The draft order is placed at the official website of the Russian Ministry for Healthcare and Social Development. In particular, the Methodology was extended by provisions stipulating that the registered sales price may not be increased higher than for the forecasted inflation rate in the current year (as per the law on the federal budget for the forthcoming financial year and planning period).
Also, the maximum sales price proposed for state registration may not exceed the manufacturer’s minimum sales price for the subject product in the producer’s state of incorporation and other states.
Should the draft be adopted, a new clause is to be added to the said Federal law, regulating the rules for item-quantitative accounting of pharmaceuticals at different circulation stages, from the production up to the retail sale and use by medical institutions. The draft also contains a provision obliging to record in special registers the data on changes in the quantity or state (condition) of all the products subject to the said accounting rules.
The discussed amendment should not however change the existing basic principles of pharmaceuticals circulation in Russia.
The Ministry for Healthcare and Social Development has posted at its website the draft Order dd. 18 September 2012 “On the Commission with the Ministry for Healthcare and Social Development for resolving conflicts of interest in medical and pharmaceutical areas”.
According to the document, the Commission is supposed to deal with cases when economic benefits or any other advantages potentially receivable by medical or pharmaceutical employees affect or could affect the integrity of their professional performance.
Particularly, one of the Commission’s responsibilities would be resolving conflicts of interest of medical and (or) pharmaceutical employees in course of their job duties.
Roszdravnadzor is arguing against terminating the cooperation between doctors and medical representatives. The department is now developing amendments to the Federal Law “On Fundamentals of Public Healthcare” which governs the said interaction principles.
Besides, Roszdravnadzor started developing the draft decree which is supposed to regulate the control procedures in pharmaceutical area. It is supposed to perform audits of the contracts for pharmaceuticals and medical goods purchases and for clinical trials conduction.
According to the Deputy Head of Roszdravnadzor, Elena Telnova, the draft document is to be discussed with the Association of the Russian Pharmaceutical Producers (ARPhP) and with multinational pharmaceutical corporations operating in Russia.
The statutory control is to be executed via issuing permissions for importing medical goods into Russia for state registration, monitoring the safety of medical goods as well as auditing the companies producing and selling medical goods with respect to their compliance with the requirements of the Federal Law “On Fundamentals of Public Healthcare”.
The Russian Prime Minister Dmitry Medvedev has instructed the Ministry for Industry and Trade to finalize and submit to the Government the draft law on medical goods production by 1 February 2013. According to Dmitry Medvedev, the law is supposed to regulate the whole “life cycle” of medical goods, from production up to the end-use stage.
The Prime Minister has also charged the Ministry for Healthcare and Social Development and the Ministry for Industry and Trade with the task of developing the list of medical equipment types, production of which should be the priority.
In particular, the Administrative Regulation determines the scope, timing and sequence of administrative actions to be made by the Ministry when performing the said function.
It is also stipulated that that the timing for releasing a decision on the state registration of the maximum ED sales price may not exceed 60 business days.
The template of a registration certificate for a pharmaceutical intended for medical use was approved by the Order of the Ministry for Healthcare and Social Development # 82n dated 13.08.2012. The earlier issued registration certificates are considered valid until the expiry date indicated therein.
If case of changes in the data stated in the registration certificate, the updated document with the same number and registration date is to be issued, with indication of the re-issuance date.