EU-Japan Business Round Table

JOINT RECOMMENDATIONS"Paving the Way for a Renewed Industrial Partnership"
27 & 28 April 2015, Brussels
1. Introduction
The EU-Japan Business Round Table (BRT) held its Annual Meeting in Brussels on
27 and 28 April 2015 with the theme of “Paving the Way for a Renewed IndustrialPartnership”. The meeting was chaired by: Mr. Fabrice Brégier, President and CEO of Airbus SAS, and Mr. Kazuo Tsukuda, Senior Executive Adviser of Mitsubishi Heavy Industries, Ltd.
The BRT had the pleasure and honour of welcoming high-level representatives of theEU and Japanese Authorities:

From the EU: European Commission – Mr. Carlos Moedas, Commissioner,Research, Science and Innovation; Mr. Daniel Calleja-Crespo, Director-Generalfor Internal Market, Industry, Entrepreneurship and SMEs; Mr. Jean-Luc Demarty,
Director-General for Trade; Ms Maria Åsenius, Head of Cabinet for Cecilia
Malmström, Commissioner for Trade; and Mr. Zoran Stančič, Deputy
Director-General, Directorate General for Communications Networks, Content &Technology.



From Japan: Mr Yoshihiro Seki, Parliamentary Vice-Minister of Economy, Tradeand Industry, Ministry of Economy, Trade and Industry; Mr Naoki Ito, Deputy
Director-General, Economic Affairs Bureau, Ministry of Foreign Affairs; and, MrKiyoshi Mori, Director-General for International Affairs, Global ICT StrategyBureau, Ministry of Internal Affairs & Communications.

The meeting consisted of the following:
1. Discussion and adoption of general and sectoral recommendations to bothsides‟ Authorities;
2. Discussions on (i) Progress Towards an EU-Japan Free Trade Agreement(FTA) / Economic Partnership Agreement (EPA), (ii) Developing Regulatory
Cooperation, (iii) Energy and Climate Change (including the BRT‟s position on
COP21), and (iv) Industrial Cooperation in the Transport Sector;3. High-level discussions with representatives of the Japanese and EUAuthorities.
The BRT Members unanimously agreed to submit their joint recommendations toPrime Minister Shinzo Abe of Japan, European Council President Donald Tusk, andEuropean Commission President Jean-Claude Juncker.

