Europe is in the middle of one of the most ambitious chemical regulatory debates in its history. The proposed restriction on PFAS, often referred to as “forever chemicals”, aims to address serious and legitimate environmental concerns. Few would dispute the importance of tackling persistent pollution. But as the process moves forward, a critical question remains insufficiently examined: what happens to patients if medicines are caught in the middle of this policy effort? 

The publication of the ECHA Risk Assessment Committee (RAC) opinion and the draft opinion from the Socio-Economic Analysis Committee (SEAC) marks an important milestone [1]. A 60 day consultation period is now open. This consultation is not just another procedural step,  it may be one of the last opportunities to ensure that public health implications are properly understood. At the moment, those implications remain worryingly underexplored. 

Medicines are not like other products

PFAS are used in a wide range of applications, many of which clearly deserve scrutiny. But medicines occupy a fundamentally different space. Medicines cannot simply be removed from the market or reformulated overnight. Every component in a medicine, including certain fluorinated substances used in active ingredients, excipients, manufacturing processes, or packaging, has been evaluated for safety, quality, and effectiveness through years of regulatory scrutiny. Environmental risk assessments are also obligatory.

Changing even a small component is rarely straightforward. Reformulation can trigger new clinical studies, regulatory reviews, manufacturing changes, and supply chain adjustments. In many cases, substitutes do not exist, or they may significantly affect how the medicine works. Furthermore, we need to consider regretable substitution, something impactful on the environment or that does not have the funactionalities or specificities of the original substance. 

This is not hypothetical. Drug shortages are already a growing concern across Europe. Introducing additional uncertainty into pharmaceutical development and manufacturing, especially without viable alternatives, could exacerbate these challenges. 

A convergence of pressures

What is striking in the current PFAS assessment is the lack of a comprehensive evaluation of how these pressures could converge. If restrictions move forward without careful consideration, developers and manufacturers could face simultaneous demands to:

- Substitute fluorinated substances without proven alternatives
- Reformulate medicines already authorised and used by patients
- Re-validate manufacturing processes
- Navigate complex regulatory re-approval pathways

All of this would occur while regulators themselves are already working under heavy workloads and increasingly complex regulatory environments.

The question is not whether environmental protection is important. Of course it is. The question is whether the current assessment sufficiently reflects the realities of medicine development and supply. 

Public health impacts must not be overlooked

Under REACH, the committees involved in restriction decisions have a responsibility to consider public health consequences. Yet in the current opinions, the analysis of the pharmaceutical sector appears limited, they actually repeatedly mention the relevant data has not been assessed. There is little discussion of medicine availability, patient access, or the potential ripple effects across healthcare systems if certain substances were restricted without workable alternatives. 

Examples from past regulatory changes show how fragile pharmaceutical supply chains can be. When key materials become unavailable, even temporarily, the consequences can include treatment delays, shortages, or fewer therapeutic options for patients. In the context of PFAS, the scale of potential impact could be much broader. 

This consultation matters

The 60 day consultation now open through ECHA is therefore particularly important. Consultations often attract technical responses from industry experts and regulators. But the voices that matter most in this discussion may include patients, clinicians, researchers, and healthcare professionals who understand how medicines move from laboratories to pharmacies. Evidence matters. Real-world experience matters. If there are potential impacts on treatment availability, on innovation, or on healthcare systems, those impacts need to be shared.

A better balance is possible

Europe does not need to choose between environmental protection and patient care. Both objectives are essential. But achieving that balance requires policies grounded in scientific evidence, realistic transition pathways, and a clear understanding of the consequences for patients.

The PFAS restriction process is still evolving. The consultation window provides an opportunity to ensure that medicines and the patients who rely on them are properly considered before decisions are finalised.

If you work in healthcare, research, medicines development, or patient advocacy, now is the moment to look closely at the proposals and to share evidence where impacts may arise [2]. Because in the end, chemical policy should protect people without unintentionally limiting the medicines they depend on.Learn more here.

References:

[1] https://echa.europa.eu/-/echa-supports-pfas-restriction-with-targeted-derogations

[2]https://ec.europa.eu/consultation/runner/echa_pfas_seac_do_consultation