The Ministry of Health of Ukraine has developed a new Regulation on the Register for declaring changes of prices for medicinal products and medical devices

July 30, 2014 the Ministry of Health of Ukraine submitted to the public discussion a draft decree of the Ministry of Health of Ukraine "On Approval of the Regulations on the Register for wholesale prices for medicinal products and medical devices, the procedure for making amendments in it and the forms of declaration of changes of wholesale prices for medicinal products and medical devices" by the publication of the draft text on the official site.

In the text of the message about the publication of the draft the Ministry of Health of Ukraine it is noted that it is designed pursuant to subparagraph 1 of paragraph 5, subparagraph 1 of paragraph 6, paragraph 14 of the Procedure for declaring changes of wholesale prices for medicinal products and medical devices approved by the Cabinet of Ministers of Ukraine dated 2 July, 2014 No. 240 "On the referential pricing in respect of medicinal products and medical devices purchased by the state and local budgets."

Thus, to replace the order MoH of Ukraine of September 07, 2012, No. 705, which is offered to be repealed, it is expected to approve the new ones:

• Regulation on the Register for wholesale prices for medicinal products and medical devices, the procedure for making amendments in it;
• form of a declaration of changes of wholesale prices for medicinal products;
• form of a declaration of changes of wholesale prices for medical devices.

The draft of the new Regulation is as a whole kept in a familiar form, however, it has been introduced a number of changes, particularly in terms of medical devices:

• prices Register contains information about the wholesale prices for medicinal products and medical devices declared by the owner of the certificate for state registration of medical devices or the person who made the declaration of conformity (hereinafter an alternative to the presentation of data either according to the certificate of state registration or by a declaration of conformity is assumed), or a person authorized by him/her;
• the list of information that is included into the Register is expanded, namely the following is enclosed: the number of units of medical devices per package (pieces, studies, etc.), number according to the catalog, changes of wholesale prices for medical devices of domestic and/or foreign production submitted to the declaration in UAH, not only the official rate, but also the type of foreign currency set by NB of Ukraine not on the date of submission of the application as it is according to the current provisions, but rather on the date of submission of the declaration of change of wholesale price for medical devices;
• the grounds for exclusion information on the declared price change from the Register are expanded, namely: at the request of the owner of the certificate for state registration of medical devices, or person who made a declaration of conformity or a person authorized by him/her;
• it is provided that the Register is kept solely in electronic form.

The draft provides that from March 1, 2015 information on the declared changes of wholesale prices for medical devices, which would not be declared in accordance with the Procedure for declaring changes of wholesale prices for medicinal products and medical devices approved by the Cabinet of Ministers of Ukraine dated 2 July, 2014 No. 240, is subject to withdrawal from the prices Register.

The draft is a regulatory act and requires the approval of the State Service of Ukraine for Regulatory Policy and Entrepreneurship Development and is subject to state registration in the Ministry of Justice of Ukraine.

In case of acceptance and registration in the Ministry of Justice the order will come into force from the day of its official publication.

Considering that according to the resolution of the Cabinet of Ministers of Ukraine of July 02, 2014 No. 240 the Ministry of Health of Ukraine has two months for bringing their legal acts into conformity, however according to the resolution of the Cabinet of Ministers of Ukraine No. 240 changes of wholesale prices, excluding duty and VAT, should be declarable with regard to only those medical devices that are included in the State register of medical equipment and medical devices or, in respect of which the declaration of conformity of the medical device are filled, from August 01, 2014, i.e. the mandatory nature of the procedures is provided for by the current legislation, but as of today there are no by-laws and regulations that would completely settle declaration mechanism.

Given this regulatory gap, there is a situation, within which from August 01, 2014 the conscientious operators of the market of medical devices can not submit the documents to the Ministry of Health of Ukraine, which, as a consequence, directly corresponds to the inability to ensure the participation in the public procurement, since such a participation requires as a 'mandatory condition a presence of the declared price for the medical device’.