A proposal for an amendment to the Reimbursement Act was published on 30 June 2021. The bill is currently undergoing public consultations and will be submitted to the Sejm for debate next year.
The main changes to reimbursement regulations would concern:
- inclusion of pharmaceutical companies in the payback mechanism at the point when the reimbursement budget is exceeded. Currently, the question of exceeding the budget is to be considered per year and does not include entities that have a risk-sharing instrument under reimbursement decisions. Under the proposed new rules, if the payback mechanism described in art. 4 of the Reimbursement Act is activated, only a firm that returns a higher amount under the risk-sharing instrument to the state payer than their payback share would be will be exempt from that mechanism (art. 4 (11) of the bill).
- the portion payable by the patient would be 10% or 15%, depending on whether the drug alone, or the active substance as well, are produced in Poland (art. 6(2)a). The change aims to increase the level of production of drugs or active substances in Poland, and thus increase the level of Medication Safety in Poland.
- introduction of reimbursement secrecy, which would mean that risk-sharing instrument documentation, and Economic Committee proceedings documentation, would be confidential, and this would apply to the documentation gathered throughout the procedure to establish reimbursement eligibility and the official sale price, increase or decrease the official sale price, and establish or change the official sale price of medicine, food for special medical purposes, or a medical device, or reduce the period of validity of a decision (art. 30b).
- the option of transferring a decision confirming eligibility for reimbursement to an entity that assumes the rights and obligations of the original recipient of the decision (art. 25d of the bill).
- extension of the time limit for publishing the reimbursement list from two to three months, to make the handling of medicines by pharmacists more efficient (art. 37(6)).
- strengthening of the patent linkage mechanism, to prevent reimbursement applications for a generic product, when at least one medicinal product, equivalent to the generic one and reimbursed for a given indication, “possesses patent protection or regulatory data protection” (art. 11(1) a).
Many of the proposed solutions are highly controversial and have been criticized by the domestic pharmaceutical sector and in scholarly literature. An update on the final form of the reimbursement law amendment will be provided in a future newsletter.