Georgian Parliament approves legislative changes on increase in pharmaceutical regulations

Tbilisi: The Georgian Parliament approved the legislative changes on the increase in the regulation of medical and pharmaceutical activities at the first hearing. 75 MPs supported the bill.

The package of changes was presented in the Georgian Parliament for discussion by the First Deputy Minister of Health, Tamar Gabunia. She noted that the main purpose of the legislative change is to ensure patient health and safety.

According to the Deputy Minister, by establishing an effective control mechanism, the quality of medical services will improve dramatically, a strong regulatory body and legislative base will be a kind of prevention mechanism.

“The Ministry of Health and the Regulatory Agency has obligations to protect the health of the population. A regulatory agency functions to identify patient-related risks and create a safer environment. This is the foundation and the main motivation of the Regulatory Agency’s activity”, – said Tamar Gabunia.

Under the planned legislative changes, the agency of regulators will be able to respond to a patient complaint immediately. Regulators nowadays can only study the quality of a patient based on court intervention while the notice is also received by a medical institution.

Therefore, there is the risk of editing or altering the documentation, which makes it difficult to recover the real picture. With the change, the quality of medical care provided to patients will be studied more effectively and in less time.

The law appears to suspend the license for medical institutions temporarily, which the court will discuss in 48 hours in an expedited order. The Regulatory Agency has no jurisdiction to temporarily suspend the clinic’s license in case of a critical discrepancy endangering a patient’s life, health, as well as epidemiological condition.

With the new bill, penalties are also increasing. According to Tamar Gabunia, the sanctions are so low that they lose the function of prevention. “Having the small amount of fines, the clinic prefers to pay rather than invest and improve quality.” “-Explained the First Deputy Minister.