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10th Korea-EU FTA working group meeting on pharmaceuticals and medical devices 2022-05-19

The Ministry of Trade, Industry and Energy (MOTIE), together with the Ministry of Health and Welfare and the Ministry of Food and Drug Safety, convened the 10th Korea-EU FTA working group (hereinafter “working group”) meeting on pharmaceuticals and medical devices on May 19 at the Government Complex Sejong via videoconference with their EU counterparts.

The Korean delegation was led by MOTIE’s Europe Division Trade Policy Director Seo Sung-tae, while the EU delegation was led by European Commission’s Deputy Head Thomas Le Vaillant.

The working group is held on an annual basis with aim to promote cooperation and implementation of pharmaceuticals and medical devices agreement as per the Korea-EU FTA. The active deployment of the working group as a consultative channel in EU’s vaccine exports authorization and vaccination status certification issues is deemed to have contributed to the outstanding zero cases of exports authorization delay in 2021.

Meanwhile, in spite of uncertainties like Brexit and COVID-19, Korea’s pharmaceuticals and medical devices trade reached USD 10 billion for the first time since FTA enforcement, piggybacked by rising demand for test kits and biosimilars.

Noting these accomplishments, Korea and EU affirmed their commitment to continue expanding trade in pharmaceuticals and medical devices.

Korea’s Ministers stressed that EU’s legislative revisions for pharmaceuticals should be in step with fostering a fair competitive environment for Korean companies, and called for higher utilization of generics and biosimilars, as well as progress updates on the installation of a price support system. Moreover, they relayed the need for streamlining EU’s medical devices QMS (quality management system) certification process to bolster trade and the wider penetration of Korean medical devices across the EU market.

The two sides will develop the aforementioned agenda items further during the upcoming Korea-EU FTA Trade Committee for more substantial outcomes.