The U.S. government is threatening to go after companies who obtained patents on drugs developed with the help of government grants. The administration did not immediately release details about how the process will work and how it will deem a drug costly enough to act. The proposed process would clarify that the drug's patent could be in jeopardy if its price is out of reach for Americans, White House officials said.
Such an action by the government, called "march in rights", has never been taken.
Here are some key points about the proposal:
Motivation: The administration argues that high drug prices are a major burden for Americans and that cancelling patents could promote competition and lower prices. This is in line with Biden's broader campaign promise to address healthcare affordability.
Scope: Initially, the proposal targeted a small number of high-priced drugs, focusing on those deemed essential or life-saving. However, details on specific medications and the price threshold for triggering patent cancellation remain unclear.
Challenges: The proposal faces legal challenges from the pharmaceutical industry, which argues that it violates intellectual property rights and could discourage future innovation. There are also concerns about the feasibility of implementing such a program, including the potential for supply chain disruptions and quality control issues.
Current Status: The White House is currently working on developing a more detailed plan for implementing the proposal. They are also seeking input from stakeholders, including the pharmaceutical industry, patient groups, and legal experts.
Timeline: No definitive timeline has been announced for when the administration will finalize the plan or take action. It is likely to be a lengthy process, potentially involving legal challenges and legislative action.
Potential Impact: If implemented, the proposal could have a significant impact on the pharmaceutical industry and drug prices. However, the long-term effects are difficult to predict at this stage.
Here are some resources where you can find more information about the proposal:
- White House announcement: https://www.whitehouse.gov/briefing-room/statements-releases/2023/12/07/fact-sheet-biden-harris-administration-announces-new-actions-to-lower-health-care-and-prescription-drug-costs-by-promoting-competition/
- Nature: https://www.nbcnews.com/health/health-news/gaming-us-patent-system-keeping-drug-prices-sky-high-report-says-rcna47507
- Time: https://www.thetimes.co.uk/article/big-pharma-hears-ticking-of-the-patent-time-bomb-bgdphpnbq
There will be a 60-day public comment period.
} The Biden administration is putting pharmaceutical companies on notice, warning them that if the price of certain drugs is too high, the government might cancel their patent protection and allow rivals to make their own versions.
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