Dies ist eine HTML Version eines Anhanges der Informationsfreiheitsanfrage 'DG GROW contacts re. pharma incentives study'.













ARES(2018)851023
Ref. Ares(2019)631504 - 04/02/2019
 
To:  Commissioner  Elżbieta  BIEŃKOWSKA  
 Internal  Market,  Industry,  Entrepreneurship  and  SMEs  
 European  Commission  
 Rue  de  la  Loi,  200  
 1049  Brussels  
 
Cc:   Lowri  Evans,  Director  General,  DG  Grow  
             Antti  Peltomäki,  Deputy  Director-­‐General,  DG  Grow  
 
,  
,  DG  Grow  
 
Ref:  NM/67.603  
 
Subject:  EFPIA  response  to  request  for  information  on  the  SPC  Manufacturing  Exemption  impact  
 
Brussels,  13  February  2018  
 
 
Dear  Commissioner  Bieńkowska,  
 
We   would   like   to   fol ow-­‐up   on   the   discussion   that   we   had   together   with   our   EFPIA   President,   Mr.   Stefan  
Oschmann,  and  a  delegation  of  our  Board  members  on  30th  January  this  year.  During  that  meeting  and  in  our  
subsequent   letter   to   you,   we   raised   the   concern   that   introducing   an   SPC   manufacturing   exemption   risks  
harming  the  innovative  pharmaceutical  industry  in  Europe,  and  that  a  further  structural  and  holistic  analysis  of  
the   innovative,   biosimilar   and   generic   industries   is   necessary   to   accurately   consider   the   impact   of   an   SPC  
exemption.  We  are  happy  to  comply  with  your  request  for  further  information  on  the  impact  that  the  proposed  
SPC  manufacturing  exemption  may  have  on  the  EU’s  trade  balance  and  took  note  of  your  reflections  on  the  so-­‐
cal ed  “first  mover”  advantage  for  Canadian  generics.  You  asked  that  any  further  submission  of  information  be  
made  within  two  weeks.  
With   regard   to   the   European   trade   balance,   we   have   reviewed   various   studies   published   in   relation   to   a  
potential   SPC   manufacturing   exemption   and   our   conclusion   is   that   the   impact   of   an   SPC   manufacturing  
exemption   on   the   EU   trade   balance   remains   uncertain   or   could   even   be   negative.   Existing   evidence   -­‐   the  
Pugatch   Consilium,   in   their   study   “Unintended   and   Unattended   Consequences:   The   Opportunity   Costs   of  
Reducing  Exclusivity  Rights  for  Intel ectual  Property”,
 estimates  that  the  impact  on  EU  export  sales  would  be  
negative  as  the  European  innovative  biopharmaceutical  industry  could  stand  to  lose  between  €  1.09  bn  (USD  
1.34   bn)   and   €1.85   bn   (USD   2.27   bn).   This   negative   effect   on   the   trade   balance   is   further   il ustrated   by   the  
QuintilesIMS   study   on   “Assessing   the   impact   of   proposals   for   a   Supplementary   Protection   Certificate   (SPC)  
Manufacturing   Exemption   in   the   EU”
  which   shows   that   the   SPC   manufacturing   exemption   could   result   in  
replacing   more   high-­‐value   innovative   exports   with   lower   value   generics.   Consequently,   this   would   cause   a  
worsening   in   the   EU’s   trade   balance.   The   conclusions   drawn   in   the   abovementioned   studies   have   also   been  
confirmed  in  the  Office  of  Health  Economics  (OHE)  report,  which  we  have  shared  as  part  of  our  response  to  the  
Consultation. 
With  regard  to  the  proposed  “first  mover”  advantage,  based  on  the  published  studies,  it  can  be  concluded  that  
such  an  advantage  for  smal   molecules  would  depend  on  the  market  to  which  generics  would  be  exported  and  
that  for  biosimilars  there  is  no  evidence  of  a  first  mover  advantage.  For  example,  generics  exports  to  Russia  and  
Turkey  (two  markets  identified  as  potential  export  targets)  would  face  a  range  of  trade  barriers,  price  levels,  
 
EFPIA  Brussels  Office  
Leopold  Plaza  Building     Rue  du  Trône  108  
B-­‐1050  Brussels     Belgium  
 
