Import substitution in Russian
Medicine is like a syringe without a needle
It is difficult for Russia to solve the problem of import substitution in medicine,
but there are successful examples of thisNadezhda Markina, "Newspaper.
Ru».
It's already getting more expensive and not enoughDespite the strengthening of the ruble, an increase in prices for goods and services is inevitable.
This also applies to medicine: in pharmacies, some medicines have already risen in price by about 8%. Last week to the correspondent of "Gazeta.Ru" had to go around eight pharmacies before he managed to find a drug that previously had no problem. Despite the fact that it all happened in the center of Moscow. Experts are confident that prices will continue to rise, but sharp jumps should not be expected.
There are still enough medicines in hospitals and polyclinics. All the doctors with whom the correspondents of the Newspaper communicated.Ru", agreed that there will be enough stocks of medicines and consumables for the next few months – at least for the first quarter of 2015. And what happens next directly depends on whether the government will revise the health budget.
The authorities are already trying to take some measures, in particular, Deputy Prime Minister Olga Golodets said that the list of vital and essential medicines (VED), the prices of which are regulated by the state, will be expanded in 2015. Nevertheless, the inability to increase the cost of medicines from the list of VED will lead to an increase in prices for other drugs, in particular imported ones.
Now it is 63.5%, but it should be 90%The share of Russian medicines on the Russian market is 55-60% in terms of assortment and 20% in monetary terms.
This is due to the fact that Russian medicines are cheaper.
The medicines that are most and most often in demand are included in the list of VED, which is periodically updated. Now there are 567 names of medicines, of which 16.4% are produced only by domestic manufacturers, 36.5% are produced only by foreign manufacturers, and 47.1% of medicines are produced by both Russian and foreign pharmaceutical enterprises. That is, the Russian pharmaceutical industry produces 63.5% of medicines from the list.
In one of the "May decrees" of 2012, Vladimir Putin set a goal to bring the volume of production of domestic strategically important medicines to 90% by 2018.
According to Larisa Popovich, director of the Institute of Health Economics, this is real if we are talking about medicines from the list of vital and essential drugs. But the director of the Institute of Polio and Viral Encephalitis of the Russian Academy of Medical Sciences, Aidar Ishmukhametov, believes that "it depends on which part of the pharmaceutical market to consider."
"It is impossible to do this in the retail segment, but in the procurement market carried out at the expense of the state budget, the share of domestic drugs in kind is already more than 60%," the expert is sure.
Completely can not be replaced anywhereIn numbers, with domestic medicines, everything turns out to be not so depressing.
But here's what the doctors say.
According to MONICA's therapist Oleg Lischuk, "the possibility of replacing foreign drugs varies depending on the specific area of medicine, but there is no question of complete replacement, in any case."
"The worst is in the areas where the newest, most difficult to manufacture and expensive medicines are used: rheumatology, hematology, transplantology and others," the expert says.
According to him, many key original drugs have not yet expired patent protection, which means that there are no generic analogues of international drugs that have expired patent protection and are produced locally.
"There is not a single field of medicine in which it would be possible to completely replace all imported drugs with Russian ones," Oleg Lischuk summed up.
A special situation with medicines for the treatment of rare (orphan) diseases. The Russian industry does not produce them.
Localization: Russian or not Russian?Enterprises of many foreign pharmaceutical companies are localized on the territory of our country, and experts believe that their products should be considered Russian, even if they are simply packaged in Russia.
Viktor Dmitriev, CEO of the Association of Russian Manufacturers of Medicines, believes that in this case, the share of Russian drugs in value terms reaches 42%.
According to available data, 70% of pharmaceutical companies believe that the current political and economic situation and sanctions have not affected their business in any way. The remaining 13% consider the changes to be positive for business. Another 17% see risks for themselves and intend to reduce investment programs. As many as 53% plan to organize full-cycle production in Russia, including companies in the process of localization of production. The situation has worsened in the last month, but, according to Viktor Dmitriev, it is unlikely to turn the pharmaceutical business away from the Russian market.
