All of UCB’s products are subject to an ongoing beneﬁt-risk assessment to ensure product labeling and safety information is kept up to date.
One critical obligation is the monitoring of the safety profile of our products both in development and on the market. Like other biopharma companies, every year UCB receives thousands of adverse event reports. These reports, along with other internal and external data (e.g., literature, external databases, etc.), are reviewed and analyzed by our safety teams to identify potential safety signals which may be associated with our medicines. These reviews, in the context of the proven or expected efficacy and the evolution of the alternative standard of care, ensure that the benefit-risk profile of our medicines is current, clearly communicated and that appropriate actions are taken to minimize potential risks to patients. All benefit-risk assessments are reviewed at a multi-disciplinary Benefit-Risk Board at regular intervals (i.e., at least annually, or biannually, depending on product risk tier).
The Benefit-Risk Board also notifies the Global Labelling Committee to ensure the timely implementation of required label changes. The Benefit-Risk Board is chaired by the Chief Medical Officer (member of the Executive Committee). In 2020, 100% of the products that required a review were assessed at the Benefit-Risk Board. In accordance with regulations, UCB provides information about individual adverse event reports, periodic summary reports, and beneﬁt-risk assessments to the health authorities.
UCB requires that a Safety Reporting Obligation training is completed every two years by all people and for newcomers within two months of recruitment. The company threshold for meeting this requirement is 90% trained company overall (last measure was 95%) and 95% trained for roles with a more direct pharmacovigilance activity in their role. These expectations also apply to strategic partners. 100% compliance is not possible due to absence, sickness, and team changes with system updates. In countries where UCB is present, 24/7 access to qualified safety staff is available to answer urgent requests for support from health care workers regarding approved products.
It is UCB’s responsibility to deliver reliable and safe drugs to our patients and Global Quality Processes and Governance safeguards this important goal. These processes are designed to ensure the best possible product quality, safety and therapeutic benefits for patients. The efficiency of the processes and compliance to regulations are periodically assessed and monitored through the audit program conducted by UCB’s Quality Department. In 2020, there were no incidents of non-compliance regarding health and safety of products regulations and voluntary codes. In case risks are identified, appropriate preventative and corrective measures are implemented.
In 2020, UCB had no FDA recalls nor were there any global product recalls. There were also no FDA enforcement actions taken in response to current Good Manufacturing Practices (cGMP).