COMMISSION STAFF WORKING DOCUMENT IMPACT ASSESSMENT REPORT Accompanying the document Proposal for a Regulation of the European Parliament and of the Council on fees and charges payable to the European Medicines Agency, amending Regulation (EU) 2017/745 of the European Parliament and of the Council and repealing Council Regulation (EC) No 297/95 and Regulation (EU) 658/2014 of the European Parliament and of the Council
Date: 2022-12-13
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: European Medicines Agency, drug surveillance, drugs classification, market approval, medicinal product, operation of the Institutions, provision of services, veterinary medicinal product

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 13.12.2022  SWD(2022) 414 final  COMMISSION STAFF WORKING DOCUMENT  IMPACT ASSESSMENT REPORT      Accompanying the document Proposal for a Regulation of the European Parliament and of the Council on fees and charges payable to the European Medicines Agency, amending Regulation (EU) 2017/745 of the European Parliament and of the Council and repealing Council Regulation (EC) No 297/95 and Regulation (EU) 658/2014 of the European Parliament and of the Council {COM(2022) 721 final} - {SEC(2022) 440 final} - {SWD(2022) 413 final} - {SWD(2022) 415 final}  
 
 
Table of contents 

1. 

2. 

INTRODUCTION: POLITICAL AND LEGAL CONTEXT.............................................................. 14 

PROBLEM DEFINITION ................................................................................................................... 17 

  What are the problems? ................................................................................... 17 

The  following  section  describes  the  main  problems  facing  the  EMA  fee 
system, as identified by the recent evaluation. It extends this analysis to 
include issues that arose subsequently due to the impact of the COVID-
19 pandemic. .................................................................................................... 17 

2.1.1.  Misalignment with provisions of new Union legislation [P0] ....................... 17 

Weaknesses identified in the evaluation ...................................................................... 18 

2.1.2.  Misalignment of some fee levels with the underlying costs – a non-cost based 
system [P1] .................................................................................................................. 18 

2.1.3.  Misalignment  of  some  NCA  remuneration  with  the  costs  incurred  to 
undertake the work [P2] .............................................................................................. 19 

2.1.4.  The fee system is complex, partly inconsistent and not flexible [P3] ........... 22 

Elements identified following the COVID-19 crisis ................................................... 23 

  What are the problem drivers? ......................................................................... 24 
2.2.1.  New  and  amended  procedures  for  veterinary  medicines  (VMP  legislation) 
and new estimated EMA costs as of 2024 for DARWIN (under the Regulation  on a 
reinforced role for EMA) [D1] .................................................................................... 24 

2.2.2.  The levels of fees and remuneration for EMA and NCAs for procedures are 
not fully cost-based [D2] ............................................................................................. 25 

2.2.3.  The fee system is complex [D3] .................................................................... 25 

2.2.4.  Assessing  innovative  medicinal  products  (e.g.  gene  therapy,  personalised 
medicines) is becoming more complex [D4] ............................................................... 25 

  How likely is the problem to persist? .............................................................. 26 

3.  WHY SHOULD THE EU ACT? ......................................................................................................... 26 

  Legal basis ....................................................................................................... 26 
  Subsidiarity: Necessity of EU action ............................................................... 27 
  Subsidiarity: Added value of EU action .......................................................... 27 

4.  OBJECTIVES: WHAT IS TO BE ACHIEVED? ................................................................................ 27 

  General objectives ........................................................................................... 27 
  Specific objectives ........................................................................................... 28 

5.  WHAT ARE THE AVAILABLE POLICY OPTIONS? ..................................................................... 29 

  What  is  the  baseline  from  which  options  are  assessed?  (The  do-

minimum scenario) .......................................................................................... 30 
  Description of the policy options..................................................................... 31 
5.2.1.  Option 1 ......................................................................................................... 31 

5.2.2.  Option 2 ......................................................................................................... 31 

5.2.3.  Option 3 ......................................................................................................... 32 

 
 
5.2.4.  Option 3 ‘light’ .............................................................................................. 33 

5.2.5.  Horizontal measures ...................................................................................... 33 

  Options discarded at an early stage ................................................................. 34 

6.  WHAT ARE THE IMPACTS OF THE POLICY OPTIONS? ............................................................ 35 

  Public  authorities  and  budgets  (including  governance  and  good 

administration) ................................................................................................. 36 

6.1.1.  Alignment of fees with underlying costs ....................................................... 41 

6.1.2.  Alignment  of  NCAs  remuneration  with  costs  incurred  to  undertake  EMA 
activities ....................................................................................................................... 42 

6.1.3.  Fee system capacity to adjust to cost changes ............................................... 44 

6.1.4.  Balance between a simple fee system and a cost-based system .................... 45 

6.1.5.  Fee system capacity to adjust to ensure financing of incentives ................... 45 

6.1.6.  Adaptability  of  fee  system  to  ensure  EMA  can  effectively  respond  to 
exceptional circumstances related to public health and animal health ........................ 46 

6.1.7.  Predictability .................................................................................................. 46 

  Administrative burden ..................................................................................... 49 
6.2.1.  Administrative burden on EMA and NCAs .................................................. 49 

6.2.2.  Administrative burden on fee payers ............................................................. 50 

6.2.3.  Administrative burden for SMEs relative to other payers ............................. 51 

  Position of SMEs ............................................................................................. 52 
  Research and innovation .................................................................................. 53 
  Functioning of internal market and  competition ............................................ 55 
  Discussion of information gaps and uncertainties ........................................... 56 

7.  HOW DO THE OPTIONS COMPARE? ............................................................................................. 57 

  Overview of impacts ........................................................................................ 57 
  Appraisal of horizontal measures .................................................................... 59 
7.2.1.  Veterinary medicines incentives .................................................................... 59 

7.2.2.  Country coefficients for NCA remuneration ................................................. 60 

7.2.3. 

Incentive sharing............................................................................................ 61 

  Effectiveness .................................................................................................... 61 
  Efficiency (balance of benefits and costs) ....................................................... 62 
  Coherence with other EU policy objectives .................................................... 62 
  Preferred option – Option 3 ‘light’ .................................................................. 63 
  REFIT (simplification and improved efficiency) ............................................ 63 
  Application of the ‘one in, one out’ approach ................................................. 63 

8.  HOW WILL ACTUAL IMPACTS BE MONITORED AND EVALUATED? .................................. 63 

ANNEX 1: PROCEDURAL INFORMATION ............................................................................................. 68 

1. 

LEAD DG, DECIDE PLANNING/CWP REFERENCES .................................................................. 68 

2 

 
 
2.  ORGANISATION AND TIMING ...................................................................................................... 68 

3. 

4. 

CONSULTATION OF THE RSB ....................................................................................................... 68 

EVIDENCE, SOURCES AND QUALITY ......................................................................................... 71 

ANNEX 2: STAKEHOLDER CONSULTATION (SYNOPSIS REPORT) ................................................. 72 

ANNEX 3: WHO IS AFFECTED AND HOW? ........................................................................................... 91 

1. 

2. 

PRACTICAL IMPLICATIONS OF THE INITIATIVE ..................................................................... 91 

SUMMARY OF COSTS AND BENEFITS ........................................................................................ 92 

ANNEX 4: ANALYTICAL METHODS ...................................................................................................... 93 

ANNEX 5: CONTEXT AND RELEVANT ACTORS ............................................................................... 135 

ANNEX 6: SUMMARY IMPACT TABLES FROM THE CONSULTATION ......................................... 140 

ANNEX 7: FINAL SUMMARY IMPACT TABLES AND FEE GRIDS .................................................. 150 

3 

 
 
 
 
Glossary 

Term or acronym 

Meaning or definition 

Abridged application 

Additional activities 

Administrative fee 

An  application  for  a  new  marketing  authorisation  for  a 
medicinal  product  for  human  or  veterinary  use  should 
normally be accompanied by a ‘full dossier’ (see further 
below  in  this  table).  However,  in  certain  instances 
applicants  are  permitted  to  submit  a  medicinal  dossier 
that does not include all of the results required for a full 
dossier.  This  is  called  an  abridged  application.  An 
applicant  can  choose  to  submit  an  abridged  application 
instead  of  a  full  dossier  when  the  results  of  an  already 
authorised  medicine  are  relevant  to  the  new  medicinal 
product and when reference can be made to these results. 
See also ‘generic’, ‘biosimilar’ and ‘full dossier’. 

Both  EMA and NCAs undertake  activities additional to 
the  activities  that  were  covered  by  the  data  gathering 
exercise  of 
the  EMA  Management  Board.  These 
‘additional  activities’  do  not  concern  time  spent  in  and 
preparatory  work  for  committees  and  working  parties, 
nor  any  of  the  procedural  activities  covered  by  the 
external study. For more information, see Section 5. 

the  provision  of 

Fees charged on a one-off basis by EMA to undertakings 
for 
the  following  administrative 
services:  negative  administrative  validation  of  an 
application, issuing of certificates outside of procedures, 
notifications  of  parallel  distribution  and  variation 
worksharing  (whereby  a  marketing  authorisation  holder 
(MAH) can submit the certain variations  affecting more 
than one marketing authorisation from the same MAH in 
one application.). 

For reference of terms see also ‘parallel distribution’ and 
‘Variation; Type IA, IB and II’.  

Advanced  Therapy  Medicinal 
Product (ATMP) 

Medicinal products for human use based on genes, cells 
or tissues used to diagnose, prevent or cure diseases or to 
replace, repair or regenerate human tissue.  

Advanced  Therapy  Medicinal 
Product (ATMP) classification 

Any  applicant  developing  a  product  based  on  genes, 
cells or tissues may request a scientific recommendation 
of  the  Agency  with  a  view  of  determining  whether  the 
referred  product  falls,  on  scientific  grounds,  within  the 

4 

 
 
Annual fee 

Basic fee 

Biosimilar application 

definition  of  an  advanced  therapy  medicinal  product. 
The  Agency  shall  deliver  this  recommendation  after 
consultation  with  the  Commission  and  within  60  days 
after receipt of the request. 

Fees  charged  annually  by  EMA  to  undertakings  for 
services related to the maintenance of a valid marketing 
authorisation  (e.g. databases). Two types of annual  fees 
exist:  

(1)  an  annual  fee  for  centrally  authorised  medicinal 
products  (CAPs)  for  human  and  veterinary  use  (CAP 
annual fee) and  

(2)  a  pharmacovigilance  annual  fee  for  nationally 
authorised medicinal products (NAPs) for human use. 

The full applicable fee before reductions (fee incentives) 
or  additional  amount  (for  the  assessment  of  additional 
strengths,  pharmaceutical  forms  or  presentations)  have 
been applied. See also under ‘procedural fee’. 

A  biological  medicinal  product  that  is  highly  similar  to 
an already authorised biological medicine (‘the reference 
product’)  and  for  which  not  all  test  results  need  to  be 
provided as for a full dossier. A biosimilar application is 
a  type  of  abridged  application.  See  also  ‘abridged 
application’ and ‘full dossier’. 

Centrally  authorised  medicinal 
product (CAP) 

Medicinal products authorised at European Union level. 
The marketing authorisation is granted by the European 
Commission and is valid in all Member States. 

CAP annual fee 

See under ‘annual fee’. 

Coordination group 

The  coordination  groups  for  human  medicinal  products 
(CMDh)  and  veterinary  medicinal  products  (CMDv) 
were set up for the examination of any questions relating 
to nationally authorised medicinal products, specifically 
related  to  disagreements  on  the  grounds  of  potential 
serious risks to public health between Member States on 
pending  initial  marketing  authorisation  and  variation 
procedures. 
certain 
to  nationally 
pharmacovigilance  activities 

include 

related 

tasks 

also 

The 

5 

 
 
authorised products. 

Data Analysis and Real World 
Interrogation Network 
(DARWIN EU®)  

The  Data  Analysis  and  Real  World  Interrogation 
Network  (DARWIN  EU)  is  the  EMA’s  infrastructure 
that will support regulatory decision-making by:  

·         establishing  and  expanding  a  catalogue  of 
in 

for  use 

observational  data  sources 
medicines regulation; 

·         providing  a 

source  of  high-quality, 
validated  real  world  data  on  the  uses,  safety 
and efficacy of medicines;  

·         addressing  specific  questions  by  carrying 
out  high-quality,  non-interventional  studies, 
including  developing  scientific  protocols, 
interrogating 
relevant  data  sources  and 
interpreting and reporting study results.  

The integration of DARWIN EU in the European Health 
the  digital 
Data  Space  (EHDS)  (as  a  node 
infrastructure  for  secondary  use  of  health  data)  will 
enable EMA’s and national competent authorities’ to use 
these data whenever needed throughout the lifecycle of a 
medicinal product. 

in 

The  creation  of  a  European  Data  Space  is  one  of  the 
priorities  of  the  Commission  2019-2025,  including  the 
health  sector.  A  common  European  Health  Data  Space 
will  promote  better  exchange  and  access  to  different 
types of health data (electronic health records, genomics 
data,  data  from  patient  registries  etc.),  not  only  to 
support  healthcare  delivery  (so-called  primary  use  of 
data)  but  also  for  health  research  and  health  policy 
making purposes (so-called secondary use of data). 

Procedure  via  which  any  of  the  following  changes  are 
made to an already existing authorisation: 

European  Health  Data  Space 
(EHDS) 

Extension 
authorisation (line-extension) 

marketing 

of 

to 

the 

strength, 
active 
Changes 
pharmaceutical form, and/or route of administration; 
Other  changes  specific  to  veterinary  medicines  to  be 
administered to food-producing animals or the change or 
addition of target species. 

substance, 

Fee payer 

Fee  payers  are  mainly  pharmaceutical  companies, 
preparing or  seeking to  either (a) apply for a marketing 

6 

 
 
 
Full dossier 

Generic application 

Generic medicine 

Health  technology  assessment 
(HTA) 

authorisation to place a medicinal product on the market, 
or  (b)  amend  an  existing  marketing  authorisation.  This 
includes  multinational  companies  as  well  as  smaller 
entities. 

An  application  for  a  new  marketing  authorisation  for  a 
should  normally  be 
human  medicinal  product 
accompanied  by  results  of  pharmaceutical  (physico-
chemical,  biological  or  micro-biological)  tests,  pre-
clinical  (toxicological  and  pharmacological)  tests  and 
clinical trials (Article 8i of Directive 2001/83/EC). In the 
case of veterinary medicinal products these are results of 
pharmaceutical  (physico-chemical,  biological  or  micro-
biological) tests, safety and residue tests, pre-clinical and 
clinical  trials,  and  tests  assessing  the  potential  risks 
posed  by  the  medicinal  product  for  the  environment 
(Article 12j of Directive 2001/82/EC). Applications that 
are submitted in accordance with these requirements are 
called a ‘full dossier’. 

See also ‘abridged application’. 

Application  for  a  medicine  containing  the  same  active 
substance(s)  and  used  at  the  same  dose(s)  to  treat  the 
same disease(s) as  an already authorised medicine (‘the 
reference medicine’).  A  generic  application is  a type of 
abridged application. See also ‘abridged application’ and 
‘full dossier’. 

A  generic  medicine  is  developed  to  be  the  same  as  a 
medicine  that  has  already  been  authorised,  called  the 
reference  medicine.  A  generic  medicine  contains  the 
same active substance(s) as the reference medicine, and 
it is used at the same dose(s) to treat the same disease(s). 
However,  a  generic  medicine's  inactive  ingredients, 
name, appearance and packaging can be different. 

HTA  bodies  provide  recommendations  on  medicinal 
products  and  other  health  technologies  with  regard  to 
their properties and direct and indirect impact as well as 
unintended  consequences. 
is  mainly  aimed  at 
informing  policy  and  decision-making  in  health  care, 
especially  on  how  best  to  allocate  funds  in  terms  of 
reimbursement. 

It 

7 

 
 
Immunological 
medicinal 
immunologicals 

veterinary 
product/ 

to  be 
A  veterinary  medicinal  product 
administered to  an animal  in  order to  produce  active or 
passive immunity or to diagnose its state of immunity. 

intended 

Inspection 

and 

developers 

Medicine 
(future)  marketing 
authorisation  holders  should  ensure  that  they  and  any 
parties working for them comply  with  standards  set  out 
in  Union  legislation  and  guidelines  for  good  clinical 
practice  (GCP),  good  laboratory  practice  (GLP)  and 
good  manufacturing  practice  (GMP)  for  investigational 
and  to  be  authorised  or  already  authorised  medicinal 
products. Compliance with these standards is verified by 
during 
the 
(GCP/GLP/GMP) 
it  concerns 
products  that  are  to  be  authorised  or  have  been 
authorised  via  the  centralised  procedure,  EMA  is 
responsible for coordinating the inspections by NCAs. 

competent 
inspections.  When 

authorities 

national 

Limited market 

A  market  for  one  of  the  following  medicinal  product 
types:  

(a)  veterinary  medicinal  products  for  the  treatment  or 
prevention  of  diseases  that  occur  infrequently  or  in 
limited geographical areas;  

(b)  veterinary  medicinal  products  for  animal  species 
other  than  cattle,  sheep  for  meat  production,  pigs, 
chickens, dogs and cats; 

In  March  2014,  the  EMA  Management  Board  set  up  a 
Data Gathering Steering Group to gather evidence on the 
time spent by staff of the EMA Secretariat and NCAs on 
EMA-related  activities,  to  support  the  evaluation  of  the 
EMA fee system by the European Commission. 

Management 
gathering (MBDG) 

Board 

data 

Maximum residue limit (MRL)  The  maximum  concentration  of  a  residue  of  a 
pharmacologically 
(veterinary 
medicine)  which  may  be  permitted  in  food  obtained 
from an animal exposed to that substance. 

substance 

active 

Micro, small and medium-sized 
enterprise (SME) 

following  definition 

The 
the 
pharmaceutical  sector,  but  instead  applies  EU-wide 
(Commission Recommendation 2003/361/EC): 

is  not  specific 

to 

Microenterprise: company which employs fewer than 10 
people and which has an annual  turnover and/or  annual 

8 

 
 
balance sheet total not exceeding €2 million. 

Small enterprise: company which employs fewer than 50 
people and which has an annual  turnover and/or  annual 
balance sheet total not exceeding €10 million. 

Medium-sized  enterprise:  company  which  employs 
fewer than 250 people and which has an annual turnover 
not  exceeding  €50  million  and/or  a  balance  sheet  total 
not exceeding €43 million.  

Minor 
(MUMS)  

use/minor 

species 

Veterinary  medicines  for  the  treatment  of  rare  diseases 
in  major  animal  species  (cattle,  sheep,  pigs,  chickens, 
salmon,  cats  and  dogs)  and  for  the  treatment  of  minor 
animal species. 

Nationally authorised medicinal 
product (NAP) 

Medicinal  products  authorised  at  the  national  level  in 
one  or  more  Member  States.  The  marketing 
the  relevant  National 
authorisation 
Competent Authority(ies) of the Member State(s) where 
the application is made. 

is  granted  by 

National Competent Authorities 
(NCAs) 

the 
National  regulatory  authorities  responsible  for 
regulation  of  medicinal  products  for  human  and 
veterinary use in the European Economic Area. 

Orphan designation 

Orphan medicinal product 

Paediatric 
(PIP); 
modification 

investigation  plan 
deferral; 

waiver; 

The  procedure  via  which  it  is  evaluated  whether  a 
medicinal  product  fulfils  the  criteria  of  an  orphan 
medicinal product.  

Medicine  used  to  diagnose,  prevent  or  treat  life-
threatening  or  chronically  debilitating  diseases  that  are 
either  rare  or  unlikely  to  generate  sufficient  return  to 
investment,  and  where  no 
justify 
satisfactory or better alternative already exists within the 
European  Union.  A  condition  is  defined  as  ‘rare’  if  it 
affects no more than five in 10 thousands people in the 
EU. 

the  necessary 

Development  plan  drawn  up  by  a  pharmaceutical 
company  containing  information  on  how  that  company 
intends  to  gather  data  on  the  use  of  the  medicine 
concerned in children. The aim is to ensure that data are 
gathered that are necessary to approve use of a medicine 
in children.  

Normally,  a  PIP  is  required  with  each  application  for 
authorisation of a new medicine. However, under certain 

9 

 
 
circumstances the applicant may request EMA to waive 
or defer the PIP. A waiver is granted if the development 
of  a  medicine  in  children  is  not  needed  or  not 
appropriate,  such  as  for  diseases  that  only  occur  in 
adults.  A  deferral  allows 
to  delay 
development  in  children  until,  for  instance,  enough 
information is gathered about its effectiveness and safety 
in adults. 

the  applicant 

An  approved  PIP  can  be  modified  at  a  later  stage  as 
knowledge 
the 
if 
implementation  of  the  PIP  is  impossible  or  no  longer 
appropriate. 

increases  or 

is  proven 

that 

it 

Parallel distribution 

Peer-review(er) 

Periodic  Safety  Update  Report 
Assessment) 
(Singe 
(PSUR/PSUSA) 

Pharmacovigilance 

The distribution of a centrally authorised medicine from 
one  Member  State  to  another  by  a  company  other  than 
the owner of the medicine. 

One  of  the  members  of  the  CHMP  or  CVMP  is 
appointed  to  review  the  scientific  evaluation  of  the 
rapporteur  and  co-rapporteur  conducted  during  the  first 
phase  of  applications  for  a  marketing  authorisation  and 
extensions of existing marketing authorisations, with the 
purpose of ensuring the quality and consistency of these 
evaluations.  The  peer-reviewer  especially  focusses  on 
the draft list of questions compiled by the rapporteurs for 
the relevant scientific committee.  

Reports containing information and a critical analysis on 
a  benefit-risk  balance  of  an  authorised  medicinal 
product.  The  report  is  compiled  by  the  owner  of  the 
marketing  authorisation  and  submitted  to  the  relevant 
competent  authority  for  evaluation.  Based  on 
the 
assessment of a PSUR, the relevant competent authority 
can  determine  whether  actions  are  needed  to  protect 
public health, for instance via the update of information 
for patients and health care professionals.  

The monitoring of adverse effects  (safety) of medicines 
or any other medicine-related problem after their placing 
on  the  market,  with  the  aim  to  identify,  assess  and 
prevent such problems.  

Pharmacovigilance annual fee 

See under ‘annual fee’. 

Pharmacovigilance  procedural  Procedural  fee  related  to  pharmacovigilance  activities 
(assessment  of  PSUR,  PASS,  pharmacovigilance 

10 

 
 
fee 

referrals). See also under ‘procedural fee’. 

Pharmacovigilance referral 

Referral (arbitration) related to the safety of a medicine. 
See further under ‘referral’. 

Post-authorisation  safety  study 
(PASS) 

A study carried out after a medicine has been approved 
in  order  to  gain  more  information  on  its  safety  or  to 
measure  the  effectiveness  of  measures  taken  to  reduce 
safety risks. 

PRIority MEdicines (PRIME)  A  voluntary  scheme 

launched  by 

the  European 
Medicines  Agency  in  2016  to  enhance  support  for  the 
development  of medicines that target  an unmet  medical 
need  or  that  offer  a  major  therapeutic  advantage  over 
existing  treatments.  Via  participation  in  this  scheme 
developers  of  medicines  receive  early  and  proactive 
support  from  EMA  to  optimise  development  plans  and 
accelerate  scientific  evaluation  with  the  aim  of  early 
access  to  patients.  This  scheme  also  provides  fee 
incentives  for  scientific  advice  requests  for  PRIME 
products from micro-sized enterprises and SMEs as well 
as academic sector applicants. 

Procedural fee 

Protocol assistance 

(Co-)Rapporteur 

Referral (arbitration) 

Fees charged by EMA to undertakings on a per-service 
basis. Procedural fees are applicable to  a specific set of 
services provided either before or after the granting of a 
marketing  authorisation  (‘pre-  and  post-authorisation 
procedural fees’). 

Protocol assistance is a special form of scientific advice 
specifically  available 
for  developers  of  orphan 
designated  medicines.  See  further  under  ‘scientific 
advice’ and ‘orphan designation’. 

Scientific  committees  of  EMA  appoint  one  of  their 
members as rapporteur and may appoint a second one as 
co-rapporteur  to  lead  the  scientific  evaluations  of 
applications  submitted  to  EMA.  The  rapporteurs  are 
responsible for drafting the assessment reports submitted 
to the committees for discussion and adoption. 

Procedure  initiated  to  resolve  issues  such  as  concerns 
over  the  safety  of  an  already  authorised  medicine  or  to 
resolve  disagreement  among  Member  States  on  the 
benefit-risk balance of a new medicine under evaluation. 
Referrals can be initiated by the European Commission, 

11 

 
 
Regulation  on  a  reinforced  role 
for EMA 

Renewal 

a  Member  State  or  the  owner  (marketing  authorisation 
holder) of the product.  

Regulation  (EU)  2022/123  of  the  European  Parliament 
and  of  the  Council  of  25  January  2022  on  a  reinforced 
role  for  the  European  Medicines  Agency  in  crisis 
preparedness  and  management  for  medicinal  products 
and medical devices 

A  new  marketing  authorisation  is  only  valid  for  five 
years  from  the  date  the  Commission  notifies  the 
marketing  authorisation  holder  the  authorisation  has 
been  granted.  An  application  for  renewal  of 
the 
authorisation shall be submitted timely (i.e. nine months 
before  its  expiry  date)  to  ensure  it  remains  valid.  Once 
renewed,  the  marketing  authorisation  is  valid  for  an 
unlimited  period,  unless  the  Commission  decides,  on 
justified  grounds 
to  pharmacovigilance, 
including exposure of an insufficient number of patients 
to 
to  proceed  with  one 
additional five-year renewal. 

the  medicine  concerned, 

relating 

Scientific advice 

Scientific services 

Synthetic year 

EMA can give advice to a developer on the appropriate 
tests and studies in the development of a medicine. This 
helps  to  facilitate  the  development  and  approval  of  a 
medicine. 

Services  provided  by  EMA  upon  application  for  any 
scientific  advice  or  opinion  by  a  scientific  committee 
other  than  those  related  to  scientific  advice,  initial 
marketing authorisation, inspection, variation, extension, 
renewal,  referral,  maximum  residue  limit,  transfer  of 
the  maintenance  of  a 
marketing  authorisation,  or 
marketing authorisation. This includes any evaluation of 
traditional  herbal  medicinal  products,  any  opinion  on 
medicinal  products 
for  compassionate  use,  any 
consultation  on  ancillary  substances,  including  blood 
derivatives,  incorporated  in  medical  devices,  and  any 
evaluation  of  plasma  master  files  and  vaccine  antigen 
master files. 

A synthetic year is used to determine costs to EMA and 
NCAs  incurred  for  EMA-related  activities  in  a  ‘typical 
year’. The synthetic year “neutralises” differences in the 
reporting  of  data  for  EMA  and  NCAs.  This  was 
necessary  to  ensure  that,  for  activities  where  NCAs  are 
involved,  the  number  and  type  of  activities  is  the  same 

12 

 
 
 
for EMA and NCAs in the ‘typical year’.  

Unitary costs and unitary fees  Costs to EMA and NCAs or fees charged to industry for 
a  given  activity,  such  as  the  evaluation  of  a  marketing 
authorisation application or variation. 

Variation; Type IA, IB and II 

to 

the 

Change 
terms  of  an  existing  marketing 
authorisation,  e.g. the change in  manufacturing site, the 
addition of an indication, the replacement of an excipient 
of the medicinal product. 

Type  II  variations  concern  major  changes  which  may 
have  a  significant  impact  on  the  quality,  safety  or 
efficacy  of  the  medicinal  product.  These  variations 
require  approval  by  the  relevant  competent  medicine 
authority before they can be implemented. 

Type  IA  variations  concern  minor  changes  which  have 
only a minimal impact or no impact at all on the quality, 
safety  or  efficacy  of  the  medicinal  product.  These 
variations  do  not  require  approval  by  the  relevant 
competent  medicine  authority  prior  to  implementation 
(‘Do & Tell’). 

Type  IB  variations  concern  changes  that  are  neither 
Type IA nor Type II variations. These variations require 
approval  by  the  relevant  competent  medicine  authority 
before they can be implemented. 

Veterinary  Medicinal  Product 
Regulation (VMP) 

Regulation (EU) 2019/6 of the European Parliament and 
of  the  Council  of  11  December  2018  on  veterinary 
medicinal products and repealing Directive 2001/82/EC 

Weighted  average  of  NCAs’ 
costs 

In the model calculating costs and income of EMA and 
NCAs for a ‘typical  year’ NCAs costs were determined 
as  a  weighted  average  of  costs  estimated  for  various 
NCAs, using as weight the frequency of involvement of 
the NCAs. 

13 

 
 
 
 
 
Introduction: Political and legal context 

1. 
Within  the  European  Union  (EU),  all  medicinal  products  for  human  and  veterinary  use 
must be authorised either at EU (central) or Member State (national) level. At EU level, the 
Commission authorises these products based on the scientific assessment of their quality, 
safety  and  efficacy,  as  delivered  by  the  European  Medicines  Agency  (EMA),  with  the 
involvement of national competent authorities (NCAs) in the Member States. The EMA is 
a decentralised Agency of the Union. It charges fees to marketing authorisation holders and 
applicants for obtaining and maintaining EU-wide marketing authorisations for medicinal 
products  for  human  and  veterinary  use.  The  EMA  remunerates  NCAs  for  their  scientific 
assessment  work.  The  services  for  which  EMA  charges  fees  include  scientific  advice, 
assessment  of  applications  for  a  marketing  authorisation,  changes  to  existing  marketing 
authorisations  (variations  and  extensions),  and  other  pre-  and  post-authorisation 
procedures,  and  annual  fees  for  the  maintenance  of  already  authorised  medicines. 
Pharmacovigilance activities conducted at EU level for nationally authorised medicines for 
human use are also financed by fees paid by marketing authorisation holders to EMA. 

The broad purpose of this initiative is to provide the EMA with a sound financial basis for 
the future.  

The proposed revision aims to address the shortcomings highlighted in the 2019 evaluation 
of  the  EMA  Fee  system,  as  defined  in  the  two  EMA  fee  regulations:  (1)  the  Fee 
Regulation  (EC)  No  297/95  and  its  implementing  rules  and  (2)  the  Pharmacovigilance 
Fee Regulation (EU) No 658/2014. The revision will also address the problems caused by, 
and the lessons learnt from the COVID-19 pandemic in order to make the new fee system 
even more effective, future proof and crisis-resistant.  

This  initiative  is  limited  to  revising  the  EMA  fee  system  based  on  an  assessment  of  the 
costs of the activities of EMA and NCAsas they are set by the current EU pharmaceutical 
legal  framework.  The  role  of  EMA  as  defined  in  its  Founding  Regulation,  the  way  in 
which  the  EMA’s  committees  operate  and  the  role  of  the  NCAs  in  relation  to  their 
contributions  to  EMA  are  out  of  the  scope  of  this  impact  assessment.  Changes  in  the 
functioning  of  these  operations  and  measures  to  improve  efficiency  of  EMA1  and  NCA 
services may be considered in the ongoing revision of the pharmaceutical legislation  and 
are therefore out of the scope of this revision.  

More  detailed  background  information  on  the  regulatory  framework,  specifically  on  the 
elements  related to  the authorisation,  maintenance and monitoring of medicinal products, 

1 The EMA also regularly revises its operations to optimise its processes and identify efficiency gains. The 
Commission publishes, at least every ten years, a general report on the experience acquired as a result of the 
operations  of  procedures  for  authorisation  and  supervision  of  medicinal  products.  The  last  report  was 
published  in  2021:  ‘Commission  report  to  the  European  Parliament  and  the  Council  on  the  experience 
acquired with the procedures for authorisation and supervision of medicinal products for human use’, 
 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52021DC0497&qid=1642068705042 

14 

 
 
 
 
                                                 
 
the tasks under the remit of EMA and their links with the EMA fee system are presented in 
Annex 5. 

Legal Context  

The general provisions laying down the composition of the EMA budget and the principles 
of  remuneration  to  rapporteurs  and  experts  are  contained  in  the  EMA  Founding 
Regulation2. The specific fee amounts and levels of remuneration for the contributions of 
the  national  experts  on  the  other  hand  are  detailed  in  the  main  Fee  Regulation3  and  its 
implementing rules4  and  in  the pharmacovigilance fee regulation5. The requirement for a 
cost-based fee system, which is the backbone of the revised system, stems from the legal 
provisions in the main EMA fee Regulations (article 12 from the main fee regulation and 
recital 7 from the pharmacovigilance fee regulation.). The cost alignment objective stems 
from the main Fee Regulation6 which stipulates that any review of the fees shall be based 
on an evaluation of the Agency’s costs and on the basis of the related costs of the services 
provided for by the Member States.  

The  EMA  Founding  Regulation  stipulates  that  EMA  revenues  and  costs  should  be 
balanced. EMA revenues include fees which should cover, as part of the revenues of EMA, 
the  costs  of  the  Agency  and  the  costs  for  remunerating  NCAs  for  their  contribution  to 
EMA’s  tasks.  The    pharmacovigilance  fee  regulation  specifically  states  that  “Any  future 
revisions of the pharmacovigilance fees or other fees levied by the Agency should be based 
on a transparent and independent evaluation of the costs of the Agency and the costs of the 
tasks carried out by the national competent authorities.”. In addition, a number of sectorial 
legislations7  provide  incentives  for  specific  types  of  products  and/or  applicants  that  are 
applied to the amount laid down in the regulations above.  

The need to ensure that EMA costs are covered is linked firstly to the budgetary principle 
in  the  Financial  regulation  whereby  revenue  and  expenditures  shall  be  balanced  (also 
reflected in the founding Regulation of the Agency) and, secondly, to the balancing nature 
of  the  contribution  from  the  Union  to  the  revenue  of  EMA.  Both  revenue  sources 
(contribution  from  the  Union  budget  and  fees)  are  part  of  the  revenue  sources  of  the 
Agency, as per its Founding Regulation.  

Recent  amendments  to  the  pharmaceutical  framework  have  introduced  provisions 
impacting  the  EMA  Fee  System.  First,  the  2018  revision  of  the  founding  regulation 
introduced the use of “charges” as an additional source of revenue for EMA. Furthermore, 
a requirement for the Commission to review the regulatory framework for fees payable to 
the  Agency  by  2019  was  also  introduced.  Secondly,  the  Veterinary  Medicinal  Products 

2 Regulation (EC) No 726/2004, Article 62 (3), Article 67 and  Article 86a 
3 Council Regulation (EC) No 297/95 
4 Implementing Rules 
5 Regulation (EU) No 658/2014 
6 Council Regulation (EC) No 297/95, Article 12 
7  The  SME  Regulation  (Regulation  (EC)  No  2049/2005), Paediatric  Regulation  (Regulation  (EC) No  1901/2006),    the 
Orphan  Regulation  (Regulation  (EC)  No  141/2000),  and  the  Advanced  Therapy  Medicinal  Products  (ATMPs) 
Regulation (Regulation (EC) No 1394/2007) 

15 

 
 
                                                 
Regulation  (Regulation  (EU)  2019/6),  which  became  applicable  on  28  January  2022, 
updated  the  rules  on  the  authorisation  and  use  of  veterinary  medicines  in  the  EU. 
Consequently,  the  current  fee  system  is  not  fully  aligned  with  the  new  and  amended 
provisions put in place for the veterinary sector. Finally, the Regulation reinforcing EMA’s 
role  in  crisis  preparedness  and  management  for  medicinal  products  and  medical  devices8 
(hereafter referred to as Regulation on a reinforced role for EMA) was recently adopted to 
codify  and  further  strengthen  structures  and  processes  established  by  EMA  during  the 
COVID-19  pandemic.  One  specific  activity  (DARWIN  EU9)  introduced  as  part  of  these 
changes  was  assigned  an  EU  budget  allocation  only  to  the  end  of  2023.  Therefore,  the 
continued operation of DARWIN EU as of 2024 will require a new financing mechanism 
through the introduction of additional fee revenue (all other activities under said regulation 
are provided for and financed through an EU budget contribution to the EMA budget). 

Political Context  

The  European  Court  of  Auditors  has  repeatedly  noted  the  need  to  introduce  a  system  of 
remuneration for services provided by Member State authorities based on their costs10. 

The  EMA  fee  legislation  is  crucial  for  the  successful  implementation  of  the  underlying 
pharmaceutical legislation of the EU. By way of example, the Regulation on a reinforced 
role  for  EMA  is  an  important  pillar  of  the  European  Health  Union.  Similarly,  the  new 
VMP  regulation  aims  inter  alia  at  enhancing  the  EU’s  action  against  antimicrobial 
resistance. Appropriate cost-based funding of the relevant activities provided for in these 
regulations, as outlined above, is fundamental for equipping the Union with the necessary 
instruments to implement the new tasks. The EMA fee system plays an important role in 
such funding. 

Furthermore, the  fee system is  closely linked to  the underlying regulatory  framework set 
by the Union pharmaceutical legislation. The ongoing revision under the Pharmaceutical 
Strategy  for  Europe,  including  the  ongoing  revision  of  the  legislation  on  orphan  and 
paediatric  medicines,  may  have  a  direct  impact  on  the  fee  system.  Given  the  time 
constraints  outlined  above,  the  revision  of  the  fees  framework  needs  to  move  forward, 
ahead of the finalisation of these other legislative revisions. However, any new fee system 
will need to be agile and adaptable in order to respond to the rapidly changing landscape in 
the  pharmaceutical  sector  to  cater  for  any  new  provisions  that  may  emerge  from  this 
revision process.  

Finally, the COVID-19 pandemic has put strain on NCAs and their available resources, in 
particular  for  those  called  on  to  make  an  intensified  contribution  to  the  authorisation 
processes  for  new  vaccines  and  therapeutics  and  to  monitor  the  availability  of  crisis-

8 Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for 
the European Medicines Agency in crisis preparedness and management  for  medicinal products and medical devices 
(OJ L 20, 31.1.2022, p. 1) 

9 Data Analysis and Real World Interrogation Network (DARWIN EU) | European Medicines Agency (europa.eu) 
10  European  Court  of  Auditors  reports  on  the  annual  accounts  of  the  European  Medicines  Agency  for  the 
financial years 2006 (OJ C 309, 19.12.2007, p. 34–39), 2010 (OJ C 366, 15.12.2011, p. 27–32) and 2011 (OJ 
C 388, 15.12.2012, p. 116–122). 

16 

 
 
                                                 
specific  medicines.  On  7  December  2021,  the  Council  adopted  Conclusions  on 
Strengthening  the  European  Health  Union  in  which  they  invited  the  Commission  to  pay 
due  attention  when  revising  the  EMA  fee  system  in  order  to  “avoid  causing  damage  to 
national competent authorities” and to safeguard and strengthen the EU regulatory system 
for medicinal products, including the scientific contributions made by NCAs11. 

2. 

Problem definition 
  What are the problems? 

The  following  section  describes  the  main  problems  facing  the  EMA  fee  system,  as 
identified  by  the  recent  evaluation12.  It  extends  this  analysis  to  include  issues  that  arose 
subsequently due to the impact of the COVID-19 pandemic. 

1.1.1.  2.1.1.  Misalignment with provisions of new Union legislation [P0] 

From a legal perspective, the main problem is the lack of alignment of the fee legislation 
with  the new provisions introduced by the VMP  Regulation  (further compounded during 
the  Covid-19  pandemic,  see  below  ‘Further  elements  identified  following  the  COVID-19 
crisis’).  

The VMP regulation introduced changes to regulatory procedures for which currently there 
are no fees. In addition, it broadened the scope of veterinary medicinal products eligible for 
the centralised procedure, which affects both EMA income and NCA remuneration as well 
as their costs related to veterinary activities.  

As an interim measure to cover the new regulatory procedures for which no fees exist, the 
Implementing  Rules  of  the  current  Fee  Regulation  have  been  amended,  to  guarantee 
continuity of funding from 28 January 2022, when the VMP regulation applied. Fees and 
remuneration amounts for new procedures have been introduced using existing amounts as 
benchmarks,  whilst  for  amended  procedures  existing  amounts  continue  to  apply.  This 
measure  cannot  be  considered  a  sustainable  solution  as  a)  not  all  necessary  fees  can  be 
introduced/amended  through  the  implementing  rules  (annual  fees)  and  b)  the  fee  and 
remuneration amounts are not cost-based. 

11  The  Council  conclusions  acknowledged  the  concerns  expressed  during  the  meeting  of  the  Heads  of 
Medicines  Agencies  (HMA),  held  under  the  Slovenian  Presidency  of  the  Council  of  the  EU  on  15  and  16 
September 2021, in relation to the anticipated update of the rules on fees payable to the European Medicines 
Agency and its potential implications for the national competent authorities (NCA) responsible for medicinal 
products.  The  concerns  expressed  were,  inter  alia,  that  the  cost-based  fee  proposal  would  reduce  existing 
centralised human medicines fees for NCAs at a time of stretched resources and increased pressure for input 
into the centralised system, would not reflect the value of services delivered, would be based on out-of-date 
information and would recognise only some of the costs incurred by NCAs; invites the Commission to pay 
due attention to the concerns expressed in order to avoid causing damage to national competent authorities 
and  to  safeguard  and  strengthen  the  EU  regulatory  system  for  medicinal  products,  including  the  scientific 
contributions made by national competent authorities. 

12  Commission  Staff  Working  Document  –  Evaluation  of 
evaluation_ema_fee_swd2019336_en_0.pdf (europa.eu) 

the  European  Medicines  Agency’s  fee  system 

17 

 
 
                                                 
 
Weaknesses identified in the evaluation  

The 2019 evaluation found that, although the existing fee system is generally effective and 
efficient,  there  are  a  number  of  weaknesses  that  might  affect  EMA’s  ability  to  meet  its 
costs in the future, including the remuneration to NCAs for their scientific contribution. 

1.1.2.  2.1.2.  Misalignment of some fee levels with the underlying costs – a 

non-cost based system [P1] 

The procedural activities, the timelines and actors involved with their respective roles are 
defined in the overarching pharmaceutical legislation. Based on the information collected 
on the frequencies of such procedures and the workload involved for the different actors, 
the evaluation showed that though the current fee system covers costs overall, it is not fully 
cost-based,  as  there are discrepancies between revenues and costs calculated per type of 
procedure.  

Some fee levels are not aligned with the respective underlying costs.13 More specifically, 
fee revenue for some procedures exceed the total EMA and NCA costs of delivering them 
whilst  for  some  other  procedures  they  fall  short  of  costs.14    For  example,  as  shown  in 
Figure  1,  human  medicine  “variation”15  fees  amount  to  €72  million/year  vs.  €18 
million/year of total underlying costs. The opposite can be observed for initial marketing 
authorisation procedures, with fees amounting to €27.5 million/year vs. €50 million/year of 
underlying costs. Similar discrepancies have been observed also for veterinary medicines, 
though  on  a  much  smaller  scale,  as  shown  in  Figure  216.  The  cost  misalignment  of 
individual fee levels with the average unitary costs drives a misalignment of the overall fee 
revenue  per  type  of  procedure  and  leads  to  a  misalignment  at  the  level  of  the  system 
whereby  overall  procedural  revenue  is  not  aligned  to  the  overall  procedural  cost,  for  all 
procedures taken together. 

Furthermore,  for  some  procedural  activities  there  are  no  fees  (e.g.  procedures  related  to 
paediatric investigation plans and orphan designation), meaning that EMA has to  rely on 
other  sources  of  income  (e.g.  annual  fees;  EU  and  EEA  budget  contributions;  etc.)  to 
address any shortfall.  

The misalignment of fees with the underlying costs also affects the fee payers, since they 
are charged fees that are not necessarily reflective of the workload required for the service 
provided.  

13 Commission Staff Working Document – Evaluation of the European Medicines Agency’s fee system page 83 
14 Commission Staff Working Document – Evaluation of the European Medicines Agency’s fee system page 83 section 6  
15 Variation : a change in the terms of an existing marketing authorisation  
16 This is separate from the misalignment in legislation explained in P0. 

18 

 
 
 
 
                                                 
80

60

40

20

0

r
a
e
y
/
s
n
o
i
l
l
i

m
€

50

36

22

28

72

18

12

7

16

15

19

13

23

4

3

2

Full fees

Total costs

Figure  1:  Comparison  of  total  costs  and  fees  for  EMA  and  NCAs  over  one  synthetic  year17 
before incentives applied under the current financial model – human medicines only 

5.146

6.000

5.000

4.000

3.000

2.000

s
d
n
a
s
u
o
h
T

3.…

1.062

1.000

431

0

1.484

813

437

702

730

714

702

729

696

216

full fees

total costs

Figure 2: Comparison of total costs and fees for EMA and NCAs over one synthetic year 
before incentives applied under the current financial model – veterinary medicines only 

1.1.3.  2.1.3.  Misalignment  of  some  NCA  remuneration  with  the  costs 

incurred to undertake the work [P2] 

At the level of individual activities, a high degree of variation exists in the extent to which 
remuneration  aligns  with  costs.18  NCAs  receive  more  remuneration  than  their  incurred 

17  Synthetic  year:  A  synthetic  year  is  used  to  determine  costs  to  EMA  and  NCAs  incurred  for  EMA-related 
activities in a ‘typical year’. The synthetic year “neutralises” differences in the reporting of data for EMA and 
NCAs. This  was necessary to ensure  that, for activities  where NCAs are involved, the  number and type of 
activities is the same for EMA and NCAs in the ‘typical year’. 

19 

 
 
 
 
 
 
                                                 
 
costs  for  certain  procedures  (e.g.  variations)  and  less  for  others  (e.g.  initial  marketing 
authorisation  procedures).19  For  example,  as  shown  in  Figure  3,  for  human  medicine 
variation and scientific advice procedures the fee revenue is almost 3 times higher than the 
underlying costs incurred to undertake the work, whilst for initial marketing authorisations 
and  inspections  costs  exceed  the  total  remuneration  received  for  those  activities. 
Discrepancies  are  not  as  large  for  veterinary  medicines,  where  only  in  the  case  of  initial 
marketing authorisations are costs considerably higher than remuneration. Furthermore, for 
some  procedural  activities  EMA  fees  do  not  exist  and,  consequently,  no  respective 
remuneration is provided to NCAs (e.g. procedures related to paediatric investigation plans 
and orphan designation).20 This affects more or less all NCAs serving as rapporteurs for a 
procedure,  with  NCAs  that  undertake  only  veterinary  activities  (16  out  of  48)  being  less 
likely to cover their aggregate costs, due to the lower fees applied to those procedures.21  

In  addition  there  is  a  difference  between  the  approach  taken  for  pharmacovigilance 
activities  compared  to  other  types  of  activities.  The  2014  Pharmacovigilance  Fee 
Regulation  introduced  fees  and  remuneration  based  on  cost  estimations  whereas  fees  set 
under the main Fee Regulation, remunerates NCAs at 50% of the fee (i.e. not cost-based). 
The  Court  of  Auditors  has  also  repeatedly  criticised  the  non-cost-based  approach  to 
remuneration of NCAs (in relation to the main fee regulation)22. 

