1. EU - JAPAN FTA Perspectives from the pharmaceutical industry EESC – Hearing on EU - Japan FTA Brussels, 15 January 2014 1

2. Pharmaceuticals: trading with Japan 2  Japan is the 2nd largest national market for pharmaceuticals: 12% of the global market, circa €74 billion.  The EU pharmaceutical industry is one of few sectors to contribute positively to the EU’s trade balance. Its trade surplus of €54 billion in 2012 was the highest among high-tech industries.  Japan is the 4th largest EU export market for pharmaceuticals.  A majority of EFPIA members have affiliates and subsidiaries in Japan and EFPIA counts Japanese companies among its members. European companies have established a cooperation platform known as EFPIA Japan in Tokyo.

3. Breakdown of the world pharmaceutical market 2012 sales 3 Note: Europe includes Turkey and Russia Source: IMS MIDAS, 2013

4. EU - Japan FTA offers opportunities  EU-Japan FTA represents a useful platform to bring both markets closer together and boost global drug development.  EU-Japan FTA can create the necessary conditions for a stable investment framework for pharmaceutical companies' research activities, enabling an early recovery of the R&D costs in Japan.  EU-Japan FTA can allow increased harmonization of regulatory processes and standards for drugs and vaccines in EU and Japan. 4

5. EU-Japan FTA negotiations 5  EFPIA recommends: Expansion of MRA on GMPs inspections: build on current MRA and expand it to all MSs and all biopharmaceutical products. Bridge vaccines gap: seek greater harmonization of regulations governing EU and Japan vaccines policies. Address transparency and predictability of market environment: Negotiate an Annex on Pharmaceutical Products. Additional elements: underscore importance of IP protection and enforcement; customs facilitation; effective institutional framework.

6. EU-Japan FTA negotiations and civil society  What benefits for civil society?  Bringing regulatory frameworks closer, facilitating R&D collaboration, creating new market opportunities: bringing innovative medicines faster to the market and enhance greater access to medicines for patients in EU and Japan.  What role for civil society?  Use all communication channels available: receive up-to-date information and input the negotiations.  Promote an informed debate and dialogue: receive regular information from negotiators, participate in public debates and hearings, communicate your preferences and resolve doubts and concerns. 6

7. EFPIA Brussels Office Leopold Plaza Building Rue du Trône 108 B-1050 Brussels - Belgium Tel: +32 (0)2 626 25 55 www.efpia.eu EFPIA Brussels Office Leopold Plaza Building Rue du Trône 108 B-1050 Brussels - Belgium Tel: +32 (0)2 626 25 55 www.efpia.eu