Enhanced environmental permitting of pharmaceutical plants in the Baltic Sea region. CWPharma project report for GoA4.3.
This report aims to identify good practices for environmental permitting of pharmaceutical plants in some Baltic Sea (BS) countries and spread them to other countries where they are lacking or inefficient. The objective is to enhance permitting of pharmaceutical plants within current legislation framework to obtain information on their active pharmaceutical ingredient (API) emissions to municipal WWTPs (MWWTPs) and environment, resulting in improved information on pharmaceutical emissions, and aiding with direct mitigation measures when necessary. The pharmaceutical industry is highly globalized, interconnected and heterogeneous both spatially and temporally. The pharmaceutical industry includes API-production and the production of pharmaceutical products. Emissions from these activities may vary significantly. Also, as many activities are patch processes, emissions of specific substances are likely to happen only sporadically. The pharmaceutical industry may also include (re)packaging and other activities. The UNESCO & HELCOM Status Report on Pharmaceuticals (2017)  contains some information on pharmaceutical production in Estonia, Finland and Sweden, but no information on permitting practices of pharmaceutical plants. Thus, this report fills in identified information gaps related to the production of pharmaceuticals, e.g. by HELCOM. The working method evaluates the current national practices for environmental permitting for pharmaceutical plants in all seven countries represented in the project CWPharma (Denmark, Estonia, Finland, Germany, Latvia, Poland and Sweden) with the aim of collecting some information also from Russia. In the Baltic Sea region (BSR), wide recommendations on good practices for environmental permitting of pharmaceutical plants are proposed to initiate the process that clarifies the role of the pharmaceutical industry as a possible source of APIs and to estimate the need for measures that control the pharmaceutical industry’s emissions. Additionally, the aim is to evaluate the industrial wastewater contracts between municipal wastewater treatment plants (MWWTPs) and pharmaceutical plants in each BS country, even if this task is more difficult than the task related to environmental permitting of pharmaceutical plants. These documents are not publicly available, and thus the information on contracts proved difficult to obtain. The BSR wide recommendations are aimed at formulating good practices for industrial wastewater contracts between MWWTPs and pharmaceutical plants. The activities of this report pose very high transnational relevance in the Baltic Sea region (i.e. transnational spreading of good practices), because the recommendations are based on the current good practices in BSR countries and improvements made for them. Furthermore, the objective is that the recommendations will be utilised and implemented in all Baltic Sea countries. The information presented in this report will be used to identify priority measures at a national level to reduce pharmaceutical emissions. The results will also increase knowledge among target groups under the CWPharma project (pharmaceutical industry, operators of MWWTPs, permitting and supervisory authorities) and other relevant stakeholders through national stakeholder meetings and reports.