The wide-ranging free trade agreement would reduce foreign tariffs for US chemical exports to the EU, Bill Allmond, VP of SOCMA, said. The chemical manufacturing sector in the US would gain the most of any manufacturing sector in the US from the agreement, which was initially set to be finished this year, Allmond said.
SOCMA is also looking to collaborate more with the EFCG (European Fine Chemicals Group) and APIC (Active Pharmaceutical Ingredients Committee), and discussions are continuing around the harmonization of EU and US pharmacopeia.
Allmond gave the example of the US free trade agreement with Korea, which he said helped to virtually eliminate tariffs between the two countries, thereby increasing US exports.
He added that SOCMA has been adamant about the need to further align US-EU inspections of manufacturing sites, as well as for the EU to become more transparent around its chemical manufacturing regulations and how they’re developed.
The EU’s position seems to be aligned with the US in terms of priorities.
“Both Parties should explore possibilities for the recognition of each other's Good Manufacturing Practices (GMP) inspections carried out in the EU and the US and in third countries,” the EU TTIP position on pharmaceutical products says. “An advantage of this approach would be that US Food Drug Administration (FDA) and EU Member States would allow better use of the inspection resources by avoiding the current overlap of inspections of third countries facilities and EU and US facilities which have been already inspected by one of the Parties.”
The EU position also calls for the harmonization of biosimilar regulations between the FDA and EMA (European Medicines Agency). “In the context of the current development of the authorisation system for biosimilars in the US, an advantage of this approach would be the potential increase of approved biosimilars in the US and limit the number of diverging requirements to demonstrate the quality, safety and efficacy of these products,” the paper says.
In addition, harmonization of generics policies is being discussed further. The EU and US “could explore the possibility to streamline authorisation systems for generics including the development or review, if need be, of respective guidelines in particular as regards bioequivalence, biowaivers and the use of reference medicines,” the EU says.