Program on Development of Biotech in Russia through 2020

A Lastest News about Agriculture and Animal Husbandry in Russia

Posted on: 28 Jun 2012

On April 24, 2012 the Russian government adopted “The Comprehensive Program for Development of Biotechnology in the Russian Federation through 2020”.

THIS REPORT CONTAINS ASSESSMENTS OF COMMODITY AND TRADE ISSUES MADE BY USDA STAFF AND NOT NECESSARILY STATEMENTS OF OFFICIAL U.S. GOVERNMENT POLICY Voluntary Public - Date: 6/8/2012 GAIN Report Number: RS1239 Russian Federation Post: Moscow Program on Development of Biotechnology in Russia through 2020 Report Categories: Biotechnology and Other New Production Technologies Approved By: Levin Flake Prepared By: Yelena Vassilieva Report Highlights: On April 24, 2012 the Russian government adopted “The Comprehensive Program for Development of Biotechnology in the Russian Federation through 2020”. This document acknowledges that Russia is lagging behind both developed and developing countries in the development and use of biotechnology (including agricultural biotechnology) and sets targets to create a biotech-oriented economy by 2020. The Program envisages 1.2 trillion rubles ($39 billion) financing from 2012 through 2020, including 200 billion rubles ($6.7 billion) for development of agricultural biotechnology. This program seems to demonstrate that the Government is serious about the development and use of agricultural biotechnology in Russia and the realization of the potential benefits of the use of this technology for Russian agriculture. General Information: On April 24, 2012, Vladimir Putin in his position as the Prime Minist [1]er approved “The Comprehensive Program for Development of Biotechnology in the Russian Federation through 2020” (hereafter referred to as the Program). The Program was posted on the web-site of the Russian Ministry of Economic Development, the drafter of the program: http://www.economy.gov.ru/minec/activity/sections/innovations/development/doc20120427_06 More than a year ago (April 1, 2011) the Russian government outlined pillars for modernizing Russia’s economy, and these focused on Russia’s development of advanced technologies and innovations in 3 spheres: information technology, nanotechnology and biotechnology. Since then the Russian Ministry of Economic Development in cooperation with other ministries and scientific centers has worked on the biotechnology program, which was finally approved on April 24, 2012. The Program states that in the field of biotechnology (except biopharmaceuticals) Russia is lagging far behind both developed and many developing countries of the world. Russia’s share in the world market of biotechnology products is less than 0.1 percent, and in the segments of biodegradable materials and biofuels is close to zero. The Program’s concept of biotechnology is very general. Thus, biotechnology is described as “the technology of living systems – 1) a discipline that studies the possibility of using living organisms, their systems or their metabolic products to solve technological problems, as well as the possibility of creating living organisms with the necessary properties by genetic engineering, and 2) use of biological structures for production of food and industrial products and for targeted transformations. Biological structures in this case are the microorganisms, plant and animal cells, cell components, such as membrane cells, ribosomes, mitochondria, chloroplasts, as well as biological macromolecules (DNA, RNA, proteins - mostly enzymes.)” (Appendix #1, Key Terms Used in the Program). As for agricultural forestry and food biotechnologies, the Program describes them as branches of biotechnology, and gives the following term definitions: Agricultural biotechnology is a “section of biotechnology dealing with issues of theory, methodology and implementation of its achievements in plant and livestock production.” Agricultural biotechnology” incorporates so called “Green” biotechnology, which is described as “the development and introduction of genetically modified plants in agriculture;” Forest biotechnology is a section of biotechnology dealing with conservation and rapid reproduction of forest biological resources; Food biotechnology (Food bio-industry) is a section of biotechnology engaged in the development of theory and practice of production of common food, preventive health food and specialized food. The priorities of the Program in the field of agricultural biotechnology are explained in section IV of the [1] Note: As of May 7th, Vladimir Putin became the President of Russia again and Dmitry Medvedev is currently the new Prime Minister. Program, and include, among other priorities, the creation of genetically modified plants and animals (currently no genetically modified crops are approved for use in Russia and there is a de facto ban on cultivation as no gove [2]rnment approval process exists ). For example, in explaining priority areas the Program lists the following in agriculture: “5.2 “Plant breeds created by means of biotechnology methods” At present time the Russian Federation does not create varieties and hybrids of new generations which are resistant to drought, diseases, herbicides, insect pests and difficult environment, using post genome technologies (breeding methods based on use of molecular markers) and genetic engineering which are wider and wider used in the world. Agricultural production of Russia will remain high-cost and will not be able to compete with foreign countries without the use of biotechnological innovations. Such situation shall have a detrimental effect on the domestic food production sector. The set of measures shall contribute to the development of advanced post genome and biotechnological methods in plant production and organization of robust markets of transgenic seeds and plants demanded by agricultural producers. 5.3 “The technologies of animals and poultry molecular breeding” The development of technologies of molecular breeding is based on the development of modern genome analysis methods enabling to detect and arrange screening of a big number of mutations (polymorphisms) related to the level of development of economically important selection traits of farm animals. The set of measures stipulates establishment of competitive national technologies of molecular breeding in animal and poultry industry focused on increase of economically beneficial traits, on animal products quality improvement and, as a result, improvement of the effectiveness of animal products production. 5.4 “Transgenic and cloned animals” The basic market factor for the segment growth is the fact that transgenic animals are many times more productive than the existing methods for obtainment of recombinant proteins and/or antibodies. The set of measures shall establish the conditions for Russian producers entering the market segments with high added value and for organization of technological advance contributing to the long-term competitiveness of the sector.” (Program, Section IV Biotechnology Development Priorities) This Program (in total) will require 1.18 trillion rubles ($39 billion) financing from 2011 through 2020, of which financing the development of agricultural biotechnology will require 17 percent of total funds, or 200 billion rubles ($6.7 billion). The Program will be implemented in two phases, 2012-2015 and 2016-2020. It envisages that the biggest portion of financing will fall within the last 5 years (2016- 2020), and for agricultural biotechnology 71 percent or 142 billion rubles ($4.7 billion) of the funds are planned for the last 5 years. However, the financing figures seem to be optimistic, and likely will largely depend on the size of the federal budget (which in itself will largely be driven by prices of key natural resources) as well as financing from other non-governmental sources. [2] For more information on the status of agricultural