POLAND Trends and Developments Contributed by: Marta Sroka-Maleta, Andrzej Siwiec, Katarzyna Kroner and Maciej Adamczyk, DBS Law Firm
ceutical Law in one act instead of introducing multiple separate amendments within a short period. Implementation of the Joint Clinical Assessment in Reimbursement Decision Making An amendment to the Polish Act on Reimbursement came into force in September 2025, adapting its provi- sions to the rules of Joint Clinical Assessment (JCA) established by European Regulation 2021/2282 on health technology assessment. Regulation 2021/2282 aims to replace dozens of national clinical assessments with a single joint analy- sis, which should result in better use of expert knowl- edge and a shorter path for innovative therapies to reach patients. JCA currently applies to two groups of medicinal products for which the application for a centralised marketing authorisation is submitted: • medicines with new active substances for which the therapeutic indication is the treatment of can- cer; and • advanced therapy medicinal products. Subsequent categories of medicinal products and selected medical devices will be covered by the pro- visions of Regulation 2021/2282 in the future. The assessment is carried out in parallel with the centralised procedure by a dedicated authority called Coordination Group, which is responsible for initiating a scoping process to identify the relevant parameters for the assessment scope, with regard to member states’ needs. In 2025, the Polish authority desig- nated to participate in JCA (ie, the Agency for Health Technology Assessment and Tariff System) served as co-assessor for one of these assessments.
The development of joint clinical assessments depends on whether the health technology devel- oper submits the relevant dossier in accordance with the submission request made by the Commission. The Regulation enables them not to submit any data, which leads to discontinuation of the assessment. In such situations, clinical assessments are to be estab- lished on a country-by-country basis. The Coordination Group is obliged to endorse a draft JCA report no later than 30 days after the Commis- sion has adopted the decision granting the central- ised authorisation. Once the joint clinical assessment report is published, the applicant seeking reimburse- ment in Poland for a medicine being subject to this report is exempt from submitting their own clinical analysis. However, it should be noted that a publica- tion of JCA reports is not a substitute for other analy- ses that cover non-clinical domains of health technol- ogy assessment (eg, economic, assessing the impact on the payer’s budget, ethical or legal), and nor does it exhaust the comprehensive review of the reimburse- ment application. After a year of EU regulations on JCA being in force, it is difficult to assess whether the reimbursement pro- ceedings will be shortened or extended. Subsequent joint assessments will show the extent to which the new regulations actually fulfil their objectives.
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