Pharmeca.cz

In proceedings concerning the determination of the price and reimbursement of a medicinal product intended for immunisation, the State Institute for Drug Control (the Institute) clarified its approach to handling information submitted as trade secrets to substantiate foreign price references.

The Institute stated that:

• to demonstrate the actual manufacturer's price in a reference country, supporting documents relating to the relevant period are generally submitted, primarily invoices or other similarly reliable evidence. Where such evidence is accepted and its content has been submitted as a trade secret, the Institute takes the substantiated price into account when determining the price and reimbursement, to the extent necessary to justify its approach and conclusions, and removes the price used from trade secret protection.
  
  
• Where the marketing authorisation holder intends to demonstrate only a different margin, for example by submitting a declaration from a third party (such as a distributor) specifying an amount to be deducted from the identified price, the entire declaration may be designated as a trade secret.
  
  

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Articles on decision-making practice are based on publicly available texts from the decisions of the Ministry of Health of the Czech Republic and the State Institute for Drug Control (SÚKL).

A continuously updated overview of decisions issued by SÚKL and the Ministry of Health in the field of pricing and reimbursement is available on the Pharmeca a.s. website.

The English translation was prepared using the latest available ChatGPT model.