The safety of patients and users 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.
For a new pharmaceutical to secure marketing authorization, it must comply with regulatory safety requirements. Based on these documents, the regulatory authority assesses whether the efficacy, safety and quality of the pharmaceutical have been demonstrated for the intended indication. The product is only approved if its benefits outweigh the risks.
The manufacturing of pharmaceuticals and medical devices is subject to very stringent quality requirements. The quality management system of the Pharmaceuticals and Consumer Health divisions is based on internationally recognized standards for all stages of the provision of a pharmaceutical or a medical device – from development to registration, production and distribution.
Benefit-Risk Management for Pharmaceuticals and Medical Devices
The preclinical and clinical studies prescribed for pharmaceutical research investigate drug candidates with regard to their quality, safety and efficacy. At the same time, the genesis and progression of a disease differ from one person to another and the effect of a drug product can vary accordingly. We continue to observe and evaluate our products following their approval and throughout their entire life cycle. This enables adverse effects to be identified at an early stage and a decision taken as regards the necessary risk mitigation measures.
The collection and evaluation of safety-relevant information about our products are the responsibility of the global Patient and Drug Safety (Pharmacovigilance) department, in which medical experts from various disciplines work together in safety management teams (SMTs). These teams evaluate internal benefit and safety data, clinical trials, post-marketing studies, external databases and scientific publications to identify potential safety concerns at an early stage and detect possible changes in the benefit-risk profile. All data evaluated is entered into our pharmacovigilance database. The evaluation of information about a benefit-risk profile applies not just to pharmaceuticals and medical devices, but also to dietary supplements and medicated skincare products.
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) as well as the Japan Pharmaceuticals and Medical Devices Agency (PMDA) and the China National Medical Products Administration (formerly China Food and Drug Administration (CFDA)).
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.
Analysis of Residues of Pharmaceuticals in the Environment
Active pharmaceutical ingredients can enter the environment, either through human excreta, improper disposal of unused medicines or during the production process. Surface waters are particularly relevant here.
To our knowledge, the existing concentrations of individual active pharmaceutical ingredients in drinking water that is partially taken from surface waters do not have any relevant adverse effects on human health. For example, according to its report on mixtures of active pharmaceutical ingredients in drinking water published in 2017, the WHO currently does not identify any immediate health risks and consequently sees no need to act in the short term.
Our Pharmaceuticals and Consumer Health divisions carry out ecotoxicological investigations of pharmaceutical residues to assess the potential environmental impact of their active pharmaceutical ingredients. In connection with the approval process for human pharmaceuticals in Europe and the United States, an environmental risk assessment of discharge following proper use by patients takes place for all new active pharmaceutical ingredients. General information on the environmental risks of pharmaceuticals is given in the specialized information for physicians and in the package inserts, including details on how to dispose of unused pharmaceuticals.
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. Compliance with the relevant wastewater thresholds at our production sites worldwide is monitored by supervisory authorities and external assessors and also reviewed at regular intervals through on-site audits by internal experts. 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.