Licensing of medical practice

Yulia Marchenko, senior lawyer at Medconsulting LLC (Ukraine)

The material will be of interest both to existing aesthetic medicine centers and beauty salons, and to those who are just planning to start such activities.

THERE WILL BE LICENSES!

Over the past year and a half, significant changes have occurred in Ukraine in the field of licensing medical practice. More than a year ago, the Law of Ukraine “On Licensing Types of Economic Activities” dated March 2, 2015 No. 222-VIII came into force, which significantly changed the approach to licensing, and finally, on April 22, 2016, the long-awaited new licensing conditions for activities in medical practice, approved by Resolution of the Cabinet of Ministers of Ukraine dated March 2, 2016 No. 285.

The licensing conditions went through a difficult path of discussion and caused many complaints and disputes. It is only worth noting that four different draft license conditions were published, which were radically different from each other, and the entire approval process took a little less than a year.

The wait was not in vain: one of the most important innovations was the opportunity to obtain a license for medical practice by an individual ⎼ entrepreneur without a medical education. We can safely call this a kind of revolution in the field of licensing medical practice.

From now on, the license, which for more than 20 years was issued only to private practicing doctors or healthcare institutions, can be obtained by anyone who registers as an individual ⎼ business entity (FE). In particular, small beauty salons (many of which operate as individual entrepreneurs) who want to attract dermatovenerologists to provide services are now in a simpler position. Previously, such institutions had to create a healthcare institution (legal entity), hire a chief physician with a specialization in “organization and management of healthcare,” and undergo accreditation two years after starting work, or obtain a license for the doctor himself, which was not always the case Maybe.

Now these restrictions are gone. According to paragraph 35 of the license conditions: “An individual ⎼ entrepreneur who does not have special education and does not meet the uniform qualification requirements approved by the Ministry of Health has the right to obtain a license.”

At the same time, such an entrepreneur is obliged to staff medical and non-medical workers in accordance with the declared specialties, that is, hire doctors or nurses to work.

But the requirements for a sole proprietor who will engage in medical practice are not limited only to the availability of the necessary specialists. In addition, it is necessary to at least have premises and material and technical base. For each place of medical practice, the entrepreneur must have an appropriate document confirming the right to use this premises (ownership, lease, or other). The premises must comply with established sanitary standards, which is confirmed by the act of sanitary and epidemiological inspection of the facility (clause 20 of the license conditions). Also, the entrepreneur must have available medical equipment, consumables and medical products approved for use in Ukraine and necessary to fulfill the scope of medical care provided for by unified clinical protocols approved by the Ministry of Health.

APPENDICES TO THE LICENSE TERMS

Data on the premises, equipment, personnel, etc. are entered by the future licensee in the statement of the state of the material and technical base and the availability of personnel, indicating the qualification and educational level, which are attached to the application for a license to practice medicine. The statements are compiled by the entrepreneur independently, they do not need to be signed and approved, the data is not checked by the Ministry of Health of Ukraine at the time of obtaining a license, but the submission of false information (which may be revealed during future inspections) is grounds for cancellation of the license. It is in the statements that the data of the doctors and/or nurses who will work for this licensee are entered. The individual entrepreneur must ensure the presence of at least one medical worker, including part-time workers, for each declared medical specialty, specialty of junior specialists with medical education and non-medical workers working in the healthcare system. The number of positions of medical and non-medical workers is determined by an individual ⎼ entrepreneur independently, depending on the volume of medical care provided at the appropriate level and declared specialties.

Compliance with the educational and personnel requirements of medical (pharmaceutical) workers from among doctors and pharmacists is certified:

• a document of higher education of the state standard (diploma);
• a certificate of a medical specialist of the established form, issued by a higher medical educational institution, postgraduate education institution;
• a certificate of assignment (confirmation) of the appropriate qualification category for medical specialties (if any).

At the same time, employees can be hired after obtaining a license. According to the licensing conditions, an entrepreneur, no later than one month from the date of receipt of notification from the licensing authority about the decision to issue him a license, enters into an employment contract with medical workers who were declared in the documents attached to the application for a license for the positions specified by him. If it is impossible to conclude employment contracts with medical workers who were declared in the documents attached to the application for a license for the positions specified by them, the licensee notifies the licensing authority about this (clause 33 of the license conditions). It is not allowed to introduce positions that are not included in the list of medical positions, positions of junior specialists with medical education (for example, according to the list of medical positions, there is no position of a trichologist).