biotechnology in Russia and legislation in the field of agricultural biotechnology see GAIN RS1132 _ Agricultural Biotechnology Annual 2011 _ Moscow _ Russian Federation _ 7/18/2011 The Program seems to demonstrate shifting views by the Government of Russia on the development and use of agricultural biotechnology and the realization of the potential benefits of this technology for Russian agriculture. This is the first Government program which calls for the long-term development and use of biotech crops, and acknowledges that Russia is falling behind many other countries of the world in this technology. The non-official translation of select parts of the Program which refer to agricultural, food, forestry and marine biotechnology is in the Annex. ANNEX. COMPREHENSIVE PROGRAM OF DEVELOPMENT OF BIOTECHNOLOGY IN RUSSIA THROUGH 2020 with ATTACHMENTS I-5 Non-official translation Table of contents Below is the complete table of contents of this Program. Titles highlighted in blue are those which relate to agricultural, food, forestry and marine biotechnology and for which a non-official translation is provided in this document. Pages Passport of the Program 4 I. Justification of the need for the Program 8 II. Program goal and objectives 13 III. Basic tools for biotechnologies development support 18 Stimulating demand for biotech products 18 Promoting the competitiveness of biotech enterprises 19 Development of education in the sphere of biotechnology 20 Development of science in the sphere of biotechnology 21 Development of experimental production base 22 Support and development of bio-collections 24 Interaction between business, science and education 25 Support of biotechnologies in regions 25 International cooperation 26 Establishment of biotechnologies informational and analytical infrastructure 27 IV. Biotechnology Development Priorities 28 Biopharmaceuticals 28 Biomedicine 30 Industrial Biotechnology 32 Bio-energy 38 Agricultural biotechnology 40 Food biotechnology 45 Forest biotechnology 47 Environmental (ecological) biotechnology 50 Marine biotechnology 51 V. Management of implementation of the Program 52 Bodies for management and coordination of the Program 52 Other participants of the Program 55 Appendix #1. Key Terms Used in the Program 57 Appendix #2. Global trends in the development of biotechnology and position of 66 the Russian Federation Biopharmaceuticals 66 Biomedicine 67 Industrial Biotechnology 69 Bio-energy 71 Agricultural biotechnology 72 Forest biotechnology 77 Marine biotechnology 79 Biological collections 80 Appendix #3. Performance targets of the Program 81 Appendix #4. Estimated funding of the Program 86 Appendix #5. Plan of priority measures for implementation of the Program 88 I. Justification of the Need for the Program A Comprehensive Program for the Development of Biotechnologies in the Russian Federation for the Period through2020 (hereinafter – the Program) is developed in accordance with the decision of the Government Commission for Advanced Technology and Innovation as of April 1, 2011 (record No.2, section I, paragraph 1). There are three key areas of technologies development for innovative development of modern economy: information technologies, nanotechnologies and biotechnologies. Implementation of modern information technologies in Russia is carried out during last 20 years. For such relatively short period modern communication systems have been established, advanced information technologies have been introduced into the sector of industry, the Internet and mobile communication have become easily accessible. During the last 5 years nanotech industry is being in the stage of its active forming. Being rather perspective and having huge market potential, the sphere of biotechnologies has not yet obtained the enough impulse for its development in Russia (save for biopharmaceuticals). By estimate the world market of biotechnologies shall reach the level of 2 billion US dollars in 2025, expansion rates in terms of certain market segments are fluctuating from 5-7 up to 30% annually. Russian share in the biotechnologies market at present is less than 0.1 %, and in some segments (biodegradable materials, biofuels) is almost close to zero. Highly developed economies like USA, Canada, Japan and European Union are the principal users of biotechnology products. However, during present decade the developing countries have also been engaged into the technological race: China, India, and Brazil are implementing large-scale development programs in all spheres of biotechnologies. World trend lines in the development of biotechnologies are presented in Appendix No. 2. It is hard to overestimate the importance of biotechnologies for the development of Russian economy. Modernization of the technological basis for modern industrial production is impossible without mass introduction of biotechnologies and biotechnological products. Moreover, for a wide range of industries (agricultural and food sector, forest sector, a range of sub-branches of chemical and petrochemical industry, pharmaceutical industry and biomedical sector of public health service) modernization shall mean a transfer to biotechnological methods and products. Due to economic and ecological advantages the share of chemical products being manufactured on the basis of renewable raw materials shall consequently increase and reach by 2025 15-20 % in the chemical sphere, and it shall reach 5-7% of the world overall production in the sphere of engine fuels. Biotechnology methods enable to fully process the agricultural industry’s waste; l and in a series of countries the very notion “waste” no longer exists for this sector. A substantial potential for the development of bioenergy may be implemented at the account of using the waste of forestry industry. The tendency for replacement of chemical products with biological ones was formed 30-40 years ago. At that time USSR widely participated in the process: large manufacturing outfits were established, a system of field and academic scientific centers was forming, and new biological products were being actively introduced in agriculture, in food and chemical industry. For the last 20 years the world developed fundamentally new biotechnologies and products and manufacturing of previously known ones has been substantially improved. Russia has almost no part in this process. As a result, more than 80 % of biotechnological products being consumed in Russia are imported and consumption of biotechnological products in Russia remains incomparably lower than in both developed and developing countries. An output of biotechnological products is arranged in small lots; laboratory equipment which is actually not intended for these purposes is used for that. Institutes and universities continue their researches but their results are not commercialized as small enterprises do not invest funds into marketing of new products and they are unable to compete with leading world companies on the terms of “equal opportunities”. Besides, the system for “scaling” of scientific biotechnological development for the purposes of industrial production and other elements of bioeconomy necessary for transformation of scientific knowledge into commercial products is totally absent in Russia. Thus, the results of scientific researches remain unclaimed or turn into the products which production output is limited by the capacity of the scientific laboratory. International companies dominate in the segments where the consumption of industrial biotechnology products is relatively more developed: 100% of feed amino acids are being imported for agriculture (lysine), up to 80% of feed enzyme preparations, 100 % of enzyme for household chemistry, more than 50% of feed and veterinary antibiotics, 100% of lactic acid, from 50 to 100% of biological nutritive ingredients. For already 20 years the products of leading biotechnological companies of the world