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            [post_date] => 2025-11-20 16:41:46
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According to Valery Afanasyev, Director for Government Relations and Regulatory Risk Assessment at Baikal Communications Group, the Resolution establishes two mandatory criteria. First, the level of calculated budgetary sufficiency must not exceed 0.65 — meaning the region must be classified as subsidized. As of 2024, there were thirty-one such regions in Russia. Second, the constituent entity of the Russian Federation must allocate at least ten percent more funds for financing the procurement of these medicinal products compared to the previous year. Among the optional additional criteria are either an increase in the cost of the medicinal products by no less than twenty percent or an increase in the number of patients in the region by no less than fifteen percent.

The Government of the Russian Federation has approved the rules and eligibility criteria for receiving additional federal co-financing for the procurement of high-cost orphan medicinal products. Resolution No. 1807 of 15 November 2025, signed by Prime Minister Mikhail Mishustin, will enter into force on 1 January 2026.

The regulatory act establishes a mechanism through which regional authorities may formally confirm that they are objectively unable to fulfill their obligations to provide medicinal support to patients with the diseases listed in Government Resolution No. 403 of 26 April 2012.

Applications for subsidies may be submitted annually by the heads of regional authorities from 1 August to 30 September. The Ministry of Health of the Russian Federation will review the applications within ten business days. In the event of a refusal — for example, due to non-compliance with the criteria or an incomplete set of documents — the region may resubmit the application.

According to Valery Afanasyev, after the adoption of Federal Law No. 252-FZ of 23 July 2025, a number of issues remained unresolved, particularly those related to the application procedure and the eligibility criteria for subsidies. The adopted Resolution clarifies that, to submit an application, a region must meet at least three criteria, two of which are mandatory.

More details are available in the Pharmvestnik report.

[post_title] => THE GOVERNMENT OF THE RUSSIAN FEDERATION HAS APPROVED THE RULES FOR ADDITIONAL FINANCING OF REGIONAL PROCUREMENT OF ORPHAN MEDICINAL PRODUCTS [post_excerpt] => [post_status] => publish [comment_status] => closed [ping_status] => closed [post_password] => [post_name] => the-government-of-the-russian-federation-has-approved-the-rules-for-additional-financing-of-regional-procurement-of-orphan-medicinal-products [to_ping] => [pinged] => [post_modified] => 2025-11-20 16:41:46 [post_modified_gmt] => 2025-11-20 13:41:46 [post_content_filtered] => [post_parent] => 0 [guid] => https://b-c-g.ru/?p=9442 [menu_order] => 0 [post_type] => post [post_mime_type] => [comment_count] => 0 [filter] => raw ) [1] => WP_Post Object ( [ID] => 9438 [post_author] => 6 [post_date] => 2025-11-11 14:51:49 [post_date_gmt] => 2025-11-11 11:51:49 [post_content] =>

Vyacheslav Kharitonov, Regulatory Risk Assessment Practice Expert at Baikal Communications Group, notes that the key impediments to the growth of exports of domestically manufactured agricultural machinery continue to be unfavorable “rules of the game,” namely: the level of the Bank of Russia’s key interest rate, reductions in state support measures, as well as increased tariff and non-tariff pressure on agricultural exporters. According to him, declining profitability among agricultural producers and the weakening of domestic demand significantly restrict the export potential of agricultural machinery manufacturers, despite support measures enacted since 2017. At the same time, the stability of Russian manufacturers is primarily grounded in the domestic market, which accounts for the overwhelming majority of agricultural machinery sales.

In Kharitonov’s opinion, while additional incentives could indeed support the industry, a significant breakthrough in foreign markets is unlikely without first stabilizing the domestic market and easing the key interest rate.

For more details, see the full article in Agroinvestor.

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The joint conference of the American Chamber of Commerce in Russia and the Pacific–Eurasian Business Alliance was held on October 28, 2025, under the theme “Business Resilience – Societal Resilience.”

The event brought together representatives of international companies, the expert community, and civil society organizations to discuss sustainable development practices and the impact of the global ESG agenda on business processes.

Anastasia Tsvetkova, Partner for International Communications and CSR Practice at Baikal Communications Group and Chief Executive Officer of the “Lake Baikal” Foundation, participated in the conference. Within the session “Global Goals and Local Solutions: Sustainable Development on the Threshold of 2030,” she delivered a presentation titled “COP 2025: Key Themes and Expectations.”