At the same time, the new licensing conditions do not contain any restrictions on the number of specialties in which a non-medical entrepreneur can conduct medical practice, or on the number of doctors that such a person can employ. That is, if desired, an individual entrepreneur can hire not only a dermatovenerologist (or several), but also, for example, a therapist or neurologist.

The only reservation contained in the licensing conditions concerns planned surgical interventions: they must be carried out only in health care institutions that are legal entities, in specially equipped operating rooms; a sole proprietor cannot perform surgical interventions that require inpatient conditions.

SUBMITTING DOCUMENTS: WHAT YOU NEED TO KNOW

In addition to the statements, the licensee submits to the Ministry of Health of Ukraine an application in the form approved by the licensing conditions, and a list of documents that are submitted to obtain a license, in two copies (in the form also defined in the licensing conditions). No other permitting documents, for example, a conclusion from the SES, are submitted.

An application for a license can be submitted:

• in person or by proxy to the “Single Window” of the Ministry of Health of Ukraine;
• by mail, letter with an inventory of the contents;
• in electronic form using telecommunications.

The most common option is for the licensee or an authorized representative to submit documents. Reception of documents from legal entities and individuals is carried out by the Ministry of Health at the address: Kyiv, st. Ushinsky, 40. Documents are accepted daily from 9:00 to 17:00 (lunch break from 13:00 to 14:00), telephone for inquiries: (044) 393-3195 (96).

Quite recently, the practice of submitting documents by mail has emerged; documents are sent directly to the Ministry of Health of Ukraine at the address: 01601, Kiev, st. Grushevskogo, 7. If the documents are sent by mail, the licensing authority, within one working day from the date of execution of the relevant document, sends a letter with the appropriate notification to the location of the license applicant. It is strongly recommended that you include a stamped, self-addressed envelope with your application so that the Ministry of Health can communicate its decision.

Unfortunately, in practice there is still no experience in submitting documents electronically. Perhaps for this you need to have a special electronic digital signature, but how this will be implemented is still unknown.

Decisions are made by the licensing authority within ten days. On the next working day, the decision to issue a license is posted electronically in the Unified State Register of Legal Entities and Individuals ⎼ Entrepreneurs.

From the date of entering information about obtaining a license into the register, the license applicant has the right to work in the direction of medical practice. After a positive decision, the licensee must make a mandatory payment (one minimum salary), only after this (usually within a month) the licensee can receive a license form on paper or in electronic form (at the request of the entrepreneur). To be honest, there is no practice of obtaining a license electronically yet, but such a possibility exists. The license is issued for an indefinite period, that is, it has no expiration date.

SPECIFICITY OF INNOVATIONS

The new licensing conditions also introduced another long-awaited innovation, which also applies to those who already have a license to practice medicine: it became possible to legally provide medical care at the patient’s place of residence (stay). According to paragraph 10 of the licensing conditions, almost any assistance can be provided at home, except for tertiary (highly specialized). This norm of licensing conditions actually legalizes the long-existing practice of providing medical care at home, including at home it is now allowed to carry out manipulations that do not require the patient to stay in a hospital. However, it is worth noting that this norm does not mean that in order to carry out business activities in medical practice, an entrepreneur does not need to have a specially equipped room, but can simply go to the patient (client) at any time. According to paragraph 9 of the licensing conditions, medical practice by the licensee is carried out at the place (places) of its production, which is (are) indicated in the application for a license and in the documents attached to it (taking into account the changes made to them, submitted by the licensee to the licensing authority). That is, the requirement for the mandatory availability of premises for medical practice remains, but there is an additional opportunity to provide medical care at the patient’s place of residence (stay) on completely legal grounds.

After obtaining a license to practice medicine, an entrepreneur must fulfill a number of requirements established by both the licensing conditions and other orders of the Ministry of Health of Ukraine, and these include requirements for signage, a consumer corner, sanitary and epidemiological regime, accounting and storage of medicines, personnel qualifications, etc. d.

But an individual ⎼ entrepreneur is not a healthcare institution, and therefore does not have to undergo accreditation in the manner established by Resolution of the Cabinet of Ministers of Ukraine dated July 15, 1997 No. 765 “On approval of the procedure for accreditation of a healthcare institution,” which will greatly facilitate the work of the entrepreneur.

All these innovations, according to the authors of the licensing conditions, are aimed at increasing the availability of medical care and improving the quality of medical services, because they will attract more investment and increase competition between licensees. Today it is difficult to say whether the number of licensees will actually increase significantly due to private entrepreneurs who do not have a medical education, but in any case, these new opportunities are useful for a fairly wide range of beauty industry specialists.