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As surprising as this may be, the overall results for the Russian clinical trials market in 2011 can be considered acceptable and on a number of indicators even positive.
The main challenges that market participants faced in 2011 could be attributed to the implementation of the law “On Circulation of Medicines”, either caused by oversights in the legislation itself, or in the practical application of said legislation. These challenges have been resolved over the course of the year. The process of importation of new medicinal products for clinical trials and establishment of necessary guidelines for patients’ insurance have been put in place by the middle of the year, by means of issuing respective government orders. The accreditation of medical organizations had been brought to a breaking point by reason of inability of authorities to issue accreditation certificates within the specified timeframe, but the issue had been resolved just in time to avoid a crisis. Several unresolved issues have been put off to the 2012 agenda — administrative,which are related to the functioning of the regulatory approval system and fundamental–inherently created bythe law “On Circulation of Medicines” itself.
The figures from the Ministry for Health and Social Development over the past year give some hope for the possibility of market growth in 2012. The Health Ministry granted approvals for 567 clinical trials, of which 370 were international multicentre clinical trials. Approvals for 370 of such trials make a record number: never in the entire history of international trials conducted in Russia have so many approvals been given in aparticular year.
Based on 2011 results ACTO has noticed significant growth in the number of local registration studies of generic drugs conducted by foreign companies in comparison with previous years—most likely this can be linked to the requirements of the new law. At the same time, the actual number of local registration trials of innovative drugs conducted by foreign companies stays relatively the same. This may be due to the fact that it is more difficult to commence such type of a trial and more expensive to conduct it. Nevertheless, the first trials are already underway. According to ACTO's figures, international companies are currently conducting 4 local registration trials of innovative drugs in Russia. As for the trials of innovative drugs conducted by Russian manufacturers, in comparing 2011 results with those of 2009, the decline in this segment amounted to 35%. It is possible that this decline is the result of the new law’s intent to build local trials into the registration system, as now it is only possible to commence such trials if you have already launched the registration process.
A separate topic for discussion is the inadequate maintenance of the registry of clinical trials. Pursuant to the order of the Ministry of Health itself, the registry entry must include the name of the protocol and information about the sites. The lack of this information does not allow patients in Russia to choose a trial in which they want to participate. Furthermore, it hinders the ability of the public to evaluate the trials on the basis of which a given medication has been registered. In addition, the Ministry’s decision to use continuous numbering of approvals (previously, numeration was re-set annually), may in the future lead to complications in patients’ trial insurance, as there are only three characters in the individual identification code allotted for the approval number.
Finally, in November, Russian media sources picked up inaccurate information about deaths in clinicaltrials, originally published in the British newspaper The Independent.