July 23, 2024

Public Citizen Comments to NIH on Proposed Access Planning Policy

Public Citizen NIH access planning comments (PDF)

On July 22, 2024, Public Citizen submitted comments to the National Institutes of Health (NIH) Office of Science Policy on its proposal to “develop and implement a new policy within its Intramural Research Program (IRP) to promote access to products stemming from taxpayer-funded inventions”. Our recommendations are summarized below.

A collection of comments submitted by civil society can be viewed here.

 

Recommendations for All NIH-Licensed Technologies (see RFI Issue 1 and 3)

First, we recommend changes to NIH’s proposed policy that should apply to all licensed technologies. Most critically, we recommend that all licensing agreements include conditions for advancing equitable access, which are appropriate regardless of a licensed technology’s stage. However, if NIH adopts the access planning approach, which has been drafted as an obligation to formulate an “Access Plan” when licensed products are within three months of the first pivotal clinical trial, we provide specific modifications that are key to ensuring efficacy of the draft policy.

We then recommend critical practices for ensuring oversight, accountability, and transparency of access obligations in all NIH licensing agreements. Next, we strongly urge NIH to include provisions to ensure access obligations survive the transfer of NIH technology to new parties. Finally, we request that NIH clarify the scope of the policy with respect to third-party intellectual property (IP) rights, which are often vital to ensuring global access to medicines and urge NIH to prioritize nonexclusive licensing in all agreements.

Our recommendations are summarized below:

1. A fair pricing standard for U.S. residents and conditions for global access in all licensing agreements are preferable to Access Plans, which should, at the very least, have specific milestones for achieving access objectives.
2. If NIH adopts the use of Access Plans, which are less desirable, the agency should:
   1. ensure that Access Plans address the needs of both underserved communities in the United States and populations in LMICs;
   2. review Access Plans to confirm they meaningfully advance access objectives;
   3. limit waivers and modifications of Access Plans to preserve the policy’s efficacy; and
   4. require licensees to formulate Access Plans concurrently with the licensing of technology, as delayed consideration of access objectives has been ineffective.
3. All licensing agreements should proactively define affordability (for access in LMICs) as the sustainable cost of production plus a reasonable profit margin.
4. Licensing of all NIH technologies should include substantive oversight and accountability provisions to ensure licensees fulfill access obligations.
5. To maintain stakeholder support, NIH must provide transparency of licensing agreements, associated access conditions or Access Plans, and licensing opportunities to supply LMICs.
6. NIH should ensure that access obligations survive the transfer of licensed technology to new parties, which will be important as early-stage NIH inventions change ownership as they advance to later stages of development.
7. The scope of the policy with respect to third-party IP rights should be clarified, as these rights are implicated in key access strategies, such as technology transfer activities.
8. Nonexclusive licensing is preferred for the development and commercialization of all NIH technologies.

Recommendations for Licensing of Later-Stage Inventions (see RFI Issue 1 and 5)

Second, we draw on the practices of universities and funders to recommend specific obligations for licensees of later-stage NIH technologies to promote effective access, which should be integrated as specific terms in licenses (RFI Issue 5). If NIH is unwilling or unable to adopt these as specific licensing conditions, they should be included in future guidance by NIH as examples of acceptable, commercially reasonable strategies to promote access (RFI Issue 1). We note that, while we urge NIH to grant nonexclusive licenses where possible, several recommendations in Section 2 presume that NIH will continue to grant exclusive licenses in certain circumstances.

1. Obligations to partner with public health organizations to advance global access to licensed technology.
2. Timely registration and supply of licensed products in LMICs.
3. Reserved rights for NIH to issue a humanitarian license to permit affordable supply of products relying on publicly owned technologies in LMICs.
4. Agreements not to assert IP rights in LMICs that, if enforced, would deprive those countries of affordable supply of licensed products.
5. Sublicensing and technology transfer commitments, particularly with respect to LMIC manufacturers.
6. Waiving marketing and data exclusivities in LMICs, which further delay access in countries that are rarely prioritized in global supply.

Recommendation to Extend the Scope of the Policy

Third, although the proposed policy is limited to NIH’s intramural research program, NIH has the opportunity and ability to ensure that its policies have a more significant impact on promoting access to medicines by extending the proposed policy to include NIH’s extramural research program, which accounts for nearly 83% of NIH’s budget.

We commend NIH for taking the first steps toward tackling global affordability and supply challenges to products developed with the agency’s technology. The licensing practices recommended in this document can truly benefit millions of people who have long been neglected. Through these recommendations, we hope that the agency can ensure its science is available to all who need it. 

Read Public Citizen’s full comment here.