 Tel:  +  32  (0)2  626  25  55     
 
 
 
www.efpia.eu     [Emailadresse]  
 
 
 
 
 













ability  to  manage  local  commercial  relations  and  local  incentives  that  give  local  generic  companies  a  significant  
advantage.   In   Canada,   Certificates   for   Supplementary   Protection   (CSPs)   were   introduced   via   Canadian  
legislation  in  September  2017,  following  CETA’s  provisional  entry  into  force.  The  export  exemption  under  CETA  
wil   however  not  have  effect  for  nearly  10  years,  since  the  newly  introduced  SPC-­‐like  protection  will  only  start  
at   the   end   of   the   patent   life   of   certain   products   launched   in   Canada   after   September   2017.   Even   then,   any  
“advantage”  would  depend  on  a  variety  of  other  factors  beyond  the  exemption.  
EFPIA   and   its   membership   remain   highly   concerned   that   numerous   uncertainties   and   gaps   remain   in   the  
analysis   of   the   short   and   long-­‐term   impact   of   a   legislative   provision   such   as   a   potential   SPC   manufacturing  
exemption.   We   have   analysed   the   different   reports   and   studies   on   the   SPC   manufacturing   exemption,   and  
conclude  that  key  questions  that  could  inform  the  actual  impact  of  the  issue  at  hand,  are  left  unexplored  and  
unanswered   such   as   the   (non)treatment   of   innovation   and   innovation-­‐related   incentives   and   the   lack   of  
analysis  of  any  displacement  effects  of  an  exemption.  We  attach  a  gap  analysis  on  the  issues  that  we  believe  
need  to  be  further  examined  before  an  informed  and  balanced  decision  can  be  taken  on  an  SPC  manufacturing  
exemption.  These  issues  would  need  to  be  addressed  in  the  spirit  of  ensuring  evidence-­‐based  policy-­‐making  
that  takes  account  of  al   available  information  and  respects  the  Innovation  Principle.  Better  Regulation  would  
also  suggest  that  where  uncertainties  or  unknown  elements  remain,  these  elements  need  further  exploration.  
EFPIA  therefore  strongly  recommends  that  the  Commission  undertake  a  robust  analysis  of  the  ful   eco-­‐system  
of  the  pharmaceutical  sector  that  can  address  the  questions  in  the  attached  gap  analysis  to  ensure  that  any  
decision  on  an  SPC  manufacturing  exemption  promotes  the  global  competitiveness  of  the  EU,  creates  jobs  and  
growth,  and  ensures  a  continued  contribution  of  the  EU  pharmaceutical  industry  to  a  positive  EU  trade  balance,  
in  line  with  the  Commission’s  Industrial  Policy  Strategy.  Furthermore,  we  believe  that  such  an  analysis  should  
assess   any   potential   inconsistencies   with   existing   EU   legislation   and   policy   on   the   overarching   incentives  
system.   Finalising   the   assessment   of   all   policy   elements   as   indicated   by   the   Commission   in   its   roadmap   of  
February   2017   remains   crucial.   More   importantly,   all   elements   of   the   incentives   evaluation   should   be  
considered  to  find  a  balanced  solution  for  al   EU-­‐based  manufacturers  in  support  of  sustainable  innovation.  
 
Thank  you  for  your  consideration  and  for  the  opportunity  to  provide  you  with  this  information.  EFPIA  and  its  
members  remain  at  your  ful   disposal  for  any  additional  information  you  may  require  and  continue  to  be  ful y  
committed  to  delivering  on  our  commitment  to  patients,  society  and  a  strong  European  economy.  
 
Best  wishes,    
 
Nathalie  Moll  
Director  General  
 
 
EFPIA  Brussels  Office  
Leopold  Plaza  Building     Rue  du  Trône  108  
B-­‐1050  Brussels     Belgium  
 
 Tel:  +  32  (0)2  626  25  55     
 
 
 
www.efpia.eu     [Emailadresse]  
 
 
 
 
 
Electronically signed on 04/02/2019 15:18 (UTC+01) in accordance with article 4.2 (Validity of electronic documents) of Commission Decision 2004/563