Why Russia

Global pharmaceutical companies and CROs have already conducted successful drug discovery research and clinical trials in Russia. These experiences have proven that Russia’s significant intellectual resources, moderate and clear regulations, and low underlying cost structures, reflect Russia’s potential as a leading destination for pharmaceutical R&D outsourcing. Among the most important factors that make Russia an attractive destination point for pharmaceutical R&D are:

• Macroeconomic characteristic:

As the growth of developed markets becomes sluggish, pharma leaders consider Russia as either untapped market for innovative drugs or as place to conduct R&D. Moreover, the new reimbursement system and growing out-of-pocket spending have resulted in fast growth of the Russian pharmaceutical market. The Pharma market is expected to reach $25-35 billion by 2020, with annual growth expected at 10-12% in local currency.

• Large pool of expertise:

Existence of a strong scientific base in Russia is the fundamental factor that supports Bonasana’s plans to locate a medical R&D facility there. Russia is famous for its excellent medical and bioscience schools. Overall, the Russian Federation has more than 50 university-level institutions in the biomedical field and more than 30 veterinary schools associated with agricultural universities. Russia has a deep pool of highly qualified experts who have practiced at leading centers of microbiology, bio-organic chemistry, and physico-chemical biology. Many scientists already have had experience in conducting preclinical and clinical studies.

• Access to new therapeutics:

Russia boasts a vast pool of untapped compounds in its traditional medicinal practices. Combined with modern drug discovery technologies, Russian traditional medicine holds vast potential for accelerating the discovery and commercialization of new therapeutic treatments. Russia has a notable track record of developing traditional medicines, as well as innovative research on diseases such as Alzheimer and Parkinson’s. Russia represents an under-exploited source of novel pharmaceutical products for global pharmaceutical companies, and consumers.

• Cost effective R&D:

The estimate is that it is possible to receive world-class services at up to 50% lower than western market costs.

• Success in clinical trials:

Russia is rapidly becoming an increasingly attractive place in which to conduct clinical trials. Large scale clinical trials have been successfully conducted in Russia since 1989. The number of clinical trials conducted in Russia by international companies has increased considerably over the past 10 years. Thus, foreign pharma companies conducted 414 clinical trials in Russia in 2008, up from 404 in 2007, according to the Russian Federal Health and Social Development Agency, a health care oversight body. In 2009, according to U.S. NIH, during the period from January to September, international pharmaceutical companies reported 153 trials in Russia.

• IPR protection:

In addition to being a member since 25 December 1991 of the World Intellectual Property Organization (WIPO) on 19 November 2006 Russia has signed a binding agreement with the United States on “Action on Critical IPR Issues,” as an integral part of the United States-Russia WTO bilateral market access agreement. One of the critical IPR issues that the Russian Federation has agreed to act on is protection of pharmaceutical test data. Implementation has already started.