The  evidence  suggests  that  misalignments  at  the  individual  activity  level  may  lead  to  an 
imbalance in the overall level of remuneration to NCAs. Whilst the total remuneration for 
procedural activities exceeds the related costs, the overall remuneration received by NCAs 
is  not  sufficient  to  cover  their  aggregate  costs  when  all  the  additional  non-procedural 
activities  they  reported  are  included23.  Such  additional  non-procedural  activities  are 
activities carried out by NCAs not directly linked to a specific procedure (e.g. activities not 
triggered  by  an  application  which  have  no  defined  timelines)  and    which  an  analysis  is 
needed to determine whether they fall into the scope of remunerable services provided to 
EMA  by  NCAs.    Such  activities  include  IT  developments,  audits,  signal  detection, 
reporting on adverse drug reactions etc. However, whether, and to what extent, the cost of 
these  additional  non-procedural  activities  should  be  covered  by  EMA  fee  remuneration, 
was  the  subject  of  a  separate  analysis  (see  Section  6.1.  Public  authorities  and  budgets 
(including  governance  and  good  administration)  to  determine  their  eligibility  under  the 
Founding  Regulation.  Annex  4  –Addendum  2  contains  further  information  on  NCA 

18 Commission Staff Working Document – Evaluation of the European Medicines Agency’s fee system page 
83 section 6 
19 Inception impact assessment - Revision of the EMA fee system page 4  
20 Inception impact assessment - Revision of the EMA fee system page 4  
21 Commission Staff Working Document – Evaluation of the European Medicines Agency’s fee system page 
83 section 6 
22  See the European Court of Auditors reports on the annual accounts of the European Medicines Agency  
for the financial years 2006 (Report on the annual accounts of the European Medicines Agency for the  
financial year 2006 together with the Agency's replies (2007/C 309/07), OJ C 309, 19.12.2007, p. 34– 
39), 2010 (Report on the annual accounts of the European Medicines Agency for the financial year  
2010, together with the Agency’s replies, 2011/C 366/06, OJ C 366, 15.12.2011, p. 27–32) and 2011 
(Report on the annual accounts of the European Medicines Agency for the financial year 2011,  
together with the Agency’s replies, 2012/C 388/20, OJ C 388, 15.12.2012, p. 116–122). 
23 Commission Staff Working Document – Evaluation of the European Medicines Agency’s fee system page 
59 section 5.1 and page 83 section 6  

20 

 
 
                                                                                                                                                    
“additional  non-procedural  activities”  eligible  for  remuneration,  how  they  have  been 
defined as well as the methodology used to calculate the costs eligible for remuneration. 

These misalignments could affect the ability of NCAs to remunerate the needed expertise 
for the evaluation of EU-level procedures. Although the evaluation did not show any major 
problem of effectiveness of the EMA fee system it found that if NCAs were to reduce their 
involvement due to lack of financial resources for remunerable contributions to EMA this 
would  negatively  affect  the  sustainability  of  the  regulatory  network  and  the  work  of 
EMA.24  

40

35

30

25

20

15

10

5

0

r
a
e
y
/
s
n
o

i
l
l
i

M
€

36

34

18

7

14

13

1

1

4

0

10

8

13

6

NCA
remuneration

NCA costs

Figure 3: NCA costs and fee revenue/income over one synthetic (modelled) year with fee 
incentives applied as per current financial model – human medicines 

24 Commission Staff Working Document – Evaluation of the European Medicines Agency’s fee system page 
61 section 5.1 

21 

 
 
 
 
 
 
 
                                                 
s
d
n
a
s
u
o
h
T

4.000

3.000

2.000

1.000

0

2.696

1.540

NCA remuneration
NCA costs

202

78

219

261

351

334

104

0

Figure 4: NCA costs and fees revenue/income over one synthetic (modelled) year with fee 
incentives applied as per current financial model – veterinary medicines 

1.1.4.  2.1.4. 

The  fee  system  is  complex,  partly  inconsistent  and  not 

flexible [P3] 

The structure of the fees paid by industry should be as simple as possible to apply in order 
to  minimise  the  related  administrative  burden  for  all  stakeholders  (EMA,  NCAs, 
industry)25. This need is not fully met by the current system. Around 90 basic procedural 
fees, relating to medicinal products for human and veterinary use, exist under the current 
system and additional amounts may be added to those basic fees. Whilst these additional 
layers  contribute  to  fairness  by  allowing  for  a  more  detailed  breakdown  of  fees  and  fee 
incentives, they  also  add to  the complexity of the fee system  (there is  a  large number of 
specific  fee  values  to  be  calculated),  and  the  resulting  financial  flows  are  not  easily 
predictable for fee payers.26 The administrative burden on EMA and industry is evident - in 
2021, 32,967 sales orders27  were triggered by EMA, resulting in  over 18,000 invoices to 
pharmaceutical  companies.  SMEs  and  research  organisations,  also  reported  difficulty  in 
navigating the rules and  amounts for fees charged, and felt that the system  is  not always 

25 Council Regulation (EC) No 297/95 and Regulation (EU) No 658/2014. 
26 Commission Staff Working Document – Evaluation of the European Medicines Agency’s fee system page 
63 section 5 

27  Sales  order  is  the  technical  equivalent  for  ‘recovery  order’  within  the  meaning  of  Article  98(2)  of  the 
general financial regulation (= Article 65 of the Agency’s and the Framework Financial Regulation), i.e. ‘the 
act by which the authoring office instructs the accounting officer [..] to recover an amount receivable that the 
authoring  officer  has  established’.  A  sales-  or  recovery  order  is  followed  by  an  invoice  issued  by  the 
accountant. 

22 

 
 
 
 
                                                 
transparent  and  easily  accessible  to  them.28  In  2021,  around  8%  of  the  sales  orders  and 
invoices issued by EMA were for SME applicants. 

Secondly, the fee system is not fully coherent internally with certain pieces of legislation 
that govern and affect the fee system.29 For example, in the main Fee Regulation incentives 
are  applied  after  remuneration  of  NCAs  (EMA  absorbs  the  shortfall),  whilst  under  the 
Pharmacovigilance  Fee  Regulation  incentives  are  applied  before  NCA  remuneration  (the 
shortfall  is  shared  proportionally  by  NCAs  and  EMA).    There  is  no  rationale  for  this 
divergence  of  approach,  and  it  points  to  a  problem  of  principle  as  to  whether  NCAs  of 
Member  States  should  share  the  burden  of  the  incentives.  Furthermore,  the  way  NCA 
remuneration is calculated is not aligned across the two regulations; NCA remuneration in 
the main fee regulation is calculated as a percentage of the fee charged to industry, whilst 
NCA remuneration in the Pharmacovigilance fee regulation is expressed as finite amounts 
based  on  estimated  underlying  costs.  The  fee  system  is  also  not  coherent  with  the 
Paediatric  Regulation  as  it  does  not  provide  remuneration  to  NCA  rapporteurs  for  their 
scientific assessments. 

These inconsistencies affect NCAs in terms of the level of remuneration they receive for 
the various scientific services they provide. Furthermore, the different ways in which their 
remuneration is calculated means that remuneration does not fully reflect underlying costs. 

While  the  main  Fee  Regulation  currently  provides  some  flexibility  to  accommodate 
changes  in  the  regulatory  system  through  implementing  rules,  the  existing  fee  system 
cannot  address  some  core  issues,  such  as  the  variability  in  workload  for  assessments 
categorised  under  the  same  procedure  type,  or  variability  in  complexity  (e.g.  for 
procedures  relating  to  the  latest  innovations  in  medical  science,  such  as  gene  therapy, 
personalised  medicines)  which  would  result  in  varying  time  required  to  complete  the 
assessment.30  It  may  also  affect  the  distribution,  in  both  number  and  type  of  activities 
across NCAs. As it stands, the only regular updating of fee levels  foreseen is  that which 
adjusts them in line with the rate of inflation. Consequently, the fee system is not flexible 
enough  to  accommodate  significant  fluctuations  in  EMA  and  NCAs’  workload  or,  more 
specifically,  the  changes  in  time  and  budget  needs  related  to  varying  complexity  of  the 
activities undertaken.31   

The current possibility to adapt the fee system through ‘implementing rules’ of the current 
main  EMA  fee  regulation  is  not  fully  adequate  to  ensure  full  alignment  to  legislative 
changes.  For  example,  while  it  has  allowed  for  a  partial  alignment  to  the  new  VMP 
provisions,  it  could  not  accommodate  the  new  costs  for  DARWIN  EU  as  changes  in  the 
amount of the annual fees require a full-fledged legislative procedure.  

28 Commission Staff Working Document – Evaluation of the European Medicines Agency’s fee system page 
62 section 5.1. For SMEs, EMA operates a specific support structure, ‘the SME office’. 

29 Commission Staff Working Document – Evaluation of the European Medicines Agency’s fee system page 
79 section 5 

30 Commission Staff Working Document – Evaluation of the European Medicines Agency’s fee system page 
66 section 5 
31 Commission Staff Working Document – Evaluation of the European Medicines Agency’s fee system page 
65 section 5.1 

23 

 
 
                                                 
Elements identified following the COVID-19 crisis 

The Regulation on a reinforced role for EMA was adopted to enable the Agency to act in 
preparation for and during major events and public health emergencies. The provisions in 
that  regulation  affect  EMA  and  NCA,  both  financially  and  operationally.  The  increased 
workload has led to additional costs, for which no quantifiable data exists, and has further 
highlighted the importance of having a flexible system that would be able to adapt to meet 
changing costs on an objective basis to guarantee the sustainability of the operation of the 
regulatory  network.  In  line  with  the  Regulation  on  a  reinforced  role  of  EMA,  additional 
payments have been put in place respectively in the current system, financed through the 
EU budget contribution. 

The  COVID-19  pandemic  also  showed  the  value  of  a  flexible  fee  system.  Upfront  fee 
payments were introduced, via the implementing rules of the main fee regulation, for the 
“rolling review” approach32, along with the possibility of additional remuneration (top-up 
payments) , beyond regular remuneration foreseen in the fee system, to NCA rapporteurs.  

  What are the problem drivers? 

Regulatory drivers 

1.2.1.  2.2.1. 

New  and  amended  procedures  for  veterinary  medicines 
(VMP  legislation)  and  new  estimated  EMA  costs  as  of  2024  for 
DARWIN (under the Regulation on a reinforced role for EMA) [D1] 

New and amended procedures for veterinary medicines have been introduced by the VMP 
Regulation,  which  has  become  applicable  in  January  2022.33  The  current  fee  legislation 
does  not  provide  fees  for  some  newly  introduced  activities,  whilst  it  includes  fees  and 
remuneration for procedures that are going to disappear.  
An interim measure34 has been put in place in order to ensure continuity of funding for the 
veterinary operations between January 2022 and the applicability of a new fee regulation. 
Nonetheless,  this  measure  cannot  be  considered  as  a  sustainable  solution  as  some  fees, 
such  as  annual  fees,  cannot  be  introduced/amended  by  the  implementing  rules  and 
amended  existing  fees  could  not  be  fully  benchmarked  on  the  new  regulatory  processes, 
and therefore cannot be considered cost-based. 

32 A rolling review is a regulatory tool that EMA uses to speed up the assessment of a promising medicine 
during  a  public  health  emergency.  Normally,  all  data  on  a  medicine  or  vaccine’s  effectiveness,  safety  and 
quality  and  all  required  documents  must  be  ready  at  the  start  of  the  evaluation  in  a  formal  application  for 
marketing  authorisation.  In  the  case  of  a  rolling  review,  EMA’s  human  medicines  committee  (CHMP) 
reviews data as they become available from ongoing studies. Once the CHMP decides that sufficient data are 
available, the company can submit a formal application. By reviewing the data as they become available, the 
CHMP can come to an opinion on the medicine’s authorisation sooner. 
33 Some of the main benefits of the Regulation are reduction in the administrative burden, simplification of 
the  regulatory  environment  (including  indefinite  authorisations,  thereby  obviating  the  need  for  renewals 
procedures), as well as the overhaul of some post authorisation activities. 
34 Rules for implementation of EMA fee regulation, EMA/MB/408059/2021, Annex II.8  

24 

 
 
                                                 
Furthermore,  with  regard  to  the  operation  of  DARWIN  EU,  financing  via  an  EU  budget 
contribution has been allocated until end of 2023 (time limited), following which financing 
will need to be ensured through fee revenue.  

1.2.2.  2.2.2. 

The levels of fees and remuneration for EMA and NCAs for 

procedures are not fully cost-based [D2] 

In accordance with the legislation, fees charged to industry should be based on the costs of 
the  Agency  and  the  costs  of  NCAs  for  services  provided  to  the  Agency.  However,  the 
current system was designed to be updated principally based  on the annual inflation rate, 
and  not  to  regularly  track  and  cater  for  workload  fluctuations  over  time.  This  has  had  a 
significant effect on the alignment of fees with underlying costs. 

1.2.3.  2.2.3. 

The fee system is complex [D3] 

The  complexity  of  the  current  EMA  fee  system  stems  from  (1)  the  wide  variety  of 
underlying  services  provided  and  activities  carried  out  by  EMA  (most  of  them  requiring 
the  contribution  of  NCAs)  and  (2)  the  several  layers  of  legislation  governing  and 
influencing the fee system.35 Since the last amendment of the main Fee Regulation in 2005, 
several pieces of sectorial legislation established additional fee incentives. The adoption in 
2014 of the Pharmacovigilance Fee Regulation has added to the overall complexity.  

Divergent approaches on elements such as the application of incentives and the way NCA 
remuneration are calculated in both EMA fee regulations lead to even more incoherence in 
the resulting system. 

Real world drivers 

1.2.4.  2.2.4. 

Assessing  innovative  medicinal  products  (e.g.  gene  therapy, 

personalised medicines) is becoming more complex [D4] 

Several  NCA  representatives  reported  that  evaluating  medicinal  products  has  become 
increasingly complex in recent years due to more sophisticated innovations and advances 
in  science  (e.g.  gene  therapy,  personalised  medicines).36  Contributors  to  this  additional 
complexity include very innovative products without clinical data or with insufficient data 
and therefore potentially requiring in future more extensive assessment, big data, analysis 
of real-world data and patient experience data (including how to address differences in data 
standardisation),  health  technology  assessments  (HTA),  and  companion  diagnostic 
reviews.37  In  the  veterinary  medicines  sector,  increasing  complexity  is  also  expected  in 
activities  related  to  monoclonal  antibodies  and  stem  cells.38  There  is  currently  no 

35 Commission Staff Working Document – Evaluation of the European Medicines Agency’s fee system. 
36 Commission Staff Working Document – Evaluation of the European Medicines Agency’s fee system page 
72 section 5.1  
37 Commission Staff Working Document – Evaluation of the European Medicines Agency’s fee system page 
72 section 5.1  
38 Commission Staff Working Document – Evaluation of the European Medicines Agency’s fee system page 
72 section 5.1  

25 

 
 
 
                                                 
monitoring system to capture the possible significant effects of these developments on the 
relevant costs. 

  How likely is the problem to persist? 

The  misalignment  of  the  fees  regulations  with  new  (and  future)  pieces  of  legislation 
represent  a  risk  for  the  financial  sustainability  of  EMA  and  the  contributions  of  NCAs. 
EMA  tasks  linked  to  the  veterinary  pharmacovigilance  procedures  are  not  covered  by 
specific fees and may in the long run be covered by an additional EU budget contribution.  

The implementation  of the Regulation  on a  reinforced role  for  EMA  as  of 2024  requires 
substantial input from fee revenue, with the current cost estimations,   and may become a 
breaking point for the capacity of the current fee system to adapt to the anticipated costs. 
As presented, the EU budget contributions will cover costs for the operation of DARWIN 
EU39 only until end of 2023, and a specific EU budget financing of that particular activity  
is no longer earmarked as of 2024.  

Secondly, significant shortfalls in the EMA budget, arising from the misalignment of fees 
and costs, could negatively affect the financial sustainability of EMA in the future.40 This 
in  turn  could  affect  the  remuneration  of  NCAs  and  consequently  their  ability  of  to 
contribute  to  the  EU  regulatory  system  by  providing  expertise  for  the  evaluation  of  EU-
level procedures  

The  EU  is  experiencing  fast  technological  transformation  and  there  is  a  general  trend 
towards convergence of industries, products, technologies and services.41 These trends will 
influence  the  research  and  innovation  landscape,  including  in  health  and  will  have  an 
impact on the functioning of EMA.  

In view of the current revision of the underlying pharmaceutical legislation, there may be 
more  changes  to  the  legal  framework  in  the  future.  The  fee  system  will  have  to  adapt 
continuously, beyond the current revision, to provide appropriate fees and remuneration for 
the services provided. 

.  

3. 

Why should the EU act? 
  Legal basis 

The  legal  basis  for  EU  action  is  that  the  proposed  regulation  would  be  based  on  a  dual 
legal  basis,  Article  114  and  Article  168(4)(c)  of  the  Treaty  on  the  Functioning  of  the 
European  Union,  and  will  aim  to  replace  or  amend  as  necessary  the  two  EMA  fee 
regulations.  
The  proposed  regulation  is  based  on  Article  114  TFEU  as  differences  between  national 
legislative, regulatory and administrative provisions on medicinal products tend to hinder 
intra-Union  trade  and  therefore  directly  affect  the  operation  of  the  internal  market.  The 

39 Objective 3 of the financial statement for Regulation (EU) 2022/123 on a reinforced role for the European 
Medicines Agency 
40 Commission Staff Working Document – Evaluation of the European Medicines Agency’s fee system page 
84 section 6 
41 European Commission. (2021). Strategic Foresight Report: The EU’s capacity and freedom to act. As of 25 
October 2021: https://ec.europa.eu/info/sites/default/files/strategic_foresight_report_2021_en.pdf 

26 

 
 
                                                 
EMA Fee Regulation ensures the availability of the necessary financial resources to apply 
the  Union  procedures  for  the  assessment  of  medicinal  products,  which  have  been 
introduced  amongst  other  things  to  prevent  or  eliminate  obstacles  that  could  result  from 
parallel  procedures  at  national  level.  Thereby  this  Regulation  contributes  to  the  well-
functioning  of  the  internal  market  and  the  common  post-marketing  surveillance  of 
medicinal products.  
In addition, the proposed Regulation is based on Article 168(4) (b) and (c) TFEU as it aims 
to  support  the  goal  of  setting  high  standards  of  quality  and  safety  of  medicinal  products 
and the protection of public health through measures in the veterinary field. It ensures the 
availability of sufficient financial resources to perform the activities that are necessary to 
guarantee that high standards are applied for the authorisation of pharmaceutical products 
and maintenance of those authorisations. 
The  EU  budget  contribution  included  in  the  current  multiannual  financial  framework 
(MFF) will be taken into account too.42 

Subsidiarity: Necessity of EU action 

EMA is a decentralised Agency of the EU, therefore decisions on its funding and the fees it 
may charge are taken at EU level. Only the Union can act to enable the Agency to charge 
fees and to define the levels of those fees. The proposed legislation will not apply to fees 
charged  by  NCAs  in  their  respective  Member  States,  for  which  the  EU  does  not  have 
competence. 

Subsidiarity: Added value of EU action 

Since only the Union can act to enable the Agency to charge fees and to define the levels 
of those fees, the added value is inherent and is linked to the necessity of EU action.  

4. 

Objectives: what is to be achieved? 
  General objectives  

The general objective of this initiative is to provide a sound financial basis for EMA and its 
activities, including cost-based remuneration for the services provided by NCAs. This will 
be achieved by better aligning fees to underlying costs and to simplify as far as possible the 
system,  while  ensuring  that  the  EMA  budget  is  in  balance.  The  EU  budget  contribution 
included in the current multiannual financial framework (MFF) is taken into account.  

In  addition,  the  initiative  has  to  respect  a  number  of  fundamental  overarching  principles 
that are crucial for the sound functioning of the fee system. 

The future fee system has to ensure that EMA’s costs (including expenditure for cost-based 
remuneration to NCAs) are covered, taking into account the balancing subsidy of the EU 
budget contribution, as provided by the EMA founding regulation. This is aligned with the 

42 The level of the Union contribution in the next MFF should take into account an evaluation of EMA needs 
and the level of  fees  established following a  legal proposal based on this impact assessment,  as per article 
67(e) of EMA’s founding regulation 726/2004. 

27 

 
 
 
 
 
 
 
 
                                                 
principle whereby the financing of certain services, for which a cost-based approach is not 
viable, is  guaranteed by  a redistribution of  the costs for those services across all revenue 
sources of EMA (including fees, charges, EU budget contribution). These services concern 
activities for specific markets, applicants and product categories where fees are reduced or 
incentivised in legislation/ policy (e.g. veterinary medicinal products, SMEs). 

Additionally, the fee system needs to guarantee an adequate level of agility to be able to 
adapt to future changes in the regulatory system, including relevant changes in the Union 
pharmaceutical  legislation  following  the  review  under  the  Pharmaceutical  Strategy  for 
Europe. 

While  it  is  an  overall  objective  of  the  fee  legislation  to  ensure  a  level-playing  field  for 
SMEs, the evaluation did not identify any issue in that respect and therefore, this is not part 
of  the  specific  objectives  of  this  revision  which  are  described  below.  The  EMA  fee 
reductions for SMEs are laid down in Commission Regulation (EC) No 2049/20053 which 
will continue to apply. In addition, it should be noted that facilitating the development and 
marketing  of  safe  and  effective  medicines  is  an  objective  of  the  overarching  EU 
pharmaceutical legislation and it is not an objective of this revision. 

Specific objectives 

Based on the problems outlined in Section 2, the specific objectives of the initiative are: 

  Objective  1:  to  align  the  fee  system  to  new  legal  provisions  introduced  by  recent 

legislation. Specifically,  

o  relevant changes to the rules applicable to the authorisation and monitoring 
of  veterinary  medicinal  products  (VMP),  as  introduced  by  the  new  VMP 
Regulation; 

o  relevant  changes  in  the  cost  basis  for  EMA  operations  introduced  by  the 

Regulation on a reinforced role for EMA  

Furthermore,  it  should  take  into  account  a  new  legal  provision,  which  introduces 
“charges”  as  a  possible  source  of  revenue  for  the  Agency  in  the  EMA  Founding 
Regulation as currently applicable.  

  Objective  2.1:  To  better  align  procedural  fees  to  respective  costs  while  respecting 

fee incentives set in existing policies 

  Objective 2.2: , To allow remuneration of NCAs based on their relevant costs; 

  Objective  3:  To  simplify  the  fee  system  in  order  to  minimise  the  administrative 
burden  generated,  as  well  as  making  the  system  more  coherent  internally  by 
harmonising the current practices introduced by existing Regulations;  

  Objective  4:  To  allow  sufficient 

fast-paced 
developments  in  the  pharmaceutical  sector  and  the  increasing  complexity  of 
products submitted to the Agency for evaluation. 

to  accommodate 

flexibility 

The objectives of simplification and flexibility stem from the experience gathered and the 
evaluation  and,  therefore,  the  Commission  enjoys  more  discretion  in  that  respect,  as 
compared to  the  cost-based objective which is the backbone of this revision.  In practical 
terms,  the  main  trade-off  is  between  cost-alignment  and  simplicity,  since  cost-alignment 
requires  more  procedural  fees,  while  simplicity  means  less  procedural  fees  and  more 

28 

 
 
 
reliance on annual fees. While flexibility can be seen as a horizontal feature (i.e. how fast 
and  simple  the  procedure  is  to  adjust  the  amounts  of  fees  and  remuneration),  it  is 
influenced  by  the  balance  between  cost-based  and  simplification,  i.e.  it  is  in  principle 
easier to monitor the cost and adjust the fee for a given type of procedure as compared to 
an annual fee. 

5. 

What are the available policy options? 

The  policy  options  assessed  were  designed  in  order  to  address  an  increasing  number  of 
objectives set for the new initiative, starting from the bare minimum, and the expanding to 
the full scope. The policy options consist of: 

  A  baseline  scenario  that  extrapolates  what  will  happen  in  the  absence  of  a 

legislative reform to the EMA fee system. 

  Three main policy options that will change substantive aspects of the fee system in 

different ways. 

  A number of horizontal measures that are used in combination with one or more of 

the main options to adjust a specific aspect of the system. 

Table 1: Policy option descriptions (main options and horizontal measures) 

Option 
category 

Policy 
Option 

Summary 

Baseline 

Do-minimum 

Fee system adjusted to account for the 2018 VMP Regulation and revised EMA 
Founding Regulation current policy commitments as these already apply. This creates 
the baseline scenario to which all other options can be assessed. 

Main policy 
options 

1 

2 

3 

3 ‘light’ 

Horizontal 
measures 

A 

In addition to the ‘do minimum’, cost-based fees are introduced for all veterinary 
medicines procedures, as per the new VMP regulation. 

Introduces a cost-based fee system for all EMA activities for both veterinary and 
human sectors. No changes to the fee system structure, but fees are included for 
additional procedural activities, for which no fees are charged currently (and no 
remuneration is paid). Unremunerated procedural activities in the current system 
become remunerated under this option. 

Cost-based fee system for human and veterinary activities, with a simpler fee 
structure.  

Implements a more limited simplification of the fee system structure described in 
option 343. 
Veterinary fee reductions: 
(i) 

Cost-based fees for veterinary medicines with a general fee reduction only, 
i.e. all fees reduced by 50% 
Cost-based fees for veterinary medicines with a 50% general fee reduction 

(ii) 

43 Under option 3, procedures for which no procedural fee is charged and the cost is covered instead through 
the annual fee are: 

 
 

human medicines: Renewals, Type IA variations, Type IB variations and Type II variations; 
veterinary medicines: five of the current six types of Variations, so that only Line Extensions still 
have a procedural fee; 

and under option 3’ light’, the list of procedures for which no procedural fee is charged is reduced to: 

 
 

human medicines: Renewals, Type IA variations and Type IB variations; 
veterinary medicines: only one of the current six types of Variations ceases to have a procedural 
charge: Simple assessments; the other Variations fees are retained. 

29 

 
 
                                                 
Option 
category 

Policy 
Option 

Summary 

(iii) 

(iv) 

and specific incentives for certain categories 
Cost-based fees for veterinary medicines with specific incentives for certain 
categories 
Same as (iii) but with larger incentives. 

Applies a country coefficient to NCA remuneration. 

Applies incentives to cost-based fees before remuneration to NCAs. 

Based on C. Applies specific incentives for veterinary medicines (limited markets and 
some immunological products), combined with a 25% reduction of the veterinary 
annual fee.  

B 

C 

C1 

  What is the baseline from which options are assessed? (The do-minimum 

scenario) 

The  baseline  (do-minimum  scenario)  is  the  reference  scenario,  against  which  the  other 
options  and  horizontal  measures  are  tested.  It  consists  of  the  current  fee  system,  which 
remains  unchanged,  while  taking  into  account  the  newly  introduced  provisions  for  the 
veterinary  sector  (to  the  extent  possible  without  legal  change)  and  the  Regulation  on  a 
reinforced role for EMA (i.e. an increased cost of EMA for Darwin EU). As a result, in the 
baseline scenario: 

  The structure of the fee system is unchanged: granular fees charged per procedure 
and annual fees for maintenance of authorisation and for pharmacovigilance. NCA 
remuneration non cost-based, in general 50% of the fee.  

  Relevant fee incentives are applied in line with existing legislation and rules. 
  The veterinary sector is  aligned with the new VMP Regulation rules to the extent 
possible without legislative change (resulting in the introduction of some new fees 
and  the  amendment  of  some  other  existing  ones).  The  amounts  for  new  and 
amended fees  are benchmarked to existing fees (i.e. they are not  cost-based). The 
current  unitary  fee  amounts  are  applied  to  the  fees  of  the  remaining  veterinary 
procedures  unaffected  by  the  VMP  Regulation.  The  current  remuneration  system 
(50% of the fee) is applied to the new veterinary classification of procedures. 

  The  part  of  the  fee  system  related  to  human  medicine  remains  unchanged.  The 
current unitary fee amounts and the current NCA remuneration system (50% of the 
fee) are applied. 

  Aggregate fee revenue is expected to change due to the change of classification and 

frequency of procedures under the VMP regulation. 

  The estimated cost of DARWIN EU appears in costs of EMA as of 2024, based on 
an  estimation  of  the  costs  of  the  operational  phase  of  DARWIN  EU.  This  cost  is 
covered neither by the EU budget nor by fees. 

30 

 
 
 
 
 
  Description of the policy options 

1.10.1. 5.2.1. 

Option 1 

The first option is alignment of the fee system with the provisions introduced by new VMP 
regulation,  including  recalculation  of  fees  for  the  veterinary  sector  in  line  with  the  cost-
based principle ( the  effect  of the Regulation  on a reinforced role  for EMA is  taken into 
account)  (Objective 1).  

The three veterinary horizontal measures can be applied to this option (see below section 
5.2.5.1) 

The  overall  architecture  of  the  system  (in  terms  of  disaggregation  of  procedural  fees  vs 
annual  fees)  remains  unchanged.  For  human  medicines,  fees  and  NCA  remuneration 
remain  unchanged.  In  addition,  the  mechanism  of  remuneration  to  NCAs  remains 
unchanged, maintaining a percentage basis. 

Hence, in this option: 

  Cost-based procedural and annual fees are introduced for the veterinary sector. 
  A pharmacovigilance annual fee for veterinary medicines is introduced to cover the 
cost of EMA pharmacovigilance activities in the veterinary sector. It is charged in 
the same way as the human pharmacovigilance annual fee in the current fee system, 
i.e. based on chargeable units for Nationally Authorised Products.44 

  Fee incentives (i.e. discounted fee rates) for SMEs are applied in line with existing 
SME  legislation  but  general  reductions  and  product-specific  reductions  are  not 
applied to veterinary medicines (these are explored through the horizontal measures 
dealing with veterinary incentives). 

However,  taking  into  account  the  Regulation  on  a  reinforced  role  for  EMA  and  the 
estimated cost of DARWIN EU as of 2024, an additional element had to be added to the 
design  to  make  it  viable,  by  introducing  additional  fee  revenue  for  the  Agency  as  of 
January 2024 to balance the budget. Therefore, whilst procedural fees and respective NCA 
remuneration for human medicines remain unchanged, as compared to the current system, 
the estimated impact of DARWIN EU on EMA’s costs is incorporated in the analysis from 
2024  onwards  and 
fee 
(Pharmacovigilance annual fee) and human CAP annual fee in proportion 75% / 25%45. 

the  human  Pharmacovigilance  annual 

is  covered  by 

1.10.2. 5.2.2. 

Option 2 

The  second  option  also  aligns  the  system  with  the  new  VMP  Regulation  and  reinforced 
role of EMA regulation (objective 1) but also aligns fees and remuneration amounts to the 

44 Chargeable units were introduced for the purpose of charging pharmacovigilance fees. A chargeable unit 
can  be  construed  as  being  equivalent  to  a  harmonised  definition  for  a  single  marketing  authorisation  of  a 
medicinal product in all Member States. 
45  This  is  the  estimated  proportion  of  number  of  medicinal  products  to  which  these  two  fee  apply 
respectively. 

31 

 
 
 
 
                                                 
respective costs of EMA and NCAs for carrying out the work (Objective 2). All horizontal 
measures can be applied to this option (see below sections 5.2.5.1- 5.2.5.3) 

Whilst the overall architecture of the system remains unchanged as compared to baseline 
and  option  1,  option  2  introduces  a  cost-based  fee  system  for  all  EMA  activities,  i.e. 
calculates cost-based fees and NCA remuneration amounts for both veterinary and human 
medicines.46  

Furthermore, in this option:  

  Cost-based fees are introduced for some activities for which fees are not currently 
charged (including but not  limited to  orphan  and paediatric procedural  activities). 
In  addition,  NCA  cost-based  remuneration  is  introduced  per  procedure  for  these 
activities. 

  The CAP annual fee (levied on Centrally Authorised Products) is calculated based 
on  all  other  costs  (non-fee  generating  and  horizontal)  and  taking  into  account  all 
available revenue sources to balance the budget. This includes the cost of financing 
DARWIN  EU,  as  of  2024.  NCAs  are  also  remunerated  via  the  annual  fee  for 
eligible additional activities.  

  Costs and associated remuneration for pharmacovigilance activities are covered by 
the  procedural  pharmacovigilance  fees  and  the  Pharmacovigilance  annual  fee 
(calculated  based  on  chargeable  units  for  Nationally  Authorised  Products),  for 
medicines for both human and veterinary use. 

  Relevant fee incentives continue to apply in line with existing legislation and rules. 
Fees for some activities continue therefore to be waived. However, full cost-based 
remuneration is paid to NCAs. 

1.10.3. 5.2.3. 

Option 3 

The  third  option  builds  on  option  2,  not  only  introducing  a  cost-based  fee  system  for 
human and veterinary activities, but also simplifying the fee system structure (objective 3) 
for  both  human  and  veterinary  medicines.  Horizontal  measures  can  be  applied  to  this 
option (see below sections 5.2.5.1 - 5.2.5.3) 

In this option the following simplifications are introduced: 

  A  reduced  number  of  procedural  fees  are  applied  for  post-authorisation  non-
pharmacovigilance  activities  for  human  and  veterinary  medicines.  Procedural 
fees  are  levied  for  pre-authorisation  activities  (human  and  veterinary), 
inspections  and  only  some  major  post-authorisation  activities  (e.g.  referrals47). 

46  Cost-based  fee  and  respective  remuneration  are  calculated  as  weighted  averages  of  cost  multiplied  by 
workload using the most recently available EMA- & NCA-obtained data on time and cost taken to complete 
activities, with distribution of relevant non-procedural EMA cost among all the revenue sources of EMA, as 
provided for in its Founding Regulation. More details are provided in the methodology. 
47 Procedure initiated to resolve issues such as concerns over the safety of an already authorised medicine or 
to  resolve  disagreement  among  Member  States  on  the  benefit-risk  balance  of  a  new  medicine  under 
evaluation. Referrals can be initiated by the European Commission, a Member State or the owner (marketing 
authorisation holder) of the product. 

32 

 
 
 
                                                 
Due  to  technical  complexities  linked  to  the  variety  of  products  included  in 
pharmacovigilance  procedures  and  activities,  pharmacovigilance  procedures 
continue to attract procedural fees.  

  The  CAP  annual  fee  covers  a  broader  set  of  costs  as  compared  to  the  current 
system  including  those  non-pharmacovigilance  post-authorisation  procedures 
that would no longer levy a procedural fee. Furthermore, it includes the cost of 
financing DARWIN EU, as of 2024. 

  NCA  remuneration  for  those  post-authorisation  procedures  that  are  charged 
under  the  CAP  annual  fee  is  no  longer  per-procedure  and  is  included  in  the 
annual remuneration paid to NCAs via the CAP annual fee.  

  The  Pharmacovigilance  annual 

fee  cover  costs  of  EMA  horizontal 

pharmacovigilance activities in both the human and veterinary sectors. 

In this option procedure-based fees are presented for pharmacovigilance procedures48.   

1.10.4. 5.2.4. 

Option 3 ‘light’ 

This option implements a partial simplification of the fee system structure (i.e. a reduced 
version  of  Option  3).  This  responds  to  feedback  received  to  the  inception  impact 
assessment to have an option with a more modest level of simplification, as compared to 
Option  3.  A  more  limited  set  of  activities  are  covered  by  annual  fees  (mainly    minor  
variations and renewals of authorisations) while  procedural  fees  are  maintained  for  a  
larger  number  of activities (mainly major variations). This option is referred to as Option 
3 ‘light’ in the remainder of the Staff Working Document. All horizontal measures can be 
applied to this option (see below sections 5.2.5.1 - 5.2.5.3). 

1.10.5. 5.2.5. 

Horizontal measures 

1.10.5.1.   A, B, C, C1 - Veterinary medicines  

Three  horizontal  measures  have  been  considered  for  the  fees  applied  to  veterinary 
medicines.  These  introduce  general  fee  reductions  and/or  incentives  for  veterinary 
medicines only. Each can be applied in combination with option 1, 2, 3 or 3 ‘light’.  

  Horizontal measure A introduces a 50% general  fee reduction applied to  all (cost-
based) fees for veterinary medicines. No additional fee incentives are applied. 
  Horizontal measure B introduces a 50% general  fee reduction applied to all (cost-
based) fees for veterinary medicines and further specific incentives. This horizontal 
measure  is  the  same  as  Horizontal  measure  A,  but  it  also  includes  in  addition 
specific fee incentives that are applied for veterinary products for limited markets 
and some immunological products. 

48 This represents a change since the inception impact assessment (IIA) whereby costs for pharmacovigilance 
procedures were included under the pharmacovigilance annual fee. However, during the initial stages of the 
study  supporting  the  impact  assessment,  the  modelling  results  showed  that  this  was  not  feasible  from  an 
operational point of view, as it would lead to significantly increased complexity in calculating the  fees and 
associated NCA remuneration. 

33 

 
 
 
                                                 
  Horizontal  measure  C  introduces  only  specific  incentives  that  are  applied  for 
veterinary  products  for  limited  markets  and  some  immunological  products.  No 
general reduction is applied to veterinary medicines cost-based fees. 

  Horizontal  measure  C1  is  based  on  sub  option C.  It  introduces  specific  incentives 
limited  markets  and  some 
that  are  applied  for  veterinary  products  for 
immunological products, combined with a 25% reduction of the cost-based annual 
fee for centrally authorised veterinary products. No general reduction is applied to 
veterinary medicines cost-based fees. 

1.10.5.2.   D - Country coefficient applied to NCA remuneration 

This horizontal measure applies a country coefficient to NCA remuneration. Application of 
country coefficients would result in an adjustment to remuneration that is linked to costs in 
each Member State. This horizontal measure could apply to Option 2, 3 or 3 ‘light’. 

1.10.5.3.  E - Sharing the cost of fee incentives between EMA and NCAs 

In  the  main  options,  remuneration  is  to  be  calculated  fully  cost-based,  even  when  fee 
incentives  apply.  This  horizontal  measure  applies  incentives  to  cost-based  fees  before 
remuneration to NCAs, which means that the NCA remuneration is reduced in proportion 
to  the  fee  reduction  (this  mechanism  applies  currently  for  pharmacovigilance  fees  and 
remuneration  under  Regulation  658/2014).  Fee  incentives  are  also  applied  to  NCA 
remuneration  so  that  the  cost  of  incentives  is  shared  in  proportion  to  the  incentive  rates 
between  EMA  and  NCAs.    This  horizontal  measure  could  apply  to  Options  2,  3  or  3 
‘light’. 

  Options discarded at an early stage 

The  following  options  were  discarded  early  in  the  process  as  their  impacts  were  largely 
undesirable and there was little, if any, support for them among stakeholders. 

 

 

Implementation  of  a  fee  system  in  which  fees  would  be  paid  to  the  Commission, 
not EMA as is currently the case. In this scenario, EMA would be fully funded by 
the  EU  budget  contribution  and  it  is  the  Commission  that  would  reimburse  the 
NCAs. This was discarded as it is out of scope of the fee legislation: it is the EMA 
Founding  Regulation  that  lays  down  the  revenue  sources  available  to  EMA,  i.e. 
fees charged by EMA itself and the EU budget contribution.  
Implementation  of  a  flat  fee  system.  This  would  mean  for  example  that  all  post-
authorisation procedures, including for pharmacovigilance, would no longer attract 
a fee and the respective cost would be included in the calculation of the annual fee.  
Whilst the evaluation indicated that such a design would be considered simpler, it 
also  found  it  would  be  much  less  fair,  e.g.,  payers  of  a  flat  fee  would  pay  for 
procedures that do not concern their products. Therefore the option was discarded 
as it was considered that it would lead to less fairness and proportionality. Instead, 
option  3  was  introduced  and,  following  feedback  from  the  inception  impact 
assessment, a ‘light’ version was introduced. 

34 

 
 
 
 
 
As presented in Section 5.1, the baseline (“do minimum scenario”) consists of the current 
fee system, with unchanged fees structure and amounts through legislative action. The only 
changes are the introduction of fees and remuneration for most of the new provisions of the 
veterinary  sector,  to  the  extent  possible  without  a  legislative  change.  The  output  of  the 
financial modelling applied to the baseline shows a significant negative balance (see table 
3 and 6). This is because, whilst new provisions stemming from the new VMP Regulation 
can be partly addressed through non-legal changes with the introduction of new procedural 
fees and remunerations, costs which can only be covered by annual fees  (e.g.: DARWIN 
EU, Vet Pharmacovigilance annual fee) would remain uncovered as it is only possible to 
change annual fees by amending the legislation. Furthermore, the targeted introduction of 
fees and remuneration  for new procedures  would not allow to reconsider the costs of the 
sector in a holistic way taking due account of changes in the frequencies of activities and in 
the  workload  involved.  Overall,  under  the  baseline,  the  Agency  would  not  be  able  to 
balance its budget and the operation of its network would become unsustainable. Therefore 
the baseline is not considered as a possible option.  

Finally, elements such as the scope of activities for which remuneration from EMA can be 
paid to NCAs and the scope and level of existing fees incentives were also considered out 
of  scope,  since  this  is  provided  for  in  EMA’s  founding  regulation  (the  former)  and  in 
sectorial legislation (the latter). 

What are the impacts of the policy options? 

6. 
Given the nature and scope of the policy choices concerned, the impacts identified in the 
screening  are  purely  of  an  economic  nature.  No  significant  social,  environmental  or 
fundamental  rights  impacts  have  been  identified  due  to  the  nature  and  scope  of  this 
initiative.  Table  2  lists  the  categories  for  which  impacts  are  foreseen,  distinguishing 
between the ones where more significant impacts are expected () and those where some 
impact is at least possible ().  

Economic Impacts 

Significance of impact 

  Public authorities and budgets 

  Administrative burdens on business 

  Position of SMEs 

  Innovation and research 

  Functioning of the internal market competition 

Table 2 Categories for which impacts are foreseen 

 

 

 

 

 

35 

 
 
 
The  impacts  of  the  options  were  assessed  based  on  the  analysis  of  the  outputs  of  the 
financial model delivered by an external study49  as well on the feedback received from the 
targeted  stakeholder  consultations,  which  were  carried  out  through  an  online  survey  and 
interviews.  Further  details  on  the  stakeholder  consultations  can  be  found  in  the  synopsis 
report, Annex 2. 

  Public  authorities  and  budgets 

(including  governance  and  good 

administration) 

Under  this  heading,  the  impacts  of  the  different  options  on  the  various  public  bodies 
involved with EMA’s activities have been assessed. These include not only EMA, but also 
the different NCAs which provide the bulk of the scientific assessment work that is core to 
EMA’s  function  as  the  agency  for  medicines  assessment  and  surveillance  of  the  EU  for 
centralised products. The basic question that arises, is whether the different levels of fees 
that  would  be  set  under  the  different  options  are  sufficient  to  enable  both  EMA  and  the 
NCAs  to  continue  to  fund  their  centralised  activities  in  the  future.    This  includes  both 
setting  fees  at  a  rate  that  is  sufficient  to  cover  the  real  and  relevant  costs  incurred,  and 
ensuring that the resulting revenues are fairly distributed between the different actors.   

Tables presented below correspond to the calculations presented at the consultation stage, 
as presented in Annex 6 

2024 

EMA income (€'000) 

Do 
minimum 

(baseline) 

Option1  Option 2  Option 3 

Option 3 
‘light’ 

Total industry procedural fees 

225,236 

230,466 

183,513 

144,976 

164,037 

Total industry annual fees  

137,174 

171,634 

195,683 

234,220 

215,159 

Total industry fees 

362,410 

402,100 

379,196 

379,196 

379,196 

Total EU budget contribution  

34,000 

34,000 

34,000 

34,000 

34,000 

Total EMA income 

396,410 

436,100 

413,196 

413,196 

413,196 

EMA expenditure (€'000) 

Total  expenditure  on  human  and 
veterinary procedures  

114,269 

114,527 

116,080 

116,080 

116,080 

Total expenditure on other activities 

162,141 

162,141 

162,141 

162,141 

162,141 

Total remuneration to NCAs (*) 

160,014 

162,647 

134,975 

134,975 

134,975 

Tot EMA expenditure 

436,424 

439,315 

413,196 

413,196 

413,196 

49 Annex 6 and Annex 7 

36 

 
 
 
  
  
  
  
  
  
  
  
  
  
  
 
  
  
  
  
  
  
  
  
  
  
  
                                                 
Variance (€'000) 

Table 3 

-40,013 

-3,215 

0 

0 

0 

The  financial  model  supporting  this  impact  assessment  was  designed  to  respect  the 
principle of a balanced EMA budget and it was tuned around the central year of the current 
MFF, 2024. As a result, as shown in Table 3 above, the majority of the options, except 
option 150, calibrate the income from industry fees so that once combined with the EU 
budget contribution, they match the projected expenditures of the specific year. The 
‘do-minimum’ baseline  scenario shows  a significant  negative balance,  which is  why it is 
discarded,  demonstrating  the  need  for  legislative  action  to  adapt  the  current  system  to 
newly  introduced  requirements  and  activities  for  the  Agency  and  the  network,  which 
would remain otherwise uncovered (see Section 5.1.1).  

The total NCA remuneration appears as an expenditure of the EMA budget. Moving to a 
cost-based system, by definition the remuneration amounts are calculated so to match the 
modelled  costs  for  the  identified  eligible  procedural  and  horizontal  activities.  Table  4 
breaks down the distribution of remuneration for procedural and horizontal activities under 
the different options, with variations depending on the different options designs.   

2024 

Do 
minimum 
(baseline) 

€'000  

Option 1  Option 2  Option 3  

Option 3 
‘light’ 

Total remuneration to NCAs (*) 
Remuneration 
from  procedural 
activities  
Remuneration from annual fees  

Total NCA remuneration 

Table 4 

120,620 

123,032 

117,808 

102,657 

114,008 

39,394 
160,014 

39,615 
162,647 

17,167 
134,975 

32,318 
134,975 

20,968 
134,975 

Whilst the model was tuned to correctly balance the budget of 2024, minor variances can 
be observed between the projected income and expenditures across the years. As shown in 
Table 5, even in presence of variances the balance is always positive for the majority of the 
options (varying from €2.1 million to €8.1 million in surplus), with the exception of Option 
1,  for  the  reasons  already  explained  above.  For  Option  1  a  negative  balance  of  between 
€1.4 million and €3.2 million would be experienced for the years from 2024 to 202651.  

Budget balancing p/year 

Do-minimum 
Option 1 

 €'000 

2022 

2023 

2024 

2025 

2026 

-14,958 
3,449 

-17,358 
2,127 

-40,013 
-3,215 

-41,475 
-2,507 

-42,666 
-1,437 

50 Policy option 1 also shows a negative balance, though a much smaller one, due to the fact that by design 
the  option  addresses  only  changes  to  the  veterinary  fees,  without  readjusting  the  rest  of  the  system  to 
guarantee the appropriate balancing. 
51 As provided in Article 17 of the EMA financial regulation, any positive balance would be returned to the 
Commission and the amount  then subtracted from the  EU  budget contribution provided  for the  subsequent 
year. 

37 

 
 
  
  
  
  
  
  
  
  
  
  
  
                                                 
Option 2 
Option 3 
Option 3 ‘light’ 
Table 5 

5,255 
4,218 
4,506 

4,851 
8,142 
4,464 

0 
0 
0 

2,779 
2,707 
3,241 

5,544 
5,711 
6,529 

EMA responded positively to options 2, 3 and 3 ‘light’ in terms of the ability of balancing 
the agency budget, whilst option 1 would cause a significant shortfall given the level of EU 
budget contribution decided under the current MFF.  EMA remarked that, whilst under all 
three  of  these  options  the  agency  would  be  able  to  balance  its  budget,  the  decrease  in 
remuneration  for  NCAs  could  undermine  the  ability  of  the  NCAs  to  contribute  to  the 
centralised system and ultimately put at risk the stability of the network.  
From  the  NCAs  side52,  the  general  opinion  with  the  calculations  presented  for  the 
consultation was that options 2, 3 and 3 ‘light’ would worsen the current situation, as they 
would receive even less remuneration than under the ‘do-minimum’ baseline. Over half of 
NCAs and one ministry of health responding to the targeted survey indicated that option 1 
would  have  no  impact  vis-a-vis  the  ‘do  minimum’  baseline  on  their  ability  to  undertake 
EMA activities, whilst implementation of options 2 and 3 would have a negative impact on 
their  ability  to  undertake  such  activities.  All  five  NCAs  dealing  only  with  veterinary 
medicines believed that option 1 could bring positive impacts in comparison to the current 
framework,  whilst  they  were  opposed  to  option  2  and  3  (NB  their  responses  seemed  to 
focus only on certain aspects, and not   the fee system as a whole). 

