Brexit and Pharmaceutical industry

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With!the!Brexit!being!announced!for!the!end!of!the!month!after!being!postponed!in!March,!
the! different! economic! and! industrial! players,! be! they! in! the! public! or! private! stage,! have!
spent! no! small! amount! of! time! studying! and! preparing! to! anticipate! the! event.! The!
pharmaceutical! industry! is! one! such! domain! that! will! be! heavily! impacted! by! the! Brexit.! So!
why!would!it!be!the!case,!and!what!are!the!solutions!to!alleviate!the!damages?!
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The!first!notable!consequence!we!will!be!able!to!observe!will!probably!be!from!import-export!
activity! in! the! pharmaceutical! domain.! In! fact,! each! month! the! United! Kingdom! imports! 37!
million!boxes!of!medicines!from!the!European!Union,!and!certain!treatments!like!Insulin!are!
exclusively! produced! away! from! the! UK.! Knowing! there! are! at! least! 3,5! million! people!
suffering!from!diabetes!in!the!country,!some!measures!will!need!to!be!taken!for!the!patients!
to!keep!taking!their!treatment.!Apart!from!Diabetes!medicines!and!according!to!BBC,!it!may!
become!difficult!to!find!almost!two!thirds!of!the!products!necessary!for!scanners!and!cancer!
treatment.! In! front! of! this! shortage! concern,! some! pharmaceutical! groups! have! begun!
accumulating! reserves! of! medicines,! moreover! the! government! has! decided! to! stock! the!
equivalent!of!6!weeks!of!treatment!some!months!ago!because!they!feared!a!«!hard!Brexit!»!
with!the!exit!of!the!UK!from!the!EU!single!market.!According!to!Anti-Brexit!organisation!«!Best!
for!Britain!»,!this!storage!would!cause!a!2!billion!pounds’!financial!surcharge.!
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However,!the!United!Kingdom!wouldn’t!be!impacted!alone.!Indeed,!even!though!the!country!
imports! a! lot,! it! exports! even! more! with! 45! million! boxes! of! medicines! shipped! to! the!
European!Union!countries!each!month.!Moreover,!the!European!Medicines!Agency!(EMA)!has!
revealed! to! be! concerned! about! the! availability! of! 108! medicines! references! that! are! only!
fabricated!in!the!UK.!In!addition!to!these!108!references,!the!production!of!almost!3000!drugs!
have!steps! that!take! place!in! the!English!country.! Even! in!the! export!domain! though,! there!
will!be!no!short!amount!of!economical!and!organisational!post-Brexit!issues!from!the!side!of!
the!United!Kingdom.!
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Focusing! on! these! sorts! of!issues,! a! direct! Brexit! consequence! could! be! observed! since! last!
year.! As! a! matter! of! fact,! the! European! Medicines! Agency! has! decided! since! September! of!
2018! to! stop! taking! medicines! evaluation! contracts! with! the! United! Kingdom.! Indeed,! for! a!
new! drug! to! be! introduced! to! the! market,! it! must! first! successfully! pass! the! numeral! steps!
from!a!long!process!to!then!be!able!to!obtain!the!marketing!authorisation!application!(AMM).!
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Yet,! these! AMMs! are! only! available! in! Europe! if! their! holders! are!legally!situated! in! the!
European!Union.!Usually,!the!Medicines!and!Healthcare!products!Regulatory!Agency!(MHRA)!
based! in! the! UK! studies! and! authorises! 20! to! 30%! of! European! medicines,! but! with! the!
coming!of!the!Brexit,!about!40!contracts!have!already!been!reallocated!to!other!organisations.!

In! fact,! the! EMA! reckons! that! an! expert! must! be! available! for! the! entire! duration! of! the!
evaluation!process,!which!can!take!a!year.!Thus,!from!the!beginning!of!2018!to!the!decision!
from! the! EMA! to! stop! taking! contracts! with! the! UK,! the! MHRA! could! only! obtain! two!
contracts!because!of!a!lack!of!availability.!As!an!economical!consequence!the!MHRA!will!thus!
lose!at!least!13!million!pounds!a!year.!
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The! European! Medicine! Agency! is! responsible! for!scientific! evaluations,!supervision! and!
safety!control!for!medicines!in!the!EU.!It!is!a!necessary!entity!for!the!flow!of!medicines!in!the!
EU! single! market.! Since! the! agency’s! foundation! in! 1995,! the! headquarters! were! originally!
situated!in!London,!but,!with!the!Brexit,!a!relocation!was!necessary,!and,!since!the!month!of!
March! this! year,! the! EMA! is! now! based! in! Amsterdam.! However,!it! is! now! faced! with!
organisational!issues.!As!a!matter!of!fact,!the!European!Agency!foresees!a!loss!of!25%!of!their!
employees,! from! a! total! workforce! of! 900! people.! The! situation! is! as! stated! because! the!
agency’s!workers!needed!to!be!transferred!to!the!new!headquarters!from!the!UK,!and!they!
may!not!be!able!to!adapt!to!this!sudden!transfer.!Thus!a!lot!of!them!could!choose!to!resign,!
causing!some! huge! financial!losses.!The!relocation!will!most!likely! cause!some!delays!in!the!
medicine!evaluation!processes,!this!leading!to!even!more!losses.!
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Juridically,!regarding!the!fate!of!marketing!authorisations,!the!following!rule!was!established!
by! the! EMA! working! jointly! with! the! Federal! Agency! for! medicines! and! Health! Products!
(FAMPH),!as!well!as!the!working!groups!from!the!Heads!of!Medicines!Agencies!(HMA)!and!it!
applies! to! all! medicines!:! If! the! address! from! the! marketing! authorisation! holder,! the!
manufacturer! responsible! for! batch! release,! the! one! responsible! for! quality! control,! for!
pharmacovigilance!or!from!the!pharmacovigilance!system!master!file!is!situated!in!the!UK,!the!
AMM! holder!needs! to! transfer! his! activities! to! another! European! Union! State! as! soon! as!
possible.!!
Incidentally,! concerning! medical! devices,! it! was! decided! for! the! UK! to! be! considered! as! a!
third-party! country! for! their! sales.! It! implies! that! British! firms! will! need! to! mandate! an!
authorised! representative! in! the! EU27! to! introduce! these! kinds! of! devices! to! the! European!
market.!
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All! in! all,! after! identifying! a! maximum! number! of! potential! issues! brought! about! by! the!
coming! of! the! Brexit,! it! was! necessary! for! the! competent! authorities! to! establish! a! priority!
order,!so!as!to! limit! the! damage! once!the!deadline!comes.!Naturally!the!first!priority!in!the!
pharmaceutical! domain! will! be! to! make! sure! that! no! product! remains! unavailable! for! the!
patients.! As! a! matter! of! fact,! this! is! an! important! public! health! issue! that! needs! to! be!
approached!with!great!care.!