18 March 2008

Will Russia be able to reduce its dependence on imported medicines?

Before and after mealsTatiana Zykova, Rossiyskaya Gazeta, 18.03.2008.

It is expected that in March the government will decide on the development of a strategy for the development of the domestic pharmaceutical industry until 2020. It should be ready by the end of this year. Its content will determine whether Russia will remain a large counter for the sale of imported medicines or will enter the pool of world manufacturers for their development and release, that is, it will have time to jump on the outgoing train and take a leading place in certain segments of the global pharmaceutical industry.

Today, 80 percent of vital antibiotics, insulins, cardiac and oncological drugs are imported into Russia from abroad. And even medicines produced domestically are made from Chinese and Indian substances. The leading market players, taking advantage of the situation, dictate their conditions to the state for the purchase of certain medicines. As a result, the cost of medicines is increasing. Nevertheless, according to the analytical agency RMBC, it is impossible to talk about "significant budget losses on import purchases". According to analysts, "the range of Russian medicines is so small that if, for example, under the program of additional drug provision (DL), all possible foreign drugs would be replaced by currently available Russian analogues, the savings would not exceed 10-15 percent." And then, are Russian consumers ready today to abandon, for example, Swiss pills in favor of Russian ones?

A script without a directorRecipes for resuscitation of the domestic pharmaceutical industry were recently exchanged by the participants of the "round table" held at the Ministry of Industry and Energy of Russia.

Several possible scenarios of state support for the industry were announced. Some of them were proposed by members of the expert club on foresight (scientific method of foresight), which includes doctors, heads of private and public pharmaceutical companies, scientists, economists.

So, what are these scenarios? The first is to attract foreign companies to produce medicines in Russia. This is the so-called "automobile". Two years ago, with the help of the preferential industrial assembly regime, the Russian government attracted almost twenty of the world's leading automakers to the country. This scenario is "the most promising", according to the head of the Expert Club, Deputy Chairman of the Coordinating Council for Long-term Forecasting of the Ministry of Industry and Energy Georgy Afanasyev.

The authors of this version propose to actively invite leading foreign pharmaceutical manufacturing companies producing innovative drugs of new generations to Russia. The authors assure that the Russian industry will not master them today, since the cost of developing one original drug reaches up to $ 1 billion. It is also expensive to buy, especially for state programs – in five years the average price of such drugs has more than quadrupled.

The second scenario is the creation of a state corporation in Russia based on the consolidation of state ownership in the pharmaceutical industry. According to the third, the bet is on financing the development of new domestic drugs, their patenting and sale to foreign manufacturers for introduction into production and promotion on international markets.

The fourth option is "packaging", perhaps the most inertial, when ready–made dosage forms are imported into Russia, brought to "mind" and packaged in boxes.

Of the four scenarios, none received a "majority of votes". The participants of the "round table" reacted extremely coolly to the first, "automobile" scenario. They motivated this by the fact that buying a car is the choice of a future car owner, and in the pharmaceutical market, a doctor does it for a patient. And this choice will be "clearly not a market one", given the strong commercial influence on the medical community of various drug manufacturers.