2. Background
The BRT deeply appreciates the recognition that the May 2014 EU-Japan Summit
Leaders gave to the BRT in their statement as follows:“We recognize the active and continued contribution of the EU-Japan Business
Round Table (BRT) to further development of bilateral economic relationship, andreaffirm our determination to promote cooperation with the business communities
on both sides, notably through the BRT, in order to strengthen relations further.”
The BRT welcomes the priority assigned by the new European Commission to more
economic growth, a European Energy Union and the reform of the Monetary Union,
and welcomes the expansion of „Abenomics‟ policy measures aimed at spurring
private sector-led growth, including significant regulatory reforms positively affecting
the investment climate.
The BRT sees 2015 as a critical step in the development of our bilateral economic
relationship as well as in tackling climate change. This year, the EU-Japan business
relationship will be framed by the increased joint efforts towards an early conclusionof the EU-Japan FTA/EPA negotiations and by the development of regulatory
cooperation. In parallel, the EU and Japan will have to play a leading role on the way
to an international agreement at the Paris Climate Change Conference (COP 21) inDecember, while securing our shared interests towards our economic recovery andsustainable growth.
At its 2013 Paris meeting, the BRT issued a Joint Statement welcoming the launch of
the EU-Japan FTA/EPA negotiations. It urged that “the negotiations should becompleted as early as possible and their outcome be compatible with the high level ofthe stated ambition”. In the BRT Recommendations adopted at the 2014 Tokyo
meeting, the EU and Japanese business communities reiterated their support for theearliest possible conclusion of the negotiations of an ambitious agreement. Today theBRT reaffirms these past statements.
The BRT welcomes the determination of Prime Minister Shinzo Abe of Japan, and theEuropean Commission President, Jean-Claude Juncker, on the occasion of theirNovember 2014 meeting in Brisbane, to work for agreement in principle on acomprehensive and ambitious EU-Japan FTA/EPA during 2015 reflecting their joint
economic strength and leadership. This strong ambition and political leadership was
repeated during the ensuing meetings between Trade Commissioner Cecilia
Malmström and Minister of Foreign Affairs Fumio Kishida and Minister of Economy,
Trade and Industry Yoichi Miyazawa.
The BRT expresses its deep concerns on man-made climate change and its
increasing disruption on our economies, and welcomes domestic and multilateralefforts to tackle climate change. The BRT views as essential the pursuit, in parallel, ofsound economic growth, and strongly welcomes the efforts by the Authorities on bothsides to promote economic recovery and growth. The BRT also hopes that Japan andthe EU will adopt strong policies to spur their industry‟s efforts to cooperate to achieve
economic sustainability and a low-carbon, circular economy.
23. Calls and Recommendations
The BRT welcomes and supports the Authorities‟ determination to work foragreement in principle on a comprehensive and ambitious EU-Japan FTA/EPA during2015. The BRT restates its longstanding conviction that an EU-Japan FTA/EPA will
boost trade and investment, promote job creation and accelerate growth in both
economies, and that it will also help create new opportunities for global economic
growth. The BRT reiterates its call for the EU and Japanese Authorities to step up
their efforts to tackle and resolve the substance of outstanding issues and toconclude a comprehensive, ambitious, high-level and mutually beneficial FTA/EPA assoon as possible, and reaffirms its commitment to making efforts to achieve thisobjective, such as making industry expertise available.
The BRT believes that an aim of a speedy conclusion must come together with a highlevel of ambition. Should a sufficiently high level of ambition seem difficult to achieveon the basis of the technical negotiations, the BRT urges, for the sake of oureconomies, political leaders at the highest level to intervene to resolve the deadlocks
and bring the negotiations to a timely and ambitious conclusion.
The EU-Japan FTA/EPA can, together with the TPP and TTIP, play a leading role inpromoting global trade rule-making, regulatory cooperation and standards‟
harmonisation and achieve an open, seamless global business environment that will
create growth opportunities for the EU, for Japan, and for the rest of the world, thus
helping to revitalise trade liberalisation efforts at the multilateral WTO level as well.
The BRT calls on the Leaders of the EU-Japan Summit to ensure that the FTA/EPA
provides a solid and comprehensive framework for regulatory cooperation to address
the sector-specific concerns of the business community. In addition, the BRT
welcomes the adoption of a Joint Document for Regulatory Cooperation at theEU-Japan Industrial Policy Dialogue between METI and DG GROW on 17 March2015. As a long-standing advocate of regulatory cooperation, and recognising that
this is a key issue for the future, the BRT hopes that this joint initiative will reinforce
and complement the upcoming FTA/EPA and set the frame for a solid,
forward-looking and long-lasting regulatory cooperation. The BRT is willing to support
the EU and Japanese Authorities on regulatory cooperation matters.
The BRT also recommends that the EU and Japan initiate or facilitate newcooperation on a broad range of issues in innovation, energy, natural resources,environment and climate change, demography, financial markets, support for smalland medium enterprises and human resources development, and also explore themany opportunities of cooperating together in or with third countries.
The BRT strongly supports the negotiation of an international agreement at COP 21
that concretely tackles climate change while ensuring fair competition in a stable andpredictable business environment. The BRT states its support to the deployment ofaffordable existing solutions, and asks for enhanced public measures encouraging
investment in innovative technologies in green energy and energy efficiency, areas
where many BRT Member companies are already firmly engaged.

