By Dr. Caroline Moermond, The Dutch National Institute for Public Health and the Environment (RIVM)
On February 2, 2021 a consortium-wide workshop was held with more than 20 participants from all PREMIER work packages. They discussed what are the characteristics that make an active pharmaceutical ingredient (API) to be an issue for the environment. The results of this workshop primarily feed into the green pharmacy working group, where an inventory is made of the possibilities to integrate environmental criteria early in the development process of APIs. Results of the workshop showed that both risk-based qualifications (e.g., an unfavorable exposure/effects relationship, low-dose toxicity) and hazard-based qualifications (e.g., slow degradation in the environment, also when coupled to toxicity, mobility in soils or bioaccumulation) should be taken into account.
The need for this consortium-wide discussion arose in WP4.2, where discussions on the concept of ‘Green Pharmacy’ showed that also the word ‘Greener’ or ‘more environmentally friendly’ was understood differently by different partners. As the work of PREMIER focusses on the APIs, only environmental issues of those substances resulting from their use phase were taken into account. Other issues that could also be important sustainability aspects, like issues related to the production process of pharmaceuticals (greenhouse gases, carbon footprint, etc) or to the process of drug design itself (e.g., reducing environmental footprint of the design process within industry) are thus out of scope of this discussion. Thus, the aim of the workshop was to come up with project-wide guiding principles on the question: “What do we understand to be greener/more environmentally friendly regarding APIs and their use?”
An important point noted during this discussion was the fundamental issue that medicines need to be both safe and efficacious. PREMIER’s work within WP4.2 will not design alternatives for current APIs, but rather focus on:
- taking environmental considerations into account when designing new APIs,
- other use scenarios, e.g., injection vs topical, personalized diagnostics, personalized medicines, improved delivery methods,
- new developments in drug discovery that could lead to more environmentally friendly treatment options.
The results of the workshop showed a wide array of environmental issues that could be further explored to be taken up in WP4.2 work, but also in other parts of PREMIER. The figure above shows a small snapshot of the result of the first brainstorm session, which was followed by a session in which these issues were further explored, focusing on the question whether there is a possible solution to this issue, and what that could mean for patient safety or efficacy. A smaller drafting group will start working on a paper elaborating on the issues with highest priority, including exceedance of predicted no effect concentrations, environmental persistence, low-dose toxicity, and PMT/PBT (persistent, mobile, and toxic/ persistent, bioaccumulative and toxic) characteristics.
Another point raised during the discussion was that in other substance-based frameworks, this topic has also received attention during the past years. A small working group will explore the views in those other frameworks to see whether those can be translated to the pharmaceutical framework.
Dr. Caroline Moermond, PhD is a Senior advisor on Pharmaceuticals and the Environment at RIVM The Dutch National Institute for Public Health and the Environment and member of PREMIER.