The  HMA  (Heads  of  Medicines  Agencies  in  the  Member  States)  stated  that  there  are 
already  some  difficulties  in  meeting  demand  for  rapporteurs  and  co-rapporteurs  to  carry 
out assessment activities and any option that reduced remuneration of NCAs would worsen 
this difficulty. Comments were also made that a strict approach to costs does not reflect the 
current situation and need for resources to cope with the Covid-19 crisis as well as the ever 
increasing  workload  and  complexity  of  the  products  that  regulators  have  to  deal  with. 
However,  no  further  data  usable  by  the  study  model  was  provided.  In  addition,  the 
availability of resources in the national agencies has likely experienced an external shock, 
possibly due to the increased frequency and accelerated pace of assessment procedures for 
products  related  to  the  pandemic.  A  link  between  this  possible  structural  problem  and 
EMA remuneration has not been demonstrated. 

The  different  parties  consulted,  including  NCAs,  did  not  express  firm  positions  on  the 
design of the different fee structures proposed under the various options. The consultation 
process  above  all  revealed  a  broad  consensus  that  the  cost  of  additional  NCA  activities 
eligible for remuneration by EMA (i.e. in line with NCAs’ role under the EMA founding 

52 Four features of the cost methodology were identified by NCAs and the HMA as responsible for the fact 
that the cost-based fee options (2, 3 and 3 ‘light’) generate, in aggregate, insufficient funding for NCAs: (1) 
the cost basis from 2016 for  the financial model is out of date (this comment does not address the updates 
described in this report); (2) centralised assessments are carried out by senior and more expensive staff (this 
comment  does  not  address  the  fact  that  the  costing  during  the  evaluation  and  Management  Board  data 
gathering  (MBDG)  were  based  specifically  on  staff  who  were  dealing  with  EMA  procedures)  ;  (3)  not  all 
NCAs  activities  for  EMA  are  considered  for  remuneration  (this  comment  does  not  address,  however,  the 
eligibility criteria and the analysis made of the eligibility of additional activities for remuneration by EMA 
and presented in the consultation); (4) not all capacity-related costs are considered for remuneration (ibid). 

38 

 
 
                                                 
regulation), and therefore included in the annual fee calculation, remained underestimated 
by the interim fee grids presented for consultation53.  

The annual fee amounts and eligible costs for NCA remuneration which are part of the cost 
base of that fee were therefore recalculated (Annex 7). The approach followed to identify 
additional NCA activities eligible for remuneration by EMA and estimate their amounts is 
described  in  Annex  4  addendum  2..    Table  7  in  section  6.1  presents  the  cost  of  the 
additional activities as estimated post-consultation The output of the calculations of option 
2,  the  annual  remuneration  to  NCAs,  are  equal  to  the  amount  of  eligible  additional 
activities, since procedural fees are cost based and no procedural cost is included under the 
annual fee in that option. Options 2, 3 and 3 ‘light’ adhere to the cost-based principle and, 
therefore, they all cover the same estimated costs for EMA and for NCAs. 

Table 6 below shows for the reference year 2024 the effect of the resulting recalculation on 
the  remuneration  provided  to  NCAs  and  its  effect  on  the  overall  balancing  of  the  EMA 
budget54.  The  overall  output  between  the  various  options  remains  largely  unvaried,  with 
Do-minimum  showing  a  considerable  negative  balances  whilst  Option  2,  3  and  3  ‘light’ 
match  exactly  the  projected  expenditures  for  the  given  year,  with  the  only  difference  of 
Option 1 showing this time a slightly positive balance. 

Comparing Table 4 and Table 7, as a result of the recalculation, remuneration from annual 
fees has more than doubled in Option 2, 3 and 3 ‘light’, reaching overall annual amounts 
ranging  between  €63  and  74  million.  The  recalculated  remuneration  results  in  a 
proportional increase in total recalculated revenue from cost-based fees.  

Tables presented below correspond to the calculations post consultation 

2024 

EMA income (€'000) 

Do 
minimum 
(baseline) 

Option 1  Option 2  Option 3 

Option 3 
‘light’ 

Total industry procedural fees 

235,918 

238,246 

185,276 

148,912 

165,927 

Total industry annual fees  

141,690 

173,683 

223,751 

260,116 

243,101 

Total industry fees 

377,608 

411,929 

409,027 

409,027 

409,027 

Total EU budget contribution  

34,000 

34,000 

34,000 

34,000 

34,000 

Total EMA income 

411,608 

445,929 

443,027 

443,027 

443,027 

53 See Annex 4 for more information on criteria for eligibility of additional activities of NCAs and how they were applied 
with the bottom-up approach used for the consultations, as well as the updated approach applied after the consultation. 
54  Some  other  minor  changes  in  the  figures  unrelated  to  this  adjustment  can  be  observed following  further 
refinements and corrections of the model and calculations. 

39 

 
 
 
 
  
  
  
  
  
  
  
  
  
  
 
 
 
 
                                                 
EMA expenditure (€'000) 

Total  expenditure  on  human  and 
veterinary procedures  

113,436 

113,436 

113,218 

113,218 

113,218 

Total expenditure on other activities 

162,141 

162,141 

162,141 

162,141 

162,141 

Total remuneration to NCAs (*) 

167,669 

167,669 

167,669 

167,669 

167,669 

Tot EMA expenditure 

443,246 

443,246 

443,027 

443,027 

443,027 

Variance (€'000) 

Table 6 

-31,637 

2,684 

0 

0 

0 

The two main factors behind the negative financial balance of the ‘do minimum’ baseline 
scenario  presented  in  Table  6  above  are  the  introduction  of  the  VMP  Regulation,  which 
accounts  for  roughly  50%  of  the  €31.6million  deficit,  and  the  introduction  of  DARWIN 
EU,  which  accounts  for  the  other  50%.  The  shortfall  linked  to  the  VMP  Regulation  is 
mainly  due  to  new  pharmacovigilance  activities  introduced  by  this  Regulation  which 
cannot be covered by new annual fees under the current system. The second factor, i.e. the 
cost of the operational phase of DARWIN EU [16 € million as per estimated costs] would 
need  to  be  financed  through  annual  fees  which  cannot  be  introduced  under  the  current 
system. These elements challenge the viability of the ‘do-minimum’ baseline scenario. 

2024 

Do 
minimum 

€'000  

Option 1   Option 2  Option 3  

Option 3 
‘light’  

Total remuneration to NCAs (*) 
Remuneration 
activities  
Remuneration from annual fees  

from 

procedural 

126,562 

128,271 

108,394 

92,864 

104,215 

41,107 

39,398 

59,274 

74,805 

63,454 

Tot NCA remuneration 

167,669 

167,669 

167,669 

167,669 

167,669 

Table 7 

Also  the  effect  on  the  balance  of  the  EMA  budget  over  the  study  years  has  not  changed 
following  the  recalculation,  with  a  positive  balance  for  majority  of  the  options  (varying 
from €2.3 million to €8.5 million in excess) this time including also Option 1. 

Budget balancing p/year 

  €'000 

2022 

2023 

2024 

2025 

2026 

Do-min 

Option 1 

Option 2 

Option 3 
Option 3 ‘light’ 
Table 8 

-7,363 

-9,364 

-31,637 

-32,681 

-33,401 

8,539 

5,402 

4,353 

4,690 

7,687 

4,949 

8,233 

4,576 

2,684 

0 

0 

0 

3,729 

2,348 

2,649 

2,759 

5,113 

4,836 

5,322 

5,756 

40 

 
 
  
  
  
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
In  the  analysis  that  follows,  the  level  of  performance  of  the  options  is  assessed  using 
indicators which are graded as Low/Medium/High, where higher means better. It has to be 
recalled that all options but option 1 are designed to cover overall the estimated costs. The 
assessment  is  based  on  indicators  that  may  be  either  qualitative  (e.g.  whether  a  balance 
between  a  simple  fee  system  and  a  cost-based  system  is  achieved)  or  quantitative  (e.g. 
whether  aggregate  costs  are  covered,  whether  individual  fee  and  remuneration  levels  are 
aligned  with  respective  cost  assessment)  elements.  Performance  levels  are  then  assigned 
based  on  a  comparison  between  the  options,  as  far  as  such  comparison  is  possible.  For 
example  options  2,  3  and  3  ‘light’  are  all  deliberately  designed  to  cover  the  aggregate 
costs, therefore the objective is considered fully achieved by all, and their performance is 
graded  in  each  case  as  High.  Option  1  does  not  achieve  the  objective  (a  deficit  is 
calculated), its performance is therefore ranked as Low. 

When the objective is considered to be achieved only to a certain extent by a given option, 
–  neither  complete  failure,  nor  complete  or  sufficient  success,  the  performance  of  the 
option in question is assessed as “Medium”. 

Overall, all options 2, 3 and 3 ‘light’ being designed to cover all costs, they are assessed at 
the  maximum  (High)  on  this  indicator,  while  option  1  is  simply  not  cost-based,  and  so 
scores the lowest possible (Low). 

Indicator  1  :  fee  system  covers  relative 
aggregate costs 

Option 1 

Option 2 

Option 3 

Option 3 
‘light’ 

Low 

High 

High 

High 

1.12.1. 6.1.1. 

Alignment of fees with underlying costs 

Cost-reflectivity of fees and remuneration reflects the will of the co-legislator expressed in 
the legal texts55.   

Moving  to  a  cost-based  system,  by  design  the  options  align  the  level  of  fees  and  the 
remuneration  amounts  with  the  underlying  costs.  Tables  6,  7,  8  in  the  previous  sections 
already showed how overall income from fees allows, when combined with the EU budget 
contribution,  to  cover  total  EMA  expenditure,  including  NCA  remuneration.    On  a  more 
granular  level,  cost-reflectivity  means  better  alignment  of  the  individual  fee  and 
remuneration levels to their respective cost base. 

Option 2 is scored high on the indicator of cost-reflectivity, given that by design this option 
sets cost-based fees to a very detailed level of granularity (as per current system). Option 1, 
on the other hand, is scored the lowest because only veterinary medicine fees/remuneration 
are  cost-based  in  that  option.  Option  3  ‘light’  has  slightly  less  granular  cost-reflectivity 
than Option 2 but because only some minor post-authorisation activities are included in the 

55  Regulation  297/95,  Article  12:  “Any  review  of  the  fees  shall  be based on an  evaluation  of  the  Agency’s 
costs and on the basis of the related costs of the services provided for by the Member States. “ 
Regulation 658/2014, recital 7:  “Any future revisions of the pharmacovigilance fees or other fees levied by 
the Agency should be based on a transparent and independent evaluation of the costs of the Agency and the 
costs of the tasks carried out by the national competent authorities.” 

41 

 
 
 
 
 
                                                 
flat annual fee, the performance is overall the same. Option 3 is considerably less granular 
than  Option  3  ‘light’,  as  in  this  case  the  vast  majority  of  post-authorisation  activities  are 
included  in  the  flat  annual  fee.  Therefore,  Option  3  is  scored  Medium  on  the  cost-
reflectivity indicator. 

Option 1 

Option 2  

Option 3  

Option 3 
‘light’ 

Low 

High 

Medium 

High 

Indicator  2:  Alignment  of  fees  with 
costs of individual activities 

Effect of the horizontal measures 

When  the  horizontal  measures  for  different  combinations  of  general  reductions  and 
specific  incentives  for  veterinary  medicines  are  considered,  as  the  magnitude  of  the 
reductions/incentives  increases,  there  is  a  decrease  in  the  cost-based  approach  of  the 
resulting net fees paid. 

With fees being set at the same level regardless of the NCA in charge of the assessments, 
use of country coefficients would have no effect on fees paid by payers, not affecting the 
cost-based approach from their perspective. On the other hand, they would have an effect 
on the balance of the EMA budget as, whilst they would bring NCAs remunerations closer 
to  the  underlying  costs,  it  would  cause  variations  in  EMA  income  according  to  which 
NCAs would take on the assessment activities. 

Similarly to the application of a country coefficient, the distribution of the loss of revenue 
from  the application of fee incentives between EMA and NCAs (or incurred, as now, by 
the EMA budget only, with the exception of fees for pharmacovigilance) would not affect 
the (net-of-incentives) fees paid by payers, and hence does not impact the cost base of the 
fees. Nonetheless, if NCAs were required to share the cost of incentives this would reduce 
NCAs’  remuneration  below  the  level  of  the  costs  the  NCAs  incur  to  undertake  EMA 
activities. There is no mechanism for making good that NCA financial shortfall within the 
EMA fees system, though it could potentially be cross-subsidised from the national budget. 
By  legislation,  EMA  has  recourse  to  an  EU  budget  contribution,  set  by  the  European 
Parliament and the Council (‘the budgetary authority’) based on an evaluation of needs and 
taking account of the level of fees set.  

1.12.2. 6.1.2. 

Alignment  of  NCAs  remuneration  with  costs  incurred  to 

undertake EMA activities 

As  was  demonstrated  in  the  evaluation  of  the  EMA  fees  and  remuneration  system,  the 
current  fee  and  remuneration  system  leaves  many  differences  between  the  costs  incurred 
by NCAs when undertaking work on the individual procedures and the remuneration they 
receive for it from EMA56. On the aggregate level of the system, NCA procedural costs are 
fully covered, while the declared non-analysed cost of additional activities was covered at 

56 Commission Staff Working Document – Evaluation of the European Medicines Agency’s fee system page 
53 figure 7 and figure 8. 

42 

 
 
 
 
 
 
                                                 
ca.  €27.5  million  which  required  further  analysis  of  whether  and  to  what  extent  such 
activities are compatible with a remuneration from EMA57. 

These  differences  in  procedural  remuneration  are  positive  in  some  cases,  negative  in 
others, when analysed type of procedure per type of procedure. Moving to cost-based fees 
and remuneration should reduce or remove those differences, by design. Option 1 matches 
NCA costs and remuneration very poorly and is given a low level of performance; Option 
2  matches  costs  and  remuneration  very  closely  and  is  therefore  scored  ‘high’;  Options  3 
‘light’ and 3 receive different scores (3 ‘light’ performs better than 3), reflecting the fact 
that  the  loss  of  granularity  relative  to  Option  2  is  significant  in  Option  3  and  the 
consequent scope for overall costs and remuneration for any individual NCA in any year to 
differ either negatively or positively58 is higher in Option 3 then in Option 3 ‘light’, while 
the  difference  generated  by  3  ‘light’  is  not  considered  significant  enough  to  trigger  a 
different performance level than Option 2. NCAs who considered that option 3 negatively 
impacts  financial  predictability  for  their  organisations  (15  NCAs  quoted  below  in  the 
indicator  on  predictability)  cited  the  potential  risk  of  increased  workload  (that  is  of 
procedures  included  under  the  annual  fee)  not  being  appropriately  remunerated,  thereby 
having  negative  consequences.  It  follows  also  from  this  argument  that  option  3  ‘light’ 
scores better in that respect as compared to option 3.  

Option 1 

Option 2 

Option 3  

Option 3 
‘light’  

Low 

High 

Medium 

High 

Indicator  3:  Alignment  of  NCA 
remuneration with NCA costs for EMA 
activities 

Effect of the horizontal measures 

If the cost  of the veterinary incentives (general  fee  reduction /  general  fee reduction  and 
specific  incentives  /  specific  incentives  only)  is  not  shared  with  NCAs,  there  will  be  no 
effect on the gap between NCA costs and NCA remuneration for EMA activities. 

Sharing  the  cost  of  incentives  with  NCAs  would  reduce  NCA  remuneration,  for  those 
activities where incentives apply. This horizontal measure consequently performs less well 
on this indicator than if the cost of incentives is not shared. 

The  application  of  country  coefficients  would,  by  design,  bring  NCA  costs  and 
remuneration  closer  together.  However,  country  coefficients  would  add  significant 
administrative  burden  and  the  effect  of  such  measure  is  considered  outweighed  by  the 
methodological approach to calculate NCA costs based on a weighted average.   

57 The approach to non-procedural activities of NCAs is discussed in detail in section 6.1 Public authorities 
and budgets (including governance and good administration) 
58  Such  difference  is  due  to  the  difference  in  the  estimated  average  frequency  of  occurrence  of  procedures 
included in the costing of the annual fee under options 3 and 3 ‘light’ and the real-life frequency observed 
year after year. 

43 

 
 
 
 
 
 
                                                 
1.12.3. 6.1.3. 

Fee system capacity to adjust to cost changes 

The  capacity  of  the  fee  system  to  adjust  to  cost  changes  is  linked  to  how  fees  and 
remuneration  amounts  can  be  adjusted  (i.e.  which  procedure  is  used  to  introduce  the 
adjustments). The current EMA fee legislation permits updating of fees in line with general 
inflation via delegated act. Beyond inflation, the principle is that fee amounts can only be 
adjusted  via  full  ordinary  legislative  procedure  (co-decision  of  the  European  Parliament 
and  the  Council).  Remuneration  amounts  are  currently  established  by  the  EMA 
management board in  relation to fees under regulation 297/95 and by the co-legislator in 
relation to fees under regulation 685/201459.  

In line with the approach followed in the most recent update of the EMA fee legislation, 
i.e.  regulation  658/2014,  both  fee  amounts  and  fee-related  remuneration  amounts  will  be 
established in  the revised legislation proposed here.60 Updating of  fees and remuneration 
based  on  inflation  is  maintained  as  a  horizontal  feature  of  the  system  in  all  options  and 
independent  of  any  horizontal  measures  applied.  The  contemplated  mechanism  is  a 
delegation of powers to the Commission (delegated acts) to adjust the amounts, based on  
the  outputs  of  a  monitoring  system  that  will  be  introduced  by  the  proposed  legislation. 
Further,  a  monitoring  system  would  be  needed  whichever  policy  option  was 
implemented61. Cost changes can be more precisely monitored in a more granular, thus less 
simple, system than in a system which relies to a greater extent on annual fees, but the cost 
and difficulty of monitoring would not vary significantly by option. However, considering 
that major procedures  attract  a separate fee under option 3  ‘light’ and  assuming that this 
increases  the  capacity  of the system to  adjust to  significant  changes in  the costs of these 
specific  procedures  compared  to  Option  3  (while  also  being  simpler  than  the  structure 
retained under options 1 and 2) option 3 ‘light’ performs Medium, i.e. higher than Option 3 
(Low)  and  lower  than  options  1  and  2  (High).  On  this  reasoning,  the  performance  of 
Option 1 is assessed as on par with that of Option 2, because this indicator is indifferent to 
the fact that the principle of non-cost-based fees is maintained under Option 1 for human 
fees, focusing instead exclusively on the effect of the fee structure (which is the same in 
these two options) on future adjustments.  

Option 1 

Option 2 

Option 3  

Option 3 
‘light’ 

High 

High 

Low 

Medium 

Indicator  4:  Capacity  of  fee  system  to 
adjust to cost changes 

Effect of horizontal measures 

59  Regulation  658/2014  foresees  some  level  of  monitoring  of  underlying  cost  data.  However,  any  update 
based  on  that  monitoring  requires  co-decision  procedure.  Such  data  was  used  in  the  EMA  Management 
Board Data Gathering (MBDG) as regards human pharmacovigilance procedures.  

61 Further reflection on a possible future monitoring system to indicate whether other changes to fees and/or 
remuneration would be appropriate in future is presented in Section 8. 

44 

 
 
 
 
 
                                                 
 
The  capacity  of  the  fee  system  to  adjust  to  cost  changes  is  independent  of  how  the 
individual fees  are initially calculated, the  incentives applied to  the fees  whether  country 
coefficients are used to determine NCA remuneration, and whether the cost of incentives is 
shared with NCAs. 

1.12.4. 6.1.4. 
system 

Balance  between  a  simple  fee  system  and  a  cost-based 

This indicator is based on the ability of the option to achieve a balanced approach between 
two  contradictory  objectives,  i.e.  a  simpler  fee  system,  and  a  fee  system  that  is  better 
aligned  to  underlying  costs.  The  first  objective  requires  fewer  fee  levels  (the  extreme 
scenario  being  one  flat  fee  and  no  procedural  fees),  while  the  latter  implies  maximum 
granularity,  i.e.  calculating  as  many  fee  and  remuneration  levels  as  there  are  procedures 
and  levels  of  complexity  (the  extreme  scenario  being  charging  fees  and  paying 
remuneration  based  on  individual  invoicing  for  each  individual  procedure).  Feedback 
received, in particular from NCAs and fee payers, points to the need to achieve a balance 
between  these  objectives,  as  respondents  seem  to  lean  towards  more  or  less  granularity 
depending  on  their  position  and  vision,  without  an  indication  that  one  should  be  given 
more  weight  than  the  other.  For  example,  fifteen  NCAs  considered  Option  3  would 
negatively impact financial predictability, because it is not granular enough, and therefore 
not  sufficiently  cost-based,  while  eleven  and  seven  NCAs  respectively  considered  the 
impact  of  Option  3  to  be  positive  or  remain  the  same,  logically  leaning  more  towards  a 
simpler,  less  granular  fee  system.  This  indicates  that  options  should  also  be  assessed 
against an indicator of achieving a system that is balanced in that respect. The maximum 
performance  level  is  attributed  to  3  ‘light’  as,  compared  to  other  options,  it  achieves 
balance by bringing some level of simplification through including some procedures in the 
scope  of  the  annual  fee,  while  catering  for  concerns  expressed  that  potential  increased 
workload  for  some  procedures  could  not  be  captured,  by  leaving  for  example  major 
variations outside the scope of the annual fee, as compared to option 3. Applying the same 
reasoning, option 3 performs less well (Medium) than 3 ‘light’ (High) and option 2 scores 
less  (Low)  than  option  3  (Medium)  because,  although  it  is  more  granular  and,  therefore, 
more  reflective  of  the  cost-based  approach,  it  does  not  offer  any  simplification  and, 
therefore,  it  does  not  introduce  a  balanced  approach  between  a  simplified  system  and  a 
cost-based  system,  which  is  tracked  by  this  indicator.  Option  1  has  the  same  score  as 
option 2 (Low), as they both have the same fee system structure. 

5: 

Indicator 
between 
simplification  and  granular  cost-based 
approach 

Balance 

Option 1 

Option 2 

Option 3 

Option 3 
‘light’ 

Low 

Low 

Medium 

High 

1.12.5. 6.1.5. 

Fee  system  capacity  to  adjust  to  ensure  financing  of 

incentives 

Under  the  current  fees  and  remuneration  system,  the  cost  of  incentives  is,  in  the  first 
instance,  borne  by  the  EMA  budget  (with  the  notable  exception  of  incentivised  fees  for 
pharmacovigilance).  The  EU  budget  contribution  amounts,  pre-determined  in  the  Multi 

45 

 
 
 
 
 
Annual  Financial  Framework  of  the  Union,  provides  a  possible  mechanism  for  ensuring 
EMA is funded sufficiently to bear the cost of incentives. This principle is laid down in the 
basic regulation 726/2004 and has therefore been assumed in this study and is retained in 
all options and independent of any horizontal measures that may be applied. Consequently, 
the capacity of the fee system to adjust to ensure financing of incentives is the same in all 
options and horizontal measures.  

Indicator  6:  Fee  system  capacity  to 
adjust to ensure financing of incentives 

Option 1 

Option 2  

Option 3  

Option 3 
‘light’ 

Medium 

Medium 

Medium 

Medium 

1.12.6. 6.1.6. 

Adaptability  of  fee  system  to  ensure  EMA  can  effectively 
respond  to  exceptional  circumstances  related  to  public  health  and 
animal health 

This indicator measures the adaptability of the fee framework during times of crisis. EMA, 
HMA  and  NCA  responses  to  the  survey  highlighted  the  importance  of  a  mechanism 
through  which  it  would  be  possible  to  make  rapid  changes  to  the  EMA  fees  system  in 
exceptional circumstances62. Such a response mechanism would  be a horizontal aspect and 
its precise nature would depend on the legal instrument used for the new regulation and the 
level of delegation of powers to the Commission and to the Agency (Management Board or 
Executive Director) that was possible under it. Therefore, there is no difference in how this 
indicator performs under the options and horizontal measures assessed here. 

Indicator 7: Adaptability to exceptional 
circumstances 

Option  1 

Option 2 

Option 3 

Option 3 
‘light’ 

Medium 

Medium 

Medium 

Medium 

1.12.7. 6.1.7. 

Predictability 

1.12.7.1.    

Predictability of EMA income 

Predictability for EMA translates as the ability of the Agency to rely over the medium to 
longer  term  on  stable  and  predictable  types  of  fees  income  (i.e.  annual  fees)  that  are  not 
subject to fluctuations depending on external conditions (as is the case for procedural fees). 
The  current  fee  system  charges  the  majority  of  fees  in  the  post-authorisation  phase, 
particularly through the charging of an annual maintenance fee, which provides EMA with 

62 Such changes  were  made  for example during the COVID-19 pandemic,  with the introduction of  upfront 
remuneration for rolling review  and additional remuneration to NCAs  to facilitate regulatory processes for 
medicines  which  had  the  potential  to  treat,  prevent  or  diagnose  COVID-19.  The  new  Regulation  123/2022 
which reinforces the role of the EMA in preparation for and response to public health emergencies, provides 
for  the  remuneration  of  rapporteurs  from  NCAs  for  assessment  activities,  in  accordance  with  financial 
arrangements established by the EMA Management Board. 

46 

 
 
 
 
 
 
 
 
                                                 
a more solid and stable platform for planning its activities. EMA considered that Option 1, 
even if it does not balance the EMA budget, would not fundamentally change this situation 
from  the ‘do minimum’  baseline in  terms  of predictability, as  only  veterinary sector fees 
would be revised, and there would be no change in the granularity of fee levels. 

For options 2, EMA considered that outcome would be less predictable than ‘do minimum‘ 
baseline  or  Option  1,  because  the  proportion  of  revenue  from  procedures  (such  as  initial 
marketing  authorisation  and  inspection  fees)  which  are  inherently  less  predictable  would 
increase. 

Indicator  8a:  predictability  of  revenue 
for EMA 

Option 1 

Option 2  

Option 3 

Option 3 
‘light’ 

Low 

Low 

High 

Medium 

1.12.7.2.   

Predictability of NCA remuneration 

As for EMA, predictability for NCAs also translates as the ability to rely on remuneration 
from  more  stable  and  predictable  fee  types  (i.e.  annual  fees),  that  are  less  subject  to 
fluctuations, to fund their EMA-related activities in the medium and longer term.  

As  reported  in  Annex  2,  the  survey  and  stakeholder  interviews  sought  feedback  on  the 
impacts of the options on the NCA’s financial predictability.  

Table  7  in  section  6.1  shows  the  distribution  of  remuneration  between  procedural  and 
annual fees across the options at the time of the consultations. 

Twelve  NCAs  responding  to  the  survey  reported  that,  compared  to  the  ‘do  minimum’ 
baseline,  Option  1  would  have  either  no  impact  or  a  positive  impact  on  the  financial 
predictability  of  their  organisations.  Other  NCA  reported  a  negative  impact  on 
predictability under this option, referring to the difficulty of predicting how the changes to 
the veterinary fees due to the VMP Regulation would impact NCA remuneration, and how 
companies  will  approach  the  new  authorisations  regime  created  by  that  regulation63 
(however, these comment relate to the predictability of the underlying VMP regulation, not 
to predictability related to the structure of the fee system under the options). Options 2 and 
3  were  considered  likely  to  have  a  negative  impact  on  financial  predictability  for  their 
organisations  by,  respectively,  ten  and  fifteen  NCAs,  with  eleven  and  seven  NCAs 
respectively considering the impact to be positive or remain the same. Veterinary industry 
representatives  focused  their  feedback  rather  on  fee  incentives,  thus  leaving  the  actual 
question on predictability of the different fee structures under the options unanswered.  

63 E.g. a larger scope of the centralised authorisation procedure for veterinary medicinal products. However, 
this argument does not relate to the predictability of the fee system per se. 

47 

 
 
 
 
 
                                                 
Increased  revenue  from  annual  fees  considerably  increases  predictability  for  NCAs  and 
EMA,  as  it  is  less  dependent  on  the  fluctuating  flow  of  procedures64.  In  the  evaluation 
phase, a possible option of funding EMA fully on annual fees and NCAs retaining 100% of 
procedural  fees  was  discarded  because  it  was  considered  that  NCAs  required  more 
predictability,  which  can  be  provided  by  the  annual  fee.  This  was  confirmed  by  the 
consultation feedback, where annual fee revenue emerged as a stabilising factor for NCA 
contributions. For this reason, option 3 performs the best on this indicator, while 3 ‘light’ 
performs  lower  (Medium)  relative  to  3  but  higher  than  2  and  1  (Low),  as  the  latter  are 
comparatively more dependent on procedural fee revenue.  

Indicator 8b: Predictability for NCAs 

Low 

Low 

High 

Option 1 

Option 2 

Option 3 

Option 3 
‘light’ 

Medium 

Effect of horizontal measures 

The  horizontal  measures  for  veterinary  medicine  fees  present  different  combinations  of 
general reductions or/and specific incentives to respond to the concerns highlighted above. 
However,  none  of  them  were  highlighted  in  the  stakeholder  feedback  as  contributing  to 
predictability. 

Application of country coefficients to NCA remuneration would add some unpredictability 
from year to year to the aggregate remuneration of NCAs by EMA – and hence the cost to 
EMA of remunerating NCAs. This is because remuneration would vary not only according 
to  the  EMA  activities  done  by  NCAs  but  also  by  reference  to  variations  in  the  cost  of 
living  index  underlying  the  coefficient,  and  to  associated  factors  (e.g.  exchange  rate 
variability for Member States that are not part of the Eurozone). 

In the case of cost of fee incentives being shared between EMA and the NCA, this would 
reduce the amount remunerated to those NCAs, relative to their costs, for activities where 
incentives apply. This would negatively impact financial predictability65, in particular for 
those  NCAs  undertaking  less  intensive  EMA  work,  because  the  amount  remunerated 
would not only vary according to the work completed but it would also  be dependent on 
whether the fee payer was entitled to incentives. In addition, sharing the cost of incentives 
would  imply  that  NCAs  would  have  to  fund  any  shortfall  through  national  budgets. 
Therefore, this would have an impact on the overall budget of those NCAs.  

While sharing of the incentives with EMA would have a positive impact on the Agency’s 
budget, EMA noted, in their feedback, that should such distribution result in lack of proper 
financing of the NCAs activities, then this measure would be very detrimental to the NCA 

64 Fee structures relying  more  on annual  fees exist in  national  fee  systems, for example in  Austria and the 
Netherlands.  
65 Financial predictability: for NCAs it concerns visibility of annual revenues from EMA remuneration; for 
payers, it concerns visibility of annual expenditure of EMA fees. 

48 

 
 
 
 
 
                                                 
remuneration and thus for the Agency and the operation of the regulatory network in their 
turn. 

This measure would not impact payers as the amount of the incentives remains unchanged.  

Sharing  the  cost  of  incentives  with  NCAs  would  thus  reduce  financial  predictability  for 
NCAs, particularly those NCAs undertaking modest amounts of EMA work, because the 
amount they would be remunerated would vary not only according to the work they did but 
also to whether the ultimate payer for that work was entitled to incentives. 

1.12.7.3.   

Predictability for payers of their payments to EMA  

The ability of payers to predict fees payable to EMA is effectively determined by how easy 
payers  find  it  to  forecast  the  frequency  of  fees  charged  and  understand  the  range  of 
different fees associated with regulatory procedures, in order to estimate their annual costs 
for EMA fees. The current fees are published on the EMA website and this should be the 
case in future. However, the current fee system contains a very large number of fees and 
incentives.  Some  payers,  particularly  companies  and  enterprises  that  have  SME  status 
assigned  by  EMA,  and  who  interact  with  EMA  less  frequently,  can  access  additional 
support to help them understand the amounts they will pay66.  

While  EFPIA  and  Medicines  for  Europe  considered  that  Option  3  allowed  the  best 
predictability compared to Options 1 and 2, EFPIA specifically identified Option 3 ‘light’ 
as  having  the  best  predictability,  while  providing  an  equitable  fee  structure  that 
significantly reduces the administrative fee-processing burden. Options 1 and 2 perform as 
‘Low’  as  they  are  at  the  same  level  of  predictability  as  the  current  fee  system,  i.e.  a 
granular  approach  reliant  on  fluctuating  procedural  fees,  without  any  simplification  that 
would not shift the system towards greater reliance on annual fees, which are more stable. 
Options  3  and  3  ‘light’  will  create  a  simpler  and  more  predictable  fee  structure  than 
Options  1  and  2,  with  Option  3  performing  the  highest,  as  major  post-authorisation 
procedures no longer give rise to a fee, while 3 ‘light’ performs as Medium to reflect its 
relatively higher reliance on less predictable procedural fee revenue than option 3. 

Indicator 8c: predictability for payers 

Low 

Low 

High 

Option 1 

Option 2  

Option 3 

Option 3 
‘light’  
Medium 

The  horizontal  measures  for  general  reductions  and/or  specific  incentives  applied  to 
veterinary medicine fees have no impact on comprehension and predictability for payers. 
The  measures  to  introduce  country  coefficients  and  incentive  sharing  both  concern 
remuneration of NCAs and do not affect the fees faced by payers, so there is no difference 
between the horizontal measures for this indicator. 

66 EMA SME office: https://www.ema.europa.eu/en/human-regulatory/overview/support-smes 

49 

 
 
 
 
 
                                                 
 Administrative burden  

1.13.1. 6.2.1. 

 Administrative burden on EMA and NCAs  

EMA  indicated  that  simplification  through  a  reduced  number  of  different  fees  in  the  fee 
grid,  in  particular  fewer  levels  of  procedural  fees  for  scientific  advice,  initial  marketing 
authorisation,  scientific  services,  and  inspections,  would  be  the  most  effective  way  to 
reduce their administrative burden. Option 3 therefore performs best on this indicator for 
EMA, as it has the fewest number of fees in the associated fee grid. As compared to the ‘do 
minimum’  baseline,  Option  3  ‘light’  performs  better  than  Options  1  and  2,  but  is  not  as 
effective as Option 3 in this regard.  

While  NCAs  do  not  operate  the  fee  system  and  thus  are  only  marginally  affected  by  the 
administrative  costs  of  running  or  using  the  fee  system,  two  of  the  seven  NCAs 
interviewed  indicated  a  slight  preference  for  reducing  the  number  of  different  fees, 
although  they  did  not  consider  it  a  significant  concern.  Responses  from  HMA  and  one 
individual NCA indicated that administrative burden was not a problem in the fee system. 
Nor  did  the  other  NCAs  interviewed  identify  any  differences  between  the  options  in 
respect  of  administrative  burden.  Therefore  it  is  considered  that  for  NCAs  the  options 
perform against this indicator as they do for EMA.  

Thus,  for  this  indicator,  Options  1  and  2  are  both  scored  at  Low  because  they  imply  no 
difference  from  the  ‘do  minimum’  baseline  in  the  administrative  burden  they  place  on 
EMA and the NCAs. Option 3 is scored High as the least burdensome option and Option 3 
‘light’, being slightly less good than 3, at Medium. 

Indicator  9a:  Reducing  administrative 
burden on EMA and NCAs 

Option 1 

Option 2 

Option 3  

Option 3 
‘light’  

Low 

Low 

High 

Medium 

With respect to horizontal measures, if EMA shared the cost of incentives with NCAs this 
would slightly increase the administrative burden on EMA and NCAs, compared to the ‘do 
minimum’ baseline. 

Specific incentives  for veterinary medicines would  also  be slightly more  burdensome for 
EMA than general fee reductions, compared to ‘do minimum’ baseline. 

Applying  country  coefficients  when  determining  NCA  remuneration  would  also  slightly 
add to the administrative burden on EMA, compared to ‘do minimum’ baseline. 

1.13.2. 6.2.2. 

Administrative burden on fee payers 

The administrative burden on payers is not significantly different between Options 1 and 2 
because the structure of the fee system and the number of fees payable remains largely the 
same.  Organisations  representing  fee  payers  that  responded  to  the  survey,  including 
representatives of the European biotech and SME sectors, did not differentiate significantly 
between  Options  1  and  2  in  terms  of  their  administrative  burden  and  associated  costs  to 
deal with the EMA fee system.  

50 

 
 
 
 
 
 
Fewer  levels  of  fees  mean  that  Options  3  ‘light’  and  3  are  increasingly  simplified  as 
compared to Options 2, 1 and ‘do minimum’ baseline. Therefore, Options 3 ‘light’ and 3 
perform  better  on  this  indicator.  In  their  response  to  the  survey  and  in  a  post-survey 
interview, EFPIA identified Option 3 ‘light’ as performing better in terms of administrative 
burden. 

Options  1  and  2  both  perform  ‘Low’  because  they  imply  no  change  in  administrative 
burden  relative  to  the  ‘do  minimum’  baseline.  Options  3  ‘light’  and  3  are  scored  better, 
with option 3 considered to perform better relatively to 3 ‘light’ due to a lower number if 
unitary fees to process.  

Indicator  9b:  Reducing  administrative 
burden on fee payers 

Option 1 

Option 2  

Option 3 

Option 3 
‘light’ 

Low 

Low 

High 

Medium 

Applying  specific  incentives  to  veterinary  medicine  fees  implies  a  slightly  greater 
complexity and consequently slight increase in administrative burden for payers compared 
to applying general fee reductions across all veterinary medicine fees. 

Whether  country  coefficients  are  applied  when  determining  NCA  remuneration,  and 
whether NCAs share the cost of incentives does not affect the administrative processes of 
payers. 

1.13.3. 6.2.3. 

Administrative burden for SMEs relative to other payers 

SME payers are not negatively affected by the administrative burden of different options, 
when compared to other payers. Representatives of SME payers responding to the survey 
did not indicate that the administrative burden was higher for any option relative to that on 
other payers.  

Indicator  9c:  Relative  administrative 
burden  on  SMEs  compared  to  other 
payers 

Option 1 

Option 2  

Option 3 

Option 3 
‘light’ 

Medium 

Medium 

Medium 

Medium 

The administrative burden would not differ significantly under the horizontal measures for 
veterinary  medicine  general  fee  reductions  and/or  specific  incentives.  On  the  contrary, 
SMEs  can  avail  of  support  from  the  EMA’s  SME  office,  including  through  free  briefing 
meetings  that  are  not  available  to  other  payers67.  This  support  provides  a  platform  for 
SMEs  to  discuss  their  planned  regulatory  strategy,  thereby  supporting  the  administrative 
process and clarifying the available fee reductions or payment deferrals.  

67 Support to SMEs | European Medicines Agency (europa.eu) 

51 

 
 
 
 
 
 
 
 
 
 
                                                 
In addition, the horizontal measures concerning country coefficients and sharing the cost of 
incentives with NCAs do not affect the fees paid and so do not impact on this indicator. 

 Position of SMEs 

SMEs and microenterprises (hereafter ‘SMEs’) are eligible for fee incentives from EMA, 
namely fee reductions, exemptions and/or deferrals, as applicable, under Articles 5 to 9 of 
Regulation (EC) No 2049/2005, specific SME provisions in Regulation 658/2014 and other 
ad-hoc reduction introduced via implementing rules.68  

Incentive  rates  for  SMEs  as  laid  out  in  the  above  provisions  are  either  40%  or  90% 
depending on the type of activities (the former mainly for post-authorisation activities, the 
latter for pre-authorisation). For microenterprises on the other hand fees are always 100% 
waived. Incentives for SMEs and micro enterprises are retained in all of the policy options. 

The  EMA’s  website  notes  that  “SMEs  developed  nearly  20%  of  all  human  medicines 
recommended for authorisation in 2020”.69 Other EMA data shows that 16% of marketing 
authorisation  holders  (MAHs)  paying  annual  fees  to  EMA  in  that  same  year  were  SMEs 
and that 25% of requests to EMA for scientific advice were from SMEs.70  

The impact  on SMEs  of setting  fees on  a  cost-based principle would depend  on whether 
the fees for the activities they could apply were higher or lower than in the current system.  

Table 9 shows the effect the new cost-based fees amount would have on SMEs under each 
option for the reference year 2024 based on applicable fee incentive rates for SMEs. 

2024 

Do 
minimum 

€'000  

Option 1  Option 2  Option 3 

Option 3 
‘light’  

Tot payment by SMEs p/y 
Human medicines 
Veterinary medicines 
Inspections, Parallel Dist., 
Certificates 

9,600 
308 

54 

9,600 
1,300 

54 

13,100 
1,000 

13,500 
1,200 

13,200 
1,100 

90 

90 

90 

Tot SMEs payment 

9,962 

10,954 

14,190 

14,790 

14,390 

Table 9 

The financial modelling confirms that by calculating fees on a cost-based principle, there is 
an increase in fees expected to be paid annually by SMEs compared to the ‘do minimum’ 
baseline scenario, ranging  from  roughly  €1 million  more  for Option  1 (as  changes affect 
only  veterinary  medicines)  up  to  over  €4  million  more  for  Option  2,  3  and  3  ‘light’.  No 

68  These  are  listed  on  pp42/43  in:  Explanatory  note  on  general  fees  payable  to  the  European  Medicines 
Agency  EMA/341156/2021  available  at:  https://www.ema.europa.eu/en/documents/regulatory-procedural-
guideline/explanatory-note-general-fees-payable-european-medicines-agency-28-january-2022_en.pdf 
and 
on  page  8  in:  Explanatory  note  on  pharmacovigilance  fees  payable  to  the  European  Medicines  Agency 
available 
https://www.ema.europa.eu/en/documents/other/explanatory-note-pharmacovigilance-fees-
payable-european-medicines-agency-1-november-2020_en.pdf 
69 https://www.ema.europa.eu/en/human-regulatory/overview/support-smes  
70 EMA Annual Activity Report 2020  

at: 

52 

 
 
 
 
  
  
  
  
  
                                                 
responses  were  received  specifically  from  SMEs  as  part  of  the  stakeholder  consultations 
based on the fee amounts presented.  

Option 1 imposes comparatively less of a financial burden on SMEs than Options 2, 3 and 
3  ‘light’;  however,  considering  further  flexibility  that  can  be  provided  within  the  fee 
system (additional ad-hoc reductions, as granted currently by the implementing rules of the 
EMA  fee  regulation)  under  any  option,  in  order  to  comply  with  horizontal  policies  to 
support  SMEs,  performance  in  that  respect  is  assessed  as  Medium  across  all  options,  to 
reflect that further reductions may be granted in this particular case than those calculated in 
the cost-based model. This is related to the transposition in the future fee legislation of the 
current provisions contained in the main fee regulation to the effect that:  

- without prejudice to more specific provisions of Union law, in exceptional circumstances 
and for imperative reasons of public or animal health, fee reductions may be granted on a 
case by case basis by the Agency’s Executive Director, stating the reasons on which it is 
based.  

- total or partial exemption from payment of the fees laid down in the regulation may be 
granted through the  rules for implementation  of  the regulation.  Consistency of the future 
criteria  for  granting  additional  reductions  with  the  specific  provisions  for  EMA  fee 
reductions for SMEs laid down in the EMA SME regulation (Commission Regulation (EC) 
No 2049/2005) should be ensured. In addition, it will be possible to use the experience thus 
gained in order to review, at a further stage, Commission Regulation (EC) No 2049/2005. 

Compared  to  larger  producers  of  veterinary  medicines,  SMEs  are  neither  significantly 
advantaged nor significantly disadvantaged by any of the horizontal measures for general 
fee reductions and/or specific incentives for veterinary medicines, taking into account the 
applicable fee incentives71.  

Indicator 10: Position of SMEs 

Medium 

Medium 

Medium 

Option 1 

Option 2  

Option 3  

Option 3 
‘light’ 
Medium 

The horizontal measures concerning country coefficients for NCA remuneration and those 
for sharing the  cost  of incentives with  NCAs do not  affect  the fees  faced by  payers, and 
hence do not affect the payments made by SMEs relative to other payers. 

  Research and innovation 

EMA fees account  for only a very small  percentage of the total  costs of  researching  and 
developing  a  new  medicine.  While  estimates  of  the  R&D  cost  of  a  new  medicine  vary 

71 Support to SMEs will continue via the specific fee incentives in accordance with Commission Regulation 
(EC)  No  2049/2005  (the  SME  regulation)  and  the  horizontal  support  provided  by  the  EMA  SME  Office. 
SME-related  provisions  in  Regulation  658/2014  and  further  reductions  laid  down  in  the  Rules  for 
implementation of Regulation 297/95 for post-authorisation procedures are equally taken into account across 
the options for a revised fee system. 

53 

 
 
 
 
 
 
                                                 
widely,  a  recent  review  of  such  estimates  for  human  medicines  published  in  2021  found 
that the estimates range from USD72 0.16-4.54 billion.73 Another 2021 study estimates that 
R&D costs per new medicine (accounting for the cost of failures) ranged from USD 0.94 
billion-2.83  billion  (adjusted  to  2019  prices)74. With  respect  to  veterinary  medicines,  the 
global veterinary medicine market is estimated at USD 29.2 billion in 2020 and is expected 
to  expand  at  a  CAGR75  of  7.4%  from  2021  to  202876.  It  is  reported  that  Animal  health 
manufacturers invest an average of 8.5% of sales in R&D77. At 29% of global sales (2021), 
Europe is  the second largest animal  medicines market  in the world78. For  2021, the total 
European sales of the originator veterinary industry are estimated at €7.4 billion79. The EU 
animal  medicines  industry  invests  over  €500  million  in  research  and  development  every 
year80. At the same time, the market value of the European veterinary medicines industry 
remains only 3% of the human one81. 

EMA fees for an application for initial marketing authorisation are measured in hundreds 
of  thousands  of  EUR,  rather  than  hundreds  of  millions.    The  overall  effect  of  alignment 
with a cost-based approach on the fee payers will be an increase of between € 31 million 
and € 35 million, i.e. some 10%-increase (projection for 2024) as indicated under Table 6 
in  section  6.1.  This  includes  the  post-consultation  re-calculation  of  NCA  remuneration, 
which  accounts  for  ca.  85%  of  that  increase.  Changes  in  EMA  fee  levels  across  policy 
options  and  horizontal  measures  considered  in  this  impact  assessment  are  therefore 
unlikely to affect research and innovation overall82. 

Consistent with this,  and supposing the application of the revised cost-based calculations 
described in section 6.2.1, responses to the survey and interviews revealed no differences 
between  the  policy  options  or  horizontal  measures  in  their  impacts  on  the  overall 
propensity of firms to seek authorisation for human medicines (Annex 2).  

EMA, HMA and two of the six NCAs interviewed who have responsibility for veterinary 
medicines, as well as the industry in their survey responses, noted that all the options imply 

72 Yearly Average Exchange Rate for 2021: 1 USD = 0.846 EUR 
73  Schlander  et  al.  How  much  does  it  cost  to  research  and  develop  a  new  drug?  A  systematic  review  and 
assessment. PharmacoEconomics; 2021; 39:1243-1269 
74 Simoens S, Huys I. R&D Costs of New Medicines: A Landscape Analysis. Front Med (Lausanne). 2021 
Oct 26;8:760762. doi: 10.3389/fmed.2021.760762. PMID: 34765624; PMCID: PMC8576181. 
75 The compound annual growth rate (CAGR) is the annualised average rate of revenue growth between two 
given years. 
76 Veterinary Medicine Market Size & Growth Report, 2021-2028 (grandviewresearch.com) 
77 The Animal Health Industry - ANIMAL HEALTH INSTITUTE (ahi.org) 
78 The European animal medicines industry in figures, AnimalHealthEurope 
79 Annual report 2021, AnimalHealthEurope, 2021 
80 Ibid. 
81 The European animal medicines industry in figures, AnimalHealthEurope 
82  Fee  incentives  for  the  academic  sector  are  currently  included  in  the  PRIME  scheme  of  EMA  which 
foresees  specific  fee  exemptions  for  scientific  advice  for  academia.  Such  possibility  would  continue  also 
under the fee proposal. The review of the basic pharmaceutical legislation under the Pharmaceutical strategy 
may  look  into  possible  codification  of  the  PRIME  approach  in  the  underlying  pharmaceutical  legislation. 
Regarding ATMPs (advanced therapy medicinal products) specifically, the specific reduction rates provided 
for in the ATMP regulation (Regulation (EC) No 1394/2007 of the European Parliament and of the Council 
of 13 November 2007 on advanced therapy  medicinal products)   will also be  carried on under the new  fee 
system (until any possible revision of that ATMP regulation). 

