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Expert opinion
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Situation in RussiaCritical situation in Russian medical industry1. Pharmaceutical substances production Before 1991 the Russian medical industry was producing more than 3 thousand proprietary medicines providing the population and medical institutions with necessary medicines by product range for 70%, by delivery capacity for 50-60 % , particularly, 58% of cardiovascular medicines, 29% of analgesics, 43% of psychoactive drugs, 45% of oncological medicines, 53% of anti-tuberculosis medicines, 78% of vitamins. The very majority of medicines were produced from Russian substances. The producing companies were providing substances for 70% of all synthetic medicines, 85% of antibiotics, 90^ of vitamins, 100% of immuno-biological preparations. Contrary to the expected tendency, the production of antibiotic substances reduced to begin with 1990 and practically ended by now. There is no strategic reserve of antibiotic substances in Russia for the extraordinary situation, taking into account that extraordinary situation doesn’t mean only military actions. For example, the pandemics of 1918, 1957, 1968 shows that it is possible for 25-30% of the population to fall ill. The flu pandemic of 1918 resulted in more than 40 million deaths. Taking into account the modern speed of migration the pessimistic prognosis for dangerous pandemic is about 100 million deaths. The tragic priority in this sphere is with infectious diseases. Atypical pneumonia, pseudomonas infection , “renovated” tuberculosis and finally the bird flu – we use antibiotics to treat these diseases. But there are no favorable conditions in Russia for producing high-effective antibiotic substances. Besides, during the period of last 15 years Russia has lost the scientific potential of working out and producing antibiotics. The rich collection of microorganisms’ cultures is under the threat of disappearance. The attempts to reanimate the antibiotics production on the basis of Russian technologies worked out some 20-30 years ago are ineffective and evidently inexpedient. To do this Russia needs newest technologies and equipment. The Security Council under the President of the Russian Federation discussed the antibiotics production issue in 2000. The Council authorized the Health Ministry to work out the list of medicines providing the national security of Russia. But such list still doesn’t exist. The Academy of Science discussed the issue, too. The issue was discussed in State Duma. All are well-informed, all know what to do, but still no practical steps. It is possible to solve the problem by buying 2 modern factories turnkey. The conditions can be various – the state builds factories and sells them to private companies. Maybe, the factories can be built under the state and private business partnership. And so, the state can provide the population with its own-made vitamins and antibiotics. (For memory: in 1980s while the discussion about HIV and AIDS prophylaxis was acute Russian authorities took the decision not to invent new technologies for producing single-use syringes but to buy necessary equipment and technologies abroad. Today Russia provides all the population with single-use syringes by its own made. 2. Short Description of today’s pharmaceutical market in Russia In 1990, before the USSR fall there were only 67 chemical-pharmaceutical factories in the country satisfying the requirements by the product range for 30% and by sales volume for 70%. The deficit was compounded by the cooperation with socialist states and buying medicines from India and other stases. Nowadays there are more than 600 specialized enterprisers in Russia have a license allowing producing medicines. The situation reminds of the situation in early 1990s, when the authorities considered the medical industry as the branch which is not important for the state. These years the share of producing medicines in Russia reduced till 30%! The situation began to change after the adoption of the Russian Government Resolution ¹ 890 aimed at the state support of the industry. But we must admit that the Russian pharmaceutical market is now more and more import-oriented. In 1998 Russia was importing 40% of all consumed medicines, today - about 70%. At that, the export is eligibly small – about 5 million USD. 3. The technical and scientific level and the quality of domestically produced medicines During 15 last years the difference between the quality and effectiveness of Russian and foreign made medicines has enormously increased. The medicines produced within that period was in fact the models of western technologies, there was no one principally new medical product. Today there are no new technologies worked out. The state doesn’t invest into the industry as well as private companies. The reasons for that are as follows: 1. The former research institutes working out new medicines don’t exist anymore. 2. The factories producing the medicines substances have transferred to the production of patent medicines. So the technological basis disappeared. 3. The lack of state control over foreign investors in Russia brakes the implementation of new technologies and equipment necessary to produce new medicines. For example, the ICN Company (USA) has bought 5 leading factories producing patent medicines. But the company not only didn’t modernize the production but only was fleecing the rest of the profits. The Russian company “Farmstandart” bought now these semi-destroyed factories and tries to modernize it. But 13 years have gone for ever. 4. The state program “The development of the medical industry for the period till 2005” was stopped in 2000. 