FEDERATION TO THE WORLD TRADE ORGANIZATION 16 страница

444. According to Article 5 of the CU Agreement on Non-Tariff Regulation, licensing was required: (i) in the event of temporary quantitative restrictions on imports of certain types of goods; (ii) to regulate the importation of certain goods for reasons of national security, health, safety or environmental protection; (iii) to grant an exclusive right to import certain goods; or (iv) to carry out international obligations. Import licenses were also required to regulate the importation of goods subject to tariff rate quotas. The type of non-tariff restrictions and the list of goods subject to these restrictions were established by the CU Commission. The current list of such goods was set-out in Table 28. The CU Commission could decide to add or remove goods from this list upon request of a CU Party or on its own initiative.

445. The representative of the Russian Federation explained that according to the CU Licensing Agreement, the Ministry of Industry and Trade (the "authorised State body of executive power" in the Russian Federation) issued three types of licenses: one time, general, and exclusive. One time licenses were issued to applicants on the basis of a foreign trade contract relating to goods subject to import licensing. One time and general licenses were issued to applicants upon a decision of the authorised body of the Russian Federation. Both types of licenses granted the right to import certain types of goods subject to licensing in the quantity determined by the licence and were valid for one year or, for goods with respect to which provisional quantitative restrictions had been introduced, until 1 January of the following calendar year. Exclusive licenses gave the applicant the exclusive right to import certain types of goods. The goods subject to exclusive licenses were to be decided by the CU Commission, but until now exclusive import licences had not been issued in the Russian Federation. Under the CU Licensing Agreement, licenses were issued within 15 working days after submission of the complete set of documents. These documents consisted of an application for licence, an electronic copy of the application, a copy of the contract, a copy of a certificate confirming that the applicant was registered with a regional tax authority as a tax-payer, a copy of the activity licence (if applicable) and other documents, as required. The fee charged for the issuance of a licence was reduced from RUB 3,000 to RUB 2,600. Renewal of a licence would be subject to a fee of RUB 200.

446. A Member requested clarification regarding the respective powers of the CU Commission and national level governments in relation to general and exclusive licenses. The representative of the Russian Federation explained that in accordance with paragraph 1 of Article 3 of the CU Licensing Agreement, exclusive licenses were issued by authorised bodies of the CU Parties in cases stipulated by the Decision of the CU Commission. He further explained that, in accordance with the CU Commission Decision No. 168 of 27 November 2009, the competent national authority (the Ministry of Industry and Trade, in the case of the Russian Federation) issued exclusive licenses for import or export to foreign trade participants, and the CU Commission, consistent with a Decision of the CU Interstate Council, issued general licenses. In accordance with CU Decision No. 168, until the CU Parties ratify the "Procedure of Licence Suspension and Expiration", the CU Commission was to base its decisions regarding suspension and expiration of licenses on the national legislation of each CU Party.

447. In response to a question from a Member, the representative of the Russian Federation confirmed that proprietary and/or confidential information contained in an import licence application would be protected under the applicable laws of the Russian Federation.

448. The authorised body of the Russian Federation had the right to terminate or suspend an import licence in the case of a change in the constituent documents of the licensee registered as a legal entity (a change of the organizational-legal form, name, or its location) or a change in the passport information of the licensee being a natural person. In such circumstances, the CU Licensing Agreement provided that the licensee was to request that the authorised body terminate the existing licence, and register a new licence. In order to register a new licence, the licensee was required to submit a new application and documents confirming the above-mentioned change(s). In case of loss of the licence, the licensee was entitled to a duplicate licence, which would be issued within five calendar days from the date of submission of the request explaining the causes and circumstances of the loss of the licence. The licence holder wishing to renew a licence had to submit a new application, along with the full set of required documents.

449. The representative of the Russian Federation explained that according to the CU Licensing Agreement, permits were issued by the authorised body of the Russian Federation without restriction to all applicants. Permits were issued within three working days from the date of the submission of the draft permit in a format approved by the Commission, and remained valid until the end of the calendar year in which they were issued. No other documents were required for issuance of a permit.

450. A Member requested clarification of whether a CU Party must apply automatic import licenses to all goods on the Common List of Goods across the CU. The representative of the Russian Federation explained that automatic licensing was carried out in respect of goods whose export/import was subject to supervision. The list of goods subject to supervision was stipulated by the CU Commission. Goods subject to supervision were included into the Common List of Goods, but not all goods included into the Common List were subject to automatic licenses. In some cases, the requirement for permit was stipulated in the Regulations on the procedure for import/export attached to each section of the Common List of Goods.