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The BRT affirms the crucial role of energy in our economies, and asks the EU andJapan to promote policies to secure energy supplies and keep energy prices low
while reducing GHG emissions. In this context, the BRT supports the restart ofnuclear power generation in Japan subject to the agreement of the safety authorities,
as well as the creation of a European Energy Union targeting the above-mentionedgoals.
Finally, the BRT not only supports concluding bilateral FTA/EPAs with key third party
economic partners, it also reaffirms its long-standing support to concluding the World
Trade Organization‟s multilateral Doha Round as soon as possible. In thatperspective the BRT applauds the decision reached by WTO Members in November
2014 to take forward the implementation of the Agreement on Trade Facilitation thatwas reached at the Bali WTO Ministerial Conference of December 2013.
The BRT calls on EU and Japanese Authorities to address the following issues.
(A) Trade, Investment, and Regulatory Cooperation
 Work for an agreements in principle during 2015 on a comprehensive andambitious EU-Japan FTA/EPA, with the aim that a speedy conclusion mustcome together with a high level of ambition.
Further make efforts to contribute to WTO‟s DDA negotiations, so as tovitalise and create momentum to move the negotiations forward.

The BRT strongly supports the regulatory cooperation initiative and theapplication of international harmonised technical requirement andprocedures for the testing and approval of products that are tradedinternationally, as to minimise re-certification.

Support the timely development of business. Specifically, the BRT calls for
expansion of the number of bilateral social security agreements that havebeen concluded and for liberalisation of the movement of intra-corporatetransferees within the framework of an FTA/EPA.

Develop measures that will promote and assist each other's SMEs within
their own jurisdictions. The BRT also calls for cross-support, such as
logistic support, various tax incentives, and other measures, to be includedin the EU-Japan FTA/EPA negotiations.

Moreover, the BRT calls for the EU Authorities to speedily resolve the EU-specificissues identified in the Working Party A document by the Japanese Members ofthe BRT, and for the Japanese Government to resolve the Japan-specific issues
identified in the Working Party A document by the EU Members of the BRT.

(B) Life Sciences and Biotechnologies, Healthcare and Well-BeingIntroduction4 The EU and Japan should formulate concrete strategies and action plans inLife Sciences & Biotechnology, thereby focusing on measures to support theimprovement of efficient healthcare practices, food security and supply andinnovations in biotechnology.
General The EU and the Japanese governments should sensitively handle theapproval/adaption of CDB/the Nagoya Protocol on Access to genetic
resources and Benefit Sharing (ABS).
HealthCare (Pharmaceuticals, Medical Devices, Medicinal Gases, etc.)
 The EU government should reinforce its innovation policy to member states
and clarify its healthcare policy, resulting in the appropriate evaluation of thevalue of pharmaceuticals and medical devices. In addition, MHLW should
consult all key stakeholders with respect to any new HTA (Health TechnologyAssessment) issues.
 Japan should further support the implementation of new innovation-rewarding
pricing systems for pharmaceutical products, including the abolishment of therule of re-pricing by market expansion and the abolishment of the 14-dayprescription rule. Such measures would enhance the pricing system‟s
promotion of innovative products.
 National tests for vaccines should be eliminated or reduced to an absoluteminimum.
 Japan should promote an innovation-rewarding pricing system for medical
devices in order to move towards a product-based, market-oriented
reimbursement pricing system for these products.
 The EU and Japan should improve the pharmaceutical and medical device
business environments by proceeding with regulatory harmonization andfurther extension of “Mutual Recognition Agreements” in order to avoid
redundant inspections of manufacturing facilities (e.g. injectable
pharmaceuticals and APIs) and ensure recognition of quality management
audit results for lower risk medical devices
 Japan should support the reinforcement of strict regulations for GMP on
medicinal gases.
Animal Health Europe should introduce a 1-1-1 concept (one dossier – one assessment –one decision on marketing authorization) for all animal health products,
thereby further harmonize the regulatory requirements for productregistrations, shorten review times and recognize the GMP certification for
veterinary products.
 Europe and Japan should promote the responsible use of antibiotics in AnimalHealth.
 Japan should clarify registration requirements and shorten the review process
for introducing recombinant vaccines from Europe.

