PNS39 Positive Decisions by Minister of Health on Increase of Ex-Factory Official Price of Publicly Funded Drugs in Poland Lack Content-Related Justifications - an Analysis of Quality of Justifications of Decisions on Increasing Prices of Reimbursed Drugs

Abstract

Decisions to increase price of reimbursed drugs may be a matter of business life and death for smaller pharmaceutical companies. Within the always limited public budget they may therefore severely impact patients’ access to drugs. This study assessed the quality of content-related justifications (C-RJ) which Minister of Health is legally obliged to provide in these decisions. All decisions on increasing a price of reimbursed drugs 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. The study included 75 decisions of which 42 were positive and 33 negative. 100% (42/42) positive decisions lacked C-RJ with a claim to clause 107.4 (C). 100% (33/33) 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). Directive 89/105/EEC requires EU countries to establish objective and verifiable criteria of decisions to increase a drug’s price. Poland accessed EU in 2004 but established the criteria seven years later in 2011 within the new law on drug reimbursement. Even the most objective and verifiable criteria will not ensure fair competition for public funds if their fulfilment is not fully referred in content-related justifications.