Mifo-pharma
Pharmaceutical substance
In the pharmaceutical industry there is no scientific groundwork to improve the level of technology
Haidar Chibilyaev, Nezavisimaya Gazeta, 12/28/2011
About the author: Haidar Shikhapovich Chibilyaev – Candidate of Pharmaceutical Sciences, Honored Chemist of the Russian Federation, former chief engineer of the All–Union Industrial Association Soyuzlexintez, head of the Technical Department - member of the Board of the Ministry of Medical Industry, head of a group of Soviet specialists in the construction of a plant of medical products in India, veteran of the Great Patriotic War.
In July of this year, at a meeting with participants of the All-Russian Popular Front, Minister of Industry and Trade Viktor Khristenko promised to make a breakthrough in pharmaceuticals by 2015 and produce 90% of the necessary medicines.
Pharma by decree
Modern medicine is impossible without medicines. That is why providing the population with affordable high-quality medicines is one of the most important tasks of the welfare state. Preventing diseases and prolonging active life, preserving and strengthening the health of citizens is the basis of economic stability and national security of the country.
The need to develop the production of medicines and medical equipment is emphasized in the "Concept of National Security of the Russian Federation", approved by Decree of the President of the Russian Federation No. 1300 dated 17.12.1997. The section on ensuring national security establishes one of the primary tasks in the field of protecting and strengthening the health of citizens – "the implementation of state protectionism in the domestic medical and pharmaceutical industry."
In another Decree of the President of the Russian Federation dated 12.05.2009 No. 537 "On the National Security Strategy of the Russian Federation until 2020", this issue is raised even more responsibly: "One of the main directions of ensuring national security in the medium term is food security and guaranteed supply of highly effective and affordable medicines to the population. In order to develop the pharmaceutical industry, conditions are being formed to overcome its dependence on foreign suppliers for raw materials."
Unfortunately, the tasks defined by the Concept and Strategy of the National Security of the Russian Federation are not being implemented effectively enough. A lot of time has passed since the entry into force of these documents, nevertheless, during this period, the dependence of domestic production of medicines on imports of foreign pharmaceutical substances has increased even more, and above all from countries where the medical industry was created with the help of research and design organizations of the Soviet Union.
Due to the lack of adequate measures aimed at implementing presidential decrees, the problem of organizing and developing the production of pharmaceutical substances remains very relevant. Probably, the reason for this situation was a misunderstanding by some high-level officials of the specific features of the pharmaceutical industry.
Pharmaceutical substance is the main component of a medicinal product, due to which its therapeutic effect is realized. The synthesis of a pharmaceutical substance is the most time-consuming and expensive stage of production. In addition, this stage requires an understanding of the features of fine organic and biochemical synthesis. In part, this is the reason for the deplorable state in which the pharmaceutical industry in Russia is located today.
Private pharma
Due to the uncontrolled privatization of state property in the early 90s, pharmaceutical enterprises fell into the hands of private individuals who do not have the appropriate qualifications and experience in this field. As a result, the production of pharmaceutical substances by domestic manufacturers was almost completely stopped, which, in turn, led to an increase in the share of imported medicines on the Russian market to 75-80% in 2010.
According to the statement of the heads of state, the aim of the privatization of pharmaceutical enterprises was the modernization and improvement of the technical level of production due to deductions from the profits that these enterprises receive in excess of the norm. At the same time, the people were assured that such measures would solve problems with the budget and at the same time improve the quality of medicines. In fact, the banal purchase and sale of strategic state property objects pursued a single goal - to make ends meet in a collapsing economy in any way.
At the same time, over the past 20 years, the scientific and experimental base of the pharmaceutical industry created in Soviet times has been destroyed. The personnel of scientific and engineering-technical workers in the field of fine organic synthesis of pharmaceutical substances and biotechnology of antibiotics has been lost.
Created in the 1920s-1980s, 12 branch research and design institutes, including the Center for the Chemistry of Medicines and Antibiotics, without receiving financial support from the state, went bankrupt and ceased their activities for the development and introduction of new medicines, technology improvement, and examination of regulatory and technical documentation. As a result, currently there is practically no development of new medicines in our country.
Planning the transition of the pharmaceutical industry to an innovative model by 2020, the heads of the Ministry of Industry and Trade note that it is applied industry science that will receive a significant impetus for development. Then the question arises: why was it necessary to destroy the branch scientific base that had been created for many decades?
Mifo-pharma
In February 2011, the Chairman of the Government of the Russian Federation approved the federal target program "Development of the pharmaceutical and medical industry of the Russian Federation until 2020 and beyond". Of the main strategically important measures aimed at the technical re-equipment of the remaining Russian pharmaceutical enterprises and the construction of new plants, attention should be paid to six tasks of the target program that are not materially and technically secured for their real implementation by 2020.
1. Technological re-equipment of the production capacities of the domestic pharmaceutical industry to an export-capable level.
2. Creation of scientific and production potential for the production of competitive products.
3. The release of strategically important medicines, vital and essential medicines by the domestic pharmaceutical industry (by the way, there are no such names of medicines in the glossary of terms).
4. Introduction to the market of innovative products manufactured by the domestic pharmaceutical industry.
5. An increase in the export potential of the domestic pharmaceutical industry by eight times compared to 2010.
6. Personnel support for the transition of the domestic pharmaceutical industry to an innovative development model.
It is extremely difficult to imagine how 85-90% of production capacities for the synthesis of pharmaceutical substances, liquidated in 1990-2000 and still not restored, can be re-equipped and even more so modernized. For example, the production of anti-tuberculosis and psychotropic drugs previously produced in the country, antibiotics and sulfonamide preparations, X-ray contrast agents, vitamins, etc. has been discontinued.
