Transition Team Announces National Responsibility System for Vaccine Adverse Reactions...Easing Burden of Proof (Comprehensive)
[Asia Economy Reporter Bu Aeri] The Presidential Transition Committee announced on the 7th that it will implement a national responsibility system for vaccine adverse reactions and expand compensation and support for vaccine adverse reaction-related diseases.
On the same day, Ahn Cheol-soo, the head of the transition committee, stated at the COVID-19 Emergency Response Special Committee meeting held at the Korea Financial Training Institute in Samcheong-dong, Jongno-gu, Seoul, "We will discuss concrete measures to implement the national responsibility system for vaccine adverse reactions and to secure sufficient treatments."
He added, "Since COVID-19 vaccines were recently developed, there were limitations in clearly identifying causal relationships with adverse reactions in a short period," emphasizing, "We must restore public trust in the government by providing broad and timely support for adverse reactions and expanding vaccine safety research."
Currently, compensation for vaccine adverse reactions is provided for diseases where causality is recognized, and for diseases related even if causality is not clearly established. This is limited to diseases recognized by credible domestic and international organizations such as the World Health Organization (WHO), European Medicines Agency (EMA), U.S. Food and Drug Administration (FDA), and the Ministry of Food and Drug Safety.
The transition committee plans to first recognize adverse reactions registered by major foreign pharmaceutical departments as related diseases eligible for support, and to expand the scope of recognized causality if the COVID-19 Vaccine Safety Committee conducts a comprehensive analysis of causality for related diseases and supplements scientific evidence.
Additionally, the committee announced plans to provide actual expense support if a disease suspected to be an adverse reaction is diagnosed and examined. Currently, support is only available if diagnosed with a disease eligible for adverse reaction compensation and support.
New condolence payments will be provided for sudden deaths occurring within 30 days after vaccination. Documentation proving causality of vaccine adverse reactions will be simplified, and the objection procedures will be improved.
The COVID-19 Emergency Response Special Committee of the transition team also requested the government to temporarily operate support organizations such as the "COVID-19 Vaccination Damage Compensation Support Center" and the "COVID-19 Vaccine Safety Research and Professional Statistical Analysis Center" to ensure rapid reporting of vaccine adverse reactions and compensation.
These organizations will create a system that promptly guides applicants from adverse reaction compensation support application to payment, with the intention of transparently disclosing the entire process.
The transition committee stated that after finalizing specific implementation plans such as easing the burden of proof and establishing support organizations, it will pursue the enactment of a temporary special law or amendments to existing laws.
On the same day, Chairman Ahn said, "Based on discussions over the past three weeks, we plan to select key tasks to be intensively promoted during the first 100 days after the new government’s launch and present guidelines."
He explained, "Starting next week, we plan to transparently disclose data to the public together with the Korea Disease Control and Prevention Agency and the National Health Insurance Service," and added, "We also reviewed necessary measures to reduce the risk of severe death and protect vulnerable groups, such as outpatient face-to-face treatment centered on local clinics and strengthening emergency medical systems."
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Regarding the government's easing of social distancing, Chairman Ahn mentioned the loss of midterm exam opportunities and the ban on eating at professional baseball games, stating, "The recovery of daily life that the public can feel has not been achieved, causing various problems," and emphasized, "Unreasonable regulatory measures must be improved as soon as possible."
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