REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the exercise of the delegation conferred on the Commission pursuant to 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
Date: 2019-09-30
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: European Commission, European Medicines Agency, drug surveillance, inflation, market approval, medicinal product, payment, powers of the institutions (EU), transfer of competence

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  EN 

   EUROPEAN COMMISSION  Brussels, 30.9.2019  COM(2019) 439 final  REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the exercise of the delegation conferred on the Commission pursuant to 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  
 
 
REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT 
AND THE COUNCIL 

on the exercise of the delegation conferred on the Commission pursuant to 
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 

1. 

INTRODUCTION 

The  legal  framework  for  the  monitoring  of  the  safety  of  medicinal  products  that  have 
been placed on the market in the Union is provided for in Regulation (EC) No 726/20041 
and in Directive 2001/83/EC2. These pharmacovigilance activities cover the whole life-
cycle management of medicinal products for human use in relation to safety. 

To finance these activities, Regulation (EU) No 658/20143 ('the Pharmacovigilance Fee 
Regulation')  provides  for  fees  to  be  charged  to  marketing  authorisation  holders. 
Additionally,  it  sets  out  the  amounts  of  remuneration  for  the  rapporteurs  and  the  co-
rapporteurs appointed by the relevant committees for the respective assessment (Parts I to 
IV of the Annex of the Pharmacovigilance Fee Regulation). 

The  Pharmacovigilance  Fee  Regulation  empowers  the  Commission  to  adopt  delegated 
acts  adjusting  the  amounts  of  the  fees  and  the  amounts  of  the  remuneration  for 
rapporteurs and co-rapporteurs, where such adjustment is considered justified in light of 
an annual monitoring of the inflation rate, measured by means of the European Index of 
Consumer prices published by Eurostat (Article 15). 

2.  LEGAL BASIS 

The  present  report  is  a  requirement  under  Article  16(2)  of  the  Pharmacovigilance  Fee 
Regulation.  This  provision  delegates  powers  to  the  Commission  for  five  years,  starting 
from  17  July  2014.  A  report  on  the  exercise  of  the  delegation  should  be  drawn  up  not 
later than nine months before the end of this  period.  The delegation of powers is  to  be 
tacitly extended for periods of an identical  duration, unless the European Parliament  or 
the  Council  opposes  such  extension  not  later  than  three  months  before  the  end  of  each 
period. 

1   Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying 
down  Community procedures for the  authorisation and supervision of  medicinal products for human 
and veterinary use and establishing a European Medicines Agency, OJ L 136, 30.4.2004, p. 1. 

2   Directive  2001/83/EC  of  the  European  Parliament  and  of  the  Council  of  6  November  2001  on  the 

Community code relating to medicinal products for human use, OJ L 311, 28.11.2001, p. 67. 

3   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, OJ L 189, 27.6.2014, p. 112. 

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3.  EXERCISE OF THE DELEGATION 

Under Article 15(5) of the Pharmacovigilance Fee Regulation, the Commission monitors, 
in relation to the amounts laid down in the Parts I to IV of the Annex of the Regulation, 
the  inflation  rate  made  available  by  Eurostat  pursuant  to  Regulation  (EC)  No  2494/95. 
Under Article 15(6) of the Pharmacovigilance Fee Regulation, where justified in light of 
that monitoring, the Commission adopts delegated acts adjusting those amounts. During 
the 5 years period in question, the Commission adopted two delegated acts, the first one 
taking  into  account  cumulatively  the  inflation  rate  of  the  Union  for  2015  and  for  2016 
and the second one taking into account the inflation rate of the Union for 2017. 

3.1.  Delegated 

act 

the 
Pharmacovigilance Fee Regulation taking into account cumulatively the 
inflation rate of the Union for 2015 and for 2016 

laid  down 

adjusting 

amounts 

the 

in 

The inflation rate of the Union, as made available by Eurostat, was 0,2 % for 2015 and 
1,2 % for 2016. In view of these inflation rates, it was considered justified to proceed to 
an adjustment in 2017. A cumulative adjustment, taking into account the inflation rates 
for 2015 and for 2016, was therefore applied. 

The  Expert  Group4  formed  by  the  Pharmaceutical  Committee  was  consulted  on  the 
subject  of  the  draft  Commission  Delegated  Regulation  through  written  procedure.  A 
four-week public consultation was held from 27 July until 24 August 2017.  

The  Commission  adopted  the  delegated  act  on  18  October  2017  and  notified  the 
European Parliament and the Council of it. Neither institution objected to the delegated 
act within the two-month period provided for in Article 16(5) of the Pharmacovigilance 
Fee  Regulation.  Commission  Delegated  Regulation  (EU)  2018/92  was  published  in  the 
Official Journal5 and started applying from 12 February 2018. 

3.2.  Delegated 

act 

the 
Pharmacovigilance Fee Regulation taking into account the inflation rate 
of the Union for 2017 

laid  down 

adjusting 

amounts 

the 

in 

The inflation rate of the Union, as made available by Eurostat, was 1,7  % for 2017.  In 
accordance  with  Article  15(6)  of  Regulation  (EU)  No  658/2014  it  was  considered 
justified to proceed to an adjustment for 2017. 

The  Expert  Group4  formed  by  the  Pharmaceutical  Committee  was  consulted  on  the 
subject  of  the  draft  Commission  Delegated  Regulation  through  written  procedure.  A 
four-week public consultation was held from 3 April until 3 May 2018.  

The  Commission  adopted  the  delegated  act  on  11  July  2018  and  notified  the  European 
Parliament and the Council of it. Neither institution objected to the delegated act within 
the  two-month  period  provided  for  in  Article  16(5)  of  the  Pharmacovigilance  Fee 

4   Expert groups that help the Commission in relation to the preparation of delegated acts are listed in the 

Register of Commission Expert groups: http://ec.europa.eu/transparency/regexpert/. 

5   Commission Delegated Regulation (EU) 2018/92 of 18 October 2017 amending Regulation (EU) No 
658/2014 of the European Parliament and of the Council as regards the adjustment to the inflation rate 
of  the  amounts  of  the  fees  payable  to  the  European  Medicines  Agency  for  the  conduct  of 
pharmacovigilance activities in respect of medicinal products for human use OJ L 17, 23.1.2018, p. 2. 

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Regulation.  Commission  Delegated  Regulation  (EU)  2018/1298  was  published  in  the 
Official Journal6 and started applying from 18 October 2018. 

4.  CONCLUSION 

To  date  the  Commission  has  exercised  in  two  instances  the  delegated  powers  provided 
for by Regulation (EU)  No 658/2014  to  adjust to the inflation the amounts  of fees  and 
remuneration  laid  down  in  that  Regulation.  The  Commission  invites  the  European 
Parliament and the Council to take note of this report. 

6   Commission  Delegated  Regulation  (EU)  2018/1298  of  11  July  2018  amending  Regulation  (EU)  No 
658/2014 of the European Parliament and of the Council as regards the adjustment to the inflation rate 
of  the  amounts  of  the  fees  payable  to  the  European  Medicines  Agency  for  the  conduct  of 
pharmacovigilance activities in respect of medicinal products for human use, OJ L 244, 28.9.2018, p. 1 

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