The state farm arable lands on which medicinal plant raw materials were grown for the production of medicines were sold off after privatization and in most cases built up with cottages and suburban areas. But this raw material was used to produce alkaloids, which are part of many dosage forms. Tinctures and extracts widely used in pediatric practice, as well as other medicinal forms based on plant components, were made from some plants. This means that Russian producers will need to buy raw materials abroad in the future, which means that the dependence on raw materials will also remain.
Failure to fulfill the first two tasks of the federal target program practically excludes any possibility of the "people's front-line soldiers" making a breakthrough in pharmaceuticals that could ensure the production of 90% of the necessary medicines by 2015. This statement by the head of the Ministry of Industry and Trade and the support of his deputy chairman of the State Duma is a kind of stupefying myth of "Khrushchev communism".
On the left: The production of medicines is a complex technological process.
On the right: a workshop for manual packaging of medicines of one of the Russian enterprises.
In the West, this is rarely seen.
Photo PhotoXPress.ru
Engineering Pharma
Since the pre-war period and until 1990, several industries have been engaged in the production of medicines in our country. At the same time, almost 90% of the total output was provided by the enterprises of the Ministry of Medical Industry. The main suppliers of raw materials, intermediates, pharmaceutical substances and certain types of packaging materials for chemical and pharmaceutical enterprises were factories of more than 10 industries.
Today, most of them are not functioning or need to be restored. The federal target program does not define the objects of new construction, taking into account the provision of their labor and infrastructure resources, there are no tasks for the production of medicines at the remaining enterprises due to their technical re-equipment, there are also no plans to expand existing and create new production facilities.
It should be borne in mind that at present, due to the liquidation of branch institutes in the pharmaceutical industry, there are no scientific reserves to improve the level of technology. However, it is unacceptable to create and expand pharmaceutical production based on the preserved technological documentation. Over the past 20 years, the level of hardware and technological design of the process of obtaining many pharmaceutical substances abroad has increased by 15-30%. In such a situation, domestic substances will be uncompetitive and raw material dependence on foreign suppliers will only increase.
The point of the program concerning the release of "essential" medicines in order to replace imports makes us wary. Currently, several thousand names of medicines are imported to Russia. The task of recreating the production of at least half of the drugs from this list from scratch in such a short period of time looks too ambitious.
Wouldn't it be more reasonable to define a list of the most necessary generics, the production technology of which could be reproduced in a short time and at a lower cost? It may be necessary to provide for the purchase of licenses for certain medicines and pharmaceutical substances. This question, like many others, remains unanswered.
Another important feature of the pharmaceutical industry that remained in the program without due attention is the need of enterprises for highly qualified personnel. Due to the complexity of the production process, the explosion hazard of production, the complexity of the equipment used, on average, every sixth employee of the industrial and production staff has an engineering and technical specialty, which is significantly more than in such industries as chemical, food, etc.
For example, in the VPO "Soyuzlexintez" the level of engineering work in the personnel structure in 1986 was 18% of the total number of personnel working in production. The number of specialists in 5 thousand people provided for in the program to meet the needs of the pharmaceutical industry is not enough to ensure even the most important thing – the production of pharmaceutical substances. Previously, the bases for the internship of young specialists were organized in the production of pharmaceutical substances. To date, such databases simply do not exist.
Pharma that treats
Another point of the program that attracts attention is the intention to create 97 innovative medicines in the foreseeable future. Even without taking into account the destroyed scientific base of the pharmaceutical industry, such a plan is hardly feasible. According to statistics for 1978-1987, the period required to create a new drug is from 8 to 12 years. Of course, science does not stand still, and today this process takes less time. But still, 97 new drugs in such a short period is an impossible task even for countries with a highly developed pharmaceutical sector.
Thus, the program, which should lay the foundation for the restoration of the pharmaceutical industry, contains many contradictions and shortcomings. The absence in the program of adequate measures necessary for the revival of the scientific industry base, the creation of highly qualified personnel and overcoming dependence on raw materials from foreign suppliers, the impracticability of the stated tasks – all this speaks only about the misunderstanding or ignorance of the officials responsible for drafting this document, the specifics of the pharmaceutical business.
It can be assumed that specialists with knowledge and experience in this field did not participate in the preparation of the program at all. It is difficult to explain the frequent use of the terms "breakthrough" and "throw" in the speeches of top-level officials in relation to pharmaceuticals. Apparently, they want to emphasize the upcoming grandiose transformations in the now destroyed chemical and pharmaceutical industry.
It should be noted that "breakthrough" and "throw" imply one-time, short-term efforts that have a clearly limited time interval. Such rhetoric is more appropriate in sports or in the field of military art. There is no need to set records or fight with anyone in the chemical and pharmaceutical industry. Unlike many other industries, pharmaceuticals has evolved throughout history through the gradual and continuous introduction of scientific achievements.
It is quite obvious that this trend should continue in the future. Systematic, permanent transformations are needed, aimed at technical re-equipment and modernization of existing production facilities, as well as the construction of new enterprises with proper production and social infrastructure. Only such measures can achieve a high level of pharmaceutical development, but this will require a period significantly exceeding five to seven years. In this regard, the possibility of fulfilling the tasks stated in the federal target program by making a "throw" and "breakthrough" looks very unrealistic.
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28.12.2011