June 28, 2016
By Doris Schernhammer, Senior Manager, Corporate Affairs – Europe and Canada, Lilly
We live in an amazing era for medicines. During the past two decades, the pharmaceutical industry has discovered life-changing treatments for some of the deadliest diseases. These innovative discoveries have improved the lives of hundreds of millions of people and will continue to benefit many more in the future. However, in order to continue the benefits this era of discovery has provided, we must maintain the environment that fosters innovation and makes these discoveries a reality.
The biopharmaceutical industry is truly a transatlantic industry. Seventy-five percent of global research and development in the life-sciences takes place in EU and the US, and the industry alone creates 1.5 million direct jobs in the sector. This is exactly why we recognize the Transatlantic Trade and Investment Partnership (TTIP) as a once-in-a-generation opportunity to stimulate growth, strengthen economic competitiveness and reach more patients than ever before.
Supporting the world’s most important trading relationship can not only serve as a gateway to collaboration and innovation but also serve as a key platform for faster delivery of medical treatments to patients around the world. Aside from greater patient access to innovative medicines, a recent study by Copenhagen Economics notes that a comprehensive pharmaceutical chapter in TTIP which aligns regulatory regimes and reduces duplicative costs can also support new long-term economic benefits: It can increase EU exports of pharmaceuticals by €9 billion, provide 19,000 highly productive and qualified jobs in the EU pharmaceutical industry and 60,000 additional jobs in related industries in the EU.
TTIP must unlock the true potential of the transatlantic pharmaceutical market. We need an ambitious, comprehensive agreement that addresses regulatory alignment; upholds intellectual property protection and enforcement; and ensures transparent and predictable processes on pricing and reimbursement.
• Regulatory Alignment: TTIP can contribute to address regulatory divergences between the systems and reduce bureaucratic barriers and duplication while ensuring faster access to safe, high-quality medicines for patients. We are not advocating de-regulation or lowering standards; but are shedding light on our industry’s need for a truly collaborative initiative that aims for the highest standards to facilitate and spur innovation in the pharmaceutical sector. Building on the long-standing cooperation between the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), further alignment of regulatory processes and procedures can reduce redundant testing, create efficiencies and optimize the use of limited regulatory agency resources.
• Intellectual Property: TTIP provides an opportunity to enshrine existing high standards for Intellectual Property (IP) protection and enforcement. IP is the lifeblood of our industry and stronger protection will significantly contribute to incentivising the development of innovative medicines that meet patients’ needs.
• Market Access: Finally, we believe TTIP can help underscore the importance of transparent and predictable pricing and reimbursement systems, enabling innovation to flourish and the biopharmaceutical industry to continue to bring new medicines to patients.
But it’s not just about setting ambitious standards for our industry, we believe TTIP can set global standards for trade as well and can be an appropriate benchmark for future trade agreements.
We encourage the TTIP negotiators to continue to aim high and continue to push towards an ambitious and comprehensive agreement. If done right, TTIP can greatly benefit patients. It has the potential to increase transatlantic investment in life sciences, foster research cooperation and facilitate global development of new medicines.
Doris Schernhammer is Senior Manager, Corporate Affairs – Europe and Canada at Lilly. Lilly is a member of the American Chamber of Commerce to the EU.