4. The Implementation of GMP in Russia within the medicines production Today there is not any technical basis in Russia allowing to transfer all enterprises producing medicines to the GMP standards. But in 2000 there were universal requirements and an equal choice: - to recognize the impossibility to provide the GMP standards in producing medicines and change completely the business - to concentrate the production at the most perspective directions which can be raised to the level of pre-determined requirements - to maximize efforts and to reach the level of 2005 according to the GMP requirements The enterprises able to evaluate the situation correctly, having taken necessary measures within the GMP standards, providing high quality of medicines have the right to discuss publicly and openly the question of the equal distribution of possibilities in the Russian market. 5. Is the GMP standard real today in Russia? The decision of GMP standard implementation can be realized today in Russia if no one ruins it with demagogical statements. About one hundred stable enterprises in Russia provide 90% of the Russian pharmaceutical market in the country, but only 20% respond to the GMP requirements. At that, they show the 30-40% (60% at maximum) productive ability, i.e. have enormous reserve. About 600 enterprises produce 10% of the whole volume and work practically out of control, being too far from the modern requirements and practical standards. Today Russia doesn’t’ need 600 poor enterprises producing medical substances. We need 40 enterprises equipped with modern technologies according international standards and a wide assortment of high-effective medicines. We have to take account that the objectively necessary number of enterprises united within the effective association of producers, will create the necessary conditions for quality management and control in producing medicines and coordinating efforts at the market. One of the most important aspect of the Russian medical industry development is its supply with medical instruments. 6. Medical instruments production In days of old, Russia was able to provide itself with the domestically produced medical instruments. Today there are only two factories producing medical instruments – MIZ-Vorsma in Nizhny Novgorod region and Tumbotino in Nizhny Novgorod region. There is no need to remind that there is no single medical institution or physician able to fulfill its functions without medical instruments. During 3 last years the situation at the Russian market of medical instruments has worsened considerably. One of the most important reasons for this – dumping import deliveries of the medical instruments from abroad, first of all, from China and Pakistan. At the same time one can affirm that most of medical instruments produced in Russia responds to the adopted international level. For example, the medical equipment and instruments produced by “KMIZ” factory in Kazan, MIZ-Vorsma in Nizhny Novgorod region and other factories are certified by the corresponding European organs. It gives these factories the possibility to export medical instruments, particularly, to the European countries. But we must admit a very strange situation about importing foreign made medical instruments into Russia. Many Moscow and regional certification centers, having now means for comparison and control give foreign companies permissions for importing and selling the mediocre medical instruments. The situation is being worsened because of one more reason – the variation in prices between foreign made and domestically made medical instruments is really enormous. Keeping the domestic industry producing medical instruments is the issue of national policy and national position for Russia. The today’s policy towards the Russian producers of medical equipment and instruments will bankrupt them and Russia will loose unique technologies and, what is most important, excellent masters knowing the professional secrets of production. It is impossible for the Russian health services to develop using foreign made medical equipment. Conclusion: 1. In the sphere of the deliveries of pharmaceutical substances (especially, antibiotics) and medical instruments Russia got into dependence of foreign producers. 2. In case of extraordinary situation, such as the war, pandemic etc., if the importation of antibiotics or medical instruments is prohibited, the Russian health protection system will not be able to protect the people. 3. It is necessary to create at the legislative level the National pharmaceutical doctrine which must be a part of the national project “Zdorovje” (The Health). 4. It is also necessary to discuss and solve the problem of buying some factories “turnkey” to begin the production of the pharmaceutical substances, especially, antibiotics. 5. To include the enterprises producing antibiotics and immunologic substances into a list of strategic Russian objects. 6. To exempt modern enterprises of the medical industry from income tax paying for the period of 10 years. |
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Expert opinion
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