1.8 Product responsibility
The Global Labelling Committee reviews the labelling of all UCB drugs.
This Committee ensures that the labelling:
- meets country regulations of drugs relative to safety, efficacy and quality of drugs as well as the accuracy of the product information provided pursuant to their regulation;
- reflects appropriately and understandably information about drugs and the safety profile for patients and physicians; and,
- in the manufacturing country is identical for patients and physicians in countries to which the same drug is exported.
In addition, UCB only promotes drugs in accordance with laws, regulations, and industry codes applicable to that country. There is oversight that promotion of drugs is accurate, fair, objective, meets the highest ethical standards, and conforms to local legal requirements. Claims must reflect the latest up-to-date scientific evidence warrants and must be deprived of ambiguity.
UCB adheres to all applicable country laws, regulations and industry codes as derived from the CIOMS/WHO recommendation as derived from the WHO Ethical Criteria of Medicinal Drug Promotion as well as the Directive of the European Parliament and of the Council on the Community Code relating to medicinal products for human use, EFPIA, IFPMA and PhRMA, among others.
Promotional, press and scientific communication relating to our compounds, products and disease are submitted to the global or local committees, with members duly trained.
In 2018, a total of 1 317 global communications were reviewed.
UCB has defined internal processes to respond to each and every unsolicited medical information request. In 2018, UCB received an average of 4 932 product-related questions per month.
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 as the company is committed to public health and adheres to a high standard of professional and personal integrity.
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 in order to identify potential safety signals which may be associated with our medicines. The objective of these reviews is to monitor the impact of our evolving product safety profiles in the context of the proven or expected efficacy and the evolution of the alternative standard of care. The reviews 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 2018, 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 Drug Safety training is completed every two years by all people and for newcomers within two months of recruitment. 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 case risks are identified, appropriate preventative and corrective measures are implemented.
UCB does not sell any products that are banned in a particular market and all UCB products comply with drug regulatory and safety requirements.