The European Commission is today publishing a report detailing the progress achieved during the 13th round of talks for a trade agreement with the United States, which took place in April 2016, together with its proposal on regulatory cooperation in pharmaceuticals, submitted to the US during this round. 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, notably 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 three main areas: co-ordinating inspections of pharmaceutical facilities to avoid unnecessary duplication, reducing the need for medicines to undergo duplicate approval processes in both EU and the US, and 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. Also today, Commissioner Malmström will deliver a keynote speech on the benefits of TTIP for the European business community, at a conference hosted by the EurActiv Institute in Brussels. The speech will be available on the Commissioner’s website. A factsheet on regulatory cooperation on pharmaceuticals can be found here, and more EU proposals are available here.
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