44
Paweł Krzywina
3) minimum net selling price obtained in individual EU member states or EFTA member states as part of funding from public funds of said countries, within one year prior to submitting an application, converted to Polish zlotys at an average National Bank of Poland conversion rate from the month preceding the month of application; in case when the subject of the application is not financed from public funds in a given country, free market prices are considered respectively, 4) official selling price of medicines with the same international name, or other international names but with similar therapeutic action, and foodstuffs intended for particular nutritional uses, with the application of the following criteria: identical indications or purposes, similar efficiency, taking into consideration the balancing of interests of payees and entrepreneurs88, payment capabilities of an entity obliged to finance benefits of public funds, and scientific research and investment activity of the applicant regarding healthcare within the Republic of Poland and in other European Union member states or EFTA member states. Apart from the above described procedure for the establishment of an official price, scientific research activities and investment activities of the applicant are also taken into consideration in case of investigating applications89 regarding, amongst others: 1) including a medicine, foodstuff intended for particular nutritional use, medical device in a reimbursement scheme; 2) allowing increase of the official selling price of a reimbursed medicine, foodstuff intended for particular nutritional use, medical device; 3) allowing reduction of the official selling price of a reimbursed medicine, foodstuff intended for particular nutritional use, medical device; The above conclusions are examined by the Economic Committee at the Ministry of Health, which conducts negotiations in the panel of five, in consideration of the following criteria90: 1) recommendation of the President of the Agency for Health Technology Assessment (AOTM), including but not limited to results of the analysis of the cost to health outcomes ratio; 2) minimum and maximum net selling price obtained in the Republic of Poland within one year prior to submitting an application for a requested dose and package size, which is the subject of said application, if applicable; 3) maximum and minimum net selling price obtained in individual EU member states or EFTA member states, as part of funding from public funds of said countries, within one year prior to submitting the application91, 4) information concerning rebates, discounts or price agreements in other EU member states or EFTA member states; 5) therapy cost with the application of the requested medicine, foodstuff intended for particular nutritional use, medical device in comparison with other medical technologies available in a particular health condition, which may be replaced with said medicine, foodstuff intended for particular nutritional use, medical device; 6) influence on the budget of the entity obliged to finance benefits with public funds; 88 Manufacturing
or marketing medicines, foodstuffs indented for particular nutritional use. 24.1 of Reimbursement Law. 90 Art. 19(1) of Reimbursement Law. 91 Converted to Polish zlotys at an average National Bank of Poland conversion rate from the month preceding the month of application; in case when the subject of the application is not financed from public funds in a given country, free market prices are considered respectively. 89 Art.