Russian president Dmitry Medvedev has signed a wide-ranging healthcare reform bill that looks set to have considerable impact on the country's pharmaceutical sector.
The headline news from the bill for many Russians is the decision to legalise paid services in state-run medical facilities, which some see as undermining Russia's constitutional requirement to provide free healthcare services to its people.
More significant for the pharmaceutical sector however are provisions related to orphan drugs, interactions between pharmaceutical representatives and healthcare professionals and reimbursement of medicines, according to IHS Global Insight's European analyst Brendan Melck.
Measures in the bill designed to improve access to orphan drugs have been controversial, with speculation that some regions would not use funds allocated for orphan drug reimbursement for that purpose. There are also some concerns about the lack of specific detail in the proposals, according to Melck.
Meanwhile, a decision to allow access to medicines not included on the national reimbursement list in some cases - for example an intolerance to certain drugs - is "a positive development for both patients and the pharmaceutical industry, as it will mean that drugs not on the list will not be ostracised in the public healthcare system", said Melck.
Rules on the interactions between drug reps and healthcare professionals seem to have been watered down somewhat from earlier drafts, according to a Moscow Times report, which may be a positive for the pharmaceutical sector if it provides wider scope for promotional activities.
"It remains to be seen how the regulations will be implemented and enforced in practice," commented Melck.
The Moscow Times also reports that total spending on healthcare is set to rise from $17bn in 2010 to $45bn in 2015, citing a senior figure in Russia's Health and Social Development Ministry.
Russia's pharmaceutical market is already undergoing considerable evolution thanks to the implementation of the Pharma 2020 strategy - first introduced under former President Vladimir Putin - which is designed to encourage local production of drugs and reduce the country's reliance on imported medicines.
Under the plan, the government will help local producers to cover the costs of the R&D that is required to boost production of innovative pharmaceuticals, with the aim of increasing the share of local drug producers in the market to 25 per cent by 2012 and 50 per cent by 2020.