As an unrepentant policy fanatic, I love talking about details, whether it be the implications of a strategically placed “shall” or where data should be in controlled access. However, most of the time, policymaking requires being a good listener.  Listening is an underrated skill and is more than just waiting for your turn to speak.  Typically, the scientific, ethical, legal, and social issues at the forefront of biomedical research are so complex that it is essential we turn to experts and members of the public to hear their perspectives before we can develop a policy responsive to their needs. Listening to this input and incorporating it into policymaking is vital to our work and to ensuring our policies hit the mark.

A recent case study in listening involves the Novel and Exceptional Technology and Research Advisory Committee, or as we like to call them, the NExTRAC.  In 2020, we asked this committee to think through the different scenarios that may be used in gene drive research to advise on whether/how we should think about updating our existing biosafety policy framework.  During its deliberations, the Committee also did a lot of listening, consulting with subject matter experts, and holding a public workshop. Ultimately, the NExTRAC produced some very thoughtful recommendations in its final report to the NIH.

Based on our internal deliberations and the NExTRAC’s recommendations, NIH is turning this listening into action by proposing some policy updates. The proposal is to revise the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) to strengthen our infrastructure for ensuring this research continues to proceed responsibly. Specifically, the proposed revisions would incorporate specific considerations and requirements for NIH-supported research involving gene drive modified organisms in contained research settings. 

It is important to emphasize that all the proposed actions at this time focus on working with gene drive modified organisms in contained research settings. This research is already performed around the globe in labs with biosafety precautions in place. However, as technology evolves, we must make sure that our policies keep pace. Thanks to the work of the NExTRAC, we believe this proposal will allow researchers to safely proceed with contained gene drive research.  I encourage all interested stakeholders to view the full proposal and provide us with your feedback.  Comments on the full proposal will be accepted until October 10, 2023, and must be submitted electronically.  I look forward to hearing your thoughts!

The importance of bringing people together to inform policy is a mainstay of OSP’s policy approach. For instance, as the world’s largest funder of biomedical research, we have been thinking carefully about our role in making federally-funded inventions more accessible to the public – and how to bring all parties to the table to make sure we get it right. The issue of access to new drugs and treatments is of paramount importance to nearly every member of the public, and NIH is key in driving the knowledge underlying their development. However, the ecosystem that supports the process relies on a broader group of actors, including partnerships across academia, non-profits, industry, patient groups, and more to make it a success.

Under this lens, the agency is hosting a workshop on July 31 to discuss NIH policies and practices that shape biomedical innovation and promote equitable access. This is an ideal time to have a transparent and focused discussion on how NIH as a research institution approaches the patenting and licensing of biomedical inventions, especially considering the outsized role we can play in advancing lifesaving treatments and economic growth.  For example, a recent study of the NIH intramural research program found that technologies licensed from NIH helped avert over 25,000 deaths from cervical cancer between 2008-2019 while also generating about 75,000 employment positions between 2001-2021.  While these numbers are impressive, NIH is concerned about the rising costs of healthcare products, and we equally realize that our agency cannot achieve its mission if people cannot access the products that emerge from our work.

Through this workshop we hope to discuss best practices and lessons learned so that we can continue doing the things that work and course correct the things that are sub-optimal.  We will also be excited to hear new ideas from meeting participants about things we could try to enhance the impact of NIH’s patent licensing program. Importantly, we invite public participation in this workshop.  The agenda will feature a 45-minute public comment session and NIH will also accept written comments from members of the public both before and after the workshop.  Full details including the agenda, webcast information and how to submit public comments can be found on the OSP website. I am looking forward to the discussion and I hope you will be able to join us.  By working across disciplines and maintaining open lines of communications with our stakeholders we can improve health, spur innovation, increase equitable access, and fulfill the mission of the NIH.