FSI SID&GP | Cooperation issues in the pharmaceutical industry and healthcare system were discussed at the Russia-Africa Summit

Cooperation issues in the pharmaceutical industry and healthcare system were discussed at the Russia-Africa Summit

Vladislav Shestakov, Director of the FSI “State Institute of Drugs and Good Practices”, moderated the session dedicated to pharmaceutical industry issues, healthcare, and international platforms for regulatory cooperation.

Leaders of Russian regulators such as the Ministry of Health of Russia, the Ministry of Industry and Trade of Russia, Rospotrebnadzor, the Federal State Budgetary Institution “Scientific center for expert evaluation of medicinal products” under the Ministry of Health of Russia, as well as representatives of Russian and African businesses, professional, scientific and public organizations took part in the discussion.

Opening the session, Vladislav Shestakov noted that in the context of healthcare globalization, pharmaceutical supply, and geopolitical changes, the question of providing our countries with modern medical technologies, effective and safe medicines of high quality became increasingly important. In this regard, Russia can be an important and reliable partner for African countries.

Participants shared positive experience of the Russian medical and pharmaceutical industries, including the development of innovative and digital technologies, collaboration in the field of pharmaceutical production and distribution, localization and export of Russian pharmaceutical products to African countries, and the initiative to create an independent platform for cooperation in the field of international inspection.

“A window of opportunity for cooperation and convergence of regulatory approaches in healthcare, registration of medicines, and pharmaceutical supply, as well as the exchange of professional knowledge and accumulated practical experience, is opening now. Interaction between experts, regulators, and pharmaceutical companies from Russia and African countries will allow us to unite efforts, strengthen trust, develop common approaches in the regulation of medicines, and ensure proper practices for enhancing pharmaceutical safety.” said Vladislav Shestakov.

Deputy Minister of Health of the Russian Federation Sergey Glagolev shared the achievements of the Russian medical industry and the high technologies developed by the department. He emphasized that Russia is ready to develop cooperation in the field of localization and export of pharmaceutical products for infectious and non-infectious diseases, which have price advantages over Western manufacturers. He elaborated on original products in the biotechnology sector. The federal project “Science for Humans” funds the early-stage researches and the development of innovative molecules. Russia has successful experience in creating innovative vaccine platforms that have proven their effectiveness during the COVID-19 pandemic, Ebola fever, smallpox, influenza, and outbreaks of other diseases.

Head of the Federal Service for Supervision of Healthcare of the Russian Federation Alla Samoylova provided examples of successful work in the field of drug regulation, control, and supervision: “Implementation of preventive measures and inspections have led to significant effects. A system for marking pharmaceutical products has been introduced in Russia and it was very successful. It allows tracking products – in a preventive mode you can identify defects, track and review availability of medicines in different regions. Overall, in 3 years, the system has significantly reduced the distribution of substandard or unregistered pharmaceutical products.”

Advisor to the Minister of Industry and Trade of the Russian Federation Aleksey Alekhin elaborated on the development of the Russian pharmaceutical industry. This includes a significant increase in the production of the effective and safe pharmaceutical products of high quality that can be directed to the international market, including African countries. In order to support the local manufacturers the significant measures were taken at the state level. The aim is to expand and increase our own production, build up the technological competencies and specifically in the production of original drugs. There is a high-quality distribution system in Russia, and the new digital technologies are being actively developed, such as online pharmacies, a system for monitoring the movement of medicines and more. The strategic goals of the pharmaceutical industry up to 2030 in our country are the further production localization, development of the new original products, and meeting the needs of the healthcare system and patients.

Aleksey Alekhin: “Speaking about the strategy of Russia and African countries, it can be noted that they largely coincide. It is based on self-sufficiency in terms of drug safety. As the pandemic has shown, each country can provide itself with pharmaceutical products if it produces them itself. The African Development Bank has allocated 3 billion dollars to support the transfer of pharmaceutical industry technologies, localization of the production, improvement of logistics conditions, research, and development in areas of interest to African countries. Just like in Russia, our colleagues from African countries focused on harmonization in the field of quality control, as well as at the international level. It is extremely important. That is why the Ministry of Industry and Trade of Russia, together with the FBI “State Institute of Drugs and Good Practices” initiated the establishment of the Global Association of Pharmaceutical Inspectors (GAPI). This alliance is supposed to become an independent platform for all pharmaceutical inspectors, regardless of the level of their development. We propose to unite our efforts to exchange best practices, create joint regulatory standards in our community of open access on a non-discriminatory basis, and work together on a system of quality, production, distribution monitoring, and unified approaches in the field of proper practices that serve the interests of our people.”

Valentina Kosenko, Acting Director General of the Federal State Budgetary Institution “Scientific Center for Expertise of Medical Products” of the Ministry of Healthcare of the Russian Federation, provided successful examples of harmonizing Russian and international requirements for the expertise and registration of medicines, as well as the mechanisms of cooperation between experts from different countries. The speed at which a pharmaceutical product can enter the market depends on the harmonization of expertise requirements. Russia demonstrates a high level of harmonization from an administrative and scientific point of view. The harmonization system is in full compliance with the international ICH requirements; the EAEU countries have common rules and pharmacopoeia. Valentina Kosenko discussed the new digital platforms of the scientific center, which allow experts from different countries to communicate on topics related to drug registration, standardization, pharmacopeia article projects, quality control, and training programs.

Uleya Ebyssé Miliussiba Innocent Kagbara, Chair of the Education Committee of the National Assembly and Director of the African Institute for Business Research from the Republic of Togo, welcomed participants of the session. He called for the development of expert collaboration in the pharmaceutical industry and drug manufacturing, joint educational programs related to healthcare and pharmaceuticals.

The General Director of Scolaris Finance Sarl and Chairman of the Administrative Board of AYA Capital from the Republic of Mali, Aziati Komlavi Mawuko, shared the experience of educating African students in Russian universities.

Aziati Komlavi Mawuko: “In Mali, there are many individuals eager to receive education in Russia. I am delighted that at the level of heads of states, there is a focus on increasing the number of joint educational programs. It is interesting to establish collaboration between our universities. More African students will get the opportunity to receive high-quality education in Russia, return to their homeland, and develop the capacity of national health systems. We also have a strong interest in the expansion of Russian pharmaceutical companies’ businesses in Africa. Currently, medicines mainly come from India, China, and European countries. I would like to learn more about the list of medicinal products from Russia and their properties.”

As he concluded, representatives from the Federal State Budgetary Institution “Scientific Center for Expertise of Medical Products” of the Ministry of Healthcare of the Russian Federation presented him the State Register of Medicinal Products of the Russian Federation in English.

Director of the Research Center at the “GEROFARM” company Roman Dray, provided examples of localizing and registering domestic insulins in Africa – Algeria, Morocco, and other countries. He also discussed the requirements of local regulators and noted the importance of dialogue in order to harmonize requirements and facilitate the access of Russian drugs to the African market.

Concluding the session, Vladislav Shestakov highlighted the huge potential of cooperation in the field of regulatory interaction, conducting scientific conferences, Russian export, and educational programs for inspectors and young specialists.

The session with heads of Russian regulators and representatives from African countries was held in the framework of the “Healthy life forum 2023” as part of the business program of the Russia-Africa Summit. The summit concluded with the signing of declarations in which the countries agreed to expand cooperation in combating infectious diseases, including new ones, in the field of drug manufacturing, and in the establishment of a network of Russian-language education centers in Africa and the opening of branches of educational organizations from the Russian Federation.

Cooperation issues in the pharmaceutical industry and healthcare system were discussed at the Russia-Africa Summit

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