For weeks, those involved in drug reimbursement (and not only) in Poland have been wondering whether DNUR - a major amendment to the Reimbursement Act - has a chance of being passed yet in this term of the Sejm. The draft of this law was first published on the pages of the Government Legislation Center in June 2021, and since then it has changed several times, with work on it gaining momentum, then dying down again for many months. The fact that work on its preparation could not be finalized for the past two years gave many interested parties hope that it would not finally be sent to the Sejm; hope, since a number of the provisions provided for in the draft are, especially by drug manufacturers, judged to be extremely unfavorable. That hope has just proved to be misplaced - DNUR has just been sent to the Diet.
The draft, whose fate as of June 23 this year can already be followed on the pages of the Polish Parliament, differs slightly from the latest version, published by the Government Legislation Center. Unfortunately, these are not differences that would significantly and positively change the assessment of its impact on the pharmaceutical market. What has changed (among other things), compared to the version from March this year. (i.e., the last one published on the RCL website)?
- The amendment to Article 4(11) of the Law, which stipulates that statutory payback must be borne by applicants who have risk-sharing instruments in place, has been dropped - under the current version of DNUR, these entities would have paid to the budget the difference between the value of the payback resulting from the RSS and the statutory payback;
- The provision amending Article 5 of the Reimbursement Law was removed - it was supposed to change the rules for calculating the price per DDD of a compounded drug;
- A lower and upper limit on the official wholesale margin has been introduced. As previously announced, the DNUR provides for an increase in the wholesale margin to 6% ...
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