The accessibility of data on environmental risk assessment of pharmaceuticals: Is the marketing authorisation procedure in conflict with the international right of access to environmental information?

Abstract

Background: 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. 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? Results: According 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. Conclusion: The environmental information law requires an improved accessibility of ERAs that could be achieved through an API-based publicly accessible database.

Environmental risks of using antibiotics in the Baikal region of Russia

“…The United States, with their widespread concept of the mandatory use of antibiotics in animal husbandry to reduce the level of infection in animals and the risk of transmission of diseases to humans, criticize the position of EU that has banned feed antibiotics. China states that until the population of the country is provided with sufficient quantities of meat, it will use antibiotics in its production [1][2][3][4][5][6][7][8][9].…”

“…Antibiotics can participate in the re-circulation in the system [4] "human -medical and medicinal waste in landfills and in sewage -surface water bodies and groundwater -irrigated agriculture when growing plant products for humans and animal feed -meat and dairy products -human" (fig.1). Accordingly, antibiotics pose a threat of chemical damage to the population; therefore, recently, there have appeared publications aimed at assessing and predicting risks for the population [5][6][7][8][9]. The first studies of pharmaceutical waste in the environment appeared in the 60s-70s of the 20th century in England and Canada.…”

“…After analyzing the available scientific publications [1][2][3][4][5][6][7][8][9][10][11][12][13][14], it can be stated that the main sources of pharmaceutical waste are: -livestock farms, feed factories, large-scale dairy farms, aquaculture, poultry farms, etc. Animal husbandry releases micropollutants into the environment through the direct discharge of animal waste containing partially metabolized drugs, surface runoff from the territory, the addition of manure containing trace amounts of drugs, as well as through the direct grazing of animals treated with drugs; -sewage wastewater from water disposal systems of settlements and wastewater from hospitals; -medicines from home first-aid kits remained unused after the completion of treatment, expired medicines purchased in excessive amount.…”

Environmental fate and effects assessment of human pharmaceuticals: lessons learnt from regulatory data

“…When comparing our database and the one used by Gunnarsson et al [26] (detailed comparison of the databases is provided in supplementary information), it became clear that only a part of the data available to regulatory authorities is published in (European) public assessment reports and available for evaluations by others. This problem and the respective background were recently discussed by Oelkers, Floeter [71]. Future efforts should aim at improving the public availability of environmental data on pharmaceuticals in the EU.…”

Transition towards sustainable pharmacy? The influence of public debates on policy responses to pharmaceutical contaminants in water

“…Such an approach could target the producers of pharmaceuticals, for instance [27]. However, the authorisation of human medicines in Germany does not necessarily depend on a prior environmental risk assessment [64]. The authorisation procedure in Germany is regulated at the EU level under EU Directive 2001/83/EC [107] and Regulation (EC) No 726/2004 [112] and on the national level under the German Medicinal Products Act [110].…”