12 January 2009

Strategic Pharmacology

The strategic role of the industry in ensuring the national security of the countryS.A.ROMANOVA, Soyuzmedprom Association, Remedium,

B.M.KHABENSKY, Ph.D., Soyuzmedprom Association
Remedium magazine No. 4-2008

At the meeting of the Chairman of the State Duma of the Russian Federation Boris Gryzlov with the head of the Federal Agency for Health and Social Development Yuri Belenkov on October 29, 2007, the speaker of the State Duma noted the problem of dependence of Russian healthcare on imported medicines. "The domestic industry practically does not produce pharmaceutical substances, 80% of the funds allocated to finance the DLO program go to the purchase of imported medicines. The need to develop a concept for the development of the domestic medical industry has long been overdue. I consider this a matter of national security," the State Duma speaker said.

Dependence on imports is the main threatEveryone knows that no country in the world produces a full range of drugs, but each of them tries to ensure that the ratio of domestic and imported drugs is at the level of 70:30, because to ensure the national security of the state, the share of domestic drugs should be at least 70%.

What is happening in the domestic market of medical products? We can assume that the Russian pharmaceutical market is developing very dynamically, but, unfortunately, due to the import component. According to expert assessment, domestic manufacturers produce less than 25% of the pharmaceutical market volume. In addition, the share of modern highly effective drugs in the structure of domestic drugs by assortment is extremely low.

The state of the domestic market of medical devices did not cause optimism until quite recently either. But thanks to the implementation of the national project "Health", the situation has changed significantly. According to various experts, the share of imported products in this market decreased from 70% to 55-60%, and domestic products respectively increased from 30% to 40-45% of the market volume in value terms. As for the Russian market of medical instruments, currently only 20% is accounted for by domestic medical instruments. Russia, which has a high scientific and technical potential in the field of creating these products, which meets the latest methods of diagnosis and treatment, is losing its position in this direction today. The domestic manufacturer is in a critical situation today, since it is practically impossible to update either the material and technical base or the range of products. The intensive introduction of cheap but low-quality medical instruments from China, Pakistan and other countries into the Russian market leads to a decrease in demand for domestic medical equipment, and, consequently, to the displacement of imported domestic products.

Thus, the growing dependence on the import of medical products exceeds all permissible limits. In such a situation, the occurrence of extraordinary circumstances (wars, epidemics, natural disasters, terrorist acts with the use of biological weapons, etc.) can lead to catastrophic consequences. In addition, such dependence creates conditions for the penetration of low-quality products into the domestic Russian market that can cause serious harm to human health.

In order to reduce dependence on imports and increase national security, it is necessary to constantly regulate and improve the regulatory framework in the field of production and control of medicines. The strategic policy of the state should be aimed at creating a high-tech industrial complex that meets international standards. It is necessary, first of all, to direct efforts to restore the production of pharmaceutical substances, the development of new technologies that ensure the production of competitive drugs and medical products that meet international quality standards and can replace imported products on the domestic market.

State regulation of the industry is the key to national securityIt can be considered that a new stage for the industry, or rather the pharmaceutical industry, began with a meeting with the First Deputy Prime Minister of the Government of Russia D.A.Medvedev on 22.03.07, where it was decided to prepare an action plan for the development of the Russian pharmaceutical industry.

Following its results, an interdepartmental working group was created with the participation of specialists from the Ministry of Industry and Energy of Russia and the Ministry of Economic Development of Russia, as well as heads of large pharmaceutical enterprises and associations. Already at the end of 2007, the Department of Chemical and Technological Complex and bioengineering technologies was created in the Ministry of Industry and Energy of Russia, where the state strategy for the development of the industry, the main directions and measures of state support will be developed.

