Patient safety is placed at the highest priority at Bayer HealthCare. We are dedicated to ensure that our products are as safe and effective as possible.
Throughout the development phase, extensive pre-clinical and clinical testing is performed to establish the new product’s safety and efficacy, and after the product’s launch, the safety and effectiveness of the product is monitored continuously.
How we develop safe products
When a new medication is identified, a number of pre-clinical studies will be conducted before it is tested in humans. Essential information will be collected about how the medication could treat the disease and what possible side effects it may have. Any medication where the benefit does not outweigh the risk will be abandoned as early as possible.
The question whether a benefit-risk profile is acceptable depends for a large part on the disease that is targeted and the patients who are treated. When treating life-threatening diseases, for example, potential side effects will be judged more acceptable because of the benefit of the product in saving or extending life.
For devices, we conduct all relevant laboratory and clinical trials to demonstrate that our products meet or exceed established internal and external standards for safety and performance. These results are reviewed in detail across different levels of the organization forming the basis for regulatory submissions. This product information is also the basis for the development of detailed User Guides to allow our customers to safely and effectively use our products.
How we monitor the safety of marketed products
As some side effects may not be picked up during the development process (e.g. very rare side effects or side effects in certain groups of the population), the use of the medication is continued to be monitored after the launch. Bayer HealthCare has a large team of medical scientists, doctors and pharmacists who are responsible for identifying, analyzing and reporting potential safety issues.
Bayer HealthCare receives safety-related information on marketed products from several sources, including doctors, pharmacists, patients and regulatory authorities. We also review reports in medical and scientific literature and other media. For some products, we conduct specific post-marketing studies to collect more structured information on the benefit-risk profile.
How we evaluate the benefit-risk profile
We continuously evaluate the benefit-risk profile of our pharmaceutical and medical products; from their development until their registration and once they are being marketed. Within the scope of benefit-risk management at Bayer HealthCare, experts from various disciplines jointly evaluate the available data on a product so as to identify safety risks as early as possible and initiate measures aimed at improving the understanding of the risk and at preventing or reducing the risk. These measures are summarized, for example, in safety risk management plans. Should adverse effects or other risks become known following the registration of a product, we take adequate steps to minimize the risks. These actions can range from revision of package inserts through systematic and comprehensive information campaigns for physicians and patients to measures restricting or stopping marketing activities.