Starting this month, tariffs and value-added taxes will be waived for medicines imported and supplied through the Korea Orphan and Essential Drug Center for the treatment of rare and intractable diseases. The measure follows the enforcement of the amended Customs Act and the Act on Restriction on Special Cases Concerning Taxation in Dec. last year.
The Ministery of Food and Drug Safety and the Korea Orphan and Essential Drug Center said on the 2nd that they completed revisions to related subordinate regulations and internal operational systems in line with the enforcement date on the 1st. The center is guiding the application procedures and document forms for duty-free eligibility on its website.
Under this measure, patients who directly purchase medicines overseas for self-treatment may apply for exemptions from tariffs and value-added taxes if they meet certain requirements. They must submit relevant documents, such as a diagnosis confirming that the purpose is to treat a rare and intractable disease, to the Korea Orphan and Essential Drug Center.
Duty-free eligibility is limited to patients with rare diseases and patients with severe intractable diseases who fall under the special calculation criteria for partial self-payments, as stipulated by the Ministry of Health and Welfare notice. The same duty-free benefit applies to emergency-introduced medicines supplied directly by the center.
The government expects the implementation of this system to partially ease the expense burden for medicines used to treat patients with rare and intractable diseases. The Korea Alliance of Rare and Incurable Diseases said the measure will help improve access to treatment.