Patient safety is Bayer’s top priority. We continuously assess the medical benefit-risk balance of our medicinal products and medical devices throughout their entire product life cycle. The efficacy, safety and tolerability of pharmaceuticals and their behavior in the body are studied in Phases I-III of preclinical and clinical development. The documentation submitted to the regulatory authorities contains the results of these studies and comprehensive information on the product’s benefit-risk assessment. Marketing authorization is only granted for a product if it satisfies the safety requirements of the health and regulatory authorities.
Following registration, Bayer continues to compile safety-relevant information in an internal pharmacovigilance database. This information is continuously evaluated and the risk-benefit balance regularly assessed by medical experts in the Global Pharmacovigilance Department. In this process, Bayer works closely with the responsible regulatory and supervisory authorities at the international and national levels. These include the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and Germany’s Federal Institute for Drugs and Medical Devices (BfArM). Additional safety-relevant information is also compiled using Post-Authorization Safety Studies (PASS) conducted after approval. Protocols and summaries of pass results are entered into the pass registry in compliance with EU pharmacovigilance legislation.
Active pharmaceutical ingredients can enter the environment, either through human or livestock excreta, improper disposal of unused medicines or during the production process. We carry out ecotoxicological investigations of the environmental behavior of residues and degradation products to assess the potential environmental impact of our pharmaceutical products. In accordance with applicable law regarding human and veterinary pharmaceuticals, an environmental risk assessment takes place for all active ingredients for which the company is targeting an approval procedure in Europe or the United States. Here it must be examined whether significant risks may arise for the environment when the pharmaceuticals are used as instructed.
Based on currently available information derived from measurements carried out by authorities and scientific institutes, the existing concentrations of individual active pharmaceutical ingredients from human or veterinary medicines in drinking water do not have any adverse effects on human health. This subject is dealt with in particular by a WHO report on pharmaceuticals in drinking water published in 2012 that comes to the conclusion that traceable effects on human health through the current extent of exposure via drinking water are highly improbable. This estimation corresponds with the studies by national authorities and institutes known to us.
In the production of our pharmaceuticals, internal company wastewater threshold values ensure that no risk to the environment results from the release of traces of active ingredients in wastewater from our production sites. All Bayer production sites worldwide are evaluated with regard to these threshold values. Site-specific measures aimed at a further reduction are taken should it not be possible to observe these standards over the long term. This includes substance-specific measures such as filtration, evaporation, oxidation, incineration or biological clarification in wastewater treatment plants.