Over the past couple of years there has been a growing focus on PFAS (per- and poly-fluoroalkyl substances) — a group of more than 10,000 synthetic chemicals that are widely used in consumer and industrial products. Their chemical stability and resistance to oil and water has made them incredibly useful across many industries, including the pharmaceutical sector, where they are critical to medicines and medical devices, manufacturing and packaging.
Following a joint REACH restriction proposal by five EU member states in 2023, this broad group of chemicals has been under the spotlight due to environment and health concerns, potentially concluding in a widespread ban on all PFAS by 2027.
The research-based pharmaceutical industry supports regulating PFAS of concern, substituting them or minimizing their use while protecting patients’ access to medicines.
There is also broad consensus within the pharmaceutical sector that environmental legislation is important in mitigating environmental impacts and climate change, and companies are working on numerous initiatives to achieve this.
€50 million project launched
Our industry is actively searching for alternatives. As part of the Innovative Health Initiative (IHI) — a public-private partnership initiative for health research and innovation between the EU and Europe’s life science industries — a call was launched for a project on PFAS exposure, emissions and end-of-life management in the health care sector.
The initiative will see at least €48 million — half of which are in-kind contributions from the industry and half EU funding for public partners — committed to explore which PFAS are currently used in the pharma and medtech sectors, identify opportunities to phase out PFAS of concern and find alternatives that maintain at least the same level of patient safety and product performance. From the industry side, the initiative is led by Belgian based pharma company, UCB, and involving 26 pharmaceutical and medtech companies. Further proposal considerations will look at the improved usage of PFAS materials and minimize environmental exposure, map the types and applications of PFAS throughout the supply chain, and develop a database of alternatives. The call is open until April, 23 for consortia to apply for the funding. Large companies that would like to contribute in-kind and join the existing industry consortium should contact EFPIA.
The IHI call is important. Currently no evidence exists of technically suitable and readily available alternatives that can substitute PFAS active pharmaceutical ingredients (APIs). No single ‘drop in’ replacement exists, given that each API is not only treating a certain medical condition, but also has individual properties like efficacy, side-effects, incompatibilities and drug interactions.
Understanding PFAS and its uses in medicines
PFAS is a broad non-specific term relating to thousands of molecules. Not all PFAS present the same risks to the environment or health. The industry relies on certain PFAS for safe manufacturing, distribution and use of medicinal products. Packaging, drug application devices and processing machinery, or items to extend a medicine’s shelf life or protect sterility, are just a few examples of what would fall under a blanket ban.
For example, high-performance fluoropolymers — especially polychlorotrifluoroethylene and ethylene tetrafluoroethylene — are vital to the containment, storage and delivery of injectable medicinal products. They help to form protective barriers, ensuring quality and safety and preventing degradation and deterioration. They also facilitate sterilization according to required Good Manufacturing Practices standards of fully coated stoppers due to the smooth hard surface. The unique properties of fluoropolymers provide resistance to biological, chemical and physical degradation.
The impact on medicines and vaccines development
It is with this in mind that the industry is urging caution on a blanket ban on PFAS. Without a derogation for medicines, 98% of the market authorizations of new medicines would need to be amended, which in turn could see around 70% of critical medicines in EU member states at risk of short supply.
An EFPIA survey of 40 pharmaceutical companies found that at least 93% of APIs manufacturing relies on PFAS.
If the ban applies as proposed, a wide range of medicines will become in short supply or unavailable, with impact on patient health anticipated both within and outside of the European Economic Area (EEA). Manufacturing and product development will have to be relocated outside of the EEA, impacting the economy and strategic autonomy of Europe. Additionally, banning PFAS within the EU while importing PFAS-containing products from elsewhere would be inconsistent and undermine the policy’s credibility.
Protecting patient care is a joint responsibility. While European lawmakers will need to make difficult decisions, changes to environmental legislation need to work for Europe and for all patients while being realistically deliverable over the long and short term.
The way forward
Our industry wants to see legislation that is proportionate, effective and safe with a transitional period of time-limited or unlimited derogations for low risk PFAS while protecting patients’ access to medicines.
There is currently no like-for-like replacement for PFAS, and making changes to medicines in this highly regulated sector requires new approvals. Any alternatives must be analyzed for their superior environmental performance and must not compromise patient safety. When a viable and scalable alternative is identified, implementation will require time and collaboration among partners in the value chain — including regulators, as any changes in manufacturing necessitate new regulatory approvals.
To make a regulation fit for purpose, EFPIA is proposing three recommendations:
- Time limited derogations until suitable alternative solutions are commonly agreed and qualified.
- The development of partnerships throughout supply chains to better manage PFAS emissions.
- Global health authorities expedite approvals of suitable fluorine-free alternatives.
Pharmaceutical companies are among the most active in the world in developing policies to mitigate climate change and improve public health. They often aim higher than the compliance targets set within the various EU legislative requirements as part of the EU Green Deal initiatives, including under the zero pollution, circular economy and climate action plans.
From the climate emergency to clean water, there are projects underway to minimize the environmental impacts of our supply chain, manufacturing and products. As the EU navigates the complexities of PFAS regulation, we must champion policies that simultaneously uphold environmental goals and ensure uninterrupted access to medicines.
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