The following is a guest blog from Andrew Hotchkiss, Lilly's President Europe, Canada and Australia.
In the week that President Obama visited Brussels and underscored the importance of the Transatlantic Trade and Investment Partnership (TTIP) to transatlantic jobs and growth, I spoke at a conference organised by the American Chamber of Commerce to the EU, TTIP Revealed: Fact and Fiction.
True to the title, conference participants, including policymakers, business and civil society, debated some of the major issues in TTIP to separate out myth from reality.
But first a reminder as to why TTIP matters to Lilly. As a leading player in research-based medicines discovery on both sides of the Atlantic, we have a vital stake in ensuring Europe and the US remain competitive in clinical research, in getting new products rapidly to patients, and in the protection and enforcement of intellectual property. Lilly spends over EUR 450m per year in research and development in Europe and we export to over 120 countries from our high-tech European manufacturing facilities.
One of the most persistent concerns raised is that TTIP is all about lowering regulatory standards. Nothing could be further from the truth for medicines. What we would like TTIP to deliver is a single, high set of standards in key areas on both sides of the Atlantic. Three examples show the importance of this:
• Cutting duplication: both European and American authorities conduct their own inspections of our manufacturing sites. Mutual recognition of Good Manufacturing Practice (GMP) certificates could cut inspections by 40% with no drop in safety standards. This would free up resources for inspections in priority countries like India or China and save companies tens of millions of Euros that could be reinvested in research.
• Speed up development of medicines for children: the EU and US have different requirements for the development of paediatric indications. A simplified and harmonised format for paediatric development plans could help accelerate development of treatments for children.
• Align different standards: changes to manufacturing processes require authorisation from the EU and US authorities - yet the information to be provided and the timescales for authorisation are different. If EU and US authorities can agree on a single, high standard, this will cut bureaucracy and reduce the risk of supply problems in getting medicines to patients.
We think it’s time to focus on fact rather than fiction in TTIP. Rapid progress in the areas I have set out here can help drive greater investment in jobs and R&D and ensure new medicines get to patients as rapidly as possible.