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Spiros Drosos

Of Counsel

Brussels +32 2 545 7529

  • About
  • Representative Matters
  • Credentials
  • About

    Spiros Drosos is a seasoned life sciences regulatory lawyer with deep expertise in EU pharmaceutical law and litigation. He draws on extensive experience as the former Head of Litigation at the European Medicines Agency (EMA)—where he led the Agency’s representation before the Court of Justice of the European Union (CJEU)—to advise and represent clients in the pharmaceutical, biotechnology, and medical device sectors in regulatory strategy, compliance matters, and litigation, leveraging his insider perspective to provide strategic, practical solutions.

    Over his ten-year tenure at EMA, Spiros oversaw legal support to all of its Scientific Committees, advising on complex regulatory and procedural issues. Notably, he served as the exclusive legal advisor to the Committee for Orphan Medicinal Products, guiding its assessments through the legal framework governing orphan designation, incentives, and market exclusivity.

    His regulatory counsel is informed by litigation considerations. Spiros has been involved in more than 30 proceedings before the CJEU, including landmark cases concerning data exclusivity, the granting and withdrawal of approvals, orphan drug designation, pharmacovigilance, clinical trial transparency and access to documents, and the procedural rights of regulated companies.

    In addition, Spiros contributed to the development of EU pharmaceutical law and policy, providing input on key legislative initiatives and regulatory reforms.

    He now applies his combined regulatory, litigation, and policy experience to help life sciences clients navigate the entire lifecycle of medicinal products and medical devices—from early-stage clinical development and marketing authorization to post-approval compliance, safety monitoring, and enforcement.

    Areas of Expertise

  • Practices and Industries
  • Representative Matters
    • Spiros led the representation of the European Medicines Agency (EMA) in over thirty proceedings before the Court of Justice of the European Union (CJEU), achieving successful outcomes in precedent-setting cases across key areas of EU pharmaceutical law.
      • Data exclusivity and new active substance – Represented EMA in its defense of its refusal to validate a generic application in Commission and Biogen and EMA v Pharmaceutical Works Polpharma (C-438/21 P, C-439/21 P and C-440/21 P). The Court of Justice upheld EMA’s understanding of the test for establishing whether two products of the same company belong or not to the same global marketing authorization. Additionally, he led the defense of EMA in the court cases on the notion of new active substance, including in Hexal v EMA (T-549/18) and Mylan Ireland v EMA (T-653/20), which concluded with EMA’s decisions remaining intact.
      • Transparency of pharmaceutical data – Successfully defended EMA’s transparency policies in the first-ever appellate challenges concerning public access to companies’ data, including PTC Therapeutics v EMA (C-175/18 P), MSD Animal Health Innovation v EMA (C-178/18 P), and Intercept Pharma v EMA (C-576/19 P); as well as EMA’s decision to not disclose the data related to a COVID-19 vaccine (Agentur für Globale Gesundheitsverantwortung v EMA, T-713/21).
      • Orphan drug exclusivity – Led the successful representation of EMA in pivotal cases on orphan medicinal products, including BMS v EMA (T-329/16), which clarified the evidentiary threshold for demonstrating the existence of “significant benefit,” and Mylan IRE v Commission (C-237/22 P), the first-ever case on the derogation from orphan exclusivity on grounds of clinical superiority.
      • Scientific assessments and product lifecycle regulation – Defended EMA’s decisions spanning the entire product lifecycle, including in Fresenius Kabi v Commission (T-416/22), where the General Court examined for the first time, and upheld the lawfulness of, EMA’s position that off-label risks may lead to the suspension of a product’s authorization. Additionally, he led EMA’s defence in the first-ever challenge of the granting of a marketing authorization on the ground of the supposed infringement of EU competition law in Virbac v Commission (T-138/21); the marketing authorization remained intact.
      • Regulatory policy and institutional law – Contributed to seminal case law on EMA’s handling of companies’ procedural rights, including Germany and Estonia v Pharma Mar (C-6/21 P and C-16/21 P), where the Court of Justice endorsed EMA’s conflict-of-interest rules for scientific experts employed at university hospitals involved in the development of medicinal products.

    Areas of Expertise

  • Credentials
    Education
    • European University Institute, LL.M., 2010
    • University College London, LL.M., 2009
    • University of Athens, LL.B., 2008
    Bar Admissions
    • Brussels
    • Athens
    Languages
    • English
    • German
    • French
    • Greek
    Memberships and Affiliations
    • Adjunct Lecturer in EU Procedural Law at the Catholic University of Lille (2015-present)
    • Coach/judge at the European Law Moot Court competition (2018-2020) and judge at the French rounds of the Philip C. Jessup International Law Moot Court competition (2015)
    Previous Experience
    • European Medicines Agency, Head of Litigation (2020-2025)
    • European Medicines Agency, Advisor at the Legal Department (2015-2020)
    • European Commission, Legal Service (2013)
    • UC Berkeley School of Law, Visiting Scholar (2012)
    • European University Institute, Researcher in EU Law (2010-2013)

    Areas of Expertise

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