Company: CMND
Filing Date: 2025-01-22
Form Type: 20-F
Source: 0001213900-25-005490
Chunk: 13

Company: Clearmind Medicine Inc.
Filing Date: 2025-01-22
Form: 20-F
Item: Item 3
Chunk 13
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  additional treatment arm (control);                                         
  recall, replacement, or discontinuance of one or more of our products; and  
  additional recordkeeping.                                                   

In addition, in the United States, there have been
a number of legislative and regulatory proposals to change the health care system in ways that could affect our ability to sell our products
profitably. The pharmaceutical industry in the United States, as an example, has been affected by the passage of the ACA, which, among
other things, imposed new fees on entities that manufacture or import certain branded prescription drugs and expanded pharmaceutical manufacturer
obligations to provide discounts and rebates to certain government programs. There have been executive, judicial and Congressional challenges
to certain aspects of the ACA. Concurrently, Congress considered legislation to repeal or repeal and replace all or part of the ACA. While
Congress has not passed comprehensive repeal legislation, several bills affecting the implementation of certain taxes under the ACA have
been enacted. The Tax Cuts and Jobs Act of 2017 includes a provision repealing, effective January 1, 2019, the tax-based shared responsibility
payment imposed by the ACA on certain individuals who fail to maintain qualifying health coverage for all or part of a year that is commonly
referred to as the “individual mandate”. In addition, the 2020 federal spending package permanently eliminated, effective
January 1, 2020, the ACA-mandated “ Cadillac” tax on high-cost employer-sponsored health coverage and medical device tax and,
effective January 1, 2021, also eliminated the health insurer tax. On December 14, 2018, a Texas U. S. District Court Judge ruled that
the ACA is unconstitutional in its entirety because the “individual mandate” was repealed by Congress as part of the Tax Act.
Additionally, on December 18, 2019, the U. S. Court of Appeals for the 5th Circuit upheld the District Court ruling that the individual
mandate was unconstitutional and remanded the case back to the District Court to determine whether the remaining provisions of the ACA
are invalid as well. The United States Supreme Court is currently reviewing this case, but it is unknown when a decision will be reached.
Although the Supreme Court has not yet ruled on the constitutionality of the ACA, on January 28, 2021, President Biden issued an executive
order to initiate a special enrollment period from February 15, 2021