Phasing Out COVID-19 Regulatory Flexibilities

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On 5 May 2023, the World Health Organization (WHO) declared that COVID-19 was no longer a public health emergency following a decrease in COVID-19 deaths, hospitalizations, and intensive care unit admissions across the globe over the past several months (1). On 6 July 2023, the European Medicines Agency (EMA), the European Commission (EC), and the Heads of Medicine Agencies (HMA) announced they would be phasing out the extraordinary COVID-19 regulatory flexibilities introduced in August 2022 in response to the pandemic (2).

Extraordinary regulatory flexibilities introduced during COVID-19

The extraordinary regulation encompassed several different aspects to ensure the continuity of supplies of medicines during the public health emergency. These included greater flexibility for:

• good manufacturing practice (GMP) and good distribution practice (GDP) issues
• issues related to marketing authorization (MA) and MA procedures
• pharmacovigilance activities
• product information and labelling
• quality variations
• manufacturing and importation of finished products and APIs (3).

EMA’s quick response to the crisis highlighted the need for rapid and coordinated feedback to developers and the importance of continued dialogue with them, to ensure that adaptions to the regulatory environment were workable for the industry (4).

Moving forward

From this point onwards, the regulatory flexibilities that were introduced jointly by the EC, EMA, and HMA during COVID-19 will no longer be granted (3). For products that have already received approved labelling flexibilities, such as COVID-19 vaccines with English-only labelling, the application will be extended until the end of 2023 to prevent any disruptions to supplies; after which time, manufacturers will revert to the original legislations on product labelling (3).

Conversely, on-site GMP and GDP inspections have been reinitiated following their postponement or implementation of remote visits performed during the pandemic (3). GMP and GDP certificates have been extended until the end of 2023, and the GMDP inspectors working group will provide further details over the coming months following a review of information gleaned from remote working of qualified persons during the pandemic (5).

Future regulation, preparedness, and response tools

The COVID-19 pandemic highlighted the importance of deploying a coordinated EU-wide strategy and revealed some vulnerabilities in the current system, including limitations in the regulations, preparedness, and response tools (6). In November 2020, the EC proposed a series of measures, including a revised regulation on serious cross‑border threats to health and proposals to extend the mandates of EMA and the European Centre for Diseases Prevention and Control (ECDC) in public health emergencies, to create a European Health Emergency Preparedness and Response Authority (HERA) (7). In February 2021, the EC also announced that it may consider targeted amendments to the pharmaceutical legislation including developing new regulatory tools to introduce an emergency authorization of vaccines at the EU level with shared liability among member states, during public health threats (6).

On 26 April 2023, EMA published two legislative proposals—a new regulation 2023/0131 and a new directive 2023/0132—to replace the current European Union (EU) regulatory framework for all medicines (8,9). As part of the overhaul, EMA plans to introduce some contingency planning procedures including the compilation of an EU-wide list of critical medicines and recommendations to companies to strengthen the supply chains should the need arise. Under the new proposal, all MA holders will need to put in place a shortage prevention plan for each medicine on the market, any critical shortages would need to be reported to EMA. In addition, the new regulation provides temporary measures such as emergency MA for crisis‑related medicines allowing the EU to take control of drug manufacturing in response to an emergency, this controversial point has raised concerns amongst some pharma industry leaders (10).

The new regulatory framework is currently being reviewed by the European Parliament and the European Council and a decision on the proposed reform is unlikely to take place before the 2024 EU parliamentary elections. In the meantime, data are being gathered by EMA’s Executive Steering Group on Shortages and Safety of Medicinal Products regarding manufacturers’ experience of the COVID-19 regulatory flexibilities (11). EMA will then reflect on how lessons learned during the pandemic can inform best practices for confronting medicine shortages in the presence of new and emerging health challenges in the future (2).

References

1. WHO. Statement on the Fifteenth Meeting of the IHR (2005) Emergency Committee on the COVID-19 Pandemic. WHO.int, News, 5 May 2023.
2. EC. Phasing out of Extraordinary COVID-19 Regulatory Flexibilities. Health.ec.europa.eu, News, 6 July 2023.
3. EC. Questions and Answers on Regulatory Expectations for Medicinal Products for Human Use During the COVID-19 Pandemic. Health.ec.europa.eu, 11 Aug. 2022.
4. Cavaleri, M.; Sweeney, F.; Gonzalez-Quevedo, R.; Carr, M. Shaping EU Medicines Regulation in the Post-COVID-19 Era. Lancet Reg. Health Eur. 2021, 9, 100192.
5. Taylor, N.P. Euro Roundup: EMA Starts Phasing Out Regulatory Flexibilities Provided During the COVID-19 Pandemic. Regulatory Focus, RAPS, 13 July 2023.
6. Beaussier, A.; Cabane, L. Strengthening the EU’s Response Capacity to Health Emergencies: Insights from EU Crisis Management Mechanisms. Eur. J. Risk Regul., 2020 11 (4) 808–820.
7. EC. HERA Incubator: Anticipating Together the Threat of COVID-19 Variants. Communication, 17 Feb. 2021.
8. EC. Reform of the EU Pharmaceutical Legislation. Health.ec.europa.eu, 26 April 2023.
9. EC. Proposal For a Regulation of the European Parliament and of the Council Laying Down Union Procedures for the Authorization and Supervision of Medicinal Products for Human Use And Establishing Rules Governing The European Medicines Agency, Amending Regulat. Regulation, 26 April 2023.
10. Barton, C. EMA Overhauls the Medicine Legislative and Regulatory Framework. Pharm. Tech. Eur. 2023 35 (6) 7–8.
11. EMA. Executive Steering Group on Shortages and Safety of Medicinal Products. EMA.europa.eu (accessed 14 July 2023).

About the author

Cheryl Barton is director at PharmaVision, Pharmavision.co.uk.