Company: BLRX
Filing Date: 2025-03-31
Form Type: 20-F
Source: 0001178913-25-001123
Chunk: 105

Company: BioLineRx Ltd.
Filing Date: 2025-03-31
Form: 20-F
Item: Item 3
Chunk 105
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 created a new Patient Centered Outcomes Research Institute to oversee, identify priorities in and conduct
comparative clinical effectiveness research, along with funding for such research; and established the Center for Medicare & Medicaid
Innovation at the CMS to test innovative payment and service delivery models to lower Medicare and Medicaid spending.

We expect that future changes or additions to the ACA, the Medicare
and Medicaid programs, and changes stemming from other healthcare reform measures, especially with regard to healthcare access, financing
or other legislation in individual states, could have a material adverse effect on the healthcare industry in the United States. For example,
on March 11, 2021, President Biden signed the American Rescue Plan Act of 2021 into law, which eliminates the statutory Medicaid
drug rebate cap, currently set at 100% of a drug’s average manufacturer price, beginning January 1, 2024.

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Additionally, on December 20, 2019, the Further Consolidated Appropriations
Act for 2020 was signed into law (P. L. 116-94) and includes a piece of bipartisan legislation called the Creating and Restoring Equal
Access to Equivalent Samples Act of 2019, or the CREATES Act. The CREATES Act aims to address the concern articulated by both the FDA
and others in the industry that some brand manufacturers have improperly restricted the distribution of their products, including by invoking
the existence of a REMS for certain products, to deny generic product developers access to samples of brand products. Because generic
product developers need samples of an RLD to conduct certain comparative testing required by the FDA, some have attributed the inability
to timely obtain samples as a cause of delay in the entry of generic products. To remedy this concern, the CREATES Act establishes a private
cause of action that permits a generic product developer to sue the brand manufacturer to compel it to furnish the necessary samples on
“commercially reasonable, market-based terms.” Whether and how generic product developments will use this new pathway, as
well as the likely outcome of any legal challenges to provisions of the CREATES Act, remain highly uncertain and its potential effects
on any of our future commercial products are unknown.

In August 2022, President Biden signed into the law the Inflation
Reduction Act of 2022, or the IRA. The IRA has multiple provisions that may impact the prices of drug products that are both sold into
the Medicare program and throughout the United States. Starting in 2023, a manufacturer of