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Innovation and Access to Medicines: Case Study for HIV/AIDS and Hepatitis C

This case study explores trends in voluntary licensing and the challenges in accessing medicines for HIV/AIDS and Hepatitis C. It discusses the role of organizations like the WHO in improving access and promoting medical innovation.

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Innovation and Access to Medicines: Case Study for HIV/AIDS and Hepatitis C

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  1. Innovation and Access to Medicines: Case Study for HIV/AIDS and Hepatitis C Trends in voluntary licensing December 5, 2014 Dr. Peter Beyer

  2. 2001: Pharma companies sue South African Government over parallel imports - no voluntary license agreements 2001: WTO-Doha Declaration; stavudine case in South Africa (Yale - BMS - Aspen) 2002: Creation of Global Fund to Fight AIDS, Tuberculosis & Malaria 2003: Decision of South African Competition Authority with respect to ARVs: settlement involving license agreements with generic manufacturers 2003 - 2012: Compulsory licenses in Brazil, Ecuador, Ghana, India, Indonesia, Malaysia, Mozambique, Thailand, Zambia, Zimbabwe 2008: Adoption WHO Global Strategy & Action Plan on PH, innovation and IP 2010: Creation of the Medicines Patent Pool 2013: 7 out of 8 originator companies with HIV products in the market have license/immunity-from-suit agreements 2014: first agreements on new hepatitis C treatments

  3. Trends & Challenges • Geographicalscope: Companies expanded products & territory over time since 2010 pushed by MPP; most agreements include SSA, LDCs and/or LICs (= 68 countries) + certain number of MICs • Challenge: (upper) middle-income (except those in SSA) • Compulsorylicenses: shipment allowed under MPP licenses to countries that issue compulsory licenses • Non-patentterritory: included in some licenses (MPP) • Transparency: very limited information available on individual agreements; MPP agreements published

  4. Countries with greatest no. of HCV infections Adapted from Gower E et al. J Hepatol (2014)

  5. Hepatitis C • Agreements signed on sofosbuvir • Draft publicly available, incl. patent data • 91 countries = around half of total number of middle-income countries • Allows shipment under compulsory licenses • Shipments to non-patent territories prohibited (text unclear) • Limited to Indian producers (including API) • Allows combinations with "foreign" products (e.g. daclatasvir) • Agreements announced for daclatasvir: 90 countries

  6. What is WHO doing?

  7. WHO’s role in improving access Screening Care Treatment Treatment Guidelines Prequalification of medicines Essential Medicines List Price Reporting Mechanism Advocacy, guidance and technical assistance for improved treatment access World Hepatitis Day Assistance with national planning Improved prevalence estimates Prequalification of diagnostics Screening/ testing guidelines Prevention, including Injection safety Hospital infections Safe blood products Needle sharing programmes

  8. HCV guidelines recommendations (2014)

  9. WHO Essential Medicines Lists Satisfy priority health care needs, should be available at all times in appropriate dosage forms, of assured quality at an affordable price • Contains more than 400 medicines (18th EML) • Revised every two years: next Expert Committee meeting: April 2015 • Everybody can file applications Applications received: • daclatasvir • simeprevir • sofosbuvir • sofosbuvir/ledipasvir FDC

  10. UN/WHO Prequalification Vision: Good quality medicines for everyone Call for Expressions of Interest Hepatitis C (2014) • sofosbuvir tablet, 400mg • simeprevir capsule, 150mg • ribavirin capsule, 200mg, 400mg, 600mg

  11. Patent landscapes www.who.int/phi/implementation/ip_trade/ip_patent_landscapes/en/

  12. Concluding Remarks • Increasing number and increasing scope of HIV licenses • Important to license early in the life-cycle with broad scope • Potential for reduced prices through increased competition if licenses allow for robust competition • Part of the solution, but countries outside the agreements have to seek other avenues • Hepatitis C: first licenses signed. Will other companies follow? • Hepatitis C: What role for the Medicines Patent Pool? • Prevention!

  13. Promoting Access to Medical Technologies and Innovation • www.who.int/phi/promoting_access_medical_innovation/en/ • www.who.int/phi/publications/category/en/ • Dr Peter BeyerSenior AdvisorWorld Health Organizationbeyerp@who.intTel. +41-22-791 25 07

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