Sustainable guidelines for pharmaceutical research & development
Enhancing environmental sustainability in drug development
K. Boon (TU Delft - Technology, Policy and Management)
G. Aguilar-Hernandez – Mentor (Universiteit Leiden)
L.M. Kamp – Mentor (TU Delft - Energy and Industry)
More Info
expand_more
Other than for strictly personal use, it is not permitted to download, forward or distribute the text or part of it, without the consent of the author(s) and/or copyright holder(s), unless the work is under an open content license such as Creative Commons.
Abstract
The pharmaceutical industry presents complex challenges and opportunities for environmental sustainability. Despite strict regulations ensuring medication quality and safety, there is a clear disconnect between pharmaceutical and sustainability guidelines. Guidelines, frameworks and regulations for pharmacy do not cover environmental sustainability sufficiently, while those for sustainability are insufficiently applicable to pharmaceutical development.
This thesis examines the global, international, and regional regulatory structures in pharmaceutical development from an environmental sustainability perspective. By evaluating the current practices in pharmaceutical R&D and operations, and modern environmental standards, this study offers a novel perspective by aligning pharmaceutical and sustainability guidelines, providing recommendations for enhancing environmental sustainability throughout the full pharmaceutical life cycle.
Through literature review of 142 sources including 55 on guidelines, regulations, frameworks and standards related to pharmaceutical development (such as ICH, EMA, FDA) and sustainability (such as SDGs, WHO), along with 60 journal and research articles along with 3 expert interviews, the current state of environmental practices in pharmaceutical development was evaluated. This revealed significant structural issues, with most pharmaceutical guidelines not aligned with modern environmental standards. For example, one of the ICH guidelines is 19 years outdated while being active and recently verified, and current practices often focus on minimal compliance.
Results from this study indicate there is significant potential for improving environmental sustainability through practices like lean manufacturing and life cycle analysis (LCA) starting from the earliest stages of drug development and operations as these have an existing structure for life cycle management which currently does not include environmental considerations. The existing structure requires an environmental risk assessment only for the active pharmaceutical component but ongoing research is looking into expanding on this as well.
Key recommendations include: 1. Harmonising global pharmaceutical guidelines with modern sustainability standards and more regular updates. 2. Establishing specific environmental impact indicators and metrics for pharmaceuticals and packaging, adapting chemistry frameworks like SSbD and green chemistry principles to pharmaceuticals. 3. Incorporating LCA methodology in life cycle management and early drug development, along with development of a dedicated database for pharmaceutical environmental impacts. 4. Enhancing collaboration to bridge knowledge gaps and improve transparency between regulatory bodies, industry, and environmental scientists. These recommendations can facilitate a systemic shift toward long term sustainability in pharmaceutical development.