POLAND Law and Practice Contributed by: Krystyna Szczepanowska-Kozłowska, Marcin Ziarkowski, Krzysztof Popławski and Kacper Sobolewski, A&O Shearman
therapeutic indications that bring significant clinical benefits compared to existing therapies. 2.3 Acceptable Pre-Launch Preparations Polish law provides for the so-called Bolar exemption. The Bolar exemption is defined very broadly in Polish law and allows for the use of an invention consisting of making, using, storing, keeping, offering, placing on the market, exporting or importing it. These activi ‑ ties can be undertaken to perform the acts that are required by law to obtain marketing authorisation. According to the law, the Bolar exemption can be invoked not only by the person who applies for the registration of a medicinal product but also by a third party, eg, a manufacturer of an active substance. The Bolar exemption can be invoked if the application was filed in the countries within the territory of the EEA, as well as in other countries. 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 authorisation issued by the President of the Polish Drug Author ‑ ity in national (NAR), mutual recognition (MRP) and decentralised (DCP) procedures; • medicinal products with a marketing authorisation issued by the European Commission in the central ‑ ised (CEN) procedure; and • medicinal products with a parallel import authorisa ‑ tion (IR). Once a month, the Polish Drug Authority announces a list of medicinal products that have obtained mar ‑ keting authorisation. In principle, information on the registration of a medicinal product is available after the marketing authorisation is granted. As part of the access to public information, the Polish Drug Authority usually refuses to provide detailed information, only stating the fact that there are ongoing proceedings for marketing authorisation and indicating the number of ongoing proceedings. The MAH of the reference product is not automati ‑ cally notified about ongoing procedures concerning
marketing authorisations for generic products or bio ‑ similars. However, they can request access to the files of such procedures. While the Polish Drug Authority has previously refused access to the files, invoking the necessity of demonstrating a legal interest, according to the latest jurisprudence of administrative courts, the MAH of the reference product is entitled to access the files of the ongoing proceedings. 2.5 Reimbursement and Pricing/Linkage Markets As a rule, the procedure for granting a marketing authorisation does not take into account the existence of patent protection. Similarly, in the case of reim ‑ bursement, patent protection is irrelevant. An excep ‑ tion arises when the responsible entity applying for the registration of a generic medicinal product submits a request to remove from the SmPC data relating to therapeutic indications or pharmaceutical forms cov ‑ ered by patent protection. In the procedure for grant ‑ ing authorisation, such an entity must submit a state ‑ ment about the existence of patent protection for the specified indications or forms from which it wants to withdraw. The authority issuing the authorisation is not obliged to examine whether the patent protection of these indications or forms exists. Therefore, a generic drug can be added to the list of reimbursed drugs, despite the existence of pat ‑ ent protection. However, in practice, drugs whose reference equivalents are protected by patents are rarely entered on the list of reimbursed drugs due to the possibility of the patent holder initiating a patent infringement proceeding and obtaining a prohibition on introducing the generic product to the market. The Minister of Health publicly announces the reimbursement list every three months. The list is announced in the month preceding the three-month period in which it will be valid. Monitoring the Minister of Health’s announcements is the only way to deter ‑ mine 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 reimbursement list. The reimbursement list indicates the range of indications covered by the reimburse ‑ ment for each drug, distinguishing, for individual prep ‑
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