451. In response to a question from a Member, the representative of the Russian Federation responded that no goods were currently subject to automatic-licensing except for goods containing encryption technology, as described in paragraph 481.

452. Import licenses were generally issued by the Ministry of Industry and Trade of the Russian Federation, based on "conclusions" issued by the relevant competent authorities following an "expert examination" of the good. In the case of weapons, ammunitions and dual-purpose goods, however, licenses were issued by the Ministry of Defence of the Russian Federation. The licensing regime was applied to imports from all non-CU countries, including imports from CIS countries without discrimination as regards to the country of origin.

453. Several Members of the Working Party expressed concern regarding the justification of the Russian Federation for the application of non-automatic import licenses pursuant to Article XX of the GATT 1994 for products listed in Table 28. These Members requested additional explanation to understand how the provisions in the chapeau of Article XX of the GATT 1994 would be met. They noted that, while import licensing might be an appropriate mechanism to administer certain controls, the justification for these controls, as well as the specifics of the import licensing procedures used to administer them, needed in all cases to be fully in accordance with WTO provisions, including those on non-discrimination.

454. In response, the representative of the Russian Federation said that neither the Russian Federation, nor the competent bodies of the CU intended to limit the quantity and value of imports by means of import licenses, except as provided for in international conventions such as the Montreal Protocol or the Basel Convention or for the implementation of other measures justified under the WTO Agreement. He added that, in his view, the application of non-automatic import licenses for the products listed in Table 28 was in conformity with Articles XX and XXI of the GATT 1994.

455. Several Members replied that the current application of licensing requirements to products such as pharmaceuticals, sugar, goods with encryption technology and alcoholic beverages clearly operated to restrict imports. They requested the Russian Federation to describe the legal basis for these measures and to explain how these restrictions would be modified or eliminated to meet WTO requirements.

(i) Sugar

456. Some Members asked for more detailed information on how the Russian authorities considered that each of the requirements of Articles 1 and 3 of the WTO Agreement on Import Licensing Procedures had been met in relation to non-automatic import licensing in the administration of its TRQ for raw sugar (HS 170111).

457. The representative of the Russian Federation responded that the TRQ on raw sugar (HS 170111) had been eliminated pursuant to the Government Resolution No. 720 of 29 November 2003 and the Government Resolution No. 757 of 18 December 2003 "On the Abolishing of the Licensing of the Import of Raw Sugar to the Russian Federation" had removed raw sugar from the list of products requiring an import licence. He added that pursuant to Government Resolution No. 782 of 17 July 1998 (as amended on 18 December 2003), imports of starch treacle had required licensing. This measure, however, had had a temporary surveillance character, had been taken in order to collect trade data that could be used, if necessary, to justify possible measures aimed at regulating imports, and was abolished since 1 January 2007 by Government Resolution No. 700 of 20 November 2006. At the current time, the Russian Federation does not require import licensing for the importation of raw sugar.

(ii) Alcoholic beverages and Alcohol-Containing Products

458. Noting that for alcoholic beverages and alcohol-containing products, import licenses were only issued where the applicant already had an activity licence, some Members requested information on the rationale for this apparent duplicative requirement. They also required information on the number of licenses issued every year and how many of these were currently in force. These Members requested the Russian Federation to make a commitment that any import licenses on ethyl alcohol, alcoholic drinks, alcohol-containing products (as well as on pharmaceutical products, and products with encryption technology, which had a similar system) would be granted automatically on the basis of a regime compatible with WTO requirements, including Article 2 of the WTO Agreement on Import Licensing Procedures.

459. Some Members expressed concerns about the need for specific licensing requirements for certain types of alcoholic products. Specifically, they asked about the rationale for the mandatory licensing requirement for wines and certain alcoholic beverages exceeding 28 per cent volume, such as vodka and tequila. Members also expressed concerns about disruption in the issuing of these licenses in the course of the change of responsibility within the Government of the Russian Federation for the licenses in question.

