의약품의 긴급사용승인과 국가책임

Abstract

There is a saying, “History of mankind is the history of diseases.” Humans are still developing numerous drugs that have not existed before to overcome or alleviate diseases, and these efforts will continue as long as humanity exists. COVID-19, which began at the end of December 2019, served as a momentum to inform all of us of the importance of the new drug development. North American countries are leading the development of new drugs, followed by China and Japan. Korea also has reorganized the legislation for the development and supply of new drugs and encouraged the development and supply of new drugs. However, it is true that Korea has been importing a lot of drugs, including COVID-19 vaccines and treatments. On March 9th, 2021, the Special Act for Promotion of Development and Emergency Supply of Medical Products Responding to Public Health Crisis was made. In this Act, Approval for Emergency Use of Drugs is allowed, which is different from the formal licensing procedure, and through this, medical products that can prevent public health crises can be quickly imported and supplied. As the products supplied under Approval for Emergency Use of Drugs have also side effects, undesirable and unintended signs, symptoms, or diseases may occur to some individuals. However, because there is no basis for damage relief in the relevant laws, the need for supplementation of the system has been pointed out. Reflecting this, it is welcome that some revised legislation specifying the basis for national compensation has been passed. National compensation presupposes the nation's regulatory or arbitrator status, and is clearly different from the administration’s compensation system that admits the national professional negligence. Even after the Approval for Emergency Use of Drugs to cope with the public health crisis, the administration still bears the risk management or risk prevention responsibility for the drugs, so it cannot be free from the liability for omission if this obligation is not fulfilled. National responsibility by administrative omission can also be applied when the form of action is administrative guidance. Of course, some point out that it is difficult to recognize the existence of a duty of action due to the randomness. However, if the probability of avoiding or mitigating damage to life and health can be increased by providing administrative guidance, its effectiveness can be verified. In addition, the obligation of administrative guidance can be actively interpreted even though the requirements for exercising administrative authority are not met, or administrative guidance is forced to respond to risks immediately due to time constraints.