The world’s largest trading partnership – between the EU and the U.S. – is set to get a significant boost should the Transatlantic Trade and Investment Partnership (TTIP) become a reality. It certainly represents a great chance to strengthen the transatlantic pharmaceutical market and deliver better health outcomes. An ambitious TTIP agreement would spur transatlantic trade and investment in life sciences and foster research cooperation, thereby increasing patient access to innovative medicines on both sides of the Atlantic. We see numerous benefits stemming from TTIP – benefits for patients, science and the economy.
The pharmaceutical sector is one of the most R&D intensive industries in the world. In 2013, five EFPIA companies ranked amongst the top 10 of the world’s largest R&D investors. Furthermore, the socio-economic footprint of the transatlantic industry is remarkable: Europe and the U.S. account for more than 75% of global R&D in life sciences already, creating and sustaining over 1.5 million direct jobs. A boost to this sector would therefore not only contribute to improved health outcomes, but also to national economies and labour markets, including by creating new employment opportunities throughout the pharmaceutical development and delivery chain.
Beyond the figures and general statements, though, concrete facts back up the pharmaceutical industry’s positive stance on TTIP. The agreement, for example, can bring the EU and U.S. regulatory environments closer together and remove barriers that decelerate innovation, while protecting existing high-level safety standards. There is much we can do through TTIP to reduce duplication and align practices between the European and U.S. regulatory agencies, building on an existing and extensive good track record of close cooperation between those agencies: TTIP might not re-invent the wheel, but it can certainly accelerate this cooperation and fast track tangible and valuable initiatives. Also, importantly, it can ensure sustainable, forward-looking cooperation that evolves with new discoveries and processes.
More efficient regulatory processes, void of duplicated efforts, will speed up patients’ access to new medicines and benefit manufacturers, particularly small- and medium-sized enterprises. For instance, the mutual recognition of Good Manufacturing Practice (GMP) inspections via TTIP could reduce duplicative inspections of manufacturing sites on both sides of the Atlantic by 40%, allowing regulatory agencies to focus on sites in higher risk countries. As many new medicines are developed through research collaborations with academic institutions and smaller enterprises, reducing costs of duplicated site inspections will undoubtedly impact positively on smaller companies that operate with fewer resources. The significant cost savings generated could also be used to boost R&D.
TTIP can strengthen research cooperation and encourage the development of new medicines and vaccines. TTIP can facilitate a supportive environment for research and innovation, which represent the backbone of our industry: more opportunity for trade means more opportunity for innovation. TTIP can promote high standards for IP protection and enforcement and provide much-needed stability for companies to continue undertaking high-risk investments into drug innovations to improve patients’ lives worldwide.
Promoting principles for predictable and transparent processes for pricing and reimbursement of medicines can also contribute to improved access to medicines, benefiting patients, healthcare systems and industry alike. This too can be achieved through TTIP by following best practices supported in recent Free Trade Agreements, such as those signed by the EU and U.S. with Korea, and consistent with already existing EU legislation. The promotion of such principles does not by any means interfere with national competences on pricing and reimbursement. On the contrary, it reaffirms the transparency commitments already agreed at EU level.
That people have raised questions – and want to know much more – about an agreement where the potential economic trade benefits to both sides exceed €200 billion is understandable. Many concerns about TTIP, though, have been based on inaccurate information and have morphed into baseless criticisms that need to be addressed. We aim to clarify some of them in our document: TTIP and healthcare: separating fact from fiction.
The pharmaceutical industry is convinced that if TTIP negotiations result in a comprehensive and ambitious agreement, it can create a win-win situation for all, benefiting patients, healthcare, science and business. It is a shot in the arm for both sides of the Atlantic that will help accelerate the global development of medicines, spur innovation and enhance timely patient access to much-needed, innovative treatments.2