Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Environmental risk requirements for human medicinal products in the EU: an outlook from an industries' perspective

Annette Mutschler (Abschlußjahr: 2015)

Summary
Language: English
Medicinal products are developed with the purpose of treating or preventing disease in humans or animals. In case of human medicinal products, the therapeutic benefit constitutes the guiding principle for the granting of a marketing authorization and environmental risks are not considered in the benefit-risk evaluation. However, when medicinal products are released, generally inadvertently, into the environment, they may pose environmental risks. Excretion due to incomplete absorption or metabolization is recognized as representing the main contributor to environmental exposure by pharmaceutical substances.
During the past years, pharmaceutical substances and their occurrence, fate and potential risk to the environment have moved increasingly into the focus of regulatory agencies, the European Commission and various research activities. To date, however, research activities and other environmental initiatives are still scattered between different stakeholders and are insufficiently coordinated.
Recent developments and initiatives within the EU Water Framework Directive suggest that environmental pollution by pharmaceutical substances is a topic of increasing concern which has to be regulated on an EU-wide scale, and because of which changes to EU legislation and provisions can be expected. Directive 2013/39/EU provides that the European Commission until September 2015 shall develop a strategic approach facing water pollution by pharmaceutical substances and by September 2017 propose measures to address the issue of environmental pollution by pharmaceutical substances.
The purpose of this work is to provide an outlook regarding the potential future environmental requirements and areas of concern from an industries’ perspective for human medicinal products in the EU. Measures which might be taken in the future have been identified, categorized and discussed regarding their potential impact on the European pharmaceutical industry.
It has been found that due to the complexity of the issue, diverse measures facing environmental pollution by pharmaceuticals might be taken, affecting the different life cycle stages of a human medicinal product. As a result, new registrations and the maintenance of existing marketing authorizations may become more challenging. Furthermore, it will have to be discussed if the efforts taken in the frame of the new environmental requirements are proportionate to the potential benefit for the environment.
Pharmaceutical companies will therefore need to heed future legislative developments regarding pharmaceuticals in the environment and will need to engage actively with regulators and other stakeholders.
Pages: 64, Annexes: pages: 3