During the discussion, Ms. Tsvetkova emphasized that COP 30 marks several significant milestones: 30 years of climate negotiations within the UNFCCC framework, the 20th anniversary of the Kyoto Protocol, and the 10th anniversary of the Paris Agreement. While COP 29 entered history as a financial summit, having resulted in an agreement on climate finance of at least USD 1.3 trillion per year by 2035, COP 30 is expected to be a turning point focused on resource allocation and the mechanisms for implementing the Global Goal on Adaptation (GGA).

From November 10 to 21, 2025, heads of state, scientists, non-governmental organizations, and civil society representatives will convene in Belém, Brazil, to develop measures to protect populations and ecosystems from the impacts of climate change and to establish transparent and equitable indicators for assessing progress on adaptation. The host country intends to pay particular attention to the ecosystem services of the Amazon, the development of the bioeconomy for mitigation and adaptation, and structural solutions to counter disinformation and climate change denial. Another important focus of COP 30 will be NDCs (Nationally Determined Contributions). Although NDCs are not negotiated directly at COP, Brazil anticipates that countries will present updated commitments aligned with the 1.5°C target.

In her remarks, Ms. Tsvetkova also addressed the role of water as a central element of climate solutions, highlighting the contribution of freshwater systems to achieving the Paris Agreement goals. The discussion underscored the importance of the Lake Baikal Foundation’s participation in the Water for Climate Pavilion at COP 30 and its role in preparing an expert session on inland freshwater ecosystems (lakes, rivers, wetlands), which serve as a point of synergy among the three Rio Conventions (UNFCCC, CBD, UNCCD) in biodiversity conservation, climate change mitigation, and sustainable land use development.

Baikal Communications Group continues to consistently advance its expertise in sustainable development and national strategic priorities, fostering a professional environment conducive to constructive dialogue among business, government, and society.

[post_title] => BAIKAL COMMUNICATIONS GROUP PRESENTED A COP 30 OVERVIEW AT THE AMCHAM CONFERENCE [post_excerpt] => [post_status] => publish [comment_status] => closed [ping_status] => closed [post_password] => [post_name] => baikal-communications-group-presented-a-cop-30-overview-at-the-amcham-conference [to_ping] => [pinged] => [post_modified] => 2025-10-31 10:48:17 [post_modified_gmt] => 2025-10-31 07:48:17 [post_content_filtered] => [post_parent] => 0 [guid] => https://b-c-g.ru/?p=9426 [menu_order] => 0 [post_type] => post [post_mime_type] => [comment_count] => 0 [filter] => raw ) [3] => WP_Post Object ( [ID] => 9422 [post_author] => 6 [post_date] => 2025-10-29 19:20:06 [post_date_gmt] => 2025-10-29 16:20:06 [post_content] =>

The Ministry of Industry and Trade of the Russian Federation has proposed the introduction of a score-based system for assessing the level of production localization for certain medical devices and rehabilitation equipment. The corresponding draft government decree has been published for public consultation and concerns amendments to Government Resolution No. 719. The new rules provide for the allocation of scores to technological operations and materials, as well as the establishment of minimum annual localization thresholds. The system is expected to enter into force on 1 January 2026.

As noted by Baikal Communications Group, these changes may significantly impact manufacturers of medical devices, particularly prosthetic and orthopedic products, where the share of imported components currently reaches up to 60%. The introduction of the score-based system will create both new opportunities and additional operational burdens for businesses.

“On the one hand, the focus on import substitution policies gives domestic and locally-based manufacturers advantages within public procurement mechanisms and stimulates the development of local production. On the other hand, it is important to take into account that confirmation of the localization status must be renewed on a regular basis. Registry entries are valid for 3–5 years, requiring companies to undergo the verification procedure periodically,” Baikal Communications Group emphasized.

In addition, manufacturers are required to submit annual reports on produced and marketed products no later than 1 April. Failure to comply may result in removal of the product from the register. At the same time, localization criteria themselves are subject to frequent revision, creating uncertainty and requiring flexibility in the modernization of production processes.

“It is crucial that the new system be implemented with maximum consideration of sector-specific factors. Market participants who were not involved in preliminary discussions now have the opportunity to submit their proposals before the close of the public consultation on 25 November. Broad involvement of interested stakeholders will help minimize business costs and enhance the effectiveness of integrating the new localization model,” Baikal Communications Group noted.