5 Japan should promote animal welfare in animal drug administration byaccepting more overseas data and an alternative approach.

Plant Protection & Biotechnology
 The EU and Japan - working closely with the private sector - should speed up
research in Plant Protection & Biotechnology and inform the public regularly
and accurately about the state of GMOs, based on sound scientific knowledge,
thereby closely working with private sectors.
 The EU should shorten the review times for new applications / productregistrations in both plant protection and biotechnology.

(C) Innovation, Information & Communication Technologies
ICT The BRT expects that the EU regulations will be streamlined under the Digital
Single Market Strategy to be released in May 2015.
 The EU and Japan should influence international negotiations by taking
harmonized actions based on our common principles regarding internet
governance, cybersecurity, privacy protection, data utilization, cross-borderdata flows and forced localization measures.
Innovation in General Initiatives under Horizon 2020 and Japan‟s forthcoming 5th Science andTechnology Basic Plan should lead to further strategic R&D cooperation.
 Both sides‟ Authorities should favour joint R&D programmes with potential forstandardisation, as in advanced manufacturing and the Internet of Things.
Aeronautics
 The BRT recommends the signature of a BASA between the JCAB and theEASA that would cover both type certification and maintenance activities.
 The BRT recommends a better bilateral cooperation at an increased level onnavigation regulations for helicopters.
Space The BRT recommends that the newly established EU-Japan Space Policy
Dialogue be used to discuss regulatory cooperation in space operations.
 The BRT recommends to bring about a mutual backup cooperation scheme ofgovernment launches using the EU and Japan‟s satellite launcher fleets.
Defence The BRT recommends to continue laying out official instruments of industrial
cooperation between Japan and individual EU Member States.
 The BRT also recommends contacts between Japan and both the EuropeanCommission and the European Defence Agency.

6Railways
 The BRT recommends an open description of compliance requirements andprocesses, and transparency of certification procedures and their evolutions.
 The Authorities‟ commitments on transparency etc. should be implemented
and result in significant improvements of actual market access conditions.
(D) Financial Services, Accounting and Tax Issues
 The BRT requests that regulating bodies fully address the impact of reforms
and new regulations on the real economy notably in the implementation phaseand take a co-ordinated approach to reduce extraterritorial impact of rules
introduced in one jurisdiction on other locations and to recognise substitutedcompliance.
 The BRT recommends that, as to the BEPS (base erosion and profit shifting)
Action Plan, the authorities should carefully consider the risks of excessive
disclosure requirements and anti-tax avoidance measures so as not to hamper
multinational enterprises‟ business activities.
 The BRT maintains its serious concern over the EC‟s proposed financialtransaction tax (FTT), particularly with respect to its wider application.
 The BRT urges the Japanese Government to devise a detailed roadmap
towards its goal of primary-balance surplus by fiscal 2020.
(E) Energy, Environment, and Sustainable Development
 The BRT supports the negotiation of new international climate agreement atcoming COP 21 that will be an ambitious challenge in terms of reduction ofworldwide GHG emissions. To achieve difficult and bitter reduction target
applicable to all developed and developing countries with fair and transparent
rules, positive commitments from major greenhouse gas emitting countries(including emerging countries) are inevitably crucial and every country should
create and maintain a proper environment to achieve a cost-effective
de-carbonation in the long-term.
 The BRT supports to call for the deployment of new sustainable and workableclimate solutions, and also to study new effective policies and measuresencouraging investment in innovative technologies in the field of green energy
or energy efficiency where many BRT members are already firmly engaged.
 The BRT recognize that business sectors have the crucial role of energy
issues as a player or a user in our societies.
 The BRT requests that the Authorities of the EU and Japan promote effective
policies to support next generation advanced and competitive technology andto secure energy supplies and keep energy prices low while reducing GHGemissions. In this context, the BRT supports the restart of nuclear reactors inJapan subject to the agreement of the safety authorities, as well as thecreation of a European Energy Union targeting goals.

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