ARFP requires state support
Topical issues of national production of substances: the position of the Association of Russian Pharmaceutical Manufacturers (ARFP)The situation that has developed in recent months with the rise in prices for medicines has clearly demonstrated the total dependence of the drug market of the Russian Federation on foreign pharmaceutical substances.
Since more than 75% of medicines in our pharmacies are imported, the growth of the dollar inevitably led to an increase in prices for foreign medicines. Russian-made drugs are growing in price at a much slower pace, but, unfortunately, an increase in their cost is also inevitable, because up to 90% of medicines in our country are made from foreign raw materials, which are also purchased for foreign currency.
Currently, the Russian pharmaceutical industry uses about 8 thousand usl. tons of substances per year, of which less than 2 thousand usl. tons are produced by Russian enterprises. For comparison, in 1992, 272 names of pharmaceutical substances were produced in Russia with a total volume of about 17 thousand tons, in particular about 70 different substances of antibiotics out of 90 known at that time. At the same time, the satisfaction of the need for the production of finished medicines in the domestic market ranged from 70 to 100%, and a significant part of the substances were exported. During the period from 1992 to 2007, the volume of production of substances decreased by more than 6 times, and the production of antibiotics stopped completely. Today, less than 8% of drugs sold in the Russian Federation are made from substances produced in the Russian Federation.
This situation makes the existence and development of the domestic pharmaceutical industry dependent on the supply of substances from abroad. It is well known that the independence of the country in the field of providing pharmaceutical substances from foreign manufacturers is a criterion for the implementation of the state security strategy of the Russian Federation.
The decline in the national production of substances is caused by a number of reasons and, first of all, was the result of a gradual decrease in the volume of drug production by local pharmaceutical manufacturers and a subsequent decrease in the need for substances. In addition, the analysis of the structure of the cost of production of substances showed that the largest share in their cost is occupied by the costs of raw materials and materials (about 40%) and fuel and energy costs (about 25%). Thus, in the conditions of a significant increase in prices for raw materials and energy carriers and, as a consequence, an increase in the cost of production of substances, their production at large–capacity facilities existing in the country becomes unprofitable, and in some cases even unprofitable.
The existing imbalance of regulatory requirements in relation to domestic and foreign manufacturers of substances does not contribute to the development of the production of substances in Russia. Thus, for foreign manufacturers of substances, there is only familiarization with the documentation and there is no physical control of the entire production cycle, which domestic manufacturers of substances undergo to obtain a license. Thus, the inequality of requirements results in issues of quality assurance of pharmaceutical substances. At the same time, it should be understood that the leaders in the supply of pharmaceutical substances to the Russian Federation are Indian and Chinese suppliers, whose product quality, as is known, does not always meet the necessary standards.
The existing examples of some ARFP member enterprises producing substances confirm the ability and potential of Russian enterprises not only to produce, but also to develop their own pharmaceutical substances. However, without a state policy to support enterprises producing substances, such examples will remain isolated.
The Association of Russian Pharmaceutical Manufacturers (ARFP) believes that it is strategically important to support full-cycle enterprises producing active substances and take the necessary measures to restore the lost production of substances. At the same time, when solving this problem, it is necessary to take into account that no country in the world has the production of all the necessary substances. It follows from this that, first of all, it is necessary to determine the nomenclature and production volumes of substances for ready-made medicines that are in demand and economically feasible for production in Russia. The state has at its disposal such measures to support the production of pharmaceutical substances as the formation of a state order for the production of pharmaceutical substances according to the approved list, simplification of the registration procedure for domestic pharmaceutical substances, the formation of a preferential tax regime, the abolition of import customs duties and value added tax on the import of equipment for the production of pharmaceutical substances, etc.
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The Association of Russian Pharmaceutical Manufacturers (ARFP) was founded in 2002. The ARFP consists of 16 leading Russian pharmaceutical enterprises, which account for more than 50% of medicines produced in the country, 40% of exports, 70% of domestic medicines in the ONLS program.
The Association's activities are designed to promote the competitiveness of the domestic pharmaceutical industry and promote the integration of the domestic pharmaceutical industry into the world market while maintaining and increasing the production and financial potential of the industry enterprises. ARFP is a member of the Chamber of Commerce and Industry of the Russian Federation, actively cooperates with relevant federal government authorities: the Ministry of Health and Social Development of the Russian Federation, Roszdravnadzor, the Ministry of Industry and Trade of the Russian Federation, the State Duma Committee on Health Protection.
According to the results of 2007, ARFP took 1st place in the nomination "Public Organization" of the Open competition of pharmaceutical market professionals "Platinum Ounce".
Portal "Eternal youth" www.vechnayamolodost.ru according to the materials of the ARFP press service
12.02.2009