It bears recalling that a similar score-based localization confirmation system for the pharmaceutical sector will also enter into force on 1 January 2026. Its objective is to stimulate the expansion of the range of medicinal products manufactured within the Russian Federation and to support the technological development of companies.

More details are available in Pharmvestnik

[post_title] => Score-Based Localization Assessment to Be Introduced for a Number of Medical Devices [post_excerpt] => [post_status] => publish [comment_status] => closed [ping_status] => closed [post_password] => [post_name] => score-based-localization-assessment-to-be-introduced-for-a-number-of-medical-devices [to_ping] => [pinged] => [post_modified] => 2025-10-29 19:20:06 [post_modified_gmt] => 2025-10-29 16:20:06 [post_content_filtered] => [post_parent] => 0 [guid] => https://b-c-g.ru/?p=9422 [menu_order] => 0 [post_type] => post [post_mime_type] => [comment_count] => 0 [filter] => raw ) [4] => WP_Post Object ( [ID] => 9417 [post_author] => 6 [post_date] => 2025-10-28 14:53:10 [post_date_gmt] => 2025-10-28 11:53:10 [post_content] => Eduard Voytenko, Ph.D. in Political Science and Chief Executive Officer of Baikal Communications Group, delivered a presentation at the GR Seminar of the Center for Eurasian Cooperation entitled “Strategic Communications with Government Authorities: Practical Aspects of Interaction.”

In his address, “Effective Tools for Interaction with Government Bodies: How Businesses Can Strengthen Their Position within the Russian Institutional Environment,” Dr. Voytenko provided a detailed analysis of situations in which the need for Government Relations (GR) is particularly acute — including market entry, the creation or regulation of new industries, maintaining competitive market positions, removing barriers and excessive regulation, as well as operating under sanctions pressure and increased oversight of foreign investors.

Voytenko emphasized that modern GR activities extend far beyond communications with public officials and represent a comprehensive system of analytical and communication tools integrated into a company’s strategic management framework. Among the key internal GR instruments, he identified the monitoring of governmental initiatives, analysis of the political and regulatory environment, stakeholder mapping, development of GR strategies, and participation in rulemaking processes. External instruments include engagement within specialized platforms under governmental bodies, participation in business associations and development institutions, involvement in regulatory impact assessment (RIA) and legislative procedures, as well as the use of PR and event management tools.

Special attention was given to the role of media and digital instruments in GR. Voytenko noted that the media environment shapes the informational background that directly influences regulatory decisions. GR-related content, he stressed, must be concise, coherent, reflect the balance of interests between business and government, and be grounded in verified data. It is crucial that the business position be aligned with the state agenda and correlated with the goals and KPIs of public authorities.

In conclusion, Dr. Voytenko underscored that the government’s readiness for dialogue with business depends on mutual interest in minimizing managerial risks, improving the quality of public administration, and undertaking joint efforts to address strategic challenges — from localization and import substitution to intellectual property protection and the implementation of national projects.

Baikal Communications Group continues to foster a professional community in the field of GR and lobbying, sharing analytical and practical tools while promoting a culture of responsible and transparent interaction between business [post_title] => Eduard Voytenko Speaks at the GR Seminar of the Center for Eurasian Cooperation [post_excerpt] => [post_status] => publish [comment_status] => closed [ping_status] => closed [post_password] => [post_name] => eduard-voytenko-speaks-at-the-gr-seminar-of-the-center-for-eurasian-cooperation [to_ping] => [pinged] => [post_modified] => 2025-10-28 14:53:10 [post_modified_gmt] => 2025-10-28 11:53:10 [post_content_filtered] => [post_parent] => 0 [guid] => https://b-c-g.ru/?p=9417 [menu_order] => 0 [post_type] => post [post_mime_type] => [comment_count] => 0 [filter] => raw ) )

THE GOVERNMENT OF THE RUSSIAN FEDERATION HAS APPROVED THE RULES FOR ADDITIONAL FINANCING OF REGIONAL PROCUREMENT OF ORPHAN MEDICINAL PRODUCTS

According to Valery Afanasyev, Director for Government Relations and Regulatory Risk Assessment at Baikal Communications Group, the Resolution establishes two mandatory criteria. First, the level of calculated budgetary sufficiency must not exceed 0.65 — meaning the region must be classified as subsidized. As of 2024, there were thirty-one such regions in Russia. Second, the constituent entity of the Russian Federation must allocate at least ten percent more funds for financing the procurement of these medicinal products compared to the previous year. Among the optional additional criteria are either an increase in the cost of the medicinal products by no less than twenty percent or an increase in the number of patients in the region by no less than fifteen percent.

