President signs off on amendment to Reimbursement Act in Poland

2012-01-24



President Bronislaw Komorowski on 23 January 2012 signed into law an amendment to the Reimbursement Act passed by the Sejm on 13 January and approved by the Senate six days later.
The centrepiece of the amendment is the abolition of paragraph eight of Article 48 of the new Reimbursement Act, which made doctors liable to return the full reimbursement amount paid by the National Health Fund (NFZ) for any prescription subsequently found wanting by the Fund’s inspectors, on medical or formal grounds. The bill also grants an amnesty for doctors and pharmacists who issued or accepted faulty prescriptions between 1 January and its coming into force. However, the amendment leaves intact a similar financial responsibility obligation for pharmacists, whose abolition is a key demand of the Supreme Apothecary Council (NRA). It does introduce an appeals procedure, however, another important issue raised by the NRA. Pharmacies will be able to apply to their voivodship branch of the NFZ and if necessary to the NFZ president against penalties, and any sanctions will be suspended pending the completion of the appeals procedure.
The amendment also e.g. requires doctors to indicate the level of reimbursement only for those drugs that are subject to more than one reimbursement level; gives the Health Ministry (but not doctors) the power to approve the reimbursement of medicines for indications other than their licensed indications; and sets the retail margin for directly-imported medicines at the same level as that for all other medicines, which is expected to increase patient access to such products. And it requires the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL), to publish on its website data on drug characteristics.