On June 5, Alexey Ivanov, Director of the International BRICS Competition Law and Policy Centre, moderated the session themed "Drug Security in BRICS Countries" within the framework of the Ensuring Drug Security Forum timed to coincide with the start of the St. Petersburg International Economic Forum.
Enhancing cooperation between the BRICS member countries is one of the priority tasks for today, Alexey Ivanov said. Cooperation has already been established between the BRICS partner countries on the antimonopoly track, discussing, among other issues, access to medicines, improving the quality of healthcare and expanding opportunities for market economy in this area.
“We hope that cooperation between the relevant ministries, experts and business will also be fruitful in the healthcare sector,”
Ivanov said. He invited the participants of the session to discuss the key issues of cooperation between the BRICS countries in the field of healthcare, joint development of medicines and development of cooperation in this sphere.
The population of the BRICS countries accounts for more than 40% of the world's population. Some of the alliance member countries have high competencies in the field of pharmaceuticals, drug development and production, including high-tech drugs and biosimilars, said Mikhail Murashko, Minister of Health of the Russian Federation. Given the scale and potential of BRICS, the tasks of cooperation in research and production, as well as the development of a common position to promote their own products and optimize regulatory procedures when bringing drugs to the market are of particular importance. One of the steps to strengthen cooperation should be the establishment of the BRICS Medical Products Regulators Association.
“It is no secret that regulatory mechanisms can be used for non-competitive struggle, for limiting the availability of certain products. Therefore, defending our interests and promoting our own high standards of product quality is a priority for us,”
emphasized the Head of the Ministry of Health. BRICS countries were the first to actively participate in the formation of new regulatory approaches to accelerate the introduction of biosimilars on the market, and now they are discussing the synchronization of procedures for their registration, added Murashko.
Daniel Pereira, Director, Brazilian Health Regulatory Agency (Anvisa), spoke about the challenges for the development of the pharmaceutical industry in Brazil. According to him, the agency is considering a possible exchange of data on drug development with Russia. This issue will be discussed in more detail next year, when Brazil assumes the BRICS presidency.
The BRICS partnership is critically important for Russia, especially in view of the task to increase exports of Russian medicines formulated in the Pharma-2030 strategy, emphasized Ekaterina Priezzheva, Deputy Minister of Industry and Trade of the Russian Federation. Currently, Russian medicines are supplied to more than 150 countries of the world. The demand for them, including from BRICS countries, continues to grow. In 2023, the amount of pharmaceutical products supplied from Russia to the BRICS countries amounted to more than $15 mln. At the same time, during the same period, the BRICS countries supplied Russia with products worth almost $800 mln.
“It is impossible not to note such a trade imbalance of 53 times. According to the Pharma-2030 strategy, we need to at least 2.5 times increase exports by 2030. We are ready to offer our BRICS partners Russian products - generics, biosimilars, original medicines necessary for the treatment of oncological, autoimmune and orphan diseases”.
An important area of work with the BRICS countries is the expansion of cooperation on the convergence and harmonization of regulatory approaches in the field of pharmaceutical products. First of all, it concerns the establishment of common approaches to the rules of production and registration procedures. There is already experience of cooperation in this area with Saudi Arabia and the United Arab Emirates, with whom the possibility of mutual recognition of GMP certificates and cooperation in training of inspectors is being discussed.
Tatyana Yakovleva, First Deputy Head, Federal Medical-Biological Agency of the Russian Federation (FMBA Russia), discussed the establishment of technology transfer in the pharmaceutical sector and the link between science and industrial production. The development of biomedicine in Russia should be carried out through a cluster approach, with close interaction between researchers, drug developers, manufacturers and medical staff. This model helps to reduce the timeframe for innovative developments. The FMBA already has experience of working with BRICS, Central and Latin American countries.
“To date, we have received approval for the delivery of the coronavirus vaccine “Convasel”, noted the speaker. “This is a new generation vaccine, it is already undergoing the third and final phase of clinical trials. It has 85% efficacy, after 60 years - 92%. According to internal monitoring, more than 265 thousand people have been vaccinated, and less than 1% of them got sick.”
Irina Panarina, General Manager, AstraZeneca Russia and Eurasia, noted the success of BRICS countries in developing innovative medicines. Efforts to create a favorable environment for innovation play an important role here. For example, in 2021, China created a patent registry, which served as a catalyst for the development of innovation.
“The portfolio of breakthrough drugs in our company more than half consists precisely of solutions that we bought and are finalizing in China and in some other BRICS countries,”
Panarina said.
Evgeniya Shapiro, Director General, PSK Pharma, noted that the role of BRICS is also increasing in solving the specialist issue in Russia. Highly qualified specialists from BRICS countries help develop R&D in the pharmaceutical sector, launch new production facilities and train personnel.
The issue of competition development is closely linked to the issue of drug safety. The issues of ensuring access to medicines, creating conditions for inclusive technology development, and combating the abuse of patent rights are discussed within the BRICS Working Group on Pharmaceutical Markets. The International BRICS Competition Law and Policy Center provides expert support to regulators and helps them to share best practices, emphasized Alexandre Cordeiro Macedo, President, Administrative Council for Economic Defense of the Federative Republic of Brazil (CADE). He believes that BRICS drug safety cannot be ensured without a well-functioning cooperation.
At the end of the meeting, Aleksandr Petrov, Deputy, member of the State Duma Committee on Health Protection of the Federal Assembly of the Russian Federation, noted that amid geopolitical turbulence, ensuring drug security in the BRICS countries is a matter of strategic importance. The countries of the association can reproduce the most complex medicines and, if necessary, apply the mechanism of compulsory licensing.
“We respect patent law. But if the lives and health of our citizens and our allies are threatened, we will violate this law. It is important to us, but it is not an absolute.”
BRICS can become the strategic force that will change the architecture of the world economy, Petrov believes.
“In fact, today we are agreeing on drug safety on almost half of the globe. Maybe this is the first step with which the big road begins,”
he concluded.
The Drug Security Forum is an annual flagship event that best reflects the current agenda of the drug supply sector and combines the efforts of the government, business, and the public in order to determine the trajectory of the industry’s development.
Forum is regarded as a leading industry platform and a meeting place for pharmaceutical and medical companies as well as opinion leaders to discuss drug supply issues.
In 2024, the event will be attended by official delegations from BRICS countries. The Forum will include the BRICS Drug Regulatory Authorities meeting.