54 

 
 
                                                 
large  increases  in  veterinary  medicine  fees  relative  to  the  current  position,  and  that  this 
might deter prospective applicants from seeking authorisation in the EU for their veterinary 
medicinal  products,  therefore  impacting  their  availability  on  the  EU/EEA  market. 
However, most of the respondents were uncertain whether this situation would materialise 
in practice. Also, this possibility applies similarly across Options 1, 2, 3 and 3 ‘light’ as all 
would  have  cost-based  fees  for  veterinary  medicines,  which  is  what  causes  the  large 
increase  from  the  do  minimum,  i.e.  current,  levels  of  those  fees.  Therefore,  there  is  no 
difference in how this indicator performs across the options. 

Option 1 

Option 2  

Option 3 

Option 3 
‘light’  

Medium 

Medium 

Medium 

Medium 

Indicator  11:  Impact  on  research  and 
innovation 

Effect of horizontal measures 

With respect to the various horizontal measures, the greater the fee reductions and specific 
incentives applied to veterinary medicines fees, the less of a potential  deterrent to launch 
new  veterinary  medicines  across  the  EU/EEA  they  will  be.  On  this  basis,  the  horizontal 
measure that applies both general fee reductions and specific incentives performs best for 
this indicator. 

The  horizontal  measures  concerning  application  of  country  coefficients  to  NCA 
remuneration and to sharing with NCAs the cost of incentives do not affect fees to payers 
and so do not influence this indicator. 

 Functioning of internal market and  competition 

None of the policy options and horizontal measures being considered are likely to have a 
significant impact on the functioning of the internal market and competition. With respect 
to  whether  the  fee  system  under  each  option  allows  for  a  level  playing  field  between 
categories of payers, it could be argued that the more cost-based fees are the more level the 
playing field is. The indicator of cost-reflectivity is discussed in section 6.2.1.1. It follows 
that option 1 performs the lowest, as it is the least reflective of a cost-based approach.   

Among  the  other  policy  options,  Option  3  puts  most  weight  on  annual  fees  relative  to 
procedural fees (65:35) and is preferred by the EU generics sector due to discontinuation of 
all variation fees. Option 3 ‘light’ is, however, preferred by the innovators sector with the 
argument that minor variations (i.e. the only ones included in the annual fee under option 3 
‘light’) numerically comprise the majority of submissions made to EMA that attract a fee 
and, therefore, Option 3 ‘light’ would offer predictable and equitable fee structure which 
significantly  reduces  the  administrative  fee  processing  burden,  while  supporting  the 
appropriate  level  of  regulatory  oversight.  Industry  stakeholders  agree  in  general  that 
Option 2 is not satisfactory due to insufficient optimisation of the fee structure. 

Indicator 12a Functioning of internal 
market and  competition: generic 
medicines 

Option 1 

Option 2 

Option 3 

Option  3 
‘light’ 

Low 

Low 

High 

Medium 

55 

 
 
 
 
 
 
 
 
 
  
  
  
Indicator  12b:  Functioning  of  internal 
market and  competition: innovators  

Low 

Low 

Medium 

High 

Effect of horizontal measures 

The horizontal measures do not in their design affect the relative competitiveness of 
generic and new medicines.  

The  veterinary  sector,  against  the  background  of  innovative  and  generic  medicines,  also 
comprises  two  sub-sectors  -  farmed  animals  and  companion  animals  -  each  driven  by 
different  marketing  rationales.  It  operates  under  different  market  conditions  from  the 
human  sector,  notably  in  the  general  absence  of  public  reimbursement  schemes,  has 
different  drivers  of  investment  and  price-setting  mechanisms  resulting  in  considerably 
lower prices, and is rather fragmented due to the various species to which it caters and their 
relative  geographical  and market  importance. Therefore the horizontal measure that  most 
reduces the veterinary fees, i.e. the application of both general fee reductions and specific 
incentives,  clearly  does  most  to  reduce  the  relative  burden  on  producers  of  veterinary 
medicines. The other horizontal measures concern remuneration of NCAs and do not affect 
the balance of fees between those paid by veterinary medicine producers and those paid by 
producers of human medicines. 

  Discussion of information gaps and uncertainties 

Every  effort  was  made  to  ensure  that  the  survey  for  the  consultation  was  known  to  all 
interested  stakeholders.  The  sample  of  interviewees  and  survey  respondents  spanned  all 
types  of  NCAs  (human,  veterinary,  large,  small,  and  a  range  of  Member  States),  and 
included  consultation  with  HMA.  A  larger  number  of  survey  responses  would  have 
provided greater depth to the qualitative analysis but the coverage of stakeholder interests 
was good, with no obvious gaps. EMA provided a survey response and participated in two 
interviews.  Representatives  of  the  pharmaceutical  industry  provided  feedback.  However, 
the  responses  from  particular  sectors  was  limited,  including  from  academia/research 
organisations and SMEs despite multiple requests to complete the survey.  

The quantitative part of the impact assessment reported here benefited from  the provision 
of  detailed  data  by  EMA  about  activities,  costs,  fees  and  remuneration  of  NCAs.  The 
financial model on which the quantitative analysis is based was originally constructed for 
the Evaluation of the EMA Fees system completed in 2018.83 Time data for activities not 
included  in  the  previous  evaluation  study  and  for  which  data  were  not  collected  in  the 
MBDG exercise have been estimated based on assumptions: using time data for EMA and 
NCAs  (as  appropriate)  from  a  ‘comparator  activity’  that  was  expected  to  take  a  similar 
amount of effort and for which time data were already available. It should be noted that the 
MBDG data for the veterinary sector was based on a much smaller number of procedures 
compared to the human one, which might have an effect on their representativeness. 

83  Commission  Staff  Working  Document  –  Evaluation  of  the  European  Medicines  Agency’s  fee  system. 
2019. 

56 

 
 
 
                                                 
The main limitation of the method was that the time data per activity and the costs of NCA 
staff time per hour, non-staff inputs and of overheads, on which the costing and hence the 
cost-based  fees  parts  of  the  model  depend,  are  five  years  old.  The  time  data  per  activity 
originate  from  the  EMA  Management  Board  Data  Gathering  exercise  of  2016,  and  the 
NCA cost  data were collected by RAND Europe  for the  year 2016 during the evaluation 
study.  Furthermore,  the  departure  of  the  UK  from  the  EU  and  the  EMA  fee  system,  the 
relocation of EMA from London to Amsterdam, and effects of the COVID-19 pandemic, 
have combined to make that cost basis dated. Efforts have been made to account for events 
since 2016 with use of data from EMA about the cost consequences of the location change 
and assumptions agreed about how the workload that would have been taken by UK NCAs 
is reallocated to other NCAs, and allowance for general cost inflation over the years since 
2016.  A  more  recent  time  inputs  and  cost  data  collection  exercise  would  have  given  the 
modelling a more up to date basis. However, in view of the history of such data collection 
and the technical time involved, this was deemed unfeasible. 

A major update of cost estimations of NCAs’ costs was performed after the consultation of 
this impact assessment. It is related to the methodology for estimating the cost for eligible 
additional  activities  of  NCAs  which  impact  on  the  calculation  of  the  annual  fee 
remuneration.  This  is  discussed  in  section  6.1  Public  authorities  and  budgets  (including 
governance and good administration). 

That  said,  these  limitations  affect  similarly  all  options  for  the  fee  system  that  are  being 
considered and do not impart a bias to the comparison between the options. 

7. 

 How do the options compare?  
  Overview of impacts 

Section 6 presented for each impact indicator the relative strengths and weaknesses of the 
policy options. Table 10 summarises the qualitative assessment of the relative performance 
of each option against the indicators.  

Do-
minimum 
(baseline) 

Option 1 

Option 2 

Option 3 

Option 3L 

Nr 

Indicator 

Performance  Performance  Performance  Performance  Performance 

1 

2 

3 

4 

system 

Fee 
aggregate costs 

covers 

relevant 

Alignment  of  fees  with    costs  of 
individual activities 

Alignment  of  NCA  remuneration 
with NCA costs for EMA activities 

Capacity  of  fee  system  to  adjust  to 
cost changes 

Low 

Low 

High 

High 

High 

Low 

Low 

High 

Medium 

High 

Low 

Low 

High 

Medium 

High 

High 

High 

High 

Low 

Medium 

57 

 
 
 
  
  
5 

6 

7 

8a, 
8b, 
8c 
9a, 
9b 

9c 

Balance between simplicity (less fee 
levels)  and  granular  cost-based 
approach (more fee levels) 

Capacity  of  fee  system  to  adjust  to 
ensure financing if incentives 

Adaptability 
circumstances 

to 

exceptional 

Predictability  for  EMA,  NCAs,  fee 
payers 

Reducing  administrative  burden  - 
EMA, NCAs, all fee payers 

Reducing  administrative  burden  on 
SMEs relative to other fee payers 

Low 

Low 

Low 

Medium 

High 

Medium 

Medium 

Medium 

Medium 

Medium 

Medium 

Medium 

Medium 

Medium 

Medium 

Low 

Low 

Low 

High 

Medium 

Low 

Low 

Low 

High 

Medium 

Medium 

Medium 

Medium 

Medium 

Medium 

10  Position of SMEs 

Medium 

Medium 

Medium 

Medium 

Medium 

11 

Impact on research and innovation 

Medium 

Medium 

Medium 

Medium 

Medium 

12a 

12b 

Functioning  of  internal  market  and  
competition: generic medicines 

Functioning  of  internal  market  and  
competition: innovative medicines 

Low 

Low 

Low 

High 

Medium 

Low 

Low 

Low 

Medium 

High 

Table 10 

It should be noted that from the indicators presented, those most reflective of a cost-based 
approach carry the most relative weight in the analysis. This is due to the clear requirement 
in  the  legislation  that  any  review  of  fees  should  be  based  on  cost  estimations.  This 
approach  was  clearly  confirmed  by  the  feedback  to  consultations  from  all  types  of 
stakeholders, where the emphasis was on a cost-based approach. 

Second in importance in that analysis comes the indicators related to the simplification of 
the  fee  system.  Indeed,  the  need  for  simplification  was  clearly  identified  during  the 
evaluation  and  in  the  consultations.  The  minimisation  of  administrative  burden  is  a 
horizontal principle of EU legislation. Nevertheless, since a cost-based approach is clearly 
mentioned in the legislation, it is recognised that this should be the major criterion84.  

84 Some level of simplification will also be achieved through merging the two current EMA fees regulation 
into one legal instrument.  

58 

 
 
 
 
                                                 
Option 1 performs noticeably less well that the other options. This is the result of Option 1 
doing especially poorly with respect to delivering a cost-based approach, assessed through 
several indicators (1, 2, 3) on both an aggregate and granular level. 

Comparing Option 3 with Option 3 ‘light’ in Table 10 there is a distinction drawn between 
them in terms of alignment to granular costs (2, 3), predictability (8a,8b,8c), administrative 
burden (9a, 9b), as well as balance achieved between the two major criteria, i.e. simplicity 
and cost-based approach (5). Option 3 ‘light’ scores relatively better overall than Option 3 
bearing in mind that a cost-based approach is a major indicator and taking into account the 
better balance achieved.  

The differences between Options 2 and 3 are less pronounced than the difference between 
3 and 3 ‘light’ (in favour of 3 ‘light’). Option 2 achieves a higher score than 3 and 3 ‘light’ 
notably  in  terms  of  alignment  to  individual  (granular)  costs  (2,3),  but  lower  in  terms  of 
predictability  (8a,b,c),  administrative  burden  (9a,b)  and  balance  achieved  between 
simplicity and cost-based approach (5). 

The  choice  between  options  3  and  3  ‘light’  is  finely  balanced.  In  the  final  analysis,  we 
suggest  that  Option  3  ‘light’  is  preferable  because  it  has  the  merit  of  achieving  some 
improvements  in  simplicity  compared  to  the  current  fee  system,  while  at  the  same  time 
introducing cost-based fees for all activities at quite a granular level. 

In the following sections, we summarise the differences between  the horizontal measures 
as they might be applied to this option. 

  Appraisal of horizontal measures  

1.19.1. 7.2.1. 

Veterinary medicines incentives 

Three horizontal measures have been considered for veterinary medicines for combinations 
of general fee reductions and specific incentives: 

A 

B 

C 

Cost-based fees for veterinary medicines with a 50% general fee reduction for 
all veterinary fees. 

Cost-based fees for veterinary medicines with a 50% general fee reduction and 
targeted fee incentives. 

Cost-based fees for veterinary medicines with targeted fee incentives. This may 
include a selection of procedural fees and the annual fee as well  

(C1 is the same as C with a 25%-reduction of the annual fee in addition). 

The analysis of these horizontal measures in Section 6 shows that the choice between them 
depends on four of the indicators: 

  How closely fees reflect costs of individual activities – the greater the value of the 
incentives and reductions, the worse this indicator performs as the more payments 
will diverge from costs; 

  Administrative burden on payers – specific incentives are slightly more 

burdensome for payers to administer than general fee reductions; 

  Administrative burden on EMA and NCAs – specific incentives are slightly more 

burdensome for payers to administer than general fee reductions; 

59 

 
 
  How well the horizontal measure delivers on the objectives of the VMP regulation 
and how adequate the fee levels are to the specificities of the veterinary medicines 
sector. 

Clearly, the greater the fee  reductions or specific incentives applied, the more favourable 
the  fee  system  is  to  the  veterinary  medicines  sector.  This  effect  would  be  greatest  in 
horizontal measure B, where both a 50% general fee reduction and specific incentives are 
applied.  However,  this  is  also  where  the  veterinary  fees  diverge  most  from  the  cost  of 
doing  the  work  and  C1  is  expected  to  deliver  better  balance  in  this  respect.  Due  to  the 
small  share  of  the  veterinary  sector  compared  to  the  human  one,  under  the  current  fee 
system,  such  incentives  have  not  had  and  are  not  expected  to  have  any  appreciable 
negative effect on the overall sustainability of the fee system. 

Specific  incentives  seem  slightly  more  administratively  burdensome  for  all  parties  than 
general  fee  reductions,  but  the  difference  is  minimal.  In  any  case,  those  incentives  are 
expected  to  help  deliver  on  the  objectives  of  the  VMP Regulation  and  the  EU’s  fight 
against  antimicrobial  resistance  by  incentivising  products  targeting  limited  markets  and 
alternatives to antimicrobials, such as immunological VMPs85. 

Horizontal measure/Indicator 

A 

B 

C 

C1 

Indicator 2: alignment of fees with costs 
of individual activities 

Indicators  5a  and  5b:  administrative 
burden on EMA and NCAs 

Indicator  5c:  administrative  burden  on 
payers 

New 
indicator  on  how  veterinary 
incentives  in  the  horizontal  measures 
align with VMP goals 

Low 

Low 

Medium 

High 

High 

Medium 

High 

Medium 

High 

Medium 

High 

Medium 

Medium 

Medium 

Medium 

Medium 

Horizontal measure C1 delivers the optimal balance between specific incentives (specific 
targeted fee reductions), overall support for the veterinary sector (reduction of the annual 
fee) and a cost-based approach (no horizontal reduction). 

1.19.2. 7.2.2. 

Country coefficients for NCA remuneration 

Country  coefficients  were  considered  to  address  the  problem  of  misalignment  between 
NCA  costs  and  remuneration.  In  particular,  different  NCAs  completing  the  same 
procedural  activities  would  receive  varying  levels  of  remuneration,  to  more  accurately 
reflect their respective costs. 

The analysis in Section 6 shows that, while country coefficients would link an individual 
NCA’s  remuneration  more  closely  to  their  own  organisation’s  costs,  they  are  likely  to 
worsen the predictability for the actors involved. 

85 Immunological VMPs i.e. vaccines, toxins, serums, and allergens. 

60 

 
 
                                                 
If the coefficients were to be applied to the fees amount, this would impact predictability 
for payers, as the amount to be paid would vary depending on which NCAs were appointed 
as rapporteurs.  

If  coefficients  were  to  be  applied  to  the  NCAs  remuneration  (i.e.  industry  would  always 
pay the same amount for a given procedure), this would impact the predictability for EMA 
as  the  agency  would  no  longer  be  able  to  predict  the  amount  for  remunerations  until 
rapporteurs  are  appointed.  Furthermore,  this  could  potentially  affect  the  ability  of  the 
agency to balance its budget, leading to strong fluctuations in the budget.  

EMA, HMA and some individual NCAs indicated that country coefficients were likely to 
undermine  scientific  capability  as  the  most  important  criterion  for  allocating  work  to 
NCAs. Scientific excellence and desire to contribute were considered by EMA and NCAs 
to  be  the  factors  determining  which  NCAs  do  EMA  work,  not  comparative  cost.  In 
addition,  adding  country  coefficients  could  represent  an  impediment  to  sub-contracting 
some  activities  to  experts  who  do  not  belong  administratively  to  the  NCA  and  whose 
labour costs, therefore, are not correlated with the level of costs that the country coefficient 
tries to capture. 

No NCA consulted supported the introduction of country coefficients, including NCAs that 
could  potentially  gain  financially  from  their  application  (See  Annex  2).  Not  applying 
country coefficients is in line with the approach of calculating average cost-based fees, i.e. 
fee  levels  do  not  depend  on  the  actual  NCA  performing  the  assessment.  It  also  avoids 
significant increase in administrative costs for EMA in calculating the remuneration to be 
paid  to  NCAs.  Nonetheless,  in  order  to  address  the  problem  of  misalignment  of 
remuneration and costs for some NCAs, the remuneration amounts are already calculated 
on  the  basis  of  weighted  averages,  taking  into  account  the  costs  of  the  NCAs  more 
frequently involved in assessment work. The application of country coefficients in addition 
would  therefore  duplicate  the  effort  and  further  unbalance  the  remunerations  rather  than 
adjust them. The assessment therefore concludes that this measure should not be retained. 

1.19.3. 7.2.3. 

Incentive sharing 

Applying  incentives  to  cost-based  fees  before  remuneration  to  NCAs  would  mean  that, 
unlike  the  current  arrangements,  part  of  the  cost  of  those  incentives  (i.e.  the  loss  of 
revenue)  would  be  financed  by  national  budgets  instead  of  EMA  budget.  Currently,  the 
EMA  budget  bears  the  cost  of  incentives.  The  horizontal  measure  of  sharing  the  cost  of 
incentives  with  NCAs  would  require  NCAs  to  fund  that  part  of  their  EMA  work  from 
national  sources.  As  reported  in  Annex  2  and  shown  by  the  analysis  in  Section  6,  the  
measure of sharing the cost of incentives with NCAs performs least well in relation to all 
indicators, and should therefore not be retained86.  

  Effectiveness 

Effectiveness  is  measured  by  the  extent  to  which  the  policy  options  and  horizontal 
measures achieve the objectives described in Section 4, namely to: 

86 The benefits from being part of a centralised system have not been quantified in this study. 

61 

 
 
                                                 
  Provide  a  sound  financial  basis  for  EMA  and  its  activities,  including  fair 

remuneration for the services provided by NCAs; 

  Ensure a level-playing field for industry in terms of access to EMA’s services, and 

thus to promote competitiveness; 

  Facilitate the development and marketing of safe and effective medicines; and 
  Limit the administrative burden generated by the fee system. 

In  Section  6  we  analysed  impact  indicators  of  how  the  options  and  horizontal  measures 
compare  in  these  terms  (all  indicators  relate  to  effectiveness).  Our  analysis  identifies,  as 
described in sections 7.1 and 7.2, Option 3 ‘light’ as overall the most effective option, in 
combination  with:  targeted  fee  reductions  for  veterinary  fees  (C1);  no  application  of 
country  coefficients  to  NCA remuneration;  and  EMA not  sharing with  NCAs the cost  of 
fee incentives. 

  Efficiency (balance of benefits and costs) 

A classical efficiency analysis, which seeks maximum benefit for minimum cost, cannot be 
applied  to  the  main  options  assessed  for  the  revision  of  the  EMA  fee  system,  since  the 
legislation requires that the fees themselves should reflect the costs incurred as closely as 
possible.  The  only  scope  for  improving  efficiency,  then,  is  in  the  administrative  costs 
generated  by  the  implementation  of  the  system  itself,  and  not  in  the  amounts  of  fees 
charged. 

the  options.  From 

As reported in Section 6 and Annex 3, the administrative costs of the fee system vary only 
very  slightly  between 
this  perspective,  “efficiency”  becomes 
pragmatically the same as “effectiveness”, as there is little difference in administrative cost 
between  options;  the  most  effective  option  is  also  the  most  efficient.  From  another 
analytical angle, looking at the benefit/cost ratio, an approach that more closely reflected a 
cost-based approach embodied in a more granular fee system might be seen as increasing 
both  the  benefit  (payment  better  aligned  closer  to  cost)  but  also  the  administrative  cost 
(more payments to process), thus neutralising the effect on the efficiency ratio.  

The  application  of  country  coefficients  to  NCA  remuneration  may  be  seen  as  adding 
additional  administrative  burden  to  calculate  and  pay  remuneration  (increasing  the  cost 
component of the efficiency ratio) while, on the benefit side,  taking better into account the 
relative  difference  in  costs  of  different  NCAs.  However,  country  coefficients  also  have 
disadvantages,  for  example  preventing  smaller  NCAs  from  having  recourse  to  external 
expertise, as well as possible negative impacts on the fee system as a whole (in the extreme 
scenario,  fluctuation  of  fee  levels  depending  on  the  attribution  of  the  rapporteurs); 
therefore, their effect may equally be either neutral or negative. 

Over  time,  continued  reflection  of  a  cost-based  approach  depends  on  monitoring  and 
adjustment mechanisms that keep fees aligned to costs, within the budgetary rules of EMA. 
Such a mechanism is discussed in Section 9. 

  Coherence with other EU policy objectives 

Overall, a cost-based and flexible EMA fees system supports the contribution of EMA to 
the  main  policy  objectives  of  the  EU  pharmaceutical  legislation.  Such  objectives  include 

62 

 
 
providing the right regulatory environment for safe and effective medicines of the highest 
quality to be made available to EU citizens. 

  Preferred option – Option 3 ‘light’ 

The analysis shows that the relative effectiveness, and likewise the efficiency, of Options 
2, 3 and 3 ‘light’ are finely balanced in comparison with one another, but all are superior to 
Option 1. The differences between Options 2 and 3 are in essence that: Option 2 aligns fees 
with costs at a more disaggregated level and hence more precisely, whereas Option 3 offers 
simplification by reducing the number of distinct fees charged to payers. Option 3  ‘light’ 
offers  a  compromise  part  way  between  Options  2  and  3  and  performs  the  highest. 
Therefore, it is the preferred option. 

With  respect  to  the  horizontal  measures,  the  better  performing  variants  appear  to  be; 
targeted  fee  reductions  for  veterinary  fees  combined  with  a  reduced  annual  fee  (C1);  no 
application of country coefficients to NCA remuneration; and not sharing with NCAs the 
cost of incentives. 

The monitoring framework discussed in Section 9 is consistent with the preferred option.  

Further  simplification  will  be  achieved  by  merging  the  relevant  provisions  of  the  two 
existing EMA Fee Regulations into one legal instrument.  

  REFIT (simplification and improved efficiency) 

Policy  options  3  and  3  ‘light’  allow  a  reduction  of  the  existing  administrative  burden 
related to the calculation and invoicing of fees to industry and consequent remuneration to 
NCAs.  Option  3,  with  post-authorisation  activities  included  in  flat  annual  fees,  thus 
reducing accordingly the number of procedural fees, results in the greatest simplification of 
the system structure and therefore greatest reduction in administrative burden. However, it 
was considered such an over-simplification of the system could lead to a lack of sufficient 
flexibility and a cost-based approach, thus making the fee system difficult to adapt to a fast 
changing  technical,  scientific  and  regulatory  context,  with  possible  impacts  on  its  future 
sustainability.  Option  3  ‘light’  was  considered  to  provide  the  greatest  balance  between 
simplification and flexibility of the fee system. 

  Application of the ‘one in, one out’ approach  

This  principle  ensures  that  any  newly  introduced  administrative  burdens  are  offset  by 
removing equivalent burdens in the same policy area. Administrative costs are covered by 
the  ‘one  in,  one  out’  approach  but  regulatory  fees  are  not.  This  initiative  is  not  in  the 
Commission Work Programme  and there are no significant administrative costs added or 
removed,  therefore  the  initiative  is  not  in  the  scope  of  the  ‘one  in,  one  out’  (OI-OO) 
approach. Nevertheless, the quantification of the administrative costs demonstrate that no 
significant administrative costs have been added or removed through this initiative, i.e. the 
estimated  effect  is  a  limited  saving  in  administrative  net  cost  in  the  range  of  €54,960  to 
€112,350, which is negligible in the context of the entire system (see Annex 3). 

8. 

How will actual impacts be monitored and evaluated? 

63 

 
 
 
The Commission will need access to evidence to monitor the revised fee system and assess 
to what extent it achieves its objectives in an efficient way.  

Stakeholder consultation elicited inputs on feasible monitoring arrangements. The proposal 
for monitoring and evaluation is divided into two timescales: 

1.  Annual  routine monitoring to  provide the basis for considering adjustments  to 
EMA fees and thereby provide some of the flexibility to adjust the fee system to 
changing circumstances; 

2.  Less  frequent,  periodic  (i.e.  no  more  than  every  five  years)  data  collection  to 
support  periodic  evaluations  and,  if  necessary,  consequent  changes  to  the  fee 
legislation. 

Data collected and monitored annually to permit consideration of adjustment of fees would 
also  provide  much  of  the  indicators  needed  for  periodic  evaluations  of  the  fee  system. 
However, data collected and monitored annually (e.g. general cost inflation across the EU, 
or  trends  in  the  number  of  assessment  hours  or  the  number  of  authorised  products  / 
chargeable  units  for  which  annual  fees  would  be  payable)  could  not  necessarily  be 
sufficient  for  periodic  evaluations.  Certain  information  is  burdensome  to  generate  and 
collect annually (e.g. data on NCA and EMA time input for the full set of EMA activities, 
such  as  were  collected  in  the  2016  MBDG  exercise)  or  exists  outside  the  EMA-NCA 
network (e.g. administrative burdens on payers associated with the fee system).  

Additional  data  could  possibly  be  collected,  as  relevant,  through  primary  research  or 
regular  contacts  with  stakeholders.  In  general  terms,  there  is  a  trade-off:  the  more 
comprehensive  and  sophisticated  the  annual  monitoring  mechanism,  the  lower  the 
incremental effort required for periodic evaluations and the greater the potential for more 
sophisticated analysis in the evaluation.  

Annual monitoring and adjustment 

The annual collection and monitoring of data related to EMA and NCA costs and activity 
levels can be used to fulfil two functions: 

  To  consider  adjusting  fee  levels  and  /  or  NCA  remuneration,  in  response  to 
confirmed trends in general cost inflation and EMA activity costs. Such adjustment 
already occurs to some extent through the annual inflation factor applied to adjust 
EMA fees and remuneration each year. 

  Beyond adjustment reflecting general cost inflation, to evidence when exceptional 
circumstances lead to significant and permanent changes in workload-related costs, 
so that such changes could be recognised and reflected in a corresponding change 
to  fees  and  remuneration.  A  mechanism  to  cope  with  exceptional  circumstances 
exists de facto in the current system, as evidenced by the response to the Covid-19 
pandemic, which introduced the possibility to charge part of the fee and pay part of 
the remuneration upfront for rolling review of pandemic-related products. Further, 
the fee legislation empowers EMA’s Executive Director to grant fee reductions in 
exceptional circumstances87, with the assumption that this is absorbed by the EMA 

87 Article 9 of Council Regulation (EC) No 297/95 

64 

 
 
                                                 
budget.  Finally, increased NCA’s remuneration for pandemic-related assessments, 
beyond  the  regular  fee-related  remuneration,  was  introduced,  thanks  to  a  legal 
possibility  beyond  the  fee  legislation,  i.e.  in  EMA’s  founding  regulation,  with 
funding  included  in  the  EU  budget  contribution  envelope  for  the  Regulation  on  a 
reinforced role for EMA. 

Some  level  of  collection  of  non-inflation  indicators  for  annual  monitoring  was  already 
created  by  Article  15  of  Regulation  (EU)  No  658/201488.  It  stipulates  indicators  that  are 
required to  be  collected  and published annually  by EMA to  monitor the  fees payable for 
the  conduct  of  pharmacovigilance  activities  in  respect  of  medicines  for  human  use  only. 
Article 15 also requires EMA to report annually to the Court of Auditors, the Commission, 
the European Parliament and the Council the information “that may have a bearing on the 
costs  to  be  covered  by  the  fees  provided  for”  pharmacovigilance  of  products  for  human 
use. 

summary 

reported  annually. 

Annex V to the abovementioned regulation provides a list of indicators that are required to 
they  cover:  numbers  of 
In 
be  collected  and 
(pharmacovigilance)  procedures;  number  of  EMA  staff  working  on  these  procedures  and 
activities covered by the annual fee; EMA staff costs and non-staff costs of these activities; 
numbers of times each kind of incentive is applied (for SMEs, etc.); how many times each 
NCA  is  rapporteur  or  co-rapporteur;  and  working  hours  spent  by  the  rapporteur/co-
rapporteur per procedure. The last of these indicators is provided by the relevant NCAs to 
EMA.  EMA  provides  the  other  indicators  and  reports  on  all  indicators  annually  to  the 
Commission and the EMA Management Board. 

A  possible  list  of  annually  collected  non-inflation  monitoring  indicators  could  include 
those listed in Table 11. The activity-specific data on workload could, initially at least, be 
limited  to  major  procedures  for  which  the  corresponding  fees  and  remuneration  amounts 
are  the  highest,  with  data  on  other  procedures  monitored  less  regularly89.  Inflation  data 
could be used for unitary cost-related monitoring, while workload data could be used for 
complexity-related monitoring. 

The Agency could collate and perform annual analysis presented to the Management Board 
(together with the raw data available). Following Management Board deliberations, if the 
Agency finds that there is sufficient evidence to consider triggering a change to fees and / 
or remuneration amounts, the analysis of indicator values over time,  with  justification  or 
discussion  of  the  limitations  of  the  reliability,  would  be  the  evidence  on  which  any 
rationale for updates (upward or downward) would need to be based and submitted to the 
Commission.  In  addition,  the  Commission  would  have  the  option  to  trigger  a  review  of 
fees if there are other compelling elements, such as new tasks given to EMA or unforeseen 
circumstances,  taking  into  account  the  balancing  nature  of  the  EU  budget  contribution 
agreed  under  the  relevant  Multi  annual  financial  framework,  in  accordance  with  EMA’s 
founding  regulation.  To  respond  to  the  need  for  flexibility,  the  legal  instrument  of  such 
adjustments could be a delegated act, based on objective triggers as discussed above. 

88  Regulation  (EU)  No  658/2014  of  the  European  Parliament  and  of  the  Council  of  15  May  2014  on  fees 
payable  to  the  European  Medicines  Agency  for  the  conduct  of  pharmacovigilance  activities  in  respect  of 
medicinal products for human use.  
89 Given the study finding that some NCAs would struggle to provide time and cost data annually. 

65 

 
 
                                                 
Objective 

Indicator 

Alignment of fees 
and remuneration 
with the costs of 
activities 

EMA income by fee 

EMA workload and costs by activity 
grouped by fee and homogeneous groups 
of fees 

Source 

EMA accounts 

EMA accounts 

Number of EMA activities, per fee 
(procedures)  

EMA records 

EMA budget outturn 

EMA budget reporting 

Allocations of activities by NCA, per 
activity 

EMA records 

EMA net remuneration payments to 
NCAs, by fee 

Total NCA income and expenditure 
balances (for both EMA-related and 
non-EMA-related activity) 

NCA workload by activity grouped by 
fee  

EMA accounts 

Budget reporting of each 
NCA 

NCAs (similar to current 
reporting on 
pharmacovigilance 
procedures) 

Table 11: Possible indicators for annual monitoring 

Periodic evaluations and data collection 

It  is  envisaged  that  the  fee  system  would  be  periodically  evaluated  (every  five  years  or 
more)  with  the  first  evaluation  taking  place  not  earlier  than  5  years  after  the  entry  into 
application of the new regulation.   

EMA and NCAs described the collection of time input data per activity, as was done for 
the  2016  MBDG  exercise,  as  burdensome  and  especially  to  those  NCAs  that  do  not 
currently  have  management  information  systems  that  record  staff  time  by  activity. 
Collecting  other  financial  data  from  NCAs  to  enable  estimation  of  their  costs  per  EMA 
activity they undertake (as was done for the evaluation of the EMA fees system in 2018) 
was not considered to be as burdensome as collecting time input data but would also not be 
straightforward  –  due  to  the  same  NCA  having  both  national  activities  and  EMA  work. 
Independent audit, e.g. at the time of evaluation, of the time and cost data provided would 
safeguard the robustness and objectivity of those data.  

To  support  periodic  evaluations  of  the  EMA  fees  system,  EMA  and  NCAs  could  collect 
some  additional  data  to  supplement  the  annual  monitoring  data  collected  over  preceding 
years, taking into account  any  fee  changes made as  a result in  the meantime. Such more 
burdensome  provision  of  monitoring  data  could  take  place  every  five  years  or  more. 
Collection  of  time-per-activity  data  could  become  automated  across  all  NCAs  as  well  as 
EMA, to ensure possibly a greater efficiency of the process. 

Table  12  sets  out  the  proposed  indicators  to  be  collected  periodically  to  supplement  the 
annual indicator data listed in Table 11.  

66 

 
 
 
Objective 

Alignment of fees 
and remuneration 
with the costs of 
activities 

Indicator 

Source 

Analysis of fee revenue and relevant cost 
elements, over a longer period of time 
(could be based on annual monitoring data)  

Regulatory burden  Payer, EMA and NCA experiences of the 

Support to SMEs  

administrative burden of the fee and 
remuneration system 

Specific SME reporting focused on fees 
and fee-system administrative burden 
issues and specific financial and other 
support provided 

Data sets based on 
annual monitoring 
data and further data 
sources 

Survey lead by EMA 
including stakeholder 
relations divisions 

EMA SME office 

Table 12: Additional indicators for periodic (every five or more years) monitoring and evaluation  

Together,  these  two  sets  of  data  can  be  input  into  the  financial  model  to  generate  the 
corresponding revised estimates of all fees. Those modelled fees can be compared with the 
then  current  fee  grid  to  determine  for  which  fees  there  are  significant  divergences  and 
hence  which  if  any  fees  need  to  be  revised,  always  bearing  in  mind  the  objective  of  a 
balanced budget and the EU budget contribution. 

67 

 
 
 
 
 
ANNEX 1: PROCEDURAL INFORMATION 

Lead DG, Decide Planning/CWP references 

1. 
The Directorate for Health and Food Safety (DG SANTE) is the lead DG on the initiative 
on the revision of the EMA Fee System. The initiative has received the  validation in  the 
Agenda  Planning  on  30  January  2019  (reference  PLAN/2018/4193)  and  the  Inception 
Impact assessment was published on 18 September 2019. 

Organisation and timing 

2. 
The  Impact  Assessment  project  started  in  Feb  2020.  The  Inter-service  Steering  Group 
(ISSG) was composed of the following DGs: SANTE, RTD, SG, LS, BUDG and GROW. 
For the follow up of the external study supporting the Impact Assessment the Group was 
consulted  in  twice  in  2020  (kick-off  and  inception  report),  twice  in  2021  (targeted 
consultation material and interim report) and in 2022 (28/03-04/04 2022). 

The  draft  Impact  Assessment  report  and  all  supporting  documents  were  submitted  to  the 
Regulatory Scrutiny Board (RSB) on 13 April 2022, in view of a meeting on 11 May 2022. 
The RSB issued a positive opinion with reservations on 13 May 2022. 

Consultation of the RSB 

3. 
The Impact Assessment report was reviewed by the Regulatory Scrutiny Board. Following 
the meeting, the RSB issued a positive opinion with the following high-level reservations 
to be addressed: 

(1)  The  report  does  not  sufficiently  explain  how  this  initiative  interlinks  with  the 
revision of the EMA founding regulation and how synergies and complementarities 
will be ensured. 

(2)  The  definition  of  what  a  ‘cost-based  system’  is  unclear.  The  report  does  not 
clarify  to  what  extent  the  current  system  and  its  key  elements  is  cost-based  and 
what the potential for cost-efficiency enhancing measures is. 

(3) The report does not  sufficiently analyse how the proposed changes impact fee 
payers. 

The  table  below  lists  the  changes  made  in  response  to  the  specific  recommendations 
provided by the RSB: 

Recommendations of the RSB 

Modifications  in  the  impact  assessment  
report 
the  Board’s  
recommendations 

in  response 

to 

(1) The report should explain in more detail 
the  interlinkages  and  coherence  with  the 
upcoming  revision  of  the  EMA  founding 
regulation.  The 
should  clearly 
report 
describe  how  the  proposed  fee  system  will 
be able to account for and adapt to changes 
regulation  and  how 
in 

founding 

the 

The  introduction  of  the  report  has  been 
amended and expanded to better clarify the 
scope of this initiative and how it interlinks 
with 
the 
pharmaceutical framework. It was explained 
that whilst this revision cannot pre-empt the 
outcomes of the work on the pharmaceutical 

revision 

general 

the 

of 

68 

 
 
synergies  and  complementarities  will  be 
maximised. 

strategy,  the  legal  draft  for  the  new  fee 
system  will  propose  measures  to  ensure 
adequate  levels  of  flexibility  in  updating 
and  adjusting  the  text  (e.g.:  delegation  of 
powers  to  Commission  and/or  EMA  MB), 
in  order  to  ensure  the  smooth  alignment  of 
the fee system to any future provisions.  

and 

(2) When presenting the problem, the report 
should  give  a  more  precise  picture  of  what 
‘cost-based’  entails.  It  should  define  the 
‘cost-
‘cost-based’ 
concepts  of 
reflectivity’  and  should  better  outline 
whether  the  current  fees  and  remunerations 
are sufficiently ‘cost-based’. For instance, it 
should  assess  to  what  extent  the  industry 
annual  fees  are  charged  on  the  principle  of 
service actually provided to fee payers. The 
the 
report  should  also  better  present 
background of the cost alignment objective, 
and it should explain the trade-offs and the 
basis  for  the  relative  weight  between  cost 
alignment,  simplicity  and  the  flexibility 
objectives. 

The  introduction  of  the  report  has  been 
amended and expanded to better clarify the 
principle of ‘cost-based’ and the legal basis 
from  where  the  objective  of  cost  alignment 
stems from. The level of cost reflectivity of 
the  current  framework  has  been  better 
explained,  showing  that  whilst  the  current 
system manages to balance the EMA budget 
and can be considered overall cost based, at 
are 
granular 
and 
discrepancies  between 
remunerations  amounts  and  the  respective 
costs  of  EMA  and  NCAs  to  undertake  the 
necessary work. The trade-off between costs 
alignment  and  simplicity  have  been  better 
outlined  and  put  in  perspective  with  what 
the initiative tries to achieve. 

level 
the 

there 
fees 

procedural 

(3)  The  report  should  better  explain  the 
overall  functioning  and  efficiency  of  the 
current system. It should better present how 
the  NCAs  are  assigned  to  their  tasks  and 
what  kind  of  process  will  be  followed  to 
ensure  excellence 
in  service  and  cost-
efficiency.  It  should  explain  why  internal 
efficiency  improvement  measures  (possibly 
in  interaction  with  the  changes  to  the 
regulation)  have  not  been 
founding 
financial 
tackle 
considered 
sustainability  challenge.  In this context,  the 
report  should  clarify  to  what  extent  the 
current  EMA  and  NCA  services  provision 
can  be  considered  as  overall  performing 
well and cost-efficient. 

the 

to 

The  functioning  of  the  current  regulatory 
framework has  been better explained in  the 
Annex on Context, with clarification on the 
procedure  for  assignment  of  rapporteurs 
from  NCAs.  The  report  has  also  been 
amended  to  better  outline  measures  to 
guarantee  efficiency  of  the  current  system 
(as  periodical  reviews  and  Commission 
reporting on the functioning of the system). 
Nonetheless,  it  has  been  clarified  that  this 
initiative is limited to revising the EMA fee 
system 
current  EU 
pharmaceutical  legal  framework  and  that 
for  efficacy  and 
.further  possibilities 
including  aspects  on 
efficiency  gains, 
governance,  are  being  discussed  separately 
as  part  of  general 
the 
pharmaceutical  framework.  Setting the new 
fee  system  with  the  appropriate  level  of 
flexibility  will  allow  to  smoothly  take  into 
account  any  governance  improvements  and 
efficiency  gains  introduced  in  future  and 

revision  of 

based 

the 

on 

69 

 
 
update  fees  and  remuneration  amounts 
accordingly. 

The  subsection  dealing  with  appraisal  on 
horizontal  measures  has  been  expanded  to 
better  clarify  the  various  elements  that 
contributed  to  the  exclusion  of  country 
coefficient  as  a  viable  way  to  address 
differences 
the  NCAs. 
in  costs  across 
Beyond the aspect of administrative burden, 
the 
coefficient  would 
negatively  impact  predictability  either  for 
payers  or  for  NCAs  and  would  ultimately 
put at risk the ability of the EMA to balance 
its budget. 

application  of 

to  better  present 

The  subsection  on  option  discarded  has 
been  amended 
the 
arguments  in  support  of  discarding  the 
baseline as a viable option. Due to the new 
legal  provisions  put  in  place  by  the  new 
VMP Regulation and the extended mandate 
of  the  EMA,  the  current  fee  system  cannot 
be  adjusted  by  non-legislative  action  to  the 
extend  needed  to  accommodate  appropriate 
funding  for  these  additional  costs  and  it 
in  a  negative 
would  ultimately  result 
financial balance for the EMA. 

The  financial  effect  of  the  changes  on 
payers  has  been  further  clarified  and 
expanded.  It  was  stressed  that  an  8-9% 
increase  in  total  industry  fees  cannot  be 
innovation, 
accounted  as  a  barrier 
especially  when  seeing  it  in  the  context  of 
total R&D costs. 

to 

(4)  The  report  should  better  substantiate 
why  country  coefficients  for  NCAs  would 
lead to significant administrative burden and 
clarify  whether  the  burden  outweighs  the 
benefits.  It  should  assess  the  risk  that  the 
current  NCA  remuneration  system  overall 
may result in delivering the NCA services at 
the cost of the most cost expensive national 
authorities. 

support 

the  apparent 
for 

(5)  The  report  should  better  describe  why 
the baseline is not a viable way forward, in 
lack  of 
particular  given 
stakeholder 
the  options 
presented.  The  report  should  outline  the 
drivers  behind 
financial 
balance and explain why it is not possible to 
balance  incomes  and  expenditures  in  the 
baseline scenario. 

the  negative 

(6) The report should clarify the impacts on 
fee payers. It should explain better how the 
recalculation results in higher total industry 
fees.  It  should  assess  the  consequences  of 
the raising the costs for fees payers, such as 
impacts  on  innovation  or  on  the  number  of 
new  applications.  In  particular,  the  report 
should 
for 
the 
consequences  on  fee  payers  from 
veterinary  medicine  sector.  It  should  also 
better  reflect  the  views  of  fee  payers  from 
the various consultation activities. 

specifically 

account 

(7)  The  report  should  better  reflect  the 
overall  impact  of  this  initiative  on  the 
development  and  availability  of  safe, 
effective,  and  quality  medicines.  It  should 
also  indicate  if  there  are  any  significant 
social, environmental or fundamental  rights 

that 

It  has  been  clarified 
the  general 
objective  of  the  initiative  is  to  provide  a 
sound  financial  basis  for  EMA  and  its 
activities.  The 
legal  basis  section  was 
expanded  to  explain  that  the  initiative  aims 
to support the goal of setting high standards 

70 

 
 
impacts. 

pharmaceutical 

of  quality  and  safety  of  medicinal  products 
by  ensuring  the  availability  of  sufficient 
financial resources to  perform the activities 
that  are  necessary  to  guarantee  that  high 
standards  are  applied  for  the  authorisation 
of 
and 
products 
maintenance of those authorisations. 
It  has  been  clarified  that  given  the  nature 
and  scope  of  the  initiative  no  significant 
social, environmental or fundamental  rights 
impacts  have  been  identified  and  that  only 
impacts  of  an  economic  nature  were 
assessed.  

Evidence, sources and quality 

4. 
A  targeted  consultation  was  conducted  with  NCAs,  EMA  and  Industry  from  June  until 
August  2021.  In  total,  10  interviews  were  conducted  with  EMA  (2  interviews)  and 
HMA/NCAs  (8  interviews)  in  the  period  between  September  2021  and  October  2021  in 
order to supplement some survey responses. 

71 

 
 
 
 
 
 
 
ANNEX 2: STAKEHOLDER CONSULTATION (SYNOPSIS REPORT) 

 

Introduction 

In accordance with the Better Regulation Guidelines, this document provides a synopsis or 
summary  of  all  the  consultation  activities  in  support  of  the  Study  supporting  the  Impact 
Assessment of the Revision of the EMA fee system. This Synopsis Report accompanies the 
Final  Report  of  the  study  supporting  the  impact  assessment,  Section  2  of  this  Annex 
presents  the  approach  to  the  consultations  and  Section  3  of  this  Annex  provides  an 
overview  of  the  results.  Stakeholders  were  not  re-consulted  following  the  recalculations 
which were undertaken to address the issues they had rised. 

 

Approach to the consultation  

The  objective  of  the  consultations  was  to  collect  information  to  support  the  qualitative 
analysis.  They  were  used  to  obtain  views  on  the  impacts  of  the  policy  options  and 
horizontal measures and to validate the list of procedural activities covered by the model.  

Stakeholder selection 

Six key stakeholder groups (EMA, national ministries and National Competent Authorities 
(hereinafter,  NCAs),  pharmaceutical  industry  for  human  medicines,  pharmaceutical 
industry  for  veterinary  medicines,  industry  representative  organisations  and  academia) 
were identified in the Terms of Reference of this study. In addition to these groups, wider 
stakeholder  associations  were  consulted  (via  an  invitation  to  respond  to  the  targeted 
survey).  A  list  of  specific  organisations  and  companies  within  each  group  was  defined 
based on the stakeholder mapping in the 2018 RAND study (Smith et al. 2018)90. The list 
was updated, the contacted stakeholder list can be found in Annex 2.1. An overview of the 
stakeholders invited to participate in the targeted surveys is shown in Table 2.1 below.  

Table 2.1 Summary of stakeholder contacted for the targeted survey  

Type of organisation 

National Competent Authority and Ministries  

Other national institutions 

Patient and Consumer Association 

Research Associations 

EU level Healthcare Professional’s Associations 

Number of 
organisations  

86 

45 

6 

13 

28 

90 Smith, E., Dunkerley, F., Altenhofer, M., Cochrane, G., Harte, E., Barberi, M., & Sussex, J. (2018). Study 
for the Evaluation of the EMA Fee System - SANTE/2016/B5/021. 
https://www.rand.org/pubs/external_publications/EP67970.html 

72 

 
 
 
                                                 
 
Industry organisations and the associations representing them 

Other (EMA and HMA) 

TOTAL 

31 

2 

211 

The sample of NCAs interviewed covered a range of organisation sizes and geographies, 
human  medicines  only  organisations,  veterinary  medicines  only  organisations,  and 
organisations responsible for both.  

Table  2.2.  provides  an  overview  of  the  targeted  consultation  activities  and  the  main 
stakeholder groups that were engaged. Stakeholders were selected to be as comprehensive 
and representative as possible and all relevant groups (see Annex 2.1 to this note for a full 
list  of  stakeholders  contacted)  were  given  the  opportunity  to  provide  their  views  and 
potential impacts concern the revision of the EMA fee system.  

