According to an official press release issued at the conclusion of the tenth round, EU and U.S. negotiators focused on consolidating their work in all three pillars of the negotiations, especially as regards: (i) market access; (ii) regulatory cooperation, covering both horizontal and sectoral elements; and (iii) rules. Special attention was dedicated to pharmaceuticals, competition, investor-to-state dispute settlement (ISDS) procedures and SMEs.
With regard to market access, EU and U.S. negotiators reached an important milestone when both sides exchanged revised services offers and the EU tabled a proposal for revised services chapters. Mr. García Bercero, the EU’s chief negotiator, confirmed that tariffs and public procurement remain essential elements of the negotiations, although they were not discussed in this last round.
Mr. García Bercero reported that a lot of time was dedicated to the regulatory pillar, resulting in a significant convergence that comprise of five elements:
- Agreement on good regulatory practices;
- Ambitious chapters on technical barriers to trade (TBT) and sanitary and phytosanitary (SPS) measures;
- A framework to facilitate regulatory cooperation in the future; and
- Greater regulatory compatibility in nine key sectors, including cars, medical devices and pharmaceuticals.
Mr. García Bercero provided an illustration of the work done in the pharmaceutical sector. Regulators have reviewed the work being conducted by both parties on assessing good manufacturing practices (GMP), which ensure that pharmaceuticals are available to consumers and are produced with the highest protection standards. Regulatory cooperation has led to compatible regulations permitting a single development programme for biosimilar medicines. This will avoid duplication in the generic medicine industry and could lead to greater availability of cheaper biosimilar medicines for patients.
Finally, Mr. García Bercero reiterated the principles on which the regulatory discussions are based:
- Nothing done in the regulatory area will reduce any standards of consumer, health, labour or environmental protection;
- Regulatory cooperation must be based on mutual interests and be led by the regulators from both sides; and
- Future decisions will be adopted according to the domestic regulatory frameworks of each side.
In the area of rules, discussions focused on competition, customs, trade facilitation, energy and raw materials and SMEs. Sustainable development was not discussed, because the EU is finalizing a proposal in this area for presentation to the U.S. in September.