Misuse of March-In Rights Could Harm Patients
TL/DR –
The U.S. Department of Health and Human Services (HHS) and the Department of Commerce (DOC) are reviewing the march-in rights under the Bayh-Dole Act, which allow the government to take over the development of pharmaceuticals that received federal funding. This review is seen as an attempt to increase government control over the pharmaceutical industry, which could potentially stifle the research and development of new drugs. Critics argue that the abuse of march-in rights could cause irreparable damage to medical innovation and discourage biopharmaceutical companies from investing in future cures.
HHS and DOC Reviewing March-in Rights Under Bayh-Dole Act
The U.S. Department of Health and Human Services (HHS) and the Department of Commerce (DOC) are actively reviewing march-in rights under the Bayh-Dole Act, an approach using the entire government’s resources. The Act institutionalized the transfer of patents from research entities to the private sector, encouraging commercialization of discoveries funded by federal government. Interestingly, these march-in rights have never been utilized since the Bayh-Dole Act was enacted.
Biden-Harris Administration’s Stance on March-in Rights
The Biden-Harris Administration aims to increase public access to the benefits of government-funded research through the use of march-in rights. HHS Secretary Xavier Becerra emphasized the need for the benefits of the taxpayer’s investment to be reasonably accessible to the public. Becerra also indicated that HHS would review findings from the Bayh-Dole Interagency Working Group to better define how to use this authority effectively.
Impact on the Pharmaceutical Industry
The review could potentially increase government control over the pharmaceutical industry, adding another disincentive for the development of new treatments and cures alongside the existing price controls in the Inflation Reduction Act. This joint agency effort represents another instance where the Biden Administration and Congress members have threatened intellectual property rights without considering the effect on innovation.
Previous Attempts to Invoke March-in Rights
In 2020, Sens. Elizabeth Warren and Bernie Sanders, along with then-California Attorney General Becerra, made unsuccessful attempts to invoke march-in rights on remdesivir, a treatment for COVID-19. However, HHS rejected these requests.
The Potential Consequences of Using March-in Rights
Implementing march-in rights could negatively impact the cost and access to healthcare without necessarily improving service. The US leads global drug research and development largely due to constitutional protections of intellectual property. The potential misuse of march-in rights could harm medical innovation, discourage biopharmaceutical companies from investing in future cures, and compromise America’s global leadership in biopharmaceutical research and development. A better approach can be reducing costs through less governmental interference and market manipulation.
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