Through a rigorous benefit-risk management process, we help to ensure that the benefits of our medicinal products always outweigh the risks for patients. Every new medicine goes through a series of precisely defined development stages. Before any medicinal product is administered to human subjects, we conduct extensive preclinical testing both in vitro and in vivo.
During clinical development, we diligently use all the collected data to continuously evaluate the medical product’s benefit-risk profile. If we consider the medical product’s benefit-risk profile to be positive, we then submit an application for marketing authorization to the relevant regulatory authorities.
Continual monitoring
Once we launch a new medicinal product, the number of patients being treated with it increases significantly. In rare circumstances, there may be adverse and potentially serious effects that were not detected during clinical development, which is why we continuously monitor and manage the benefit-risk profiles after its market release. Pharmacovigilance includes the process of monitoring a medical product on an ongoing basis to detect and assess safety signals as part of signal management activities. Continuous monitoring of adverse effects allows us to proactively and transparently minimize and communicate any risks. In addition, we always provide healthcare professionals and patients with the latest information on the safety of all our marketed medicinal products. The scope of continuous safety monitoring includes the entire life cycle of a product, ranging from development, market launch, and commercialization to expiration of the marketing authorization.
Roles and responsibilities
Our Global Patient Safety unit is responsible for pharmacovigilance. It continuously collects current safety data from a wide variety of sources across the globe, including clinical studies, early access programs, spontaneous reports on adverse effects, patient support programs, and articles published in medical and scientific journals.
Our experts help to ensure all information on the risks and adverse effects of our medical products is properly documented, tracked, and reported to the respective health authorities in accordance with regulatory requirements. Our Global Patient Safety unit analyzes all data and reassesses the benefit-risk profile based on these data, where required. We then inform regulatory authorities, healthcare professionals and patients about new risks, additional risk mitigation measures, and potential changes in the benefit-risk profile.
In order to implement our R&D Strategy 2023, our Global Patient Safety unit is on a journey of transformation. Our vision is to embed a deep knowledge of safety into early decision-making as we evolve to practice predictive safety. In 2021 we continued to refine our approach to benefit-risk assessments. For example, we applied a scoring system based on safety aspects and used it to determine the prioritization levels of our products. We also redesigned our pharmacovigilance processes using a business process management model that ensures cross-functional alignment between our corporate functions. We expect to complete the implementation of these processes in 2022.
Our Global Patient Safety unit hosts a Pharmacovigilance Intelligence Council that focuses on changes in pharmacovigilance legislation and its impacts on our global and local pharmacovigilance systems. This initiative enables us to make strategic decisions and govern changes in our pharmacovigilance requirements, ensuring continuous compliance with regulatory requirements.
Our Medical Safety and Ethics Board
Our Medical Safety and Ethics Board (MSEB) oversees the safety and benefit-risk assessments of our medicinal products throughout their clinical development and commercialization. It endorses appropriate measures to minimize risks, such as updates to product information. This board is chaired by our Chief Medical Officer and comprises experienced physicians, scientists and experts from our company. Throughout a medicinal product’s entire life cycle, the MSEB reviews and assesses important medical safety risks and benefit-risk issues and reviews human-related ethical matters as appropriate.
Our commitment: Guidelines and statutory requirements
We follow international guidance and standard procedures, such as the International Council for Harmonisation (ICH) guidelines and the Good Pharmacovigilance Practices (GVP) established by the European Medicines Agency (EMA) and national health authorities. In addition, we comply with all new statutory pharmacovigilance regulations in the countries where we market our products.
Monitoring drug safety
Regulatory authorities conduct periodic inspections to verify that we comply with statutory requirements as well as our own internal pharmacovigilance standards. We follow up on the findings of health authority inspections and take necessary actions to ensure the ongoing compliance of our pharmacovigilance system. In 2021, we had eight pharmacovigilance inspections.
Furthermore, we perform audits to ensure that all our units and subsidiaries involved in pharmacovigilance consistently meet all global requirements. In 2021, we conducted a total of 18 pharmacovigilance audits and found no significant deviations in our pharmacovigilance systems from these requirements and standards. We also audit our vendors and licensing partners involved in pharmacovigilance, which helps us improve our pharmacovigilance processes and comply with regulatory requirements.
Redefining our approach to benefit-risk assessments
We have developed an improved benefit-risk strategy to help us transform from a reactive and compliance-driven organization into a proactive and benefit-risk-focused organization. By truly understanding the benefit-risk profiles of our products, we can enable early decision-making within the organization to protect the safety of patients. Ultimately, the aim is to be able to provide the right medicine to the right patient at the right time. As part of this initiative, we have also developed the concepts and principles for conducting benefit-risk assessments at each stage of product development and post-marketing.
We have concluded the pilot phase of our new benefit-risk strategy and are now following up with incremental implementation by the end of 2022.
Up-to-date labeling and product information
Our product information explains to healthcare professionals and patients how to correctly use the respective product and make informed treatment decisions.
We review and update all product information documents, such as package leaflets, to ensure our medicinal products contain the latest information on safety, efficacy, and pharmaceutical formulation. In accordance with regulatory requirements, we submit all modifications to our leaflets to the respective regulatory authorities for approval. In 2021, there were no incidents of non-compliance with regulations concerning the labeling of our medicinal products.
Internal and external training
Our pharmacovigilance experts are regularly trained so that they gain the experience and knowledge required to carry out their activities. We manage our training via a global learning platform and verify compliance with training our requirements by producing training completion reports.
All our approximately 23,000 Healthcare employees receive basic pharmacovigilance training once a year that covers the procedure for reporting adverse effects or special circumstances associated with the use of our products.