COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE 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

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  EN 

   EUROPEAN COMMISSION  Brussels, 13.12.2022  SWD(2022) 415 final  COMMISSION STAFF WORKING DOCUMENT  EXECUTIVE SUMMARY OF THE 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) 414 final}  
 
 
Introduction 
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 
contribution of national competent authorities (NCAs) in Member States. The EMA 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 
the EMA. 

The legislation requires that EMA fees be based on an evaluation of the Agency’s costs and of 
the related costs of services provided by Member States (national competent authorities). 

The main problems facing the EMA fee system 
The main problems, identified in the 2019 evaluation of the EMA fee system, are as follows: 

  misalignment of some fees with the underlying costs of the activities estimated by the 

evaluation; 

  misalignment of some NCA remuneration with the underlying costs estimated by the 

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evaluation; 
the fee system may not be flexible enough to keep pace with innovations, meaning 
that, in the future, some assessment processes for new medicinal products will likely 
be more complex than in the past; and 
the fee system is rather complex and not fully coherent both externally with the 
underlying pharmaceutical legislation and internally between the two EMA Fee 
Regulations1, thus creating unnecessary administrative burden and difficulties for 
some stakeholders when predicting the fees that will be charged. 

These problems are driven by: 

  new and amended procedures for veterinary medicines introduced as a result of 

revisions to the Veterinary Medicinal Products (VMP) Regulation2; and a new EMA 
activity included in Regulation (EU) 2022/123 on a reinforced role for the European 

Council Regulation (EC) No 297/95  on fees payable to the European Agency for the Evaluation of 

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Medicinal Products and Regulation (EU) No 658/2014 of the European Parliament and of the Council on fees 
payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of 
medicinal products for human use. 
2 
products and repealing Directive 2001/82/EC. 

Regulation (EU) 2019/6 of the European Parliament and of the Council on veterinary medicinal 

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Medicines Agency in crisis preparedness and management for medicinal products and 
medical devices, which requires additional funds as of 20243; 
levels of fees and remuneration that are not fully cost-based on the granular level (i.e. 
unitary fees and unitary remunerations); 
lack of a clear approach to the distribution of the financial burden of fee incentives 
between the EMA and NCAs; 
lack of a monitoring system to track and detect significant trends having an impact on 
the cost base of fee and remuneration amounts, e.g. changes in complexity of scientific 
assessments; 
the wide variety of EMA activities and the complexity of the underlying 
pharmaceutical legislation; and 
lack of an appropriate mechanism to easily adjust the fee system to changes in EMA 
responsibilities (the full ordinary legislative procedure is required to amend the fee 
amounts set in the legislation beyond inflation adjustments). 

These problems are a challenge to the financial sustainability of the EMA going forward, 
including the capacity of the Agency to remunerate NCAs for their contributions to EMA 
activities in line with the pharmaceutical legislation. 

The case for and objectives of EU action 
The  general  objective  pursued  is  to  provide  the  EMA  with  a  sound  financial  basis  for  the 
future.  The  EMA  is  a  decentralised  Agency  of  the  EU.  The  terms  of  its  funding,  including 
fees as a source of revenue, are determined exclusively by EU legislation. Any amendment of 
the two EMA Fee Regulations requires an ordinary legislative procedure. Hence, only the EU 
can act to enable the Agency to charge fees. 

The specific objectives of the revision of the EMA fee system are to: 

  align revenue from fees with estimated costs; 
  align the EMA fee system with the VMP regulation; 
  ensure a fair distribution of cost-based fees and cost-based NCA remuneration, while 

respecting applicable fee incentives; and 

  achieve a balance between simplification of the system and a cost-based approach. 

Options 
This impact assessment analysed several policy options together with a number of horizontal 
measures and compared them with a ‘do-the-minimum’ scenario describing what would likely 
happen in the absence of legal action to update the EMA fee legislation. 