have been introduced at the Russian market but neither of these companies has organized its manufacturing in Russia. A number of tools for the support of biotechnologies development have been involved in Russia in recent years. A number of important decisions has been made recently aimed at elaboration of a long- term state strategy in the sphere of biotechnologies: the Strategy for the development of pharmaceutical industry of the Russian Federation for the period through2020 (hereinafter – “PHARMA-2020”), and the Strategy for the development of forest complex of the Russian Federation through 2020 have been approved; and federal special-purpose Program (hereinafter - FSP) “The Development of Pharmaceutical and Medical Industry of the Russian Federation for the Period up to 2020 and Further Perspective” has been adopted. The Strategy for the development of medical industry of the Russian Federation for the period through 2020 is being worked out. Therefore, the perspectives for improvement of the situation in the forestry industry, in pharmaceutical branch and in medical industry have appeared. Certain aspects of fundamental and industrial biotechnology are developed under the number of Programs: FSP “Research and Development in terms of Priority Areas for the Development of Scientific and Technological Complex of Russia for 2007 – 2013”, FSP “Scientific and Academic and Teaching Staff of Innovative Russia” for 2009 - 2013, FSP “The Development of Nanotech Industry Infrastructure in the Russian Federation for 2008 – 2011”, other Programs including Russian Federation state Programs under development (among them “Public Health Service Development” – Ministry of Health Care and Social Development of the Russian Federation; “State Program for Agriculture Development and Control of Agricultural Products, Raw Materials and Food’ Markets” – Ministry of Agriculture of the Russian Federation; “Natural Resources Restoration and Use” – Ministry of Natural Resources of the Russian Federation; “Fisheries Industry Development” – Russian Federal Fisheries Agency and others.) Biotechnological topics are widely supported by the Russian Foundation for Basic Research and Scientific Programs of state academies like RAS, RAMS, Russian Agricultural Academy. Applied and implementable projects are financed by the Fund for the Promotion of the Development of Small Businesses in the Sphere of Science and Technology, JSC “RUSNANO”, JSC “RVC”. Regional Programs for the development of biotechnology are implemented (the Chuvash Republic, the Republic of Tatarstan.) Three technological platforms of biotechnological orientation have been organized and included into the List of Technological Platforms by the decision of the Government Commission for Advanced Technology and Innovations, these platforms are “Future Medicine”, “Bioindustry and Bioresources - BioTech2030” and “Bioenergy”. Bioenergy has been growing rather rapidly in the recent years (obtainment of electrical and heat energy from biomass, first of all from waste of forestry industry.) At the same time, it is obvious that these implemented measures are not enough. Modern state of bioindustry in the world shows that many technologies and products are experimental by nature, using of biopreparations is more complicated than using of traditional chemical products and their cost is higher. These facts are taken as disadvantage and reason for refusal from rapid development of biotechnologies in Russia. It needs to be acknowledged that “intermediary” status of many technological decisions and biotechnological products is a chance for Russia to enter the international system of production of new knowledge and technologies. Bioindustry is developing at a fast pace in the world and the decisions and products applicable for mass and global introduction shall be found in 10-15 years. If by that time Russia establishes conditions for bioeconomic development, then the country shall appear among beneficiaries and co-owners of new technologies. And if the skepticism existing nowadays remains unchanged then Russia shall appear to be only the consumer at the world technological market and shall have to spend huge resources for import of new branches. The scales of this technological import may be comparable with the import of industrial technologies in 1930s. Lagging behind in development and implementation of biotechnologies in a number of branches and markets Russian industry risks to appear behind the line of modern technological practice which is being formed in the world during the last 15-20 years. In the medium term it may lead to the systematic degradation of a number of industrial branches as both the development at the world markets and the competitive reproduction of production capacities shall not be possible without using the biotechnologies. It is important to point out that the scale and pace of required changes is defined not by the preparedness of Russian economy but by the speed with which these changes take place in the world. Therefore, it is necessary to make decisions in a wide range of issues in very short terms. The development of bioeconomy in Russia is impossible without active involvement of large industrial corporations: both Russian and international. Meanwhile Russian companies almost do not invest into establishment of assets in the sphere of biotechnologies, do not implement biotechnologies at existing industrial enterprises as such implementation requires, as a rule, engagement of workers with the respective qualification and transfer into new management technologies. International companies which products are presented in Russia are interested in sales increase but they do not show interest in organization of production and transfer of some researches and development to Russia. Taking into account the carried out analysis of the state of biotechnology in Russia and in the world, it is possible to conclude that the development of biotechnological industry, moving of scientific researches and industrial production in this sphere onto the global level of competitiveness are impossible without implementation of targeted state policy. The question is not only in financial support but also in removal of existing regulatory barriers including in the field of customs and technical regulation, formation of stimuli for organization of the industry, establishment of necessary technological infrastructure, creation of demand for products, coordination of efforts of the state, scientific organizations and market participants. The Program serves to: lay the systematic basis for the development of bioeconomy in Russia; provide establishment of new sub-branches of industry focused on issuance of innovative biotechnological products for chemical and petrochemical industry, processing of forestry products; stimulate the development of production and consumption at the existing markets in Russia, first of all, in agricultural and food sector; to establish a basis for industrial development of bioenergy; to add to the existing system of measures for medicine and pharmaceutics support. A long-term goal for Program implementation is to reach in 2020 the volume of bioeconomy in Russia amounting to around 1% of GDP and in 2030 amounting to at least 3% of GDP. II. Program Goal and Objectives Russia’s entrance to the leading positions in the sphere of biotechnologies, including in certain areas of biomedicine, agrobiotechnology, industrial biotechnology and bioenergy and establishment of globally competitive sector of bioeconomy, which along with nanoindustry and information technologies should be a basis for modernization and development of postindustrial economy is the strategic goal of the Program. Program goal achievement is characterized by the following main aspects: 8.3 times increase in the consumption of biotechnological products; 33 times increase in the production of biotechnological