[co-author: Anna Wiktorow]

The President of the Office for the Registration of Medicinal Products, Medical Devices, and Biocidal Products (URPL) estimates that approximately 20% of all the 10,000 medicinal products registered in Poland will be affected by the effects of Brexit. Out of this number, according to media reports, new reimbursement decisions will need to be issued for up to 500 products.

In view of a potential “no-deal” Brexit, and the transfers of UK based entities to other EU member states, the Minister of Health has recently issued a statement [1] in which he presented the Ministry’s position concerning the effects of Brexit on the reimbursement decision that had previously been issued in Poland.

The Minister informed that in the event of a change of a marketing authorization holder, which at the same time was the applicant for the reimbursement decision, the recommended procedure would be to simultaneously submit:

• by the existing applicant, an application for shortening the validity period of the current reimbursement decision, and
• by the new applicant, a new application for covering the reimbursement and setting the official sales price for the medicinal product.

In addition, the Minister reminded that reimbursement applications were examined in a normal manner, i.e. in the order in which they were received, and within 180 days of their submission.

Nonetheless, according to press reports, the Ministry of Health is working on procedures to accelerate the processing of reimbursement applications affected by Brexit. However, this information was published after the Minister of Health’s announcement had been released, and has not, as yet, been officially confirmed.

This means that, in practice, the current status is that there exists no special procedure, or, in particular, no fast track that has been adopted for the examination of reimbursement applications filed as a result of Brexit. One should also note that the examination process might take even longer than the period indicated by the Minister of Health, since the 180-day deadline will stop running for the time required in order to supplement an incomplete application with any necessary data. Therefore, there is a considerable risk that the reimbursement continuity might not be ensured, not only for the relevant entities which have not, as yet, submitted their applications, but also for those entities which have only recently carried them out.

[1]  Available in the Polish language only: https://www.gov.pl/web/zdrowie/komunikat-ministra-zdrowia-w-sprawie-skutkow-brexitu-dla-systemu-refundacji

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