460. In response, the representative of the Russian Federation said that, pursuant to the CU Agreements listed in paragraph 440, as well as CU Commission Decision No. 132 and the "Regulations of the Order of Import of Ethyl Alcohol and Alcoholic Products to the Customs Territory of the Customs Union", imports of ethyl alcohol, wines, and some alcoholic beverages exceeding 28 per cent volume (vodka and other white distilled alcoholic beverages) as listed in Table 28 were subject to import licensing in the Russian Federation. Licenses were issued by the Ministry of Industry and Trade upon receipt of the documents listed in paragraph 445 of this Report, including a copy of the import contract. In his view, import licensing of alcohol and alcoholic beverages was undertaken for purposes consistent with the requirements of Article XX (b) of the GATT 1994. However, the representative of the Russian Federation confirmed that the non-automatic import licensing requirement for alcoholic beverages would be eliminated and replaced upon accession by an automatic licensing procedure whereby licenses would be issued upon submission of the appropriate and complete documentation as described above. At present, fees charged for the issuance of all types of import licence amounted to RUB 2,600. The representative of the Russian Federation noted that according to Order No. 1212 of the Ministry of Industry and Trade of the Russian Federation of 30 December 2009 "On the Distribution of Authorities in the Ministry of Industry and Trade of the Russian Federation and its Territorial Bodies for Issuing the Licenses and other Permissive Documents for the Implementation of Export-Import Operations with Particular Types of Goods", vodka was in the list of goods subject to licensing procedures and there were no additional licensing requirements for vodka.

(iii) Pharmaceuticals

461. The representative of the Russian Federation noted that the importation of medicines and pharmaceutical ingredients was governed by the CU Agreements listed in paragraph 440, as well as by Decision No. 132, and more specifically by the "Regulations On the Order of Entry into the Customs Territory of the Customs Union of Medicines and Pharmaceutical Ingredients", as well as relevant domestic legislation, i.e., Government Resolution No. 438 of 17 July 2005 "On the Order of Importation and Exportation from the Russian Federation of Pharmaceuticals for Medical Use" and Federal Law No. 61-FZ of 12 April 2010 "On the Circulation of Medicines". Some Members noted that pharmaceutical licensing requirements were extremely burdensome and constituted a problem for their exporters. A major obstacle was that pharmaceuticals had to be re-registered periodically, e.g., once every four years, and this re-registration was not automatic, often resulting in firms losing their current licence and being unable to import products for a period of time. Regarding Government Resolution No. 438 "On the Procedure of Importation in and the Exportation from the Russian Federation of Pharmaceuticals for Medical Use", some Members indicated that paragraph 2 of that Resolution appeared to suggest that foreign manufacturers were required to have offices in the Russian Federation in order to obtain an import licence. They requested clarification as to whether this requirement would imply that foreign manufacturers of pharmaceuticals must have an office in the Russian Federation to obtain a licence to import, and noted that in this case such a requirement would be inconsistent with WTO provisions. In addition, they asked the Russian Federation to elaborate on the purpose of these requirements, particularly in the case of licensing products such as flavourings and dual use precursor chemicals, and on whether they required the examination of every contract to import. Members also expressed concerns regarding treatment of imports when there were differences between the quantity shipped and that listed in the contract. In some cases, small disparities had resulted in a refusal to permit import even of the contracted amount. Members also requested information on possible expedited procedures to obtain licenses for any significant coverage. The same Members also recalled the concerns raised under the Section "Registration Requirements for Import/Export Operations" of this Report.

462. In response, the representative of the Russian Federation explained that, in his view, import licensing of pharmaceuticals was justified by Article XX (b) of the GATT 1994 and was aimed at implementing the policies of the Government in the field of human and animal life and health protection.

463. He further explained that, currently, in accordance with the Federal Law No. 61-FZ "On the Circulation of Medicines" of 12 April 2010, and Federal Law No. 128-FZ of 8 August 2001 "On Licensing of Specific Types of Activities" (as amended on 14 July 2008), to import pharmaceuticals into the territory of the Russian Federation, foreign enterprises that were producers or wholesalers could be registered as legal persons on the territory of the Russian Federation (described in paragraph 256 of this Report), and granted a licence for relevant type of activity (pharmaceutical production or distribution), and a licence for importation. The issuance of a licence for pharmaceutical wholesale or production allowed the legal entity to obtain a licence for importation of medicines. The fee charged for the issuance of the licence to import/export medicines amounted to RUB 1,300. He also noted that foreign enterprises were subject to the same uniform procedures as provided under Government Resolution No. 438 of 16 July 2005 "On the Procedure for Importation and Exportation of Medicines for Medical Purposes". In response to a question from Members, regarding future requirements to obtain and present import and/or activity licenses in connection with importation of pharmaceuticals, the representative of the Russian Federation referred Members to paragraph 275 and the requirements and procedures that would apply to pharmaceuticals, alcohol and goods with encryption technology from the date of the accession of the Russian Federation to the WTO. As regards concerns from Members in respect of the periodic re-registration requirement, the representative of the Russian Federation noted that according to the registration procedure of the Ministry of Health and Social Development, the first registration of a pharmaceutical in the territory of the Russian Federation was valid for five years. However, when the registration was renewed there were no restrictions on the duration of validity of that registration and in that case a temporary loss of the licence due to re-registration was not possible. The representative of the Russian Federation further explained that the validity of the first registration would be automatically prolonged until the re-registration procedure was completed to avoid any interruptions in delivery to the market. In response to a question from a Member, the representative of the Russian Federation confirmed the five-year limit period applied to the first registration of each producer in the Russian Federation.