products; reduction of share of imports in the consumption of biotechnological products up to 50%; increase of share of exports in the production of biotechnological products by more than 25 times; reaching the level of biotechnical products manufacturing in the Russian Federation amounting to around 1 % of GDP by 2020 and provision of conditions for achievement of at least 3% of GDP by 2030. Program implementation shall lead to substantial social effects. The efficiency of medical treatment shall increase in the sphere of medical service due to new widely distributed methods of diagnostics and practice of individualized medicine. In the sphere of ecology effective methods for pollution elimination and prevention of harmful environmental impact shall be established. In agricultural sphere introduction of biotechnologies shall contribute to the improving of the country food supply security. The development of bioenergy sphere shall contribute to appearance of new accessible energy sources. Program primary objectives are: establishment of infrastructure for biotechnology development; organization and implementation of priority innovative and investment projects in biotechnology; large-scale development of bioindustry in Russian regions in all sectors of biotechnology; support of the development of science about life and physicochemical biology; establishment of modern educational programs and system of staff training in the sphere of biotechnology; maintenance and development of bioresources potential as a basis for bioindustry; solving of essential social and economic, energy, ecological and other issues of the country by methods and means of biotechnology; integration of national biotechnology into the world bioeconomy; improvement of legal, economic, informational and organizational basis for biotechnology development. The implementation of Program strategic goal includes 2 stages: Stage I - 2011 - 2015 years, Stage II - 2016 - 2020 years. The goal for implementation of the I stage is to develop domestic demand and export of biotechnological products that shall result in substantial growth of bioeconomy in short terms in such sectors as biomedicine and agricultural and food biotechnology and shall increase substantially the production of electric energy and heat out of biomass; establishment of production and technological basis for organization of new industry sub-branches able in the long-term to replace a substantial part of products which are produced by chemical synthesis method with biological synthesis products; establishment of technological and experimental-industrial basis for organization of biofuel industry. To achieve the goals of the Stage I of the Program it is necessary to solve the following primary objectives: 1. To establish the system for assisting promotion of bioindustry products to the domestic and foreign markets for a profound increase output of already produced and demanded biotechnologies products, and saturation of existing markets with specified products. 2. To establish efficient stimuli for localization of production for part of biological products of international companies in Russia. To improve the effectiveness of mechanisms for commercialization of research and development results in the sphere of biotechnologies, among other things on the basis of private-public partnership. 3. To establish adequate bioeconomy structure in Russia including pilot, experimental-industrial, industrial enterprises, engineering companies and centers of fine-tuning technologies for biotechnological products implementation. 4. To provide substantial growth of electric energy and heat production output at the account of mass introduction of modern biopower plants. 5. To arrange a motivated range of industrial companies in chemical, petrochemical industry, agroindustrial sector and forestry industry, which are able to become a driving force for new technologies introduction. 6. To establish organizational and legal basis for the organization of new biotechnological products markets, first of all in industrial biotechnology and biofuel production. 7. To establish a system of voluntary ecological certification taking into account international experience for implementation of “green” standards. 8. To arrange conditions for stable functioning and development of a system for staff training, retraining and employee retention to provide effectiveness of research and development in the sphere of biotechnologies. 9. To organize regional biotechnological programs and bioclusters in a number of constituent entities of the Russian Federation. 10. To take an inventory of biological collections of the Russian Federation and to organize basic bioresources centers of federal significance The goal of Stage II of bioeconomy development in the Russian Federation is to organize institutional conditions for a profound modernization of technological basis for existing industry branches at the account of mass introduction of biotechnological methods and products into the production. An integration of scientific and process engineering sector of Russia into international system of knowledge production is necessary with moving to the priority development of scientific potential focused on establishment of knowledge and technologies able to provide industrial sector modernization along with nanotechnologies and information technologies. To achieve the goal of Stage II of the Program a set of objectives should be solved, including: 1. Organization of production and technological basis in terms of all basic kinds of products of industrial biotechnology. 2. Establishment of industrial basis for bioenergy development including electric power and heat production out of biomass, biofuel production. 3. Establishment of complex interdisciplinary system of research and development which is deeply integrated into international technological environment. 4. Improvement of support mechanisms for small innovative business focused on engagement of scientific organizations’ potential into the creation and production of new biotechnological products. At the Stage I of Program implementation a basic growth of consumption and production output shall be seen in biomedicine, agricultural and food sector (including waste recycling of the Agro-Industrial Complex) and bioenergy (including waste recycling of forestry industry). At the Stage II of Program implementation a technological and production basis for new markets shall be established (in the first place, in industrial biotechnology, forestry industry and in biofuel production), the consumption of biotechnological products shall increase by 2.5 times, product exports shall increase by 5 times. Performance targets for development of Russian biotechnologies resulting from Program implementation are shown in Appendix No.3. Program financial provision shall be carried out at the account of federal budget funds, budgets of constituent entities of the Russian Federation, local budgets and non-budgetary financing. Program financing at the account of federal budget funds shall be carried out in terms of financing of federal executive bodies and their subordinate organizations’ activities acting or newly established federal special-purpose Programs, long-term state Programs, state Programs of the Russian Federation stipulated by the instruction of the Government of the Russian Federation as of 11 November 2010 No. 1950-r “Concerning the Approval of the List of State Programs of the Russian Federation” and other mechanisms defined by the Government of the Russian Federation. At the Stage I of Program implementation basic investments shall be focused on: bioeconomy infrastructure establishment; organization of scientific and process capacity in the sphere of biotechnologies (financing of research programs with respect to bioeconomy key areas through the programs of fundamental studies, scientific funds grants, projects with