Among the main directions of development , it is necessary to highlight the following:

  • Restoration of the production of pharmaceutical substances.
  • Development of production of highly effective drugs within the framework of import substitution for the treatment of socially significant diseases: cardiovascular, pulmonary, oncological, endocrinological, neuropsychiatric, allergic, infectious, including viral infections, etc.
  • Development of the production of disposable and reusable medical instruments, as well as other groups of medical products, where it is possible to replace imported domestic products.
  • Quality and safety of medical products.
  • Stimulating innovation and investment processes in the industry.
  • Legislative regulation of the medical industry.

Production of pharmaceutical substances – the basic sub-industryInefficient state policy in the field of medical industry has led to the fact that the domestic pharmaceutical industry, the basis of which is the production of medicinal substances, practically no longer exists.

And the proof of this is the numbers. In 1992, 272 types of pharmaceutical substances with a volume of 17.5 thousand tons were produced in Russia. Substance-producing enterprises provided 70% of the need for substances for the production of synthetic medicines, 85% for antibiotics, 90% for vitamins, and 100% for immunobiological preparations for the production of GLS. At the same time, many domestic substances were exported to foreign countries. Over the past 15 years, the total production of substances in the nomenclature has decreased by more than 3 times, and in physical terms – by almost 18 times, including substances of synthetic drugs – by 12 times, antibiotics – by 100 times, vitamins – by 500 times. From year to year, the withdrawal of capacities for the production of substances is carried out. The average annual production capacity for the production of pharmaceutical substances as a whole has decreased by almost 6 times since 1992, including synthetic drug substances – by 5 times, antibiotic substances - by 13 times, vitamins – by 30 times. At the same time, the capacity utilization coefficient at a number of enterprises has reached such a value that their operation is already inefficient. At the same time, the average level of production capacity utilization for the production of substances in general is about 17.5%, including synthetic drugs – 18.3%, antibiotics – 9.6% and vitamins – 4.6%. This indicator is significantly higher in the production of finished drugs: in packages – 69.6%, in ampoules – 68.9%.

In order to reduce dependence on imports and strengthen national security, it is necessary to develop production facilities for the production of pharmaceutical substances based on modern high-tech technologies capable of producing GLS that are competitive in the domestic and foreign pharmaceutical markets.

Drug production: priority areas of developmentCurrently, the issue of the need to strengthen the role of the state in the pharmaceutical industry of Russia is very acute, only this will guarantee the provision of strategic medical products to the population and health authorities, interruptions in the supply of which may threaten the security of the country.

With the dynamic growth of the pharmaceutical market in Russia, the share of drugs of domestic production is decreasing from year to year. There are about 600 enterprises operating in the industry, more than 90% of them are non–state owned. To begin with, it is necessary to define the concept of a Russian manufacturer. There are many different definitions and classifications of Russian manufacturers. The simplest definition is a pharmaceutical company that produces drugs on the territory of Russia. Of interest is the classification by the origin of capital (foreign, Russian) and the range of the business model used. Here we can conditionally distinguish 4 main groups:

  1. Russian leaders are a limited number of successful Russian companies (Pharmstandard, OL) that have the necessary resources for further development.
  2. Undecided – most of the other Russian pharmaceutical companies.
  3. A Russian contract manufacturer is a rare example of Russian enterprises specializing in the provision of production services (Sotex).
  4. Strategically independent business units with foreign capital are Russian manufacturing companies with foreign capital that have significant potential for development. The market strategy is determined by them to a large extent independently. At the same time, several elements of the business model have been developed (Nizhpharm, Makiz-Pharma, Akrikhin).
  5. Foreign production asset – production units of foreign companies that do not have an independent market strategy. They are often managed by the parent company (Gideon Richter-RUS, Hemofarm, KRKA).