Meanwhile, many foreign companies are already trying to settle in Russia by themselves. Someone buys a ready-made business, someone builds their own production sites or transfers the production of individual drugs to Russian factories. But, according to the heads of domestic companies, foreign medicines produced in Russia are not becoming cheaper and more accessible to Russians. Moreover, in their opinion, the revival of the domestic pharmaceutical market has nothing to do with it, since foreigners exclusively produce all drugs based on their licenses and technologies. "Tomorrow, the owners of these companies will say, we don't need penicillin, we will sell Viagra. And then what to do?" – the interlocutors of "RG" are worried. As a result, we agreed that it is much more reasonable to build new pharmaceutical plants both in Russia and abroad. But this, according to the participants of the discussion, is also a big problem for now: investments in the creation of a pharmaceutical enterprise start from $ 50 million. Nevertheless, according to Sergey Tsyba, Director of the Department of Chemical and Technological Complex and Bioengineering Technologies of the Ministry of Industry and Energy of Russia, the state should actively promote the creation of pharmaceutical plants in Russia, including to ensure national drug safety. "This issue will be actively discussed," Tsyb stressed. But the representative of the Ministry of Industry and Energy tried not to comment in detail on the idea of creating a pharmaceutical state corporation in Russia at the round table. To the question of the correspondent of "RG", how do the developers of the future strategy assess the prospects of such a corporation, Sergey Tsyb said: "First of all, we need to answer the question "why"? That is, for what purpose it needs to be created and what prospects it will have in the domestic and foreign markets. Then answer the questions "when" and "how". Later, in a private conversation, one of the officials participating in the round table noted that "the state corporation in pharmaceuticals is a possible engine for the development of the industry, and Brazil and many other emerging markets have now taken this path." Opponents "from business" reacted to the possible appearance of a powerful competitor on the market without enthusiasm, calling the state corporation a "mass grave". However, a short "behind-the-scenes" dispute once again exacerbated the essence of the problem - the discussions ahead are tough.

The third scenario, which provides for financing the scientific development of new original drugs, was generally considered difficult to implement, at least in the short term. According to experts, international companies will not take our original drugs even for clinical trials, since everything that the Russian pharmaceutical company produces does not comply with the world standardization system. In addition, representatives of domestic business are extremely doubtful about the possibility of creating "turnkey" new original Russian drugs.

"Pharmaceuticals is the riskiest industry in terms of investments – it is not always possible to "repel" them, that is, to create such medicines that will be in demand. And neither business nor the state are ready to take risks on multibillion–dollar projects," the head of one of the pharmaceutical companies warned. However, the third scenario has a more real twist, experts say. For example, the participants of the discussion were very impressed by the possible financial assistance of the state for the acquisition of foreign licenses that have expired for the production of medicines at domestic plants. "This is the shortest and least expensive way. One such license will cost not billions of dollars, but from 5 to 20 million dollars," experts say. That's just on what principles and which of the market participants will receive these licenses, it remains unclear.

The results of the discussion were summed up by Stanislav Naumov, Director of the Department of Economic Analysis and Long-term Planning of the Ministry of Industry and Energy. According to him, in Russia today, small and medium-sized enterprises are engaged in scientific and commercial developments in the field of pharmaceuticals (they account for up to 70 percent of developments), and large academic institutions, and private pharmaceutical companies. "The only thing that is clear so far: any government programs should go through the integration of all these companies, through reducing the gap between drug development and their commercial implementation. So the state hopes to see corporate players in this market as partners, and with their own scenarios," Naumov stressed.

Mutation of the pillMeanwhile, the complexity of the issue is also that the strategy should be projected onto the so-called global "roadmap" of health biotechnology.

And preferably - for 20 years ahead, Georgy Afanasyev noted. That is, specialists must understand what will happen in the world after 2020 in the field of pharmaceutical production. In 12 years, according to him, the emphasis will be placed on non-medicinal pharmaceuticals, that is, humanity will gradually move from fighting diseases to expanding the biological capabilities of the human body. And new sensational super-developments in the field of decoding the genomes of various viruses and the human gene code can generally change both diagnostics and methods of treating diseases, which, accordingly, will turn over pharmaceuticals. And from the production of medicines on an industrial mass scale, it will move to the production of "individual" dosage forms, taking into account the characteristics of the patient. "Such serious global challenges cannot be ignored. Russia should not miss the stage of creating new generations of medicines," Afanasyev said. Moreover, abroad today, the entire infrastructure that ensures the transition from scientific developments to prototypes of medicines is intensively funded by foreign governments."

It was decided that following the results of the round table, a section of the pharmaceutical industry will be created within the framework of the Coordinating Council for Industrial Energy Foresight of the Ministry of Industry and Energy. The Ministry of Health and Social Development has also organized a platform on its website to discuss the concept of healthcare and the development of pharmaceuticals in the country. So the discussion continues. And the question of the future of the domestic pharmaceutical industry remains open.

Portal "Eternal youth" www.vechnayamolodost.ru18.03.2008

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