The Ministry of Health of the Russian Federation has developed a draft Procedure for maintaining the federal register of citizens entitled to state-funded pharmaceuticals, medical devices, and specialized therapeutic nutrition products (the "Draft Regulation").

As a matter of regulatory background, Federal Law No. 206-FZ dated July 13, 2020, "On Amending Certain Legislative Acts of the Russian Federation Regarding the Provision of Pharmaceuticals, Medical Devices, and Specialized Therapeutic Nutrition Products to Citizens," established the Federal Register of Citizens Entitled to State-Funded Pharmaceuticals, Medical Devices, and Specialized Therapeutic Nutrition Products (the "Federal Register"). This statutory framework coordinates the activities of federal executive authorities, regional executive bodies, local governments, and medical organizations across state, municipal, and private healthcare systems. The Government of the Russian Federation establishes the procedure for maintaining the Federal Register, including data access protocols and reporting timelines.

The Ministry has published the Draft Regulation on the federal portal for draft regulatory legal acts. Following the public comment period, which concluded on August 10, 2020, the regulatory authorities incorporated several revisions into the text.

The revised Draft Regulation stipulates that authorities shall maintain the Federal Register in an electronic format using an automated system. The system will record information by creating individual registry entries, each assigned a unique registry number and date of entry.

The Federal Register aggregates data on the following categories of eligible citizens:

• Individuals with disabilities, including children with disabilities;

• Beneficiaries entitled to state social assistance in the form of essential pharmaceuticals, medical devices, and/or therapeutic nutrition;

• Persons living with HIV;

• Patients under clinical supervision due to tuberculosis;

• Individuals suffering from conditions included in the list of life-threatening and chronic progressive rare (orphan) diseases;

• Patients requiring palliative care;

• Certain groups entitled to free or 50% discounted pharmaceuticals and medical devices.

Specialized patient registries and multi-level healthcare information systems shall supply data regarding these categories of citizens on a daily basis.

Under the proposed framework, the Federal Register will capture the following information:

• Full name (first name, patronymic, and surname, if applicable) of the eligible beneficiary;

• Insurance Number of an Individual Personal Account (SNILS), alongside birth dates and residential addresses;

• Passport details and Compulsory Health Insurance (CHI) policy numbers;

• Citizenship status;

• Clinical diagnoses (conditions) and corresponding ICD codes;

• Identifying information of the managing medical organization, including its corporate name, Primary State Registration Number (OGRN), and All-Russian Classifier of Enterprises and Organizations (OKPO) code.

The Ministry of Health of the Russian Federation acts as the operator of the information system, ensuring its uninterrupted operation and safeguarding the confidentiality of the data stored within the Federal Register.

According to the summary of public feedback, stakeholders proposed amendments to Clause 8 of the Draft Regulation due to data accessibility ambiguities. While the initial draft mandated that the Ministry ensure the confidentiality, storage, and security of data in compliance with personal data protection laws, Clause 8 restricted direct access solely to specific federal state bodies approved by the Russian Government. However, Clause 4 defines the Federal Register as a nationwide system comprising distinct regional segments. Stakeholders noted that restricting access exclusively to federal bodies clouded the operating mechanism for managing regional-level beneficiaries whose healthcare benefits derive from subject-level (regional) budgets.

The Ministry accepted this feedback and amended Clause 8 of the Procedure. The revised text establishes that the Ministry shall grant access to the Federal Register in strict compliance with the Regulations on the Unified State Health Information System, approved by Government Decree No. 555 dated May 5, 2018. Specifically, registered users who successfully pass proper identification and authentication protocols will receive authorized access to the repository.

Furthermore, during the public consultation process, the developers noted that the technical functionality of the Federal Register will enable tracking of both primary and secondary (comorbid) medical conditions. Regional authorities can populate the Federal Register with data from regional public health information systems either through automated electronic data interchange or via the direct interfaces of the Federal Register itself.

The regulatory authorities intend to bring the specified Procedure into force effective September 1, 2020.