Korea to Loosen Breakthrough Gene Therapy Research Laws

Aug 22, 2019 | Compliance, Gene Therapy, Korea, Laws, Regulations

Genetic Engineering. The study of the structure of DNA and RNA, the introduction of changes at the gene level. Modern medical research of stem cells. 3D illustrations

South Korea seeks to liberalize the rules to allow research on breakthrough gene therapies using gene editing and other advanced gene correction tools as the Ministry of Health and Welfare seeks to revise the Bioethics Act to allow gene therapy research.

The Current Law

The current law permits gene therapy research only if some extracting conditions are met, such as when there is no currently available therapy for specific diseases including cancer and AIDs or alternatively a novel investigative therapy evidence significant efficacy.

The Proposed Changes

The proposed revisions do the following: A) removes the condition for specific diseases, opening up the option for gene therapy research when there is no available therapy or B) when the therapy shows significant efficacy reports Pulse News.

New Opportunity & Responsibilities

If the new bill is passed by the National Assembly, investigators can access gene-editing technology to conduct their clinical research. Importantly, the bill commands greater ethical responsibility of researchers not to mention review and approval of an institutional review board as well as researchers’ reporting obligation and the request for document submission for direct investigation by the National Bioethics Committee.

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