POLAND LAW AND PRACTICE Contributed by: Krystyna Szczepanowska-Kozłowska, Marcin Ziarkowski, Krzysztof Popławski and Kacper Sobolewski, A&O Shearman, A. Pedzich Sp. k .
2.4 Publicly Available Drug and Patent Information The Polish Drug Authority maintains the Register of Medicinal Products Authorised for Marketing in Poland. The following are entered into the Register: • medicinal products with a marketing authori - sation issued by the President of the Pol- ish Drug Authority in national (NAR), mutual recognition (MRP) and decentralised (DCP) procedures; • medicinal products with a marketing authori - sation issued by the European Commission in the centralised (CEN) procedure; and • medicinal products with a parallel import authorisation (IR). Once a month, The Polish Drug Authority announces a list of medicinal products that have obtained marketing authorisation. In principle, information on the registration of a medicinal product is available after the marketing authori - sation is granted. As part of the access to pub - lic information, the Polish Drug Authority usu - ally refuses to provide detailed information, only stating the fact that there are ongoing proceed - ings for marketing authorisation and indicating the number of ongoing proceedings. The MAH for the reference product registration does not get notified about the ongoing proce - dure concerning marketing authorisations for generic products or biosimilars. However, they can request access to the files of the ongoing procedure. Although the Polish Drug Authority refuses access to the files, invoking the necessi - ty of demonstrating a legal interest, according to the latest jurisprudence of administrative courts, the MAH of the reference product should receive access to the files of the ongoing proceedings.
2.5 Reimbursement and Pricing/Linkage Markets As a rule, the procedure for granting a market - ing authorisation does not take into account the existence of patent protection. Similarly, in the case of reimbursement, patent protection is irrelevant. An exception is a situation when the responsible entity applying for the registration of a generic medicinal product submits a request to remove from the SmPC data relating to thera - peutic indications or pharmaceutical forms cov - ered by patent protection. In the procedure for granting authorisation, such an entity submits a statement about the existence of patent protec - tion for the specified indications or forms from which it wants to withdraw. The authority issu - ing the authorisation is not obliged to examine whether the patent protection of these indica - tions or forms exists. Therefore, a generic drug can be added to the list of reimbursed drugs despite the existence of patent protection. However, in practice, drugs whose reference equivalents are protected by patents are rarely entered on the list of reim - bursed drugs due to the possibility of the patent holder initiating a patent infringement proceed - ing and the possibility of obtaining a prohibition of introducing the generic product to the market in the PI proceeding. The Minister of Health publicly announces the reimbursement list every three months. The list is announced in the month preceding the next three-month period in which it will be valid. Mon - itoring the Minister of Health’s announcements is the only way to determine if a given medicinal product will be reimbursed because the MAH of the reference drug is not notified of the inclusion of the generic/biosimilar drug on the reimburse - ment list. The reimbursement list indicates the range of indications covered by the reimburse -
229 CHAMBERS.COM
Powered by FlippingBook