Generation Patient is the largest organization representing adolescents and young adults with chronic and rare conditions. We are led entirely by young adults with chronic conditions. We take no pharma funding. We work to increase the health literacy, confidence, self-management skills, and advocacy strategies of young adult patients.

Patient-centered patents

NIH has a unique opportunity to support the issuance of only high quality patents by ensuring that its patents serve as valuable prior art. Your agency can set the stage for comprehensive and thorough discussions of existing work in the field that can be cited to challenge other patents effectively. Instead of merely describing the patent claims, NIH should clearly elucidate the background and scope of the innovation you intend to safeguard for future advancements. In this same vein, NIH must create quality guidelines for NIH patents to set a standard that others should follow. This might include the number of claims, the broadness of claims, and the robustness of disclosures.

March-in rights

When drug prices get out of control, we urge the NIH to use its march-in rights. The public dollars NIH expended for development of certain therapeutics should be returned for the public benefit, by making over-priced drugs more affordable through the use of march-in rights. Additionally, today’s drug shortages are affecting our young-adult community; march-in rights provide a critical opportunity to allow for widespread manufacturing.

Reasonable Pricing

The NIH should enforce reasonable-pricing claims. You must use your authority to ensure that publicly funded medical technology is priced fairly. Patients in the United States are struggling to afford medicines that have been at least partly available due to public investment. The American public deserves to benefit from reasonable pricing protections which will enable them to have access to such life-saving medicines.

Conclusion

According to the CDC, over half of young adults in the United States have a chronic condition. This number is only growing. The NIH can help young, lifelong patients across the U.S. and internationally afford therapeutics which help them improve their quality of life and allow them to thrive into adulthood and beyond. As a patient group, we do not believe innovation and affordability are mutually exclusive. The NIH has a responsibility to balance innovation with affordability and access.