Department of Law

Harmonisation of the regulation and the design of pharmaceutical take-back systems in the EU

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When pharmaceuticals that are designed to treat humans enter the natural environment, they may irreversibly harm living species and ecosystems. While the extent of such harm remains veiled with uncertainties, there is a growing evidence of pharmaceuticals’ presence in the environment globally. Some of the latest research shows that human exposure to individual pharmaceuticals through the environment surpasses the predicted no-effect levels, casting doubts on the so-far prevailing understanding that the risks of pharmaceuticals in the environment (PiE) to human health are only negligible. Concerns raised by this research are only mounting when combined with the knowledge about the current status of global anti-microbial resistance and the current lack of knowledge about the ‘cocktail’ effects of pharmaceuticals and other chemicals through the environment on human health.
Improper disposal of household pharmaceutical waste through sink, toilet, garbage bins, or their burning at unauthorized places increases the concentration levels of active pharmaceutical ingredients in the environment and thus their detrimental impact on environmental and human health. As a part of the response to the threat, the EU has in 2004 introduced Article 127b to the Community code requiring member states to establish ‘an appropriate collection system’ for unused and/or expired medication. However, the EU does not provide any guidelines on the implementation of these systems. The vagueness of the directive’s text and the lack of proper guidelines have contributed to the absence of the introduction of such collection systems in some Member States and significant differences among the collection systems in the Member States where they exist. There is a growing political pressure in the European Parliament to introduce clear guidelines, which would lead to the unification of the collection systems across the EU.
We address the question whether the PiE could be mitigated by the harmonisation of the take-back systems’ design across EU member states, and which regulatory measures are appropriate to take in this respect. We propose an answer to the above by conducting a comparative investigation of the legal regulation of pharmaceutical take-back systems and an empirical study of citizens’ intentions and behaviour across four European countries: the Czech Republic, Denmark, Greece, and the UK.
Effective pharmaceutical take-back systems are one of the easier achievable pieces in the EU’s regulatory solutions to the PiE puzzle. However, as reported by others and confirmed in this paper, the current setting of the take-back systems in the EU is not optimal, reaching only about 50% of compliance level by citizens. Thus, improvements are necessary. The EU is currently assessing the functioning of pharmaceutical take-back systems and the potential for their improvements, including the question of whether the harmonisation of the system across the EU is desirable. Our paper provides both dogmatic analysis and empirical data, which contributes to such assessment.
We find that there is a potential for raising the effectiveness of pharmaceutical take-back systems through their harmonisation at the EU level, and that the EU has the competence and available tools to regulate in this area.
Original languageEnglish
Publication year2021
Publication statusPublished - 2021

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