Life Sciences Legal Update. Uzbekistan – January - March 2024

Legislative Amendments and Supplements to the Legal Acts Governing Pharmaceutical Activities 

A New Pharmacovigilance System is Introduced

The President of the Republic of Uzbekistan (“Uzbekistan”) signed the Decree “On Additional Measures to Regulate the Pharmaceutical Industry” No. UP-20 dated January 23, 2024 (the “Decree”). According to the Decree, starting from July 1, 2024, organizations engaged in production and sale of medicines and medical products are responsible for the quality, safety, and effectiveness of their products. Activities of these organizations are now governed by special rules of state control.

Thus, starting from July 1, 2024, a new supervision procedure is being introduced in organizations engaged in the production and sale of medicines and medical products. According to this procedure, organizations are required to notify the Pharmaceutical Industry Development Agency under the Ministry of Health of Uzbekistan about their compliance with the licensing requirements no more than once a year. The exception to this rule is the monitoring carried out based on requests of individuals and legal entities.

Meanwhile, a pharmacovigilance system is being introduced aimed at prompt identification and response to potential threats associated with the use of medicines. The new pharmacovigilance system provides for the following:

• Implementation of the “Good Pharmacovigilance Practices – GVP” standard,
• Establishing an electronic information system within the Ministry of Health aimed at collecting and analyzing data on the side effects of medicines.

Furthermore, starting from July 1, 2024, a new medicines’ safety control system is being introduced within a course of issuing permissions to use medicines in medical practice. At the same time, a list of high-risk medicinal substances is to be formed based on the results of pharmacovigilance analysis.

Also, staring from July 1, 2024, the following changes are introduced:

• Materials advertising medicines and dietary supplements aimed at broadcasting on television and radio channels must be examined by the Ministry of Health.
• New customs and free storage warehouses must comply with the requirements of “Good Storage Practices - GSP.”

It is also worth noting that starting from January 1, 2026, it is prohibited to store medicines in customs and free warehouses that do not have a certificate of compliance with the requirements of “Good Storage Practices - GSP”.

Licensing procedures for pharmaceutical activities are organized in coordination with pharmaceutical inspections for compliance with the requirements of Good Practices (GxP).

Pursuant to the Decree, the Ministry of Health is instructed within 3-month period to:

• Ensure pharmacological supervision of medicines in accordance with international requirements,
• Conduct an in-depth review of pharmacovigilance activities,
• Approve the national standard of “Good Pharmacovigilance Practice – GVP.”

Also, the Decree approved a plan of measures aimed at developing a pharmaceutical industry and providing population with quality medicines including the following:

• Post-marketing control of medicines,
• Development of the National Electronic Information System “Pharmacovigilance,”
• Conducting a corruption risk assessment in the course of prescribing medicines by medical workers,
• Introducing a “risk analysis” system to the sale of medicines and medical products,
• Harmonazing advertisement of medicines and dietary supplements, etc.

Please note that Annex No. 2 of the Decree stipulates the following measures:

• By July 1, 2024, all domestic enterprises engaged in the wholesale distribution of pharmaceutical products are to be certified in accordance with the national requirements of Good Distribution Practice (GDP),
• Until January 1, 2025, network of pharmacies engaged in the retail sale of pharmaceutical products, and until January 1, 2026 – the other pharmacies, are subject to mandatory certification in accordance with the national requirements of Good Pharmacy Practice (GPP).

Priority Directions for the Development of Healthcare System of Uzbekistan have been Identified

The President of the Republic of Uzbekistan signed the Resolution “On Additional Measures to Enhance Reforms in the Healthcare Sector” No. PP-38 dated January 22, 2024 (the “Resolution No. 38”).

According to the Resolution No. 38, to further enhance the quality of medical services and accelerate healthcare sector reforms in Uzbekistan, a government agency, the Project Office “Center for Healthcare Projects” (the “Center”), was established within the Ministry of Health.

The Center is responsible for introducing new mechanisms in the field of state medical insurance, improvement of the quality of education and working environment of medical workers, public-private partnership, monitoring the quality of medical services, patient rehabilitation, digitalization of healthcare sector, efficiency of public procurement, and update of the sanitary standards.

According to the Resolution No. 38, the Ministry of Health is responsible for updating and bringing into compliance with international standards the existing 40 (forty) sanitary rules, as well as introducing modern management methods and safety standards in the republican specialized medical centers.

In addition, the Ministry of Health is instructed to ensure international accreditation of all republican specialized scientific and practical medical centers in Uzbekistan in 2025.

The Resolution No. 38 adopted a road map consisting of the priority measures aimed at improving the healthcare system of Uzbekistan (the “Roadmap”).

Until October 1, 2024, the Roadmap provides for the development of a competitive environment in the medical services’ market through the involvement of private medical organizations to the provision of state-guaranteed medical services via annual tenders. Thus, non-governmental medical organizations will have the right to provide the population with preferential services at the expense of the state budget.

The Roadmap also provides for the following measures and mechanisms for their implementation:

• Ensuring the fully-fledged implementation and financing of a package of state-guaranteed free medical services and medicines with a precise distinction between paid and free services in order to improve the quality of primary healthcare until 2024–2025,
• Launching a state health insurance system by the end of 2024 in Tashkent city and the Republic of Karakalpakstan and by the end of 2026 - in all regions of Uzbekistan,
• Developing a system of medical rehabilitation of patients until June 1, 2024,
• Accelerating the implementation of the previously initiated public-private partnership projects until December 1, 2024, and others.

The State Trust Fund for the Development of Medicine was Established

Pursuant to the Order of the Minister of Health No. 3500 dated March 7, 2024, the State Trust Fund for the Development of Medicine (the “Fund”) was created. The Fund is not established in the form of a legal entity. Its funds are accumulated from the State Budget, as well as from funds received through the public auction sale or leasing of property belonging to institutions and organizations within the Ministry of Health.

Resources of the Fund must be spent exclusively for the following purposes:  

• Financing the training and retraining of employees of the state healthcare authorities and medical government institutions abroad, attracting foreign specialists to organization of trainings, advanced trainings, and experience exchange,
• attracting experts, including foreign ones, to carry out high-tech complex oncohematological and intractable diseases’ surgeries,
• reimbursement of expenses associated with surgical operations on orphans and children deprived of parental care suffering from intractable deceases, which are conducted in foreign countries, and cannot be performed in Uzbekistan,
• reimbursement of costs associated with the purchase of high-tech diagnostic, treatment, and preventive services of state and non-state medical organizations for patients suffering from oncohematological and intractable diseases, and others.

The Ministry of Health approves the list of oncohematological and intractable diseases, which can be diagnosed and treated at the expense of the Fund.

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