailand
– Commitment to eliminate tariffs on 99% of U.S. goods. See USTR Thailand Fact Sheet, Oct. 26. 2025.– Commitment to drop/lower various non-tariff barriers. See Joint Statement on Framework Agreement, Oct. 26, 2025.– Commitment to strengthen cooperation on supply chain security, dumping, transshipment, and export control issues. See Joint Statement on Framework Agreement, Oct. 26, 2025.
– U.S. maintains overall 19% tariff rate, products under Annex III receive 0% tariff treatment. See USTR Thailand Fact Sheet, Oct. 26. 2025.
USTR Thailand Fact Sheet, Oct. 26. 2025.
Joint Statement on Framework Agreement, Oct. 26, 2025.
FOOTNOTES
[1] See Annex III “Potential Tariff Adjustments for Aligned Partners” starting on page 38. Annex III is an a-la-carte menu of reciprocal tariffs that the president may lift in the event of a trade deal or agreement with a country.
[2] Malaysian customs duties on goods with staging codes beginning with an “E” will be eliminated either immediately or over time in annual installments. Duties on goods with staging codes beginning with an “R” will be reduced to a specified level (e.g., R5 = reduced to 5%). Goods under codes “A”, “B”, “C”, “D”, or “Z” will remain at dutiable at current rates. Finally, goods marked with staging code “TRQ” are governed by tariff-rate quotas as described in Appendix 1 to Schedule 1.
[3] Schedule 2 is substantially similar to Annex III contained in E.O. 14346, with slight variances in HTSUS codes listed.
[4] Cambodian customs duties on originating goods provided for in the items in staging category A shall remain zero and customs duties on originating goods provided for in the items in staging category EIF shall be eliminated entirely, and these goods shall be duty-free on the date of entry into force of the Agreement.
Google Agrees to $1.375 Billion Settlement as Texas Attorney General Continues Data Privacy Push
On October 31, 2025, the Office of the Texas Attorney General announced the execution of a $1.375 billion settlement agreement with Google regarding privacy claims originating from two lawsuits filed by Texas against Google in 2022. The lawsuits concerned Google’s handling of data derived from geolocation, incognito browsing activities and biometric identifiers.
In the first lawsuit, Texas alleged violations of the Texas Deceptive Trade Practices Act, asserting that Google “systematically misled, deceived, and withheld material facts” about how Google tracked, used, and monetized geolocation data. Texas further alleged that Google deceptively captured information while users were in “Incognito” mode, continuing to track, collect and utilize data contrary to its public representations. The disclosures in Google’s own privacy policy were used to support the Deceptive Trade Practices Act claims.
The second lawsuit accused Google of collecting biometric identifiers, including voiceprints and facial geometry records, through Google Photos, Google Assistant and Nest Hub Max, in violation of Texas’ Capture or Use of Biometric Identifier Act (CUBI). Notably, the Texas Attorney General has previously used CUBI to curb use of Texans’ data without consent.
If the substantial size of the settlement does not catch your attention, the continued commitment and willingness of Texas to deploy every available tool in the privacy toolbox should.
White House Suspends BIS Affiliates Rule for One Year
On November 1, 2025, the White House issued a Fact Sheet announcing a one-year suspension of the “Affiliates Rule” effective November 10, 2025. The Bureau of Industry and Security (“BIS”) will implement the one-year suspension as part of a broader set of bi-lateral concessions reached during the recent U.S.-China trade negotiations occurring prior to the 2025 APEC Summit in Gyeongju, South Korea. Correspondingly, China announced a suspension of its current, and proposed, export control restrictions on rare earth elements and other critical minerals.
Background of Affiliates Rule
On September 29, 2025, BIS issued a pivotal and sweeping interim final rule under the U.S. Export Administration Regulations (“EAR”) significantly broadening the scope of end-user-based export controls. Effective immediately, the Affiliates Rule expanded existing export control restrictions to cover export, reexport, and transfer (in-country) of items subject to the EAR involving any entity that is 50 percent or more owned, directly or indirectly, individually or in aggregate, by one or more parties designated on the: (i) Entity List, (ii) Military End-User List, or (iii) Specially Designated Nationals and Blocked Persons designated under programs listed in EAR Part §744.8 (see our previous alert BIS Expands Export Controls with New Affiliates Rule).
Key Takeaways of Suspension
A few key takeaways of the suspension are as follows:
The Affiliates Rule is not rescinded, but rather the Affiliates Rule is now subject to a one-year suspension. Once BIS publishes a formal notice in the Federal Register suspending the Affiliates Rule, hopefully additional details, including the potential expiration date, will become clear.
The administration frames the suspension as part of a U.S.-China arrangement, but the suspension applies to all designated entities from any country — not just the designated entities from China.
Companies may want to proactively use this suspension period to continue to assess supply chains and foreign partners covered by the Affiliates Rule, while mapping ownership structures to identify entities that may be targeted affiliates to minimize future exposure to enforcement actions if the suspension is lifted or the Affiliates Rule is reinstated.
