Company: BDRX
Filing Date: 2025-01-28
Form Type: 424B3
Source: 0001214659-25-001409
Chunk: 201

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-28
Form: 424B3
Chunk 201
---
 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 on pharmaceuticals and these efforts could continue as countries attempt to manage health care expenditures, especially
in light of the severe fiscal and debt crises experienced by many countries in the European Union. The downward pressure on health care
costs in general, particularly prescription products, has become intense. As a result, increasingly high barriers are being erected to
the entry of new products. Political, economic and regulatory developments may further complicate pricing negotiations, and pricing negotiations
may continue after reimbursement has been obtained. Reference pricing used by various Member States, and parallel trade, i.e., arbitrage
between low-priced and high-priced Member States, can further reduce prices. There can be no assurance that any country that has price
controls or reimbursement limitations for pharmaceutical products will allow favorable reimbursement and pricing arrangements for any
products, if approved in those countries.

Patent Term Extension

In order to compensate the
patentee for delays in obtaining a marketing authorization for a patented product, a supplementary certificate, or SPC, may be granted
extending the exclusivity period for that specific product by up to five years. Applications for SPCs must be made to the relevant patent
office in each European Union member state and the granted certificates are valid only in the member state of grant. An application has
to be made by the patent owner within six months of the first marketing authorization being granted in the European Union (assuming the
patent in question has not expired, lapsed or been revoked) or within six months of the grant of the patent (if the marketing authorization
is granted first). In the context of SPC