Table 2.2 Targeted consultation strategy activities per stakeholder group 

Stakeholder group  Consultation Activity/ Tool  Answer received / Interviews carried 

NCAs 

Targeted surveys and 
interviews 

Fee payers 

Targeted surveys 

out 

24 survey responses/standalone 
position papers contributions and 7 
interviews conducted 

6 survey responses, one position paper 
and 1 interview conducted 

EMA 

HMA 

Targeted survey and interview  1 survey response and 2 interviews 

conducted 

Targeted survey and interview  1 position paper and 1 interview 

conducted 

Note: ICF and RAND Europe analysis of the stakeholder consultations.  

Targeted surveys  

The analysis of the targeted surveys included cross-tabulations of closed answer questions 
and a qualitative analysis of additional textual feedback provided by respondents in open 
answer  questions  and  through  position  papers.  Manual  qualitative  analysis  was  used  to 
provide insight into the themes being discussed. 

The  different  themes  were  pre-identified  as  key  areas  covered  in  the  impact  assessment 
exercise.  In  order  to  understand  which  questions  respond  to  the  covered  themes,  each 
survey question was connected to an indicator under each theme. Questions solicited views 
on the general impacts of the policy options and horizontal measures as well as the more 
specific impacts estimated with the financial model.  

73 

 
 
 
 
 
The  questions  asked  in  each  of  the  survey  covered  the  following  themes:  good 
administration,  regulatory  burdens  on  industry,  public  health  and  animal  health,  research 
and  innovation,  functioning  of  the  internal  market  and  competition,  impacts  on  SMEs, 
monitoring and evaluation of the fee system.  

No  duplicates  were  identified  among  the  replies.  However,  several  NCAs  supported  and 
shared the comments submitted by the HMA that represents them. 

ICF launched the targeted surveys on 17 June 2021 via Qualtrics and they remained open 
until 23 August 2021, a period of nine and a half weeks.  

Interviews 
Targeted  interviews  were  undertaken  in  September  and  October  2021,  following  the 
targeted  surveys.  Interviews  were  conducted  with  EMA  (two),  HMA  (one),  individual 
NCAs (seven: AT, BE, CZ, FR, NL, PT, SE) and one pan-European payer organisation.  

These  interviews  built  on  the  replies  to  the  targeted  survey,  giving  interviewees  the 
opportunity  to  emphasise  issues  of  particular  importance  in  their  view,  and  to  provide 
further background to, and explanations of, their survey responses. The topics covered in 
the interviews were: 

a.  consequences  (including  financial)  of  involvement  in  the  centralised,  EMA-level 

activities;  

b.  sustainability  of  the  fee  system:  flexibility  to  adjust  to  significant  changes  (e.g., 
new  activities,  new  legislation,  innovation,  increasing  complexity)  and  related 
indicators, predictability of income;  

c.  administrative burden;  

d.  coherence of the fee system (external and internal); 

e.  impact on fee payers and innovation. e.g. fairness, competitiveness; 

f.  how the policy options compare;  

g.  monitoring and evaluation in a future fee system. 

Limitations  

The  online  surveys  yielded  fewer  replies  than  anticipated,  despite  a  dissemination 
campaign  and  reminder  emails.  This  may  be  due  to  the  topic  being  highly  technical  and 
that the consultation period was during the European summer months. Some stakeholders 
group invited refused to respond to the targeted surveys because of the technical nature of 
the subject matter. A larger number of survey responses would have provided greater depth 
to  the  qualitative  analysis  but  the  coverage  of  stakeholder  interests  was  good,  with  no 
obvious gaps. 

All but one of the organisations approached for interviews responded positively and were 
interviewed.  One  NCA  did  not  respond,  despite  reminders.  Nevertheless,  the  desired 
spread  of  NCA  perspectives  was  covered  by  the  seven  NCAs  that  were  interviewed,  as 
detailed in Section 3 of this Annex, below. 

74 

 
 
 
 
 

Overview of contributions  

Six  key  stakeholder  groups  were  identified  in  the  terms  of  reference:  the  European 
Commission,  EMA,  national  ministries  and  NCAs,  pharmaceutical  industry  for  human 
medicines,  pharmaceutical  industry  for  veterinary  medicines,  industry  representative 
organisations and academia. Responses were received from stakeholders from every group 
except academia.   

Targeted survey 

The  targeted  survey  elicited  31  responses,  of  which  14  included  a  position  paper  as  an 
attachment. Table 3 presents an overview of the contributions to the targeted survey by key 
stakeholder group (as self-identified by the respondents). Of the 31 replies, 24 were from 
NCAs, 6 of which had an interest only in human health, 6 had an interest only in animal 
health  and  12  had  an  interest  in  both  human  and  veterinary  health.  Two  responses  were 
received  from  a  ministry  of  health  and  another  government  institution  (along  with  their 
NCAs),  two  additional  NCAs  provided  their  feedback  as  standalone  documents  to  the 
consultation, and six responses were received from organisations representing fee payers.  

Survey  responses were  received  from  NCAs located in  17 Member States (BE,  BG, HR, 
CY, CZ, DK, FI,  FR, DE,  IE,  IT, MT, NL, PT,  SI, ES, SE)  and two EEA countries  (IS, 
NO).  Separately,  responses  from  the  HMA  and  two  NCAs  were  received  as  standalone 
contributions  (AT,  FR)  Authorities  located  in  the  remaining  9  Member  States  (EE,  EL, 
HU,  LV,  LT,  LU,  PL,  RO,  SK)  did  not  respond.  The  HMA  is  an  umbrella  body 
representing the NCAs, in this consultation the HMA provided feedback presenting these 
NCAs, some of these NCAs also responded individually to the consultation. Organisations 
representing fee payers were all pan-European and based in Belgium.  

Table 2.3 Number of survey contributions by stakeholder group 

Total 

Human 

Veterinary  Human and 
Veterinary 

6 

1 

7 

12 

1 

1 

14 

National Competent Authorities 
(incl. ministries and other 
government institutions) 

24 

6 

Organisations representing fee 
payers and their associations 

EMA 

Total 

4 

6 

1 

31 

10 

Note: ICF analysis of consultation replies. 

Interviews  

75 

 
 
 
 
 
 
Two  interviews  were  undertaken  with  EMA  representatives.  The  first  took  a  strategic 
perspective  and  the  second  was  focused  on  technicalities  of  the  options  and  their 
implementation.  

One  interview  was  undertaken  with  senior  representatives  of  the  Heads  of  Medicines 
Agencies  (HMA).  Four  senior  NCA  managers  were  present,  representing  human  and 
veterinary medicines and both smaller and larger NCAs. With the assistance of the HMA 
eight  NCAs  were  identified  to  interview  so  as  to  cover  a  spread  of  NCA  types  and 
locations.  One  NCA  did  not  respond  to  requests  for  an  interview.  The  seven  NCAs 
collectively covered: 

  NCAs undertaking: human medicine activities only (n=1); human and veterinary 

medicine activities (n=4); and veterinary medicine activities only (n=2); 

  A geographical distribution of NCAs across the EU, covering NCAs in Northern 

and Southern Europe as well as in newer and older Member States; 

  NCAs with different degrees of involvement with EMA; 

  NCAs with different costs and different country coefficients associated with their 

activities. 

The  final  interview  was  with  three  senior  representatives  of  European  Federation  of 
Pharmaceutical Industries and Associations (EFPIA)91. 

 

Analysis of the replies 

The categories of impact that were analysed for each of the policy options and horizontal 
measures for the different responses received from the consultation activities were: 

  Governance and good administration (including financial sustainability) 
  Regulation burdens on business, EMA and NCAs 
  Public health and animal health in the face of emerging risks 
  Research and innovation  
 

Impact on SMEs. 

The analysis also considered the monitoring and adjustment mechanism.  
The  following  subsections  summarise  the  evidence  collected  and  analysed  in  the 
consultation activities for the categories above.  

Governance and good administration (including financial sustainability) 

Over  half  of  the  survey  consultees  found  that  all  options  would  negatively  affect  the 
financial  stability  and  sustainability  of  the  operation  of  EMA  and  NCAs  as  a 
regulatory  network.  The  general  opinion  among  countries  responding  to  the  survey 

91 EFPIA: The federation representing the biopharmaceutical industry operating in Europe. 
Direct  membership  of  national  associations,  pharmaceutical  companies  and  a  growing 
number of small and medium-sized enterprises (SMEs). 

76 

 
 
 
 
 
                                                 
 
questions was that Options 2 and 3 would worsen the current situation. Veterinary NCAs 
believed  that  Option  1  could  bring  positive  impacts  and  rejected  Options  2  and  3.  EMA 
and some NCAs favoured the system’s simplification. Moreover, EMA noted that Options 
2  and  3  would  balance  the  EMA  budget;  however  it  noted  that  they  could  mean  less 
remuneration  for  NCAs  and  this  could  put  at  risk  the  stability  of  the  network.  In  the 
NCAs’  view  (especially  NCAs  undertaking  both  human  medicine  and  animal  medicine 
activities) Option 1 would not guarantee that the costs they incur contributing to network 
activities  will  be  covered.  The  HMA  stated  that  there  are  already  some  difficulties  in 
meeting demand for rapporteurs and co-rapporteurs to carry out assessment activities and 
any option that reduced remuneration of NCAs would worsen this difficulty.  

The  HMA  emphasized  the  importance  of  the  future  fee  system  fairly  remunerating  all 
activities undertaken by NCAs, not just procedural activities. In the opinion of the HMA, 
supported by individual NCAs, reimbursement should be calculated to include other costs; 
if  other  costs  (e.g.,  Committees,  Working  Groups,  additional  EMA  related  activities)  are 
added  to  the  totals,  the  remuneration  paid  by  EMA  to  NCAs  for  undertaking  procedural 
activities for human and veterinary will leave a shortfall.  

Four features of the cost methodology were identified by NCAs and the HMA as leading to 
the cost-based fee options (2, 3 and 3  ’light’)  yielding, in  aggregate, insufficient  funding 
for NCAs: 

  Not all NCAs activities for EMA are remunerated; 
  Not all capacity-related costs are remunerated; 
  The nature of the work undertaken by NCAs means that they use proportionately 

more senior scientific staff than EMA; 

  The cost basis for the financial model is out of date. 

The  first  and  main  theme  raised  in  all  ten  of  the  interviews  conducted  to  follow  up  the 
survey (two with EMA, one with HMA and seven with a range of individual NCAs), was 
the need for any option for the fees and remuneration system to provide sufficient funds to 
NCAs, as well as EMA, to enable them to continue to play a full role in the EMA system.  

EMA  and  HMA  supported  by  all  seven  NCAs  interviewed  stressed  that  options  that 
reduced funding to NCAs in total – Options 2, 3 and 3 ‘light’ – would mean that the EMA 
system would not be sustainable. On these grounds alone, Option 1 was preferred over the 
others because it would yield the highest amount of remuneration of NCAs. However, this 
has to be interpreted not as a preference for the design of the option but rather as a strong 
concern  that  remuneration  should  not  be  reduced  in  any  option  implemented  in  a  future 
proposal. 

Over half of NCAs and one ministry of health responding to the targeted survey indicated 
that  Option  1  would  have  no  impact  on  their  ability  to  undertake  activities.  Some  NCAs 
tasked with veterinary activities expected some positive impact if Option 1 is implemented. 
NCAs overall expected that the implementation of Options 2 and 3 would have a negative 
impact on their ability to undertake EMA activities; only a few NCAs believed Option 2 
could have some positive impact. NCAs believed that Options 2 and 3 could have negative 
impacts,  mainly  because  a  cost-based  approach  method  used  will  result  in  a  decrease  in 
overall reimbursement and reduce the network’s ability to cross-subsidise NCA activities. 
The proposal  to  move to  cost-based fees was also rejected by the HMA  as it results in a 
reduction of income in relation to human medicines.  

77 

 
 
 
Financial predictability 

The  general  opinion  among  the  NCAs  and  one  ministry  of  health  responding  to  this 
consultation  was  that  none  of  the  options  would  improve  the  outlook  or  could  have 
negative  impacts  in  the  financial  predictability  of  their  organisations.  In  their  view,  the 
least  impactful  options  would  be  Options  1  and  2.  Similarly,  none  of  the  organisations 
representing fee payers and its associations believed that these policy option would impact 
their  financial  predictability.  Half  of  the  veterinary  NCAs  had  the  same  beliefs  about 
Options 1 and 2.  

Almost  all  NCAs  and  one  ministry  of  health  interested  on  both  human  and  animal 
medicines believed that  Option  3 would bring negative impact  to  financial  predictability. 
This option was rated more negatively than the other options. To a lesser extent the same 
NCAs  and  one  ministry  of  health  believed  that  Options  1  and  2  would  have  negative 
impacts. Option 2 was believed to have no impacts or negative impacts (here the opinion of 
NCAs was divided).  

Many NCAs indicated that the proposed fixed amounts/fees in Option 1 provide a level of 
predictability  and  would  be  helpful  for  forecasting  veterinary  activities.  However,  for 
veterinary  medicines,  potential  fee  increases  make  predicting  future  income  very 
challenging,  as  NCAs  noted  that  it  is  hard  to  predict  how  companies  will  approach  new 
authorisation applications fees for veterinary medicines under the VMP regulation rules in 
the first place. Option 1 was liked by NCAs expecting an increase in their income or those 
undertaking  veterinary  medicines’  activities,  therefore  Option  3  was  less  liked.  NCAs 
rejecting Options 2 and 3 noted disagreement with the changes on the variation activities 
being included in an annual fee.  

HMA supported by individual contributions of NCAs believed that Option 3 (full version) 
would  have  a  negative  impact  on  financial  predictability.  The  HMA  supported  by  many 
NCAs explained that moving to a cost-based fee system with the proposed methodological 
approach showing in their views that for human medicines fees, as in Options 2, 3 and 3 
‘light’ would reduce the fee income of NCAs. The problem was expected to be most severe 
for  those  NCAs  undertaking  the  most  human-medicine  activities.  However,  moving  to 
cost-based  fees  was  expected  to  increase  income  for  NCAs  undertaking  veterinary 
activities.  

HMA supported by individual contributions of NCAs believed that Option 3 (full version) 
would have a negative impact on financial predictability. Veterinary NCAs considered that 
this  option  would  mean  that  NCAs  receive  less  remuneration  and  would  not  recover  the 
full costs. They also considered that this policy option may work in favour of EMA and its 
future financial position, but not for all NCAs. 

EMA  believed  that  Option  1  would  not  impact  its  financial  predictability  and  Options  2 
and 3 would see financial predictability deteriorate for EMA. It stated that with these two 
options, the proportion of revenue from less predictable procedures would rise from 11% 
(today) to 22%. 

Monitoring and adjustment mechanism  
Survey  respondents  were  asked  to  provide  their  opinion  on  what  indicators  should  be 
monitored  in  respect  of  each  objective  of  the  EMA  fee  system,  in  view  of  future 
amendments to the fee system. Around half of the NCAs responding to these questions did 

78 

 
 
not know what indicators to choose under each system objective. Most of the respondents 
(EMA and NCAs) considered that the indicators should be monitored on a yearly basis. 

NCAs with responsibility for animal medicines tended to see the list of procedures in the 
fee  grid  as  incomplete  or  were  unsure  whether  the  list  of  procedures  in  the  fee  grid 
captured all EMA procedures and that there will be further activities in future that need to 
be recognised beyond DARWIN EU.  

Horizontal measures: country coefficients, reduction of 50% for veterinary fees, cost 
incentives shared between EMA and NCAs 
Country coefficients:  

The consultation activities revealed strong, but not unanimous, opposition to using country 
coefficients. Only a few NCAs showed positive support. EMA and HMA along with four 
of the seven NCAs interviewed (including two NCAs that would gain financially from the 
introduction  of  coefficients  and  two  that  would  lose  out)  opposed  the  use  of  country 
coefficients when determining NCA remuneration. Objections were based mainly on two 
positions:  Solidarity  among  NCAs  and  between  EMA  and  NCAs;  and  the  principle  that 
scientific excellence and desire to contribute should be the sole criteria determining which 
NCAs do which work, not costs. This lack of support contrasts with the general acceptance 
of the principle that fees and remuneration should reflect costs.  

Reduction of 50% for veterinary fees: 
Some NCAs and EMA called for fee reductions to be set at levels different to what they 
are  today.  EMA  explained  that  a  50%  general  fee  reduction  is  not  sustainable  under  the 
different scenarios and would generate a significant negative budget deficit in 2024 as well 
as  significantly  reduced  remuneration  for  the  NCAs.  Some  NCAs  noted  that,  if  fee 
increases  for  veterinary  medicines  caused  by  either  of  the  options  would  deter  some 
veterinary  medicine  companies  from  using  the  EMA  system  (particularly  for  medicines 
with  small  markets)  then  a  general  50%  reduction  would  reduce  the  likelihood  of  that 
happening. 

Cost of incentives shared between EMA and NCAs: 

None of EMA, HMA or the individually interviewed NCAs expressed support for the cost 
of incentives to be shared with NCAs. The HMA and some NCAs, and EMA argued that 
EMA  could  be  recompensed  through  the  financial  contribution  it  receives  from  the  EU 
budget. 

Regulation burdens on business, EMA and NCAs 
All  organisations  representing  fee  payers  thought  Option  2  had  the  highest  potential  for 
negative impacts. Half of the organisations found Option 3 to be the most attractive option. 
The administrative burden of the fee system - currently and under any of the options under 
consideration  -  was  not  a  major  worry  for      the  HMA  or  individual  NCAs.  EMA 
considered that Options 1 and 2 would have a somewhat  negative impact,  as in its view, 
new fees would generate additional administrative work that would not be compensated by 
the  simplification  of  the  fee  structure.  On  the  other  hand,  even  though  Options  3  and  3 
‘light’ could generate additional administrative work, EMA believed these options have the 
potential  to  compensate  the  work  generated  by  some  simplification  of  the  new  proposed 
fee structure or a reduced number of financial procedures. 

Public health and animal health in the face of emerging risks 

79 

 
 
Most  respondents  to  the  consultation  activities  did  not  expect  Option  1  to  change  the 
likelihood of new medicines being authorised in the EU. Most organisations representing 
fee  payers  preferred  policy  Option  3  (with  the  exception  of  an  organisation  representing 
fee payers of animal health products). EMA found that all three policy options could put 
innovation  and  public  health  at  risk  and  the  EU  could  become  slower  in  approving  new 
medicines compared to other region.  

It was also noted – by EMA, HMA and two of the NCAs – that all the options imply large 
increases  in  veterinary  medicine  fees  relative  to  the  current  position,  and  that  this  might 
deter some organisations from seeking authorisation for their veterinary products. 

Research and innovation  
An organisation representing European bio-industries noted that removal of fee incentives 
for  orphan/paediatric  would  not  be  coherent  with  the  objective  of  the  Pharmaceutical 
Strategy for Europe to foster European innovation. EMA found that Options 2 and 3 could 
put innovation and public health at risk. 

Impact on SMEs 
The HMA noted that producers of veterinary medicines may be sensitive to  fee changes. 
One veterinary-only NCA and the HMA noted that fees for new products under all three 
options  may  have  an  unintended  consequence  that  would  affect  certain  animals  (e.g. 
chickens) where the economic value of the treated organism is comparatively small. 

Feedback on the consultation process  

Furthermore,  HMA  and  the  NCAs  consulted,  noted  that  in  their  view  the  cost  exercise 
presented  in  the  consultation  activities  is  flawed  as  it  is  based  on  pre-Brexit  data  (this 
comment does not address the methodological explanations provided on tackling the effect 
of Brexit in the MBDG data set), pre-Covid-19 time data from 2016, and does not reflect 
the  emergence  of  more  complex  procedures  from  the  regulatory  and  scientific  points  of 
view  (however,  no  supporting  data  was  presented).  Therefore,  in  their  opinion,  the 
methodology did not reflect the current situation, including new tasks of NCAs stemming 
from the legal proposal for an extension of the EMA mandate (this comment does not take 
into account the fact that additional remuneration for these new activities has already been 
introduced under the current system and that the regulation on EMA’s reinforced role will 
continue to apply regardless of a revision of the fee legislation, with the respective increase 
in  the  EU  budget  contribution).  In  general,  although  more  specific  comments  and  input 
were  invited,  including  during  interviews  of  NCAs,  no  further  data  or  substantiation  has 
been provided for use by the study model.  

A significant number of stakeholders did not respond to the survey. Reasons given include 
the technical  nature of the subject  matter and that the consultation  period was during the 
European  summer  months.  The  medical  device  industry  did  not  provide  a  reply  to  the 
survey.   

Issues with the fee grids were notified by some respondents, these were addressed by the 
study team and all participating stakeholders were informed of the undated questionnaires 
and fee grids. They were given an extension to provide their replies.  

80 

 
 
 
 
Annex 2.1 Targeted survey – list of stakeholders contacted  

This  annex  contains  the  six  lists  of  stakeholders  invited  to  participate  in  the  targeted 
surveys. In addition to the stakeholders listed below, EMA and HMA were also contacted.  

Table 2.1.1 National Competent Authorities and Ministries  

Institution name 

Austrian Agency for Health and Food Safety (AGES) 

Austrian Ministry of Health (BMG) 

Federal Ministry of Labour, Social Affairs, Health and 
Consumer Protection-Health and Women's Affairs 
(BMEIA) 

Area of 
Interest 
(Human 
health/ 
Animal  
health 
/both) 

Both  

Both  

Country 

Austria 

Austria 

Animal   

Austria 

Federal Ministry of Social Affairs, Health, Care and 
Consumer Protection, Austria (Sozialministerium) 

Human  

Austria 

Federal Office for Safety in Health Care, Austria (BASG)  Both  

Austria 

Federal Agency for Medicines and Health Products 

Animal     Belgium 

Federal Agency for Medicines and Health Products 
(FAGG-AFMPS)   

Bulgaria Drug Agency (BDA) 

Bulgarian Food Safety Agency (BFSA) 

Both  

Belgium 

Human  

Bulgaria 

Animal     Bulgaria 

Ministry of Agriculture, Food and Forestry  

Animal     Bulgaria 

Ministry of Health of Bulgaria  

Agency for Medicinal Products and Medical Devices of 
Croatia (HALMED) 

Human  

Bulgaria 

Human  

Croatia 

Ministry of Agriculture, Veterinary and Food Safety 
Directorate 

Animal     Croatia 

Ministry of Health of Croatia (MIZ) 

Veterinary Services, Ministry of Agriculture, Natural 
Resources and Environment (MOA) 

Human  

Croatia 

Animal     Cyprus 

Ministry of Health of Cyprus 

Human  

Cyprus 

81 

 
 
Institution name 

Country 

Area of 
Interest 
(Human 
health/ 
Animal  
health 
/both) 

Institute for State Control of Veterinary Biologicals and 
Medicines (ÚSKVBL) 

Animal     Czechia 

Ministry of Health, Czechia (MZCR) 

Human  

Czechia 

State Institute for Drug Control, Czechia (SUKL) 

Human  

Czechia 

Ministry of Food, Agriculture and Fisheries 

Animal     Denmark 

The Danish Medicines Agency (DKMA) 

Health Board of Estonia  

State Agency of Medicines 

Both  

Both 

Both  

Denmark 

Estonia  

Estonia 

Finnish Medicines Agency (FIMEA) 

Both   

Finland 

Finnish Ministry of Social Affairs and Health (STM)  

Human  

Finland 

Ministry of Agriculture and Forestry 

  Agency for Food, Environmental and Occupational  Health 

& Safety (ANSES)  

Animal    

Finland 

Veterinary   France 

French Agency for the Safety of Health Products (ANSM)  Human  

France 

French Ministry of Solidarity and Health 

Ministry of Agriculture 

Human  

France 

Animal    

France 

Federal Institute for Drugs and Medical Devices 

Human 

Germany 

Federal Ministry of Food and Agriculture 

Animal   

Germany 

Federal Ministry of Health, Germany (BMG) 

Human  

Germany 

Federal Office of Consumer Protection and Food Safety 
(BVL) 

Ministry of Social Affairs, Health and Integration Baden-
Wurttember, Germany 

Animal  

Germany 

Human  

Germany 

Paul-Ehrlich-Institute (PEI) 

 Human 

Germany 

National Organization for Medicines (EOF) 

Both  

Greece 

Ministry of Rural Development and Food 

Animal   

Greece 

82 

 
 
Institution name 

Country 

Area of 
Interest 
(Human 
health/ 
Animal  
health 
/both) 

Hungarian National Institute of Pharmacy and Food Health 
(OGYEI) 

Human  

Hungary 

National Food Chain Safety Office, Directorate of 
Veterinary Medicinal Products 

Animal     Hungary 

lyfjastofnun (Icelandic Medicines Agency) 

Both  

Iceland 

Ministry of Health, Iceland (HRN) 

Human  

Iceland 

Department of Agriculture, Food and the Marine 

Animal   

Ireland 

Department of Health, Ireland 

Human  

Ireland 

Health Products Regulatory Authority, Ireland (HPRA) 

Both   

Ireland 

Italian Medicines Agency (Aifa) 

Human  

Italy 

Ministry of Health, Directorate General for Animal Health 
and Veterinary Medicines 

Food and Veterinary Service (PVD) 

Ministry of Agriculture 

Ministry of Health of Latvia 

State Agency of Medicines  

Animal   

Italy 

Animal   

Latvia 

Animal   

Latvia 

Human  

Latvia 

Human  

Latvia 

State administration of Liechtenstein - Office of Public 
Health  

Human  

Liechtenstein 

Ministry of Health of Lithuania (SAM)  

Human  

Lithuania 

State Accreditation Service for Health Care Activities 
under the Ministry of Health 

Both 

Lithuania 

State Food and Veterinary Service 

States Medicine Control Agency     

Animal    

Lithuania  

Human 

Lithuania 

Ministry of Health of Luxembourg 

Human  

Luxemburg 

Ministry for the Environment, Sustainable Development 
and Climate Change 

Animal     Malta  

83 

 
 
Institution name 

Country 

Area of 
Interest 
(Human 
health/ 
Animal  
health 
/both) 

Ministry of Health of Malta, Medicines Authority 

Human  

Malta 

Veterinary and Phytosanitary Regulation Department 
(VMANS) 

Ministry of Health and Care Services 

The Norwegian Medicines Agency 

Animal    Malta 

Human  

Norway 

Human  

Norway 

Chief Pharmaceutical Inspectorate of Poland 

Human  

Poland 

Ministry of Health of Poland 

Human  

Poland 

Office for Registration of Medicinal Products 

Human  

Poland 

Office for Registration of Medicinal Products, Medical 
Devices and Biocidal Products 

Medical University of Warsaw 

National Medicines and Health products Authority, 
Portugal (Infarmed) 

Poland   

Poland 

Human  

Poland 

Human  

Portugal 

Portuguese General Directorate of Food and Veterinary 
(DGAV) 

Animal   

Portugal 

Institute for Control of Biological Products and Veterinary 
Medicines 

National Agency for Medicines and Medical Devices of 
Romania 

Animal   

Romania 

Human  

Romania 

National Sanitary Veterinary authority and Food Safety 
Authority 

Animal     Romania 

Institute for State Control of Veterinary Biologicals and 
Medicaments (USKVBL) 

Ministry of Health of Slovakia 

Animal   

Slovakia 

Both 

Slovakia 

State Institute For Drug Control (SUKL) 

Human 

Slovakia 

State Veterinary and Food Administration of the Slovak 
Republic 

Animal    

Slovakia 

84 

 
 
Institution name 

Country 

Area of 
Interest 
(Human 
health/ 
Animal  
health 
/both) 

Agency for Medicinal Products and Medical Devices of 
Slovenia (JAZMP) 

Both 

Slovenia 

Ministry of Health of Slovenia 

National Laboratory for Health, Environment and Food, 
Slovenia 

Ministry of Health of Spain  

Spanish Medicines Agency (AEMPS) 

Human  

Slovenia 

Human  

Slovenia 

Both 

Both  

Spain 

Spain 

Swedish Medical Products Agency (MPA) 

Human  

Sweden 

Medicines Evaluation Board (CBG-MEB) 

Both   

Netherlands 

Ministry of Agriculture, Nature and Food Quality 

Animal     Netherlands 

Ministry of Economic Affairs and Climate Policy 

Animal   

Netherlands 

Ministry of Health, Welfare and Sport of the Netherlands  Human  

Netherlands  

Table 2.1.2 Other Member States' institutions 

Institution name  

Ministry of Foreign Affairs and European Affairs of Slovakia 

Representative of Federal Council of Germany 

Secrétariat Général des Affaires Européennes 

Foreign Affairs, Foreign Trade and Development Cooperation of 
Belgium  

Finnish Ministry of Foreign Affairs (FORMIN) 

Ministry of Foreign Affairs of the Republic of Croatia (MVEP) 

Ministry of Foreign Affairs, Czechia (MZV) 

Country 

Slovakia 

Germany 

 France 

Belgium 

Finland 

Croatia 

Czechia 

Ministry of Foreign and European Affairs of Luxembourg 

Luxembourg 

Hungarian Ministry of Human Resources (EMMI) 

Hungary 

85 

 
 
 
Department of Foreign Affairs (DFA) 

Ministry of Foreign Affairs of the Netherlands 

Ministry of Economic Affairs and Climate Policy 

Romanian Permanent Representation to the EU  

Federal Foreign Office 

Swedish Ministry of Foreign Affairs 

Ministry of Enterprise and Innovation  

Ministry of Foreign Affairs of Latvia 

Hungarian Ministry of Foreign Affairs and Trade (MFA) 

Ireland 

The Netherlands 

The Netherlands 

Romania 

Germany 

Sweden 

Sweden 

Latvia 

Hungary 

Federal Ministry for European and International Affairs (BMEIA) 

Austria 

Spanish Ministry of Foreign Affairs 

Bulgarian Permanent Representation to the EU  

Belgian Permanent Representation to the EU  

Czech Permanent Representation to the EU 

Danish Permanent Representation to the EU 

German Permanent Representation to the EU 

Estonian Permanent Representation to the EU 

Irish Permanent Representation to the EU 

Greek Permanent Representation to the EU 

Spanish Permanent Representation to the EU 

French Permanent Representation to the EU 

Croatian Permanent Representation to the EU 

Cypriote Permanent Representation to the EU 

Latvian Permanent Representation to the EU 

Lithuanian Permanent Representation to the EU 

Spain 

Bulgaria 

Belgium 

Czechia 

Denmark 

Germany 

Estonia 

Ireland 

Greece 

Spain 

France 

Croatia 

Cyprus 

Latvia 

Italy 

Luxembourgish Permanent Representation to the EU 

Luxembourg 

Hungarian Permanent Representation to the EU 

Maltese Permanent Representation to the EU 

Hungary 

Malta 

Dutch Permanent Representation to the EU 

The Netherlands 

86 

 
 
Austrian Permanent Representation to the EU 

Polish Permanent Representation to the EU 

Portuguese Permanent Representation to the EU 

Slovak Permanent Representation to the EU 

Finnish Permanent Representation to the EU 

Swedish Permanent Representation to the EU 

Italian Permanent Representation to the EU 

Austria 

Poland 

Portugal 

Slovakia 

Finland 

Sweden 

Italy 

Table 2.1.3 Industry stakeholders and organisations representing them  

 Organisations/Association name  

Vaccines Europe 

Medicines for Europe 

Alliance for Regenerative Medicine (ARM) 

Affordable Medicines Europe 

Active Pharmaceutical Ingredients Committee (APIC) 

Plasma Protein Therapeutics Association (PPTA) 

Association of the European Self-Medication Industry 

European Paediatric Formulation Initiative (EuPFI) 

European Federation of Pharmaceutical Industries and Associations (EFPIA) 

European Biopharmaceuticals Enterprises (EBE) 

European Alliance for Personalised Medicines (EAPM) 

European Coalition on Homeopathic and Anthroposophic Medicinal Products (ECHAMP) 

Association of Clinical Research Organization (ACRO) 

European CRO Federation (EUCROF) 

European Healthcare Distribution Association (GIRP) 

Parenteral Drug Association (PDA) 

European Federation of Statisticians in the Pharmaceutical Industry (EFSPI) 

Confédération Européenne des Syndicats 

IndustriAll 

87 

 
 
 
European Group for Generic Veterinary Products (EGGVP) 

AnimalhealthEurope 

Animal Cell Technology Industrial Platform (ACTIP) 

European Network of Centres for Pharmaco-epidemiology and Pharmacovigilance (ENCePP) 

The European Association for Bioindustries (EuropaBio) 

Europharm SMC 

European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) 

European Federation for Exploratory Medicines Development (EUFEMED) 

European Quality Assurance Confederation (EQAC) 

Medtech 

COCIR (European Coordination Committee of the Radiological, Electromedical and 
Healthcare IT Industry) 

Team NB (The European Association for Medical devices of Notified bodies) 

Table 2.1.4 Patient and consumer associations and organisations representing them  

Organisation name 

European Patients’ Forum (EFP) 

The European Consumer Organisation (BEUC) 

European Hospital and Healthcare Federation (HOPE) 

International Association of Mutual Benefit Societies (AIM) 

European Social Insurance Platform (ESIP) 

European Renal Association/European Dialysis and Transplantation Association/European 
Renal Best Practice 

Table 2.1.5 Research Associations  

Organisation name  

European Federation for Pharmaceutical Sciences (EuFEPS) 

Federation of European Academies of Medicine (FEAM)  

Science Europe 

European Academy of Allergy and Clinical Immunology (EAACI)  

88 

 
 
 
 
ELIXIR 

Infrastructure for Systems Biology (ISBE) 

ECRIN-ERIC (European Clinical Research Infrastructure Network) 

EATRIS-ERIC (European Infrastructure for Translational Medicine) 

BBMRI-ERIC (European research infrastructure for biobanking) 

European Society of Endocrinology (ESE) 

INFRAFRONTIER 

Network of Coordinating Centres for Clinical Trials (KKS Netzwerk) 

European Renal Association (ERA-EDTA) 

Table 2.1.6 EU level Healthcare Professionals' Associations 

 Organisation name  

Federation of Veterinarians of Europe (FVE) 

Pharmaceutical Group of the European Union (PGEU) 

European Association for Clinical Pharmacology and Therapeutics (EACPT) 

European Respiratory Society 

Comité Permanent des Médecins Européens/ Standing Committee of European Doctors 
(CPME) 

European Union Geriatric Medicine Society 

European Academy of Paediatrics (EAP) 

European College of Neuropsychopharmacology (ECNP) 

European League Against Rheumatism (EULAR) 

European Society for Medical Oncology (ESMO) 

European Society of Cardiology 

European Society of Endocrinology 

European Society of Radiology (ESR) 

European Specialists Nurses Organisations 

European Union of General Practitioners 

European working group on Gaucher Disease 

89 

 
 
 
 
Health Care Without Harm Europe 

International League Against Epilepsy 

United European Gastroenterology (UEG) 

European Academy of Neurology (EAN) 

European Federation of Internal Medicines (EFIM) 

European Association for the Study of Diabetes (EASD) 

European Association of Hospital Pharmacists (EAHP) 

European Association of Urology (EAU) 

European Forum for Primary Care (EFPC) 

European Hematology Association (EHA) 

European Society for Blood and Marrow Transplantation (EBMT) 

International Society for Cellular Therapy Society (ISCT) 

90 

 
 
 
 
ANNEX 3: WHO IS AFFECTED AND HOW? 

Practical implications of the initiative 

1. 
Payers of fees and charges collected by EMA are mainly marketing authorisation holders 
and  applicants.  They  will  have  the  legal  obligation  to  pay  the  applicable  amount  when  a 
submission  is  sent  to  EMA (e.g. request  for a new authorisation  or for  a  variation of the 
terms of an existing authorisation) or when EMA requests the payment of an annual fee for 
an  existing  authorisation.  Such  obligation  is  currently  equally  in  place.  In  all  cases,  an 
invoice  is  sent  by  EMA.  An  invoice  may  group  several  fees.  The  aggregate  annual 
administrative  cost  for  fee  payers  associated  with  the  EMA  fee  system  depends  on  the 
unitary cost to process a payment and on the frequency of such payments. 

Based  on  data  provided  by  EMA,  taking  account  of  all  fee  types  and  charges  foreseen, 
based  on  2021  figures,  the  ‘do-minimum’  baseline  scenario  triggered  32,967  payable 
services (number of unitary fees charged), cumulated in 18,420 invoices to payers of fees, 
i.e. an average of 1.7 unitary fees on one invoice. 

Under  the  preferred  option  3  ‘light’  sub  option  (C1),  procedures  corresponding  to  minor 
(“Type  I”)  variations  and  renewals  will  no  longer  attract  a  fee  per  procedure.92  The 
estimated effect of that would be that the number of payable unitary fees would drop 
from 32,967 to 29,757 and the number of invoices would drop from 18,420 to 17,504 
(decrease of ca. 5%).  

An additional simplification  is  related to  the fact that fees  for initial  applications will no 
longer  be  increased  for  additional  strength,  pharmaceutical  forms  or  presentation,  which 
will  reduce  complexity  and  will  increase  predictability  about  the  amount  that  will  be 
charged.  

The  proposed  measures  will  not  influence,  in  a  substantial  way,  the  safety,  efficacy  and 
quality  of  medicines  and,  therefore,  the  measures  will  not  have  an  effect  on  the  UN 
Sustainable Development Goals. 

Summary of costs and benefits 

2. 
Based  on  a  benchmark  approach93,  it  can  be  estimated  that  an  EU-average  value  for 
administrative cost per invoice is 60€ (or 35€ per fee). On that basis, the initiative does not 

92 This is true for the human  sector, while  the equivalent procedures  will be  discontinued  in the  veterinary 
sector; in parallel, pharmacovigilance fees for veterinary products are introduced in addition to the existing 
system. For these veterinary pharmacovigilance fees, the number of payable services and invoice cannot be 
estimated at the moment. Nevertheless, it is assumed that the frequency of new payments will compensate the 
frequency of discontinued payments and thus the effect of  this particular change on the administrative cost 
related to paying EMA fees will be neutral. This assumption cannot be verified, however, due to the fact that 
for veterinary pharmacovigilance fees, the  number of payable services and invoices cannot be estimated at 
the moment. 
93  EMA  administrative  invoicing  costs  scaled  to  an  average  estimated  level  used  as  a  benchmark  for  EU 
administrative invoice processing cost for the EU. The EMA administrative invoicing costs stem from EMA 
own calculations.  

91 

 
 
                                                 
result in any new additional administrative costs whilst it leads to some minor benefits for 
fee payers (mainly industry), as follows: 

Overview of costs – Preferred option(s) 

Businesses (payers of EMA fees) 

One-off 

Recurrent 

n.a. 

No additional costs 

Payment 
of  EMA 
invoices 

Aggregate 
administrative  
costs 

Overview of Savings (total for all provisions) – Preferred Option(s) 

One-off 

Payment 
of  EMA 
invoices 

Aggregate 
administrative  
costs 

n.a. 

Businesses (payers of EMA fees) 

Recurrent 
Range  from  €54,960  to  €112,350idem  (depending  on  whether 
yearly  administrative  cost  is  estimated  based  on frequency  of 
invoices or of unitary fees) 

The weight of payments processed by SMEs is estimated, based on historic EMA data, at 
13%  of  all  payments.  This  means  that  13%  of  the  estimated  on  administrative  costs  and 
respective savings affect payers of EMA fees that are SMEs .  

Overall,  based  on  the  estimated  overview  of  benefits  in  the  table  above  (i.e.  reduced 
administrative cost related to the preferred option) it can be concluded that the effect of the 
proposal on administrative costs of businesses is neutral (or slightly positive). 

92 

 
 
 
 
 
 
 
 
 
 
ANNEX 4: ANALYTICAL METHODS 

 Introduction 

       91  

1. 
2. 

 

3. 

 
 
 

3.1.1. 
3.1.2. 

Model overview ...................................................................................... 92 
Financial model ....................................................................................... 92 
Model scope ............................................................................................ 94 
Model outputs .......................................................................................... 96 
Key elements of the financial model ....................................................... 96 
Cost model .............................................................................................. 96 
EMA costs ............................................................................................... 97 
NCA costs ............................................................................................. 101 
Revenue model ...................................................................................... 105 
Detailed implementation of the baseline scenario and the policy options
 ............................................................................................................... 112 
  Annex 4, Addendum 1 Fee and remuneration rules under the existing fee system .... 119 
  Annex 4, Addendum 2 NCAs:  participation  in  EMA  committees  and  working  parties 
and activities declared in  addition  to  procedures  –  analysis of relevance 
to the EMA fee and remuneration system ............................................. 121 
  Annex 4, Addendum 3 DARWIN  EU,  its  interplay  with  the  European  Health  Data 
Space (EHDS) and expected annual maintenance cost ......................... 130 

4. 

 

93 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1. 

Introduction 

This  note  provides  a  modelling  methodology  note  for  the  ‘Study  supporting  the  Impact 
Assessment  of  the  Revision  of  the  EMA  Fee  System’.  It  provides  information  about  the 
financial  modelling  undertaken  as  part  of  the  study.  The  financial  modelling  used  in  the 
impact assessment builds on a model (hereafter, the ‘2016 model’) developed for the ‘Study 
for  the  Evaluation  of  the  Fee  System’  conducted  on  behalf  of  the  European  Commission, 
Directorate  General  for  Health  and  Food  Safety  (DG  SANTE).94  The  fee  and  remuneration 
rules of the current Fee and remuneration system are summarised in Annex 4, Addendum 1 to 
this note. 

The financial model is designed to convert data on EMA and associated NCA activities and 
costs  into  cost-based  fees,  and  thereby  to  quantify  the  impact  of  different  options  and 
horizontal  measures  for  the  revision  of  the  EMA  fee  system  on  the  revenues  of  EMA  and 
NCAs  and  the  payments  made  by  fee  payers.  The  model  is  also  used  to  conduct  sensitivity 
analyses  of  the  effects  on  fees  and  financial  flows  of  a  number  of  different  possible  future 
states of the world with respect to key variables including EMA activity levels, and time taken 
per procedure. Impacts are calculated for each option over a five-year projection period from 
2022  to  2026  inclusive  and  compared  to  the  baseline  (a  ‘do-minimum’  scenario),  which 
represents a continuation of the existing fee system over the same period. The accuracy of the 
model in projecting future fees and hence payments by fee payers and the revenues received 
by EMA and NCAs, depends on how accurate the data and assumptions input into the model 
turn out to be in the future. This is a limitation of any model. 

The  model  is  constructed  (in  MS  Excel)  in  such  a  way  that  future,  not  currently  foreseen, 
changes  to  the  fee  system  (including  legislative  changes)  can  be  readily  built  into  it,  for 
example  by  the  addition  of  rows  in  input  and  output  tables  that  relate  to  new  (or  newly 
defined) activities.  

This document provides: 

  An overview of the approach to the financial modelling and how the model is used in 

the impact assessment; 

  An explanation of the financial model, including adjustments made to the 2016 model 

to support the impact assessment;  

  Details  regarding  implementation  of  the  do-minimum  and  the  policy  options  in  the 

model; and 

  Appendices  setting  out  additional  detail  concerning  updates  to  the  model  for  the 

purposes of the impact assessment.   

The  results  of  the  financial  modelling  presented  in  the  final  report  are  based  on  the  data, 
assumptions and implementation of the policy options outlined in this document.  

94 Further information is available in the detailed methodology note for the 2016 model that was provided as a 
formal 
at: 
https://ec.europa.eu/health/sites/default/files/files/fees/evaluation_ema_fee_methodology_en.pdf  

deliverable 

Available 

alongside 

report. 

final 

the 

94 

 
 
                                                 
 
1.  Model overview 

Financial model 

The  financial  model  is  designed  to  calculate  cost-based  fees,  revenues  to  EMA  and 
remuneration to NCAs, and to quantify the impact of different options for the revision of the 
fee  system  on  these  financial  variables.  The  model  is  not  intended  to  replicate  the  financial 
accounting systems of stakeholders. It also does not, and cannot, take account of the impact of 
the timing of payments on stakeholders. In practice, this means that the model considers that 
for all EMA procedures started in a given year the fee is levied by EMA and the remuneration 
to  NCAs  is  paid,  as  relevant,  during  the  same  year.  This  approach  is  appropriate  for  the 
impact assessment as none of the policy options or horizontal measures affects the timings of 
payments. 

The financial model has two parts: 

a)  A cost model of the costs for NCAs to undertake EMA activities that are eligible for 
remuneration  and  for  EMA  to  undertake  its  activities  (NCA  costs  for  national  and 
non-eligible activities are not included): 

  A  costing  methodology  was  developed  to  calculate  costs  for  all  procedural 
activities undertaken by EMA and NCAs using information from EMA and NCAs 
on staff costs, overhead costs and direct non-staff costs, time spent on individual 
activities  and  the  numbers  of  activities  undertaken.  In  this  approach  costs  are 
allocated  to  one  ‘average  scientific  staff  type’  and  one  ‘average  administrative 
staff type’ in each organisation in order to match the type of data available from 
the evaluation on which this exercise builds.  

  Other  costs  are  included  in  the  model  as  inputs.  Costs  for  horizontal  activities 
undertaken  by  EMA  are  provided  by  EMA.  Costs  for  additional  activities 
undertaken  by  NCAs  eligible  for  remuneration  by  EMA  have  been  calculated 
separately and are detailed in Annex 4, Addendum 2 to this note. 

b)  A  revenue  model  of  the  remuneration  income  that  NCAs  receive  from  EMA  for 
procedural  activities  and  the  additional  eligible  EMA  scientific  activities  they 
undertake,  and  the  share  of  total  net  fee  revenue  that  EMA  retains  (i.e.  EMA  fee 
income),  as  well  as  the  European  Union  (EU)  /  European  Economic  Area  (EEA) 
budget contributions to the EMA budget:95 

  The fees paid by the pharmaceutical industry and other fee payers enter the model 
as the total fee revenue that is received by EMA. This revenue is net of incentives 
that  are  applied  in  order  to  reduce  the  level  of  fees  due  for  some  activities  (e.g. 
related to orphan medicinal products) and/or organisations (e.g. SMEs).96 

  NCA income in this model consists of the payments for procedural activities and 
scientific work they receive from EMA.97 (NCA income from other sources, such 

95 In addition, in any year EMA may receive miscellaneous revenue from outstanding invoices, staffing changes 
and minor corrections. As this revenue is small (circa €370 p.a.) and difficult to forecast, it does not impact on 
the integrity of the model and has not been included in the model.  
96 Incentives are targeted reductions applied to unitary fees. 
97  Reimbursement  of  travel  and  hotel  costs,  the  travel  allowance  in  case  of  arrival/departure  outside  of  the 
meeting days and the daily allowance for each day of the meeting are not included as these are separate transfers 
from EMA to NCAs to reimburse expenses not related to specific scientific services (and would be included in 
both the cost and revenue sides of the model for NCAs which neutralises their effect in the model). 

95 

 
 
 
                                                 
as national fees or national budget contributions, is not included as it is not related 
to EMA).  

  EMA fee income consists of the fee revenue it receives, net of incentives, less the 

payments NCAs receive from EMA (remuneration).  

Two rules are implemented in the financial model:  

a)  A  fee  rule  that  establishes  the  unitary  EMA  fees.  Such  fees  are  calculated  by  the 
model under each option, taking into account the estimated costs of EMA and NCAs 
and  the  number  of  procedures  undertaken.  The  model  takes  into  account  the  EU 
budget  contribution  and  implements  the  budgetary  principle  that  all  revenues  taken 
together cover all costs for EMA. EMA fee revenue depends on the fee rules and the 
incentives that are applied to the fees. For the ‘do minimum’ baseline, the unitary fees 
are  those  currently  applying  and  are  therefore  inputs  to  the  model  rather  than 
calculated by the model, and are updated by inflation for future years, as in all other 
options. 

b)  An  NCA  remuneration  rule  that  establishes  NCA  unitary  remuneration  for  EMA 
activities. Such remuneration is calculated by the model under each option, taking into 
account  the  estimated  NCA  costs  for  such  activities.  For  the  do  minimum  baseline 
scenario, remuneration is based on the existing fee system.98 NCA income depends on 
the  remuneration  rule.  EMA  net  fee  income  after  making  payments  to  NCAs  also 
depends  on  the  remuneration  rule,  as  this  rule  determines  the  EMA  costs  for 
remuneration to NCAs for scientific services.  

