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Generic Competition

Generic Competition. Universities Allied for Essential Medicines April 12, 2007 Adopted from UPenn Nat’l Conference Presentation. Defining the problem. Adequate drugs and diagnostics simply do not exist for many neglected diseases

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Generic Competition

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  1. Generic Competition • Universities Allied for Essential Medicines • April 12, 2007 • Adopted from UPenn Nat’l Conference Presentation

  2. Defining the problem • Adequate drugs and diagnostics simply do not exist for many neglected diseases • Even where drugs and diagnostics do exist, prices in developing countries are often out of reach when the market is not competitive • Even where prices are affordable, other barriers to delivery exist (human resources, infrastructure, management capacity)

  3. ARV Price Comparison: 3TC+d4T(40)+NVP October 2003 January 2006 $562 $562 $290 $192 Branded Best Price Generic List Price Branded Best Price Generic List Price

  4. Effect of generic competition on market prices

  5. Other problems associated with originator market exclusivity • Untimely product launch • – Heat-stable LPV/r • – Tenofovir • Unreliability of supply in single-source situations • Barriers to innovation Pricing is not the sole concern with respect to patent-protected market exclusivity: do not equate ‘access’ with ‘low prices’

  6. Features of generic competition Economics (cost advantages, competition) Innovation (eg, FDCs, pediatric formulations) Quality + + Generic competition produces superior outcomes

  7. EAL (Equitable Access Licensing)

  8. Equitable Access License (EAL) overview • Basic idea: Means of maintaining open door for robust generic competition • Deals with three basic hurdles: patent, regulatory/data, and production capacity • Major benefits include simplicity and ease of administration, maximum flexibility for generic producers, and wide coverage • Leaves relatively little discretion to university or licensee: self-executing rights, covers all LMIs, no eligibility (eg, quality) restrictions on suppliers, etc.

  9. EAL schematic: Cross-license and grant-back

  10. EAL schematic: Notification

  11. EAL schematic: Notifier improvements 4. Royalties flow to university and licensee

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