The Government of the Russian Federation has approved the rules and eligibility criteria for receiving additional federal co-financing for the procurement of high-cost orphan medicinal products. Resolution No. 1807 of 15 November 2025, signed by Prime Minister Mikhail Mishustin, will enter into force on 1 January 2026.

The regulatory act establishes a mechanism through which regional authorities may formally confirm that they are objectively unable to fulfill their obligations to provide medicinal support to patients with the diseases listed in Government Resolution No. 403 of 26 April 2012.

Applications for subsidies may be submitted annually by the heads of regional authorities from 1 August to 30 September. The Ministry of Health of the Russian Federation will review the applications within ten business days. In the event of a refusal — for example, due to non-compliance with the criteria or an incomplete set of documents — the region may resubmit the application.

According to Valery Afanasyev, after the adoption of Federal Law No. 252-FZ of 23 July 2025, a number of issues remained unresolved, particularly those related to the application procedure and the eligibility criteria for subsidies. The adopted Resolution clarifies that, to submit an application, a region must meet at least three criteria, two of which are mandatory.

More details are available in the Pharmvestnik report.

AGRICULTURAL MACHINERY EXPANDS ITS REACH: WILL ADDITIONAL SUPPORT MEASURES BOOST EXPORT SHIPMENTS ABROAD?

Vyacheslav Kharitonov, Regulatory Risk Assessment Practice Expert at Baikal Communications Group, notes that the key impediments to the growth of exports of domestically manufactured agricultural machinery continue to be unfavorable “rules of the game,” namely: the level of the Bank of Russia’s key interest rate, reductions in state support measures, as well as increased tariff and non-tariff pressure on agricultural exporters. According to him, declining profitability among agricultural producers and the weakening of domestic demand significantly restrict the export potential of agricultural machinery manufacturers, despite support measures enacted since 2017. At the same time, the stability of Russian manufacturers is primarily grounded in the domestic market, which accounts for the overwhelming majority of agricultural machinery sales. Read more…

BAIKAL COMMUNICATIONS GROUP PRESENTED A COP 30 OVERVIEW AT THE AMCHAM CONFERENCE

The joint conference of the American Chamber of Commerce in Russia and the Pacific–Eurasian Business Alliance was held on October 28, 2025, under the theme “Business Resilience – Societal Resilience.”

The event brought together representatives of international companies, the expert community, and civil society organizations to discuss sustainable development practices and the impact of the global ESG agenda on business processes.

Anastasia Tsvetkova, Partner for International Communications and CSR Practice at Baikal Communications Group and Chief Executive Officer of the “Lake Baikal” Foundation, participated in the conference. Within the session “Global Goals and Local Solutions: Sustainable Development on the Threshold of 2030,” she delivered a presentation titled “COP 2025: Key Themes and Expectations.”

During the discussion, Ms. Tsvetkova emphasized that COP 30 marks several significant milestones: 30 years of climate negotiations within the UNFCCC framework, the 20th anniversary of the Kyoto Protocol, and the 10th anniversary of the Paris Agreement. While COP 29 entered history as a financial summit, having resulted in an agreement on climate finance of at least USD 1.3 trillion per year by 2035, COP 30 is expected to be a turning point focused on resource allocation and the mechanisms for implementing the Global Goal on Adaptation (GGA).

From November 10 to 21, 2025, heads of state, scientists, non-governmental organizations, and civil society representatives will convene in Belém, Brazil, to develop measures to protect populations and ecosystems from the impacts of climate change and to establish transparent and equitable indicators for assessing progress on adaptation. The host country intends to pay particular attention to the ecosystem services of the Amazon, the development of the bioeconomy for mitigation and adaptation, and structural solutions to counter disinformation and climate change denial. Another important focus of COP 30 will be NDCs (Nationally Determined Contributions). Although NDCs are not negotiated directly at COP, Brazil anticipates that countries will present updated commitments aligned with the 1.5°C target.