The model is illustrated in Figure 4.1. Costs and income not included in the model have been 
greyed  out.  Under  the  centralised  system,  NCAs  receive  their  remuneration  for  EMA 
activities from EMA because they contribute to an EMA output: the payment is treated within 
the  model  as  a  transfer  of  income  and  is  therefore  included  in  the  revenue  model  as  a 
reduction in the EMA’s share of fee revenue from industry, rather than as a cost to EMA. The 
same  approach  to  NCA  remuneration  applies  to  all  the  options  considered  in  the  impact 
assessment.     

98 See Annex 4, Addendum 1 to this Annex for more explanation of the existing system.  

96 

 
 
                                                 
Figure 4.1: Schematic presentation of the cost and revenue model 

There  is  no  a  priori  reason  for  the  fee  and  remuneration  rules  to  be  connected.  However, 
legislation states that revisions of the fees levied by EMA should be based on an evaluation of 
both the costs of EMA and the costs of the tasks carried out by the NCAs. In the existing fee 
system, NCA remuneration is linked to the fees charged to industry, as NCA remuneration is 
a  fixed  percentage  of  the  fee  EMA  charges  industry  and  a  fixed  amount  in  the  case  of 
pharmacovigilance activities. Hence the remuneration rule de facto is currently linked to the 
fee  rule.  This  approach  is  applied  in  the  ‘do-minimum’  baseline  scenario.  In  the  policy 
options, the remuneration rule depends on the costs of carrying out the procedures and, for the 
annual fee, the costs of eligible additional activities, and this then determines the fee rule.  

  Model scope 

The financial model for the current study extends the 2016 evaluation model99 in a number of 
ways to support the impact assessment of options for the revision of the legislation governing 
the EMA fee system. 

Firstly,  the  model  takes  account  of  changes  to  the  existing  fee  system  that  have  been 
implemented  since  the  2016  model  (e.g.  scientific  services  related  to  medical  devices)  and 
changes in legislation, in particular the Veterinary Medicines Product (VMP) Regulation that 
comes into force from January 2022 and the changes to the EMA Founding Regulation. The 
model  also  takes  account  of  the  financial  statement  of  the  Regulation  of  the  European 
Parliament  and  of  the  Council  on  a  reinforced  role  for  EMA  in  crisis  preparedness  and 
management  for  medicinal  products  and  medical  devices  (hereinafter  called  proposal  for 
EMA reinforced role). The financial statement  of that proposal  includes three objectives, of 

99 Available at: Evaluation of the European Medicines Agency’s (EMA) fee system (europa.eu)   

97 

 
 
 
                                                 
which  objective  3  has  a  future  impact  on  EMA  fees  (relating  to  EMA  as  a  node  in  the 
European Health Data Space, i.e. DARWIN EU100). 

The  financial  model  is  used  to  quantify  the  impacts  of  four  policy  options  and  a  set  of 
horizontal measures on  EMA, NCAs and industry  stakeholders. Three of the policy  options 
were first described in the Inception Impact Assessment. The fourth was added subsequently 
by DG SANTE. The options as implemented in the model for the present study are described 
in the Final Report. Additional detail of the options’ implementation is provided later in this 
modelling methodology note. The options introduce different possibilities for changes to the 
current EMA fee and remuneration system. The ways in which fees are charged and fees and 
NCA remuneration are calculated are explained below.  

The  impact  of  the  changes  related  to  the  Veterinary  Medicines  Regulation,  the  EU  budget 
contribution  and  the  proposal  for  EMA  reinforced  role  are  modelled  in  the  ‘do  minimum’ 
baseline  scenario,  separately  from  the  impact  of  the  policy  options.  This  ‘do  minimum’ 
scenario  represents  a  continuation  of  the  current  system  but  with  the  inclusion  of  new 
legislation impacting on EMA tasks only, through non-legislative amendments of EMA fees, 
and,  to  the  extent  possible,  the  proposal  for  EMA  reinforced  role  and  updated  EU  budget 
contribution. The impacts of the policy options is thus assessed after taking into account the 
impact of these ‘do minimum’ changes. 

Secondly,  the  list  of  procedural  activities  included  in  the  2016  model  has  been  extended  so 
that  procedural  fees  can  be  calculated  for  all  procedural  activities  undertaken  by  EMA  and 
NCAs, where applicable, as well as annual  fees. New or amended activities introduced as a 
result  of  the  VMP  Regulation  and  the  proposal  for  EMA  reinforced  role  in  relation  to 
EHDS/DARWIN  EU,  have  also  been  included.  These  apply  in  the  ‘do-minimum’  scenario 
and  all  policy  options.101  The  full  list  of  activities  included  is  presented  in  the  fee  grid 
provided  for  each  option,  supplied  as  Excel  files  as  a  supplementary  Annex  to  this  note. 
Activities for which procedures are not expected to be undertaken every year and where the 
volume  is  low  are  designated  ‘infrequent’  activities.  This  means  that  unitary  fees  and 
remuneration  are  calculated  for  these  ‘infrequent’  activities  but  as  their  impacts  are  de 
minimis they are not included in the yearly cost and income calculations for EMA and NCAs 
(see section 2.3).  

In addition, some changes to activities for which procedural fees can be charged are proposed 
as part of the options. These changes are explained later in this note.  

A number of costs to NCAs are excluded from the model, namely:  

  costs  to  NCAs  for  undertaking  roles  for  procedural  activities  that  are  unremunerated 

under the existing system, such as peer review;102  

  costs of time spent in committee meetings and working groups by NCA representatives 

when they are not appointed as rapporteur or co-rapporteur; and  

  some of the additional activities declared by  NCAs as  EMA-related activities, which 
do not meet the criteria for remuneration. These are discussed in Annex 4, Addendum 
2. 

100 See Annex 4, Addendum 2. 
9 Charges for activities are also permitted under changes to the EMA Founding Regulation but no charges were 
put forward for implementation in the modelling exercise. 
102  This  does  not  apply  to  rapporteur  or  co-rapporteur  roles  for  paediatric  or  orphan  medicine  procedural 
activities, for which costs are included in the model. 

98 

 
 
                                                 
Finally, the model has been extended to cover the period 2022 to 2026 inclusive. This five-
year period was selected because: (i) the VMP Regulation starts to apply in January 2022; (ii) 
EMA EHDS  node  activities under the  proposal  for EMA reinforced role  are  expected to  be 
funded through fee income as of 2024; and (iii) it balances the need to consider impacts over 
the  Multiannual  Financial  Framework  (MFF)  budget  period  against  the  robustness  and 
reliability of the forecast activity for EMA and NCAs. 

The existing  system  was  also  modelled using  updated  EMA  data  for  2020,  which  is 
before any changes  resulting from  the VMP  Regulation,  the EMA Founding Regulation  and 
the proposal for EMA reinforced role are introduced. EMA provided aggregate cost data for 
2020,  including staff  costs,  direct  costs,  overhead costs and  costs  of  reimbursing  NCAs  for 
attending  meetings.  Payments  made  to  NCAs  are  not  included  in  these  costs  and  are 
calculated according to the existing system remuneration rules.  

  Model outputs 

The financial impacts are calculated as yearly totals for each year over a five-year period from 
2022 to 2026, for the ‘do minimum’ baseline and for each of the options. For each year, the 
model generates the EMA costs and NCA costs for EMA activities undertaken. These costs 
are  independent  of  the  fee  and  NCA  remuneration  rules  and  are  the  same  for  both  the  ‘do-
minimum’ scenario and the policy options tested.  

The  model  also  generates  the  following  yearly  outputs,  which  depend  on  the  fee  and  NCA 
remuneration rule applied in the ‘do minimum’ baseline and the options: 

Total yearly fees paid to EMA by fee payers.  
EMA yearly fee income, which is the yearly fees paid to EMA net of remuneration paid to 
NCAs. This is used to identify whether EMA’s costs are balanced in the budget by all 
sources of revenue including the agreed EU/EEA budget contributions.   

Total NCA yearly remuneration by EMA (for NCAs undertaking human medicine 

activities only, veterinary medicine activities only, and both human and veterinary 
medicine activities). 

In  addition  to  the  yearly  totals  that  are  used  to  determine  the  financial  impacts  on 
stakeholders, the model also generates: 

  EMA unitary fees: that is, fees before any incentives are applied. These fees are 

generated for each procedural activity included in the fee grids that are provided as 
an output to this study, including centrally authorised products (CAP) and 
(Pharmacovigilance) Pharmacovigilance annual fees. For the cost-based options, 
indicative fees are additionally generated for procedural activities for which fees 
are not currently levied under the existing fee system. 

  NCA unitary remuneration (payments from EMA) for EMA procedural activities 

undertaken and yearly remuneration for additional eligible activities.   

These outputs depend on the fee and remuneration rules and are presented in detailed fee grids 
together with the corresponding incentives.  

2.  Key elements of the financial model 

  Cost model 

The cost model includes the costs for EMA to undertake its activities and costs for NCAs to 
undertake EMA activities.  

99 

 
 
 
2.1.1.  EMA costs 

EMA costs are for the scientific and administrative work that EMA staff undertake as part of 
fee- and non-fee-generating services EMA provides to industry and horizontal activities.  

Costs of fee- and non-fee-generating services 

An activity-based costing methodology was used to determine costs for the EMA’s procedural 
activities (i.e. costs for the scientific and administrative work EMA undertakes as part of fee- 
and non-fee-generating services they provide to industry), including those for paediatric and 
orphan medicines activities. This  approach allocates overhead  costs (i.e.  costs related to  the 
operation  of  an  organisation  –  e.g.  overall  corporate  management,  accounts,  HR  (‘human 
resources’) functions, building rents and maintenance costs – but not directly due to any one 
individual  activity)  as  well  as  non-staff  direct  costs  and  staff  direct  costs  to  individual 
activities,  thus  enabling  cost-based  fees  to  be  calculated  for  individual  activities  in  the 
modelling. 

The costing methodology consisted of two steps: 

Step 1: Determine the full cost per hour of an activity. Salary costs per hour for each of 
two staff types (scientific and administrative) were  calculated from total  EMA salary 
costs divided by total annual number of hours worked (number of full time equivalents 
(FTEs)  x  annual  hours  per  FTE)  for  each  staff  type.  Overhead  and  non-staff  direct 
costs  were  then  allocated  to  each  of  these  staff  types  in  proportion  to  staff  numbers, 
because  overheads  and  non-staff  direct  costs  are  likely  to  be  aligned  with  staff 
numbers. 

Step 2: Multiply full cost per hour by hours spent on an activity. The total time spent on an 
activity by each staff type was determined from the time taken to carry out a procedure 
for  the  given  activity  and  the  number  of  procedures  undertaken.  Total  costs  were 
calculated by multiplying the time taken by the costs per hour for each staff type and 
activity.  

The following data sources and assumptions were used. 

EMA staff were categorised as one of two staff types: scientific or administrative staff. These 
definitions  are  consistent  with  those  used  by  EMA  in  the  2016  MBDG  exercise,  which 
provides the data on time inputs per  activity. This categorisation was made by EMA  and is 
consistent with the overall EMA budget reporting provided to, and checked by, the study team 
as part of this study. 

The annual number of hours worked per FTE is based on 41 working weeks per  year (after 
allowing for holidays, sick leave etc.) of 40 hours per week for both staff types. This is based 
on data provided by EMA for the 2016 model. 

The hourly cost of each staff type was assumed to be independent of the type of activity they 
undertake  (e.g.  the  average  salary  cost  per  hour  of  scientific  staff  time  is  the  same  for  all 
activities). Costs of each staff type not directly involved in scientific activities were included 
as  overhead  costs.  All  reported  EMA  costs  are  allocated  to  either  procedural  activity  or 
horizontal  activity  costs.  This  includes  EMA  staff  time  related  to  committees  or  working 
groups, which are not reported separately by EMA or included as a separate category in the 
model.  

Hourly  cost  data  for  EMA  staff  have  been  derived  from  EMA  budget  data  provided  to  the 
study  team  by  EMA  for  2020  and  EMA’s  forecast  budget  data  over  the  period  2022  to 

100 

 
 
2026.103 The projected costs increase by 5% per annum for labour costs and 2% per annum for 
non-labour  costs  in  accordance  with  EMA  forecasts.  FTEs  data  for  scientific  and 
administrative  staff  types  from  the  2016  model  were  updated  based  on  the  forecast  cost 
increases.   

The  full  list  of  procedural  activities  for  which  costs  are  calculated  are  presented  in  the  fee 
grids. In the fee grids, inspection activities and other EMA fee generating services to industry 
that  do  not  involve  NCAs  are  presented  together  with  human  medicine  activities  for 
convenience, although they may cover both human and veterinary medicines. Costs that were 
allocated  to  CAP  annual  fees  and  NAP  Pharmacovigilance  annual  fees  in  the  budget  data 
provided to the study team form part of the EMA horizontal activity costs104. The projected 
numbers of procedures for each activity for each year from 2022 to 2026 have been provided 
by EMA based on historic data and projections. These are disaggregated by incentive type.  

The MBDG exercise carried out  from  2015 to  2017 by the EMA Management Board is  the 
main  source  of  data  on  time  taken  to  undertake  procedural  activities.  For  those  activities 
where data is not available from the MDBG, including new and amended activities as a result 
of the VMP regulation, suitable ‘comparator’ activities were agreed with EMA and the time 
taken for those comparator activities was used to proxy the time taken. This approach ensures 
that a consistent estimate of the time taken is used for EMA and NCAs for activities where 
both are involved. 

Meeting  cost  data  were  provided  for  each  year  at  an  aggregate  activity  level  (e.g.  scientific 
advice,  marketing  authorisations).  These  reflect  the  cost  to  EMA  of  reimbursing  NCA 
representatives for attending meetings. The meeting costs are then allocated to disaggregated 
activities in proportion to the number of procedures and added to the procedural activity costs. 
To  avoid  calculating  excessive  fees  for  veterinary  activities,  meeting  costs  have  been 
combined and distributed equally across human and veterinary activities where appropriate.  

A scaling factor (of 0.92) was used to match the procedural costs calculated in the model to 
costs  provided  by  EMA  at  the  aggregate  activity  level  for  2020.  The  latter,  2020,  costs  are 
based  on  data  from  EMA’s  financial  accounting  system,  which  has  a  more  detailed  cost 
specification than the model used in this study. This calibration takes account of differences in 
actual time spent and the type of EMA staff working on different activities.  

The costs to EMA of remunerating NCAs for their contribution to EMA activities depend on 
the  remuneration  rule  applied.  The  NCA  remuneration  is  a  cost  reported  in  EMA  budget 
reporting and can be considered as a transfer of fee income from EMA to NCAs, subject to an 
administration cost. 

Costs of EMA horizontal activities 

Horizontal activities of EMA and their costs are shown in Table 4.1, as provided to the study 
team  by  EMA.  Horizontal  activities 
include  product  maintenance  activities  and 
pharmacovigilance  (CAPs)  costs  and  general  Pharmacovigilance  (data  management  and 
databases)  (NAPs)  costs  (human  only)  that  annual  CAP  and  Pharmacovigilance  fees, 

11 These forecasts may not fully align with financial budget forecasts as the full costs of procedures are assumed 
to be covered in a single year in the model, while in reality some costs are distributed over a longer period.   
104 Costs were allocated to CAP and NAP Pharmacovigilance annual fees in the EMA budget data in the study 
for  the  evaluation  of  the  fees  system.  The  study  team  understands  that  these  are  costs  the  annual  fees  are 
intended to cover in the existing system. However, as EMA does not undertake work directly related to annual 
fees, these costs are considered horizontal. 

101 

 
 
                                                 
respectively, are intended to cover under the existing system. For the future  years, there are 
expected  to  be  additional  horizontal  activities  resulting  from  the  VMP  and  the  proposal  for 
EMA reinforced role, and hence there is a further allocation of horizontal costs to human and 
veterinary medicines activities for these in the forecast data provided by EMA. The approach 
to  covering  the  costs  of  EMA  horizontal  activities  under  the  do-minimum  and  the  policy 
options is explained further in the discussion of the revenue model in Section 3.2 of this note 
and in Section 4. 

Costs  associated  with  the  proposal  for  EMA  reinforced  roleare  covered  by  a  corresponding 
increase  of  the  EU  budget  contribution  (see  Table  4.3  in  Section  3.2),  except  for 
EHDS/DARWIN  EU  operating  expenditure  (maintenance  phase),  as  of  2024,  as  per  the 
financial statement of the proposal. For 2022 and 2023, the project phase costs will be fully 
covered by the EU/EEA budget contributions. From 2024 onwards, fee revenue should cover 
the costs of the maintenance phase. It is understood that use of EHDS/DARWIN EU will be 
proportional  to  the  number  of  products  on  the  EU  market  and  is  therefore  likely  to  support 
more  NAPs  than  CAPs.  Therefore,  for  all  the  policy  options,  maintenance  costs  of 
EHDS/DARWIN  EU  (i.e.  objective  3  of  the  financial  statement  of  the  proposal  for  a 
reinforced role of EMA) are allocated to the human Pharmacovigilance annual fee and human 
CAP  annual  fee  in  proportion  to  the  number  of  NAPs  (75%)  and  CAPs  (25%).  More 
information regarding EHDS node reuse data/DARWIN EU activities is presented in Annex 4 
to this note. 

102 

 
 
Table 4.1: Yearly cost (€) for EMA horizontal activities 

EMA activity list 

Total (€) 

2022 

2023 

2024 

2025 

2026 

Typical 
budget 
(2020) 

1.  Product maintenance activities and 

Pharmacovigilance (CAPs) - human  

5,902,000 

6,577,000 

6,873,000 

7,182,000 

7,682,000 

8,202,000 

2. 

Signal detection (CAPs)   

5,667,000 

5,979,000 

6,318,600 

6,673,616 

7,052,545 

7,447,301 

3.  General Pharmacovigilance (data management and 

11,745,000 

12,487,000 

12,839,000 

13,204,000 

13,743,000 

14,223,000 

databases) (NAPs) - (PHARMACOVIGILANCE) - 
human  

4.  Literature monitoring (Pharmacovigilance)  

1,980,000 

2,081,000 

2,130,000 

2,179,000 

2,238,000 

2,293,000 

5.  DARWIN EU (investment and maintenance 

8,000,000 

8,000,000 

16,000,000 

16,000,000 

16,000,000  

expenditure) 

6.  Expenditure related to proposal on extended 

mandate (objectives 1 & 2) 

7.  Product maintenance activities and 

Pharmacovigilance (CAPs) - Vet  

14,090,000 

14,700,000 

15,300,000 

15,300,000 

15,300,000 

1,923,000 

2,501,000 

2,586,000 

2,675,000 

2,900,000 

3,136,000 

8.  Vet public health -product availability/MUMS 

285,000 

306,000 

317,000 

330,000 

346,077 

362,746 

(CAPs) 

9. 

Signal management (vet) (CAPs) 

440,000 

466,400 

494,384 

522,455 

551,699 

10.  Vet public health - AMR - Total expenditure  

626,000 

1,163,000 

1,214,000 

1,268,000 

1,340,884 

1,416,902 

11.  Vet databases (Pharmacovigilance) 

2,500,000 

2,652,250 

2,731,818 

2,813,772 

2,908,910 

2,996,302 

12.  Databases for use outside EMA: EudraVigilance, 

28,524,000 

30,125,750 

30,904,183 

31,701,228 

32,773,090 

33,757,698 

103 

 
 
 
 
  
 
 
 
EMA activity list 

Total (€) 

2022 

2023 

2024 

2025 

2026 

Typical 
budget 
(2020) 

EudraPharm - Corporate  

13.  Guidelines for good practice (including working 

10,745,000 

11,587,000 

11,983,000 

12,396,000 

12,902,000 

13,362,000 

parties) 

14.  (Non-Guideline) Published information for 

7,487,000 

8,230,000 

8,597,000 

8,981,000 

9,314,000 

9,640,000 

healthcare professionals, patients and general public 

15. 

 EU Network Training Centre  

490,000 

528,000 

546,000 

565,000 

588,000 

609,000 

16.  Public Health activities: AntiMicrobialResistance, 
Stakeholders, PRIME( Priority Medicines), Health 
Technology Assessment, and SME etc.  

13,272,000 

14,500,000 

15,252,000 

15,909,000 

16,590,443 

17,288,889 

17.  Vet public health - EU Co-Operation Costs 

527,000  

571,000  

595,000  

620,000  

652,596  

686,464  

18.  Projects which create costs – Innovation Medicines 
Initiatives (IMI), GRIP, European Network of 
Centres for Pharmacoepidemiology and 
Pharmacovigilance (ENCePP)  

19. 

 Transparency on non-fee generating areas e.g. 
Access to documents and publication of clinical 
trials  

5,829,000  

6,383,000  

6,658,000  

6,945,000  

7,276,000  

7,511,000  

6,848,000  

7,716,000  

8,150,000  

8,601,000  

9,071,000  

9,565,000  

20.  International Activities 

4,466,000  

4,842,000  

5,025,000  

5,218,000  

5,458,000  

5,672,000  

21.  Coordination Group (Cmd) Human & Vet 

2,774,000  

2,934,000  

3,009,000  

3,085,000  

3,159,000  

3,243,000  

104 

 
 
 
 
  
 
2.1.2.  NCA COSTS 

NCA  costs  can  be  considered  to  consist  of  three  types:  costs  for  EMA  activities,  costs  for 
other  (non-EMA)  activities  that  NCAs  undertake,  and  overhead  costs.  The  current  study  is 
concerned only with costs for EMA activities by NCAs and the proportion of NCA overheads 
that can be attributed to NCA work for these EMA activities. Costs associated with all other, 
non-EMA, activities undertaken by NCAs are excluded from the model. This is illustrated in 
Figure 4.2. 

Figure 4.2: Cost allocation for NCAs 

NCA  costs  for  undertaking  EMA  activities  cover  procedural  activities  for  EMA-level 
procedures and eligible additional activities (see Annex 4, Addendum 2 to this note). 

Costs for scientific and administrative work on procedural activities  

An  activity  based  costing  methodology  was  also  used  for  NCAs.  The  following  steps  were 
applied to each NCA separately: 

1.  Determine  hourly  costs  of  NCA  scientific  and  administrative  staff  conducting  EMA 

activities.   

2.  Determine the annual cost of EMA-related activities by activity type. This includes not 
only  staff  costs  but  also  non-staff  costs  and  an  allocation  of  overhead  costs,  as 
illustrated in Figure 4.2. 

The following data and assumptions were used. 

Hourly  cost  data  for  each  NCA  have  been  derived  from  aggregate  organisational  cost  data 
collected for the 2016 model.  Twenty-nine NCAs provided data to  that model. The original 
respondents  included  the  two  UK  NCAs.  The  UK  bodies’  time  inputs  contribute  to  the 

105 

 
 
 
 
 
estimates of  average time taken, due to limited sample sizes in  the MBDG exercise. But  as 
UK NCAs no longer contribute to the EMA system, the hourly costs of UK NCA staff have 
now  been  removed  from  the  dataset,  and  the  time  previously  spent  by  UK  NCAs  has  been 
replaced by the same time being allocated to the NCAs that have taken over that work. The 
projection  of  how  EMA  activities  allocated  away  from  the  UK  NCAs  would  be  distributed 
across  other  NCAs  was  provided  by  EMA.  Thus,  the  estimates  of  average  NCA  costs  per 
activity in the financial model no longer take into account the UK organisations’ staff costs 
per hour but only the staff costs per hour of the NCAs that conduct the work in future. For the 
remaining 27 NCAs, cost information is based on that which was provided by the NCAs for 
the calendar year 2016 for the evaluation exercise. The information included salary, overhead 
and non-staff costs, FTEs and annual hours worked for the two scientific and administrative 
staff types. 

For  the  NCAs  that  provided  data,  overheads  and  non-staff  costs  were  added  to  the  annual 
salary  costs  to  determine  the  annual  costs  of  undertaking  EMA  activities  for  two  different 
staff types:  administrative and scientific. The cost  per hour of EMA activities for each staff 
type  was  calculated  by  dividing  the  annual  costs  by  the  annual  hours  worked.  The  cost  per 
hour  was  then  multiplied  by  a  factor  of  1.2  to  allow  for  FTEs  working  on  EMA  activities 
being  more  senior  than  the  average  level  of  staff  in  the  NCAs  and  spending  some  time  on 
non-assessment activities (such as administrative tasks).  
For NCAs that did not provide data to the 2016 model,105 the average cost/hour of NCAs that 
did  provide  data  has  been  applied.  This  average  cost/hour  was  also  used  to  calculate  cost-
based fees for infrequent activities. 

To determine hourly costs for the period 2022 to 2026, the 2016 cost data of all NCAs (both 
those who have provided data and those who have not) have been increased in the same way 
as  EMA  costs:  by  an  assumed  5%  per  annum  for  labour  costs  and  2%  per  annum  for  non-
labour costs since 2016. This applies to both procedural cost and additional costs.  These are 
the same rates of cost increase that were applied to EMA costs (see section 3.1.1). They have 
also been used for NCAs for consistency as no new cost data was collected from NCAs in this 
study.  In  addition  to  this  adjustment  for  inflation,  projected  NCA  staff  costs  have  been 
multiplied  by  a  further  factor  of  1.2,  to  allow  for  NCAs  on  average  allocating  more  senior, 
and  hence  more  costly,  staff  to  EMA  activities  (based  on  NCA  responses  to  the  targeted 
consultation exercise).  

Beyond  the  above  updates,  the  2016  cost  data  of  all  NCAs  (both  those  who  have  provided 
data  and  those  who  have  not)  have  been  increased  in  the  same  way  as  EMA  costs:  by  an 
assumed 5% per annum for labour costs and 2% per annum for non-labour costs since 2016. 

The  term  ‘procedural  role’  is  used  for  each  instance  that  an  NCA  undertakes  a  particular 
assessment activity within a procedure. NCAs undertake two types of procedural roles that are 
remunerated under the existing system. These are rapporteur or equivalent lead role and co-
rapporteur or equivalent role. For any given type of procedure, a number of NCAs may carry 
out  different  procedural  roles.  For  example,  for  five  procedures  of  the  activity  ‘Type  II 
variation  –  level  I’,  NCA  X  could  undertake  three  rapporteur  roles,  NCA  Y  two  rapporteur 
roles  and  NCA  Z  five  co-rapporteur  roles.  Some  activities  only  have  rapporteurs  and  some 

105 Study for the evaluation of the EMA fee system – Methodology note. SANTE/2016/B5/021, December 2018, 
https://op.europa.eu/en/publication-detail/-/publication/15cbe704-d9d0-11e9-9c4e-
available 
01aa75ed71a1/language-en  

at: 

106 

 
                                                 
always  have  both  rapporteurs  and  co-rapporteurs.  This  was  confirmed  by  EMA  for  each 
activity and is reflected in the fee grid produced by the model for each option. 

For  a  given  type  of  procedural  activity  and  role,  the  total  cost  of  a  given  NCA  in  a  year  is 
calculated  based  on  the  average  time  taken  of  the  procedural  activity  multiplied  by  the 
number  of  procedures  undertaken  in  the  year.  These  costs  are  summed  across  the  different 
roles  (rapporteur,  co-rapporteur  and  equivalents)  and  activities  to  provide  the  total  yearly 
procedural activity cost of a given NCA. The procedural activity costs include rapporteur and 
co-rapporteur roles, as well as peer review roles, in line with MBDG data. Other activities that 
are undertaken in addition to the remunerated roles for a given activity are not included in the 
procedural  activity costs (however, please see below the eligible  additional activities costs). 
The total yearly activity costs are presented separately for human and veterinary medicines in 
the  model’s  output  tables.  A  weighted  yearly  average  cost  per  procedure  for  each  type  of 
procedural  activity  is  calculated  from  the  total  yearly  cost  divided  by  the  number  of 
procedures. 

As different NCAs have different costs for the same procedure, the distribution of procedures 
across NCAs affects the total cost of NCAs work on EMA activities in a year. (Note that post-
Brexit,  no  EMA  activity  in  2022-2026  is  projected  to  be  undertaken  by  UK  NCAs).  The 
distribution  of  rapporteur  and  co-rapporteur  roles  across  NCAs  is  derived  from  ‘purchase 
order’  data  (i.e.  data  on  actually  recorded  procedures)  provided  by  EMA,  supplemented  by 
information reported in the survey of NCAs for  the 2016 model for those activities, such as 
paediatric  and  orphan  medicines  activities,  for  which  NCAs  undertake  rapporteur  or  co-
rapporteur roles but these are unremunerated under the current system.106 This distribution is 
scaled  to  the  forecast  total  number  of  procedures  for  each  activity  provided  by  EMA 
according to available information.  

The 2016 MBDG exercise is the main source of time input data for procedural activities for 
NCAs. The MBDG exercise was a major undertaking, providing time input data at a granular 
level,  and  has  not  been  repeated.  Hence  the  2016  MBDG  data  are  the  best  time  input  data 
currently available. For the 2016 model, data from the MBDG exercise was used to calculate 
an NCA average time for rapporteurs and co-rapporteurs separately for a given activity that 
was used as the default for each NCA in the model.107 As discussed for EMA, time data from 
comparator  activities  for  both  EMA  and  NCAs  have  been  used  where  appropriate.  More 
detailed information on the time data for activities included in the 2016 model and used in this 
study can be found in the Methodology Note published with the EMA Fee System Evaluation 
in 2018.108 

NCA costs for additional activities eligible for EMA remuneration 

In addition to procedural activities, the evaluation study estimated overall costs (for all NCAs 
taken together) for two other groups of activities:   

106  Purchase  orders  (POs)  are  a  commitment  for  future  payment  to  NCAs  by  EMA.  Under  the  existing  fee 
system,  one  purchase  order  is  sent  out  for  each  rapporteur,  co-rapporteur  or  equivalent  remunerable  role 
undertaken by NCAs for a given procedure.  
107  The  MBDG  time  input  data  include  data  from  the  UK  NCAs,  MHRA  and  VMD,  and  this  has  not  been 
excluded from the time data used due to the limited sample size.  
108  RAND  Europe,  2018,  Study  for 
the  evaluation  of 
(SANTE/2016/B5/021).  

the  EMA  fee  system:  Methodology  note 

107 

 
                                                 
 

time spent by NCA representatives in committees and working groups of EMA, 
without being in charge of an assessment procedure (cost estimated based on 
respective MDBG time collected); and  

  a range of ‘additional activities’ reported by NCAs as related to the EMA fees system 
in the evaluation study (cost estimated as a remainder of an overall cost related to 
EMA reported by NCAs).  

These  costs  have  been  increased  for  inflation  in  the  same  way  as  the  costs  for  procedural 
activities.  The  additional  EMA  activities  of  NCAs  that  are  considered  eligible  for 
remuneration  from  EMA  fee  revenue109  are  allocated  across  NCAs  in  proportion  to  the 
rapporteur and co-rapporteur ‘purchase orders’ for CAP annual fees for human and veterinary 
products  and  are  reflected  in  the  annual  remuneration  presented  in  the  fee  grids  that  are 
produced as outputs by the model. The rationale for this allocation is based on the observation 
during the evaluation study that the level of additional activities increases in proportion to the 
level of involvement in procedural activities. 

.  

For NCAs responsible for veterinary medicines, the introduction of the VMP regulation rules 
is  expected  to  result  in  changes  in    pharmacovigilance-related  costs  with,  on  one  hand,  an 
increase for updates by NCAs to the EU pharmacovigilance database and, on the other hand, a 
decrease  due  to  the  discontinuation  of    Periodic  Safety  Update  Reports  for  CAPs  (PSUR) 
activities. The total yearly PSUR costs that NCAs incur under the existing system have been 
used as a proxy for the additional costs and are allocated across NCAs in proportion to the co-
rapporteur  ‘purchase  orders’  for  CAP  annual  fees  for  veterinary  products  and  are  reflected 
accordingly  in  the  respective  annual  remuneration  presented  in  the  fee  grids  produced  as 
model outputs. 

As is more fully explained in Section 6.2.1 of the Final Report, the analysis of the stakeholder 
opinion gathered during the consultation process for the impact assessment indicated a broad 
consensus that the cost  of additional NCA activities eligible for remuneration by EMA, and 
therefore included in the annual fee calculation, was underestimated in the interim fee grids 
presented  for  the  consultation.  The  approach  to  determining  what  portion  of  additional 
activities would be eligible for remuneration through EMA fees was reviewed by DG SANTE 
taking  into  account  the  feedback  to  the  consultations.  As  a  result,  a  revised  approach  was 
applied, which preserves the approximately 1/4 ratio of NCA remuneration from annual fees 
to NCA total remuneration that exists in the ‘do minimum’ baseline. This implies increasing 
annual fees and de facto maintains NCA remuneration in aggregate at the level it would be in 
the ‘do minimum’ scenario. The resulting adjusted annual remuneration of NCAs as estimated 
by  the  financial  model  still  falls  within  the  overall  maximum  cost  envelope  originally 
estimated for all additional activities (see Table 4.2.1 in Annex 4). 

 Revenue model 

The revenue model includes: 

  EMA fee income, which is the share of total fee revenue that EMA retains after 

remunerating NCAs for the EMA activities they undertake and after fee reductions 
due to incentives; and 

109 See Annex 4, Addendum 1. 

108 

 
 
                                                 
  EU/EEA budget contributions.110  

NCAs’ income is also calculated as the remuneration they receive from EMA for their EMA 
activities111.  

There are three stages to the revenue model, as detailed below. 

First, EMA receives fees from undertakings for the services it provides. The total fees paid by 
industry  depend  on  the  fee  rule,  the  fee  reductions,  referred  to  as  ‘incentives’,  and  the 
number of procedures for a given activity. The fee rule determines the full fee, which is the 
maximum fee that could be paid. Incentives (discounts or waivers) are applied to the full fees 
depending on the nature of the product and of the organisation paying the fee (e.g. whether it 
is an SME), as well as for other reasons. For a given activity, the model calculates the unit full 
fee, which is the full fee per procedure before any incentive, (i.e. discount or waiver), as well 
as the total fees paid by industry in a year. Three types of fees may be covered by the fee rule. 
These  are  procedural  activity  based  fees  for  CAPs  charged  per  procedure,  annual  fees  for 
CAPs charged per authorisation and annual Pharmacovigilance fees for nationally authorised 
products  (NAPs)  charged  per  chargeable  unit  as  defined  in  Article  2(1)  of  Regulation  (EU) 
No 658/2014.  

Second,  NCA  income  takes  the  form  of  a  payment  from  EMA  to  provide  remuneration  to 
each  NCA  for  the  EMA  activities  it  has  undertaken.  The  amount  of  this  payment  is 
determined by the remuneration rule.112 EMA’s net fee income is calculated as the total fee 
revenue minus the NCA remuneration minus fee incentives applied. For EMA and each NCA, 
fee  income  from  annual  fees  and  procedural-activity  based  fees  are  provided  separately  for 
both human and veterinary medicines.113 

In  addition  to  revenue  from  its  share  of  industry  fee  income,  EMA  receives  EU  and  EEA 
budget  contributions  (hereafter  ‘EU  budget  contribution’).  The  EU  budget  contributions 
foreseen for the upcoming period (as provided by DG SANTE) are shown in Table 4.3.  

EMA  fee  income  is  calculated  from  the  unit  fee,  the  number  of  procedures  (or  number  of 
products for the annual fees) and the incentive rates. The EU budget contributions include a 
specific  component  for  DARWIN  EU114  in  2022  and  2023  to  offset  the  costs  incurred  by 
EMA for that purpose (project phase). This is replaced by fee income as of 2024. 

Table 4.3: EU/EEA yearly budget contributions (€) to EMA 

EU/EEA budget contributions 

2022 

2023 

2024 

2025 

2026 

110 Miscellaneous revenue to EMA is not included in the model because it is de minimis. 
111  In  line  with  EMA  budgetary  reporting,  this  is  considered  as  equivalent  to  EMA  expenditure  for  NCA 
remuneration. 
112  NCA  delegates  are  additionally  also  reimbursed  by  EMA  for  travel  and  subsistence  costs  for  attending 
meetings. This is included in the costs to EMA but is not included in the NCA income or costs in the model (as 
the  income  would  exactly  balance  the  cost  in  each  instance  and  so  has  no  effect  on  any  of  the  options  whose 
impact is being assessed). 
113  The  exception  is  inspections,  for  which  human  and  veterinary  procedures  are  not  distinguished  at  the 
aggregate level. 
114 Data Analytics and Real World Interrogation Network: allow timely access and analysis of EU-wide health 
data to support better decision-making throughout the product lifecycle on medicines with valid and reliable real 
world evidence  

109 

 
 
                                                 
Initial MFF proposal non-orphan  

22,500   22,500   18,700   18,700   18,700  

Initial MFF proposal - orphan medicines 
contribution 

EMA Reinforced Role proposal (objectives 
1&2)  

 EMA Reinforeced Role proposal, specifically 
for Node reuse data* (specific objective 3, 
DARWIN EU) 

14,000   14,000   14,000   14,000   14,000  

22,090   22,700   15,300   15,300   15,300  

8,000   8,000  

0  

0  

0  

TOTAL 

44,590   45,200   34,000   34,000   34,000  

Finally, in the financial model for EMA, revenues are compared to costs to determine whether 
the budget is balanced, so that EMA total revenue matches its costs. Under the ‘do minimum’ 
baseline,  and  given  the  EU  budget  contributions  presented  in  Table  4.3,  no  additional 
mechanisms  beyond  reducing  costs  are  available  to  balance  the  EMA  budget,  and  costs  are 
assumed fixed for the purposes of the study. A budget excess or deficit may therefore occur 
for a projection year in the ‘do minimum’ baseline. However, under the policy options, annual 
CAP  fees  are  calculated  to  balance  the  EMA  budget  after  taking  into  account  cost-based 
procedural and pharmacovigilance fees and EU budget contributions. 

The EMA fee income, NCA remuneration (total for all NCAs contributing to EMA activities) 
and EU budget contributions that are used in the revenue model are yearly totals. To compare 
the policy options against the ‘do minimum’ baseline, an approach was developed to compare 
the  impact  of  introducing  cost-based  fees  and  remuneration  over  the  five-year  projection 
period  (2022-2026),  updated  annually  by  inflation.  The  revenue  model  was  used  to  balance 
the EMA budget for the central  year of the forecast period (2024) only. The cost-based fees 
and remuneration amounts calculated by the model for the central year, adjusted by inflation, 
were then used to determine the impact over the five-year period (2022-2026) for the different 
stakeholders, given the outputs of the model for each year.     

The details of the fee and remuneration calculations and the role of fee reductions for the cost-
based  options  are  provided  in  the  following  sections.  The  existing  fee  system  rules  are 
presented in Annex 1 to this note.  

EMA fees 

In the model, under the current fee system, there is a single basic fee for each activity that is 
updated for inflation each year.115 For the assessment of the impact of each policy option, a 
single fee is likewise determined. To do this the fees that balance the EMA budget for 2024 
(the  central  estimate  for  the  study  model)  are  calculated.116  These  are  then  adjusted  for 

115 The fee may be increased for additional strengths and presentations for some activities or number of active 
substances. The fee grids presented under each option represent the detailed fee grid that would be implemented 
under the legislation for that option. 
116  For  option  1,  only  part  of  the  EMA  budget  deficit  that  is  allocated  to  veterinary  medicines  based  on  their 
share  of additional EMA activities is balanced, as the  existing system  still applies  for human  medicines  under 
this option. 

110 

 
 
                                                 
inflation and used to calculate the stakeholder impacts for each year modelled.117 As a further 
step,  based  on  the  analysis  of  these  impacts  and  feedback  from  the  targeted  consultation, 
single  fees  may  be  replaced  by  fee  bands  for  some  activities,  provided  that  the  legal 
instrument can accommodate such a choice.  

Under the current  fee system some fees can be varied depending  on the number of different 
presentations and dosage strengths of the medicine to be marketed. In the model, however, we 
just calculate a single basic fee. No variations to the basic fee are calculated by the model for 
the cost-based options as no data are available on the different time inputs needed for different 
presentations  and  dosage  strengths.  There  are a  number  of activities  for  which  different  fee 
levels apply under the existing system and similarly there are three different levels of annual 
fees for human medicines and two levels  of annual  fees for veterinary medicines. For these 
activities,  the  ratios  between  the  different  levels  of  each fee in  the  current  fee  system 
have been used to derive corresponding fee levels in the model.118  

Under the cost-based options (i.e. Options 2, 3 and 3  ‘light’), rules are also implemented to 
allocate EMA horizontal costs to  human and veterinary medicines  (specifically  to  CAP  and 
Pharmacovigilance annual fees) based on which products the type of activity is addressed to. 
The allocation is  shown  in  Table 4.4. The remaining horizontal costs (as per Table 4.2)  are 
allocated to human  and  vet  CAP  annual fees in  the ratio 85% to  15% based on the relative 
number of CAPs and NAPs.119 

Table 4.4: Allocation of horizontal costs to CAP and Pharmacovigilance annual fees 

Product maintenance activities and 
Pharmacovigilance (CAPs) - human  

Signal detection (CAPs)   

Genral Pharmacovigilance (data management 
and databases) (NAPs) - 
(PHARMACOVIGILANCE) - human  

Literature monitoring (Pharmacovigilance)  

DARWIN EU (as of 2024) 

Product maintenance activities and 
Pharmacovigilance (CAPs) - Vet  

Vet public health -product availability / 
MUMS (CAPs) 

Signal management (vet) (CAPs) 

Vet public health - AMR - Total expenditure  

Vet databases (Pharmacovigilance) 

CAP 

100% 

100% 

25% 

100% 

100% 

100% 

75% 

Pharmacovigilance 

100% 

100% 

75% 

25% 

100% 

117 Inflation rates are based on ECB staff macroeconomic projections for the euro area, March 2021 (europa.eu) 
with the 2024 forecast of 1.4% per annum assumed to apply also to 2025 to 2026.  
118 Scientific services – PMF, scientific services traditional herbal, scientific services certification for advanced 
therapies, pharmacovigilance referrals and annual CAP fees. 
119 Objectives 1 & 2 expenditure is offset by EU/EEA budget contributions. 

111 

 
  
 
 
 
 
 
 
 
 
                                                 
Fee reductions 

Reduction rates from the current fee system are applied to the ‘do minimum’ baseline and all 
options for human medicines. For veterinary medicines, the existing system applies in the ‘do 
minimum’  baseline  but  changes  to  these  incentives  are  applied  in  the  policy  options  in 
connection to the overhaul of the veterinary sector stemming from the VMP regulation. This 
is  because  a  number  of  horizontal  measures  with  different  combinations  of  specific  and 
general  reductions are implemented in Option 1. As the impact of the incentive and general 
reduction horizontal measures could be assessed using the model results from Option 1, only 
SME incentives are carried forward to Options 2, 3 and 3  ‘light’ in the model. The changes 
implemented  in  Options  2,  3  and  3  ‘light’  can  then  be  compared  with  Option  1  with  a 
common set of incentives. 

Under  the  current  fee  system  nearly  all  incentives  are  borne  by  the  EMA  budget  (NCA 
remuneration  is  not  reduced  by  incentives),  except  for  pharmacovigilance  fees.  In  the  cost-
based options, two approaches are implemented for all fees: the main option, in which the cost 
of incentives is borne by EMA budget alone, and a horizontal measure, in which the cost of 
incentives is shared with NCAs, i.e. NCA remuneration is reduced in the same proportion as 
the  fee  reduction  and  the  burden  of  the  fee  reduction  is  thereby  shared  proportionately 
between  EMA  and  NCAs.  In  the  fee  grids,  the  fee  and  remuneration  amounts  before  any 
incentives  are  applied  are  presented  in  a  separate  row  for  each  procedural  activity.  The 
incentives  that  should  be  applied  to  the  fees  are  provided  in  subsequent  columns.  These 
incentives are applied to the fees in all cases. They are only applied to the NCA remuneration 
for the horizontal measure where the cost of incentives is shared between EMA and NCAs. 

The  incentives  in  the  ‘do  minimum’  baseline  and  the  policy  options  are  presented  in  the 
corresponding fee grids output by the model. 

NCA remuneration 

EMA makes payments  to  NCAs to  remunerate them for the provision  of scientific  services. 
Under the existing system these payments are covered by specific rules as outlined in Annex 
4, Addendum 1. These are implemented in the model for the ‘do minimum’ baseline scenario. 
These remuneration amounts are adjusted for inflation each year. 

For  the  cost-based  options,  NCA  remuneration  for  a  given  activity  is  determined  from  a 
weighted average of NCAs’ costs that typically undertake the activity, and the time taken to 
undertake it. The remuneration differs between activities because these take different amounts 
of  time  to  complete  and  because  NCAs  have  different  costs.  As  discussed  in  Section  3.1.2, 
purchase  order  data  are  used  to  determine  the  distribution  of  rapporteur  and  co-rapporteur 
roles  across  NCAs  for  a  given  activity  that  are  used  in  this  calculation  in  the  model.  For 
infrequent activities, a simple average cost is used.  

Purchase order data are not available for activities for which NCAs are not remunerated under 
the  current  system.  For  these  activities  remuneration  is  calculated  under  the  cost-based 
options.  Self-reported  data  from  the  NCA  survey  collected  during  the  ‘Study  for  the 
Evaluation of the Fee System’ (being the most recent data available from NCAs overall) are 
used to provide a distribution of roles across NCAs for this purpose. This distribution is then 
scaled to match the total number of procedures for the activity provided by EMA. The data 
are then used in the same way as the purchase orders data to calculate the weighted average 
costs that determine the remuneration amounts and to allocate the remuneration across NCAs. 

In line with the approach to the fee calculations, a corresponding NCA remuneration amount 
is  first  identified  for  each  relevant  procedural  activity  under  each  policy  option;  this  is  the 

112 

 
 
cost-based  unit  remuneration  for  2024.  These  figures  are  adjusted  for  inflation  and  used  to 
calculate the impacts for each of the other years modelled. The assumed inflation rate is 1.2% 
per annum up to 2024 and 1.4% per annum after that. A specific inflation update was used for 
2020 and 2021 closer to the finalisation of this Staff Working Document, based on actual the 
inflation rate used for the update of EMA fee regulation in 2022, which was higher than the 
initial estimations. 

Under  the  policy  options,  when  cost-based  remuneration  is  introduced,  the  calculated 
remuneration  for  rapporteur  and  co-rapporteur  roles  may  be  different  if  they  do  not,  on 
average, spend the same amount of time on an activity, as revealed by the MBDG exercise. 
Remuneration  for  co-rapporteur  roles  is  constrained  to  always  be  less  than  or  equal  to 
remuneration for rapporteur roles. All NCAs continue to receive the same level of payment as 
one  another  for  each  of  these  roles.  An  alternative  approach  is  tested  in  the  horizontal 
measures where country coefficients are applied (see below). 

Remuneration is then allocated across NCAs in the same way as under the existing system for 
procedural  activities,  i.e.  to  the  NCA  of  the  rapporteur/co-rapporteur  (where  relevant)  or 
similar role (e.g. lead role in scientific advice). The allocation is based on the distribution of 
purchase orders or self-reported survey data used in  the cost  calculations.  Remuneration for 
eligible additional costs is covered by the annual CAP fees remuneration and is allocated in 
proportion  to  the  corresponding  rapporteur  and  co-rapporteur  activity  levels  (based  on 
purchase order data). In Options 3 and 3 ’ light’, the annual remuneration also covers the costs 
of some procedural activities that are no longer remunerated directly in those options. 

