The BIA provided brief comments about the key issues for the bioscience sector in the ongoing EU-US Transatlantic Trade and Investment Partnership (TTIP)  discussions following a request from the Minister for Universities and Science, the Rt Hon David Willets MP. Hana Janebdar, an Imperial College Biology student undertaking a Cogent placement at the BIA, outlines the submission. 

The BIA highlighted its support for an ambitious and comprehensive trade agreement between the EU and US. In particular, the BIA observed that the TTIP would significantly improve the business and operating environment for life science companies if it achieved both regulatory convergence and cooperation on intellectual property (IP) protection.

Regulatory convergence

The BIA noted that the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), both world leading regulatory bodies, have already taken steps to increase regulatory convergence.

The BIA recommended that the TTIP should cement these early efforts by:

  1. Providing for the mutual recognition of Good Manufacturing Practices (GMP) inspections as well as Good Clinical Practice (GCP) inspections.
  2. Expanding the current programme of parallel scientific advice.

Both of these measures would reduce costs and delays as they would remove the need for duplicative inspections and streamline regulatory processes.

Cooperation on IP protection

As the importance of a robust, reliable and enforceable IP framework within which innovative companies can operate is equally recognised by both the EU and the US, the BIA suggested the TTIP should also seek to further cooperation with regards to this in three ways:

  1. The TTIP should seek to align regulatory data protection to support ongoing innovation.
  2. The TTIP could harmonise post-grant review procedures to encourage early patent dispute resolutions.
  3. It should ensure the highest standards of IP protection that includes adequate compensation for any regulatory or administrative delay that erodes protection.

The second round of talks are due to get underway shortly and the BIA looks forward to further engagement where possible.