464. Noting the concerns expressed by Members regarding the treatment of imports when there were differences between the quantity shipped and that listed in the contract, the representative of the Russian Federation explained that the quantity shipped could be smaller than that listed in the contract, but not larger. In the latter case, customs clearance would be refused for the amount exceeding that in the contract.

465. One Member requested clarification of the requirements for importing products for testing purposes related to obtaining registration and approval for circulation of pharmaceuticals in the Russian Federation. This Member requested information on whether a representative office, for example, could import products into the Russian Federation for such purposes without obtaining an activity licence or import licence.

466. In response, the representative of the Russian Federation explained that, under the new Law, a product imported into the Russian Federation for testing and examination related to its registration as a pharmaceutical in the Russian Federation was considered to be a non-registered pharmaceutical. In accordance with Government Resolution No. 771 of 29 September 2010 "On the Rules of Importation of Pharmaceutical Products for Medical Use into the Territory of the Russian Federation", the import of certain amounts of non-registered pharmaceuticals, necessary for clinical trials, or with the view of their State Registration, or non-registered pharmaceutical products used for medical treatment of certain patients were allowed under permission of the Ministry of Health and Social Development of the Russian Federation. Thus, a representative office could import such products for testing and examination without obtaining an activity licence or import licence.

467. Noting further that pharmaceutical exporters had expressed concerns over certain Russian import licensing requirements (for instance, if the molecule unique to the pharmaceutical had not changed, periodic renewal of licenses appeared unnecessary and could be expensive and burdensome to the industry), some Members asked whether such requirements were equally applied to similar domestic products, as the failure to do so could constitute a violation of Article III of the GATT 1994. Noting that some pharmaceutical exporters had expressed concerns that the administration of licenses by the Ministry of Health and Social Development and the Ministry of Industry and Trade did not presently meet WTO requirements, such as transparency, fees for services rendered, processing within a reasonable time-frame and forbearance on minor documentation errors, these Members requested clarification on the steps that the Russian Federation intended to take to ensure that the administration of import licenses would conform to WTO requirements. In this regard, some Members asked the Russian Federation to explain how the 0.05 per cent administrative fee charged by the Ministry of Health and Social Development for issuing permits to import pharmaceutical products was consistent with the requirements of Article VIII of the GATT 1994.

468. Some Members also requested additional clarification of the status of any legislative initiative in the Russian Federation, which could operate to restrict imports of pharmaceuticals having domestic analogues. These Members felt that, if adopted, such legislation could be inconsistent with the provisions of Articles III and XI of the GATT 1994. Noting further that the Russian Federation had acknowledged that the Law concerning pharmaceuticals (Federal Law No. 86-FZ of 22 June 1998 "On Medicines") was inconsistent with the new Foreign Trade Law and Import/Export Licensing Resolution, some Members expressed their expectation that this Law would be amended or repealed to ensure WTO conformity by the date of accession.

