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Settlement of some issues of the Affordable Medicines program: the Ministry of Health has published draft resolution

On May 21st Resolution of the Cabinet of Ministers of Ukraine “On Amending Some Resolutions of the Cabinet of Ministers of Ukraine” (hereinafter – draft resolution) was published on the official website of the MHO. The draft resolution was developed in order to refine the medicines reimbursement mechanism.

Thus, one of the most important issues of the reimbursement program implementation nowadays is difference between real prices of medicines in pharmacies and prices which appear on the Register of Medicines Subject to Reimbursement (hereinafter – the Register).

Actually, supplier and sale mark-ups can be 3%, 7% or 10%. It means that the reimbursement amount, surcharges and retail price for medicines are different from those mentioned in the Register. It created difficulties for reimbursement to pharmacies for released medicines for budgetary funds.

To settle this and other issues of the reimbursement program, the draft resolution offers:

1)Prescribe in Resolution of the Cabinet of Ministers of Ukraine No. 955 as of October 17th, 2008 obligation to observe fixed retail prices for medicines whose trade names are included to the Register.

Such prices will include supplier and sale mark-ups and retail mark-ups in the total amount of 26.5% to ex-factory price inclusive of taxes (in terms of the current regulation general amount of mark-ups does not change). The amount of maximum supplier and sale mark-ups should not exceed 10% (is not fixed), and the amount of retail mark-ups will depend on it. Therefore, pharmacies will be able to add mark-ups more than 15% as now if distributor mark-up is less than maximum 10%.

Such medicines will be sold by pharmacies at prices specified in the Register despite of the fact if they are subject to reimbursement or bought at consumer’s money (i.e. if a brand is under the reimbursement program, its retail price in all pharmacies must be equal, including in those which do not take part in the reimbursement program);

2) Determine that compliance with the abovementioned requirement of para 1(3) of Resolution of the CMU No. 955 as of October 17th, 2008 on mark-up amounts will apply to brands included to the Register (i.e. other brands not claimed to inclusion to the Register, however whose INN were included to the list approved by the Resolution, will be under state regulation of prices in accordance with para 1(1) of Resolution of the CMU No. 955 as of October 17th, 2008).

3) Determine transition period for the retail segment when remainders of medicines procured before the MHO approved the updated Register can be sold.

4) Simplify the process of Register approval by cancelling the necessity to approve by MHO order the provisional Register version (preliminary results will be published on the official website of the National Health Service of Ukraine).

5) Provide that the application form to include a brand to the Register and obligations of the applicant must be submitted in the form provided on the official website of the National Health Service of Ukraine in the announcement on application acceptance start.

6) Considering long procedure of the Register formation, establish that the Register will be updated annually in February and August (instead of January and July respectively).

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