On January 29, 2024, KEI submitted comments in response the Federal Register notice posted by the Department of Health and Human Services (HHS) concerning, “the Implications of Access and Benefit Sharing (ABS) Commitments/Regimes and Other Proposed Commitments Being Considered Under a WHO Convention, Agreement or Other International Instrument on Pandemic Prevention, Preparedness and Response” (88 FR 88637).
KEI’s comments responded to questions posed by HHS, and concerned:
- Article 9, Research and Development
- Article 10, Sustainable Production
- Royalties
- Suggested language of intellectual property exceptions
- Article 11, Transfer of Technology and Know-How
- “Mutually agreed terms”
- Incentives
- Article 12, Access and Benefit Sharing
- Article 13, Global Supply Chain and Logistics (SCL) Network
- Sanctions exceptions and exemptions
- Play-or-Pay technology transfer
- Head-to-head trials
Also included in our comments were annexes on the incentives to share inventions, data, manufacturing know-how or biologic resources.
KEI’s full comments are available here: KEI-Comments-HHS-WHO-pandemic-negotiations-29Jan2024
Note: The comment period was extended to January 31, 2024 per 89 FR 4319.