The Supreme Court’s Tariff Case and Its Ripple Effects for Chemical Regulation
On Wednesday, November 5, 2025, the Supreme Court of the United States heard arguments on executive tariff authority, a case that promises to have ripple effects far beyond the bounds of pure trade law. Trump v. V.O.S. Selections, Inc., No. 25-250.In the chemical sector — where global chemical feedstocks, complex supply chains, and regulatory compliance are already famously complicated — the stakes are especially high. If the Court limits or invalidates the President’s ability unilaterally to impose broad tariffs under statutes such as the Trade Expansion Act of 1962 (Section 232) and the International Emergency Economic Powers Act (IEEPA), the chemical and pesticide industry (and its regulatory ecosystem) will need to adjust quickly. Conversely, if such power is affirmed or even expanded, chemical and pesticide manufacturers and regulators must brace for compliance shocks and additional supply chain disruption.
Section 232 authorizes the President, upon a finding by the United States Department of Commerce that imports threaten national security, to impose duties or quotas. The 2025 version of this policy significantly increased duties on steel and aluminum (up to 50 percent) and extended coverage to derivative products. For chemical firms, feedstocks and catalysts often rely on imported metals, minerals, and chemical intermediates — meaning the ripple effects from metal tariffs are non-trivial. The derivative list now explicitly mentions “chemical products” in its Harmonized Tariff Schedule (HTS) codes.
When input costs spike or supply chains shift rapidly, chemical companies face choices: absorb the cost, pass it on, or switch suppliers — which may in turn affect regulatory alignment (e.g., different chemical inventories (and thus regulatory status), different hazard profiles). The regulatory implications under the Toxic Substances Control Act (TSCA) and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) — for example import certifications, feedstock substitutions, potential new chemical reviews — cannot be ignored. For pesticide companies, given the fragility of the farm economy, farmers’ ability to tolerate a price increase would mean absorbing the higher production cost or face reduced sales.
Chemical firms operating globally rely on precise tariff classification and are driven by a commitment to regulatory compliance. For example, under TSCA import certification, importers must declare compliance with TSCA provisions. Under FIFRA Section 17, importers wishing to turn to foreign pesticide actives or formulants lacking U.S. registration may not do so. Rapid shifts in chemical inventory can undermine customs/regulatory coordination and invite the specter of regulatory noncompliance, creating potential regulatory consequences under TSCA and FIFRA.
If tariffs trigger raw material substitution (e.g., switching to a non-U.S. feedstock with different regulatory status or lesser toxicity data), companies may face new regulatory risk. If the chemical is “new,” slower throughput under the TSCA Section 5 new chemical review process likely renders the substitute chemical, even if less toxic, a non-starter. A changed source for an active ingredient in a pesticide formulation could mean a required step for a U.S. Environmental Protection Agency (EPA) that is likely to see delays due to the shutdown.
From the policy side, a shift in trade law destabilizes the regulatory baseline. Regulators (EPA, Customs, and other regulatory agencies) may struggle to assess accurately volumes and supply chain dynamics — complicating administrative planning.
Trade policy is increasingly intersecting with industrial policy. Materials once considered commodities — lithium, cobalt, rare-earths, per- and polyfluoroalkyl substances (PFAS) substitutes — are now the subject of investigations under Section 232 and similar authorities. For the chemical industry, this means both opportunity and risk:
Opportunity: Tariff or import-adjustment pressure may spur domestic sourcing or research and development (R&D) into alternative chemistries (aligning with TSCA’s incentives for safer alternatives).
Risk: If trade disruptions force reliance on less‐tested or non-regulated substitutes, regulatory uncertainty increases.
For policymakers, coordination matters: trade, environment, health, and industrial policy cannot operate in silos. A fractured approach may lead to unintended consequences — e.g., cheaper imports with potentially higher hazard burdens, or supply disruptions that delay regulatory review and safe product entry.
The Supreme Court’s looming consideration of cases like Trump v. V.O.S. Selections, Inc. underscores how foundational trade-authority questions are. The Court will consider whether the President has independent authority to impose broad tariffs absent clear congressional authorization. The Court is expected to announce its ruling by June 2026, or sooner.
If the Court limits executive tariff power, the chemical sector might face a period of regulatory and supply chain recalibration: companies may renegotiate imports, suppliers may shift, and regulatory programs (which assume certain flows) may need to adjust. If authority is affirmed or expanded, companies may face surprise duties, rapidly shifting sourcing, and compliance burdens tied to both trade and regulation.
What Chemical and Regulatory Stakeholders Should Do Now
Next steps for chemical and regulatory stakeholders should include the following:
Supply chain stress test: Chemical firms should map feedstocks, catalysts, imports, and derivatives to assess tariff-exposure risk and overlap with regulatory status.
Regulatory alignment: Firms should review whether substituting inputs will trigger new regulatory reviews (TSCA new chemicals; Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)-type obligations abroad).
Policy engagement: Trade policy is no longer a distant concern for chemical regulation — companies, trade associations, and regulators should engage proactively.
Watch the Court: The Supreme Court’s decision will affect tariffs, but it could also affect how regulatory agencies anticipate and model supply chain dynamics.
This week’s oral arguments at the Supreme Court may appear at first glance to be about tariff law and the limits of executive power. For the chemical sector, however — where every import, every feedstock, every new intermediate enters a regulatory universe of its own — the Court’s decision will ripple through regulatory review, compliance timelines, sourcing flexibility, and strategic materials planning. Whether the outcome tightens or broadens executive trade authority, the message is clear: chemical regulatory strategy cannot ignore trade policy.
For industry and regulators alike, the call to action has shifted from “watch this space” to “plan for whichever space we land in.”