OBJECTIVES: Decisions to reimburse highly priced innovative drugs are crucial for patients’ access. This study assessed the quality of content-related justifications (C-RJ) which Minister of Health is legally obliged to provide in these decisions.

METHODS: All decisions to include a drug in reimbursement requested and received under Polish FOIA by the Foundation for Transparency and Predictability of Administrative Decisions in 2017-2020 were identified. Every decision was assessed and classified as (A) C-RJ included and verifiable, (B) C-RJ probably included but not verifiable due to redactions, and lack of C-RJ with (C) and without (D) a claim to clause 107.4 of law on administrative conduct. This clause allows for abandoning any justification when decision fulfils all the applicant requested but excluding cases when competing interests are involved. Number and percentage of decisions in each category was calculated separately for positive and negative decisions.

RESULTS: The study included 122 decisions of which 118 were positive and 4 negative. 100% (118/118) positive decisions lacked C-RJ without a claim to clause 107.4 (D). In every justification the most C-RJ resembling excerpt was identical paraphrased clause from law on drug reimbursement which stipulates criteria to be taken into account when deciding on inclusion in reimbursement. 100% (4/4) negative decisions were extensively redacted in contrast to positive decisions with usually only personal applicant data redacted. Based on the length of justification by far exceeding that in positive decisions they were all classified as (B).

CONCLUSIONS: Directive 89/105/EEC requires EU countries to establish objective and verifiable criteria of reimbursement inclusion. Poland accessed EU in 2004 but established the criteria in 2011 within the new law on drug reimbursement. Even the most objective and verifiable criteria will not ensure fair competition for public funds and fair reimbursement decisions if their fulfilment is not fully reflected in content-related justifications.