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Luca Tosoni
Brussels +32 2 545 7504 Download V-card

Luca Tosoni is an associate in the firm’s Life Sciences practice. He assists clients on a wide range of regulatory, legal, legislative and contentious matters.

Mr. Tosoni regularly counsels multinational companies and trade associations on complex issues that affect pharmaceuticals, medical devices, cosmetics and other consumer products. His practice focuses on public health, data privacy, product safety and environmental regulations, including REACH, RoHS and WEEE. He also has experience in assisting clients in litigation proceedings before the EU Courts in Luxembourg and the Board of Appeal of the European Chemicals Agency.

Advisory/Regulatory Experience 

  • Advised multinational pharmaceutical companies on regulatory compliance with EU and Italian pharmaceutical legislation.
  • Assisted trade associations and pharmaceutical companies in their advocacy efforts during EU legislative and regulatory procedures.
  • Assisted a major medical device manufacturer during a dispute with a notified body.
  • Drafted and submitted complaints against Member States’ national measures to the European Commission.
  • Advised and represented several companies in the context of product recall campaigns across Europe.
  • Provided regulatory, contractual and strategic advice to chemical manufacturers and downstream users in their efforts to ensure REACH compliance.
  • Assisted a major chemical manufacturer in the context of a REACH data sharing dispute.
  • Advised multinational companies on regulatory compliance with EU and Italian data privacy rules, including in the context of inspections from the Italian DPA.
  • Assisted multinational companies in obtaining approval of their binding corporate rules in several EU jurisdictions.

Contentious Experience

  • Assisted the European Chemicals Agency in 11 cases before the General Court of the European Union. Most recently, in case T-758/15 EDF Toruń v ECHA concerning the annulment of a decision of the European Chemicals Agency imposing an administrative charge on a REACH registrant.
  • Assisted a major chemical manufacturer in challenging a REACH compliance check decision of the European Chemicals Agency before ECHA’s Board of Appeal.

Commercial Experience

  • Regulatory due diligence for a U.S. pharmaceutical company in its acquisition of a Chinese company.
  • Regulatory due diligence for a U.S. medical device manufacturer in the context of its IPO.
  • Drafted and negotiated distribution, consultancy and clinical trial agreements for pharmaceutical companies and medical device manufacturers.