EU - JAPAN FTA

Perspectives from the pharmaceutical industry

EESC – Hearing on EU - Japan FTABrussels, 15 January 2014

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Pharmaceuticals: trading with Japan

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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.

Breakdown of the world pharmaceutical market 2012 sales

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Note: Europe includes Turkey and RussiaSource: IMS MIDAS, 2013

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.

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EU-Japan FTA negotiations

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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.

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.

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EFPIA Brussels Office

Leopold Plaza BuildingRue du Trône 108B-1050 Brussels - Belgium Tel: +32 (0)2 626 25 55

www.efpia.eu

EFPIA Brussels Office

Leopold Plaza BuildingRue du Trône 108B-1050 Brussels - Belgium Tel: +32 (0)2 626 25 55

www.efpia.eu