Ministry of Health of Ukraine Has Proposed Draft Regulation on Registry of Patients in Need of Insulin Therapy

14.09.2015 Ministry of Health published on its web-site for public consideration the Draft Order “On Approval of Register of Patients in Need for Insulin Therapy”.

The Regulation designates the procedures for establishment and maintenance of register of patients in need of insulin therapy as well as the usage of the information from this register.

The Draft foresees that the register will take the form of electronic centralized data base which will include the information on users and patients, and on prescriptions and distributions of insulin preparations.

The Draft offers a strict users gradation, different scope of rights for changes introduction into the register, and different access levels to the information contained in the register depending on each category. In view of this, there are three users categories designated:

• I level users – doctors with a specialization in «Therapy», «Endocrinology», «Pediatric Endocrinology», «General Practice – Family Medicine» being authorized, but not limited to, to include the information on patients into the register.
• II level users – bodies authorized, but not limited to, to review and analyze impersonal data.
• III level users – pharmaceutical institutions being allowed in accordance with law to sell the prescription medicinal products.

It is worth to mention that the Draft provides for the opportunity to include the information on patients being in need of insulin only in case of prior consent for personal data processing.

Prescription should be prior to insulin obtainment, and according to the Draft it should be developed by I level users with the help of the register. Thus, each prescription is provided with its individual number. In the future the users of III level shall use this individual number in order to conduct the search within the register and mark the sales of insulin.

Please pay attention that the Draft does not indicate who shall administer the register. Nevertheless, it contains the provisions stating that the future register administrator should be affiliated to the state enterprise being managed by relevant ministry.

It is worth to remind that the Regulation has been developed based on the framework of pilot project on implementation of state regulation of insulin preparations prices. Please note that such regulation had to be implemented by 01.09.2015.