Charleston Leader

U.S. Senator Shelley Moore Capito and a group of 16 Republican colleagues have expressed serious concerns regarding President Biden's proposal to allow agencies to seize drug patents under the Bayh-Dole Act if the administration deems the prices too high. Senator Bill Cassidy M.D., who led the effort, highlighted that such actions could hinder healthcare innovation and limit access to lifesaving treatments.

In a letter addressed to NIH Director Monica Bertagnolli, the senators emphasized the potential negative impact of utilizing "march-in" rights. They stated, "A short-sighted decision to exercise march-in rights would work against your stated goal and jeopardize patient access by discouraging individuals from partnering with NIH to develop new cures and treatments."

The senators underscored the importance of maintaining public-private partnerships in biomedical research, cautioning against the illegal seizure of intellectual property. They stressed that the use of march-in rights to address drug prices would be counterproductive and could harm the investments made by Congress in NIH each year.

Furthermore, former U.S. Senators Birch Bayh and Bob Dole, the authors of the Bayh-Dole Act, clarified that the legislation did not intend for the government to set prices on resulting products. Senator Cassidy also raised concerns about the Biden proposal meeting the definition of a rule under the Congressional Review Act, potentially allowing for its overturning.

During her nomination hearing, Dr. Bertagnolli affirmed her commitment to "follow all the laws of our land," indicating a stance aligned with the congressional intent of the Bayh-Doyle Act. Past administrations, both Republican and Democratic, have affirmed that agencies do not possess the authority to seize patents under Bayh-Dole in response to commercial drug costs.

The potential use of march-in rights based on drug prices has drawn criticism from various stakeholders. The nonpartisan Bayh-Dole Coalition warned that such actions could impede critical public-private partnerships and hinder the dissemination of groundbreaking discoveries to consumers. Universities and research institutions, where a significant amount of NIH-funded research occurs, have denounced the use of march-in rights as an ineffective mechanism to reduce drug prices that could undermine innovation.

In conclusion, the opposition led by Senator Capito and her colleagues highlights the concerns surrounding President Biden's proposal and its potential repercussions on healthcare innovation and patient access to essential treatments.