Appropriate collection and disposal of medicine-related waste has been identified as one of the main ways to decrease the emission of active pharmaceutical ingredients (APIs) into the environment. Improvement to the take-back and treatment of collected pharmaceutical waste may be considered lowhanging fruit when one is considering measures to reduce API emissions. However, comparable information that would enable estimating the potential impact of these efforts has not been available. Directive 2004/27/EC, related to medicinal products for human use, mandates that EU member states implement appropriate collection schemes for unused or expired human-use medicinal products. However, it does not provide any guidelines on practical implementation of these schemes. Several studies have pointed out significant differences among Member States in this regard. In March 2019, the European Commission published the European Union Strategic Approach to Pharmaceuticals in the Environment. The actions specified therein cover all stages of the pharmaceutical life cycle, from design and production to disposal and waste management. It emphasizes such elements as sharing good practices, co-operating at international level, and improving understanding of the risks. This report is aimed at filling knowledge gaps and proposing good practices for take-back and disposal of unused human and veterinary medicines and other pharmaceutical waste. The report is targeted to e.g. ministries, environment and medicines agencies, supervisory authorities, municipalities, hospitals, NGOs, pharmacists, doctors, and veterinarians. For the report, current national practices for take-back and disposal of unused medicines and other pharmaceutical waste in Denmark, Estonia, Finland, Germany, Latvia, Lithuania, Poland, Russia, and Sweden were evaluated. The pharmaceutical waste originating from households, hospitals and other health care institutions, the pharmaceutical industry, and veterinary use was considered. The proportion of citizens who return unused pharmaceuticals via designated collection points varies greatly between Baltic Sea countries, from about 10% to 70%, with 16–80% disposing of them of as mixed household waste and 3–30% flushing them down the drain. The most commonly cited reason for improper disposal of medicines on households’ part is lack of information about their environmental impacts and how to get rid of them in an environmentally sound manner. Separate collection of unused household pharmaceuticals does not exist in Russia, and the collection mechanism functions poorly in Latvia, Lithuania and Poland. Information on the take-back schemes for unused human medicines is more readily available than is corresponding information on veterinary medicines. We identified, all told, 21 good practices and recommendations for take-back and disposal of unused pharmaceuticals and other pharmaceutical waste and for promoting the rational use of pharmaceuticals in the Baltic Sea region. Nevertheless, implementing them at national level requires particular consideration due to differences in national legislation and other characteristics of the EU Baltic Sea countries and Russia. The good practices identified in this report answer the call issued in the EU strategic approach for an efficient risk-reduction strategy.

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) [1] 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.

This report describes the contamination by pharmaceuticals and the environmental risks associated with their environmental levels in the Baltic Sea Region. Data were collected within the three-year project Clear Waters from Pharmaceuticals (CWPharma) funded by the EU’s Interreg Baltic Sea Region Programme. Sampling was performed in the river basin districts of Vantaanjoki in Finland, Pärnu in Estonia, Lielupe and Daugava in Latvia, Vistula in Poland, Warnow-Peene in Germany and Motala ström in Sweden. Analyses were performed on surface water, coastal water, sediment and soil that was fertilized with sewage sludge or manure. Analyses were also performed on emissions from municipal wastewater treatment plants, hospitals, pharmaceutical manufacturing facilities, landfills, and fish and livestock farms. In total, the study covered 13 365 data points from 226 samples as well as collection of human and veterinary consumption data of selected active pharmaceutical ingredients (APIs). Samples were screened for up to 80 APIs, representing antibiotics, antiepileptics, antihypertensives, asthma and allergy medications, gastrointestinal disease medications, hormones, metabolic disease medications, non-steroidal anti-inflammatory drugs (NSAIDs) and analgesics, other cardiovascular medicines, psychopharmaceuticals, veterinary medicines and caffeine. The measured APIs were selected based on analytical capacity, consumption rates, identified data gaps and potential environmental risks. Literature and databases were screened for ecotoxicological information. Acute toxicity tests were performed for two APIs, nebivolol and cetirizine, for which ecotoxicological data were lacking. Measured environmental concentrations were compared with predicted no-effect concentrations (PNEC) to assess environmental risks of the selected APIs.