Drug Security in a Global Context: Intensifying Cooperation

Pharmaceuticals
Drug Security in a Global Context: Intensifying Cooperation
Photo: forumspb.com 18.06.2025 362

On June 18, Alexey Ivanov, Director of the BRICS Competition Centre, served as moderator of the session titled "Drug Security in a Global Context: Intensifying Cooperation", held as part of the Russian Ensuring Drug Security Forum at the St. Petersburg International Economic Forum (SPIEF) 2025.

The pharmaceutical industry has historically evolved through global collaboration. Even during periods of serious geopolitical tension, international exchanges of technology continued, along with joint research and vaccine development. A striking example of this was the COVID-19 pandemic, which clearly demonstrated the importance of international cooperation in addressing global health threats, noted Alexey Ivanov. He invited participants to discuss the issue of pharmaceutical security specifically within an international context.

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Valentina Kosenko, Acting General Director, Scientific Centre for Expert Evaluation of Medicinal Products of the Ministry of Health of the Russian Federation, spoke about ways to improve access to essential medicines for patients in Russia and other developing countries. According to her, the key areas of focus include the harmonization of requirements for drug registration and evaluation, as well as the mutual recognition of certain studies and procedures involved in the registration process.

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She cited examples of harmonization efforts within the Cooperation Council for the Arab States of the Gulf, the East African Community, and the Economic Community of West African States (ECOWAS). For Russia, Ms. Kosenko highlighted the Eurasian Economic Union (EAEU) as the most effective platform for such work. She noted that within the EAEU, efforts are underway to align pharmacopoeial monographs—documents outlining drug quality control methods—with those of the Pharmacopoeial Discussion Group (PDG), which includes the EU, the United States, Japan, and India.

“There is a need to align regulatory requirements not only within the EAEU, but also with other foreign countries, as our pharmaceutical industry is already entering new markets,”

the speaker emphasized.

Ye Myint, Director General, Department for Control of Food and Drugs, Ministry of Health of the Republic of the Union of Myanmar, highlighted the specifics of drug registration harmonization within ASEAN and the Chinese Belt and Road Initiative. According to him, despite language barriers, the process runs smoothly due to adherence to international ACCD (ASEAN Common Clinical Data) standards, which cover both administrative and manufacturing aspects. The use of English in documentation simplifies the alignment of requirements and enhances collaboration, he noted.

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Myanmar is exempt from the TRIPS agreement until 2034, creating favorable conditions for investment in generic drug manufacturing from Russia and BRICS+ countries. Companies from Bangladesh, Nepal, and Cambodia are already actively investing in the country. Mr. Ye Myint emphasized that Myanmar sees Russia as a promising partner for the supply and joint production of generics, as well as modern anticancer and radiopharmaceutical products.

Russian pharmaceutical companies continue to integrate into the global pharmaceutical community despite the challenges of the past three years. Mikhail Tsyferov, President, Petrovax Pharm, shared that the company’s exports amounted to approximately 2.3 billion rubles in 2024, with a target of 3 billion rubles for the current year — representing around 20% of total sales. The main export markets are EAEU countries, although the company also continues shipments to Europe. Cooperation with international partners on the import of medicines and technologies remains ongoing.

“In the next 5 to 7 years, we aim to move beyond the role of a simple recipient of technologies or seller of medicines toward full-fledged partnerships, where the country’s involvement will deepen and where we’ll be able to give an additional boost to the development of our scientific base,” 

said Mr. Tsyferov.

According to a survey conducted by the Association of European Businesses (AEB), more than 150 new medicines have been introduced to the Russian market over the past three years, reported AEB Chief Executive Officer Tadzio Schilling. He emphasized the importance of fostering cooperation aimed at accelerating and simplifying the entry of innovative drugs into the Russian market.

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In his view, it is essential to maintain the current intellectual property rights protection framework and ensure a transparent mechanism for including new medicines in the list of Vital and Essential Drugs (VED). Furthermore, he stressed that government funding programs should prioritize medicines that combine innovation with economic feasibility, particularly in the context of public procurement.

The AEB also plans to hold a roundtable dedicated to studying BRICS countries' experiences in improving access to innovative pharmaceuticals.

In the context of pharmaceutical security, providing Russian patients with access to innovative medicines is more important than organizing local production, according to Anatoliy Klimenkov, Deputy General Director for Strategic Interaction with Government Authorities and Healthcare Development, Roche Moscow JSC. He emphasized the need to consider companies’ ECG-ratings (business reputation indices) when making decisions about including drugs in the list of Vital and Essential Drugs (VED) or issuing compulsory licenses.

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“If a company makes a significant social contribution to the lives of patients, society, and the state, then the issue of license transfer should, in our view, be considered in a special way — with due regard for the company's ECG-rating,” 

Mr. Klimenkov stated.

Russia must ensure its own independence in pharmaceutical supply, stated Alexander Sumin, Executive Secretary, Expert Council on the Circulation of Medicines, Development of the Pharmaceutical and Medical Industry of the State Duma of the Federal Assembly of the Russian Federation on Health Protection. To achieve this, the country has built a flexible system capable of making unconventional decisions without compromising patient safety, he emphasized.

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Mr. Sumin noted that the discussion on pharmaceutical security has also commenced within the BRICS framework — an essential alliance that shares values close to Russia’s and offers opportunities for cooperation, access to new markets, and unification of manufacturers and scientific platforms.

“We are in dialogue with regulators from BRICS countries and recognize the need to align regulatory practices,” he said. “Moreover, it is necessary to establish a system for identifying the demand for specific medicines within the group. This will enable the development of a unified pharmaceutical security strategy for BRICS countries.”

The work described within the Health Protection Committee is inherently competitive in nature, addressing the issue of how to remove barriers to market entry, noted Alexey Ivanov. Meanwhile, the BRICS Competition Law and Policy Centre, in cooperation with the BRICS Working Group for the Research of Competition Issues in Pharmaceutical Markets, is conducting a comparative analysis of procedures for introducing biosimilars of innovative biopharmaceuticals to the markets of the BRICS countries, he explained.

“There are different approaches worldwide to bringing these drugs to market. In the upcoming report, we have gathered key ideas on how to accelerate this process from the perspective of antitrust policy. It would be beneficial if the Ministry of Health and pharmaceutical companies joined our efforts,” 

said the director of the BRICS Centre.

At the conclusion of the session, meeting participants agreed on the need to develop cooperation both between companies and between regulatory authorities of different countries and responded to questions from the audience.

The ‘Ensuring Drug Security’ Russian Pharmaceutical Forum traditionally takes place on the opening day of the of the St. Petersburg International Economic Forum. The Drug Security Forum is a leading industry platform and a meeting place for pharmaceutical and medical companies and opinion leaders on drug supply issues. The Forum continues to focus on such issues as continuous drug supply tools and ways to develop the drug policy regulation system, pricing, and import substitution policy for drugs.

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