Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 202

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 202
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 longer met, including
where it is shown that the product is sufficiently profitable not to justify maintenance of market exclusivity. In addition, a competing
similar medicinal product may in limited circumstances be authorized prior to the expiration of the market exclusivity period, including
if it is shown to be safer, more effective or otherwise clinically superior to the already approved orphan drug. Furthermore, a product
can lose orphan designation, and the related benefits, prior to us obtaining a marketing authorization if it is demonstrated that the
orphan designation criteria are no longer met.

General Data Protection Regulation

As further discussed in “Risk
Factors” under the heading “We may incur substantial costs in our efforts to comply with evolving global data protection laws and regulations, and any failure or perceived failure by us to comply with such laws and regulations may harm our business and operations,”
the collection, use, disclosure, transfer, or other processing of personal data regarding individuals in the European Union and United
Kingdom, including personal health data, is subject to the GDPR and UK GDPR, respectively, which are wide-ranging in scope and impose
numerous requirements on companies that process personal data, impose strict rules on the transfer of personal data to countries outside
the European Union and United Kingdom, respectively, and permits data protection authorities to impose large penalties for violations.
Compliance with the GDPR and UK GDPR is a rigorous and time-intensive process that may increase the cost of doing business or require
companies to change their business practices to ensure full compliance.

Pricing Decisions for Approved Products

In the European Union, pricing
and reimbursement schemes vary widely from country to country. Some countries provide that products may be marketed only after a reimbursement
price has been agreed. Some countries may require the completion of additional studies that compare the cost-effectiveness of a particular
product candidate to currently available therapies or so-called health technology assessments, in order to obtain reimbursement or pricing
approval. For example, the European Union provides options for its Member States to restrict the range of products for which their national
health insurance systems provide reimbursement and to control the prices of medicinal products for human use. Member States may approve
a specific price for a product or it may instead adopt a system of direct or indirect controls on the profitability of the company placing
the product on the market. Other Member States allow companies to fix their own prices for products, but monitor and control prescription
volumes and issue guidance to physicians to limit prescriptions. Recently, many countries in the European Union have increased the amount
of discounts required