Medicinal products, due to their nature, have both therapeutic effects and side effects. In general, side effects that develop during correct use of medicinal product gradually disappear when the concerned product is discontinued or switched to another product. However, in rare cases, side effects may lead to death, disability, or disease.

Adverse Drug Reaction Relief System provides lump sum death benefit, funeral expense, lump sum disability benefit, and medical expense to victims or their family in case of harm such as death, disability, or disease during correct use of medicinal product. Since its institution on 19 Dec 2014, this system has gradually expanded its coverage, encompassing lump sum death benefit in 2014-2015, funeral expense and lump sum disability benefit in 2016, and medical expense in 2017.

Adverse Drug Reaction Relief System is funded by fees from pharmaceutical companies based on their sales performance.

Before this system has started in Korea, victims of adverse drug reactions had to prove the causal relationship between the product and side effects personally via individual lawsuit, which took long time (5 years on average). Now, through this system, victims can receive indemnity in about 6 months from the reception. The system has given innovative benefits to the victims of unexpected ADR, performing a key role as a social safety net as a part of postmarketing safety regulation in Korea.

Adverse Drug Reaction Relief System is sponsored by MFDS, and performed by KIDS practically, as a government-affiliated institution under MFDS. KIDS plays a key role, such as investigation for causality assessment, and collection of fees paid by pharmaceutical companies.
Pharmaceutical companies, by paying yearly fees that fund the Adverse Drug Reaction Relief System, supports smooth operation of the system.

People inflicted by adverse drug reaction are indemnified via Adverse Drug Reaction Relief System. Pharmaceutical companies are cooperating for its funding, and experts including physicians and pharmacists are striving to analyze the causal relationship between medicinal products and side effects.

Since its institution on 19 Dec 2014, a total of 283 cases have been opened by the first half of 2018. The number of case has been increasing from 20 cases in 2015 to 65 cases in 2016 and 126 cases in 2017. 215 out of 283 cases have been reviewed until now. 168 out of these 215 cases have been accepted as adverse drug reactions, and thus lump sum death benefit, funeral expense, lump sum disability benefit, or medical expense have been paid to victims or their family. Payouts amount to approximately 40 billion KRW until now.

o Indemnity Payouts (2015 ~ 2017)
- Lump sum death benefit : 36cases(2,748,768,000won)
- Funeral expense : 36cases(234,099,380won)
- Lump sum disability benefit : 6cases(354,066,900won)
- Medical expense : 50cases(79,611,254won)

Although it was specified in the Pharmaceutical Affairs Act in 1991, Adverse Drug Reaction Relief System could not come into effect for a long time since details for its operations were not defined.
Proposal of revised Pharmaceutical Affairs Act during the National Assembly meeting in 2007 triggered social debate. However, the proposal was rejected and thus Adverse Drug Reaction Relief System was not introduced in Korea.

Adverse Drug Reaction Relief System fits domestic circumstances since pharmaceutical companies actively cooperated for its funding and consumer groups and experts of relevant fields actively provided inputs.