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EMA is facing a dilemma in trying to restore activities back to normal after relocating and the COVID-19 pandemic.
Editor’s Note: This article was published in Pharmaceutical Technology Europe’s July 2020 print issue.
In the aftermath of COVID-19, the European Medicines Agency (EMA) has the task of returning to its level of activities before the onset of the pandemic. But it also faces the longer-term challenge-not directly related to the disease-of restoring all the broad spread of activities of the agency before it had to relocate from London in the United Kingdom in 2019 to Amsterdam in the Netherlands. A move that is required by European Union rules as a result of the UK’s referendum vote in June 2016 in favour of ending the country’s membership of the EU, commonly referred to as Brexit.
Due to the upheaval of the relocation, including the loss of some specialist staff, the agency had to suspend some non-core activities. EMA was scheduled to return to pre-Brexit normality in June 2020, but the arrival of COVID-19 has forced it to postpone this deadline.
Now there is the possibility that some of the suspended activities may have to be abandoned so that EMA can adequately take on new responsibilities. A major reason for this outcome is that the agency would require a larger budget after already receiving extra funds to help pay for the relocation and costs of implementing new legislation.
“At the end of 2019, the agency was in as good a shape as it could have been following its move,” wrote Christa Wirthumer-Hoche, chair of EMA management board in the foreword to the agency’s annual report, published in June 2020 (1). “However, the board remains concerned about the longer-term prospects of the agency’s full recovery if the on-going constraints cannot be addressed,” she warned.
Important areas of the agency’s work remained mostly suspended throughout 2019. In June 2019, the agency was able to resume a small number of IT and digitalization activities, which had helped underpin the effectiveness of its medicines’ evaluations and various administrative processes (1).
Also, in September 2019, some of the working groups within the EU medicines regulation network, which contributed to the EMA’s core activities, were restarted (1). These groups included one focused on good manufacturing and distribution practices, a working party on quality, and a team covering process analytical technology (PAT) (1). Working parties for patients and consumers and healthcare professionals also restarted (1).
Nonetheless most of the operations, which were suspended or reduced in 2018, remained on hold. This comprised a lot of guideline development work, engagement in international activities, most working party meetings, and the agency’s proactive publication of clinical data.
The COVID-19 outbreak earlier this year resulted in the full recovery of EMA operations being delayed once again. Instead, priority had to be given to regulatory work on vaccines and treatments for the pandemic even over other non-COVID core activities.
EMA’s work during the pandemic is geared to giving precedence to dealing with the emergency development and authorization of COVID-19 vaccines and treatments. This is being done, however, without sacrificing standards in its key central role of authorizing and monitoring the marketing of all medicines.
The agency has established dedicated task forces for meeting the scientific, regulatory, and operational challenges of disease. An EMA business continuity plan (BCP) for COVID-19 aims both to ringfence resources for dealing with the disease while exercising the agency’s core responsibilities for the evaluation and supervision of medicines.
The EMA pandemic Task Force (COVID-ETF) helps EU member states and the European Commission (EC) to take quick and coordinated regulatory action on COVID-19 treatments and vaccines. The taskforce, which is accountable to EMA’s Committee for Medicinal Products for Human Use (CHMP), reviews scientific data on potential COVID-19 medicines while also identifying promising candidates. Furthermore, it assists the agency’s pharmacovigilance risk assessment committee on post-marketing safety issues with COVID-19 products.
The European Medicines Regulatory Network (EMRN), headed by EMA and comprising the medicines licensing authorities of all EU member states and also non-EU members like Norway and Iceland, has also drawn up a BCP ensuring that priority is given by regulators across much of Europe to COVID-19 issues (2). This BCP includes not just the development and authorization of COVID-19 vaccines and treatments but also potential shortages of essential medicines for COVID-19 patients, particularly those in intensive care units (ICUs).
“The magnitude of this additional work is difficult to quantify at the moment,” said the EMRN BCP, in a joint statement issued by the EC, EMA, and Heads of Medicines Agencies (HMA), representing national authorities (2).
As a result of pressure on the work time of regulators from COVID-19 matters, pharmaceutical companies are thought to be holding back the application for marketing authorizations of their products or approval of variations of marketing authorizations. “The extent of the impact on the pharmaceutical industry is also unknown, including whether it will result in the reduction or delay of submissions (for authorizations),” the BCP stated (2).