Currently, the pharmaceutical industry produces about 3,000 names of drugs, most of which are obsolete generics. In addition, the range of products of domestic companies significantly intersects, which leads to price competition and the absence of any prospects for development. For example, out of the top ten best–selling INN of domestic production, 7 are produced by more than 5 companies, and 2 are produced by more than fifty. Despite this, in recent years, successful examples of the introduction of original drugs (or with signs of originality) by Russian pharmaceutical companies to the domestic market can be noted:

  • JSC "Domestic Medicines" – Phenotropil, Zorex;
  • Pharmstandard LLC, MASTERLEK CJSC – Afobazol, Arbidol, Amixin;
  • LLC "NTFF "POLISAN" – Cycloferon, Reamberin. The company's specialists continue to work intensively on the creation of new original drugs. In the scientific portfolio of the enterprise there are 6 medical preparations, the preclinical stage of the study of which is fully completed: Polyviran, Cytoflavin, Lacrivit, etc.;
  • Mir-Pharm CJSC – Mexidol.

And yet, in the structure of drugs produced in Russia, the share of modern highly effective drugs is extremely low and the need for them is closed mainly through imports. As the analysis of medical care has shown, currently 4 disease profiles are most common: oncology, ophthalmology, cardiovascular surgery, traumatology and orthopedics, which occupy over 70% of the total volume of VMP. The remaining 16 profiles account for less than 30%. Providing these areas of medicine with domestic modern and effective drugs and medical products is the primary task of the medical industry. Do not forget about socially significant diseases – cardiovascular, pulmonary, endocrine, allergic, neuropsychiatric and viral, for the treatment of which domestic affordable drugs are needed. First of all, developers and manufacturers of medicines need to focus on these areas and develop them.

Production of medical devices: problems, searches, solutionsA serious situation has developed in the production of medical devices, where there is a constant process of curtailing the development and production of the most important groups of these products, including medical instruments.

There is a loss of personnel, capacity is being reduced, and the level of use of production facilities at the leading medical instrument factories in the industry, such as OJSC KMIZ, OJSC MIZ-Vorsma, OJSC MIZ im. Gorky", JSC "Mozhaisk MIZ", ranges from 31 to 65%. An even more difficult situation has developed in the single-use syringes sector, where due to the unprofitability of production at a number of enterprises, there was a significant decrease in production volumes, and nine enterprises stopped their production altogether. The continuation of such a policy will lead to the complete destruction of domestic production of disposable and reusable medical instruments. At the same time, the production of micro-tools for surgery will be impossible to restore, because there will be an irreversible loss of highly qualified personnel (whose training, according to world estimates, is 20-25 years) in an industry where manual labor accounts for a significant share, and this will lead to complete dependence on imports. The production of disposable and reusable medical instruments, designed to ensure the supply of vital medical products in the event of a special period or pandemic, is a priority area of the medical industry. In addition, these products are simply necessary for military field surgery.

According to leading industry experts, in many areas of medical equipment, especially mass use, it is possible to displace imported domestic products from the Russian market of medical devices. Currently, the creation of competitive products has become quite real thanks to the use of modern element base and high technologies of defense enterprises, as well as the high level of scientific potential of the country in this area.

According to expert estimates, the share of competitive or brought to this level of medical devices and devices produced by major Russian enterprises is: for topical diagnostics – about 20%; functional diagnostics – 45%; life support, resuscitation, surgery – 50%; therapy – 70%; laboratory diagnostics – 15%.

About 23% of imported products from the volume of the Russian market of medical devices do not have competitive Russian analogues. These are, first of all, tomographs (except for low-floor MRI), angiography equipment, ultrasound diagnostic equipment, endoscopic equipment (flexible and part of rigid endoscopes), artificial kidney, dialyzers and disposable systems, laboratory equipment for complex physical and chemical analyses, lithotripters, as well as certain types of diagnostic and surgical equipment.

The import area, where there is a possibility of replacing foreign products with domestic ones, accounts for about 47% of the volume of the Russian market of medical devices. The purchase of imported equipment in areas developed in the domestic industry ultimately leads to a decrease in the equipment of healthcare institutions due to the fact that imported equipment is on average 2-4 times more expensive than Russian. At the same time, operating costs increase – repair, maintenance, purchase of imported components and consumables. The redistribution of funds in favor of the purchase of imported equipment deprives the domestic medical industry of the possibility of stable development.

