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Skrzekowska-Baran Iwona (Janssen-Cilag Polska Sp. z o.o.), Podgórny Borys (PwC)
"Pay-back" Mechanism in The Polish Reimbursement System - Analysis and Appraisal
Journal of Health Policy and Outcomes Research, 2014, nr 1, s. 94-103, tab., bibliogr. 12 poz.
Słowa kluczowe
Koszty, Analiza kosztów, Zarządzanie
Costs, Cost analysis, Management
The text of this review has been based on a diploma thesis, prepared by Mr Borys Podgorny under the supervision of Dr Iwona Skrzekowska-Baran, as part of the XXII Edition of the Advanced Management Training in Pharmacoeconomics, HTA, Pharma Marketing and Law of the Warsaw University Of Technology Business School. The presented review has employed a detailed analysis of appropriate provisions of the Reimbursement Act, while benefiting from the practical experience of the authors, regarding the implementation of the Act and the practical application of its principles. The results of the conducted analysis indicate a number of significant drawbacks in the current version of the pay-back mechanism, which either prevent any correct calculation of the amounts to be paid back or which may become a breeding ground for disputes and conflicts with marketing authorisation holders, as regards the administrative and legal aspects of the process. In consequence, should the pay-back mechanism remain an integral part of the Polish reimbursement system, it will need urgent legislative amendments to ensure its effective management and, first of all, to streamline the calculation of reimbursable amounts, based on available and verifiable data. Above all, however, it seems still reasonable and appropriate to ask about the sensibleness of and reasons for further existence of such a solution in the Polish legal system, where other legal mechanisms successfully execute the systemic goals in terms of reducing the payer's expenses(original abstract)
Pełny tekst
  1. Citations from the explanatory memorandum to the Act on the reimbursement of medicinal products, foodstuffs intended for special uses and medical products, forwarded for social consultations in a letter of September 9, 2010
  2. See. Art. 3 and Art. 74 of the Reimbursement Act
  3. Art. 4 section 8 of the Act, providing that the exceeded amount and the pay-back amount are calculated by the Fund within 30 days from the approval of the financial statement for the previous year, may be regarded as a kind of an "interpretation gate", supporting the verification of the preliminary condition for calculation of exceeded amounts on annual basis. This provision may, however, be interpreted as referring exclusively to the time-point of technical calculation and not to the time-point, constituting the occurrence of the pay-back mechanism
  4. Constituting the ratio of the total budget for reimbursement during financial year, decreased by the reserve, mentioned in Art. 3 section 3 of the Act, and of the total budget for reimbursement in the previous year
  5. The limit grounds were in that time published in the regulation of the Minister of Health, issued on the basis of Art. 38 section 6 of the Act on providing Healthcare services financed from public funds. The price limits were introduced for the drugs with the same international name or with different international names but revealing the same therapeutic effect
  6. For example, the Minister of Health may in certain situations routinely issue decisions, changing limit group definition
  7. Resolution of the Senate of May 2, 2011 r., Print No. 4152
  8. This coefficient is a ratio (i) of the amount, by which the total budget for the reimbursement of prescribed products is exceeded and (ii) of the sum of exceeded amount in particular limit groups. It may then be assumed that this coefficient is to compensate possible disparities between the total amount of exceeded reimbursement at the total budget level and the summed amount of exceeded reimbursement at the level of the limit groups
  9. Source: presentation of the Minister of Health of December 18, 2013 "Summary of the Reimbursement Act". Availabel from:
  10. It is, among others, indicated in the records from the margin-price dispute, where the main axis of controversy was the legal appropriateness of imposing penalties for some pharmaceutical companies for their alleged exceeding of official prices and margins
  11. A draft of September 18, 2013 on amending the Act on the reimbursement of medicinal products, foodstuffs intended for special uses and medical products, as well as of some other acts. Available from:
  12. DEF Communications of May 8, 2012, May 7, 2013 and May 6, 2014 - Information on reimbursement amounts, together with the percentage of total reimbursement budget implementation
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