Document 2RBeMV9xjR1Mgov6BnN36J2QN

Brussels, September 23rd, 2023 EFCG response to the ECHA consultaon on the proposed restricon on the manufacture, placing on the market and use of per- and polyfluoroalkyl substances (PFAS) The European Fine Chemicals Group (EFCG), a sector group of Cefic1, represents the European manufacturers of Acve Pharmaceucal Ingredients (APIs), their pharmaceucal intermediates and excipients. Europe tradionally has a very strong and important API manufacturing base, using highly technological and regulated industrial processes, both during the R&D and commercial producon phases.2 EFCG members are an essenal part of the European pharmaceucal supply chain, developing and manufacturing the essenal components that are responsible for the pharmaceucal effect of medicines. As such, we would like to draw atenon to the future impact of the ongoing work within the European Union on per- and polyfluoroalkylated substances known under the generic name of PFAS. The restricon proposal submited in January 2023 by the Netherlands, Germany, Sweden, Denmark and Norway to ECHA includes a proposal for a me-unlimited derogaon for acve substances in human and veterinary medicinal products. As explained in this cover note and in the detailed atachment, the proposed derogaon as it is formulated now will not be sufficient and will not avoid profound negave consequences on essenal health products and technologies sector. API synthesis is a very complex process requiring numerous steps and raw materials. We think that the impact of the restricon has been underesmated by the five competent authories as their proposal considers a derogaon for APIs but does not extend the derogaon to the synthesis routes used to produce them and thus oming to take into account either the number of APIs requiring the use of PFAS for their producon or the raw materials, synthesis intermediates and reagents required for their producon. The absence of a derogaon for all steps of the API supply chain (starng materials, intermediates, APIs, excipients, etc ...) would impede their producon in Europe and lead to the off-shoring of their producon and a weakening of their supply and availability. The proposed restricon would thus have an in-depth impact on the accessibility and availability of medicinal products for European cizens and on the EU's Strategic Autonomy targets and compeveness. The expected consequences of the ban would jeopardise all producon of pharmaceucal substances in Europe and would counteract the efforts of most European Member States to relocate crical pharmaceucal producon chains on EU territory. Furthermore, it would 1 Cefic is the European Chemical Industry Council, aisbl 2 How is a pharmaceucal specialty developed: htps://efcg.cefic.org/acve-pharmaceucal-ingredients/rdproducon/ definitely curb the iniave of European Member States to promote a "Crical Medicines Act" to reduce Europe's health dependence on non-European countries. Impact on paents EFCG strongly believes that the most important socio-economic aspect to evaluate is the impact of the restricon in terms of non-availability of medicinal products on paents. To assess this, EFCG teamed up with the four major pharmaceucal industry associaons3 and gathered evidence across its membership to inform ECHA of the potenal impact of the PFAS Restricon on the medicinal product supply chain and, ulmately, on medicine shortages. The survey4 shows that the proposed restricon would negavely impact the availability of compounds from very diverse chemical and therapeuc classes, including 674 medicines from the WHO list of essenal medicines, distributed across a variety of pharmacological/therapeuc groups. Many of the medicines manufactured using PFAS are used in treang life-threatening condions, including cancer and cardiovascular diseases. In the absence of a full derogaon for all steps of API manufacturing, paents would face delays or be forced to switch to less effecve treatments, compromising paent outcomes and safety. In many cases, they would completely lose access to treatments. Furthermore, a heavy impact was also idenfied across the European Member State's "Crical Medicines lists" developed to counter shortages and to reduce Europe's health dependence on non-EU imports. Notably, the supply chains of 93% of the acve substances listed in the survey were found to involve EU manufacturing operaons, which depend on fluoropolymers, within plant, equipment and single use systems. If the proposed PFAS restricon prohibits the supply of these crical raw materials, manufacturing operaons at EU facilies will have to cease once conngency stock levels are depleted. Availability of substutes Survey responses show that there are currently no "drop-in" alternaves available, either for APIs or for their intermediates and producon equipment. Companies are aware of the hazards involved in the use of PFAS, and are endeavouring to find suitable alternaves - including in the supply chain, quality, and manufacturing processes. Currently it is esmated that it may take approximately a minimum of 10 years to find, test and implement replacements, which entails an elevated risk of not meeng regulatory demands. Conclusion If the proposed restricon is implemented in its current state, a large number of essenal medicines would be heavily impacted and many will no longer be available, restricng paent's access to medicines. To allow for the connued research, development and manufacturing of medicines including biopharmaceucals and vaccines, the products in scope of specific regulaons should generally be derogated from a universal PFAS restricon, including all steps which are necessary for their manufacturing, packaging and delivery devices, in the EEA. 3 The European Federaon of Pharmaceucal Industries and Associaons (EFPIA), the European Fine Chemicals Group (EFCG), the Associaon of the European Self-Care Industry (AESGP), Medicines for Europe (MfE) and Vaccines Europe 4 Human health associaons' Paent impact survey