Current and Future Perspectives on Environmental Impact Assessment for Medicines: Regulation, Implementation and Pharmaceutical Sustainability
Environmental risk assessment for medicines in the framework of current regulation involves a comprehensive analysis of the physico-chemical, toxicological, and ecotoxicological properties of active substances and their metabolites. Some studies have shown that certain active substances can affect soil microbiota and even contribute to antibiotic resistance.
The environmental risk assessment is carried out in accordance with the guidelines set out in the regulatory agencies’ guidelines. It aims to ensure that medicines do not have a negative impact on the environment throughout their life cycle. The main elements of an environmental risk assessment include:
- Identification and Characterization of Active Substances and Metabolites: The chemical and physical properties of active substances and their metabolites, as well as their degradation and transformation pathways in the environment, are determined.
- Persistence, Bioaccumulation, and Toxicity (PBT) Assessment: The environmental persistence, bioaccumulation capacity, and intrinsic toxicity of substances are analyzed to determine their potential environmental risk.
- Ecotoxicity studies: Studies are carried out to assess the adverse effects of active substances and metabolites on aquatic organisms, plants, and other elements of the ecosystem.
- Environmental Modelling: Mathematical models are used to simulate the dispersion and behavior of substances in different environmental compartments, allowing prediction of potential concentrations and assessment of exposure.
- Establishment of Emission Limits and Threshold Concentrations: Emission limits and threshold concentrations are defined based on the results of the assessment, establishing acceptable levels to avoid adverse impacts on the environment.
- Post-marketing monitoring: Ongoing monitoring programs are established to evaluate the effectiveness of risk management measures and to detect possible unanticipated effects on the environment after marketing.
The regulation of new drugs is a major issue in the pharmaceutical industry, as these regulations dictate the guidelines and requirements that drugs must meet before they are approved and placed on the market. However, with the passage of time and the advancement of technology, the need has arisen to update these regulations to address increasingly complex issues, such as the environmental impact of medicines.
Therefore, a more rigorous process for updating and periodically reviewing the effects on the environment has been established. One of the most relevant changes concerns the marketing authorization process for a new medicinal product. Previously, this process focused mainly on aspects related to human health, now environmental protection is also included.
In terms of possible changes in the near future, further harmonization and standardization of environmental risk assessment requirements at the international level are expected. In addition, there could be a more proactive approach towards the early identification of potential risks, incorporating emerging technologies, such as advanced modeling and in-silicon methods, to improve the accuracy of risk predictions. In addition, consideration of environmental aspects could be more closely integrated into the early phases of drug development, seeking to optimize therapeutic efficacy and minimize negative environmental impacts from the initial design of compounds. These potential changes aim to strengthen environmental protection and improve the sustainability of pharmaceutical products throughout their life cycle.