respect to R&D development institutes and private business). At the Stage II basic investments shall be focused on new production establishment and development of production capacities at organized markets and also on financing of programs for products and technologies mass introduction in a wide range of industry branches. The supposed amount of financing with respect to Program areas is given in Appendix No. 4. During federal budget organization and administration the amount of financing may be specified. Federal budget funds, budgets of constituent entities of the Russian Federation, state institutes for development, state corporations and companies with state participation, large and middle business shall be the basic source of financing of the I stage of Program implementation. The substantial part of investments may be drawn from international corporations interested in localization of production capacity in Russia; funds drawn at Russian and international capital market shall compose some part of financing. The funds of Russian and international corporations, funds of enterprises of middle and small business, funds of state institutes for development and investments drawn at the stock market shall be the basic source of financing of Program’s Stage II. III. Basic Tools for Biotechnologies Development Support 1. Stimulating demand for biotech products Biological products demand stimulation in terms of the Program implementation shall be carried out according to several basic areas: 1. Setting of specific guidelines for increase of biological products consumption in program documents of the Government of the Russian Federation focused on the development of certain economy sectors. 2. Development of the system of measures for statutory and technical regulation of certain kinds of products stimulating recycling of products and waste products. 3. Development of the program for consistent and predictable increase of payments and stiffening of technological specifications for emissions and disposals of substances and microorganisms for stationary, mobile and other sources on the basis of using the best existing technologies. 4. Forming of necessary tools and mechanisms for the support of state procurement of biotechnological products in terms of establishment of federal contractual system and in terms of state defense order. 5. Inclusion of biotechnology products in the state support of agricultural producers; 6. Establishment of mechanisms that provide equal status of chemical and biological products (including fertilizer, means of plant protection) during the state support of agricultural producers; 7. Improvement of regulatory support of biomedical products and services circulation. 8. Stimulating the use of biotechnologies in public sector of economy including companies with state participation and public corporations, among other things by means of inclusion of business improvement issues (productivity, ecological compatibility, industrial safety and others) at the account of biotechnologies using into business-strategies and Programs of companies’ innovative development. 9. Development of set of measures for stimulation of biotechnological projects implementation by private sector, among other things for establishment of corporate research and development centers in Russia by transnational companies. 2. Promoting the competitiveness of biotech enterprises Implementation of set of measures for stimulation of business innovative activity shall contribute to accelerated development of biotechnologies. The set is provided by the Strategy for innovative development of the Russian Federation for the period through 2020 approved by the Decree of the Government of the Russian Federation as of December 8, 2011 No. 2227-r; among other things the set includes necessary tax package, measures for infrastructure establishment, for support of small innovative business. At the same time, with respect to biotechnologies common institutes and tools for stimulation of innovative activity and companies’ competitive growth shall have some specific character. In terms of this Program the contribution to competitive growth shall be carried out according to the following areas: 1. Provision of financing on a grant basis including in the line of RFTD or on the conditions of interest-free loan for implementation of Research and Advanced Development Programs for middle and large enterprises of bioeconomy and Programs of strategic researches in terms of technological platforms. 2. Extension of priority for biotechnologies development in the activity of development finance institutions directed to intensive growth of financial support at early stages of innovative activity – “pre-seed” and “seed”, and in terms of the support Program for small and medium businesses, the activity of the Fund for the Promotion of the Development of Small Businesses in the Sphere of Science and Technology (hereinafter – the Fund for the Promotion), and the activity of seed investments funds being established at the federal and regional levels, the activity of JSC “RVC”, of JSC “RUSNANO”, of the Bank for Foreign Economic Activities. 3. Improvement of the system for export support in the part of promotion of biotechnological products onto foreign markets. 4. Defining of the mechanisms for import support of certain advanced foreign technologies (and respective technological equipment) which are characterized by high potential for distribution in the economy and contribute to the transfer to new technological practice. 5. Development and establishment of resources support mechanisms for establishment and activities of new biotechnological companies at the account of development of innovative infrastructure network including prototyping centers, pilot, experimental-industrial companies, centers for fine-tuning technologies for use of biotechnological products, technologies transfer centers, centers for public access to equipment and others. 6. Using of financial mechanisms of United Nations Framework Convention on Climate Change for stimulation of biotechnologies. 7. Establishment of the system of voluntary ecological certification which takes into account international experience for implementation of “green” standards for the provision of minimization of negative impact of industrial facilities on the environment, rational use of natural resources, introduction of advanced energy-efficient and energy-saving solutions, rendering help to consumers during selection of products which do not make a negative impact on the environment, assistance to the development of “green” technologies in Russia. 8. Acceleration of the process for adoption of new standards and harmonization of regulatory and legal framework of the Russian Federation, EAEC, European Union and other countries in the sphere of production control and biotechnological products circulation including introduction of mechanisms of mutual recognition of certification results by laboratories and certification centers. 3. Development of education in the sphere of biotechnology The primary tasks for staff training in the sphere of biotechnologies are: forming of a path for obtainment of necessary competence, knowledge and skills on pre-higher, higher, post graduate stages of education on the basis of renovated educational standards and programs, forming-up of the system for continuous professional development, substantial raising of biotechnological business influence on forming of educational programs, especially on late (undergraduate courses, master course, postgraduate education and professional development) stages. In terms of the Program the advancement of education shall be carried out according to the following areas: 1. Development of efficient interaction of the most competitive educational institutions in the sphere of biotechnologies with establishing leadership centers with respect to various biotechnological areas in the part of education, arrangement of joint studies, development of new technologies and products. The financial support of such interaction is carried out by means of existing support tools for higher institutions innovative activities. 