For  veterinary  medicines,  given  the  overhaul  of  the  pharmacovigilance  system,  the 
remuneration also covers pharmacovigilance-related costs that are proxied by the PSUR costs 
incurred  by  NCAs  under  the  current  system.  In  addition,  the  veterinary  annual  fee  covers 
relevant eligible additional activities. 

NCA unitary remuneration for rapporteur and co-rapporteur (or equivalent) roles is presented 
in the fee grids for the policy options. 

Two  possible  adjustments  to  NCA  remuneration  are  considered  as  part  of  the  horizontal 
measures:  

  NCAs  share  the  cost  of  incentives  applied  to  fee  income  with  EMA,  so  that  NCA 

remuneration is reduced accordingly. 

  Each NCA’s remuneration is scaled by a country-specific coefficient so that different 
NCAs  receive  a  different  level  of  remuneration  for  the  same  activity.  Country 
coefficients similar to those used by the European Chemicals Agency (ECHA), based 
on the country  correction coefficients  used by the European Commission,  have been 
adopted for this study as these cover almost all NCAs. The coefficients are presented 
in Table 4.5.120   

These  adjustments  to  NCA  remuneration  affect  fees  because  they  change  the  EMA  budget 
deficit in the model that has to be balanced. In the results presented in the Final Report, only 
the  annual  CAP  fees  are  used  to  balance  the  EMA  budget  and  therefore  only  these  fees 

120 ECHA Country coefficients. Available at: 
https://echa.europa.eu/documents/10162/2792271/FINAL_MB_36_2017_Transfer_of_Fees_revised_decis
ion_signed_at_MB48_en.pdf/235fdafe-6652-6c44-dc60-2412e504903c. For Liechtenstein, a value of 100 
was assumed. 

113 

 
                                                 
change;  procedural  fees  remain  as  calculated  under  the  cost-based  principle  as  explained 
above.  

As  far  as  possible,  under  the  cost-based  options,  the  annual  CAP  fees  for  human  and 
veterinary  activities  are  used  to  cover  the  costs  for  human  and  veterinary  activities, 
respectively. In each case, a share of the EU budget contribution is added to the revenue from 
fees for procedural activities to cover the cost of incentives and EMA horizontal activities. As 
shown  in  Table  4.4,  some  horizontal  activity  costs  are  designated  as  human  or  veterinary 
related.  In  the  model  it  is  assumed  that,  from  the  EU  budget  contribution,  all  the  orphan 
designation contribution and 85% of the remaining EU budget contribution are added to the 
human procedural fees, and 85% of the horizontal activity costs, not pre-assigned to human or 
veterinary activities, are considered to be human activity costs. The remaining 15% of the EU 
budget contribution and 15% of the horizontal costs are allocated to the veterinary activities in 
the  same  way.  This  allocation  was  agreed  with  EMA  and  reflects  the  relative  size  of  the 
human and veterinary workloads.  

Table 4.5:  Country-specific scaling coefficients 

Country 
Austria 
Belgium 
Bulgaria 
Croatia 
Cyprus 
Czech Republic 
Denmark 
Estonia 
Finland 
France 
Germany 
Greece 
Hungary 
Ireland 
Italy 
Latvia 
Lithuania 
Luxembourg 
Malta 
Netherlands 
Poland 
Portugal 
Romania 
Slovakia 
Slovenia 
Spain 
Sweden 
Norway 
Iceland 

Coefficient 
105 
100 
51 
74 
74 
73 
133 
78 
119 
114 
96 
79 
70 
118 
98 
73 
70 
100 
86 
108 
67 
81 
64 
76 
81 
88 
127 
136 
134 

ECHA Country coefficients. Available at: 
https://echa.europa.eu/documents/10162/2792271/FINAL_MB_36_2017_Transfer_of_Fees_r

114 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
evised_decision_signed_at_MB48_en.pdf/235fdafe-6652-6c44-dc60-2412e504903c. For 
Liechtenstein, a value of 100 was assumed. 

3.  Detailed implementation of the ‘do minimum’ baseline scenario and the policy 

options 

This section presents details of the implementation of the ‘do minimum’ baseline scenario and 
the  policy  options.  This  implements  the  options  that  were  outlined  in  the  Inception  Impact 
Assessment  (IIA),121  taking  account  of  feedback  received  on  that  exercise  (Annex  4, 
Addendum 3).  

‘Do minimum’ scenario 

The ‘do-minimum’baseline  scenario represents the fee system in the forecast years when no 
legal  action  is  undertaken  in  relation  to  the  fee  system,  while  taking  into  account  current 
policy  commitments,  i.e.  the  VMP  regulation  and  the  effect  on  fees  the  Regulation  on  a 
reinforced  role  for  EMA,  i.e.  objective  3  of  the  respective  financial  statement  relating  to 
EHDS/DARWIN  EU.  It  provides  the  reference  against  which  the  impacts  of  the  cost-based 
policy  options  can  be  assessed.  Under  the  ‘do  minimum’  scenario,  changes  are  limited  to 
ensuring  that  the  fee  system  aligns  with  the  2018  VMP  Regulation  and  the  revised  EMA 
Founding Regulation (although no charges enabled under the latter legislation were proposed 
for  inclusion  in  the  modelling).  The  costs  and  EU  budget  contributions  associated  with  the 
proposal  for  EMA  reinforced  roleare  also  included  as  they  affect  fees  from  2024  onwards 
(EHDS  node).  The  structure  of  the  fee  system  is  otherwise  unchanged  from  the  current 
system.  

The main changes to procedural activities for veterinary medicines from 2022 triggered as a 
result of the VMP Regulation are: 

  Classification  of  initial  market  authorisations  (MA),  both  in  terms  of  the  new  legal 

basis and further sub-classifications for fee levels; 

  Classification  of  variations  requiring  assessment  and  not  requiring  assessment, 

covering line extensions, Type IA, Type IB and Type II variations; 

  Classification of referrals; 

  Procedural activities in relation to renewals and PSURs are no longer undertaken.122  

The Pharmacovigliance database and the Union Product database are introduced and a small 
change  is  made  to  the  supplier  database  (EUDRA  GMP)  by  adding  veterinary  wholesalers. 
The  additional  costs  of  these  to  EMA  are  included  in  Table  4.1.  The  mechanism  of 
remuneration  to  NCAs,  as  well  as  fees  for  human  and  veterinary  medicines  procedures  and 
the incentives applied to fees remain unchanged from the existing system.   

For  new  and  amended  procedural  activities  under  the  VMP  Regulation,  the  fee  from  the 
closest matching existing procedural activity is applied (no cost-based fees are implemented 
because the ‘do minimum’ scenario is a continuation of the current system). 

Costs  to  EMA  resulting  from  the  veterinary  databases  implemented  under  the  VMP 
Regulation  and  from  the  proposal  for  an  EMA  reinforced  role  are  included  in  the  EMA 
horizontal costs (Table 4.1). 

121 https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/2091-Revision-of-EMA-fees  
122 The costs for renewals that may need to be undertaken for products approved prior to 2022 under the existing 
legislation are already included in EMA horizontal costs.  

115 

 
                                                 
Information  about  EHDS  node  reuse  data  activities  under  objective  3  of  the  proposal  to 
reinforce EMA’s mandate (EHDS/DARWIN EU) is provided in Annex 4, Addendum 3. It is 
understood  that  the  use  will  be  proportional  to  the  number  of  products  on  the  market  and 
therefore  likely  to  support  more  NAPs  than  CAPs.  For  2022  and  2023,  the  DARWIN  EU 
phase costs will be fully covered by the EU budget contributions (Table 4.3)123. Thereafter, as 
there  is  no  legal  action  under  the  ‘do  minimum’  baseline,  these  maintenance  costs  will  not 
give rise to changes in fees under the ‘do minimum’ baseline scenario.  

In  the  ‘do  minimum’  baseline,  there  are  no  further  changes  to  annual  fees  or  to  procedural 
fees.  The  model  calculates  the  impact  on  the  EMA  budget  variance  (whether  income  is 
sufficient to cover costs) of the costs to EMA, payments to NCAs and income from fees and 
EU  budget  contributions,  given  the  forecast  frequency  of  procedural  activities,  EMA 
horizontal activities and eligible NCA additional activities. 

Option 1: Introduce cost-based fees for veterinary medicines only 

Option 1 introduces the minimum legislative action required to address recent changes to EU 
legislation affecting EMA activities. In addition to the changes made to procedural activities 
under  the  VMP  Regulation,  changes  are  also  introduced  as  a  result  of  DARWIN  EU.  For 
Option 1 and the other policy options described below, DARWIN EU maintenance costs are 
allocated  to  the  human  Pharmacovigilance  annual  fee  and  human  CAP  annual  fee  in 
proportion to the number of NAPs (75%) and CAPs (25%).  

The following changes to fees and remuneration are thus introduced in Option 1: 

  Cost-based  fees  are  implemented  for  all  fee-paying  veterinary  medicines  procedural 
activities. This includes new and amended activities under the VMP Regulation. Fee-
paying procedural activity  in relation  to renewals and PSURs  is  discontinued in  line 
with underlying VMP regulation provisions. 

  An  annual  fee  for  veterinary  CAPs  is  maintained.  In  addition  to  EMA  horizontal 
veterinary costs (Table 4.1), this fee will also cover the eligible NCA additional costs 
for veterinary activities, including eligible pharmacovigilance costs, as a result of the 
VMP Regulation to the extent that they contribute to the EMA mandate (04). The fee 
is  calculated  to  balance  the  EMA  budget  after  taking  into  account  cost-based 
procedural and pharmacovigilance fees and EU budget contributions. 

 

In  view  of  the  EMA  pharmacovigilance  mandate  in  the  VMP  Regulation,  a 
pharmacovigilance annual fee for veterinary NAPs, based on an estimated number of 
chargeable  units,124  is  introduced  to  cover  the  cost  to  EMA  of  non-procedural 
veterinary  pharmacovigilance  activities,  namely  veterinary  databases  and  veterinary 
public health activities in  relation  to  product  availability, MUMS, AMR  and EU co-
operation. (These activities are marked in grey in Table 4.1).  

  The  mechanism  of  remuneration  to  NCAs  for  veterinary  medicines  remains 
unchanged from the ‘do minimum’ baseline for procedural activities. NCAs will also 
receive a flat annual remuneration to cover the costs of eligible NCA additional costs 
for veterinary activities, including eligible pharmacovigilance costs, as a result of the 
VMP Regulation to the extent that they contribute to the EMA mandate. 

123 Objectives 1 and 2 of the proposal for EMA reinforced role are fully covered by the EU budget contributions 
for the entire period covered by the study. 
124 Defined for the purpose of the model estimations, following the same principle as for the pharmacovigilance 
annual fee for human NAPs. 

116 

 
                                                 
  Cost-based  fees  are  introduced  for  a  small  number  of  veterinary  activities  for  which 
fees  are  not  currently  charged  and  to  which  incentives  are  not  applied,  namely  pre-
submission  and  re-examination  activities.  Cost-based  remuneration  for  NCAs  is 
introduced for these activities.125 

  For human medicines, the majority of fees and NCA remuneration remain unchanged 
from the ‘do-minimum’, i.e. they remain the same as in the current system. Only the 
annual fees, both CAP and pharmacovigilance, are adjusted as of 2024 to allow EMA 
to recover operational costs of DARWIN EU (maintenance phase).   

  SME  fee  reductions  from  the  existing  system  are  first  applied;  there  are  no  other 
specific  fee  incentives  or  general  reductions  on  fees.    Different  combinations  of  fee 
incentives  and  general  reductions  to  fees  for  veterinary  medicines  are  then  tested  as 
further horizontal measures, as per the inception impact assessment. Specifically: 

o  Horizontal measure A introduces cost-based fees for veterinary medicines with 
a general fee reduction. This horizontal measure is the same as Option 1, but a 
50%  general  reduction  for  veterinary  medicines  is  applied  to  all  veterinary 
fees. No additional incentives are applied. 

o  Horizontal measure B introduces cost-based fees for veterinary medicines with 
a 50% general fee reduction and incentives. This horizontal measure is similar 
to horizontal measure A but it also includes specific incentives that are applied 
for limited markets.126 

o  Horizontal measure C introduces cost-based fees for veterinary medicines with 
specific incentives applied for limited markets. No general reduction is applied 
to veterinary medicines cost-based fees. 

o  Horizontal measure C1 is the same as A(iii) but with larger incentives. 

Option 2: A cost-based fee system for human and veterinary activities with the level of 
granularity of the current system 

In addition to the changes implemented to the fee system under Option 1, Option 2 introduces 
a cost-based system for both human and veterinary activities. These further changes to human 
and veterinary procedural activities are implemented relative to Option 1: 

  Cost-based  fees  reflecting  EMA  and  NCAs  costs  are  also  implemented  for  human 

medicine procedural activities.  

 

In  addition  to  EMA  horizontal  costs  including  a  proportion  of  EHDS/DARWIN  EU 
costs,  the  CAP  annual  fee-human  also  covers  remuneration  for  the  eligible  NCA 
additional costs for human activities.  

  The  annual  pharmacovigilance  NAP  fee  covers  EMA  horizontal  pharmacovigilance 

costs and a proportion of EHDS/DARWIN EU costs. 

125 If the respective procedural fees, included in the fee grid for information, were to be created, the remuneration 
amount linked to the annual fee would need to be reduced in order to avoid double charging. 
126 In addition to the MUMS incentives from the existing system, reductions of 50% are applied all other limited 
market applications.  

117 

 
 
                                                 
  The  annual  CAP  fee  income  is  then  matched  to  procedural  fee  income  and  the  EU 
budget  contributions  to  ensure  that  the  EMA’s  income  after  cost-based  payments  to 
NCAs is sufficient to cover its costs. This leads to calculating the annual CAP fee at 
the  appropriate  level,  after  taking  into  account  the  cost  of  NCAs’  eligible  additional 
activities. 

  For human medicines,  relevant  fee incentives continue to  apply in  line  with  existing 
legislation and rules  (implementing rules, EMA decisions, sectorial  legislation, SME 
regulation).  For  veterinary  medicines,  the  SME  incentives  from  Option  1  are 
implemented.127  

  Cost-based  fees  are  calculated  for  all  procedural  activities  but  these  may  be  fully 
waived  in  accordance  with  the  applicable  legislation  for  activities  such  as  paediatric 
and  orphan  medicines.  In  these  cases,  NCA  remuneration  is  still  maintained  and  is 
calculated  as  part  of  EMA’s  remuneration  costs,  together  with  EMA’s  respective 
costs. 

  NCA  remuneration  for  human  and  veterinary  procedural  activities  is  cost-based. 
NCAs  also  receive  a  flat  annual  remuneration,  also  cost-based.  For  human  and 
veterinary medicines, this remuneration covers eligible additional NCA costs.128  

  Fees for Type II variations for human medicines are re-classified to align with patterns 
stemming  from  analysis  of  the  data  collected  during  the  MBDG  data  gathering 
exercise  (only  fees  are  concerned,  not  the  variations  themselves).  Fees  and 
remuneration  are  determined  for  Type  II  variations  in  Quality,  Clinical  safety,  and 
Clinical indication, respectively.  

  Cost-based fees are introduced for a small number of human and veterinary activities 
for  which  fees  are  not  currently  charged  and  to  which  incentives  are  not  applied  in 
addition  to  paediatric  and  orphan  designation  activities,  namely  pre-submission  and 
re-examination  activities.  Cost-based  remuneration  for  NCAs  is  introduced  for  these 
activities.129 This is aimed at covering all procedural activities by a fee. 

Figures 4.3, 4.4, 4.5 and 4.6 illustrate for Option 2, for the example year of 2024, how human 
medicine  fee  revenues  match  the  costs  of  corresponding  activities  (Figure  4.3),  how 
veterinary medicine fees match corresponding costs (Figure 4.4); and how EMA and NCAs 
respectively share the financial burden of incentives on human medicine fees (Figure 4.5) and 
veterinary medicines fees (Figure 4.6) respectively. As Option 2 is for fully cost-based fees, 
the revenues and costs in Figures 4.3 and 4.4 match for each category of activities. Figures 4.5 
and 4.6 show that EMA bears the cost of incentives.  

[The  same  is  true  for  Options  3  and  3  ’  light’,  so  equivalent  illustrative  Figures  would  be 
redundant  and  are  not  reproduced  in  the  discussion  of  those  options  in  the  following 
paragraphs.]  

127 These can be compared with the results for the policy option 1 sub-options.  
128 For veterinary medicines, the current PSUR  assessment revenue of NCAs is used as a proxy to remunerate 
NCAs  for  relevant  additional  activities  under  the  VMP  regulation  (updates  of  products  under  databases),  for 
which no data are otherwise available. 
129 If the respective procedural fees, included in the fee grid for information, were to be created, the remuneration 
amount linked to the annual fee would need to be reduced in order to avoid double charging.  

118 

 
 
 
                                                 
Figure 4.3:  Comparison of total fee revenues and total costs projected in Option 2 for 
2024 (before incentives have been applied) – human medicines 

70

60

50

40

30

20

10

0

r
a
e
y
/
s
n
o

i
l
l
i

M
€

Total costs
(EMA+NCA)

Full fees (before
incentive)

Figure 4.4:  Comparison of total fee revenues and total costs projected in Option 2 for 2024 (before 
incentives have been applied) – veterinary medicines 

12

10

8

6

4

2

0

r
a
e
y
/
s
n
o

i
l
l
i

M
€

Total costs
(EMA+NCA)

Full fees (before
incentive)

119 

 
 
 
 
 
Figure 4.5: EMA and NCA shares of costs and fees projected in Option 2 for 2024 after incentives have 
been applied – human medicines 

45

40

35

30

25

20

15

10

5

0

r
a
e
y
/
s
n
o

i
l
l
i

M
€

EMA costs

NCA costs

EMA fee share

Figure 4.6: EMA and NCA shares of costs and fees projected in Option 2 for 2024 after incentives have 
been applied – veterinary medicines 

EMA costs

NCA costs

EMA fee share

NCA
remuneration

r
a
e
y
/
s
n
o

i
l
l
i

M
€

7

6

5

4

3

2

1

0

Scientific
Advice

Marketing
authorisations

MRL

referrals

variations

120 

 
 
 
 
 
Option 3:  A cost-based fee system with a simplified structure 

The purpose of this option is to simplify the cost-based fee system implemented in Option 2 
for both human and veterinary medicines by applying a reduced number of procedural fees for 
post-authorisation activities (human and veterinary):  

  A  reduced  number  of  procedural  fees  are  applied  for  post-authorisation  non-
pharmacovigilance activities for human and veterinary medicines. Procedural fees are 
levied  for  pre-authorisation  activities  (human  and  veterinary),  inspections  and  only 
some major post-authorisation activities (e.g. referrals). Due to technical complexities 
linked  to  the  variety  of  products  included  in  pharmacovigilance  procedures  and 
activities, pharmacovigilance procedures continue to attract procedural fees. 

  The  annual  fee  for  CAPs  covers  a  broader  set  of  costs  as  compared  to  the  current 
system,  including  those  non-pharmacovigilance  post-authorisation  procedures  that 
would no longer levy a procedural fee.  

  The  annual 

fees 

for  pharmacovigilance  cover  costs  of  EMA  horizontal 
pharmacovigilance  activities  in  both  the  human  and  veterinary  sectors  (separate 
amounts for human and veterinary products, to match the respective estimated costs).  

  NCA remuneration for procedures charged under the CAP annual fee is no-longer per-
procedure  and  is  included  in  the  annual  remuneration  paid  to  NCAs  via  the  CAP 
annual fee. 

Option 3 ’ light’:  A cost-based fee system with a simplified structure 

Following  the  feedback  from  the  IIA,  a  further  option  is  considered,  namely  a  partial 
simplification  of  the  cost-based  fee  system  relative  to  Option  2  but  not  as  simplified  as  in 
Option 3. Option 3 ‘light’ is based on Option 3 but a more limited set of activities are covered 
by annual fees (mainly minor variations) and procedural fees are retained for a larger number 
of activities (mainly major variations). 

The  lists  of  activities  included  in  the  annual  fees  in  Option  3  and  Option  3  ‘light’  are 
presented in the fee grids produced as model outputs. For these activities no procedural fees 
are charged and these fees are therefore set to zero in the fee grids. 

Presentation of the options and horizontal measures in the fee grids 

In  the  fee  grids,  for  each  option  and  horizontal measure,  the  fee  and  remuneration  amounts 
before any targeted incentives are applied are presented in a separate row for each procedural 
activity.  These  fees  are  subject  to  any  general  reductions  (or  mark-ups)  that  have  been 
implemented.  The  incentives  that  should  be  applied  to  the  fees  are  provided  in  subsequent 
columns. These incentives are applied to the fees in all cases. The remuneration amounts for 
NCAs are those amounts that apply when all NCAs receive the same level of remuneration for 
the same work and when EMA bears the cost of incentives. This is the case for all the main 
options and horizontal measures. 

Incentives  are  also  applied  to  the  NCA  remuneration  for  the  particular  horizontal  measure 
where the cost of incentives is shared between EMA and NCAs. Applying incentives to the 
NCA  remuneration  has  implications  for  the  annual  CAP  fees  that  are  used  to  balance  the 
EMA  budget.  The  CAP  annual  fees  for  NCA  remuneration  after  incentives  are  shown  in  a 
separate row in the fee grid. 

121 

 
 
 
To  determine  the  NCA  remuneration  when  this  is  scaled  by  country  coefficients,  the 
remuneration shown in the fee grids is scaled by the coefficient shown in Table 4.5.  

The procedural activity and CAP annual fees and remuneration and pharmacovigilance annual 
fees are shown separately  for human and  veterinary  activities. An additional contribution  to 
the  annual  human  CAP  and  pharmacovigilance  fees  to  cover  the  cost  of  DARWIN  EU  is 
shown at the bottom of the fee grid. This is the same for all options. 

Annex 4, Addendum 1  

Fee and remuneration rules under the existing fee system 

Under  the  current  fee  system,  each  procedural  activity  (or  service)  for  which  a  fee  can  be 
charged has a full fee associated with it. This is the maximum fee that an organisation could 
be asked to pay for a given activity (i.e. if there were no discount or waiver) and has a specific 
legal  basis.  The  different  full  fees  were  the  main  basis  for  the  level  of  disaggregation  of 
procedural activities in the NCA survey for the evaluation study and hence in the model. In 
addition, there are a number of procedural activities for which no fees are currently charged. 

The unitary full fees used in the model were taken from published EMA values for 2019: 

  A yearly inflationary adjustment is applied to the fees charged for years in the future.  

  The fee charged for some procedures (full application for marketing authorisation and 
line extensions) contains  a fixed and a variable  fee, as per rules defined in currently 
applicable system.  The variable part is  linked to  the requests from  the applicants  for 
additional “strength, pharmaceutical forms and presentations, so the higher the number 
of additional requests the higher fee charged. In these cases a single total unitary fee 
was calculated based on the proportion of procedures that would be expected to have 
additional requests and this was used in the model. 

For  procedural  activities,  detailed  data  on  incentives  was  provided  by  EMA.  From  this,  the 
study  team  calculated  the  average  incentive  rate  for  a  given  activity,  in  percentage  terms, 
which  was  implemented  in  the  model  to  calculate  EMA  and  NCA  incomes.  Thus  the 
modelling assumption is that the mix of activity in future will be similar to that in the past, so 
that the outturn average rate of incentive remains unchanged. 

The rule for the remuneration of NCAs under the existing fee system is implemented in the 
model as follows: 

1.  For  a  rapporteur  or  co-rapporteur  role  for  a  non-pharmacovigilance,  fee  generating 
procedural-activity, the NCA receives 50 per cent of the full fee before incentives are 
applied.  Where  more  than  one  NCA  undertakes  a  remunerated  role  for  the  same 
procedure, 
them.  For 
is  distributed 
pharmacovigilance activities, NCAs are remunerated a fixed amount, which is reduced 
in proportion to the incentive applied to the full fee.130   

equally  between 

remuneration 

the 

2.  Rapporteurs and co-rapporteurs of eligible procedures receive 30 per cent (15 per cent 
each)  of  the  CAP  annual  fees  for  human  and  veterinary  medicines.  NCAs  do  not 

130  The  combined  NCA  remuneration  for  rapporteurs  and  co-rapporteurs  for  post-authorisation  safety  studies 
(PASS)  is  €7280  for  the  draft  report  and  a  further  €10920  for  the  final  report.  For  PSURs  and  PSUSAs,  it  is 
€13100. The  remuneration is  scaled proportionally to the incentive rate  applied to the  full  fee (EU Regulation 
658/2014).  

122 

 
                                                 
receive  a  share  of  pharmacovigilance  annual  fees  which  cover  activities  undertaken 
only by EMA. 

The net fee income that EMA receives from fee-generating activities is the remainder of the 
full  fee  income  less  NCA  remuneration  and  the  incentives  applied.  Hence,  for  procedural 
activities, other than pharmacovigilance activities, EMA retains:  

Full fee x (100% – 50% paid to NCAs – incentive rate (%)) 

For pharmacovigilance activities, EMA fee income is calculated as: 

(Full fee – NCA remuneration) x (100% – incentive rate (%)) 

EMA receives 70% of the annual fees for CAPs and 100% of the annual pharmacovigilance 
fees. In both cases the EMA fee income is net of incentives. 

Based  on  the  above  rules,  the  yearly  fee  income  for  EMA  and  remuneration  for  NCAs  is 
calculated as follows:  

  The total full fee income was calculated as the product of the full fee per activity and 

the number of invoiced procedures for a given activity. 

  Data  on  the  actual  number  of  CAP  authorisations  attracting  an  annual  fee  and  NAP 
chargeable units attracting a Pharmacovigilance annual fee, the incentive rates and the 
number of purchase orders (POs) for CAP annual fees sent to individual NCAs acting 
as  rapporteur  /  co-rapporteur  was  provided  by  EMA  based  on  actual  records.  These 
data were used to determine the share of CAP annual fee income EMA received. 
  EMA net fee income is the total fee income net of the NCA share and incentives. 
  NCA  remuneration  per  year  was  calculated  for  a  given  type  of  activity  according  to 
the  rules  outlined  above.  The  remuneration  was  allocated  across  NCAs  according  to 
the number of rapporteur/co-rapporteur roles undertaken by each NCA (The formula is 
modified slightly for pharmacovigilance activities.) 
Annual remuneration of NCA X = NCA share of fee x unit full fee x (no. rap + no. co-
rap NCA X) /(no. rap + no. co-rap per procedure) 

The remuneration is summed over all NCAs to determine the total NCA remuneration. 

Annex 4, Addendum 2  

NCA participation and additional activities 

NCA  participation  in  EMA  committees  and  working  parties  and  activities  declared  in 
addition to procedures – analysis of relevance to the EMA fee and remuneration system  

The  evaluation  of  the  EMA  fee  system  found  that,  overall  and  at  an  aggregate  level,  the 
remuneration paid by the Agency to NCAs exceeds the total costs calculated for undertaking 
procedures for human and veterinary medicines, if the two sectors are taken together. 

Beyond this group of NCAs activities, i.e. procedural activities, the evaluation also considered 
two other groups of NCAs’ activities: (1) Attending EMA’s committees and working groups, 
outside  procedures,  costed  based  on  time  collected  by  the  EMA  Management  Board  data 
gathering  131  and  (2)  Additional  activities  declared  by  NCAs  as  potential  EMA  activities, 

131 EMA committees’ and  working parties’ time related to procedural activities has been taken into account in 
the procedural time. 

123 

 
                                                 
beyond  the  assessment  procedures  and    the  committee  and  working  groups  non-procedural 
time, costed based on a remainder of an overall EMA related cost declared by NCAs during 
the  evaluation  exercise.  These  two  groups  of  NCAs  activities  were  considered  in  the 
evaluation  study  and  their  cost  was  estimated,  but  their  relevance  was  not  analysed  with 
regard to the remuneration that EMA pays to NCAs.  

NCAs’  time  for  attending  EMA  committees  and  working  parties  when  not  in  charge  of  a 
procedure 

The evaluation estimated the cost of time for participating in committees and working parties 
outside procedures at €17.9 million/year for all NCAs in aggregate. This figure did not take 
into account the reimbursement of travel and subsistence costs.  

This time relates to taking part in common EU-level structures and is therefore seen as part of 
the  overall  setting  of  the  EU  regulatory  system,  consistent  with  the  model  of  the  EU  in 
general.  Without  a  relation  to  a  specific  assessment  procedure,  and  in  common  with  many 
other  sectors,  this  is  part  of  the  collective  responsibility  of  all  Member  States  within  the 
centralised  regulatory  system,  which  is  combined  with  their  collective  benefit  of  having 
medicines authorised and monitored throughout the Union via a single centralised assessment 
procedure and a single centralised authorisation adopted by the Commission. Therefore, being 
part of these EU-level structures is not consistent with the remuneration paid by EMA, as an 
EU  decentralised  agency,  specifically  for  the  work  carried  out  by  the  national  competent 
authorities  of  the  Member  States  which  act  as  rapporteurs  and,  where  applicable,  co-
rapporteurs  in  accordance  with  Articles  61(6)  and  62(1)  of  Regulation  (EC)  No  726/2004. 
Moreover,  calculating  a  monetary  equivalent  of  benefits  associated  with  the  EU  centralised 
system  is  also  not  considered  appropriate  for  the  purpose  of  this  exercise.  This  rationale  is 
applied as an overarching matter of principle. 

Separately,  NCAs  receive  in  principle  reimbursement  of  travel  and  hotel  costs,  a  travel 
allowance in case of arrival/departure outside of the meeting days, and a daily allowance for 
each day of the meeting. The reimbursement in principle of travel and subsistence costs is not 
affected by the above considerations.  

NCAs’ declared activities in addition to procedures  

In  relation  to  the  EMA  fee  system  evaluation,  NCAs  have  declared  broader  ‘additional 
activities’,  i.e.  other  than  procedural  activities.  Examples  of  such  additional  activities,  as 
declared  by  NCAs,  included:  work  related  to  IT  and  databases,  participation  in  the  EMA 
Management Board, surveillance of safety of medicines, giving or attending scientific training 
sessions, actions  on AMR, providing comments  to  draft assessment  reports when not  in  the 
role  of  co-/rapporteur,  updating  national  registries  and  publishing  information  on  medicinal 
products,  national  implementation  of  EU  decisions,  national  inspections  related  to  EMA 
requests,  work  related  to  EU  presidency,  work  on  ICH  (International  Conference  on 
Harmonisation), WHO work, etc.  
The  evaluation  study132  estimated  the  overall  costs  of  this  type  of  activities  at  €52.5 
million/year  for  all  NCAs  in  aggregate,  based  on  the  overall  cost  declarations  by  NCAs. 
According  to  the  estimations  of  the  evaluation,  €22.7  million/year  are  currently  paid  to  the 
NCAs via a share of the annual fee in the current system.133 However, whether and to what 

132 https://ec.europa.eu/health/human-use/legal-framework/ema_fees_en 
133 The Implementing Rules of the Fee Regulation provide that NCAs of the rapporteur and co-rapporteur receive 
15% each of the annual fee. 

124 

 
                                                 
extent such ‘additional activities’ should be remunerated by EMA in a cost-based system was 
not  analysed  by  the  evaluation  and  has  therefore  been  subject  to  further  analysis  by  DG 
SANTE services. 

Analysis of NCAs additional activities and relevant costs 

Up to 88 activities were declared by NCAs, with a very high level of variation in the number 
of  activities  declared  and  in  the  level  of  precision  of  the  description.  This  called  for  a 
pragmatic  approach  of  the  analysis.  After  the  evaluation,  NCAs  were  surveyed  to  provide 
further  detail  and  to  specify  a  relative  distribution  of  the  estimated  time  spent  on  those 
declared activities. The outcome allowed for a relative distribution of the overall aggregated 
costs estimated by the evaluation, across the various activities (see Table 4.2.1 in Annex 4). 

An  assessment  of  potential  eligibility  for  remuneration  by  EMA  consistent  with  calculating 
such  remuneration  in  the  level  of  EMA  fees  was  carried  out,  based  on  the  activities  and 
additional  explanations  on  content  of  activities  provided  by  the  NCAs  respondents  and  a 
preliminary analysis of the principles established by the legislation134. The resulting amount 
of such additional activities eligible for a remuneration calculated in the annual fee was added 
to the overall costs used as a basis for the calculation of the CAP annual fee and respective 
NCA remuneration. The fee amount and the NCA remuneration amount presented in the fee 
grids take these costs into account. This approach to remunerating eligible additional activities 
of NCAs on an annual basis, through an amount calculated in the annual fee is consistent with 
the  trend  observed  in  the  evaluation  study  estimations  that  the  level  of  possible  additional 
activities is proportionate to the level of procedural activities of NCAs. 

The  general  criterion  for  the  assessment  of  eligibility  for  remuneration  by  EMA  which  is 
consistent with  calculating the EMA fees paid  by  undertakings, is  whether the  activity is  in 
support of the EMA’s scientific services, at central level, or, whether it is instead an activity 
that EMA fees are not called to fund, e.g. a national activity (such as implementation of EU 
legislation at national level).135  

The  Founding  Regulation  of  EMA  provides  in  general  that  the  Agency  is  responsible  for 
coordinating  the  existing  scientific  resources  put  at  its  disposal  by  Member  States  for  the 
evaluation, supervision and pharmacovigilance of medicinal products (Article 55). Further, it 
stipulates (Article 67) that fees are paid by undertakings: 

(i)  for  obtaining  and  maintaining  Union  marketing  authorisations  for  medicinal 
products  for human use  and for veterinary medicinal products  and for other services 
provided  by  the  Agency,  as  provided  for  in  this  Regulation  and  in  Regulation  (EU) 
2019/6; and 

(ii)  for  services  provided  by  the  coordination  group  as  regards  the  fulfilment  of  its 
tasks  in  accordance  with  Articles  107c,  107e,  107g,  107k  and  107q  of  Directive 
2001/83/EC 

In addition,  it stipulates  (Article 62) that the provision  of services by rapporteurs or experts 
shall be remunerated.  

In the most recent EMA fee legislation, i.e. Regulation 658/2014, the legislator stated that any 
revisions  of  fees  levied  by  the  Agency  should  be  based  on  a  transparent  and  independent 

134 Further legal scrutiny may be needed for the purpose of a legislative proposal. 
135 This does not exclude a priori such activities from eligibility for financing through EU financial instruments. 

125 

 
 
                                                 
evaluation  of  the  costs  of  the  Agency  and  the  costs  of  the  tasks  carried  out  by  the  national 
competent authorities (recital 7). It also clarified that such costs cover the work carried out by 
the national competent authorities of the Member States which act as rapporteurs and, where 
applicable, co-rapporteurs in accordance with Articles 61(6) and 62(1) of Regulation (EC) No 
726/2004  (recital  6).  Similar  provisions  exist  in  Regulation  297/95.  Further,  Regulation 
2019/6 confirmed (Article 2(8) that it is without prejudice to national provisions on fees. 

In light of the above, three cumulative conditions can be established to guide the assessment 
of the eligibility for remuneration calculated in the level of EMA fees of each of the so-called 
‘additional  activities’  considered  by  the  evaluation:  (1)  the  activity  must  be  of  scientific 
nature, consistent with Articles 61(6) and 62(1) of Regulation (EC) No 726/2004 (2) it must 
be part of EMA’s services, consistent with Articles 67(3)(c) of Regulation (EC) No 726/2004 
and  (3)  it  must  be  a  service  provided  to  EMA  consistent  with  Articles  61(6)  and  62  of 
Regulation (EC) No 726/2004. In addition, for a fair and proportionate EMA fee system, any 
risk  of  double  charging  between  the  Agency’s  fee  system  and  the  national  fee  systems  in 
Member States should be eliminated. 

Examples of activities potentially eligible for remuneration under the annual fee   

Activities  such  as  for  example  work  on  the  additional  monitoring  list,  or  checking  national 
translations of safety communications on centralised procedures and annual reassessment of a 
marketing  authorisation  under  exceptional  circumstances  may  qualify  for  remuneration  in 
accordance with the eligibility criteria and the analytical conditions.  

Examples of activities potentially non-eligible for remuneration under the annual fee 

Some activities declared are at national level or do not constitute a service to EMA and/or can 
be charged for at national level and, therefore, are not eligible. Examples include updates of 
national  drug  registries,  DSURs,  adverse  drug  reaction  reporting,  signal  management136, 
national  safety  communication  following  a  pharmacovigilance  procedure  of  a  centrally 
authorised  product,  participation  in  IT  projects  relating  to  databases  and  portals,  and 
participation in ICH/VICH meetings (which are reimbursed by the Commission).  

Regarding the provision of comments to scientific reports from non-rapporteur NCAs and IT 
activities of NCAs, following the same reasoning as for committee and working parties time, 
remuneration  is  not  consistent.  These  activities  are  part  of  the  overall  setting  of  the  EU 
regulatory  system,  which  is  based  on  the  collective  responsibility  of  all  Member  States  and 
which provides a collective benefit to all.  

Examples  of  activities  potentially  non-eligible  for  remuneration  under  the  annual  fee  but 
eligible under a procedural fee 

Another  group  of  activities  are  considered  as  “non-eligible”  for  remuneration  through  the 
annual fee not because they do not fulfil the criteria but because, instead, the proposed fee and 
remuneration  grids  (see  consultation  materials)  comprise  a  procedural  remuneration, 
calculated in a procedural fee. 

The following activities (totalling €3.9 million) appear thus in the table below as “non-eligible 
for remuneration through EMA annual fee”, because it is considered to charge instead a cost-

136 The  Council  working party’s discussions in relation to Regulation 658/2014 on fees for pharmacovigilance 
indicated  that  national  fees  may  apply  for  this  type  of  activities  and  there  should  be  no  risk  of  creating  legal 
grounds for double charging as Member States would keep that possibility. 

126 

 
                                                 
based procedural fee. Such fee could be potentially reduced or fully exempted; however, a fee 
level could be calculated and a remuneration for NCAs could be included: 

  Pre-submission  meetings  -to  cover  Qualification  Opinion  meeting,  Pre-submission 
meetings/hearings,  Eligibility  requests  (including  Eligibility  requests,  PRIME 
requests,  Letter  of 
intent,  Accelerated  assessment/  review  requests,  ATMP 
certification,  notification  changes  and  withdrawals,  total  requests  and  notifications: 
procedural  fee  Pre-submission  activities  Compassionate  use  programme:  procedural 
fee  for  Scientific  services  -  Compassionate  use  opinions  (Scientific  services 
compassionate other than MA) 

  Paediatric  Investigation  Plan  (PIP)  modifications:  procedural  fee  for  Paediatrics  - 

PIPs (modification) 

  Orphan designation, review of maintenance of an orphan designation at the time of the 
initial  marketing  authorisation,  including  assessment  of  significant  benefit  criteria: 
procedural fee for Orphan medicinal product designation procedures 

  Classification  MUMS/limited  markets:  procedural 

fee 

for  Limited  market 

classification 

  HMPC  operation  and  associated  procedures:  procedural  fee  for  centralised  herbal 

application 

  Plasma Master File (PMF) – initial certification, procedural fee for Scientific services  

PMF 

  PMF - annual updates, procedure aligned with Scientific services PMF Type IA/IB 

  ATMP  classification/  certification-  procedural 

fee 

for  Scientific  Services  - 

Certification for Advanced Therapies (Scientific services ATMP certification) 

  Establishment,  modification  or  extension  of  maximum  residue  limits  (MRLs)  – 
procedural fee Maximum residual limit (MRL) applications (Establishment of MRL) 

  Re-examination procedure:  procedural re-examination fee  

  Art.  5(3)  procedure  (Regulation  (EC)  No  726/2004):  procedural  fee  for  referral  – 

Article 5(3) 

  Annual renewal of a conditional marketing authorisation – new procedural fee.137 

The  total  estimated  average  cost  (of  NCAs)  for  those  activities  which  are  considered  at  the 
current  stage eligible for remuneration calculated in  the CAP  annual  fee is  ca. €8.3 million, 
while the cost of those activities eligible for remuneration calculated in procedural fees is ca. 
€3.9 million. 

137 A fee has not been calculated for this activity for the consultation.  

127 

 
 
 
                                                 
Table 4.2.1 Additional activities declared by NCAs in 2016138 

‘Additional activities’ declared by NCAs 

Total 

Not eligible under annual fee because does not meet eligibility 
criteria  
(Work related to being a) member of the EMA Management Board 
Member of and work related to EMA-hosted boards and forums (e.g. 
Scientific Coordination Board (SciCoBo)) 
Member of and work related to ad-hoc working groups for organisational 
matters 
Participation in multi-stakeholder meetings/forums (e.g. European 
Forum for Good Clinical Practice (EFGCP)) ; Stakeholder engagement 
(e.g. patients and healthcare professionals, industry, European and 
International partners) 
Attending and presenting at Drug Information Association (DIA) events 
Patient Registries Initiative, e.g. member of Cross-Committee Task 
Force and/or of one of the Cross-Committee Task Force Working 
groups, or participation in their workshops 
Member of and work related to EU Telematics Management Board and 
Telematics Working Group (e.g. meetings for Clinical Trials Interface 
Working groups (Application Programming Interface), Consultative 
Group for Veterinary Product Data Systems (CGVPS, former TIG), 
Consultative Group for Veterinary Pharmacovigilance Systems 
(CGVPhS, former JIG)); 
EMA Strategic Review & Learning Meeting (SRLM) 
PDCO Non-clinical Working Group (NcWG) and PDCO Formulation 
Working Group (FWG) 
ICH or VICH (Expert) Working Group (EWG) (meetings and other 
related work) 
Medical dictionary for regulatory activities (MedDRA) or Veterinary 
Dictionary for Drug Regulatory Activities (VeDDRA): establishment 
and maintenance of terminology standards  
EudraLex - Volume 8 of the publications “The Rules Governing 
Medicinal Products in the European Union” (‘Volume 8’), titled: ‘Notice 
to applicants and Guideline – Veterinary medicinal products – 
Establishment of maximum residue limits (MRLs) for residues of 
veterinary medicinal products in foodstuffs or animal origin’ 
WHO collaboration, other than related to antimicrobial resistance  
Reaction of EFSA 
Lumpy skin disease (focus group) and FishMed 
Transparency: access to documents (ATD) (Policy/0043)  

 Estimated 
average cost in 
2016 for all 
NCAs (€) 

52.634.924 € 

33.822.704 € 

730.881 € 

586.721 € 

277.537 € 

337.080 € 

99.151 € 

243.269 € 

2.197.168 € 

289.628 € 

298.378 € 

391.015 € 

115.715 € 

221.023 € 

134.925 € 
155.908 € 
301.106 € 
68.722 € 

138 The approach to the eligibility assessment was reviewed post-consultation (see under section 6, Indicator 1: 
fee system covers relative aggregate costs). 

128 

 
                                                 
‘Additional activities’ declared by NCAs 

Total 

Transparency: proactive publication of clinical trial data (CDP) 
(Policy/0070) 
Transparency: reviewing of the contents of documents made public on 
the EMA website (e.g. review of the European Public Assessment 
Report (EPAR) for human or veterinary medicinal products and the 
Assessment Report Summaries for the Public (ARSPs) for herbal 
medicinal products) 
Transparency: linguistic review of documents made public on the EMA 
website (e.g. product information or the EPAR summary for the public)  
Transparency: preparation of responses to queries related to referral 
procedures 
Coordination of safety communication 
Communication 
Attendance, organisation or giving training, presentations, webinars or 
workshops (outside working parties/committees) in the framework of the 
EU Network Training Centre (EU NTC) 
Attendance, organisation or giving training, presentations, webinars or 
workshops (outside working parties/committees), other than EU NTC-
related activities 
Work related to EU presidency 
Data gathering, EMA or EC surveys 
OMCL laboratory projects, incl. taking samples from the market 
GLP inspection 
GMP/GDP inspection: national 
Speeding up access to medicines 
Assessment of invented names 
Comments on non-(co)rap procedures (concerned comments) 
Monitoring of the advertising of all medicinal products 
Checking of the content of the QR (quick response) code 
National implementation of EC decisions (e.g. after safety referrals) 
Update of national drug registry and publishing of drug information 
Work related to product defects ; Rapid Alert (RA)/Non-Urgent 
Information (NUI)/Incident Management Plan (IMP)  
Medicine shortages 
Parallel distribution activities 
EMA Guidance dev rapporteur 
Herbal legislation 
WHO collaboration, other than related to antimicrobial resistance 
Development Safety Update Report (DSUR) 

Eligible under annual fee 

129 

 Estimated 
average cost in 
2016 for all 
NCAs (€) 

52.634.924 € 

101.693 € 

72.138 € 

2.230.843 € 

663.620 € 

533.021 € 
591.853 € 

1.892.036 € 

800.922 € 

512.557 € 
600.285 € 
1.472.747 € 
719.795 € 
3.832.751 € 
356.985 € 
212.024 € 
3.489.140 € 
2.098.283 € 
52.860 € 
932.278 € 
1.927.568 € 

770.357 € 

1.518.487 € 
323.511 € 
429.653 € 
28.601 € 
134.925 € 
1.075.544 € 
33.822.704 € 
14.819.059   € 

 
 
‘Additional activities’ declared by NCAs 

Total 

Post-authorisation measures (PAMs) (REC, MEA, ANX, LEG, SOB) / 
follow-up measures (FUM) 
Annual reassessment of a marketing authorisation under exceptional 
circumstances 

List of Union reference dates and frequency of submission of period 
safety update reports (the EU reference dates (EURD) list) 

 Estimated 
average cost in 
2016 for all 
NCAs (€) 

52.634.924 € 

1.024.082 € 

88.981 € 

32.687 € 

Pharmacovigilance audit, including (non)conformity reports 

641.750 € 

Signal management human medicines (this includes the following 
actions: 1. Signal detection (incl. review e-RMR), 2. Signal validation, 3. 
Signal confirmation, 4. Signal analysis and prioritisation, 5. Signal 
assessment, 6. Recommendation for action) ; Signal detection and 
surveillance veterinary medicines 
Adverse drug reaction (ADR) reporting  
Checking of national translations of additional risk minimization 
materials (educational materials etc.) and DHPC letters 
Drafting, peer-review and commenting on herbal monographs and list 
entries 
Modification of a herbal monograph 
Regular revision of a herbal monograph (every five years) 
Member of and work related to (smaller) (ad-hoc) working  groups for 
scientific matters (e.g. for review and implementation of ICH guidelines 
or those related to the different annual Committee Work Plans (e.g. 
improving the full MA/AR-documentation process and templates)) 
CODEX 
HTA collaboration 
Additional monitoring list 
Work related to addressing antimicrobial resistance (AMR), including 
JIACRA, AMEG, RONAFA, ESVAC, CADVVA 
European Pharmacopoeia work and corresponding laboratory work  
Post-Authorisation Efficacy Studies (PAES): PAES protocol 

Not eligible for annual fee because procedural fee remuneration 
either exists or is to be created 
Qualification Opinion meeting 
Compassionate use programme 
Paediatric work-sharing in accordance with Article 45 and 46 of 
Regulation (EC) No 1901/2006 (Paediatric Regulation) in case of 
centrally authorised products 
Paediatric Investigation Plan (PIP) modifications 

1.625.948 € 

4.900.673 € 

2.183.163 € 

209.826 € 

105.502 € 
116.486 € 

660.040 € 

134.187 € 
118.377 € 
267.950 € 

1.701.743 € 

821.439 € 
186.225 € 
14.819.059 € 

3.993.161 € 

87.763 € 
113.875 € 

475.691 € 

335.843 € 

130 

 
 
‘Additional activities’ declared by NCAs 

Total 

 Estimated 
average cost in 
2016 for all 
NCAs (€) 

52.634.924 € 

Orphan designation, review of maintenance of an orphan designation at 
the time of the initial marketing authorisation, including assessment of 
significant benefit criteria; orphan derogation 

263.217 €  
+ 106.242€ 

Classification at the request of the MAH on MUMS/limited markets 

HMPC operation and associated procedures 
National GCP inspection linked to EMA request (MA), including 
preparation of supporting documents for sanctions imposed for GCP 
non-compliance 
Plasma Master File (PMF) – initial certification  
PMF - annual updates 
ATMP certification 
Pre-submission meetings/hearings 
Establishment, modification or extension of maximum residue limits 
(MRLs) 
PRIME  
Accelerated assessment, including eligibility requests 
Eligibility assessment for the centralised procedure 
ATMP classification 
Re-examination procedure 

Annual renewal of a conditional marketing authorisation 

Art. 5(3) procedure (Regulation (EC) No 726/2004): 

TOTAL ALL 

20.021 € 

62.016 € 

502.268 € 

72.032 € 
75.137 € 
23.040 € 
532.818 € 

93.203 € 

363.965 € 
161.024 € 
9.772 € 
63.619 € 
477.784 € 

101.523 € 

52.308 € 

3.993.161 € 
52.634.924 € 

Final calculations of NCAs remunerations (post-consultations) 

Consultation feedback pointed out the role the annual fee remuneration has historically played 
as  a  “stabilising  factor”  that  enabled  NCAs  to  continue  to  contribute  to  EMA’s  work  in 
accordance  with  the  founding  Regulation,  and  to  finance  the  horizontal  activities  this 
contribution requires, and suggested that this had not been taken sufficiently into account. 

