Annexes to COM(2019)439 - Exercise of delegation conferred on EC on fees payable to the EMA for conduct of pharmacovigilance activities in respect of medicinal products for human use - Main contents
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| dossier | COM(2019)439 - Exercise of delegation conferred on EC on fees payable to the EMA for conduct of pharmacovigilance activities in respect of ... |
|---|---|
| document | COM(2019)439  |
| date | September 30, 2019 |
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.
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 adjusting the amounts laid down in the Pharmacovigilance Fee Regulation taking into account cumulatively the inflation rate of the Union for 2015 and for 2016
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 Group 4 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 Journal 5 and started applying from 12 February 2018.
3.2.Delegated act adjusting the amounts laid down in the Pharmacovigilance Fee Regulation taking into account the inflation rate of the Union for 2017
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 Regulation. Commission Delegated Regulation (EU) 2018/1298 was published in the Official Journal 6 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.
(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.
(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.
(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