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PFAS – why ECHA proposals could have far-reaching consequences

9 January 2024
Development Group
Drug Substance
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MediPhorum
Supply Partner
Sustainability
Louisa Mitchell
Global Change Facilitator

Per- and polyfluoroalkyl substances (PFAS) are commonly used synthetic polymers with great properties around inertness and hydrophobicity and are widely used in the biopharmaceutical industry. However, these ‘forever chemicals’ do not degrade, are increasingly considered environmental pollutants, and some can cause serious harm to humans.

The European Chemicals Agency (ECHA) has started a regulatory process to ban the import and use of more than 10,000 PFAS and has issued a proposal referencing suggested derogation periods and exemptions for some industries. However, the biopharmaceutical industry is not mentioned in the proposals and the ECHA might not have fully understood the impact its PFAS proposals will have on our industry and the patients it serves.

These impacts will be significant as 100% of the biopharmaceutical products being developed or already licensed for sale in the EU use PFAS in their development, manufacture, testing, storage of intermediates, or drug delivery systems. If the ban is enforced, all those drugs would have to be removed from the market until PFAS alternatives (where they exist) could be developed, sourced, validated, and approved for use. In some applications, no alternatives to PFAS that would maintain product quality exist. Moving away from PFAS will also likely impact regulatory filings because of the significant number of change notifications and potential revalidation activity.

With consultation, we hope our industry will be given appropriate exemptions or derogations to find, test, and validate alternatives and execute a transition out of these materials (where alternatives are available). This is why a collaboration of BioPhorum members, including major manufacturers of biopharmaceuticals and their suppliers, have submitted a two-part comprehensive industry analysis, documented in BioPhorum response to the Annex XV report on the proposal for universal PFAS restrictions and in BioPhorum response to the Annex XV report on the proposal for universal PFAS restrictions (part II).

These include a discussion of issues such as the types of PFAS used in our industry and why the most commonly used type – fluoropolymers, which have different properties to other PFAS of concern – have been inappropriately included in the proposed regulation. It also covers the key functionalities provided by PFAS and the socio-economic impacts of the proposal, including the number of companies in the sector estimated to be affected by the restriction. There is also a (non-exhaustive) list of PFAS applications in biopharma.

MediPhorum

MediPhorum, a global medical technology collaboration within BioPhorum comprising major manufacturers and suppliers of medical technologies from the biopharma sector, has also submitted a comprehensive response to the ECHA proposals in its paper Response to Annex XV restriction report proposal for a restriction on per- and polyfluoroalkyl substances.

The collaboration has similar concerns to those in the biopharma industry. The MediPhorum response contains a series of key concerns that the ECHA Risk Assessment and Socio-Economic Analysis committees should recognize and consider, including:

  1. The extensive use of PFAS across the biopharma and medical technology sector in medically critical applications, e.g., it is estimated that 20% of all active pharmaceutical ingredients in the EU would fall under the PFAS definition and more than 600 licensed products in the US are potentially impacted if they are manufactured or distributed within Europe
  2. The impact on approvals by regulatory authorities, e.g., any changes to registered drug and/or device manufacturing and analytical testing processes (including changes to the registered use of PFAS) must be approved by regulatory authorities – this process can take 3–5 years
  3. Improved environmental stewardship and waste management vs. a wide-reaching ban, e.g., cleaner end-of-life paradigms with a low environmental impact are achievable and fluoropolymers can be disposed of with a minimal environmental impact. For example, PTFE can be effectively incinerated above 800°C to reach complete thermal decomposition. 

However, it is crucial to approach the proposal by carefully considering the impact on the manufacturing and supply of critical, lifesaving products – the development and production of which involve complex processes requiring adherence to stringent quality standards, regulatory compliance, and extensive testing. Any significant changes in practices can have far-reaching consequences for patients, innovation, and the ability of the industry’s supply chains to respond.

The biopharma and medical technology industries acknowledge the concerns around the potential adverse effects of PFAS on human health and the environment, and fully support efforts to minimize and mitigate the presence of these and other potential materials of concern in our manufacturing processes and products. Yet, any efforts to restrict their use must be pragmatic. The risk of drug shortages and the failure to supply medicines to patients must be evaluated against the risk the materials pose to the environment and that same population.

BioPhorum and MediPhorum look forward to a continuing and productive dialog with the ECHA to recognize the implications of FPAS on human health while allowing the continued manufacture and availability of critical therapies.

For more information, download the responses here, here and here and contact Louisa Mitchell, Global Change Facilitator, at louisa.mitchell@biophorum.com for BioPhorum queries or Soroosh Bagheriasl, Senior Account Manager, at soroosh.bagheriasl@biophorum.com for MediPhorum querie

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