Korean bio firms wrangle over DTC regulatory sandbox

By Lim Jeong-yeo

Companies upset over genetic testing deregulation

  • Published : Feb 21, 2019 - 16:38
  • Updated : Feb 21, 2019 - 16:38

The South Korean government’s recent decision to temporarily deregulate direct-to-consumer genetic testing of serious diseases has evoked many complaints from unprepared genomics companies.

On Feb. 11, the Trade Ministry announced a set of deregulatory measures which included bio firms’ DTC research for 13 previously-regulated serious diseases such as Parkinson’s, apoplexy, stomach cancer and more. Genetic testing enables healthy consumers to gain foresight of diseases they can potentially contract, allowing them to take preventive therapy.

DTC of serious diseases, however, was so far largely regulated due to ethical reasons and opposition from doctors. 

(Flickr @Caroline Davis2010)

In the latest regulatory sandbox, among four genomics companies that applied for a research permit, Macrogen was the only one to get the green light.

Macrogen Chairman Seo Jeong-sun is also the chairman of the Korea Biotechnology Industry Organization, which has raised controversy.

The partial deregulation allows Macrogen to carry out research of DTC genetic testing on 2,000 people living in the satellite city of Songdo for two years. Should its research prove safety of DTC for serious diseases, the government will consider revising relevant laws that require a medical institution’s supervision.

While Macrogen says it hopes its research will benefit the whole genomic industry, initial reactions from other companies were mixed, with many calling it a betrayal.

“How can the chairman’s company backstab other members?” said Medizen Humancare CEO Shin Dong-jik.

The company along with Theragen Etex and DNA Link had applied for the DTC regulatory sandbox. The ministry is yet to approve their applications, but said it will continue to receive more applications and supplementary materials for approval.

Meanwhile on Wednesday, the Korea Genome Industry Council announced it would boycott the Welfare Ministry’s separate DTC program directed more toward lighter health issues, in order to join the Trade Ministry’s measure.

The Welfare Ministry’s “wellness” track has been seeking for ways to deregulate DTC for lighter health issues such as obesity, hair loss and skin aging. Although the genomics companies wanted to tackle serious illnesses, they followed the ministry’s guidance to yield more immediate commercial benefits.

The ministries, for their part, expressed regret that the companies are choosing one ministry’s move over another, saying they hope for a two-track development of DTC.

By Lim Jeong-yeo (