A proposed restriction on the use of fluorinated substances across the EEA could see the widespread shut down of medicines manufacturing, according to analysis by EFPIA. 

The proposal by the Competent Authorities (CAs) of Germany, the Netherlands, Sweden, Denmark and Norway under REACH, the EU chemical legislation, aims to limit the risks to the environment and human health from the manufacture and use of a wide range of Per- and Polyfluoroalkyl Substances (PFAS). 

Concerning up to 10,000 substances, the restriction proposal would be the widest ever put in place, restricting the manufacture, marketing and use of PFAS substances. In its current form it would have an irredeemable impact on many industrial sectors, including the essential health products and technologies sectors. The procedure currently underway could lead to a ban on all PFASs by 2027, with very limited derogations. 

The innovative pharmaceutical industry is concerned about the impact of PFAS on the environment and does not oppose the close consideration of certain harmful PFAS. However, not all PFAS have the same hazardous properties with some considered of low concern by the OECD. PFAS are used across medicines production, however those used in actual medicines have no or low identified risk through medicines risk benefit or environmental risk assessments. Therefore, while there is a need to minimise emissions, the approach should ensure the continued production and availability of medicines for patients in Europe.

EFPIA has submitted a sector response to the ECHA open consultation earlier this week, with the objective to provide scientific and technical evidence to justify derogations and prevent medicine shortages, by informing ECHA and the Commission of the potential impact of the PFAS restriction on medicinal product supply chains.

In the consultation response, a patient impact analysis showed that if the proposals go ahead in their current form, they would lead to:

• At least 47,677 global marketing authorisations being affected if the proposed restriction is implemented, with a significant number of critical medicines no longer available, impacting patient access to medicines.
• More than 600 medicines from the WHO Essential Medicines List covering a variety of pharmacological/therapeutic groups are at risk. 
• A particularly heavy impact across the European Member State’s "Critical Medicines lists" developed to counter shortages and to reduce Europe's health dependence on non-European countries.  
• For example, 78% of the critical medicines list in Norway could be impacted by the proposed restriction; in Finland 74%; Sweden 73%; France 72%; and Germany 60%

The pharmaceutical sector manufactures a variety of medicines which include materials meeting the broad definition of PFAS. These include the building blocks and the raw materials used within chemical synthesis of PFAS and non-PFAS medicines as well as reagents and equipment falling within the scope of the restriction. It would apply to packaging materials using fluoropolymers, or combination products such as pre-filled syringes. In addition, the whole process of manufacturing and developing medicines depends heavily on a number of PFAS materials in a wide variety of applications.

A further socio-economic assessment, concluded that:

• Under the two restriction options, a broad restriction of PFAS used in the production of human medicines would have disproportionate negative impacts on the European economy and society.
• Without additional derogations, the entire pharmaceutical industry would no longer be able to manufacture active pharmaceutical ingredients (APIs) (whether classified as PFAS or non-PFAS APIs) or associated medicinal products in the EEA. 
• As a result, production of APIs would have to move out of the EEA.
• If global capacity is not available, medicine shortages would become a realistic possibility. 
• As a result, the PFAS restriction would have severe impacts on human health of patients in Europe and outside of Europe, but also on European competitiveness, on the competition in the internal market, on innovation, and on the overall trade balance.
• The replacement of PFAS is limited by availability, technical applicability, and environmental trade-offs of alternatives which are to date not (readily) available. 

Information gathered justifies a time unlimited derogation of the whole process of human medicines developing and manufacturing – not just APIs – from the scope of the upcoming REACH restriction proposal.

Speaking about the proposal, Nathalie Moll, Director General, EFPIA, said: 

"While we support the need to restrict certain PFAS, we need to find the right approach to ensure the continued manufacturing and availability of medicines in Europe. A total ban would see medicines’ manufacturing in the EU grind to a halt in under three years. It would also jeopardise the production of all pharmaceutical substances in Europe and would be in conflict with the EU’s strategy of reducing dependency on nations outside of the EEA in the event of shortages or pandemics.”

Ends

Notes to editors

- Report: EFPIA response to the ECHA consultation on the proposal for a universal ban on PFAS
- Annex 1: EFPIA SEA report prepared by EPPA
- Annex 2: Human Health Medicinal Products Sector Survey - Impact of Proposed PFAS Restriction on Patient Access to Medicines & EU Strategic Autonomy
- Annex 3: ISPE_Industrial Use of Fluoropolymers & Fluoro-Elastomers in Pharmaceutical Manufacturing Facilities