The way countries declared public health emergencies during the COVID-19 pandemic varied greatly across the globe, and this variability persists even as emergency conditions are improving and official declarations are being ended.

Of the 10 jurisdictions reviewed in this report, three countries—Canada, China, and the United Kingdom—did not declare national health emergencies. Instead, they relied on other existing authorities or new legislation to address the pandemic. Three countries declared emergencies but have since revoked them or allowed them to expire—Colombia, Mexico, and Japan. Three countries still had emergencies in place as of the first quarter of 2023 (Argentina, India, and the United States). On May 5, 2023, the World Health Organization (WHO) declared the end of the pandemic. In the United States, the emergency ended on May 11, 2023, after repeated extensions.

In the European Union (EU), member states took different approaches to declaring emergencies. The EU has taken more action than other jurisdictions to address emergency powers. New life sciences regulations that became effective in March 2022 reinforce the role of the European Medicines Agency (EMA) in crisis preparedness and management for medicinal products and medical devices. These regulations also formally establish the Emergency Task Force (ETF) as an advisory and support body for public health emergencies. The ETF is responsible for accelerating the assessment of scientific evidence on vaccines and medicines that target emergencies.

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During the first wave of the pandemic in 2020, health authority inspections were reduced in many places. Since then, inspections have increased, but some countries still have fewer inspections than before the pandemic.

To adapt to pandemic conditions, regulators have changed the way they inspect. They now use remote inspections that include document production, remote access to data and electronic systems, video tours of facilities, and video interviews with personnel. Hybrid inspections that mix remote and in-person techniques have also become more common, even in countries that didn’t do virtual inspections before, like Japan. Regulators in Argentina, Canada, China, the United States, and the United Kingdom have issued new guidance on remote or hybrid inspections. These new approaches are especially helpful for smaller markets like Colombia, where faraway, rural facilities make it difficult to inspect.

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Prior to the pandemic, jurisdictions’ procedures for granting accelerated approval to new vaccines, drugs, or treatments—a status generally known as emergency use authorization (EUA)—varied widely. Those countries that lacked EUA procedures (e.g., Colombia) quickly adopted new regulations specifically for COVID-19 vaccines and treatments. All 10 of the jurisdictions discussed in this report ended up approving vaccines and, in some cases, treatments under EUA-type processes. The average number of EUA-approved vaccines, drugs, and biological products in the 10 jurisdictions was 11, with numbers ranging from five vaccines in Colombia to 18 products (four vaccines, 14 drugs or biologics) in the United States. Smaller countries tended to rely upon the WHO and its Emergency Use Listing Procedure or on approvals in peer or larger jurisdictions in granting EUAs.

In many jurisdictions, relatively few EUA products have transitioned to regular commercial approval: Argentina, China, Colombia, and Mexico—for example—have not approved any EUA products for commercial use, and the United States has transitioned only five EUA products (two vaccines and three drugs or biologics) to commercial approval.
Conversely, revocations of drug and vaccine EUAs have been rare, as have been recalls or compliance problems for EUA vaccines or treatments. Those low rates of revocation or recall are a testament to the risk–benefit analysis that, in most cases, preceded the invocation of EUA procedures.

Many countries have intensified their surveillance for adverse reactions. Colombia and India, for example, launched new online platforms for adverse reaction reporting.

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The COVID-19 pandemic acted as a catalyst on efforts in many jurisdictions to accelerate drug approvals, modernize clinical trials, and advance the use of telemedicine.

Canada and other jurisdictions are applying lessons of the pandemic to efforts to make drug licensing more agile. The European Commission is preparing to enact legislative revisions to improve timelines and speed patient access to new medications by removing unnecessary steps and reinforcing expertise-driven assessments. The UK government has announced a Life Sciences Vision Program intended to apply lessons learned from the COVID-19 response to other daunting health problems, including dementia, cancer, and aging. In India, the government has issued guidelines directing states and union territories to build buffer stocks of drugs used for COVID-19.

In each of the 10 jurisdictions discussed in this report, efforts to modernize clinical trials were launched or accelerated in response to pandemic conditions. Techniques included use of digital tools for finding trial subjects, obtaining subject consent, and monitoring trials; home delivery and administration of trial drugs; and streamlining of trial design and approval. In Europe, EMA launched an online platform to facilitate multinational clinical trials, for which sponsors can seek authorization to conduct trials in up to 30 countries with one application.² The US Food and Drug Administration (FDA) has issued draft guidance on use of digital health technologies for gathering data remotely in clinical investigations.³

Telemedicine also gained greater regulatory flexibility, particularly in countries (e.g., Japan) where adoption had been low. In India, the government released a national telemedicine platform, called eSanjeevani, for patient-to-provider and provider-to-provider consultations.⁴

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The urgent need to respond to the COVID-19 pandemic broke down barriers and spurred a wave of collaborative efforts among players in the life sciences ecosystem—health authorities, global bodies, life sciences companies, and others in the health care system. These collaborations were a major focus of Deloitte’s 2021 report, Never the same again.

As pandemic conditions eased, many of those collaborative relationships appear to have persisted and deepened, including:

• Transnational collaborations among regulators and health authorities
• Collaborations between regulators and industry
• International collaborations involving health authorities and life sciences companies
• Industry collaborations

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