On the basis of the feedback, the approach to determining what portion of additional activities 
would be eligible for remuneration through EMA fees was reviewed and NCA remuneration 
under  the  different  options  was  recalculated  accordingly.  It  became  clear  that  the  granular 
bottom-up  approach  applied  for  the  consultations,  that  sought  to  determine  eligible  costs 
activity  by  activity  according  to  criteria  for  compatibility  with  the  legislation,  could  not 
provide a comprehensive basis for determining the level of remuneration for those activities, 
due  to  the  degree  of  variability  involved,  and  the  impossibility  of  gathering  all  the  relevant 
data with sufficient precision and detail.  

131 

 
 
 
The great variety of activities declared as additional by NCAs includes some that are clearly 
national only, others that clearly contribute to EMA’s work, and yet others in which these two 
dimensions are very difficult to disentangle, due to the level of disaggregation and precision 
of  the  description  provided.  A  different  approach  was  therefore  required,  one  which  could 
reconcile the heterogeneous and incomplete bottom-up information that was available with a 
broader,  top-down  analytical  framework  for  determining  what  level  of  cost-based  annual 
remuneration, in addition to the cost-based per-procedure remuneration, would enable NCAs 
to fund in a sustainable manner those additional activities that are eligible,  i.e. which do make 
a contribution to EMA’s activities, in accordance with the founding Regulation.  

The  starting  point  chosen  for  this  revised  approach  was  the  estimated  aggregated  level  of 
annual  fee  remuneration  as  a  proportion  of  total  fee  remuneration  received  by  NCAs  from 
EMA. Based on a projection of the current fee system, this proportion averages around 1/3 of 
total  NCA  remuneration  received  from  EMA  on  aggregate.  This  ratio  was  considered  to 
provide  a  good  proxy  for  estimating  the  level  of  annual  remuneration  which  would  be 
consistent with the arguments put forward in the abovementioned consultation feedback.  

The cost used by the financial model to calculate the annual fee and remuneration was then 
adjusted in the study model so that this approximate 1/3 ratio was preserved within the study 
model calculations  (that  is  at  aggregate level,  for the whole system).  This led to  an upward 
adjustment  of  unitary  annual  remuneration  (and,  therefore,  of  unitary  annual  fees)  as 
compared  to  the  amounts  presented  for  consultations.  The  resulting  higher  annual 
remuneration  of  NCAs,  as  estimated  by  the  study  model,  still  falls  within  the  overall 
maximum  envelope  of  ca.  EUR  53  million  covering  all  additional  activities,  including  both 
eligible and non-eligible activities. This envelope can be considered as the maximum possible 
amount  for  cost  of  NCAs’  additional  activities  included  in  the  calculation  of  the  NCAs’ 
annual remuneration.  

It has to be noted that, because of the difficulties, explained above, in accurately quantifying 
the  actual  cost  of  eligible  activities  not  compensated  through  the  per-procedure  fee,  this 
choice  implies  the  acceptance  of  some  costs  which,  had  complete  quantification  been 
possible,  might  ultimately  not  have  been  deemed  fully  eligible.  At  the  same  time,  this  top-
down  approach  compensates  for  possible  shortcomings  of  the  methodology  in  updating 
granular  level  costs  since  the  evaluation.  Therefore,  this  methodological  choice  is  only 
relevant  to  the  estimations  generated  for  the  study  supporting  this  particular  impact 
assessment, in order to establish initial fees under a revised fee system. The conditions under 
which the annual and procedural  fees will be updated in future depend upon the monitoring 
mechanism that will be established under the revised fee system (see section on Monitoring 
below). The validity of this approach (i.e. reflecting the cost of eligible additional activities in 
the annual fee remuneration paid to rapporteurs) is supported by the observation made during 
the evaluation study that, for a given NCA, the level of engagement in additional activities is 
likely to be proportionate to the level of engagement in procedural activities139.  

139Evaluation study report figure 13, p. 55 

132 

 
 
 
                                                 
Annex 4, Addendum 3 

DARWIN EU, its interplay with the European Health Data Space (EHDS) and expected 
annual maintenance cost  

The  creation  of  the  EHDS  is  one  of  the  main  priorities  of  the  Commission  in  the  area  of 
health. The EHDS will enable the cross-border exchange of and access to different types of 
health  data  originating  from  real-world  data  sources  such  as  electronic  health  records, 
administrative  databases  or  patient  registries.  The  EHDS  will  not  only  support  healthcare 
delivery but also health research and innovation, public health policy-making and regulatory 
activities. The EHDS is an overarching initiative that covers four key strands of work: 

  a  governance  framework  and  rules  for  the  secure  exchanges  of  health  data  for 

primary and secondary purposes;  
 
the deployment of the interoperable digital infrastructure for such exchanges;  
  specific actions for improved quality and semantic interoperability of health data; 
  capacity  building  activities  in  Member  States,  including  on  digital  skills  of 

competent authorities and health workforce. 

The  Commission  is  currently  working  on  the  preparation  of  a  legal  framework  for  the 
governance, rules and requirements for a common EHDS. A legal proposal is expected to be 
adopted  by  the  end  of  the  year  of  the  beginning  of  2022.  The  Commission,  together  with 
relevant stakeholders, and including EMA, is preparing a pilot that aims at demonstrating the 
added-value of the EHDS, among others in use cases related to EMA’s regulatory activities at 
the level of the Union. The integration of DARWIN EU in the EHDS (as a node in the digital 
infrastructure  for  secondary  use  of  health  data)  will  facilitate  the  EMA’s  and  national 
agencies’ ability to launch cross-countries observational studies.  

The  Data  Analysis  and  Real  World  Interrogation  Network  (DARWIN  EU)  is  the  future 
EMA’s infrastructure that will support regulatory decision-making by:  

  establishing  and  expanding  a  catalogue  of  observational  data  sources  for  use  in 

medicines regulation; 

  providing a source of high-quality, validated real world data on the uses, safety and 

efficacy of medicines;  

  addressing  specific  questions  by  carrying  out  high-quality,  non-interventional 
studies,  including  developing  scientific  protocols,  interrogating  relevant  data 
sources and interpreting and reporting study results. 

DARWIN  EU  will  connect  EMA  and  the  European  medicines  regulatory  network  to  the 
European Health Data Space (EHDS), an initiative to promote better exchange of and access 
to  different  types  of  health  data.  DARWIN  EU  will  include  a  coordination  centre  for  the 
exchange  of  queries  and  information  across  European  medicines  agencies  and  EMA,  and  it 
will be integrated in the broader EHDS infrastructure network for access to real-world health 
data. DARWIN EU would also support FAIRification of datasets140, which can also be made 
available to other re-users.  

The  DARWIN  EU  infrastructure  and  organisational  structure  are  expected  to  be  developed, 
deployed and operated in two phases: 

140  FAIR  data  sets  are  those  that  meet  principles  of  findability,  accessibility,  interoperability  and  reusability. 
FAIRification is the process through which data sets are made compliant with FAIR principles. 

133 

 
                                                 
  A project phase (Phase 1), which covers the development and deployment of the core 
components  of  the  DARWIN  EU  infrastructure  (2021-2023):  covered  through  EU 
budget contribution 

  A  maintenance  phase  (Phase  2),  which  covers  the  operations  and  further 
development of the DARWIN EU infrastructure (from 2024 onwards): included 
under EMA cost calculations for the fee model of this study as from 2024. 

Phase  1  is  expected  to  be  funded  through  the  Union  budget  contribution  allocated  to  EMA 
under  its  revised  mandate.  Phase  2  is  expected  to  be  covered  annually  by  fees  collected  by 
EMA.  EMA  has  estimated  the  yearly  amount  for  Phase  2  at  16  million  EUR  (see  Table 
below).  This  yearly  amount  includes  the  operation  of  the  Coordination  Centre  and  its 
integration in the EHDS, the operation of the associated infrastructure, and the execution of 
routine and complex data analysis studies. 

Expected annual maintenance cost (phase 2) 

Type 

Category 

Amount € 

Analysis and Studies 

Analyses and Studies 

Operational 

Governance 

Training and Missions 

Maintaining Data Sources 

Infrastructure 

Technology Infrastructure 

Total expected annual maintenance cost  

7,200,000 

3,750,000 

258,000 

2,998,187 

1,720,713 

15,926,900 

134 

 
 
 
 
ANNEX 5: CONTEXT AND RELEVANT ACTORS 

A  medicinal  product  for  human  or  veterinary  use  can  only  be  placed  on  the  market  in  the 
European Union (EU) when a marketing authorisation has been granted either by a Member 
State national competent authority (national procedure for access to that territory’s market) or 
by the European Commission (centralised procedure for access to the EU market).  

In addition, once a medicinal product has been authorised and placed on the market, its safety 
profile continues to be monitored throughout its entire lifespan (pharmacovigilance). 

EMA (or ‘the Agency’) is the decentralised agency of the EU responsible for coordinating the 
existing  scientific  resources  put  at  its  disposal  by  the  Member  States,  usually    National 
Competent  Authorities  (NCAs),  for  the  evaluation,  supervision  and  pharmacovigilance  of 
medicinal products at centralised level, both for human and veterinary use. EMA is governed 
by  a  Management  Board,  which  includes  members  from  each  of  the  EU  Member  States. 
While authorisations to place centrally authorised medicines on the EU market are granted by 
the  European  Commission,  these  decisions  are  based  on  the  scientific  evaluation  and 
consequent  opinion  issued  by  the  Agency.  The  work  carried  out  by  the  Agency’s  seven 
committees informs this. 

EMA  provides  technical,  scientific  and  administrative  support  for  each  assessment  and  it 
coordinates the work and operations of all committees and working parties/groups. EMA also 
provides the same technical, scientific and administrative support to the coordination groups 
and  ensures  adequate  coordination  between  the  coordination  groups  and  the  committees.  In 
addition  the  Agency  carries  out  a  number  of  horizontal  activities,  such  as  IT  developments 
and maintenance, international activities, stakeholder engagement, access to documents etc. 

Each  EEA  Member  State  has  one  or  more  NCAs,  with  over  50  in  total,  dealing  with  the 
evaluation and maintenance of marketing authorisations of medicinal products for human and 
veterinary  use  in  their  own  territory.  While  the  NCAs  have  regulatory  responsibilities  at 
national  level  and  participate  in  fora  at  international  level,  only  NCAs  centralised  work  is 
within the scope of this impact assessment. Their contribution to the work of EMA, to support 
the  centralised  system,  involves  the  provision  of  the  vast  majority  of  scientific  experts, 
carrying  out  the  scientific  work  at  Union  level  (centralised  work),  including  through  the 
Committees of the Agency.  

–  EMA structure and functioning 

a.  Composition of EMA MB 

Members include: 

  one representative of each of the EU Member States; 
 
two representatives of the European Commission; 
 
two representatives of the European Parliament; 
 
two representatives of patients' organisations; 
  one representative of doctors' organisations; 
  one representative of veterinarians' organisations. 

135 

 
 
In addition to the members, the Management Board also has one observer each from Iceland, 
Liechtenstein  and  Norway.  The  Board  sets  the  Agency's  budget,  approves  the  annual  work 
programme and is responsible for ensuring that the Agency works effectively and co-operates 
successfully with partner organisations across the EU and beyond. The Agency’s day-to-day 
operations are carried out by the EMA staff, overseen by EMA's Executive Director.  

b.  Committees, associated Working Parties and associated groups 

EMA  has  seven  scientific  committees  (established  by  Union  legislation)  and  over  40 
working  parties  and  related  groups141  which  conduct  scientific  work  of  the  Agency. 
Membership  to  the  committees  is  based  on  the  representation  of  each  Member  State  (one 
main  member  and  one  alternate,  appointed  by  each  MS),  usually  experts  from  NCAs  and 
other relevant experts in line with the Rules of Procedure for each committee. Membership of 
committee associated working parties and associated groups is based purely on expertise and 
presence on the list of European experts maintained by the Agency. Experts are nominated by 
Member  States  or  by  the  Agency  and  are  primarily  made  available  by  NCAs,  with  a  few 
members from academia or hospitals. The committees are:  

 
 
 
 
 
 
 

the Committee for Medicinal Products for Human Use (CHMP) - opinion 
the Committee for Medicinal Products for Veterinary Use (CVMP) - opinion 
the Pharmacovigilance Risk Assessment Committee (PRAC)  
the Paediatric Committee (PDCO)  
the Committee for Orphan Medicinal Products (COMP) 
the Committee for Advanced Therapies (CAT) 
the Committee on Herbal Medicinal Products (HMPC). 

During its evaluation of marketing-authorisations, the relevant committee may consult EMA’s 
working parties, scientific advisory groups or other related groups on scientific issues relating 
to their particular field of expertise. 

In  addition  to  their  primary  role,  the  committees  and  working  parties,  together,  support 
medicines’  developers  and  provide  clarifications  with  respect  to  medicine  regulation,  by 
providing  scientific  advice  to  companies  researching  and  developing  new  medicines,  by 
preparing scientific guidelines and regulatory guidance to help companies prepare marketing 
the  harmonisation  of  regulatory 
authorisation  applications,  and  by  contributing 
requirements both in the EU and internationally.142  

to 

To carry out  a scientific assessment, usually  a committee appoints a rapporteur from  within 
the  committee  to  prepare  an  assessment  report,  which  the  committee  will  consider  and 
eventually  adopt  as  part  of  a  scientific  opinion  or  recommendation.  For  certain  procedures 
(the majority in the case of initial marketing authorisation procedures), a 'co-rapporteur' also 

141 This figure dates form the evaluation phase in 2019. Since then the Agency has undertaken a revision of the 
working parties/groups of the Agency to streamline the governance of the activities undertaken and the rules of 
procedures.  
142 For more information, see the individual work plans of the committees as published on EMA’s website under 
‘Committees’ (www.ema.europa.eu). 

136 

 
 
                                                 
prepares an  assessment independently from  the  rapporteur. An optional  peer-review process 
provides additional quality assurance for certain scientific assessments, although this is not a 
legal requirement.  

EMA  committees  try  to  reach  their  conclusions  by  consensus  whenever  possible,  but  if  not 
the committee holds a vote. 

An assessment team  supports the rapporteur and  co-rapporteur with  necessary  expertise and 
resources.  The  EMA  secretariat  provides  technical,  scientific  and  administrative  support  for 
each  assessment.  Furthermore,  it  coordinates  the  work  of  all  committees  and  working 
parties/groups.  To  be  noted  that  EMA  provides  the  same  technical,  scientific  and 
administrative  support  also  to  the  coordination  groups143  and  ensures  adequate  coordination 
between the coordination groups and the committees. Remuneration is paid to the respective 
NCAs via a cooperation agreement, in accordance with Article 62(3) of Regulation (EC) No 
726/2004. 

Appointment of (co)-rapporteurs144 

All  Members  and  alternates  can  act  as  rapporteur/co-rapporteur.  The  rapporteurs  are 
supported also by a team of assessors/experts made available either from their own NCAs or 
from across the EEA (multinational teams). 

The  appointment  of  the  rapporteur/co-rapporteur  is  made  on  the  basis  of  objective  criteria, 
which ensures the provision of objective scientific opinions and allows the use of the best and 
available  expertise  in  the  EEA  in  the  relevant  scientific  area,  over  the  lifecycle  of  the 
medicinal product. These objective criteria can be summarised in: 

  Ability  of  rapporteur/co-  rapporteur  to  fulfil  their  role,  which  refers  mainly  to  their 
ability  to  take  responsibility  for  the  scientific  assessment  /evaluation  undertaken  by  the 
assessment team, coordination input etc.  

  Assessment team objective criteria, which refer to the scientific competence, regulatory 
experience,  complementary  cross-team  scientific  expertise  and  competence  of  the 
assessment team(s) as well as the availability of an adequate Quality Assurance System at 
the level of the EEA NCAs 

  Individual  objective  criteria,  which  refer  to  the  academic  expertise  and  the  practical 
working  experience  and  competence  of  the:  (1)  Individual  assessor(s)/expert(s);  (2) 
Rapporteur/co-rapporteur  (when  acting  as  assessor/expert  in  the  scientific  assessment  of 
the application). 

143 The coordination groups for human medicinal products (CMDh) and veterinary medicinal products (CMDv) 
were  set  up  for  the  examination  of  any  questions  relating  to  nationally  authorised  medicinal  products, 
specifically related to disagreements on the grounds of potential serious risks to public health between Member 
States  on  pending  initial  marketing  authorisation  and  variation  procedures.  The  tasks  also  include  certain 
pharmacovigilance activities related to nationally authorised products. 

144  For  more  information  on  the  appointment  procedure:  https://www.ema.europa.eu/en/documents/regulatory-
procedural-guideline/procedural-advice-chmp/cat/prac-rapporteur/co-rapporteur-appointment-principles-
objective-criteria-methodology-accordance-article-62-1/2004_en.pdf 

137 

 
 
                                                 
On  the  practical  level,  when  an  application  is  submitted  to  the  EMA,  the  secretariat  of  the 
concerned committee sends a request to all members and alternates to indicate their interest in 
rapporteur/co-rapporteurships.  The  committee  Chairperson, 
the 
Chairperson of any other involved committees, will then assess the various candidates, on the 
basis  of  the  objective  criteria  mentioned  above,  and  decide  on  the  final  rapporteur/co-
rapporteur and their assessment team appointment as applicable.  

in  consultation  with 

The rapporteurs and co-rapporteurs are bound to the EMA Rules on the handling of declared 
interests. 

–  EMA budget 

The budget of EMA is established and implemented in accordance with principles set out in 
the Financial Regulation applicable to the budget of the European Medicines Agency (EMA 
financial  Regulation)  in  accordance  with  the  financial  regulation  applicable  to  the  general 
budget  of  the  Union.    In  particular,  under  the  principle  of  “equilibrium”,  it  is  intended  that 
revenue  and  payment  appropriations  of  the  Agency  should  be  in  balance  and  that  the 
commitment  appropriations  may  not  exceed  the  amount  of  the  Union  contribution  plus  the 
Agency’s own revenue (fees and other sources of income).145   

The figure below shows the relation between EU budget contribution and fee income over a 
10-year  period,  up  to  2020.  It  shows  that  whilst  the  EU  budget  contribution  remained 
relatively  constant,  the  Agency  relied  primarily  on  income  from  fees  to  cover  incremental 
increases  in  costs  associated  with  a  steady  increase  in  activities.  Over  the  period  2010  and 
2020 income from fees more than doubled. 

145 EMA Financial Regulation, Article 16 

138 

 
 
 
 
                                                 
Fig 7.1: Total amount of Union budget contributions146 vs. industry fees and other sources of income for 
the years 2010-2020 

350.000.000 €

300.000.000 €

250.000.000 €

200.000.000 €

150.000.000 €

100.000.000 €

50.000.000 €

0 €

310.595.246 €

153.681.470 €

251.490.173 €

47.878.259 €

33.934.672 €

58.880.754 €

2010

2011

2012

2013

2014

2015

2016

2017

2018

2019

2020

Union budget contributions

Fee income

Other income

In  2020,  the  Agency’s  total  budget  was  €369.7  million.  Approximately  83.9%  (€310.5 
million)  was  funded  by  fees  paid  by  undertakings  for  obtaining  and  maintaining  marketing 
authorisations and for other services provided by the Agency and ca.15.9% (€58.9 million) by 
EU/EEA budget contributions. The remainder of the EMA revenue (0.2%) stems from other 
sources  of  income,  such  as  administrative  operations  and  revenue  for  projects  and 
programmes. 

In 2020, the EMA expenditure relates to staff costs (€115.5 million), infrastructure costs (€85 
million) and operational expenditure (€169.2 million). Of the latter, 80% represents payments 
to experts for contribution to the centralised system, including expenditure for reimbursement 
of  attendance  to  meetings  (€1.3  million147),  remuneration  to  NCAs  for  work  of  rapporteurs 
and  co-rapporteurs,  coordinators,  inspectors  and  experts  for  their  scientific  assessments 
(€121.7  million)  and  remuneration  to  NCAs  for  work  of  rapporteurs  and  co-rapporteurs  on 
pharmacovigilance procedures (€12.3 million).148 The Regulation for a reinforced mandate of 
EMA adds to this expenditure € 8 million for DARWIN EU (set to become €16 million as of 
2024) and ca. €15 million for the other two objectives of that regulation. 

146  'Union budget contributions' consists of the general EU contribution, EEA contribution, specific contribution for orphan 
medicinal  products;  corrections  for  outturn/surplus  from  previous  year  (as  provided  for  in  Art.  17  of  the  EMA  Financial 
Regulation) are taken into account. 
147 This figure dropped from €7.9 million in 2018, as an effect of the COVID-19 crisis 
148  Figures  quoted  are  for  2020,  based  on  EMA  Budget  Report  for  2021,  as  adopted  by  the  Management  Board  on  7 

December 2020. 

139 

 
 
 
 
 
 
                                                 
ANNEX 6: SUMMARY IMPACT TABLES FROM THE CONSULTATION 

Fee revenue 

Do-minimum 

Total revenue  

Human medicines 

Procedural fees  

Annual fees - CAP 

Annual fees –PhV 

Veterinary medicines  

Procedural fees  

Annual fees - CAP 

Annual fees –PhV 

Total 

Option 1 

Total revenue  

Human medicines 

Procedural fees 

Annual fees - CAP 

Annual fees –PhV 

Veterinary medicines  

Procedural fees  

Annual fees - CAP 

Annual fees –PhV 

Total 

2020 

2022 

2023 

2024 

2025 

2026 

€'000 

€'000 

€'000 

€'000 

€'000 

€'000 

194.662  202.161  207.292  213.756  219.510  226.808 

90.342  103.685  110.556  117.809  126.214  135.199 

9.929  10.182  10.304  10.448  10.594  10.743 

5.800 

8.101 

9.752  11.480  13.383  13.965 

5.958 

7.632 

8.210 

8.917 

9.843  10.861 

0 

0 

0 

0 

0 

0 

306.690  331.761  346.113  362.410  379.544  397.576 

2022 

2023 

2024 

2025 

2026 

€'000 

€'000 

€'000 

€'000 

€'000 

202.161 

207.292 

213.756 

219.510 

226.808 

103.685 

110.556 

121.809 

130.499 

139.790 

10.182 

10.304 

22.448 

22.762 

23.081 

13.046 

14.835 

16.709 

18.739 

19.328 

20.752 

22.321 

24.246 

26.809 

29.594 

3.051 

3.088 

3.131 

3.175 

3.219 

352.877 

368.395 

402.100 

421.494 

441.821 

140 

 
 
 
 
 
 
Option 2  

Total revenue  

Human medicines 

Procedural fees 

Annual fees - CAP 

Annual fees –PhV 

Veterinary medicines  

Procedural fees  

Annual fees - CAP 

Annual fees –PhV 

Total 

Option 3 

Total revenue  

Human medicines 

Procedural fees 

Annual fees - CAP 

Annual fees –PhV 

Veterinary medicines  

Procedural fees  

Annual fees - CAP 

Annual fees –PhV 

Total 

2022 

2023 

2024 

2025 

2026 

€'000 

€'000 

€'000 

€'000 

€'000 

155.478 

160.379 

166.804 

172.972 

181.624 

125.412 

133.723 

146.496 

156.948 

168.122 

14.991 

15.171 

27.383 

27.766 

28.155 

13.046 

14.835 

16.709 

18.739 

19.328 

15.982 

17.190 

18.673 

20.652 

22.798 

3.051 

3.088 

3.131 

3.175 

3.219 

327.960 

344.385 

379.196 

400.251 

423.247 

2022 

2023 

2024 

2025 

2026 

€'000 

€'000 

€'000 

€'000 

€'000 

122.294 

126.364 

131.769 

136.150 

143.158 

156.247 

170.354 

181.531 

194.482 

208.328 

14.991 

15.171 

27.383 

27.766 

28.155 

10.203 

11.675 

13.207 

14.779 

14.986 

18.980 

20.415 

22.175 

24.525 

27.075 

3.051 

3.088 

3.131 

3.175 

3.219 

325.766 

347.067 

379.196 

400.878 

424.921 

141 

 
 
 
 
 
 
Option 3 ‘Light’ 

Total revenue  

Human medicines 

Procedural fees 

Annual fees - CAP 

Annual fees –PhV 

Veterinary medicines  

Procedural fees  

Annual fees - CAP 

Annual fees –PhV 

Total 

NCA remuneration 

Do-minimum 

2022 

2023 

2024 

2025 

2026 

€'000 

€'000 

€'000 

€'000 

€'000 

138.274 

142.633 

148.499 

154.004 

161.989 

141.522 

150.901 

164.801 

176.558 

189.129 

14.991 

15.171 

27.383 

27.766 

28.155 

12.104 

13.786 

15.538 

17.433 

17.872 

16.985 

18.269 

19.844 

21.947 

24.229 

3.051 

3.088 

3.131 

3.175 

3.219 

326.927 

343.847 

379.196 

400.883 

424.593 

2020 

2022 

2023 

2024 

2025 

2026 

€'000  

€'000  

€'000  

€'000  

€'000  

€'000  

All NCAs 

Remuneration from procedural 
activities  

105.442 

111.240 

115.344 

120.620 

124.501 

128.789 

Remuneration from annual fees  

29.928 

34.651 

36.931 

39.394 

42.264 

45.386 

NCAs conducting human medicines activities only (n=17) 

Remuneration from procedural 
activities  

35.629 

37.020 

38.146 

39.627 

40.648 

42.026 

Remuneration from annual fees  

10.600 

12.276 

13.075 

13.929 

14.912 

15.981 

NCAs conducting veterinary medicines activities only (n=12) 

Remuneration from procedural 
activities  

959 

1.144 

1.462 

1.791 

2.130 

2.159 

Remuneration from annual fees 

806 

930 

1.001 

1.087 

1.200 

1.324 

NCAs conducting both human and veterinary medicines activities (n=14) 

Remuneration from procedural 
activities  

68.853 

73.076 

75.736 

79.201 

81.723 

84.604 

Remuneration from annual fees 

18.522 

21.445 

22.855 

24.378 

26.152 

28.081 

142 

 
 
 
  
 
 
 
Option 1 

All NCAs 

2022 

2023 

2024 

2025 

2026 

€'000  

€'000  

€'000  

€'000  

€'000  

Remuneration from procedural activities  

113.515 

117.686 

123.032 

126.973 

131.262 

Remuneration from annual fees  

34.840 

37.134 

39.615 

42.508 

45.655 

NCAs conducting human medicines activities only (n=17) 

Remuneration from procedural activities  

36.843 

37.966 

39.444 

40.461 

41.835 

Remuneration from annual fees  

12.276 

13.075 

13.929 

14.912 

15.981 

NCAs conducting veterinary medicines activities only (n=12) 

Remuneration from procedural activities  

1.463 

1.818 

2.186 

2.563 

2.599 

Remuneration from annual fees 

1.004 

1.080 

1.173 

1.294 

1.428 

NCAs conducting both human and veterinary medicines activities (n=14) 

Remuneration from procedural activities  

75.209 

77.902 

81.403 

83.949 

86.828 

Remuneration from annual fees 

21.560 

22.980 

24.513 

26.301 

28.246 

143 

 
 
  
 
 
 
Option 2  

All NCAs 

2022 

2023 

2024 

2025 

2026 

€'000  

€'000  

€'000  

€'000  

€'000  

Remuneration from procedural activities  

105.168 

110.553 

117.808 

122.712 

129.455 

Remuneration from annual fees  

15.056 

16.062 

17.167 

18.475 

19.900 

NCAs conducting human medicines activities only (n=17) 

Remuneration from procedural activities  

36.614 

38.263 

40.419 

41.922 

44.161 

Remuneration from annual fees  

4.771 

5.082 

5.413 

5.796 

6.211 

NCAs conducting veterinary medicines activities only (n=12) 

Remuneration from procedural activities  

1.201 

1.465 

1.738 

2.019 

2.047 

Remuneration from annual fees 

1.004 

1.080 

1.173 

1.294 

1.428 

NCAs conducting both human and veterinary medicines activities (n=14) 

Remuneration from procedural activities  

67.352 

70.825 

75.651 

78.771 

83.246 

Remuneration from annual fees 

9.281 

9.901 

10.581 

11.385 

12.261 

144 

 
 
  
 
 
 
Option 3 

All NCAs 

2022 

2023 

2024 

2025 

2026 

€'000  

€'000  

€'000  

€'000  

€'000  

Remuneration from procedural activities  

90.945 

95.909 

102.657  106.683 

112.565 

Remuneration from annual fees  

28.121 

30.097 

32.318 

35.203 

38.297 

NCAs conducting human medicines activities only (n=17) 

Remuneration from procedural activities  

32.067 

33.604 

35.620 

36.832 

38.774 

Remuneration from annual fees  

9.195 

9.816 

10.506 

11.404 

12.376 

NCAs conducting veterinary medicines activities only (n=12) 

Remuneration from procedural activities  

1.201 

1.465 

1.738 

2.019 

2.047 

Remuneration from annual fees 

1.254 

1.370 

1.507 

1.691 

1.878 

NCAs conducting both human and veterinary medicines activities (n=14) 

Remuneration from procedural activities  

57.678 

60.840 

65.299 

67.833 

71.744 

Remuneration from annual fees 

17.671 

18.911 

20.305 

22.108 

24.043 

145 

 
 
  
 
 
 
Option 3 ‘Light’ 

All NCAs 

Remuneration from procedural 
activities  

2022 

2023 

2024 

2025 

2026 

€'000  

€'000  

€'000  

€'000  

€'000  

101.648 

106.891 

114.008 

118.768 

125.369 

Remuneration from annual fees  

18.292 

19.573 

20.968 

22.590 

24.347 

NCAs conducting human medicines activities only (n=17) 

Remuneration from procedural 
activities  

35.771 

37.388 

39.511 

40.979 

43.183 

Remuneration from annual fees  

5.896 

6.302 

6.734 

7.226 

7.757 

NCAs conducting veterinary medicines activities only (n=12) 

Remuneration from procedural 
activities  

1.201 

1.465 

1.738 

2.019 

2.047 

Remuneration from annual fees 

1.004 

1.080 

1.173 

1.294 

1.428 

NCAs conducting both human and veterinary medicines activities (n=14) 

Remuneration from procedural 
activities  

64.675 

68.039 

72.758 

75.770 

80.139 

Remuneration from annual fees 

11.392 

12.192 

13.061 

14.070 

15.162 

146 

 
 
  
 
 
 
EMA budget 

Do-minimum 

EMA income  

Total industry fees  

2020 

2022 

2023 

2024 

2025 

2026 

€'000   €'000   €'000   €'000   €'000   €'000  

306.690  331.761  346.113  362.410  379.544  397.576 

Total EU budget contribution  

58.881  44.590  45.200  34.000  34.000  34.000 

EMA expenditure 

Total expenditure on human and veterinary 
procedures  

95.064  101.725  107.501  114.269  120.436  126.804 

Total expenditure on other activities 

111.590  143.693  148.895  162.141  167.818  173.264 

Total payments to NCAs 

135.370  145.891  152.275  160.014  166.765  174.175 

Option 1 

EMA income  

Total industry fees  

2022 

2023 

2024 

2025 

2026 

€'000   €'000   €'000   €'000   €'000  

352.877  368.395  402.100  421.494  441.821 

Total EU budget contribution  

44.590  45.200  34.000  34.000  34.000 

EMA expenditure 

Total expenditure on human and veterinary procedures  

101.969  107.752  114.527  120.702  127.078 

Total expenditure on other activities 

143.693  148.895  162.141  167.818  173.264 

Total payments to NCAs 

148.355  154.820  162.647  169.481  176.917 

147 

 
 
  
 
  
 
 
 
Option 2  

EMA income  

Total industry fees  

2022 

2023 

2024 

2025 

2026 

€'000   €'000   €'000   €'000   €'000  

327.960  344.385  379.196  400.251  423.247 

Total EU budget contribution  

44.590  45.200  34.000  34.000  34.000 

EMA expenditure 

Total expenditure on human and veterinary procedures  

103.379  109.223  116.080  122.467  129.084 

Total expenditure on other activities 

143.693  148.895  162.141  167.818  173.264 

Total payments to NCAs 

120.224  126.616  134.975  141.188  149.355 

Option 3 

EMA income  

Total industry fees  

2022 

2023 

2024 

2025 

2026 

€'000   €'000   €'000   €'000   €'000  

325.766  347.067  379.196  400.878  424.921 

Total EU budget contribution  

44.590  45.200  34.000  34.000  34.000 

EMA expenditure 

Total expenditure on human and veterinary procedures  

103.379  109.223  116.080  122.467  129.084 

Total expenditure on other activities 

143.693  148.895  162.141  167.818  173.264 

Total payments to NCAs 

119.066  126.006  134.975  141.886  150.862 

148 

 
 
  
 
  
 
 
 
Option 3 ‘Light’ 

EMA income  

Total industry fees  

2022 

2023 

2024 

2025 

2026 

€'000   €'000   €'000   €'000   €'000  

326.927  343.847  379.196  400.883  424.593 

Total EU budget contribution  

44.590  45.200  34.000  34.000  34.000 

EMA expenditure 

Total expenditure on human and veterinary procedures  

103.379  109.223  116.080  122.467  129.084 

Total expenditure on other activities 

143.693  148.895  162.141  167.818  173.264 

Total payments to NCAs 

119.940  126.464  134.975  141.358  149.716 

149 

 
 
  
 
 
 
 
ANNEX 7: FINAL SUMMARY IMPACT TABLES AND FEE GRIDS 

Fee revenue 

Total revenue  

Human medicines 

Procedural fees 

Annual fees - CAP 

Annual fees –PhV 

Veterinary medicines  

Procedural fees  

Annual fees - CAP 

Annual fees –PhV 

Total 

NCA remuneration 

2022 

2023 

2024 

2025 

2026 

€'000 

€'000 

€'000 

€'000 

€'000 

143,377 

148,055 

154,417 

159,669 

168,240 

175,454 

187,081 

203,355 

217,863 

233,374 

11,153 

11,286 

23,444 

23,773 

24,105 

9,159 

10,748 

12,421 

14,163 

14,484 

10,242 

11,190 

12,259 

13,669 

15,132 

3,051 

3,088 

3,131 

3,175 

3,219 

352,436 

371,448 

409,027 

432,312 

458,554 

All NCAs 

Remuneration from procedural 
activities  

2022 

2023 

2024 

2025 

2026 

€'000  

€'000  

€'000  

€'000  

€'000  

92,426 

97,398 

104,215 

108,409 

114,705 

Remuneration from annual fees  

55,466 

59,317 

63,454 

68,311 

73,593 

NCAs conducting human medicines activities only (n=17) 

Remuneration from procedural 
activities  

31,965 

33,479 

35,490 

36,741 

38,827 

Remuneration from annual fees  

17,969 

19,161 

20,433 

21,892 

23,474 

NCAs conducting veterinary medicines activities only (n=12) 

Remuneration from procedural 
activities  

1,357 

1,622 

1,898 

2,180 

2,211 

Remuneration from annual fees 

3,186 

3,466 

3,775 

4,177 

4,620 

NCAs conducting both human and veterinary medicines activities (n=14) 

Remuneration from procedural 
activities  

59,104 

62,297 

66,827 

69,488 

73,667 

Remuneration from annual fees 

34,311 

36,690 

39,246 

42,242 

45,500 

150 

 
 
 
 
  
 
EMA budget 

EMA income  

2022 

2023 

2024 

2025 

2026 

€'000  

€'000  

€'000  

€'000  

€'000  

Total industry fees  

352,436 

371,448 

409,027 

432,312 

458,554 

Total EU budget contribution  

44,590 

45,200 

34,000 

34,000 

34,000 

EMA expenditure 

Total expenditure on human and 
veterinary procedures  

100,621 

106,412 

113,218 

119,195 

125,567 

Total expenditure on other activities 

143,693 

148,895 

162,141 

167,818 

173,264 

Total payments to NCAs 

147,893 

156,714 

167,669 

176,720 

188,298 

Variance 

4,820 

4,626 

0 

2,579 

5,425 

151 

 
 
  
  
 
 
 
 
Fee grid 

152 

 
 
Medicinal products for human use 

Scientific advice 

Initial request 

Initial request 

Initial request 

Follow-up request 

Follow-up request 

Follow-up request 

Application for marketing 
authorisation 

New active substances 

Known active substances 

level I 

level II 

level III 

level I 

level II 

level III 

Fixed combination 

‘Biosimilars’ 

Informed consent 

Generics 

Well established use 

Hybrids 

Compassionate use 

Outside EU Art. 58 

Application for MA patent (G) 

Application for MA patent (B) 

PIPs  

PIPs  

Waivers 

Finalised procedures for compliance check on PIPs 

Compliance checks 

Compliance checks 

‘Orphan’ Designation  

Orphan medicinal product designation procedures 

New 

Modification 

New 

Interim procedure 

Final compliance 

153 

NCA REMUNERATION 

unitary full fee  

rapporteur 

co-
rapporteur 

€ 

€ 

€ 

35,000 

44,700 

54,100 

40,600 

44,700 

60,100 

684,900 

549,800 

456,500 

575,000 

26,000 

141,200 

624,300 

339,700 

541,200 

541,200 

22,400 

27,600 

38,400 

23,500 

13,500 

39,100 

9,000 

9,000 

18,200 

5,000 

6,700 

10,500 

8,700 

7,100 

14,900 

217,300 

153,000 

141,500 

236,500 

4,900 

40,200 

160,600 

89,100 

160,600 

160,600 

2,400 

6,800 

6,700 

6,400 

1,800 

7,400 

1,000 

1,000 

1,500 

3,800 

6,100 

8,700 

4,500 

6,400 

12,500 

189,300 

143,300 

83,000 

151,700 

1,500 

0 

149,400 

89,100 

149,400 

149,400 

800 

1,000 

6,700 

5,900 

1,500 

6,800 

1,000 

1,000 

1,400 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
  
 
 
 
 
 
 
 
 
 
 
  
  
Scientific services 

PMF 

PMF 

PMF  

PMF 

PMF  

PMF 

PMF  

VAMF 

VAMF 

VAMF 

Medical device  

Medical devices composed of substance 

Medical devices composed of substance  

Medical devices companion diagnostics 

Medical devices companion diagnostics 

154 

8,600 

8,600 

Level I 

Level II 

Level III 

Submitted simultaneously 
with a new  MAA 

Type IA (charged separately) 

57,200 

57,200 

51,800 

17,300 

5,800 

3,700 

0 

0 

0 

Type IB (charged separately) 

5,200 

1,200 

AU re-certification (no 
variations) - AU (minor 
admin fee) 

Re-certification (AU with 
major T. II 

Re-certification (variations 
T. II ) 

lvl I, II (merged) 

Submitted simultaneously 
with a new  MAA 

Variations T. I 

Initial consultation  

Initial consultation  

Follow-up 

Initial consultation  

Follow-up 

10,400 

1,500 

1,500 

10,600 

1,600 

1,600 

10,400 

57,200 

5,800 

10,400 

198,100 

198,100 

212,000 

43,800 

31,400 

1,500 

8,600 

1,500 

8,600 

1,500 

23,500 

23,500 

29,600 

6,600 

6,300 

1,500 

23,500 

23,500 

29,600 

6,600 

3,500 

 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
Extension of marketing 
authorisation 

Renewals 

Non-pharmacovigilance 
Referrals 

Variations 

Follow-up 

Follow-up 

Follow-up 

Traditional herbal 

Traditional herbal 

Type II / X 

Type IB 

Type IA 

Level I 

Level II 

Certification for Advanced Therapies (ATMP certification) 

Level I Clinical (Extension of marketing authorisation (MA)) 

Level II Quality (Extension of MA - no new clinical data) 

Level III Patent Usage (Extension of marketing authorisation 1st year) 

Referral - Article 29(4) 

Referral -Article 30 

Referral -Article 31 

Referral -Article 13 

Referral -Article 5(3) 

Type II variations 
Type II variations 
Type II variations 

Type II variations 
Type IB variations 

Type IB  

Quality 
Clinical safety & safety 
Clinical indication 

WS Administrative Fee 

WS Administrative Fee 

Pharmacovigilance referrals 
(Art.31, Art.20, Art.107i) 

Pharmacovigilance referrals (Art.31, Art.20, Art.107i) 

1 active substance/combination of active substances and 1 MAH 

155 

12,500 

3,400 

3,700 

51,600 

33,800 

186,800 

161,000 

138,000 

161,500 

0 

83,000 

128,200 

180,700 

262,400 

136,700 

12,600 
13,300 
99,800 

800 
0 

0 

285,600 

172,100 

4,300 

1,400 

0 

6,200 

47,400 

55,300 

45,300 

42,200 

0 

2,800 

7,300 

13,400 

17,600 

12,400 

5,500 
7,600 
29,400 

0 
0 

0 

3,800 

0 

0 

6,200 

43,600 

31,200 

26,600 

26,600 

0 

2,800 

6,200 

11,400 

13,000 

12,400 

0 
0 
29,400 

0 
0 

0 

29,100 

29,100 

 
 
 
 
  
  
  
 
 
 
  
 
 
 
≤ 2 active substances/combinations of active substances and ≥ 
2 MAHs 

> 2 active substances/combinations of active substances and ≥ 
2 MAHs 

> 2 active substances/combinations of active substances and ≥ 
2 MAHs 

PASS/PSUR 

Post-Authorisation Safety Studies (PASS)  

Other  

Inspections 

Number of imposed PASS result procedures started 

Periodic Safety Update Reports for CAPs (PSURS) 

Periodic Safety Update Reports for NAPs & CAP/NAP (PSUSA) 

Procedural re-examination 

Pre-submission activities 

GMP  

GMP 

GCP 

GCP 

PMF  

PMF  

GLP 

≤ 2 active 
substances/combinations of 
active substances and ≥ 2 
MAHs 
3 active 
substance/combination of 
active substances and 1 
MAH 
5 active 
substance/combination of 
active substances and 1 
MAH 

In Europe 

Outside Europe 

In Europe 

Outside Europe 

Distinct inspections  

Consecutive inspections  

Administrative Fees 

Type IA variations 

Pharmacovigilance inspections  

Transfers  (of marketing authorisations between different  companies) 

156 

258,200 

314,100 

426,100 

43,300 

44,900 

27,000 

27,000 

161,500 

11,700 

24,800 

37,800 

37,100 

44,200 

36,100 

36,100 

34,900 

52,700 

0 

3,700 

17,100 

18,500 

12,900 

12,900 

42,200 

2,800 

6,900 

12,500 

14,700 

19,600 

10,800 

10,800 

13,200 

16,200 

0 

0 

0 

0 

0 

0 

26,600 

0 

6,900 

12,500 

9,100 

10,400 

10,800 

10,800 

8,700 

10,100 

0 

0 

 
 
 
 
 
 
  
  
 
  
  
  
 
  
  
Worksharing ADM + other Admin fees (Type IA WS Administrative Fee) 

Export Certificates 

Export Certificates 

Export Certificates 

Parallel distribution  

Parallel distribution  

Parallel distribution  

Annual Fees 

Centrally authorised products   

Inspections cancellations 

Pharmacovigilance 

Standard requests 

Urgent requests 

Withdrawal 

Initial Notifications 

Annual Updates 

Bulk change 

Level I 

Level II 

Level III 

Veterinary medicinal products 

Scientific advice 

Initial request 

Initial request 

Initial request 

Follow-up request 

Follow-up request 

Follow-up request 

Scientific advice CVMP classification MUMS data  

level I 

level II 

level III 

level I 

level II 

level III 

157 

0 

370 

370 

370 

750 

450 

450 

840 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

185,100 

20,100 

17,700 

92,700 

46,000 

100 

0 

0 

NCA REMUNERATION 

unitary full 
fee  

rapporteur 

co-
rapporteur 

€ 

€ 

€ 

20,700 

23,700 

23,700 

21,300 

24,300 

33,100 

16,600 

4,300 

9,300 

6,800 

6,100 

10,100 

15,800 

6,100 

0 

0 

0 

0 

0 

0 

0 

 
 
  
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
Marketing Authorisation 

New active substances 

Known active substances 

Combination VMP  

Abridged-Hybrid  

Abridged-Informed consent 

Generics (Abridged Generics) 

Reduced immunological generics 

Application under article 138 (opinion for a market outside EU) 

Maximum Residue Limit 

Establishment of MRL 

Re-examinations 

Modification or extension of MRL 

LM re-examinations 

EC re-examinations 

Referrals 

Referral Art 13 Reg 1234/2008 or Referral Art 33(4) Dir 2001/82/EC 

Referral Art 34 Dir 2001/82/EC 

Referral Art 35 Dir 2001/82/EC 

Procedure Art 45 Reg 726/2004 or Referral Art 78 Dir 2001/82/EC 

Procedure Art 30(3) Reg 726/2004 

Variations 

Variation fee level 1  

Variations fee level 2 

Variations fee level  

Variations fee level 4 

PASS/PSUR 

Post-Authorisation Safety Studies (PASS)  

Periodic Safety Update Reports for CAPs (PSURS) 

Other  

Transfers of marketing authorisations 

Procedural re-examination 

Pre-submission activities 

(ex. Line extensions) 

(ex. type II major) 

(ex. type II quality) 

Simple assessment 

158 

295,500 

267,700 

295,500 

136,800 

136,800 

136,800 

140,700 

238,600 

84,700 

86,100 

19,000 

19,000 

152,700 

209,200 

209,300 

147,200 

147,200 

87,800 

47,500 

23,900 

0 

107,000 

82,100 

107,000 

30,800 

30,800 

30,800 

31,600 

82,100 

21,400 

17,300 

3,100 

3,100 

21,100 

29,200 

29,200 

17,500 

17,500 

28,600 

9,800 

3,600 

0 

37,800 

15,400 

0 

3,200 

188,400 

8,200 

0 

0 

29,700 

2,200 

38,100 

35,300 

38,100 

17,900 

17,900 

17,900 

21,000 

35,300 

10,300 

15,800 

2,400 

2,400 

9,600 

12,900 

12,900 

7,700 

7,700 

8,600 

7,600 

3,600 

0 

0 

0 

0 

14,200 

0 

 
 
 
 
 
 
 
 
 
  
  
  
  
 
 
  
 
 
 
Annual Fees 

Limited market classification  

Centrally authorised products 

Pharmacovigilance 

Level I 

Level II 

Level III 

0 

0 

17,800 

16,400 

5,200 

65,600 

0 

16,100 

100 

159