A single globally-recognised approval process for medical devices has long been at the top of the medtech industry’s wish list. No one expects a fully harmonised system to materialise any time in the foreseeable future, but the Transatlantic Trade and Investment Partnership (TTIP) negotiations, which began today, may represent the best opportunity in a long time to bridge some of the gaps of a fragmented system. A cohort of industry associations, including AdvaMed and Eucomed, stressed that point back in April, when the group met with senior US and EU government officials as part of a high-level regulatory forum in advance of the TTIP talks.
The TTIP pact has the potential to be the world’s largest free-trade deal, writes Reuters, encompassing about 50% of global economic output, 30% of global trade and 20% of foreign direct investment. Although the recent revelations of systematic US surveillance at home and abroad have cast a pall over the proceedings, many observers are still optimistic that the two sides could reach a landmark deal. Here’s why: according to the Centre for Economic Policy (London), as cited by Reuters, “an ambitious agreement . . . could boost US and EU economic growth by more than US$100 billion annually.”
Given some of the epic issues that negotiators will tackle—genetically modified crops, differing expectations of online privacy and aircraft subsidies, to name three—the medical technology industry has a comparatively modest agenda. The joint delegation in April recommended the following, as noted in a press release posted on the AdvaMed website:
- mutual recognition of ISO 13485;
- single audit process;
- harmonised format for product registration submissions;
- common tracing of products through a single unique device identification process with interoperable databases.
Expecting the two blocs to reach a deal before the current European Commission finishes its term in 2014, as some have suggested, seems overly optimistic. But for the first time in a long time, many believe that some sort of consensus will be reached, and perhaps as soon as 2015.
To gain some forward momentum, negotiators would do well to address medtech regulatory convergence early on. As noted by Serge Bernasconi, CEO of MedTech Europe, Eucomed and Edma, “this agreement could create new jobs that will improve access to the life-saving medical technologies that EU and US companies manufacture.”