United States | Brussels, 24 May 2016

The European Commission today publishes a report detailing the progress achieved during the 13th round of talks for a trade and investment agreement with the United States, together with its proposal on regulatory cooperation in pharmaceuticals, submitted to the US during the last round of talks. The publication of these documents from the ongoing negotiations on a Transatlantic Trade and Investment Partnership (TTIP) is in line with the European Commission’s commitment to enhanced transparency.

The round report shows that negotiators made good progress in all three pillars of the negotiations, namely:

i) better access to markets for EU and US firms, ii) simplifying technical regulations without lowering standards and iii) global rules of trade, including sustainable development, labour and the environment and a dedicated chapter for smaller firms (SMEs).

However, significant differences still remain, such as in the areas of services and public procurement.

The proposal for cooperation in the pharmaceuticals sector aims to help regulators work more closely together to achieve better efficiency and thereby deliver benefits for patients.

The cooperation would take place in areas such as:

i) recognising good manufacturing practice inspections to avoid unnecessary duplication, ii) exchange of confidential and trade secret information between regulators, iii) supporting each other's work on developing regulations in new areas which could lead to faster and cheaper approval of medicines.

The proposal clearly states that both the EU and the US reserve the full right to regulate to achieve public policy objectives and protect human and animal health, and the environment.

More information

Report detailing the progress Proposal on regulatory cooperation in pharmaceuticals Factsheet on regulatory cooperation on pharmaceuticals EU proposals