2. Development of new and modification of existing educational standards for various categories of specialists in various branches of bioeconomy. 3. Establishment of new educational programs in accordance with staffing needs of biotechnological business. 4. Using of modern educational methods with compulsory engagement of high-level specialists from abroad who present leading companies and university biotechnological centers. 5. Organization of flexible modular structure for educational programs. 6. Establishment of continuous system for professional development and retraining of biotechnological staff with the remaining possibility to change specialization without losing skills in terms of peculiar branch of bioeconomy. 7. Organization of advanced scientific and technological basis in the most competitive educational institutions in the sphere of biotechnologies. 4. Development of science in the sphere of biotechnology Progress in the sphere of fundamental fields of biosciences, in the first place in physiochemical biology, development of new methodological approaches and research platforms are the basis for the development of modern biotechnologies. Merely for the last several years such scientific fields as systems and synthetic biology have appeared, high-performance methods for research of genome, transcriptome, proteome and others (so called “omics”) are booming. The implementation of set of measures for the support and development of scientific studies is necessary to provide scientific basis for biotechnologies development: 1. General increase of share of the expenditures for science in the structure of budget of the Russian Federation during outrunning growth of expenditures for studies in the sphere of biosciences. According to the information of the Ministry of Education and Science of the Russian Federation, 27.3 billion rubles have been assigned for research projects in the sphere of biosciences in 2007 - 2011. For the same period China which rapidly develops biotechnologies has invested into R&D approximately 1.7 billion US dollars of public funds and drawn approximately 2 billion US dollars of private investments. In Russia there is almost no drawing of private funds into R&D in the sphere of biotechnologies. 2. Development of strategic research Programs with respect to subject-matter biotechnology branches – medicine, industrial, agricultural, forest biotechnologies, bioenergy with the participation of specialized technological platforms. 3. Coordination of study designs of state academies of sciences, companies with state participation and state corporations, grant topics of scientific funds with strategic study Programs of specialized technological platforms. 4. Improvement of competitive selection mechanisms for research and technological projects being financed in terms of federal and regional Programs of all levels. 5. Simplification of tendering procedures and forms of reporting, provision of disclosure and transparency during tendering process. Registration of topics and fields of studies entered in strategic study Programs as priority ones during announcement of topics of respective tenders and Programs. 6. Establishment of leadership centers with respect to subject fields of biotechnology – biomedicine, bioenergy, industrial, agricultural, forest biotechnologies on the basis of scientific and academic educational institutions leading in this field. 5. Development of experimental production base The establishment of modern flexible experimental base focused on mass introduction of biotechnological products into industry, agriculture and at the consumer’s market is a key element for Program implementation providing both drastic improvement of efficiency of budgetary expenditures for research work, efficient use of existing scientific capacity and organization and development of biotechnological products markets. State support of Program measures in the sphere of development of experimental production capacities of bioeconomy shall be carried out with respect to the following areas: 1. Innovative infrastructure development in the part of biotechnologies at the account of establishment of pilot enterprises and prototyping centers aimed at small-capacity production, development of industrial regulations for the production of biotechnological products and for preliminary studies with small production lots for arrangement of production testing, clinical research and preliminary studies with production lots for testing sales. 2. Innovative infrastructure establishment for the production of selective seed products on the basis of agricultural and forest biotechnologies and for arrangement of long-term field testing of up-to- date biotechnological and selective forms of plants with set characteristics. 3. Stimulation of industrial and experimental industrial production for large-capacity output of biotechnological products created on the basis of experimental technologies with the purpose of further optimization of basic technological processes. 4. Overcoming of deficit of innovative projects acceptable for financing by venture capital funds in terms of the activity of the Fund for the Promotion and funds of seed investments at the account of establishment of biotechnological centers able to integrate the requests of user industries and capabilities provided by R&D centers. 5. Creation of organizational conditions for engagement of specialized international companies to the process of bioeconomy infrastructure development in Russia which are able to introduce the respective competencies and to provide integration of establishing infrastructure elements into international system of knowledge and technologies production. 6. Development of mechanisms of private-public partnership stipulated for stimulation of late-stage projects at the account of establishment of specialized centers for fine-tuning technologies for biotechnological products implementation. 7. Organization of sub-Programs and certain measures for the establishment of pilot and experimental industrial enterprises, prototyping centers, engineering centers, specialized centers for fine-tuning technologies for biotechnological products implementation in terms of respective state Programs of the Russian Federation and federal special-purpose Programs. 6. Support and development of bio-collections The Program stipulates establishment of special infrastructure for provision of centralization, standardization and availability of genetic resources of biotechnological importance; the infrastructure includes large national and specialized centers of bio-resources (or genetic resources) and research collections which differ according to their functions (including service ones). Program support and implementation shall be carried out with respect to the following areas: 1. Taking of inventory of existing biological collections (microorganisms, fungi, plants, animals). 2. Defining a list of collections authorized to arrange deposit for the purposes of national patent procedure on behalf of the Russian Federation and approval of deposit guidance. 3. Development of set of measures for establishment of Russian Federation biological collections network with the prospect of their further integration into the European and Global (worldwide) information networks of BRC (Global Biological Resource Centre Network, GBRCN) in accordance with OECD recommendations. 4. Development of set of measures for reorganization of largest biological collections of the Russian Federation into national biological resource centers in accordance with OECD recommendations. 