Concerns Persist over Implementation of 2012 Russian Vital and Essential Drug List

The regular annual update of the List of Vital and Essential Drugs (ZHNVLP) for 2012 is proving to be problematic, reports Russian newspaper Rossiyskaya Gazeta. Several months ago, details of the new update to the list for 2012 were published by the Ministry of Health and Social Development of the Russian Federation. The list included 24 drugs, including a number of innovative cancer medicines. As the source reports, a number of experts were concerned at the expansion of the list, which means that it will include not only "life-saving" drugs for use in hospitals—such as injectable and infusion-based drugs, tablets and capsules—but also forms such as drops, suppositories and ointments. As there are a good number of brand names for each international non-proprietary name (INN) included on the list, if all the dosage forms are included, as well as the different formulation types (i.e. ointment, tablet), the list would have been extended by around 1,000 items, the source estimates. After manufacturers and wholesalers made their concerns known to the MoH, the pharmaceutical formulations corresponding to the recommendations of the World Health Organization have been restored to the ZHNVLP. Thus, potentially severe delays to the registering of prices of drugs on the updated list have been avoided.

Although this problem has been addressed, there continue to be other issues causing concern for pharmaceutical companies supplying medicines on the ZHNVLP list, according to Rossiyskaya Gazeta. First, the government has yet to approve the list, meaning that producers are not yet able to apply to register their prices. Second, the source reports that companies involved in supplying drugs on the list view the process of price registration as "opaque", and there are problems seen with the quality of medicines included on the list, as the lowest prices for drugs included on it are sometimes offered by companies that do not operate a proper system to ensure the quality of the medicines they produce.

Concerns About Quality

Rossiyskaya Gazeta insinuates that the quality of medicines included on the list is not the primary concern. Instead, it suggests that what is the most important aspect of the price-registration process is which producer can register the given product's price first. This, it suggests, is often done by companies that do not have proper quality control systems, and so the low price of the drug reflects its low cost of development and production. Furthermore, the source reports that subsequent equivalent products cannot submit prices higher than the first for a given INN. This is in spite of the fact that later-registered drugs may have added advantages, and may be of much better quality. As the source suggests, this acts as both a disincentive for multinational and foreign drug makers to base their production in Russia and a disincentive for Russian pharmaceutical producers to implement the changes required to attain European good manufacturing practice (GMP) early, before the set deadline of 2014. Additionally, Rossiyskaya Gazeta reports that prices of active pharmaceutical ingredients are not registered in Russia, so producers tend to buy the cheapest available, creating concerns about their efficacy and safety.

Reform Set to Bring Changes to ZHNVLP List

The source foresees changes to the ZHNVLP list as the process of modernisation continues in Russia. Thus, with the introduction of mandatory GMP standards in 2014, companies that invest in the modernisation of their facilities may opt not to produce medicines on the list because they are unable to recoup the costs of investing in renovation. Thus, companies producing medicines in plants that are not being upgraded will be able to charge lower prices and will make it unprofitable for those investing in upgrades to include their drugs on the list.

Meanwhile, in light of the recent passing of the bill on the basis of public health protection in the Russian Federation, Sergey Kolesnikov, the deputy chairman of the Duma Committee on Health, is reported by Rossiyskaya Gazeta as saying that it is most likely that the principles of the formation of the ZHNVLP list will change. The Federal Antimonopoly Service is reported to be opposed to all restrictive lists, advocating that doctors should be guided by international standards of treatment.

Outlook and Implications

The expansion of the ZHNVLP list and issues surrounding its formulation have caused some concern within the Russian pharmaceutical sector (see Russia: 14 October 2011: Pharma Companies Concerned at Lack of Time to Register Prices for New Russian List of Vital and Essential Drugs).

GMP standards are due to become obligatory in Russia from 2014 (although there is considerable doubt over the ability of a large number of producers to implement these standards within the deadline), but until then, there will continue to be concerns regarding cheaper, non-GMP-compliant products on the Russian market, and this is likely to continue after that date, as many producers will fail to meet the deadline, and there will continue to be stocks of non-GMP-compliant medicines on the market.

The new law on the basis of health protection in the Russian Federation is set to define the scope of free medical care, and is expected to establish standards of care within legal definitions. What effects this will have on the ZHNVLP List and how it is managed will depend largely on how far the Russian authorities are willing to go in terms of state-provided medical treatment.