"I literally just returned from a meeting with a representative of a foreign pharmaceutical company," he explained to the Newspaper.Ru", – and I can say that all serious players are not going to leave the market."
Consumables will be sent to the expenseThe situation with medical products and medical equipment is depressing.
Moreover, this applies to both complex high-tech devices for diagnosis and treatment, as well as the simplest products.
So, in Russia there are several manufacturers that produce plastic disposable syringes of different volumes, including insulin syringes. But life is not easy for these enterprises. In addition to rising prices for raw materials – polypropylene, they are in a state of fierce competition with the Chinese, who produce very cheap products. Another significant disadvantage of Russian syringes is that they are actually defective, since they are equipped with foreign needles.
There are also problems with components for cardiac operations. "If we talk about stents, coronary and peripheral, then today we have to buy mainly imported ones," he told the newspaper.Ru" Head of the Department of Heart and Vascular surgery of MONICA Alexander Osiev. – There are products of domestic production, but they do not always suit us in quality." This is not surprising – stents have been produced in the USA for a long time, all know-how and patents are concentrated there, and Russia has lagged behind in this regard. "It's like with cars," the surgeon continues. "The only way out is localization of production."
The production of Russian catheters has not yet been established. The situation is especially bad with balloon catheters. Because this is already a high-tech production, in which there are a lot of subtleties.
As for heart valves, in our country they produce valves for replacement on an open heart, according to Alexander Osiev, they are not bad in quality, but endovascular valves that are delivered to the heart through blood vessels exist only imported.
Modern medical devices of foreign production are based on modern technologies that simply do not exist in Russia. This applies to the entire range of products – from the simplest, such as catheters, to diagnostic hardware complexes and surgical robots.
If, in the current situation, the purchase of imported medical devices and equipment, as well as imported medicines, stops, this will lead to a complete collapse of the healthcare system as a whole.
According to experts, it is realistic to replace heart valves with Russian ones, but according to Vakhtang Kostava, head of the Department of Medical Biotechnology at the A.N. Bakulev NC SSH, "foreign competitors have been intensively and successfully using all kinds of ways to primarily promote their products for many decades." Therefore, the domestic manufacturer must be "intelligently" protected at the state level.
Medical equipment: "deep systemic backwardness"All high–tech medical equipment operating in Russian clinics – X-ray machines, tomographs, radiation therapy units - are imported only.
"I work as an X–ray surgeon and operate in different regions of the country and abroad and have not met domestic devices," says Alexander Osiev. - So we need either Philips, or Siemens, or General Electric, or Toshiba – the whole market revolves between these four companies. The same applies to computed tomographs, magnetic resonance imaging and other equipment
If it happens that Russia stops importing medical equipment, then a complete collapse will occur with diagnosis and treatment in the country, experts say. However, they immediately add that there will be a "loophole" through China and Turkey, through which the simplest equipment will pass. But the complex – such as computed tomographs, NMR tomographs, high-quality anesthesia machines – will simply have nowhere to take.
Alexander Osiev believes that the only possible way to have medical equipment in Russia today is to localize the production of foreign manufacturers in Russia.
But to localize such a serious production, conditions are needed – regulatory and tax breaks. Last but not least, foreign companies in another country are attracted by cheap labor. Judging by the devaluation of the ruble and the fall in the level of income of the population, we will have it.
Restrictions against preferencesOne of the methods of solving the problem of increasing the share of domestic medicines is to introduce restrictions on imports.
So, in September, a public discussion was held on the initiative of the Ministry of Industry and Trade to restrict foreign manufacturers in the purchase of medicines. According to Deputy Minister of Health Sergey Kraevoy, this measure is aimed precisely at stimulating the Russian pharmaceutical industry. But the experts interviewed by the Newspaper.Ru", expressed unequivocally – it is better not to impose restrictions, but to use the existing preferences for Russian manufacturers.
