Progress in the April rounds of TTIP negotiations: the EU Commission published an Annex version 24 May 2016 and a Report. The next round in July will further focus on human & veterinary medicines & other sectors.
A Report by Copenhagen Economics for EFPIA highlighted the importance of agreeing terms within TTIP to reduce trade barriers on medicines, estimated to be about 19%. This could boost annual EU pharma exports by 9 billion Euros.
EFPIA welcomed the TTIP Annex on Medicines proposals to further recognize GMP inspections, regulate the exchange of trade secrets trade & regulatory cooperation between the Commission supported by the EMA. It also called for these initiatives to include common standards for paediatric medicines, a harmonization of clinical trials data fields and post-approval variation submissions for manufacturing changes.
There are still opportunities to also address convergence on IP & market access, key factors for a global pharma industry.
Life Sciences businesses should prepare for further coordination & sharing of information between US & EU authorities; continue to call for reduction in duplication of studies and to focus on innovation & support of public health initiatives.