Investment Screening Guidance

  • Investment Screening in the EU

    For acquirers in the life sciences, foreign-investment screening now shapes European deal timetables as much as merger control. Since 2020, health has sat squarely inside Europe’s strategic perimeter: vaccines, APIs, biotechnology, diagnostics, bioprocessing and medical devices all feature in national regimes that have multiplied, hardened, and increasingly deliver conditional clearances rather than quiet non-decisions.


  • The new EU framework: three changes that matter

    Table comparing European countries’ smoking regulations, with columns for country, tobacco use, and restrictions.
    1. Screening everywhere. Every member state must establish and maintain a screening mechanism — no more voluntary opt-outs, no more gaps in the map.
    2. A common floor. Mandatory screening at minimum for dual-use and defence items, advanced technologies (semiconductors, quantum, AI), critical infrastructure, strategic raw materials, certain financial entities and electoral infrastructure — with a harmonized 45-day Phase 1. Biotechnology and critical medicines enter through the new risk-factor annexes instead, which member states are expected to mirror in national lists.
    3. Structures reached. The framework extends to certain acquisitions routed through foreign-controlled EU vehicles, closing the gap highlighted by the Court of Justice’s Xella judgment.

  • Five regimes do most of the work in European life-sciences M&A

    Italy

    Golden Power — D.L. 21/2012

    Germany

    AWG / AWV

    France

    Code monétaire et financier

    Spain

    Law 19/2003, art. 7 bis; RD 571/2023

    Ireland

    Screening of Third Country Transactions Act 2023



  • The third track: foreign subsidies

    Alongside merger control and FDI screening, the EU Foreign Subsidies Regulation adds a third mandatory clearance: concentrations with an EU target or joint-venture turnover of €500 million or more, where the parties received combined non-EU financial contributions above €50 million over three years, must be notified to the Commission and observe a standstill. The hard part is rarely the theory of harm — it is assembling group-wide contribution data on a deal timeline; build that data set once, and maintain it.

  • What this means for the deal team

    Screen at term-sheet stage. The target’s activities — vaccines, APIs, synthetic biology, diagnostics — drive the filing map more than deal value; a two-day feasibility screen prevents a two-month surprise.

    Sequence the conditions precedent. Name each FDI clearance alongside antitrust, and set the long-stop date by the slowest realistic clock — often an FDI Phase 2 rather than merger review.

    Respect standstill. Germany, Ireland— and Italy in practice— make early closing void or worse; carve-out structures rarely cure it.

    Price in conditions, not vetoes. Supply-continuity, R&D and IP-localisation and governance commitments are the currency of health-sector clearances; integration planning should assume them.

    Re-run the analysis, every deal. Perimeters move yearly — Italy’s decrees, the UK’s 2026 schedules, the EU floor arriving in January 2028 — and the new EU rules add multi-year look-back powers over non-notified deals. Last year’s “no filing” conclusion is not precedent.


  • Looking ahead

    Between now and 17 January 2028, member states will legislate toward the EU floor. Across the Atlantic, the U.S. outbound-investment program was codified and expanded by statute in 2026, with debate continuing over extending it toward biotechnology. The direction of travel is one-way; the sophistication of the response is the variable.