New regulations have been enacted for dental offices in Georgia since 1 May 2014. Davit Sergeenko, Minister of Labour, Health and Social Affairs of Georgia, explained the reasons for introducing the new regulations: ”We had a severe situation in Georgia in terms of our dental service. Anyone opening a dental office had no obligation to report about this activity to the Ministry of Health. That is why we do not know the number of dental offices in Georgia, the conditions under which their services are carried out and how safe they are for the patients.” FactCheck took interest in the Minister’s statement and verified the kinds of obligations the dental offices have to the Ministry of Labour, Health and Social Affairs. We reviewed the Government’s Decree N359 of 22 November 2010 which comprises a regulation for high-risk medical activities. According to Article 7 of this Decree, the provider of high-risk medical services was required to report to the LEPL State Regulation Agency for Medical Activities under the Ministry of Labour, Health and Social Affairs about the commencement and the end of high-risk medical service activity. According to Article 11 of the Decree, the reporting obligation did not apply to dental services. The dental offices were, however, obliged to follow prescribed technical regulations for the conducting of medical activity. These regulations included the following:

• Ensuring hygienic norms
• Managing medical and statistical documentation
• Recruiting medical personnel who meet the qualification requirements set by the legislation.

According to the list of regulations, a special licence was required for equipping dental offices with x-rays issued by the Ministry of Environment Protection and Natural Resources. Of note is that according to the LEPL State Regulation Agency for Medical Activities, no control mechanism for dental offices existed from 2005 until 2014 and, therefore, no checking or monitoring of these facilities was conducted. The only times dental offices were checked during cases of litigations. According to the Georgian Government’s Decree N159 of 13 February 2014, amendments were made to the abovementioned Decree N359 of 22 November 2010. According to these amendments, new regulations were added for dental offices. Certain obligations were imposed upon the owners of dental offices dating from 1 May 2014. In particular, the offices were obliged to install access ramps for the safe movement of people with disabilities. In addition, dental office space in case of a one-chair office was to be at least 14 m² with 7 m² more required for each additional dental chair. In addition, Article 11 of the regulation for high-risk medical activity was annulled which exempted dental offices from reporting to a relevant agency about the commencement or end of their activities. Accordingly, the dental office as a provider of high-risk medical service is obliged to report to the State Regulation Agency for Medical Activities about the commencement or end of its activities. Current dental offices had until a 1 May 2014 deadline to report about their activities to the State Regulation Agency for Medical Activities. As for control mechanisms, the State Regulation Agency for Medical Activities must check the high-risk medical activity once per year (as a selective control). In the case of non-compliance with the legislation, the Agency is obliged within its competences to provide appropriate consultation to the dental office, determine a reasonable period of time for correcting the problems and then inspect it once again. For further information FactCheck contacted the Control Department of LEPL State Regulation Agency for Medical Activities. According to what we found out, for the first time a dental office does not comply with the requirements of the regulations for high-risk medical activities as determined by the selective control process, the office will be given both instructions and a period of time for correcting the problems (the time period varies from one month to three months). For a second incidence of non-compliance with the requirements of the regulations, the office will be fined GEL 200-500. In the case of a third-time offence, the fine becomes tripled. Of note is that the checking of dental offices was to have started from 1 May 2013 with this process having an advisory nature. However, as we found out, this has not yet started. We also checked this information with the Control Department of the LEPL State Regulation Agency for Medical Activities. According to the explanation provided to us by a representative, the inspection schedule for dental offices is currently being determined with advisory monitoring to begin in the near future. The Georgian Stomatologys Association is working on a recommendation package which will be a type of guideline for dental offices. The recommendation package will include the issues of dental education and the institutional and sanitary-hygienic setting-up of dental offices. FactCheck contacted Ketevan Gogilashvili, Head of the Georgian Stomatologys Association. According to her, the Association shares the Ministry’s position about the regulations. However, problematic issues do exist. For some dental offices, the installing of access ramps constitutes a problem. Owing to the fact that this obligation was not imposed upon providers of dental services according to the Decree of 2010. A good portion of dental offices were opened on upper floors of multi-storey buildings which do not have elevators and which leave no possibility for adapting to the physical conditions. The Georgian Stomatologys Association proposed the following to the Ministry of Labour, Health and Social Affairs of Georgia: "Universal physical conditions should be required for all dental offices which will open for business after the enactment of the technical regulations. The installing of ramps for currently operating dental offices should be discussed individually." The biggest problem for the majority of dental offices is the space (14 m²+ 7 m²) which is required according to the new list of regulations. According to the Ministry of Labour, Health and Social Affairs, the Decree of 2002 determined the requirement for this size of space. This Decree was cancelled on 1 September 2005. FactCheck took interest in the position of the Director of the Georgian Stomatologys Associations who stated: "After the annulment of the Decree of 2002, a part of the dental offices were opened in compliance with different standards of Western countries where the minimum area is equal to 10-12 m² on average. Therefore, a good part of the offices do not meet the space requirement of 14 m². The working group at the Association will study the situation of dental offices on the Georgian market and prepare a recommendation which will be adjusted to the Georgian reality, on one hand, and to the world’s now modern standards, on the other." At this point it is difficult to tell whether or not the Ministry of Labour, Health and Social Affairs of Georgia will take recommendations of the Georgian Stomatologys Association into account. This will be determined in the future.   Conclusion  According to the regulation for high-risk medical activity, providers of high-risk medical services were obliged to report about the commencement and end of their activities to the State Regulation Agency for Medical Activities. This obligation did not apply to the dental activity/service until 13 February 2014. Therefore, the Ministry of Labour, Health and Social Affairs does not have exact statistics about the number of dental offices in Georgia. According to the amendments made to the regulation for high-risk medical activity of 13 February 2014, the owners of dental offices had a deadline of 1 May 2014 to report about their activities to the State Regulation Agency for Medical Activities. In addition, according to the regulation for high-risk medical activity, dental activity has fallen under the process of selective control and monitoring since 1 May 2014. FactCheck concludes that the statement by Davit Sergeenko, "Anyone opening a dental office had no obligation to report about this activity to the Ministry of Health. That is why we do not know the number of dental offices in Georgia," is TRUE.