EFPIA welcomes the publication of the European Commission’s negotiating proposal on regulatory cooperation in pharmaceuticals, and its efforts to increase transparency in the TTIP negotiations.  EFPIA attaches great importance to these negotiations: we see it as an important opportunity to strengthen the transatlantic pharmaceutical marketplace, accelerate regulatory convergence and deliver tangible benefits for our industry, patients, science and the European economy.

The negotiating proposal provides welcome recognition of important principles that spur innovation, trade and competitiveness. It also acknowledges the existing regulatory collaboration between the EU and US – both on a bilateral and international level – including on major regulatory platforms such as ICH[1]. 

We note with enthusiasm the good progress made to date in advancing a mutual recognition agreement on Good Manufacturing Practice (GMP) inspections and commend the efforts of the European Commission and regulators in addressing this well-known request from EFPIA and other stakeholders.

However, we fail to see additional and necessary regulatory proposals that would allow TTIP to deliver ambitious outcomes once it enters into force. To that end, EFPIA hopes to see a broader range of concrete deliverables, such as in the area of paediatric medicines. Progress here in streamlining procedures could reduce the unnecessary duplication of clinical trials in children. Likewise, there are other areas where TTIP would be an opportunity to make a meaningful impact in streamlining regulatory processes while maintaining the strong standards existing today, such as the harmonisation of clinical trials data fields and a common approach to address post-approval variation submissions for manufacturing changes.

Overall, we would like to emphasise the importance of further tackling unnecessary regulatory barriers and administrative burdens within the transatlantic pharmaceutical marketplace, if TTIP is to be considered an ambitious agreement. This approach would go hand-in-hand with ensuring that TTIP remains a ‘living agreement’ in the years to come, addressing new issues as they arise, and as science evolves. This can be addressed effectively in the joint annual programmes that are set out in the negotiating proposal, and which we would see our industry as playing a key role in contributing to.

While noting that this negotiating proposal is meant only to cover regulatory-related issues, we continue to encourage the negotiators to address other important areas for the pharmaceutical industry – notably regarding Intellectual Property (IP) and market access. Such a broad approach would help realise all the untapped potential to further strengthen our competitiveness, spur innovation on both sides of the Atlantic and result in faster patient access to innovative medicines. 

This untapped potential has been quantified by a TTIP economic study conducted by Copenhagen Economics and commissioned by EFPIA, launched on 24^th May. The study concludes that an ambitious TTIP pharmaceutical chapter can increase EU pharmaceutical exports by €9 billion and provide 19,000 highly productive and qualified jobs in the EU pharmaceutical industry and 60,000 additional jobs in related industries in the EU.