Regulation on the Registry of Patients that Require Insulin Therapy, Again Presented for Public Discussion

On the 06.11.2015 the official website of Ministry of Health of Ukraine published for public discussion a new draft decree “On approval of the register of patients requiring insulin therapy « (hereinafter - «draft order " and "Patients’ Registrar ").

We would like to recall that Legal Alliance highlighted the main provisions of a similar draft decree, which was published on the website of Ministry of Health of Ukraine in September this year.

In general, the draft decree, like its predecessor, regulates the procedure for providing access to the Patients’ Registrar doctors of health facilities authorized to have information about patients by employees of the Ministry of Health of Ukraine, responsible for the review and analysis of impersonal information, as well as pharmacies, which are entitled to perform supply of medicines on prescriptions with access to the patients registrar.

Another common feature is the establishment of a comprehensive list of information about the patient included in the Patients’ Registrar and the procedure for its formation and maintenance.

In addition, both documents stipulate that the doctor’s prescription is formed via the Patients’ Registrar by adopting a unique number for it which identifies the prescription in the Patients’ Registrar, and then printing and issuing accordance with the rules of advocating prescriptions after which it is issued to the patient. When dispensing insulin on prescription the pharmaceutical institution identifies the prescription via its number and makes a note about the admission of the insulin drug.

Despite considerable similarities the decree drafts have significant differences. According to the Draft Order, the Patient Registry Administrator is the "Center of Electronic Security of the Health Ministry of Ukraine» (hereinafter - «the CESHMU Ukraine "), which was not provided for in the previous draft decree.

Also it is necessary to stress the following differences between these documents:

• The norm, according to which in case of appointment / deprivation of the status of subjects registered as users among staff of health facilities / relevant authorities, it was necessary to issue appropriate orders or other administrative document was abolished.
• User information that CESHMU receives from the relevant body or organization which appointed such a person has been disseminated. Therefore, in according to the draft decree a business phone number; a mobile phone of the user (with the consent of the user) should be added. If the doctors and staff of health facilities / relevant authorities, i.e. level I and II users, have not given their consent for the release of their mobile phone numbers to the CESHMU, they should get the means of identification (username and password) for the access of the Registrar in person from the CESHMU and not by receiving a text message / email.

In general adoption of the Draft Decree is to establish an effective mechanism to ensure the full and fair accounting of insulin, the value of which, we recall, is subject to public reimbursement.