Driving better clarity on global life sciences regulations

On April 17, 2020, the National Institutes of Health (NIH) and its Foundation (FNIH) created the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program to develop an international strategy for a coordinated research response to COVID-19. Was this unprecedented level of collaboration a one-off, or will it continue across life sciences industry in the future?

As the industrial and regulatory landscape continues to evolve, it’s vital for stakeholders to have clarity on next steps to help them prepare their people and systems for the next global crisis.

With that in mind, the Global Regulatory Intelligence Team (GRIT) at Deloitte has created an in-depth report, “Never the same again: How COVID-19 created seismic change in life sciences regulations.” Our subject-matter specialists on the ground, leveraging long-term relationships and in-depth research spanning in time from the onset of the pandemic to March 2021, co-wrote this life sciences industry report that richly integrates global insights and relevant findings. In it, they share what fundamentally changed in life sciences regulation through a prism of five of the world’s most populous economies and largest life sciences markets—the United States, China, the European Union, Japan, and India.

Addressing four facets of the new global life sciences regulatory landscape

Given the expansive scope of the report, we have focused the report around four key areas: governments declaring health emergencies, regulators collaborating with companies, regulatory agencies collaborating across borders, and companies collaborating with each other.

Racing to catch up: Digital technology adoption accelerates

While digitalization of processes, transactions, and relationships had been underway for some time, pandemic-related developments and restrictions surely accelerated this trend. Organizations in all locations studied moved rapidly to technology-enabled work from home (WFH), digital communication, and digitalization for monitoring of clinical trials. As our report notes, while technology brought positive impacts, it also presented new risks. The downsides included lines between work and home activities being blurred, long hours in front of computers reducing movement and impacting health, and heightened exposure to fraud and digital breaches—impacts which should be examined and more deeply understood.

Read the report to explore more examples.

United States:
• Regulatory modifications by US regulators triggered enhanced responses to the pandemic, such as relaxing clinical trial application (CTA) provisions to accelerate the administrative process.¹
• Unlike ever before, several large pharmaceutical companies, including Eli Lilly, Novartis, Gilead, and AstraZeneca, formed a group called COVID R&D to share knowledge and resources.²

China:
• In January 2020, the genome sequence of the virus was isolated in China, and Chinese regulators soon shared the research results with the WHO for global research purposes.³
• Manufacturers and distributors collaborated with Central and provincial governments on volume-based procurement (VBP) of drugs that have passed their patent protection period.

European Union:
• The EU European Medicines Agency (EMA) established a pandemic task force to accelerate the development, authorization, and monitoring of COVID-19 treatments and vaccines⁴
• EMA collaborated with the US Food and Drug Administration to exchange information on products and clinical trials and jointly interpreted data supporting regulatory decisions.⁵

Japan:
• The Ministry of Health, Labour and Welfare (MHLW) collaborated with industry groups to stabilize supplies of essential items in response to the declaration of a state of emergency.⁶
• Pharmaceuticals and Medical Devices Agency (PMDA)—the regulatory authority for medical devices, vaccines, and drugs in Japan—introduced several regulatory changes that supported life sciences.

India:
• India responded by establishing a regulatory framework for rapid COVID-19 response, including fast-tracking the approval process for vaccines, diagnostics, prophylactics, and therapeutics.⁷
• In May 2020, the Ministry of Health and Family Welfare set up an approval system permitting applicants to manufacture and stock COVID-19 vaccines under clinical trial. ⁸

Moving forward, with caution and vision

As the industry continues to ponder the global impacts of new regulatory regimes, now is the time to understand how your priorities were set, examine ways in which communication changed, assess how impacts were absorbed, and be ready to respond more effectively to future crises.

Download “Never the same again: How COVID-19 created seismic change in life sciences regulations” today and gain clarifying insights that may help you collaborate better, accelerate innovation, and expand.

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End notes

1 Rod MacKenzie et al., “COVID-19 must catalyse changes to clinical development,” Nature Reviews Drug Discovery 19 (2020): pp. 653–4.
2 Diane Kwon, “How the pharma industry pulled off the pivot to COVID-19,” The Scientist, July 13, 2020.
3 People’s Daily, “WHO is confident in China’s ability to control the epidemic,” February 1, 2020.
4 EMA, “EMA’s governance during COVID-19 pandemic.”
5 Anna Abram and Mark Abdoo, “Partnering with the European Union and global regulators on COVID-19,” FDA, June 25, 2020.
6 https://www.mhlw.go.jp/content/10800000/000620794.pdf
7 Timothy Herr, “India’s CDSCO responds to COVID-19 with new approval, import, and safety measures”; Ritika Ganju, “India: India’s regulatory response to COVID-19 – Support for vaccine development and distribution,” Phoenix Legal, October 5, 2020.
8 Velayudhan Mohan Kumar et al., “Strategy for COVID-19 vaccination in India: The country with the second highest population and number of cases,” npj Vaccines 6, no. 60 (2021); Herr, “India’s CDSCO responds to COVID-19 with new approval, import, and safety measures.”