COVID-19 and the Emerging Regulatory Guidance for Ongoing Clinical Trials in the European Union.

The coronavirus disease 2019 (COVID-19) pandemic and the accompanying control measures have significantly affected clinical trial (CT) conduct, and sponsors have needed to make rapid changes to their CT operations. As a result, regulatory guidance was pivotal during the initial phases of the pandemic. This study aimed to evaluate the regulatory readiness and guidance related to COVID-19 in the European Union (EU). The European Medicines Agency (EMA) and national competent authorities' (NCAs') websites were searched in September and October 2020 for guidances on the management of CTs during the pandemic published from January 2020 onward. "Regulatory readiness" was defined as the number of days from the first European COVID-19 case (January 24, 2020) to the first published guidance by the respective NCA. "Regulatory guidance" was evaluated by coding the guidances for the following predefined operational trial activities important for ongoing CTs: obtaining informed consent, participant information, clinic visits, home health visits, telemedicine visits, self-monitoring, investigational medicinal product (IMP) supply, IMP adherence monitoring, CT monitoring, documentation management, regulatory management, and safety management. Twenty-four of the 27 EU NCAs published country-specific guidance. The time from the first European COVID-19 case to the first published EMA guidance was 56 days and ranged from 47 to 66 days for the first national guidances. Guidance was provided most frequently for regulatory management (24/24), safety management (23/24), documentation management (22/24), and CT monitoring (22/24). The regulatory guidance provided during the pandemic, ensuring participant safety and data integrity, may now be the starting point to innovate future CT conduct.

What Is EU Public Health and Why? Explaining the Scope and Organization of Public Health in the European Union.

Public health is notoriously difficult to define, and that is the case for public health in the European Union as much as other political systems. In this article, the authors try to identify the actual scope and meaning of public health as it is institutionalized in the EU political system. Using a mixture of historical policy and legal analysis, the authors show how the evolution of the institutional space called public health in the EU has been shaped by the EU's distinctive constitutional nature, its focus on regulation, and the legacy of its focus on market making as well as the preferences of its political leaders. The European Union does have an increasingly large space named "public health," in which health ministers, the health directorate-general, and invocation of its public health treaty article 168 can be found, as well as a much broader and older area of activities justified by the need to manage adverse health consequences of market-making policies in other areas such as labor standards and agriculture. The COVID-19 crisis of 2020 not only led to a strengthening of EU public health but also showed that the EU is one of the many political systems in which the legal and bureaucratic domain of public health is far smaller than the actual issues affecting the public's health.