Perspectives on future international regulatory cooperation -some lessons from Japan s experience-

Transcription

1 Perspectives on future international regulatory cooperation -some lessons from Japan s experience- Shigehiro TANAKA Director-General Multilateral Trade System Department Ministry of Trade, Economy and Industry 1

2 Our objectives for international regulatory cooperation Case 1: Mutual Recognition Agreement (MRA) Facilitate trade by reducing cost of technical regulation Case 2: Patent Prosecution Highway Streamline duplication of tasks among national authorities. Case 3: Business Environment Improvement Committee Solve regulatory issues raised by businesses under the framework of FTA/EPA(Economic Partnership Agreement) Case 4: MRAs of IT Engineer Examination Bring down barriers of IT services through tailored-approach 2

3 Case 1: Mutual Recognition Agreement Arrangements for mutual recognition between governments are called Mutual Recognition Agreements (MRAs). As the conclusion of an MRA allows conformity assessment procedures that were previously required to take place in an importing country to take place in an exporting country, it is expected to contribute to simplifying procedures and reducing the cost associated with conformity assessment, thereby further smoothing international trade. <Example of Japan s MRAs> 1) Japan-Europe MRA (effective into force in Apr. 2002); - Telecommunications terminal equipment and radio equipment - Electrical products - Good Laboratory Practice (GLP) for chemicals - Good Manufacturing Practice (GMP) for medical devices 2) Japan-Singapore MRA (effective in Nov under Japan-Singapore Economic Partnership Agreement); - Telecommunications terminal equipment and radio equipment - Electrical products 3) Japan-Thailand MRA (effective in Nov under Japan-Thailand Economic Partnership Agreement); - Electrical products 4) Japan-US MRA (effective in Jan. 2008); - Telecommunications terminal equipment and radio equipment 5) Japan-Philippines MRA (effective in Dec under Japan-Philippines Economic Partnership Agreement); - Electrical products 3

4 Types of MRAs of Japan 1. Delegation of designation-type (e.g. EU, US, Singapore) 1) The government of an export country designates its domestic conformity assessment bodies(cabs) based on standards of an importing country. 2) CABs of the export country issue the certifications of a conformity to manufactures. 3) The government of the import country accepts the certifications as equivalence to those issued by CABs in the import country. Japan Government <Designate domestic CABs by standards of Country A> 1Application 3Request conformity assessment CABs Manufactures 2Designation 4Issue of certification Japanese Market 5 Export products Country A Government <Designate domestic CABs by standard of Japan> Market of Country A 5 Export products 1Application CABs 3Request conformity assessment 2Designation 4Issue of certification Manufactures *CAB: conformity assessment body 2.Cross-border designation-type (e.g. Thailand, Philippines) 1) The government of an import country designates CABs in an export country based on its domestic standards. 2) CABs of the export country issue the certifications of a conformity to manufactures. 3) The government of the import country accepts the certifications as equivalence to those issued by CABs in the import country. 3Request conformity assessment Japan Government <Designate CABs in Country A by its own standards> 1Application 1Application CABs Manufactures 4Issue of certification Japanese Market 5 Export products Country A Government <Designate CABs in Japan by its own standards> Market of Country A 5 Export products 2Designation CABs 3Request conformity assessment 2Designation 4Issue of certification Manufactures

5 Case 2: Patent Prosecution Highway (PPH) The number of patent applications in the world is increasing along with the globalization of businesses. In particular, the number of applications filed in many offices is increasing significantly. Duplication of work among individual patent offices is also on the rise, which takes longer time to prosecute patent application. Work sharing is effective in the context of the utilization of search & examination results from the office of earlier examination. Search The number of applications filed in many offices is increasing. Changes in Patent Applications Filed Worldwide (Unit: 10 thou.) 2.14 mil mil. 78 an application Search Search Increasing duplicate work! Search 89 Work sharing Case Finished Search Utilization of Results! Source: WIPO Industrial Property Statistics an application prior arts, office actions Refer to the results 5 before searching

6 Case 1: Patent Prosecution Highway (PPH) (cont.) The Patent Prosecution Highway (PPH) is a framework in which an application whose claims have been determined to be patentable in the Office of First Filing (OFF) is eligible to go through an accelerated examination in the Office of Second Filing (OSF) with a simple procedure. The PPH, through the exploitation of all the search/examination-related information of the OFF, (1) supports applicants in their efforts to obtain stable patent rights efficiently around the world (2) reduces the search/examination burden and improves the quality of the examination of the major patent offices in the world. OFF (Office of First Filing) Office Merit Application A Decision to grant a patent OSF (Office of Second Filing) Submit examination documents to the OSF OSF examination burden can be reduced by PPH Applicant Merit Corresponding Application A PPH Request Accelerated Examination 6

7 Case 1: Patent Prosecution Highway (PPH) (cont.) SIC (Colombia) IPOPHL (Philippines) IPO-CZ (Czech) PPO (Poland) EAPO (Eurasia) DGIPR (Indonesia) DIP (Thai) JPO (JAPAN) USPTO (USA) KIPO (Korea) UKIPO (UK) As of January 6, 2014 CIPO (Canada) DPMA (Germany) IP Australia (Australia) IPO (Iceland) SIPO (China) January countries and regions have concluded PPHs. JPO has implemented PPHs with 28 countries and regions. DKPTO (Denmark) EPO (Europe) IPOS (Singapore) NIPO (Norway) PRH (Finland) TIPO (Taiwan) NPI (Nordic) ILPO (Israel) PRV (Sweden) INPI (Portugal) IMPI (Mexico) SPTO (Spain) HIPO (Hungary) APO (Austria) ROSPATENT (Russia) 7

