Resolution of the VI Annual International Scientific and Practical Conference "RWD/RWE. Possible and Real"

Preamble

The VI Annual Scientific and Practical Conference with international participation "Real Clinical Practice. Possible and Real" (Moscow, September 25, 2025) was organized and conducted by the Association of Health Technology Assessment Specialists, the Association of Clinical Pharmacologists, and the St. Petersburg Chapter of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR). The conference theme brought together leading specialists in the field of RWD/RWE and Real Clinical Practice.

During the Plenary Session, welcoming addresses to the conference participants were delivered by: the Chief External Specialist in Clinical Pharmacology of the Russian Ministry of Health, Academician V.I. Petrov; Deputy Minister of Health of Russia S.V. Glagolev; Rector of the First St. Petersburg State Medical University named after Academician I.P. Pavlov, Academician S.F. Bagnenko; Scientific Director of the Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology, Academician A.G. Rumyantsev; Rector of Yaroslavl State Medical University, Academician A.L. Khokhlov; Rector of Smolensk State Medical University, Corresponding Member R.S. Kozlov; Scientific Director of the World-Class Genomic Research Center "Center for Predictive Genetics, Pharmacogenetics and Personalized Therapy" of the B.V. Petrovsky Russian Scientific Center of Surgery, Russian Ministry of Science and Higher Education, Academician D.A. Sychev; President of the Union of Pediatricians of Russia, Academician L.S. Namazova-Baranova; Chairman of the Standing Commission on Social Policy and Healthcare of the Legislative Assembly of St. Petersburg of the VII convocation, A.N. Rzhanenkov; Chairman of the Association of Health Technology Assessment Specialists A.S. Kolbin; Executive Director of the Association of International Innovative Pharmaceutical Companies V.V. Kukava; Executive Director of the Association of International Pharmaceutical Manufacturers L.V. Matveeva; T.I. Galimov (Data Management 365). The Plenary Session was moderated by Elena Voitsekhovskaya, a medical journalist, editor-in-chief, author, and host of medical programs.

Within the framework of seven symposia, leading Russian and international experts in the field of RWD/RWE delivered presentations: V.V. Kalinichenko (Russian Ministry of Health); T.A. Goldina (Association of International Pharmaceutical Manufacturers); R.V. Dray (GEROPHARM); N.S. Reshetova (N.N. Petrov National Medical Research Center of Oncology); M.A. Borzova (Trubor Law Bureau); Guvenc Kockaya (ECONiX Research & Yeditepe University); N. Shcherbakova (Western New England University); Nguyen Thi Thu Thuy (Hong Bang International University); S.E. Korolev (Roche Moscow); O.V. Reshetko (Saratov State Medical University named after V.I. Razumovsky); A.G. Solodovnikov (Statandocs); A.V. Matveev (Russian Medical Academy of Continuous Professional Education); E.V. Nazarova (NAERES); E.I. Alexeeva (Sechenov First Moscow State Medical University); S.K. Zyryanov (Peoples' Friendship University of Russia); E.T. Tuleutayev (Republican Center for Coordination of Orphan Diseases, Kazakhstan); M.Yu. Samsonov (R-Pharm); A.Yu. Kuzmenkov (Smolensk State Medical University); M.V. Zhuravleva (Sechenov First Moscow State Medical University); M.Yu. Frolov (Volgograd State Medical University); L.K. Valieva (AstraZeneca Pharmaceuticals); A.S. Salasyuk (Volgograd State Medical University); K.A. Kolobova (VERBA Legal); A.V. Gusev (Webiomed); E.I. Khatkova (A.S. Loginov Moscow Clinical Scientific Center); M.A. Isakov (Aston Health); D.G. Shchurov (Sechenov First Moscow State Medical University).

The symposia were moderated by: D.A. Rozhdestvensky (Department of Technical Regulation and Accreditation of the Eurasian Economic Commission), Z.M. Golant (St. Petersburg State Chemical-Pharmaceutical University), K.V. Gorelov (Roszdravnadzor), N.Z. Musina (CIS Orphan Consortium), S.K. Zyryanov (Peoples' Friendship University of Russia), M.V. Zhuravleva (Research and Development Institute of the Federal State Budgetary Institution "National Center for Expert Evaluation of Medical Products"), Yu.A. Zhulev (All-Russian Hemophilia Society).

