Altered Regulatory Systems

The COVID-19 pandemic prompted regulators around the world to find innovative ways of working to accelerate development and delivery of vaccines and therapeutics and to fulfil their regular duties in the face of pandemic-related lockdowns without compromising quality, safety, or efficacy. Many of these agilities leveraged new types of data and new technologies and processes to facilitate virtual interactions.

As policymakers begin to shift focus from pandemic response to recovery, a window of opportunity is available for stakeholders to consider which regulatory flexibilities, policies, or procedures are valuable and sustainable. Avalere partnered with Merck on an initiative to identify and understand the impacts of key regulatory agilities that were catalyzed by or accelerated during the pandemic.

New or Altered Ways of Working

Using a combination of desk research and expert interviews with global regulators, industry leaders, and civil society organizations, Avalere identified 10 regulatory agilities that played a critical role in the regulatory response to the COVID-19 pandemic.

Note: For the purpose of this initiative, Avalere defined “regulatory agilities” as “actions taken by a regulatory agency (as part of broader health authorities) driven by the COVID-19 public health emergency that depart from that regulatory agency’s pre-pandemic actions, procedures, and approaches.”

Rapid Rollout of New Processes Revealed Tradeoffs

Many of these regulatory agilities existed in a limited or nascent capacity prior to the pandemic, but pandemic-related lockdowns and compressed research and development timelines amplified or accelerated efforts that were already underway. The rapid rollout revealed tradeoffs and bottlenecks that will need to be addressed if these practices are to become sustainable.

Tradeoffs and Considerations for Future Implementation

Accelerated Timelines

Increased communication between regulators and industry shortened time to access for patients, but the high burden on human resources led to burnout and backlog. Maximizing efficiencies will be key to sustaining this work moving forward.

Data Sharing

Data sharing was at the core of many regulatory agilities, but current frameworks do not adequately balance the need for transparency with protecting intellectual property and trade secret integrity. More robust data infrastructure is needed to support data sharing.

Expedited Pathways

Determining guardrails and appropriate criteria will be critical for implementation of regulatory agilities moving forward. For instance, known manufacturers may be allowed more flexibility than newer players.

Patient Engagement

Engaging patient groups increases trust in the regulatory and clinical development process and product; however, modes of engagement are ill-defined. A lack of harmonized standards for patient engagement can create challenges and inconsistencies.

Real-World Evidence

While the need to make quick decisions catalyzed greater use of real-world evidence in COVID-19 approvals, absence of standards may limit trust in the process. Expanding use of real-world evidence will require strategies to incentivize data collection and information sharing, and establishment of transparent guidelines.

Funding for this research was provided by Merck. Avalere retained full editorial control.

To learn more about how Avalere can help you convene stakeholders and assess innovative global policies and processes that impact clinical development and product access, connect with us.

Methodology

Avalere spoke with 25 global experts, including current and recent regulators, industry leaders, patient and advocacy groups, multilateral organizations, and thought leaders, to surface agilities that were broadly understood to be impactful across therapeutic areas and geographies. To explore process details that illustrate the nuance of these agilities in practice, Avalere identified specific case studies and reviewed regulatory guidance documents, public statements, journal and news articles, and other source materials. The case studies sought to understand enabling factors and challenges, key stakeholders, and what is known about impact.

Finally, Avalere and Merck convened a 1-day workshop with more than 50 cross-functional global stakeholders to discuss the impact and sustainability of the featured regulatory agilities. The workshop was the first step in what is intended to be an ongoing collaborative and participatory process of assessing impact of global regulatory agilities on diverse stakeholders.