The NIH has announced a new Intramural Research Program Access Planning Policy that seeks to widen access to health technologies emerging from NIH-owned patents.The policy, which applies to wholly US government-owned patents related to the development of drugs, biologics (including vaccines), or devices, will require organizations applying for commercial patent licenses to submit an Access Plan to the NIH “outlining steps they intend to take to promote patient access to those licensed products.”  Access Plans will then be incorporated into the licenses granted by NIH as part of a licensee’s development plan. 

NIH has also released an implementation guidance document to accompany the new policy. This guidance clarifies that Access Plans must describe strategies for addressing affordability, availability, acceptability, and sustainability. The guidance document also provides examples of potential strategies for consideration, as well as additional information on assessment criteria, waiver applications, the review and update process for Access Plans, and potential enforcement actions in the event of non-compliance.  

GHIAA applauds the NIH for moving the needle on equitable access to publicly funded health technologies. Having submitted a response with the Medicines Patent Pool to the Request for Information (RFI) previously issued by NIH, we are pleased to note that the published policy aligns with a number of our recommendations, including:

• Clarifying that the starting point for all Access Plans should be to consider global access needs, including the needs of underserved communities in the U.S. as well as those of underserved populations around the world.
• Outlining potential enforcement actions that may be taken if a licensee does not comply with the Access Plan requirements;
• Requiring the submission of Access Plans as a component of license applications; and 
• Incorporating progress reporting on Access Plans into licensees’ periodic progress reporting obligations. 

We were also pleased to see that our Equitable Access Toolkit and other materials from our MAPGuide Platform, were highlighted as useful resources in comments from other organizations.

The new policy could, we believe, go even further to ensure equitable access to publicly funded health technologies, such as those that are co-invented or funded by the US government. However, we recognize the immense effort it took to develop, discuss, and publish this policy, and we view it as a positive step toward increasing global equitable access to health technologies. As an organization, GHIAA stands ready to advise potential NIH licensees in developing their Access Plans.