All of the issues surrounding COVID-19 trace back to a single legal stream — innovation policy — says an expert on drug policy and health law at Washington University in St. Louis.
The lack of diagnostic testing. The lagging development and distribution of personal protective equipment. Shortages of ventilators. Finding prescription medications to treat the disease. They all are related by law and policy.
“The spread of COVID-19 has brought into the public consciousness many of the issues implicated in my research on innovation policy,” said Rachel Sachs, associate professor of law.
“Innovation policy focuses on the ways in which different areas of law — primarily intellectual property law, food and drug regulation, and health law — impact the development of new health-care technologies and access to those technologies,” she said. “Public discussions around COVID-19 have dealt extensively with the need to develop new diagnostic tests, pharmaceutical therapies and vaccines, as well as with the need to ensure access to existing pharmaceuticals and to personal protective equipment (PPE) for health-care workers.”
“Initially, the Centers for Disease Control (CDC) provided test kits to laboratories around the country, but pulled back once it discovered a mistake in its kits, a mistake that was not corrected for weeks,” Sachs said. “The Food & Drug Administration (FDA) strictly limited the number of testing providers on the market, meaning that other actors could not fill the space left by the CDC.
“Additional regulatory requirements imposed by the Centers for Medicare and Medicaid Services (CMS) may have limited the number of labs even eligible to obtain authorization to provide their own tests. Each individual agency therefore contributed to the initial lack of available tests, but the situation also represents a failure of coordination among these agencies. The CDC, FDA and CMS are all under the control of the Department of Health and Human Services (HHS), which could have exercised a stronger oversight role in identifying and eliminating testing barriers imposed by the interactions of these agencies.”
Similar issues have plagued the development and distribution of protective gear, like N95 masks, Sachs said.
“Recently, innovators have begun to use 3D printing technology to address production shortages,” she said. “But centralized regulation and incentives, such as in the form of guaranteed purchase commitments from the federal government, may be needed to expand supply further.”
In addition, the pandemic caused a shortage of existing essential medications needed to maintain hospitalized COVID-19 patients on ventilators.
“Ventilated patients receive a set of medications to keep them comfortable while on the ventilator, but many of those sedatives have experienced shortages as demand now far exceeds typical use,” Sachs said. “To increase the supply of these drugs in the near term, manufacturers must expand the production capacity of existing facilities or add new facilities. Each of these options is controlled by innovation policy levers.”
These different policy levers will continue to be relevant as issues in health-care technologies arise in the COVID-19 context, she said.
“The federal government must coordinate across federal agencies to ensure that conflicting policies do not create barriers for patients and health-care workers, but also to ensure that new products for COVID-19 are supported by clinical evidence.”
To read more of Sachs’ comments, visit the Cordell Institute for Policy in Medicine & Law Perspectives blog page.