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Data Exclusivity in FTAs and Access to Originator Medicine

This study examines the impact of data exclusivity provisions in Free Trade Agreements on access to originator (R&D Pharma) medicine and the availability of affordable medicines. It explores different scenarios and strategies, highlighting how reliance on foreign marketing approval and sequential or simultaneous filing affect access and market share.

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Data Exclusivity in FTAs and Access to Originator Medicine

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  1. Data Exclusivity in Free Trade Agreements and Access to Originator (R&D Pharma) Medicine Owais Hassan Shaikh IMPRS-CI 2010 WIPO – 31.05.2012

  2. Preliminaries • What is data exclusivity... • Protection of clinical trial data, submitted with a new drug application, against usage (reliance) by either drug regulatory authorities or generic companies for approving subsequent generic applications. • Data exclusivity through FTAs • Current debate focuses on availability of affordable medicines • However, data exclusivity provisions in specific FTAs (mainly US) may restrict total access (originator + generic) How specific FTA provisions relating to data exclusivity affect access to originator company’s medicine? 2

  3. Reliance on prior foreign marketing approval not allowed • If a Party requires or permits,... the submission of evidence of prior marketing approval (of originator’s medicine) in the other territory, the Party shall not, without the consent of a person that previously submitted the safety or efficacy information to obtain marketing approval in the other territory, authorize another to market a same or a similar product based on:... (ii) evidence of prior marketing approval in the other territoryfor at least five years for pharmaceutical products from the date of marketing approval of the new product in the Party. (Art. 14.9(b) US-Bahrain FTA) • Art. 17.10(c) US-Australia FTA; Art 15.10.1(b) CAFTA-DR; Art 18.9.1(b) US-Korea; Art 15.10.1 US-Morocco; Article 15.9.1(b) US-Oman and Article 16.8.2 US-Singapore. Reduced or no access to originator medicine (as well as noor delayedaccess to generic medicine)

  4. Two Scenarios; Four Strategies EU FTA Scenario: Reliance on foreign marketing approval allowed US FTA Scenario: Reliance on foreign marketing not allowed

  5. Hypothetical FTA between countries A, B and US/EU Assumptions: Other that data exclusivity no exclusivity (patent, orphan drug or pediatric) remaining for the originator medicine. Parallel importation is not allowed (National exhaustion); Drug authorities take 1 year to approve (originator or generic) medicine; Generic companies take 1 year to develop a bioequivalent generic drug; Term of data exclusivity is 5 years.

  6. No Data Exclusivity • Simultaneous filing in the absence of data exclusivity in FTA De facto Exclusivity (All) Generic Competition starts from year 3 (All) O Appl (All) O Appr (All) G Appl (All) G Appr (All) Legend: O/G: Originator/Generic; Appl/Appr: Application/Approval; All: A+B+US/EU

  7. EU FTA Scenario: Strategy 1 • Sequential filing when reliance is allowed in the presence of data exclusivity De facto Exclusivity (EU) Data Exclusivity (EU) Generic Competition from year 7 (EU) O Appli (EU) G Appl (EU) G Appr (EU) G Appr (All – EU) G Appli (All – EU) O Appr (EU) Generic Competition from year 3 (All – EU) No Medicine(All – EU) Legend: O/G: Originator/Generic; Appl/Appr: Application/Approval; All: A+B+EU

  8. EU FTA Scenario: Strategy 2 • Simultaneous filing when reliance is allowed in the presence of data exclusivity De facto Exclusivity (All) Data Exclusivity (All) Generic Competition from year 7 (All) O Appr (All) O Appl. (All) G Appl (All) G Appr (All) Legend: O/G: Originator/Generic; Appl/Appr: Application/Approval; All: A+B+EU

  9. US FTA Scenario: Strategy 1 Sequential filing when reliance is not allowed in the presence of data exclusivity De facto Exclusivity (US) De facto Exclusivity (A) Data Exclusivity (US) Data Exclusivity (A) Data Exclusivity (B) G Appl (A) O Appl (B) G Appl (A) O Appl (A) G Appr (A) O appr (B) O Appli (US) G Appr (A) O appr (A) O Appr (US) Generic Competition from year 7 (US) No Medicine (All – US) Generic Competition from year 13 (A) No Medicine (B)! Legend: O/G: Originator/Generic; Appl/Appr: Application/Approval; All: A+B+US

  10. US FTA Scenario: Strategy 2 • Simultaneous filing when reliance is not allowed in the presence of data exclusivity De facto Exclusivity (All) Data Exclusivity (All) Generic Competition from year 7 (All) O Appr (A) O Appl. (All) G Appl (All) G appr (All) Legend: O/G: Originator/Generic; Appl/Appr: Application/Approval; All: A+B+US

  11. Impact on Revenue of Originator’s Medicine EU FTA: Strategy 1: Sequential filing when reliance is allowed EU FTA: Strategy 2: Simultaneous filing when reliance is allowed Mean Market Share for 5-year (%) Mean Market Share for 5-year (%) Years Years US FTA: Strategy 2: Simultaneous filing when reliance is not allowed US FTA: Strategy 1: Sequential filing when reliance is not allowed Mean Market Share for 5-year (%) Mean Market Share for 5-year (%) Years Years

  12. Insights • In the presence of data exclusivity protection reliance on prior foreign marketing approval (EU FTAs) increases access to medicine in parties to an FTA. • Access to medicine is most enhanced when originator simultaneously applies under EU and US FTA and most restricted when sequentially applies under US FTA. • Originator company earns relatively more revenue when it applies simultaneously under both EU and US FTAs. • A binding provision should be included in FTAs to ensure that Originator files simultaneously in under both EU and US FTAs. • A centralized approval mechanism may be adopted in an FTA (EMEA).

  13. Thank you! 14

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