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Global Access Licensing Framework & University Statement of Principles

Global Access Licensing Framework & University Statement of Principles. Sarah Sorscher UAEM National Conference, New Haven, Fall 2009. Equal Access License. Low-cost availability of essential medicines in developing countries Use of university patents for neglected disease research

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Global Access Licensing Framework & University Statement of Principles

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  1. Global Access Licensing Framework & University Statement of Principles Sarah Sorscher UAEM National Conference, New Haven, Fall 2009

  2. Equal Access License • Low-cost availability of essential medicines in developing countries • Use of university patents for neglected disease research This session: low-cost availability of essential medicines

  3. How it Works • University Licenses patents • Reserves rights to sub-license to generic producers in developing countries • Licensee grants back rights on improvements • University can also sub-license these improvements to generic producers in developing countries

  4. “OMS” Canudine

  5. Canudine

  6. “The GALF”

  7. GLOBAL ACCESS LICENSING FRAMEWORK • Access to medicines and health-related technologies for all is the primary purpose of technology transfer of health-related innovations. • Technology transfer should protect access to the final end product needed by patients (e.g., formulated pills or vaccines).

  8. GLOBAL ACCESS LICENSING FRAMEWORK 3. Generic provision is the best way to ensure access in resource-limited countries for products that also have markets in developed countries.

  9. Impact of Generic Competition: Uganda

  10. GLOBAL ACCESS LICENSING FRAMEWORK 4. Proactive licensing provisions are essential to ensure that follow-on patents and data exclusivity cannot be used to block generic production. Other barriers may need to be addressed for the licensing of biologics.

  11. GLOBAL ACCESS LICENSING FRAMEWORK 4. University licensing should be systematic in its approach, sufficiently transparent to verify its effectiveness, and based on explicit metrics that measure the success of technology transfer by its impact on access and continued innovation.

  12. “Our intellectual property should not become a barrier to essential health-related technologies needed by patients in developing countries.” In cases where universities can fully preclude intellectual property barriers to generic provision by not patenting in developing countries, or by filing and abandoning patents, we will pursue these strategies.

  13. We will work together to develop and apply meaningful metrics to evaluate the success of our efforts to facilitate global access and support continued innovation with particular relevance to global health.

  14. “We will…revisit these principles on a biennial basis, to ensure that they reflect currently-understood best practices.”

  15. Gaps and Ambiguities • Does not cover “reach-through” to other intellectual property incorporated into the end product. • Is ambiguous about generic production in manufacturing countries

  16. Gaps and Ambiguities • No enforcement mechanism

  17. Where Do We Go From Here • Detailed Analysis • Approach your home institution • Keep pushing

  18. Thank You

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