One major uncertainty for regulators is how much a reduction in submissions for authorizations of non-COVID-19 drugs will be offset by a rise in applications for approval of COVID-19 medicines. Also, regulators in EMA and national agencies are concerned that once the threat of COVID-19 cases fades there will be a sharp rise in previously delayed submissions from pharmaceutical companies (2).
Regulators are not only worried about having to grapple with a rush of delayed submissions but also the extra burden of implementing new EU legislation in areas like veterinary medicine, medical devices, and personal data protection. A new veterinary medicines regulation, due to come into effect in January 2022, represents a major overhaul of the agency’s system for authorization of veterinary medicines while strengthening EMA’s action against antimicrobial resistance (1). It is all being done without a staffing increase.
Under the new medical devices regulation, in which EMA has a role in the approval of products such as drug–device combinations, the agency’s responsibilities have been considerably extended (3).
“With the ever increasing pace of innovation and the blurring of the traditional boundaries between medicines and devices, it is inevitable for the agency to assume new responsibilities in the regulation of complex medicines with a medical device component,” said Guido Rasi, EMA’s executive director, in the agency’s latest annual report (1). “The big challenge we face is to ensure we have appropriate expertise and resources to adequately carry out these tasks,” he added.
A lot of time and resources has also been taken up with the establishment, under the new Clinical Trials Regulation (4), of an EU-wide integrated information system throughout all the member states. “This is one of the most complex and ambitious IT developments ever undertaken by EMA,” said Wirthumer-Hoche in the annual report (1).
EMA has been expanding its overall infrastructure and staff expertise in data analytics and artificial intelligence (AI). The agency initiated an in-depth review of its organization last year in what it calls a ‘future proofing’ exercise to strengthen its ability to take on new activities. Four task forces have been set up to deal with key priorities, two of them in digitalization-digital business transformation and data analytics-with the other two covering regulatory science and innovation, and clinical trials and manufacturing strategy.
Digitalization will help provide a stronger evidence base for regulatory decision-making. It will also improve productivity when even after a recruitment drive the agency was still suffering staff shortages at the end of last year. Total staff then numbered 775 compared with around 900 in London. Lack of staff with the right expertise remained a concern.
A joint HMA/EMA Big Data Task Force recommended in December 2019 that the regulatory network set up a platform for access and analysis of healthcare data from across the EU (5). The platform would be called Data Analysis and Real-World Interrogation Network (DARWIN).
It would initially focus on the analysis of electronic health records to support regulatory decision-making. One objective would be to complement data from randomized clinical trials with evidence from healthcare practice so that regulators could validate claims by pharmaceutical companies about their products.
The system would need to be supported by a lot of expertise from external sources and the recruitment of data scientists and specialists in advanced analytics and AI.
It would also be expensive, putting further strains on EMA’s finances. With all the other additional burdens on its budget, the agency faces a dilemma about the resumption of activities, which have been put on hold since the move from London. Some may have to be sacrificed by being permanently shelved.
Rasi, who is due to retire from his job at the end of 2020, said in his introduction to the agency’s annual report that he hopes that by then EMA can finally “close the chapter on our relocation.” He, or his successor, may find that first some controversial decisions may have to be taken before closure is achieved.
1. EMA, “Annual Report 2019” (Amsterdam, June 2020).
2. EC, HMA, and EMA, “European Medicines Regulatory Network COVID-19 Business Continuity Plan” (Brussels, 28 May 2020).
3. EU, Regulation (EU 2017/745) on Medical Devices (Brussels, 24 April 2017).
4. EU, Regulation (EU 2014/536) on Clinical Trials on Medicinal Products for Human Use (Brussels, 16 April 2014)
5. HMA and EMA, “Joint Big Data Taskforce Phase II report: Evolving data-driven regulation” (Brussels, January 2020).
Pharmaceutical Technology Europe
Vol. 32, No. 7
When referring to this article, please cite it as S. Milmo, “Business on Hold? EMA’s Full Recovery in Question,” Pharmaceutical Technology Europe 32 (7) 2020.