Navigating the PFAS Challenge in Pharma
Per- and polyfluoroalkyl substances (PFAS) have emerged as a major concern in the pharmaceutical industry and beyond. Restricting their use is heavily debated. On the one hand, these “forever chemicals” can pose environmental and human health risks. On the other hand, their unique physical and chemical properties can make them important for pharma and ultimately for helping to enable access to medicines.
Many in the pharmaceutical industry share the concern about the environmental impact of certain PFAS and steps are being taken to minimize this impact. The lack of readily available substitutes must also be carefully considered. To avoid disruptions in access to medicines and patient care, strategic planning is essential to identify the appropriate approach to manage the transition towards more sustainable pharmaceutical manufacturing. This includes more proactive cooperation across the value chain to identify and mitigate the risks of supply disruption of critical materials. By interacting with regulators and other stakeholders important for the pharmaceutical industry in a compliant and collaborative way, companies can discuss and learn how to address evolving regulations, which may include exploring and investing in viable alternatives.
It is important to consider the unique applications and risk profiles of the specific substances used in pharmaceuticals with robust regulations that continue to enable the supply of critical medicines. As the regulatory landscape evolves, with increasing scrutiny on the use of PFAS in widely prescribed drugs, it is important to seek substitutions that do not create an unnecessary regulatory burden and can be implemented without overly disrupting the supply chain. Therefore, while it is essential to minimize emissions and address environmental concerns, the regulatory approach should be balanced to ensure the continued production and availability of essential medicines for patients in Europe.
As the pharmaceutical industry progresses in emission control, there are many initiatives aimed at reducing the environmental impact of PFAS. This includes research on seeking alternatives and safer waste streams. By proactively engaging in these efforts, the goal is to find a balanced solution that protects both the environment and the ability to provide essential medicines to patients.
The ISPE Sustainability Community of Practice (CoP) was launched in July 2024 to support industry efforts in delivering quality medicines while reducing environmental impact. The CoP focuses on various sustainability aspects, including energy and carbon reduction, waste reduction, green chemistry, and product stewardship. Within this framework, the Product Stewardship Subcommittee was established to address the significant challenges posed substances of concern.
The webinar is intended for professionals in the pharmaceutical value chain who are seeking to proactively identify the impact of PFAS and minimize negative environmental impacts throughout the product lifecycle. Organized by the ISPE Sustainability CoP Steering Committee, this webinar brings together experts from leading pharmaceutical companies to discuss the latest regulatory developments and strategies in managing PFAS. This session will serve as an introduction to a broader discussion about PFAS at the 2025 ISPE Europe Annual Conference in May.
Speakers and Topics:
Sarah Ebadi with Roche will provide an overview of the global regulatory landscape for PFAS, highlighting key regulations and compliance requirements that pharmaceutical companies need to navigate.
Kelly LaCarubba with Takeda will present a case study on Takeda's approach to assessing and managing PFAS risks. She will share her experience of conducting a company risk assessment, along with ongoing projects and lessons learned.
Franz-Manfred Schuengel with Merck) will discuss the health implications of PFAS exposure and the importance of sustainability in addressing these challenges. He will explore the intersection of health, environmental impact, and sustainable practices in the pharmaceutical industry.
The webinar will conclude with a Q&A session, allowing participants to engage with the speakers and gain further insights into PFAS management in the pharmaceutical sector.
Join this informative session to learn about the latest regulatory updates, practical risk management initiatives, and the health and sustainability implications of PFAS in the pharmaceutical industry.
Disclaimer:
iSpeak Blog posts provide an opportunity for the dissemination of ideas and opinions on topics impacting the pharmaceutical industry. Ideas and opinions expressed in iSpeak Blog posts are those of the author(s) and publication thereof does not imply endorsement by ISPE.
About the Author
Acknowledgements
ISPE Sustainability Community of Practice (CoP) Steering Committee Chair
Takeda Pharmaceuticals