A separate symposium "Real-World Data in Orphan Diseases" was held as part of the VI conference.

Conference participants discussed tools for researching real-world clinical practice, the growing importance of Real-World Clinical Practice in modern medicine, legislation, and global perspectives worldwide, in Russia, and in the EAEU.

A total of 27 reports were presented at the conference.

RESOLUTION

on the results of the VI Annual Scientific and Practical Conference with international participation "Real Clinical Practice. Possible and Real", held on September 25, 2025. The text uses the term and abbreviation "Real Clinical Practice" (RCP), which combines the two international terms: RWD (Real-World Data) – data related to a patient's health status and/or the process of providing medical care, obtained from various sources; RWE (Real-World Evidence) – evidence obtained from the analysis of real-world clinical practice data – clinical evidence regarding the use and potential benefits or risks of using a medicinal product, obtained through the collection and analysis of real-world clinical practice data [Decision of the EEC Council No. 78 (as amended on March 17, 2022) "On Amending the Rules for Registration and Expertise of Medicinal Products for Medical Use"].

Conference participants noted the positive developments that have occurred since the previous conference.

Within the framework of the Eurasian Economic Union (EAEU) working group, an expert group was formed, which developed a series of guidance documents (a roadmap) for the collection, analysis, and application of real-world clinical practice (RWD/RWE) data:

At the end of 2024, the Council of the Eurasian Economic Commission (EEC) approved Recommendation No. 1 dated October 18, 2024, defining general approaches to the development of regulations for the circulation of medicinal products in the EAEU regarding the collection, analysis, and use of RWD/RWE (RWD/RWE Concept);

At the beginning of 2025, the EEC Board adopted Recommendation No. 15 dated June 10, 2025, approving the Guidance on Key Issues of Using Real-World Clinical Practice Data in the Process of Medicinal Product Circulation in the Union;

As of autumn 2025, 3 recommendations are at various stages of development and discussion.

These documents aim to form unified principles and methods for working with RWD/RWE to support regulatory decisions, improve the quality of pharmacovigilance, and develop digital technologies in healthcare in the EAEU countries and Russia.

Systemic issues requiring immediate resolution were presented for discussion by the conference participants.

Main Body

I. The following limitations for the implementation of RWD and evidence derived from it were identified during the conference.

In regulatory framework in Russia at the national level:

1. Lack of legislative norms regulating the procedures for collecting and analyzing RWD, including developed approaches to ensuring the quality of the obtained data and the representativeness of final conclusions based on the collected data.
2. Lack of developed regulatory approaches regarding the implementation of RWD and/or evidence based on the analysis of RWD, and their use in conjunction with the results of clinical trials.
3. Lack of tools allowing to correlate data on a specific medicinal product with patient data, since data sources containing (or from which information can be obtained) information about patients are often not integrated with monitoring systems.
4. Confidentiality of information remains the most acute issue causing discussions among the expert community, as well as ethical aspects of conducting research.
5. Lack of a clear legal mechanism allowing state customers to rely on RWD to justify the need for procurement of a medicinal product or medical device with specific characteristics, the use of which is optimal based on the accumulated clinical experience of the medical institution. As a result, contradictory administrative practice is formed.

In the use of RWD and RWE in health technology assessment in Russia at the national level:

1. Lack of regulatory structures governing the procedure for using RWD, which prevents the widespread use of such data in decision-making during health technology assessment.
2. According to the Rules for the Formation of Lists of Medicinal Products for Medical Use and the Minimum Assortment of Medicinal Products Necessary for Providing Medical Care, approved by Decree of the Government of the Russian Federation No. 871 dated August 28, 2014, regarding the scale for assessing the reliability and persuasiveness of evidence, the submission of RWD study results often leads to a lower score than if they were absent or does not affect the assessment result in the case of voluntary submission of RWD study results.
3. Within the procedure for the comprehensive assessment of medicinal products for inclusion in the VED List (and other lists), the submission of results from observational studies, which are essentially conducted under RWD conditions, is permitted. However, the lack of developed regulatory approaches to conducting such studies complicates the process of obtaining data and evidence and generates distrust in the obtained results.

