Tamar Gabunia: “It is important that Regulation Agency to have possibility for prompt reaction. Around 18 entities have such authority and the Ministry of Health deals with more risks.”
“The first, important thing for us is that Regulation Agency to have possibility for prompt reaction. Around 18 entities have such authority, including our Labour Inspection and the Ministry of Health deals with more risks. Labour Inspector does not need a court decision for entering a clinic. Lots of entities already possess this right, while the Ministry of Health deals with more risks”, - stated Tamar Gabunia in connection with legislative changes on expansion of the mandate of the Regulation Agency for Medical and Pharmaceutical Activities.
According to the First Deputy Minister, inspection of a clinic without prior notification is a common, widely used practice in many countries of the world.
“If you see international sources, in the majority of cases, everywhere, it is referred to inspection without notification. For example, legislation of the US, namely of Washington State. You are aware, how cautiously the US makes decision regarding entrepreneurs. And it reads very distinctly and clearly of inspection without notification. The same, quite wide experience of surprise inspections exists in the European countries as well. There are also planned inspections. Though, in this case we encounter certain difficulty as well. Clinics know in advance that the inspection occurs once a year. When the inspection is passed, they think no one will inspect them until the next year. There are cases, though infrequent, when the device was transferred form one clinic to another after completion of inspection”, - stated Tamar Gabunia.
As stated by the Deputy Minister, the sanction amount will be increased with the purpose to prevent such and other violations.
“The penalties are set long time ago. Consideration of only inflation rate could itself cause the rationale for revision of penalty amount. Though this is not a decisive factor. The decisive factor was frequency of repeated violations reaching 40-45%. That means that the clinic violating a certain condition prefers to pay a penalty which could be 500 GEL instead of taking corrective measures for a concrete violation that could cost 5,000 GEL.
Thus, this novelty would have more preventive notion”, - stated Tamar Gabunia.