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Maintaining Orphan Drug Status Through Product Approval – Recent Court Decision May Enhance Predictability for Drug Developers and Investors


In a landmark case, the General Court of the European Union (EU) annulled a regulatory decision that withdrew a medicinal drug product’s orphan status at the time of marketing authorization. European regulators had previously interpreted the legal requirement – that an orphan drug must demonstrate “significant benefit” over existing “satisfactory methods” of treatment at the time of authorization – to require comparison against drugs authorized for different indications and populations and against unapproved, compounded preparations. The recent trial court decision clarifies that “satisfactory methods” of treatment only refers to authorized products and in a manner defined by the approved summary of product characteristics.

This roundtable will:

  • Analyze the EU requirements for orphan drug products, with focus on the significance and status of the Medac v. Commission decision
  • Summarize an additional recent review by the European Commission to focus orphan drug and pediatric incentives in areas of “unmet medical need”
  • Address comparable considerations arising under U.S. orphan drug regulations
  • Anticipate U.S. and EU orphan drug and pediatric exclusivity issues to watch during 2021
CLE

King & Spalding is an accredited provider of CLE credit in California, Georgia, Illinois, New York and Texas. We can issue reciprocal credit for attorneys licensed in Connecticut, Florida, and New Jersey. We will apply for credit in Colorado, North Carolina and Virginia (subject to MCLE Board approval). For jurisdictions not listed, attendees are provided with a Universal Certificate of Attendance. New York licensed attorneys: Transitional/Appropriate for newly-admitted and experienced attorneys. Financial aid is available for qualifying lawyers. For CLE-related questions, please contact Gisel Arias, garias@kslaw.com. King & Spalding, 1180 Peachtree Street NE, Atlanta, GA 30309. CA Provider #10947.

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If you have questions concerning this roundtable webinar, email lifesciences-healthcare@kslaw.com.

Event Details

Date: November 24, 2020

Time: 12:00 pm (ET)

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