Russian government to change rules on public procurement of drugs
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28 August 2013
The Pharma Letter
The Russian government is considering providing permission for the state purchases of essential drugs, in accordance with their brand names, but in line with protection of their chemical formula by patents and the existence of evidences that the drug cannot be replaced by its analogue. Such proposals were recently prepared by the Russian Ministry of Health, Ministry of Industry and Trade and the Federal Antimonopoly Service (FAS).
Currently, public procurement accounts for more than 30% of the Russian pharmaceutical market. In 2012 the value of the segment reached 236 billion roubles ($7.18 billion), with the value of the whole market about 773 billion roubles. At present, all the drugs are purchased in accordance with their international non-proprietary name and price for the same drugs may vary greatly.
As part of state plans, a list of drugs which will be purchased under their brand names will soon be released. It is planned that such a list will be comprised of vital and essential medicines, however not for all, but only for those that have a patent for their chemical formula. This will protect the manufacturers of patented drugs from the purchase of their analogues.
Moves have prompted criticism
The proposal has already sparked comment from critics from some leading Russian observers in the field of pharmaceutical business. According to Vladimir Shipkov, executive director of the Association of International Pharmaceutical Manufacturers, it is impossible to receive a patent for a chemical formula. In addition, according to Mr Shipkov, patented drugs already have exclusive status.
Another way to enter in the list is to prove the impossibility of therapeutic substitution of the drug. It is planned that the right for submitting an application will have both manufacturers of original drugs and generics.
The Russian government believes that successful implementation of these plans will make drugs more accessible to patients and decrease risk of corruption during the conduction of the procedure of public procurement. It is planned that such criteria will be finally approved by the first week of September.
As part of state plans, a list of drugs which will be purchased under their brand names will soon be released. It is planned that such a list will be comprised of vital and essential medicines, however not for all, but only for those that have a patent for their chemical formula. This will protect the manufacturers of patented drugs from the purchase of their analogues.
Moves have prompted criticism
The proposal has already sparked comment from critics from some leading Russian observers in the field of pharmaceutical business. According to Vladimir Shipkov, executive director of the Association of International Pharmaceutical Manufacturers, it is impossible to receive a patent for a chemical formula. In addition, according to Mr Shipkov, patented drugs already have exclusive status.
Another way to enter in the list is to prove the impossibility of therapeutic substitution of the drug. It is planned that the right for submitting an application will have both manufacturers of original drugs and generics.
The Russian government believes that successful implementation of these plans will make drugs more accessible to patients and decrease risk of corruption during the conduction of the procedure of public procurement. It is planned that such criteria will be finally approved by the first week of September.
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