469. The representative of the Russian Federation replied that the Federal Law No. 86-FZ of 22 June 1998 "On Medicines" had recently been replaced by Law No. 61-FZ of 12 April 2010 "On the Circulation of Medicines". This new Law was intended to achieve WTO compliance. He also added that there were no plans in the Russian Federation to introduce new legislation, which could operate to restrict imports of pharmaceuticals, including veterinary drugs, having domestic substitutes. Activity licences to engage in production or wholesale were made available to all registered companies (domestic or foreign owned) which satisfied government regulatory criteria. For issuance of preliminary permits for imports of pharmaceutical products, the Ministry of Health and Social Development of the Russian Federation (or Rosselkhoznadzor in cases of veterinary drugs) did not now levy any charge or fees. Consultations and preparation of the documents for examination of an application were done by the Federal State Unitary Enterprise "The Information and Methodical Centre on Expertise, Registration and Analysis of the Turnover of Medicines for Medical Purposes" of the Federal Health and Social Development Supervision Service. The cost of the services was determined according to the Civil Code of the Russian Federation on the basis of the volume of performed work as agreed by the parties to the corresponding contract. A preliminary permit issued by the Federal Health and Social Development Supervision Service of the Ministry of Health and Social Development of the Russian Federation or Rosselkhoznadzor in cases of veterinary drugs was the ground for issuing an import licence. He also referred to his explanations under the above Section on "Registration Requirements for Import/Export Operations" of this Report. As regards concerns from Members on conformity of administration of licenses by the Ministry of Health and Social Development of the Russian Federation and the Ministry of Industry and Trade of the Russian Federation with WTO requirements (such as transparency, fees for services rendered, processing within a reasonable time-frame and forbearance on minor documentation errors), the representative of the Russian Federation noted that information on this issue was contained in paragraphs 193, 194 and 200 of the Section "Government Entities Responsible for Making and Implementing Policies Affecting Foreign Trade; Right of Appeal". Responding to the question of a Member, in respect of differences in application of regulations relevant for implementation of safety and other types of controls in respect of imported and domestic products, he explained that, such differences were caused by the fact that imported goods were subject to controls at the point of customs clearance and domestic goods at production sites, but such differences had not created different burdens for importers and domestic producers and hence, had not caused protection to domestic production. Answering a question by a Member on the consistency of the 0.05 per cent administrative fee, charged by the Ministry of Health and Social Development for issuing permits to import pharmaceutical products, he stated that this fee had been abolished.

470. Some Members of the Working Party stated that their traders had experienced difficulties with other Ministries or institutions charging extra fees in connection with importation permits based upon the contract value of the goods. These Members requested that the Russian Federation enter into a commitment to eliminate all such non-WTO consistent measures upon its accession to the WTO.

(iv) Products with Encryption Technology

471. Some Members requested information on the application by the Russian Federation of requirements for importation of goods containing encryption technology. These Members noted that most countries did not limit imports of these products and questioned the need and justification for licensing, in particular, non-automatic licensing of commercially traded, mass-market goods, and goods that were covered under the Information Technology Agreement (ITA). Members expressed concern that such licensing requirements could nullify or impair the market access commitments on a wide-range of products of undertaken by the Russian Federation. Members stated that, to the extent that the Russian Federation intended to establish or apply licensing requirements, such requirements should apply only to products that clearly presented a threat to security. In such cases, licensing procedures should be applied in a non-discriminatory manner and comply with all WTO requirements.

472. In response, the representative of the Russian Federation explained that, prior to 1 January 2010, the Russian Federation administered a system of import licensing of all goods, which contained encryption technologies. Since that date, the CU Agreements listed in paragraph 440 and CU Commission Decision No. 132, and the CU Regulation "On the Order of Entry into the Customs Territory of the Customs Union and Removal of the Customs Territory of the Customs Union of Encryption (cryptographic) Means", dated 1 December 2009, and national regulation set-out the requirements for importing goods with encryption technology. He confirmed that any procedures or requirements relating to licensing imports of goods containing encryption technology, whether by the Russian Federation or by the competent bodies of the CU, would be applied on a non-discriminatory basis and in conformity with the relevant provisions of the WTO Agreement, in particular, Articles I and III of the GATT 1994, and that procedures related to the notification, evaluation, approval, and licensing of goods containing encryption technology, would be transparent and predictable and would not impose unreasonable or burdensome requirements on such goods. The Working Party took note of these commitments.

473. The representative of the Russian Federation explained that, in order to facilitate trade, the Russian Federation would develop and apply an interim system of regulation of goods containing encryption technology. Under this interim system, all encryption products would be divided into three groups: (i) certain goods containing encryption technology could be imported without any formalities related to encryption; (ii) other goods with encryption technology would be subject to a one-time notification requirement; and, (iii) a category of goods with encryption technology would be subject to an expert evaluation and require an import licence. This import licence would be issued by the Ministry of Industry and Trade, based on a "conclusion" issued by the executive body in the field of national security of the CU Party (the Federal Security Service in the Russian Federation), following an "expert examination". He noted that other formalities, such as customs or those necessary to implement technical regulations would continue to apply in respect of imports of all these goods.

474. In response to a request by one Member to clarify the meaning of the wording "without any formalities related to encryption" in paragraph 473, the representative of the Russian Federation said that such formalities were understood as the formalities concerning the goods listed in Table 29 and described in the second and subsequent sentences of paragraph 477, and the formalities listed in paragraph 481 concerning the goods, which were subject to import licensing and expert evaluation.