Abstract

The Reimbursement Act adopted in 2011 introduced official prices on medicines, foodstuffs for special nutritional purposes and medical devices which are reimbursed from public funds. For all of those products, negotiations with the Ministry of Health resulted in a reduction of their retail prices, and for some the price is lowest in the entire EU. In consequence reimbursed products became exported, which phenomenon has intensified since 2013. In addition, from the very beginning doubts arose as to the obligatory nature of official prices for exported products. In the light of clarifications issued by the Ministry of Health the interpretation that official selling prices apply only within the territory of Poland has been set.

As if in response to the inability to prevent export of key medicines with the use of official prices and mark-ups, the so-called anti-exportation regulation was adopted. This regulation also introduced a list of products for which pre-export registration is obligatory. on the list includes medicinal products, foodstuffs intended for special nutritional purposes and medical devices that are for the time being in short supply in Poland. At the same time, an obligation has been imposed on wholesalers to report their intention to export those products. In addition, the Main Pharmaceutical Inspector has been given authority to raise an objection to their export or sale outside the territory of Poland. The notification of such an objection is important as it is tantamount to a ban on such exportation.