2022 discharge: European Medicines Agency (EMA)

The European Parliament decided to grant discharge to the Executive Director of the European Medicines Agency (EMA) for the financial year 2022 and to approve the closure of the accounts for that year.

Noting that the Court of Auditors has stated that it has obtained reasonable assurance that the Agency's annual accounts for the financial year 2022 are reliable and that the underlying transactions are legal and regular, Parliament adopted, by 528 votes to 71 with 4 abstentions, a resolution containing a series of recommendations which form an integral part of the discharge decision and which complement the general recommendations set out in the resolution on the performance, financial management and control of EU agencies.

Agency’s financial statements

The Agency's final budget for the year 2022 was EUR 421 815 000, representing an increase of 11.23 % compared to 2021. The Agency is a fee-funded agency, with approximately 88 % of its 2022 revenue stemming from fees derived from the evaluation of medicines and other business-related activities, and 12 % stemming from the Union budget and miscellaneous income.

Budgetary and financial management

Budget monitoring efforts during the financial year 2022 resulted in a budget implementation rate of current year commitment appropriations of 96.80 %, representing a decrease of 0.42 % compared to 2021. Payment appropriations execution rate was 71.48 %, representing a decrease of 0.88 % compared to 2021.

The resolution recalled that potential liabilities arising, until 2039, from the lease on the Agency’s former office premises in London remain an ongoing issue. On 31 December 2022, the total estimated outstanding rent, associated service charges and landlord insurance to be paid by the Agency up to the end of the lease term was EUR 366 million, that is approximately EUR 23 million annually. In 2019, the Agency reached an agreement with its landlord, and sublet its former premises to a subtenant with effect from July 2019. The term of the sublease lasts until the Agency´s lease expires in June 2039 and, since the Agency remains a party to the head lease, it could be held liable for the entire amount remaining payable under the contractual obligations of the head lease, if the subtenant fails to meet its obligations.

Other observations

Parliament also made a series of observations concerning performance, staff policy and digitalisation.

In particular, it noted that:

- the Agency reported on 41 performance indicators, estimating an implementation rate of 92.60 %;

- on 1 March 2022, the Agency’s mandate was extended reinforcing its role in crisis preparedness and management of medicinal products and medical devices;

- other key achievements in 2022 include the approval of two new vaccines and two COVID-19 treatments, the ETF recommended the temporary use of the US-approved monkeypox vaccine Jynneos for Monkeypox to support vaccination efforts by national EU authorities, alongside an extension of the use of Imvanex to also protect adults from monkeypox;

- adequate Union funding should be allocated to the Agency to carry out all of its activities;

- 52 % of applicants who have been granted a positive opinion for their medicinal product have received scientific advice or protocol assistance from the Agency during the development phase of their product, with this figure rising to 78 % for applicants for medicinal products with new active substances;

- the Agency should be more proactive regarding digitalisation;

- on 31 December 2022, the establishment plan was 99.39 % implemented, with 658 temporary agents appointed out of 662 temporary agents authorised under the Union budget (compared to 657 authorised posts in 2021);

- the lack of gender balances and geographical balance should be addressed;

- in order to increase cybersecurity, the Agency adopted the Information Security Strategy.