In the use of RWD and RWE in the development of clinical guidelines in Russia at the national level:

1. There is no developed mechanism for considering the results of RWD studies during the development/updating of clinical guidelines.
2. There are no special norms allowing professional non-profit organizations to use RWD contained in healthcare information systems during the development/revision of clinical guidelines.

In the use of RWD and RWE in the implementation of innovative drug supply models in Russia at the national level:

1. The absence of an RWD paradigm in the domestic healthcare system does not allow for the implementation of a value-based approach and innovative drug supply models. At the same time, launching pilot projects for the implementation of innovative drug supply models requires, among other things, an analysis of data on the clinical effectiveness of a medicinal product for state procurement (for example, under a "risk-sharing" model).

In the implementation of information systems as a source of RWD in Russia at the national level:

1. The low quality and fragmentation of data collected by medical information systems of healthcare organizations, including clinical, statistical, and other data, and their incompatible formats do not allow for systematic processing and use of RWD in decision-making within the healthcare system.
2. There is no regulatory framework allowing for the safe collection and analysis of anonymized data from healthcare information systems, which slows down research, development, and ultimately the availability of RWD.
3. There is no regulated mechanism for access to RWD for medical professionals, experts, scientists, non-governmental and commercial companies, taking into account legislative requirements for the protection and processing of personal data and information security.
4. There are no special norms for processing RWD when creating clinical decision support systems (including those using artificial intelligence technologies) and ensuring access to this information for medical professionals, researchers, and developers in the field of artificial intelligence.

In obtaining RWD from registries in Russia at the national level:

1. The Federal Registry combines data on specific categories of patients (listed nosologies and persons entitled to receive state social assistance).
2. Lack of a unified registry of patients receiving medical care within the state healthcare system, i.e., a registry that would combine all registries and provide access to the data contained therein.
3. There is a noted need to adjust the regulatory framework in the field of personal data processing and ensure access to it by third parties.

In the field of personal data protection and processing:

1. Confusion between the concepts of "depersonalization of personal data" as an obligation of the personal data operator upon achieving the purpose of personal data processing, which reasonably implies irreversibility (clause 7, article 5 of the Federal Law "On Personal Data" No. 152-FZ dated July 27, 2006), and as an action implying reversibility and subsequent protection of personal data obtained as a result of depersonalization ("Requirements and Methods for Depersonalization of Personal Data", approved by Order of Roskomnadzor No. 996 dated September 5, 2013).
2. Lack of the concept of "anonymization of personal data" and regulation regarding working with anonymized data and data anonymization under a simplified procedure compared to personal data obtained as a result of depersonalization.
3. Lack of opportunity for organizations conducting scientific and clinical research, development and implementation of medical drugs, medical equipment, and medical devices to interact with healthcare information systems and medical organizations, including in accordance with Decree of the Government of the Russian Federation No. 447 dated April 12, 2018; absence of a unified system containing real-world clinical practice data accessible for use by the aforementioned organizations.

In improving the model for organizing the storage of medical data in the Russian Federation:

1. Lack of uniformity in data entry approaches by the main users of medical information systems (MIS).
2. Heterogeneity and fragmentation of existing information systems.
3. One-way data flow from the regions to the federal level.
4. Use of different formats and information exchange technologies by different information sources.
5. Lack of systemic demand and funding for bilateral data exchange in the Unified State Health Information System (EGISZ).
6. Lack of a full-fledged regulatory framework for organizing a system of access to data for its analysis and secondary processing.

