1. Public Consultation on the future of EU-US trade and economic relations Guy Villax EFCG Board Member, CEO of Hovione, Portugal EFCG Press Conference, 9° October 2012, CPhI Madrid

2. Background EU US Transatlantic trade and investment = largest economic relationship in the world Vital to the strength of both economies Committed to identify new ways to strengthen this EU US Leaders Summit meeting 28 November 2011  EU-US High Level Working Group (HLWG) on Jobs and Growth  EU-US High Level Regulatory Cooperation Forum (HLRCF) Public consultation process to end October 2012 http://trade.ec.europa.eu/consultations/index.cfm

3. Potential Options for Expanding Trade and Investment Elimination, reduction, prevention of barriers to trade and investment (e.g., tarrifs and non-tarrif) Enhancing the compatibility of regulations and standards Development of rules on global issues to help achieve shared economic goals re. 3rd countries Consultation aimed at trade and industry bodies in both EU and US ideally with joint submissions

4. EFCG involvement in Joint Submissions 1.HLWG deadline 30th September, 2012 Submitted a joint EFCG / APIC paper via Cefic/American Chemistry Council (ACC) 2. HLRCF deadline 31st October, 2012 Submitting a similar joint EFCG / APIC/ SOCMA paper via SOCMA, IBEC/American Chamber of Commerce, and Cefic/ACC

5. Proposed areas for action All related to regulatory harmonisation and standardisation proposals affecting the EU and US Pharmaceutical Industries (APIs): – Mutual Recognition Agreements – Regulatory Assessment of Changes – Harmonisation of Pharmacopoeia – Good Manufacturing Practices (GMP) Certification

6. Next Steps Before the end of 2012, HLWG and HLRCF to meet to consider all inputs from the public consultation process and to provide feedback.