The US-EU Free Trade Agreement: Tipping Over the Regulatory Barriers
U.S. House of Representatives Committee on Energy and Commerce
Subcommittee on Commerce, Manufacturing, and Trade
July 24, 2013 official record
John Castellani, President and CEO, Pharmaceutical Research and Manufacturers of America
1. In 2011, 80% of medicines in development were researched and tested in US and in EU.
2. The costs to develop new medicines continue to increase and global ecosystem grow more hostile to innovation.
3. PhRMA supports TTIP to eliminate unnecessary nontariff barriers between these regions and establishes a model for future trade agreements.
4. US –EU negotiations should address both regulatory compatibility and IPR, market access provisions and customs and public procurement measures.
5. Our industry are concerned about the current European environment because:
1. Shortsighted cost-containment measures, especially as responses to financial crisis
§ Measures were implemented without predictable, transparent and consultative processes.
§ These measures raises serious concern about EU member states’ commitment to reward innovation.
2. EMA current and proposed data disclosure policy
§ disclosure of nonpublic data submitted in clinical and preclinical dossiers and patient-level data sets risks damaging both public health and patient welfare
§ PhRMA urge US government to ensure responsible data sharing with EU.
3. Market Access Commitments
§ PhRMA recommend to include a US-Korea FTA like commitments in US-EU trade agreement
§ The commitments should recognize the value of biopharmaceuticals and the value they play in reducing more costly medical interventions and the increased quality of life
6. Both EU and US should recognize IP as the lifeblood of innovation and strong IPR rules within legal regimes. Any agreements must not dilute IPR.
7. PhRMA, FDA and EMA has proposed a number of regulatory compatibility initiatives to reduce regulatory burden. (e.g. reduce redundant testing, seeking mutual recognition of manufacturing and clinical principles)