In regulatory framework at the EAEU level:

1. Methodological approaches to obtaining reliable clinical evidence based on relevant real-world clinical practice data have not been fully formalized; issues of access to real-world clinical practice data are not regulated.
2. The use of real-world clinical practice data is significantly limited by the lack of developed approaches in the current legislation of the EAEU member states; there are no regulatory approaches regarding cross-border data transfer/acceptability of real-world clinical practice data sources.
3. Data standardization problems persist. These problems include, but are not limited to: (1) diversity of real-world clinical practice data sources and their incompatible formats; (2) differences in source data collected at different levels using different standards, terminology, and exchange formats to represent the same or similar data elements; (3) a wide range of methods and algorithms used to create datasets intended for generating aggregated data.
4. Post-registration monitoring of effectiveness (PAES) and safety (PASS) of medicinal products is not transparent; there are no unified approaches from manufacturers, professional associations, and government bodies. Currently, information is published on official portals only regarding interventional studies, while there are no regulatory requirements for conducting and publishing non-interventional studies.

II. The following solutions for implementing RWD were proposed during the conference.

In regulatory framework in Russia at the national level, the following are necessary:

1. Amendments to the Federal Law No. 61-FZ dated April 12, 2010 "On the Circulation of Medicinal Products" to include the terms adopted at the Eurasian Economic Union level, for the further development of the national regulatory framework in the field of collection, analysis, and use of RWD for addressing issues not regulated at the EAEU level.
2. RWD and/or evidence based on the analysis of RWD, and their use in conjunction with the results of clinical trials, should in the future (in the medium or long term) have the possibility to become scientific justification for making regulatory decisions within the competence of national federal authorized bodies, taking into account regulatory requirements developed at the EAEU level.
3. The need to support a national registry of observational and other studies as a public source of RWD.
4. Creation of a body (committee) controlling the quality of methods and tools for collecting and processing real-world clinical practice data.
5. Introduce into Article 2 of Law No. 152-FZ a definition of the term "depersonalized personal data". Possible approach: depersonalized personal data – a set of structured and unstructured depersonalized (including through anonymization and pseudonymization) personal data of large volumes, characterized by high velocity of change, which are subjected to automatic processing using computer algorithms to identify certain correlations, trends, and patterns.
6. Introduce into clause 2 of Article 3 of Law No. 152-FZ a direct exception stating that a person to whom depersonalized personal data related to health status is transferred for processing within the functioning of clinical decision support systems is not considered a personal data operator.
7. In clause 9.1, part 1, Article 6 of Law No. 152-FZ, specify that the subject's consent is not required for the processing of depersonalized personal data for scientific and/or medical purposes related to the creation of clinical decision support systems.
8. In clause 9.1, part 1, Article 6 of Law No. 152-FZ, specify that the subject's consent is not required for the processing of depersonalized personal data for scientific and/or medical purposes related to the creation of clinical decision support systems. (Note: This point is repeated in the original Russian text).
9. It is also necessary to work out the possibility of making corresponding amendments to the Federal Law No. 323-FZ dated November 21, 2011 "On the Fundamentals of Protecting the Health of Citizens in the Russian Federation".

In the use of RWD and evidence derived from it in health technology assessment in Russia at the national level:

1. Amend clause 55, article 4 of the Federal Law No. 61-FZ dated April 12, 2010 "On the Circulation of Medicinal Products": "... analysis of information on the comparative clinical effectiveness and safety of a medicinal product, including based on real-world clinical practice data".
2. Amend the Rules for the Formation of Lists of Medicinal Products for Medical Use and the Minimum Assortment of Medicinal Products Necessary for Providing Medical Care, approved by Decree of the Government of the Russian Federation No. 871 dated August 28, 2014, regarding the consideration of real-world clinical practice evidence during the comprehensive assessment of medicinal products. As a basic option, it is proposed to introduce RWD study designs into the scale for assessing the reliability and persuasiveness of evidence, assigning them scores sufficient to reach the threshold value (in accordance with the general requirements established in the EAEU regulatory acts on obtaining and using real-world clinical practice data, and subject to the formation of positive law enforcement practice).
3. Amend the Rules for the Formation of Lists of Medicinal Products for Medical Use and the Minimum Assortment of Medicinal Products Necessary for Providing Medical Care, approved by Decree of the Government of the Russian Federation No. 871 dated August 28, 2014, regarding ensuring the possibility of inclusion in the lists subject to the conclusion of risk-sharing and conditional reimbursement agreements with the collection of RWD and RWE (in accordance with the general requirements established in the EAEU regulatory acts on obtaining and using real-world clinical practice data, and subject to the formation of positive law enforcement practice).
4. Work out the issue of amending the Rules for the Formation of Lists of Medicinal Products for Medical Use and the Minimum Assortment of Medicinal Products Necessary for Providing Medical Care, approved by Decree of the Government of the Russian Federation No. 871 dated August 28, 2014, to include in the Scale for Quantitative Assessment of Additional Data on a Medicinal Product an additional assessment criterion "Availability of data indicating the effectiveness of the medicinal product in real-world clinical practice in the territory of the Russian Federation";
5. It is necessary to create industry guidelines that can ensure the quality of research under RWD conditions and the reliability of the provided results for the purpose of conducting a comprehensive assessment of medicinal products, as well as clarifications on the possibility of considering real-world clinical practice data, for example, regarding the consideration of the real frequency of drug use during a course (year), as this issue causes a lot of discussion and significantly affects the economic characteristics of the drug.