3 Financial statement of the Commission proposal, COM/2020/725 final, Specific objective No 3 ‘Allow timely 
access and analysis of EU-wide health data to support better decision-making throughout the product lifecycle 
on medicines (development, authorisation, performance monitoring) with valid and reliable real-world 
evidence.’ 

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  Option 1 – align the fee system with the VMP regulation only, with cost-based fees for 
all veterinary medicine procedures as per the new VMP Regulation. Unchanged fees 
for human medicines. 

  Option 2 – revise the entire EMA fee system with a cost-based principle being used to 
set all fees and all NCA remuneration rates for both veterinary and human medicine 
activities. 

  Option 3 – same as Option 2, except that the fee system is simplified by including the 

cost of the majority of post-authorisation procedures under the annual fees (as opposed 
to charging a fee as the procedure occurs, as in Option 2). 

  Option 3 Light – same as Option 3, however, with only partial simplification of the fee 

system structure by including in the annual fee the cost of only minor post-
authorisation procedures (other procedures continue to attract a per-procedure fee). 

The horizontal measures, considered for all four of these policy options, include: 

  various  combinations  of  general  fee  reductions  and/or  specific  incentives  for 
veterinary medicine fees, designed in line with the objectives of the VMP Regulation; 
the possible use of country coefficients to adjust NCA remuneration; and 
the possible allocation from the EMA to NCAs of some of the financial burden of fee 
incentives (i.e. the loss of fee revenues they imply). 

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All four options are cost-reflective, i.e. based on estimated respective average costs(options 2, 
3 and 3 Light are cost-reflective for both the human and the veterinary sectors). 

Conclusions 
Options  2,  3  and  3  Light  enable  the  EMA  to  cover  on  aggregate  its  costs,  including  for 
remuneration  of  contributions  of  NCAs.  Of  these,  Option  3  Light  is  assessed  as  overall  the 
most efficient option. Its implementation would be combined with targeted fee reductions for 
veterinary  fees in  line with the objectives  of the  VMP  regulation, no  application of country 
coefficients  to  modulate  NCA  remuneration,  and  no  sharing  with  NCAs  of  the  cost  of  fee 
reductions (i.e. EMA budget to cover that cost). It achieves balance between the objective of a 
cost-based  fee  system  and  the  objective  of  simplification  of  the  fee  system.  Both  ‘do-the-
minimum’  scenario  and  Option  1  were  dismissed,  as  they  would  result  in  a  deficit  for  the 
EMA  budget,  given  the  cost  estimations  made  for  the  impact  assessment,  and  taking  into 
account  the  EU  budget  contribution  to  the  EMA  budget  under  the  current  multiannual 
financial framework. 

The  administrative  burden  generated  by  the  fee  system  on  payers,  including  SMEs  and 
microenterprises, NCAs and the EMA, would not vary significantly between Options 1 and 2. 
Options 3 and 3 Light  are, however, simpler and so imply a slightly  reduced  administrative 
burden. 

None  of  the  options  would  provide  complete  predictability  of  fees  due  from  payers,  but 
Options 3 and 3 Light would go further in addressing this issue than would Options 1 and 2. 
SMEs  are  eligible  for  fee  incentives  from  the  EMA  (fee  reductions,  exemptions  and/or 

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deferrals)  under  Commission  Regulation  (EC)  No 2049/2005  (the  SME  Regulation). 
Incentives  for  SMEs  remain  applicable  in  all  policy  options  and  sub-options.  Relative  to 
Option  1, the other policy  options imply slightly  higher fee payments (net of incentives) by 
SMEs.  However,  further  reductions  granted,  within  the  system,  would  compensate  for  that 
impact. 

Also  proposed is  an effective  and proportionate  monitoring and evaluation framework. This 
would  support  future  changes  in  the  EMA  fee  system  by  providing  a  factual  basis  for 
adjustment  of  fees  and  remuneration.  Flexibility  of  the  fee  system  could  be  achieved  by 
delegating  some  powers  to  the  Commission  to  adjust  the  fee  system,  based  on  evidence 
generated by the monitoring system. 

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