International Affairs Bureau
KEIDANREN
The following is a summary, not an exhaustive list, of progress on EU-Japan dialogues in major sectors. Some progress was reported at the third sector-to-sector meeting that BUSINESSEUROPE and KEIDANREN hosted on 4 March 2014 in Brussels#1.
Automobiles:
Since the 1990s, JAMA (Japan Automobile Manufacturers Association, Inc.) has worked with ACEA (European Automobile Manufacturers Association) through bilateral dialogue to improve the business environment in both the EU and Japan. On 3 March 2014, JAMA and ACEA held a regular bilateral consultation meeting in which many common issues, including six non-tariff measures in Japan, were discussed. At the sector-to-sector meeting on 4 March, JAMA reported on such issues as the progress made with respect to new, auto-related tax initiatives and the continuing adoption of the UN Regulations.
Chemicals:
In November 2013, JCIA (Japan Chemical Industry Association) issued a statement jointly with Cefic (European Chemical Industry Council)#2, calling for an ambitious and comprehensive EPA/FTA between the EU and Japan. JCIA reconfirmed with Cefic that an ambitious and comprehensive trade agreement—rather than watered-down compromises, especially in areas such as intellectual property rights and the rules of origin in the area of industrial chemicals—would benefit the entire manufacturing industry of both the EU and Japan. At the sector-to-sector meeting on 4 March, JCIA expressed its intention to continue to call upon both governments of the EU and Japan to streamline Japan's CSCL (Chemical Substances Control Law) as well as the EU's REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) and BPR (Biocidal Products Regulation).
ICT:
At the sector-to-sector meeting on 4 March, JEITA (Japan Electronics & Information Technology Industries Association), together with DIGITALEUROPE, called for relaxing or harmonizing the regulatory framework for cloud computing, cybersecurity, movement of personnel, and patents, among other things, and requested the governments of both the EU and Japan to make sure that an EU-Japan EPA/FTA set the right standards for third markets, such as prohibiting forced localization and taking anti-counterfeit measures.
Medical devices:
At the last Diet session, Japan's Pharmaceutical Affairs Law was amended to establish new clauses on medical devices separate from pharmaceuticals. Under the new law, QMS audits are to be streamlined and conducted on the basis of groups of products rather than on the basis of individual products, as is the case currently. Stand-alone medical software is to be regulated as an independent medical device. The third party accreditation system has been expanded to include specially controlled devices. The regulatory authority needs to be notified of package inserts (Tempu-Bunsyo), but the inserts may be omitted if certain conditions are met. Ordinances and designated standards are to be prepared before the enforcement of the amendment. JIRA (Japan Medical Imaging and Radiological Systems Industries Association), together with COCIR (European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry), reported these developments at the sector-to-sector meeting on 4 March.
Pharmaceuticals:
In Japan, the GCP (Good Clinical Practice) Ordinance was amended in December 2012 in order to ensure consistency with the contents of the ICH-GCP Guidelines. The Minimum Requirements for Biological Products were revised in September 2013 with a view to ensuring consistency with international standards in terms of specifications and testing methods for vaccines. Application of the Mutual Recognition Agreement on the GMP (Good Manufacturing Practice) has been expanded to include new EU member states. JPMA (Japan Pharmaceutical Manufacturers Association), together with EFPIA (European Federation of Pharmaceutical Industries and Associations), reported these developments at the sector-to-sector meeting on 4 March.
Railways:
Japanese railway companies have made efforts to provide procurement information and enhance exchange of information with EU companies in order to utilize high-quality products, and they have already purchased many EU-made products. On 27 March 2014, the European Commission and the Japanese Government hosted the first meeting of the Railways Industrial Dialogue in which Japanese railway companies and the UNIFE (Association of the European Rail Industry) participated among others. At the meeting, Japanese railway companies explained their technical needs with a view to adopting excellent technologies from the EU and expressed their intention to make procurement information more available.
Textile:
In November 2013, JTF (Japan Textile Federation) issued a statement jointly with EURATEX#3 on promoting an EU-Japan EPA/FTA. The statement says that JTF and EURATEX consider it essential that the agreement foresee duty-free access from day one for all textile and clothing products with full reciprocity and no exceptions, adopt double transformation (two steps rule) as the basis for the rules of origin, and achieve harmonization and compliance with international standards in regulatory areas (e.g., labelling).