The 10th round of negotiations for The Transatlantic Trade and Investment Partnership (TTIP) was concluded on July 17th 2015, in Brussels. During the negotiations, the parties discussed all three pillars of the TTIP – namely: 1) market access, 2) the regulatory component and 3) the so-called ‘rules’ issues. According to the Statement of the EU chief negotiator – Ignacio Garcia Bercero, much of the discussion focused on regulatory affairs with significant convergence between the parties.
Potential Content of the Upcoming TTIP and Position of the EU Institutions
In this regard, the EU chief negotiator identified the concrete possibility of achieving agreement on the following aspects:
- Good Regulatory Practices
- Enhanced cooperation in the areas of technical barriers to trade (TBT) sanitary and phytosanitary (SPS).
- Creation of a framework to facilitate regulatory cooperation in the future
- Greater regulatory compatibility in nine sectors, among which are Medical Devices and Cosmetics
Specifically in the case of Medical Devices, according to the Report published by the Commission, during the negotiations the parties updated each other on recent developments within the field, while acknowledging their cooperation progress to date. The negotiation efforts of the parties at present are aimed at establishing:
- Medical Devices Quality Management System Audits (QMS);
- Unique Device Identification (UDI); and
- Regulated Product Submission (RPS)
According to the EU chief negotiator, the position of the Commission remains firm on three pivotal points. Firstly, the TTIP will not affect the EU’s high standards in respect to consumer, health, labor or environmental protection. Secondly, the main driving force behind regulatory cooperation should be the pursuit of a common interest. Thirdly, the EU regulatory processes will not be altered as a result of the TTIP.
This statement of reassurance is a direct response to the European Parliament’s (EP) Resolution from July 8th 2015. Although the resolution of the Parliament provides a strong indication of political support, it also raises specific concerns. In addition, the EU chief negotiator´s statement further compliments the position of the Commission on medical devices, published in April 2015.
In respect to cosmetics, the report from the Commission indicates that one of the main objectives “remains the approximation of safety assessment methods and the streamlining of the authorization procedure in the US.”
Obelis European Authorized Representative Center in its role as professional consultant – providing constant updates on the upcoming and potential regulatory changes – has closely followed the political, legal and regulatory discussions on this topic and has provided the following articles in the past:
- Transatlantic Trade and Investment Partnership: Steps towards faster access to Medical Devices
- TTIP and SMEs: what potential?
- European Parliament rejects the inclusion of health in the TTIP talks
- The TTIP will not get banned ingredients into the EU
Want more information on this topic? Please contact us!