Transatlantic Trade and Investment Partnership (TTIP): Towards better health outcomes for patients and economic growth 1
About EFPIA Þ EFPIA is the voice of the European innovative pharmaceutical industry, representing the world s leading research-based pharmaceutical companies Þ The pharmaceutical industry directly employs over 700.000 people in Europe, including 115.000 in research and innovation, as well as creating four times as many jobs downstream Þ The pharmaceutical industry is one of the key assets of the EU economy, creating employment and investing in medical progress through research and development - bringing new and innovative medicines that improve the health and quality of life for patients all over Europe, and the world 2
Outline Þ TTIP: a unique opportunity for our industry and for patients Þ Main TTIP objectives bringing benefits to both industry and patients Þ Regulatory Convergence Þ Intellectual Property Protection and Enforcement Þ Market Access 3
Strong support for an ambitious TTIP - bringing benefits to patients, science and the economy (I) Þ TTIP can serve as a key platform to foster benefits for the broader life sciences sector, but also has the potential to facilitate the development of new medicines and improve health outcomes. Quicker and more efficient regulatory processes could benefit patients by resulting in faster access to new medicines Þ We support an ambitious and comprehensive agreement that addresses regulatory compatibility initiatives, intellectual property protection and provides for greater market access, which also contains strong commitments for increased investment protection, elimination of all tariffs and streamlined rules of origin 4
Strong support for an ambitious TTIP - bringing benefits to patients, science and the economy (II) Þ Aware of the challenges - longstanding process of bridging gaps Þ 20 months after launch of negotiations, slow but steady progress has been made with technical discussions underway. Þ Need to realise the significant potential of TTIP to strengthen the competitiveness of European industry, providing jobs, economic growth, innovation opportunities and faster new medicines to patients Þ Political will needed to deliver an ambitious agenda Þ Continued support from 28 EU Member States is essential Þ Strengthened engagement with European Parliament Þ Increased dialogue with civil society 5
The value of our Industry 6
EU US pharmaceutical marketplace Þ Transatlantic pharmaceutical marketplace: EU and US represent the two largest markets for pharmaceuticals. Þ EU and US together attract more than 75% of global investment in life-science research. Þ It is the combined home for 9 out of the top 10 worldwide pharmaceutical companies. Geographical breakdown (by main markets) of sales of new medicines launched during the period 2009-2013 3 % Pharmerging 55 % US 23 % Europe 10% Japan 9 % ROW Source: IMS Health MIDAS April 2014 7
EU bilateral trade with the US EU Exports EU Imports USA Switzerland USA Switzerland Russia Japan Singapore China China Others Israel Others 44% 27% 4% 13% 4% 6% 37% 10% 5% 7% 7% 36% The US is the largest market both for EU exports and imports Source: Eurostat COMEXT database April 2014 8
Great potential for strengthening the pharmaceutical market Large companies and SMEs all benefit from greater opportunities: ü Increased bilateral trade ü Predictable investment climate ü Closer research cooperation Resulting in: Ø Enhanced efficiency of drug development Ø Expedited patient access to new, innovative medicines. 9
Regulatory convergence (I) Þ TTIP is a unique opportunity to seek greater regulatory convergence and to create streamlined processes and procedures between the EU and the US Þ The ultimate goal should be to facilitate R&D investment in new and innovative medicines, targeting the unmet needs of patients around the globe Þ TTIP provides a powerful platform to address remaining divergences, in a more expeditious manner, building on longstanding cooperation between the two parties Þ Regulatory convergence can result in: Þ Elimination of unnecessary duplicative submissions, evaluations testing and inspections Þ Harmonisation of processes, which can speed up patients access to medicines Þ Optimising deployment of resources in regulatory agencies and reducing red tape for companies Þ Stimulation of the development and competitiveness of the industry, while ensuring the maintenance of high standards for the quality, safety and efficacy of medicines 10
Regulatory convergence (II) Our proposals: Þ Mutual recognition of GMP (Good Manufacturing Practice) inspections Þ Potential to reduce inspections by 40%, generating significant savings for industry and regulators, allowing agencies to focus on higher risk areas Þ Streamlining of the content and timing of submission of harmonised paediatric plans Þ Establishment of a harmonised list of clinical trial results data fields Þ Establishment of a harmonised approach to post-approval variation submissions for CMC (chemistry, manufacturing and control) changes Ø Need for a built-in agenda allowing for progressive greater regulatory convergence over time in order to address joint approaches to compatibility processes as science evolves 11
Intellectual Property Rights (I) Þ Both the EU and US recognize the value of IP as the lifeblood of innovative industries and provide for strong protection of IPRs within their respective systems Þ TTIP is a great opportunity for the inclusion of a commitment to shared principles Þ To ensure future competitiveness, both systems should be open to further adaptation in order to incentivise research into unmet needs 12
Intellectual Property Rights (II) Our proposals Þ Joint commitment to existing high-level standards for IP protection and enforcement and the establishment of joint IP principles that the EU and the US should treat as a point of reference in all future bilateral and multilateral trade agreements Þ Joint commitment to support enhanced cooperation between patent offices, working towards substantive patent law harmonisation, including a grace period Þ Provide for effective patent enforcement opportunities and support the introduction of an Early Resolution Mechanism 13
Market Access Þ TTIP should ensure that government policies for pricing and reimbursement processes do not create obstacles to pharmaceutical trade between the two parties. Þ Need to negotiate a Pharmaceutical Annex on government pricing and reimbursement policies that Þ Promotes transparency principles in processes Þ Adequately recognises the value of pharmaceuticals and rewards innovation Þ In line with the EU Transparency Directive (Directive 89/105/EEC) Þ Building on recently agreed EU FTAs, i.e. EU-Korea FTA Þ Also covered by U.S.-Korea FTA 14
TTIP can benefit patients, science and the economy Increasing the efficiency of approving new medicines results in patients getting faster access to new treatments Mutual recognition of manufacturing site inspections can optimise regulators resources and reduce costs Reducing the number of clinical trials involving children Increasing regulatory convergence can stimulate SMEs and the life sciences ecosystem Encouraging the development of new medicines and vaccines, and strengthening research cooperation Increasing transparency and due process in pricing and reimbursement systems Sustaining the creation of jobs in the pharmaceutical sector 15
Thank you! 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 TTIP Brochure