Marketing pharmaceuticals in Poland

As throughout the world, the issue of pharmaceuticals in Poland is a sensitive subject. The respective legal regulations have to provide for the best possible healthcare for the Polish population and at the same time be entrepreneur-friendly. The law on pharmaceuticals dated Sept. 6, 2001, currently regulates this market. Amendments to the law are scheduled to take effect in October, adapting Polish regulations to European Union standards. In addition, other legal regulations such as the law on prices, the law on public health insurance and various other ordinances apply. Despite this effort, it does not appear that compliance with EU regulations has been reached in full, although the government has taken a large step in this direction. What follows is a short overview of some of the most important aspects of Polish pharmaceutical regulations.

Placing medical products on the Polish market In principle, a medical product to be placed on the Polish market must first obtain authorization for such placement. Products that already have obtained authorization from the European Council or the European Commission may be placed without further requirements. Other foreign medical products that have obtained the relevant authorization in their country of origin may be placed on the Polish market, but only under certain limited conditions. Of course, there is also a range of products enumerated by the law that may be placed on the market without any prior authorization. The authorization may be applied for by the so-called person responsible, that is, any natural or legal person or any entity without legal personality undertaking business. The authorization procedures and requirements in Poland are substantially regulated in the same way as in the European Union. The law provides for an authorization period of 210 days from the date of submission of the application. Should it become necessary for further documents to be submitted to the relevant authorities, such a term is suspended until the completion of the application. However, if the granting of such authorization concerns a product already authorized or in the process of being authorized to be placed on the market in one of the EU member states, the procedure should be finished within 90 days from the receipt of the relevant documentation from the respective EU country. This procedure is in general referred to as the procedure of mutual recognition. Its details are subject to an ordinance, which has yet to be issued by the Health Ministry. The authorization is valid in general for a period of five years from issuance.

Pricing of medical products in Poland In general, pricing limitations are only provided for specific pharmaceuticals and medical materials enumerated by legal regulations. Non-restricted products may be marketed at freely determined prices. Those products to which pricing limitations apply are enumerated in a list published by the Health Ministry. To market one of the listed products, a manufacturer must file a motion to set the price and propose a price for such a product. The process to obtain a price should not exceed 90 days from the date of filing the motion or, if additional information is required, 90 days from the date of providing the additional information. Unlike in other legal regulations, the requirement to provide additional information does not suspend the 90-day period. The expiration of the said term, however, does not mean that the relevant product may be marketed at a price set forth by the pharmaceutical company.

Reimbursable pharmaceutical and medical products Lists of basic and supplementary pharmaceutical and medical products prescribed free of charge, for a lump sum or with partial payment covered by the public health insurance system were published in May and announced by the Health Ministry as ordinances. Again, the law provides for the possibility to file a motion to the Health Ministry to include a pharmaceutical or medical product in those lists. The importer or producer of the relevant product may file such a motion. The procedure to review the motion may, according to legal regulations, not exceed 90 days after the motion was filed. Again, unlike in other legal regulations, the requirement to provide additional information does not suspend this period. The Health Ministry is entitled to issue an ordinance specifying the scope of information that must be included in the motion and also specifying the procedure of reviewing the motion.

Medical product advertising The legal regulations regarding medical product advertising specify very explicitly the meaning of the term "advertising" within the framework of this regulation. Advertising, for example, includes the sponsoring of meetings and scientific congresses of persons entitled to issue prescriptions and persons who supply medical products and, in particular, the coverage of the costs of travel and lodging for people who attend such meetings. There are strong limitations on medical product advertising in general. Products not authorized to be placed on the Polish market may not be advertised at all. Considering the legal regulations as a whole and probable pharmaceuticals law amendments due in October, companies can only hope that procedures will be transparent and effective, and not made inadequate by loopholes the regulations will most certainly contain.

Alina Szarlak is a partner heading the German desk at White & Case.