In the use of RWD study results in the development of clinical guidelines in Russia at the national level:

1. Amend Appendix 1 to the Order of the Russian Ministry of Health No. 103n dated February 28, 2019 "On Approval of the Procedure and Timeframes for the Development of Clinical Guidelines, Their Revision, the Standard Form of Clinical Guidelines and Requirements for Their Structure, Composition and Scientific Justification of the Information Included in Clinical Guidelines" regarding the possibility of considering RWD when forming clinical guidelines, as well as the use of such data by professional non-profit organizations during the development/revision of clinical guidelines (in accordance with the general requirements established in the EAEU regulatory acts on obtaining and using real-world clinical practice data, and subject to the formation of positive law enforcement practice).

In the use of RWD and RWE in the implementation of innovative drug supply models in Russia at the national level:

1. Improve antimonopoly legislation to eliminate the risks of unjustified application of existing norms to innovative drug supply models.
2. Introduce a mechanism for considering RWD when analyzing information on the clinical effectiveness of a medicinal product for state procurement under innovative models (in accordance with the general requirements established in the EAEU regulatory acts on obtaining and using real-world clinical practice data, and subject to the formation of positive law enforcement practice).
3. Introduce a mechanism for considering RWD when assessing treatment outcomes in the pay-for-performance agreement model (in accordance with the general requirements established in the EAEU regulatory acts on obtaining and using real-world clinical practice data, and subject to the formation of positive law enforcement practice).
4. In obtaining RWD during the operation of healthcare information systems in Russia at the national level, the following are necessary:
5. Implementation of enforcement measures for quality control of data collected/entered within healthcare information systems, including medical information systems (MIS).
6. Development of a set of national standards and unified regulatory reference information for coding medical records to ensure compatibility and increase the interoperability of real-world clinical practice data collected from MIS.
7. Creation and use of a national registry of observational and other studies, which will allow publishing data on studies and their results to increase the level of accessibility of real-world clinical practice data.

In the implementation of information systems as a source of RWD:

1. Implementation of enforcement measures for quality control of data collected/entered within healthcare information systems, including medical information and other systems, including clinical data, information on the provision and payment of medical care, and other data characterizing the methods and volumes of provision and payment of medical care, statistical data.
2. Harmonization of the activities of experts and expert institutions involved in the development of RWD methodology and in the development of structured electronic medical documents and reference books.
3. Work out the issue of regulating access to data for third parties, subject to ensuring personal data protection, including as one of the solutions, considering the introduction of a regulated institution of data intermediaries.

In obtaining RWD from the analysis/maintenance of registries in Russia at the national level, the following are necessary:

1. Revision of approaches to registry maintenance to improve the quality and accessibility of sources of reliable scientific information about the patient population, prescribed and applied therapy, treatment outcomes, etc.
2. Use of registries in clinical practice, as well as within health technology assessment.
3. Within the framework of the Decree of the Government of the Russian Federation "On the Unified State Information System in Healthcare", it is advisable to provide for the procedure for collecting, storing, and accessing RWD, as well as organizing a system of access to RWD (and not to its individual subsystems) for medical professionals, experts, scientists, non-governmental and commercial companies (IT sector, pharmaceutical industry, manufacturers of medical and diagnostic equipment) by developing a separate mechanism that provides such access and ensures effective protection of personal data.
4. Development of a Decree that will provide for the procedure for collecting, storing, and accessing RWD, as well as organizing a system of access to RWD for medical professionals, experts, scientists, non-governmental and commercial companies (IT sector, pharmaceutical industry, manufacturers of medical and diagnostic equipment) by developing a separate mechanism that provides such access and ensures effective protection of personal data.

