CLS Comments on NIH Proposed Policy That Would Require Access Plans in Licensing Agreements
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CLS has prepared comments in response to NIH’s proposed policy that would make licensing agreements for NIH owned inventions conditional on the inclusion of “Access Plans” to address barriers to access and affordability that NIH deems “acceptable.” While CLS shares in NIH’s goal of addressing barriers to equitable access, CLS is concerned about the negative impact these new requirements could have on the public-private partnerships that lead to new medical products for patients, especially those with high unmet medical needs. CLS believes that the proposed policy is misplaced, and we reject any mechanisms that unfairly hold licensees accountable for factors that are out of their control. CLS reiterated staunch support for comprehensive PBM reforms that would more appropriately address the affordability and accessibility concerns outlined by the NIH.