DTC Devices to Be Deregulated Under Regulation Sandbox
Korean patients with cancer and dementia will soon be allowed to have genetic tests without going to hospitals by using direct-to-consumer (DTC) devices, which test using their saliva.
DTC usually refers to the marketing of pharmaceutical products but also applies to the direct marketing of medical devices and consumer diagnostics. Currently, DTC is limited to simple diagnostic devices for blood sugar and blood pressure measurement, but it will be deregulated through the regulation sandbox to be implemented starting Jan. 17. Industry watchers expect deregulation would increase the DTC market more than five times.
An official from the Ministry of Trade, Industry and Energy said on Jan. 3, "At the moment, DTC devices, which allow patients to self-diagnose without having to go to hospitals, are limited to simple tests, such as measuring blood sugar and blood pressure. In the future, we will seek to expand the scope of DTC tests to genetic analysis for cancer and dementia through the regulation sandbox.”
Soon after the regulatory sandbox goes into effect, the Ministry of Trade, Industry and Energy will allow a company to launch safety tests on DTC devices for genetic analysis of cancer and dementia free from the existing regulations.
At present, DTC analysis is only available for 12 test items such as blood sugar, blood pressure, cholesterol, and skin aging under the Act on Bioethics and Safety. Patients need to visit hospitals in person to have genetic tests related to diseases such as cancer or dementia. Whole-genome analysis called “pool-sequencing” can only be done in hospitals.
In many advanced countries, regulations on DTC are relatively much softer than in Korea or do not exist at all. For example, the United States additionally approved DTC for 10 diseases, including dementia and Parkinson's disease, in April 2017. Therefore, a patient can purchase a test kit on the internet or at a convenience store for US$199 and send his or her saliva to the vendor to get a genetic analysis. Japan, the United Kingdom, and China are also known to have only guidelines and recommendations given out by associations without DTC-related legal regulations.
If regulations are eased, the domestic DTC market is expected to expand. The Korea Labor Institute estimated that deregulation would increase sales of the industry by 503 percent, investment by 458 percent, and the number of jobs by 45 percent in the next 10 years. Global demand will also grow. Market research firm Credence Research estimated that the global DTC market grew by 61 percent from 65.6 billion won (US$58.25million) in 2014 to 105.5billion won (US$93.69 million) in 2016 and will rapidly grow to 405.3 billion won (US$360 million) in 2022.