Russian pharmaceutical production ordered to expand and deepen
National PHARMA Strategy 2020: expert opinionsParlComm
The Ministry of Industry and Trade of Russia has approved a Strategy for the development of the pharmaceutical industry for the period up to 2020 ("PHARMA 2020").
According to the text of the Order of the Ministry of Industry and Trade of Russia dated 23.10.2009 No. 965, "the main goal of the strategy is to increase the internal and external competitiveness of domestic industry, which should lead to an increase in the provision of the population of healthcare institutions with medicines of domestic production."
Among the important objectives of the strategy is to increase the share of domestic products in the domestic market to 50% in value terms by 2020. PHARMA 2020 assumes a change not only in the quantitative, but also in the qualitative characteristics of Russian medicines: an increase in the share of innovative drugs in the portfolios of local manufacturers is planned to increase to 60% in value terms. Special attention will be paid to stimulating the organization of production of pharmaceutical substances in Russia to ensure the production of 50% of finished dosage forms in monetary terms, including at least 85% of the nomenclature from the list of strategic medicines.
According to the head of the Ministry of Industry and Trade Viktor Khristenko, "we are setting very ambitious goals: by 2015 to conquer more than half of the domestic market of general medicines and innovative drugs, as well as to increase eight times the volume of exports of Russian pharmaceutical products and medicines." According to market experts, the need for radical changes in the pharmaceutical industry is obvious, but there are serious doubts about the achievability of most of the strategy's goals. Specialists are also confused by the emphasis on the growth of cost, rather than natural indicators: after all, the share of domestic medicines can now be increased by simply raising prices.
In general, as experts note, such a program is necessary, even with some utopianness of its main provisions. Otherwise, the share of imports will grow and will reach 90% in the next 10 years. "Of course, there is a danger that a number of provisions of the strategy will not be implemented or not implemented as intended," said Nastasia Ivanova, director of the National Distribution Company. "For example, an increase in the share of medicinal products of domestic production to 50% in value terms will be achieved, but mainly due to inflation and an increase in their cost." So, in general, the implementation of such ambitious goals raises certain questions. "Firstly, it is unclear whether the Ministry of Industry and Trade will receive such serious financing - investments should amount to almost $ 6 billion over 11 years, that is, $550 million a year, and the state will have to take over the bulk of these costs," Ivanova continues. "Secondly, the very possibility of creating original Russian drugs in such a short time seems unlikely."
According to Ivanova, in Russia today, the research and experimental base has been almost completely destroyed, in particular, in some industry research institutes, equipment wear reaches 80-90%. There are about 650 different pharmaceutical industries operating in the country, but no more than 10% of them are fully or partially equipped according to international product quality standards (GMP). Accordingly, the medicines manufactured by them are not able to compete with foreign ones. There is an obvious high shortage of qualified, highly intelligent and motivated personnel. Corruption and the current legislation cannot be discounted, these reasons are in many ways a significant barrier to the creation of an innovative domestic pharmaceutical industry.
The editor of the pharmaceutical portal Pharm-MedExpert also points out the difficulties in implementing the strategy.En Ivan Danilov. "As a rule, Russian drug manufacturers do not invest in innovative developments, because they do not have the financial means to do so," the analyst explains. – Today, the average price of developing one new drug is $ 800 million, and according to forecasts, this amount will soon exceed $ 1 billion. For example, the PHARMA 2020 strategy for the period from 2009 to 2020 includes only $3.5 billion for the development of all new Russian medicines. In addition, it is necessary to solve a lot of other issues, since the development of innovative domestic medicines is hindered by the complex and multi-stage registration procedure for new medicines in Russia, which lasts from 3 to 5 years."
In general, according to experts, the strategy correctly describes the difficult state of the domestic pharmaceutical industry. The forecasts are disappointing: in the next decade, Russia will remain a country that does not produce its own medicines, but reproduces generic medicines. According to research, the share of registered generics in our country is 78-80%, while in the USA it does not exceed 25%, and in Japan – 20%. Of course, with the planned financing and the successful implementation of at least part of the tasks proposed by the PHARMA 2020 strategy, the situation in the industry will improve. However, at the moment, the Russian pharmaceutical market has nothing to boast about, except for a good growth potential – since 2003 it has been steadily gaining 10-12% in ruble equivalent. The planned market volume by 2020 is 1-1.5 trillion rubles.
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29.10.2009