[Contribution] Tips for responding to the practice of requesting fact confirmation when investigating medical institutions and pharmacies

When investigators from public health centers or the Health Insurance Review and Assessment Service knock on the doors of medical institutions or pharmacies, there is a document that inevitably appears at the end of the investigation. It is a document called a ‘confirmation of fact’ or ‘confirmation of violation.’ The format is simple. The person being investigated signs in his/her handwriting, ‘I confirm that I have committed the following violations.’ However, the legal ramifications are by no means simple.

The court treats this document as evidence equivalent to a de facto confession. The Supreme Court maintains the position that if an administrative agency receives a confirmation letter admitting a specific violation during an on-site investigation, it is difficult to deny its evidentiary value unless there are special circumstances such as it was written forcibly or it is difficult to use as proof due to insufficient content. The problem is that the burden of proof lies with the person being investigated to prove that it was written under ‘special circumstances’, that is, under compulsion. Even if there was pressure from the investigator, it is realistically very difficult to prove this after the fact.

In actual investigation sites, there are many cases where direct psychological pressure is applied. Among the cases I consulted with, there was one where the investigator said, "If you stamp the confirmation now, that's it, but if you don't stamp it, you have to look at the entire ledger of the headquarters." In another case, the person under investigation stated, “I don’t know if it violated the law or not, but I wrote it because they told me to.” There was also a case where the confirmation written by the client, who runs a pharmacy, following the investigator's instructions on the day of the field investigation contained some information that the client himself did not remember.

If the above situation arises, the person being investigated may be subject to unfair treatment because he or she must prove that the contents of the statement are not true.

Such coercion of a statement of fact may constitute criminal coercion, and furthermore, it is very unfair in that it violates the right to refuse to make a statement guaranteed under the Constitution. However, unlike criminal procedures, the guarantee of the rights of the parties in administrative investigation procedures falls far short of this, and awareness of the procedural legitimacy of courts and administrative agencies is weak. Therefore, it is important for the parties involved in the case to take good care of their procedural rights. Specifically, medical institutions and pharmacy managers should keep the following in mind when conducting field investigations.

First, it is necessary to distinguish whether the wording of the confirmation is a ‘statement of facts’ or a ‘legal evaluation’. ‘There is a specific post on the website’ is a confirmation of fact, but ‘the post constitutes a violation of medical law’ is a legal judgment. Even if the person being investigated can confirm the facts, they have no legal basis to admit for themselves whether it is a violation. The determination of whether or not there is a violation is the responsibility of the administrative office and the court. Therefore, it is justifiable to refuse to sign a statement containing a legal evaluation, so it is not an unreasonable request to request that the statement be modified to state only objective facts.

Second, refusal to sign is a right, not disobedience. If the investigator forces you to sign or makes comments implying that you will be disadvantaged if you refuse, you must take note of the contents. It is best to contact a lawyer immediately during the investigation process, and if this is not possible, at least securing time by saying, 'I will review the contents and then sign' can make a difference in the situation.

Third, if you have already signed, you must move immediately. You must immediately secure materials to prove facts different from what is stated in the confirmation, such as prescriptions, dispensing records, medical records, accounting ledgers, and transaction statements. If a coercive atmosphere has been created, recording the circumstances in detail immediately after the conclusion of the investigation can also be useful evidence. CCTV footage from the day of the investigation and statements from bystanders are especially important. Since it is automatically overwritten after a certain period of time, you should request preservation of the video or save it yourself as soon as possible.

A single fact-confirmation letter can be the decisive basis for administrative action leading to license suspension, business suspension, fines, and even criminal charges. If you treat signing the documents presented by the investigator as if it were an insignificant procedure, you may end up facing unfair circumstances later. Therefore, it is important to check the contents before signing and, if necessary, seek expert assistance.

|Contribution| Attorney Lee Il-hyung of Daeryun Law Firm (Pharmaceutical & Bio-Healthcare Center)

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[Contribution] Tips on responding to the practice of requesting fact-finding documents when investigating medical institutions and pharmacies (link)