Russia. Difficult procedures prevent Russia's pharmaceutical industry from rapid growth
The Russian pharmaceutical industry has grown substantially in recent years. In 2009, the sector grew by 17.5% and by the year 2014 it is expected to reach a value of $10.7 billion. However there are some crucial structural defects in the Russian pharmaceutical market, such as complex administrative procedures and insufficient international cooperation, which tend to inhibit full development for this economic field.
In 2010, Dmitry Medvedev, the then Russian President, called for further development of the domestic pharmaceutical industry to reduce the country’s dependence on foreign medicines.
One year later, in 2011, Vladimir Putin, then the Prime Minister, reiterated the same hope. He supported the development of medical and pharmaceutical industries saying that Russia should be manufacturing at least half the medical equipment it needs by 2020.
Federal authorities responded with a special program: ‘the Russian government’s 2020 Strategy to encourage growth in the Russian pharmaceutical industry’. The plan aims to support local companies and foster the production of innovative drugs.
In the here and now, the pharmaceutical market is growing in Russia with enormous potential for further domestic development. The Russian pharmaceutical market represents about 3.6% of the European pharmaceutical industry. The Russian sector grew by 17.5%, in 2009 and by the year 2014, it is expected to reach a value of $10.7 billion.
However, Ramil Abdrashitov, Clinical Research Director of AstraZeneca Russia and Ukraine, said on November 21st, during the 3rd International Forum on Innovative Drug R&D, that Russia is far behind other European countries in regard to clinical trials and that Russia is still a long way from achieving full realization of potential growth in the field. The Russian pharmaceutical market presents several structural failings, which are preventing it from developing fully.
First, the Russian pharmaceutical market is quite closed and, according to professionals in the field, it is difficult to bring new medicines to the Russian market. Indeed, at the 3rd International Forum on Innovative Drugs, Svetlana Zavidova, Executive Director of the Association for Clinical Trials Organisations, explained that to be registered, all new drugs in Russia are required to undergo an all-Russian testing process, even medicines that are internationally certified.
This procedure complicates and extends the process of introducing new medicines to the market. Overall, both the pharmaceutical industry and patients are negatively affected. On one hand, in the opinion of Ramil Abdrachilov, it is harmful to the competitiveness of the Russian pharmaceutical sector, and on the other hand, it restricts access to modern drugs and innovative therapies for Russian patients’.
Moreover, there are no international agreements between Russia and other countries on the certification of medicines. Svetlana Zabidova reported that negotiations have, for instance, taken place between Russia and the European Union, though for now, there is still no mutual recognition in clinical trials. Abdrachilov believes that it is necessary to reduce customs tax on the import of drugs, equipment and material for clinical trials.
Major players in the Russian pharmaceutical market would like to have more flexible domestic and international procedures for the recognition and sale of medicines. During the innovative drugs forum, Mikhael Samsonov, Chief Medical Officer of R-Pharma, confirmed that there is no precedent for drugs being made in Russia and exported to Europe. The call for a more open and international pharmaceutical market in Russia seems therefore to be thoroughly justified.
Some positive new steps appear to have been taken recently with the signing of a deal worth more than $4 million USD, between Buffalo based Cleveland BioLabs Inc. and the Russian Federation's Ministry of Industry and Trade, to develop anti-infection drugs.
There was also the recent announcement that Russian pharmaceutical company NovaMedica has opened a US office on November 12.
In 2010, Dmitry Medvedev, the then Russian President, called for further development of the domestic pharmaceutical industry to reduce the country’s dependence on foreign medicines.
One year later, in 2011, Vladimir Putin, then the Prime Minister, reiterated the same hope. He supported the development of medical and pharmaceutical industries saying that Russia should be manufacturing at least half the medical equipment it needs by 2020.
Federal authorities responded with a special program: ‘the Russian government’s 2020 Strategy to encourage growth in the Russian pharmaceutical industry’. The plan aims to support local companies and foster the production of innovative drugs.
In the here and now, the pharmaceutical market is growing in Russia with enormous potential for further domestic development. The Russian pharmaceutical market represents about 3.6% of the European pharmaceutical industry. The Russian sector grew by 17.5%, in 2009 and by the year 2014, it is expected to reach a value of $10.7 billion.
However, Ramil Abdrashitov, Clinical Research Director of AstraZeneca Russia and Ukraine, said on November 21st, during the 3rd International Forum on Innovative Drug R&D, that Russia is far behind other European countries in regard to clinical trials and that Russia is still a long way from achieving full realization of potential growth in the field. The Russian pharmaceutical market presents several structural failings, which are preventing it from developing fully.
First, the Russian pharmaceutical market is quite closed and, according to professionals in the field, it is difficult to bring new medicines to the Russian market. Indeed, at the 3rd International Forum on Innovative Drugs, Svetlana Zavidova, Executive Director of the Association for Clinical Trials Organisations, explained that to be registered, all new drugs in Russia are required to undergo an all-Russian testing process, even medicines that are internationally certified.
This procedure complicates and extends the process of introducing new medicines to the market. Overall, both the pharmaceutical industry and patients are negatively affected. On one hand, in the opinion of Ramil Abdrachilov, it is harmful to the competitiveness of the Russian pharmaceutical sector, and on the other hand, it restricts access to modern drugs and innovative therapies for Russian patients’.
Moreover, there are no international agreements between Russia and other countries on the certification of medicines. Svetlana Zabidova reported that negotiations have, for instance, taken place between Russia and the European Union, though for now, there is still no mutual recognition in clinical trials. Abdrachilov believes that it is necessary to reduce customs tax on the import of drugs, equipment and material for clinical trials.
Major players in the Russian pharmaceutical market would like to have more flexible domestic and international procedures for the recognition and sale of medicines. During the innovative drugs forum, Mikhael Samsonov, Chief Medical Officer of R-Pharma, confirmed that there is no precedent for drugs being made in Russia and exported to Europe. The call for a more open and international pharmaceutical market in Russia seems therefore to be thoroughly justified.
Some positive new steps appear to have been taken recently with the signing of a deal worth more than $4 million USD, between Buffalo based Cleveland BioLabs Inc. and the Russian Federation's Ministry of Industry and Trade, to develop anti-infection drugs.
There was also the recent announcement that Russian pharmaceutical company NovaMedica has opened a US office on November 12.
Source: http://goo.gl/J09tB
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