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Reforming Current Legislation On the Import and Export of Research Materials
A. E. Voinov, I. B. Khlebnikov, Sh. A. Dzhabrailov*
Autonomous Non-Profit Organization for Higher Education "Skolkovo Institute of Science and Technology"
*E-mail: [email protected]
The current procedure for importing and exporting materials for research and development activity prevents their prompt delivery, which leads to a decrease in the effectiveness of research and development activity conducted by Russian scientific and educational organizations. A simplified procedure for importing and exporting research materials (issuing a uniform permit required for importing and exporting research materials into and from the Russian Federation) is proposed at the legislative level.
Russia proceeds to an innovation-driven economic development model, reforms aimed at stimulating research and development activity (hereinafter referred to as R&D) and improving R&D performance are currently underway. Along with other factors, the possibility of prompt delivery of the materials and equipment required for organizing and conducting R&D is among the key factors that predicate the success and effectiveness of R&D. Leading Russian scientists and experts continue to insist that the current procedure for importing and exporting research materials does not allow one to ensure prompt delivery: thus, it hampers the effectiveness of the R&D conducted by Russian scientific and educational organizations and curtails the ability of Russian scientists to participate in international research projects. One of the major problems is the overbearing legislative control (multiple legal norms concerning the same issues) that accompany the importing and exporting of biological materials, including human materials, reagents, and laboratory animals (hereinafter referred to as research materials),
which requires going through a large number of approval processes to obtain the permit documents required to import/export research materials (permits, veterinary certificates, etc.).
At the current stage, the working group of the Skolkovo Institute of Science and Technology (hereinafter referred to as the working group) has developed recommendations on improving the current rules and regulations governing the import/export of research materials.
It seems reasonable to regulate the import/export of research materials based on a comprehensive approach. This approach involves the establishment of a simplified procedure for importing/exporting research materials by issuing a uniform permit for importing/exporting research materials into and from the Russian Federation, which would be valid for an unlimited period of time with respect to the types of research materials specified in it and their hazard (patho-genicity) classes; expedited customs clearance of these research materials; application of special simplified procedures foreseen in article 197 of the customs code of the cus-
toms union [1] to certain categories of research materials (a simplified declaration procedure for research materials in accordance with article 178 of the customs code of the customs union); application of a simplified declaration procedure to research materials, identical to that foreseen in articles 279 and 283 of the Federal Law On customs Regulation in the Russian Federation [2] for commercial and research samples.
Furthermore, subsequent control over the targeted use of research materials imported into the Russian Federation in compliance with the simplified procedure by scientific and educational organizations needs to be established. In this connection, it is reasonable to provide control mechanisms that would include the following components: • state accreditation of organizations entitled to use the simplified procedure for importing/ exporting research materials and establishing a registry of the accredited scientific and educational organizations, imposing requirements on these organizations, including the requirements concerning the development and implementation of in-house pro-
grams for controlling the use of research materials at these organizations;
• imposing reporting requirements on the accredited scientific and educational organizations and establishing mechanisms for controlling the targeted use of research materials by the authorized federal executive bodies;
• identifying new research materials, characterizing research materials into hazard (pathogenicity) classes, and establishing a registry of research materials; and
• establishing penalties for the non-targeted use of research materials.
The order of using the simplified procedure for importing/exporting research materials into/from the Russian Federation by scientific and educational organizations is suggested to be as follows:
• The authorized federal executive body (hereinafter referred to as AFEB) shall organize state accreditation of scientific and educational organizations participating in import and export, which have established in-house programs for controlling the use of research materials; shall issue the uniform permit for importing/exporting research materials for the purposes of conducting R&D into/from the Russian Federation (hereinafter referred to as uniform permit); and shall keep the registry of accredited organizations;
• The AFEB shall render a decision on state accreditation of scien-
tific and educational organizations based on their applications if they comply with the requirements. The AFEB shall issue a uniform permit for importing/ exporting research materials according to the simplified procedure to the accredited scientific or educational organizations (material type and hazard class being specified);
• the accredited scientific or educational organizations are entitled to import/export research materials into/from the Russian Federation based on the uniform permit, without the need to provide any additional permitting documents (except for licenses and permits issued in accordance with the legislation of the Russian Federation concerning narcotic drugs, psychoactive substances and their precursors (except for the precursors listed in Table III of Registry IV [3]), as well as veterinary and phytosanitary certificates);
• scientific and educational organizations shall undertake the obligation to use research materials only for R&D, without the right to transfer the material to third parties, either for compensation or free of charge (except for the transferring of research materials under research collaboration, while retaining control over targeted use of these materials);
• scientific and educational organizations entitled to use the simplified procedure for importing/exporting research materials shall report on all materials that have
been imported/exported and their consumption to the AFEB. The AFEB shall perform a regular inspection of the control over the targeted use of materials (if needed, with the assistance of other appropriate federal executive bodies).