Quality and safety of medical productsCurrently, there are 525 Russian enterprises registered in our country that have received a license to produce medicines, and 1,264 foreign companies that have their production sites in Russia.

At the same time, only 47 domestic pharmaceutical companies comply with GMP standards, and according to some experts, there are no more than 10 of them at all. Individual production sites operate according to the international standard at 120 enterprises; 100 enterprises are able to modernize their production capacities, and there is absolutely no modernization program at 258 enterprises. These are mainly small and medium-sized firms with a small capitalization and, accordingly, insufficient potential for technical re-equipment and the introduction of modern high-tech processes. For them, modernization will result in a complete restructuring of the enterprise at a cost of at least $ 10 million. It turns out that it is cheaper and faster to build an enterprise from scratch than to adjust it to the international standard of production.

The transition of Russian pharmaceutical enterprises to international GMP standards has been talked about for a long time, the deadlines for this transition have been repeatedly appointed and not fulfilled. The costs of the Russian pharmaceutical industry for technical re-equipment, personnel training, and validation of production systems as a whole are estimated by experts at $1.5-2.0 billion. According to A.L.Mladentsev, "the alignment of business conditions in the Russian Federation will allow the industry to find these funds in the conditions of market relations." Our enterprises do not have to rely on state support in the form of subsidies, credit or tax benefits. Moreover, the Government's program on measures to stimulate the domestic pharmaceutical industry in Russia has not yet been developed.

Meanwhile, the introduction of international GMP standards, which guarantees the quality of medicines, is beneficial both to the state as a guarantor of the rights of its citizens (patients), and to the pharmaceutical industry itself as a resource for increasing the competitiveness of the industry in domestic and foreign markets. Today, the presence of substandard and falsified medicines on the Russian pharmaceutical market not only leads to an increase in the death rate and disability of Russians, but also causes direct damage to the legitimate economic interests of bona fide manufacturers, forms an unfavorable image of Russia in the system of international relations. Only in 2006, Roszdravnadzor seized 988 series of domestic medicines, which is 13% of the total number of tested series, or 0.6% of the total number of series of medicines released into circulation. Note that this figure is not absolute, since we are talking only about the number of tested series. Pirates of the pharmaceutical market prefer to fake the most well–known and frequently used drugs: antibiotics – almost 38%, antispasmodics – 7%, anti-inflammatory drugs - 6%. Insulin, which is vital for diabetic patients, has also become one of the "popular" drugs among falsifiers. In this case, taking even a harmless "limestone" drug, but not a genuine insulin, can send a person to a hospital bed at best. The "leading positions" are also occupied by widely advertised medicines: no-shpa, mezim-forte, suprastin, tavegil, etc. Falsification of medicines, says a member of the State Duma Committee on Health Protection  Tatiana Yakovleva, is a crime not so much in the field of economics and copyright infringement, as a crime against the security of humanity, comparable to the use of weapons of mass destruction and terrorism. Unlike other types of products, even a relatively small volume of counterfeit medicines in circulation, especially vital drugs, can lead to disastrous consequences. Unfortunately, Russian legislation has not kept up (and still does not) with the growth rate of the turnover of counterfeit medicines. It was only in 2004 that the concepts of "falsified drugs" and "substandard drugs" were introduced into the Federal Law "On Medicines". This happened more than five years after the entry into force of the fundamental law on the circulation of medicines and with a great delay after the appearance of falsifications on the domestic pharmaceutical market. Amendments to the Criminal Code have been proposed that impose sanctions for the production, sale, storage and importation of counterfeit medicines into Russia: from a fine of 500,000 rubles to imprisonment for a period of 6 to 15 years if two or more people died as a result of the use of "left" pharmaceutical products. But toughening the punishment alone will not solve the problem. A whole system of pharmaceutical market control is needed to prevent illegal drugs from being sold at all. Preventive methods are sometimes much more effective than punitive ones. A working group under the National Anti-Terrorism Committee is already preparing a legislative initiative introducing special labeling for a number of goods. This will be a new degree of protection of the market from counterfeiting and falsification. Do not think that fake medicines are only a Russian problem. Unfortunately, there are no effective levers to combat counterfeiting anywhere in the world. According to analysts, the global turnover of counterfeit drugs is estimated at $ 2.5 billion per year and may increase 20 times by 2010.

