U.S. Public Policy Inspired by Patients: Innovation
UCB is committed to the development of transformative solutions that treat, modify, or cure severe diseases for patients with unmet medical needs. Therefore, we support policy approaches that:
Ensure the U.S. Food and Drug Administration (FDA) remains true to its mission1 of protecting patient safety, and preserve the U.S. system of track and trace
- We oppose weakening the FDA’s preeminent mission to ensure that medical treatments, including prescription drugs, are safe, effective, and secure for patients.
Incorporate the patient voice in treatment development and regulatory decision-making
- We support the inclusion of the patient voice in all aspects of drug development and delivery, including regulatory decision-making, development of patient-reported outcomes, patient-focused drug development forums, and the use of real-world evidence (RWE).3
Support patient-preferred, innovative clinical trial designs
- We support policies that encourage the creation and adoption of clinical trial designs that minimize the time and cost of drug development by incorporating new technologies to enable decentralized studies that are more convenient and accessible to patients.
- We support increasing the inclusion of patient-reported outcomes in clinical trial designs.
- We support promoting diversity in clinical trials by removing barriers for the inclusion of historically underrepresented subpopulations.
Accelerate innovation through incentives for continued investment and the use of RWE as a supplement to randomized clinical trials (RCT) in regulatory decision making
- We support the further development of policies or pathways such as expedited FDA approval pathways and other incentive frameworks to encourage the development of therapies targeting unmet patient needs in the treatment of a serious or life-threatening condition.4
- We support the use of RWE as a supplement to RCT data in regulatory decision-making to expedite clinical development and patient access to new treatments and to ensure that product labels more closely reflect clinical practice.
Increase the ability of payers to partner with innovators earlier in the drug development process
- We support allowing payers to partner with innovators in creating coverage, financing, and access strategies earlier in the drug development and review process, allowing patients to benefit from innovative treatment more quickly upon FDA approval.
- Advance meaningful protections for innovator intellectual property
- We support policies that enable a system of intellectual property protections that reward and strengthen core innovation that serves patients, rather than creating IP protection for the sake of creating barriers to competition.
UCB recognizes our obligation to patients, the healthcare ecosystem, and society and is committed to driving sustainable solutions that recognize and reward innovation by:
- Continuing to invest above industry average revenues in the research and development of innovative and transformative medicines;
- Incorporating rigorous, internal value assessments into all phases of our discovery and development to ensure our treatments provide significant and differentiated value;
- Leading the establishment of responsible approaches to sharing clinical trial data that accelerate the development of additional therapies by other healthcare innovators;
- Empowering patients through the development and publication of patient-accessible clinical trial lay-summaries;
- Creating, maintaining, and defending intellectual property of core innovations that deliver real patient and societal value; and
- Promoting a global shift in the approach to intellectual property, innovation, and access through active public policy engagement, patent portfolio transparency, and risk-sharing among healthcare stakeholders.
3 UCB considers RWE to be any clinical and/or economic findings with respect to disease burden, treatment utilization and outcomes, comparative effectiveness, etc. that analyzes real-world data. Real-world data includes, but is not limited to, medical and pharmacy administrative claims, electronic medical/health records, product/disease registries, and patient-reported outcomes collected through various channels. Methods and analytical approaches (including artificial intelligence) to real-world data collection and RWE generation can vary, but acknowledge that RWE must be appropriately executed based on proposed research objectives and be fit for purpose.