From Regulation to Resilience: How U.S. Policy Shifts Are Reshaping Global Pharma

In the pharmaceutical and biotech industry, disruption is not new. The sector has been reshaped over the decades by breakthrough science, digital innovation and changing patient needs. However, today there is another force of change that is shaping the events: U.S policy and geopolitics.

To European pharma and biotech leaders, American legislation is becoming the determinant of international rivalry. What is done in Washington does not remain in Washington, it permeates the sourcing, pricing and alliance of companies across continents. The more recent changes, including the BIOSECURE Act, the renewed attempts at the Much-Favored-Nation (MFN) drug pricing, depict how rapidly the rules of engagement evolve.

The New Policy Landscape

One of the most significant proposals on the table is the BIOSECURE Act (H.R. 8333). If enacted, it would prohibit U.S. federal agencies and grant recipients from purchasing biotechnology products and services from so-called “companies of concern.” The list includes major Chinese firms such as BGI and MGI, both central players in global genomics and biotech. For European firms that rely on Chinese suppliers or CDMOs, this bill introduces more than a compliance risk; it threatens market access and raises the possibility of reputational damage by association.

At the same time, the White House has made another push to introduce the concept of the Most-Favored-Nation (MFN) pricing in U.S drug policy. This would be a way of aligning the prices of particular medicines to those offered in other localities at lower prices. To exporters, especially in Europe, the effects are direct: reduced profit margins, greater contract scrutiny, and the requirement to change the models of pricing to become less aggressive regarding reimbursement.

Meanwhile, U.S. politicians are contemplating something that goes farther than the lab bench and the pharmacy. One bill sponsored by Senator Josh Hawley will bar the consulting firms that have the U.S. government contracts unless they also represent the entities connected to the People Republic of China. This has a trickle-down impact on the pharma sector, where narrowing the range of neutral consultants that can facilitate U.S.-China-EU connections makes cross-border strategy that much harder.

Other bills, including the Risky Research Review Act, which broadens the governmental supervision of sensitive life sciences investigations, and the Royalty Transparency Act, which requires release of monetary connections in scientific consulting, reflect a wider inclination: Washington is increasing the conditions surrounding influence, transparency, and worldwide collaboration.

What It Means for Pharma and Biotech

Combined, these policies do not represent simple tweeking but are structural adjustments that are transforming the operating space. There has never been a greater examination of supply chains particularly when they reach China. New uncertainty is being experienced in pricing models as the U.S. becomes aggressor in taking a step in international benchmarking. And compliance, which has been considered merely as a needed shield, is actually turning into a competitive edge very fast.

The effect is three times to European pharma and biotech executives. One, there should be a reasoned second thought on relying on Chinese manufacturing or equipments, not only so that it can fit in regarding regulatory compliance, but also so as not to lose credibility with its U.S. collaborators. Second, the financial constraint of MFN pricing will have to be factored into the revenue forecasts associated with U.S. markets, which would necessitate a sharper contract and market access approach. Third, firms should not view compliance systems as paperwork rather as strategic resources that define their ability to obtain funds, collaborations, and long-term developments.

The Strategic Imperative

In this new reality, policy is no longer an issue on the core strategy background. The companies that are able to predict the trends of regulations are able to restructure their supply chains in advance as well as showing transparency will be in the best position to prosper. Those who fail to adapt quickly also face not only penalties and lost contracts, but also undermined itself in a market where reputation and compliance are becoming increasingly interdependent.

Pharma and biotech leaders should thus adopt a futuristic mindset. It refers to the tightening of internal controls, making advisory and lobbying operations to the standards of greater disclosures, and getting early into policy discussions that will inform the structures that will frame the opportunities of tomorrow.

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How SILREAL Helps Pharma Navigate U.S. Policy Risks

Companies need not only awareness of shifting U.S. policies but also concrete strategies to adapt supply chains, pricing, and compliance frameworks. That is why SILREAL has developed a structured suite of services, each designed to turn regulatory disruption into actionable advantage:

• US Policy Risk Radar: Monthly intelligence briefings on White House, FDA, HHS, USTR, and Congressional actions. This service provides early warning on emerging threats such as MFN pricing enforcement, executive orders on export restrictions, and new compliance mandates, giving leaders the foresight to plan ahead rather than react late.

• BIOSECURE Compliance Audit: A structured review of biotech equipment sourcing, CDMO/CMO partners, and data policies in light of the BIOSECURE Act (H.R. 8333). The goal is to protect companies from U.S. procurement bans and reputational risks associated with “biotech companies of concern,” ensuring readiness for funding and partnership eligibility.

• China Pivot Strategy: Identification and vetting of alternative Chinese CDMO partners with lower U.S. policy exposure, particularly in hubs like Suzhou and Nantong. This enables European firms to reduce dependency risks while securing compliant, scalable manufacturing capacity.

• US–EU Tariff Navigation Advisory: Scenario-based tariff impact models and sourcing recommendations. By mapping the potential costs of trade realignments, this service helps supply chain and policy teams design resilient, cost-optimized structures for a volatile regulatory environment.

• Strategic Positioning for Resilience Funds: Support for applications to U.S. and EU incentive programs such as the Strategic API Reserve and German IPCEIs. This improves a company’s chances of securing grants and co-investment opportunities tied to reshoring and resilience initiatives.

• Market Access Monitoring: MFN & Medicare: Continuous tracking of MFN drug pricing reforms and Medicare negotiation changes. This allows pricing and market access teams to build proactive repricing strategies and mitigate U.S. contract risks before they materialize.

• Policy Influence & Delegation Strategy: Coordination of pharma-relevant delegations and dialogues, including EU–China forums, Berlin–DC exchanges, and Shanghai World Health Summit tracks. Through this, clients gain visibility in strategic health diplomacy and a stronger voice in transnational policy discussions.

  
  

  Turning Regulation into Opportunity

  
  

  The U.S. policy climate is no longer a far away variable, it is a signature of how pharma and biotech conduct business across the globe. Manipulatives such as BIOSECURE Act, MFN pricing, and increased regulation of research and consulting practices underswelling a new reality: compliance, transparency, and resiliency are strategic requirements. Those firms which expect such transitions and see regulation as a way to act as a business strategy will not just endure but will emerge stronger in the market place and with a reputation that will stand more scrutiny in a more focus world.

  
  

  This is where SILREAL plays a vital role. By combining foresight with tailored advisory, SILREAL equips life sciences leaders to navigate this chaotic policy landscape with clarity and confidence. From diversifying supply chains and mitigating pricing risks to ensuring BIOSECURE compliance and positioning for resilience funding, our expertise helps turn regulatory headwinds into catalysts for growth. In partnership with SILREAL, pharma and biotech companies can transform uncertainty into long-term advantage building resilience, securing opportunity, and staying ahead in the transatlantic healthcare race.