For MZ SR:
Director General of the Department of Pharmacy and Drug Policy MUDr. Adam Table
Director of the Division of Classification, Pricing and Drug Policy PharmDr. Rastislav Pullmann
For MGP, co. Ltd.:
Dr. Karel Green, CSc.
The meeting took place at the request of MZ SR, which started MUDr. Adam The Director General of the Department of Pharmacy and Drug Policy asked representative of MGP, spol. s r.o. on the presentation of its requirements.
Dr. Karel Green, CSc.:
He commented on the application of the main expert of MZ SR for nuclear Medical doc. MUDr. Ivana Režňák, CSc., m. prof. for support and assistance in dealing with the impending crisis with the 99mTc/99Mo supply generators. Due to global production problems 99Mo and related production of 99mTc/99Mo generators (change in technology imposed by restrictions in the fight against terrorism; and the decommissioning of some nuclear reactors) to be increased prices for final customers, i.e. medical facilities. He realizes is that in this respect it will be necessary to adjust the price for 99mTc/99Mo generators by an amount contrary to the legislation allowing the maximum increase in the price of the product by 5% in the calendar year.
It calls for these forced price adjustments for technetium generators did not lead to a stop in the supply of technetium generators to Slovakia. It would have a devastating impact on all medical nuclear facilities. medicine in Slovakia and the provision of diagnostic and medical-prevention care in the field.
He informed that an exception to the law was provided for in the Czech Republic, 99mTc/99Mo generators were not subject to price regulation and their price has been increased.
MUDr. Adam Dormouse:
He informed MGP, spol. s r.o. about legislative options when dealing with an application for an increase in an officially determined price.
He informed that MZ SR cannot take action on this issue and can not increase anti-law prices.
The holder of the registration must proceed with the price change in accordance with the applicable legislation. The proposal for an official price of the medicinal product cannot exceed the European the reference price of the medicinal product. According to § 2 letter. f) Act 363/2011 Z.z. on the scope and conditions for reimbursement of medicinal products, medical devices and dietary food based on public health insurance and amending European reference the price of the medicinal product is the average of the three lowest prices from the official determined prices of the medicinal product in other Member States; if the medicinal product is officially designated price only in one of the other Member States, the official price of the product in that State; if the medicinal product is officially priced in two of the other Member States States, average prices in these Member States.
The marketing authorisation holder shall be able to cancel the officially determined price of the medicinal product which not included in the list of categorised medicinal products and discard a list of officially determined prices.
The registration holder has the possibility to apply for a health insurance waiver and special payment 99mTc/99Mo generators.
He said he would inform the Minister of MZ SR about this problem.
The meeting was concluded by the Director General of the Department of Pharmacy and Drug Administration Policy Dr. Adam Hlôška.
Signed up by Mgr. Judita Janek
Verified by Dr. Karel Green, CSc.
Approval: MUDr. Adam Hlôška, Director General of the Department of Pharmacy, and
drug policy