Roszdravnadzor proposed its plan for the consistent transition of pharmaceutical enterprises to GMP standards. According to this plan, it is necessary to develop and adopt appropriate legislative amendments and regulatory legal acts by mid–2008, and to establish a transitional period for enterprises: the second quarter of 2009 for non-sterile manufacturers, and December 31, 2009 for sterile drugs. Thus, from January 1, 2010, all pharmaceutical companies should start working in full compliance with international GMP standards.

The plan for the phased transition of the pharmaceutical industry to GMP standards assumes:

  1. Creation of a regulatory framework for the transition to national Rules for the organization of production and quality control of medicines (GMP standards) – improvement of legislation and regulatory regulation in the field of drug circulation.
  2. Improvement of the mechanism of state control – creation of a network of control laboratories to confirm the quality of medicines integrated into the international system of control laboratories; expansion of the staff of state inspectors of Roszdravnadzor for the purpose of full and systematic inspection of production enterprises; improvement of the procedure for organizing the examination of the quality, effectiveness and safety of medicines, including issues of accreditation by Roszdravnadzor of certification bodies, testing centers, laboratories and others expert bodies.
  3. Establishing a unified procedure for confirming compliance and requirements for the production and quality control of medicines for foreign and domestic manufacturers – developing new ones and making adjustments to existing regulatory documents.

Additional measures to ensure compliance with the established requirements in the field of organization of production and quality control of medicines include the development and approval of the Procedure for the transition of drug manufacturing organizations to the established requirements and inspections of production sites.

Subject to the comprehensive implementation of the plan, the introduction of quality assurance systems in the field of drug circulation can be expected on January 1, 2010. The application of GMP requirements primarily to foreign companies will allow the Russian industry to find financial resources for technical re-equipment; and enterprises that will not be able to fulfill the plan of technical re-equipment and the introduction of quality assurance systems will be able to adjust the production profile in advance (food, cosmetic products, veterinary products).

Stimulating innovation and investment processesThe development of the domestic pharmaceutical industry and its integration into the world economy is impossible without the revival of its own scientific and production base, capable of providing the Russian and world market of medical products with original patented drugs and modern highly effective medical products.

The leading scientific institutions of the medical industry of Russia have recently created many new original medicines and medical products that surpass the analogues known in world practice in terms of efficiency and safety. Thus, the scientific basis for the implementation of the program of the strategic direction of the development of the medical industry and science (development, creation and introduction into medical practice of innovative drugs, high-tech medical equipment and medical products) in Russia is still there.

The following types of product innovations can be distinguished in the pharmaceutical business:

  1. Development of an original drug – a new molecule with a new mechanism of action.
  2. Creation of "me-too" drugs – a molecule "similar" to a molecule already existing on the market. The mechanism of action of these drugs is the same, the differences are in the strength of the effect and the safety profile.
  3. The creation of "quasi-original" drugs is a combination of molecules existing on the market, the development of new forms of delivery of the active substance.
  4. Expanding the spectrum of indications – conducting clinical trials to prove the effectiveness of an existing molecule on the market in new therapeutic groups.

According to experts, the costs of developing and promoting one innovative drug in the world amount to $ 500-800 million, and in the coming years will reach $ 1 billion. In Russia, these costs are currently about 100 times lower, i.e. about $ 1 million.

