Relocating EMA: A Far from Ideal Situation

The European Medicines Agency’s (EMA’s) role as one of the world’s leading regulators, which has been a major force in the drive to harmonize medicines regulations across the globe, could be seriously weakened as a result of the need to relocate its current London headquarters to Amsterdam. EMA, which is responsible for centralized approval of medicines in the European Union (EU), has been a big influence in areas such as the standardizing global rules on good manufacturing practice, medicines identification, the introduction of biosimilars and post-marketing pharmacovigilance.

Within Europe itself, as a result of its job as co-ordinator of the activities of approximately 30 national medicines licensing authorities in the region, EMA has done much to establish uniform approaches to the authorization of medicines and to keep pharmaceutical regulation in line with advances in science.

But now it is being threatened with such a large reduction in staff due to the relocation of its headquarters in 2019 that it will have to concentrate mainly on high-level priorities such as the assessment and safety monitoring of medicines. With some of its international activities in bodies like the International Council for Harmonization of Technical Requirements for Pharmaceuticals (ICH) and the International Coalition of Medicines Regulatory Authorities (ICMRA), it may only be able to act mainly as an observer.

Cutbacks and staff losses

EMA has stressed that the cutbacks or suspensions of its activities will only be temporary (1), lasting until 30 June 2019, soon after Brexit is scheduled to take place on 29 March 2019. It also points out that cutbacks will mainly result in slowdowns of specific operations while suspensions will mean they will be completely halted for a period. But it has itself admitted that there could be longer-term effects on the agency’s operations (1).

After the United Kingdom voted in June 2016 to leave the EU, making necessary EMA’s relocation to an EU member state, the agency estimated that with an attractive location like Amsterdam it would lose initially approximately 20% of its 900 employees (2). However, in August 2018, it revealed that the staff exodus was likely to be around 30% (3).

This was despite the choice of Amsterdam as the site for EMA’s new headquarters. Among 19 competing bids from EU countries, the Dutch city was the favoured choice among the agency’s employees (2). A winning bid by most of the other cities would have resulted in even more drastic staff losses (4).

The agency has been operating out of London since its foundation in the early 1990s, since then it has built up a staff with considerable expertise. The most qualified of these employees who are leaving the agency will be difficult to replace in the short to medium-term.

Before it started to lose employees who did not want to relocate, EMA’s 900 staff in London included a number of temporary and part-time workers, giving it a total of full time equivalents (FTE) of approximately 700, according to agency figures (4).

A 30% reduction, as forecasted by the agency which had been hoping for a retention rate of at least around 80%, would lower the staff total, including temporary and part-time employees, to approximately 600 (4), with the FTE total probably dropping below 500.

For carrying out its highest priority-category 1-activities, mainly the assessment and monitoring of the safety of medicines, EMA estimates it requires 462 FTEs. With medium priority category 2 operations, such as combating antimicrobial resistance (AMR), collaboration with health technology assessment bodies which decide on reimbursement entitlements at the national level, and dealing with medicine shortages, it needs 140 FTEs. For the lowest category 1 activities, covering governance and support activities, audits and participation and organization of meetings, 110 FTEs are required (4).

External dependencies

In addition to its own staff, the agency relies on medical and other scientific experts provided by EU and other European agencies, particularly in the assessment of new drug applications.

For much of its existence in London, EMA has depended a lot on experts in the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). It has accounted for around 15–20% of the more burdensome rapporteur and co-rapporteur work on new drug assessments.

Since the Brexit referendum result, EMA has been sharply reducing contributions by the MHRA. This year, the UK agency has been given only two (co)-rapporteur contracts by EMA compared with an annual average of 22 before the referendum (5). Instead, work previously allocated to the UK agency has been spread around other EU national authorities. Also, the post-marketing responsibilities of a total of 370 human and veterinary medicines for which the MHRA had been (co)-rapporteur are being moved to other agencies (5). So, Brexit has not only increased the individual workloads of EMA staff but that of national agencies as well.

Staff surveys

EMA’s surveys of its own staff before the selection of Amsterdam as the relocation site showed that at its new Dutch headquarters it would retain the necessary 462 FTEs for category 1 work but hang onto only 102 for category 2 and 11 for category 3 work (4). But these should be jobs which will be easier to fill than those for high priority category 1 positions.

