TTIP as a Platform for Progress in Pharma and Medtech Regulations

TY - JOUR

T1 - TTIP as a Platform for Progress in Pharma and Medtech Regulations

AU - Van Vooren, Bart

AU - Ryckmann, Charlotte

PY - 2016/6/22

Y1 - 2016/6/22

N2 - Opponents of the transatlantic trade and investment partnership treaty (TTIP) fear that, the EU might lose the capacity to protect public health as it deems appropriate. The freedom to regulate would be jeopardized because TTIP would bind the EU to the United States’ regulatory interests, which are expressly or implicitly assumed to live up to a ‘lower’ standard than those in the EU. The ‘TTIP-leaks’ provide a good opportunity to examine the potential impact of the agreement on EU public health regulation.We conclude that TTIP negotiation documents on pharmaceuticals and medical devices do not suggest that EU public health is threatened. In both areas, negotiations focus on relatively technical-procedural issues where benefits are clearly mutual. On pharmaceuticals, the benefits of mutual recognition of good manufacturing practices (GMP) exist for consumers, regulators and business alike: efficiency gains through removing duplicate regulatory requirements, regulators can more efficiently leverage resources by focusing inspections where needed the most, and medicines can be brought to market more efficiently while concurrently being subject to more rigorous GMP checks.

AB - Opponents of the transatlantic trade and investment partnership treaty (TTIP) fear that, the EU might lose the capacity to protect public health as it deems appropriate. The freedom to regulate would be jeopardized because TTIP would bind the EU to the United States’ regulatory interests, which are expressly or implicitly assumed to live up to a ‘lower’ standard than those in the EU. The ‘TTIP-leaks’ provide a good opportunity to examine the potential impact of the agreement on EU public health regulation.We conclude that TTIP negotiation documents on pharmaceuticals and medical devices do not suggest that EU public health is threatened. In both areas, negotiations focus on relatively technical-procedural issues where benefits are clearly mutual. On pharmaceuticals, the benefits of mutual recognition of good manufacturing practices (GMP) exist for consumers, regulators and business alike: efficiency gains through removing duplicate regulatory requirements, regulators can more efficiently leverage resources by focusing inspections where needed the most, and medicines can be brought to market more efficiently while concurrently being subject to more rigorous GMP checks.

M3 - Journal article

SN - 1867-299X

VL - 2

SP - 274

EP - 279

JO - European Journal of Risk Regulation

JF - European Journal of Risk Regulation

ER -