The State Duma deputies are considering new restrictions for advertising of biologically active additives. The draft law initiators suggest distributing these advertisements solely via medical and pharmaceutical editions and in specialized events, in particular, conferences and exhibitions. Besides, according to the draft, the advertising materials must not create an impression for consumers, that biologically active additives could be used for disease treatment.
According to Veronika Skvortsova, the Head of the Ministry for Healthcare and Social Development, in 2014 the “pilot” projects of social insurance or other types of pharmaceuticals price reimbursement need to be introduced in several regions of Russia.
During 2012 the regions should get prepared to startup of the “pilot” projects. Should the results be successful, the new system will be implemented all over the country. However, due to some financial restrictions, global implementation of the pharmaceutical insurance system is planned not earlier than in 2015.
The Rules for maintaining the state Register of medical products and medical products manufacturers are adopted. The respective Decree comes into force on 1 July 2012. The data on medical products and equipment registered in the territory of Russia prior to this date should be included into the Register as well.
The Register is maintained by Roszdravnadzor electronically, via entering the records under unique numbers. The information contained in the Register is publicly available, published at the official web-site of Roszdravnadzor and provided to the state authorities, other legal entities and individuals free of charge.
The State Duma Committee for Healthcare chose for further consideration one of the proposed draft laws on rescheduling the deadline for adopting the state registration rules for medical products. The said document suggests postponing to 1 January 2013 the deadline for enacting the provisions which allow circulation in Russia of the medical products registered according to the new rules.
The Federal Antitrust Service of Russia believes that, due to the lack of clear legislative definitions and criteria for substitutability of pharmaceuticals, the state customers have the possibility of blocking the market entry for new pharmaceuticals (especially those of Russian origin), which results in abusing the patients’ rights by imposing expensive generics.
With this respect, the FAS suggests to define the notions of generic and substitutable drugs by law and to oblige the Ministry for Healthcare and Social Development to provide information on the corresponding generics in course of state registration of drugs.
Besides, the FAS experts consider that the current ways of state regulation for essentials leads to loss-making manufacturing of particular drugs, induces registration and sales of drugs at maximum high prices and leads to price inflation for non-essentials too. For resolving these issues, a special working group was arranged with the Ministry for Economic Development of Russia, which is supposed to improve the methodology for determining maximum manufacturers’ prices for essentials.
The Ministry for Industry and Trade is preparing suggestions simplifying the registration of ED prices which are below RUB 100 – 150. The proposed amendments are drafted together by the Ministry for Industry and Trade, the Ministry for Healthcare and Social Development and FAS. Though the particular timeframe is not certain at this point, the respective drafts are supposed to be prepared during 2012.
The members of the International Medical Device Association (IMEDA) plan introducing the amendments into Article 74 of the Federal law “On public healthcare in Russia” which currently allows medical professionals to interact with the pharmaceuticals and medical goods producers only in respect of clinical trials and qualification upgrade events.
In particular, it is suggested to include into the scope of permitted activities also extended briefings on medical products use, performance of technical maintenance of medical devices/equipment and due fulfillment of contract obligations before medical institutions. The Association also suggests allowing companies to pay the travel, accommodation, meals and qualification upgrade costs of medical professionals directly, i.e. without providing the doctors with cash.
The suggested amendments to the law were submitted by the Association for consideration by the State Duma deputies.
After accession of Russia to the WTO, a significant reduction of customs duties for pharmaceuticals is expected (from 15% to 5 – 6.5%). The anticipated timeframe for duties decrease should comprise 2-3 years for most of the pharmaceuticals. Overall, the transition is planned to be completed by 2016.
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Prepared for you by KPMG Tax Department.