The session of the Russian Government Presidium considered the draft Federal law “On introducing amendments into federal law “On placing orders on goods, works, services supply for state and municipal needs” prepared by the Ministry for Economic Development.
According to Vladimir Putin, the Head of the Cabinet Council, the existing procedures for state and municipal order on pharmaceuticals supply should be revised. According to Vladimir Putin, the currently effective rules allow customers artificially limit the range of suppliers, act to the benefit of monopolists and lock the access to the orders for independent producers. The Head of the Government expressed the hope for resolving these issues via the planned amendments.
In particular, the amendments concern the definition of radiopharmaceutical drugs, registration of generics, the list of documents accompanying applications for state registration of pharmaceuticals, requirements to the employment terms of specialists responsible for clinical trials and for children’s participation in such trials.
The introduction of the document is obligatory according to the law “On the basics of public healthcare”. As per the law, all the medical products and their producers should be indicated in a unified register. The respective draft resolution charges Roszdravnadzor with the responsibility to maintain the register.
Meanwhile, the Ministry for Economic Development released a negative opinion in respect of the presented draft resolution. One of the reasons for the refusal was the concern that the document is not clear about the procedures for obtaining the data by Roszdravnadzor on the state registration decisions for medical products and the procedures for excluding particular medical products from the Register.
The medical products manufacturers did not support the document either. In particular, the business community believes that the document entails “excessive administrative and other restrictions and liabilities” which would result in “unjustified costs for both the industry and the state budget at different levels”.
According to the Minister for Healthcare Tatiana Golikova, pharmaceutical insurance is to be introduced in Russia starting from 2014-2015. In particular, in 2014-2015 some compensatory or insurance elements will be provided to particular subsidized categories of citizens.
Also, as per Tatiana Golikova, enactment of pharmaceutical insurance should be applied in the first turn for those citizens who are now eligible for subsidized pharmaceutical treatment, i.e. the patients aided at the federal level and in the regions. Under preliminary estimates, this stage of the insurance program should cover 26-27 million citizens overall.
The Order of the Ministry for Economic Development of Russia # 120 dd. 12.03.2012 determines the conditions (in effect till 31 December 2012) for eligibility of particular goods of foreign origin for inclusion into supplies for state and municipal needs. In particular, such eligibility conditions apply to medical appliances of non-Russian origin.
The Association of Russian Pharmaceutical Producers (ARPhP) suggests regulating the access of representatives of pharmaceutical companies, manufacturers and medical products distributors to employees of medical institutions in the following cases:
Also, the draft document provides for prohibitory measures for pharmaceutical companies and medical employees. The draft document was forwarded to the Ministry for Healthcare and Social Development, the State Duma and Roszdravnadzor.
According to Dmitry Ter-Stepanov, Deputy Director of the Department for competition development of the Ministry for Economic Development, the Ministry is planning to present the new methodology for ED pricing already by October 2012. According to Mr. Ter-Stepanov, this will be the first step to introducing the pharmaceutical insurance system. Determination of reference prices should be the further step.
The representatives of the Ministry for Healthcare and Social Development note that the work in this respect has just started and the applicable approaches are to be developed, so the timing for introducing the new rules is not certain yet.
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Prepared for you by KPMG Tax Department.