Brussels, 24/05/2016 (Agence Europe) - On Tuesday 24 May, the European Commission published the EU's proposal on regulatory cooperation for pharmaceuticals as part of the EU-US free trade talks (TTIP). The EU had sent this proposal to the US at the time of the 13th round of technical level negotiations in New York at the end of April (see EUROPE 11453).
The proposal is aimed at helping EU and US pharmaceutical regulators work more closely together so as to achieve greater efficiency and offer more advantages for patients, the Commission states.
Increased cooperation in the pharmaceutical sector has three main objectives: (1) to coordinate inspections of pharmaceutical facilities so avoid unnecessary duplication; (2) to reduce the need for medicines to undergo duplicate approval processes in both the EU and US; and (3) to support each other's work on developing regulations in new areas which could lead to faster and cheaper approval of medicines.
The EU's proposal clearly indicates that the EU and US reserve the full right to regulate to achieve public policy objectives and protect human and animal health, and the environment, the Commission states.
The proposal can be consulted at: http://goo.gl/Ip0wG2 .
Progress report. The Commission also published a detailed report on Tuesday on the progress made during the 13th round of negotiations in New York on 25-29 April. The report shows progress in the three pillars of the TTIP negotiations - market access (tariffs, services and public procurement); regulatory cooperation (horizontal and sectoral); and rules (including on SMEs, sustainable development, energy and raw materials, investment protection and customs).
Despite “good progress” being made in New York, “significant differences still remain, notably in the areas of services and public procurement”, the Commission states.
The report is available at: http://goo.gl.HRQMoF . (Original version in French by Emmanuel Hagry)
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