Workshop Abstract:
The COVID-19 pandemic illuminated the need for and challenges with making available the medical countermeasures (MCMs), that is the diagnostics, devices, therapies, and vaccines needed to respond to public health emergencies, disasters, and wars, available to the impacted populations in a timely manner. Healthcare and political leaders alike agree on the goals-- immediate access to reliable diagnostics, sufficient supplies of personal protective equipment and other medical supplies, and rapid deployment of safe and effective vaccines and therapeutics. Many public health emergency planners anticipated that for a public health event of the magnitude of COVID-19, that the regulatory agencies would be barriers to accessing the needed MCMs. COVID-19 demonstrated that wasn’t necessarily the case. Now, as the COVID-19 pandemic continues its world-wide simmer, intentional and continued collaboration between public health and regulatory agencies is needed to identify the elements of regulatory emergency preparedness and response that are working and change the ones that are not. “For too long, we have allowed a cycle of panic and neglect when it comes to pandemics: we ramp up efforts when there is a serious threat, then quickly forget about them when the threat subsides. It is well past time to act.” (Global Preparedness Monitoring Board, 2019). Building on the assessment of regulatory activities that did and did not work, now is the time for countries to assess and potentially change their legal authorities and regulations to ensure that they are working to expedite access to needed MCMs and are fit for all-hazard purposes. This workshop will consider the importance of regulatory preparedness for making MCMs accessible from the perspectives of the regulators of MCMs, public health, medical, and non-profit communities. Workshop components: * Scene Setting- defining the issues regarding regulatory preparedness (5 mins) * Lessons learned from COVID-19- a regulator’s view- 2 regulators (5 mins each) * Preparing for the next pandemic (20 mins) * 100 Days * Interface with public health and regulatory authorities * Introduction of the GHSA Legal Preparedness Action Package (25 mins) * Overview: Legal preparedness * Regulatory Sub Working Group- workplan and deliverables Key questions: * How can public health preparedness include lessons learned by MCMs regulators? * What actions can help to expedite access to MCMs in the next pandemic * How can countries assess the gaps in their legal/regulatory frameworks for responding to the next pandemic?