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Biotechnology

For more than 20 years, Biotechnology has been at the core of Steptoe’s Environment & Life Sciences practice.  We focus on assisting clients developing and marketing genetically modified (GM) plants, seed, food and feed (and the complementary Agricultural Chemicals that many of them supply).  Steptoe is counsel to companies supporting some of the most high-profile genetically modified products on the market.  We also advise regional and international trade associations operating in the agribusiness sector.  In addition to these “green biotech” applications, we have a strong body of experience with “white biotech” industrial applications.  The politically-charged regulatory framework in the European Union has the potential to create barriers to market access for our clients, and Steptoe lawyers work to assist them in navigating this sometimes complex landscape. 

Through longstanding work in this area, Steptoe has built a reputation for constructive dialogue with legislators, policy makers, regulators and enforcement authorities, including Regulatory Advocacybefore the European Commission, Council, European Parliament and EU national competent authorities.  This helps clients to shape their business environment and achieve their commercial objectives.

As in all of the areas covered by our Environment & Life Sciences practice, we have built an integrated team of lawyers, scientists, and technical consultants to guide our clients.  There are key themes on which clients regularly turn to us for strategic guidance and support.  Steptoe covers the complete lifecycle of biotechnology regulation including:

Regulatory Requirements

  • Pre-market authorizations and renewals
  • Data confidentiality and protection
  • Data requirements, regulatory negotiation, and risk assessment
  • Co-existence rules on cultivation
  • Labelling and marketing requirements
  • Safe and sustainable use requirements, including monitoring
  • Export and import requirements

Commercial Requirements

  • Supply agreements
  • Antitrust  & Competition compliance issues
  • Commercial due diligence for acquisitions and divestitures

Compliance, Enforcement & Litigation

  • Regulatory challenges
  • Environmental liabilities
  • Compliance audits and non-compliance response strategies
  • Strategic advocacy
  • Challenging the compatibility of national laws with EU/WTO market access rules

Noteworthy

  • Band One, Chambers Europe, Regulatory: Environment (Europe-wide), 2014-2016
  • Tier One, Legal 500 EMEA, EU Regulatory: Chemicals, REACH (Belgium), 2011-2016
  • Tier One, Legal 500 EMEA, EU Regulatory: Environment (Belgium), 2013-2016
  • Tier One, Legal 500 EMEA, EU Regulatory: Food (Belgium), 2013-2016

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