Annex XV report on the proposal for universal PFAS restrictions

The industry is committed to minimizing and mitigating the presence of potential substances of concern in manufacturing processes and products. While acknowledging the concerns regarding the adverse effects of various PFAS materials on human health and the environment, the industry fully supports efforts to manage the transition away from materials of concern while ensuring the safety and well-being of patients and the communities in which they operate.

However, there is a need for a pragmatic consideration of the risks of drug shortages and the impact on patient access to medicines against the risks posed by the materials to the environment and the population.

Challenges arising from restrictions on PFAS materials

The potential restrictions on PFAS materials pose significant challenges to the biopharmaceutical industry, particularly in Europe where substantial investments have been made in state-of-the-art drug manufacturing facilities.

Relocation of facilities

The unavailability of PFAS materials could lead to the relocation of manufacturing facilities out of the region, potentially resulting in facility closures and irreversible damage to the economy. With the biopharma industry employing 2.4 million people in Europe, the closure of facilities would have a detrimental effect on the workforce and revenues currently generated in the region.

Recall of drugs from the market

One hundred per cent of the biopharmaceutical products currently being developed or already licensed for sale in the EU utilize PFAS somewhere in their development, manufacture, testing, storage of intermediates or in their drug delivery systems. If the ban is enforced, all those drugs would be removed from the market until PFAS  alternatives could be developed, sourced, validated and approved for use, thus preventing access to lifesaving therapies.

Impact on time, cost and resources required.

Substituting PFAS materials with alternatives presents complex challenges, including the time, cost, and resources required to test alternatives and obtain regulatory approval for their use in various markets. This process can take several years for each product under consideration.

Additionally, the cost of substitution involves factors such as R&D, qualification and validation of alternative materials in existing manufacturing processes, and the capacity of third-party test labs to evaluate extractables and leachables of the alternatives.

The proposed restrictions do not provide derogation for the biopharma industry, and an immediate ban would have significant implications, potentially leading to disruptions in the supply of critical medicines.

The industry emphasizes the need for a thorough evaluation of the proposal's impact on its ability to supply safe and effective therapies to patients suffering from life-threatening/debilitating illnesses.

Conclusions

In conclusion, the potential restrictions on PFAS materials present critical socio-economic challenges for the biopharmaceutical industry. The complexities and timeframes involved in finding and approving alternatives, as well as the potential consequences for the supply of critical drugs and patient access to life-saving therapies, underscore the need for a comprehensive evaluation of the proposal's impact.

References

1 europeanpharmaceuticalreview.com
2 marketdataforecast.com
3 European Commission Priority sector report: Biopharmaceuticals ec.europe.eu
4 Budzinski et al., New Biotechnology, Vol 49, 25 March 2019, 37-42.

5 BioPhorum Response to the Annex XV report on the proposal for universal restrictions (Part II) October 2023.pdf, https://doi.org/10.46220/2023SP005