Abstract
BackgroundFor a large part of the active pharmaceutical ingredients (APIs) available on the market, there is no or no comprehensive environmental risk assessment (ERA) existent/available. Existing ERAs are, moreover, treated as commercially/industrial confidential information (CCI) and the information content on the ERAs contained in the Public Assessment Reports is very limited. Thus, neither the public can inform itself sufficient nor environmental authorities can use the ERAs to compile environmental quality standards. Environmental information law, on the other hand, requires the general accessibility of environmental information. Against this background, this investigation examines the following questions in conformity with the environmental information law: Which environmental information on pharmaceuticals is generated in the marketing authorisation? Which of the environmental information generated in the marketing authorisation is available to the public? Does the environmental information on pharmaceuticals concern CCI?ResultsAccording to international and European environmental information law, there is in principal a right of access to the ERAs of pharmaceuticals (environmental information according to Art. 2(3)(b) Aarhus Convention), which is ineffective due to product-based data and allegedly conflicting CCI. The practised blanket classification of CCI by the marketing authorisation holders is in conflict with the principle of transparency of environmental information law. In any case, the outcomes of the ERA (in particular the ecotoxicity endpoints) may not be classified as CCI. Furthermore, the publicly accessible information in the format of the Public Assessment Report does not sufficiently reflect the information from ERAs and thus does not fulfil the mandate of active access to information (Art. 5 Aarhus Convention). The conflict between the actual accessibility of environmental information on pharmaceuticals and the requirements of environmental information law could be resolved through an API-based publicly accessible database with the outcomes of the ERAs (including all underlying ecotoxicity endpoints). To fulfil the right of access to environmental information effectively, the database also needs to be extended to “old” APIs for which environmental risk assessments have not yet been carried out. This would be the basis for prioritisation of API and establishing a monograph system.ConclusionThe environmental information law requires an improved accessibility of ERAs that could be achieved through an API-based publicly accessible database.
Highlights
For a large part of the active pharmaceutical ingredients (APIs) available on the market, there is no or no comprehensive environmental risk assessment (ERA) existent/available
Which environmental information on pharmaceuticals is generated in the marketing authorisation? During the authorisation process, two documents containing environmental information are generated for one pharmaceutical: The ERA created by the applicants and a corresponding assessment report of the approval authority
Based on a comparison of the data availability generally required according to the environmental information law with the data availability determined for the pharmaceutical sector, concrete deficits were identified and solution options were discussed
Summary
For a large part of the active pharmaceutical ingredients (APIs) available on the market, there is no or no comprehensive environmental risk assessment (ERA) existent/available. Neither the public can inform itself sufficient nor environmental authorities can use the ERAs to compile environmental quality standards. Which of the environmental information generated in the marketing authorisation is available to the public? Environmental risk assessments (ERAs), including environmental toxicity data, play a key role in the entire substance management process beyond marketing authorisation: They are the basic prerequisite for prioritisation [8], for subsequent risk mitigation measures and monitoring measures in sectoral environmental protection and the prerequisite for a systematic reduction in the exposure of pharmaceuticals to the environment. There is a lack of information exchange between the authorities for the establishment of environmental quality standards (EQS). For reasons of confidentiality, the determined effect values are generally not passed on to environmental authorities, e.g., for environmental monitoring [9]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