In her remarks, Ms. Tsvetkova also addressed the role of water as a central element of climate solutions, highlighting the contribution of freshwater systems to achieving the Paris Agreement goals. The discussion underscored the importance of the Lake Baikal Foundation’s participation in the Water for Climate Pavilion at COP 30 and its role in preparing an expert session on inland freshwater ecosystems (lakes, rivers, wetlands), which serve as a point of synergy among the three Rio Conventions (UNFCCC, CBD, UNCCD) in biodiversity conservation, climate change mitigation, and sustainable land use development.

Baikal Communications Group continues to consistently advance its expertise in sustainable development and national strategic priorities, fostering a professional environment conducive to constructive dialogue among business, government, and society.

Score-Based Localization Assessment to Be Introduced for a Number of Medical Devices

The Ministry of Industry and Trade of the Russian Federation has proposed the introduction of a score-based system for assessing the level of production localization for certain medical devices and rehabilitation equipment. The corresponding draft government decree has been published for public consultation and concerns amendments to Government Resolution No. 719. The new rules provide for the allocation of scores to technological operations and materials, as well as the establishment of minimum annual localization thresholds. The system is expected to enter into force on 1 January 2026. Read more…

EEC to Update Pharmaceutical Registration Rules in the EAEU

As noted by Valery Afanasyev, Director of the GR and Regulatory Risk Assessment Practice at Baikal Communications Group, the amendments approved by the Eurasian Economic Commission (EEC) are aimed at harmonizing pharmaceutical registration procedures within the Eurasian Economic Union (EAEU) and enhancing transparency in regulatory processes.

“Applicants will have the opportunity to request the exclusion of confidential information from expert reports. Additionally, clear timelines and procedures for dossier review have been established, and document submission requirements have been standardized,” the expert emphasized.

The Board of the Eurasian Economic Commission (EEC) has approved the draft decision “On Amendments to the Rules for Registration and Expertise of Medicinal Products for Medical Use.” The directive No. 148 dated October 14, 2025, has been published on the EAEU legal portal.

The document aims to update the regulatory framework governing the circulation of medicinal products in the EAEU single market, including clarifications on the interaction between national competent authorities and expert organizations. The updated rules are expected to reduce the timelines for assessment of registration dossiers and strengthen trust between regulators and pharmaceutical market participants.

Further details are available in the article by Pharmvestnik

The Ministry of Health Establishes New Rules for Interaction Between Healthcare Professionals and Dietary Supplement Manufacturers

The Government of the Russian Federation has incorporated requirements related to the prescription of dietary supplements (DS) into the scope of state control (supervision). Resolution No. 1560 dated October 8, 2025, was published on the Legal Information Portal. Valery Afanasyev, Director of Regulatory Risk Assessment Practice at Baikal Communications Group, commented on the changes to Pharmvestnik. Read more…

The Ministry of Health Introduces New Requirements for Medical and Pharmaceutical Education

The Russian Ministry of Health has prepared a draft resolution requiring educational institutions that offer programs in medical and pharmaceutical specialties to obtain a mandatory conclusion from Roszdravnadzor (the Federal Service for Surveillance in Healthcare). The document establishes the procedure for issuing such conclusions, evaluation criteria, grounds for refusal, and regulates the electronic submission of applications through the State Services portal. Decisions on issuing conclusions must be made within 25 working days. The public discussion of the draft will continue until October 23, 2025, and the resolution is scheduled to take effect on March 1, 2026. Read more…

Eduard Voytenko conducted a training session on Government Relations and lobbying for the top management of “Soglasie” Insurance Company

Eduard Voytenko, PhD in Political Science and Chief Executive Officer of Baikal Communications Group, conducted a corporate training session for the senior management of the insurance company Soglasie. The event focused on contemporary approaches to Government Relations (GR) and lobbying practices within the Russian regulatory and institutional framework. Read more…

GR and Lobbying Training Program at Synergy

As part of the Executive MBA program of the Russian School of Management at Synergy Business School, Eduard Voytenko, PhD in Political Science and CEO of Baikal Communications Group, conducted a series of lectures on the topic “Government Relations (GR) and Lobbying in Russia. ”The educational sessions were included in the module “Strategic Business Communications: GR, PR, IR.” Read more…

The 3rd Corporate Government Relations Forum is rescheduled to February 5, 2026

Baikal Communications Group announces that The 3rd Corporate Government Relations Forum has been moved to February 5, 2026. This decision was made in response to requests from participants and speakers and establishes the forum as an annual event in early February. This timing allows the forum to be naturally integrated into the start of the business season and to provide a highly relevant agenda for the professional community. Read more…

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