OREANDA-NEWS. November 18, 2011. A new No.99-FZ Federal Law of the Russian Federation “On Licensing Certain Types of Activities” of 4th May 2011 (except certain provisions) came into effect that replaced No.128-FZ Federal Law of the Russian Federation “On Licensing Certain Types of Activities” of 8th August 2001, reported the press-centre of FAS Russia.

At the same time FAS completed and summarized its analysis of practice of licensing medical activities in the constituent territories of the Russian Federation that was carried out by regional offices the Federal Antimonopoly Service. Overall, FAS revealed 385 violations when licenses were not granted. In 78% (301) violations were committed by the licensing bodies regarding private companies and individual entrepreneurs. One third of the refusals (301 out of 1070) to private companies and individual entrepreneurs were accompanied by violations committed by the licensing bodies. Violations against state and municipal institutions constituted 4% (84 out of 1874) refusals.

In the majority of cases instead of re-registering the current license, new licenses were issued: 11,234 – for a new period, 4270 – for a new place, and 5753 – for a new type of works (services). For about 10 years the licensing bodies have not applied license re-registration procedures when the applicants change locations of the licensed activities or changed the works (services) as part of their medical activities.

The licensing bodies issued 11,234 licenses for a new period (with on-site inspections, within 45 days), and re-registered 4222 licenses (without on-site inspections, within 10 days) or 27% of all prolonged licenses. Thus, the licensing bodies predominantly issued a new license, which is not provided for by the law.

For state and municipal institutions licenses were extended by re-registration in 42% cases, while for private companies and individual entrepreneurs – in 16% cases, or 2.6 times less. In other cases new licenses were issued.

Follow-up inspections upon complaints from the general public (4 260) in the overall pre-licensing (43 206) and unscheduled (4260) inspections reached 9%. 3 188 complaints (43% of all complaints) did not have a follow-up inspection.

Excessive pre-licensing inspections did take place (at least 23 749 inspections). The period for issuing a new license is 45 days and it requires an on-site inspection. Some of the on-site pre-licensing inspections were not justified and caused significant budget expenditures and increase of administrative barriers.

Efforts of licensing bodies are put predominantly to verify conditions and possibilities to exercise license activities. At the same time they do not fully check whether specific results of the licensees’ activities meet licensing requirements and conditions, particularly, following complaints from the general public.

In the period in question the number of complaints from the general public increased considerably, which shows that the general public is not satisfied with the medical services. The number of unscheduled inspections increased pro rata. However, increasing the number of inspections reduced their effectiveness – the percentage of holding licensees liable upon the findings of the inspections decreased from 53% in 2008 to 33% in 2010.

The new law on licensing certain types of activities incorporated many provisions of the guidelines drafted by FAS Russia that are aimed at excluding administrative barriers in licensing procedures, protecting the rights and legitimate interests of the license holders and seekers.

At the same time, to re-register a license the new law requires to carry out an on-site inspection. It was not required previously if a legal entity or an individual entrepreneur changed locations of the licensed activity and (or) changed the list of works, services comprising the licensed activity. The law also extends the period for decision-making - 30 days instead of 10 days.

This norm would preserve the established practice when a considerable part of inspections verify whether the licensees comply with licensing requirements and conditions instead of checking their activities (upon complaints or in course of scheduled inspections). In such a situation, the number of complaints from the general public will continue increasing, along with decreasing the level of satisfaction with the quality of medical services and increasing administrative barriers, because when the licensing bodies verify whether the licensees are able to comply with the requirements they often overstep their authority checking licensees’ activities, which replaces the mechanism of scheduled inspections.

The Law specifies that in this case the subject of an inspection (the list of documents) will be determined by the Regulations on licensing particular types of activities. Therefore, when legal persons or individual entrepreneurs re-register their licensees because they have changed locations of licensed activities and (or) have changed the list of works, services comprising the licensed activity, FAS finds it expedient to specify in the Regulations on licensing medical activities that only documentary inspections should take place (without an on-site inspection) and the licensee should provide a certificate from Rospotrebnadzor (the Federal Service for Protection of Consumer Rights and Human Well-Being) for the new location (new works, services), and if a list of works, services is extended – also the documents confirming education of the specialists required to render these services.

This measure will change the emphasis of licensing control and supervision towards checking real activities of the licensees when complaints are received or in course of scheduled inspections carried out as prevention measures, which would certainly make the general public more satisfied with the quality of medical services (within bounds that depends on the licensing bodies) and reduce administrative barriers.

The Analytical Note assessing the established practice of licensing medical activities and the Reference Table can be found on FAS web-site.