Despite incentives for development Korea remains dependant on imported orphan drugs
Korea is one of the few countries within the APAC region which already has an implemented legislation for promoting orphan drugs research and development. The active patient community led by the Korea Organization for Rare Disease (KORD), lobbying amongst hospitals, and advanced clinical and genetic data exchange management technologies has contributed to the advancements in making the country a favourable environment for orphan drug developers.
Nonetheless, according to Biotech Policy Research Center (Korea), Korea heavily depends on imported orphan drugs, with minimal domestic orphan drug manufacturers. And still, the government does not provide sufficient incentives for preclinical stage research and orphan drugs development.
Just last week, the Ministry of Health & Welfare has introduced a new legislation which exempts certain orphan drugs from the ‘economic evaluation’. Hence, instead of being stuck with a lack of clinical evidence, the Ministry will refer to a drug’s lowest price amongst the G7 countries as its base price and determine its economic value.
Chief of Division of Pharmaceutical Benefits, Bureau of Health Insurance Policy, Dr. Lee, Sun Young has stated that this was to “provide greater access to orphan drugs, and through strict and fair phamaceutical/health insurance, lessen the burden on rare disease patients.” Adding that the Ministry will consider a comprehensive policy that “maintains reasonable price, provides assurance and support for local companies to enter the global pharma market”, Dr. Lee has remained positive on Korea’s new drug pricing policies for orphan drugs.
More Korean orphan drug developers have voiced out that the exemption should apply to all orphan drugs in Korea.
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