5. Development and implementation of state support measures for existing biological collections and biological resource centers under establishment including provision of long-term financing, tax remissions and improvement of customs regulation during transfer or exchange with collection biomaterials. 6. Harmonization of Russian and international statutory regulation for the activities on circulation of genetic resources and biological collections. 7. Interaction between business, science and education Along with involvement of already existing tools for improvement of interaction between business, science and education technological platforms including “Bioenergy”, “Bioindustry and Bioresources - BioTech2030”, “Future Medicine” are the main instrument providing interaction between business, science and education in terms of Program implementation. The assistance to organization and implementation of technological platforms with respect to Program areas shall be carried out by means of using the following mechanisms: 1. Registration of proposals from technological platforms coordinating organizations during organization of tender topics and distribution of financing funds with respect to Program areas in terms of special-purpose Programs, state Programs, Programs of fundamental scientific studies of state academies of science, RFBR, RFTD tenders, the activities of state institutes for development. 2. Participation of representatives of organizations included into technological platforms in consultative bodies that carry out preparations of proposals in terms of topics of research, R&D works being financed out of budgetary sources, financing of measures for innovative infrastructure development and support of innovative activities with respect to Program areas. 3. Engagement of technological platforms coordinating organizations in the development and approval of draft regulatory documents affecting the issues of their activity including development of federal special-purpose programs and state Programs. 8. Support of biotechnologies in regions The support of Program implementation at the regional level shall be carried out with respect to the following areas: 4. Coordination of expenditures for biotechnologies support at the federal, regional and municipal level. 5. Contribution to implementation of regional initiatives including regional Programs for the development of biotechnologies on the basis of private-public partnership. 6. Discovery of the most competitive clusters in the sphere of biotechnologies and development of measures for their support. 7. Support of regions of the Russian Federation as subjects of international cooperation in the sphere of biotechnologies. 9. International cooperation The implementation of Program measures is focused both on the deep integration of research and production capacity of Russia into international bioindustry and on the substantial growth of presence of international corporations at the Russian market, first of all at the account of localization of production capacities and establishment of international research centers and world-class engineering companies in Russia. The support of international cooperation development in terms of the Program shall be provided at the account of implementation of a set of measures: 1. Consideration of issues for activation of participation of Russian research organizations and companies in international research and technology Programs of multilateral cooperation in the sphere of biotechnologies including EC framework Programs with respect to researches, technological development and demonstrational activities and international technological platforms. 2. Membership provision for Russia and respective Russian organizations in international scientific organizations in the sphere of biotechnologies (European Molecular Biology Laboratory; Federation of European Biochemical Societies and others), networks and research projects, establishment of national divisions of international biotechnological associations, international and regional organizations for standardization in Russia. 3. Initiation of projects for scientific and technological development with respect to Program areas with broad international participation. 4. Engagement of international biotechnological corporations for participation in the development of joint scientific research projects and stimulation of establishment of international research and development centers and corporate centers for research and development at the territory of Russia. 5. Russia participation in the development of market mechanisms for ecological regulation in terms of UN and on bilateral and multilateral basis. 10. Establishment of biotechnologies informational and analytical infrastructure The system of informational and analytical support of Program measures stipulates: 1. Establishment of biotechnological network uniting research and development centers, multi- access centers, institutions of RAS, Russian Agricultural Academy, and RAMS, higher institutions, biotechnological laboratories with respect to subject-matter topical bioindustry areas. 2. Establishment of a database and a knowledge base in the sphere of biotechnologies, among other things in the part of evaluation of bioresources integrated with systems for data storage with respect to subject topics established in the federal executive bodies and state institutes for development. 3. Development of the federal website “Modern biotechnologies and bioindustry development” including videoconference service support system for commercialization of progress in the sphere of biotechnologies and popularization of biotechnologies in the society. 4. Provision of access to the system of cloud computing established at the federal level – these are services for possibilities to use geographically distributed supercomputer resources and unique equipment for the purposes of biotechnologies development. 5. Organization of the system of statistical monitoring for the development of biotechnologies sphere in the Russian Federation including development of methodology and toolkit for the statistical monitoring of establishment, commercialization and use of biotechnologies and production of biotechnological products on the basis of international statistical standards OECD adopted in this sphere. IV. BIOTECHNOLOGY DEVELOPMENT PRIORITIES In addition to basic tools for Program implementation representing “horizontal” measures for biotechnologies sector development the Program distinguishes measures with respect to basic areas of biotechnologies development representing “vertical” measures for the sector development; they are united by general subject of the respective biotechnology results application. Taking into account existing scientific capacities and tendencies, current state and potential of markets development and social and economic effect the following priorities are distinguished: biopharmaceutics and biomedicine; industrial biotechnology and bioenergy; agricultural and food biotechnology; forest biotechnology; environmental (ecological) biotechnology; marine biotechnology. In terms of specified priorities the sets of measures interrelated and coordinated by time, resources and performers are organized, including R&D, logistical, staffing, informational, regulatory and economic support. Below these sets of measures are set out with respect to the areas. Furthermore, extension No. 5 represents a list of priority actions with respect to Program implementation. Every basic priority for biotechnologies implementation or every distinguished part of priorities is allocated to the federal executive bodies responsible for state policy exercise in this sphere. These include: 1. Biopharmaceutics 2. Biomedicine 3. Industrial biotechnology 4. Bio-energy 5. Agricultural biotechnology 6. Food biotechnology 7. Forest biotechnology 8. Environments (ecological) biotechnology 9. Marine biotechnology 5. Agricultural biotechnology In agriculture