Regarding the improvement of personal data protection and processing, it is necessary:

1. Introduce into Article 2 of Law No. 152-FZ definitions of the terms "anonymization of personal data" and "anonymized data", separating the concepts of "anonymization" and "depersonalization". Possible approach: "anonymization of personal data" – a method of data processing, the result of which is data aggregation that precludes their correlation with directly or indirectly identified or identifiable individuals; "anonymized data" – data obtained as a result of anonymization of personal data.
2. Add to clause 2 of Article 1 of Law No. 152-FZ a direct exception of the application of Law No. 152-FZ in relation to anonymized data. Possible approach: "This Federal Law does not apply to relations arising during the processing of anonymized data or data obtained as a result of anonymization".
3. Simplify access to healthcare information systems for operators that are not medical or pharmaceutical organizations but are engaged in the development and supply of medicinal products and medical devices (equipment), scientific and clinical research in the field of medicine and pharmacology.
4. Introduce into Law No. 152-FZ a specific procedure for depersonalizing personal data concerning health status and constituting medical secrecy, providing for an indication of the categories of information subject to mandatory depersonalization, allowing operators to use the obtained data without restrictions for statistical, scientific, and research purposes, including for processing within the functioning of clinical decision support systems and with the involvement of foreign organizations.
5. Expand the possibilities for processing special category personal data without obtaining the subject's consent (clause 2, article 10 of Law No. 152-FZ), providing for the possibility of such processing by operators that are not medical or pharmaceutical organizations but are engaged in the development and supply of medical drugs and devices (equipment), scientific and clinical research in the field of medicine and pharmacology, for statistical, scientific, and research purposes, including for processing within the functioning of clinical decision support systems.

Regarding the improvement of the model for storage, management, and interoperability of medical data in the Russian Federation:

1. Ensuring that medical data is recorded in a uniform standardized format to facilitate data processing and enable their subsequent joint processing.
2. Implementation of developed and widely used modern information exchange standards (HL7 FHIR) to enhance data interoperability, mandatory for all participants in the healthcare system.
3. Technical implementation of the possibility of data exchange between medical organizations in real-time or a format close to it.
4. Involving the patient in information exchange within the framework of managing access to their medical data through special aggregator applications to increase trust in the data storage system.
5. Facilitating the exchange of patient-provided data, including information recorded from wearable devices, to expand the volume and diversity of routine medical data.

In regulatory framework at the EAEU level, it is necessary:

1. Continue standardizing approaches regarding the implementation of real-world clinical practice data and/or evidence based on the analysis of real-world clinical practice data, and their use in conjunction with the results of clinical trials for scientific justification and making relevant regulatory decisions.
2. Continue work on unifying approaches to the collection, analysis, and use of real-world clinical practice data, by developing at the EAEU level additional relevant guidelines concerning the use of electronic medical records as a source of real-world clinical practice data, quality and transformation of real-world clinical practice data, application of biostatistics principles in research, conducting studies based on real-world clinical practice data and their designs, using real-world clinical practice data for decision-making in the healthcare system.

Recommendations for patient communities:

1. Take direct part in developing recommendations regarding new and effective methods for collecting evidence from RWD.

In organizing interdepartmental and expert interaction, it is necessary:

1. Create working groups to address the above issues with the aim of promptly implementing the RWD approach.
2. Organize interaction between experts and expert institutions regarding the harmonization of the developed RWD methodology with approaches to electronic medical document management, data collection and processing within the framework of digital transformation.

Experts who spoke at the conference; Association of Health Technology Assessment Specialists; Association of Clinical Pharmacologists; St. Petersburg Chapter of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR).