Company: BLRX
Filing Date: 2025-03-31
Form Type: 20-F
Source: 0001178913-25-001123
Chunk: 208

Company: BioLineRx Ltd.
Filing Date: 2025-03-31
Form: 20-F
Item: Item 4
Chunk 208
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 of additional studies that compare the cost-effectiveness of a particular drug candidate to currently available therapies in order to obtain reimbursement. For example, the European Union provides options for its member states to restrict the range of drug products for which their national health insurance systems provide reimbursement and to control the prices of medicinal products for human use. European Union member states may approve a specific price for a drug product, or it may instead adopt a system of direct or indirect controls on the profitability of the company placing the drug product on the market. Other member states allow companies to fix their own prices for drug products but monitor and control company profits and issue guidance to prescribers. The downward pressure on health care costs in general, particularly prescription drugs, has become intense. As a result, increasingly high barriers are being erected to the entry of new products. In addition, reference pricing and cross-border imports from low-priced markets exert competitive pressure that may reduce pricing within a country. Any country that has price controls or reimbursement limitations for drug products may not allow favorable reimbursement and pricing arrangements.
 
Other Healthcare Laws and Regulation
 
Healthcare providers and third-party payors play a primary role in the recommendation and prescription of drug products that are granted regulatory approval. Arrangements with providers, consultants, third-party payors and customers are subject to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain our business and/or financial arrangements. Such restrictions under applicable federal and state healthcare laws and regulations include the following:

•                                         the federal Anti-Kickback Statute, which prohibits, among other                                       
    things, persons and entities from knowingly and willfully soliciting, offering, receiving or providing remuneration (including any kickback,
    bribe or rebate), directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase,
       lease or order of, any good or service, for which payment may be made, in whole or in part, under a federal healthcare program such as   
                                                               Medicare and Medicaid;                                                           
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•                                            the federal civil and criminal false claims laws, including                                          
      the civil False Claims Act, and civil monetary penalties laws, which prohibit individuals or entities from, among other things, knowingly   
    presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement
                                 to avoid, decrease or conceal an obligation to pay money to the federal government;                              
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•                                           the federal Health Insurance