Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 210

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 210
---
 obtain and maintain third-party coverage or adequate reimbursement for our product candidate
in whole or in part.

Healthcare Reform

In the United States and some
foreign jurisdictions, there have been, and continue to be, several legislative and regulatory changes and proposed changes regarding
the healthcare system that could prevent or delay marketing approval of product and therapeutic candidates, restrict or regulate post-approval
activities, and affect the ability to profitably sell product and therapeutic candidates that obtain marketing approval. The FDA’s
and other regulatory authorities’ policies may change and additional government regulations may be enacted that could prevent, limit
or delay regulatory approval of our product and therapeutic candidates. If we are slow or unable to adapt to changes in existing requirements
or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval
that we otherwise may have obtained and we may not achieve or sustain profitability, which would adversely affect our business, prospects,
financial condition and results of operations.

In addition, the containment
of healthcare costs has become a priority of federal and state governments and the prices of therapeutics have been a focus in this effort.
The U.S. government, state legislatures and foreign governments have shown significant interest in implementing cost-containment programs
to limit the growth of government-paid healthcare costs, including price controls, restrictions on reimbursement, and requirements for
substitution of generic and biosimilar products for branded prescription medicines and biologics, respectively. In recent years, the U.S.
Congress has considered reductions in Medicare reimbursement levels for medicines administered by physicians. CMS, the agency that administers
the Medicare and Medicaid programs, also has authority to revise reimbursement rates and to implement coverage restrictions for most drugs
and biologics. Cost reduction initiatives and changes in coverage implemented through legislation or regulation could decrease utilization
of and reimbursement for any approved products we may market in the future. While Medicare regulations apply only to pharmaceutical benefits
for Medicare beneficiaries, private payors often follow Medicare coverage policy and payment limitations in setting their own reimbursement
rates. Therefore, any reduction in reimbursement that results from federal legislation or regulation may result in a similar reduction
in payments from private payors.

The ACA, as amended by the
Health Care and Education Affordability Reconciliation Act, was enacted in 2010 and substantially changed the way healthcare is financed
by both governmental and private insurers in the United States, and significantly impacted the pharmaceutical industry. The ACA was intended
to broaden access to health insurance, reduce or constrain