CELEX: 
Language: en
Date: 2020-07-14 00:00:00
Title: COMMISSION DELEGATED REGULATION (EU) …/... 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

EUROPEAN
                           COMMISSION
                                                      Brussels, 14.7.2020
                                                      C(2020) 4635 final
                 COMMISSION DELEGATED REGULATION (EU) …/...
                                         of 14.7.2020
   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
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 ---pagebreak---                               EXPLANATORY MEMORANDUM
   1.  CONTEXT OF THE DELEGATED ACT
       Fees collected by the European Medicines Agency are laid down in two legal acts.
       Firstly, Council Regulation (EC) 297/95 of 10 February 1995 on fees payable to the
       European Agency for the Evaluation of Medicinal Products1 sets the level of fees
       payable to the European Medicines Agency for the activities of authorisation and
       supervision of medicinal products in respect of medicinal products for human and
       veterinary use. Article 12(5) of that Regulation provides that with effect from 1 April
       of each year the Commission shall review the fees by reference of inflation rate as
       published in the Official Journal of the European Union and update them. This
       update is not in the scope of this delegated Regulation.
       Secondly, 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
       use2, sets the levels of the fees specifically for pharmacovigilance activities of the
       Agency for medicinal products for human use and the respective remuneration to
       rapporteurs and co-rapporteurs for the relevant scientific assessment services that
       they provide . Article 15(5) of that Regulation provides that the inflation rate,
       measured by means of the European Index of Consumer prices published by Eurostat
       pursuant to Regulation (EC) No 2494/95, shall be monitored annually in relation to
       the amounts set out in the Regulation. Article 15(6) of that Regulation provides that,
       where justified in light of that monitoring, the Commission shall adopt delegated acts
       adjusting the amounts of the fees and the amounts of the remuneration for
       rapporteurs and co-rapporteurs that are laid down in the Regulation. It also provides
       that where the delegated act enters into force before 1 July, those adjustments shall
       take effect as from 1 July and where the delegated act enters into force after 30 June,
       they shall take effect as from the date of entry into force of the delegated act. The
       purpose of this delegated Regulation is to set the amounts of those adjustments for
       2020.
       The last adjustment of the abovementioned amounts was carried out in 2018 based
       on the inflation rate of 2017. Therefore, for this adjustment a cumulative approach
       will be applied, taking into account the inflation rate both for 2018 (1,7%) and for
       2019 (1,6%). For this purpose, the amounts in this regulation were calculated by first
       applying the 1,7% rate and rounding the results to the nearest 10 (with the exception
       of the annual fee, rounded to the nearest 1) and then applying to the newly calculated
       amounts the 1,6% rate, followed by a second such rounding.
       With regards to the fee for assessments in the context of referrals initiated as a result
       of the evaluation of pharmacovigilance data, the same method of adjustment was
       applied to the amounts set out in Part III of the Annex of the Regulation, except for
       the maximum amount of the fee, which is applicable when five or more active
       substances and/or combinations of active substances are included in the assessment.
       In order to avoid discrepancies due to the rounding, the adjusted maximum amount
       of that fee was calculated by increasing incrementally each fee level with the
   1
      OJ L 35, 15.2.1995, p. 1.
   2
      OJ L 189, 27.6.2014, p. 112.
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 ---pagebreak---         adjusted amount of the fee increase per each additional active substance or
        combination of active substances that is laid down in the legislation.
   2.   CONSULTATIONS PRIOR TO THE ADOPTION OF THE ACT
        The Pharmaceutical Committee3 was consulted as an expert group4 through written
        procedure from. No objections were raised.
        The draft delegated Regulation was subject to a feedback period of 4 weeks, in line
        with the Better Regulation guidelines. No feedback was received.
   3.   LEGAL ELEMENTS OF THE DELEGATED ACT
        The legal base of this delegated Regulation is Article 15(6) of Regulation (EU)
        No 658/2014.
        Article 1 of this delegated Regulation sets the adjusted amounts of the fees and the
        amounts of the remuneration for rapporteurs and co-rapporteurs that are laid down in
        the Regulation (EU) No 658/2014.
        Article 2 of this delegated Regulation sets the rules of its entry into force and
        application.
   3
      Council Decision of 20 May 1975 setting up a pharmaceutical committee, OJ L 147, 9.6.1975, p. 23.
   4
      http://ec.europa.eu/transparency/regexpert/index.cfm?do=groupDetail.groupDetail&groupID=2858
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 ---pagebreak---                      COMMISSION DELEGATED REGULATION (EU) …/...