It is also reasonable that the federal data resource devoted to the import/export of research materials into/from the Russian Federation be established, which would contain thorough and well-structured information on rules and regulations in the field of import/ export of research materials into/ from the Russian Federation, including the title and matter of the legal acts; the edition they have been published; the information on the procedure of assigning code numbers of the Foreign Economic Activity Commodity Nomenclature of the Customs Union to research materials; and other legal, reference, and analytical information related to the import/export of research materials into/from the Russian Federation.
An overhaul of the current legislation for importing/exporting research materials based on the proposed recommendations would significantly expedite the import/ export of research materials and, therefore, increase the effectiveness and performance of R&D conducted by Russian scientific and educational organizations, and broaden opportunities for Russian scientists to participate in international collaborative R&D projects. •
REFERENCES
1. The Customs Code of the Customs Union (Appendix to the Agreement on the Customs Code of the Customs Union approved by Decree of the Interstate Council of the Eurasian Economic Community No. 17 dated November 27, 2009).
2. The Federal Law No. 311-FZ dated November 27, 2010 (re-
vised June 4, 2014) On Customs Regulation in the Russian Federation.
3. Decree No. 681 of the RF Government dated June 30, 1998, On Approval of the List of Narcotic Drugs, Psychotropic Substances and Their Precursors Subject to Control in the Russian Federation (amended and revised).
A COMMENT ON THE INFORMATION PRESENTED BY THE WORKING GROUP OF THE SKOLKOVO INSTITUTE OF SCIENCE AND TECHNOLOGY
Acta Naturae focuses again on the problem of customs handling of research materials (AN 2010, vol. 2, No. 2(5)).
The debate-provoking article presented by the Skolkovo Institute of Science and Technology (Skoltech) provides a rather detailed overview of the "possible formalization" of customs clearance of research materials and equipment. Since the very first publication in our journal and my speech at the meeting chaired by D.A. Medve-dev on March 11, 2011, the number of problems associated with exporting high-tech products for Russian scientists has increased. It is absolutely clear that a Russian researcher has to buy reagents and equipment abroad with an extra charge (50, and sometimes even 100%) and wait for them to be delivered for 1-2 months. It is a systemic problem. The Russian market is rather small, and prominent players in the research industry usually find it unprofitable to keep large warehouses in Russia. How can the state help Russian researchers who are not involved in commercial activity and the research companies deriving profits from their research activity (it should be mentioned that these companies have not been paid due attention in Skoltech's publication)?. The information presented in the article seems to be excessively formalized to me. There is a well-defined problem related to customs code numbers. All high-tech goods contributing to the development of the country's potential should be indicated with a special mark in the customs reference books. It is a large amount of work, and qualified experts are needed to have it done. Verification is rather simple: relatively small quantities of these groups of goods are imported, and the use of the code numbers for "research goods" to import
regular commodity goods can be avoided. Special attention should be paid to products requiring special storage conditions, such as deep freezing (e.g., cell lines). These products should be given a special status in the customs reference books and have the proper legal requirements for conditions and duration of customs clearance. Failure to comply with these requirements should imply a penalty for the customs officers responsible for the violation in accordance with the established procedure. As for the certificates for hazardous chemical or biological materials, one-stop shop service should be established at customs terminals. Specially trained experts who can make adequate decisions according to the established procedure should work in this service. Certificates complying with the international regulations and preventing ambiguous interpretation should be elaborated. A terminal lacking such services should be temporarily closed. This measure would prevent getting the runaround and make customs clearance of research materials a much faster procedure. What about the "scientific export" (in other words, sending genetic constructs, or proteins, or samples to one's foreign colleagues to conduct joint studies)? It is clear that a non-bureaucratic structure of customs certification needs to be established, involving the Federal Agency for Scientific Organizations, the Ministries of Healthcare and Education, and Federal universities. The issued certificate should constitute grounds for export customs clearance. The key is to work with qualified experts at all stages rather than with people who try to wall themselves off from the existing problem because of lack of knowledge or understanding of the situation. One should be aware, however, that there still will be some violations, but it is a problem that law enforcement authorities are supposed to deal with. •
Aleksandr Gabibov
The editorial board of Acta Naturae has invited representatives of Sigma-Aldrich to comment on the article by Voinov etal. from the Skolkovo Institute of Science and Technology. Sigma-Aldrich is among the key importers of self-produced materials for chemical and biological research into Russia. The representatives of Sigma-Aldrich have commented on such aspects as excessive legislative control over the import (exporting) of biological materials, the lenght of the customs clearance process, etc.