The remaining top four favourite cities bidding for selection as the relocation site would also retain sufficient category 1 staff, according to EMA figures (4). These would have included Milan, which in the selection process attracted the same number of votes as Amsterdam but lost out in the equivalent of a toss of the coin to decide the winning city.

With the remaining 15 contestants, staff retention rates ranged from 72% to as low as 26%, so that with the majority of bidders employees losses would have been so high the agency would not have been able to carry out its core public health responsibilities (4). 

Brexit preparedness

EMA’s latest report on its Brexit preparedness issued in October 2018 reveals that it is having to make further cutbacks and suspensions in its operations six months before its move to Amsterdam, extending into areas of medium, category 2 priorities (1). These priorities include international activities, guidelines development, working party activities, stakeholder interaction, and clinical data publication.

International level collaboration will be further scaled back until the end of June 2019 with the exception of responses to product‑related requests, supply chain issues-such as medicine shortages-and the EUMed4all scheme, under which EMA does product assessments for developing countries (1).

Involvement in other international activities will be decided on a case-by-case basis with the agency taking, if necessary, only a reactive or observer role, especially in areas like harmonization of global medicine regulations.

Guideline development will be restricted to subjects relating to urgent public health needs, Brexit requirements, and the implementation of new or revised legislation. Work on guidelines will continue on, for example, revised or new annexes in the EU GMP guide on sterile products and medicine imports and quality requirements for drug device combinations (DDCs) (1).

Within the ICH’s operations, EMA will continue to act as topic lead or rapporteur with four guidelines, including one on electronic standards for regulatory information transfers. It will also continue to be involved in the preparation of the Q12 guideline on pharmaceuticals lifecycle management because of its ‘particular interest’. However, with the remaining ICH’s ongoing guidelines, EMA will switch to an observer role (1).

Meetings of the agency’s non-product related working parties, except those involved in priority guidelines development, will be suspended from 1 October 2018, to end of June 2019. The frequency of meetings of certain expert groups, such as the GMDP Inspectors Working Group, may be decreased or reduced to virtual meetings.

EMA has warned that there will be further cutbacks and suspensions in its activities from 1 January 2019 lasting until the end of June 2019 (1). These could be more severe than expected if the relocation runs into major problems. From early January 2019, EMA staff will start moving into temporary offices in Amsterdam to await the completion, scheduled for November 2019, of its eventual headquarters in a custom-designed new building.

‘Not an optimal solution’

“This is not an optimal solution,” Guido Rasi, EMA’s executive director, complained at a press conference in the Netherlands early last year (2). The temporary offices will only have half the space in the current London headquarters and will require the use of external meeting facilities.

Members of the European parliament have been so concerned about complications with the relocation that the Dutch authorities are now legally obliged to submit quarterly reports to the parliament and EU member states on the new building’s progress.

Once the agency’s full range of activities are resumed in mid-2019, it will still need time to make up for lost ground. It estimated last year that even with a staff retention level of over 65% it would take two to three years to fully recover. If retention rates slipped to 50–64%, full recovery could be delayed by up to five years and to 30–49% by up to 10 years (4).

References

1. EMA, “EMA Brexit Preparedness Business Continuity Plan-Phase 3 Implementation Plan,” EMA/701082/2018 (London, 9 October 2018).
2. EMA, “Statement by Executive Director Guido Rasi in The Hague,” Press Release, 29 January 2018.
3. EMA, “Brexit Preparedness: EMA to Further Temporarily Scale Back and Suspend Activities,” Press Release, 1 August 2018.
4. EMA, “EMA Business Continuity Planning and Impact of Staff Retention Scenarios from EMA Staff Survey,” (London, 26 September 2017).
5. EMA, Cut-off Days for UK Rapporteurship Appointments for Pre- and Post-authorization Procedures for Centrally Authorized Products (London, 9 October 2018).

Article Details

Pharmaceutical Technology Europe
Vol. 30, No. 12
December 2018
Pages: 8–9

Citation

When referring to this article, please cite it as S. Milmo, “Relocating EMA: A Far From Ideal Situation," Pharmaceutical Technology Europe 30 (12) 2018.