                                                   of 14.7.2020
     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
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard 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, and in
   particular Article 15(6) thereof,
   Whereas:
   (1)     In accordance with Article 67(3) of Regulation (EC) No 726/2004 of the European
           Parliament and of the Council2, the revenue of the European Medicines Agency
           includes fees paid by undertakings for obtaining and maintaining Union marketing
           authorisations and for other services provided by the Agency, and 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 of the
           European Parliament and of the Council3.
   (2)     The last adjustment of the fees and remuneration amounts laid down in Regulation
           (EU) No 658/2014 was carried out in 2018 based on the inflation rate of 2017. The
           inflation rate of the Union for the years 2018 and 2019, as published by the Statistical
           Office of the European Union, was respectively 1,7% and 1,6%. Taking into
           consideration the level of the inflation rates for those years, it is considered justified to
           adjust, in accordance with Article 15(6) of Regulation (EU) No 658/2014, the amounts
           of the fees and the amounts of the remuneration for rapporteurs and co-rapporteurs
           referred to in Parts I to IV of the Annex of that Regulation. A cumulative adjustment
           taking into account the inflation rates for both 2018 and 2019 should therefore be
           applied.
   (3)     For the sake of simplicity, the adjusted amounts should be rounded to the nearest EUR
           10, with the exception of the annual fee for information technology systems and
           literature monitoring where the adjusted level should be rounded to the nearest EUR 1.
   (4)     Fees laid down in Regulation (EU) No 658/2014 are due either at the date of the start
           of the respective procedure or, in the case of the annual fee for information technology
           systems and literature monitoring, on 1 July of every year. Consequently, the
   1
           OJ L 189, 27.6.2014, p. 112.
   2
           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).
   3
           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).
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 ---pagebreak---            applicable amount will be determined by the due date of the fee and there is no need to
           set specific transitional provisions for pending procedures.
   (5)     Regulation (EU) No 658/2014 should therefore be amended accordingly,
   HAS ADOPTED THIS REGULATION:
                                                 Article 1
   The Annex to Regulation (EU) No 658/2014 is amended as follows:
   (1)      in Part I, point 1 is amended as follows:
            (a)    'EUR 20 110' is replaced by 'EUR 20 780;
            (b)    'EUR 13 520' is replaced by 13 970’;
   (2)      in Part II, point 1 is amended as follows:
            (a)    in the introductory sentence, 'EUR 44 340' is replaced by 'EUR 45 810';
            (b)    point (a) is amended as follows:
                   (i)    'EUR 17 740' is replaced by 'EUR 18 330';
                   (ii)   'EUR 7 510' is replaced by 'EUR 7 760';
            (c)    point (b) is amended as follows:
                   (i)    'EUR 26 600' is replaced by 'EUR 27 480';
                   (ii)   'EUR 11 260' is replaced by ’11 630';
   (3)      in Part III, point 1 is amended as follows:
            (a)    the first subparagraph is amended as follows:
                   (i)    'EUR 184 600' is replaced by 'EUR 190 740';
                   (ii)   'EUR 40 020' is replaced by 'EUR 41 350';
                   (iii) 'EUR 304 660' is replaced by 'EUR 314 790';
            (b)    the second subparagraph is amended as follows:
                   (i)    in point (a), 'EUR 123 060' is replaced by 'EUR 127 150';
                   (ii)   in point (b), 'EUR 149 740' is replaced by 'EUR 154 730';
                   (iii) in point (c), 'EUR 176 420' is replaced by 'EUR 182 290';
                   (iv) in point (d), 'EUR 203 090' is replaced by 'EUR 209 840';
            (c)    in the fourth subparagraph, point (b) is amended as follows:
                   (i)    'EUR 1030' is replaced by 'EUR 1070';
                   (ii)   'EUR 2050' is replaced by 'EUR 2110';
                   (iii) 'EUR 3100' is replaced by 'EUR 3200';
   (4)      in point 1 of Part IV, 'EUR 69' is replaced by 'EUR 71'.
                                                 Article 2
   This Regulation shall enter into force on the twentieth day following that of its publication in
   the Official Journal of the European Union. It shall apply from [if the date of entry into force
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 ---pagebreak---    is prior to 1 July 2020, please insert–"1 July 2020" as date, if the date of entry force is after
   30 June 2020, please insert the date of entry into force].
   This Regulation shall be binding in its entirety and directly applicable in all Member States.
   Done at Brussels, 14.7.2020
                                                 For the Commission
                                                 The President
                                                 Ursula VON DER LEYEN
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