Medical license in Ukraine: new license requirements

On January 19, 2013 a new version of License requirements for conduction of business activities related to medical practice entered into force. It is approved by the Order number 981 of the Ministry of Healthcare of Ukraine dated 30.11.2012. It contains a significant number of innovations majority of which will make medical practice for legal entities and sole proprietorships more complicated. But while the first ones received only additional obligations the latter were imposed with a number of limitations.

New requirements for private practitioners:

First of all from now on sole proprietorships will be able to hire doctors (pharmacists) only if they have higher qualification category. Those who do not have such category will not be able to hire new employees. And even those who have higher qualification category from now on will be able to hire only those doctors (pharmacists) who have the same specialty as sole proprietor has. As for other directions they will be able to hire only junior specialists.

Luckily limitations which were set by the new License terms affected only hiring of new employees and therefore there is no need to dismiss employees that that had been hired before. But these limitations significantly limit opportunities of sole proprietor in case of voluntary dismissal of one of previously hired employees. This makes many of sole proprietorships to do their best in keeping their current employees until completion of qualification development. At the same time such development should be done as soon as possible since there is a possibility that when current employees find out about such changes they may demand to raise their wages. Besides it is possible that inspectors from the Ministry of Healthcare of Ukraine may interpret limitations related to hiring of new employees as prohibition to keep employees that were hired before the changes since they do not comply with set requirements. And it will be possible to prove them wrong only in court.

Secondly from now on it is prohibited to use a single medical room in which medical practice of different functional specialties is conducted. This means that those sole proprietorships who would share their office with their colleague of different specialty will either have to move themselves or move out the colleague. If the same office is used by sole proprietorships that are doctors of the same specialty they must have required rental agreements (rental, subrental) of theses premises.

Thirdly sole proprietors must draft and approve a number of internal regulations (nomenclature of cases in medical and pharmaceutical documentation, regulations and instructions for conduction of manipulations and procedures, instruction for washing and disinfection of hands, list and cost of services) and secure storage of these and other documents at the location of their activities conduction. Sole proprietorship will have to keep audit and report statistics forms in the field of healthcare, keep and provide information about patient, provide conditions for washing and disinfection of hands and take a number of other measures. Besides they will have to place a signboard on the front side of the building where they conduct their activities. The sign must include information about medical specialties of sole proprietorship’s medical practice and his full name.

It is possible that these requirements and limitations will make many sole proprietors to establish their own medical establishments (legal entities that have a license for medical practice). But we shall warn you at once that it will be difficult to comply with the requirements for medical establishments having scarce finances.

New requirements for medical institutions:

1. Medical establishments must draft and approve a significant number of internal documents. Besides those that are required for sole proprietorships these documents include standards of nursing (medical) care, regulations of patients stay in a medical establishment, internal control of medical treatment provision quality, local clinical protocols (itinerary for patients) and other. They must secure storage of these and other documents at their location (in particular an extract from the Unified State Register, license, audit and report statistic forms, conclusion of sanitary and epidemiologic expertise and other).
2. They must appoint a person that will be responsible for provision of medical products and employees that are required for conduction of business activities related to pharmaceutical specialties and specialties of junior specialists with pharmaceutical education. Thus besides employees of medical specialties medical establishments will have to have pharmacists one of which apparently will have to be responsible for provision of medicines for a medical establishment. At the same time staff of medical and pharmaceutical employees of specialties listed in application must be full.
3. All employees of medical establishments must undergo medical examinations and comply with the requirements of their attestation. Medical establishments must ensure qualification development of their employees.
4. Medical establishments must provide their employees with sanitary clothes and products of individual protection, required washing and disinfecting products. They also must provide first aid kits, comply with sanitary regulations and rules of removal and destruction of trash and medical wastes. They also must comply with a number of other requirements.
5. New requirements for the premises of a medical establishment:

• They must have entrance and exit for free access by incapacitated persons as well as restrooms and wardrobes for visitors;
• The location and area of their premises must be in compliance with State Construction Regulations 2.2-10-2001 (for example doctor’s office in ward division must not be less than 10 square meters and office of nurse on duty must have not less than 6 square meters);
• Materials by which walls, ceilings and floors are covered must allow wet cleaning with use of disinfection products;
• There must be separate emergency departments for child, maternity (gynecological one for maternity hospitals), infectious, dermatology and venereology, tuberculosis and psychiatric (psychosomatic) wards;
• Heating of premises where medical practice is conducted cannot be provided by gas equipment with open fire sources or electric heating equipment with open spiral.

6. Name of a legal entity that is a medical institution must include name of one healthcare institutions which are included in the List of healthcare institutions approved by the Order number 385 of the Ministry of Healthcare of Ukraine dated 28.10.2002. Use of types of healthcare institutions and word combinations that do not comply with the List is prohibited. There must be a signboard on the front side of the building where medical establishment is located which includes information about type of medical establishment, name of legal entity, location and code from the Unified State Register.

7. Names of departments must correlate with medical specialties of medical practice. These departments must consist of offices of doctors and junior specialists with medical education. Establishment of separate medical offices outside the location of medical establishment is not allowed without creation of branch office and appointment of head. Name of an office must obligatory contain information about medical (pharmaceutical) specialty and specialty of junior specialists.

As we can see the list of new requirements which is set for medical establishments is much broader than the one for sole proprietors. Additional there are no requirements for sole proprietorships on their state accreditation which is to be completed every three years as well as a number of other requirements that were set for medical establishments before (starting with requirement for additional documents obtainment and ending with availability of required premises, devices and equipment).

However it makes no sense to compete whoever got more obligations and limitations. The only thing that is clear is that the Ministry of Healthcare of Ukraine while taking care about increase of medical services quality created additional complications for those who provide these services. And while major part of requirements can really help to make quality of services better the other part which consists of absurd limitations has nothing to do with quality of medical services.

This material is based on our firm’s experience related to obtainment of medical practice licenses within Medical and pharmaceutical law.