While COVID-19 introduced many global challenges in the life sciences industry, it also brought accelerated global scientific and regulatory collaborations and innovations. In our new extensive report, you’ll discover the impact of COVID-19 on the life sciences industry, what has been accomplished by the industry and its regulators globally, and what opportunities may emerge going forward.
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.
Governments declared health emergencies
A declaration of a public health emergency positions a country’s decision-makers to enact extraordinary measures. Those measures impact citizens’ behavior as well as regulatory governmental agencies, life sciences companies, and the health care industry. As our report reveals, one common effect was enabling governments to deploy a whole-of-government approach (to various degrees) to enact public health measures as well as steps that impacted life sciences industry supply chains and working arrangements. Regulatory agencies and industry responses soon followed, shaping the transition to operating in “crisis mode.”
Into the future, together: a report written through a global prism
Our life sciences industry report takes a deep dive by region and shows how each country’s responses varied in approach, timing, intensity, and effectiveness. Here are just a few snapshots of the findings we uncovered globally.
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.
• 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.
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.
• 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 vaccines
• EMA collaborated with the US Food and Drug Administration to exchange information on products and clinical trials and jointly interpreted data supporting regulatory decisions.
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.
• 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.
• 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.
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.