Leading Russian scientists and experts keep saying that the current procedure for importing and exporting research materials does not allow one to ensure prompt delivery, thus reducing the effectiveness of the research conducted by Russian scientific and educational establishments and limits the chances of Russian scientists to participate in international research projects.
Today, if no additional permits are required, the customs clearance of research materials takes 1—2 days.
One of the major problems is the excessive legislative control (multiple legal norms concerning the same issues) in importing and exporting biological materials, including human materials, reagents, and laboratory animals.
The "excess" legislative control in this field is needed to prevent importing or exporting of hazardous materials . It is a high-risk commodity group, and the requirement to provide a large number of permits is more than
justified . Furthermore, preferences are provided in description to certain code numbers of the Commodity Classifier for Foreign Economic Activities . Thus, a product with the specification "for laboratory studies" can be imported without any additional permits
At the current stage, the working group of the Skolkovo Institute of Science and Technology (hereinafter referred to as the working group) has elaborated recommendations for improving the current procedure of importing (exporting) materials for research and diagnostics.
Issuing a uniform permit seems infeasible, since the list of research materials is too long and is continuously being updated (e .g., Sigma-Aldrich catalogue contains over 300,000 items) . They can be classified into absolutely different commodity groups and are regarded as potentially high-risk goods requiring special attention when being imported into the Russian Federation .
State accreditation of organizations entitled to use the simplified procedure for importing (exporting) research materials and establishing a registry of accredited scientific and educational institutions, imposing requirements to these organizations, including the requirements concerning the development and implementation of in-house programs for controlling research materials at these organizations.
Research materials are typically imported by commercial companies rather than by research institutions As research institutions are not foreign trade operators, they buy these materials from importers Therefore, I would rather be speaking about establishment of state accreditation for the importers of research materials
The certified federal executive agency (hereinafter referred to as CFEA) shall render a decision on state accreditation of scientific and educational institutions based
on applications if they comply with the requirements. The CFEA shall issue a uniform permit for importing (exporting) research materials according to the simplified procedure to the accredited scientific or educational institutions (material type and hazard class being specified).
It is impossible to use a single import permit to embrace the catalogue including 300,000 research items, which is constantly updated . The permit for a uniform code number will make it extremely difficult and almost infeasible to monitor the fate of these materials in Russia in order to determine their targeted (non-targeted) use . Furthermore, it may facilitate criminal intent .
Scientific and educational institutions shall undertake an obligation to use materials only for research and experimental developments, without the right to transfer the material to third parties, either for a compensation or free of charge (except for transferring research materials under research collaboration, while retaining the control over targeted use of these materials).
Unification would make control infeasible for the reasons described above .
It is also reasonable that a federal data resource devoted to import/export of research materials into/from the Russian Federation be established.
This data resource is available at any customs office, any customs station and any customs declarant has it as a part of specialized customs software . It provides comprehensive data on the Commodity Classifier for Foreign Economic Activities and regulatory acts of foreign economic activities In addition, it is used as a database of all the imported and exported goods If needed, the data can be copied from this resource to a separate website . •
Andrey Zubkov, foreign economic activity
and logistics director, Sigma-Aldrich Russia
