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We would like to thank you once again on behalf of EFPIA and AESGP for the
opportunity to meet with you on December 2TM, this was a very beneficial and
informative discussion on the EUC (Essential Use Concept). We would like to
take this opportunity to re-iterate certain key points made during the meeting. Development of an EUC -- Work by Commission Appointed Consultant,
Wood
We have reviewed the Woods presentation from the CARACAL meeting of 17
November 2021, on the Essential Use study, and would like to reiterate the
following:
+ Screening of legislation and stakeholders It was noted during the meeting that the mapping of relevant legislation and kReEyAsCtaHkeahnodldtehresiimspnaocttcoonmpotlheetreryeetg.ulaTthoerypfroorpaoes.ge.d MEeUdiCcignoaelsPbroedyuocntds
Directive and associated regulations needs due consideration by the
Commission.
Testing the application of EUC -- case studies
We agree it is not appropriate to conduct a case study on the use of PFAS or POrPeEvioinusanpyhasremcatcoeruatticthails mpoainnutf,adcuteurtion"gosnegcotionrgerxepgeurliaetnocreypwriotchetshsees'. authorisation application process, involving the use of Bis(2-methoxyethyl)
ether (Diglyme) and 1,2-dichloroethane is very relevant and should be
`considered as a suitable case study.
During the meeting we expressed our keen interest to be partof the consultation process. Please confirm our contact details have been shared with the consultant
wood? (EFPIA:[ll@etoia.cu and AESGP:[Il@2eson.cu).
EFPIA Position on Essential Use
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the meeting.
The EUC has been raised in the context of a proposed PFAS Restriction. We
npuobtleiusnhseudbsbtyatnhteiamteedmbceormmsetnatteasrpyrienpcalruidnegdthinebAancnkegxroXuVndRedsotcruicmteinotnadtoisosnier, "For
medicinal products non-PFAS alternatives are available". To apply such a blanket statement to all fluorinated medicines is inappropriate, in our opinion, for two
reasons:
Today in drug discovery and development, fluorine is introduced into APIs (active pharmaceutical ingredients) when required to achieve stability/clearance, potency, pharmacokinetics and/or bioavailability of the drug candidate when these cannot be achieved by other means. It is incorrect to assume that fluorinated & non-fluorinated drugs in the same therapeutic class are interchangeable. Due to the pharmacology and distinct activity/side effect profiles, a medical professional will select between them based on the unique circumstances of the patient e.g. health status, complications with other prescribed medication or individual response etc. Limiting the treatment options in a therapeutic class because some have fluorinated groups would have a profound impact on the ability to treat patients with the most safe and efficacious medicine.
As recommended during the meeting we intend to provide additional information on the impact of the proposed PFAS Restriction to the relevant member states, preparing the Annex XV dossier.
As a key stakeholder we are open to continued dialogue on the reform of the REACH regulation and the application of the EUC. Please do not hesitate to contact us if we can help with any additional clarification on any of the information provided above.
With kind regards and best wishes for the festive season.
European Federation of Pharmaceutical Industries and Associations Leopold Plaza Building Rue du Trne 108 B-1050 Brussels (Belgium) Tel: +32 www.efpia.eu