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TTIP: Global Regulatory Cooperation and Convergence

August 16, 2013
The Transatlantic Trade and Investment Partnership (TTIP) initiative holds tremendous promise for the long-term competitiveness of the Transatlantic economy by supporting research and development of innovative technologies. A concerted effort through the TTIP to unleash the potential of biotechnology in the Transatlantic economy can help bring innovative products to consumers, create jobs, and improve economic prospects on both sides of the Atlantic.

The recent (TTIP) negotiations focus on several principles that BIO promotes to boost the global biotech industry (access our Global Policy Principles here).

Governments can promote innovation and ensure the safety and efficacy of biotech products by creating regulatory review processes that are science-based, transparent, and time-limited. Such processes provide the legal certainty necessary to bring innovative products to market, promote consumer confidence, facilitate scientific dialogue between industry and regulators, avoid unnecessary delay, and enable regulators to make the most informed decisions.

The prospect of significantly deeper regulatory cooperation and convergence related to bio-pharmaceuticals represents one of the most promising aspects of the TTIP. Such convergence will enhance Transatlantic innovative leadership in the sector. The regulatory focus within TTIP will build on the considerable work that U.S. and EU regulatory authorities have undertaken in recent years.

Under the framework of the Transatlantic Economic Council and the High Level Regulatory Cooperation Forum, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have solidified relationships, collaborated on inspections, consulted on issues related to approval of pediatric therapies, and worked to streamline reporting requirements, among other initiatives.

These efforts are producing real world results, and helping to reduce costs and administrative burdens for many biotech innovators on both sides of the Atlantic. This is particularly important for emerging biotech companies, and the challenges they face in navigating regulatory systems.

However, much more can be done to minimize or eliminate unnecessary regulatory divergences or duplicative requirements. This can reduce the considerable cost of therapeutic innovation, and speed the development and delivery of safe, life-saving medicines to patients. Intensified regulatory cooperation and convergence has assumed particular importance in light of the challenges – in terms of cost and regulatory complexity – involved in the development and approval of biologic drugs.

A final TTIP agreement should directly incorporate convergence outcomes, as well as allow for adaptability and the ongoing integration of regulatory approaches, taking into account constantly evolving scientific and other factors surrounding the development of biologic drugs and other bio-pharmaceuticals.

Through dialogue with negotiators, regulators, and other stakeholders, we expect to further refine and expand upon these suggestions as the TTIP process moves forward.