In brief

Since late 2020 a reimbursement fast-track program for the most innovative oncology and rare disease treatments (defined as highly innovative medicinal technologies (HIMT)). For example, the first ever HIMT has become reimbursed for this new procedure in less than two years since its authorization. We also observe an increasing number of rare disease therapies being reimbursed in a standard procedure and the Minister of Health (MoH) has recently reported progress in the implementation of the Plan for Rare Disease for 2021-2023. The above significantly changes the perception of Poland as one of the last countries where fast reimbursement of such therapies is possible.

Key takeaways

On 30 June 2021, the initial draft of the largest amendment to the Polish Act on Reimbursement of 2012 (“Draft“) since its introduction into the Polish legal system was published for public consultations by the MoH.

Analysis of the comments submitted within the public consultations took quite a long time as the MoH sent the new version of the Draft to the Permanent Committee of the Council of Ministers on 26 August 2022. This means that the works on the Draft have resumed, although the expectations of the pharmaceutical industry were that the MoH would discontinue them.

The resumption of works 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, the new regulations would be detrimental to the Polish reimbursement system in whole. It would also obviously hit hard 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.

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