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Recently, the Polish Minister of Health ("MoH") has resumed work on the largest amendment to the Polish Act on Reimbursement ("Draft") since its introduction into the Polish legal system in 2012. Although during almost eleven years of this Act being in force some areas requiring amendments have been identified, the Draft is all about something different.
The initial version of the Draft was published for public consultation by the MoH on 30 June 2021.
Analysis of the comments submitted within the public consultations took a long time as the MoH only sent the new version of the Draft to the Permanent Committee of the Council of Ministers on 26 August 2022. This means that work on the Draft has now resumed, although the expectation of the pharmaceutical industry was that the MoH would discontinue them.
The resumption of work is all the more problematic as the MoH has chosen to leave in place most of the unfavorable proposals that have been criticized by the industry. If adopted in its current shape, there are concerns that the new regulations would be detrimental to the Polish reimbursement system as a whole. It would hit hard particularly on oncology and rare disease drugs by introducing solutions, summarized in this newsletter, setting up real barriers for their reimbursement in the future.
Below please see a brief summary of the most important amendments proposed by the MoH.
Click here to access the full alert.
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