Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 203

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 203
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 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patent in question has not expired, lapsed or been revoked) or within six months of the grant of the patent (if the marketing authorization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 SPCs, the term “product” means the active ingredient or combination of active ingredients
for a medicinal product and the term “patent” means a patent protecting such a product or a new manufacturing process or application
for it. The duration of an SPC is calculated as the difference between the patent’s filing date and the date of the first marketing
authorization, minus five years, subject to a maximum term of five years.

A six month pediatric extension
of an SPC may be obtained where the patentee has carried out an agreed pediatric investigation plan, the authorized product information
includes information on the results of the studies and the product is authorized in all member states of the European Union.

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United Kingdom Regulation

From January 1, 2021, European
Union law no longer directly applies in the United Kingdom. The United Kingdom has adopted existing European Union medicines regulation
as standalone United Kingdom legislation with