In a notice to the federal register, the NIH is announcing a new policy to address issues of access and equity in the licensing of NIH patented inventions. (The Federal Register notice is here. Secretary Becerra announcement is here).
The policy is narrow in the sense that is limited to the NIH intramural funding program, and not to the much larger part of the NIH budget which provides funding to universities, research institutes and companies.
The summary in the Federal Register notice reads:
SUMMARY: The National Institutes of Health (NIH) is proposing to develop and implement a new policy within its Intramural Research Program (IRP) to promote access to products stemming from taxpayer-funded inventions. NIH seeks input on this draft policy and accompanying draft license agreement language that incorporates patient access in the commercialization process for NIH-owned inventions.
The policy will take into account both domestic and global access and equity concerns, which is significant, particularly since many NIH funded invention are priced out of reach for the majority of the global population.
The approach outlined by the NIH will be to require licensees to have access plans. The plans will be context specific, taking into account a variety of factors including the stage of development, and the specific access challenges for a product.
The notice asks that comments be sent to Abby Rives, the Director of the Technology Transfer and Innovation Policy at the NIH, a position she has held since September 2023. People following the NIH see the Rives appointment as encouraging and a sign that the NIH is open to new thinking on equity issues.
The notice makes it clear this is the beginning of a public conversation, but also that the NIH has given some thought and structure for the new policy direction.
The last NIH Director to show any interest in access and equity was Dr. Bernadine Healy, appointed by George HW Bush. Biden’s new NIH Director, Dr. Monica Bertagnolli, is approaching this in a serious and structured way. While narrow in its application, only involving a fraction of the NIH budget, it is a welcome start, and is bound to meet considerable opposition from the usual opponents of reasonable pricing or affordability, in part because it suggests a model for thinking about access that can scale.
Many people have long sought better policies from the NIH on access and equity, including Senator Bernie Sanders, Chairman on the HELP Committee, and non-government organizations such as KEI, Public Citizen, MSF, DNDi, Health Gap, UAEM, the Medicines Patent Pool (MPP), GHIAA, and several NGOs working in developing countries such as ITPC, and the WHO/South Africa mRNA hub, as well as others. (let me know if you should be on this list).
People should read the notice and provide comments to the NIH, which will be due 60 days after the official publication in the Federal Register. (July 22)
========================================================
Below is a notice sent via email from the NIH to some groups on May 21, 2024
========================================================
Request for Information on Draft NIH Intramural Research Program Policy: Promoting Equity in Access Planning
NIH is proposing to develop and implement a new policy within the NIH’s Intramural Research Program, the internal research arm of the agency. The policy would require organizations partnering with NIH through a patent licensing agreement that succeed in bringing certain products to market to submit a plan outlining steps they intend to take to promote patient access to any resulting drug, biologic, vaccine, or device. NIH seeks input on this draft policy and accompanying draft license agreement language that incorporates patient access in the commercialization process for NIH-owned inventions.
NIH will use the responses to this request for information to develop a final policy. Comments on the proposed policy must be submitted at: https://osp.od.nih.gov/comment-form-draft-nih-intramural-research-program-policy-promoting-equity-through-access-planning. Comments must be received by July 22, 2024.
In addition, NIH will be hosting an informational webinar on the proposed policy on June 11, 2024. More information on the agenda and how to register will be provided shortly.
For additional context on the benefits of access planning, please see NIH’s 2023 Workshop on Transforming Discoveries into Products: Maximizing NIH’s Levers to Catalyze Technology Transfer.
Questions may be sent to SciencePolicy@od.nih.gov. Also, please consider following us on Twitter @NIH_OSP