AstraZeneca                            PFAS0104

Written evidence submitted by AstraZeneca

UK Environmental Audit Committee Inquiry: Addressing the risks from Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS)

• AstraZeneca is the UK’s leading biopharmaceutical company, focusing on the discovery, development, and delivery of medicines and vaccines.
• We take action across our value chain to reduce our impact on the climate and the environment. This includes our commitment to achieving net-zero greenhouse gas emissions, ongoing reduction in the use of water and the production of waste, sustainable sourcing of raw materials, as well as other ongoing sustainability-related efforts.
• PFAS is a broad non-specific term for a range of materials, with current definitions and classifications used for PFAS not indicating whether a compound is harmful or not.1
• PFAS have many uses in healthcare products, including as active pharmaceutical ingredients (APIs), components of medicines, vaccines, medical devices and delivery solutions (e.g. inhalers and injectables), diagnostics, and components of solutions and other materials used for biomedical and pharmaceutical research and development (R&D) and manufacturing.1
• Identifying safe alternatives for use in essential medicines has proven very difficult to date, despite significant research and investment. As such, an international consortium, funded by the EU Innovative Medicines Initiative, is now being established to evaluate alternatives.2
• Given the lack of alternatives, the introduction of any PFAS policies in the biopharmaceutical sector risks hindering patients' access to essential medicines. Evidence shows that more than 600 medicines from the WHO Essential Medicines List would be at risk, which represents ~70% of the critical medicines list in European countries.3
• Furthermore, any change to the composition of medicines, would have to be thoroughly tested for patient safety through clinical trials and approved by international and UK regulatory authorities. This would require significant lead times.
• We recommend that UK authorities focus any future PFAS policies in sectors where alternatives do exist, e.g. consumer goods, before considering PFAS policies in the biopharmaceutical sector.
• In the particular case of fluorinated gases used as propellants in pressured meter-dose inhalers (pMDIs) for respiratory diseases, the UK should exclude the next-generation propellant HFO-1234ze(E) with a near-zero Global Warming Potential from any potential restrictions on PFAS, which in May 2025 received a world-first, industry-first approval by the MHRA4. Under the European Chemicals Agency (ECHA) proposed definition, HFO-1234ze(E) has been classified as a PFAS due to its chemical structure. However, under the US EPA definition of a PFAS, HFO-1234ze(E) is not a PFAS. There is comprehensive evidence demonstrating that HFO-1234ze(E) does not demonstrate the harmful properties that other PFAS of concern have, such as bio-accumulation and toxicity. HFO-1234ze is the only currently viable long-term solution for maintaining access to essential respiratory medicines, while complying with evolving environmental legislation including the EU F-gas and US AIM legislation.
• The UK Government should explore incentive schemes and the establishment of public-private consortia to support the life sciences sector and medicines regulators to identify and adopt safe alternatives for use in medicines and biopharmaceutical products.
• We welcome the opportunity to respond to the Environmental Audit Committee’s inquiry on PFAS and would be happy to provide additional evidence.

May 2025

References:
 

1. EFPIA. A universal PFAS ban: availability of medicines, manufacturing, jobs and economic growth will be put at risk. Available online: www.efpia.eu/media/k24nszud/pfas-infographic.pdf
2. European Commission, 2025. EU Funding & Tenders Portal: Per- and Poly-fluoroalkyl substance (PFAS) exposure, emissions, and end of life management in the healthcare sector. Available online: https://ec.europa.eu/info/funding-tenders/opportunities/portal/screen/opportunities/topic-details/HORIZON-JU-IHI-2025-10-03-two-stage
3. EFPIA, September 2023. Evidence shows more than 600 essential medicines at risk, and manufacturing in Europe will ‘grind to a halt’ if wide-ranging chemical ban is implemented. Available online: https://www.efpia.eu/news-events/the-efpia-view/statements-press-releases/evidence-shows-more-than-600-essential-medicines-at-risk-and-manufacturing-in-europe-will-grind-to-a-halt-if-wide-ranging-chemical-ban-is-implemented/
4. MHRA, May 2025. MHRA approves world’s first low-carbon version of COPD inhaler Trixeo Aerosphere [press release]. Available online: https://www.gov.uk/government/news/mhra-approves-worlds-first-low-carbon-version-of-copd-inhaler-trixeo-aerosphere

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