If we talk about Russian medicines, then among them there is a certain number of innovative medicines created "from and to" according to their own developments. Thus, the DNA vaccine against HIV, created with the Biomedical Center and produced at the Research Institute of Especially Pure Biological Products in St. Petersburg, is undergoing the second phase of clinical trials. Two other HIV vaccines created at the Institute of Immunology in Moscow and at the Vector Center for Virology and Biotechnology in Novosibirsk have passed the first phase of clinical trials. The second phase of the clinic is also undergoing a drug against HIV, created in the Viriom company of the Himrar Center for Chemical Diversity in partnership with MIPT. But the production of a 13-valent pneumococcal vaccine in the Moscow region is the result of the transfer of Pfizer's production technology to the Russian company Petrovax.
Double standardsPeople want medicines not only to be available, but also to be treated well.
The quality of Russian drugs traditionally causes distrust. Probably, this is not always correct. But in order to qualify for quality, medicines must be manufactured according to the international standards of "good manufacturing practice" GMP. And now there is an even bigger problem with production standards in the country.
Although these standards have been in force in Russia since January 2014, no one can answer how many pharmaceutical companies actually work according to them, because there is no established system of expertise and audit. The head of the Ministry of Economic Development Denis Manturov believes that 80% of domestic medicines meet these standards.
And according to Danil Blinov, CEO of Pfizer in Russia, "attempts to bring the local pharmaceutical industry in line with international standards are failing."
The head of the Association of Russian Manufacturers of Medicines Viktor Dmitriev believes that about 20% of Russian pharmaceutical industries operate according to GMP standards. "But at the same time they produce 90% of products," he added. – So even if the rest of the enterprises are closed, the situation will not change significantly."
India is an example to followNot everyone is so optimistic about the problem of import substitution of medicines.
For example, Russian pharmaceutical expert Dmitry Martynov believes that the main problem of the Russian pharmaceutical industry is that the chemical industry has been killed in the country. "We produce very few chemical substances for medicines," he said "Газете.Ru ". – Even the simplest substances have to be purchased. Even those substances that are considered Russian are actually not Russian, but Chinese or Indian, they come to us under the guise of chemical reagents. To restore the chemical industry at least to the level of the Soviet Union is very difficult, it requires a lot of money. Now in Novocherkassk, where there was a zone of Soviet chemical production, they are going to build a plant for the production of 50 substances. But when will it still work!"
If you look at the examples of countries that have managed to create their own pharmaceutical industry in a short time, the most striking example, according to Martynov, is India, where an incredible breakthrough has occurred in this area over the past 15-20 years. Now India produces almost all generic drugs on its own substances, and their production is not lower than the European level. It was worth the money that the state invested in the development of its pharma. "I know many Indian entrepreneurs," the expert adds, "they know how to work, they are very purposeful."
Alone in the fieldAgainst this hopeless background, there are individual manufacturers who produce high-quality products for the Russian market, and some even sell their products to other countries.
For example, there are manufacturers of small Holter monitors that sell them abroad. There is also very good equipment for instant disinfection – it is supplied in the USA. The problem is that there are few of them and they "don't make the weather."
There are products that are under development, but have not yet passed clinical trials. The same endovascular valves created in the Bakulevsky Center, or "occluders" in the form of an umbrella for closing the left atrium ear and saving patients with atrial fibrillation from stroke. The latter are created in Tomsk, at the Institute of Strength Physics and Materials Science SB RAS, and about them "Newspaper.Ru" said the director of the Institute, Corresponding member of the Russian Academy of Sciences Sergey Psakhye.
Against this background, the difficult "success story" of the medical accelerator for proton therapy of cancer stands out, which was created by physicist Vladimir Balakin, corresponding member of the Russian Academy of Sciences, head of the Physico-Technical Center of the Physical Institute of the Russian Academy of Sciences. Work on it lasted for decades. In early 2014, Roszdravnadzor granted scientists permission to conduct clinical trials.
At the same time, one proton accelerator has already been sold in the USA. Two more American clinics signed a contract with the authors for the supply of accelerators, while Russian scientists won a tender from several world-famous companies. Now Russian physicists are making an accelerator to be sent to Israel.
Portal "Eternal youth" http://vechnayamolodost.ru29.12.2014