Consortium, Data Rights & Trade Association Management

Chemical regulatory compliance increasingly requires development of risk assessments, negotiation of appropriate data needs, and submission of dossiers requiring data generation or proof of legitimate access to data.  Steptoe’s Environment & Life Sciences practice provides legal, regulatory, and technical support to cost-effectively facilitate competitors working together to fulfill these regulatory and stewardship needs.

Steptoe’s integrated team of experienced professionals provide the legal, technical and consulting services to administer consortia focused on product-specific advocacy, negotiation of data requirements, and generation of data.  For some groups, we help form not-for-profit associations and provide all necessary legal support.  Others operate as unincorporated associations and rely on our lawyers and scientists to achieve their objectives. 

Data development can represent a significant investment, and managing data ownership rights and costs is important to commercial and regulatory success.  Steptoe’s lawyers and in-house specialists are experienced with data management, formatting and submission in both the United States and the European Union.

This includes such data-sharing regimes such as:

  • FIFRA and FFDCA, including Antimicrobial Pesticides and Agricultural Pesticides
  • TSCA
  • REACH
  • Plant Protection Products (Agricultural Pesticides) and Biocidal Products (Antimicrobial and other Pesticides)

Specific examples of Steptoe’s experience include:

  • Reviewing and drafting cost sharing, data licensing and consortia agreements
  • Management of consortia organized to support specific compounds
  • Formation of an association to facilitate long-term collaborative work, and drafting documents for unincorporated consortia
  • Advising consortium management and legal committees on regulatory strategy, data sharing, joint dossier submissions, and advocacy strategy
  • Advising consortium members on data valuation, fair compensation, and management of antitrust risks
  • Advocacy with regulatory authorities regarding evaluation and utilization of existing data while minimizing any need for additional data
  • Coordination of multi-disciplinary product defense teams, including outside scientific experts, government affairs, and public affairs consultancies
  • Negotiating the terms of data call-ins
  • Negotiating access agreements for data owners and, in unrelated matters, data citers

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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