Not all domestic manufacturers of drugs can invest heavily in long-term and expensive projects to create original drugs. Under the present conditions, it is necessary to invest in fundamental research and promote the innovation process in the pharmaceutical industry on the part of the state. At the same time, the development of medicines for children should become a separate area of innovative activity. Despite the huge demand, the number of drugs produced in children's dosage forms is not so large. In conditions of insufficient state financing of the industry, it is necessary, first of all, to stimulate the joint work of scientists and businessmen. At the same time, state support should consist in attracting the maximum possible amount of funds from the private sector to finance R&D. A simple injection of more public money into research and development work is unlikely to be effective and will improve the situation in the innovation sector, it must necessarily be accompanied by the active participation of private investors to finance the most attractive innovative projects on a competitive basis. At the same time, it is necessary to take into account the degree of innovation of the project, its focus on the market conditions of medical products, as well as the payback period and profitability for the manufacturer. At the stage of preliminary evaluation of the project , the following types of pharmaceutical innovations can be distinguished:

  • the basic ones, which include the so–called revolutionary inventions - the development and introduction into production of fundamentally new products or new technological processes for the production of medical products;
  • improving – improvement or modernization of existing types of products and production technologies;
  • pseudo–innovations are insignificant modifications in medical products (as a rule, aesthetic changes) and technological processes (partial improvement of outdated technologies).

Such an analysis of innovations carried out at the stage of preliminary evaluation of projects will make it possible to identify and exclude projects with questionable performance that are not innovative. Still, one should not hope that private business will finance high-risk applied research, since they are associated with large-scale investments that do not bring obvious commercial benefits to investors. But these studies create conditions for the rapid growth of industrial production based on the development of new technologies. The functions of organizing and financing such research should be assumed by the State.

Regional and sectoral venture investment institutions that attract funds from Russian and foreign private capital and invest these funds in Russian venture enterprises can be considered as sources of investment in the development and implementation of innovative projects in the medical industry. At the same time, venture capital should be considered as a special kind of financial capital. It is caused to economic life not so much by the lack of budgetary funds for the development of science and high-tech (high-tech complex), but by the modern stage of scientific and technological progress, which is characterized by the priority position of innovation in the totality of development factors. Venture capital is best suited for investment support of innovation reproduction, which is associated with a wide variety of risks characteristic of the pharmaceutical industry. Venture investment cannot compensate for the lack of funds from other sources for the development of the scientific and technical sphere. It is useful in its specific "niche" of the development of innovative activity of economic systems, it is not for nothing that the share of venture capital in the total amount of invested funds in many countries does not exceed several percent.

The creation of a venture investment system in the medical industry pursues the following goals and objectives:

  • improvement of investment support for innovation activities, primarily small innovative entrepreneurship, due to the reorientation of some financial resources;
  • creation of optimal financial, personnel, organizational and regulatory conditions for venture investment of innovative, including technological projects that increase the competitiveness of medical products of domestic manufacturers in the Russian and world markets;
  • development of small innovative entrepreneurship in the real sector of the economy, in the scientific and technical sphere, in the high-tech complex;
  • promotion of commercialization of the results of scientific, technical and innovative activities;
  • creation of scientific and innovative concerns in the industry that are adequate to the post-industrial stage of scientific and technological progress, representing a corporation with a developed innovative economic zone consisting of a set of economic entities from among small innovative enterprises, research institutions and venture capital investment firms.

