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🇰🇷 South Korea /Health & Science

Fast-track drug approval for rare diseases: Where are the patient protections?

From Hankyoreh · () Korean

Translated from Korean, summarized and contextualized by DistantNews.

At a glance

Analysis Named sources New plan
  • Patients with rare and intractable diseases are frustrated by delays in accessing new treatments, with some even considering emigration due to lack of access.
  • While a fast-track drug approval system is being implemented, patients feel it doesn't address their immediate need for existing, but inaccessible, medications.
  • Patient advocates emphasize the need for a system that ensures actual treatment access and includes patient protection measures, not just administrative speed.

Patients battling rare and intractable diseases in South Korea are growing increasingly frustrated with the slow pace of accessing new treatments, with some even contemplating emigration. During a recent workshop for patient groups, the prevailing sentiment was one of urgency, with many lamenting the current situation where treatments available elsewhere remain out of reach.

Why can't we get treatment in Korea when it's available in other countries? So some people have even emigrated because of this.

— Patient advocateExpressing the frustration and desperation of patients facing treatment access barriers.

"Why can't we get treatment in Korea when it's available in other countries?" one patient expressed, highlighting the desperation that leads some to consider leaving their homeland. The focus for many is not on the administrative process of drug approval, but on the immediate need for the medications themselves. While a fast-track drug approval system is being introduced, patients feel it primarily applies to new drugs and does not expedite access to existing treatments that have been long unavailable.

The fast-track approval system is for new drugs starting from approval, not for old drugs that we couldn't use.

— Patient advocateExplaining the limitations of the new system from a patient's perspective.

Patient advocates stress that while a streamlined approval process is necessary, it must be accompanied by robust measures to ensure actual treatment accessibility. This means removing arbitrary age restrictions or stringent criteria that delay access for patients who need treatment urgently. They also call for clear patient protection mechanisms within the system, ensuring that patients are not unfairly burdened with costs or treatment interruptions due to issues with post-approval evaluations or drug supply.

The system should clearly include 'actual treatment access' and 'patient protection measures during post-management.'

— Patient advocateStating the key demands from patient groups regarding the new drug approval system.

The upcoming implementation of the fast-track system is expected, but patient groups are pushing for their voices to be heard. They have previously raised concerns about the lack of patient input in the system's design and are urging authorities to incorporate their perspectives to guarantee that the "fast-track" truly translates into timely and accessible treatment for those who need it most.

Why are patients completely excluded when the system is supposed to increase patient access?

— Patient advocateQuestioning the lack of patient involvement in the design of the fast-track approval system.
DistantNews Editorial

Originally published by Hankyoreh in Korean. Translated, summarized, and contextualized by our editorial team with added local perspective. Read our editorial standards.

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