biological preparations for diseases treatment, prevention and diagnosis are represented by a wide range of products both imported and Russian. The expansion of physical volume of production in agricultural sector has severe restrictions at the world markets: at some time further expansion of volume shall be impossible without change of technological approach (cultivation, storage and transportation conditions in plant science, management, feeding and processing conditions in animal industry). Using of biotechnology in agriculture is focused on stable development of agricultural production, solving of issue of food security, obtainment of high-quality, ecologically clean food products, recycling of agricultural production waste, soil fertility recovery. In this area the most prioritized are: development of new cultivars of agricultural plants and farm animals using new modern postgenomic and biotechnological methods; development and implementation of genomic certification to increase the efficiency of selective stock breeding, breeding animals cloning technologies; production of biopreparations for plant science; production of supplementary feeds for farm animals; production of veterinary biopreparations. For implementation of this area the sets of measures specified below shall be included into the state Program of the Russian Federation “State Program for Agricultural Development and Regulation of Agricultural Products, Raw Materials and Food Supplies Markets”, Ministry of Agriculture of the Russian Federation is the executive in charge. 5.1 “Biological plant protection” During the last 10 years new generations of biological plant protection products have been created by means of biotechnology methods which may easily compete with chemical protection products in terms of cost performance. As a result, almost in all large agricultural areas of the world there is a large-scale growth of use of biological products. The measures for biological plant protection provide means for crop yield increase, reduce losses in plant production industry, and implement integrated plant protection systems. They lead to reduction of active ingredients residue in the end products and this is crucially important during control in countries importing Russian agricultural products (grain at present stage). At present time there is a directive in the European Union which approved REACH Program defining a sharp increase of requirements towards chemicals use (besides, not only in agriculture). The development of biological plant protection leads to substantial reduction of chemical burden in plant industry and contributes to a long-term competitiveness of the sector. 5.2 “Plant breeds created by means of biotechnology methods” At present time Russian Federation almost does not create varieties and hybrids of new generation which are resistant to drought, diseases, herbicides, insect pests and difficult environment, using post genome technologies (breeding methods based on use of molecular markers) and genetic engineering which are wider and wider used in the world. Agricultural production of Russia will remain high-cost and will not be able to compete with foreign countries without use of biotechnological innovations. Such situation shall have a detrimental effect on domestic food production sector. The set of measures shall contribute to the development of advanced post genome and biotechnological methods in plant production and organization of robust markets of transgenic seeds and plants demanded by agricultural producers. 5.3 “The technologies of animals and poultry molecular breeding” The development of technologies of molecular breeding is based on the development of modern genome analysis methods enabling to detect and arrange screening of a big number of mutations (polymorphisms) related to the level of development of economically important selection traits of farm animals. The set of measures stipulates establishment of competitive national technologies of molecular breeding in animal and poultry industry focused on increase of economically beneficial traits, on animal products quality improvement and, as a result, improvement of the effectiveness of animal products production. 5.4 “Transgenic and cloned animals” The basic market factor for the segment growth is the fact that transgenic animals are many times more productive than the existing methods for obtainment of recombinant proteins and/or antibodies. The set of measures shall establish the conditions for Russian producers entering the market segments with high added value and for organization of technological advance contributing to the long-term competitiveness of the sector. 5.5 “Biotechnology of soils and biofertilizers” In the framework of the set of measures the conditions for development of biotechnological means of soil improvement and development of biofertilizers production shall be created. Soils biotechnology may improve substantially the quality and productivity of soils at the account of use of plants containing necessary bacteria without use of chemical fertilizers or with the substantial reduction of amounts of their use. During organic waste recycling the use of bacteria may substantially reduce the price and advance the processes for organic fertilizers creation and that shall contribute to the development of organic farming in Russia and shall contribute to the reduction of ecological damage arising from agricultural activities. 5.6 “Biopreparations for animal industry” Biological preparations for animal diseases treatment, prevention and diagnosis are represented by a wide range of products both imported and Russian. As a rule, international companies occupy segments of expensive high-efficiency preparations, including the ones obtained by means of using methods of genetic engineering. The use of local microbial strains isolated in Russia or in the neighboring countries for production of domestic immunobiological drugs for veterinary application is their most important competitive advantage. As a rule, it provides highest specific efficacy of specified drugs during their use at the territory of the Russian Federation and at the Eurasian Continent. The implementation of set of measures shall lead to entering of domestic producers into higher-value-added segments keeping the existing competitive advantages. 5.7 “Feed protein” Feed microbial protein (feeding yeast) is a dry concentrated biomass of yeast cells specially cultivated as a feedstuff for farm animals, poultry, fur-bearing animals, and fish. Supplement of feed protein into the feedstuff improves their quality greatly and contributes to productivity improvement in animal industry. The set of measures shall provide the development of feed protein production in Russia and establishment of new technological advances improving technologies of its production and kinds of use. 5.8 “Agricultural waste recycling” The technology of microbiological conversion is increasingly applied recently in the recycling of agricultural waste and food industry organic waste. The technology of microbiological conversion is really “omnivorous” and uses most diverse organic waste. Waste remaining during harvest of agricultural crop, brewery waste, waste from grain, milk, fruits and vegetables processing, meat processing waste, etc. may be used as initial raw material. Microbiological conversion enables recycling wine and sugar industry waste, waste appearing in the result of various products conservation, during the production of vegetable oil and vegetable fats in general. The technology perfectly disposes tea, wine and perfume industry waste. Thank to such technology even infested, partially decomposed waste contaminated with microbial flora may be recycled. Bioconversion may restore and improve feeding quality of poor-quality waste. The set of measures shall prov
Posted: 28 June 2012

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