8 Case 3: Business Environment Improvement Committee Many of Japan s Economic Partnership Agreements* have a framework where specific matters of concern to companies relating to the business environment in the partner country are discussed with the governments and related institutions of both countries. (*Implementing countries: Mexico, Malaysia, Chile, Thailand, Philippines, Switzerland, and India, Peru. Future implementation: Indonesia, Brunei, and Viet Nam) Scheme of the Business Environment Improvement Committee (Example of Mexico) Japan-Mexico EPA Joint Committee Mexican Ministries & Agencies Function: Instructions Composition: To operate and manage the agreement in general, supervise the subcommittees and consider revisions to the agreement Representatives of both governments Advice Supervision, direction Business Environment Improvement Committee Instructions Japanese Ministries & Agencies Discussion with each ministry/ agency Response from each ministry/ agency Ministry of Economy of Mexico Composition: Designated Japanese Authorities Reporting of observations Representatives of both governments. Representatives of related industry groups & institutions invited as required Direct Participation Reporting of observations Response from each ministry/ agency Ministry of Foreign Affairs of Japan Designated Mexican Authorities Discussion with each ministry/ agency Complaints, inquiries, consultation requests Sending response Sending response Complaints, inquiries, consultation requests Japanese companies in Mexico Mexican companies in Japan 8

9 Case 3: Business Environment Improvement Committee (cont.) -Recognition of equivalence in Mexico to Japanese regulatory requirements for medical devices - Japanese manufactures sought the recognition of equivalence to Japanese regulatory requirement for medical devices in Mexico to secure the level playing field with US and Canadian producers in Mexico for whom the recognition of equivalence was already applied. In February 2011, Japanese manufacturers raised this issue at the business environment improvement committee under Japan-Mexico EPA as there was no appropriate framework to address it between two countries at that time. The discussion in the committee triggered the cooperation between authorities in two countries towards the creation of the recognition of equivalence. The Ministry of Health, Labour and Welfare(MHLW) of Japan, the Pharmaceuticals and Medical Devices Agency(PMDA), in cooperation with Japanese manufactures, explained the Japanese regulatory system for medical devices, upon the request from the Federal Commission for Protection against Sanitary Risks(COFEPRIS) of Mexico. In January 2012, the Department of Health of Mexico recognized the equivalence. This allowed Japanese applicants to reduce the amount of documentation regarding the application for their medical device registration in Mexico, if the products have already been approved/certified in Japan. (Japan is the third country following the US and Canada.) 9

10 Case 4: MRA of IT Engineer Examination with Asian countries Background As IT industry developed rapidly in Asia, a common challenge for Asian countries is to foster skilled IT engineers. Some of them introduced a national examination to certify IT knowledge and skills. However, as each countries introduced different examination system, it was difficult to evaluate the competence of IT engineers in different Asian countries. This became de facto barrier for cross-border services. In order to solve this problem, Japan, using its rich experience of IT Engineers Examination (ITEE)*, took lead by establishing a network of mutual recognition agreements with those countries. A preferential immigration treatment of Japan for holders of Japan s ITEE certification would also become a incentive for Asian countries to conclude the MRAs with Japan. * ITEE was first administered in 1969, and in 1970 it became a national examination. Since its commencement, the examination has played an important role in the development of IT engineers. ITEE has grown into one of the largest scale national examinations in Japan, with approximately 600,000 applicants each year. 10

11 Case 4: MRA of IT Engineer Examination with Asian countries 2. Japan concluded MRAs with 11 Asian countries/regions 11

12 Case 4: MRA of IT Engineer Examination with Asian countries 3. Combination of different forms of cooperation for establishing broad network of MRAs Countries and regions that already introduced the national examination (India, Singapore, Korea, China, Chinese Taipei) MRA between Japan s ITEE and ITEEs of those members Countries and regions that HAD NOT yet introduced the national examination (Philippines, Thailand, Vietnam, Malaysia, Myanmar, Mongolia) Adopt ITPEC common examination as their national examination MRA between Japan s ITEE and IPTEC common examination * Information Technology Professionals Examination Council (ITPEC) was established in 2005 to create and conduct the common examination on the same date and time with the same set of questions. This consistency enables accurate measurement of the skills of the examinees in any of these countries. ** Bangladesh is now preparing to join ITPEC common examination system in cooperation with JiCA 12 (Japan International Cooperation Agency).

13 Some lessons from Japan s experience As for regulatory issues, first and foremost, 1) unnecessary regulations must not be introduced. 2) All stakeholders in domestic market must be involved in rulemaking process if regulations are introduced. On that basis: 1) There is no single best approach for international regulatory cooperation, and types of cooperation differ based on issues and countries. 2) Business interests are a driving force for international regulatory cooperation. 3) Transparency of rule-making process and their implementation is above all important. In particular, transparency to foreign stakeholders is crucial in the global economy. 4) Capacity building is an important tool when involving developing countries. 13

14 (Government Ordinance) (National Law) Japan s standard rule-making process Publication Implementation enactment Publication Implementation Advisory committee Discussion and its materials are principally open to public. If necessary, stakeholders are invited to express their opinion. Public Consultation (30 days) Report/ Recommendation Draft National law/ Government Ordinance Check by Cabinet Legislation Bureau Inter-ministry consultation Adoption by the Cabinet Deliberations in Parliament Regulatory Impact Analysis(RIA) Publication Check by Cabinet Legislation Bureau Interministry consultation Public Consultation (30 days) Adoption by the Cabinet Prior Confirmation Procedures on the application of laws and regulations ( No Action Letter ) RIA Publication 14

15 Thank you so much. 15