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The European Commission’s New Compulsory Licensing Proposal: A Step Forward?

Bill of Health

By Sarah Gabriele On April 27, 2023, the European Commission proposed new legislation that would allow companies to make drugs without the patent holder’s consent in emergency situations. The COVID-19 crisis demonstrated how the need for protecting and incentivizing innovation clashed with the need to make products widely available.

Licensing 285
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COVID-19 Vaccine Patent Infringement? The Battle Between Moderna and Pfizer/BioNTech Continues

Bill of Health

Last month, the patent battle between COVID-19 mRNA vaccine manufacturers continued with BioNTech/Pfizer filing a strong defense and counter-claim to Moderna’s allegations of patent infringement. Interestingly, as of January 12, 2023, Moderna has listed 10 patents covering Spikevax (its mRNA vaccine) on its website.

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Strategic Maneuvers in Response to COVID-19 Denialist Laws and Policies

Bill of Health

Over the course of the COVID-19 pandemic, now entering its fourth year in 2023, legislators, executives, and judges at every level of government have sought measures to derail efficacious public health interventions. And most relate solely to COVID-19 interventions, which sunset permanently as states withdraw their emergencies.

COVID-19 176
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No Take-Backs: Moderna’s Attempt to Renege on its Vaccine Patent Pledge

Bill of Health

On October 8, 2020, Moderna, the maker of one of the first mRNA-based vaccines for COVID-19 and the recipient of billions of dollars of U.S. As a result, it publicly promised that “ while the pandemic continues, Moderna will not enforce our COVID-19 related patents against those making vaccines intended to combat the pandemic.”

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November 2023 Regulatory Compliance Updates

Verisys

Compliance Updates: November 2023 Here is our monthly regulatory update. Effective July 1, 2023, pharmacy services can be allowed outside the confines of the permitted facility. Proposed rules are as follows: The implementation of HB 2584 (2023) and HB 3036 (2021) shifting physician assistants to the collaborative practice model.

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License Verification and Monitoring Critical Amidst Healthcare Labor Shortages

Provider Trust

An increasing trend of nurse strikes and hospital staffing shortages across the country in early 2023 has led many healthcare organizations to turn to travel nurses and staffing agencies to fulfill their workforce needs. However, this solution comes with its share of compliance risks, especially if interstate licenses are involved.

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Highlights from the HHS-OIG 2023 Spring Semiannual Report

Provider Trust

The Department of Health and Human Services (HHS) Office of Inspector General (OIG) has released its latest 2023 Spring Semiannual Report to Congress, providing a comprehensive overview of its activities from October 2022 to March 2023. Led by acting Inspector General Christi A. A Message from Acting Inspector General Christi A.