The infrastructure and institutional block should be considered an integral part of the venture investment system. The main forms of this block include:

  • Scientific, scientific and technological parks, business incubators, as well as their associations. It is difficult to overestimate the role of incubators, technoparks and technopolises in creating the optimal classical triad of venture investment (capital – innovative projects – management).
  • Various consulting firms on: marketing of high-tech products; information support; training; project management; financial planning; protection and management of intellectual property, patenting; commercialization of technologies and other innovations, legal issues, etc. There is a reason to include only those consulting firms in the venture system that are associated with the education and effective use of venture capital, as well as innovations.
  • A set of centers, schools, courses, etc. for training, advanced training, retraining of personnel in all variety of specialties and specializations for the venture industry.
  • Insurance organizations associated with the venture business. The risks of venture investments are, first of all, the risks of entrepreneurial activity. They are not insured anywhere in the world. However, almost always insurance of property risks of innovative enterprises – objects of venture investment, risks associated with the life and health of top managers of these enterprises, liability insurance, insurance of other classical risks is carried out.
  • The organizations that make up the venture capital market infrastructure are exchanges, brokerage offices, etc., i.e. the venture investment system includes part of the venture capital market and part of the stock market infrastructure. These are the structures that ensure the movement of venture capital.

Thus, the venture investment system consists of 2 blocks. The first is scientific and technical organizations engaged in applied research and technology transfer. In these institutions, as a rule, the main activities are consulting and training, research and certification, information, technical support and technology transfer. The second block is guarantee funds, which are often referred to as financial infrastructure. Guarantee funds do not allocate funds for investments in firms. They only provide guarantees to financial institutions, reducing their risks when investing in innovative enterprises.

An important role in the development of the innovative potential of the industry should be assigned to regional governments, which are often not ready to invest significant funds in expensive and long-term projects to create original medicines. Russian banks are no exception in this sense.

The experience of the Republic of Tatarstan on the creation of the Technopark "Idea", including in the field of high technologies, is of interest. The main purpose of the creation is the accelerated innovative development of high–tech industries, the production of new types of high-tech products based on the scientific, educational and industrial potential of the republic. The concept of the Technopark is a combination of a venture management company of early-stage projects, woven into the infrastructure of administrative and project support, where in most cases the managers of the Technopark are involved in the operational management of the enterprise. The total amount of financing of the Technopark in the field of high technologies for 2007-2009 will amount to 7.814 billion rubles, including from the budget of the Russian Federation – 3.354 billion rubles, the budget of the Republic of Tatarstan – 2.761 billion rubles and extra–budgetary sources - 1.7 billion rubles. In addition to technopark structures, in order to increase the innovative potential of the republic, the development of high-tech industries and the introduction of new technologies, a closed mutual investment fund "Regional Venture Fund for Investments in Small Enterprises in the Scientific and Technical Sphere of the Republic of Tatarstan" was created with a total investment of 800 million rubles., formed at the expense of budgetary funds of the Russian Federation and the Republic of Tatarstan – 200 million rubles and 400 million rubles . private investment.

Further development of the medical industry is impossible to imagine without combining the efforts of specialists in industry science and industry, not the least role should be given to the training of highly qualified innovative managers, the formation of a venture investment system in the industry.

Legislative and regulatory regulationThe foundations of legislative support for the development, production and sale of medical products are laid down in a number of federal laws: "Fundamentals of the legislation of the Russian Federation on the protection of citizens' health", "On medicines", "On licensing of certain types of activities", "On narcotic drugs and psychotropic substances", etc.

In the field of improving legislation and regulatory regulation, the following draft federal laws have been developed:

  • On Amendments and additions to the Federal Law "On Medicines" – in the procedure of state registration; authorized persons and release into circulation; judicial competence on the protection of the rights and legitimate interests of subjects of drug treatment; improvement of the procedure for conducting clinical trials of drugs; clarification of basic concepts.
  • On Amendments and additions to the Federal Law "On Technical Regulation".
  • On Amendments and additions to the Code of Administrative Offences of the Russian Federation.
  • On amendments and additions to the Criminal Code of the Russian Federation.

However, all these legislative acts require further improvement in accordance with the objectives of the development of the industry and the economic situation in the country.

