Russia’s pharmaceuticals market grew 18% in 2009 against an 8% decline in Gross Domestic Product (GDP), and will increase 16% in US$ terms to reach $20 billion this year, forecasts a new report.

Even greater growth is expected for 2011, according to local market research firm DSM, which expects the market to continue advancing strongly over the next 10 years, driven by factors including the development of the nation’s drug reimbursement programme, the growth of health insurance, modernisation of the hospital supply programme and rising average per capita drug consumption.

Russia’s pharma market is divided into three segments, the largest of which is the commercial segment, where sales grew 22% to $9.1 billion in 2009, mainly on price rises for imported medicines which were higher than in previous years, says DSM; it does not expect similarly fast growth for this segment in 2010. Next is the state-owned medicines segment, which accounted for around 25% of 2009’s market with sales up 11% at $4.2 billion, and third is the parapharmaceuticals segment, whose growth has been outpacing the rest of the market and continued to do so last year, rising 15% to $3.7 billion.

Another new report, from RNCOS, says the Russian pharmaceutical industry has immense growth potential and is in the initial stages of development. The sector will grow an average 26% a year during 2010-2013, driven by high levels of investment from both the government and the private sector, and the boost given to consumption of high-priced medicines by the new compulsory and voluntary insurance schemes, it says.

“Russia is transforming into a more conducive environment for clinical trials, which will further pave the way for the growth of the pharmaceutical industry in the country,” RNCOS adds.

However, US and European business groups have this month called on the Russian authorities to consider changes to policy proposals related to clinical trial and intellectual property regulation contained within the country’s Draft Law on the Circulation of Medicines, which has now passed its first reading in the Duma, Russia’s Parliament.

As it now stands, the proposed legislation would require applicants to reconduct the full cycle of clinical studies for a drug, regardless of whether clinical trials have already taken place elsewhere. “This provision would not reflect the international trend toward regulatory harmonization and greater transparency,” said the signatories to the joint letter, which include the Pharmaceutical Research and Manufacturers of America (PhRMA). Nor, they add, does the draft clarify the decision-making process and responsibilities for preregistration of clinical trials, which means the duration of trials required in Russia for an applicant could last three to 10 years.

The signatories also note that the draft law’s failure to provide any regulatory data protection is contrary to Russia’s international obligations to the US and European Union (EU) to enact six years’ protection into law. Almost all innovative R&D worldwide takes place in countries with strong regulatory data protection, and Russia needs to implement the six-year standard of protection to be competitive, they say.

“With its strong scientific background and long-term commitment to innovation, Russia is uniquely positioned to become a leader in biopharmaceutical development,” said Christopher Singer, PhRMA’s president of international affairs. “Right now, Russian legislators have the chance to make key improvements that will improve their investment climate and speed access to innovative medicines for Russian patients,” he added.