However, in the background of this important and eagerly awaited legislative process by the pharmaceutical market, we have changes in the law introduced by DNUR, which have only now (as of July 1 this year) come into force. These are, of course, the amended provisions in Article 34 of the Reimbursement Law, concerning the liability of applicants for violation of the obligation to ensure the continuity of supply (and declared supply volumes) of a reimbursed drug. This provision, which provides for the imposition of financial penalties on applicants, in the event of a violation of the obligations of continuity and volume of supply, has so far not been of great concern to applicants, and this is because it was extremely difficult in practice to bring about the punishment of an applicant. This was due to the fact that the law provided two grounds for exemption from liability; the applicant was not obliged to reimburse the National Health Fund for the amount representing the product of the number of non-delivered unit packs of a drug and their official sales price, if the non-delivery of these packs was due to force majeure or the patients' needs were met by an equivalent of the drug that was not delivered.
Due to the above, financial penalty proceedings w...
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