At the meeting of the Commission on Healthcare and Medical Industry of the Council of the Russian Union of Industrialists and Entrepreneurs, held on September 26, 2007, at which the issues of providing the population and medical institutions with medicines and medical products were considered, it was noted that discriminatory conditions were created for domestic manufacturers due to the imperfection of the current legislation. Violation of the principles of equal competition gives unjustified advantages to importers. At the same time, exports to Russia are encouraged by foreign governments in the absence of countermeasures from the Russian Federation. To date, there is no clear state policy in the country to support and stimulate the development of the domestic medical industry. To solve the problem of the production of medicinal substances and medical devices of proper quality and in sufficient quantities, the RSPP proposed to take a number of urgent measures. In order to protect domestic producers from unfair competition from foreign manufacturers and to prevent them from granting legislative preferences, it is advisable:

  • Introduce amendments to the Federal Law "On Protection of Competition" dated 26.07.2006 aimed at combating the practice of price dumping in the drug market.
  • Expand the list of mandatory requirements for participants in placing an order by bidding in terms of confirming the qualifications of participants established by the Federal Law of 21.07.2005 "On placing orders for the supply of goods, performance of works, provision of services for state and municipal needs". To introduce into the Federal Law a norm according to which, when comparing the prices of participants and determining the winner of the competition, the price offered by a domestic manufacturer is conditionally reduced by 20% with equal quality.
  • To develop and adopt the Federal Law "On Medical Devices".
  • To bring the requirements for the implementation of the state registration of medicines in accordance with the requirements adopted in the EU.

In order to create equal conditions for domestic and foreign manufacturers:

  • To amend the Law of the Russian Federation of 07.02.1992 "On Consumer Rights Protection" in terms of establishing the responsibility of one legal entity, i.e. the manufacturer (both domestic and foreign), for the quality of drugs at all stages of its treatment.
  • To accept as a mandatory requirement for the state registration of medicinal products of foreign production the presence of a GMP certificate from the manufacturer, to develop and adopt regulations for the inspection of production of foreign manufacturers that comply with EU requirements.
  • Eliminate unequal requirements to domestic and foreign manufacturers regarding the justification of the price at the state registration of the maximum selling prices of producers for vital and essential drugs.
  • Cancel the state registration of pharmaceutical substances.
  • Ratify the Convention on the Development of the European Pharmacopoeia (ETS No. 50) and participate in the work of the Commission of the European Pharmacopoeia as its member.

In order to innovatively develop the medical industry and create conditions for technical re-equipment and modernization of medical industry enterprises, it is advisable:

  • To develop the Federal program "Development of the medical industry for 2009-2015".
  • To provide for the abolition of customs duties on the import of technological equipment for the medical industry (as well as spare parts and components for it) that are not produced in Russia.
  • Provide industry enterprises with a deferred payment of VAT on the import of technological equipment for up to 3 years (subject to payment guarantees provided by the manufacturer).
  • To stimulate foreign investment in the industry by increasing the rates of customs duties on the import of GLS and medical devices manufactured in the territory of the Russian Federation to Russia.
  • To use the funds of the Federal Targeted Investment Program to finance measures for technical re-equipment and modernization of industry enterprises, as well as to intensify the use of existing venture investment mechanisms to support R&D on the development of innovative medicines, medical devices and technologies for their production.
  • To provide legal mechanisms ensuring mandatory compliance by Russian manufacturers of medicines with the requirements of the national GMP standard, and to adopt a comprehensive plan for the transition to work according to GMP, GLP, GCP standards until 2010, taking into account state support measures.

The implementation of the proposed comprehensive measures will make it possible to approach the solution of the most important state task – the production of high-quality, effective, safe, vital and essential medicines and medical devices, the creation of a modern medical industry capable of responding to the demands of society, both in normal times and during epidemics, emergencies, ensuring the national security of the country.

Portal "Eternal youth" www.vechnayamolodost.ru12.01.2009

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