The proposed regulatory reform in the Korean biotech sector is going nowhere due to hardline policy of related ministries, parliamentary inaction and opposition from civic groups. In particular, the Ministry of Health and Welfare maintains a tough certification standard with regard to direct to customer (DTC) genetic testing services, going against the government’s push for regulatory reform.
The Ministry of Commerce, Industry and Energy has applied the regulatory sandbox system to some biotech products, exempting them from existing regulations for two to three years. But the biotech industry is having a hard time selecting the beneficiaries.
Industry sources reported on Feb. 24 that the Ministry of Health and Welfare is still keeping its conservative stance towards deregulation. The ministry has maintained its hardline stance by requiring companies participating in the pilot DTC genetic testing service project to meet more than 74 mandatory certification conditions.
The companies protested by saying that the ministry’s policy is too demanding and that certification conditions are unclear, but it is unlikely that the standard will be eased off.
The ministry made it clear that a DTC genetic testing service provider must be certified later by meeting its 74 requirements, even if it is allowed to launch its service under the regulatory sandbox.
Meanwhile, other bills related to biotechnology regulatory reform, on top of the DTC genetic testing service, are still on hold in the National Assembly. Bills on advanced regenerative medicine and high-tech biopharmaceuticals and in vitro diagnostic devices, are facing the risk of being delayed for an indefinite amount of time. The bills were expected to be passed during the extra assembly session in December last year, but were delayed to the February session on the grounds that more public hearings were needed. However, as the February session has not been held yet and opposition from civil organizations is getting stronger, it is unclear whether the bills will be passed in the March assembly session.
An official from an opposition political party in the National Assembly said, "The bills cannot pass the standing committee if any of its members is against them, and yet the voice of civic groups opposed to the biotech deregulation bills is now getting bigger."